Piercing device and interventional system

CN117257422BActive Publication Date: 2026-08-07SHANGHAI MICROPORT EP MEDTECH CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
SHANGHAI MICROPORT EP MEDTECH CO LTD
Filing Date
2023-11-09
Publication Date
2026-08-07

AI Technical Summary

Technical Problem

[0004]本发明的目的在于提供一种穿刺装置及介入系统,以解决如何提高穿刺靶点的定位准确性,如何降低手术成本以及如何降低手术复杂度中的至少一个问题

Benefits of technology

[0019] In summary, this invention provides a puncture device and interventional system. The puncture device includes a puncture unit and an ultrasound unit; the puncture unit includes a first catheter and a puncture needle; the puncture needle is nested within the first catheter, with its distal end extending beyond the distal end of the first catheter, for puncturing target tissue; the ultrasound unit includes an ultrasound transducer; the ultrasound transducer is positioned near the distal end of the puncture needle for identifying the thickness of the target tissue. Compared to existing technologies, the puncture device provided by this invention integrates the ultrasound transducer and the puncture needle into a single device, enabling precise positioning of the puncture target point using the combined effects of ultrasound and X-ray imaging. Furthermore, the operator only needs to operate the same device to complete the puncture, effectively reducing the complexity and cost of the procedure.

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Abstract

The application provides a puncture device and an intervention system. The puncture device comprises a puncture unit and an ultrasound unit. The puncture unit comprises a first catheter and a puncture needle. The puncture needle is nested in the first catheter, and the distal end of the puncture needle extends out of the distal end of the first catheter for puncturing a target tissue. The ultrasound unit comprises an ultrasound transducer. The ultrasound transducer is arranged close to the distal end of the puncture needle for identifying the thickness of the target tissue. Compared with the prior art, the puncture device integrates the ultrasound transducer and the puncture needle on the same device, which can not only realize the accurate positioning of the puncture target point by the combined action of ultrasound and X-ray imaging, but also can complete the puncture by operating the same device, thereby effectively reducing the complexity and cost of the operation.
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Description

Technical Field

[0001] This invention relates to the field of medical device manufacturing technology, and in particular to a puncture device and interventional system. Background Technology

[0002] Atrial septal puncture is one of the most commonly used techniques in interventional cardiology. It involves creating a pathway from the right ventricle to the left ventricle using a septal puncture needle. A key technical challenge in atrial septal puncture is obtaining the accurate puncture location. Current techniques utilize X-ray imaging to determine the puncture location intraoperatively. However, X-ray imaging only provides a two-dimensional view and cannot capture the three-dimensional spatial location of the puncture target, resulting in low accuracy in target localization. To address this, current techniques incorporate ultrasound-guided catheter-assisted localization in addition to X-ray imaging to improve puncture location accuracy. However, ultrasound-guided catheter-assisted localization requires the additional use of an ultrasound catheter and equipment, increasing the cost per procedure. Furthermore, the introduction of the ultrasound catheter often requires the operator to manipulate two instruments simultaneously, increasing the complexity of the procedure.

[0003] Therefore, there is an urgent need for a new transseptal puncture needle to solve the above-mentioned technical problems. Summary of the Invention

[0004] The purpose of this invention is to provide a puncture device and interventional system to solve at least one of the following problems: how to improve the accuracy of puncture target positioning, how to reduce surgical costs, and how to reduce surgical complexity.

[0005] To solve the above-mentioned technical problems, the present invention provides a puncture device, comprising: a puncture unit and an ultrasonic unit;

[0006] The puncture unit includes a first catheter and a puncture needle; the puncture needle is nested inside the first catheter, and the distal end of the puncture needle extends beyond the distal end of the first catheter for puncturing the target tissue;

[0007] The ultrasound unit includes an ultrasound transducer; the ultrasound transducer is positioned near the distal end of the puncture needle and is used to identify the thickness of the target tissue.

[0008] Optionally, in the puncture device, the puncture unit further includes a second catheter; the second catheter is nested within the puncture needle, and the distal end of the second catheter extends beyond the distal end of the first catheter; and the ultrasonic transducer is disposed at the distal end of the second catheter.

[0009] Optionally, in the puncture device, the outer sidewall of the proximal end of the second catheter is provided with a plurality of guide rails, and the guide rails extend radially along the second catheter to the inner sidewall of the first catheter; wherein, the sidewall of the puncture needle is provided with a plurality of through grooves, so that the guide rails pass through the corresponding through grooves and connect with the inner sidewall of the first catheter; and, the through grooves extend a predetermined distance along the axial direction of the puncture needle, so that the puncture needle can slide relative to the first catheter and the second catheter along its own axial direction.

[0010] Optionally, in the puncture device, the puncture device has a detection state and a puncture state; and in the detection state, the distal end of the puncture needle is located on the outer wall of the second catheter; in the puncture state, the distal end of the puncture needle extends toward the target tissue and away from the distal end of the second catheter.

[0011] Optionally, in the puncture device, the side wall of the puncture needle is provided with a first fluid outlet, and the side wall of the second catheter is provided with a second fluid outlet; and in the detection state, the first fluid outlet and the second fluid outlet are staggered; in the puncture state, the first fluid outlet and the second fluid outlet are connected.

[0012] Optionally, in the puncture device, the ultrasonic transducer is disposed inside the puncture needle and close to the distal end of the puncture needle.

[0013] Optionally, in the puncture device, the side of the ultrasonic transducer facing the distal end of the puncture needle is adapted to the shape of the distal end of the puncture needle, and both are pointed.

[0014] Optionally, in the puncture device, the ultrasound unit further includes a wire, one end of which is connected to the ultrasound transducer, and the other end of which is led out through the proximal end of the first catheter and / or the proximal end of the puncture needle.

[0015] Optionally, in the puncture device, the puncture device further includes a sealing sleeve, which is at least fitted over the proximal end of the puncture needle and the outer surface of the extended portion of the wire.

[0016] Optionally, in the puncture device, the puncture device further includes a handle; the handle has an inner cavity extending through its own axis, and the proximal end of the first catheter and the proximal end of the puncture needle are both disposed in the inner cavity.

[0017] Optionally, in the puncture device, the handle further has a push button; the proximal end of the puncture needle extends from the proximal end of the first catheter and is connected to the push button to move the puncture needle.

[0018] Based on the same inventive concept, the present invention also provides an interventional system, including the aforementioned puncture device.

[0019] In summary, this invention provides a puncture device and interventional system. The puncture device includes a puncture unit and an ultrasound unit; the puncture unit includes a first catheter and a puncture needle; the puncture needle is nested within the first catheter, with its distal end extending beyond the distal end of the first catheter, for puncturing target tissue; the ultrasound unit includes an ultrasound transducer; the ultrasound transducer is positioned near the distal end of the puncture needle for identifying the thickness of the target tissue. Compared to existing technologies, the puncture device provided by this invention integrates the ultrasound transducer and the puncture needle into a single device, enabling precise positioning of the puncture target point using the combined effects of ultrasound and X-ray imaging. Furthermore, the operator only needs to operate the same device to complete the puncture, effectively reducing the complexity and cost of the procedure. Attached Figure Description

[0020] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention.

[0021] Figure 1 This is a schematic diagram of the puncture device in Embodiment 1 of the present invention.

[0022] Figure 2 This is a side view of the distal end of the puncture device in Embodiment 1 of the present invention.

[0023] Figure 3 This is a schematic diagram of the puncture needle in Embodiment 1 of the present invention.

[0024] Figure 4 This is a schematic diagram of the puncture device in the detection state in Embodiment 1 of the present invention.

[0025] Figure 5 This is a schematic diagram of the puncture device in the puncture state in Embodiment 1 of the present invention.

[0026] Figure 6 This is a schematic diagram of the position of the conductor in Embodiment 1 of the present invention.

[0027] Figure 7 This is in Embodiment 1 of the present invention Figure 6 Cross-sectional view of A-A'.

[0028] Figure 8 This is a schematic diagram of the handle structure in Embodiment 1 of the present invention.

[0029] Figure 9 This is in Embodiment 1 of the present invention Figure 8 Enlarged view of the structure of region B in the middle.

[0030] Figure 10 This is a schematic diagram of the output puncture device in Embodiment 1 of the present invention.

[0031] Figure 11 This is a schematic diagram of ultrasonic detection using a puncture device in Embodiment 1 of the present invention.

[0032] Figure 12 This is a schematic diagram of the puncture device in Embodiment 1 of the present invention, in which the puncture needle is aimed at the target tissue.

[0033] Figure 13 This is a schematic diagram of the puncture device puncturing the target tissue in Embodiment 1 of the present invention.

[0034] Figure 14 This is a schematic diagram of the puncture device in Embodiment 2 of the present invention.

[0035] Figure 15 This is a schematic diagram of the handle structure in Embodiment 2 of the present invention.

[0036] Figure 16 This is a schematic diagram showing the position of the ultrasonic transducer in Embodiment 2 of the present invention.

[0037] And, in the attached image:

[0038] 101-First catheter; 102-Puncture needle; 1021-Gateway; 1022-First outlet; 1023-Proximal end; 1024-Distal end; 103-Second catheter; 1031-Guide rail; 1032-Second outlet; 201-Ultrasonic transducer; 202-Wire; 300-Sealing sleeve; 401-Shell; 402-Push button; 403-Connector; M-Adapter; Q-Puncture sheath assembly; SVC-Superior vena cava; IVC-Inferior vena cava; OF-Fornix ovalis. Detailed Implementation

[0039] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clearly illustrate the objectives of the embodiments of the present invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may have different focuses and sometimes use different scales. It should also be understood that, unless specifically stated or indicated, the terms "first," "second," "third," etc., in the specification are only used to distinguish the various components, elements, steps, etc., in the specification, and are not used to indicate the logical or sequential relationships between the various components, elements, steps, etc. Also, the definitions of "proximal" and "distal" in this document are as follows: "distal" generally refers to the end of the medical device that first enters the patient's body during normal operation, while "proximal" generally refers to the end of the medical device that is closer to the operator during normal operation; "axial" generally refers to the direction from one end of the tube towards the other end.

[0040] <Example 1>

[0041] Please see Figure 1 This embodiment provides a puncture device, including a puncture unit and an ultrasound unit; the puncture unit includes a first catheter 101 and a puncture needle 102; the puncture needle 102 is nested within the first catheter 101, and the distal end of the puncture needle 102 extends beyond the distal end of the first catheter 101 for puncturing target tissue; the ultrasound unit includes an ultrasound transducer 201; the ultrasound transducer 201 is disposed near the distal end of the puncture needle 102 for identifying the thickness of the target tissue.

[0042] As can be seen, the puncture device provided in this embodiment integrates the ultrasonic transducer 201 and the puncture needle 102 into the same device. It can not only achieve precise positioning of the puncture target by utilizing the combined effect of ultrasound and X-ray imaging, but also allow the surgeon to complete the operation by operating only the same device, effectively reducing the complexity and cost of the operation.

[0043] The following is in conjunction with the appendix Figures 1 to 13 The puncture device provided in this embodiment will be described in detail.

[0044] Please continue reading. Figure 1 The puncture device provided in this embodiment includes a puncture unit and an ultrasound unit. The puncture unit is used to puncture the target tissue, release contrast fluid, and cooperate with X-ray imaging equipment to obtain imaging information of the target tissue. The ultrasound unit is used to use ultrasound detection to identify the thickness information of the target tissue, so that the operator can determine the optimal puncture position in the target tissue.

[0045] Please see Figure 1 and Figure 2 The puncture unit includes a first catheter 101, a puncture needle 102, and a second catheter 103. The first catheter 101, the puncture needle 102, and the second catheter 103 are all hollow tubes, and are sequentially arranged from the outside to the inside. In other words, the second catheter 103 is housed within the cavity of the puncture needle 102, and the puncture needle 102 is housed within the cavity of the first catheter 101. The first catheter 101 serves as the outer tube of the puncture unit, protecting and supporting the puncture needle 102 and the second catheter 103. The distal end of the puncture needle 102 is pointed, used to puncture the target tissue to form a pathway. The second catheter 103 supports the ultrasonic transducer 201, enabling both ultrasonic and X-ray detection and improving the accuracy of target point localization.

[0046] Furthermore, the distal ends of the puncture needle 102 and the second catheter 103 both extend beyond the first catheter 101, and the distal end of the puncture needle 102 can extend beyond the distal end of the second catheter 103 to puncture the target tissue. Specifically, the outer sidewall of the proximal end of the second catheter 103 is provided with a plurality of guide rails 1031, and the guide rails 1031 extend radially along the second catheter 103 to the inner sidewall of the first catheter 101; wherein, the sidewall of the puncture needle 102 is correspondingly provided with a plurality of through grooves 1021, so that the guide rails 1031 pass through the corresponding through grooves 1021 to connect with the inner sidewall of the first catheter 101; and the through grooves 1021 extend a predetermined distance along the axial direction of the puncture needle 102, so that the puncture needle 102 can slide relative to the first catheter 101 and the second catheter 103 along its own axial direction. In other words, the guide rail 1031 is a convex guide rail and extends radially toward the inner wall of the first conduit 101 along the second conduit 103. Each through slot 1021 corresponds to one guide rail 1031 to ensure that the guide rail 1031 passes through the corresponding through slot 1021 and connects to the inner wall of the first conduit 101. This embodiment does not limit the specific number and position of the guide rails 1031 and through slots 1021. Preferably, multiple guide rails 1031 and multiple through slots 1021 are provided, and all guide rails 1031 and all through slots 1021 are evenly distributed circumferentially along the corresponding structure. Furthermore, this embodiment does not limit the specific connection position between the proximal end of the second conduit 103 and the inner wall of the first conduit 101. Optionally, the proximal end of the second conduit 103 connects to the inner wall of the distal end of the first conduit 101.

[0047] For example, the outer wall of the proximal end of the second catheter 103 is provided with two guide rails 1031, and the wall of the puncture needle 102 is provided with two corresponding through grooves 1021. The two guide rails 1031 protrude toward the inner wall of the first catheter 101 and respectively pass through the corresponding through grooves 1021 to connect with the inner wall of the distal end of the first catheter 101. Preferably, the two guide rails 1031 are 180 degrees apart in the circumferential direction of the second catheter 103 to restrict the rotation of the puncture needle 102 in the circumferential direction and effectively constrain the movement direction of the puncture needle 102.

[0048] Optionally, the guide rail 1031 is fixedly connected to the first catheter 101 by welding, bonding, or other connection methods to ensure that the position of the second catheter 103 relative to the first catheter 101 remains fixed during the sliding of the puncture needle 102. Furthermore, both the guide rail 1031 and the through groove 1021 extend axially, and the axial length of the guide rail 1031 is less than the groove length of the through groove 1021, ensuring that the puncture needle 102 can move a certain distance along its own axial direction or close to its own axial direction (deviating from the axial direction by a certain angle). It is understood that the guide rail 1031 and the through groove 1021 limit the displacement range of the puncture needle 102 to assist the operator in performing the puncture operation and prevent the puncture distance of the puncture needle 102 from being too large, thus avoiding damage to organ tissue.

[0049] Furthermore, since the first catheter 101, the puncture needle 102, and the second catheter 103 are sequentially fitted from the outside to the inside, and the puncture needle 102 can move relative to the first catheter 101 and the second catheter 103, the difference between the inner diameter of the first catheter 101 and the outer diameter of the second catheter 103 is greater than or equal to twice the wall thickness of the puncture needle 102. Preferably, the puncture needle 102 is tightly fitted against the outer wall of the second catheter 103 to achieve a seal and prevent leakage of contrast fluid and other liquids. The distal end of the puncture needle 102 is provided with a first fluid outlet 1022, and the distal end of the second catheter 103 is provided with a second fluid outlet 1032. When the puncture needle 102 punctures the target tissue, i.e., in the puncture state, the first fluid outlet 1022 moves to a position opposite to the second fluid outlet 1032, and the two are interconnected, allowing contrast fluid, saline, and other liquids to flow out sequentially through the second fluid outlet 1032 and the first fluid outlet 1022. When the puncture needle 102 is in the non-puncture state, i.e., in the probing state, the first fluid outlet 1022 and the second fluid outlet 1032 are offset from each other. That is, the first fluid outlet 1022 and the second fluid outlet 1032 are sealed by the side walls of the puncture needle 102 and the second catheter 103 to prevent fluid leakage. It should be noted that this embodiment does not limit the number and diameter of the first liquid outlet hole 1022 and the second liquid outlet hole 1032, and when multiple first liquid outlet holes 1022 and second liquid outlet holes 1032 are provided, each first liquid outlet hole 1022 and second liquid outlet hole 1032 is distributed circumferentially at intervals along the corresponding structure.

[0050] Please see Figure 3 As described above, the puncture needle 102 is placed between the first catheter 101 and the second catheter 103, and the first catheter 101 and the second catheter 103 are connected via the guide rail 1031. Therefore, to ensure convenient installation of the puncture needle 102, preferably, the puncture needle 102 is divided into two parts: a proximal end 1023 and a distal end 1024. The proximal end 1023 and the distal end 1024 also divide the through groove 1021 into two parts. When installing the puncture needle 102, the proximal end 1023 and the distal end 1024 can be moved towards each other from the proximal and distal ends of the second catheter 103, respectively, and then the two parts of the through groove 1021 are joined together to form a closed through groove 1021, which is then fitted onto the guide rail 1031 of the second catheter 103. Optionally, the proximal end portion 1023 and the distal end portion 1024 are connected by means of bonding, snap-fitting, or other methods.

[0051] Please see Figure 4 and Figure 5The ultrasonic transducer 201 is disposed at the distal end of the second catheter 103 to identify the thickness of the target tissue, thereby assisting X-ray imaging in locating the puncture target. Based on this, the puncture device has two states: a detection state and a puncture state. Figure 4 As shown, when the puncture device is in the detection state, the distal end of the puncture needle 102 is located on the outer wall of the second catheter 103. In other words, the distal end of the puncture needle 102 does not extend beyond the distal end of the second catheter 103 to avoid damage to the target tissue or other tissues caused by the sharp distal end of the puncture needle 102 during the detection process. At this time, the distal end of the puncture device is the distal end of the second catheter 103, and the distal end of the second catheter 103 is attached to the target tissue, so that the ultrasound transducer 201 can accurately detect the thickness of the target tissue, thereby allowing the operator to select the thinnest position as the puncture target point based on the thickness of each region of the target tissue. Figure 5 As shown, when the puncture device is in the puncture state, the distal end of the puncture needle 102 extends toward the target tissue and away from the distal end of the second catheter 103. In other words, when the distal end of the puncture needle 102 extends out of the second catheter 103, the pointed distal end of the puncture needle 102 is the farthest end of the puncture device, which facilitates the distal end of the puncture needle 102 piercing the target tissue through the puncture target point, thereby establishing a pathway. It should be noted that the ultrasonic transducer 201 can be in a working state in both the puncture state and the detection state to achieve ultrasonic imaging.

[0052] Please see Figure 1 , Figure 6 and Figure 7 The ultrasound unit further includes a wire 202 for transmitting signals from the ultrasound transducer 201. One end of the wire 202 is connected to the ultrasound transducer 201 via the inner cavities of the puncture needle 102 and the second conduit 103, while the other end of the wire 202 is led out from the proximal end of the puncture needle 102. It should be noted that the conduit 202 should be positioned to avoid the location of the second fluid outlet 1032 as much as possible to prevent blockage or partial blockage of the fluid passage, which would affect the outflow of fluid. Furthermore, the wire 202 in this embodiment is not limited to a single wire in the electrical field; it can be multiple wires or a group of wires.

[0053] For further details, please refer to Figure 8 and Figure 9The lead wire 202 is led out from the proximal end of the puncture needle 102 and connected to an adapter M. The adapter M is then connected to an external electronic device to generate thickness information of various regions of the target tissue based on the signal transmitted by the lead wire 202, thereby facilitating the operator to determine the optimal puncture target point. Since the lead wire 202 needs to be led out from the proximal end of the puncture needle 102, the puncture device also includes a sealing sleeve 300 to avoid the influence of the lead wire 202's exit on fluid injection. Preferably, the sealing sleeve 300 is fitted over the proximal end of the first catheter 101, the proximal end of the puncture needle 102, and the outer surface of the led wire 202 to seal the lead wire 202 exit point and prevent fluid leakage.

[0054] For further information, please refer to [link / reference]. Figure 8 and Figure 9 The puncture device also includes a handle for easy gripping and operation by the operator. The handle has a housing 401 with an axially extending cavity within it. The proximal ends of the first catheter 101 and the puncture needle 102 extend into the cavity via the distal end of the housing 401. The proximal end of the first catheter 101 is fixed to the side wall of the cavity, communicating with it. The proximal end of the puncture needle 102 is connected to a push button 402 in the handle. Specifically, the housing 401 has a strip-shaped groove; part of the push button 402 is located on the outer surface of the housing 401, while the remaining part extends through the groove and is located within the cavity, connecting with the proximal end of the puncture needle 102. Furthermore, the push button 402 is movable along the direction of the strip-shaped groove, thereby driving the puncture needle 102 to move axially. Preferably, the direction of the strip-shaped groove is axial with that of the housing 401. Therefore, based on the push button 402, in the puncture state, the operator can push the push button 402 to puncture the target tissue with the distal end of the puncture needle 102. In addition, a connector 403 is provided at the inner cavity interface at the proximal end of the housing 401 to allow connection of an external syringe, so that contrast fluid, physiological saline or heparin saline, etc., can enter the inner cavity through the connector 403, and then enter the first catheter 101, the puncture needle 102 and the second catheter 103, and flow out at least through the first outlet hole 1022 and the second outlet hole 1032.

[0055] For further explanation of the puncture device provided in this embodiment, please refer to [link to relevant documentation]. Figure 1 , Figure 9 , Figures 10 to 13 This embodiment uses puncture of the fossa ovalis (OF) as an example to illustrate the specific usage procedure of the puncture device:

[0056] First, the puncture sheath assembly Q is advanced along the guidewire from the inferior vena cava (IVC) to the superior vena cava (SVC) to reach the vicinity of the fossa ovalis (OF). The puncture sheath assembly Q serves as the delivery sheath, providing a pathway for the puncture device. Then, as... Figure 10 As shown, the guidewire is withdrawn, and the puncture device is advanced along the inner cavity of the puncture sheath assembly Q to the distal end of the puncture sheath assembly Q. It should be noted that the puncture device remains in the probing state at this time. Subsequently, as... Figure 11 As shown, pulling down the puncture sheath Q will generally produce two distinct tactile sensations, indicating that the distal end of the puncture sheath Q is aligned with the fossa ovalis OF. Then, the puncture device is pushed distally, but the distal end of the puncture device does not protrude from the inner sheath and is flush with the distal end of the inner sheath. Simultaneously, as... Figure 12 As shown, in the detection state, the puncture sheath assembly Q and the puncture device are moved to confirm the approximate position of the puncture device under X-ray assistance. Then, the thinnest point in the fossa ovalis (OF) is identified by the ultrasonic transducer 201 and used as the puncture target point. Finally, as... Figure 13 As shown, align the needle with the target point and push the knob 402 on the handle to move the puncture needle 102, thus completing the puncture. Generally, after a successful puncture, the ultrasound image should show a significant change, which the operator can use to determine whether the puncture was successful.

[0057] Based on the same inventive concept, this embodiment also provides an interventional system, including the aforementioned puncture device.

[0058] In summary, the puncture device and interventional system provided in this embodiment, by placing the ultrasonic transducer 201 on the second catheter 103 to achieve a combination with the puncture needle 102, not only can the combined effect of ultrasound and X-ray imaging be used to achieve precise positioning of the puncture target, but also the surgeon only needs to operate the same device to complete the surgery, effectively reducing the complexity and cost of the surgery.

[0059] <Example 2>

[0060] To further reduce the manufacturing cost of the puncture device and simplify its structure, this embodiment also provides a puncture device. Please refer to [link to relevant documentation]. Figures 14 to 16 This embodiment provides a puncture device, including a puncture unit and an ultrasound unit. The puncture unit includes a first catheter 101 and a puncture needle 102. The puncture needle 102 is nested within the first catheter 101, and the distal end of the puncture needle 102 extends beyond the distal end of the first catheter 101 for puncturing target tissue. The ultrasound unit includes an ultrasound transducer 201. The ultrasound transducer 201 is disposed at the distal end of the puncture needle 102 for identifying the thickness of the target tissue. For details not covered in this embodiment, please refer to the relevant description in Embodiment 1.

[0061] It is understood that in this embodiment, the ultrasonic transducer 201 is directly disposed within the puncture needle 102 and close to the distal end of the puncture needle 102. That is, the puncture needle 102 not only serves the function of puncture but also serves to support and house the ultrasonic transducer 201. Based on this, in this embodiment, one end of the wire 202 connected to the ultrasonic transducer 201 needs to extend to the distal end of the puncture needle 102, while the other end is led out through the proximal end of the puncture needle 102 or the first conduit 101 and connected to the conversion head M to realize the transmission of ultrasonic signals.

[0062] Furthermore, the proximal ends of both the first catheter 101 and the puncture needle 102 are disposed within the handle. That is, the puncture needle 102 does not need to slide relative to the first catheter 101, and both the puncture needle 102 and the proximal ends of the first catheter 101 are fixedly housed within the inner cavity of the handle's housing 401 and communicate with the inner cavity. Preferably, the housing 401 is integrally injection molded, so the gap between the lead wire 202 and the proximal end of the puncture needle 102 or the first catheter 101 is also sealed by injection molding. Therefore, in this embodiment, there is no need to provide a sealing sleeve to ensure sealing, further simplifying the structure.

[0063] Furthermore, since the ultrasonic transducer 201 is directly disposed at the distal end of the puncture needle 102, due to the circular structure of the ultrasonic transducer 201, there will be a certain gap between the distal tip of the puncture needle 102 and the ultrasonic transducer 201. Therefore, during the puncture process, the target tissue, the ultrasonic transducer 201, and the distal end of the puncture needle 102 will form a cavity. This cavity will have a negative impact during the puncture, such as causing the puncture process to be uneven or causing jamming. In addition, during the puncture process, the target tissue will compress the ultrasonic transducer 201, causing the ultrasonic transducer 201 to shift. Therefore, please refer to... Figure 16 In this embodiment, the side of the ultrasonic transducer 201 facing the distal end of the puncture needle 102 is adapted to the shape of the distal end of the puncture needle 102, and both are pointed. In other words, the shape of the ultrasonic transducer 201 matches the shape of the beveled tip of the distal end of the puncture needle 102 to eliminate the cavity. Based on this, not only can the target tissue be prevented from directly compressing the ultrasonic transducer 201, avoiding its displacement or damage, but the resistance experienced by the ultrasonic transducer 201 during puncture can also be reduced, preventing damage. Furthermore, compared to a circular plane, the beveled ultrasonic transducer 201 has a larger surface area, so with the same outer diameter, a larger surface area can result in better ultrasonic imaging quality.

[0064] It is understood that when using the puncture device provided in this embodiment to puncture the target tissue, and after confirming the location of the puncture target point through ultrasound imaging and X-ray imaging, the operator can directly push the handle to push the puncture needle 102, thereby achieving puncture of the target tissue and establishing a channel.

[0065] Based on the same inventive concept, this embodiment also provides an interventional system, including the aforementioned puncture device.

[0066] In summary, the puncture device and interventional system provided in this embodiment place the ultrasound transducer 201 on the distal end of the puncture needle 102, so that the puncture needle 102 not only performs the function of puncture but also enables ultrasound imaging and X-ray imaging, achieving precise positioning of the puncture target. Furthermore, the puncture device has a simple structure, is easy to operate, and has low manufacturing cost, effectively reducing the complexity and cost of the surgery.

[0067] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Similar or identical parts between embodiments can be referred to mutually. In addition, different parts between embodiments can also be combined with each other, and this invention does not limit this.

[0068] Furthermore, it should be understood that although the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the present invention. For any person skilled in the art, many possible variations and modifications can be made to the technical solutions of the present invention based on the disclosed technical content, or equivalent embodiments can be modified accordingly, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention, without departing from the content of the present invention, shall still fall within the scope of protection of the present invention.

Claims

1. A puncture device, characterized in that, include: Puncture unit and ultrasound unit; The puncture unit includes a first catheter, a puncture needle, and a second catheter; the puncture needle is nested within the first catheter, and the distal end of the puncture needle extends beyond the distal end of the first catheter for puncturing target tissue; the second catheter is nested within the puncture needle, and the distal end of the second catheter extends beyond the distal end of the first catheter. The ultrasound unit includes an ultrasound transducer; the ultrasound transducer is disposed at the distal end of the second catheter and close to the distal end of the puncture needle, and is used to identify the thickness of the target tissue. The puncture needle has a first fluid outlet on its side wall, and the second catheter has a second fluid outlet at its distal end. The puncture device has a detection state and a puncture state. In the puncture state, the first fluid outlet moves to a position opposite to the second fluid outlet and connects with it, so that liquid flows out sequentially through the second fluid outlet and the first fluid outlet, and the liquid includes contrast fluid. In the detection state, the first fluid outlet and the second fluid outlet are staggered and blocked by the side wall of the second catheter and the puncture needle, respectively.

2. The puncture device according to claim 1, characterized in that, The second catheter has a plurality of guide rails on its proximal outer sidewall, and the guide rails extend radially to the inner sidewall of the first catheter; wherein, the puncture needle has a plurality of through grooves on its sidewall, so that the guide rails pass through the corresponding through grooves and connect with the inner sidewall of the first catheter; and the through grooves extend a predetermined distance axially along the puncture needle, so that the puncture needle can slide relative to the first catheter and the second catheter along its own axial direction.

3. The puncture device according to claim 1 or 2, characterized in that, In the probing state, the distal end of the puncture needle is located on the outer wall of the second catheter; in the puncture state, the distal end of the puncture needle extends toward the target tissue and away from the distal end of the second catheter.

4. The puncture device according to claim 1, characterized in that, The ultrasonic transducer is disposed inside the puncture needle and near the distal end of the puncture needle.

5. The puncture device according to claim 4, characterized in that, The side of the ultrasonic transducer facing the distal end of the puncture needle is adapted to the shape of the distal end of the puncture needle, and both are pointed.

6. The puncture device according to claim 1 or 4, characterized in that, The ultrasound unit also includes a wire, one end of which is connected to the ultrasound transducer, and the other end of which is led out through the proximal end of the first catheter and / or the proximal end of the puncture needle.

7. The puncture device according to claim 6, characterized in that, The puncture device further includes a sealing sleeve, which is fitted over at least the proximal end of the puncture needle and the outer surface of the extended portion of the lead wire.

8. The puncture device according to claim 1, characterized in that, The puncture device further includes a handle; the handle has an inner cavity extending through its own axis, and the proximal end of the first catheter and the proximal end of the puncture needle are both disposed in the inner cavity.

9. The puncture device according to claim 8, characterized in that, The handle also has a push button; the proximal end of the puncture needle extends from the proximal end of the first catheter and is connected to the push button to move the puncture needle.

10. An intervention system, characterized in that, Includes the puncture device as described in any one of claims 1 to 9.

Citation Information

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