An atrial septal puncture assembly

Abstract

The application discloses an atrial septum puncture assembly, which comprises an adjustable bending guide sheath assembly and an atrial septum puncture needle assembly; the adjustable bending guide sheath assembly comprises a sheath distal end and an adjustable bending section, the distal end of the sheath distal end is provided with two ring electrodes, the ring electrodes are used for collecting cardiac electrophysiological signals, and then it is judged whether the sheath distal end successfully passes through the atrial septum; the sheath distal end is also provided with two positioning sensor adapters; the atrial septum puncture needle assembly comprises a needle tube assembly and a sensor assembly, the sensor assembly comprises a puncture needle positioning sensor, the puncture needle positioning sensor is located at the top end of the needle tip, and is used for judging the position of the puncture needle tip and the relative position of the puncture needle tip and other components. The positioning sensor adapter is arranged on the sheath distal end, the positioning sensor is added to the atrial septum puncture needle, two ring electrodes are added to the sheath distal end, the changes of the electrophysiological signals before and after the sheath distal end position passes through the fossa ovalis are compared, and the cardiac cavity modeling can be completed without magnetic positioning catheters after entering the cardiac cavity.

Description

Technical Field

[0001] This invention relates to the field of medical-guided atrial septal puncture technology, and in particular to an atrial septal puncture assembly. Background Technology

[0002] Atrial septal puncture was first reported by Ross et al. in 1959. Subsequently, Brockenbrough and Mullins et al. improved the puncture needle, sheath, and puncture technique based on this. At that time, it was mainly used for left ventricular catheterization for valvular lesions. Now, with the increasing popularity of atrial fibrillation catheter ablation, atrial septal puncture has become a commonly used clinical technique.

[0003] In catheter ablation procedures, atrial septal puncture can be used for ablation of the left lateral bypass via the atrial septal route, atrial fibrillation ablation, ablation of left atrial tachycardia, and ablation of left atrial flutter. At the same time, atrial septal puncture is also an alternative route and a necessary supplement to ablation of left ventricular arrhythmias.

[0004] The catheter cannot reach the left atrium via the percutaneous approach. It needs to pass through the aortic valve and mitral valve, both of which have certain curvatures, making it difficult for the catheter to reach them. Even if it can reach them, the catheter operation is very complicated.

[0005] The atrial septum is located between the left and right atria, and the fossa ovalis is the thinnest part of the atrial septum, making it an ideal location for atrial septal puncture to access the left atrium. Before atrial septal puncture, the location of the fossa ovalis must be determined. In traditional procedures, because there is still electrical potential at the fossa ovalis, it is difficult to determine its exact location solely from electrophysiological signals; therefore, puncture is primarily performed using radioanatomical localization. By visualizing the shape and position of the puncture system under a two-dimensional X-ray system, the tip of the guide component is moved across the atrial septum. Because the fossa ovalis is an anatomically concave fossa, the movement provides feedback to the operator, thus confirming its location. After determining the location of the fossa ovalis, X-ray imaging at a specific angle is required to determine if the puncture system is perpendicular to the atrial septal surface. Only if it is perpendicular can the puncture needle be inserted for atrial septal puncture; an incorrect puncture direction can be dangerous.

[0006] In traditional atrial septal puncture, locating the fossa ovalis and determining the puncture direction requires a physician with considerable experience. Even so, multiple X-rays are still needed to visualize the heart shape, determine the position of the guide assembly, and confirm the puncture direction. This exposes both the patient and the physician to significant radiation exposure.

[0007] Therefore, there is an urgent need for a technology that can accurately locate the atrial septal puncture components in the heart and the relative positions between the components, in order to reduce the X-ray radiation to patients and doctors during atrial septal puncture. Summary of the Invention

[0008] The purpose of this invention is to address the problem of excessive radiation exposure to patients and doctors caused by the repeated use of X-rays to visualize the heart shape, determine the position of the guiding component, and confirm the puncture direction in traditional atrial septal puncture procedures. This is addressed by providing an atrial septal puncture component.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0010] A transseptal puncture assembly includes an adjustable-bend guide sheath assembly and a transseptal puncture needle assembly;

[0011] The adjustable-bend guide sheath assembly includes a distal sheath and an adjustable bend. The distal end of the distal sheath is provided with two ring electrodes, which are used to collect cardiac electrophysiological signals and thus determine whether the distal sheath has successfully passed through the interatrial septum. The distal sheath is also provided with two positioning sensor adapters, which are used to determine the relative position between the sheath and the interatrial septum puncture needle.

[0012] The transseptal puncture needle assembly includes a needle tube assembly and a sensor assembly. The needle tube assembly and the sensor assembly are adapted to each other. The sensor assembly includes a puncture needle positioning sensor located at the tip of the needle and used to determine the position of the puncture needle tip and its relative position to other components.

[0013] This invention places a positioning sensor adapter at the distal end of the sheath to determine the relative position of the sheath and the puncture needle / catheter. Two ring electrodes are added to the distal end of the sheath for acquiring cardiac electrophysiological signals. By comparing the changes in electrophysiological signals before and after the distal end of the sheath passes through the fossa ovalis, cardiac chamber modeling can be completed without a magnetic positioning catheter after the sheath enters the heart chamber. A positioning sensor is added to the atrial septal puncture needle; the relative position of the sheath and the puncture needle is determined by the changes in the positioning sensor parameters on the atrial septal puncture needle caused by the positioning sensor adapter.

[0014] By incorporating the ring electrode and positioning sensor adapter on the sheath of the atrial septal puncture assembly, and the positioning component on the atrial septal puncture needle assembly, atrial septal puncture becomes more precise, faster, safer, and more effective. Simultaneously, this technology significantly reduces the radiation dose during the puncture process, lowering the risk of radiation damage to patients and users.

[0015] As a preferred embodiment of the present invention, there is a difference between the electrophysiological signals of the right atrium and the left atrium acquired by the ring electrode. By comparing the electrophysiological signals of the right atrium and the left atrium, it can be determined whether the distal end of the sheath enters the left atrium from the right atrium through the fossa ovalis.

[0016] As a preferred embodiment of the present invention, the adjustable bending section is provided with a plurality of ring electrodes, which are used to collect cardiac electrophysiological signals and assist in positioning after being adapted with a positioning sensor.

[0017] As a preferred embodiment of the present invention, the positioning sensor adapter includes a first sheath distal end positioning sensor adapter and a second sheath distal end positioning sensor adapter. The second sheath distal end positioning sensor adapter is disposed close to the adjustable bend section. The positioning sensor adapter causes a change in the positioning information in the nearby positioning sensor, thereby indirectly determining the relative position of the positioning sensor and the sheath.

[0018] As a preferred embodiment of the present invention, an exhaust port is provided at the distal end of the sheath tube, and the exhaust port is located 3-5 mm away from the farthest end of the sheath tube, in order to reduce the suction operation and reduce air bubbles.

[0019] As a preferred embodiment of the present invention, the puncture needle positioning sensor is a magnetic positioning coil.

[0020] As a preferred embodiment of the present invention, the puncture needle is marked with a scale near the handle, which can determine the relative position of the needle tip and the distal end of the sheath.

[0021] As a preferred embodiment of the present invention, the atrial septal puncture assembly further includes a processor, which is connected to the puncture needle positioning sensor and the ring electrode. The processor constructs a physical model of the right atrium based on the information collected by the puncture needle positioning sensor and the ring electrode, and marks the position of the fossa ovalis in the model.

[0022] As a preferred embodiment of the present invention, the processor determines the relative position of the sheath and the puncture needle based on the information collected by the puncture needle positioning sensor.

[0023] As a preferred embodiment of the present invention, the processor determines whether the distal end of the sheath enters the left atrium from the right atrium through the fossa ovalis by comparing the electrophysiological signals of the right and left atria based on the information collected by the ring electrode.

[0024] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0025] This invention places a positioning sensor adapter at the distal end of the sheath to determine the relative position of the sheath to the puncture needle / catheter. Two ring electrodes are added to the distal end of the sheath to acquire cardiac electrophysiological signals and compare changes in these signals before and after the distal end of the sheath passes through the fossa ovalis. The sheath, equipped with multiple ring electrodes, works in conjunction with the positioning sensor on the atrial septal puncture needle, allowing for cardiac chamber modeling and fossa ovalis location calibration without the need for a magnetic positioning catheter after the sheath enters the heart chamber. A positioning sensor is added to the atrial septal puncture needle to determine the needle tip position and its relative position to other components before and after puncture.

[0026] By incorporating the ring electrode and positioning sensor adapter on the sheath of the atrial septal puncture assembly, and the positioning component on the atrial septal puncture needle assembly, atrial septal puncture becomes more precise, faster, safer, and more effective. Simultaneously, this technology significantly reduces the radiation dose during the puncture process, lowering the risk of radiation damage to patients and users. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the adjustable bendable guide sheath assembly.

[0028] Figure 2 This is a schematic diagram of the expander.

[0029] Figure 3 A schematic diagram of the overall assembly of the transseptal puncture needle.

[0030] Figure 4 This is a schematic diagram of the puncture needle.

[0031] Figure 5 Schematic diagram of the distal end of the sheath Figure 1 (Full cutaway).

[0032] Figure 6 Schematic diagram of the distal end of the sheath Figure 2 (Sliced ​​down to the braided layer).

[0033] Figure 7 Schematic diagram of the sensor assembly for atrial septal puncture needle.

[0034] Figure 8 A schematic diagram of the interventricular septal puncture needle assembly and the adjustable bendable guide sheath assembly.

[0035] Figure 9 Instructions for use of the transseptal puncture device Figure 1 (Preparing for puncture)

[0036] Figure 10 Instructions for use of the transseptal puncture device Figure 2 (In the process of puncture)

[0037] Icons: 100 - distal sheath, 101 - adjustable bend, 102 - proximal tube body, 103 - handle knob, 104 - handle, 105 - hemostatic valve, 106 - tee, 107 - sheath connector, 108 - ring electrode, 109 - damage-resistant section, 110 - vent, 111 - traction assembly, 112 - metal braided layer, 201 - dilator, 301 - septal puncture needle tube, 302 - puncture needle positioner, 303 - septal puncture needle handle, 304 - puncture needle seat switch, 305 - sensor assembly handle, 306 - sensor assembly connector, Y1 - first sheath distal positioning sensor adapter, Y2 - second sheath distal positioning sensor adapter, M1 - puncture needle positioning sensor, 401 - fossa ovalis. Detailed Implementation

[0038] The present invention will now be described in detail with reference to the accompanying drawings.

[0039] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0040] Example 1

[0041] like Figures 1-4 As shown, the transseptal puncture assembly mainly includes an adjustable guide sheath assembly and a transseptal puncture needle assembly.

[0042] like Figure 1 , 5 As shown in Figure 6, the adjustable bending guide sheath assembly consists of a distal sheath 100, an adjustable bending section 101, a proximal tube body 102, and a control handle 104. Adjusting the handle knob 103 on the control handle 104 controls the bending of the adjustable bending section 101. Rotating the handle knob 103 clockwise and counterclockwise allows the adjustable bending section 101 to bend to over 135° in each direction, i.e., dual-bend control. The inner lumen of the adjustable bending guide sheath is designed to be 8.5F, and the inner lumen channel is made of a polymer material with good self-lubricating properties. A metal braided layer 112 is provided on the outer side of the inner lumen channel, and an outer tube is provided on the outermost side. The outer tube is made of a polymer material containing contrast agent and has a certain strength. A three-way valve 106 is provided at the tail of the adjustable bending guide sheath control handle for the injection of drugs and other liquids. A hemostatic valve 105 is located at the tail of the handle and coaxial with the sheath body, allowing the catheter, the interventricular septal puncture needle assembly, and the dilator 201 to pass through. The adjustable-bend guide sheath is equipped with a sheath connector 107 at its tail end for transmitting electrophysiological signals acquired by the ring electrode 108 to the device. Preferably, the distal end 100 of the sheath can be designed as a damage-resistant section 109.

[0043] like Figure 1 ,5 As shown in Figure 6, the adjustable-bend guide sheath has two or more ring electrodes 108 for measuring intracardiac electrophysiological signals. The distal straight section of the adjustable-bend guide sheath has two magnetic positioning sensor adapters and two ring electrodes. A first distal positioning sensor adapter Y1 is fixed behind the two ring electrodes at the top of the distal end of the sheath, and a second distal positioning sensor adapter Y2 is located behind the first distal positioning sensor adapter Y1. "Behind" refers to the direction closer to the handle 104, and "distal" refers to the position away from the handle 104; the distal end is used to contact human tissue.

[0044] Other ring electrodes 108 are disposed on the adjustable bend 101 behind the second sheath distal positioning sensor adapter Y2, for collecting electrophysiological signals to assist in positioning. In addition, the distal end 100 of the sheath is provided with an exhaust port 110 to reduce aspiration operations and reduce air bubbles.

[0045] like Figure 1 , 5 As shown in Figure 6, the distal end 100 of the sheath is sequentially provided with an exhaust port 110, two ring electrodes 108, a first distal end positioning sensor adapter Y1, a second distal end positioning sensor adapter Y2, a traction ring, and other ring electrodes 108 located on the adjustable bend section 101. The exhaust port 110 is located 3-5 mm from the top. The traction ring is located at the rear end of the first distal end positioning sensor adapter Y1 and is mounted on the metal braided layer 112. Two traction steel wires are welded at a 180-degree angle on the traction ring to form a traction assembly 111. The traction assembly 111 is used to achieve double-bend control of the adjustable bend section 101 of the sheath through the control of the handle. The proximal end tube body 102 and the adjustable bend section 101 are both provided with metal braided layers 112 to enhance the rigidity and torque of the tube body. The metal braided layer 112 is integrally formed on the inner cavity of the sheath.

[0046] like Figure 3 , 4As shown in Figure 7, the atrial septal puncture needle assembly consists of a needle tube assembly and a sensor assembly. The sensor assembly is housed inside the needle tube and can be inserted and removed independently. The needle tube assembly includes an atrial septal puncture needle tube 301, a puncture needle positioner 302, an atrial septal puncture needle handle 303, and a puncture needle seat switch 304. The sensor assembly includes a sensor assembly handle 305 and a sensor assembly connector 306. The sensor assembly cooperates with the needle tube assembly, with its top located at the tip exit of the puncture needle. A puncture needle positioning sensor M1 is located at the top of the sensor assembly, and the sensor assembly connector 306 is located at its tail. The puncture needle positioning sensor is a magnetic positioning coil, which can induce different magnetic fluxes at different positions in a magnetic field. The sensor signal is transmitted to the device through the sensor assembly connector 306, thereby indirectly obtaining the spatial coordinate position of the puncture needle assembly. The atrial septal puncture needle has graduations near the handle, which can be used to determine the position of the needle tip relative to the distal end 100 of the sheath when matched with an adjustable guide sheath. After the puncture needle assembly passes through the atrial puncture site, the sensor assembly can be retracted. The location of the puncture needle in the left atrium can be verified by observing the type of blood returning from the puncture needle.

[0047] like Figure 3 , 4 As shown, the basic principle of the two magnetic positioning sensor adapters in the adjustable guide sheath is as follows: when the magnetic positioning sensor installed in the components of the sheath (atrial septal puncture needle assembly or electrophysiological catheter) approaches the adapter, the magnetic positioning sensor adapters Y1 and Y2 will cause a change in the positioning signal in the magnetic positioning sensor. The installation position and distance of the two magnetic positioning sensor adapters Y1 and Y2 are fixed, and the installation position of the magnetic positioning sensor of the atrial septal puncture needle assembly or electrophysiological catheter is also fixed. The position information of the magnetic positioning sensor in each component during the atrial septal puncture procedure can be monitored in real time. Based on the time and position of the change, the relative position between the atrial septal puncture needle assembly or electrophysiological catheter and the sheath, as well as the accurate position of the adjustable guide sheath, can be indirectly determined, thereby determining whether the tip of the atrial septal puncture needle or electrophysiological catheter has extended out of the sheath.

[0048] like Figure 1 , 9 As shown in Figure 10, the ring electrode 108 of the distal end 100 of the adjustable-bend guide sheath can detect cardiac electrophysiological signals in real time to determine the position of the distal end 100 of the adjustable-bend guide sheath in the heart chamber. The basic principle is that there is a difference in electrophysiological signals between the right and left atria. When the adjustable-bend guide sheath contacts the fossa ovalis 401 before interatrial septal puncture, the electrophysiological signal detected by the ring electrode 108 is a right atrial signal. When it passes from the fossa ovalis 401 to the left atrium, the detected electrophysiological signal is a left atrial signal. By comparing the difference between the two electrophysiological signals, it can be determined whether the distal end of the adjustable-bend guide sheath has entered the left atrium from the right atrium through the fossa ovalis 401.

[0049] like Figure 8 As shown, the distal end 100 and the adjustable bend section 101 of the adjustable guiding sheath are each equipped with two or more ring electrodes 108. Combined with the atrial septal puncture needle assembly with a magnetic positioning sensor, it functions similarly to a magnetically positioned electrophysiological catheter during cardiac modeling. The magnetic positioning sensor adapter on the sheath and the magnetic positioning sensor on the atrial septal puncture needle assembly determine the relative position of the sheath and the needle tip, ensuring the needle tip is positioned at the top of the sheath dilator 201 without protruding from the sheath. The magnetic positioning sensor at the tip of the atrial septal puncture needle calculates the accurate position of the needle tip, thereby obtaining the position of the atrial septal puncture assembly (including the sheath and the atrial septal puncture needle assembly). The ring electrodes 108 of the sheath collect intracardiac electric field information, allowing for the calculation of the relative positions of each component. Using the magnetic and electric field position information, the accurate position of the adjustable guiding sheath within the cardiac chamber can be calculated, and a cardiac physical model can be established to locate the fossa ovalis 401.

[0050] like Figure 9 , 10 As shown, when the adjustable-bend guide sheath is manipulated and its tip is perpendicular to the plane of the fossa ovalis 401, the atrial septal puncture needle assembly is pushed to puncture the fossa ovalis 401 and reach the left atrium. The puncture needle sensor assembly is then withdrawn. If the blood returning through the needle is venous blood, it proves that the puncture position is correct. The atrial septal puncture needle assembly is fixed to ensure that the needle tip does not continue to penetrate the left atrium. The adjustable-bend guide sheath is pushed forward. When the electrophysiological signal collected by the sheath ring electrode 108 changes from a right atrial signal to a left atrial signal, the push of the adjustable-bend guide sheath is stopped. The accurate position of the distal end 100 of the sheath can also be displayed in the cardiac physical model. At this point, the atrial septal puncture is completed. The atrial septal puncture needle and dilator 201 are withdrawn, and the catheter atrial septal channel is constructed. When the magnetically positioned electrophysiological catheter enters the adjustable-bend guide sheath, the relative position of the catheter and the magnetic positioning sensor adapter in the sheath can be monitored in real time to determine whether the catheter tip has extended from the distal end 100 of the sheath.

[0051] The procedure for using the transseptal puncture device is as follows:

[0052] Step 1: Vascular puncture to insert the adjustable guide sheath into the right atrium;

[0053] Step 2: Using the magnetic positioning sensor adapters Y1 and Y2 and the ring electrode 108 on the adjustable bendable guide sheath, in conjunction with the atrial septum puncture needle assembly with magnetic positioning sensor M1, the sheath is manipulated to construct a physical model of the right atrium.

[0054] Step 3: Determine the location range of the fossa 401 based on the established physical model;

[0055] Step 4: Use the magnetic positioning sensor adapters Y1 and Y2 on the adjustable bendable guide sheath and the positioning sensor M1 on the puncture needle assembly to determine the relative positions of each component. The tip of the puncture needle must not extend beyond the sheath. Simultaneously, the scale markings on the puncture needle handle can help determine the relative position of the puncture needle and the sheath.

[0056] Step 5: Adjust the controllable curved guide sheath so that the tip of the interatrial septum puncture needle is perpendicular to the plane of the fossa ovalis 401.

[0057] Step 6: Atrial septal puncture. Advance the atrial septal puncture needle until the needle tip passes through the fossa ovalis 401. Withdraw the atrial septal puncture needle positioning sensor assembly and observe the blood return from the needle assembly. If the returned blood is bright red arterial blood, the puncture is successful.

[0058] Step 7: Secure the atrial septal puncture needle assembly, ensuring the needle tip does not penetrate further into the left atrium. Push the adjustable guide sheath perpendicular to the fossa ovalis 401 along the puncture direction of the needle. The distal end 100 of the sheath passes through the fossa ovalis 401. Observe the electrophysiological signals acquired by the sheath ring electrode 108. If the electrophysiological signal changes from a right atrial signal to a left atrial signal, it proves that the distal end of the sheath has passed through the fossa ovalis 401. Remove the atrial septal puncture needle assembly and dilator 201. The atrial septal passage is now constructed. Insert the electrophysiological catheter to continue the procedure.

[0059] Example 2

[0060] The difference between this embodiment and the previous embodiment is that this embodiment also includes a processor. The processor is connected to the puncture needle positioning sensor M1 and the ring electrode 108. The processor constructs a physical model of the right atrium based on the information collected by the puncture needle positioning sensor M1 and the ring electrode 108, and marks the position of the fossa ovalis in the model.

[0061] The processor determines the relative position of the sheath and the puncture needle based on the information collected by the puncture needle positioning sensor M1.

[0062] The processor determines, based on the information collected by the ring electrode 108, whether the distal end 100 of the sheath enters the left atrium from the right atrium through the fossa ovalis 401 by comparing the electrophysiological signals of the right and left atria.

[0063] Therefore, the procedure for using the transseptal puncture device in this embodiment is as follows:

[0064] Step 1: Vascular puncture to insert the adjustable guide sheath into the right atrium;

[0065] Step 2: The processor uses the magnetic positioning sensor adapters Y1 and Y2 and the ring electrode 108 on the adjustable bendable guide sheath, in conjunction with the atrial septum puncture needle assembly with magnetic positioning sensor M1, to manipulate the sheath to construct a physical model of the right atrium.

[0066] Step 3: The processor determines the location range of the fossa 401 based on the established physical model;

[0067] Step 4: The processor uses the magnetic positioning sensor adapters Y1 and Y2 on the adjustable bendable guide sheath and the positioning sensor M1 on the puncture needle assembly to determine the relative positions of each component. The tip of the puncture needle must not extend out of the sheath. Simultaneously, the scale markings on the puncture needle handle position can assist in determining the relative position of the puncture needle and the sheath.

[0068] Step 5: Adjust the controllable curved guide sheath so that the tip of the interatrial septum puncture needle is perpendicular to the plane of the fossa ovalis 401.

[0069] Step 6: Atrial septal puncture. Advance the atrial septal puncture needle until the needle tip passes through the fossa ovalis 401. Withdraw the atrial septal puncture needle positioning sensor assembly and observe the blood return from the needle assembly. If the returned blood is bright red arterial blood, the puncture is successful.

[0070] Step 7: Secure the atrial septal puncture needle assembly, ensuring the needle tip does not penetrate further into the left atrium. Push the adjustable guide sheath perpendicular to the fossa ovalis 401 along the puncture direction of the needle. The distal end 100 of the sheath passes through the fossa ovalis 401. The processor processes the electrophysiological signals acquired by the sheath ring electrode 108. If the electrophysiological signal changes from a right atrial signal to a left atrial signal, it proves that the distal end of the sheath has passed through the fossa ovalis 401. Remove the atrial septal puncture needle assembly and dilator 201. The atrial septal passage is now constructed. Insert the electrophysiological catheter to continue the procedure.

[0071] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An atrial septal puncture assembly, comprising: The adjustable bending guide sheath assembly and the atrial septum puncture needle assembly are included. The adjustable bending guide sheath assembly includes a sheath distal end (100) and an adjustable bending section (101), the distal end of the sheath distal end (100) is provided with two ring electrodes (108), the ring electrodes (108) are used to collect the cardiac electrophysiological signals, and then it is judged whether the sheath distal end (100) successfully passes through the atrial septum; the sheath distal end (100) is also provided with two positioning sensor adapters, which are used to determine the relative position between the sheath and the atrial septum puncture needle. The atrial septum puncture needle assembly includes a needle tube assembly and a sensor assembly, the needle tube assembly and the sensor assembly are adapted, the sensor assembly is lined in the inside of the needle tube assembly, the sensor assembly can be inserted and pulled out separately, the sensor assembly includes a puncture needle positioning sensor (M1), the puncture needle positioning sensor (M1) is located at the top of the needle tip, which is used to determine the position of the puncture needle tip and its relative position with other components, the ring electrode (108) cooperates with the puncture needle positioning sensor (M1), without magnetic positioning catheter, the heart cavity modeling can be completed, and the location of the oval fossa is calibrated.

2. An atrial septostomy assembly according to claim 1, wherein, The cardiac right atrial and left atrial electrophysiological signals collected by the ring electrode (108) are different, by comparing the cardiac right atrial and left atrial electrophysiological signals, it is judged whether the sheath distal end (100) enters the left atrium from the right atrium through the oval fossa.

3. An atrial septostomy assembly according to claim 1 wherein, The adjustable bending section (101) is provided with a plurality of ring electrodes (108), the ring electrodes (108) are used to collect the cardiac electrophysiological signals and assist positioning after being matched with the positioning sensor.

4. An atrial septostomy assembly according to claim 1 wherein, The positioning sensor adapter includes a first sheath distal end positioning sensor adapter (Y1) and a second sheath distal end positioning sensor adapter (Y2), the second sheath distal end positioning sensor adapter (Y2) is arranged close to the adjustable bending section (101).

5. An atrial septostomy assembly according to claim 1 wherein, The sheath distal end (100) is provided with an exhaust hole (110), the exhaust hole (110) is arranged at a distance of 3-5 mm from the distal end of the sheath.

6. An atrial septostomy assembly according to claim 1 wherein, The puncture needle positioning sensor (M1) is a magnetic positioning coil.

7. An atrial septostomy assembly according to claim 1 wherein, The puncture needle close to the handle position is marked with a scale, which can determine the relative position of the needle tip and the sheath distal end.

8. An atrial septostomy assembly according to any one of claims 1-7, wherein, It also includes a processor, the processor is connected with the puncture needle positioning sensor (M1) and the ring electrode (108), the processor constructs the right atrial physical model according to the information collected by the puncture needle positioning sensor (M1) and the ring electrode (108), and calibrates the location of the oval fossa in the model.

9. An atrial septostomy assembly according to claim 8, wherein, The processor determines the relative position of the sheath and the puncture needle according to the information collected by the puncture needle positioning sensor (M1).

10. An atrial septostomy assembly according to claim 8, wherein, The processor determines whether the sheath distal end (100) enters the left atrium from the right atrium through the oval fossa according to the information collected by the ring electrode (108) by comparing the cardiac right atrial and left atrial electrophysiological signals.

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