Puncture device and atrial septum puncture method

Abstract

The present invention relates to the technical field of medical instruments, and in particular to a puncture device and an atrial septum puncture method. The puncture device comprises a first shell, a dilator, a puncture needle, a guide wire and a pushing mechanism. The dilator passes through a guide sheath tube of a guide sheath assembly, the puncture needle penetrates through the first shell and the dilator, the guide wire penetrates through the puncture needle, the pushing mechanism is arranged on the first shell, the puncture needle is connected to an output end of the pushing mechanism, and the pushing mechanism is configured to push the puncture needle to reciprocate in a first direction, so that the distal end of the puncture needle protrudes from the distal end of the dilator or is hidden in the distal end of the dilator, wherein the first direction is the extension direction of the dilator. According to the puncture device, the time for inserting the puncture needle is saved, the operation time is saved, and the safety during use is ensured. According to the atrial septum puncture method, the steps of inserting a puncture needle and withdrawing a puncture needle are not needed, in addition, the step of inserting and exchanging a guide wire is omitted, thereby facilitating saving the operation time.

Description

TECHNICAL FIELD

[0001] The present invention relates to the technical field of medical instruments, and particularly to a puncture device and an atrial septum puncture method. BACKGROUND OF THE PRESENT INVENTION

[0002] With the popularization of electrophysiological and structural heart surgery, atrial septum puncture has become the most common technique to enter a left atrium for cardiologists, and indications comprise atrial fibrillation ablation, left atrial appendage occlusion, mitral valvular disease, congenital heart disease intervention and percutaneous left ventricular assist device implantation. In the prior art, a mechanical puncture device is usually used to complete an atrial septum puncture surgery. The puncture device comprises a first shell, a dilator and a puncture needle. One end of the dilator is arranged on the first shell. During the surgery, an operator inserts an introducer sheath and a distal end of the dilator into the heart along a guide wire. After the distal end of the dilator reaches a preset position, the guide wire needs to be withdrawn first, and then the puncture needle penetrates through the dilator. Moreover, a distal end of the puncture needle is set as a needle-like structure, so as to facilitate the operator to operate the puncture needle, so as to make the distal end of the puncture needle protrude from the dilator and puncture an atrial septum, thereby achieving the atrial septum puncture.

[0003] However, it is difficult to master the atrial septum puncture technology of the puncture device, and the puncture needle and the guide wire need to be exchanged frequently in the puncture process, so that the operation takes a long time, the puncture difficulty is high, and when there are special patients suffering from, such as atrial septum fibrosis, thickening, superelasticity and turnorigenesis, it is very easy to cause serious complications, such as pericardial tamponade, sliding puncture position and heart rupture.

[0004] In order to solve the above problems, it is urgent to provide a puncture device and an atrial septum puncture method. SUMMARY OF THE PRESENT INVENTION Technical problem

[0005] The present invention aims to provide a puncture device and an atrial septum puncture method, wherein a puncture needle is hidden in a dilator, so as to facilitate transporting the puncture needle and the dilator to a to-be-punctured preset position of a heart at the same time, save time for inserting and exchanging the puncture needle and a guide wire, and be conductive to saving operation time, thereby effectively avoiding complications. Technical solution

[0006] In order to achieve the objective, the present invention adopts the following technical solution.

[0007] A puncture device comprises:

[0008] a first shell, which is capable of being detachably connected with different types of introducer sheath assemblies;

[0009] a dilator, one end of which is arranged on the first shell, wherein the dilator penetrates through an introducer sheath of the introducer sheath assembly during a surgery;

[0010] a puncture needle, which penetrates through the first shell and the dilator;

[0011] a guide wire, which penetrates through the puncture needle; and

[0012] a pushing mechanism, which is arranged on the first shell, wherein the puncture needle is connected with an output end of the pushing mechanism the pushing mechanism is configured to push the puncture needle to reciprocate in a first direction, so that a distal end of the puncture needle protrudes from a distal end of the dilator or is hidden in the distal end of the dilator, and the first direction is an extension direction of the dilator.

[0013] As one optional solution, the first shell comprises a first end and a second end, the first end and the second end are located at two ends of the first shell in the first direction, the first end is provided with a mounting hole extending in the first direction, the dilator is fixed in the mounting hole, the second end is provided with a penetrating hole extending in the first direction, the puncture needle penetrates into the first shell from the penetrating hole and penetrates through the dilator, and before the distal end of the dilator reaches a pre-puncture position of a heart, the distal end of the puncture needle is hidden in the dilator.

[0014] As one optional solution, the first shell is provided with a guide hole extending in the first direction, and the pushing mechanism comprises:

[0015] a driving assembly, wherein the puncture needle is connected with the driving assembly, and a part of the driving assembly is arranged to penetrate through the guide hole to protrude from the first shell, so that when an operator carries out atrial septum puncture, the operator is capable of pushing the driving assembly to move in the first direction to make the distal end of the puncture needle protrude from the dilator.

[0016] As one optional solution, the driving assembly comprises:

[0017] a fixing block sleeved on the puncture needle; and

[0018] a driving block arranged on the first shell, wherein the driving block penetrates through the guide hole to be connected with the fixing block.

[0019] As one optional solution, the pushing mechanism further comprises:

[0020] a guide assembly arranged between the driving assembly and the first shell, wherein the guide assembly is configured to provide guidance for the driving assembly to push the puncture needle to move in the first direction.

[0021] As one optional solution, the guide assembly comprises:

[0022] a guide groove arranged on an inner wall of the first shell or the driving assembly in the first direction; and

[0023] a guide member connected with the driving assembly or the first shell without the guide groove, wherein the guide member is partially located in the guide groove, and the guide member is capable of moving in the guide groove in the first direction.

[0024] As one optional solution, the pushing mechanism further comprises:

[0025] a reset member sleeved on the puncture needle, wherein two ends of the reset member respectively abut against the first shell and the driving assembly.

[0026] As one optional solution, the puncture device further comprises:

[0027] a first sealing member sleeved on the puncture needle, wherein the first sealing member is hermetically connected with the first end of the first shell.

[0028] As one optional solution, the first end is provided with a first pressure measuring hole, the first pressure measuring hole is communicated with the mounting hole, and an operator is capable of measuring a blood pressure in the mounting hole through the first pressure measuring hole.

[0029] As one optional solution, the puncture needle is welded and fixed with the pushing mechanism, or the puncture needle is provided with a limiting protrusion, in a pushing direction of the pushing mechanism, the limiting protrusion is located in front of the pushing mechanism, and the limiting protrusion is capable of abutting against an end face of the pushing mechanism.

[0030] As one optional solution, the puncture needle is electrically connected with a radio-frequency puncture instrument.

[0031] As one optional solution, the first shell further comprises an end cover sleeved on the second end, and the guide wire penetrates through the end cover; and the second end comprises:

[0032] a second sealing member sleeved on the guide wire, wherein the second sealing member is arranged between the end cover and the second end, and the second sealing member is configured to seal a gap between an inner cavity of the puncture needle and an outer diameter of the guide wire.

[0033] As one optional solution, an inner wall of the puncture needle is provided with an insulating layer.

[0034] According to an atrial septum puncture method implemented by the puncture device above, the atrial septum puncture method comprises the following steps of:

[0035] allowing the introducer sheath, the dilator, the puncture needle and the guide wire to enter a heart of a patient at the same time, and hiding the distal end of the puncture needle in the distal end of the dilator in the process of entering the heart of the patient;

[0036] positioning a puncture position of the dilator;

[0037] pushing, by the pushing mechanism of the puncture device, the distal end of the puncture needle out of the distal end of the dilator, and carrying out atrial septum puncture; and

[0038] withdrawing the introducer sheath, the dilator and the puncture needle at the same time, and maintaining the guide wire, or withdrawing the dilator, the puncture needle and the guide wire at the same time, and maintaining the introducer sheath; and

[0039] carrying out follow-up surgery. Beneficial effects

[0040] The present invention provides the puncture device, and the puncture device comprises the first shell, the dilator, the puncture needle, the guide wire and the pushing mechanism. The first shell can be detachably connected with the different types of introducer sheath assemblies, one end of the dilator is arranged on the first shell, and during the surgery, the dilator penetrates through the introducer sheath of the introducer sheath assembly, the puncture needle penetrates through the first shell and the dilator, the guide wire penetrates through the puncture needle, the pushing mechanism is arranged on the first shell, the puncture needle is connected with the output end of the pushing mechanism, and the pushing mechanism is configured to push the puncture needle to reciprocate in the first direction, so that the distal end of the puncture needle protrudes from the distal end of the dilator or is hidden in the distal end of the dilator, and the first direction is the extension direction of the dilator. According to the puncture device, the puncture needle is hidden in the dilator, so as to facilitate transporting the puncture needle and the dilator to the to-be-punctured preset position of the heart at the same time, save the time for inserting and exchanging the puncture needle and the guide wire, and be conductive to saving the operation time, thereby effectively avoiding the complications.

[0041] The present invention further provides the atrial septum puncture method, the atrial septum puncture method is implemented by the puncture device above, and the atrial septum puncture method comprises the following steps of: allowing the introducer sheath, the dilator, the puncture needle and the guide wire to enter the heart of the patient at the same time, and hiding the distal end of the puncture needle in the distal end of the dilator in the process of entering the heart of the patient; pushing, by the puncture device, the distal end of the puncture needle out of the distal end of the dilator; positioning the puncture position of the puncture needle and carrying out the atrial septum puncture; withdrawing the introducer sheath, the dilator and the puncture needle at the same time, and maintaining the guide wire, or withdrawing the dilator, the puncture needle and the guide wire at the same time, and maintaining the introducer sheath; and then carrying out follow-up surgery. Compared with an existing atrial septum puncture method, in the atrial septum puncture method, the steps of inserting the puncture needle and withdrawing the puncture needle are omitted, and meanwhile, the step of inserting and exchanging the guide wire is omitted, and it is unnecessary to replace the puncture needle, which is conductive to saving the operation time, thereby avoiding the complications and being conductive to ensuring a safety of a use process. DESCRIPTION OF THE DRAWINGS

[0042] In order to illustrate the technical solutions in the embodiments of the present invention more clearly, the drawings to be used in the descriptions of the embodiments of the present invention will be briefly introduced below. Obviously, the drawings in the following descriptions are merely some embodiments of the present invention. For those of ordinary skills in the art, other drawings may also be obtained based on the contents in the embodiments of the present invention and these drawings without going through any creative work.

[0043] FIG. 1 is a first schematic structural diagram of a puncture device assembled with an introducer sheath assembly provided by an embodiment of the present invention;

[0044] FIG. 2 is a sectional structure diagram of the puncture device assembled with the introducer sheath assembly provided by the embodiment of the present invention;

[0045] FIG. 3 is a second schematic structural diagram of the puncture device assembled with the introducer sheath assembly provided by the embodiment of the present invention;

[0046] FIG. 4 is a locally enlarged view of a part A in FIG. 2;

[0047] FIG. 5 is a locally enlarged view of a part B in FIG. 3;

[0048] FIG. 6 is a locally enlarged view of a part C in FIG. 1;

[0049] FIG. 7 is a locally enlarged view of a part D in FIG. 2;

[0050] FIG. 8 is a logic diagram of an atrial septum puncture method provided by the embodiment of the present invention; [0051 ] FIG. 9 is a locally enlarged view of a part E in FIG. 2;

[0052] FIG. 10 is a first sectional structure diagram of the puncture device provided by the embodiment of the present invention;

[0053] FIG. 11 is a locally enlarged view of a part G in FIG. 10;

[0054] FIG. 12 is a second sectional structure diagram of the puncture device provided by the embodiment of the present invention; and

[0055] FIG. 13 is a locally enlarged view of a part F in FIG. 12.

[0056] Reference numerals are as follows:

[0057] 100 refers to first shell; 110 refers to first end; 111 refers to mounting hole; 112 refers to first pressure measuring hole; 113 refers to connecting portion; 114 refers to boss; 115 refers to limiting portion; 116 refers to limiting block; 120 refers to second end; 121 refers to penetrating hole; 122 refers to second sealing member; 123 refers to second pressure measuring hole; 130 refers to guide hole; and 140 refers to end cover;

[0058] 200 refers to dilator; 210 refers to subject; and 220 refers to guide port;

[0059] 300 refers to puncture needle;

[0060] 400 refers to pushing mechanism; 410 refers to driving assembly; 411 refers to fixing block; 412 refers to driving block; 420 refers to guide assembly; 421 refers to guide groove; 422 refers to guide member; and 430 refers to reset member;

[0061] 500 refers to first sealing member;

[0062] 600 refers to introducer sheath assembly; 610 refers to second shell; 611 refers to limiting groove; and 620 refers to introducer sheath;

[0063] 700 refers to guide wire; and

[0064] 800 refers to radio-frequency puncture instrument. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0065] The present invention is further described in detail hereinafter with reference to the drawings and embodiments. It can be understood that the specific embodiments described herein are only used for explaining the present invention and are not intended to limit the present invention. In addition, it should also be noted that, for convenience of description, only some structures but not all structures related to the present invention are shown in the drawings.

[0066] In the description of the present invention, the terms "connected", "connection” and "fixation" should be understood in broad sense unless otherwise specified and defined. For example, they may be fixed connection, removable connection or integrated connection; may be mechanical connection or electrical connection; and may be direct connection, or indirect connection through an intermediate medium, and connection of structures inside two elements, or interaction relation of two elements. The specific meanings of the above terms in the present invention can be understood in a specific case by those of ordinary skills in the art.

[0067] In the present invention, unless otherwise specified and limited, the first feature “on” or “under” the second feature may comprise direct contact between the first feature and the second feature, and may also comprise the contact between the first feature and the second feature through another feature therebetween instead of the direct contact. Furthermore, the first feature "on", "above" and "over" the second feature comprises that the first feature is directly above and obliquely above the second feature, or only indicates that the first feature is higher than the second feature in a horizontal height. The first feature "under", "below" and "underneath" the second feature comprises that the first feature is directly below and obliquely below the second feature, or only indicates that the first feature is lower than the second feature in a horizontal height.

[0068] In the description of the embodiment, the orientation or position relationship indicated by the terms “up”, “down”, “left”, “right”, and the like is based on the orientation or position relationship shown in the drawings, it is only for the convenience of description and simplification of the operation, and it is not to indicate or imply that the indicated device or element must have a specific orientation, and be constructed and operated in a specific orientation. Therefore, the terms shall not be understood as limiting the present invention. In addition, the terms "first" and "second" are only used to distinguish in description and have no special meaning.

[0069] As shown in FIG. 1 to FIG. 13, the embodiment provides a puncture device, and the puncture device comprises a first shell 100, a puncture needle 300, a guide wire 700 and a dilator 200. The first shell 100 is capable of being detachably connected with different types of introducer sheath assemblies 600, so as to expand an application range of the puncture device. One end of the dilator 200 is arranged on the first shell 100, and during a surgery, the dilator 200 penetrates through an introducer sheath 620 of the introducer sheath assembly 600, and the guide wire 700 penetrates through the dilator 200. During the surgery, an operator inserts distal ends of the dilator 200 and the guide wire 700 into a heart, and after the distal ends of the dilator 200 and the guide wire 700 reach a preset position, the puncture needle 300 penetrates through an interior of the dilator 200, so as to facilitate the operator to operate the puncture needle 300 to make a distal end of the puncture needle protrude from the dilator 200 and puncture an atrial septum, thereby achieving the atrial septum puncture. Further, in order to improve a puncture accuracy, the distal end of the puncture needle 300 is set as a needle-like structure. Certainly, in other embodiments, the distal end of the puncture needle 300 may also have any other shape, such as an arc shape. In the embodiment, the first shell 100 is detachably matched with different types of introducer sheath assemblies 600, which is conductive to expanding the application range of the puncture device.

[0070] Further, in the embodiment, before the surgery, the guide wire 700 penetrates through the puncture needle 300, and the guide wire 700, the puncture needle 300, the introducer sheath 620 and the dilator 200 are transported to the heart at the same time, so that when the distal end of the dilator 200 reaches a preset puncture position, the puncture needle 300 is capable of puncturing the atrial septum in time, so as to omit steps and time consumption for withdrawing the guide wire and inserting the puncture needle in the prior art, improve surgery efficiency and shorten surgery time, thereby improving the safety of the surgery process.

[0071] Specifically, with reference to FIG. 1 to FIG. 7, the introducer sheath assembly 600 is detachably connected with the first shell 100, and the introducer sheath assembly 600 comprises a second shell 610 and the introducer sheath 620 penetrating through the second shell 610. During the surgery, the introducer sheath assembly 600 is assembled first, the dilator 200 penetrates through the introducer sheath 620, and then the first shell 100 and the second shell 610 are connected, so as to fix relative positions of the introducer sheath assembly 600 and the puncture device.

[0072] Optionally, the introducer sheath assembly 600 is a controllable bending introducer sheath 620. Specifically, the second shell 610 is provided with a knob, a bending angle of one end of the second shell 610 far away from the puncture device may be controlled by 180 degrees in both directions, and angles of the dilator 200, the puncture needle 300 and the guide wire 700 penetrating through an interior of the second shell are driven at the same time, which is convenient for a doctor to adjust a puncture point.

[0073] In order to further improve an atrial septum puncture technology of the puncture device and improve a prediction accuracy of a puncture point position, thereby ensuring a puncture accuracy, the puncture needle 300 of the puncture device is electrically connected with the radio-frequency puncture instrument 800. When the distal end of the puncture needle 300 reaches the preset position, a radio-frequency current switch or a foot switch of the radio-frequency puncture instrument 800 is turned on, and quick and highly focused radio-frequency energy is emitted to penetrate through the atrial septum.

[0074] Optionally, the radio-frequency puncture instrument 800 has a real-time impedance measurement function and is connected with the puncture needle 300. After successful puncture, an impedance change is displayed on a display screen to remind the successful puncture. The radio-frequency puncture instrument 800 connects the puncture needle 300 with an electrocardiogram monitor through a data line to measure an electrocardiogram in real time. After successful puncture, the electrocardiogram shows an obvious change, which reminds the operator of the successful puncture.

[0075] With reference to FIG. 1 to FIG. 7, in the embodiment, the puncture needle 300 penetrates through the first shell 100 and the dilator 200, and the distal end of the puncture needle 300 has a needle-like structure. The puncture device further comprises a pushing mechanism 400 arranged on the first shell 100, the puncture needle 300 is connected with an output end of the pushing mechanism 400, and the pushing mechanism 400 is capable of pushing the puncture needle 300 to reciprocate in a first direction, so that the distal end of the puncture needle 300 protrudes from the distal end of the dilator 200 or is hidden in the distal end of the dilator 200, and the first direction is an extension direction of the dilator 200. According to the puncture device, the puncture needle 300 is hidden in the dilator 200, which avoids damages to other organs caused by the distal end of the puncture needle 300 in a process of transporting the puncture needle 300 into the heart, enables the puncture needle 300 and the dilator 200 to be transported to a to-be-punctured preset position of the heart at the same time, saves the time for inserting the puncture needle 300, and is conductive to saving the operation time, thereby avoiding complications, and being conductive to ensuring a safety of a use process. FIG. 6 shows a state when the pushing mechanism 400 pushes the puncture needle 300 out of the dilator 200.

[0076] In the embodiment, the puncture needle 300 having the needle-like structure can give consideration to both a mechanical puncture ability and a puncture point stability, form a tent shape at the puncture point with a small thrust, and penetrate through the atrial septum with the quick and highly focused radio-frequency energy at the same time, so that the puncture device no longer relies entirely on a mechanical thrust to forcibly puncture the atrial septum, thereby greatly reducing the risk of excessive puncture and accidental puncture of a posterior wall of a left atrium. Meanwhile, the puncture needle 300 having this structure can still puncture the atrial septum without connecting the radio-frequency puncture instrument 800, which is conductive to expanding the application range of the puncture device. In other embodiments, the needle-like head end of the puncture needle 300 may also adopt an elliptical tip (blunt head), and the blunt head is not designed with a mechanical puncture function, which can further reduce the risk of misoperation during the surgery.

[0077] Specifically, in a non-puncture process, the distal end of the puncture needle 300 is always hidden in the dilator 200. Optionally, in order to reduce time consumption for pushing the puncture needle 300 out of the dilator 200 and reduce a pushing stroke of the pushing mechanism 400, the distal end of the puncture needle 300 is hidden in a position 5 mm to 20 mm away from an interior of the distal end of the dilator 200. When the puncture needle 300 needs to be pushed out of the dilator 200, the pushing mechanism 400 pushes the puncture needle 300, so that the distal end of the puncture needle 300 protrudes from the distal end of the dilator 200, thereby carrying out atrial septum puncture.

[0078] Further, the puncture needle 300 is divided into three sections in a direction from the distal end to the first shell 100. A first section is designed as a rigid tubular needle tip at the head end, so as to facilitate achieving the atrial septum puncture. In order to reduce scratches on an inner wall of the dilator 200 caused by a reciprocating movement of the puncture needle 300 inside the dilator 200, an obliquely sectional tube wall of the needle tip of the first section of the puncture needle 300 has a fillet structure, which prevents foreign bodies on the inner wall of the dilator 200 from falling off during the movement of the puncture needle 300, thereby reducing the surgical risk. A second section is a middle section, and the middle section adopts a flexible multi-strand twisted-wire spring tube, or a single-strand hollow spring-guided tube or a flexible tubular body, so as to adapt to various bending angles of the whole system in body of a patient. A third section is a tail end, and the tail end adopts a rigid tubular body and is located inside a handle and inside a small part of the dilator 200, so as to facilitate transferring a thrust of a pushing rod. The above materials may be made of medical stainless steel or medical nickel-titanium alloy.

[0079] Optionally, because the puncture needle 300 is generally made of metal and has electrical conductivity, in order to avoid the conduction of current from the guide wire 700 to other parts during radio-frequency puncture, an inner wall of the puncture needle 300 is provided with an insulating layer. Meanwhile, the insulating layer can also reduce a friction when the guide wire 700 penetrates through the inner wall of the puncture needle 300, thereby preventing a coating of the guide wire 700 from falling off to cause the surgical risk. Illustratively, the insulating layer may be made of polyimide (PI). Certainly, the insulating layer is not limited to this material.

[0080] As shown in FIG. 1 to FIG. 13, the embodiment further provides an atrial septum puncture method, the atrial septum puncture method is implemented by the puncture device above, and the atrial septum puncture method comprises the following steps of:

[0081] allowing the introducer sheath 620, the dilator 200, the puncture needle 300 and the guide wire 700 to enter a heart of a patient at the same time, and hiding the distal end of the puncture needle 300 in the distal end of the dilator 200 in the process of entering the heart of the patient;

[0082] pushing, by the puncture device, the distal end of the puncture needle 300 out of the distal end of the dilator 200;

[0083] positioning a puncture position of the puncture needle 300 and carrying out atrial septum puncture;

[0084] withdrawing the introducer sheath 620, the dilator 200 and the puncture needle 300 at the same time, and maintaining the guide wire 700, or withdrawing the dilator 200, the puncture needle 300 and the guide wire 700 at the same time, and maintaining the introducer sheath 620; and

[0085] carrying out follow-up surgery.

[0086] Compared with an existing atrial septum puncture method, in the atrial septum puncture method, the processes of withdrawing the guide wire 700 and inserting the puncture needle 300 before puncture are omitted, the processes of withdrawing the puncture needle 300 and exchanging the guide wire 700 after puncture are omitted, and it is unnecessary to replace the puncture needle 300, which is conductive to saving the operation time, thereby avoiding the complications and being conductive to ensuring the safety of the use process.

[0087] Specifically, when the introducer sheath 620, the dilator 200 and the puncture needle 300 are withdrawn at the same time, and the guide wire 700 is maintained, the sheath can be introduced into the left atrium of the patient in the follow-up surgery. When the dilator 200, the puncture needle 300 and the guide wire 700 are withdrawn at the same time, the introducer sheath 620 compatible with the follow-up surgery is maintained, and an access to the left atrium for the follow-up surgery is directly established.

[0088] Further, after the puncture needle 300 completes the atrial septum puncture, because a diameter of the puncture needle 300 is smaller than that of the dilator 200, in order to make the dilator 200 with the larger diameter sleeved outside the puncture needle 300 and the introducer sheath 620 smoothly enter the left atrium, the dilator 200 comprises a main body 210 and a guide port 220 connected with a distal end of the main body 210, and a diameter of the guide port 220 is gradually reduced in a direction far away from the main body 210 to form a trumpet shape, so that the guide port 220 is wrapped on the puncture needle 300. When the puncture needle 300 completes the puncture and enters the left atrium, a smaller-diameter end of the guide port 220 more easily enters the left atrium, and a size of a puncture hole is enlarged by gradually increasing the diameter of the guide port 220, so that the dilator 200 can smoothly enter the left atrium, thereby making the distal end of the introducer sheath 620 sleeved outside the dilator 200 enter the left atrium, so as to facilitate carrying out the follow-up surgery.

[0089] As shown in FIG. 2, FIG. 7 and FIG. 8, the first shell 100 comprises a first end 110 and a second end 120, the first end 110 and the second end 120 are located at two ends of the first shell 100 in the first direction, the first end 110 is provided with a mounting hole 111 extending in the first direction, the dilator 200 is fixed in the mounting hole 111, the second end 120 is provided with a penetrating hole 121 extending in the first direction, the puncture needle 300 penetrates into the first shell 100 from the penetrating hole 121 and penetrates through the dilator 200, and before the distal end of the dilator 200 reaches a pre-puncture position of a heart, the distal end of the puncture needle 300 is hidden in the dilator 200, so as to achieve the reciprocating movement of the puncture needle 300 in the dilator 200 in the first direction. Illustratively, the second end 120 is a Luer connector, and the guide wire 700 and the puncture needle 300 can penetrate into the dilator 200 through the Luer connector. After the surgery is completed, the operator may inject normal saline into the Luer connector with a syringe, so as to facilitate flushing an inner cavity of the puncture needle 300. Further, as shown in FIG. 9, in order to avoid overflow of the normal saline in the flushing process, the second end 120 further comprises a second sealing member 122, the second sealing member 122 is sleeved on the puncture needle 300 and embedded in the penetrating hole 121.

[0090] As shown in FIG. 10 and FIG. 11, in another embodiment, an outer end of the second end 120 is provided with an end cover 140, the end cover 140 is sleeved on the second end 120, and the guide wire 700 can penetrate through a middle portion of the end cover 140. In order to facilitate connecting the end cover 140 with an end face of the second end 120, the end cover 140 is threadedly connected with the second end 120. In this case, the second sealing member 122 is sleeved on the guide wire 700, and the second sealing member 122 is arranged between the end cover 140 and the second end 120. The second sealing member 122 can seal a gap between one end of the puncture needle 300 close to the end cover 140 and an outer diameter of the guide wire 700, so as to achieve the sealing between the guide wire 700 and the inner cavity of the puncture needle 300, thereby preventing blood from flowing out from a tail portion of the guide wire 700. More specifically, the second end 120 is provided with a groove, the second sealing member 122 is located in the groove, and two ends of the second sealing member 122 respectively abut against the end cover 140 and the second end 120, so that the second sealing member 122 seals the inner cavity of the puncture needle 300.

[0091] Further, the second end 120 is further provided with a second pressure measuring hole 123 communicated with the penetrating hole 121, and the second pressure measuring hole 123112 may have a Luer connector structure, so as to facilitate connecting with a pressure sensor. In addition, the Luer connector can be connected with a pressure detection device, so as to facilitate detecting a blood pressure inside the puncture needle. In the surgery process, the second pressure measuring hole 123 can be used to detect the blood pressure without withdrawing the guide wire 700.

[0092] As shown in FIG. 2, FIG. 4 and FIG. 7, due to the existence of various types of introducer sheath assemblies 600 in the market, in order to adapt to the various types of introducer sheath assemblies 600, the first end 110 is a compatible connector for detachable connection with the second shell 610 of the introducer sheath assembly 600. At present, one end of the commonly used second shell 610 close to the puncture device has an inner hole structure. In order to connect the first end 110 with the inner hole, the first end 110 comprises a connecting portion 113, an outer diameter of the connecting portion 113 is set corresponding to an inner diameter of the inner hole, and an end face of the connecting portion 113 far away from the second end 120 is provided with a boss 114. An outer diameter of the boss 114 is in interference fit with the inner diameter of the inner hole, the first end 110 is provided with a limiting portion 115, and an outer diameter of the limiting portion 115 is larger than that of the connecting portion 113. When assembling, the operator needs to insert the first end 110 into the inner hole, so that the boss 114 can be clamped into an end face of an inner wall of the second shell 610, and the limiting portion 115 abuts against an outer wall of the second shell 610, so as to achieve rapid assembly of the first end 110 and the second shell 610. After the surgery, a user may manually pull out the first end 110 to separate the introducer sheath assembly 600 from the puncture device. The first end 110 is designed as a quick-replaceable tip, so that the puncture device can be compatible with various brands of sheaths.

[0093] In addition, as shown in FIG. 2, FIG. 5 and FIG. 7, the second shell 610 may be further provided with a limiting groove 611, and the first end 110 comprises a limiting block 116 corresponding to the limiting groove 611. When assembling the introducer sheath assembly 600 and the puncture device, the limiting block 116 is inserted into the limiting groove 611, so as to ensure a correct angle when connecting the introducer sheath assembly 600 and the puncture device, thereby avoiding a misoperation of the operator.

[0094] With reference to FIG. 7, FIG. 12 and FIG. 13, the first shell 100 is provided with a guide hole 130 extending in the first direction, the pushing mechanism 400 comprises a driving assembly 410, the puncture needle 300 is connected with the driving assembly 410, and a part of the driving assembly 410 penetrates through the guide hole 130 to protrude from the first shell 100, so as to facilitate manual operation by the operator outside the first shell 100. When the operator carries out atrial septum puncture, the operator is capable of pushing the driving assembly 410 to move in the first direction to make the distal end of the puncture needle 300 protrude from the dilator 200.

[0095] The driving assembly 410 comprises a fixing block 411 and a driving block 412. The fixing block 411 is sleeved on the puncture needle 300, which is conductive to improving a stability of the puncture needle 300 driven by the fixing block 411 in the first direction. The driving block 412 is arranged on the first shell 100, and the driving block 412 is connected with the fixing block 411 through the guide hole 130, so that the operator can directly drive the puncture needle outside the first shell 100, which is conductive to improving the convenience for the operator in the use process.

[0096] With reference to FIG. 12 and FIG. 13, the pushing mechanism 400 further comprises a guide assembly 420, and the guide assembly 420 is arranged between the driving assembly 410 and the first shell 100, wherein the guide assembly 420 is configured to provide guidance for the driving assembly 410 to push the puncture needle 300 to move in the first direction, so as to improve a stability of a movement of the pushing assembly in the first direction, thereby avoiding the occurrence of jamming.

[0097] Specifically, the guide assembly 420 comprises a guide groove 421 and a guide member 422, wherein the guide groove 421 is arranged on the inner wall of the first shell 100 in the first direction, and the guide member 422 is connected with the driving assembly 410 without the guide groove 421. The guide member 422 is partially located in the guide groove 421, and the guide member 422 is capable of moving in the guide groove 421 in the first direction. The guide assembly 420 is simple in structure and easy to realize.

[0098] In other embodiments, the guide groove 421 may be arranged on the driving assembly 410 in the first direction, and the guide member 422 is connected with the first shell 100 without the guide groove 421. The guide member 422 is partially located in the guide groove 421, and the guide member 422 is capable of moving in the guide groove 421 in the first direction, thereby achieving an effect the same as above, which will not be repeated herein.

[0099] As shown in FIG. 12 and FIG. 13, the puncture device further comprises a first sealing member 500, the first sealing member 500 is sleeved on the puncture needle 300, and the first sealing member 500 is hermetically connected with the first end 110 of the first shell 100, so as to block blood flowing back from one end of the heart, thereby avoiding the blood from overflowing to one side of the first sealing member 500 far away from the first end 110.

[0100] In addition, the pushing mechanism 400 further comprises a reset member 430 sleeved on the puncture needle 300, wherein two ends of the reset member 430 respectively abut against the first shell 100 and the driving assembly 410. When the operator pushes the driving block 412, so as to drive the fixing block 411 to push the distal end of the puncture needle 300 to protrude from the dilator 200, the reset member 430 is compressed. After the puncture is completed, the operator releases the driving block 412, and an elastic action of the compressed reset member 430 can drive the fixing block 411 to retract into the dilator 200, thereby achieving an effect of automatic reset.

[0101] Illustratively, the reset member 430 is a spring, and the spring has a very good automatic reset function, a low cost and a stable performance.

[0102] Further, two ends of the reset member 430 respectively abut against the fixing block 411 and the first sealing member 500, thereby achieving an effect of fixing the two ends. In order to improve an effect of fixing the reset member 430 by the fixing block 411 and the first sealing member 500, opposite ends of the fixing block 411 and the first sealing member 500 are respectively provided with accommodating grooves, and two ends of the reset member 430 are respectively located in the two accommodating grooves, thereby improving a stability of the reset member 430.

[0103] The first end 110 is provided with a first pressure measuring hole 112, the first pressure measuring hole 112 is communicated with the mounting hole 111, and the operator is capable of measuring a blood pressure in the mounting hole 111 through the first pressure measuring hole 112, so as to facilitate the operator to detect a heart blood pressure in real time in the surgery process. Specifically, the puncture device further comprises a pressure sensor arranged in the first pressure measuring hole 112. Due to an obvious pressure difference between a right atrium and a left atrium, after the puncture needle 300 enters the left atrium, the pressure sensor can immediately obtain atrial pressure change data to remind the operator whether the puncture is successful or not. Illustratively, the first pressure measuring hole 112 may have a Luer connector structure, so as to facilitate connecting with the pressure sensor. In addition, the Luer connector can be connected with a syringe, so as to facilitate the operator to inject normal saline into the first pressure measuring hole 112, thereby flushing a gap between the outer wall of the puncture needle 300 on one side of the first sealing member 500 close to the first end 110 and the inner wall of the dilator 200.

[0104] Alternatively, the puncture needle 300 may be welded and fixed with the pushing mechanism 400. Specifically, the fixing block 411 is welded and fixed with the puncture needle 300, thereby improving a stability of stably driving the puncture needle 300 to move in the first direction by the fixing block 411.

[0105] In other embodiments, the puncture needle 300 is provided with a limiting protrusion, in a pushing direction of the pushing mechanism 400, the limiting protrusion is located in front of the pushing mechanism 400, and the limiting protrusion is capable of abutting against an end face of the pushing mechanism 400, thereby improving the stability of stably driving the puncture needle 300 to move in the first direction by the fixing block 411.

[0106] In addition, the first shell 100 is provided with an energy on-off switch electrically connected with the radio-frequency puncture instrument 800, so that the operator may control a radio-frequency energy switch without operating the radio-frequency puncture instrument 800 during the surgery. Alternatively, the puncture device is provided with a foot switch electrically connected with the radio-frequency puncture instrument 800, so as to facilitate the operator to control the radio-frequency energy switch by pedaling in the surgery process.

[0107] By using the puncture device, the operator transports the distal end of the dilator 200 into the right atrium through an inferior vena cava of the patient, and after confirming that the distal end of the dilator reaches a puncture site of the atrial septum by an ultrasound or an X-ray, the operator pushes the driving block 412 on the first shell 100 to push out the automatically hidden puncture needle 300, and simultaneously operates the radio-frequency current switch or the foot trigger switch on the first shell 100 to emit the quick and highly focused radio-frequency energy to penetrate through the atrial septum, so as to transport the puncture needle 300 into the left atrium, thereby establishing an access into the left atrium for the follow-up surgery.

[0108] Meanwhile, according to the puncture device, it is unnecessary to exert an excessively large mechanical thrust by a sharp mechanical needle to forcibly penetrate through the atrial septum during the surgery, so that the puncture position of the atrial septum is more accurate, safe and controllable, an incidence of complications related to the atrial septum puncture is reduced, a technical difficulty of the atrial septum puncture is reduced, and a learning curve is shortened. Therefore, the puncture device is a safe, reliable, controllable and convenient novel puncture device.

[0109] According to the puncture device, it is unnecessary to withdraw the guide wire 700 and insert the puncture needle 300, and withdraw the puncture needle 300 and insert the guide wire 700 in the whole atrial septum puncture surgery process, thereby achieving a zero-exchange workflow, and it is unnecessary to replace the needle, the guide wire 700, the dilator 200, the introducer sheath 620, and the like Meanwhile, after confirming the puncture position, if the operator is not satisfied with the puncture position and repositions the puncture position, the operator only needs to release the driving block 412. In this case, the distal end of the puncture needle 300 retracts into the dilator 200 under the elastic action of the reset member 430, and then the operator may push out the guide wire 700 for repositioning. Alternatively, an angle of the controllable bending introducer sheath 620 is adjusted after the retraction of the distal end of the puncture needle 300, so as to adjust the puncture point.

[0110] It is noted that the basic principle, main features and advantages of the present invention have been shown and described above. Those skilled in the art should understand that the present invention is not limited by the above embodiments, the descriptions in the above embodiments and the specification only illustrate the principles of the present invention, the present invention may have various changes and improvements without departing from the spirit and scope of the present invention, and all of the changes and improvements fall within the scope sought to be protected by the present invention. The scope of protection of the present invention is defined by the appended claims and their equivalents.

Claims

1. A puncture device, comprising:a first shell (100), which is capable of being detachably connected with different types of introducer sheath assemblies (600);a dilator (200), one end of which is arranged on the first shell (100), wherein the dilator (200) penetrates through an introducer sheath (620) of the introducer sheath assembly (600) during a surgery;a puncture needle (300), which penetrates through the first shell (100) and the dilator (200);a guide wire (700), which penetrates through the puncture needle (300); anda pushing mechanism (400), which is arranged on the first shell (100), wherein the puncture needle (300) is connected with an output end of the pushing mechanism (400), the pushing mechanism (400) is configured to push the puncture needle (300) to reciprocate in a first direction, so that a distal end of the puncture needle (300) protrudes from a distal end of the dilator (200) or is hidden in the distal end of the dilator (200), and the first direction is an extension direction of the dilator (200).

2. The puncture device according to claim 1, wherein the first shell (100) comprises a first end (110) and a second end (120), the first end (110) and the second end (120) are located at two ends of the first shell (100) in the first direction, the first end (110) is provided with a mounting hole (111) extending in the first direction, the dilator (200) is fixed in the mounting hole (111), the second end (120) is provided with a penetrating hole (121) extending in the first direction, the puncture needle (300) penetrates into the first shell (100) from the penetrating hole (121) and penetrates through the dilator (200), and before the distal end of the dilator (200) reaches a pre-puncture position of a heart, the distal end of the puncture needle (300) is hidden in the dilator (200).

3. The puncture device according to claim 1, wherein the first shell (100) is provided with a guide hole (130) extending in the first direction, and the pushing mechanism (400) comprises:a driving assembly (410), wherein the puncture needle (300) is connected with the driving assembly (410), and a part of the driving assembly (410) is arranged to penetrate through the guide hole (130) to protrude from the first shell (100), so that when an operator carries out atrial septum puncture, the operator is capable of pushing the driving assembly (410) to move in the first direction to make the distal end of the puncture needle (300) protrude from the dilator (200).

4. The puncture device according to claim 3, wherein the driving assembly (410) comprises:a fixing block (411) sleeved on the puncture needle (300); anda driving block (412) arranged on the first shell (100), wherein the driving block (412) penetrates through the guide hole (130) to be connected with the fixing block (411).

5. The puncture device according to claim 3, wherein the pushing mechanism (400) further comprises:a guide assembly (420) arranged between the driving assembly (410) and the first shell (100), wherein the guide assembly (420) is configured to provide guidance for the driving assembly (410) to push the puncture needle (300) to move in the first direction.

6. The puncture device according to claim 5, wherein the guide assembly (420) comprises:a guide groove (421) arranged on an inner wall of the first shell (100) or the driving assembly (410) in the first direction; anda guide member (422) connected with the driving assembly (410) or the first shell (100) without the guide groove (421), wherein the guide member (422) is partially located in the guide groove (421), and the guide member (422) is capable of moving in the guide groove (421) in the first direction.

7. The puncture device according to claim 3, wherein the pushing mechanism (400) further comprises:a reset member (430) sleeved on the puncture needle (300), wherein two ends of the reset member (430) respectively abut against the first shell (100) and the driving assembly (410).

8. The puncture device according to claim 3, wherein the puncture device further comprises:a first sealing member (500) sleeved on the puncture needle (300), wherein the first sealing member (500) is hermetically connected with the first end (110) of the first shell (100).

9. The puncture device according to claim 2, wherein the first end (110) is provided with a first pressure measuring hole (112), the first pressure measuring hole (112) is communicated with the mounting hole (111), and an operator is capable of measuring a blood pressure in the mounting hole (111) through the first pressure measuring hole (112).

10. The puncture device according to claim 1, wherein the puncture needle (300) is welded and fixed with the pushing mechanism (400), or the puncture needle (300) is provided with alimiting protrusion, in a pushing direction of the pushing mechanism (400), the limiting protrusion is located in front of the pushing mechanism (400), and the limiting protrusion is capable of abutting against an end face of the pushing mechanism (400).

11. The puncture device according to any one of claims 1 to 10, wherein the puncture needle (300) is electrically connected with a radio-frequency puncture instrument (800).

12. The puncture device according to claim 2, wherein the first shell (100) further comprises an end cover (140) sleeved on the second end (120), and the guide wire (700) penetrates through the end cover (140); and the second end (120) comprises:a second sealing member (122) sleeved on the guide wire (700), wherein the second sealing member (122) is arranged between the end cover (140) and the second end (120), and the second sealing member (122) is configured to seal a gap between an inner cavity of the puncture needle (300) and an outer diameter of the guide wire (700).

13. The puncture device according to any one of claims 1 to 10, wherein an inner wall of the puncture needle (300) is provided with an insulating layer.

14. An atrial septum puncture method implemented by the puncture device according to any one of claims 1 to 13, wherein the atrial septum puncture method comprises the following steps of:allowing the introducer sheath (620), the dilator (200), the puncture needle (300) and the guide wire (700) to enter a heart of a patient at the same time, and hiding the distal end of the puncture needle (300) in the distal end of the dilator (200) in the process of entering the heart of the patient;positioning a puncture position of the dilator (200);pushing, by the pushing mechanism (400) of the puncture device, the distal end of the puncture needle (300) out of the distal end of the dilator (200), and carrying out atrial septum puncture; andwithdrawing the introducer sheath (620), the dilator (200) and the puncture needle (300) at the same time, and maintaining the guide wire (700), or withdrawing the dilator (200), the puncture needle (300) and the guide wire (700) at the same time, and maintaining the introducer sheath (620); and carrying out follow-up surgery.INTERNATIONAL SEARCH REPORT International application No. PCT / CN2024 / 091468A. CLASSIFICATION OF SUBJECT MATTER A61B 17 / 34(2006.01)1 According to International Patent Classification (IPC) or to both national classification and IPC B. FIELDS SEARCHED Minimum documentation searched (classification system followed by classification symbols) IPC:A61B Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched Electronic data base consulted during the international search (name of data base and, where practicable, search terms used) CNTXT, ENTXTC, CNKI, web of science: fill®, M4¾ (Eft, Wif, K’S, W®, ® Mift, RJK®, ft®, ftfi, Tfe®, SEE, WEE, EE®, UllfE, puncture, needle, dilator, detachab??, reciprocate-, sheath tube, push+, control+, handle, shell, pressure C. DOCUMENTS CONSIDERED TO BE RELEVANT Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. PX CN 117017440 A (HUIYANG MEDICAL TECHNOLOGY (SUZHOU) CO., LTD.) 10 November 2023 (2023-11-10) description, paragraphs [0058]-[0110], and figures 1-13 1-13 X CN 115919431 A (SHANGHAI MICROPORT EP MEDTECH CO., LTD.) 07 April 2023 (2023-04-07) description, paragraphs [0040]-[0074], and figures 1-10 1-13 X CN 216090714 U (RING-HEART MEDICAL SCIENCE AND TECHNOLOGY (SUZHOU) LIMITED COMPANY) 22 March 2022 (2022-03-22) description, paragraphs [0034]-[0052], and figures 1-8 1-13 A CN 216962580 U (WUHAN WEIKE MEDICAL TECHNOLOGY CO., LTD.) 15 July 2022 (2022-07-15) entire document 1-13 A CN 217593014 U (SHANGHAI TUOMAI MEDICAL TECHNOLOGY CO., LTD.) 18 October 2022 (2022-10-18) entire document 1-13 | Z | Further documents are listed in the continuation of Box C. | Z | See patent family annex. * Special categories of cited documents: “A” document defining the general state of the art which is not considered to be of particular relevance ■‘D” document cited by the applicant in the international application “E” earlier application or patent but published on or after the international filing date “L” document which may throw doubts on priority claim(s) or which is cited to establish the publication date of another citation or other special reason (as specified) “O” document referring to an oral disclosure, use, exhibition or other means “P” document published prior to the international filing date but later than the priority date claimed “T” later document published after the international filing date or priority date and not in conflict with the application but cited to understand the principle or theory underlying the invention ■‘X” document of particular relevance; the claimed invention cannot be considered novel or cannot be considered to involve an inventive step when the document is taken alone “Y” document of particular relevance; the claimed invention cannot be considered to involve an inventive step when the document is combined with one or more other such documents, such combination being obvious to a person skilled in the ait document member of the same patent family Date of the actual completion of the international search Date of mailing of the international search report 16 July 2024 22 July 2024 Name and mailing address of the ISA / CN Authorized officer China National Intellectual Property Administration (ISA / CN) China No. 6, Xitucheng Road, Jimenqiao, Haidian District, Beijing 100088 Telephone No.

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