CN117017440A - Puncture device and method for puncture of septum - Google Patents

Abstract

The invention relates to the technical field of medical instruments, in particular to a puncture device and a atrial septum puncture method. The puncture device comprises a first shell, a dilator, a puncture needle, a guide wire and a pushing mechanism. The expander is worn to locate in the guiding sheath pipe of guiding sheath subassembly, and the pjncture needle is worn to locate in first casing and the expander, and the seal wire is worn to locate in the pjncture needle, and push mechanism sets up on first casing, and the pjncture needle is connected with push mechanism's output, and push mechanism is configured to promote pjncture needle along the reciprocal motion of first direction to make the distal end protrusion expander's of pjncture needle distal end or hide in the distal end of expander, first direction is the extending direction of expander. The puncture device saves the time for inserting the puncture needle, is beneficial to saving the operation time and is beneficial to ensuring the safety in the use process. The septum penetration method does not need the steps of inserting and withdrawing the puncture needle, reduces the steps of inserting and exchanging the guide wire, and is beneficial to saving the operation time.

Description

Puncture device and method for puncture of septum

Technical Field

The invention relates to the technical field of medical instruments, in particular to a puncture device and a atrial septum puncture method.

Background

With the popularity of electrophysiological and structural heart disease surgery, atrial septum puncture has become the most common technique for cardiologists to access the left atrium, and indications include atrial fibrillation ablation, left atrial appendage occlusion, mitral valve lesions, congenital heart disease intervention, percutaneous left ventricular assist device implantation, and the like. In the prior art, a mechanical puncture device is generally adopted to complete the atrial septum puncture operation. The lancing device includes a first housing, a dilator and a lance. One end of the dilator is arranged on the first shell, an operator inserts the distal ends of the guiding sheath tube and the dilator into the heart along the guide wire during operation, after the distal end of the dilator reaches a preset position, the guide wire is withdrawn, then the puncture needle is arranged in the dilator in a penetrating way, and the distal end of the puncture needle is in a needle-shaped structure, so that the operator can operate the puncture needle to enable the distal end of the puncture needle to protrude out of the dilator and puncture the atrial septum, and atrial septum puncture is realized.

However, the atrial septum puncture technique of the puncture device is not well known, the puncture needle and the guide wire need to be frequently exchanged in the puncture process, the operation time is long, the puncture difficulty is high, and serious complications such as pericardial tamponade, sliding puncture positions, heart rupture and the like are easily caused when special patients are met, such as atrial septum fibrosis, thickening, hyperelasticity, neoplasia and the like.

In order to solve the above-mentioned problems, it is needed to provide a puncturing device and a method for puncturing the septum.

Disclosure of Invention

The invention aims to provide a puncture device and a septum primum puncture method, wherein a puncture needle is hidden in a dilator so that the puncture needle and the dilator can be simultaneously conveyed to a preset position to be punctured by a heart, the time for inserting and exchanging the puncture needle and a guide wire is saved, the operation time is saved, and complications are effectively avoided.

To achieve the purpose, the invention adopts the following technical scheme:

a lancing device, comprising:

the first shell can be detachably connected with the guide sheath assemblies of different types;

one end of the expander is arranged on the first shell, and the expander penetrates through the guide sheath tube of the guide sheath assembly in operation;

the puncture needle is arranged in the first shell and the expander in a penetrating way;

the guide wire is arranged in the puncture needle in a penetrating way; and

the pushing mechanism is arranged on the first shell, the puncture needle is connected with the output end of the pushing mechanism, the pushing mechanism is configured to push the puncture needle to reciprocate along a first direction, so that the distal end of the puncture needle protrudes out of the distal end of the expander or is hidden in the distal end of the expander, and the first direction is the extending direction of the expander.

As an alternative, the first housing includes a first end and a second end, the first end and the second end are located at two ends of the first housing along the first direction, the first end is provided with a mounting hole extending along the first direction, the dilator is fixed in the mounting hole, and the second end is provided with a penetrating hole extending along the first direction, the puncture needle penetrates the first housing from the penetrating hole and penetrates the dilator, and before the distal end of the dilator reaches the pre-puncture position of the heart, the distal end of the puncture needle is hidden in the dilator.

As an alternative, the first housing is provided with a guide hole extending along the first direction, and the pushing mechanism includes:

the puncture needle is connected with the driving assembly, part of the driving assembly penetrates through the guide hole to protrude out of the first shell, and when an operator performs atrial septum puncture, the operator can push the driving assembly to move along the first direction to enable the distal end of the puncture needle to protrude out of the expander.

As an alternative, the driving assembly includes:

the fixed block is sleeved on the puncture needle; and

the driving block is arranged on the first shell and penetrates through the guide hole to be connected with the fixed block.

As an alternative, the pushing mechanism further includes:

a guide assembly disposed between the drive assembly and the first housing, the guide assembly configured such that the drive assembly urges the needle to move in the first direction to provide guidance.

As an alternative, the guide assembly includes:

a guide groove provided on an inner wall of the first housing or the driving assembly in the first direction; and

and a guide member connected to the driving assembly or the first housing without the guide groove, the guide member being partially located in the guide groove, and the guide member being movable in the first direction in the guide groove.

As an alternative, the pushing mechanism further includes:

the restoring piece is sleeved on the puncture needle, and two ends of the restoring piece are respectively abutted to the first shell and the driving assembly.

As an alternative, the puncture device further comprises:

the first sealing piece is sleeved on the puncture needle and is in sealing connection with the first end of the first shell.

As an alternative, a first pressure measuring hole is formed in the first end, the first pressure measuring hole is communicated with the mounting hole, and an operator can measure the blood pressure in the mounting hole through the first pressure measuring hole.

As an alternative scheme, the pjncture needle with push mechanism welded fastening, perhaps be equipped with spacing arch on the pjncture needle, push mechanism's propelling movement direction, spacing arch is located push mechanism's the place ahead, just spacing arch can with push mechanism's terminal surface butt.

As an alternative, the puncture needle is electrically connected with the radio frequency puncture instrument.

As an alternative, the first housing further comprises an end cover sleeved on the second end, and the guide wire is arranged in the end cover in a penetrating way; the second end includes:

the second sealing piece is sleeved on the guide wire, is arranged between the end cover and the second end and is configured to seal a gap between the inner cavity of the puncture needle and the outer diameter of the guide wire.

As an alternative, the inner wall of the puncture needle is provided with an insulating layer.

The method for puncturing the septum is characterized by comprising the following steps of:

the guiding sheath tube, the expander, the puncture needle and the guide wire enter the heart of the patient simultaneously, and the distal end of the puncture needle is hidden in the distal end of the expander in the process of entering the heart of the patient;

positioning a puncture location of the dilator;

the pushing mechanism of the puncture device pushes the distal end of the puncture needle out of the distal end of the dilator and performs interatrial septum puncture;

simultaneously withdrawing the introducer sheath, the dilator and the needle, retaining the guidewire, or simultaneously withdrawing the dilator, the needle and the guidewire, retaining the introducer sheath; and

and performing subsequent operations.

The beneficial effects of the invention are as follows:

the invention provides a puncture device, which comprises a first shell, a dilator, a puncture needle, a guide wire and a pushing mechanism. The first casing can be connected with the guiding sheath subassembly of different models can be dismantled, and the one end setting of expander is on first casing, and in the operation, and the expander wears to locate in the guiding sheath pipe of guiding sheath subassembly, the pjncture needle wear to be located first casing with in the expander, the seal wire wear to locate in the pjncture needle, push mechanism sets up on the first casing, the pjncture needle with push mechanism's output is connected, push mechanism is configured to promote the pjncture needle is along first direction reciprocating motion, so that the distal end protrusion of pjncture needle the distal end of expander or hide in the distal end of expander, first direction is the extending direction of expander. The puncture device is hidden in the dilator through the puncture needle, so that the puncture needle and the dilator are simultaneously conveyed to a preset position to be punctured by the heart, the time for inserting and exchanging the puncture needle and the guide wire is saved, the operation time is saved, and complications are effectively avoided.

The invention also provides a room septum puncture method, which is realized by the puncture device, and comprises the following steps: the guiding sheath tube, the expander, the puncture needle and the guide wire enter the heart of the patient simultaneously, and the distal end of the puncture needle is hidden in the distal end of the expander in the process of entering the heart of the patient; the puncture device pushes the distal end of the puncture needle out of the distal end of the dilator; positioning the puncture position of the puncture needle and performing interatrial septum puncture; simultaneously withdrawing the introducer sheath, the dilator and the needle, retaining the guidewire, or simultaneously withdrawing the dilator, the needle and the guidewire, retaining the introducer sheath; and then performing subsequent operations. Compared with the existing septum puncture method, the septum puncture method reduces the steps of inserting and withdrawing the puncture needle, reduces the steps of inserting and exchanging the guide wire, does not need to replace the puncture needle, is beneficial to saving operation time, further avoids complications, and is beneficial to ensuring the safety in the use process.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following description will briefly explain the drawings needed in the description of the embodiments of the present invention, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to the contents of the embodiments of the present invention and these drawings without inventive effort for those skilled in the art.

FIG. 1 is a schematic illustration of an assembled puncturing device and introducer sheath assembly according to an embodiment of the present invention;

FIG. 2 is a schematic cross-sectional view of a puncture device and introducer sheath assembly according to an embodiment of the present invention;

FIG. 3 is a schematic diagram showing a second structure of an assembly of a puncture device and an introducer sheath assembly according to an embodiment of the present invention;

FIG. 4 is an enlarged view of a portion of FIG. 2 at A;

FIG. 5 is a partial enlarged view at B in FIG. 3;

FIG. 6 is an enlarged view of a portion of FIG. 1 at C;

FIG. 7 is a partial enlarged view at D in FIG. 2;

FIG. 8 is a logic diagram of a method of atrial septum penetration provided by an embodiment of the present invention;

FIG. 9 is an enlarged view of a portion of FIG. 2 at E;

FIG. 10 is a schematic cross-sectional view of a lancing device according to an embodiment of the present invention;

fig. 11 is a partial enlarged view at G in fig. 10;

FIG. 12 is a schematic diagram showing a cross-sectional structure of a puncture device according to an embodiment of the present invention;

fig. 13 is a partial enlarged view at F in fig. 12.

The figures are labeled as follows:

100-a first housing; 110-a first end; 111-mounting holes; 112-a first pressure tap; 113-a connection; 114-boss; 115-a limit part; 116-limiting blocks; 120-second end; 121-perforating holes; 122-a second seal; 130-a guide hole; 123-a second pressure tap; 130-end caps;

200-dilators; 210-a body; 220-guiding port;

300-puncture needle;

400-pushing mechanism; 410-a drive assembly; 411-fixed block; 412-a drive block; 420-a guide assembly; 421-guide slots; 422-guides; 430-a reset member;

500-a first seal;

600-an introducer sheath assembly; 610-a second housing; 611-limit grooves; 620-an introducer sheath;

700-a guidewire;

800-radio frequency puncture instrument.

Detailed Description

The invention is described in further detail below with reference to the drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not limiting thereof. It should be further noted that, for convenience of description, only a part of structures related to the present invention, not the whole structures, are shown in the drawings.

In the description of the present invention, unless explicitly stated and limited otherwise, the terms "connected," "connected," and "fixed" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be the communication of structures in two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

In the present invention, unless expressly stated or limited otherwise, a first feature "above" or "below" a second feature may include both the first and second features being in direct contact, as well as the first and second features not being in direct contact but being in contact with each other through additional features therebetween. Moreover, a first feature being "above," "over" and "on" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is higher in level than the second feature. The first feature being "under", "below" and "beneath" the second feature includes the first feature being directly under and obliquely below the second feature, or simply means that the first feature is less level than the second feature.

In the description of the present embodiment, the terms "upper", "lower", "left", "right", and the like are orientation or positional relationships based on those shown in the drawings, merely for convenience of description and simplicity of operation, and do not indicate or imply that the apparatus or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the invention. Furthermore, the terms "first," "second," and the like, are used merely for distinguishing between descriptions and not for distinguishing between them.

As shown in fig. 1 to 13, the present embodiment provides a puncture device including a first housing 100, a puncture needle 300, a guide wire 700, and a dilator 200. The first housing 100 can be detachably connected with different types of introducer sheath assemblies 600 to expand the applicability of the lancing device. One end of the dilator 200 is disposed on the first housing 100, and in operation, the dilator 200 is inserted into the guide sheath 620 of the guide sheath assembly 600, the guide wire 700 is inserted into the dilator 200, and in operation, an operator inserts the distal ends of the dilator 200 and the guide wire 700 into the heart, and after the distal ends of the dilator 200 and the guide wire 700 reach a preset position, the puncture needle 300 is inserted into the dilator 200, so that the operator can operate the puncture needle 300 to protrude the distal end of the dilator 200 and puncture the atrial septum, thereby realizing atrial septum puncture. Further, in order to improve the puncture accuracy, the distal end of the puncture needle 300 is provided in a needle-like structure. Of course, in other embodiments, the distal end of the needle 300 can be any other shape, such as circular arc. The first housing 100 of the present embodiment is detachably matched with the guiding sheath assembly 600 of various types, which is beneficial to improving the application range of the puncturing device.

Further, in this embodiment, the guide wire 700 is inserted into the puncture needle 300 before the operation, and the guide wire 700, the guiding sheath 620 of the puncture needle 300 and the dilator 200 are simultaneously delivered into the heart, so that when the distal end of the dilator 200 reaches the preset puncture position, the puncture needle 300 can timely perform the septum puncture, thereby saving the step and time for withdrawing the guide wire and inserting the puncture needle in the prior art, improving the operation efficiency, shortening the operation time, and further improving the safety of the operation process.

Specifically, referring to fig. 1 to 7, the introducer sheath assembly 600 is detachably connected to the first housing 100, and the introducer sheath assembly 600 includes a second housing 610 and an introducer sheath 620 penetrating the second housing 610. In operation, the introducer sheath assembly 600 is assembled first, the dilator 200 is inserted into the introducer sheath 620, and then the first housing 100 and the second housing 610 are connected, thereby fixing the relative positions of the introducer sheath assembly 600 and the puncturing device.

Optionally, the introducer sheath assembly 600 is a steerable introducer sheath 620. Specifically, the second housing 610 is provided with a knob, and the end of the second housing 610 far away from the puncture device can control the bending angle by 180 degrees in two directions, and simultaneously drive the angle of the dilator 200, the puncture needle 300 and the guide wire 700 penetrating through the second housing to facilitate the adjustment of the puncture point position by a doctor.

In order to further improve the atrial septum puncturing technology of the puncturing device, improve the accurate predicted puncturing point position, further ensure the puncturing precision, the puncturing needle 300 of the puncturing device is electrically connected with the radio frequency puncturing instrument 800, and when the distal end of the puncturing needle 300 reaches the preset position, a radio frequency current switch or a foot-operated switch of the radio frequency puncturing instrument 800 is opened to emit short-time and highly focused radio frequency energy to penetrate the atrial septum.

Optionally, the rf puncture instrument 800 has a real-time impedance measurement function, and is connected to the puncture needle 300, and displays an impedance change on a display screen after successful puncture, so as to remind that the puncture is successful. The radio frequency puncture instrument 800 connects the puncture needle 300 with the electrocardiograph detector through a data line, and measures the electrocardiogram in real time, and the electrocardiogram shows obvious change after the puncture is successful, so as to prompt the operator that the puncture is successful.

With continued reference to fig. 1 to 7, in this embodiment, the puncture needle 300 is disposed in the first housing 100 and the dilator 200, the distal end of the puncture needle 300 is in a needle-like structure, and the puncture device further includes a pushing mechanism 400 disposed on the first housing 100, the puncture needle 300 is connected to an output end of the pushing mechanism 400, and the pushing mechanism 400 can push the puncture needle 300 to reciprocate along a first direction, so that the distal end of the puncture needle 300 protrudes out of the distal end of the dilator 200 or is hidden in the distal end of the dilator 200, and the first direction is an extending direction of the dilator 200. The puncture device is hidden in the dilator 200 through the puncture needle 300, so that the damage to other organs caused by the distal end of the puncture needle 300 in the process of conveying the puncture needle 300 into the heart is avoided, the puncture needle 300 and the dilator 200 are simultaneously conveyed to the preset position to be punctured by the heart, the time for inserting the puncture needle 300 is saved, the operation time is saved, the complications are avoided, and the safety in the using process is ensured. Fig. 6 shows the pusher mechanism 400 when the puncture needle 300 is pushed out of the dilator 200.

In this embodiment, the needle-like puncture needle 300 can achieve both mechanical puncture capability and puncture point stability, and forms a tent shape at the puncture point with a small thrust force, and simultaneously uses the radio frequency energy which is short and highly focused to penetrate the septum to realize septum puncture, so that the puncture device does not completely rely on the mechanical thrust force to puncture the septum, thereby greatly reducing the risk of excessive breakthrough and false puncture of the back wall of the left atrium. Meanwhile, the puncture needle 300 with the structure can still realize the septum puncture when not connected with the radio frequency puncture instrument 800, thereby being beneficial to expanding the application range of the puncture device. In other embodiments, the tip of the needle-like structure of the needle 300 may also be an oval tip (blunt tip), which is designed without mechanical piercing, but may further reduce the risk of intraoperative mistakes.

Specifically, the distal end of the needle 300 is always hidden within the dilator 200 during non-piercing procedures. Alternatively, to reduce the time required to push the lancet 300 out of the dilator 200, the pushing stroke of the pushing mechanism 400 is reduced, with the distal end of the lancet 300 hidden from 5mm to 20mm from the interior of the distal end of the dilator 200. When it is desired to push the lancet 300 out of the dilator 200, the pushing mechanism 400 pushes the lancet 300 such that the distal end of the lancet 300 protrudes beyond the distal end of the dilator 200, thereby performing the septal puncture.

Further, the needle 300 is divided into three sections in the distal direction to the proximal direction of the first housing 100, the first section being designed for a rigid tubular tip at the head end, in order to facilitate septum penetration. In order to reduce the scratch of the inner wall of the expander 200 caused by the reciprocating motion of the puncture needle 300 in the expander 200, the pipe wall of the tangential plane of the first section of the puncture needle 300 in the inclined design of the needle tip is of a rounded structure, so that foreign matters on the inner wall of the expander 200 are prevented from falling off in the motion process of the puncture needle 300, and the operation risk is reduced. The second section is a middle section, and the middle section adopts a flexible multi-strand torsion wire spring tube or a single-strand hollow coiled spring tube or a flexible tubular body so as to conform to various bending angles of the whole system in a patient. The third section is the trailing end, which uses a rigid tubular body inside the handle and inside a small portion of the dilator 200 to facilitate the transfer of the pushing force of the push rod. The materials can be prepared from medical stainless steel or medical nickel-titanium alloy.

Optionally, since the puncture needle 300 is generally made of metal and has conductivity, in order to avoid conducting current from the guide wire 700 to other parts during radio frequency puncture, the inner wall of the puncture needle 300 is provided with an insulating layer, and at the same time, the insulating layer can reduce friction when the guide wire 700 passes through the inner wall of the puncture needle 300, so as to prevent the surgical risk caused by the falling-off of the coating of the guide wire 700. Illustratively, the insulating layer may be Polyimide (abbreviated PI), although the insulating layer is not limited to such a material.

As shown in fig. 1 to 13, the present embodiment further provides a method for puncture of a septum, which is implemented by the puncture device, and includes the steps of:

the introducer sheath 620, the dilator 200, the needle 300, and the guidewire 700 are simultaneously advanced into the patient's heart, and the distal end of the needle 300 is hidden within the distal end of the dilator 200 during advancement into the patient's heart;

the puncturing device pushes the distal end of the puncturing needle 300 out of the distal end of the dilator 200;

positioning the puncture site of the puncture needle 300 and performing interatrial septum puncture;

simultaneously withdrawing the introducer sheath 620, the dilator 200, and the needle 300, retaining the guidewire 700, or simultaneously withdrawing the dilator 200, the needle 300, and the guidewire 700, retaining the introducer sheath 620; and

and performing subsequent operations.

Compared with the existing septum penetration method, the septum penetration method reduces the process of withdrawing the guide wire 700 before penetration and inserting the puncture needle 300, simultaneously reduces the process of withdrawing the puncture needle 300 after penetration and exchanging the guide wire 700, does not need to replace the puncture needle 300, is beneficial to saving operation time, further avoids complications, and is beneficial to ensuring the safety of the use process.

In particular, when the guide sheath 620, dilator 200, and needle 300 are withdrawn simultaneously, the guidewire 700 remains, which can be used to guide the sheath of a subsequent procedure into the left atrium of the patient. When the dilator 200, the needle 300, and the guidewire 700 are withdrawn simultaneously, the subsequent-procedure compatible introducer sheath 620 remains, directly establishing access for the subsequent procedure to the left atrium.

Further, after the puncture needle 300 completes the atrial septum puncture, since the diameter of the puncture needle 300 is smaller than that of the dilator 200, in order to allow the dilator 200 and the guiding sheath 620, which are sleeved on the outer diameter of the puncture needle 300, to smoothly enter the left atrium, the dilator 200 includes a main body 210 and a guiding opening 220 connected to the distal end of the main body 210, and the diameter of the guiding opening 220 is gradually reduced along the direction away from the main body 210, so that the guiding opening 220 is formed in a horn shape to cover the puncture needle 300. When the puncture needle 300 completes the puncture and enters the left atrium, the smaller end of the guide opening 220 is easier to enter the left atrium, and the size of the puncture hole is gradually enlarged by using the diameter of the guide opening 220, so that the dilator 200 can smoothly enter the left atrium, and the distal end of the guiding sheath 620 sleeved outside the dilator 200 enters the left atrium, so that the subsequent operation is facilitated.

As shown in fig. 2, 7 and 8, the first housing 100 includes a first end 110 and a second end 120, the first end 110 and the second end 120 are located at both ends of the first housing 100 along a first direction, the first end 110 is provided with a mounting hole 111 extending along the first direction, the dilator 200 is fixed in the mounting hole 111, and the second end 120 is provided with a penetrating hole 121 extending along the first direction, the puncture needle 300 penetrates the first housing 100 from the penetrating hole 121 and is penetrated in the dilator 200, and before the distal end of the dilator 200 reaches a pre-penetration position of the heart, the distal end of the puncture needle 300 is hidden in the dilator 200, thereby realizing reciprocating movement of the puncture needle 300 in the first direction in the dilator 200. Illustratively, the second end 120 is a luer fitting from which the guidewire 700 and the penetrating needle 300 can be threaded into the dilator 200. After the operation is completed, an operator can inject physiological saline or the like into the luer by using a syringe so as to flush the lumen of the puncture needle 300. Further, as shown in fig. 9, in order to avoid the overflow of the physiological saline during the flushing process, the second end 120 further includes a second sealing member 122, and the second sealing member 122 is sleeved on the puncture needle 300 and is embedded in the through hole 121.

In another embodiment, as shown in fig. 10 and 11, the outer end of the second end 120 is provided with an end cap 130, the end cap 130 is sleeved on the second end 120, and the guide wire 700 can be threaded through the middle of the end cap 130. To facilitate connection of the end cap 130 to the end face of the second end 120, the end cap 130 is threadably connected to the second end 120. At this time, the second sealing member 122 is sleeved on the guide wire 700, and the second sealing member 122 is disposed before the end cover 130 and the second end 120, where the second sealing member 122 can seal the gap between the end of the puncture needle 300, which is close to the end cover 130, and the outer diameter of the guide wire 700, so as to seal the inner cavity between the guide wire 700 and the puncture needle 300, and prevent blood from flowing out from the tail 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 are respectively abutted against the end cover 130 and the second end 120, so that the second sealing member 122 seals the inner cavity of the puncture needle 300.

Further, the second end 120 is further provided with a second pressure measuring hole 123 communicating with the through hole 121, and the second pressure measuring hole 123112 may be a luer connector structure so as to be connected with the pressure sensor. In addition, the luer fitting can be connected with a pressure detection device so as to detect the blood pressure inside the puncture needle. The second pressure tap 123 can be used to detect blood pressure during surgery without withdrawing the guidewire 700.

As shown in fig. 2, 4 and 7, since various types of introducer sheath assemblies 600 exist on the market, the first end 110 is a compatible connector for detachably connecting with the second housing 610 of the introducer sheath assembly 600 in order to be able to fit with a plurality of different types of introducer sheath assemblies 600. At present, the end that the second casing 610 that is used often is close to piercing depth is the hole structure, in order to make first end 110 this female connection, first end 110 includes connecting portion 113, connecting portion 113's external diameter and the corresponding setting of hole internal diameter, and be equipped with boss 114 on the terminal surface that connecting portion 113 kept away from second end 120, boss 114's external diameter and hole internal diameter interference fit, first end 110 is equipped with spacing portion 115, spacing portion 115's external diameter is greater than connecting portion 113, and during the equipment, the operator needs wear first end 110 in locating the hole, make boss 114 can block into the inner wall terminal surface of second casing 610, spacing portion 115 and the outer wall butt of second casing 610, in order to realize first end 110 and the fast assembly of second casing 610. After surgery, the user may manually withdraw the first end 110 to separate the introducer sheath assembly 600 from the puncturing device. The first end 110 is designed for a quick replaceable tip so that the lancing device is compatible with multiple brands of sheaths.

In addition, as shown in fig. 2, 5 and 7, the second housing 610 may further be provided with a limiting groove 611, where the first end 110 includes a limiting block 116 corresponding to the limiting groove 611, and when the guiding sheath assembly 600 and the puncturing device are assembled, the limiting block 116 is inserted into the limiting groove 611, so as to ensure that the angle between the guiding sheath assembly 600 and the puncturing device is correct, and avoid operator misoperation.

Referring to fig. 7, 12 and 13, the first housing 100 is provided with a guide hole 130 extending along a first direction, the pushing mechanism 400 includes a driving assembly 410, the puncture needle 300 is connected to the driving assembly 410, and a part of the driving assembly 410 protrudes out of the first housing 100 through the guide hole 130, so as to facilitate manual operation of an operator outside the first housing 100. When the operator performs the septal puncture, the operator can push the drive assembly 410 in a first direction to cause the distal end of the needle 300 to protrude beyond the dilator 200.

The driving assembly 410 includes a fixed block 411 and a driving block 412. The fixing block 411 is sleeved on the puncture needle 300, which is beneficial to improving the stability of the fixing block 411 for driving the puncture needle 300 to move along the first direction. The driving block 412 is disposed on the first housing 100, and the driving block 412 is connected with the fixing block 411 through the guide hole 130, so that an operator can directly drive outside the first housing 100, which is beneficial to improving convenience of the operator in the use process.

With continued reference to fig. 12 and 13, the pushing mechanism 400 further includes a guide assembly 420, where the guide assembly 420 is disposed between the driving assembly 410 and the first housing 100, and the guide assembly 420 is configured to provide guidance for the driving assembly 410 to push the puncture needle 300 to move along the first direction, so as to improve the stability of the pushing assembly moving along the first direction and avoid jamming.

Specifically, the guide assembly 420 includes a guide groove 421 and a guide piece 422, the guide groove 421 is provided on an inner wall of the first housing 100 in a first direction, the guide piece 422 is connected with the driving assembly 410 where the guide groove 421 is not provided, the guide piece 422 is partially located in the guide groove 421, and the guide piece 422 can move in the guide groove 421 in the first direction, and the guide assembly 420 is simple in structure and convenient to implement.

In other embodiments, the guide groove 421 may be disposed on the driving assembly 410 along the first direction, the guide piece 422 is connected to the first housing 100 where the guide groove 421 is not disposed, the guide piece 422 is partially disposed in the guide groove 421, and the guide piece 422 can move in the guide groove 421 along the first direction, which has the same effect as that described above and will not be repeated herein.

As shown in fig. 12 and 13, the puncture device further comprises a first sealing member 500, wherein the first sealing member 500 is sleeved on the puncture needle 300, and the first sealing member 500 is in sealing connection with the first end 110 of the first housing 100, so as to seal the blood backflow from one end of the heart, and prevent the blood from overflowing to the side of the first sealing member 500 away from the first end 110.

In addition, the pushing mechanism 400 further includes a reset element 430 sleeved on the puncture needle 300, and two ends of the reset element 430 respectively abut against the first housing 100 and the driving assembly 410. When the operator pushes the driving block 412, thereby driving the fixing block 411 to push the distal end of the puncture needle 300 to protrude out of the dilator 200, the restoring member 430 is compressed. After the puncture is completed, the operator releases the driving block 412, and the elastic action of the compressed reset element 430 can drive the fixed block 411 to retract into the expander 200, so as to achieve the effect of automatic reset.

Illustratively, the return member 430 is a spring that has a good automatic return function, and is low in cost and stable in performance.

Further, both ends of the reset member 430 are respectively abutted against the fixing block 411 and the first sealing member 500, and the effect of fixing both ends is achieved. In order to improve the effect of fixing the reset member 430 by the fixing block 411 and the first sealing member 500, receiving grooves are respectively formed at opposite ends of the fixing block 411 and the first sealing member 500, and both ends of the reset member 430 are respectively located in the two receiving grooves, thereby improving the stability of the reset member 430.

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 can measure the blood pressure in the mounting hole 111 through the first pressure measuring hole 112, so that the operator can detect the heart blood pressure condition in the operation process in real time. Specifically, the puncture device further includes a pressure sensor disposed in the first pressure measuring hole 112, and the pressure sensor can immediately obtain the pressure change data of the atrium after the puncture needle 300 enters the left atrium due to the obvious pressure difference between the right atrium and the left atrium, so as to remind the operator of whether the puncture is successful. Illustratively, the first pressure tap 112 may be a luer fitting configuration to facilitate connection with a pressure sensor. In addition, the luer fitting can be connected to a syringe to facilitate the injection of saline into the first pressure port 112 by an operator to flush the gap between the outer wall of the needle 300 and the inner wall of the dilator 200 on the side of the first seal 500 adjacent the first end 110.

Alternatively, the puncture needle 300 may be welded to the pushing mechanism 400, specifically, the fixing block 411 is welded to the puncture needle 300, so as to improve the stability of the fixing block 411 capable of stably driving the puncture needle 300 to move along the first direction.

In other embodiments, the puncture needle 300 is provided with a limiting protrusion, the pushing direction of the pushing mechanism 400 is the limiting protrusion, and the limiting protrusion is located in front of the pushing mechanism 400 and can be abutted to the end face of the pushing mechanism 400, so that the stability of the fixing block 411 for stably driving the puncture needle 300 to move along the first direction is improved.

In addition, an energy on-off switch electrically connected with the radio frequency puncture instrument 800 is arranged on the first shell 100, so that the radio frequency energy on-off control can be realized without operating the radio frequency puncture instrument 800 in an operation of an operator. Alternatively, the lancing device is provided with a foot switch electrically connected to the rf lancing device 800 so that the operator can control the rf energy switch in a foot-operated manner during the surgical procedure.

With this puncturing device, the operator sends the distal end of the dilator 200 into the right atrium via the inferior vena cava of the patient, confirms the arrival at the atrial septum puncturing site by ultrasound or X-ray, pushes the driving block 412 on the first housing 100, pushes out the automatic concealed puncture needle 300, simultaneously operates the radio frequency current switch or the foot-operated trigger switch on the first housing 100, sends out the radio frequency energy which is transiently and highly focused to penetrate the atrial septum, and sends the puncture needle 300 into the left atrium, thereby establishing a pathway into the left atrium for the subsequent operation.

Meanwhile, by the puncture device, the mechanical needle does not need to be sharp in operation to give excessive mechanical thrust to forcedly pass through the room space, so that the position of the room space puncture is more accurate, safer and more controllable, the complication incidence rate related to the room space puncture is reduced, the room space puncture technical difficulty is reduced, and the learning curve is shortened.

By the puncture device, the whole process of the atrial septum puncture operation does not need to withdraw the guide wire 700, insert the puncture needle 300 and withdraw the puncture needle 300 and insert the guide wire 700, thereby realizing a zero exchange work flow, and not needing to replace the needle, the guide wire 700, the dilator 200, the guide sheath 620 and the like. Meanwhile, after confirming the puncture site during the operation of the operator, if the operator is not satisfied with the repositioning, the driving block 412 is only released, at this time, the distal end of the puncture needle 300 is retracted into the dilator 200 by the elastic action of the resetting member 430, and then the operator can push out the guide wire 700 for repositioning. Or the angle of the controllable curved guiding sheath 620 is adjusted after the distal end of the puncture needle 300 is retracted, and the puncture site is adjusted.

Note that the basic principles and main features of the present invention and advantages of the present invention are shown and described above. It will be understood by those skilled in the art that the present invention is not limited to the foregoing embodiments, but rather, the foregoing embodiments and description illustrate the principles of the invention, and that various changes and modifications may be effected therein without departing from the spirit and scope of the invention as defined by the appended claims and their equivalents.

Claims (14)

1. A lancing device, comprising:

a first housing (100) detachably connectable to different types of introducer sheath (620) assemblies (600);

a dilator (200) with one end arranged on the first shell (100), wherein the dilator (200) is arranged in an introducer sheath tube (620) of an introducer sheath assembly (600) in a penetrating way in operation;

a puncture needle (300) which is inserted into the first housing (100) and the dilator (200);

a guide wire (700) penetrating the puncture needle (300); and

the pushing mechanism (400) is arranged on the first shell (100), the puncture needle (300) is connected with the output end of the pushing mechanism (400), the pushing mechanism (400) is configured to push the puncture needle (300) to reciprocate along a first direction, so that the distal end of the puncture needle (300) protrudes out of the distal end of the expander (200) or is hidden in the distal end of the expander (200), and the first direction is the extending direction of the expander (200).

2. The puncturing device as claimed in claim 1, wherein the first housing (100) comprises a first end (110) and a second end (120), the first end (110) and the second end (120) being located at both ends of the first housing (100) along the first direction, the first end (110) being provided with a mounting hole (111) extending along the first direction, the dilator (200) being fixed in the mounting hole (111), and the second end (120) being provided with a penetration hole (121) extending along the first direction, the puncture needle (300) penetrating the first housing (100) from the penetration hole (121) and penetrating into the dilator (200), the distal end of the puncture needle (300) being hidden within the dilator (200) before the distal end of the dilator (200) reaches the pre-penetration position of the heart.

3. The lancing device according to claim 1, wherein the first housing (100) is provided with a guide hole (130) extending in the first direction, and the pushing mechanism (400) comprises:

the driving assembly (410), the puncture needle (300) is connected with the driving assembly (410), and part of the driving assembly (410) penetrates through the guide hole (130) to protrude out of the first shell (100), and when an operator performs interatrial septum puncture, the operator can push the driving assembly (410) to move along the first direction so that the distal end of the puncture needle (300) protrudes out of the expander (200).

4. A puncturing device as claimed in claim 3, wherein the drive assembly (410) comprises:

a fixed block (411) sleeved on the puncture needle (300); and

and a driving block (412) disposed on the first housing (100), and the driving block (412) is connected with the fixing block (411) through the guide hole (130).

5. A lancing device according to claim 3, wherein said pushing mechanism (400) further comprises:

a guide assembly (420) disposed between the drive assembly (410) and the first housing (100), the guide assembly (420) configured such that the drive assembly (410) urges the lancet (300) to move in the first direction to provide a guide.

6. The lancing device according to claim 5, wherein said guiding assembly (420) comprises:

a guide groove (421) provided on an inner wall of the first housing (100) or the driving assembly (410) in the first direction; and

-a guide (422) connected to the drive assembly (410) or the first housing (100) without the guide groove (421), the guide (422) being partly located in the guide groove (421), and the guide (422) being movable in the first direction in the guide groove (421).

7. A lancing device according to claim 3, wherein said pushing mechanism (400) further comprises:

and the resetting piece (430) is sleeved on the puncture needle (300), and two ends of the resetting piece (430) are respectively abutted with the first shell (100) and the driving assembly (410).

8. A lancing device according to claim 3, wherein the lancing device further comprises:

the first sealing piece (500) is sleeved on the puncture needle (300), and the first sealing piece (500) is in sealing connection with the first end (110) of the first shell (100).

9. The puncture device according to claim 2, characterized in that a first pressure measuring hole (112) is provided in the first end (110), the first pressure measuring hole (112) is in communication with the mounting hole (111), and an operator can measure the blood pressure in the mounting hole (111) through the first pressure measuring hole (112).

10. The puncture device according to claim 1, characterized in that the puncture needle (300) is welded to the pushing mechanism (400), or a limit protrusion is provided on the puncture needle (300), the pushing direction of the pushing mechanism (400) is the limit protrusion, the limit protrusion is located in front of the pushing mechanism (400), and the limit protrusion can be abutted to the end face of the pushing mechanism (400).

11. The lancing device according to any one of claims 1 to 10, wherein said lancet (300) is electrically connected to a radio frequency lancing instrument (800).

12. The lancing device according to claim 2, wherein said first housing (100) further comprises an end cap (130) that is sleeved over said second end (120), said guidewire (700) being threaded into said end cap (130); the second end (120) comprises:

and the second sealing piece (122) is sleeved on the guide wire (700), the second sealing piece (122) is arranged between the end cover (130) and the second end (120), and the second sealing piece (122) is configured to seal a gap between the inner cavity of the puncture needle (300) and the outer diameter of the guide wire (700).

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

14. A method of atrial septal penetration by a penetration device according to any one of claims 1 to 13, the method comprising the steps of:

the guiding sheath (620), the dilator (200), the puncture needle (300) and the guide wire (700) enter the heart of the patient simultaneously, and the distal end of the puncture needle (300) is hidden in the distal end of the dilator (200) in the process of entering the heart of the patient;

positioning a puncture location of the dilator (200);

a pushing mechanism (400) of the puncture device pushes the distal end of the puncture needle (300) out of the distal end of the expander (200) and performs interatrial septum puncture;

-simultaneously withdrawing the introducer sheath (620), the dilator (200) and the needle (300), retaining the guide wire (700), or simultaneously withdrawing the dilator (200), the needle (300) and the guide wire (700), retaining the introducer sheath (620); and

and performing subsequent operations.