CN115919431A

CN115919431A - Interatrial septum puncture device

Info

Publication number: CN115919431A
Application number: CN202310231499.6A
Authority: CN
Inventors: 宁方羿; 孙毅勇; 陈艳; 韩庆
Original assignee: Shanghai Microport EP MedTech Co Ltd
Current assignee: Shanghai Microport EP MedTech Co Ltd
Priority date: 2023-03-09
Filing date: 2023-03-09
Publication date: 2023-04-07
Anticipated expiration: 2043-03-09
Also published as: CN115919431B

Abstract

The invention provides an interatrial septum puncture device, which comprises an expansion tube, a puncture needle, a handle and a driving assembly, wherein the expansion tube is connected with the puncture needle; the puncture needle is movably arranged in the axial direction of the expansion tube in a penetrating way and has a storage position and an extending position relative to the expansion tube, and when the puncture needle is located at the storage position, the far end of the puncture needle does not exceed the far end of the expansion tube; when the puncture needle is positioned at the extending position, the distal end of the puncture needle extends out of the distal end of the dilation tube; the handle is arranged along the axial direction of the expansion tube, the near end of the expansion tube is connected with the handle, the driving assembly is arranged on the handle, the puncture needle is connected with the driving assembly, and the puncture needle is driven by the driving assembly to be switched between the accommodating position and the extending position. So the configuration, the expansion tube and the puncture needle are integrated into a whole, and the function of simplifying the operation steps is played.

Description

Interatrial septum puncture device

Technical Field

The invention relates to the technical field of medical instruments, in particular to an interatrial septum puncture device.

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 generally requires the use of an introducer sheath to provide support and access to an intracardiac catheter during the interventional procedure. For interventional therapy of atrial fibrillation, atrial flutter, etc., it is often necessary to perform an atrial septal puncture to create a pathway from the right atrium to the left atrium, since surgery is required in the left cardiac system. In the interatrial puncture, a puncture needle is used to puncture at the fossa ovalis position in cooperation with an expander and a guide sheath, and the catheter is conveyed into the left atrium through the guide sheath after the puncture is finished.

A common transseptal puncture assembly includes a guidewire, a dilator, an introducer sheath, and a transseptal needle. The interatrial septum puncture needle and the dilator are independent components, and the inner cavity of the needle is thin and can not pass through a guide wire. Therefore, when performing the interatrial septum puncture, the operator first fits the guidewire, dilator and introducer sheath together and enters the patient's superior vena cava from the femoral vein. After that, the operator needs to withdraw the guide wire, put the interatrial septum puncture needle into the dilator and pay attention to keep the needle point of the puncture needle not extending out of the dilator, and then attach the distal end of the dilator to the fossa ovalis under the assistance of X-ray or ultrasound. After the precise location of the dilator is determined, the operator pushes the puncture needle out of the dilator and pierces the fossa ovalis. After the puncture is finished and the puncture position is confirmed to be correct, the dilator and the guide sheath are pushed into the left atrium together, then the positions of the guide sheath and the dilator are kept unchanged, the puncture needle is withdrawn, and the guide wire is placed again. In the above process, the interatrial septum puncture needle mainly has the function of puncturing the interatrial septum by mechanical force, and the introducer sheath and the dilator mainly have the functions of providing support and establishing a passage.

The above procedures for interatrial septum puncture have four drawbacks: (1) the operation steps are complicated, the operation time is long, and the guide wire and the dilator need to be replaced after the sheath is put into the path; (2) when the puncture needle enters the dilator, the sharp tip risks to shave the inner wall of the dilator, and the scraps generated by shavings can cause thrombus; (3) after the puncture needle enters the dilator, the needle point needs to be kept from extending out of the dilator by mistake, otherwise, the risk of scratching the endocardium exists; (4) after the sheath assembly is integrally inserted into the left atrium, in the process of withdrawing the puncture needle, the sheath assembly may fall out of the left atrium along with the puncture needle, and the puncture is needed again at the moment.

Disclosure of Invention

It is an object of the present invention to provide a transseptal puncture device to address one or more of the problems with existing transseptal puncture assemblies.

In order to solve the above technical problem, the present invention provides an interatrial septum puncture device, comprising: the device comprises an expansion tube, a puncture needle, a handle and a driving assembly;

the puncture needle is movably arranged in the axial direction of the expansion tube in a penetrating way and has a storage position and an extending position relative to the expansion tube, and when the puncture needle is located at the storage position, the far end of the puncture needle does not exceed the far end of the expansion tube; when the puncture needle is positioned at the extending position, the distal end of the puncture needle extends out of the distal end of the dilation tube;

the handle is arranged along the axial direction of the expansion tube, the near end of the expansion tube is connected with the handle, the driving assembly is arranged on the handle, the puncture needle is connected with the driving assembly, and the puncture needle is driven by the driving assembly to be switched between the accommodating position and the extending position.

Optionally, the dilator tube has a side hole, and when the puncture needle is in the storage position, the puncture needle contacts with liquid in the environment through the side hole to obtain an electrical signal.

Optionally, the puncture needle has a predetermined bending shape when not subjected to external force; the expansion tube is provided with a bending section matched with the preset bending shape of the puncture needle; the puncture needle can be bent under the action of external force; the puncture needle is provided with a guide wire through hole which is communicated along the axial direction of the puncture needle.

Optionally, the driving assembly includes a push button movably disposed on the handle in an axial direction of the handle, an axial position of the push button relative to the puncture needle is defined, and the push button moves in the axial direction to drive the puncture needle to move.

Optionally, the drive assembly further comprises a damping member configured to apply a resistance force to the push button when the distal end of the puncture needle extends out of the distal end of the dilation tube and moves in the axial direction of the dilation tube.

Optionally, the damping member includes a damping groove and/or an elastic member, and the push button has a protrusion extending in an axial direction of the handle;

when the damping piece comprises a damping groove, the damping groove narrows towards the far end, and the narrowed damping groove is abutted with the bulge to apply resistance to the push button;

when the damping member includes an elastic member, the elastic member abuts against the projection by being pressed and deformed, and applies resistance to the push button.

Optionally, the drive assembly further comprises a locking member for locking the axial position of the push button relative to the handle.

Optionally, the locking member comprises a rack extending along the axial direction of the handle and arranged on the handle, and the rack is provided with a plurality of tooth grooves arranged at intervals; the push button comprises a latch matched with the tooth groove;

the push button is movably arranged along the radial direction of the handle and is configured to move along the radial direction of the handle so as to drive the clamping tooth to be clamped into the tooth socket or be separated from the tooth socket;

when the latch is clamped into the tooth groove, the axial position of the push button relative to the handle is locked;

and when the latch is disengaged from the tooth groove, the axial position of the push button relative to the handle is unlocked.

Optionally, the driving assembly further includes a potential energy component, and the potential energy component is configured to apply potential energy to the push button, so that when the push button is not subjected to an external force, the latch is driven to be clamped into the tooth socket.

Optionally, the push button is provided with a limiting cavity and a strip-shaped hole;

the strip-shaped hole is formed along the axial direction of the handle and is communicated with the limiting cavity; the cross section of the strip-shaped hole is provided with a long shaft and a short shaft, and the strip-shaped hole allows the puncture needle to movably penetrate through the strip-shaped hole along the direction of the long shaft; the push button is configured to move along the direction of the long axis to drive the clamping tooth to be clamped into the tooth socket or be separated from the tooth socket;

the driving assembly further comprises an insert fixedly connected with the puncture needle, the insert is movably arranged in the limiting cavity along the direction of the long shaft, and the insert is limited in the limiting cavity along the axial direction of the handle and driven by the push button;

the displacement of the insert along the direction of the short shaft is limited by the limiting cavity, and/or the displacement of the puncture needle along the direction of the short shaft is limited by the strip-shaped hole.

Optionally, the driving assembly comprises a knob and a screw fixedly connected with the puncture needle, the knob is rotatably arranged on the handle around the axis of the handle, and the axial position of the knob relative to the handle is limited; the screw rod extends along the axial direction of the handle and is in threaded connection with the knob; the screw rod is limited in circumferential rotation relative to the handle, and the knob is rotated to drive the screw rod to move along the axial direction of the handle so as to drive the puncture needle to move.

Optionally, the handle has a scale for indicating the driving amount of the driving assembly.

Optionally, the interatrial septum puncture device comprises a safety mechanism movably disposed on the handle and movable between a locked position and an unlocked position; when the safety mechanism is located at the locking position, the driving stroke of the driving assembly is limited by abutting or clamping, so that the puncture needle is located at the accommodating position; when the safety mechanism is located at the unlocking position, the limit on the driving stroke of the driving assembly is removed, and the puncture needle is allowed to be converted to the extending position.

Optionally, the interatrial septum puncture device includes a side branch pipe arranged along the radial direction of the handle, the handle includes an expansion pipe seat, the expansion pipe seat is connected with the proximal end of the expansion pipe along the axial direction of the handle, the side branch pipe is connected with the expansion pipe seat along the radial direction of the handle, and the expansion pipe seat allows the puncture needle to movably penetrate through along the axial direction; the dilating tube holder has a hemostasis valve therein for preventing the flow of liquid out to the proximal end of the dilating tube holder.

Optionally, the interatrial septum puncture device comprises a first lead and a second lead arranged along the radial direction of the handle, the handle is provided with a first lead accommodating cavity arranged around the puncture needle, one end of the first lead is connected with the puncture needle in the first lead accommodating cavity, and the other end of the first lead is connected with the second lead; the first wire is provided with a loose section in the first wire accommodating cavity.

Optionally, the handle has a limiting hole formed along the axial direction, the inner diameter of the limiting hole is matched with the outer diameter of the puncture needle, and the limiting hole is used for the puncture needle to penetrate through and limits the radial displacement of the puncture needle.

Optionally, the interatrial septum puncture device comprises an introducer sheath assembly, the introducer sheath assembly comprising an introducer sheath, a sheath hub and a ring electrode; the guide sheath is movably sleeved outside the expansion pipe and is detachably connected with the handle through the sheath seat; the ring electrode is disposed on an outer circumferential surface of the introducer sheath and is configured to acquire an electrical signal.

Optionally, the interatrial septum puncture device includes a three-dimensional navigation unit, the three-dimensional navigation unit is electrically connected to the ring electrode and the puncture needle respectively, and obtains the spatial pose information of the puncture needle and the guide sheath based on the electrical signal of the ring electrode and the electrical signal of the puncture needle.

In summary, the interatrial septum puncture device provided by the invention comprises an expansion tube, a puncture needle, a handle and a driving assembly; the puncture needle is movably arranged in the axial direction of the expansion tube in a penetrating way and has a storage position and an extending position relative to the expansion tube, and when the puncture needle is located at the storage position, the far end of the puncture needle does not exceed the far end of the expansion tube; when the puncture needle is positioned at the extending position, the distal end of the puncture needle extends out of the distal end of the dilation tube; the handle is arranged along the axial direction of the expansion tube, the near end of the expansion tube is connected with the handle, the driving assembly is arranged on the handle, the puncture needle is connected with the driving assembly, and the puncture needle is driven by the driving assembly to be switched between the accommodating position and the extending position.

So dispose, the expansion pipe is integrated as an organic whole with the pjncture needle, through the drive assembly on the operating handle, can control stretching out and accomodating of pjncture needle, saves the loaded down with trivial details process that the art person exchanged pjncture needle and seal wire before accomplishing the puncture, plays the effect of simplifying the operation step. Furthermore, an operator does not need to penetrate the puncture needle into the expansion tube during preoperative preparation, so that the movement distance of the puncture needle in the expansion tube is reduced, and the risk of thrombus caused by the inner wall of the puncture needle shaving expansion tube is reduced.

Drawings

It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation to the scope of the invention. Wherein:

FIG. 1 is a schematic view of a transseptal puncture device in accordance with an embodiment of the present invention (which does not include an introducer sheath).

Fig. 2 is a schematic view of an introducer sheath in accordance with an embodiment of the invention.

FIG. 3 is a schematic view of a portion of the distal end of the needle and dilation tube of an embodiment of the present invention.

FIG. 4 is a schematic view of a handle of an embodiment of the present invention.

FIG. 5 is a schematic axial cross-section of a handle of an embodiment of the present invention.

FIG. 6 is a schematic view of a push button and a damping slot according to an embodiment of the present invention.

Fig. 7 is a schematic view of a push button and an elastic member according to an embodiment of the invention.

Fig. 8 is a schematic view of a push button and a locking member according to an embodiment of the present invention.

Fig. 9 is a partial cross-sectional view of a locking element of an embodiment of the present invention.

FIG. 10 is a schematic view of a knob of an embodiment of the present invention.

In the drawings:

1-expanding the tube; 11-a transition section; 12-a curved section; 13-side holes; 2, puncturing needle; 3-a handle; 30-a limit piece; 31-a snap-fit structure; 32-a chute; 33-a housing chamber; 34-a rotation limiting groove; 35-graduation; 36-expanding the tube seat; 37-a first wire receiving cavity; 38-a limiting hole; 39-partition walls; 4-a drive assembly; 41-push button; 411-protrusions; 412-latch; 413-a limiting cavity; 414-bar holes; 415-a step; 42-a damping member; 421-damping slot; 422-an elastic member; 43-a locking member; 431-rack; 432-gullet; 44-potential energy pieces; 45-an insert; 46-a knob; 461-arrow head; 47-screw rod; 5-an introducer sheath assembly; 51-an introducer sheath; 511-metal mesh grid; 52-sheath seat; 53-ring electrode; 54-tail interface; 6-a safety mechanism; 7-side branch pipeline; 81-a first wire; 82-a second wire; 83-loose section; 9-luer.

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 specific embodiments thereof which are illustrated in the appended drawings. It is to be noted that the drawings are in greatly simplified form and are not to scale, but are merely intended to facilitate and clarify the explanation of the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.

As used in this application, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally employed in a sense including "and/or," the terms "a" and "an" are generally employed in a sense including "at least one," the terms "at least two" are generally employed in a sense including "two or more," and the terms "first", "second" and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicit to the number of technical features indicated. Thus, a feature defined as "first," "second," or "third" may explicitly or implicitly include one or at least two of that feature, "one end" and "the other end," and "proximal end" and "distal end" generally refer to the corresponding two parts, including not only the endpoints. The terms "proximal" and "distal" are defined herein with respect to a transseptal puncture device having one end for introduction into the human body and a manipulation end (e.g., handle) located outside the body. The term "proximal" refers to a location of an element that is closer to the extracorporeal-located manipulation end of the transseptal puncture device, and the term "distal" refers to a location of an element that is closer to the end of the transseptal puncture device that is inserted into the body and, thus, further away from the manipulation end of the transseptal puncture device. Alternatively, in a manual or hand-operated application scenario, the terms "proximal" and "distal" are defined herein with respect to an operator, such as a surgeon or clinician. The term "proximal" refers to a position of an element closer to an operator, and the term "distal" refers to a position of an element further from the operator. Furthermore, as used herein, the terms "mounted," "connected," and "disposed" on another element should be construed broadly and generally merely indicate that a connection, coupling, fit, or drive relationship exists between the two elements, and a connection, coupling, fit, or drive relationship between the two elements, whether direct or indirect through intervening elements, should not be construed as indicating or implying any spatial relationship between the two elements, i.e., an element may be located in any orientation within, outside, above, below, or to one side of another element unless the content clearly indicates otherwise. The specific meanings of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art. Moreover, directional terminology, such as upper, lower, upward, downward, left, right, etc., is used with respect to the exemplary embodiments as they are shown in the figures, with the upward or upward direction being toward the top of the corresponding figure and the downward or downward direction being toward the bottom of the corresponding figure.

It is an object of the present invention to provide a transseptal puncture device to address one or more of the problems with existing transseptal puncture assemblies. The following description refers to the accompanying drawings.

Referring to fig. 1, an embodiment of the present invention provides an interatrial septum puncturing device, which includes: the dilating tube 1, the puncture needle 2, the handle 3 and the driving component 4; the puncture needle 2 is movably arranged in the axial direction of the dilation tube 1 in a penetrating way through the dilation tube 1, the puncture needle 2 has a storage position and an extending position relative to the dilation tube 1, and when the puncture needle 2 is in the storage position, the far end of the puncture needle 2 does not exceed the far end of the dilation tube 1; when the puncture needle 2 is in the extending position, the distal end of the puncture needle 2 extends out of the distal end of the dilation tube 1; the handle 3 is arranged along the axial direction of the expansion tube 1, the near end of the expansion tube 1 is connected with the handle 3, the driving component 4 is arranged on the handle 3, the puncture needle 2 is connected with the driving component 4, and the driving component 4 is driven to switch between the accommodating position and the extending position.

The puncture needle 2 is bendable by an external force, and the stent 1 is also bendable by an external force. Since the stent 1 and the puncture needle 2 are bent when they are inserted into the human body, the axial direction of the stent 1 is not limited to a straight line but means along the extending direction of the stent 1, and the axial direction of the stent 1 is understood to be capable of bending along with the bending of the stent 1 and the puncture needle 2. Optionally, the dilation tube 1 comprises a gradual section 11 that tapers towards the distal end to facilitate dilation. Optionally, the puncture needle 2 has a predetermined bending shape when not being subjected to external force; the dilating tube 1 has a bending section 12 matched with the preset bending shape of the puncture needle 2; since the bend 12 is adapted to the predetermined curvature of the puncture needle 2, the puncture needle 2 does not scrape the inner wall of the stent 1 during the advancement, which significantly reduces the risk of shaving the inner wall of the stent 1. Alternatively, the puncture needle 2 may have a guide wire insertion hole (not shown) that penetrates in the axial direction thereof. It will be understood that the axial direction of the expansion tube 1 is also understood to be the bending in accordance with the predetermined bending of the puncture needle 2. The guidewire is threaded through a hole that allows the guidewire to pass therethrough. Therefore, after the interatrial puncture is completed, the guide wire can be introduced without withdrawing the puncture needle 2, the complex process that an operator exchanges the puncture needle 2 with the guide wire before the puncture is completed is omitted, the effect of simplifying the operation steps is achieved, and the risk that the puncture needle 2 mistakenly falls out of the left atrium in the instrument exchange operation is also reduced.

During the intervention, when the dilation tube 1 and the puncture needle 2 are passed through the blood vessel, the puncture needle 2 should be configured to be in the storage position, so as to avoid the far end of the puncture needle 2 extending out of the dilation tube 1 and scratching the blood vessel. By the time the predetermined puncture position is reached, the drive assembly 4 on the handle 3 is provided, which can drive the puncture needle 2 into the extended position, so that the puncture can be performed. So dispose, expansion tube 1 is integrated as an organic whole with pjncture needle 2, through drive assembly 4 on the operating handle 3, can control stretching out and accomodating of pjncture needle 2, saves the loaded down with trivial details process of art person's exchange pjncture needle 2 and seal wire before accomplishing the puncture, plays the effect of simplifying the operation step. Furthermore, an operator does not need to penetrate the puncture needle 2 into the expansion tube 1 during preparation before the operation, so that the movement distance of the puncture needle 2 in the expansion tube 1 is reduced, and the risk of thrombus caused by shaving the inner wall of the expansion tube 1 by the puncture needle 2 is further reduced.

Preferably, the puncture needle 2 is located at a predetermined distance of several millimeters (e.g., three millimeters) from the tip (i.e., the distal end of the puncture needle 2) within the distal opening of the dilation tube 1 when the puncture needle 2 is in the stowed position. Thus, when the needle point of the puncture needle 2 needs to be extended, the operator operates the driving component 4 on the handle 3, and the needle point of the puncture needle 2 only needs to advance a few millimeters in the dilating tube 1. This operation has a significantly smaller effect on the position of the stent 1 than if the puncture needle 2 were withdrawn entirely.

Further, referring to fig. 2, the interatrial septum puncture device further includes an introducer sheath assembly 5, where the introducer sheath assembly 5 includes an introducer sheath 51, a sheath seat 52, and a ring electrode 53; the guide sheath 51 is movably sleeved outside the dilating tube 1 and detachably connected with the handle 3 through the sheath seat 52; the ring electrode 53 is provided on the outer circumferential surface of the introducer sheath 51, and is used to acquire an electric signal. Optionally, the sheath wall of the guiding sheath 51 has a metal mesh 511, and the ring electrode 53 transmits the electrical signal through the metal mesh 511. Referring to fig. 1, in an alternative embodiment, the distal end of the handle 3 has a snap structure 31, and the snap structure 31 is matched with the sheath seat 52 and can be locked with the sheath seat 52, so that the handle 3 and the introducer sheath assembly 5 are fixed relatively. The ring electrode 53 can function as a mapping electrode and enhance visualization. Alternatively, the introducer sheath 51 includes a sheath wall made of a polymer material, and the metal mesh 511 is embedded in the sheath wall. On the one hand, the strength of the introducer sheath 51 is increased, and on the other hand, the metal mesh 511 can be used for transmitting electrical signals. Through the mode of metal mesh grid 511 transmission signal of telecommunication, need not bury the wire in the sheath wall additional, showing reduction in production cost and promotion production efficiency. Optionally, the introducer sheath assembly 5 further includes a tail interface 54, and the tail interface 54 is disposed on the sheath seat 52 and electrically connected to the metal mesh 511. The tail interface 54 is used to interface with a three-dimensional navigation unit (described in detail below).

Optionally, the interatrial septum puncture device includes a three-dimensional navigation unit (not shown), the three-dimensional navigation unit is electrically connected to the ring electrode 53 and the puncture needle 2, and obtains spatial pose information of the puncture needle 2 and the guide sheath 51 based on an electrical signal of the ring electrode 53 and an electrical signal of the puncture needle 2. The traditional interatrial septum puncture device does not have a three-dimensional positioning function and has the following defects: (1) positioning needs to be carried out under the assistance of X-rays or ultrasound, and the X-rays and the ultrasound only can reflect two-dimensional position information, so that an operator cannot accurately know the far-end spatial position of the interatrial septum puncture device and cannot accurately select a puncture point; (2) the operator needs to be skilled in the heart anatomy structure to read the X-ray image, and the operation skill of the ultrasonic catheter is complex, which makes it difficult for the new operator to learn the atrial septal puncture; (3) the ultrasonic catheter needs an additional operator for assisting operation, is high in price and increases operation cost; (4) prolonged exposure to X-rays can cause injury to the operator and patient. Based on the above-mentioned research, by configuring the puncture needle 2 as one electrode and the ring electrode 53 in the introducer sheath assembly 5 as the other electrode, after the three-dimensional navigation unit obtains the electrical signal of the ring electrode 53 and the electrical signal of the puncture needle 2, the spatial positions of the ring electrode 53 and the distal end of the puncture needle 2 can be obtained by calculating the electrical field signal, and the distal end of the interatrial puncture device can be modeled accordingly. The operator can judge the space pose information of the puncture needle 2 and the guide sheath 51 according to the relative position of the far end of the atrial septal puncture device and the cardiac chamber modeling. The spatial pose information comprises information such as shapes and spatial positions of the puncture needle 2 and the distal end of the guide sheath 51, the needle point orientation of the puncture needle 2 and the like, so that the identification of the puncture point position is more accurate, the error risk of the puncture point position is reduced, and the operation and learning difficulty of an operator is reduced. In addition, the three-dimensional navigation unit can realize three-dimensional visualization through modeling the far end of the atrial septal puncture device, thereby being convenient for observation of an operator. The three-dimensional navigation unit is arranged, so that the use amount of X rays in an operation can be effectively reduced, the complete ray-free green three-dimensional interatrial puncture is realized, and the radiation injury to an operator and a patient is reduced.

Referring to fig. 3, optionally, the dilation tube 1 has a side hole 13, and when the puncture needle 2 is in the storage position, the side hole 13 is in contact with liquid (such as blood) in the environment to obtain an electrical signal. With the needle 2 in the extended position, it is understood that it is in direct contact with the blood and therefore makes it possible to obtain an electrical signal. However, when the puncture needle 2 is in the accommodated position, the distal end thereof does not protrude beyond the stent 1, and therefore, it may not be possible to obtain an electric signal by directly contacting blood. The side hole 13 is provided to ensure that the puncture needle 2 can be always in contact with blood to obtain an electric signal. Further, the three-dimensional navigation unit electrically locates the position of the side hole 13 in three dimensions accordingly. Since the position of the side hole 13 on the stent 1 is known and the position of the puncture needle 2 with respect to the stent 1 is also known based on the control of the driving assembly 4, the three-dimensional navigation unit can determine the posture of the needle tip of the puncture needle 2 based on the position of the side hole 13 and the driving amount of the driving assembly 4.

Referring to fig. 4, in one embodiment, the driving assembly 4 includes a push button 41, the push button 41 is movably disposed on the handle 3 along the axial direction of the handle 3, the axial positions of the push button 41 and the puncture needle 2 are defined, and the push button 41 moves along the axial direction to drive the puncture needle 2 to move. Because the axial position of the push button 41 relative to the puncture needle 2 is limited, when the push button 41 moves along the axial direction, the puncture needle 2 can be driven to move synchronously along the axial direction, the operation logic is simple and intuitive, and the operation is easy for an operator to learn and is not easy to cause misoperation. The push button 41 has simple mechanical structure, the handle 3 has small volume and high reliability, and is convenient to manufacture. In addition, the push button 41 can be operated by a single hand, and the operator can directly apply force to puncture.

Preferably, the driving assembly 4 further comprises a damping member 42, and the damping member 42 is configured to apply a resistance force to the push button 41 when the distal end of the puncture needle 2 is extended out of the distal end of the dilation tube 1 and moved in the axial direction of the dilation tube 1. After the distal end of the puncture needle 2 has been extended beyond the distal end of the stent 1, the damping member 42 can apply a resistance force to the push button 41, which can serve as a cue to the operator during the operation to intuitively feel that the puncture needle 3 is about to be extended or has been extended beyond the distal end of the stent 1. The resistance can also prevent the puncture needle 2 from extending out of the dilation tube 1 due to the push button 41 being accidentally touched, so that the risk of scratching the endocardium is reduced, and the safety is further improved.

Referring to fig. 5 to 7, optionally, the damping member 42 includes a damping groove 421 and/or an elastic member 422, the push button 41 has a protrusion 411 extending along the axial direction of the handle 3, and when the puncture needle 2 is in the accommodated position, the damping groove 421 and/or the elastic member 422 are located at a distal end side of the protrusion 411. The damping groove 421 and/or the elastic member 422 are located on the path of the push button 41 moving from the proximal end to the distal end when the puncture needle 2 moves from the accommodated position to the extended position.

As shown in fig. 6, when the damping member 42 includes the damping groove 421, the damping groove 421 is narrowed toward the distal end (right end in fig. 6), and the narrowed damping groove 421 applies resistance to the push button 41 by abutting against the protrusion 411. In the example shown in fig. 6, the protrusion 411 is disposed on the side wing of the push button 41, and the handle 3 has a sliding slot 32 matching with the protrusion 411, and the protrusion 411 and the sliding slot 32 are both disposed along the axial direction of the handle 3, and the sliding slot 32 is used to limit the protrusion 411 to only reciprocate therein. Further, the sliding slot 32 is in clearance fit with the protrusion 411, and the sliding slot 32 does not generate resistance or has small resistance to the movement of the protrusion 411. An appropriate amount of lubricant is preferably disposed in the slide groove 32 to make the movement of the push button 41 smooth and stable. The damping groove 421 is provided on the distal end side of the slide groove 32 in the axial direction, and is tapered toward the distal end to form a close fit with the protrusion 411.

In the exemplary embodiment shown in fig. 6, the puncture needle 2 is passed through the push button 41 and fixedly connected to the push button 41, for example by gluing or other means. Thus, the axial position of the push button 41 relative to the puncture needle 2 is defined, and the resistance gradually increases as the protrusion 411 moves distally to the section of the damping groove 421, at which the tip of the puncture needle 2 just protrudes from the distal end of the dilation tube 1. It can be understood that one skilled in the art can adjust the pushing resistance by adjusting the fit clearance of the damping groove 421 and the protrusion 411 to fit different requirements.

As shown in fig. 7, when the damping member 42 includes the elastic member 422, the elastic member 422 is pressed against the protrusion 411 to apply a resistance force to the push button 41. In an alternative embodiment, the handle 3 has a receiving cavity 33, a majority of the elastic member 422 is received in the receiving cavity 33, and a small portion of the elastic member 422 protrudes out of the receiving cavity 33. The protrusion 411 is flush with the end surface of the receiving cavity 33, so that when the protrusion 411 moves to the position corresponding to the receiving cavity 33, the protrusion abuts against and presses the elastic member 422, so that the elastic member 422 deforms. Accordingly, the elastic member 422 applies resistance to the protrusion 411. The elastic member 422 is preferably made of a soft elastic material having fatigue resistance and no toxicity, such as silicone or rubber. When the protrusion 411 is moved to a position contacting the elastic member 422, the tip of the puncture needle 2 is just protruded from the distal end of the dilation tube 1.

It should be noted that fig. 6 and 7 respectively show the damping slot 421 and the elastic member 422, and in some embodiments, the damping member 42 may include both the damping slot 421 and the elastic member 422.

Referring to fig. 8, optionally, the driving assembly 4 includes a locking member 43, and the locking member 43 is used for locking the axial position of the push button 41 relative to the handle 3. It will be appreciated that the puncture needle 2 should be kept from extending beyond the distal end of the dilation tube 1 during the intervention, so as to avoid the risk of scoring. During the puncture, the puncture needle 2 is kept at a certain distance from the distal end of the dilation tube 1, and preferably at a constant distance. The locking member 43 is provided to effectively lock the axial position of the push button 41 with respect to the handle 3, whereby the position of the puncture needle 2 with respect to the stent 1 is locked. So that the puncture needle 2 can keep the position unchanged during the operation without the operator continuously applying the driving force to the push button 41.

As shown in fig. 8, in an alternative example, the locking member 43 includes a rack 431 provided on the handle 3 in an axial direction of the handle 3, and the rack 431 has a plurality of spaced teeth 432; the push button 41 comprises a latch 412 adapted to the socket 432; the push button 41 is movably disposed along a radial direction of the handle 3, and the push button 41 is configured to move along the radial direction of the handle 3 to drive the latch 412 to be latched into the slot 432 or disengaged from the slot 432; when the latch 412 is snapped into the tooth slot 432, the axial position of the push button 41 relative to the handle 3 is locked; when the latch 412 is disengaged from the teeth recess 432, the axial position of the push button 41 relative to the handle 3 is unlocked. Fig. 8 shows a state in which the latch 412 is engaged with the spline 432, and at this time, the axial displacement of the push button 41 is locked by the handle 3 via the rack 431, that is, the push button 41 cannot move in the axial direction, and thus the position of the puncture needle 2 with respect to the extension tube 1 is also locked at this time. On the basis of fig. 8, when the push button 41 is pressed down, the latch 412 will be disengaged from the tooth slot 432, and at this time, the axial position of the push button 41 relative to the handle 3 is no longer locked, so that the operator can push the push button 41 to move back and forth, thereby driving the puncture needle 2 to move.

Further, the driving assembly 4 further includes a potential energy member 44, wherein the potential energy member 44 is used for applying potential energy to the push button 41 to drive the latch 412 to be latched into the slot 432 when the push button 41 is not subjected to an external force. The potential energy member 44 may be, for example, an elastic potential energy member such as a spring or a leaf spring, or a magnetic potential energy member such as a magnet, and the potential energy member 44 shown in fig. 8 is a spring, and one end thereof is connected to the push button 41, and the other end thereof is slidably connected to the handle 3 in the axial direction of the handle 3. The spring can apply an upward elastic force to the push button 41, so that the push button 41 is always kept at a position where the latch 412 is latched into the slot 432 when no external force is applied. When the operator presses the push button 41, the operator presses the push button 41 against the elastic force of the spring, so that the latch 412 is disengaged from the teeth groove 432, thereby unlocking the lock. When the operator removes the pressing force, the spring releases the elastic force to drive the latch 412 to be latched into the slot 432, so as to form a locking state, and the push button 41 is locked at the current releasing position of the operator.

Optionally, the handle 3 has a limiting member 30 disposed along the axial direction, the push button 41 has a step 415, and the limiting member 30 abuts against the step 415 to limit the radial position of the push button 41. In an exemplary embodiment, when the potential energy part 44 pushes the latch 412 to be latched into the slot 432, the step 415 abuts against the limiting part 30 to be limited from displacing in a direction away from the potential energy part 44 along a radial direction of the handle 3, so as to prevent the latch 412 from being pushed by the potential energy part 44 to be disengaged from the other side of the slot 432, and ensure that the latch 412 can be reliably latched into the slot 432. When the operator pushes the push button 41, the step 415 is separated from the position-limiting member 30.

Referring to fig. 9, further, the push button 41 has a limiting cavity 413 and a strip-shaped hole 414; the strip-shaped hole 414 is formed along the axial direction of the handle 3 and is communicated with the limiting cavity 413; the cross section of the strip-shaped hole 414 has a long axis and a short axis, and the strip-shaped hole 414 allows the puncture needle 2 to movably penetrate through the strip-shaped hole along the direction of the long axis; the push button 41 is configured to move in the direction of the long axis to drive the latch 412 to latch into the slot 432 or disengage from the slot 432; the driving assembly 4 further comprises an insert 45 fixedly connected with the puncture needle 2, the insert 45 is movably arranged in the limiting cavity 413 along the direction of the long shaft, and the insert 45 is limited in the limiting cavity 413 along the axial direction of the handle 3 and is driven by the push button 41. Further, the displacement of the insert 45 along the direction of the short axis is limited by the limiting cavity 413, and/or the displacement of the puncture needle 2 along the direction of the short axis is limited by the strip-shaped hole 414. According to the example shown in fig. 8, the push button 41 needs to be pushed and released to unlock and lock the locking member 43, whereby the push button 41 is displaced radially with respect to the puncture needle 2. In order not to influence the radial position of the puncture needle 2, the radial movement of the push button 41 and the fixed radial position of the puncture needle 2 are decoupled by the arrangement of the strip-shaped hole 414, the limiting cavity 413 and the insert 45.

In the example shown in fig. 8 and 9, the long axis direction of the bar-shaped hole 414 is arranged in the radial direction of the handle 3 and is parallel to the direction in which the push button 41 is pressed. It will be appreciated that since the insert 45 is movable along the longitudinal axis within the stopper chamber 413, when the push button 41 is depressed or released, the insert 45 moves in the direction of the longitudinal axis within the stopper chamber 413, and the puncture needle 2 also moves in the direction of the longitudinal axis within the bar-shaped hole 414. Furthermore, because the insert 45 is limited by the limiting cavity 413 along the axial displacement, after the operator presses the push button 41, when the push button 41 is pushed to move along the axial direction of the handle 3, the inner wall of the limiting cavity 413 abuts against and drives the insert 45 to move along the axial direction of the handle 3, and the insert 45 is fixedly connected with the puncture needle 2, so that the puncture needle 2 is driven to move along the axial direction, and the radial position of the puncture needle 2 cannot be influenced.

It should be noted that the latch 412 and the spline 432 shown in fig. 8 are only an example of the locking member 43 and are not limited to the locking member 43, and in some other embodiments, the locking member 43 may also include structures capable of locking with each other, such as threads, slots, etc., and those skilled in the art can adapt the embodiments according to the prior art, and the embodiments will not be described again.

Referring to fig. 10, in another example, the driving assembly 4 includes a knob 46 and a screw 47 fixedly connected to the puncture needle 2, the knob 46 is rotatably disposed on the handle 3 around the axis of the handle 3, and the axial position of the knob 46 relative to the handle 3 is limited; the screw rod 47 extends along the axial direction of the handle 3 and is in threaded connection with the knob 46; the screw rod 47 is limited from rotating in the circumferential direction relative to the handle 3, and the knob 46 rotates to drive the screw rod 47 to move along the axial direction of the handle 3 so as to drive the puncture needle 2 to move. Rather than the push button 41 moving axially to effect actuation of the lancet 2, in the exemplary embodiment shown in fig. 10, the knob 46 effects actuation of the lancet 2 by rotation about the axis of the handle 3. The knob 46 is configured to be rotatably disposed on the handle 3, but its axial position is defined, for example by means of a snap ring fitted on the handle 3. Optionally, the knob 46 has an internal thread, the screw 47 has an external thread matching the internal thread of the knob 46, and the knob 46 is threadedly coupled to the screw 47. Further, the handle 3 has a rotation-restricting groove 34 provided in the axial direction, and the screw 47 has a slider (not shown) movably provided in the rotation-restricting groove 34 in the axial direction of the rotation-restricting groove 34, the slider movably penetrating into the rotation-restricting groove so that the rotation of the screw 47 relative to the handle 3 is restricted but the axial movement of the screw 47 relative to the handle 3 is allowed. Thus, when the knob 46 is rotated, the screw 47 is driven to move in the axial direction of the handle 3 by the screw. The threaded rod 47 is fixedly connected to the puncture needle 2, for example by gluing or other means. This achieves that the puncture needle 2 is driven to move axially by turning the knob 46. Compared to the push button 41, the knob 46 is rotated by a distance greater than the actual movement of the threaded rod 47, and this "amplification effect" helps the surgeon to control the movement distance of the puncture needle 2 more accurately.

Referring to fig. 1 and 10, optionally, the handle 3 has a scale 35, and the scale 35 is used for indicating the driving amount of the driving assembly 4. Preferably, the scale 35 includes a long scale line and a short scale line, and when the mark of the driving assembly 4 (corresponding to the push button 41, which may be the proximal end of the push button 41, corresponding to the knob 46, which may be the arrow 461 on the knob 46, etc.) corresponds to the long scale line of the scale 35, it indicates that the needle tip of the puncture needle 2 is flush with the distal opening of the dilation tube 1. The drive assembly 4 continues to move, marking past a short tick mark, indicating 1 mm of needle 2 movement. The function can help the operator to directly observe the extending distance of the needle point of the puncture needle 2, and the operation safety and efficiency are improved.

Referring to fig. 1 and 3, optionally, the interatrial septum puncture device includes a safety mechanism 6, wherein the safety mechanism 6 is movably disposed on the handle 3 and moves between a locked position and an unlocked position; when the safety mechanism 6 is located at the locking position, the driving stroke of the driving component 4 is limited by abutting or clamping, so that the puncture needle 2 is located at the accommodating position; when the safety mechanism 6 is located at the unlocking position, the limit of the driving stroke of the driving component 4 is released, and the puncture needle 2 is allowed to be converted to the extending position.

In the example shown in fig. 4, the safety mechanism 6 is movably provided on the handle 3 in the circumferential direction of the handle 3, and the safety mechanism 6 protrudes above the outer surface of the handle 3. When the safety mechanism 6 is moved to the lock position (as shown in fig. 3) along the circumferential direction of the handle 3, the push button 41 is blocked from moving distally so that the push button 41 cannot push the puncture needle 2 to protrude out of the distal end of the stent 1. When the safety mechanism 6 moves to the unlocking position in the circumferential direction, the movement of the push button 41 is released, thereby allowing the push button 41 to push the puncture needle 2 between the protruding position and the accommodated position. Preferably, the handle 3 has a window for movement of the safety mechanism 6, and when the safety mechanism 6 is moved to the locked position, the window reveals a "LOCK" character, and when the safety mechanism 6 is moved to the unlocked position, the window reveals a "UNLOCK" character to indicate to the surgeon. Preferably, when the interatrial septum puncture device leaves the factory, the safety mechanism 6 is in the locking position, so that the puncture needle 2 can be prevented from being mistakenly pulled out before puncture, and the safety of the product is improved. It should be noted that while fig. 3 shows the safety mechanism 6 adapted to the push button 41, in the case of the knob 46, a similar safety mechanism 6, such as a rotation limiting member, may be provided to limit the rotation of the knob 46, which can be understood and configured by those skilled in the art.

Referring to fig. 1 and 5, in an exemplary embodiment, the interatrial septum puncture device includes a side branch tube 7 disposed along a radial direction of the handle 3, the handle 3 includes an expansion tube holder 36, the expansion tube holder 36 is connected to a proximal end of the expansion tube 1 along an axial direction of the handle 3, the side branch tube 7 is connected to the expansion tube holder 36 along the radial direction of the handle 3, and the expansion tube holder 36 allows the puncture needle 2 to be movably inserted therethrough along the axial direction; the dilating tube holder 36 has a haemostatic valve (not shown) therein for preventing the egress of liquid towards the proximal end of the dilating tube holder 26. The side branch pipeline 7 is communicated with the gap between the expansion pipe 1 and the puncture needle 2, and can play a role in cleaning the surface of the puncture needle 2 before operation and evacuating air in the gap, and the side branch pipeline 7 can also be used for sucking and supplementing liquid during operation.

The hemostatic valve acts as a seal to prevent blood from flowing back into the handle 3 through the gap between the stent 1 and the puncture needle 2, while allowing the agent flowing in through the side branch line 7 to flow toward the distal outlet of the stent 1.

Further, the interatrial septum puncture device comprises a first lead 81 and a second lead 82 arranged along the radial direction of the handle 3, the handle 3 is provided with a first lead accommodating cavity 37 arranged around the puncture needle 2, one end of the first lead 81 is connected with the puncture needle 2 in the first lead accommodating cavity 37, and the other end is connected with the second lead 82; the first wire 81 has a loose section 83 in the first wire accommodating cavity 37.

Furthermore, the second wire 82 is used to connect with the radio frequency apparatus and the three-dimensional navigation unit through a puncture needle tail and a tail adapter box (the puncture needle tail, the tail adapter box and the radio frequency apparatus are not shown, and those skilled in the art can understand according to the prior art, and the embodiment is not described in detail), so that the radio frequency current output by the radio frequency apparatus can be transmitted to the puncture needle 2 through the tail adapter box, the puncture needle tail, the second wire 82 and the first wire 81, and the radio frequency current is released at the needle point of the puncture needle 2 to assist in puncturing, so as to improve the puncturing capability. Particularly, for patients with special anatomical structures (thickened and fibrosis oval fossa) or special pathological changes (such as bulging oval fossa) or the like, the puncture difficulty can be obviously reduced, the puncture safety can be improved, and the pericardium is prevented from being stuffed due to over puncture. On the other hand, the electrical signal acquired by the puncture needle 2 can be transmitted to the three-dimensional navigation unit through the first lead 81, the second lead 82, the puncture needle tail and the tail adapter box for calculation by the three-dimensional navigation unit.

It can be understood that, the first wire 81 and the second wire 82 both have a conductive inner core and an outer insulating layer, in order to realize the electrical connection with the puncture needle 2, a small amount of the outer insulating layer may be removed from one end of the first wire 81, so that the conductive inner core is electrically connected with the puncture needle 2, and then the connection between the conductive inner core and the puncture needle 2 is insulated by way of encapsulation, and the like, and similarly, the connection between the first wire 81 and the second wire 82 may also be insulated by way of removing the outer insulating layer, electrically connecting by way of welding, and then encapsulating, and the like. The other end of the second wire 82 may have a wire interface for connection to a needle tail. The first wire 81 and the second wire 82 may be integrally formed, but the outer diameter of the first wire 81 is smaller than that of the second wire 82. The invention is not limited in this regard.

Optionally, the atrial septum puncture device can be compatible with the electrophysiology radio frequency apparatus for use without using other unverified devices such as a high-frequency electrotome for radio frequency puncture through a heating element and a temperature measuring line (neither the heating element nor the temperature measuring line is shown, and those skilled in the art can understand according to the prior art, and the embodiment is not described herein). The disconnection protection element (not shown, and those skilled in the art can understand according to the prior art, and this embodiment is not described herein) in the tail adapter box can disconnect the three-dimensional navigation unit from the radio frequency instrument during the radio frequency discharge process, so as to protect the three-dimensional navigation unit from the interference of the radio frequency current.

In the example shown in fig. 1 and 5, the side branch line 7 and the second wire 82 are arranged in parallel at the connection with the handle 3, and the parallel arrangement should have a certain length, preferably about 10cm, to prevent the side branch line 7 and the second wire 82 from intertwining, and reduce the influence on the operation of the operator. Preferably, the side branch 7 and the second wire 82 are made of a relatively flexible material. The side branch pipe 7 and the second wire 82 are bendable at a portion away from the handle 3. The first wire 81 is used to connect the puncture needle 2 and the second wire 82 for transmitting electrical signals and radio frequency current. Because the puncture needle 2 needs to move along the axial direction of the handle 3, the first lead 81 in the first lead accommodating cavity 37 has a loose section 83, that is, the first lead 81 leaves a certain length of margin in the first lead accommodating cavity 37, so as to avoid the puncture needle 2 from breaking the first lead 81 when moving along the axial direction, and ensure the stable conduction of electrical signals and radio frequency current.

Optionally, the proximal end of the needle 2 is connected to a luer 9 and a guidewire may be advanced through the luer 9. Heparin saline or contrast media may also be injected into luer 9 during an interatrial septum puncture procedure, and the corresponding agent may be expelled from the needle tip through needle 2.

Optionally, the handle 3 has a limiting hole 38 formed along the axial direction, the inner diameter of the limiting hole 38 is adapted to the outer diameter of the puncture needle 2, and the limiting hole 38 is used for the puncture needle 2 to penetrate through and limits the radial displacement of the puncture needle 2. As shown in fig. 5, in an exemplary embodiment, the inner cavity of the handle 3 has two partition walls 39, the two partition walls 39 are axially disposed at two sides of the push button 41, each partition wall 39 is opened with a position-limiting hole 38, and the two position-limiting holes 38 are coaxially disposed along the handle 3. The arrangement of the limiting hole 38 limits the radial displacement of the puncture needle 2, so that the puncture needle 2 cannot leak or tear due to radial movement.

In summary, the interatrial septum puncture device provided by the invention comprises an expansion tube, a puncture needle, a handle and a driving assembly; the puncture needle is movably arranged in the axial direction of the expansion tube in a penetrating way and has a storage position and an extending position relative to the expansion tube, and when the puncture needle is located at the storage position, the far end of the puncture needle does not exceed the far end of the expansion tube; when the puncture needle is positioned at the extending position, the distal end of the puncture needle extends out of the distal end of the dilation tube; the handle is arranged along the axial direction of the expansion tube, the near end of the expansion tube is connected with the handle, the driving assembly is arranged on the handle, the puncture needle is connected with the driving assembly, and the driving assembly is driven to switch between the accommodating position and the extending position. So dispose, the expansion pipe is integrated as an organic whole with the pjncture needle, through the drive assembly on the operating handle, can control stretching out and accomodating of pjncture needle, saves the loaded down with trivial details process that the art person exchanged pjncture needle and seal wire before accomplishing the puncture, plays the effect of simplifying the operation step. Furthermore, an operator does not need to penetrate the puncture needle into the expansion tube during preoperative preparation, so that the movement distance of the puncture needle in the expansion tube is reduced, and the risk of thrombus caused by the inner wall of the puncture needle shaving expansion tube is reduced.

It should be noted that, several of the above embodiments may be combined with each other. The above description is only for the purpose of describing the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are intended to fall within the scope of the appended claims.

Claims

1. An interatrial septum puncture device, comprising: the device comprises an expansion tube, a puncture needle, a handle and a driving assembly;

2. The transseptal puncture device of claim 1, wherein the dilator tube has a side hole through which the puncture needle contacts fluid in the environment when in the stowed position to obtain an electrical signal.

3. The transseptal puncture device of claim 1, wherein the puncture needle has a predetermined curvature when not subjected to an external force; the expansion tube is provided with a bending section matched with the preset bending shape of the puncture needle; the puncture needle can be bent under the action of external force; the puncture needle is provided with a guide wire through hole which is communicated along the axial direction of the puncture needle.

4. The transseptal puncture device of claim 1, wherein the actuation assembly comprises a push button movably disposed on the handle in an axial direction of the handle, an axial position of the push button relative to the puncture needle being defined, the push button moving in the axial direction to actuate movement of the puncture needle.

5. The transseptal puncture device of claim 4, wherein the drive assembly further comprises a damping member configured to apply a resistive force to the push button as the distal end of the puncture needle extends out of the distal end of the dilation tube and moves axially of the dilation tube.

6. The transseptal puncture device of claim 5, wherein the damping member comprises a damping groove and/or a resilient member, and the push button has a projection disposed along an axial extension of the handle;

when the damping piece comprises an elastic piece, the elastic piece abuts against the protrusion through extrusion deformation, and resistance is applied to the push button.

7. The transseptal puncture device of claim 4, wherein the drive assembly further comprises a lock for locking an axial position of the push button relative to the handle.

8. The transseptal puncture device of claim 7, wherein the locking member comprises a rack disposed on the handle along an axial extension of the handle, the rack having a plurality of spaced splines; the push button comprises a latch matched with the tooth groove;

9. The interatrial septum penetration device of claim 8, wherein the drive assembly further comprises a potential energy member for applying a potential energy to the push button to force the latch into the socket when the push button is not subjected to an external force.

10. The transseptal puncture device of claim 8, wherein the push button has a stopper cavity and a strip-shaped hole;

the drive assembly further comprises an insert fixedly connected with the puncture needle, the insert is movably arranged in the limiting cavity along the direction of the long shaft, and the insert is limited in the limiting cavity along the axial direction of the handle and driven by the push button;

11. The transseptal puncture device of claim 1, wherein the drive assembly comprises a knob and a screw fixedly connected to the puncture needle, the knob is rotatably disposed on the handle about an axis of the handle, and an axial position of the knob relative to the handle is limited; the screw rod extends along the axial direction of the handle and is in threaded connection with the knob; the screw rod is limited in circumferential rotation relative to the handle, and the knob is rotated to drive the screw rod to move along the axial direction of the handle so as to drive the puncture needle to move.

12. The transseptal puncture device of claim 1, wherein the handle has a scale for indicating the amount of actuation of the drive assembly.

13. The transseptal puncture device of claim 1, wherein the transseptal puncture device comprises a safety mechanism movably disposed on the handle and movable between a locked position and an unlocked position; when the safety mechanism is located at the locking position, the driving stroke of the driving assembly is limited by abutting or clamping, so that the puncture needle is located at the accommodating position; when the safety mechanism is located at the unlocking position, the limit on the driving stroke of the driving assembly is removed, and the puncture needle is allowed to be converted to the extending position.

14. The transseptal puncture device of claim 1, wherein the transseptal puncture device comprises a side branch conduit arranged along a radial direction of the handle, the handle comprises an expansion tube seat, the expansion tube seat is connected with a proximal end of the expansion tube along an axial direction of the handle, the side branch conduit is connected with the expansion tube seat along the radial direction of the handle, and the expansion tube seat allows the puncture needle to movably penetrate along the axial direction; the dilating tube holder has a hemostasis valve therein for preventing the flow of liquid out to the proximal end of the dilating tube holder.

15. The transseptal puncture device of claim 1, wherein the transseptal puncture device comprises a first wire and a second wire arranged along a radial direction of the handle, the handle has a first wire receiving cavity arranged around the puncture needle, one end of the first wire is connected with the puncture needle in the first wire receiving cavity, and the other end of the first wire is connected with the second wire; the first wire is provided with a loose section in the first wire accommodating cavity.

16. The interatrial septum puncture device according to claim 1, wherein the handle has a limiting hole formed along an axial direction, an inner diameter of the limiting hole is adapted to an outer diameter of the puncture needle, and the limiting hole is used for the puncture needle to pass through and limits a radial displacement of the puncture needle.

17. The transseptal puncture device of claim 1, wherein the transseptal puncture device comprises an introducer sheath assembly comprising an introducer sheath, a sheath hub, and a ring electrode; the guide sheath is movably sleeved outside the expansion pipe and is detachably connected with the handle through the sheath seat; the ring electrode is disposed on an outer circumferential surface of the introducer sheath and is configured to acquire an electrical signal.

18. The atrial septum puncture device according to claim 17, comprising a three-dimensional navigation unit electrically connected to the ring electrode and the puncture needle, respectively, and configured to obtain spatial pose information of the puncture needle and the introducer sheath based on an electrical signal of the ring electrode and an electrical signal of the puncture needle.