Puncture assembly and medical kit

Abstract

The puncture assembly comprises a puncture needle and a needle catheter, the near end of the puncture needle is provided with a first opening, the far end of the puncture needle is provided with a solid needle tip, the side wall of the puncture needle on the near side of the needle tip is provided with a second opening, and the puncture needle is provided with an axially-arranged inner cavity. The inner cavity extends from the first opening to the second opening, so that the first opening and the second opening are communicated with each other; the puncture needle is used for being arranged in the needle catheter in a sealed and penetrating mode and can axially move relative to the needle catheter so as to be switched between a first state and a second state, and when the puncture needle is switched to the first state relative to the needle catheter, the second opening is opened by the needle catheter; and when the puncture needle is switched to the second state relative to the needle catheter, the second opening is closed by the needle catheter. The puncture needle has the advantages of a hollow needle and a solid needle, so that the puncture efficiency is higher in the puncture process, the operation time is shortened, and the probability of adverse events such as tissue damage and embolism of a patient is reduced.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a puncture component and a medical kit. Background Technology

[0002] Puncture devices play a central role in interventional procedures and are one of the key tools for achieving minimally invasive treatments. They are primarily used to establish access to the lesion site, providing an entry point for further procedures. Puncture devices are applied in various fields, including percutaneous puncture, tumor ablation, vascular intervention, and drainage decompression. Taking Transjugular Intrahepatic Portosystemic Shunt (TIPS) as an example, TIPS is an interventional procedure used to treat portal hypertension and its complications caused by cirrhosis. Its basic principle is to establish an artificial channel within the liver using instruments such as puncture devices, directly draining portal vein blood into the hepatic vein, thereby reducing portal vein pressure.

[0003] Currently, puncture needles in puncture kits are available in solid and hollow varieties, each with its own drawbacks. When using a hollow needle to puncture liver parenchyma, the needle lumen is prone to cutting and carrying small pieces of liver tissue, which may enter the bloodstream and cause embolism, increasing surgical risks. When using a solid needle, it is necessary to withdraw the needle and use a syringe to aspirate blood and / or inject contrast agent to confirm the distal end of the puncture kit's position in the portal vein. Furthermore, if the puncture is unsuccessful, it is necessary to readjust the position, puncture again, withdraw the needle, and aspirate blood / inject contrast agent for confirmation, repeating this process. This results in low puncture efficiency, increased surgical time, and a higher risk of liver tissue damage. Therefore, a new puncture kit is needed in this field. Utility Model Content

[0004] This utility model aims to at least partially solve one of the technical problems in related technologies. Therefore, one object of this utility model is to provide a puncture assembly, comprising:

[0005] A puncture needle, wherein the proximal end of the puncture needle has a first opening, the distal end of the puncture needle has a solid needle tip, and a second opening is provided on the side wall of the puncture needle near the needle tip. The puncture needle has an axially arranged inner cavity that extends from the first opening to the second opening so that the first opening and the second opening communicate with each other.

[0006] The needle conduit is used to seal the puncture needle inside the needle conduit and can move axially relative to the needle conduit to switch between a first state and a second state. When the puncture needle is in the first state, the second opening communicates with the outside; when the puncture needle is in the second state, the second opening is closed by the needle conduit.

[0007] Preferably, the puncture needle includes a needle tube, which includes a needle tip, a side hole section, a transition section and a push section connected in sequence from the distal end to the proximal end. The second opening is provided on the side hole section, the inner cavity is provided in the needle tube, the transition section is used to reduce the resistance when the puncture needle bends, and the push section is used to transmit external forces.

[0008] Preferably, the needle catheter includes a conduit, and the needle tube is sealed inside the conduit.

[0009] Preferably, the puncture needle further includes a first connector, which is located at the proximal end of the push section and communicates with the first opening;

[0010] The needle catheter further includes a second connector, which is located at the proximal end of the catheter and has a first coupling and a second coupling with the first connector;

[0011] When the second connector is first coupled to the first connector, the puncture needle is in a second state; when the second connector is second coupled to the first connector, the puncture needle is in a first state.

[0012] Preferably, the second connector is threadedly connected to the first connector;

[0013] When the first connector and the second connector are first coupled, the screw-in amount between the first connector and the second connector is within a first range, and the puncture needle is configured in a second state.

[0014] When the first connector and the second connector are second coupled, the amount of screwing between the first connector and the second connector is within a second range, and the puncture needle is configured in a first state.

[0015] Preferably, the first connector is provided with a radially expandable first protrusion, and the inner wall of the second connector is provided with a circumferentially arranged first groove and second groove, the first groove and the second groove are axially spaced apart, and the first groove is located near the axial end of the second groove.

[0016] When the first protrusion engages with the first groove to form a first coupling, the puncture needle is configured in a second state; when the first protrusion engages with the second groove to form a second coupling, the puncture needle is configured in a first state.

[0017] Preferably, the needle cannula further includes a stop block, which is positioned between the first connector and the second connector when the first connector and the second connector are first coupled, so as to prevent the first connector and the second connector from being second coupled.

[0018] Preferably, the first connector has a male head arranged in the axial direction, and the second connector has a female head arranged in the axial direction, wherein the male head is used for threaded connection with the female head;

[0019] The male head has a second protrusion extending in the axial direction on its outer peripheral surface, and the female head has a third groove extending in the axial direction on its inner peripheral surface.

[0020] When the male and female heads rotate to the point where the second protrusion and the third groove engage with each other, the first connector and the second connector form a first coupling. When the male and female heads rotate to the end of their travel, the first connector and the second connector form a second coupling.

[0021] Another objective of this invention is to provide a medical kit comprising:

[0022] Such as the puncture components described above;

[0023] A guide component for providing a guide channel for the puncture assembly.

[0024] Preferably, the device further includes an inlet assembly, which includes an inlet sheath and at least one dilator. The inlet sheath provides an inlet channel for the guiding assembly and the dilator. The dilator is inserted through the inlet sheath to expand the puncture channel so that the inlet sheath can be accommodated in the expanded puncture channel.

[0025] The above-described solution of this utility model has at least the following beneficial effects:

[0026] The puncture assembly provided by this utility model allows for axial movement of the puncture needle and needle guide relative to each other, enabling the puncture needle and needle guide to switch between a first state and a second state. When the puncture needle is switched to the first state relative to the needle guide, the second opening communicates with the outside, allowing fluid from the body to flow in through the second opening and out through the inner cavity from the first opening, or vice versa. In this state, the structure formed by the puncture needle resembles a hollow needle. When the puncture needle is switched to the second state relative to the needle guide, the second opening is blocked by the needle guide, preventing fluid and particles from entering the inner cavity from the second opening. In this embodiment, the needle tip is solid, and the structure formed by the puncture needle resembles a solid needle. When puncture is required, the puncture needle is switched to the second state. After successful puncture, the puncture needle is switched back to the first state, and blood is drawn or contrast agent is injected to confirm the puncture effect. If the puncture fails, the puncture needle can be switched back to the second state, the position of the puncture needle adjusted, and the puncture effect reconfirmed. Therefore, the puncture assembly of this embodiment can combine the advantages of hollow needles and solid needles. In the first state, blood and / or contrast agents, drugs, saline and other liquids can be drawn without removing the puncture needle and confirming the puncture effect. In the second state, it can avoid cutting human tissue and generating debris during the puncture process, which could lead to embolism. This makes the puncture process more efficient, reduces the operation time, and reduces the probability of adverse events such as tissue damage and embolism.

[0027] Additional aspects and advantages of this invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0028] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0029] Figure 1 This is a schematic diagram of the puncture assembly provided in one embodiment of the present invention;

[0030] Figure 2a This is a schematic diagram of the structure of a puncture needle provided in one embodiment of the present invention;

[0031] Figure 2b yes Figure 2a A magnified view of a portion of the puncture needle shown;

[0032] Figure 3This is a schematic diagram of the structure of the needle provided in one embodiment of the present invention;

[0033] Figure 4 This is a schematic diagram of the transition section provided in one embodiment of the present invention;

[0034] Figure 5 This is an example diagram of the unfolded structure of the needle tip provided in one embodiment of the present invention;

[0035] Figure 6a This is a schematic diagram of a needle tip structure with microgrooves and a corresponding unfolded structure provided in one embodiment of the present invention;

[0036] Figure 6b This is a schematic diagram of a needle tip structure with microgrooves and a corresponding unfolded structure provided in another embodiment of this utility model;

[0037] Figure 7 This is a schematic diagram of the needle catheter provided in one embodiment of the present invention;

[0038] Figure 8 This is a cross-sectional view of the distal end of the needle catheter provided in one embodiment of the present invention;

[0039] Figure 9 This is a cross-sectional view of the distal end of the needle catheter and the distal end of the puncture needle in one embodiment of the present invention.

[0040] Figure 10a This is a top view of the distal end of the puncture assembly when the puncture needle is in the first state according to one embodiment of the present invention.

[0041] Figure 10b yes Figure 10a Side view of the distal end of the puncture assembly shown;

[0042] Figure 11a This is a top view of the distal end of the puncture assembly when the puncture needle is in the second state according to one embodiment of the present invention;

[0043] Figure 11b yes Figure 11a Side view of the distal end of the puncture assembly shown;

[0044] Figure 12 This is a schematic diagram of the structure of the first connector and the second connector when the stop block and the second connector are engaged in the embodiment of this utility model;

[0045] Figure 13 This is a schematic diagram of the first and second joints when the stop block deviates from the second joint according to an embodiment of the present utility model;

[0046] Figure 14This is a cross-sectional view of the second connector provided in this embodiment of the present invention;

[0047] Figure 15 This is a schematic diagram of the structure of the first connector provided in this embodiment of the utility model;

[0048] Figure 16 This is a cross-sectional view of the first connector and the second connector in the first coupling according to the embodiment of this utility model;

[0049] Figure 17 This is a schematic cross-sectional view of the first connector and the second connector during the first coupling in an embodiment of this utility model;

[0050] Figure 18 This is a cross-sectional view of the first connector and the second connector in the second coupling provided in the embodiment of this utility model;

[0051] Figure 19 This is a schematic diagram of the structure of the guiding component provided in the embodiment of this utility model;

[0052] Figure 20 This is a schematic diagram of the active tube provided in the embodiment of this utility model;

[0053] Figure 21 This is a schematic diagram of the unfolded first flexible part provided in an embodiment of the present invention;

[0054] Figure 22 This is a schematic diagram of the structure of the follower tube provided in the embodiment of this utility model;

[0055] Figure 23 This is a schematic diagram of the structure of the outer tube provided in the embodiment of this utility model;

[0056] Figure 24 This is a schematic diagram of the unfolded second flexible part provided in an embodiment of the present invention;

[0057] Figure 25 This is a schematic diagram showing the cooperation between the control component and the active tube and the follower tube provided in the embodiment of this utility model;

[0058] Figure 26 This is a schematic diagram of the structure of the import component provided in the embodiment of this utility model;

[0059] Figure 27 This is a schematic diagram of the structure of the inlet sheath provided in an embodiment of this utility model;

[0060] Figure 28 This is an exploded view of the hemostatic valve provided in the embodiments of this utility model.

[0061] Explanation of icon numbers:

[0062] 11. Puncture needle; 111. Needle tube; 1111. Needle tip; 1112. Side hole section; 1113. Transition section; 11131. Microgroove; 1114. Pushing section; 1115. First opening; 1116. Second opening; 1117. Micropore; 112. First connector; 1121. Male connector; 1121a. Second protrusion; 1122. Skirt;

[0063] 12. Needle guide; 121. Guide tube; 1211. Narrowing; 122. Second connector; 1221. Female head; 1221a. Third groove; 123. Stop;

[0064] 13. Inlet sheath; 131. Outer sheath; 132. Hemostatic valve; 133. Extension tube assembly; 1321. Valve seat; 1322. Silicone plug; 1323. Valve cover;

[0065] 14. Active tube; 141. First flexible section; 1411. First ridge; 1412. First curved section; W1. First window;

[0066] 15. Follower tube; 151. Outer tube; 1511. Second flexible section; 15111. Second ridge; 15112. Second curved section; W2. Second window;

[0067] 16. Control components; 161. Housing; 162. Screw; 163. Actuator wheel;

[0068] 17. Expander.

[0069] The realization of the purpose, functional features and advantages of this utility model will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0070] The embodiments of the present invention are described in detail below. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout.

[0071] In the description of this utility model, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "circumferential", "radial", etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model.

[0072] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this utility model, "a plurality of" means two or more, unless otherwise explicitly specified.

[0073] In this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0074] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0075] In this utility model, unless otherwise explicitly specified and limited, "proximal end" or "proximal side" refers to the end that is relatively far from the patient and close to the operator; "distal end" or "distal side" refers to the end that is relatively close to the patient and far from the operator.

[0076] The puncture assembly and medical kit of the present invention will now be described in detail with reference to the accompanying drawings. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0077] Reference Figure 1As shown, a puncture assembly provided in one embodiment of the present invention includes: a puncture needle 11 and a needle guide 12. The proximal end of the puncture needle 11 has a first opening 1115, and the distal end of the puncture needle 11 has a solid needle tip 1111. A second opening 1116 is provided on the side wall of the puncture needle 11 near the needle tip 1111. The puncture needle 11 also has an axially arranged inner cavity that extends from the first opening 1115 to the second opening 1116, so that the first opening 1115 and the second opening 1116 communicate with each other. The puncture needle 11 is used to be sealed inside the needle guide 12 and can move axially relative to the needle guide 12 to switch between a first state and a second state. When the puncture needle 11 is in the first state, the second opening 1116 communicates with the outside. When the puncture needle 11 is in the second state, the second opening 1116 is closed by the needle guide 12.

[0078] In this embodiment, the needle tip 1111 is used to puncture tissue, blood vessels, etc. For example, in TIPS surgery, the needle tip 1111 punctures the hepatic vein, liver parenchyma, and portal vein branches to form a preliminary pathway between the portal vein and the hepatic vein. The axially oriented lumen can be used to deliver drugs, blood, saline, contrast agents, or other fluids. The first opening 1115 is used to inject fluid into and withdraw fluid from the lumen. Since the second opening 1116 communicates with the lumen, fluid can flow into the lumen or out of the body through the second opening 1116.

[0079] The puncture assembly provided in this embodiment can move axially relative to the puncture needle 11 and the needle guide 12, allowing the puncture needle 11 to switch between a first state and a second state. When the puncture needle 11 is in the first state, the second opening 1116 is connected to the outside, allowing fluid in the body to flow in through the second opening 1116 and out through the inner cavity from the first opening 1115, or the fluid to flow in through the first opening 1115 and out through the inner cavity from the second opening 1116 into the body. At this time, the structure formed by the puncture needle 11 is similar to a hollow needle. When the puncture needle 11 is in the second state, the second opening 1116 is blocked by the needle guide 12, thereby preventing fluid and particles from entering the inner cavity from the second opening 1116. At the same time, in this embodiment, the needle tip 1111 is solid, and the structure formed by the puncture needle 11 is similar to a solid needle. When puncture is required, the puncture needle 11 is switched to the second state. After successful puncture, the puncture needle is switched back to the first state, and blood is drawn or contrast agent is injected to confirm the puncture effect. If the puncture fails, the puncture needle 11 can be switched back to the second state, the position of the puncture needle 11 is adjusted, and the puncture effect is confirmed again. Thus, the puncture assembly of this embodiment can overcome the disadvantages of hollow needles and solid needles. In the first state, blood can be drawn and / or contrast agents, drugs, saline, and other liquids can be injected without removing the puncture needle 11 to confirm the puncture effect. In the second state, the generation of human tissue debris during puncture can be avoided, which could lead to embolism. This makes the puncture process more efficient, reduces the operation time, and lowers the probability of adverse events such as patient tissue damage and embolism.

[0080] This embodiment does not impose any particular limitation on the specific shape of the needle tip 1111. For example, the needle tip 1111 can be a beveled tip, a tapered tip, a cutting tip, a double beveled tip, a blunt tip, etc. Figure 5 , Figure 6a as well as Figure 6b The diagram shows the unfolded shape of the needle tip 1111. In the diagram, the edge of the needle tip 1111 unfolds into a bell-shaped curve. Similarly, this embodiment does not impose any particular limitation on the method of preparing a solid needle tip. In one example, the edge shape of the needle tip 1111 can be prepared first using a hollow tube, and then the inner cavity of the hollow tube corresponding to the portion of the needle tip 1111 can be filled with metal or polymer material to seal the needle tip 1111, forming a solid needle tip 1111. In this embodiment, the filler can be in block form, for example, solder or polyethylene polymer (PE), etc., which is injected into the inner cavity of the hollow tube after melting. In this embodiment, the filler can be in sheet form, extruded into the inner cavity of the hollow tube through interference fit or other methods. As a preferred example, such as... Figure 6a , 6b As shown, one or more micropores 1117 may also be provided on the needle tip 1111 to enhance the mechanical connection strength between the filler and the needle tip 1111.

[0081] This embodiment does not impose any particular limitation on the shape of the second opening 1116. For example, the second opening 1116 can be circular, rectangular, elliptical, etc. Preferably, the second opening 1116 is rectangular or elliptical. More preferably, the longer end of the rectangular or elliptical second opening 1116 is arranged along the axial direction. Similarly, this embodiment does not impose any particular limitation on the number of second openings 1116, for example, one, two, or three. Multiple second openings 1116 are preferably arranged evenly circumferentially.

[0082] Reference Figure 2a , Figure 2b as well as Figure 3 The puncture needle 11 includes a needle tube 111 and a first connector 112. The first connector 112 is sleeved on the proximal end of the needle tube 111 and communicates with a first opening 1115. Further, the needle tip 1111 is a component of the needle tube 111 and is located at the distal end of the needle tube 111. In addition, the needle tube 111 includes a side hole section 1112, a transition section 1113, and a push section 1114 connected sequentially from the distal end to the proximal end. The side hole section 1112 is located proximal to the needle tip 1111, a second opening 1116 is provided on the side hole section 1112, and the first connector 112 is sleeved on the proximal end of the push section 1114, with its inner cavity located within the needle tube 111.

[0083] In this embodiment, the transition section 1113 is a flexible structure that is easy to bend, which helps to reduce the resistance when the puncture needle 11 passes through the guide assembly and bends. In one example, such as Figure 4 As shown, the transition section 1113 has a thallium tube structure. Specifically, the outer surface of the transition section 1113 has multiple microgrooves 11131, which are spirally spaced around the axis of the transition section 1113. These microgrooves 11131 can be used to change the rigidity of the transition section 1113, maintaining a certain degree of flexibility, thus reducing the resistance when the puncture needle 11 bends through the guide assembly during puncture. In another example, the transition section 1113 is made of a flexible material, such as a titanium alloy or nickel-titanium alloy with a low elastic modulus. Furthermore, changes in shape, cold working, and localized heat treatment can be used to make the transition section 1113 easier to bend. The pushing section 1114 can be used to transmit the external force applied during puncture.

[0084] In one example, the needle tube 111 is integrally formed. Preferably, the integrally formed needle tube 111 is made of stainless steel or nickel-titanium alloy. In another example, the needle tip 1111, side hole section 1112, transition section 1113, and push section 1114 of the needle tube 111 are each made of tubing and then fixedly connected. Preferably, the tubing material is either stainless steel or nickel-titanium alloy.

[0085] Reference Figure 7 As shown, the needle catheter 12 includes a catheter 121 and a second connector 122. The needle tube 111 is sealed inside the catheter 121. The second connector 122 is sleeved on the proximal end of the catheter 121 and has a first coupling and a second coupling with the first connector 112. When the second connector 122 is first coupled with the first connector 112, the puncture needle 11 is in a second state. When the second connector 122 is second coupled with the first connector 112, the puncture needle 11 is in a first state.

[0086] In this embodiment, the catheter 121 can be made of a thin-walled tube of PEEK (Polyether Ether Ketone) material so that it can bend with the needle tube 111. This embodiment does not particularly limit the specific method by which the needle tube 111 is sealed within the catheter 121. In one example, such as Figure 8-9 As shown, the distal end of the catheter 121 has a constriction 1211, the shape and size of which conform to the outer surface of the needle tube 111 to prevent liquid from flowing in or out of the gap between the needle tube 111 and the catheter 121. This improves the sealing effect of the second opening 1116 when the needle catheter 12 closes it, and also prevents the gap from damaging tissue. In one example, sealing rings are provided on the proximal and distal side hole sections 1112 of the second opening 1116 to prevent liquid from flowing in or out of the gap between the needle tube 111 and the catheter 121.

[0087] This embodiment does not impose any particular limitation on the specific coupling method between the second connector 122 and the first connector 112. In one example, refer to... Figure 13 and Figure 14 As shown, the second connector 122 and the first connector 112 are connected by a thread. Figure 11a , 11b As shown, when the first connector 112 and the second connector 122 are first coupled, the amount of insertion between them is small, which is within the first range. The puncture needle 11 is configured in the second state, and the distal end of the catheter 121 blocks the second opening 1116. At this time, the puncture needle 11 is similar to a solid needle. Figure 10a , 10bAs shown, when the first connector 112 and the second connector 122 are secondly coupled, the screw-in amount between them is relatively large. At this time, the screw-in amount is within the second range, and the puncture needle 11 is configured in the first state. The distal end of the catheter 121 can partially or completely not obstruct the second opening 1116, which communicates with the outside. At this time, the puncture needle 11 is similar to a hollow needle. Obviously, the second range is larger than the first range. This embodiment does not limit the specific values ​​of the first and second ranges, and they can be determined by the thread length, the axial dimension of the second opening 1116, etc. Therefore, the puncture assembly can meet the different needs at different stages of the puncture process and can combine the advantages of both hollow and solid needles.

[0088] Furthermore, the needle guide 12 also includes a stop 123. When the first connector 112 and the second connector 122 are first coupled, the stop 123 is engaged between the first connector 112 and the second connector 122 to prevent a second coupling between them. (Refer to...) Figure 12 and Figure 13 As shown, the stop 123 is pivotally connected to the second connector 122, so that the second connector 122 and the first connector 112 are limited or unlimited by the stop 123. Specifically, when the stop 123 is pivoted to engage with the second connector 122, a first coupling occurs between the first connector 112 and the second connector 122, and the first connector 112 is limited by the stop 123 and cannot be further screwed in. At this time, the puncture needle 11 is in the second state. When the stop 123 is pivoted away from the second connector 122, the first connector 112 can be further screwed in, and a second coupling occurs between the first connector 112 and the second connector 122. At this time, the puncture needle 11 is in the first state. Therefore, the puncture needle 11 can reliably switch between the first and second states, improving the ease of use of the instrument and shortening the instrument operation time.

[0089] In an alternative example, the first connector 112 has a radially retractable first protrusion (not shown); the inner wall of the second connector 122 has a circumferentially arranged first groove (not shown) and second groove (not shown), axially spaced apart, with the first groove located axially proximal to the second groove. The first protrusion can engage with the first groove to form a first coupling, in which case the puncture needle 11 is configured in a second state, and the distal end of the catheter 121 can block the second opening 1116; the first protrusion can also engage with the second groove to form a second coupling, in which case the puncture needle 11 is configured in a first state, and the distal end of the catheter 121 can partially or completely not block the second opening 1116, which communicates with the outside. Similarly, the needle catheter 12 may also include a stop 123, which, when the first protrusion in the first connector 112 is first coupled with the first groove of the second connector 122, is engaged between the first connector 112 and the second connector 122 to prevent a second coupling between the first protrusion of the first connector 112 and the second groove of the second connector 122.

[0090] In another example, refer to Figures 14 to 18 As shown, the distal end of the first connector 112 has a male head 1121 arranged in the axial direction, and the proximal end of the second connector 122 has a female head 1221 arranged in the axial direction. The male head 1121 is used for threaded connection with the female head 1221. Furthermore, the outer circumferential surface of the male head 1121 has a second protrusion 1121a extending in the axial direction, and the inner circumferential surface of the female head 1221 has a third groove 1221a extending in the axial direction. When the male head 1121 and the female head 1221 are rotated until the second protrusion 1121a and the third groove 1221a engage with each other, the first connector 112 and the second connector 122 form a first coupling; when the male head 1121 and the female head 1221 are rotated to the end of their stroke, the first connector 112 and the second connector 122 form a second coupling.

[0091] Specifically, such as Figure 14 As shown, the female head 1221 of the second connector 122 has a hollow structure, and two third grooves 1221a are provided inside the cavity of the female head 1221, preferably arranged at 180° intervals. External threads are provided on the outer circumferential surface of the female head 1221. Figure 15 As shown, the first connector 112 also includes a skirt 1122 surrounding the male head 1121. The skirt 1122 has an internal thread that matches the external thread of the female head 1221, and the male head 1121 has a pair of second protrusions 1121a spaced 180° apart. Thus, as Figure 16-17As shown, when the first connector 112 and the second connector 122 are threadedly rotated together, and the second protrusion 1121a falls into the third groove 1221a, a first coupling is formed. At this time, the puncture needle 11 is configured in the second state, and the second opening 1116 on the needle tube 111 is closed by the needle guide tube 12. Figure 18 As shown, when the first connector 112 and the second connector 122 continue to be tightened to the end of the stroke (when they can no longer be rotated), a second coupling is formed. At this time, the puncture needle 11 is configured in the first state, and the second opening 1116 on the needle tube 111 is at least partially open and not obstructed. Thus, the puncture assembly combines the advantages of both hollow and solid needles to meet different puncture needs.

[0092] Reference Figures 19 to 25 As shown, another embodiment of the present invention provides a medical kit, including: a puncture assembly as described above; a guide assembly for providing support for the puncture assembly, the guide assembly also being used to change the extension direction of the puncture assembly.

[0093] In this embodiment, the aforementioned guiding component provides a guide channel for the puncture component to pass through, thus supporting the puncture component; and the guiding component can adjust its state to change the extension direction of the puncture component. In this way, the guiding component can provide precise guidance, assisting the puncture component in completing the puncture at the desired puncture point, helping the doctor to successfully complete the surgery, reducing surgical risks and complications, and improving surgical efficiency. It is understood that the puncture component in this embodiment is largely the same as the puncture component in the above embodiments, and using the puncture component provided in this embodiment also has the beneficial effects described in the above embodiments, which will not be repeated here. Here, the change in the state of the guiding component can be from a straight state to a bent state, from a bent state to a straight state, or from a first bending angle to a second bending angle.

[0094] This embodiment does not impose any particular restrictions on the specific structure of the bootloader component. In one example, such as... Figure 19 As shown, the guiding assembly includes: an active tube 14, a follower tube 15, and a control element 16. The active tube 14 has a distal end and a proximal end; the follower tube 15 is sleeved on the active tube 14 to support the active tube 14, and the proximal and distal ends of the active tube 14 extend beyond the follower tube 15; the control element 16 is located at the proximal end of the active tube 14 and is used to control the switching of the state of the distal end of the active tube 14. For example, the distal end of the active tube 14 switches from a straight state to a bent state; the distal end of the active tube 14 switches from a bent state to a straight state; the distal end of the active tube 14 switches from one bent state to another bent state.

[0095] like Figure 20-21As shown, the distal end of the active tube 14 is provided with a flexible first portion 141, and the control member 16 is used to control the first flexible portion 141 to change its state. The first flexible portion 141 includes a circumferentially arranged first ridge 1411 and a first curved portion 1412. The first curved portion 1412 is provided with at least one first window W1 extending from one side of the first ridge 1411 and ending at the other side of the first ridge 1411, so as to reduce the rigidity of the first curved portion 1412. Preferably, the needle tip 1111 of the puncture needle 11 is configured circumferentially on the same side as the first ridge 1411. When the active tube 14 needs to be in a curved state, the first ridge 1411 can be arranged on the outer side circumferentially, so that when the puncture assembly is inserted into the guide assembly, the needle tip 1111 of the puncture needle 11 can slide along the first ridge 1411, avoiding the needle tip 1111 from getting stuck in the first window W1, thereby preventing damage to the needle tip 1111.

[0096] like Figure 22-24 As shown, the follower tube 15 includes an outer tube 151, a thickening layer, and a sleeve. The distal end of the outer tube 151 is provided with a flexible second portion 1511. The flexible second portion 1511 includes a circumferentially arranged second ridge 15111 and a second bend 15112. The bend 15112 is provided with at least one second window W2 extending from one side of the second ridge 15111 and ending at the other side of the first ridge 1411 to reduce the rigidity of the bend 15112. The first flexible portion 141 and the second flexible portion 1511 are axially corresponding, and the first ridge 1411 and the second ridge 15111 are circumferentially opposite to each other. The thickened layer covers the outer surface of the second flexible portion 1511, locally increasing the outer diameter of the follower tube 15. This allows for a tighter fit between the inner cavity of the guide component through which the bending assembly passes and the thickened layer, without increasing the overall outer diameter of the follower tube 15. Consequently, when the bending assembly passes through the guide component, the pushing resistance is minimized while ensuring a tight fit, and tissue abrasion is reduced. The sleeve is located on the outer surface of the thickened layer to reduce surface friction of the bending assembly.

[0097] like Figure 25As shown, the control component 16 includes: a housing 161, a screw 162, and an actuating wheel 163. The actuating wheel 163 is rotatable relative to the housing 161 and is at least partially housed within the housing 161. The screw 162 is movably disposed within the housing 161 and threadedly connected to the actuating wheel 163, and fixedly connected to the proximal end of the active tube 14. The housing 161 is fixedly connected to the outer tube 151. When the actuating wheel 163 is rotated, it drives the screw 162 to move axially, thereby causing the proximal end of the active tube 14 to move and change the state of the first flexible portion 141 of the active tube 14. That is, the first flexible portion 141 can be switched between a bent state and a straight state, or its bent state can be changed, for example, from a first bending angle to a second bending angle, so that it can be flexibly adjusted for different application scenarios. In this embodiment, by redundantly setting the stroke end point of the screw 162, the actuating wheel 163 can drive the screw 162 in the opposite direction, thereby causing the first flexible part 141 to bend in the opposite direction, so that the first flexible part 141 can still be in a straight state after bending fatigue.

[0098] In another alternative example, the guiding component includes: a distally flexible sheath, a control unit located at the proximal end of the sheath, at least two bending wires, the distal ends of the bending wires being connected to the distal end of the sheath, the proximal ends of the bending wires being coupled to the control unit, the control unit being used to drive a portion of the bending wires to move distally, and simultaneously drive a portion of the bending wires to move proximally, so that the distal end of the sheath is driven to change state.

[0099] Reference Figure 26-28 As shown, the medical kit also includes an insertion component, which comprises an insertion sheath 13 and at least one dilator 17. The insertion sheath 13 provides an insertion channel for the insertion component, dilator 17, and other instruments, while preventing perforation of the patient's blood vessels. The dilator 17 can be inserted into the insertion sheath 13 to expand the puncture channel, allowing the insertion sheath 13 and other instruments to be accommodated within the expanded puncture channel. Here, the puncture channel is formed by the puncture needle in the puncture kit piercing the skin to the jugular vein.

[0100] This embodiment does not impose any particular limitations on the specific structure of the inlet component, the inlet sheath 13, and the expander 17. In one example, refer to... Figure 27 and 28As shown, the inlet sheath 13 includes an outer sheath 131, a hemostatic valve 132, and an extension tube assembly 133. The outer sheath 131 provides a passage for the insertion of other instruments, such as the dilator 17 and bending devices; the hemostatic valve 132 prevents intracorporeal fluid from leaking out through the gap between the passage and the instruments housed within it; the extension tube assembly 133 facilitates the injection of saline solution into the aforementioned gap using a syringe, thereby expelling air from the gap. The dilator 17 includes, from distal to proximal, a dilator body and a dilator connector. The dilator connector is used for coupling with the inlet sheath 13.

[0101] In this embodiment, the hemostatic valve 132 includes a valve seat 1321, a silicone plug 1322, and a valve cover 1323. The proximal portion of the outer sheath 131 is inserted into the distal end of the valve seat 1321 and can be sealed and fixedly connected to it by means of adhesive bonding or other methods; the extension tube assembly 133 is sealed and fixedly connected to the inlet port on one side of the valve seat 1321 by means of adhesive bonding or other methods. The silicone plug 1322 is used to be fitted onto the instrument housed in the channel and is fitted inside the valve seat 1321. When the valve cover 1323 is coupled to the valve seat 1321 to compress the silicone plug 1322, the silicone plug 1322 undergoes a deformation that decreases axially and increases radially, thereby making closer contact with the outer surface of the instrument and the inner wall of the valve seat 1321. Thus, compression by the valve cover 1323 ensures better sealing. Furthermore, a stress diffusion structure is provided on the outer sheath tube 131 to prevent the outer sheath tube 131 from breaking due to sudden stress change at the junction of the outer sheath tube 131 and the valve seat 1321.

[0102] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0103] The above description is only a preferred embodiment of the present utility model and does not limit the patent scope of the present utility model. All equivalent structural transformations made under the inventive concept of the present utility model using the contents of the present utility model specification and drawings, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present utility model.

Claims

1. A piercing assembly, characterized by, include: A puncture needle, wherein the proximal end of the puncture needle has a first opening, the distal end of the puncture needle has a solid needle tip, and a second opening is provided on the side wall of the puncture needle near the needle tip. The puncture needle has an axially arranged inner cavity that extends from the first opening to the second opening so that the first opening and the second opening communicate with each other. The needle conduit is used to seal the puncture needle inside the needle conduit and can move axially relative to the needle conduit to switch between a first state and a second state. When the puncture needle is in the first state, the second opening communicates with the outside; when the puncture needle is in the second state, the second opening is closed by the needle conduit.

2. The piercing assembly of claim 1, wherein, The puncture needle includes a needle tube, which includes a needle tip, a side hole section, a transition section, and a push section connected sequentially from the distal end to the proximal end. The second opening is provided on the side hole section, and the inner cavity is provided in the needle tube. The transition section is used to reduce the resistance when the puncture needle bends, and the push section is used to transmit external forces.

3. The puncture assembly according to claim 2, characterized in that, The needle catheter includes a conduit, and the needle tube is sealed inside the conduit.

4. The puncture assembly according to claim 3, characterized in that, The puncture needle also includes a first connector, which is located at the proximal end of the push section and communicates with the first opening; The needle catheter further includes a second connector, which is located at the proximal end of the catheter and has a first coupling and a second coupling with the first connector; When the second connector is first coupled to the first connector, the puncture needle is in a second state; when the second connector is second coupled to the first connector, the puncture needle is in a first state.

5. The puncture assembly according to claim 4, characterized in that, The second connector is threadedly connected to the first connector; When the first connector and the second connector are first coupled, the screw-in amount between the first connector and the second connector is within a first range, and the puncture needle is configured in a second state. When the first connector and the second connector are second coupled, the amount of screwing between the first connector and the second connector is within a second range, and the puncture needle is configured in a first state, wherein the second range is greater than the first range.

6. The puncture assembly according to claim 4, characterized in that, The first connector is provided with a radially expandable first protrusion, and the inner wall of the second connector is provided with a circumferentially arranged first groove and second groove, the first groove and the second groove are axially spaced apart, and the first groove is located near the axial end of the second groove. When the first protrusion engages with the first groove to form a first coupling, the puncture needle is configured in a second state; when the first protrusion engages with the second groove to form a second coupling, the puncture needle is configured in a first state.

7. The puncture assembly according to claim 5 or 6, characterized in that, The needle cannula also includes a stop block. When the first connector and the second connector are first coupled, the stop block is positioned between the first connector and the second connector to prevent the first connector and the second connector from being second coupled.

8. The puncture assembly according to claim 4, characterized in that, The first connector has a male head arranged in the axial direction, and the second connector has a female head arranged in the axial direction, wherein the male head is used for threaded connection with the female head; The male head has a second protrusion extending in the axial direction on its outer peripheral surface, and the female head has a third groove extending in the axial direction on its inner peripheral surface. When the male and female heads rotate to the point where the second protrusion and the third groove engage with each other, the first connector and the second connector form a first coupling. When the male and female heads rotate to the end of their stroke, the first connector and the second connector form a second coupling.

9. A medical kit, characterized in that, include: The puncture assembly as described in any one of claims 1 to 8; A guide component for providing a guide channel for the puncture assembly.

10. The medical kit according to claim 9, characterized in that, It also includes an inlet component, which includes an inlet sheath and at least one dilator. The inlet sheath provides an inlet channel for the guide component and the dilator. The dilator can be inserted into the inlet sheath to dilate the puncture channel so that the inlet sheath can be accommodated in the dilated puncture channel.

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