Piercing system

Abstract

This invention relates to a puncture system, comprising: a catheter; a puncture needle; and a support assembly including a core assembly and a cannula, the cannula being fitted over the core assembly, and the cannula and core assembly being axially movable relative to each other. When the cannula is inserted into the shaping section through the proximal end of the catheter, the shaping section is in a straight state; when the cannula is withdrawn from the shaping section, the shaping section is in a bent state. The core assembly includes a connector and a stop, the stop being connected to the connector, the proximal end of the connector extending beyond the proximal end of the cannula. The stop is compressibly disposed within the cannula. When the stop is released from the cannula, the stop expands radially and abuts radially against the catheter wall at the distal end of the puncture hole. The distal end of the puncture needle can abut against the stop. This puncture system effectively enhances the anchoring stability of the catheter within the blood vessel, preventing the distal end of the catheter from detaching from the vessel wall and axial displacement, thereby solving the problems of puncture position deviation and inaccurate positioning, and has the advantages of improved puncture reliability and success rate.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to a puncture system. Background Technology

[0002] Severe limb ischemia (CLI) can lead to high amputation and mortality rates. Surgical bypass surgery and endovascular interventional procedures can effectively reduce these rates. However, more than 20% of patients, known as "desert foot," are ineligible for vascular reconstruction due to occlusion of most of the vascular bed in the foot. Venous arterialization, as an alternative, has shown clinical efficacy to some researchers. Venous arterialization includes traditional open surgery and the newly developed percutaneous endovascular intervention. While open surgical venous arterialization has achieved some clinical success, its significant surgical trauma, long operation time, extended hospital stay, and difficult postoperative recovery have led to clinical trials of percutaneous endovascular venous arterialization for "desert foot." This technique has been implemented abroad but not yet in China, and the dedicated "Limflow" system has not been introduced domestically.

[0003] Currently, the puncture needle of the Limflow system also has an opening on the side of the catheter. However, since the catheter cannot be anchored in the blood vessel, the reliability of puncture through the side opening is low. Summary of the Invention

[0004] The purpose of this invention is to at least solve the problem of poor catheter anchorage in existing puncture systems. To address the shortcomings of the prior art, a puncture system is provided.

[0005] The technical problem solved by this invention is achieved through the following technical solution: This invention provides a puncture system, comprising: The catheter has a shaping section that can switch between a straightened state and a bent state. Compared to the shaping section in the straightened state, the shaping section in the bent state is arched in a radially outward direction. In the bent state, along the radial direction of the catheter, one side of the shaping section forms an inward bend and the other side forms an outward bend. The catheter has a puncture hole located on the outward bend. A puncture needle, which is movably inserted into the catheter, and the distal end of the puncture needle can extend out of the catheter through the puncture hole; A support assembly includes a core assembly and a sleeve. The sleeve is fitted over the core assembly, and the sleeve and the core assembly are axially movable relative to each other. When the sleeve is inserted into the molding section through the proximal end of the conduit, the molding section is in a straight state; when the sleeve is removed from the molding section, the molding section is in a bent state. The core assembly includes a connector and a stop. The stop is connected to the connector, and the proximal end of the connector extends out of the proximal end of the cannula. The stop is compressibly disposed within the cannula. When the stop is released from the cannula, the stop expands radially and abuts against the wall of the catheter at the distal end of the puncture hole. The distal end of the puncture needle abuts against the stop.

[0006] The puncture system proposed in this invention, by forming an inner and outer curved side by radially arching the shaping section in a bent state, and setting the puncture hole on the outer curved side, effectively enhances the anchoring stability of the catheter in the blood vessel, avoids the distal end of the catheter detaching from the blood vessel wall and axial displacement, thereby solving the problems of puncture position deviation and inaccurate positioning. It has the advantages of improved puncture reliability and success rate. Simultaneously, by setting a support component, the shaping section can switch between a straight and curved state. The straight state of the catheter facilitates delivery within the body, while the curved state enables anchoring of the catheter in the blood vessel, thus making the catheter more adaptable and convenient. The support component includes a core component and a cannula. The core component includes a connector and a stop component. The stop component is compressibly disposed within the cannula. When the stop component is released from the cannula, it expands radially and abuts against the catheter wall radially at the distal end of the puncture hole. The distal end of the puncture needle can abut against the stop component, preventing the puncture needle from missing the puncture hole and entering other parts of the catheter, thereby improving the puncture efficiency.

[0007] Furthermore, the stop includes an opening. When the stop is released from the cannula, the opening faces the proximal end, and the distal end of the puncture needle can extend into the stop through the opening and abut against the stop. When it is necessary to retract the stop into the cannula, the proximal end of the connector is pulled, the stop flips, and the opening faces the distal end.

[0008] Furthermore, the stop member includes a dense mesh structure.

[0009] Furthermore, the interior of the dense mesh structure is covered with a membrane.

[0010] Furthermore, the coating comprises at least one of silicone, rubber, or thermoplastic polyurethane elastomer.

[0011] Furthermore, a fixing member is connected to the distal end of the connector. The fixing member is compressibly disposed within the sleeve. When the fixing member is released from the sleeve, the fixing member expands radially and is located on the distal side of the catheter, where it can radially abut against the tissue. The fixing member can be retracted into the sleeve.

[0012] Furthermore, the fastener includes a closed, sac-like structure.

[0013] Furthermore, a developing element is provided at the end of the opening.

[0014] Furthermore, the catheter includes a main body segment, a molding segment, and a guide segment connected in sequence, with the guide segment located on one side of the distal end of the molding segment.

[0015] Furthermore, the guide section is provided with a developing element, the developing element is provided with an indicating structure, and the indicating direction of the indicating structure is perpendicular to the penetration direction of the puncture hole. Attached Figure Description

[0016] 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 invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. Wherein: Figure 1 This is a schematic diagram of the puncture system after catheter removal according to an embodiment of the present invention; Figure 2 This is a schematic diagram of the puncture system according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of the catheter and support assembly in one embodiment of the present invention; Figure 4 This is a schematic diagram of another state of the catheter and support assembly in accordance with an embodiment of the present invention; Figure 5 This is a schematic diagram of the structure of a support component according to an embodiment of the present invention; Figure 6a This is a schematic diagram of the structure of a stop member according to an embodiment of the present invention; Figure 6b This is a schematic diagram of the structure of a stop member according to an embodiment of the present invention; Figure 6c This is a schematic diagram of the stop member after it has been flipped according to an embodiment of the present invention; Figure 7 This is a schematic diagram of another state of the catheter and support assembly in accordance with an embodiment of the present invention; Figure 8 This is a schematic diagram of another state of the support component according to an embodiment of the present invention; Figure 9a This is a schematic diagram of the structure of a stop member according to an embodiment of the present invention; Figure 9b This is a schematic diagram of the structure of a stop member according to an embodiment of the present invention; Figure 9c This is a schematic diagram of the stop member after it has been flipped according to an embodiment of the present invention; Figure 10This is a schematic diagram of a catheter with a first balloon according to an embodiment of the present invention; Figure 11 This is a schematic diagram of a catheter with a first balloon and a second balloon according to an embodiment of the present invention; Figure 12 This is a schematic diagram of the structure of a shaping needle according to an embodiment of the present invention; Figure 13 This is a schematic diagram of the structure of a puncture needle according to an embodiment of the present invention; Figure 14 This is a schematic diagram of the puncture needle according to another embodiment of the present invention; Figure 15 This is a cross-sectional schematic diagram of a puncture needle according to an embodiment of the present invention; Figure 16 This is a schematic diagram of the structure of a catheter with a first balloon and a second balloon according to another embodiment of the present invention; Figure 17 This is a partial structural diagram of a catheter according to an embodiment of the present invention; Figure 18 It shows Figure 17 A cross-sectional view of section AA. Figure 19 This is a schematic diagram of the puncture system of the present invention used in venous arterialization surgery to implant a guidewire into an artery; Figure 20 This is a schematic diagram of the puncture system of the present invention used in venous arterialization surgery to implant a catheter and cannula into an artery under the guidance of a guidewire; Figure 21 This is a schematic diagram illustrating the removal of the guidewire from the catheter during venous arterialization surgery using the puncture system of the present invention; Figure 22 This is a schematic diagram of the puncture system of the present invention during venous arterialization surgery, showing the removal of the cannula; Figure 23 This is a schematic diagram illustrating how, in a venous arterialization surgery, the puncture system of the present invention inserts a puncture needle into an artery under the guidance of a catheter and punctures a vein through a puncture hole. Figure 24 This is a schematic diagram of the puncture system of the present invention used in venous arterialization surgery to implant a guidewire into a vein via a puncture needle; Figure 25 This is a schematic diagram of the removal of the puncture system during venous arterialization surgery using the puncture system of the present invention. Figure 26 This is a schematic diagram of implanting vascular stents in arteries and veins under the guidance of a guidewire. Detailed Implementation

[0017] Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the invention and to fully convey the scope of the invention to those skilled in the art.

[0018] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0019] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0020] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure rotates, then an element described as "below other elements or features" or "below other elements or features" will subsequently be oriented "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations.

[0021] It should be noted that the terms "distal" and "proximal" are used as directional terms, which are commonly used in the field of interventional medical devices. "Distal" refers to the end furthest from the operator during the procedure, while "proximal" refers to the end closest to the operator. Axial direction refers to the direction parallel to the line connecting the center of the distal and proximal ends of the medical device; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0022] According to an embodiment of the present invention, a puncture system 100 is provided. Please refer to... Figure 1 , Figure 2 , Figure 10 and Figure 24 As shown, the device includes a catheter 10 and a puncture needle 20. The catheter 10 is made of polymer materials such as Pebax (polyether block amide) and PA (polyamide). A shaping segment 11 is provided near the distal end of the catheter 10. The shaping segment 11 is a tubular structure with shape memory function or elastic deformation capability. When the catheter 10 is inserted into the target location of the artery 61, the shaping segment 11 is bent under a first preset condition. The bending shape of the shaping segment 11 can be designed into various geometric shapes, such as arc, wave, or other asymmetrical curves. Its main purpose is to enable the catheter 10 to form a stable support point in the blood vessel, thereby reducing the possibility of axial movement. When the shaping section 11 is in a bent state, along the radial direction of the conduit 10, one side of the shaping section 11 forms an inner bend side 111, and the other end forms an outer bend side 112. The conduit 10 is provided with a puncture hole 113, which is located on the outer bend side 112. Specifically, the puncture hole 113 is located on the outer bend side 112, and its position can be selected in various ways. For example, the puncture hole 113 can be opened at the highest arch point of the shaping section 11, or it can be located in the area close to the arch point. The selection of its position needs to be adjusted according to the specific bending shape of the shaping section 11. In addition, the shape of the puncture hole 113 can be designed as circular, elliptical, or slit-shaped to accommodate puncture needles 20 of different sizes and types.

[0023] In some embodiments, such as Figure 2 and Figure 10 As shown, in the bent state, along the radial direction of the catheter 10, the shaping segment 11 arches from one side of the catheter 10 to the other, making the shaping segment 11 an arc-shaped tubular segment. The two sides of the shaping segment 11 along the radial direction form an inner curved side 111 and an outer curved side 112, respectively. The puncture hole 113 is set as an elliptical hole, the major axis of which is parallel to the axial direction of the catheter 10. The puncture hole 113 is located at the arched position of the shaping segment 11. When the shaping segment 11 is inserted into the artery 61 and is in a bent state under the first preset condition, the arched area of ​​the shaping segment 11 is close to the inner wall of the blood vessel, thereby making the puncture hole 113 close to the inner wall of the blood vessel and having a certain pressing effect on the inner wall of the blood vessel. When the puncture needle 20 extends out from the puncture hole 113, it can directly puncture the artery 61, improving the puncture efficiency.

[0024] In some embodiments, such as Figure 3 and Figure 4 As shown, the puncture system 100 also includes a support component 20a. The shaping segment 11 is a tubular component with elastic deformation capability. Without external force intervention, the shaping segment 11 elastically recovers to a natural bending state. Specifically, during the intervention procedure, the catheter 10 moves to the target position of the aorta 61 under the guidance of the support component 20a. When the support component 20a is not withdrawn, the shaping segment 11 is in an elastic deformation and maintains a straight shape under the constraint of the support component 20a. When the support component 20a is withdrawn, the shaping segment 11 elastically recovers to a bending state.

[0025] Among them, see Figure 3 , Figure 4 and Figure 5 The support component 20a includes a core component 20a1 and a cannula 20a2. The cannula 20a2 is sleeved outside the core component 20a1, and the cannula 20a2 and the core component 20a1 can move axially relative to each other. When the cannula 20a2 is inserted into the shaping section 11 through the proximal end of the catheter 10, the shaping section 11 is in a straight state; when the cannula 20a2 is withdrawn from the shaping section 11, the shaping section 11 is in a bent state. In this embodiment, by setting the support component 20a, the shaping section 11 can switch between a straight state and a bent state. The catheter 10 in the straight state can be easily delivered in the body, and the catheter 10 in the bent state can be anchored in the blood vessel, thereby improving the flexibility and positioning accuracy of the catheter 10 in the blood vessel. When the catheter 10 is inserted into the blood vessel, it can adapt to complex blood vessel paths and avoid jamming or accidental movement caused by excessive size, thereby ensuring the accuracy of the puncture point and the angular stability of the puncture needle 20 and the blood vessel wall.

[0026] Further, the core assembly 20a1 includes a connector 20a11 and a stop 20a12. The stop 20a12 is connected to the connector 20a11, and the proximal end of the connector 20a11 extends beyond the proximal end of the cannula 20a2. The stop 20a12 is compressibly disposed within the cannula 20a2. When the stop 20a12 is released from the cannula 20a2, the stop 20a12 expands radially and abuts radially against the wall of the catheter 10 at the distal end of the puncture hole 113. The distal end of the puncture needle 20 can abut against the stop 20a12. Figure 4 and Figure 23Understandably, after the cannula 20a2 is withdrawn from the proximal end of the catheter 10, the puncture needle 20 is inserted from the proximal end of the catheter 10. Due to the radial expansion of the stop 20a12, which abuts against the wall of the catheter 10 at the distal end of the puncture hole 113, when the distal end of the puncture needle 20 reaches the vicinity of the puncture hole 113 and abuts against the stop 20a12, the operator can quickly determine that they have reached the vicinity of the puncture hole 113. At this point, the operator only needs to slightly pull and / or rotate the puncture needle 20 proximally, and the distal end of the puncture needle 20 can then pass through the puncture hole 113. This design, on the one hand, allows for the determination of whether the operator has reached the vicinity of the puncture hole 113, and on the other hand, prevents the puncture needle 20 from missing the puncture hole 113 and entering other parts of the catheter 10, thereby improving the puncture efficiency of the puncture needle 20.

[0027] In one embodiment, see Figure 5 and Figure 6a The stop 20a12 includes an opening A. When the stop 20a12 is released from the cannula 20a2, the opening A faces the proximal end, and the distal end of the puncture needle 20 can extend into the stop 20a12 through the opening A and abut against the stop 20a12. See also Figure 7 and Figure 8 When it is necessary to retract the stop 20a12 into the cannula 20a2, pulling the proximal end of the connector 20a11 causes the stop 20a12 to flip, with opening A facing the distal end, facilitating its retraction into the cannula 20a2. Understandably, in this embodiment, one end of the stop 20a12 is connected to the connector 20a11. When the stop 20a12 is released from the cannula 20a2, it expands radially and abuts radially against the wall of the catheter 10 at the distal end of the puncture hole 113. When the proximal end of the connector 20a11 is pulled, the end of the stop 20a12 connected to the connector 20a11 moves proximally along with the connector 20a11, while at least the portion of the stop 20a12 away from the connector 20a11 abuts radially against the wall of the catheter 10, thus facilitating the flipping of the stop 20a12.

[0028] In this embodiment, see Figure 6a and Figure 6bThe stop member 20a12 includes a cylindrical structure 71 and a conical structure 72 axially connected to each other. The cylindrical structure 71 is radially expanded and located at the distal end of the puncture hole 113. The axial length of the cylindrical structure 71 that radially abuts against the wall of the conduit 10 is longer than the axial length of the conical structure 72, thereby enabling better abutment against the wall of the conduit 10. The conical structure 72 facilitates the connection between the cylindrical structure 71 and the connector 20a11. Further, in one embodiment, the radial support force of the conical structure 72 is less than the radial support force of the cylindrical structure 71. Here, the radial support force can be understood as the degree of softness or deformability. That is, the conical structure 72 is more flexible and more easily deformable than the cylindrical structure 71, thereby facilitating the flipping of the stop member 20a12.

[0029] In other embodiments, see Figure 9a and Figure 9b The stop component 20a12 can be in the form of a conical structure.

[0030] In this embodiment, the stop member 20a12 includes a dense mesh structure 73. The dense mesh structure can be understood as a mesh structure woven from metal wires, or a mesh structure formed by cutting metal tubes.

[0031] In this embodiment, see Figure 6a and Figure 9a The dense mesh structure 73 has a membrane 74 inside, which keeps the inside of the dense mesh structure 73 smooth and prevents the distal end of the puncture needle 20 from getting stuck inside the stop member 20a12, thus preventing it from passing through the puncture hole 113. See Figure 6c and Figure 9c After the stop member 20a12 is flipped over, the opening A faces the distal end, and the coating 74 is flipped onto the outer surface of the mesh structure 73, allowing the stop member 20a12 to be more smoothly inserted into the sleeve 20a2. The coating 74 comprises at least one of silicone, rubber, or thermoplastic polyurethane elastomer.

[0032] In one embodiment, an imaging element (not shown) is provided at the end of the opening A, which allows for easier and clearer observation outside the body of whether the stop 20a12 has completed its rotation, thereby improving the success rate of the surgery.

[0033] See Figure 5The distal end of the connector 20a11 is connected to a fixing member 20a3. The fixing member 20a3 is compressibly disposed within the sleeve 20a2. When the fixing member 20a3 is released from the sleeve 20a2, it expands radially and is located on the distal side of the catheter 10, where it radially abuts against the tissue. The fixing member 20a3 can be retracted into the sleeve 20a2. In this embodiment, the fixing member 20a3 is provided to further fix the axial position of the stop member 20a12, that is, to further ensure that after the stop member 20a12 expands radially, it abuts radially against the wall of the catheter 10 at the distal position of the puncture hole 113 and remains fixed in place. This prevents the stop member 20a12 from easily shifting axially even when axially abutted by the distal end of the puncture needle 20, allowing the distal end of the puncture needle 20 to quickly and accurately pass through the puncture hole 113, thus improving puncture efficiency. It is understood that in other embodiments, the fixing member 20a3 may not be provided.

[0034] In one embodiment, the fixation member 20a3 includes a closed, sac-like structure, which increases the contact area of ​​the fixation member 20a3 with the tissue, thereby improving the fixation ability of the fixation member 20a3. Furthermore, after puncture, the fixation member 20a3 can be easily retrieved into the cannula 20a2. In other embodiments, the fixation member 20a3 can also be an open structure with an opening, as long as the fixation function is achieved.

[0035] In this embodiment, see Figure 13 and Figure 15 The puncture needle 20 includes a shaping needle 21 and a polymeric membrane 22. The shaping needle 21 is a hollow, threaded metal tube. The inner lumen of the shaping needle 21 can be used to insert a guidewire. The hollow, threaded metal tube has good flexibility, which facilitates the movement of the instrument in tortuous blood vessels. The polymeric membrane 22 covers the shaping needle 21. The polymeric membrane 22 is made of PTFE (polytetrafluoroethylene) or FEP (fluorinated ethylene propylene copolymer), and its thickness is approximately 0.001 mm to 0.005 mm. The main function of the polymeric membrane 22 is to prevent the shaping needle 21 from unraveling. At the same time, the surface of the polymeric membrane 22 has low friction, which can effectively reduce the friction when the puncture needle 20 is used with the catheter 10, making needle withdrawal smoother.

[0036] In this embodiment, when the shaping section 11 of the catheter 10 is in a curved state, the shaping section 11 arches radially outward, thereby forming an inner curved side 111 and an outer curved side 112. This allows the shaping section 11 to adjust its shape according to the morphology of the blood vessel, thus providing an adaptive support base. Furthermore, when the shaping section 11 is in a curved state, the arched shaping section 11 protrudes beyond other parts of the catheter 10, allowing the shaping section 11 to be firmly supported on the inner wall of the blood vessel. This ensures that the outer curved side 112 of the shaping section 11 fits tightly against the blood vessel wall and effectively prevents axial movement of the catheter 10. The puncture hole 113 is located on the outer curved side 112 to ensure the stability of the puncture area. When the puncture needle 20 moves within the catheter 10, the distal end of the puncture needle 20 can extend out of the catheter 10 through the puncture hole 113. Because the puncture hole 113 is located on the outer curved side 112, the puncture needle 20 can naturally form a suitable angle when it extends from this position, avoiding the problem of angular deviation between the needle and the blood vessel wall. Specifically, the curved structure of the shaping section 11 provides a stable anchor point for the catheter 10, preventing the catheter 10 from moving, while the puncture hole 113 on the outer curved side 112 optimizes the puncture direction, improves the accurate positioning of the puncture point and the stability of the puncture angle, thereby solving the problems of puncture point deviation, inaccuracy and angular deviation between the needle and the blood vessel wall, and improving the accuracy and reliability of puncture.

[0037] In summary, this invention solves the problem of puncture point displacement caused by the lack of a fixed fulcrum at the distal end of the catheter 10 in the prior art by combining the curved design of the shaping segment 11 with the optimized position of the puncture port 113. Specifically, the inner curved side 111 and outer curved side 112 formed by the shaping segment 11 in its curved state can closely adhere to the blood vessel wall, providing stable support and thus preventing axial movement of the catheter 10. At the same time, the design of the puncture port 113 located on the outer curved side 112 allows the puncture needle 20 to naturally form a suitable angle when extended, avoiding angular displacement between the needle and the blood vessel wall. Thus, this technical solution achieves precise positioning and stable operation during the puncture process.

[0038] In some embodiments, such as Figure 10 , Figure 20 and Figure 21As shown, catheter 10 includes a main body segment 12, a shaping segment 11, and a guiding segment 13 connected in sequence. The guiding segment 13 is located on one side of the distal end of the shaping segment 11. The main body segment 12 is the main structure of the proximal portion of catheter 10, and its main function is to provide stability for connection with external devices. In practical applications, the main body segment 12 can be made of a medical-grade polymer material with high rigidity to ensure stable shape during operation. The shaping segment 11 is a flexible portion of catheter 10, forming a specific bending state under a first preset condition. The guiding segment 13 is an extension of the distal end of catheter 10, positioned on one side of the distal end of the shaping segment 11 to provide a direct support point for the puncture operation.

[0039] In this embodiment, the shaping segment 11, based on its bendable characteristics, forms an arched shape, which accurately positions the puncture hole 113. The guide segment 13, as an extension of the distal side of the shaping segment 11, directly abuts against the vessel wall during the puncture operation, forming a stable support point. This ensures uniform support for the catheter 10 in the axial direction, effectively preventing the distal end of the catheter 10 from moving due to suspension. Simultaneously, the guide segment 13, located on the distal side of the shaping segment 11, ensures immediate distal anchoring when the puncture needle 20 extends through the puncture hole 113 on the outwardly curved side 112. This significantly reduces puncture point displacement and angular deviation caused by catheter 10 movement, improving the accuracy and reliability of the puncture operation.

[0040] In some embodiments, such as Figure 17 As shown, the guide section 13 is provided with a developing element 30, which is an annular element and sleeved on the outside of the guide section 13. The developing element 30 is provided with an indicating structure 31, which is configured to be provided in a groove of the developing element 30. The opening of the groove is set towards the far end, and the depth direction of the groove is the indicating direction of the indicating structure 31. Furthermore, the indicating direction of the indicating structure 31 is perpendicular to the penetration direction of the puncture hole 113.

[0041] The imaging element 30 is a component that can clearly display the position under imaging equipment. The imaging element 30 is a metal marker or a coating containing contrast agent to achieve the imaging function. The purpose of setting the imaging element 30 is to provide the operator with accurate positioning of the guide segment 13 in the blood vessel. The indicator structure 31 is a visually directional form. In addition to grooves, the indicator structure 31 can also be set as, for example, an arrow, a scribing line, or other markers with directional indication function. The indicator structure 31 is used to convey relevant information about the penetration direction of the puncture hole 113. The fixed spatial relationship between the imaging element 30 and the puncture needle 20 simplifies the operator's judgment process, thereby improving the accuracy of the puncture direction.

[0042] In this embodiment, the combination of the imaging element 30 and the indicating structure 31 enables effective control of the puncture direction. The imaging element 30 provides the operator with information on the position of the guide segment 13 within the blood vessel. The indicating structure 31, through its visual shape, conveys clear directional information to the operator. When the orientation of the puncture hole 113 changes due to the bending of the catheter 10 or rotation within the blood vessel, the operator can infer the accurate penetration direction of the puncture hole 113 based on the fixed vertical relationship of the indicating structure 31. For example, when adjusting the catheter 10 to align the indicating structure 31 with the target blood vessel area, the vertical relationship automatically ensures that the puncture hole 113 faces the ideal puncture angle, thereby avoiding the problem of puncture point deviation caused by directional deviation, further improving the stability and accuracy of the puncture operation, and solving the problem of insufficient puncture reliability due to the lack of a directional indicating device. The operator can more precisely control the needle exit direction of the puncture needle 20, significantly improving the success rate and reliability of the puncture, while reducing the surgical risks caused by puncture point deviation or angle deviation.

[0043] In some embodiments, such as Figure 10 As shown, the puncture system 100 also includes a first balloon 41, which is fitted onto the guide segment 13. The first balloon 41 is a flexible structure that can be inflated with air or liquid. The first balloon 41 can be made of a high-molecular elastic material, such as polyurethane or silicone. The purpose of setting the first balloon 41 is to achieve stable anchoring of the distal end of the catheter 10 by tightly adhering to the inner wall of the blood vessel after inflation. In this embodiment, the catheter 10 is a double-lumen tube, which includes a first lumen and a second lumen. The first lumen contains a guidewire and a puncture needle 20. The second lumen communicates with the first balloon 41 and is used to inflate the first balloon 41 with liquid or gas, or to withdraw the liquid or gas from the first balloon 41, so as to achieve the expansion and contraction of the first balloon 41.

[0044] In other embodiments, such as Figure 11As shown, the puncture system 100 also includes a first balloon 41 and a second balloon 42. The first balloon 41 is fitted onto the guide segment 13, and the second balloon 42 is positioned on the main body segment 12 near the shaping segment 11. The dual-balloon design allows the operator to choose to use one or both balloons simultaneously as needed, providing a stronger anchoring effect in complex vascular pathways and simplifying the operation process in simple pathways. In this embodiment, the catheter 10 is a three-lumen tube, which includes a first lumen, a second lumen, and a third lumen. The first lumen contains a guidewire and a puncture needle 20. The second lumen communicates with the first balloon 41, and the third lumen communicates with the second balloon 42. The second lumen is used to fill the first balloon 41 with liquid or gas medium, or to withdraw the liquid or gas medium from the first balloon 41, so as to realize the expansion and contraction of the first balloon 41. The third lumen is used to fill the second balloon 42 with liquid or gas medium, or to withdraw the liquid or gas medium from the second balloon 42, so as to realize the expansion and contraction of the second balloon 42.

[0045] In this embodiment, a balloon is used to address the stability issue of the catheter 10 within the blood vessel. When the first balloon 41 and the second balloon 42 are inflated, the distal end of the catheter 10 is firmly fixed to the inner wall of the blood vessel, effectively preventing axial movement of the distal end of the catheter 10 due to a lack of support. This technical solution not only solves the problem of the catheter 10's inability to be stably anchored within the blood vessel, but also enhances the system's adaptability to different clinical scenarios through flexible balloon configuration, significantly improving the accuracy and reliability of the puncture procedure.

[0046] In some embodiments, such as Figure 17 and Figure 18 As shown, the puncture system 100 also includes an annular component 14, which is disposed on the inner wall of the catheter 10 and surrounds the puncture hole 113. The hardness of the annular component 14 is greater than that of the catheter 10. The annular component 14 is a component with high hardness and can be made of metal, high-hardness polymer, or composite material to enhance the structural stability around the puncture hole 113. The shape of the annular component 14 can be circular, elliptical, or other geometric shapes adapted to the inner wall of the catheter 10. The thickness and width of the annular component 14 can be adjusted according to actual needs to effectively prevent deformation or tearing of the edge of the puncture hole 113 during the puncture process.

[0047] Specifically, the annular member 14 is disposed on the inner wall of the catheter 10 and surrounds the puncture hole 113. Its high rigidity provides stable support when the distal end of the puncture needle 20 abuts near the puncture hole 113. When the distal end of the puncture needle 20 moves to the puncture hole 113, the presence of the annular member 14 allows the puncture needle 20 to move relatively smoothly along the inner surface of the annular member 14, preventing the puncture needle 20 from embedding in the polymer material of the inner wall of the catheter 10. This improves the accuracy of the puncture and ensures the stability of the puncture angle, thereby significantly improving the reliability of the puncture operation. It should be noted that the annular member 14 is embedded within the catheter 10 so that the side of the annular member 14 facing inwards is flush with or smoothly transitions to the inner wall of the catheter 10, allowing the puncture needle 20 to slide smoothly from the inner wall of the catheter 10 to the annular member 14.

[0048] In this embodiment, the area around the puncture hole 113 of the puncture system 100 is effectively reinforced, avoiding deformation or tearing of the edge of the puncture hole 113 that may occur during the puncture process, thereby achieving a more accurate and reliable lateral puncture operation.

[0049] In some embodiments, such as Figure 12 , Figure 13 and Figure 14 As shown, the distal end of the shaping needle 21 is provided with a puncture section 201. Along the radial direction of the puncture needle 20, at least one incision 2011 is provided on one side of the puncture section 201. By setting the incision 2011, the puncture section 201 has higher bending performance compared to other areas of the puncture needle 20. Specifically, the puncture section 201 is a functional area at the distal end of the puncture needle 20 specifically used for performing puncture operations. The puncture section 201 can be achieved by a metal processing technology that sets a specific shape or structure at the distal end of the puncture needle 20, with the aim of concentrating and strengthening the puncture function and improving puncture efficiency. The incision 2011 is a groove-like structure opened along the radial direction of the puncture needle 20. The incision 2011 can be formed by laser cutting, machining, or chemical etching. The purpose of setting the incision 2011 is to allow the puncture needle 20 to produce moderate and directional elastic bending deformation when it performs puncture and contacts the blood vessel wall, thereby adapting to the curvature changes of the blood vessel wall and maintaining the consistency of the puncture angle.

[0050] In detail, the puncture needle 20 is made of nickel-titanium tubing. After heat setting, the nickel-titanium tubing has a small bending angle and greater stress on the curved side. When the puncture needle 20 is used in conjunction with the catheter 10, it will cause the catheter 10 to bend, making it difficult to insert the puncture needle 20 into the catheter 10. The design of setting an incision 2011 on the small curved side in this embodiment to reduce stress can effectively solve the above problem. The outer polymer film prevents the guidewire from being overselected from the incision 2011 on the small curved side when it enters the inner lumen of the puncture needle 20.

[0051] The cutout 2011 can be configured in various structural forms; for example, in some embodiments, such as Figure 13 As shown, there is one incision 2011, which is configured as an elliptical hole, with its major axis parallel to the axis of the puncture needle 20. In other embodiments, such as Figure 14 As shown, the puncture section 201 has multiple incisions 2011, each with a groove-like structure. The depth direction of the incisions 2011 is inclined relative to the axial direction of the puncture needle 20, and the openings of the incisions 2011 face proximally. Multiple incisions 2011 are spaced apart sequentially along the axial direction of the puncture needle 20. In this embodiment, the bending angle θ of the puncture needle 20 is typically between 10° and 60°.

[0052] In some implementations, the puncture system 100 also includes a restraint tube (not shown in the figure), which is movably fitted over the puncture needle 20 and inserted into the catheter 10. Specifically, the restraint tube is a tubular structure capable of binding the puncture needle 20. The restraint tube can be made of a medical polymer material with appropriate elastic modulus and flexibility, such as polyurethane or polytetrafluoroethylene. The inner diameter of the restraint tube is slightly larger than the outer diameter of the puncture needle 20 to ensure that the puncture needle 20 can move smoothly within it. Through the binding effect of the restraint tube, the pre-bent puncture needle 20 is kept in a straight position during delivery.

[0053] In detail, when the distal end of the puncture needle 20 has a puncture section 201 with an incision 2011, a movable restraint tube is provided to ensure stable delivery of the puncture needle 20 within the catheter 10. The restraint tube is sleeved on the outside of the puncture needle 20. When a puncture operation is required, the pre-bent puncture needle 20 is first placed into the restraint tube, binding the puncture needle 20 into a straight tube structure. Then, the puncture needle 20 with the restraint tube is inserted entirely into the catheter 10. Due to the presence of the restraint tube, the movement of the puncture needle 20 within the catheter 10 is smoother and will not deviate due to the bending of the catheter 10. When the puncture needle 20 reaches the puncture hole 113 of the shaping section 11 of the catheter 10, the pre-bent shape of the puncture needle 20 is released by withdrawing the restraint tube, allowing it to accurately extend from the puncture hole 113 and complete the puncture operation. This ensures the accuracy of the puncture point and the stability of the puncture angle, effectively improving the operational accuracy and reliability of the puncture system 100.

[0054] In some embodiments, such as Figure 17As shown, this application further proposes that in the bent state, the shaping section 11 is an arc-shaped bend, and the central angle α of the shaping section 11 ranges from 60° to 120°. For example, α can be set to 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 110°, 120°, etc. In this embodiment, by designing the shaping section 11 as an arc-shaped bend and limiting its central angle range, the catheter 10 can fit more closely to the vessel wall inside the blood vessel, thereby forming a reliable support point. This not only effectively reduces local stress concentration but also ensures that the puncture hole 113 can be located on the outer bend side 112, thereby improving the axial positional stability of the puncture needle 20 when it is extended. At the same time, since the central angle of the shaping section 11 is controlled within a reasonable range, the catheter 10 can arch sufficiently in the bent state without shaking due to excessive bending, thereby significantly reducing the risk of puncture point deviation.

[0055] In this embodiment, the anchoring ability of the catheter 10 in the blood vessel is significantly improved, which enhances the stability of the puncture needle 20 when it is withdrawn, thereby effectively solving the problem of puncture point displacement and angle deviation caused by the movement of the catheter 10 during the puncture process.

[0056] In some embodiments, such as Figure 16 As shown, the catheter 10 has multiple shaping segments 11, which are arranged sequentially and at intervals along the axial direction of the catheter 10. Specifically, the multiple shaping segments 11 refer to several structural units with bending capabilities distributed on the catheter 10. The multiple shaping segments 11 can bend under specific conditions, thereby forming a stable contact support with the inner wall of the blood vessel. This multi-point fixation method improves the overall stability of the catheter 10 and avoids puncture deviation problems caused by insufficient support at a single point.

[0057] Furthermore, a multi-point support structure is formed by the spaced distribution of multiple molded segments 11 along the axial direction of the catheter 10. When the molded segments 11 are in a bent state, the inner curved side 111 and the outer curved side 112 of each molded segment 11 work together to disperse the axial stress on the catheter 10, while avoiding stress concentration. This allows each molded segment 11 to independently perform its support function and prevents the catheter 10 from slipping as a whole. On this basis, when the puncture needle 20 extends from the puncture hole, the multi-point support structure effectively inhibits the axial movement of the distal end of the catheter 10, maintaining the relative fixation between the puncture hole 113 and the vessel wall. In addition, the design of multiple molded segments 11 can adapt to vascular environments of different diameters and shapes, further enhancing the applicability and operational reliability of the catheter 10. Understandably, the core assembly 20a1 includes a connector 20a11 and multiple stops 20a12, with the stops 20a12 connected to the connector 20a11. The stops 20a12 are respectively positioned at the distal ends of the puncture holes 113 in different molding sections 11. Alternatively, the core assembly 20a1 may comprise multiple sets, each set including a connector 20a11 and a stop 20a12, with each stop 20a12 positioned at the distal end of the puncture hole 113 in each molding section 11.

[0058] In some embodiments, the puncture system 100 further includes a first balloon 41, which is fixedly disposed on the inner curved side 111 of the molding section 11. The first balloon 41 is a flexible structure that can be inflated with air or liquid. The first balloon 41 can be made of a high-molecular elastic material, such as polyurethane or silicone. The purpose of setting the first balloon 41 is to achieve stable anchoring of the distal end of the catheter 10 by tightly adhering to the inner wall of the blood vessel after inflation. In this embodiment, the catheter 10 is a double-lumen tube, which includes a first lumen and a second lumen. The first lumen is provided with a guidewire and a puncture needle 20. The second lumen communicates with the first balloon 41 and is used to inflate the first balloon 41 with liquid or gas medium, or to withdraw the liquid or gas medium from the first balloon 41, so as to realize the expansion and contraction of the first balloon 41.

[0059] In other embodiments, such as Figure 16As shown, the puncture system 100 also includes a first balloon 41 and a second balloon 42. The first balloon 41 is fixedly disposed on the inner curved side 111 of one molding section 11, and the second balloon 42 is disposed on the inner curved side 111 of another molding section 11. In this embodiment, the catheter 10 is a three-lumen tube, which includes a first lumen, a second lumen, and a third lumen. The first lumen contains a guidewire and a puncture needle 20. The second lumen communicates with the first balloon 41, and the third lumen communicates with the second balloon 42. The second lumen is used to fill the first balloon 41 with liquid or gas medium, or to withdraw the liquid or gas medium from the first balloon 41, so as to realize the expansion and contraction of the first balloon 41. The third lumen is used to fill the second balloon 42 with liquid or gas medium, or to withdraw the liquid or gas medium from the second balloon 42, so as to realize the expansion and contraction of the second balloon 42.

[0060] In this embodiment, when the first balloon 41 and the second balloon 42 are inflated, the shaping section 11 of the catheter 10 can be firmly fixed on the inner wall of the blood vessel, effectively avoiding axial movement of the distal end of the catheter 10 due to lack of support points, solving the problem that the catheter 10 cannot be stably anchored in the blood vessel, and significantly improving the accuracy and reliability of the puncture process.

[0061] In some embodiments, such as Figure 1 , Figure 2 , Figure 23 and Figure 24 As shown, the puncture system 100 also includes a fixed handle 51, a push handle 52, a handle end cap 53, a limiting slider 54, a connecting nut 55, and a Y valve 56. The proximal end of the conduit 10 is connected to the Y valve 56, and the proximal end of the Y valve 56 is detachably fixed to the distal end of the fixed handle 51 by a connecting nut. The handle end cap 53 is located at the proximal end of the fixed handle 51. The limiting slider 54 is rotatably connected to the handle end cap 53. The push handle 52 passes through the limiting slider 54, and the proximal end of the push handle 52 is located inside the fixed handle 51 and slidably connected to the fixed handle 51, so that the push handle 52 can slide axially relative to the fixed handle 51. The proximal end of the puncture needle 20 is located inside the fixed handle 51 and connected to the push handle 52, thereby using the push handle 52 to push the puncture needle 20 to perform the puncture action. A locking structure is provided between the limiting slider 54 and the push handle 52, and the push handle 52 can be locked or unlocked by rotating the limiting slider 54.

[0062] In some embodiments, at least a portion of the outer curved side 112 of the shaping segment 11 is configured as a flexible region, the puncture hole 113 is located within the flexible region, and the material hardness of the flexible region is lower than that of other regions of the shaping segment 11. For example, the flexible region and other regions of the shaping segment 11 are fused together using Pebax materials of different hardness. This configuration allows the flexible region with the puncture hole 113 to better conform to the deformation of the shaping segment 11 after the shape transition between a bent state and a straight state, preventing the area around the puncture hole 113 from lifting up and scratching the blood vessel wall when the shaping segment 11 is in a straight state.

[0063] In some embodiments, the distal end of the catheter 10 is configured as an oblique opening, allowing the distal end of the catheter 10 to better adhere to the vessel wall and improve the anchoring force of the catheter 10. Specifically, a conventional flat-ended catheter 10 has a distal end face that is a plane perpendicular to the axis of the catheter 10. When in contact with the vessel wall, it is only a circular line contact or a point contact, resulting in a small contact area. This makes it susceptible to displacement due to blood flow impact or movement of the puncture needle 20. In this embodiment, the distal end of the catheter 10 is configured as an oblique opening, with the distal end face of the catheter 10 forming an angle of 15°-45° with the axis of the catheter 10, creating an oblique cut. When the catheter 10 is inserted into the vessel, the oblique cut can form local surface contact with the vessel wall (arc-shaped surface). The elastic restoring force of the vessel wall will generate lateral pressure on the oblique cut, further increasing the frictional resistance F and preventing axial displacement or rotation of the catheter 10.

[0064] In this embodiment, the operation procedure of the puncture system 100 during the venous 62 and arterial 61 puncture surgery is as follows: like Figure 19 , Figure 20 , Figure 21 and Figure 22 As shown, guidewire 63 is inserted into artery 61 to the lesion location in sequence, and catheter 10 and cannula 20a2 are inserted along guidewire 63. Under the action of cannula 20a2, the shaping section 11 of catheter 10 will straighten to facilitate delivery. After the catheter 10 reaches the designated position, the imaging element 30 is observed under the guidance of X-ray until the catheter 10 is rotated to the required puncture site. The guide wire 63 is withdrawn, and then the core assembly 20a1 is delivered through the cannula 20a2. The cannula 20a2 is slowly withdrawn. First, the fixation element 20a3 is released, so that the fixation element 20a3 expands and abuts against the inner wall of the artery 61. Then, the stop element 20a12 is released until the cannula 20a2 leaves the shaping section 11, so that the shaping section 11 naturally returns to the bent shape, so that the catheter 10 is anchored in the blood vessel. At this time, the puncture hole 113 opened on the arch back (i.e., the outward curved side 112) of the shaping section 11 of the catheter 10 presses against the inner wall of the artery 61. Finally, the cannula 20a2 is completely withdrawn from the catheter 10.

[0065] like Figure 23As shown, the puncture needle 20 is inserted into the hollow lumen of the Y-valve 56 of the catheter 10. The connecting nut 55 is tightened to the Y-valve 56, the limiting slider 54 is unlocked, and the push handle 52 is pushed to activate the system to extend the needle, allowing the needle tip to pass through the vessel wall of the artery 61 and the vessel wall of the vein 62 in sequence. After the puncture is completed, contrast agent can be introduced through the side branch Luer connector of the Y-valve 56 to confirm whether the puncture was accurate. Figure 24 and Figure 25 As shown, a relatively soft guidewire 65 is then inserted along the tail end of the push handle 52 and inserted into the vein 62. The push handle 52 is withdrawn so that the puncture needle 20 is fully retracted into the catheter 10 until the puncture needle 20 is withdrawn from the catheter 10. Then, the cannula 20a2 is inserted along the catheter 10, and the fixation member 20a3 and the core assembly 20a1 are retracted into the cannula 20a2. Finally, the entire puncture system 100 is slowly withdrawn.

[0066] like Figure 25 As shown and Figure 26 As shown, guidewire 65 is left in artery 61 and vein 62. Then, a suitable delivery system is selected to pass through artery and vein 62 sequentially along guidewire 65. The vascular stent 64 is released to allow blood from artery 61 to be drained into vein 62. Finally, guidewire 65 is withdrawn.

[0067] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A puncture system, characterized in that, include: The catheter has a shaping section that can switch between a straightened state and a bent state. Compared to the shaping section in the straightened state, the shaping section in the bent state is arched in a radially outward direction. In the bent state, along the radial direction of the catheter, one side of the shaping section forms an inward bend and the other side forms an outward bend. The catheter has a puncture hole located on the outward bend. A puncture needle, which is movably inserted into the catheter, and the distal end of the puncture needle can extend out of the catheter through the puncture hole; A support assembly includes a core assembly and a sleeve. The sleeve is fitted over the core assembly, and the sleeve and the core assembly are axially movable relative to each other. When the sleeve is inserted into the molding section through the proximal end of the conduit, the molding section is in a straight state; when the sleeve is removed from the molding section, the molding section is in a bent state. The core assembly includes a connector and a stop. The stop is connected to the connector, and the proximal end of the connector extends out of the proximal end of the cannula. The stop is compressibly disposed within the cannula. When the stop is released from the cannula, the stop expands radially and abuts against the wall of the catheter at the distal end of the puncture hole. The distal end of the puncture needle abuts against the stop.

2. The puncture system according to claim 1, characterized in that, The stop includes an opening, which faces the proximal end when the stop is released from the cannula, and the distal end of the puncture needle can be inserted into the stop through the opening to abut against the stop. When it is necessary to retract the stop into the sleeve, pull the proximal end of the connector, and the stop flips over, with the opening facing the distal end.

3. The puncture system according to claim 2, characterized in that, The stop member includes a dense mesh structure.

4. The puncture system according to claim 3, characterized in that, The interior of the dense mesh structure is covered with a membrane.

5. The puncture system according to claim 4, characterized in that, The coating comprises at least one of silicone, rubber, or thermoplastic polyurethane elastomer.

6. The puncture system according to claim 3, characterized in that, The distal end of the connector is connected to a fixing member, which is compressibly disposed within the cannula. When the fixing member is released from the cannula, it expands radially and is located on the distal side of the catheter, where it can radially abut against the tissue. The fixing member can be retracted into the cannula.

7. The puncture system according to claim 6, characterized in that, The fastener includes a closed, sac-like structure.

8. The puncture system according to claim 2, characterized in that, A developing element is provided at the end of the opening.

9. The puncture system according to claim 1, characterized in that, The catheter includes a main body segment, a shaping segment, and a guide segment connected in sequence, with the guide segment located on one side of the distal end of the shaping segment.

10. The puncture system according to claim 9, characterized in that, The guide section is provided with a developing element, and the developing element is provided with an indicating structure. The indicating direction of the indicating structure is perpendicular to the penetration direction of the puncture hole.

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