Puncture device and atrial septal puncture method

Abstract

The present invention relates to the technical field of medical devices, and more particularly to a puncture device and atrial septal puncture method. The puncture device includes a first shell, a dilator, a puncture needle, a guide wire, and a push mechanism. The dilator is inserted into the guide sheath of a guide sheath assembly, the puncture needle is inserted into the first shell and the dilator, the guide wire is inserted into the puncture needle, the push mechanism is provided in the first shell, the puncture needle is connected to the output end of the push mechanism, and the push mechanism is configured to reciprocate the puncture needle in a first direction, causing the distal end of the puncture needle to protrude from or conceal within the distal end of the dilator, the first direction being the extension direction of the dilator. The puncture device is advantageous in saving time for inserting the puncture needle, saving operating time, and ensuring safety during use. This atrial septal puncture method eliminates the need for inserting and removing a puncture needle, and also reduces the steps of inserting and replacing a guidewire, which is advantageous in saving operating time.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a puncture device and a method for atrial septum puncture.

Background Art

[0002] With the popularization of electrophysiological and structural heart surgeries, atrial septum puncture has become the most common technique for cardiologists to enter the left atrium. The indications include atrial fibrillation ablation, left atrial appendage closure, mitral valve lesions, congenital heart disease intervention, percutaneous left ventricular assist device implantation, etc. In the prior art, usually, a mechanical puncture device is used to complete the atrial septum puncture surgery. The puncture device includes a first shell, a dilator, and a puncture needle. One end of the dilator is provided on the first shell. During the surgery, the operator inserts the guide sheath and the distal end of the dilator along the guide wire into the heart. When the distal end of the dilator reaches a predetermined position, first, the guide wire needs to be removed, and then the puncture needle needs to be inserted into the dilator. The distal end of the puncture needle is provided as a needle-like structure, so that the operator can operate the puncture needle to protrude its distal end from the dilator and puncture the atrial septum, thereby realizing atrial septum puncture.

[0003] However, the atrial septum puncture technique of this puncture device is difficult to master, and it is necessary to frequently exchange the puncture needle and the guide wire during the puncture process. The operation time is long, the difficulty of puncture is high, and when encountering special patients, such as fibrosis, hypertrophy, superelasticity, tumorization, etc. of the atrial septum, serious complications such as cardiac tamponade, puncture position deviation, and cardiac rupture are likely to occur.

[0004] ​​​​​​​​​​​The present invention aims to provide a puncture device and atrial septal puncture method, which simultaneously delivers the puncture needle and dilator to a predetermined location in the heart to be punctured by concealing the puncture needle in a dilator, saving time for insertion and replacement of the puncture needle and guidewire, which is advantageous for saving operational time, and furthermore, effectively avoids complications. [Means for solving the problem]

[0006] To achieve this objective, the present invention employs the following technical solutions.

[0007] A puncture device, A first shell that can be detachably connected to guide sheath assemblies of different model numbers, An expander, one end of which is provided on the first shell, is inserted into the guide sheath of the guide sheath assembly during surgery, The puncture needle inserted into the first shell and the expander, A guide wire inserted into the aforementioned puncture needle, The push mechanism provided in the first shell includes a push mechanism to which the puncture needle is connected to the output end of the push mechanism, the push mechanism is configured to reciprocate the puncture needle in a first direction so that the distal end of the puncture needle protrudes from or is concealed within the distal end of the expander, the first direction being the extension direction of the expander.

[0008] As a selectable solution, the first shell includes a first end and a second end, the first and second ends located at opposite ends of the first shell along the first direction, the first end having a mounting hole extending along the first direction, the expander being fixed to the mounting hole, the second end having an insertion hole extending along the first direction, the puncture needle being inserted into the first shell through the insertion hole and inserted into the expander, the distal end of the puncture needle being hidden within the expander before the distal end of the expander reaches a preliminary puncture site in the heart.

[0009] As a selectable solution, the first shell is provided with guide holes extending along the first direction, and the push mechanism includes a drive assembly. The puncture needle is connected to the drive assembly, and a portion of the drive assembly is provided to protrude from the first shell through the guide hole, so that when an operator performs an atrial septal puncture, the operator can move the drive assembly along the first direction and cause the distal end of the puncture needle to protrude from the dilator.

[0010] As a selectable solution, the drive assembly is A fixing block fitted onto the aforementioned puncture needle, The system includes a drive block provided in the first shell and connected to the fixed block through the guide hole.

[0011] As a selectable solution, the push mechanism further includes a guide assembly, The guide assembly is provided between the drive assembly and the first shell, and is configured to provide a guide for the drive assembly to move the puncture needle along the first direction.

[0012] As a selectable solution, the guide assembly is A guide groove provided in the inner wall of the first shell or the drive assembly along the first direction, A guide member connected to the drive assembly or the first shell, which is not provided with the guide groove, wherein a portion of the guide member is located in the guide groove, and the guide member is movable in the guide groove along the first direction.

[0013] As a selectable solution, the push mechanism is The system further includes a reset member fitted onto the puncture needle, with both ends in contact with the first shell and the drive assembly, respectively.

[0014] As a selectable solution, the puncture device, The system further includes a first sealing member that is fitted onto the puncture needle and sealed to the first end of the first shell.

[0015] As a selectable solution, a first pressure-sensing hole is provided at the first end, the first pressure-sensing hole is in communication with the mounting hole, and the operator can measure the blood pressure inside the mounting hole through the first pressure-sensing hole.

[0016] As a selectable solution, the puncture needle may be welded to the push mechanism, or the puncture needle may be provided with a position-limiting projection, wherein the position-limiting projection is located in front of the push mechanism in the pushing direction of the push mechanism and can contact the end face of the push mechanism.

[0017] As a possible solution, the puncture needle is electrically connected to an RF puncture device.

[0018] As a selectable solution, the first shell further includes an end cover fitted to the second end, the guide wire is inserted into the end cover, and the second end is The present invention includes a second sealing member which is fitted onto the guide wire and positioned between the end cover and the second end, and which is configured to seal the gap between the lumen of the puncture needle and the outer diameter of the guide wire.

[0019] As a selectable solution, an insulating layer is provided on the inner wall of the puncture needle.

[0020] A method for atrial septal puncture, which is realized by the above-mentioned puncture device, and the atrial septal puncture method is The procedure involves simultaneously inserting the guide sheath, dilator, puncture needle, and guide wire into the patient's heart, and during the process of insertion into the patient's heart, concealing the distal end of the puncture needle within the distal end of the dilator. The steps include positioning the puncture site of the dilator, The step of using the push mechanism of the puncture device to push out the distal end of the puncture needle from the distal end of the dilator and perform atrial septum puncture; The step of simultaneously removing the guide sheath, the dilator and the puncture needle, leaving the guide wire, or simultaneously removing the dilator, the puncture needle and the guide wire, leaving the guide sheath; The step of performing subsequent surgery, characterized by including these steps.

Advantages of the Invention

[0021] The present invention provides a puncture device, which includes a first shell, a dilator, a puncture needle, a guide wire and a push mechanism. The first shell can be detachably connected to guide sheath assemblies of different model numbers. One end of the dilator is provided on the first shell. During the operation, the dilator is inserted into the guide sheath of the guide sheath assembly. The puncture needle is inserted into the first shell and the dilator. The guide wire is inserted into the puncture needle. The push mechanism is provided on the first shell. The puncture needle is connected to the output end of the push mechanism. The push mechanism is configured to reciprocate the puncture needle in a first direction, so as to protrude the distal end of the puncture needle from the distal end of the dilator or hide it within the distal end of the dilator. The first direction is the extending direction of the dilator. By hiding the puncture needle in the dilator, the puncture device can simultaneously deliver the puncture needle and the dilator to a predetermined position to be punctured in the heart, save the time for inserting and replacing the puncture needle and the guide wire, which is beneficial for saving the operation time. Furthermore, it can effectively avoid complications.

[0022] The present invention further provides a method for atrial septum puncture, which is realized by the above-mentioned puncture device. The method for atrial septum puncture includes the steps of simultaneously inserting a guide sheath, a dilator, a puncture needle and a guide wire into a patient's heart, and hiding the distal end of the puncture needle within the distal end of the dilator during the process of inserting them into the patient's heart; the step of the puncture device pushing out the distal end of the puncture needle from the distal end of the dilator; the step of positioning the puncture position of the puncture needle and performing atrial septum puncture; the step of simultaneously removing the guide sheath, the dilator and the puncture needle, leaving the guide wire, or simultaneously removing the dilator, the puncture needle and the guide wire, leaving the guide sheath; and the step of performing subsequent surgery. Compared with the conventional method for atrial septum puncture, the method for atrial septum puncture reduces the steps of inserting and removing the puncture needle, reduces the steps of inserting and replacing the guide wire, eliminates the need to replace the puncture needle, is beneficial for saving operation time, further avoids complications, and is also beneficial for ensuring safety during use.

Brief Description of the Drawings

[0023] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for describing the embodiments of the present invention will be briefly described below. Obviously, the drawings described below are only some embodiments of the present invention, and those skilled in the art can obtain other drawings based on the content of the embodiments of the present invention and these drawings without creative labor.

[0024] [Figure 1] FIG. 1 is a schematic structural diagram of the assembly of the puncture device according to an embodiment of the present invention and a guide sheath assembly. [Figure 2] FIG. is a schematic cross-sectional structural diagram of the assembly of the puncture device according to an embodiment of the present invention and a guide sheath assembly. [Figure 3] FIG. 2 is a schematic structural diagram of the assembly of the puncture device according to an embodiment of the present invention and a guide sheath assembly. [Figure 4] FIG. 2 is a partial enlarged view of part A in FIG. 2. [Figure 5]This is a magnified view of area B in Figure 3. [Figure 6] This is a magnified view of area C in Figure 1. [Figure 7] This is a magnified view of area D in Figure 2. [Figure 8] This is a logic diagram of an atrial septal puncture method according to an embodiment of the present invention. [Figure 9] This is a magnified view of area E in Figure 2. [Figure 10] This is a schematic diagram 1 of the cross-sectional structure of a puncture device according to an embodiment of the present invention. [Figure 11] This is a magnified view of area G in Figure 10. [Figure 12] This is a schematic diagram of the cross-sectional structure of a puncture device according to an embodiment of the present invention. [Figure 13] This is a magnified view of area F in Figure 12. [Modes for carrying out the invention]

[0025] The present invention will be described in further detail below with reference to the drawings and examples. For ease of understanding, the specific examples described herein are for interpretation purposes only and do not limit the present invention. For ease of description, the drawings show only partial structures relevant to the present invention, not the complete structure.

[0026] In the description of this invention, unless otherwise explicitly defined or limited, the terms “connection,” “bonding,” and “fixing” should be understood broadly, for example, that they may be fixedly connected, detachably connected, or integrally connected; that they may be mechanically connected, electrically connected, directly connected, or indirectly connected via an intermediate medium; or that they may be a communication of structures within two elements or an interaction relationship between two elements. Those skilled in the art will be able to understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0027] In the present invention, unless otherwise explicitly stated or limited, the presence of a first feature "above" or "below" a second feature may include direct contact between the first and second features, or it may include contact between the first and second features via another feature between them, without direct contact. Furthermore, the presence of a first feature "above," "above," and "upper side" of a second feature may include the first feature being directly above and obliquely above the second feature, or simply indicating that the horizontal altitude of the first feature is higher than that of the second feature. The presence of a first feature "below," "below," and "below side" of a second feature may include the first feature being directly below and obliquely below the second feature, or simply indicating that the horizontal altitude of the first feature is lower than that of the second feature.

[0028] In the description of this embodiment, terms such as "up," "down," "left," and "right," which refer to directions or positional relationships, are based on the directions or positional relationships shown in the drawings and are merely for the purpose of facilitating description and simplifying operation. They do not indicate or imply that the shown devices or elements necessarily have a specific direction or are constructed and operated in a specific direction, and therefore should not be understood as limiting the present invention. Furthermore, the terms "first" and "second" are merely for the purpose of distinguishing descriptions and have no special meaning.

[0029] As shown in Figures 1 to 13, this embodiment provides a puncture device comprising a first shell 100, a puncture needle 300, a guide wire 700, and a dilator 200. The first shell 100 can be detachably connected to guide sheath assemblies 600 of different types, thereby expanding the range of application of the puncture device. One end of the dilator 200 is provided on the first shell 100. During surgery, the dilator 200 is inserted into the guide sheath 620 of the guide sheath assembly 600, and the guide wire 700 is inserted into the dilator 200. During surgery, the operator inserts the distal ends of the dilator 200 and the guide wire 700 into the heart. When the distal ends of the dilator 200 and the guide wire 700 reach a predetermined position, the puncture needle 300 is inserted into the dilator 200. The operator can then manipulate the puncture needle 300 to make its distal end protrude from the dilator 200, puncture the atrial septum, and perform atrial septal puncture. Furthermore, to improve the accuracy of the puncture, the distal end of the puncture needle 300 is provided as a needle-shaped structure. Of course, in other embodiments, the distal end of the puncture needle 300 may be any other shape, such as an arc shape. The first shell 100 of this embodiment can be removably fitted with guide sheath assemblies 600 of multiple model numbers, which is advantageous for expanding the range of application of the puncture device.

[0030] Furthermore, in this embodiment, the guide wire 700 is inserted into the puncture needle 300 before surgery, and the guide wire 700, puncture needle 300, guide sheath 620, and dilator 200 are delivered to the heart simultaneously. As a result, when the distal end of the dilator 200 reaches the predetermined puncture site, the puncture needle 300 can quickly perform atrial septal puncture. This eliminates the steps and time required to remove the guide wire and insert the puncture needle in conventional techniques, improving surgical efficiency, shortening surgical time, and further enhancing the safety of the surgical process.

[0031] Specifically, as shown in Figures 1 to 7, the guide sheath assembly 600 is removably connected to the first shell 100, and the guide sheath assembly 600 includes a second shell 610 and a guide sheath 620 inserted into the second shell 610. During surgery, first the guide sheath assembly 600 is assembled, the dilator 200 is inserted into the guide sheath 620, and then the first shell 100 and the second shell 610 are connected, thereby fixing the relative position of the guide sheath assembly 600 and the puncture device.

[0032] Selectively, the guide sheath assembly 600 is a curve-controllable guide sheath 620. Specifically, a knob is provided on the second shell 610, and one end of the second shell 610 away from the puncture device controls a bidirectional 180-degree curvature angle, and also allows adjustment of the angles of the dilator 200, puncture needle 300, and guide wire 700 that pass through it, thereby making it easier for the physician to adjust the position of the puncture point.

[0033] To further improve the atrial septal puncture technique of the puncture device, enhance the accuracy of predicting the puncture point location, and ensure puncture accuracy, the puncture needle 300 of the puncture device is electrically connected to the RF puncture device 800. When the distal end of the puncture needle 300 reaches a predetermined position, the RF current switch or foot switch of the RF puncture device 800 is turned on, emitting highly focused RF energy in a short time to penetrate the atrial septum.

[0034] Selectively, the RF puncture device 800 has a real-time impedance measurement function and is connected to the puncture needle 300. After successful puncture, the impedance change is displayed on the display screen to notify the operator of the successful puncture. The RF puncture device 800 connects the puncture needle 300 to an electrocardiograph via a data line, measures the electrocardiogram in real time, and after successful puncture, a clear change is displayed on the electrocardiogram to indicate the successful puncture to the operator.

[0035] As can be seen in Figures 1 to 7, in this embodiment, the puncture needle 300 is inserted into the first shell 100 and the expander 200, and the distal end of the puncture needle 300 has a needle-like structure. The puncture device further includes a push mechanism 400 provided in the first shell 100, the puncture needle 300 is connected to the output end of the push mechanism 400, and the push mechanism 400 reciprocates the puncture needle 300 in a first direction, thereby causing the distal end of the puncture needle 300 to protrude from the distal end of the expander 200 or to be hidden within the distal end of the expander 200, the first direction being the extension direction of the expander 200. The puncture device, by concealing the puncture needle 300 within the dilator 200, avoids the distal end of the puncture needle 300 causing damage to other organs during the process of delivering the puncture needle 300 into the heart. It simultaneously delivers the puncture needle 300 and the dilator 200 to the predetermined location in the heart to be punctured, saving time for inserting the puncture needle 300, which is advantageous for saving operational time, further avoiding complications, and ensuring safety during use. Figure 6 shows the state when the push mechanism 400 pushes the puncture needle 300 out of the dilator 200.

[0036] In this embodiment, the needle-shaped puncture needle 300 achieves both mechanical puncture capability and puncture point stability. It forms a tent-like structure at the puncture point with a small thrust and penetrates the atrial septum using highly focused RF energy in a short time, thereby achieving atrial septal puncture. As a result, the puncture device does not forcibly puncture the atrial septum with mechanical thrust, significantly reducing the risk of over-penetration and accidental puncture of the posterior wall of the left atrial cavity. Furthermore, the puncture needle 300 with this structure can achieve atrial septal puncture even when not connected to the RF puncture device 800, which is advantageous in expanding the range of application of the puncture device. In other embodiments, the tip of the needle-shaped structure of the puncture needle 300 can be an elliptical tip (blunt tip). The blunt tip design does not have the function of mechanical puncture, but it can further reduce the risk of intraoperative error.

[0037] Specifically, during the non-puncture process, the distal end of the puncture needle 300 is always hidden within the dilator 200. To selectively reduce the time required to push the puncture needle 300 out of the dilator 200 and to reduce the push stroke of the push mechanism 400, the distal end of the puncture needle 300 is hidden 5 mm to 20 mm from inside the distal end of the dilator 200. When it is necessary to push the puncture needle 300 out of the dilator 200, the push mechanism 400 pushes the puncture needle 300, causing its distal end to protrude from the distal end of the dilator 200, thereby performing atrial septal puncture.

[0038] Furthermore, the puncture needle 300 is divided into three parts in the direction from the distal end toward the first shell 100. The first part is designed as a rigid tubular needle tip, thereby facilitating atrial septal puncture. To reduce friction against the inner wall of the dilator 200 due to the reciprocating movement of the puncture needle 300 inside the dilator 200, the tubular wall of the obliquely designed cut surface of the first part of the puncture needle 300, which is designed as the needle tip, has a chamfered structure, preventing foreign matter from falling out of the inner wall of the dilator 200 during the movement of the puncture needle 300 and reducing the risk of surgery. The second part is the middle part, which uses a flexible multi-strand twisted spring tube, a single-strand hollow wound spring tube, or a flexible tubular body to adapt to various curvature angles of the entire system within the patient's body. The third part is the posterior end, which uses a rigid tubular body and is located inside the handle and part of the dilator 200, thereby transmitting the thrust of the push rod. The above materials can be manufactured using medical-grade stainless steel or medical-grade nickel-titanium alloy.

[0039] Selectively, since the puncture needle 300 is generally made of metal and is conductive, an insulating layer is provided on the inner wall of the puncture needle 300 to prevent current from being conducted from the guide wire 700 to other sites during RF puncture. This insulating layer also reduces friction when the guide wire 700 penetrates the inner wall of the puncture needle 300 and can prevent surgical risks due to the detachment of the coating on the guide wire 700. Exemplarily, the insulating layer can be made of polyimide (abbreviated as PI), and of course, the insulating layer is not limited to such materials.

[0040] As shown in Figures 1 to 13, this embodiment further provides an atrial septal puncture method, which is realized by the above-mentioned puncture device, and the atrial septal puncture method is The guide sheath 620, dilator 200, puncture needle 300, and guide wire 700 are simultaneously inserted into the patient's heart, and during the process of insertion into the patient's heart, the distal end of the puncture needle 300 is concealed within the distal end of the dilator 200, The puncture device pushes the distal end of the puncture needle 300 out from the distal end of the expander 200, The steps include positioning the puncture site of the puncture needle 300 and performing atrial septal puncture, The steps include simultaneously removing the guide sheath 620, dilator 200, and puncture needle 300, leaving the guide wire 700, or simultaneously removing the dilator 200, puncture needle 300, and guide wire 700, leaving the guide sheath 620, This includes the subsequent steps of performing surgery.

[0041] Compared to conventional atrial septal puncture methods, this method reduces the process of withdrawing the guidewire 700 and inserting the puncture needle 300 before puncture, and also reduces the process of removing the puncture needle 300 and replacing the guidewire 700 after puncture. It eliminates the need to replace the puncture needle 300, which is advantageous in saving operating time, avoiding complications, and ensuring safety during use.

[0042] Specifically, if the guide sheath 620, dilator 200, and puncture needle 300 are removed simultaneously, and the guide wire 700 is left in place, the sheath for subsequent surgery can be guided into the patient's left atrium. If the dilator 200, puncture needle 300, and guide wire 700 are removed simultaneously, the guide sheath 620, which is suitable for subsequent surgery, is left in place, directly establishing a passage for subsequent surgery into the left atrium.

[0043] Furthermore, after the puncture needle 300 completes the atrial septal puncture, because the diameter of the puncture needle 300 is smaller than that of the dilator 200, the dilator 200 includes a main body 210 and a guide opening 220 connected to the distal end of the main body 210, and along the direction away from the main body 210, the diameter of the guide opening 220 gradually decreases, forming a trumpet shape, thereby enclosing the puncture needle 300. Once the puncture needle 300 completes the puncture and enters the left atrium, the smaller diameter end of the guide opening 220 easily enters the left atrium, and the diameter of the guide opening 220 gradually increases, thereby enlarging the size of the puncture hole, which allows the dilator 200 to enter the left atrium smoothly. Furthermore, the distal end of the guide sheath 620 fitted outside the dilator 200 enters the left atrium, facilitating subsequent surgery.

[0044] As shown in Figures 2, 7, and 8, the first shell 100 includes a first end 110 and a second end 120, the first end 110 and the second end 120 located at opposite ends of the first shell 100 along a first direction, the first end 110 having a mounting hole 111 extending along the first direction, the expander 200 being fixed to the mounting hole 111, the second end 120 having an insertion hole 121 extending along the first direction, the puncture needle 300 being inserted into the first shell 100 through the insertion hole 121 and inserted into the expander 200, the distal end of the puncture needle 300 being hidden within the expander 200 before the distal end of the expander 200 reaches the preliminary puncture position in the heart, thereby enabling the puncture needle 300 to reciprocate within the expander 200 in a first direction. Exemplary, the second end 120 is a Luer taper, and the guidewire 700 and puncture needle 300 can be inserted into the dilator 200 from the Luer taper. After the surgery is complete, the operator can use a syringe to inject saline solution or the like into the Luer taper to flush the lumen of the puncture needle 300. Furthermore, as shown in Figure 9, in order to prevent saline solution from overflowing during the flushing process, the second end 120 further includes a second sealing member 122, which is fitted onto the puncture needle 300 and fitted into the insertion hole 121.

[0045] As shown in Figures 10 and 11, in another embodiment, an end cover 140 is provided on the outer end of the second end 120, the end cover 140 is fitted onto the second end 120, and the guide wire 700 can be inserted from the middle of the end cover 140. To facilitate connection between the end cover 140 and the end face of the second end 120, the end cover 140 is screwed onto the second end 120. In this case, the second sealing member 122 is fitted onto the guide wire 700 and is positioned in front of the end cover 140 and the second end 120, and the second sealing member 122 closes the gap between the end of the puncture needle 300 closest to the end cover 140 and the outer diameter of the guide wire 700, thereby achieving a seal between the guide wire 700 and the lumen of the puncture needle 300, and preventing blood from flowing out from the proximal end side of the guide wire 700. More specifically, a groove is provided in the second end 120, the second sealing member 122 is located within the groove, and both ends of the second sealing member 122 abut against the end cover 140 and the second end 120, respectively, thereby the second sealing member 122 closes the lumen of the puncture needle 300.

[0046] Furthermore, the second end 120 is further provided with a second pressure-sensing hole 123 that communicates with the insertion hole 121. The second pressure-sensing hole 123 may have a Luer taper structure, which facilitates connection to a pressure sensor. The Luer taper can also be connected to a pressure detection device, thereby facilitating the detection of blood pressure inside the puncture needle. During the surgical process, the second pressure-sensing hole 123 can detect blood pressure without removing the guidewire 700.

[0047] As shown in Figures 2, 4, and 7, since various types of guide sheath assemblies 600 are commercially available, the first end 110 is a compatible joint and is used to removably connect to the second shell 610 of the guide sheath assembly 600 so that it can be compatible with multiple guide sheath assemblies 600 of different types. Currently, the end of the second shell 610 that is commonly used has an internal bore structure, and in order to connect the first end 110 to the internal bore, the first end 110 includes a connecting portion 113, the outer diameter of which is set to correspond to the inner diameter of the internal bore, a boss 114 is provided on the end face of the connecting portion 113 away from the second end 120, the outer diameter of which is which is which is an interlocking fit between the outer diameter of which is which of which is which of which is which of which is which of which is which of which is which of which is which of which is which of which is which of which is which of which is which of which is which of which is which of which is which of which is which of which is currently commonly used, and the end face that is closer to the puncture device has an internal bore structure, and the first end 110 includes a connecting portion 113, and the boss 114 is engaged with the inner wall end face of the second shell 610, and the position limiting portion 115 is in contact with the outer wall of the second shell 610, thereby enabling rapid assembly of the first end 110 and the second shell 610. After surgery, the user can separate the guide sheath assembly 600 from the puncture device by manually withdrawing the first end 110. The first end 110 has a quickly replaceable end design, thereby allowing the puncture device to be compatible with many brands of sheaths.

[0048] Furthermore, as shown in Figures 2, 5, and 7, a position limiting groove 611 may be provided in the second shell 610, and the first end 110 includes a position limiting block 116 provided corresponding to the position limiting groove 611. When assembling the guide sheath assembly 600 and the puncture device, inserting the position limiting block 116 into the position limiting groove 611 ensures that the angle when connecting the guide sheath assembly 600 and the puncture device is accurate, thereby preventing operator errors.

[0049] As shown in Figures 7, 12, and 13, the first shell 100 is provided with a guide hole 130 extending along a first direction, the push mechanism 400 includes a drive assembly 410, the puncture needle 300 is connected to the drive assembly 410, and a portion of the drive assembly 410 is provided to protrude from the first shell 100 through the guide hole 130, thereby facilitating manual manipulation outside the first shell 100 by the operator. When performing an atrial septal puncture, the operator can move the drive assembly 410 along the first direction, causing the distal end of the puncture needle 300 to protrude from the dilator 200.

[0050] The drive assembly 410 includes a fixed block 411 and a drive block 412. The fixed block 411 is fitted onto the puncture needle 300 and is advantageous in improving the stability of moving the puncture needle 300 in a first direction. The drive block 412 is provided on the first shell 100 and is connected to the fixed block 411 by passing through a guide hole 130, thereby allowing the operator to drive it directly outside the first shell 100, which is advantageous in improving the convenience of the operator's use.

[0051] As further referenced in Figures 12 and 13, the push mechanism 400 further includes a guide assembly 420, which is located between the drive assembly 410 and the first shell 100, and is configured to provide a guide for the drive assembly 410 to move the puncture needle 300 along a first direction, thereby improving the stability of the push assembly as it moves in the first direction and avoiding any movement that would otherwise be inconsistent.

[0052] Specifically, the guide assembly 420 includes a guide groove 421 and a guide member 422, the guide groove 421 being provided on the inner wall of the first shell 100 along a first direction, the guide member 422 being connected to a drive assembly 410 which does not have a guide groove 421, a portion of the guide member 422 being located in the guide groove 421, and the guide member 422 being movable along the first direction in the guide groove 421, the guide assembly 420 being simple in structure and easy to implement.

[0053] In other embodiments, the guide groove 421 may be provided in the drive assembly 410 along a first direction, and the guide member 422 is connected to a first shell 100 which does not have the guide groove 421, a portion of the guide member 422 is located in the guide groove 421, and the guide member 422 is movable along the first direction in the guide groove 421, the effect being the same as described above and not to be repeated here.

[0054] As shown in Figures 12 and 13, the puncture device further includes a first sealing member 500, which is fitted onto the puncture needle 300 and is sealed to the first end 110 of the first shell 100, thereby sealing against the backflow of blood from the cardiac side and preventing blood from overflowing to the side away from the first end 110 of the first sealing member 500.

[0055] The push mechanism 400 further includes a reset member 430 fitted onto the puncture needle 300, the ends of which contact the first shell 100 and the drive assembly 410, respectively. When the operator pushes the drive block 412 and then drives the fixed block 411 to push the distal end of the puncture needle 300 out of the expander 200, the reset member 430 is compressed. After the puncture is complete, the operator releases the drive block 412, and the elastic action of the compressed reset member 430 retracts the fixed block 411 into the expander 200, thus achieving an automatic reset effect.

[0056] For example, the reset component 430 is a spring, which has a better automatic reset function, is low-cost, and has stable performance.

[0057] Furthermore, both ends of the reset member 430 abut against the fixing block 411 and the first sealing member 500, respectively, achieving the effect of fixing both ends. In order to enhance the effect of the fixing block 411 and the first sealing member 500 in fixing the reset member 430, a receiving groove is provided at one opposing end of the fixing block 411 and the first sealing member 500, so that both ends of the reset member 430 are each located in two receiving grooves, thereby improving the stability of the reset member 430.

[0058] A first pressure-sensing port 112 is provided at the first end 110, and the first pressure-sensing port 112 communicates with the mounting port 111, allowing the operator to measure the blood pressure in the mounting port 111 via the first pressure-sensing port 112, thereby enabling the operator to detect the cardiac blood pressure status in real time during the surgical procedure. Specifically, the puncture device further includes a pressure sensor provided in the first pressure-sensing port 112, and because there is a clear pressure difference between the right and left atria, when the puncture needle 300 enters the left atrium, the pressure sensor can immediately acquire atrial pressure change data and notify the operator whether the puncture was successful or not. Exemplarily, the first pressure-sensing port 112 may have a Luer taper structure, thereby facilitating connection to the pressure sensor. Furthermore, the Luer taper can be connected to a syringe, thereby allowing the operator to inject saline solution into the first pressure-sensing hole 112, thereby cleaning the gap between the outer wall of the puncture needle 300 on the side of the first seal member 500 closest to the first end 110 and the inner wall of the expander 200.

[0059] Selectively, the puncture needle 300 may be welded to the push mechanism 400, specifically, the fixing block 411 may be welded to the puncture needle 300, thereby improving stability so that the fixing block 411 can move the puncture needle 300 stably along the first direction.

[0060] In another embodiment, the puncture needle 300 is provided with a position-restricting projection, which is located in front of the push mechanism 400 in the pushing direction of the push mechanism 400, and which can contact the end face of the push mechanism 400, thereby improving stability so that the fixing block 411 can move the puncture needle 300 stably along the first direction.

[0061] Furthermore, the first shell 100 is equipped with an energy on / off switch electrically connected to the RF puncture device 800, so that the operator does not need to operate the RF puncture device 800 during surgery and can control the RF energy switch. Alternatively, the puncture device is equipped with a foot switch electrically connected to the RF puncture device 800, so that the operator can control the RF energy switch by foot during the surgical process.

[0062] With the puncture device, the operator guides the distal end of the dilator 200 through the patient's inferior vena cava into the right atrium, confirms by ultrasound or X-ray that it has reached the atrial septal puncture site, then pushes the drive block 412 in the first shell 100 to push out the auto-concealing puncture needle 300, and operates the RF current switch or foot-operated trigger switch in the first shell 100 to emit highly focused RF energy in a short time to penetrate the atrial septum and guide the puncture needle 300 into the left atrium, thereby establishing a passage into the left atrium for subsequent surgery.

[0063] Furthermore, this puncture device eliminates the need to use a sharp mechanical needle and apply a large mechanical thrust to forcibly penetrate the atrial septum during surgery, making the atrial septal puncture location more accurate, safe, and controllable, reducing the incidence of complications associated with atrial septal puncture, lowering the difficulty of the atrial septal puncture technique, shortening the learning curve, and resulting in a safe, reliable, controllable, and simple new type of puncture device.

[0064] This puncture device eliminates the need to remove the guidewire 700 and insert the puncture needle 300, and then remove the puncture needle 300 and insert the guidewire 700, throughout the entire atrial septal puncture procedure, achieving a zero-exchange workflow and eliminating the need to replace the needle, guidewire 700, dilator 200, guide sheath 620, etc. Furthermore, if the operator is not satisfied with the position after confirming the puncture position during surgery and wishes to reposition it, they only need to loosen the drive block 412. At this time, the elastic action of the reset member 430 causes the distal end of the puncture needle 300 to retract into the dilator 200, after which the operator can push out the guidewire 700 and reposition it. Alternatively, after retracting the distal end of the puncture needle 300, the angle of the bendable guide sheath 620 can be adjusted to adjust the position of the puncture point.

[0065] The above describes the basic principles, main features, and advantages of the present invention. As those skilled in the art will understand, the present invention is not limited to the embodiments described above, and the embodiments and specification described above are merely for illustrating the principles of the present invention. The present invention can be modified and improved in various ways without departing from the spirit or scope of the invention, and these modifications and improvements fall within the scope of the invention for which protection is claimed, and the scope of protection of the present invention is in accordance with the appended claims and their equivalents. [Explanation of symbols]

[0066] 100 First shell, 110 First end, 111 Mounting hole, 112 First pressure-sensing hole, 113 Connection part, 114 Boss, 115 Position limiting part, 116 Position limiting block, 120 Second end, 121 Insertion hole, 122 Second sealing member, 123 Second pressure-sensing hole, 130 Guide hole, 140 End cover, 200 Expander, 210 Main body, 220 Guide opening, 300 Puncture needle, 400 Push mechanism, 410 Drive assembly, 411 Fixing block, 412 Drive block, 420 Guide assembly, 421 Guide groove, 422 Guide member, 430 Reset member, 500 First sealing member, 600 Guide sheath assembly, 610 Second shell, 611 Position limiting groove, 620 Guide sheath, 700 Guide wire, 800 RF puncture device

Claims

1. A puncture device, A first shell (100) that can be detachably connected to a guide sheath assembly (600) of a different model number, An expander (200) is provided at one end on the first shell (100) and is inserted into the guide sheath (620) of the guide sheath assembly (600) during surgery. A puncture needle (300) inserted into the first shell (100) and the expander (200), A guide wire (700) is inserted into the aforementioned puncture needle (300), A puncture device comprising: a push mechanism (400) provided on the first shell (100), wherein the puncture needle (300) is connected to the output end of the push mechanism (400), and the push mechanism (400) is configured to reciprocate the puncture needle (300) in a first direction, thereby causing the distal end of the puncture needle (300) to protrude from or be hidden within the distal end of the expander (200), the first direction being the extension direction of the expander (200); and the push mechanism (400).

2. The puncture device according to claim 1, wherein the first shell (100) includes a first end (110) and a second end (120), the first end (110) and the second end (120) are located at opposite ends of the first shell (100) along the first direction, the first end (110) is provided with a mounting hole (111) extending along the first direction, the expander (200) is fixed to the mounting hole (111), the second end (120) is provided with an insertion hole (121) extending along the first direction, the puncture needle (300) is inserted into the first shell (100) through the insertion hole (121) and inserted into the expander (200), and the distal end of the puncture needle (300) is hidden inside the expander (200) before the distal end of the expander (200) reaches the preliminary puncture site of the heart.

3. The first shell (100) is provided with a guide hole (130) extending along the first direction, and the push mechanism (400) includes a drive assembly (410). The puncture device according to claim 1, wherein the puncture needle (300) is connected to the drive assembly (410), and a portion of the drive assembly (410) is provided to protrude from the first shell (100) through the guide hole (130), and when performing an atrial septal puncture, the operator moves the drive assembly (410) along the first direction, causing the distal end of the puncture needle (300) to protrude from the dilator (200).

4. The drive assembly (410) is A fixing block (411) fitted onto the aforementioned puncture needle (300), The puncture device according to claim 3, further comprising a drive block (412) provided in the first shell (100) and connected to the fixed block (411) through the guide hole (130).

5. The push mechanism (400) further includes a guide assembly (420), The puncture device according to claim 3, wherein the guide assembly (420) is provided between the drive assembly (410) and the first shell (100), and the guide assembly (420) is configured to provide a guide for the drive assembly (410) to move the puncture needle (300) along the first direction.

6. The guide assembly (420) is A guide groove (421) provided in the inner wall of the first shell (100) or in the drive assembly (410) along the first direction, The puncture device according to claim 5, comprising a guide member (422) connected to the drive assembly (410) or the first shell (100) which is not provided with the guide groove (421), wherein a part of the guide member (422) is located in the guide groove (421), and the guide member (422) is movable in the guide groove (421) along the first direction.

7. The push mechanism (400) is The puncture device according to claim 3, further comprising a reset member (430) fitted onto the puncture needle (300), the reset member having both ends in contact with the first shell (100) and the drive assembly (410), respectively.

8. The aforementioned puncture device, The puncture device according to claim 3, further comprising a first sealing member (500) fitted onto the puncture needle (300) and sealed to the first end (110) of the first shell (100).

9. The puncture device according to claim 2, characterized in that a first pressure-sensing hole (112) is provided at the first end (110), the first pressure-sensing 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-sensing hole (112).

10. The puncture device according to claim 1, characterized in that the puncture needle (300) is welded to the push mechanism (400), or the puncture needle (300) is provided with a position-limiting projection, the position-limiting projection is located in front of the push mechanism (400) in the pushing direction of the push mechanism (400), and the position-limiting projection can contact the end face of the push mechanism (400).

11. The puncture device according to any one of claims 1 to 10, characterized in that the puncture needle (300) is electrically connected to an RF puncture device (800).

12. The first shell (100) further includes an end cover (140) fitted to the second end (120), the guide wire (700) is inserted into the end cover (140), and the second end (120) is The puncture device according to claim 2, characterized in that it includes a second sealing member (122) fitted onto the guide wire (700), installed between the end cover (140) and the second end (120), and configured to seal the gap between the lumen of the puncture needle (300) and the outer diameter of the guide wire (700).

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

14. A method for atrial septal puncture, which is implemented by a puncture device according to any one of claims 1 to 13, and the atrial septal puncture method is The procedure involves simultaneously inserting the guide sheath (620), dilator (200), puncture needle (300), and guidewire (700) into the patient's heart, and during the process of insertion into the patient's heart, concealing the distal end of the puncture needle (300) within the distal end of the dilator (200), The steps include positioning the puncture site of the dilator (200), The puncture device's push mechanism (400) pushes the distal end of the puncture needle (300) out from the distal end of the dilator (200) to perform atrial septal puncture, The steps include simultaneously removing the guide sheath (620), the dilator (200), and the puncture needle (300) while leaving the guide wire (700), or simultaneously removing the dilator (200), the puncture needle (300), and the guide wire (700) while leaving the guide sheath (620), A method for atrial septal puncture, characterized by including the step of performing a subsequent surgery.

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