Equipment and methods for drilling the atrial septum.

Abstract

Invention details;

Description

Puncture device and atrial septal puncture method Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a puncture device and an atrial septum puncture method. Background Art

[0002] With the popularity of electrophysiology and structural heart disease surgery, atrial septal puncture has become the most common technique for cardiologists to enter the left atrium. Indications include atrial fibrillation ablation, left atrial appendage occlusion, mitral valve disease, congenital heart disease intervention, percutaneous left ventricular assist device implantation, etc. In the prior art, a mechanical puncture device is usually used to complete atrial septal puncture surgery. The puncture device includes a first shell, a dilator, and a puncture needle. One end of the dilator is set on the first shell. During the operation, the operator inserts the guide sheath and the distal end of the dilator into the heart along the guide wire. When the distal end of the dilator reaches the preset position, the guide wire must be withdrawn first, and then the puncture needle is inserted into the dilator. The distal end of the puncture needle is set as a needle-like structure, so that the operator can operate the puncture needle so that its distal end protrudes from the dilator and can puncture the atrial septum to achieve atrial septal puncture.

[0003] However, the atrial septum puncture technique of this puncture device is not easy to master. The puncture needle and guide wire need to be frequently exchanged during the puncture process. The operation time is long and the puncture is difficult. When encountering special patients, such as those with atrial septal fibrosis, thickening, hyperelasticity, and tumor formation, it is also very easy to cause serious complications, such as pericardial tamponade, slippage of the puncture site, and heart rupture.

[0004] In order to solve the above problems, it is urgent to provide a puncture device and an atrial septum puncture method. Technical issues

[0005] The purpose of the present invention is to propose a puncture device and a method for atrial septal puncture, in which the puncture needle is hidden in the dilator so that the puncture needle and the dilator can be simultaneously delivered to the preset position of the heart to be punctured, saving the time of inserting and exchanging the puncture needle and guide wire, which is conducive to saving operation time and effectively avoiding complications. Technical Solutions

[0006] To achieve this object, the present invention adopts the following technical solutions:

[0007] A puncture device, comprising:

[0008] A first housing capable of being detachably connected to different models of introducer sheath assemblies;

[0009] An expander, one end of which is disposed on the first housing, and during surgery, the expander is inserted into the guide sheath of the guide sheath assembly;

[0010] a puncture needle, inserted into the first shell and the dilator;

[0011] a guide wire, inserted into the puncture needle; and

[0012] A pushing mechanism is provided on the first shell, and the puncture needle is connected to 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 from the distal end of the expander or is hidden inside the distal end of the expander. The first direction is the extension direction of the expander.

[0013] As an optional solution, the first shell includes a first end and a second end, the first end and the second end are located at both ends of the first shell along the first direction, the first end is provided with a mounting hole extending along the first direction, the expander is fixed in the mounting hole, and the second end is provided with a penetration hole extending along the first direction, the puncture needle penetrates into the first shell from the penetration hole and is penetrated in the expander, and the distal end of the puncture needle is hidden in the expander before the distal end of the expander reaches the pre-puncture position of the heart.

[0014] As an optional solution, the first housing is provided with a guide hole extending along the first direction, and the pushing mechanism includes:

[0015] The drive assembly is connected to the puncture needle, and a portion of the drive assembly passes through the guide hole and protrudes from the first shell setting. When the operator performs atrial septal puncture, the operator can push the drive assembly to move along the first direction so that the distal end of the puncture needle protrudes from the expander.

[0016] As an optional solution, the driving component includes:

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

[0018] The driving block is arranged on the first shell, and the driving block passes through the guide hole and is connected with the fixing block.

[0019] As an optional solution, the pushing mechanism further includes:

[0020] The guide assembly is arranged between the driving assembly and the first housing, and the guide assembly is configured to provide guidance for the driving assembly to push the puncture needle to move along the first direction.

[0021] As an optional solution, the guide assembly includes:

[0022] a guide groove, provided along the first direction on the inner wall of the first housing or on the driving assembly; and

[0023] The guide member is connected to the driving assembly or the first shell without the guide groove, the guide member is partially located in the guide groove, and the guide member can move along the first direction in the guide groove.

[0024] As an optional solution, the pushing mechanism further includes:

[0025] A reset member is sleeved on the puncture needle, and two ends of the reset member are respectively in contact with the first shell and the driving assembly.

[0026] As an optional solution, the puncture device further includes:

[0027] The first sealing member is sleeved on the puncture needle, and the first sealing member is sealed and connected to the first end of the first shell.

[0028] As an optional solution, a first pressure measuring hole is provided on the first end, and the first pressure measuring hole is connected to the mounting hole, so that the operator can measure the blood pressure in the mounting hole through the first pressure measuring hole.

[0029] As an optional solution, the puncture needle is welded and fixed to the pushing mechanism, or a limiting protrusion is provided on the puncture needle, and the limiting protrusion is located in front of the pushing mechanism in the pushing direction of the pushing mechanism, and the limiting protrusion can abut against the end face of the pushing mechanism.

[0030] As an optional solution, the puncture needle is electrically connected to a radiofrequency puncture device.

[0031] As an optional solution, the first housing further includes an end cap sleeved on the second end, and the guide wire is passed through the end cap; the second end includes:

[0032] The second seal is sleeved on the guide wire and disposed between the end cap and the second end. The second seal is configured to seal the gap between the inner cavity of the puncture needle and the outer diameter of the guide wire.

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

[0034] A method for atrial septal puncture, characterized in that it is implemented by the above-mentioned puncture device, and the method for atrial septal puncture comprises the following steps:

[0035] The guide sheath, dilator, puncture needle and guide wire enter the patient's heart at the same time, and during the process of entering the patient's heart, the distal end of the puncture needle is hidden in the distal end of the dilator;

[0036] Locating the puncture position of the dilator;

[0037] 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 atrial septal puncture;

[0038] withdrawing the guide sheath, the dilator, and the puncture needle simultaneously, and retaining the guide wire, or withdrawing the dilator, the puncture needle, and the guide wire simultaneously, and retaining the guide sheath; and

[0039] Perform follow-up surgery. Beneficial effects

[0040] The present invention provides a puncture device, which includes a first shell, a dilator, a puncture needle, a guide wire, and a pushing mechanism. The first shell can be detachably connected to different models of guide sheath assemblies. One end of the dilator is set on the first shell. During surgery, 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, and the guide wire is inserted into the puncture needle. The pushing mechanism is set on the first shell, and the puncture needle is connected to the output end of the pushing mechanism. The pushing mechanism is configured to push the puncture needle to move back and forth along a first direction so that the distal end of the puncture needle protrudes from the distal end of the dilator or is hidden within the distal end of the dilator. The first direction is the extension direction of the dilator. The puncture device is hidden in the dilator through the puncture needle, so that the puncture needle and dilator can be simultaneously delivered to the preset position of the heart to be punctured, saving time for inserting and exchanging the puncture needle and guide wire, which is conducive to saving operation time and effectively avoiding complications.

[0041] The present invention also provides a method for atrial septal puncture, which is implemented using the above-mentioned puncture device. The method includes the following steps: a guide sheath, a dilator, a puncture needle, and a guidewire are simultaneously introduced into the patient's heart, and during the process of entering the patient's heart, the distal end of the puncture needle is hidden within the distal end of the dilator; the puncture device pushes the distal end of the puncture needle out of the distal end of the dilator; the puncture position of the puncture needle is located and atrial septal puncture is performed; the guide sheath, the dilator, and the puncture needle are simultaneously withdrawn, retaining the guidewire, or the dilator, the puncture needle, and the guidewire are simultaneously withdrawn, retaining the guide sheath; and then subsequent surgery is performed. Compared with existing atrial septal puncture methods, this method for atrial septal puncture reduces the steps of inserting and withdrawing the puncture needle, and also reduces the steps of inserting and exchanging the guidewire. There is no need to replace the puncture needle, which is beneficial for saving operation time, thereby avoiding complications, and ensuring the safety of the use process. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in describing the embodiments of the present invention. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the contents of the embodiments of the present invention and these drawings without any creative work.

[0043] FIG1 is a structural diagram of the assembly of a puncture device and an introducer sheath assembly according to an embodiment of the present invention;

[0044] FIG2 is a schematic cross-sectional view of the assembled puncture device and guide sheath assembly provided by an embodiment of the present invention;

[0045] FIG3 is a second structural diagram of the assembly of the puncture device and the guide sheath assembly provided in an embodiment of the present invention;

[0046] FIG4 is a partial enlarged view of point A in FIG2 ;

[0047] FIG5 is a partial enlarged view of point B in FIG3;

[0048] FIG6 is a partial enlarged view of point C in FIG1 ;

[0049] FIG7 is a partial enlarged view of point D in FIG2;

[0050] FIG8 is a logic diagram of an atrial septum puncture method provided by an embodiment of the present invention;

[0051] FIG9 is a partial enlarged view of point E in FIG2 ;

[0052] FIG10 is a schematic diagram of a cross-sectional structure of a puncture device according to an embodiment of the present invention;

[0053] FIG11 is a partial enlarged view of point G in FIG10 ;

[0054] FIG12 is a second schematic cross-sectional view of the puncture device according to an embodiment of the present invention;

[0055] FIG13 is a partial enlarged view of point F in FIG12 .

[0056] The following are marked in the figure:

[0057] 100 - first housing; 110 - first end; 111 - mounting hole; 112 - first pressure measuring hole; 113 - connecting portion; 114 - boss; 115 - limiting portion; 116 - limiting block; 120 - second end; 121 - through hole; 122 - second sealing member; 123 - second pressure measuring hole; 130 - guide hole; 140 - end cap;

[0058] 200- expander; 210- main body; 220- guide port;

[0059] 300-puncture needle;

[0060] 400- pushing mechanism; 410- driving assembly; 411- fixing block; 412- driving block; 420- guiding assembly; 421- guiding groove; 422- guiding member; 430- resetting member;

[0061] 500-first seal;

[0062] 600 - guide sheath assembly; 610 - second housing; 611 - limiting groove; 620 - guide sheath tube;

[0063] 700-guidewire;

[0064] 800-Radiofrequency puncture device. Best Mode for Carrying Out the Invention

[0065] The present invention will be further described in detail below with reference to the accompanying drawings and examples. It should be understood that the specific embodiments described herein are intended only to illustrate the present invention and are not intended to limit the present invention. It should also be noted that, for ease of description, the accompanying drawings only illustrate portions of the present invention, not the entire structure.

[0066] In the description of the present invention, unless otherwise expressly specified or limited, the terms "connected," "connected," and "fixed" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and may refer to the interconnection of structures within two components or the interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention in specific contexts.

[0067] In the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Furthermore, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0068] In the description of this embodiment, terms such as "upper," "lower," "left," and "right" are used to refer to positions or locations based on those shown in the accompanying drawings. These terms are intended solely to facilitate description and simplify operation, and are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first" and "second" are used solely for descriptive purposes and have no special meaning.

[0069] As shown in Figures 1 to 13, this embodiment provides a puncture device, which includes a first housing 100, a puncture needle 300, a guidewire 700, and a dilator 200. The first housing 100 can be detachably connected to different models of guide sheath assemblies 600 to expand the application range of the puncture device. One end of the dilator 200 is disposed on the first housing 100. During surgery, the dilator 200 is inserted into the guide sheath 620 of the guide sheath assembly 600, and the guidewire 700 is inserted into the dilator 200. During surgery, the operator inserts the distal ends of the dilator 200 and guidewire 700 into the heart. When the distal ends of the dilator 200 and guidewire 700 reach a predetermined position, the puncture needle 300 is inserted into the interior of the dilator 200, allowing the operator to manipulate the puncture needle 300 so that its distal end protrudes from the dilator 200 and punctures the atrial septum, thereby achieving atrial septal puncture. Furthermore, to improve puncture accuracy, the distal end of the puncture needle 300 is configured as a needle-like structure. Of course, in other embodiments, the distal end of the puncture needle 300 can also have any other shape, such as an arc. The first housing 100 of this embodiment is removably compatible with various models of guide sheath assemblies 600, which helps expand the applicability of the puncture device.

[0070] Furthermore, in this embodiment, before the operation, the guide wire 700 is inserted into the puncture needle 300, and the guide wire 700, the puncture needle 300 guide sheath 620 and the dilator 200 are simultaneously delivered to the heart, so that when the distal end of the dilator 200 reaches the preset puncture position, the puncture needle 300 can perform atrial septal puncture in time, thereby saving the steps and time of withdrawing the guide wire and inserting the puncture needle in the prior art, improving the efficiency of the operation, shortening the operation time, and thereby improving the safety of the operation process.

[0071] Specifically, referring to Figures 1 to 7 , the guide sheath assembly 600 is detachably connected to the first housing 100 and includes a second housing 610 and a guide sheath tube 620 inserted into the second housing 610. During surgery, the guide sheath assembly 600 is first assembled, the dilator 200 is inserted into the guide sheath tube 620, and then the first housing 100 and the second housing 610 are connected to fix the relative position of the guide sheath assembly 600 and the puncture device.

[0072] Optionally, the guide sheath assembly 600 is a controllable bendable guide sheath 620. Specifically, a knob is provided on the second housing 610, and the end of the second housing 610 away from the puncture device can be bent 180 degrees in both directions, thereby simultaneously driving the angle of the dilator 200, puncture needle 300, and guide wire 700 inserted therein, so as to facilitate the doctor to adjust the puncture point.

[0073] In order to further improve the atrial septum puncture technology of the puncture device, improve the accurate prediction of the puncture point position, and thus ensure the puncture accuracy, the puncture needle 300 of the puncture device is electrically connected to the radiofrequency puncture device 800. When the distal end of the puncture needle 300 reaches the preset position, the radiofrequency current switch or foot switch of the radiofrequency puncture device 800 is turned on, emitting a short and highly focused radiofrequency energy to penetrate the atrial septum.

[0074] Optionally, the radiofrequency puncture device 800 has a real-time impedance measurement function and is connected to the puncture needle 300. After a successful puncture, the impedance change is displayed on the display screen, indicating a successful puncture. The radiofrequency puncture device 800 connects the puncture needle 300 to an electrocardiogram (ECG) monitor via a data cable to measure the electrocardiogram in real time. After a successful puncture, the ECG shows a significant change, indicating a successful puncture to the operator.

[0075] Please continue to refer to 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 is a needle-shaped structure. The puncture device also includes a pushing mechanism 400 provided on the first shell 100. The puncture needle 300 is connected to the output end of the pushing mechanism 400. The pushing mechanism 400 can push the puncture needle 300 to reciprocate along the first direction so that the distal end of the puncture needle 300 protrudes from the distal end of the expander 200 or is hidden in the distal end of the expander 200. The first direction is the extension direction of the expander 200. This puncture device conceals the puncture needle 300 within the dilator 200, preventing the distal end of the puncture needle 300 from damaging other organs during delivery to the heart. This allows the puncture needle 300 and dilator 200 to be delivered simultaneously to the pre-set location in the heart for puncture, saving time during insertion of the puncture needle 300 and thus reducing operating time, thus avoiding complications and ensuring safety during use. Figure 6 shows the state of the pushing mechanism 400 pushing the puncture needle 300 out of the dilator 200.

[0076] In this embodiment, the needle-like structure of the puncture needle 300 balances mechanical puncture capability and puncture point stability, creating a tent-like shape at the puncture point with a relatively small thrust. Simultaneously, a brief, highly focused burst of radiofrequency energy is used to penetrate the atrial septum to achieve transseptal puncture. This eliminates the need for the puncture device to rely solely on mechanical thrust to forcibly puncture the atrial septum, significantly reducing the risk of excessive penetration and accidental puncture of the posterior wall of the left atrium. Furthermore, the puncture needle 300 with this structure can still achieve transseptal puncture even when not connected to the radiofrequency puncture device 800, thereby expanding the scope of application of the puncture device. In other embodiments, the needle-like structure of the puncture needle 300 may also have an elliptical tip (blunt tip). This blunt tip design lacks mechanical puncture capability but further reduces the risk of misoperation during surgery.

[0077] Specifically, when not undergoing puncture, the distal end of the puncture needle 300 remains concealed within the dilator 200. Optionally, to reduce the time required to push the puncture needle 300 out of the dilator 200 and shorten the pushing stroke of the pushing mechanism 400, the distal end of the puncture needle 300 is concealed 5 mm to 20 mm from the interior of the distal end of the dilator 200. When the puncture needle 300 needs to be pushed out of the dilator 200, the pushing mechanism 400 pushes the puncture needle 300, causing the distal end of the puncture needle 300 to protrude beyond the distal end of the dilator 200, thereby performing a transseptal puncture.

[0078] Furthermore, the puncture needle 300 is divided into three sections along the direction from the distal end to the first shell 100. The first section is a rigid tubular needle tip design at the head end to facilitate atrial septal puncture. In order to reduce the scratches on the inner wall of the dilator 200 caused by the reciprocating motion of the puncture needle 300 inside the dilator 200, the tube wall of the inclined cross-section of the first section of the puncture needle 300 with a needle tip design has a rounded corner structure to prevent foreign matter from falling off the inner wall of the dilator 200 during the movement of the puncture needle 300, thereby reducing surgical risks. The second section is the middle section, which uses a flexible multi-strand torsion spring tube or a single-strand hollow reed tube or a flexible tubular body to adapt to the various bending angles of the entire system in the patient's body. The third section is the tail end, which uses a rigid tubular body and is located inside the handle and a small part of the dilator 200 to facilitate the transmission of the thrust of the push rod. The above materials can be made of medical stainless steel or medical nickel-titanium alloy.

[0079] Optionally, since the puncture needle 300 is generally made of conductive metal, an insulating layer is provided on the inner wall of the puncture needle 300 to prevent current from being conducted from the guidewire 700 to other parts during radiofrequency puncture. This insulating layer also reduces friction when the guidewire 700 passes through the inner wall of the puncture needle 300, preventing surgical risks caused by the coating of the guidewire 700 peeling off. For example, the insulating layer can be made of polyimide (PI), but the insulating layer is not limited to this material.

[0080] As shown in FIG1 to FIG13 , this embodiment further provides a method for atrial septal puncture, which is implemented by the above-mentioned puncture device and includes the following steps:

[0081] The guide sheath 620, the dilator 200, the puncture needle 300, and the guide wire 700 simultaneously enter the patient's heart. During the process of entering the patient's heart, the distal end of the puncture needle 300 is hidden in the distal end of the dilator 200.

[0082] The puncture device pushes the distal end of the puncture needle 300 out of the distal end of the dilator 200;

[0083] Locating the puncture position of the puncture needle 300 and performing atrial septal puncture;

[0084] Simultaneously withdraw the guide sheath 620, the dilator 200, and the puncture needle 300, leaving the guide wire 700, or simultaneously withdraw the dilator 200, the puncture needle 300, and the guide wire 700, leaving the guide sheath 620; and

[0085] Perform follow-up surgery.

[0086] Compared with the existing atrial septal puncture method, this atrial septal puncture method reduces the process of withdrawing the guide wire 700 and inserting the puncture needle 300 before puncture, and also reduces the process of withdrawing the puncture needle 300 and exchanging the guide wire 700 after puncture. There is no need to replace the puncture needle 300, which is beneficial to saving operation time, thereby avoiding complications, and ensuring the safety of the use process.

[0087] Specifically, when the guide sheath 620, dilator 200, and puncture needle 300 are simultaneously withdrawn, while the guide wire 700 remains, the guide sheath 620 compatible with subsequent procedures is retained, directly establishing access to the left atrium for subsequent procedures.

[0088] Furthermore, after the puncture needle 300 completes the atrial septal puncture, since the diameter of the puncture needle 300 is smaller than that of the dilator 200, in order to allow the dilator 200 (with a larger diameter) and the guide sheath 620, which are sheathed outside the puncture needle 300, to smoothly enter the left atrium, the dilator 200 includes a main body 210 and a guide opening 220 connected to the distal end of the main body 210. The diameter of the guide opening 220 gradually decreases as it moves away from the main body 210, forming a trumpet shape so that the guide opening 220 covers the puncture needle 300. When the puncture needle 300 completes the puncture and enters the left atrium, the smaller diameter end of the guide opening 220 is more easily accessible. The diameter of the guide opening 220 gradually increases, expanding the size of the puncture hole, allowing the dilator 200 to smoothly enter the left atrium. This, in turn, allows the distal end of the guide sheath 620, which is sheathed outside the dilator 200, to enter the left atrium, facilitating subsequent surgery.

[0089] As shown in Figures 2, 7, and 8, the first housing 100 includes a first end 110 and a second end 120, which are located at opposite 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, in which the dilator 200 is fixed. The second end 120 is provided with a penetration hole 121 extending along the first direction. The puncture needle 300 penetrates the first housing 100 through the penetration hole 121 and is inserted into the dilator 200. Before the distal end of the dilator 200 reaches the pre-puncture position of the heart, the distal end of the puncture needle 300 is hidden within the dilator 200, thereby enabling the puncture needle 300 to reciprocate along the first direction within the dilator 200. Exemplarily, the second end 120 is a Luer connector, through which the guidewire 700 and the puncture needle 300 can be inserted into the dilator 200. After the procedure, the operator can use a syringe to inject saline solution into the Luer connector to flush the inner cavity of the puncture needle 300. Furthermore, as shown in FIG9 , to prevent saline solution from overflowing during the flushing process, the second end 120 further includes a second sealing member 122 , which is sleeved onto the puncture needle 300 and embedded in the puncture hole 121 .

[0090] As shown in Figures 10 and 11, in another embodiment, an end cap 140 is provided at the outer end of the second end 120. The end cap 140 is sleeved on the second end 120, and the guidewire 700 can be passed through the middle of the end cap 140. To facilitate the connection between the end cap 140 and the end surface of the second end 120, the end cap 140 is threadedly connected to the second end 120. In this case, a second seal 122 is sleeved on the guidewire 700 and is disposed between the end cap 140 and the second end 120. The second seal 122 can block the gap between the end of the puncture needle 300 near the end cap 140 and the outer diameter of the guidewire 700, thereby sealing the guidewire 700 and the inner lumen of the puncture needle 300 and preventing blood from flowing out of the tail of the guidewire 700. More specifically, a groove is provided on the second end 120 , and the second seal 122 is located in the groove. Both ends of the second seal 122 abut against the end cap 140 and the second end 120 respectively, so that the second seal 122 blocks the inner cavity of the puncture needle 300 .

[0091] Furthermore, a second pressure tap 123 is provided on the second end 120, communicating with the perforation 121. This second pressure tap 123112 may be a Luer connector for connection to a pressure sensor. Furthermore, this Luer connector can be connected to a pressure detection device to monitor blood pressure within the puncture needle. During surgery, this second pressure tap 123 can be used to monitor blood pressure without removing the guidewire 700.

[0092] As shown in Figures 2, 4 and 7, since there are various models of guide sheath assemblies 600 on the market, in order to be able to adapt to a variety of different models of guide sheath assemblies 600, the first end 110 is a compatible connector for detachably connecting to the second shell 610 of the guide sheath assembly 600. Currently, the commonly used second housing 610 has an inner hole at one end near the puncture device. To enable the first end 110 to connect to the inner hole, the first end 110 includes a connecting portion 113. The outer diameter of the connecting portion 113 is set to correspond to the inner diameter of the inner hole. A boss 114 is provided on the end surface of the connecting portion 113 away from the second end 120. The outer diameter of the boss 114 has an interference fit with the inner diameter of the inner hole. The first end 110 is also provided with a stopper 115. The outer diameter of the stopper 115 is larger than that of the connecting portion 113. During assembly, the operator needs to insert the first end 110 into the inner hole so that the boss 114 can be snapped into the inner wall end surface of the second housing 610. The stopper 115 abuts the outer wall of the second housing 610, thereby achieving rapid assembly of the first end 110 and the second housing 610. After surgery, the user can manually remove the first end 110 to separate the introducer sheath assembly 600 and the puncture device. The first end 110 is designed as a quickly replaceable end so that the puncture device can be compatible with sheaths of various brands.

[0093] In addition, as shown in Figures 2, 5 and 7, a limiting groove 611 can also be provided on the second shell 610, and the first end 110 includes a limiting block 116 arranged corresponding to the limiting groove 611. When assembling the guide sheath assembly 600 and the puncture device, the limiting block 116 is inserted into the limiting groove 611 to ensure that the angle of the guide sheath assembly 600 and the puncture device is correct when connected, thereby avoiding operator errors.

[0094] Referring to Figures 7, 12, and 13, first housing 100 is provided with a guide hole 130 extending in a first direction. Pushing mechanism 400 includes a drive assembly 410, to which puncture needle 300 is connected. A portion of drive assembly 410 extends through guide hole 130 and protrudes from first housing 100, facilitating manual operation by an operator from outside first housing 100. When performing transseptal puncture, the operator pushes drive assembly 410 in the first direction, causing the distal end of puncture needle 300 to protrude from dilator 200.

[0095] Drive assembly 410 includes a fixed block 411 and a drive block 412. Fixed block 411 is mounted on puncture needle 300, facilitating stability when fixed block 411 drives puncture needle 300 in the first direction. Drive block 412 is mounted on first housing 100 and connected to fixed block 411 through guide hole 130, enabling the operator to directly drive the device from outside first housing 100, thereby enhancing user convenience.

[0096] Please continue to refer to Figures 12 and 13. The pushing mechanism 400 also includes a guide assembly 420. The guide assembly 420 is arranged between the driving assembly 410 and the first shell 100. 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, thereby improving the stability of the pushing assembly moving along the first direction and avoiding jamming.

[0097] Specifically, the guide assembly 420 includes a guide groove 421 and a guide member 422. The guide groove 421 is arranged on the inner wall of the first shell 100 along the first direction. The guide member 422 is connected to the driving assembly 410 on which the guide groove 421 is not arranged. The guide member 422 is partially located in the guide groove 421, and the guide member 422 can move along the first direction in the guide groove 421. The guide assembly 420 has a simple structure and is easy to implement.

[0098] In other embodiments, the guide groove 421 can be set on the driving assembly 410 along the first direction, the guide member 422 is connected to the first shell 100 where the guide groove 421 is not set, the guide member 422 is partially located in the guide groove 421, and the guide member 422 can move along the first direction in the guide groove 421. The effect is the same as above and will not be repeated here.

[0099] As shown in Figures 12 and 13, the puncture device also includes a first seal 500, which is mounted on the puncture needle 300. The first seal 500 is sealed to the first end 110 of the first shell 100, thereby sealing the backflow of blood from one end of the heart and preventing this part of the blood from overflowing to the side of the first seal 500 away from the first end 110.

[0100] In addition, the pushing mechanism 400 also includes a reset member 430, which is mounted on the puncture needle 300. The two ends of the reset member 430 respectively abut the first housing 100 and the drive assembly 410. When the operator pushes the drive block 412, which in turn drives the fixed block 411 to push the distal end of the puncture needle 300 out of the dilator 200, the reset member 430 is compressed. After the puncture is completed, the operator releases the drive block 412. The elastic action of the compressed reset member 430 drives the fixed block 411 to retract into the dilator 200, achieving an automatic reset effect.

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

[0102] Furthermore, the two ends of the reset member 430 abut against the fixed block 411 and the first sealing member 500, respectively, achieving a fixed effect at both ends. To improve the effectiveness of the fixed block 411 and the first sealing member 500 in fixing the reset member 430, the fixed block 411 and the first sealing member 500 are each provided with a receiving groove at one end opposite to the other, and the two ends of the reset member 430 are respectively located in the two receiving grooves, thereby improving the stability of the reset member 430.

[0103] A first pressure tap 112 is provided on the first end 110 and is connected to the mounting hole 111. The operator can measure the blood pressure within the mounting hole 111 through the first pressure tap 112, allowing the operator to monitor the heart's blood pressure in real time during the procedure. Specifically, the puncture device also includes a pressure sensor disposed in the first pressure tap 112. Due to the significant pressure difference between the right and left atria, once the puncture needle 300 enters the left atrium, the pressure sensor can immediately obtain data on atrial pressure changes, alerting the operator to the success of the puncture. For example, the first pressure tap 112 can be configured as a Luer connector for easy connection to the pressure sensor. Furthermore, the Luer connector can be connected to a syringe, allowing the operator to inject saline solution into the first pressure tap 112 to flush the gap between the outer wall of the puncture needle 300 on the side of the first seal 500 near the first end 110 and the inner wall of the dilator 200.

[0104] Optionally, the puncture needle 300 may be fixed to the pushing mechanism 400 by welding, specifically the fixing block 411 may be fixed to the puncture needle 300 by welding, thereby improving the stability of the fixing block 411 in stably driving the puncture needle 300 to move along the first direction.

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

[0106] In addition, the first housing 100 is provided with an energy on / off switch electrically connected to the radiofrequency puncture device 800, allowing the operator to control the radiofrequency energy on / off during surgery without having to operate the radiofrequency puncture device 800. Alternatively, the puncture device may be provided with a foot-operated switch electrically connected to the radiofrequency puncture device 800, allowing the operator to control the radiofrequency energy on / off by foot during surgery.

[0107] Using this puncture device, the operator inserts the distal end of the dilator 200 into the right atrium through the patient's inferior vena cava. After confirming that the atrial septal puncture site has been reached through ultrasound or X-ray, the operator pushes the drive block 412 on the first shell 100 to push out the automatically hidden puncture needle 300. At the same time, the operator operates the radio frequency current switch or foot-operated trigger switch on the first shell 100 to emit a short and highly focused radio frequency energy to penetrate the atrial septum and send the puncture needle 300 into the left atrium, thereby establishing a pathway into the left atrium for subsequent surgery.

[0108] At the same time, with this puncture device, there is no need to use a sharp mechanical needle to apply excessive mechanical thrust to forcibly penetrate the atrial septum during surgery, making the position of the atrial septum puncture more accurate, safe and controllable, reducing the incidence of complications related to atrial septal puncture, reducing the technical difficulty of atrial septal puncture, and shortening the learning curve. It is a safe, reliable, controllable and convenient new puncture device.

[0109] With this puncture device, during the entire atrial septal puncture procedure, there is no need to withdraw the guidewire 700, insert the puncture needle 300, or withdraw the puncture needle 300 and insert the guidewire 700, achieving a zero-exchange workflow without having to replace the needle, guidewire 700, dilator 200, guide sheath 620, etc. At the same time, after the operator confirms the puncture position during the operation, if the operator is not satisfied with the repositioning, they only need to release the drive block 412. At this time, under the elastic action of the reset member 430, the distal end of the puncture needle 300 is retracted into the dilator 200. The operator can then push out the guidewire 700 and reposition it. Alternatively, after retracting the distal end of the puncture needle 300, the angle of the controllable bend guide sheath 620 can be adjusted to adjust the puncture point.

[0110] Note that the basic principles and main features of the present invention and the advantages of the present invention are shown and described above. It should be understood by those skilled in the art that the present invention is not limited to the above-described embodiments, which are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention, and such changes and modifications are intended to fall within the scope of the present invention as claimed, which is defined by the appended claims and their equivalents.

Claims

DEPCT691. A puncture device which is assembled with: a first shell (100) which is capable of being detachably connected to different types of lead housing assembly parts (600); a speculum (200) whose end is arranged on the first shell (100) in which the speculum (200) is inserted through the lead housing (620) of the lead housing assembly parts (600) during surgery; a puncture needle (300) which is inserted through the first shell (100) and the speculum (200); a guide wire. The passage (700) which penetrates through the piercing needle (300) and the pushing mechanism (400) which is arranged on the first casing (100) where the piercing needle (300) is connected to the output end of the pushing mechanism (400), the pushing mechanism (400) is designed to push the piercing needle (300) back and forth in one direction so that the far end of the piercing needle (300) protrudes from the far end of the retractor (200) or is hidden in the far end of the retractor (200) and the first direction is the extension direction of the retractor (200).2.The puncture device under claim 1, in which the first envelope (100) is comprised of the first end (110) and the second end (120), the first end (110) and the second end (120) are positioned at the two ends of the first envelope (100) in the first direction, the first end (110) is provided with the mounting hole (111) which is extended in the first direction, the speculum (200) is secured in the mounting hole (111), the second end (120) is provided with the penetration hole (121) which is extended in the first direction, the puncture needle (300) is inserted into the first envelope (100) from the penetration hole (121) and passes through the speculum (200), and before the distal end of the speculum (200) reaches the pre-puncture position of the heart, the distal end of the puncture needle (300) is concealed in the speculum (200).3.The puncture device under claim 1 in which the first shell (100) is provided with a guide hole (130) which is extended in the first direction and the thrusting mechanism (400) is incorporated: a drive unit (410) in which the puncture needle (300) is connected to the drive unit (410) and a portion of the drive unit (410) is arranged so that it penetrates through the guide hole (130) so that it protrudes from the first shell (100) so that when the operator performs the puncture of the septal wall The operator can push the drive assembly (410) to move in one direction to cause the far end of the drill bit (300) to protrude from the spreader (200).

4. The drilling device according to claim 3, in which the drive assembly (410) is assembled, consists of: a fixing block (411) fitted over the drill bit (300) and a drive block (412) arranged on the first housing (100), in which the drive block (412) is thrust through the guide hole (130) to be connected to the fixing block (411).5.The drilling device under claim 3, in which the thrusting mechanism (400) is further incorporated: a guide element (420) arranged between the drive element (410) and the first housing (100), in which the guide element (420) is constructed to provide guidance for the drive element (410) to push the drill bit (300) to move in the first direction.

6. The drilling device under claim 5, in which the guide element (420) is incorporated: a guide groove (421) arranged on the inner wall of the first housing (100) or the drive element (410) in the first direction, and a guide element (422) connected to the drive element (410) or the first housing (100) without a guide groove (421), in which the guide element (422) is partially positioned in the guide groove (421), and the guide element (422) is capable of moving in the guide groove (421) in the first direction.7.The drilling device under claim 3, in which the thrusting mechanism (400) is further incorporated, includes: a readjustment part (430) fitted onto the puncture needle (300), in which the two ends of the readjustment part (430) are respectively adjacent to the first housing (100) and the drive assembly (410).

8. The drilling device under claim 3, in which the drilling device is further incorporated, includes: a first sealing part (500) fitted onto the puncture needle (300), in which the first sealing part (500) is hermetically connected to the first end (110) of the first housing (100).

9. The drilling device under claim 2, in which the first end (110) is provided with the first pressure-gauge port (112), the first pressure-gauge port (112) is communicating with the mounting port (111), and the operator can measure blood pressure in the mounting port (111) through the first pressure-gauge port (112). 10.

11. Any drilling device under claims 1 through 10 in which the drilling needle (300) is welded and firmly attached to the thrusting mechanism (400), or the drilling needle (300) is provided with a limiting protrusion, in the thrusting direction of the thrusting mechanism (400), the limiting protrusion is positioned in front of the thrusting mechanism (400) and the limiting protrusion is capable of being close to the end face of the thrusting mechanism (400).

12. Drilling device. According to claim 2, the first shell (100) is further incorporated with an end cap (140) fitted over the second end (120) and a guide wire (700) penetrates through the end cap (140), and the second end (120) is incorporated with: a second sealing piece (122) fitted over the guide wire (700), in which the second sealing piece (122) is arranged between the end cap (140) and the second end (120), and the second sealing piece (122) is constructed to seal the gap between the inner cavity of the piercing needle (300) and the outer diameter of the guide wire (700).13.Atrial septal puncture device under any of the claims 1 through 10 in which the inner wall of the puncture needle (300) is provided with an insulating layer.

14. An atrial septal puncture method achieved by an atrial septal puncture device under any of the claims 1 through 13 in which the atrial septal puncture method consists of the following steps: allowing the guide sheath (620), speculum (200), puncture needle (300) and guide wire (700) to enter the patient's heart at the same time and concealing the distal end of the puncture needle (300) in the distal end of the speculum (200). The procedure involves the entry of the patient's heart, the positioning of the speculum (200) to the puncture site, the pushing, by the pushing mechanism (400) of the puncture device, the distal end of the puncture needle (300) exiting the distal end of the speculum (200), and the operation of atrial septal puncture and retrieval of the estrogen sheath (620), the speculum (200) and the puncture needle (300) simultaneously and the retention of the guide wire (700), or the retrieval of the speculum (200), the puncture needle (300) and the guide wire (700) simultaneously and the retention of the estrogen sheath (620), and the operation of follow-up surgery.

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