A puncture needle assembly and a puncture system

Abstract

The present invention relates to a puncture needle assembly and a puncture system, wherein the puncture needle assembly comprises a needle seat and a needle body, wherein the needle seat has an axially through passage, wherein at least a portion of the side wall of the passage is configured as a conductor, and the proximal end of the needle body extends in the passage and is electrically connected to the conductor. The puncture system further comprises a dilator, wherein the dilator comprises an expansion catheter and an elastic conductive component that can be selectively arranged on the expansion catheter, and when the distal end of the needle body is hidden in the expansion catheter, it is electrically connected to external blood through the elastic conductive component or directly. The puncture needle assembly and the puncture system of the present invention have the advantages of being safe and convenient to use and having high reliability.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a puncture needle assembly and a puncture system. Background Art

[0002] Cardiovascular diseases seriously threaten human health, with high morbidity, disability and mortality. Interventional therapy is a relatively effective treatment for cardiovascular diseases. When performing interventional therapy, such as the treatment of atrial fibrillation and atrial flutter, puncture is often required to allow the interventional therapy device to pass through the atrial septum and reach the lesion site.

[0003] The dilator and puncture needle are important components of atrial septal puncture. The puncture needle uses the puncture ability of the stainless steel needle tube at the distal end to pass the dilator and the catheter sheath through the atrial septum when the catheter sheath and dilator are assembled. The dilator uses the distal tapered opening to establish a transition between the catheter sheath and the puncture needle based on the puncture needle passing through the atrial septum, thereby reducing resistance, reducing the wound and shortening the puncture time.

[0004] Traditional atrial septal puncture is performed under the guidance of X-ray fluoroscopy. It is a two-dimensional plane perspective technology. Doctors can only combine X-ray imaging and operation methods to find the puncture site in the body. The accuracy is low and the risk is high. Mastering this technology requires a long period of clinical accumulation. In recent years, the "green electrophysiological three-dimensional system" has been widely used in the field of interventional surgery. It has the characteristics of extremely low radiation, precise positioning and navigation, which greatly reduces the learning time and reduces the damage of radiation to both doctors and patients, making interventional surgery more and more accurate, safe and easy. However, atrial septal puncture is still in a two-dimensional mode combined with X-ray imaging. It has not been widely used in the field of "electric positioning three-dimensional system" surgery, and it is impossible to achieve the characteristics of extremely low radiation, precise positioning and navigation. Therefore, in the existing technology, there is no puncture system that combines the electric positioning system with the guidance of the electrocardiogram signal to achieve precise puncture. Summary of the invention

[0005] The object of the present invention is to provide a puncture needle assembly and a puncture system, which can be applied to three-dimensional atrial septum puncture technology, are easy to use and have high reliability.

[0006] To achieve the above-mentioned purpose, the present invention provides a puncture needle assembly, including a needle seat and a needle body, wherein the needle seat has an axially through-going channel, and at least a portion of the side walls of the channel are configured as a conductor, and the proximal end of the needle body extends in the channel and is electrically connected to the conductor.

[0007] Optionally, the conductor is a block structure.

[0008] Optionally, all side walls of the channel are configured as the electrical conductor.

[0009] Optionally, a portion of the sidewall of the channel is configured as the conductor, and another portion of the sidewall of the channel is configured as an insulator.

[0010] Optionally, the insulator has a first inner cavity that runs axially through, the first inner cavity constitutes part of the channel, the insulator is provided with a window that communicates with the first inner cavity, the conductor is arranged at the window, and the inner wall of the conductor and the inner wall of the first inner cavity together constitute the channel.

[0011] Optionally, the insulator and the conductor are arranged along the axial direction of the needle seat and are connected to each other, and the channel runs through the insulator and the conductor.

[0012] Optionally, the needle body is connected to the insulator.

[0013] Optionally, a receiving groove is provided on the inner wall of the conductor; the needle seat also includes a first elastic element, which is arranged in the receiving groove; the first elastic element is configured to store elastic potential energy to press against the needle body so that the needle body and the conductor maintain electrical conduction.

[0014] Optionally, the first elastic element is a spring, and the axis of the spring is arranged perpendicular to the axis of the needle body.

[0015] Optionally, the conductor is connected to the needle body through a conductive adhesive layer.

[0016] Optionally, a slot is provided on the conductor, and the slot is used to plug in a pin of a connecting line of an external positioning device.

[0017] Optionally, the conductor includes a main body portion and an extension portion that are connected to each other, wherein the main body portion is used to connect with the needle body, and the slot is arranged on the extension portion; the needle seat also includes an insulator, the insulator includes a first insulating portion and a second insulating portion, the extension portion is covered on at least a portion of the first insulating portion, and the main body portion is arranged between the first insulating portion and the second insulating portion.

[0018] To achieve the above objectives, the present invention also provides a puncture system, comprising a dilator and a puncture needle assembly as described in any of the preceding items; the dilator comprises a dilation catheter, the dilation catheter has an axially through-going second inner cavity, and the distal end of the needle body is used to be movably inserted into the second inner cavity.

[0019] Optionally, a side hole communicating with the second inner cavity is formed on the distal side wall of the dilatation catheter.

[0020] Optionally, the expander further comprises an elastic conductive component, wherein the elastic conductive component is disposed at the side hole, and the elastic conductive component is used to contact the needle body and press against the needle body by elastic force.

[0021] Optionally, the elastic conductive component includes a second elastic element, the second elastic element includes an arc-shaped portion, one end of the arc-shaped portion is fixed at the side hole, the other end is a free end, and the arc-shaped portion at least partially protrudes from the inner surface of the dilatation catheter.

[0022] Optionally, the elastic conductive component further includes an end cap and a frame, the end cap is disposed in the side hole, the frame is connected to the end cap and is disposed between the end cap and the second inner cavity, and the arc portion is connected to the frame.

[0023] Optionally, the elastic conductive component further includes a limit stopper, and the limit stopper is arranged on the arc-shaped portion; when the needle body contacts the arc-shaped portion, the limit stopper contacts the end cover.

[0024] Optionally, an annular groove is further formed on the inner wall of the side hole, and the end cover includes a protrusion matching the annular groove, and the protrusion is fixed to the annular groove.

[0025] The puncture needle assembly and puncture system of the present invention have the following advantages:

[0026] First, the aforementioned puncture needle assembly includes a needle seat and a needle body, the needle seat includes a conductor, the needle seat has an axially through channel, at least a portion of the side wall of the channel is configured as a conductor, and the proximal end of the needle body extends in the channel and is electrically connected to the conductor. When performing atrial septal puncture, the conductor is connected to a three-dimensional positioning device, so that the electrical signal connection between the needle body and the three-dimensional positioning device can be achieved, and the puncture needle can be used in the field of "electrical positioning three-dimensional system" surgery.

[0027] Second, the puncture needle assembly also includes an elastomer and / or a conductive adhesive layer. The elastomer and / or the conductive adhesive layer are provided to enhance the connection between the needle body and the conductor, thereby ensuring good transmission of electrical signals during the puncture process and improving the success rate of puncture.

[0028] Third, a slot is provided on the conductor, and the slot is used to insert the pin of the three-dimensional positioning device, which has the advantages of easy use and reliable connection.

[0029] Fourth, the aforementioned puncture system includes the puncture needle assembly and a dilator, the dilator includes a dilation catheter, the dilation catheter has a second inner cavity extending along its axial direction, and a side hole connected to the second inner cavity is provided at the distal end of the dilation catheter, so that the needle body is electrically connected to the external blood; optionally, the dilator can also be provided with an elastic conductive component, the elastic conductive component is arranged in the side hole, and when performing atrial septal puncture, the distal end of the needle body extends along the second inner cavity to the side hole and contacts with the elastic conductive component, so that the needle body is electrically connected to the blood outside the dilation catheter. That is, when the distal end of the needle body can be hidden in the dilator, the three-dimensional system can still display the position of the distal end of the needle body in real time to prevent the distal end of the needle body from causing damage to human tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is a schematic structural diagram of a puncture system provided according to an embodiment of the present invention;

[0031] Figure 2 It is a schematic diagram of performing atrial septal puncture using the puncture system provided by the present invention;

[0032] Figure 3 is a partial schematic diagram of a puncture system provided according to an embodiment of the present invention;

[0033] Figure 4 yes Figure 3 AA cross-sectional view of the puncture system shown;

[0034] Figure 5 is a partial schematic diagram of a puncture needle assembly of a puncture system provided according to an embodiment of the present invention;

[0035] Figure 6 is a partial cross-sectional view of a puncture needle assembly of a puncture system provided according to an embodiment of the present invention, in which the conductor is arranged at a window formed by an insulator;

[0036] Figure 7 is a partial schematic diagram of a puncture needle assembly of a puncture system provided according to an embodiment of the present invention in one direction;

[0037] Figure 8 yes Figure 7 The schematic diagram of the puncture needle assembly of the puncture system shown in another direction, in which a slot is provided on the conductor;

[0038] Fig. 9 yes Figure 8 A BB cross-sectional view of the puncture needle assembly of the puncture system shown;

[0039] Fig.10is a partial cross-sectional view of a dilator of a puncture system provided according to an embodiment of the present invention;

[0040] Fig.11 yes Fig.10 A schematic diagram of the structure of the elastic conductive component of the dilator of the puncture system shown;

[0041] Fig.12 is a partial cross-sectional view of a dilator of a puncture system provided according to another embodiment of the present invention;

[0042] Fig.13 yes Fig.12 A schematic diagram of the structure of the elastic conductive component of the dilator of the puncture system shown;

[0043] Fig.14 1 is a schematic diagram of the distal end structure of a dilation catheter of a dilator of a puncture system provided by the present invention according to an embodiment, wherein the side hole is circular;

[0044] Fig.15 yes Fig.14 CC cross-sectional view of the dilator in the puncture system shown;

[0045] Fig.16 It is a schematic diagram of the distal structure of the dilation catheter of the dilator in the puncture system provided according to one embodiment of the present invention, in which the side hole is a square hole.

[0046] Fig.17 yes Fig.16 DD cross-sectional view of the dilator of the puncture system shown.

[0047] [Description of reference numerals is as follows]:

[0048] 100-Puncture system;

[0049] 1000-Puncture needle assembly;

[0050] 1100-needle holder;

[0051] 1110-conductor;

[0052] 1111-main body, 1112-extension part, 1113-slot;

[0053] 1120-Insulator;

[0054] 1130-first elastic element;

[0055] 1200-needle body;

[0056] 2000-dilator;

[0057] 2100- dilatation catheter;

[0058] 2110-step, 2120-side hole;

[0059] 2200-Elastic wire assembly;

[0060] 2210- second elastic element;

[0061] 2211-arc-shaped portion;

[0062] 2220-end cover;

[0063] 2221- protrusion;

[0064] 2230-framework;

[0065] 2240-limit stopper;

[0066] 200- three-dimensional positioning device;

[0067] 300-Introducer Sheath. DETAILED DESCRIPTION

[0068] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the accompanying drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0069] As used in this specification, the singular forms "one", "an" and "the" include plural objects, and the plural form "plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is usually used in a sense that includes "and / or", unless the content clearly indicates otherwise, and the terms "install", "connect", "connect" and "connect" should be understood in a broad sense, for example, it can be a fixed connection, it can also be a detachable connection, or it can be connected as a whole. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the two elements can be adjacent to or abutting each other. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. The same or similar figure marks in the drawings represent the same or similar parts.

[0070] In this article, the terms "proximal" and "distal" refer to the relative orientation, relative position, and direction of components or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" usually refers to the end of the medical device that is close to the doctor during normal operation, and "distal" usually refers to the end that first enters the patient's body.

[0071] The embodiment of the present invention provides a puncture needle assembly and a puncture system including the puncture needle assembly, and a doctor can use the puncture system to perform puncture in a three-dimensional interface. Figure 1 As shown, the puncture system 100 includes a puncture needle assembly 1000 and a dilator 2000. The puncture needle assembly 1000 includes a needle seat 1100 and a needle body 1200. The needle seat 1100 includes a conductor 1110. The needle seat 1100 has an axially through channel, and at least a portion of the side wall of the channel is configured as the conductor 1110. The proximal end of the needle body 1200 extends in the channel and is connected to the conductor 1110. The dilator 2000 includes a hollow dilation catheter 2100, and the distal end of the needle body 1200 enters the human tissue along the dilation catheter 2100 to perform puncture.

[0072] like Figure 2 As shown, during the puncture procedure, the distal end of the needle body 1200 is electrically connected to the blood to obtain an electrical signal. The proximal end of the needle body 1200 is connected to a three-dimensional positioning device 200, such as an electrical positioning device, and the three-dimensional positioning device 200 receives the electrical signal to position the distal end of the needle body 1200. In this embodiment, by providing a conductor 1110 on the needle seat 1100, the connection between the needle body 1200 and the three-dimensional positioning device 200 is achieved by connecting the conductor 1110 to the three-dimensional positioning device, and there is no need to additionally provide a wire on the needle body 1100, which further improves the operability of the puncture needle assembly 1000.

[0073] Please combine Figure 1 In an embodiment of the present invention, the conductor 1110 can be made of a metal conductive material such as stainless steel, aluminum, etc. The needle body 1200 can be a slender hollow structure made of a metal conductive material, and can be formed by one section of tube, or can be formed by connecting two sections of tube. The distal end of the needle body 1200 can be bent, and the diameter of the distal end of the needle body 1200 is smaller than the diameter of the proximal end, and can have a sharp tip to facilitate piercing human tissue. The proximal end of the needle body 1200 is electrically conductive with the conductor 1110 to transmit the electrical signal to the conductor 1110, and then to the three-dimensional positioning device 200.

[0074] In some embodiments, the needle seat 1100 is entirely composed of the conductor 1110, so that all the side walls of the channel are composed of the conductor 1110. For the needle seat of the existing puncture needle, doctors have requirements for the feel of the needle seat during operation, that is, the needle seat must have a certain weight. Therefore, the needle seat is entirely composed of the conductor 1110 to meet this requirement, but at the same time, the conductor is a metal, and its cost is relatively high. For the commonly used metal copper, its biocompatibility is poor, and surface coating is required. For such small cavity coating, the technical difficulty is very high. If stainless steel with good biocompatibility is used, it is difficult to process it into an ideal shape due to its poor plasticity.

[0075] Therefore, in other embodiments, Figure 3 As shown, the needle seat 1100 further includes an insulator 1120, which is formed separately from the conductor 1110 and then connected as a whole, and the conductor 1110 constitutes a part of the side wall of the channel, and the insulator 1120 constitutes another part of the side wall of the channel. This can reduce the use of metal materials and the cost of the puncture needle assembly 1000, and can also be made of a polymer material with good biocompatibility, which is safer for the human body and easier to process.

[0076] The specific structure of the needle seat 1100 can be set according to actual needs, but usually the conductor 1110 is designed as a block structure. Figures 3 to 5 As shown, in one embodiment, the conductor 1110 and the insulator 1120 are arranged along the axial direction of the needle seat 1100, the conductor 1110 is provided with a first through hole extending along the axial direction, and the insulator is provided with a second through hole penetrating along the axial direction, and the second through hole is connected to the first through hole to form the channel. Figure 6As shown, in another embodiment, the insulator 1120 is provided with a first inner cavity which is axially penetrated, and the first inner cavity constitutes part of the channel, and the insulator 1120 is provided with a window which is connected with the first inner cavity, and the conductor 1110 is arranged at the window, and the inner wall of the conductor 1110 and the inner wall of the first inner cavity together constitute the channel. Generally, the needle body 1200 is arranged in the channel and connected with the conductor 1110. For the convenience of assembly, the inner diameter of the channel is larger than the outer diameter of the proximal end of the needle body 1200, but this will cause a gap between the needle body 1200 and the conductor 1110, resulting in an unreliable connection between the two. To solve this problem, conductive glue is also injected between the inner surface of the conductor 1110 and the needle body 1200 in this embodiment. After the conductive glue is cured, a conductive glue layer (not shown in the figure) is formed. The conductive glue layer strengthens the connection between the conductor 1110 and the needle body 1200, so that the electrical signal collected at the far end of the needle body 1200 can be smoothly transmitted to the three-dimensional positioning device 200.

[0077] Or, if Fig. 9 As shown, in an alternative embodiment, the problem of unreliable connection between the conductor 1110 and the needle body 1200 caused by the mismatch between the aperture of the channel and the outer diameter of the needle body 1200 can also be solved by providing a first elastic element 1130. Specifically, a receiving groove (marked in the figure) is provided on the inner surface of the conductor 1110, and the first elastic element 1130 is provided in the receiving groove and is configured to store elastic potential energy. The first elastic element 1120 presses against the needle body 1200 under the action of the elastic potential energy, so that the needle body 1200 is in close contact with the inner surface of the conductor 1110. The first elastic element 1130 includes but is not limited to a spring. When the first elastic element 1130 is a spring, the axis of the spring is perpendicular to the axis of the needle body 1200.

[0078] Furthermore, the needle body 1200 is also connected to the insulator 1120 to enhance the connection reliability between the needle body 1200 and the needle seat 1100 and prevent the needle body 1200 from loosening during use.

[0079] When performing a puncture operation using the puncture system 100 provided in this embodiment, the conductor 1110 of the puncture needle assembly 100 can be connected to the connecting tail wire of the three-dimensional positioning device 200 through a conductive clip.

[0080] The method of connecting the conductor 1110 and the connecting tail wire of the three-dimensional positioning device 200 through a conductive clip may affect the transmission effect of the electrical signal due to the small electrical connection contact surface or unstable contact. In view of this, in further improvements, such as Figures 7 to 9As shown, the conductor 1110 is provided with a slot 1113, and the slot 1113 is used to insert the pin of the connecting tail line, which is not only convenient to use, but also has the advantages of firm and reliable connection. Optionally, the conductor 1110 includes a main body 1111 and an extension 1112 connected to each other, wherein the main body 1111 is used to connect with the needle body 1200, and the slot 1113 is arranged on the extension 1112. In order to reduce the use of metal materials, reduce the cost of the puncture needle assembly 1000, and further improve biosafety, the needle seat 1100 also includes an insulator 1120, and the insulator 1120 includes a first insulating part 1120a and a second insulating part 1120b, the extension 1112 is coated on at least a part of the first insulating part 1120a, and the main body 1111 is arranged between the first insulating part 1120a and the second insulating part 1120b. This design not only meets the requirements for connection with the three-dimensional positioning device 200, but also takes into account biological safety and cost issues. On the other hand, the pin is connected to the slot 1113, and the slot wall of the slot 1113 is a conductor, which can further improve the stability and reliability of signal transmission.

[0081] Based on the technical concept of the present invention, technicians in this field can also design a variety of needle seat structures, for example, part of the insulator is covered on the conductor, and a slot is set on the insulator, and the slot extends to the conductor, so that the pin inserted into the slot can be connected to the conductor. The present invention does not limit this.

[0082] Please refer to Figure 1 Combined with Fig.10 and Fig.12 The dilation catheter 2100 of the dilator 2000 is a slender structure, and the distal end of the dilation catheter 2100 is formed as a pointed end. The dilation catheter 2100 has a second inner cavity that runs axially therethrough. A step 2110 is also provided on the inner surface of the dilation catheter 2100. The step 2110 is used to limit the length of the needle body 1200 extending from the distal end of the dilation catheter 2100 to avoid danger caused by excessive needle extension.

[0083] For further information, please refer to Figure 14-17The distal end of the dilatation catheter 2100 is provided with a side hole 2120 connected to the second inner cavity of the dilatation catheter 2100. Through the side hole, the needle body 1200 is electrically connected to the blood outside the dilatation catheter 2100. In this way, when the distal end of the puncture system 100 enters the patient's body and searches for the puncture point, the distal end of the needle body 1200 can be hidden in the dilatation catheter 2100 of the dilator 2000, and the needle body 1200 is electrically connected to the blood to obtain electrical signals, thereby avoiding damage to human tissues in the process of searching for the puncture point at the distal end of the needle body 1200.

[0084] In this embodiment, the cross-section of the side hole 2120 can be any suitable shape, such as a circle (such as Fig.14 and Fig.15 As shown), square (as Fig.16 and Fig.17 As shown), oval, polygonal, irregular, etc. The number of the side hole 2120 can be one, or multiple, such as two, and the two side holes 2120 can be symmetrically arranged at the distal end of the dilatation catheter 2100.

[0085] In order to further enhance the electrical conductivity between the needle body 1200 and the blood, in another embodiment, the expander 2000 also includes an elastic conductive component 2200, which is arranged in the side hole 2120, and the blood contacts the elastic conductor 2200, and the elastic conductor 2200 is utilized to electrically conduct with the needle body 1200.

[0086] Please continue to refer to Fig.10 and Fig.11 In an exemplary embodiment, the elastic conductive component 2200 includes a second elastic element 2210, which is formed by bending a metal sheet and includes an arc-shaped portion 2211, one end of the arc-shaped portion 2211 is fixed at the side hole 2120, the other end is a free end, and the arc-shaped portion 2211 at least partially protrudes from the inner surface of the dilatation catheter 2100. In the process of finding the puncture point, the arc-shaped portion 2211 presses against the distal end of the puncture needle 1200, so that the needle body 120 and the elastic conductive component 220 are effectively in contact.

[0087] Optionally, the elastic conductive component 2200 further includes an end cap 2220 and a frame 2230. The end cap 2220 and the frame 2230 may be integrally formed, or the two may be separate structures and connected as one through a suitable connection method such as welding. The end cap 2220 is fixed to the inner side of the side hole 2120, and one end of the arc portion 2211 is fixed to the inner side of the frame 2230. Further, as Fig.12 and Fig.13As shown, the elastic conductive component 2200 further includes a limit stopper 2240, which is disposed on the arc portion 2211, and preferably connected to the free end of the arc portion 2211. When the needle body 1200 contacts the arc portion 2211, the second elastic element 2210 moves the limit stopper 2240 toward the end cap 2220 under the action of elastic force until the limit stopper 2240 contacts the end cap 2220, which can enhance the conduction effect between the needle body 1200 and the external blood, and also improve the doctor's hand feeling when using the needle body 1200.

[0088] In addition, an annular groove may be formed on the inner wall of the side hole 2120, and a protrusion 2221 matching the annular groove may be formed on the end cover 2220. The end cover 2220 is fixed in the side hole 2120 by the cooperation between the protrusion 2221 and the annular groove to enhance firmness.

[0089] Next, this article will combine Figure 2 The process of performing atrial septal puncture using the puncture system 100 provided in an embodiment of the present invention is introduced. The process of atrial septal puncture is as follows:

[0090] Step S1, delivering a guide wire along the right femoral vein to the junction of the superior vena cava and the subclavian vein.

[0091] In step S2, the dilator 2000 cooperates with a catheter sheath 300 and together enters the superior vena cava along the guide wire.

[0092] Step S3, withdrawing the guide wire and flushing the catheter sheath 300 with heparin saline.

[0093] Step S4, connecting the conductor 1110 of the puncture needle assembly 1000 to the three-dimensional positioning device 200, and at the same time, inserting the needle body 1200 into the dilation catheter 2100 of the dilator 2000, and making the distal end of the needle body 1200 reach the side hole 2120 to contact with the elastic conductive assembly 2200, so that the three-dimensional positioning device 200 positions the distal end of the needle body 1200.

[0094] Step S5, withdraw the catheter sheath 300, the dilator 2000 and the needle body 1200, rotate the needle body 1200, and find the oval fossa according to the position of the His bundle and the tubular venous sinus in combination with the image displayed in the three-dimensional positioning device 200. After finding the oval fossa, stop withdrawing the catheter sheath 300, the dilator 2000 and the needle body 1200.

[0095] Step S6, finding a puncture point, which is located at a position 1 / 3 of the back of the level height of the spaced His bundle.

[0096] Step S7, pushing the dilator 2000 and the catheter sheath 300 forward, the pushing distance is about 2-3 mm.

[0097] Step S8, fix the catheter sheath 300 and the dilator 2000, and according to the image displayed by the three-dimensional positioning device 200, push the needle 1200 forward about 5-10 mm so that the distal end of the needle 1200 extends out of the distal end of the dilation catheter 2100 and passes through the atrial septum.

[0098] Step S9, fix the needle body 1200, and push the catheter sheath 300 and the dilator 2000 forward so that the distal end of the dilator 2000 enters the left atrium.

[0099] Step S10, withdrawing the needle 1200 from the body and fixing the dilator 2000.

[0100] Step S11, pushing the catheter sheath 300 forward so that the distal end of the catheter sheath 300 enters the left atrium.

[0101] Step S12, fix the catheter sheath 300, and withdraw the dilator 2000 from the body to complete the puncture.

[0102] The embodiment of the present invention provides a puncture needle assembly and a puncture system, wherein the puncture needle assembly includes a needle seat and a needle body, wherein the needle seat is provided with a conductor, and the proximal end of the needle body extends into the needle seat and is connected to the conductor. The conductor is used to establish an electrical signal connection between the needle body and a three-dimensional positioning device, thereby increasing the safety and success rate of atrial septal puncture. The puncture system includes the puncture needle assembly and a dilator, and further, the dilator includes an expansion catheter, wherein the expansion catheter has an inner cavity extending along its axial direction, and a side hole connected to the inner cavity is provided at the distal end of the expansion catheter, wherein an elastic conductive component is provided in the side hole. In the process of searching for the puncture point, the needle body is hidden in the expansion catheter and electrically connected to the blood outside the expansion catheter by using the elastic conductive component, so that the three-dimensional positioning device can position the needle body, thereby avoiding damage to the superior vena cava and endocardial tissue, thereby improving safety.

[0103] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A puncture needle assembly, characterized in that: The needle holder comprises a needle body, wherein the needle holder has an axially extending channel, a part of the side wall of the channel is configured as a conductor, and another part of the side wall of the channel is configured as an insulator; the proximal end of the needle body extends in the channel and is electrically connected to the conductor; The insulator has a first inner cavity that runs axially through, and the first inner cavity constitutes part of the channel. The insulator is provided with a window that communicates with the first inner cavity, and the conductor is arranged at the window. The inner wall of the conductor and the inner wall of the first inner cavity together constitute the side wall of the channel.

2. The puncture needle assembly according to claim 1, characterized in that: The conductor is a block structure.

3. The puncture needle assembly according to claim 1, characterized in that: The insulator and the conductor are arranged along the axial direction of the needle seat and are connected to each other, and the channel runs through the insulator and the conductor.

4. The puncture needle assembly according to claim 1, characterized in that: The needle body is connected to the insulator.

5. The puncture needle assembly according to claim 1, characterized in that: An accommodating groove is provided on the inner wall of the conductor; the needle seat also includes a first elastic element, which is arranged in the accommodating groove; the first elastic element is configured to store elastic potential energy to press against the needle body so that the needle body and the conductor maintain electrical conduction.

6. The puncture needle assembly according to claim 5, characterized in that: The first elastic element is a spring, and the axis of the spring is arranged perpendicular to the axis of the needle body.

7. The puncture needle assembly according to claim 1 or 5, characterized in that: The conductor is connected to the needle body through a conductive adhesive layer.

8. The puncture needle assembly according to claim 1, characterized in that: The conductor is provided with a slot, and the slot is used to plug in the pin of the connecting line of the external positioning device.

9. The puncture needle assembly according to claim 8, characterized in that: The conductor includes a main body portion and an extension portion which are connected to each other, wherein the main body portion is used to connect with the needle body, and the slot is arranged on the extension portion; the needle seat also includes an insulator, which includes a first insulating portion and a second insulating portion, the extension portion is covered on at least a portion of the first insulating portion, and the main body portion is arranged between the first insulating portion and the second insulating portion.

10. A puncture system, characterized in that: It comprises a dilator and a puncture needle assembly as described in any one of claims 1-9; the dilator comprises a dilation catheter having an axially extending second inner cavity, and the distal end of the needle body is used to be movably inserted into the second inner cavity.

11. The puncture system according to claim 10, characterized in that: The distal side wall of the dilatation catheter is provided with a side hole communicating with the second inner cavity.

12. The puncture system according to claim 11, characterized in that: The expander further includes an elastic conductive component, which is disposed at the side hole and is used to contact the needle body and press against the needle body through elastic force.

13. The puncture system according to claim 12, characterized in that: The elastic conductive component includes a second elastic element, which includes an arc-shaped portion, one end of which is fixed at the side hole and the other end is a free end, and the arc-shaped portion at least partially protrudes from the inner surface of the dilatation catheter.

14. The puncture system according to claim 13, characterized in that: The elastic conductive component also includes an end cover and a frame. The end cover is arranged in the side hole. The frame is connected to the end cover and is arranged between the end cover and the second inner cavity. The arc portion is connected to the frame.

15. The puncture system according to claim 14, characterized in that: The elastic conductive component further comprises a limit stopper, and the limit stopper is arranged on the arc-shaped portion; when the needle body contacts the arc-shaped portion, the limit stopper contacts the end cover.

16. The puncture system according to claim 15, characterized in that: An annular groove is also formed on the inner wall of the side hole, and the end cover includes a protrusion matching the annular groove, and the protrusion is fixed to the annular groove.

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