Ultrasonic probe, device and kit for easy assembly

Abstract

The ultrasonic probe comprises a connecting tube, which comprises a main pipe section with a side wall provided with a working hole and a secondary pipe section arranged in parallel with the main pipe section; the tip end portion comprises a connecting section provided with a first channel and an extension section arranged in parallel with the connecting section in sequence, the first channel is communicated with the side wall and the proximal end surface of the connecting section, the side wall of the extension section is provided with an acoustic window, the acoustic window is arranged on the same side of the distal end of the first channel; the extension section is inserted into the connecting tube through the proximal end of the main pipe section, the connecting section is blocked in the main pipe section under the limiting action of the connection between the main pipe section and the secondary pipe section, the distal end of the first channel is aligned with and communicated with the working hole, the acoustic window is sequentially extended to the outside through the secondary pipe section, and the acoustic window is arranged on the same side of the working hole; a pipeline assembly is inserted into the proximal end of the main pipe section, a channel port at the distal end surface of the pipeline assembly is connected with a channel port at the proximal end surface of the tip end portion, the pipeline assembly is limited to rotate in the connecting tube, and the distal end of a second channel provided in the pipeline assembly is connected with the proximal end of the first channel.

Description

Technical Field

[0001] This application relates to the field of ultrasonic puncture technology, specifically to ultrasonic probes, ultrasonic devices, and medical ultrasonic puncture kits with puncture functions. Background Technology

[0002] Ultrasound tubing is an important tool for diagnosing lesions in the body's natural cavities. However, for the body's ultra-thin natural cavities, such as the bronchi, ureters, pancreatic and bile ducts, the outer diameter of current ultrasound endoscopes with operating channels exceeds 6 mm, making it impossible to enter these ultra-thin natural cavities.

[0003] An ultrasonic probe consists of a tip and a multi-lumen tube connected to the tip. Because the multi-lumen tube and the tip have different functional requirements—for example, the multi-lumen tube needs to provide a channel for the cable connecting to the ultrasonic transducer at the tip, and it needs to be flexible enough to pass through the body's natural cavities—while the tip needs to have a certain degree of rigidity to prevent deformation of the acoustic window for ultrasonic waves, which could alter the propagation path—the multi-lumen tube and the tip must be manufactured separately due to factors such as materials and molding methods, and then connected. Multi-lumen tubes are often produced using extrusion molding, and they only have axially extending channels; it is difficult to process complex shapes radially.

[0004] Because ultrasonic probes need to be manufactured with small outer diameters to pass through the ultra-thin natural cavities of the human body, the multi-lumen tube and tip of the ultrasonic probe need to have small outer diameters. If the tip and the multi-lumen tube are directly connected, the connection area is small, and it is difficult to guarantee the connection strength and accuracy. Therefore, an additional connecting device is needed to ensure a smooth connection between the tip and the multi-lumen tube. Existing connecting devices are mostly used in large-diameter ultrasonic probes to achieve a detachable connection between the tip and the multi-lumen tube, and to allow for the disinfection and reuse of the tip and the multi-lumen tube. However, such connecting devices are large in size and complex to assemble, and are not suitable for use on small-diameter ultrasonic probes.

[0005] Furthermore, for different diseases, devices such as puncture needles and ablation needles need to be used in conjunction with ultrasound devices. However, due to the small inner diameter of the human body's ultra-fine natural cavities, the ultrasound device may not be able to pass through the human body's ultra-fine natural cavities in parallel with the puncture device. Even if it reaches the target area, the space inside the natural cavity cannot provide enough space for the puncture device to turn. This causes the puncture device, which originally extends along the axis of the human body's natural cavity, to deviate along the radial direction of the natural cavity towards the scanning area established by the ultrasound device, and to perform puncture operations on tissues far away within the scanning area. Summary of the Invention

[0006] In order to enable safe and efficient puncture operations while performing ultrasound scanning in ultra-fine natural cavities, and to reduce the assembly difficulty of small-diameter ultrasound devices, this application provides an easy-to-assemble ultrasound probe, device, and kit, specifically an ultrasound probe with puncture function, an ultrasound device with puncture function, and a medical ultrasound puncture kit.

[0007] An ultrasound probe with puncture function includes a tubing assembly, a connecting tube, and a tip with an acoustic window. The connecting tube, along its proximal to distal direction, sequentially includes a main tube section with a working hole on its sidewall and a secondary tube section offset parallel to the main tube section. The tip, along its proximal to distal direction, sequentially includes a connecting section with a first channel and an extension section offset parallel to the connecting section. The proximal end of the first channel communicates with the proximal end face of the connecting section, and the distal end communicates with the sidewall of the connecting section. The sidewall of the extension section has an acoustic window for ultrasound waves to pass through, and the acoustic window communicates with the first channel. The distal end is set on the same side; the protruding section is inserted into the connecting pipe through the proximal end of the main pipe section. The connecting section is blocked in the main pipe section by the limiting action at the connection between the main pipe section and the auxiliary pipe section. The distal end of the first channel is aligned with and connected to the working hole. The protruding section extends to the outside through the main pipe section and the auxiliary pipe section in sequence. The sound window is set on the same side as the working hole. The pipeline assembly is inserted into the proximal end of the main pipe section. The channel opening provided at the distal end face of the pipeline assembly is connected to the channel opening provided at the proximal end face of the tip end, restricting the rotation of the pipeline assembly in the connecting pipe. The distal end of the second channel provided in the pipeline assembly is connected to the proximal end of the first channel.

[0008] The connecting pipe adopts a parallel off-axis setting for the main pipe section and the auxiliary pipe section. With the structural design of the connecting section and the extension section with the parallel off-axis setting, the extension section is inserted into the connecting pipe from the proximal end of the main pipe section and extends from the far end of the auxiliary pipe section. This can prevent relative rotation between the connecting pipe and the tip end, and achieve circumferential limiting between the connecting pipe and the tip end. Under the limiting effect at the connection between the main pipe section and the auxiliary pipe section, the connecting section is blocked by the main pipe section, and the axial limiting between the connecting pipe and the tip end is achieved. The inner diameter of the main pipe section can be equal to the outer diameter of the connecting section, thereby achieving radial limiting between the connecting pipe and the tip end, and thus ensuring accurate connection between the connecting pipe and the tip end. Subsequently, the tubing assembly is inserted into the proximal end of the main pipe section. The channel opening at the distal end face of the tubing assembly connects with the channel opening at the proximal end face of the tip end, restricting the rotation of the tubing assembly within the connecting pipe. This achieves axial and circumferential positioning between the tubing assembly and the connecting pipe. The outer diameter of the tubing assembly is equal to the inner diameter of the main pipe section, achieving radial positioning between the tubing assembly and the connecting pipe. This ensures accurate connection between the tubing assembly and the connecting pipe, achieving accurate connection between the tubing assembly, the connecting pipe, and the tip end. The cable passes through a channel within the tubing assembly to supply power to the ultrasonic transducer at the tip end. The ultrasonic waves generated by the ultrasonic transducer enter the external environment through the acoustic window to establish a scanning area. The working needle can enter the scanning area established by the ultrasonic waves through the acoustic window via the second channel, the first channel, and the working hole.

[0009] This off-axis layout optimizes the internal spatial distribution, avoiding interference between functional channels and achieving spatial separation between the ultrasound scanning and puncture paths, thus improving imaging quality and puncture safety. Furthermore, the parallel off-axis approach achieves axial, radial, and circumferential positioning of the probe tip and connecting tube, eliminating the need for complex structures within the connecting tube and probe tip, reducing the manufacturing difficulty of small-diameter ultrasound probes. This positioning method does not require a large space, and while achieving accurate positioning, it helps reduce the outer diameter of the ultrasound probe composed of connecting tubes and probe tip components, facilitating the passage of the ultrasound probe through the body's fine natural cavities.

[0010] Furthermore, the first channel has a certain degree of rigidity, providing support for the working needle during puncture.

[0011] In one embodiment of this application, the tip end is provided with a first liquid passage capable of exchanging liquid with a liquid bladder sleeved on the tip end. The distal end of the first liquid passage is connected to the outer wall of the protruding section, and the proximal end faces outward along the axial direction of the tip end. The pipeline assembly is provided with a second liquid passage, and the distal end of the second liquid passage is connected to the proximal end of the first liquid passage. The tip end is provided with two first liquid passages symmetrically arranged about the longitudinal section of the tip end where the acoustic window is located. The pipeline assembly is provided with two second liquid passages respectively connected to the two first liquid passages.

[0012] In one embodiment of this application, the outer wall of the protruding section is further provided with a liquid-passing long groove that communicates with the far end of the first liquid path and is capable of exchanging liquid with the liquid bladder. The liquid-passing long groove is located in the area outside the acoustic window and has an extension direction parallel to the axial direction of the protruding section.

[0013] In one embodiment of this application, the outer diameter of the protruding section is smaller than the inner diameter of the secondary pipe section, and an installation space is formed between the outer wall of the protruding section and the inner wall of the secondary pipe section to compress and fix the liquid bladder.

[0014] In one embodiment of this application, the connecting pipe further includes a bent section whose axis can be bent. The bent section is located at the proximal end of the main pipe section and is coaxially arranged with the main pipe section. The distal end of the pipe assembly is inserted into the main pipe section through the proximal end of the bent section.

[0015] The bend increases the connection area between the connecting tube and the tubing assembly, which helps to improve the connection strength between the two. Furthermore, the axis of the bend can bend with the tubing assembly. The connecting tube adopts a rigid structure, but its proximal end is provided with a bendable section, which not only ensures the rigid guidance of the ultrasound probe and the support of the connecting tube, but also gives the proximal end of the connecting tube a certain degree of flexibility, so that the ultrasound probe has good compliance when passing through the curved cavities of the human body.

[0016] An ultrasound device with puncture function includes any of the aforementioned ultrasound probes with puncture function and a fixed base; an ultrasound unit including a tip, a connecting tube, a tubing assembly, an ultrasound transducer disposed in the tip, and a first operating element connected to the proximal end of the tubing assembly. The ultrasound transducer can emit ultrasound waves to the outside through an acoustic window to establish a scanning area in the outside. The first operating element is connected to the fixed base and is movably disposed along the axial direction of the fixed base. The ultrasound unit also has an instrument channel, which includes a first channel and a second channel; and a puncture unit including a working needle, a second operating element, and a connector disposed along the instrument channel, connecting the second operating element and the working needle. The second operating element is connected to the first operating element and is movably disposed along the axial direction of the first operating element, so as to drive the working needle in the instrument channel through the working hole into the scanning area or return to the instrument channel in the scanning area via the connector.

[0017] The operator can fix the mounting base to a device, such as an endoscope, and then use the first operating element to move relative to the mounting base along the axial direction of the mounting base to slowly push the ultrasound probe toward the target area. Then, using the second operating element to move relative to the first operating element along the axial direction of the first operating element, the operator can slowly push the working needle into or out of the scanning area. Thus, through the small outer diameter ultrasound probe, the operator can stably perform puncture operations in the ultra-fine natural cavities of the human body under ultrasound guidance, reducing the possibility of damage to the natural cavities during the operation.

[0018] In one embodiment of this application, the ultrasound device with puncture function further includes a negative pressure unit; both the working needle and the connector are provided with hollow channels; the negative pressure unit is connected to the proximal end of the connector and is connected to the working needle through the connector.

[0019] The working needle is inserted into the target area through the instrument channel and working hole. The negative pressure unit works to generate negative pressure at the distal end of the working needle, which draws the sample generated during the puncture into the hollow channel between the working needle and the connector.

[0020] In one embodiment of this application, the ultrasound device with puncture function further includes a piercing needle; the negative pressure unit is detachably connected to the proximal end of the connector; after the negative pressure unit is disconnected from the proximal end of the connector, the piercing needle can be inserted into the connector through the proximal end of the connector, and enter the outside through the hollow channel between the connector and the working needle at the distal end of the working needle.

[0021] The negative pressure generated by the negative pressure unit draws the sample through the distal end of the working needle into the hollow channel between the working needle and the connector. To allow passage through the ultra-fine natural cavities of the human body, the diameter of the tubing assembly in this application is small, and the inner diameter of the working needle and connector moving within the instrument channel is also small, making it difficult to remove the sample from the hollow channel between the working needle and connector. To collect as much sample as possible, a through-needle is inserted into the connector proximal to the connector, and then enters the external environment through the hollow channel between the connector and the working needle at the distal end of the working needle. This allows the through-needle to push the sample out from the distal end of the working needle, facilitating sample collection by medical personnel at the distal end of the working needle.

[0022] In one embodiment of this application, the working needle is elastic and is arc-shaped when in its natural state; as the working needle gradually enters the outside world through the working hole, it gradually returns to its natural state in the plane defined by the working hole and the far end of the instrument channel, and the working needle gradually bends away from the axis of the connecting tube.

[0023] In one embodiment of this application, the ultrasonic device with puncture function further includes two locking bolts; one locking bolt is threadedly connected to one of the fixed seat and the first operating member, and the end of the locking bolt can abut against the side wall of the other, restricting the movement of the first operating member relative to the fixed seat in the axial direction; the other locking bolt is threadedly connected to one of the first operating member and the second operating member, and the end of the locking bolt can abut against the side wall of the other, restricting the movement of the second operating member relative to the first operating member in the axial direction.

[0024] The two locking bolts are used to limit the axial movement of the first operating member relative to the fixed seat and the axial movement of the second operating member relative to the first operating member, respectively. They can selectively fix the axial position of each component as needed during operation, thereby improving the accuracy and stability of puncture.

[0025] In one embodiment of this application, the fixed base or the first operating member is provided with a length scale along the axial direction to indicate the position of the first operating member relative to the fixed base; the first operating member or the second operating member is provided with a length scale along the axial direction to indicate the position of the second operating member relative to the first operating member.

[0026] During the procedure, doctors can accurately determine the distance the first operating piece moves relative to the fixed seat and the distance the second operating piece moves relative to the first operating piece based on the length scale, thereby precisely controlling the operation and ensuring the treatment effect.

[0027] A medical ultrasonic puncture kit includes any of the aforementioned ultrasonic devices with puncture function, and also includes an endoscope device. The ultrasonic unit includes an ultrasonic probe comprising a tip, a connecting tube, a tubing assembly, and an ultrasonic transducer disposed within the tip. The endoscope device includes a connecting cylinder for inserting the ultrasonic probe, and a first limiting portion is provided on the side wall of the connecting cylinder. A fixing base is provided with a connecting hole along its axial direction for inserting the connecting cylinder. The fixing base is slidably connected to a second limiting portion, which can move radially along the connecting hole between a locked position and an unlocked position. When the connecting cylinder enters the connecting hole, the second limiting portion can reach the locked position and connect with the first limiting portion, restricting the connecting cylinder from moving relative to the fixing base along the axial direction of the fixing base. When the second limiting portion moves from the locked position to the unlocked position, the second limiting portion disconnects from the first limiting portion, and the connecting cylinder can disengage from the connecting hole along the axial direction of the fixing base.

[0028] The fixed base has a connecting hole along its axial direction for inserting the connecting tube. The fixed base is slidably connected to a second limiting part, which can move between a locked position and an unlocked position along the radial direction of the connecting hole. When the connecting tube enters the connecting hole, the second limiting part can reach the locked position and connect with the first limiting part, restricting the movement of the connecting tube relative to the fixed base along the axial direction of the fixed base, thereby installing the ultrasound device onto the endoscope device. When the second limiting part moves from the locked position to the unlocked position, the second limiting part disconnects from the first limiting part, and the connecting tube can disengage from the connecting hole along the axial direction of the fixed base, thereby separating the ultrasound device from the endoscope device. Attached Figure Description

[0029] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0030] Figure 1 This is a schematic structural diagram of one embodiment of the ultrasonic probe in this application;

[0031] Figure 2 This is a schematic diagram illustrating one embodiment of the main pipe section and the auxiliary pipe section in this application;

[0032] Figure 3 This is a schematic structural diagram illustrating one embodiment of the connecting segment and the extending segment in this application;

[0033] Figure 4 This is a schematic diagram of one embodiment of the two first liquid channels in this application;

[0034] Figure 5This is a schematic structural diagram of one embodiment of the piping assembly in this application;

[0035] Figure 6 This is a schematic diagram illustrating one embodiment of the scanning area in this application;

[0036] Figure 7 This is a schematic diagram of one embodiment of the connection tube when the tip of the liquid-filled bladder is inserted into the tube in this application;

[0037] Figure 8 This is a schematic diagram of a possible embodiment of the pipe assembly inserted into the bend section in this application;

[0038] Figure 9 This is a schematic diagram illustrating one embodiment of the installation space in this application;

[0039] Figure 10 This is a schematic structural diagram of one embodiment of the secondary tube section and the extended section clamping the liquid bladder in this application;

[0040] Figure 11 This is a schematic structural diagram of one embodiment of the ultrasonic unit in this application;

[0041] Figure 12 This is a schematic structural diagram of one embodiment of the fixing seat in this application;

[0042] Figure 13 This is a schematic diagram of a possible embodiment of the first limiting part and the second limiting part in this application when they are about to be connected;

[0043] Figure 14 This is a schematic structural diagram of one embodiment in which both the fixed base and the second operating component of this application are provided with locking bolts;

[0044] Figure 15 This is a schematic structural diagram of one embodiment of the first operating member inserted into the fixing seat and the second operating member in this application;

[0045] Figure 16 This is a schematic diagram of one embodiment of the working needle in this application when it is arc-shaped;

[0046] Figure 17 This is a schematic diagram of one embodiment of the present application where the needle is inserted into the connector and the working needle;

[0047] Figure 18 This is a schematic diagram of a pipeline assembly in which the second channel can be inserted into the first channel and the second liquid path can be inserted into the first liquid path.

[0048] Figure 19 This is a schematic diagram of a pipe assembly comprising an outer pipe and a thin tube disposed inside the outer pipe.

[0049] Label Explanation:

[0050] 100. Mounting base; 101. First operating component; 102. Second operating component; 103. Locking bolt; 104. Length scale; 105. Shut-off valve; 106. Syringe; 107. Cable; 108. Fluid interface; 109. First mating part; 110. Second mating part; 111. Fluid bladder; 112. Scanning area;

[0051] 200. Tip section; 201. Connecting section; 202. Extending section; 203. Receiving channel; 204. Ultrasonic transducer; 205. First liquid passage; 206. Liquid passage trough; 207. Acoustic window; 208. First channel; 209. Installation space; 210. Guide wall; 211. Liquid passage pipe;

[0052] 300. Connecting pipe; 301. Main pipe section; 302. Secondary pipe section; 303. Bend section; 304. Working hole; 305. Long bend hole;

[0053] 400. Piping assembly; 401. Second channel; 402. Second fluid circuit; 403. Cable channel; 404. Outer pipe;

[0054] 500. Working needle; 501. Connector; 502. Through needle; 503. Sample;

[0055] 600, Connecting cylinder; 601, First limiting part; 602, Second limiting part. Detailed Implementation

[0056] To provide a clearer understanding of the technical features, objectives, and effects of this application, specific embodiments of this application are now described with reference to the accompanying drawings. In the drawings, the same reference numerals indicate components with the same or similar structures but the same function.

[0057] In this document, “illustrative” means “serving as an example, illustration or description”, and any illustration or implementation described herein as “illustrative” should not be construed as a more preferred or advantageous technical solution.

[0058] To keep the drawings concise, only the parts relevant to this application are shown schematically in each drawing, and they do not represent the actual structure of the product. In addition, to make the drawings concise and easy to understand, in some drawings, only one of the components with the same structure or function is shown schematically, or only one of them is labeled.

[0059] In this application, "distal" refers to the end of the medical device that is closer to the patient during operation, and "proximal" refers to the end of the medical device that is closer to the operator.

[0060] Please see Figures 1 to 19 Learn more about this application.

[0061] See Figure 1 The ultrasonic probe with puncture function includes a tubing assembly 400, a connecting tube 300, and a tip 200 with an acoustic window 207. In order for the ultrasonic probe of the ultrasonic device to pass smoothly through the ultra-fine natural cavities of the human body, the cross-sectional shape of the ultrasonic probe should be as circular as possible. Furthermore, due to the small outer diameter of the ultrasonic probe, for ease of production, the tip 200, connecting tube 300, and tip 200 of the ultrasonic probe are cylindrical.

[0062] The connecting pipe 300, in the direction from its proximal end to its distal end, sequentially includes a main pipe section 301 with a working hole 304 on its sidewall and a secondary pipe section 302 disposed parallel and off-axis to the main pipe section 301. See [link / reference] Figure 2 The axis a of the main pipe section 301 is not coaxial with the axis b of the auxiliary pipe section 302.

[0063] The tip portion 200, pointing from its proximal end to its distal end, sequentially includes a connecting section 201 with a first channel 208 and an extending section 202 disposed off-axis parallel to the connecting section 201. (See also...) Figure 3 The axis c of connecting section 201 is not coaxial with the axis d of extending section 202. See also Figure 4 The proximal end of the first channel 208 is connected to the proximal end face of the connecting section 201, and the distal end is connected to the side wall of the connecting section 201. The side wall of the protruding section 202 is provided with an acoustic window 207 for ultrasonic waves to pass through. The acoustic window 207 is located on the same side as the distal end of the first channel 208, both on the same side of the tip end 200. The tip end 200 is provided with a receiving channel 203 for accommodating the ultrasonic transducer 204. After the piezoelectric element of the ultrasonic transducer 204 is energized, it emits ultrasonic waves to the outside through the acoustic window 207. Then, the ultrasonic transducer 204 enters the receiving state and receives the ultrasonic echo, thereby establishing a scanning area 112 in the outside. The reflected ultrasonic waves act on the piezoelectric element of the ultrasonic transducer 204, causing it to vibrate slightly. The piezoelectric element converts the vibration into an electrical signal. After receiving the electrical signal, the host establishes an ultrasonic image based on the electrical signal.

[0064] See Figure 5The conduit assembly 400 has a cable channel 403 along its axial direction through which the cable 107 supplying power to the ultrasonic transducer 204 passes. The external cable 107 can utilize the cable channel 403 of the conduit assembly 400, pass through the connecting pipe, and connect to and supply power to the ultrasonic transducer 204 inside the tip end 200. Furthermore, the cable 107 enables the ultrasonic transducer 204 to exchange information with external devices. The conduit assembly 400 also has a second liquid passage 402 for supplying or removing liquid from the liquid bladder 111 fitted onto the tip end 200, and a second channel 401 for the movement of the working needle 500. The cable channel 403, the second liquid passage 402, and the second channel 401 communicate with the outside at the distal end face of the conduit assembly 400 along its axial direction.

[0065] See Figure 6 The maximum outer diameter of the tip section 200 is not greater than the inner diameter of the main pipe section 301. Thus, the tip section 200 is inserted into the connecting pipe 300 from the proximal end of the main pipe section 301. The protruding section 202 is inserted into the connecting pipe 300 from the proximal end of the main pipe section 301, passes through the main pipe section 301 and the secondary pipe section 302 in sequence, and extends to the outside from the distal end of the secondary pipe section 302. Thus, the acoustic window 207 enters the outside, and the ultrasonic waves through the acoustic window 207 can establish a scanning area 112 in the outside. At the same time, the connecting section 201 enters the main pipe section 301. The outer diameter of the connecting section 201 is equal to the inner diameter of the main pipe section 301, and the two are coaxially arranged. Because the main pipe section 301 and the secondary pipe section 302 are not coaxial, the connecting section 201, which is coaxially arranged with the main pipe section 301, cannot enter the secondary pipe section 302. Therefore, the connecting section 201 is blocked by the main pipe section 301 at the connection point of the main pipe section 301 and the secondary pipe section 302, thus axially limiting the tip 200. Simultaneously, the protruding section 202 inserted into the secondary pipe section 302 restricts the connecting section 201 from rotating within the main pipe section 301. Preferably, the outer diameter of the protruding section 202 is equal to that of the secondary pipe section 302. The inner diameter of pipe section 302 and the circumferential limitation of the protruding section 202 on the tip end 200 are achieved. The inner diameter of the main pipe section 301 is equal to the outer diameter of the connecting section 201, thereby achieving radial limitation between the connecting pipe 300 and the tip end 200. Through dimensional fit, the distal end of the first channel 208 is aligned and connected with the working hole 304. Since the distal end of the first channel 208 is located on the same side as the acoustic window 207, the acoustic window 207 and the working hole 304 are located on the same side. This ensures accurate connection of the channels between the tip end 200 and the connecting pipe 300.

[0066] The piping assembly 400 has a second channel 401 along its axial direction. See also Figure 1After the tip end 200 is inserted into the connecting tube 300 from its proximal end, the distal end of the tubing assembly 400 is inserted into the proximal end of the main tube section 301 from its proximal end. The distal end of the second channel 401 provided in the tubing assembly 400 is connected to the proximal end of the first channel 208. Since the position of the tip end 200 relative to the connecting tube 300 is determined, the tip end can prevent the tubing assembly 400 from rotating and moving axially within the connecting tube 300. Furthermore, the outer diameter of the tubing assembly 400 is equal to the inner diameter of the main tube section, thereby achieving an accurate connection between the tubing assembly 400 and the tip end 200. The working needle 500, which performs the puncture operation, can extend to the outside through the second channel 401, the first channel 208, and the working hole 304. Since the working hole 304 and the acoustic window 207 are located on the same side, the working needle 500 can enter the scanning area 112 through the working hole 304, and the working needle 500 can perform the puncture operation under ultrasound guidance.

[0067] See Figure 6 In order to facilitate the working needle 500 to enter the outside through the first channel 208 and the working hole 304, or to allow the working needle 500 to return to the first channel 208 through the working hole 304 and move towards the far end along the axial direction of the connecting section 201, the first channel 208 has a guide wall 210 that gradually moves away from the axis of the connecting section 201 and guides the working needle 500 to deflect outward, so that the working needle 500 can pass through the first channel 208 more smoothly through the guide wall 210.

[0068] Furthermore, the first channel 208 has a certain rigidity, providing support for the working needle 500 during puncture.

[0069] See Figure 4 , Figure 6 Furthermore, the working hole 304 is located at the furthest point of the connecting section 201 from the axis of the secondary tube section 302, and the distal end of the first channel 208 is located at the furthest point of the connecting section 201 from the axis of the extension section 202. The space of the connecting section 201 is utilized as much as possible to establish the first channel 208 that allows the working needle 500 to pass through, so that the working needle 500 can be as far away from the axis of the connecting section 201 as possible, and cooperate with the scanning area 112 established by the ultrasonic transducer 204 to perform puncture at the distance of the scanning area 112.

[0070] Furthermore, the sidewall of the main tube section 301 is cylindrical, and the extension section 202 and the secondary tube section 302 are located within the curved surface of the sidewall of the main tube section 301, thereby keeping the sidewall of the ultrasonic probe approximately cylindrical as much as possible, so that the ultrasonic probe can pass through the ultra-fine natural cavities of the human body.

[0071] Furthermore, the angle between the tangent at the distal end of the first channel 208 and the axis of the connecting segment 201 is approximately 15° to 45°, so that the working needle 500 can better reach the scanning area 112.

[0072] By using a parallel off-axis, the tip 200 is inserted into the connecting tube 300 and then extends out of the connecting tube 300, achieving axial, circumferential, and radial limiting. This increases the connection area between the tip 200 and the connecting tube 300, thereby improving the stability of the connection and ensuring that the working needle 500 can stably reach the scanning area 112. The insertion method greatly reduces the assembly difficulty of the connecting tube 300 and the tip 200, and improves assembly efficiency.

[0073] See Figure 4 In one embodiment of this application, the tip end 200 is provided with a first liquid passage 205 capable of exchanging liquid with the liquid bladder 111 sleeved on the tip end 200. The distal end of the first liquid passage 205 communicates with the outer side wall of the protruding section 202, and the proximal end faces outward along the axial direction of the tip end 200; see also Figure 5 The piping assembly 400 includes a second liquid passage 402, the distal end of which is connected to the proximal end of the first liquid passage 205; the tip end 200 has two first liquid passages 205 symmetrically arranged about the longitudinal section of the tip end 200 where the acoustic window 207 is located, see [reference]. Figure 4 The pipeline assembly 400 is provided with two second liquid passages 402 that are respectively connected to the two first liquid passages 205.

[0074] The inflated liquid bladder 111 fills the gap between the ultrasound probe and the body cavity, ensuring that ultrasound waves can be efficiently transmitted from the probe to the body tissue, reducing signal attenuation and artifacts. The distal ends of the two second liquid paths 402 are connected to the proximal ends of the two first liquid paths 205, forming two liquid channels that can communicate with the liquid bladder 111 fitted on the tip end 200. One liquid channel can be used to supply liquid to the liquid bladder 111 from the outside, and the other liquid channel can be used to extract liquid from the liquid bladder 111, thus achieving dynamic and rapid adjustment of the liquid volume in the liquid bladder 111 using the two liquid channels. It is also possible to simultaneously supply liquid to or extract liquid from the liquid bladder 111 using both liquid channels. The symmetrical layout of the two liquid channels effectively avoids the uneven expansion of the liquid bladder 111 caused by uneven liquid delivery, ensuring its uniform adhesion to the target tissue wall, thereby improving the transmission efficiency of ultrasound waves and image quality. In addition, the symmetrical layout of the first liquid path 205 about the longitudinal section of the front end 200 where the acoustic window 207 is located enhances the system balance, reduces instrument vibration caused by supplying liquid to the liquid bladder 111 or removing liquid from the liquid bladder 111, and improves the stability of ultrasound imaging.

[0075] See Figure 4In one embodiment of this application, the outer side wall of the protruding section 202 is also provided with a liquid-passing long groove 206 that communicates with the far end of the first liquid passage 205 and is capable of exchanging liquid with the liquid bladder 111. The liquid-passing long groove 206 is located in the area outside the sound window 207 and has an extension direction parallel to the axial direction of the protruding section 202.

[0076] When the liquid bladder 111 is sleeved on the tip end 200 and adheres to the tip end 200, the liquid can be quickly dispersed into the liquid bladder 111 through the liquid passage groove 206, causing the liquid bladder 111 to expand rapidly. At the same time, the liquid in the liquid bladder 111 can also quickly leave the liquid bladder 111 through the liquid passage groove 206, reducing the liquid residue in the liquid bladder 111 and causing the liquid bladder 111 to contract rapidly.

[0077] The piping assembly 400 has channels including a second channel 401 and a second liquid passage 402, and the tip end 200 has channels including a first channel 208 and a first liquid passage 205. There are various ways to connect the piping assembly 400 and the channels of the tip end 200, such as through dimensional fit, where the outer diameter of the channel of the piping assembly 400 is equal to the inner diameter of the channel of the tip end 200, and the channel of the piping assembly 400 is inserted into the channel of the tip end 200. (See [reference]). Figure 18 This allows for the connection between channels. Alternatively, the inner diameter of the channel in the conduit assembly 400 can be equal to the outer diameter of the channel in the tip end 200. The channel of the tip end 200 can be inserted into the channel of the conduit assembly 400, enabling a quick and accurate connection between the conduit assembly 400 and the tip end 200. This eliminates the need for additional tubular components, simplifying the assembly process. Of course, the channel of the conduit assembly 400 can also be connected to the channel of the tip end 200 via additional tubular components. The two ends of the tubular component are connected to the channel of the tip end 200 and the channel of the conduit assembly 400, respectively. For example, see [link to relevant documentation]. Figure 7 The two second liquid passages 402 are connected to the two first liquid passages 205 respectively through two liquid passages 211, with the two ends of the liquid passages 211 inserted into the first liquid passage 205 and the second liquid passage 402 respectively.

[0078] Of course, those skilled in the art to which this application pertains will understand that the number of first liquid channels 205 and second liquid channels 402 in this application is not limited to the two mentioned above, but can also be one, or other numbers. The arrangement of the two first liquid channels 401 is not limited to the symmetrical arrangement of the longitudinal section of the front end 200 where the acoustic window 207 is located, as mentioned above, but can also have other arrangements, which will not be elaborated here.

[0079] See Figures 8 to 10In one embodiment of this application, the outer diameter of the protruding section 202 is smaller than the inner diameter of the secondary pipe section 302, and an installation space 209 is formed between the outer wall of the protruding section 202 and the inner wall of the secondary pipe section 302, which can compress and fix the liquid bladder 111.

[0080] When the wall of the liquid bladder 111 is located in the installation space 209, the protruding section 202 and the secondary tube section 302 can clamp the wall of the liquid bladder 111, resulting in a larger fixed connection area between the liquid bladder 111 and the ultrasound probe, and a stronger connection between the liquid bladder 111 and the tip 200. Simultaneously, the way the inner walls of the protruding section 202 and the secondary tube section 302 tightly clamp the wall of the liquid bladder 111 prevents water in the liquid bladder 111 from flowing out of its opening and into the body's natural cavities. See also Figure 7 During assembly, the liquid bladder 111 can be first fitted onto the extension section 202, and then the liquid bladder 111 is inserted into the proximal end of the main pipe section 301 of the connecting tube 300 along with the extension section 202, and extends out from the distal end of the secondary pipe section 302. This ensures the connection strength while facilitating the installation of the liquid bladder 111. It is beneficial to achieve a small outer diameter of the ultrasonic probe while facilitating assembly and ensuring the connection strength of each component of the ultrasonic probe.

[0081] Furthermore, the stepped structure at the connection between the main pipe section 301 and the auxiliary pipe section 302, and the stepped structure between the extension section 202 and the connecting section 201, can clamp the wall of the liquid bladder 111, further ensuring the connection strength between the liquid bladder 111 and the pipeline.

[0082] Furthermore, the distal end of the first liquid passage 205 is located inside the secondary pipe section 302, so that when the liquid is filled into the liquid bladder 111 through the first liquid passage 205, the inner wall of the secondary pipe section 302 is subjected to the impact of the liquid flow, thereby reducing the radial vibration amplitude of the liquid bladder 111.

[0083] Furthermore, the liquid passage trough 206 extends into the secondary pipe section 302 to allow liquid to enter and exit the liquid bladder 111 normally.

[0084] Those skilled in the art to which this application pertains will understand that there are other ways to fix the liquid bladder 111 to the tip 200, such as by adhesive or snap-fit, which will not be elaborated here. Of course, the liquid bladder 111 may be omitted if necessary.

[0085] Those skilled in the art to which this application pertains will understand that the number of the first liquid path 205 and the second liquid path 402 is not limited to two, but can also be one or other numbers, which will not be elaborated here.

[0086] Those skilled in the art to which this application pertains will understand that the connection between the pipe assembly 400 and the tip end 200 in this application to prevent the pipe assembly 400 from rotating within the connecting pipe 300 can also be achieved in other ways. For example, the alignment and connection of the receiving channel 203 and the cable channel 403 can be achieved through the insertion and cooperation of the first liquid channel 205 and the second liquid channel 402, and the alignment and connection of the first channel 208 and the second channel 401. Alternatively, the connection of the first channel 208 and the second channel 401, the first liquid channel 205 and the second liquid channel 402 can be achieved through the insertion and cooperation of the receiving channel 203 and the cable channel 403. Or, the first channel 208 and the second channel 401, the first liquid channel 205 and the second liquid channel 402, the receiving channel 203 and the cable channel 403 can be simultaneously inserted to achieve accurate connection between the tip end 200, the connecting pipe 300, and the pipe assembly 400. Further details are omitted here. Subsequently, bonding, welding, or other methods can be used to achieve a fixed connection between the three components, which will also be omitted here.

[0087] The tip end 200 can be produced by injection molding, 3D printing, or other methods, with a diameter not exceeding 3.5 mm and a length of 1 mm to 30 mm. The outer diameter of the tubing assembly 400 is not exceeding 3.5 mm, and the length is 70 cm to 200 cm. The inner diameter of the second channel 401 is approximately 0.5 mm to 2.0 mm, and the inner diameter of the second liquid channel 402 is 0.2 mm to 0.6 mm. The tubing assembly 400 is made of single or composite materials such as PTFE, PE, and polyurethane, and is bendable. The connecting tube 300 has a wall thickness of 0.05-0.1 mm and a length of approximately 5-20 mm, and can be made of metal materials such as stainless steel. The connecting tube 300 in this application can be directly stamped from metal tubes, making the production method simple and reliable. The medical ultrasound tubing of this application, with its simple structure of connecting tube 300, tip end 200, and tubing assembly 400, is easy to manufacture and can be mass-produced as a disposable consumable, eliminating the need for repeated sterilization of the ultrasound probe during clinical use.

[0088] Of course, those skilled in the art to which this application pertains will understand that the connecting pipe in this application can also be produced by additive manufacturing technology, powder metallurgy forming, or metal powder injection molding, etc.

[0089] See Figure 5 In one embodiment of this application, the cross-sectional area of ​​the cable channel 403 is larger than that of the second liquid channel 402 and the second channel 401. The space of the ultrasonic probe is fully utilized, and the cable channel 403, the liquid channel and the instrument channel are reasonably laid out to ensure the normal use of the working needle 500, the liquid bladder 111 and the ultrasonic transducer 204.

[0090] See Figure 7 , Figure 8In one embodiment of this application, the connecting pipe 300 further includes a bent section 303 whose axis can be bent. The bent section 303 is located at the proximal end of the main pipe section 301 and is coaxially arranged with the main pipe section 301. The distal end of the pipe assembly 400 is inserted into the main pipe section 301 through the proximal end of the bent section 303. The bent section 303 can be implemented in various ways. For example, the bent section 303 includes multiple bent elongated holes 305. The bent elongated holes 305 are through holes provided on the sidewall of the bent section 303. The multiple bent elongated holes 305 are provided on the sidewall of the bent section 303 along the axial direction of the bent section 303 and extend along the circumference of the bent section 303. When the bent section 303 is in a straight state, the projections of two adjacent bent elongated holes 305 on the cross-section of the bent section 303 are staggered. This allows for the bending of the medical ultrasound tubing connector 300. Since the diameter of the medical ultrasound tubing connector 300 is small, using complex processes to create the bending section 303 would increase manufacturing difficulty. However, the processing of the bending elongated hole 305 is simpler. For example, laser cutting can be used to create the bending elongated hole 305. Utilizing multiple bending elongated holes 305 to achieve bending of the medical ultrasound tubing connector 300 significantly reduces the manufacturing difficulty. Simultaneously, the connection between the area of ​​the bending section 303 (excluding the bending elongated hole 305) and the outer wall of the tubing assembly 400 ensures the connection area and strength between the two. Of course, the bending section 303 can also be implemented in other ways, such as a corrugated tube structure or a spring tube structure.

[0091] The bend 303 increases the connection area between the connecting tube 300 and the tubing assembly 400, which helps to improve the connection strength between the two. Furthermore, the axis of the bend 303 can bend with the tubing assembly 400. The connecting tube 300 adopts a rigid structure, but its proximal end is provided with a bendable bend 303, which not only ensures the rigid guidance of the ultrasound probe and the support of the connecting tube 300, but also gives the proximal end of the connecting tube 300 a certain degree of flexibility, so that the ultrasound probe has good compliance when passing through the curved cavities of the human body.

[0092] Of course, the connection method between the proximal end of the connecting pipe 300 and the distal end of the pipe assembly 400 is not limited to the connection method described above, which is to connect the pipe assembly 400 through the bending section 303. Other methods are also possible. For example, the bending section 303 may not be provided, and the pipe assembly 400 may be directly inserted into the main pipe section 301. The outer diameter of the distal end of the pipe assembly 400 is smaller than the outer diameter of the pipe body of the adjacent pipe assembly 400, thus forming a shoulder at the connection point. The inner diameter of the proximal end of the connecting pipe 300 is equal to the outer diameter of the distal end of the pipe assembly 400. The proximal end face of the main pipe section 301 of the connecting pipe 300 abuts against the shoulder. The shoulder at the distal end of the pipe assembly 400 axially positions the connecting pipe 300. Then, the relative positions between the components are fixed by means of bonding, welding, etc., to ensure the connection stability between the connecting pipe 300 and the channel of the tip end 200 and the pipe assembly 400 when the connection structure is subjected to complex forces.

[0093] See Figure 11 An ultrasonic device with puncture function is provided, comprising any of the aforementioned ultrasonic probes with puncture function, a mounting base 100, an ultrasonic unit, and a puncture unit. The ultrasonic unit comprises an ultrasonic probe composed of components such as a tubing assembly 400, a connecting tube 300, and a tip 200. The puncture unit comprises components such as a working needle 500 and a connector 501.

[0094] The mounting base 100 can be detachably connected to devices such as endoscopes. There are various ways to achieve this detachable connection, such as threaded connection via bolts, or snap-fit ​​connection. Other implementations exist, for example, in a medical ultrasonic puncture kit, it includes an ultrasonic device with puncture function and an endoscope device. See [link to relevant documentation]. Figure 12 The endoscope device includes a connecting tube 600 for inserting an ultrasound probe. The connecting tube 600 is connected to the working channel of the endoscope device, so that the ultrasound probe in the ultrasound unit passes through the connecting tube 600 and enters the working channel of the endoscope device. After the lens of the endoscope device reaches the designated position, it can extend out of the working channel and enter the ultra-fine natural cavity of the human body to scan the designated position using the ultrasound waves emitted by the ultrasound probe.

[0095] The fixed base 100 has a connecting hole along its axial direction for inserting the connecting cylinder 600. A second limiting part 602 is slidably connected to the fixed base 100, and the second limiting part 602 can move radially between a locked position and an unlocked position along the connecting hole. A first limiting part 601 is provided on the side wall of the connecting cylinder 600. When the connecting cylinder 600 enters the connecting hole and reaches a preset position, the second limiting part 602 reaches the locked position and connects with the first limiting part 601, restricting the connecting cylinder 600 from moving axially relative to the fixed base 100 along the fixed base 100. When the second limiting part 602 moves from the locked position to the unlocked position, the second limiting part 602 disconnects from the first limiting part 601, and the connecting cylinder 600 can disengage from the connecting hole along the axial direction of the fixed base 100. (See also...) Figure 12 , Figure 13 The first limiting part 601 is a groove provided on the side wall of the connecting cylinder 600. The groove is provided along the circumference of the connecting cylinder 600, so as to... Figure 13 Described in the direction of movement, the second limiting part 602 slides radially along the connecting hole. The second limiting part 602 has a small hole and a large hole communicating with the small hole along the direction of movement. The diameter of the small hole is smaller than the maximum outer diameter of the connecting cylinder 600 but not smaller than the inner diameter of the first limiting part 601. The large hole is not smaller than the maximum outer diameter of the connecting cylinder 600. When the second limiting part 602 is in the unlocked position, the large hole and the connecting hole are coaxially arranged. The connecting cylinder 600, entering along the connecting hole, can pass through the large hole and then the second limiting part 602. Position 602 is adjusted to the locked position, and the small hole and the connecting hole are coaxially arranged, so that the inner wall of the small hole enters the groove, preventing the connecting cylinder 600 from moving along the connecting hole. Thus, the relative position of the fixing seat 100 and the connecting cylinder 600 is locked by the inner wall of the connecting hole and the second limiting part 602, thereby locking the relative position of the fixing seat 100 and the endoscope device. Subsequently, by adjusting the position of the ultrasound unit relative to the fixing seat 100, the position of the ultrasound unit in the working channel of the endoscope device is adjusted to meet different treatment needs.

[0096] The mounting base 100 includes a main body and a locking assembly detachably connected to the main body. The locking assembly includes a second limiting portion 602. (See also...) Figure 12 The locking component is sleeved on the main body and is detachably connected by a snap-fit ​​mechanism, which facilitates the separation of the main body of the fixing base 100 and the locking component, and allows the locking component in this application to lock other devices.

[0097] Of course, the implementation of the first limiting part 601 and the second limiting part 602 is not limited to the methods described above, but can also be implemented in other ways. For example, the second limiting part 602 can be an insertion rod, and the first limiting part 601 can be an insertion hole provided on the outer wall of the connecting cylinder 600. The insertion rod can be inserted into the insertion hole to restrict the axial movement of the connecting cylinder 600 along the connecting hole, thereby locking the relative position of the fixing seat 100 and the endoscope device. Furthermore, through the size fit and shape setting, the rotation of the connecting cylinder 600 relative to the connecting hole can also be prevented. For example, see [reference needed]. Figure 13 As shown in the diagram, below the connecting hole is a plane parallel to the axis of the connecting hole. The connecting cylinder 600 has a plane that abuts against this plane. When the second limiting part 602 reaches the locking position to lock the axial position of the fixing seat 100 and the connecting cylinder 600, the two planes abut against each other. See [reference needed]. Figure 13 This prevents the connecting cylinder 600 from rotating relative to the connecting hole, thus improving the stability of the connection between the connecting cylinder 600 and the fixed base 100.

[0098] The medical puncture kit combines an ultrasound device with a puncture function with an endoscope. Through a structure including a connecting cylinder 600, a connecting hole, a first limiting part 601, a fixing base 100, and a second limiting part 602, it enables quick connection and disassembly of the two devices, facilitating flexible use in different operational scenarios and improving the device's versatility and practicality. Simultaneously, the first limiting part 601 and the second limiting part 602 can fix the position of the connecting cylinder 600 and the connecting hole, ensuring the stability of the combined ultrasound device with the endoscope and guaranteeing smooth operation. Of course, the ultrasound device with puncture function can also be used with other devices besides endoscopes, or used independently as needed; these details will not be elaborated further here.

[0099] The ultrasound unit includes a tip 200, a connecting tube 300, a tubing assembly 400, an ultrasound transducer 204 disposed within the tip 200, and a first operating element 101 fixedly connected to the proximal end of the tubing assembly 400. The ultrasound probe of the ultrasound unit includes the tip 200, the connecting tube 300, the tubing assembly 400, and the ultrasound transducer 204 disposed within the tip 200.

[0100] The first operating element 101 is connected to the fixed base 100 and is movable along the axial direction of the fixed base 100. The first operating element 101 moves distally or proximally along the axial direction of the fixed base 100, causing the ultrasound probe to move within the ultra-fine natural cavities of the human body, allowing the ultrasound probe to reach the target position through these cavities. There are various ways to achieve the movement of the first operating element 101 relative to the fixed base 100 along its axial direction; see [reference needed]. Figures 11 to 15The fixed base 100 is a sleeve structure. The first mating part 109 of the first operating member 101 is inserted into the fixed base 100. The first mating part 109 is slidably connected to the fixed base 100 or rolled by a rolling element, so that the first operating member 101 can move relative to the fixed base 100 along the axial direction of the fixed base 100. Of course, the fixed base 100 can also be a sleeve, and the first mating part 109 can also be a sleeve, but the inner diameter of the first mating part 109 is larger than the outer diameter of the fixed base 100, so that the fixed base 100 can insert the first mating part 109. The first mating part 109 is movably arranged along the axial direction of the fixed base 100. Of course, there are other ways to realize the movement of the fixed base 100 and the first operating member 101, which will not be described in detail here.

[0101] Based on the ultrasound scan results, medical staff adjust the position of the first operating element 101 relative to the fixed base 100, thereby adjusting the position of the ultrasound probe within the body's ultra-fine natural cavities to achieve the optimal ultrasound scan effect. (See also...) Figure 16 The ultrasonic transducer 204 can emit ultrasonic waves laterally and scan the target area of ​​the human body outside the ultrasonic probe through the acoustic window 207 provided on the side wall of the tip 200 to establish a scanning area 112.

[0102] Furthermore, a liquid bladder 111 can be provided on the outer side of the tip end 200. The ultrasonic unit also has a liquid channel, which includes the first liquid path 205 and the second liquid path 402 mentioned above. Liquid can be exchanged with the liquid channel via a liquid pump or syringe 106 through the liquid path interface 108. When the liquid bladder 111 is a single-layer bladder, the outer wall of the tip end 200 is closed, and the acoustic window 207 can be sealed with a material that facilitates the passage of ultrasonic waves, or sealed with an ultrasonic lens. The ultrasonic lens is placed in the ultrasonic propagation path to enhance the ultrasonic scanning effect. Of course, the liquid bladder 111 can be configured as a double-layer bladder as needed. When the liquid bladder 111 is fitted onto the tip end 200, the distal end of the first liquid path 205 is connected to the interface of the liquid bladder 111 to change the degree of expansion of the liquid bladder 111 through the liquid channel.

[0103] The ultrasound unit also has instrument channels, including a first channel 208 and a second channel 401.

[0104] The puncture unit includes a working needle 500, a second operating member 102, and a connecting member 501 disposed along the instrument channel, connecting the second operating member 102 and the working needle 500. The second operating member 102 is connected to the first operating member 101 and is axially movable along the first operating member 101, so that the connecting member 501 can drive the working needle 500 in the instrument channel through the working hole 304 into the scanning area 112, or return it from the scanning area 112 to the instrument channel. There are various ways to achieve the movement of the second operating member 102 relative to the first operating member 101; see [link to relevant documentation]. Figure 14 , Figure 15 The first operating member 101 also includes a second mating part 110 coaxially disposed with the first mating part 109. The first mating part 109 and the second mating part 110 are respectively disposed at both ends of the first operating member 101. The first operating member 101 has a through hole along the axial direction, forming part of the instrument channel. The second mating part 110 is inserted into the second operating member 102, or the second operating member 102 is inserted into the second mating part 110. The second mating part 110 and the second operating member 102 are slidably connected or rolledly connected through a rolling element, so that the second operating member 102 can be moved along the axial direction of the first operating member 101 and move relative to the first operating member 101 and the fixed base 100. See also Figure 16 The distal end of the first channel 208 in the instrument channel gradually deflects outward and eventually connects with the working hole 304. (See [reference]). Figure 11 , Figure 14 , Figure 16 The second operating element 102 is fixedly connected to the working needle 500 via the connector 501. When the second operating element 102 moves relative to the first operating element 101, the second operating element 102 drives the working needle 500 in the instrument channel to move along the instrument channel via the connector 501. The distal end of the instrument channel gradually deviates outward from the axis of the ultrasound probe. Guided by the instrument channel, the working needle 500 enters the scanning area 112 established by the ultrasound probe in the outside through the working hole 304, or returns to the instrument channel from the scanning area 112. The working needle 500 can be a puncture needle or an ablation needle to perform different medical operations.

[0105] This device integrates the ultrasound unit and the puncture unit. Compared to existing ultrasound endoscopes with an operating channel and an outer diameter exceeding 6mm, this device reduces the overall outer diameter by rationally arranging the components. This allows it to enter ultra-fine natural cavities such as the bronchi, ureters, pancreaticobiliary ducts, etc., for diagnosis and puncture. The working needle 500 of the puncture unit can enter the scanning area 112 established by the ultrasound probe through the instrument channel and the working hole 304. This solves the problems in the prior art where the ultrasound device cannot pass through ultra-fine natural cavities in parallel with the puncture device and where it is difficult to complete the puncture operation within the cavity. It also avoids the puncture device deflecting in ultra-fine natural cavities and causing damage to surrounding tissues. The operator can fix the mounting base 100 to a device, such as an endoscope, and then use the first operating member 101 to move relative to the mounting base 100 along the axial direction of the mounting base 100 to slowly push the ultrasound probe toward the target area. During this process, the second operating member 102 moves with the first operating member 101, so that the working needle 500 in the instrument channel reaches the designated position with the ultrasound unit. Then, the second operating member 102 moves distally relative to the first operating member 101 to slowly push the working needle 500 into the target area, or the second operating member 102 moves proximally relative to the first operating member 101 to withdraw it from the target area, which facilitates the operator to perform puncture operations under ultrasound guidance.

[0106] When the axis of the distal end of the instrument channel is perpendicular to the axis of the working hole 304, the working needle 500 cannot easily enter the outside through the distal end of the instrument channel and the working hole 304. To allow the working needle 500 to smoothly leave the distal end of the instrument channel and enter the outside through the working hole 304, the distal end of the instrument channel has an extending direction that gradually approaches the working hole 304. (See [reference]). Figure 16 The distal end of the first channel 208 of the instrument channel is arc-shaped. In one embodiment of this application, see... Figure 16 In its natural state, the working needle 500 is curved. If the working needle 500 is straight, when it enters the outside through the working hole 304, the distal end of the working needle 500 is closer to the axis of the ultrasonic probe (see...). Figure 16 As shown in the diagram (n), it is not possible to puncture tissue located at a distance within the scanning area 112. Therefore, by setting the working needle 500 in its natural state to an arc shape, after the working needle 500 leaves the working hole 304, the distal end of the working needle 500 can bend away from the axis of the ultrasound probe (see...). Figure 16 (m shown in the figure), increase the distance between the distal end of the working needle 500 and the axis of the ultrasonic probe (see [reference]). Figure 16 (The difference between m and n in the middle), thus enabling puncture of distant tissues in the scanning area 112.

[0107] Because the ultrasound probe and tubing assembly have a small outer diameter designed to pass through the ultra-fine natural cavities of the human body, the distal inner diameter of the instrument channel within them is also small. To ensure the working needle 500 can smoothly extend from the instrument channel through the working hole 304 to the outside, and to minimize the requirements of the curved working needle 500 on the inner diameter of the instrument channel, the working needle 500 is made of materials such as nickel-titanium alloy or stainless steel, and undergoes heat treatment or cold rolling processes to make it elastic. The axis of the working needle 500 can bend, allowing it to elastically deform under the constraint of the inner wall of the instrument channel when it is inside, reducing the degree of bending and the requirement for the inner diameter of the instrument channel. Furthermore, the elasticity of the working needle 500 allows it to elastically deform when withdrawn from the proximal end of the instrument channel, conforming to any possible bending of the instrument channel and ensuring smooth withdrawal. As the working needle 500 gradually enters the outside world through the working hole 304, it gradually returns to its natural state in the plane defined by the working hole 304 and the distal end of the instrument channel. The working needle 500 gradually bends away from the axis of the ultrasound probe, increasing the distance between the distal end of the working needle 500 and the axis of the ultrasound probe. As a result, the working needle 500 can puncture tissues located at a distance in the scanning area 112, improving the puncture distance and puncture efficiency.

[0108] Because the working needle 500 is elastic and has a natural arc-shaped design, when the working needle 500 leaves the first channel 208 through the working hole 304, the guiding requirements of the first channel 208 are low. Thus, after moving a short axial distance, the working needle 500 can smoothly extend to the outside through the working hole 304. As a result, the axial length of the first channel 208 can be smaller and the degree of bending can be larger. The smaller axial length of the first channel 208 shortens the length of the connecting section 201, thereby reducing the turning radius of the ultrasonic probe.

[0109] In one embodiment of this application, the fixed base 100 or the first operating member 101 is provided with a length scale 104 along the axial direction to indicate the position of the first operating member 101 relative to the fixed base 100; the first operating member 101 or the second operating member 102 is provided with a length scale 104 along the axial direction to indicate the position of the second operating member 102 relative to the first operating member 101. See also Figure 11 , Figure 15 The first mating part 109 is inserted into the fixed base 100 along the axial direction and is movable along the axial direction of the fixed base 100. A length scale 104 is provided on the outer wall of the first mating part 109 along the axial direction of the first operating member 101. By observing the positional change of the length scale 104 on the first mating part 109 relative to the proximal end of the fixed base 100, the axial movement distance of the connecting member 501 relative to the fixed base 100 can be determined, thereby determining the movement distance of the ultrasound probe and thus the position of the ultrasound probe. The second mating part 110 is inserted into the second operating member 102 along its axial direction, and the second operating member 102 is movable along the second mating part 110. A length scale 104 is provided on the outer wall of the second mating part 110 along the axial direction of the first operating member 101. By observing the length scale 104 on the second mating part 110, the movement distance of the distal end of the second operating member 102 relative to the second mating part 110 can be determined, thereby helping medical personnel determine the position of the working needle 500 relative to the instrument channel.

[0110] The outer walls of the first mating part 109 and the second mating part 110 of the first operating member 101 are provided with length scales 104. During operation, the doctor can accurately determine the movement distance of the first operating member 101 relative to the fixing seat 100 and the second operating member 102 relative to the first operating member 101 according to the scales, thereby precisely controlling the insertion depth and ensuring the treatment effect. The length scales 104 for determining the relative position of the fixing seat 100 and the first operating member 101 and the length scales 104 for determining the first operating member 101 and the second operating member 102 are both located on the first operating member 101, which facilitates processing.

[0111] Of course, those skilled in the art to which this application pertains will understand that when the first mating part 109 is inserted into the fixed base 100, the length scale 104 can also be set in the fixed base 100. When the second operating member 102 is inserted into the second mating part 110, the second operating member 102 can be set with the length scale 104. Those skilled in the art to which this application pertains can select the setting position of the length scale 104 as needed, so as to know the position of the first operating member 101 relative to the fixed base 100 and the position of the second operating member 102 relative to the first operating member 101 through the length scale 104. This will not be elaborated further here.

[0112] In one embodiment of this application, the ultrasonic device with puncture function further includes two locking bolts 103; one locking bolt 103 is threadedly connected to one of the fixed base 100 and the first operating member 101, and the end of the locking bolt 103 can abut against the side wall of the other, restricting the axial movement of the first operating member 101 relative to the fixed base 100; the other locking bolt 103 is threadedly connected to one of the first operating member 101 and the second operating member 102, and the end of the locking bolt 103 can abut against the side wall of the other, restricting the axial movement of the second operating member 102 relative to the first operating member 101. See also Figure 14 , Figure 15 When the first mating part 109 is inserted into the fixed seat 100 and the second mating part 110 is inserted into the second operating member 102, the fixed seat 100 and the second operating member 102 are provided with threaded holes for locking bolts 103 to be threadedly connected in the radial direction. The locking bolts 103 can be screwed into the threaded holes and abut against the side walls of the first mating part 109 and the second mating part 110. Thus, the two locking bolts 103 are used to restrict the axial movement of the first operating member 101 relative to the fixed seat 100 and to restrict the axial movement of the second operating member 102 relative to the first operating member 101, respectively. This allows for selective fixing of the axial position of each component as needed during operation, improving the accuracy and stability of puncture. Of course, when the fixed seat 100 is inserted into the first mating part 109, the first mating part 109 can also be threadedly connected to the locking bolt 103; when the second operating member 102 is inserted into the second mating part 110, the second mating part 110 can also be threadedly connected to the locking bolt 103. This will not be elaborated further here.

[0113] In use, the mounting base 100 is fixedly connected to a device. Then, the position of the first operating member 101 relative to the mounting base 100 along the axial direction of the mounting base 100 is adjusted, causing the ultrasound probe to move distally or proximally, adjusting the position of the ultrasound probe and instrument channel within the body. Simultaneously, when the positions of the second operating member 102 and the first operating member 101 are locked, the working needle 500 can move synchronously with the ultrasound unit until the ultrasound probe reaches the designated position. At this point, the positions of the mounting base 100 and the first operating member 101 can be locked, and the position lock of the second operating member 102 relative to the first operating member 101 can be released. The second operating element 102 moves distally relative to the first operating element 101 along the axial direction of the first operating element 101 (parallel to the axial direction of the fixed base 100), so that the working needle 500 can enter the scanning area 112 established by the ultrasound probe through the instrument channel and the working hole 304, and perform puncture under ultrasound guidance. Subsequently, the second operating element 102 moves proximally relative to the first operating element 101 along the axial direction of the first operating element 101 (parallel to the axial direction of the fixed base 100), and the working needle 500 can withdraw from the human tissue. The movement of the second operating element 102 relative to the first operating element 101 is repeated to achieve repeated puncture.

[0114] In one embodiment of this application, the ultrasound device with puncture function further includes a negative pressure unit; both the working needle 500 and the connector 501 are provided with hollow channels; the negative pressure unit communicates with the proximal end of the connector 501 and with the working needle 500 through the connector 501. The working needle 500 punctures the target area through the instrument channel and the working hole 304. The negative pressure unit operates to generate negative pressure at the distal end of the working needle 500, drawing the sample 503 generated during the puncture process into the hollow channel of the working needle 500 and the connector 501. There are various ways to configure the negative pressure unit; see [link to relevant documentation]. Figure 11 , Figure 14 In one embodiment of this application, the negative pressure unit comprises a syringe 106 and a shut-off valve 105 connected to the syringe 106. The syringe 106 is connected to the proximal end of the connector 501 through the shut-off valve 105. By drawing air through the syringe 106, a negative pressure is generated at the distal end of the working needle 500, which adsorbs the sample 503. Furthermore, when the working needle 500 is withdrawn from the distal end along the instrument channel, the shut-off valve 105 can be closed to prevent air from entering the hollow channel between the working needle 500 and the connector 501, thus maintaining a certain negative pressure state within the hollow channel. Of course, the negative pressure unit can also be implemented in other ways, such as including a controller and a negative pressure pump electrically connected to the controller, and a negative pressure sensor capable of monitoring the negative pressure value at the connector 501. The negative pressure sensor sends a negative pressure signal to the controller, and the controller controls the operation of the negative pressure pump according to the negative pressure signal to keep the negative pressure at the distal end of the working needle 500 within a suitable range.

[0115] In one embodiment of this application, the ultrasound device with puncture function further includes a needle 502; the negative pressure unit is detachably connected to the proximal end of the connector 501, and there are various ways to achieve the detachable connection between the negative pressure unit and the distal end of the connector 501, see [link to relevant documentation]. Figure 11 , Figure 17 The negative pressure unit is threadedly connected to the distal end of the connector 501 via components such as Luer connectors. The negative pressure unit can also be detachably connected to the proximal end of the connector 501 via a snap-fit ​​mechanism (not shown in the figure), which will not be elaborated further here. After the negative pressure unit is disconnected from the proximal end of the connector 501, the needle 502 can be inserted into the connector 501 through the proximal end, and enter the outside through the hollow channel between the connector 501 and the working needle 500 at the distal end of the working needle 500. The piercing needle 502 can puncture difficult-to-puncture locations within the working needle 500, thereby improving the structural strength of the working needle 500 and ensuring smooth puncture. The piercing needle 502 is then pulled out from the hollow channel between the working needle 500 and the connecting member 501 through the proximal end of the connecting member 501. Subsequently, the negative pressure unit is connected to the proximal end of the connecting member 501 for negative pressure suction to collect the sample 503. Then, the second operating member 102 moves proximally relative to the first operating member 101 and... First, the operating element 101 separates, and the second operating element 102 pulls the working needle 500 out through the proximal end of the instrument channel. Because the inner diameter of the hollow channel between the working needle 500 and the connector 501 is small, the sample 503 inside the hollow channel is not easily discharged directly. Finally, the connection between the negative pressure unit and the connector 501 is disconnected, and the through needle 502 re-enters the hollow channel between the connector 501 and the working needle 500 through the proximal end of the connector 501. Thus, the through needle 502 pushes the sample 503 inside the hollow channel out through the distal end of the working needle 500. (See [reference]). Figure 17 Medical staff can collect sample 503 at the distal end of the working needle 500. Of course, the working needle 500 can also be used alone for easily punctured sites.

[0116] Of course, the hollow channel provided by the working needle 500 and the connector 501 can also be used to inject drugs and extract liquid from the target area, providing more operating methods for diagnosis and treatment in ultra-fine natural cavities and meeting the treatment needs of different diseases. The working needle 500 can also be a medical tool such as an ablation needle. By moving the second operating member 102 relative to the first operating member 101, the working needle 500 can be inserted into the scanning area 112 through the working hole 304, and medical operations can be performed through the ultra-fine natural cavities of the human body under ultrasound guidance.

[0117] Those skilled in the art to which this application pertains will understand that the pipe assembly 400 in this application can be an integrated multi-cavity pipe produced by methods such as extrusion molding; see [link to relevant documentation]. Figure 18It can also be a composite pipe system consisting of an outer tube 404 and a thinner tube with an outer diameter smaller than the inner diameter of the outer tube 404, which can be inserted into the outer tube 404. See [link to documentation]. Figure 19 Multiple thin tubes form a second liquid path 402 and a second channel 401 within the outer tube 404, respectively. The remaining space within the outer tube 404 serves as a cable channel 403, or another thin tube can be provided as a cable channel 403. The multiple thin tubes can be fixed within the outer tube 404 by means of bonding or other methods. When the outer tube 404 is inserted into the connecting tube 300, the multiple thin tubes are respectively inserted into the channels of the tip end 200, or the channels of the tip end 200 are inserted into the multiple thin tubes, or the channels of the tip end 200 are connected to the thin tubes through an additional tubular component, which will not be elaborated here. Of course, the composite pipe system can also be implemented in a way where the thin tubes are not directly connected to the outer tube 404, or the proximal ends of the outer tube 404 and the proximal ends of the multiple thin tubes are both fixedly connected to the first operating member 101, and the outer tube 404 is not directly connected to the thin tubes. The outer tube 404 is merely sleeved on the tube bundle composed of multiple thin tubes, and the axis of the thin tubes can be parallel to or not parallel to the axis of the outer tube 404. During assembly, the distal ends of multiple thin tubes are first connected to multiple channel openings provided on the proximal end face of the tip 200, and then the outer tube 404 is inserted into the proximal end of the connecting tube 300 to realize the assembly of the ultrasonic unit. Of course, there are other ways to implement the tube components 400, as long as the assembly of the ultrasonic unit can be realized and the functional requirements are met.

[0118] A medical ultrasonic puncture kit includes any of the aforementioned ultrasonic devices with puncture function, and also includes an endoscope device. The ultrasonic unit includes an ultrasonic probe comprising a tip 200, a connecting tube 300, a tubing assembly 400, and an ultrasonic transducer 204 disposed within the tip 200. The endoscope device includes a connecting cylinder 600 for inserting the ultrasonic probe, and the side wall of the connecting cylinder 600 is provided with a first limiting part 601. A fixing base 100 is provided axially with a connecting hole for inserting the connecting cylinder 600, and the fixing base 100 is slidably connected with a second limiting part. The second limiting part 602 can move radially between the locked position and the unlocked position along the connecting hole. When the connecting cylinder 600 enters the connecting hole, the second limiting part 602 can reach the locked position and connect with the first limiting part 601, restricting the connecting cylinder 600 from moving relative to the fixed seat 100 along the axial direction of the fixed seat 100. When the second limiting part 602 moves from the locked position to the unlocked position, the second limiting part 602 disconnects from the first limiting part 601, and the connecting cylinder 600 can disengage from the connecting hole along the axial direction of the fixed seat 100.

[0119] The medical puncture kit combines an ultrasound device with a puncture function and an endoscope device. Through structures such as the connecting cylinder 600, the first limiting part 601, the fixing base 100, and the second limiting part 602, it enables quick connection and disassembly of the two devices, facilitating flexible use in different operational scenarios and improving the device's versatility and practicality. Simultaneously, the first limiting part 601 and the second limiting part 602 can fix the position of the connecting cylinder 600 and the connecting hole, ensuring the stability of the combined ultrasound device with the endoscope device and guaranteeing smooth operation.

[0120] It should be understood that although this specification describes various embodiments, not every embodiment contains only one independent technical solution. This way of describing the specification is only for clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

[0121] The detailed descriptions listed above are merely specific descriptions of feasible embodiments of this application and are not intended to limit the scope of protection of this application. All equivalent implementations or modifications made without departing from the spirit of the art of this application, such as combinations, divisions or repetitions of features, should be included within the scope of protection of this application.

Claims

1. An ultrasonic probe with puncture function, characterized in that, Includes piping components, connecting pipes, and an end piece equipped with an acoustic window; The connecting pipe, along its proximal end to distal end, sequentially includes a main pipe section with working holes on its sidewalls and a secondary pipe section arranged off-axis parallel to the main pipe section. The tip portion, in the direction from its proximal end to its distal end, sequentially includes a connecting section with a first channel and an extending section arranged off-axis parallel to the connecting section. The proximal end of the first channel is connected to the proximal end face of the connecting section, and the distal end is connected to the side wall of the connecting section. The side wall of the extending section is provided with an acoustic window for ultrasonic waves to pass through, and the acoustic window is arranged on the same side as the distal end of the first channel. The protruding section is inserted into the connecting pipe through the proximal end of the main pipe section. The connecting section is blocked by the main pipe section under the limiting action at the connection between the main pipe section and the secondary pipe section. The distal end of the first channel is aligned with and connected to the working hole. The protruding section extends to the outside through the main pipe section and the secondary pipe section in sequence. The acoustic window is set on the same side as the working hole. The pipeline assembly is inserted into the proximal end of the main pipe section. The channel opening at the distal end face of the pipeline assembly is connected to the channel opening at the proximal end face of the distal end, restricting the rotation of the pipeline assembly within the connecting pipe. The distal end of the second channel provided by the pipeline assembly is connected to the proximal end of the first channel.

2. The ultrasonic probe with puncture function according to claim 1, characterized in that, The tip end is provided with a first liquid passage that can exchange liquid with the liquid bladder sleeved on the tip end. The distal end of the first liquid passage is connected to the outer wall of the protruding section, and the proximal end faces outward along the axial direction of the tip end. The pipeline assembly is provided with a second liquid passage, and the distal end of the second liquid passage is connected to the proximal end of the first liquid passage. The tip end is provided with two first liquid passages symmetrically arranged about the longitudinal section of the tip end where the sound window is located, and the pipeline assembly is provided with two second liquid passages respectively connected to the two first liquid passages.

3. The ultrasonic probe with puncture function according to claim 2, characterized in that, The outer wall of the extended section is also provided with a liquid-passing groove that communicates with the far end of the first liquid path and can exchange liquid with the liquid bladder. The liquid-passing groove is located in the area outside the acoustic window and has an extension direction parallel to the axial direction of the extended section.

4. An ultrasonic probe with puncture function according to claim 2, characterized in that, The outer diameter of the protruding section is smaller than the inner diameter of the secondary pipe section, and an installation space is formed between the outer wall of the protruding section and the inner wall of the secondary pipe section, which can compress and fix the liquid bladder.

5. An ultrasonic probe with puncture function according to claim 1, characterized in that, The connecting pipe also includes a bent section whose axis can be bent. The bent section is located at the proximal end of the main pipe section and is coaxially arranged with the main pipe section. The distal end of the pipe assembly is inserted into the main pipe section through the proximal end of the bent section.

6. An ultrasonic device with puncture function, characterized in that, It includes any one of the ultrasound probes with puncture function as described in claims 1 to 5, and also includes... Fixed base; An ultrasound unit includes a tip end, a connecting tube, a tubing assembly, an ultrasound transducer disposed within the tip end, and a first operating element connected to the proximal end of the tubing assembly. The ultrasound transducer is capable of emitting ultrasound waves to the outside through an acoustic window to establish a scanning area in the outside. The first operating element is connected to the fixed base and is movably disposed along the axial direction of the fixed base. The ultrasound unit also includes an instrument channel, which includes a first channel and a second channel. The puncture unit includes a working needle, a second operating member, and a connector disposed along the instrument channel, connecting the second operating member and the working needle. The second operating member is connected to the first operating member and is axially movable along the first operating member so as to drive the working needle in the instrument channel through the working hole into the scanning area via the connector, or to return to the instrument channel from the scanning area.

7. An ultrasonic device with puncture function according to claim 6, characterized in that, The ultrasound device with puncture function also includes a negative pressure unit; Both the working needle and the connector are provided with hollow channels; The negative pressure unit is connected to the proximal end of the connector and is connected to the working needle through the connector.

8. An ultrasonic device with puncture function according to claim 7, characterized in that, The ultrasonic device with puncture function also includes a puncture needle; The negative pressure unit is detachably connected to the proximal end of the connector; After the negative pressure unit is disconnected from the proximal end of the connector, the needle can be inserted into the connector through the proximal end of the connector and enter the outside through the hollow channel between the connector and the working needle at the distal end of the working needle.

9. An ultrasonic device with puncture function according to claim 6, characterized in that, The working needle is elastic and is arc-shaped when in its natural state. As the working needle gradually enters the outside world through the working hole, it gradually returns to its natural state in the plane defined by the working hole and the distal end of the instrument channel, and gradually bends away from the axis of the connecting tube.

10. An ultrasonic device with puncture function according to claim 6, characterized in that, The ultrasonic device with puncture function also includes two locking bolts; One of the locking bolts is threadedly connected to one of the fixed seat and the first operating member, and the end of the locking bolt can abut against the side wall of the other to restrict the axial movement of the first operating member relative to the fixed seat. Another locking bolt is threadedly connected to one of the first and second operating members, and the end of the locking bolt can abut against the side wall of the other, restricting the movement of the second operating member relative to the first operating member in the axial direction.

11. An ultrasonic device with puncture function according to claim 6, characterized in that, The fixed base or the first operating member is provided with a length scale along the axial direction to indicate the position of the first operating member relative to the fixed base; The first or second operating member is provided with a length scale along the axial direction to indicate the position of the second operating member relative to the first operating member.

12. A medical ultrasonic puncture kit, characterized in that, It includes any one of the ultrasound devices with puncture function as described in claims 6 to 11, and also includes an endoscope device. The ultrasound unit includes an ultrasound probe that includes the tip end, the connecting tube, the tubing assembly, and an ultrasound transducer disposed in the tip end. The endoscope device includes a connecting tube for inserting the ultrasound probe, and the side wall of the connecting tube is provided with a first limiting part. The fixed base is provided with a connecting hole for inserting the connecting cylinder along its axial direction. The fixed base is slidably connected with a second limiting part, which can move between a locked position and an unlocked position along the radial direction of the connecting hole. When the connecting cylinder enters the connecting hole, the second limiting part can reach the locking position and connect with the first limiting part, restricting the connecting cylinder from moving relative to the fixed seat along the axial direction of the fixed seat; when the second limiting part moves from the locking position to the unlocking position, the second limiting part disconnects from the first limiting part, and the connecting cylinder can disengage from the connecting hole along the axial direction of the fixed seat.

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