Atrial septum puncture needle and atrial septum puncture system

Abstract

The utility model provides an atrial septum puncture needle and an atrial septum puncture system, the atrial septum puncture needle comprises a needle tube and a needle tip, and the needle tip is connected to the far end of the needle tube; the needle point has a first puncture mode and a second puncture mode, the needle point is electrically connected with energy source equipment in the first puncture mode, a target object is punctured through discharging, and the needle point mechanically punctures the target object in the second puncture mode; a height difference exists at the joint of the needle tube and the needle tip, the surface of the needle tube is covered with an insulating layer, and the thickness of the insulating layer is matched with the height difference. Therefore, pure physical atrial septum puncture can be completed when facing normal atrial septum tissue, an energy source can be used for assisting in completing stoma when facing specific diseased tissue, meanwhile, during puncture, the atrial septum puncture needle is in smooth transition, no abrupt step exists, and the puncture process can be smooth.

Description

Technical Field

[0001] The utility model relates to the field of medical technology, in particular to an atrial septal puncture needle and an atrial septal puncture system. Background Art

[0002] With the development of science and technology, medical devices are constantly being updated and iterated. Among them, the atrial septal puncture needle is a puncture product that creates a pathway in the heart. It is widely used in heart-related surgeries, such as left atrial appendage occlusion, left atrium cryoballoon ablation, radiofrequency ablation, and other required procedures. For this purpose, a gap is created to provide a pathway from the right heart to the left heart. Traditional products used for atrial septal puncture are mechanical pure physical punctures. The difficulty of puncturing the target tissue mainly depends on the sharpness of the puncture tip. The sharper the puncture tip, the easier it is to break through the target tissue during puncture. Of course, the sharper the puncture tip, the higher the risk. Possible problems include, but are not limited to, the following: heart perforation, pericardial effusion, etc., or when the puncture needle is used with the inner sheath used with it, the inner sheath is peeled off, causing foreign matter to enter the human body and cause embolism.

[0003] In order to improve the above situation, radiofrequency atrial septal puncture needles have appeared on the market. The distal end of this type of product is a completely blunt structure, and it is impossible to complete the puncture independently without an energy source. The advantage of this is that it can reduce or avoid some of the above safety issues. And because of the introduction of the energy source, it is easier to puncture the oval fossa with fibrosis, calcification and other lesions. And it can also be used for puncturing normal atrial septal tissue. However, due to the blunt structure, energy puncture must be used when it is not necessary. The resulting gap has a longer healing period than pure mechanical puncture. Utility Model Content

[0004] The utility model aims to provide an atrial septal puncture needle and an atrial septal puncture system to solve one or more problems existing in the prior art.

[0005] In order to solve the above problems, the utility model provides an atrial septal puncture needle, comprising: a needle tube and a needle tip, wherein the needle tip is connected to the distal end of the needle tube;

[0006] The needle tip has a first puncture mode and a second puncture mode. In the first puncture mode, the needle tip is electrically connected to the energy source device to puncture the target object by discharging. In the second puncture mode, the needle tip mechanically punctures the target object.

[0007] At the connection point between the needle tube and the needle tip, relative to the axis of the needle tube, the outer surface of the needle tip is higher than the outer surface of the needle tube, thereby forming a height difference, and the surface of the needle tube is covered with an insulating layer, and the thickness of the insulating layer matches the height difference. Optionally, in the atrial septal puncture needle, the needle tip includes a connecting portion extending along the axial direction, and the connecting portion is sleeved on the needle tube or plugged into the distal end of the needle tube to achieve the connection between the needle tip and the needle tube.

[0008] Optionally, in the atrial septal puncture needle, the distal end portion of the needle tube has a first channel penetrating the side wall, and the first channel is connected to the inner cavity of the needle tube.

[0009] Optionally, in the atrial septal puncture needle, the needle tube includes a first part and a second part, the distal end of the first part is fixedly connected to the needle tip, and the proximal end of the first part is detachably connected to the second part.

[0010] Optionally, in the atrial septal puncture needle, the first part has a second channel penetrating the side wall, and after the second part is connected to the first part, at least a portion of the second channel remains connected to the inner cavity of the first part.

[0011] Optionally, in the atrial septal puncture needle, the second part has a docking portion, and the docking portion is used to extend into the inner cavity of the first part along a direction parallel to the axis to achieve connection between the first part and the second part;

[0012] The side wall of the first part has a notch extending from the proximal end toward the distal end. After the first part and the second part are connected, the docking portion blocks the connection between part of the notch and the inner cavity of the first part, and the remaining part of the notch forms the second channel.

[0013] Optionally, in the atrial septal puncture needle, the needle tube includes a first tube segment and a second tube segment, and the needle tip, the first tube segment and the second tube segment are connected in sequence from the distal end to the proximal end; the outer diameter of the second tube segment is greater than the outer diameter of the first tube segment.

[0014] Optionally, in the atrial septal puncture needle, the first tube segment includes an expanded diameter segment, the inner diameter of the expanded diameter segment matches the outer diameter of the second tube segment, and the expanded diameter segment is sleeved on a portion of the second tube segment to achieve connection between the first tube segment and the second tube segment.

[0015] Optionally, in the atrial septal puncture needle, the distal end of the second tube segment has a bevel chamfer, and the bevel chamfer allows a gap to exist between the second tube segment and the expanded diameter segment, and the gap is used to fill with solder.

[0016] Optionally, in the atrial septal puncture needle, the first tube segment and the second tube segment are integrally formed by stretching, and / or the first tube segment and the needle tip are integrally formed by extrusion.

[0017] Optionally, the atrial septal puncture needle further includes a handle, which is connected to the proximal end of the needle tube. The handle is electrically connected to the energy source device through a tail wire to ensure electrical conduction between the needle tip and the energy source device.

[0018] Optionally, in the atrial septal puncture needle, the handle is electrically connected to the three-dimensional system via a tail wire, so that electrical conduction is achieved between the needle tip and the three-dimensional system.

[0019] The utility model also provides an atrial septal puncture system, comprising:

[0020] Energy source equipment;

[0021] Three-dimensional systems; and,

[0022] The transseptal puncture needle as described in any of the preceding items is selectively electrically connected to one or both of the energy source device and the three-dimensional system.

[0023] In summary, the atrial septum puncture needle and atrial septum puncture system provided by the utility model include: a needle tube and a needle tip, the needle tip is connected to the distal end of the needle tube; the needle tip has a first puncture mode and a second puncture mode, the needle tip is electrically connected to the energy source device in the first puncture mode, and punctures the target object by discharging, and the needle tip mechanically punctures the target object in the second puncture mode; at the connection between the needle tube and the needle tip, relative to the axis of the needle tube, the outer surface of the needle tip is higher than the outer surface of the needle tube, thereby forming a height difference, and the surface of the needle tube is covered with an insulating layer, and the thickness of the insulating layer matches the height difference. The atrial septum puncture needle can normally complete the purely physical atrial septum puncture when facing normal atrial septum tissue, and can also use the energy source to assist in completing the stoma when facing specific pathological tissue. At the same time, when performing the puncture, the distal part of the atrial septum puncture needle has a smooth transition without abrupt steps, which can make the puncture process smooth. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Those skilled in the art will appreciate that the drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0025] Figure 1 A schematic diagram of the overall structure of the atrial septal puncture needle provided in an embodiment of the utility model;

[0026] Figure 2 This is a schematic diagram of the structure of the atrial septal puncture needle in Example 1 of the utility model except for the handle;

[0027] Figure 3 This is a schematic diagram of the distal structure of the needle tube of the atrial septal puncture needle in the first embodiment of the utility model when the needle tube is not covered with an insulating layer;

[0028] Figure 4 This is a schematic diagram of the distal structure of the atrial septal puncture needle in the first embodiment of the utility model when the needle tube is covered with an insulating layer;

[0029] Figure 5 Schematic diagram of the cuff extending into the superior vena cava;

[0030] Figure 6 This is a schematic diagram of the connection state between the first part and the second part in the second embodiment of the utility model;

[0031] Figure 7 This is a schematic diagram of the separation state of the first part and the second part in the second embodiment of the utility model;

[0032] Figure 8 This is a schematic diagram of setting an inclined chamfer at the far end of the second pipe section in the third embodiment of the utility model;

[0033] Fig. 9 for Figure 8 A magnified image of area A;

[0034] Fig.10 This is a schematic diagram of the connection between the needle tip and the needle tube in Example 4;

[0035] Fig.11 This is a schematic diagram of the integral molding of the needle tip and the needle tube in Example 5;

[0036] In the attached figure:

[0037] 1-needle tip; 2-needle tube; 3-insulation layer; 4-handle; 5-tail wire; 6-port;

[0038] 11-connecting part; 12-puncturing part;

[0039] 21-first pipe section; 22-second pipe section;

[0040] 211-first channel; 212-enlarged diameter section; 213-second channel; 214-joint portion; 215-bevel chamfer;

[0041] 201-Part 1; 202-Part 2;

[0042] 2011-Gap Department;

[0043] 100- steps;

[0044] 301-superior vena cava; 302-inferior vena cava; 303-fossa ovalis; 304-set. DETAILED DESCRIPTION

[0045] In order to make the purpose, advantages and features of the utility model clearer, the utility model is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the utility model. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0046] As used in the present invention, the singular forms "a", "an" and "the" include plural objects, the term "or" is generally used in a sense including "and / or", the term "several" is generally used in a sense including "at least one", and the term "at least two" is generally used in a sense including "two or more". In addition, the terms "first", "second" and "third" are used for descriptive purposes only and cannot be understood as indicating or suggesting relative importance or implicitly indicating the number of the indicated technical features. Thus, the features defined as "first", "second", and "third" may explicitly or implicitly include one or at least two of the features, "one end" and "the other end" and "the proximal end" and "the distal end" generally refer to two corresponding parts, which are not only included in the present application document, "proximal end" and "distal end" are the relative orientation, relative position, and direction of the elements or actions relative to each other from the perspective of the doctor using the medical device, although "proximal end" and "distal end" are not restrictive, but "proximal end" generally refers to the end of the medical device close to the doctor during normal operation, and "distal end" generally refers to the end that first enters the patient's body. In addition, as used in the present utility model, "installed", "connected", "connected", and one element "set" on another element should be understood in a broad sense, usually only indicating that there is a connection, coupling, matching or transmission relationship between the two elements, and the connection, coupling, matching or transmission between the two elements can be direct or indirect through an intermediate element, and cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, one element can be in any orientation such as inside, outside, above, below or on one side of another element, unless the content clearly indicates otherwise.

[0047] [Example 1]

[0048] This embodiment provides an atrial septal puncture needle, such as Figure 1 and Figure 2 As shown, the atrial septal puncture needle includes a needle tube 2 and a needle tip 1 , and the needle tip 1 is connected to the distal end of the needle tube 2 .

[0049] The needle tip 1 has a first puncture mode and a second puncture mode. In the first puncture mode, the needle tip 1 is electrically connected to the energy source device and punctures the target object by discharging. In the second puncture mode, the needle tip 1 mechanically punctures the target object.

[0050] That is, the needle tip 1 of the atrial septal puncture needle provided in this embodiment is sharper than the head end of the puncture needle of general radio frequency energy puncture, and can complete mechanical atrial septal puncture in the absence of radio frequency energy, and can also be used as a discharge electrode to complete radio frequency atrial septal puncture when mechanical atrial septal puncture cannot effectively complete the puncture. For example, it can normally complete purely physical atrial septal puncture when facing normal atrial septum tissue, and can use an energy source to assist in completing the stoma when facing specific diseased tissue.

[0051] In addition, in this embodiment, Figure 3 As shown in , at the connection point between the needle tube 2 and the needle tip 1, the outer surface of the needle tip 1 is higher than the outer surface of the needle tube 2 relative to the axis of the needle tube 2, thereby forming a height difference, resulting in a step 100 at the connection point where the needle tip 1 is higher than the needle tube 2, and the height difference is the height of the step 100; Figure 4 As shown, the surface of the needle tube 2 is covered with an insulating layer 3, and the material of the insulating layer 3 can be a polymer material such as PTFE (polytetrafluoroethylene), Pebax (polyamide), etc. The thickness of the insulating layer 3 matches the height difference, so that after covering the insulating layer 3, the surface of the needle tip 1 and the needle tube 2 are roughly flat. Here, roughly flat can be understood as, preferably, the height difference between the two surfaces does not exceed 0.1mm.

[0052] When the insulating layer 3 is coated on the outer surface of the needle tube 2, it provides insulation protection for the instrument. At the same time, the insulating layer 3 can also have super-smooth characteristics, so that the product is smooth and not stuck when transported in the matching instrument. Usually, the needle tip and the needle tube of some products have the same outer diameter at the connection point, which also means that when the insulating layer 3 exists, there will be a size difference between the insulating layer 3 and the needle tip or needle tube, which will cause jamming and discomfort during puncture. The atrial septal puncture needle provided in this embodiment is designed to form a step 100 where the needle tip 1 is higher than the needle tube 2 at the connection point between the needle tube 2 and the needle tip 1, so that after the insulating layer 3 is covered on the needle tube 2, the needle tip 1 and the needle tube 2 transition smoothly, and there will be no obvious sense of difference or jamming during puncture.

[0053] In addition, in order to achieve mechanical puncture, the needle tip 1 is generally designed to have a variable diameter. In this embodiment, the needle tip 1 is designed to be higher than the needle tube 2 at the connection between the needle tube 2 and the needle tip 1, so that the size of the needle tip 1 can be reduced from a relatively large value from the proximal end to the distal end, so that the needle tip 1 is relatively smooth when changing its diameter, reducing its sharpness, and when the puncture needle is pushed in the matching dilator, it will not scratch the inner wall, causing foreign matter to fall off.

[0054] It can be seen that in this embodiment, the step 100 design between the needle tip 1 and the needle tube 2 can not only achieve a smooth transition between the needle tube 2 and the needle tip 1, but also make the needle tip 1 relatively smooth when changing diameter, thereby reducing its sharpness.

[0055] In some specific embodiments, the needle tip 1 may be in a cone shape, while in other specific embodiments, the needle tip 1 may be in a polygonal pyramid shape, and so on. The present application does not impose any particular limitation on the contour shape of the needle tip 1. Figure 3 and Figure 4 As shown in FIG, the needle tip 1 is a conical shape. Fig.10 As shown in FIG. , the polygonal pyramid type is used as an example.

[0056] In this embodiment, Figure 3 and Figure 4 As shown, the needle tip 1 includes a connecting portion 11 extending in the axial direction, and the connecting portion 11 is sleeved on the distal end of the needle tube 2 to achieve the connection between the needle tip 1 and the needle tube 2. The portion other than the connecting portion 11 constitutes the puncture portion 12 of the needle tip 1, and the puncture portion 12 and the connecting portion 11 can be integrally formed, with a smooth transition at the junction, and the surface of the connecting portion 11 and the surface of the needle tube 2 are located on different planes to form the step 100. The connecting portion 11 and the distal end of the needle tube 2 can also be further fixed by gluing, welding, etc.

[0057] Furthermore, in this embodiment, the distal end of the needle tube 2 has a first channel 211 penetrating the side wall, the first channel 211 is connected to the inner cavity of the needle tube 2, and the first channel 211 is kept in communication with the inner cavity of the needle tube 2. When the connecting section 11 is sleeved on the distal end of the needle tube 2, the first channel 211 is exposed. The first channel 211 can be formed by opening a hole in the side wall of the needle tube 2 along the radial direction, and the first channel 211 is connected to the inner cavity of the needle tube 2, and is used for injection of contrast solution, blood withdrawal and other operations during surgery.

[0058] It should be noted that the distal portion of the needle tube 2 described in the present application refers to a section of the needle tube 2 extending from the distal surface toward the proximal end. The understanding of this section can be adjusted according to actual conditions. For example, although in the previous description, it is described that the connecting section 11 is sleeved on the distal portion of the needle tube 2, and it is also described that the first channel 211 is also provided at the distal portion of the needle tube 2, it can be understood that the distal portion is also used to limit the position. The distal portion of the needle tube 2 used to set the first channel 211 has a longer axial extension length relative to the distal portion used to sleeve the connecting section 11. The first channel 211 can be set at a certain distance from the distal surface of the needle tube, so that when the connecting section 11 is sleeved on the distal portion of the needle tube 2, the first channel 211 is not blocked.

[0059] In this embodiment, Figure 2 As shown, the needle tube 2 includes a first tube segment 21 and a second tube segment 22, and the needle tip 1, the first tube segment 21 and the second tube segment 22 are sequentially connected from the distal end to the proximal end; the outer diameter of the second tube segment 22 is greater than the outer diameter of the first tube segment 21. The second tube segment 21 has a larger outer diameter to provide a harder support, and the first tube segment 22 has a smaller outer diameter to make it easier to enter the heart cavity.

[0060] The first pipe section 21 and the second pipe section 22 can be assembled together by interference fit, thread fit, welding, etc. Preferably, the first pipe section 21 includes an expanded diameter section 212, the inner diameter of which matches the outer diameter of the second pipe section 22, and the expanded diameter section 212 is sleeved on the distal end of the second pipe section 22 to achieve the connection between the first pipe section 21 and the second pipe section 22. When the first pipe section 21 includes the expanded diameter section 212, it can be understood that the outer diameter of the expanded diameter section 212 refers to the outer diameter of the first pipe section 21 except the expanded diameter section 212. The design of the expanded diameter section 212 can preliminarily define the relative position of the first pipe section 21 and the second pipe section 22 in the axial direction when the first pipe section 21 and the second pipe section 22 are fixedly connected.

[0061] In addition, if Figure 1 As shown, the atrial septal puncture needle provided in this embodiment may also include a handle 4, and the handle 4 is connected to the proximal end of the needle tube 2. The handle 4 is electrically connected to the energy source device through the tail line 5, so that the needle tip 1 and the energy source device are electrically conductive. The handle 4 can also be selectively connected to a three-dimensional system in the field of electrophysiology through the tail line 5, so that the distal end of the atrial septal puncture needle can be displayed on the three-dimensional system, thereby achieving matching use with the three-dimensional system. The end of the tail line 5 used for connecting to the three-dimensional system may have a port 6, which is connected to the external plug of the three-dimensional system or the energy source device through the port 6.

[0062] That is, this embodiment is equivalent to further providing an atrial septal puncture system, including an energy source device, a three-dimensional system, and an atrial septal puncture needle as described in this embodiment, wherein the atrial septal puncture needle is selectively electrically connected to one or both of the energy source device and the three-dimensional system. The energy source device may be an ablation device, or may be an ultrasound device or a PFA (pulsed electric field) device that can provide energy.

[0063] See also Figure 5 , using the atrial septum puncture system provided in this embodiment, its workflow is roughly as follows:

[0064] 1. Preoperative preparation: clean the surgical instruments with saline, connect the puncture needle to the energy source device through the tail line, and set the energy parameters;

[0065] 2. Femoral vein puncture, and the sheath group is delivered along the guide wire from the inferior vena cava 302 to the superior vena cava 301;

[0066] 3. Withdraw the guide wire and deliver the puncture needle along the inner cavity of the sheath group to the distal end of the sheath group, but the needle tip 1 does not protrude from the distal end of the sheath group;

[0067] 4. Pull back and pull down the set 304 (including the puncture needle and the sheath set) to the position of the oval fossa of the atrial septum. Usually, there will be two jumps when you feel it. Confirm the position of the set by X-ray or other imaging methods;

[0068] 5. The push set presses against the oval fossa 303 to make it present a tent shape;

[0069] 6. Remove the needle and prepare for puncture. If you pierce directly at this time and feel a sense of missing, there is no need to release energy.

[0070] 7. If you cannot successfully break through at this time, release the energy to puncture. If you still cannot puncture successfully, you can adjust the amount of released energy and release time to try again;

[0071] 8. After the puncture is completed, contrast fluid is injected to confirm that the needle has successfully entered the left atrium;

[0072] 9. Push the sheath group into the left atrium and withdraw the puncture needle to complete the puncture.

[0073] [Example 2]

[0074] In the first embodiment, the needle tip 1 is connected to the needle tube 2 through the connecting portion 11. Different from the first embodiment, in this embodiment, the needle tube 2 is detachable, and a part of the needle tube 2 is fixedly connected to the needle tip 1. Figure 6 and Figure 7The needle tube 2 includes a first part 201 and a second part 202 , the distal end of the first part 201 is fixedly connected to the needle tip 1 , and the proximal end of the first part 201 is detachably connected to the second part 202 .

[0075] When the needle tube 2 includes the first tube segment 21 and the second tube segment 22 of different thicknesses, it can be understood that the first tube segment 21 includes the first part 201 and the second part 202, and the first part 201 can be understood as being roughly equivalent to the distal part of the needle tube 2 described in Example 1.

[0076] In an optional embodiment, the first part 201 has a second channel 213 that penetrates the side wall, and after the second part 202 is connected to the first part 201, at least part of the second channel 213 is connected to the inner cavity of the first part 201. Similar to the first embodiment, the second channel 213 can be formed by opening a hole in the side wall of the first part 201 along the radial direction. Similarly, the second channel 213 is connected to the inner cavity of the needle tube 2 for injection of contrast solution, blood withdrawal and other operations during surgery.

[0077] In another preferred embodiment, the second part 202 has a docking portion 214, and the docking portion 214 is used to extend into the inner cavity of the first part 201 in a direction parallel to the axis to achieve the connection between the first part 201 and the second part 202, and the side wall of the first part 201 has a notch portion 2011 extending from the proximal end to the distal end. After the first part 201 and the second part 202 are connected, the docking portion 214 blocks the communication between part of the notch portion 2011 and the inner cavity of the first part 201, and the remaining part of the notch portion 2011 forms the second channel 213. The design of the notch portion 2011, on the one hand, allows the proximal end of the first part 201 to have a certain opening angle, so that the docking portion 214 can extend into the inner cavity of the first part 201 to achieve the connection between the first part 201 and the second part 202. On the other hand, the design of the notch portion 2011 can also be used to form the second channel 213 for injection of contrast fluid, blood withdrawal and other operations during surgery.

[0078] Better, such as Figure 7 As shown, the docking portion 214 may be formed by protruding outward in a direction parallel to the axis, and the number of the docking portions 214 may be 2 or 3, etc., and all the docking portions 214 are distributed at intervals along the circumferential direction. In some other embodiments, the distal end of the second portion 202 may be flush and directly extend into the first portion 201 to complete the connection with the first portion 201.

[0079] [Example 3]

[0080] The difference from the first and second embodiments is that, see Figure 8 and Fig. 9 In this embodiment, the distal end of the second pipe segment 22 has a chamfer 215, so that after the expanded diameter segment 212 is connected to the second pipe segment 22, there is a gap between the second pipe segment 22 and the expanded diameter segment 212, and the gap is used to fill the solder. Filling the gap with metal powder or other auxiliary materials for welding facilitates subsequent welding and makes the connection between the second pipe segment 22 and the first pipe segment 21 more secure. Of course, in some embodiments, the distal end of the second pipe segment 22 may also not have the chamfer 215, and the second pipe segment 22 and the first pipe segment 21 are in end-to-end contact, and then connected by different connection methods.

[0081] [Example 4]

[0082] In the first embodiment, the connecting portion 11 is sleeved on the needle tube 2 to realize the connection between the needle tip 1 and the needle tube 2. The difference from the first embodiment is that Fig.10 As shown, in this embodiment, the connecting portion 11 is inserted into the distal end of the needle tube 2 to achieve the connection between the needle tip 1 and the needle tube 2, and the surface of the puncture portion 12 and the surface of the needle tube 2 form the step 100. Similarly, the connecting portion 11 and the needle tube 2 can be further fixed by gluing, welding, etc.

[0083] [Example 5]

[0084] Different from the above-mentioned embodiment, in this embodiment, the first tube segment 21 and the second tube segment 22 are integrally formed by stretching, and / or the first tube segment 21 and the needle tip 1 are integrally formed by extrusion.

[0085] That is, optionally, the first tube segment 21 and the second tube segment 22 of the needle tube 2 are integrally formed, or the first tube segment 21 of the needle tube 2 and the needle tip 1 are integrally formed, or the entire needle tube 2 and the needle tip 1 are integrally formed. Fig.11 The example shown is that the entire needle tube 2 is integrally formed with the needle tip 1 .

[0086] When the first tube segment 21 and the second tube segment 22 are integrally stretched and formed, the outer diameter of the first tube segment 21 remains substantially unchanged and is slightly smaller than the outer diameter of the second tube segment 22. The outer diameter of the second tube segment 22 also remains substantially unchanged. The manufacturing method of the needle tube 2 and the needle tip 1 is as follows: firstly, the metal at the distal end of the needle tube 2 is heated to soften it, and then a forming force is applied to the distal end of the needle tube 2 to achieve the closure of the distal end and form the needle tip 1 which gradually decreases from the proximal end to the distal end. Similarly, the first tube segment 21 and the second tube segment 22 can be covered with an insulating layer 3 to protect the user when the product is powered on. Fig.11 As shown in the figure, although there is no step 100 at the connection between the needle tip 1 and the needle tube 2, in the integrated molding method, the step 100 can also be formed by axially extruding the needle tip 1 part after the preliminary molding of the needle tip 1 part, so that the insulating layer 3 will not form a size difference with the tubular body or the head end due to the existence of the insulating layer 3, thereby affecting the smoothness of the puncture needle during puncture.

[0087] In summary, the atrial septum puncture needle and atrial septum puncture system provided by the embodiment of the utility model include: a needle tube and a needle tip, wherein the needle tip is connected to the distal end of the needle tube; the needle tip has a first puncture mode and a second puncture mode, wherein the needle tip is electrically connected to an energy source device in the first puncture mode, and punctures the target object by discharging, and the needle tip mechanically punctures the target object in the second puncture mode; at the connection between the needle tube and the needle tip, the outer surface of the needle tip is higher than the outer surface of the needle tube relative to the axis of the needle tube, thereby forming a height difference, and the surface of the needle tube is covered with an insulating layer, and the thickness of the insulating layer matches the height difference. The atrial septum puncture needle can normally complete purely physical atrial septum puncture when facing normal atrial septum tissue, and can also use an energy source to assist in completing stoma when facing specific pathological tissue. At the same time, when performing puncture, the distal end of the atrial septum puncture needle has a smooth transition without abrupt steps, which can make the puncture process smooth.

[0088] It should be noted that the various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other. In addition, the different parts between the various embodiments can also be used in combination with each other, and the present utility model is not limited to this.

[0089] In addition, it should be recognized that although the present invention has been disclosed as a preferred embodiment, the above embodiment is not intended to limit the present invention. For any technician familiar with the art, without departing from the scope of the technical solution of the present invention, the above disclosed technical content can be used to make many possible changes and modifications to the technical solution of the present invention, or modified into equivalent embodiments of equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiment based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still falls within the scope of protection of the technical solution of the present invention.

Claims

1. A transseptal puncture needle, characterized in that: include: A needle tube and a needle tip, wherein the needle tip is connected to the distal end of the needle tube; The needle tip has a first puncture mode and a second puncture mode. In the first puncture mode, the needle tip is electrically connected to the energy source device to puncture the target object by discharging. In the second puncture mode, the needle tip mechanically punctures the target object. At the connection point between the needle tube and the needle tip, the outer surface of the needle tip is higher than the outer surface of the needle tube relative to the axis of the needle tube, thereby forming a height difference. The surface of the needle tube is covered with an insulating layer, and the thickness of the insulating layer matches the height difference.

2. The atrial septal puncture needle according to claim 1, characterized in that: The needle tip comprises a connecting portion extending along the axial direction, and the connecting portion is sleeved on the distal end portion of the needle tube or plugged into the distal end portion of the needle tube to achieve the connection between the needle tip and the needle tube.

3. The atrial septal puncture needle according to claim 2, characterized in that: The distal end portion of the needle tube has a first channel penetrating through the side wall, and the first channel is communicated with the inner cavity of the needle tube.

4. The atrial septal puncture needle according to claim 1, characterized in that: The needle tube comprises a first part and a second part, the distal end of the first part is fixedly connected to the needle tip, and the proximal end of the first part is detachably connected to the second part.

5. The atrial septal puncture needle according to claim 4, characterized in that: The first part has a second channel penetrating the side wall, and after the second part is connected to the first part, at least a portion of the second channel remains in communication with the inner cavity of the first part.

6. The atrial septal puncture needle according to claim 5, characterized in that: The second part has a docking portion, and the docking portion is used to extend into the inner cavity of the first part along a direction parallel to the axis to achieve connection between the first part and the second part; The side wall of the first part has a notch extending from the proximal end toward the distal end. After the first part and the second part are connected, the docking portion blocks the connection between part of the notch and the inner cavity of the first part, and the remaining part of the notch forms the second channel.

7. The atrial septal puncture needle according to claim 1, characterized in that: The needle tube includes a first tube segment and a second tube segment. The needle tip, the first tube segment and the second tube segment are connected in sequence from the distal end to the proximal end. The outer diameter of the second tube segment is greater than the outer diameter of the first tube segment.

8. The atrial septal puncture needle according to claim 7, characterized in that: The first pipe segment includes an expanded diameter segment, the inner diameter of which matches the outer diameter of the second pipe segment, and the expanded diameter segment is sleeved on the distal end of the second pipe segment to achieve connection between the first pipe segment and the second pipe segment.

9. The atrial septal puncture needle according to claim 8, characterized in that: The distal end of the second tube segment has a chamfered surface, and the chamfered surface allows a gap to exist between the second tube segment and the expanded diameter segment, and the gap is used to be filled with solder.

10. The atrial septal puncture needle according to claim 7, characterized in that: The first tube segment and the second tube segment are integrally formed by stretching, and / or the first tube segment and the needle tip are integrally formed by extrusion.

11. The atrial septal puncture needle according to claim 1, characterized in that: It also includes a handle, which is connected to the proximal end of the needle tube. The handle is electrically connected to the energy source device through a tail line, so that the needle tip and the energy source device are electrically conductive.

12. The atrial septal puncture needle according to claim 11, characterized in that: The handle is electrically connected to the three-dimensional system via a tail wire, so that the needle tip is electrically connected to the three-dimensional system.

13. An atrial septal puncture system, characterized in that: include: Energy source equipment; Three-dimensional system; as well as, The atrial septal puncture needle according to any one of claims 1 to 12, wherein the atrial septal puncture needle is selectively electrically connected to one or both of the energy source device and the three-dimensional system.

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