阅读说明：本技术 一种穿刺针组件及穿刺系统 (Puncture needle assembly and puncture system ) 是由 查飞翔 梁波 孙毅勇 宋宇文 刘梦瑶 于 2020-05-12 设计创作，主要内容包括：本发明涉及一种穿刺针组件和穿刺系统,所述一种穿刺针组件包括针座和针体,所述针座具有轴向贯通的通道,所述通道的至少一部分侧壁被配置为导电体,所述针体的近端在所述通道内延伸并与所述导电体电连接。所述穿刺系统还包括扩张器,所述扩张器包括扩张导管和可选择地设置在所述扩张导管上的弹性导电组件,所述针体的远端隐藏于所述扩张导管内时,通过所述弹性导电组件或直接与外部血液电性导通。本发明的穿刺针组件和穿刺系统具有使用安全方便,可靠性高的优点。(The invention relates to a puncture needle assembly and a puncture system, the puncture needle assembly comprises a needle seat and a needle body, the needle seat is provided with a channel which is axially communicated, at least one part of the side wall of the channel is configured into an electric conductor, and the proximal end of the needle body extends in the channel and is electrically connected with the electric conductor. The puncture system also comprises a dilator, the dilator comprises a dilating catheter and an elastic conductive component which is selectively arranged on the dilating catheter, and when the distal end of the needle body is hidden in the dilating catheter, the needle body is electrically conducted with external blood directly or through the elastic conductive component. The puncture needle assembly and the puncture system have the advantages of safety and convenience in use and high reliability.)

1. A needle assembly comprising a hub having an axially extending channel therethrough, at least a portion of a sidewall of the channel being configured as an electrical conductor, and a needle body having a proximal end extending within the channel and electrically connected to the electrical conductor.

2. The needle assembly of claim 1, wherein the electrical conductor is a block-like structure.

3. A puncture needle assembly according to claim 1 or 2, wherein all side walls of the channel are configured as the electrical conductors.

4. The needle assembly of claim 1 or 2, wherein a portion of the sidewall of the channel is configured as the electrical conductor and another portion of the sidewall of the channel is configured as an insulator.

5. The lancet assembly of claim 4, wherein the insulator has a first lumen extending therethrough in an axial direction, the first lumen forming part of the channel, the insulator defines a window in communication with the first lumen, the electrical conductor is disposed at the window, and an inner wall of the electrical conductor and an inner wall of the first lumen together form the channel.

6. The lancet assembly of claim 4, wherein the insulator and the electrical conductor are disposed axially of the hub and are connected to each other, and wherein the channel extends through the insulator and the electrical conductor.

7. The lancet assembly of claim 4, wherein the needle body is connected to the insulator.

8. The needle assembly of claim 1, wherein the inner wall of the electrical conductor defines a receiving channel; the needle seat further comprises a first elastic element, and the first elastic element is arranged in the accommodating groove; the first elastic element is configured to store elastic potential energy to press against the needle body so as to enable the needle body to be electrically conducted with the electric conductor.

9. The lancet assembly of claim 8, wherein the first resilient element is a spring and an axis of the spring is disposed perpendicular to an axis of the needle body.

10. The lancet assembly of claim 1 or 8, wherein the electrical conductor is connected to the needle body by a layer of conductive glue.

11. The needle assembly of claim 1, wherein the electrical conductor includes a slot configured to receive a pin of a connector cord of an external positioning device.

12. The needle assembly of claim 11, wherein the electrical conductor includes a body portion and an extension portion coupled to each other, wherein the body portion is configured to interface with the needle body, and wherein the slot is disposed on the extension portion; the needle seat further comprises an insulator, the insulator comprises a first insulating portion and a second insulating portion, the extending portion covers at least one part of the first insulating portion, and the main body portion is arranged between the first insulating portion and the second insulating portion.

13. A puncture system comprising a dilator and a puncture needle assembly of any of claims 1-12; the dilator comprises a dilating catheter, the dilating catheter is provided with a second inner cavity which is axially communicated, and the distal end of the needle body is movably inserted into the second inner cavity.

14. The puncture system of claim 13, wherein the distal sidewall of the dilation catheter defines a side aperture in communication with the second lumen.

15. The puncture system of claim 14, wherein the dilator further comprises a resilient conductive member disposed at the side aperture, and the resilient conductive member is configured to contact the needle body and press against the needle body with a resilient force.

16. The lancing system of claim 15, wherein the resilient conductive assembly comprises a second resilient element comprising an arcuate portion having one end secured at the side aperture and a free end, the arcuate portion at least partially protruding from the inner surface of the dilatation catheter.

17. The lancing system of claim 16, wherein the resilient conductive assembly further comprises an end cap disposed within the side aperture and a frame coupled to the end cap and disposed between the end cap and the second lumen, the arcuate portion coupled to the frame.

18. The lancing system of claim 17, wherein the resilient conductive assembly further comprises a retention tab disposed on the arcuate portion; when the needle body contacts with the arc-shaped part, the limiting blocking piece contacts with the end cover.

19. The lancing system of claim 18, wherein an annular groove is further formed on an inner wall of the side hole, and the end cap includes a projection that mates with the annular groove, the projection being secured to the annular groove.

Technical Field

The invention relates to the technical field of medical instruments, in particular to a puncture needle assembly and a puncture system.

Background

Cardiovascular diseases seriously threaten the health of human beings, and have the characteristics of high morbidity, disability and mortality. Interventional therapy is a more effective treatment for cardiovascular diseases, and when interventional therapy such as atrial fibrillation and atrial flutter is performed, puncture is often required to enable an interventional therapy device to pass through the interatrial septum to reach a lesion site.

The dilator and the puncture needle are important parts for atrial septal puncture, the puncture needle utilizes the puncture capability of the stainless steel needle tube at the far end to enable the dilator and the catheter sheath to penetrate through the atrial septal under the condition that the catheter sheath and the dilator are assembled, and the dilator utilizes the tapered necking at the far end to establish transition between the catheter sheath and the puncture needle on the basis that the puncture needle penetrates through the atrial septal, so that the resistance is reduced, the wound is reduced, and the puncture time is shortened.

The traditional interatrial puncture is implemented under the guidance of X-ray fluoroscopy, is a technology under a two-dimensional plane view angle, and doctors can only combine X-ray imaging and operation methods to search puncture sites in vivo, so that the accuracy is low, the risk is high, and long-time clinical accumulation is needed for mastering the technology. In recent years, a 'green electrophysiological three-dimensional system' is widely applied to the field of interventional surgery, has the characteristics of extremely low ray, accurate positioning, navigation and the like, reduces the learning time to a great extent, and also reduces the damage of the ray to a doctor and a patient, so that the interventional surgery treatment is more and more accurate, safe and easy. However, the interatrial puncture is still in a two-dimensional mode combined with X-ray imaging, has not been widely applied in the field of 'electric positioning three-dimensional system' surgery, and cannot realize the characteristics of extremely low ray, accurate positioning, navigation and the like. Therefore, in the prior art, no puncture system which is guided by an electrical positioning system and an electrocardiosignal is provided for realizing accurate puncture.

Disclosure of Invention

The invention aims to provide a puncture needle assembly and a puncture system, which can be applied to a three-dimensional interatrial septum puncture technology, are convenient to use and have high reliability.

In order to achieve the above object, the present invention provides a puncture needle assembly comprising a needle holder and a needle body, wherein the needle holder has a channel axially extending therethrough, at least a portion of a sidewall of the channel is configured as an electrical conductor, and a proximal end of the needle body extends within the channel and is electrically connected to the electrical conductor.

Optionally, the electrical conductor is a bulk structure.

Optionally, all sidewalls of the channel are configured as the electrical conductor.

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

Optionally, the insulator has a first inner cavity penetrating axially, the first inner cavity forms part of the channel, a window communicated with the first inner cavity is formed in the insulator, the electric conductor is arranged at the window, and the inner wall of the electric conductor and the inner wall of the first inner cavity together form the channel.

Optionally, the insulator and the conductor are arranged and connected to each other in the axial direction of the needle holder, and the channel penetrates through the insulator and the conductor.

Optionally, the pin body is connected to the insulator.

Optionally, an accommodating groove is formed in the inner wall of the conductor; the needle seat further comprises a first elastic element, and the first elastic element is arranged in the accommodating groove; the first elastic element is configured to store elastic potential energy to press against the needle body so as to enable the needle body to be electrically conducted with the electric conductor.

Optionally, the first resilient element is a spring, and an axis of the spring is arranged perpendicular to an axis of the needle body.

Optionally, the conductor is connected to the pin body through a conductive adhesive layer.

Optionally, a slot is provided on the conductor, and the slot is used for plugging a pin of the external positioning device connection line.

Optionally, the electrical conductor includes a main body portion and an extension portion connected to each other, wherein the main body portion is configured to be connected to the needle, and the slot is disposed on the extension portion; the needle seat further comprises an insulator, the insulator comprises a first insulating portion and a second insulating portion, the extending portion covers at least one part of the first insulating portion, and the main body portion is arranged between the first insulating portion and the second insulating portion.

To achieve the above object, the present invention also provides a puncture system comprising a dilator and a puncture needle assembly as described in any one of the above; the dilator comprises a dilating catheter, the dilating catheter is provided with a second inner cavity which is axially communicated, and the distal end of the needle body is movably inserted into the second inner cavity.

Optionally, the distal sidewall of the dilation catheter is provided with a side hole communicating with the second lumen.

Optionally, the dilator further includes an elastic conductive component, the elastic conductive component is disposed at the side hole, and the elastic conductive component is used for contacting with the needle body and pressing against the needle body through elastic force.

Optionally, the elastic conductive assembly 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 of the arc-shaped portion is a free end, and at least a part of the arc-shaped portion protrudes out of the inner surface of the dilatation catheter.

Optionally, the elastic conductive assembly further includes an end cover and a frame, the end cover is disposed in the side hole, the frame is connected to the end cover and disposed between the end cover and the second inner cavity, and the arc portion is connected to the frame.

Optionally, the elastic conductive assembly further comprises a limiting blocking piece, and the limiting blocking piece is arranged on the arc-shaped part; when the needle body contacts with the arc-shaped part, the limiting blocking piece contacts with the end cover.

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

The puncture needle assembly and the puncture system have the following advantages:

first, the above-described needle assembly includes a hub including an electrical conductor, the hub having an axially extending channel with at least a portion of a sidewall configured as the electrical conductor, and a needle body having a proximal end extending within the channel and electrically coupled to the electrical conductor. During the atrial septal puncture, the electric conductor is connected with the three-dimensional positioning device, so that the electric signal connection of the needle body and the three-dimensional positioning device can be realized, and the application of the puncture needle in the field of 'electric positioning three-dimensional system' operation is realized.

Secondly, the puncture needle assembly further comprises an elastic body and/or a conductive adhesive layer, and the elastic body and/or the conductive adhesive layer are arranged to enhance the connection between the needle body and the electric conductor, so that the good transmission of electric signals in the puncture process is ensured, and the puncture success rate is improved.

And thirdly, the conductive body is provided with a slot which is used for inserting a contact pin of the three-dimensional positioning device, and the conductive body has the advantages of convenience in use and reliability in connection.

Fourthly, the puncture system comprises the puncture needle assembly and the dilator, the dilator comprises a dilating catheter, the dilating catheter is provided with a second inner cavity which is communicated along the axial direction of the dilating catheter, and the distal end of the dilating catheter is provided with a side hole which is communicated with the second inner cavity so as to ensure that the needle body is electrically communicated with external blood; optionally, the dilator may further include an elastic conductive component, the elastic conductive component is disposed in the side hole, and during the atrial septal puncture, the distal end of the needle body extends to the side hole along the second inner cavity and contacts with the elastic conductive component, so that the needle body is electrically conducted with blood outside the dilation catheter. Namely, 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, and the damage of the distal end of the needle body to human tissues is avoided.

Drawings

FIG. 1 is a schematic diagram of a lancing system according to one embodiment of the present invention;

FIG. 2 is a schematic illustration of a puncture system according to the present invention during a puncture procedure at an interrow space;

FIG. 3 is a partial schematic view of a lancing system according to one embodiment of the present invention;

FIG. 4 is a cross-sectional view A-A of the lancing system shown in FIG. 3;

FIG. 5 is a partial schematic view of an introducer needle assembly of the lancing system according to one embodiment of the present invention;

FIG. 6 is a partial cross-sectional view of a lancet assembly of the lancing system according to one embodiment of the present invention showing an electrical conductor disposed at a window formed by an insulator;

FIG. 7 is a partial schematic view of a lancet assembly of the lancing system provided in accordance with one embodiment of the present invention in one orientation;

FIG. 8 is a schematic view of the lancet assembly of the lancing system of FIG. 7 in another orientation showing the electrical conductors having slots;

FIG. 9 is a B-B cross-sectional view of the lancet assembly of the lancing system shown in FIG. 8;

FIG. 10 is a partial cross-sectional view of a dilator of a puncture system provided in accordance with an embodiment of the present invention;

FIG. 11 is a schematic view of the resilient, electrically-conductive member of the dilator of the puncture system shown in FIG. 10;

FIG. 12 is a partial cross-sectional view of a dilator of a puncture system provided in accordance with another embodiment of the present invention;

FIG. 13 is a schematic diagram of the construction of the resilient conductive member of the dilator of the puncture system of FIG. 12;

FIG. 14 is a schematic view of the distal end of a dilation catheter of a dilator of a puncture system according to one embodiment of the present invention showing a circular side hole;

FIG. 15 is a C-C cross-sectional view of the dilator of the puncture system shown in FIG. 14;

FIG. 16 is a schematic view of the distal end of a dilation catheter of a dilator in a puncture system according to one embodiment of the present invention, showing a side hole as a square hole.

Fig. 17 is a cross-sectional view, taken along line D-D, of the dilator of the puncture system shown in fig. 16.

[ reference numerals are described below ]:

100-a puncture system;

1000-an introducer needle assembly;

1100-needle seat;

1110-an electrical conductor;

1111-main part, 1112-extension part, 1113-slot;

1120-insulator;

1130-a first elastic element;

1200-needle body;

2000-dilator;

2100-a dilatation catheter;

2110-step, 2120-side hole;

2200-an elastic lead assembly;

2210-a second elastic element;

2211-arc;

2220-end cap;

2221-projection;

2230-frame;

2240-limit stop sheet;

200-a three-dimensional positioning device;

300-catheter sheath.

Detailed Description

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "coupled" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. They may be directly connected to each other or indirectly connected to each other through an intermediate member, or they may be connected to each other through the inside of two members or they may be adjacent to each other or abutted against each other. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations. The same or similar reference numbers in the drawings identify the same or similar elements.

As used herein, the terms "proximal" and "distal" refer to the relative orientation, relative position, and orientation of elements or actions with respect to one another from the perspective of a clinician using the medical device, and although "proximal" and "distal" are not intended to be limiting, the term "proximal" generally refers to the end of the medical device that is closer to the clinician during normal operation, and the term "distal" generally refers to the end that is first introduced into a patient.

The embodiment of the invention provides a puncture needle assembly and a puncture system comprising the same, and a doctor can perform downlink puncture on a three-dimensional interface by using the puncture system. As shown in fig. 1, the puncture system 100 includes a puncture needle assembly 1000 and a dilator 2000. The puncture needle assembly 1000 comprises a needle seat 1100 and a needle body 1200, wherein the needle seat 1100 comprises an electric conductor 1110, the needle seat 1100 is provided with a channel which is axially communicated, and at least one part of the side wall of the channel is configured as the electric conductor 1110. The proximal end of the needle body 1200 extends within the channel and interfaces with the electrical conductor 1110. The dilator 2000 includes a hollow dilating catheter 2100, and the distal end of the needle body 1200 is advanced into the body tissue along the dilating catheter 2100 for puncture.

As shown in fig. 2, during the course of performing the paracentesis, the distal end of the needle body 1200 is electrically connected to blood to obtain an electrical signal. The proximal end of the needle 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 1200. In this embodiment, the conductor 1110 is disposed on the needle holder 1100, and the conductor 1110 is connected to the three-dimensional positioning device to connect the needle body 1200 to the three-dimensional positioning device 200, so that no additional lead is required to be disposed on the needle body 1100, and the operability of the puncture needle assembly 1000 is further improved.

Referring to fig. 1, in the embodiment of the invention, the conductive body 1110 may be made of a metal conductive material, such as stainless steel, aluminum, and the like. The needle body 1200 may be a slender hollow structure made of a metal conductive material, may be formed by integrally forming a section of tube, or may be formed by connecting two sections of tubes. The distal end of the needle body 1200 may be curved and the distal end of the needle body 1200 may have a smaller diameter than the proximal end and may have a pointed end to facilitate piercing of body tissue. The proximal end of the needle body 1200 is electrically connected to the electrical conductor 1110, so as to transmit the electrical signal to the electrical conductor 1110 and further to the three-dimensional positioning device 200.

In some embodiments, the hub 1100 is formed entirely of the conductor 1110 such that all of the sidewalls of the channel are formed by the conductor 1110. For the needle seat of the existing puncture needle, a doctor can have a requirement on the hand feeling of the needle seat in the operation process, namely the needle seat has to have certain weight, so the whole needle seat is composed of the electric conductor 1110 to meet the requirement, but meanwhile, the electric conductor is used as metal, the cost is higher, the biocompatibility of the common metal copper is poor, a surface coating is needed, the technical difficulty of the small cavity coating is very high, and if the stainless steel with good biocompatibility is adopted, the ideal shape is difficult to process due to poor plasticity.

Therefore, in other embodiments, as shown in fig. 3, the wafer 1100 further includes an insulator 1120, the insulator 1120 and the conductor 1110 are respectively molded and then connected into a whole, and the conductor 1110 forms a part of a sidewall of the channel, and the insulator 1120 forms another part of a sidewall of the channel. Therefore, on one hand, the use of metal materials can be reduced, and the cost of the puncture needle assembly 1000 can be reduced, and on the other hand, the insulator 1120 can be made of high polymer materials with good biocompatibility, is safe for human bodies, and is easy to process.

The specific structure of the wafer 1100 may be set according to actual needs, but generally the conductive body 1110 is designed as a block structure. Referring to fig. 3 to 5, in an embodiment, the conductor 1110 and the insulator 1120 are disposed along an axial direction of the hub 1100, the conductor 1110 is provided with a first through hole extending along the axial direction, the insulator is provided with a second through hole penetrating along the axial direction, and the second through hole is communicated with the first through hole to form the channel. Alternatively, as shown in fig. 6, in another embodiment, the insulator 1120 is provided with a first inner cavity penetrating in the axial direction, the first inner cavity forms part of the channel, the insulator 1120 is provided with a window communicating with the first inner cavity, the conductor 1110 is provided at the window, and the inner wall of the conductor 1110 and the inner wall of the first inner cavity together form the channel. Generally, the needle body 1200 is disposed within the channel and is connected to the electrical conductor 1110. For ease of assembly, the inner diameter of the channel is larger than the outer diameter of the proximal end of the needle 1200, but this results in a gap between the needle 1200 and the conductor 1110, which results in an unreliable connection between the two. In order to solve this problem, in this embodiment, a conductive adhesive is further filled between the inner surface of the conductive body 1110 and the needle body 1200, a conductive adhesive layer (not shown in the figure) is formed after the conductive adhesive is cured, and the connection between the conductive body 1110 and the needle body 1200 is strengthened by the conductive adhesive layer, so that the electrical signal collected at the distal end of the needle body 1200 can be smoothly transmitted to the three-dimensional positioning device 200.

Alternatively, as shown in fig. 9, in an alternative embodiment, the problem of unreliable connection between the conductor 1110 and the needle body 1200 caused by the mismatch between the bore diameter of the channel and the outer diameter of the needle body 1200 can be solved by providing the first elastic element 1130. Specifically, an accommodating groove (labeled in the figure) is disposed on an inner surface of the conductor 1110, the first elastic element 1130 is disposed in the accommodating groove and configured to store elastic potential energy, and 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, and when the first elastic element 1130 is a spring, an axis of the spring is perpendicular to an axis of the needle body 1200.

Further, the needle body 1200 is further connected to the insulator 1120, so as 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.

When the puncture system 100 provided by the embodiment is used for puncture, the conductive body 1110 of the puncture needle assembly 100 can be connected with the connecting tail of the three-dimensional positioning device 200 through a conductive clip.

The way of connecting the conductive body 1110 and the connecting tail of the three-dimensional positioning apparatus 200 by the conductive clip may affect the electrical signal transmission effect due to small contact surface or unstable contact of the electrical connection. In view of this, in a further improvement, as shown in fig. 7 to 9, the conductive body 1110 is provided with an insertion slot 1113, and the insertion slot 1113 is used for inserting a pin of the connection tail, so that the conductive body is not only convenient to use, but also has the advantage of firm and reliable connection. Optionally, the conductive body 1110 includes a main portion 1111 and an extension portion 1112 connected to each other, wherein the main portion 1111 is configured to interface with the needle body 1200, and the slot 1113 is disposed on the extension portion 1112. In order to reduce the use of metal materials, reduce the cost of the lancet assembly 1000, and further improve the bio-safety, the hub 1100 further includes an insulator 1120, the insulator 1120 includes a first insulator 1120a and a second insulator 1120b, the extension 1112 is wrapped around at least a portion of the first insulator 1120a, and the body 1111 is disposed between the first insulator 1120a and the second insulator 1120 b. Through this design, both satisfied the requirement in the aspect of being connected with three-dimensional positioner 200, also considered biological safety and cost problem. On the other hand, the pin is connected with the slot 1113, and the slot walls of the slot 1113 are all electric conductors, so that the stability and reliability of signal transmission can be further improved.

Based on the technical concept of the present invention, a person skilled in the art may also design a plurality of pin seat structures, for example, a part of the insulator is coated on the conductor, and the insulator is provided with a slot extending to the conductor, so that the pin inserted into the slot can be conducted with the conductor.

Referring to fig. 1 in combination with fig. 10 and 12, the dilating catheter 2100 of the dilator 2000 is an elongated structure, the distal end of the dilating catheter 2100 is formed as a tip, the dilating catheter 2100 has a second inner cavity axially penetrating through, and a step 2110 is further disposed on the inner surface of the dilating catheter 2100, and the step 2110 is used for limiting the length of the needle body 1200 protruding from the distal end of the dilating catheter 2100, so as to avoid the danger of over-long needle.

Further, referring to fig. 14-17, a side hole 2120 is disposed at the distal end of the dilating catheter 2100 and communicates with the second lumen of the dilating catheter 2100. The needle body 1200 is electrically connected to blood outside the dilatation catheter 2100 through the side hole. Thus, when the distal end of the puncture system 100 enters the body of the patient and searches for a 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 conducted with blood to obtain an electrical signal, thereby avoiding damaging human tissues when the distal end of the needle body 1200 searches for a puncture point.

In this embodiment, the cross-section of the side hole 2120 may be any suitable shape, such as a circle (as shown in fig. 14 and 15), a square (as shown in fig. 16 and 17), a kidney circle, a polygon, an irregular shape, and the like. The number of the side holes 2120 may be one, or may be a plurality of, for example, two, and two side holes 2120 may be symmetrically disposed at the distal end of the dilation catheter 2100.

In order to further enhance the electrical conduction between the needle body 1200 and blood, in another embodiment, the dilator 2000 further includes an elastic conductive element 2200 disposed in the side hole 2120, and the blood contacts the elastic conductive body 2200 to electrically conduct with the needle body 1200 through the elastic conductive body 2200.

With continued reference to fig. 10 and 11, in an exemplary embodiment, the resilient conductive member 2200 comprises a second resilient element 2210 formed by bending a thin metal sheet and including an arc-shaped portion 2211, wherein one end of the arc-shaped portion 2211 is fixed to the side hole 2120, and 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. During the process of finding the puncture point, the arc-shaped portion 2211 is pressed against the distal end of the puncture needle 1200, so that the needle body 120 is effectively contacted with the elastic conductive member 220.

Optionally, the elastic conductive member 2200 further comprises an end cap 2220 and a frame 2230, and the end cap 2220 and the frame 2230 may be integrally formed, or they may be separate structures and integrally connected by a suitable connection means, such as welding. The end cap 2220 is fixed to the inner side of the side hole 2120, and one end of the arc-shaped portion 2211 is fixed to the inner side of the frame 2230. Further, as shown in fig. 12 and 13, the elastic conductive member 2200 further includes a limiting stopper 2240, wherein the limiting stopper 2240 is disposed on the arc-shaped portion 2211, and preferably, the limiting stopper 2240 is connected to the free end of the arc-shaped portion 2211. When the needle body 1200 contacts the arc-shaped portion 2211, the second elastic element 2210, under the action of elastic force, causes the limiting blocking piece 2240 to move towards the end cover 2220 until the limiting blocking piece 2240 contacts the end cover 2220, so that on one hand, the conduction effect of the needle body 1200 and external blood can be enhanced, and on the other hand, the use hand feeling of a doctor can be improved.

In addition, an annular groove may be formed on the inner wall of the side hole 2120, a protrusion 2221 matched with the annular groove may be formed on the end cap 2220, and the end cap 2220 is fixed in the side hole 2120 by the matching of the protrusion 2221 and the annular groove, so that the firmness is enhanced.

Next, the procedure of the atrial septal puncture using the puncture system 100 provided by the embodiment of the present invention will be described with reference to fig. 2. The process of the interatrial septum puncture is as follows:

in step S1, a guidewire is delivered along the right femoral vein to the junction of the superior vena cava and the subclavian vein.

At step S2, the dilator 2000 and an introducer sheath 300 are mated and brought together along the guidewire into the superior vena cava.

Step S3, the guidewire is withdrawn and the catheter sheath 300 is flushed with heparin saline.

Step S4, the conductive body 1110 of the puncture needle assembly 1000 is connected to the three-dimensional positioning device 200, and at the same time, the needle body 1200 is inserted into the dilating catheter 2100 of the dilator 2000, and the distal end of the needle body 1200 reaches the side hole 2120 to contact with the elastic conductive member 2200, so that the three-dimensional positioning device 200 positions the distal end of the needle body 1200.

Step S5, retracting the catheter sheath 300, the dilator 2000 and the needle 1200, and rotating the needle 1200 while finding the fossa ovalis according to the his bundle and the position of the tubular sinus in conjunction with the image displayed in the three-dimensional positioning device 200. After finding the fossa ovalis, withdrawal of the catheter sheath 300, the dilator 2000, and the needle 1200 is stopped.

Step S6, a puncture point is sought that is located 1/3 posterior to the flush height of the spaced his bundle.

Step S7, the dilator 2000 and the introducer sheath 300 are advanced by a distance of about 2-3 mm.

Step S8, fixing the catheter sheath 300 and the dilator 2000, and pushing the needle 1200 forward about 5-10mm according to the image displayed by the three-dimensional positioning device 200, so that the distal end of the needle 1200 protrudes out of the distal end of the dilating catheter 2100 and crosses the interatrial septum.

Step S9, the needle body 1200 is fixed and the catheter sheath 300 and the dilator 2000 are pushed forward to advance the distal end of the dilator 2000 into the left atrium.

Step S10, the needle 1200 is withdrawn from the body, and the dilator 2000 is fixed.

Step S11, the catheter sheath 300 is pushed forward to advance the distal end of the catheter sheath 300 into the left atrium.

At step S12, the catheter sheath 300 is fixed and the dilator 2000 is withdrawn from the body to complete the puncture.

The embodiment of the invention provides a puncture needle assembly and a puncture system, wherein the puncture needle assembly comprises a needle seat and a needle body, the needle seat is provided with an electric conductor, and the near end of the needle body extends into the needle seat and is connected with the electric conductor. The electric signal connection relationship between the needle body and the three-dimensional positioning device is established through the electric conductor, and the safety and the success rate of atrial septal puncture are improved. The puncture system includes puncture needle subassembly and expander, furtherly, the expander includes the expansion pipe, the expansion pipe has the inner chamber of following its axial and lining up, be equipped with on the distal end of expansion pipe with the side opening of inner chamber intercommunication, be provided with elasticity conducting component in the side opening. In the process of searching for a puncture point, the needle body is hidden in the expansion catheter and is electrically communicated with the blood outside the expansion catheter by the aid of the elastic conductive component, so that the needle body can be positioned by the three-dimensional positioning device, damage to superior vena cava and endocardium tissue is avoided, and safety is improved.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such 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 such modifications and variations.