Dilator for three-dimensional atrial septal puncture

Abstract

This invention discloses a dilator for three-dimensional atrial septal puncture, comprising a tube body including a central chamber, a distal end, and a proximal end. The distal end of the tube body has a curved structure, and a cutting end is provided at the distal end of the curved structure. The dilator of this invention allows the position of the needle tip to be accurately displayed in real time in a three-dimensional system, and eliminates the risk of needle tip damage to the superior vena cava and endocardial tissue in other three-dimensional puncture methods.

Description

Technical Field

[0001] This invention relates to a dilator for three-dimensional atrial septal puncture. Background Technology

[0002] Radiofrequency ablation under three-dimensional system guidance is the preferred treatment for atrial fibrillation. One of the important steps in completing this procedure is atrial septal puncture.

[0003] Currently, the mainstream atrial septal puncture procedure both domestically and internationally remains X-ray fluoroscopy-guided atrial septal puncture. This technique, developed over half a century ago, is a two-dimensional planar view. X-rays cannot directly determine the location of the fossa ovalis, and lack precise three-dimensional structural indications. Mastering this technique requires extensive clinical experience. If the patient has cardiac variations, the puncture becomes extremely difficult. Obese patients and those with low X-ray machine clarity further negatively impact the success rate and safety. Intracardiac echocardiography-guided atrial septal puncture adds an intracardiac echocardiography (ICE) catheter to X-ray fluoroscopy. While this increases the accuracy of localization, it is still primarily a two-dimensional planar technique, struggling to accurately represent the true three-dimensional space of the heart. Furthermore, it lacks electrical analysis for fossa ovalis localization, making even more precise localization difficult. The need for relevant cardiac ultrasound knowledge and expensive ultrasound catheters significantly raises the equipment and technical barriers.

[0004] In recent years, with the increasingly widespread application of three-dimensional systems, a novel three-dimensional atrial septal puncture method has emerged. This method operates entirely within a three-dimensional interface, eliminating the need for X-rays and contrast agents. It not only improves the accuracy and success rate of atrial septal puncture but also significantly enhances safety. One of the key steps in this method is the visualization of the guidewire and atrial septal puncture needle. In the three-dimensional system, any good conductor, such as a guidewire or puncture needle, can be defined as a binary mapping catheter, and the conductor is connected to the three-dimensional mapping system via corresponding binary connecting wires. During puncture, the guidewire and long sheath are first inserted into the superior vena cava. Using a catheter equipped with a magnetic positioning device, the long sheath is then inserted into the superior vena cava, and then exchanged for an inner sheath dilator and guidewire. The guidewire is always kept outside the inner sheath dilator. When the distal end of the guidewire protrudes 1-2 mm beyond the inner sheath dilator, the tip of the guidewire can be visualized in the three-dimensional system. The guidewire is then exchanged for the atrial septal puncture needle. The relative position of the puncture needle and the long sheath is determined by the length of the needle handle remaining outside the long dilator; this confirms the location of the atrial septal puncture needle.

[0005] Finally, the three-dimensional structure of the right atrium was reconstructed, and the septal puncture needle was visualized using a three-dimensional mapping system. When the needle tip protrudes 1-2 mm from the sheath, the needle can be displayed on the three-dimensional mapping system, allowing the determination of its position within the heart and blood vessels. Pointing the needle handle indicator and the long sheath towards the 4-5 o'clock position while pulling down, the movement of the needle can be observed in the three-dimensional system. When the needle slides to the marked puncture point, i.e., the foramen ovale of the atrial septum, a feeling of emptiness is usually felt, allowing for a trial puncture. A breakthrough sensation is typically felt upon passing through the septum. At this point, the needle can be clearly seen entering the left atrium approximately 1 cm in the three-dimensional system. If image fusion is used, the three-dimensional spatial relationship between the needle and structures such as the left and right atria and the aorta can be clearly seen.

[0006] The problem with this puncture method is that the needle tip must always protrude 1-2 mm from the inner sheath in order to display the position of the puncture needle in real time in the three-dimensional system. When the septal puncture needle slides from the superior vena cava to the foramen ovale puncture point, the needle tip may cause damage to the superior vena cava and endocardial tissue. There is an urgent need for a new dilator head structure that can complete the puncture procedure with reduced or no X-rays or intracardiac ultrasound guidance, and reduce or eliminate the damage to the superior vena cava and endocardial tissue caused by the needle tip.

[0007] Therefore, a new type of expander is needed. Summary of the Invention

[0008] A three-dimensional dilator for atrial septal puncture includes a tube body comprising a central chamber, a distal end, and a proximal end. The distal end of the tube body has a curved structure, and the distal end of the curved structure has a cutting opening.

[0009] According to one embodiment of the present invention, the cutting edge is an inclined cutting edge.

[0010] The distance between the proximal edge of the cutting opening and the distal end face of the curved structure is 1-3 mm, preferably 1 mm.

[0011] According to one embodiment of the present invention, the cutting edge is a horizontal cutting edge, which is arranged along the axial direction of the expander.

[0012] The distal end of the cutting edge cuts into the distal end face of the curved structure.

[0013] The cross-section of the cutting edge is rectangular, elliptical, square, or irregular in shape.

[0014] The cross-sectional area of ​​the cutting opening gradually decreases from the near end to the far end, and then gradually increases again near the far end face of the tube body.

[0015] The cutting edge is located in the direction perpendicular to the curved plane of the curved structure.

[0016] Preferably, the cutting edge is located on the outer side of the bend of the curved structure.

[0017] The distal end of the central chamber of the tube is a stepped end face.

[0018] The distance between the stepped end face and the far end face of the curved structure is 8-9 mm.

[0019] According to a three-dimensional dilator for atrial septal puncture in one embodiment of the present invention, the distal end of the tube is provided with a cutting end, so that the tip of the atrial septal puncture needle can be electrically connected with the blood. The three-dimensional system can display the position of the needle tip in real time, eliminating the risk of the needle tip causing damage to the superior vena cava and endocardial tissue. Attached Figure Description

[0020] Figure 1 The diagram shows the structure of the dilator 10 for three-dimensional atrial septal puncture.

[0021] Figure 2 The diagram shown is a schematic diagram of the distal structure of a three-dimensional atrial septal puncture dilator 10 according to an embodiment of the present invention.

[0022] Figure 3 What is shown is along Figure 2 Sectional view of line AA in the middle;

[0023] Figure 4 The diagram shown is a schematic diagram of the distal structure of a three-dimensional septal puncture dilator 100 according to another embodiment of the present invention.

[0024] Figure 5 What is shown is along Figure 4 Sectional view of the middle BB line;

[0025] Figure 6 What is shown is Figure 5 Enlarged view of point I in the middle. Detailed Implementation

[0026] The technical solution of the present invention will be further described in detail below through embodiments and in conjunction with the accompanying drawings, but the present invention is not limited to the following embodiments.

[0027] Figure 1 The diagram shows the structure of the dilator 10 for three-dimensional atrial septal puncture. Figure 2 The diagram shown is a schematic diagram of the distal structure of a three-dimensional atrial septal puncture dilator 10 according to an embodiment of the present invention. Figure 3 What is shown is along Figure 2 A cross-sectional view along line AA. (e.g.) Figure 1 , Figure 2 and Figure 3As shown, a three-dimensional atrial septal puncture dilator 10 includes a tube body 15, which includes a central chamber, a distal end, and a proximal end. The proximal end of the tube body 15 can be connected to a connector 14, which can be a Luer connector. The distal end of the tube body 15 is a curved structure 16. The distal end of the curved structure 16 is provided with an inclined cutting opening 17, the cross-section of which can be any suitable shape, such as an arc. The distance between the proximal edge of the cutting opening 17 and the distal end face of the curved structure 16 is 1-3 mm, preferably 1 mm. The cutting opening 17 is located in the direction perpendicular to the curved plane of the curved structure 16. The cutting opening 17 can be located on either side of the curve of the curved structure 16, such as the outer or inner side. According to one embodiment of the present invention, the cutting opening 17 is located on the outer side of the curve of the curved structure 16. The distal end of the cutting opening 17 may cut to the distal end face of the curved structure 16, or it may not cut to the distal end face of the curved structure 16. That is, the distal end of the cutting opening 17 may be a certain distance away from the distal end face of the curved structure 16.

[0028] When the tip of the atrial septal puncture needle moves to the cutting opening 17, electrical conductivity is achieved between the needle tip and the blood. At this point, the atrial septal puncture needle can be displayed on the three-dimensional mapping system, allowing the determination of its position in the heart and blood vessels. When the dilator slides in the superior vena cava, because the distal end face of the curved structure 16 directly contacts the tissue, and the cutting opening 17 does not directly contact the tissue, the risk of damage to the superior vena cava and endocardial tissue caused by the atrial septal puncture needle tip can be eliminated. Even if the distal end of the cutting opening 17 cuts into the distal end face of the curved structure 16, the needle tip only slightly protrudes from the cutting opening 17 to achieve blood conductivity, and since the cutting opening 17 does not directly contact the tissue, it will not cause tissue damage.

[0029] The septal puncture needle can pass through the central chamber of the tube body 15. The distal end of the central chamber of the tube body 15 is a stepped end face 19, and the distance between the stepped end face 19 and the distal end face of the curved structure 16 is 8-9 mm. The stepped end face 19 is used to limit the extension length of the septal puncture needle to avoid the danger caused by excessive needle extension.

[0030] In use, the dilator 10 according to an embodiment of the present invention first inserts a long sheath into the superior vena cava using a catheter equipped with a magnetic positioning device, and then exchanges it for the dilator 10 and a guidewire. The guidewire remains outside the dilator 10 at all times. When the tip of the guidewire extends 1-2 mm beyond the dilator 10, the tip of the guidewire can be displayed in the three-dimensional system, confirming that the guidewire and dilator are located in the superior vena cava. Then, the guidewire is exchanged for an atrial septal puncture needle. When the needle tip slightly protrudes from the cutting opening 17, electrical communication is established between the needle tip and the blood. At this point, the atrial septal puncture needle can be displayed on the three-dimensional mapping system, allowing the determination of its position in the heart and blood vessels. By aligning the needle handle indicator and the long sheath coaxially and pulling them down simultaneously, the movement of the puncture needle can be seen in the three-dimensional system. When the puncture needle slides to the puncture point marked by the three-dimensional system, i.e., the foramen ovale of the atrial septum, a feeling of emptiness is generally felt, allowing for a trial puncture. Upon passing through the septum, a feeling of breakthrough and a change in intracardiac pressure are generally felt. At this point, the puncture needle entering the left atrium can be clearly seen in the three-dimensional system. If image fusion is performed, the three-dimensional spatial relationship between the puncture needle and structures such as the left and right atria and the aorta can be clearly seen.

[0031] Figure 4 The diagram shown is a schematic diagram of the distal structure of a three-dimensional septal puncture dilator 100 according to another embodiment of the present invention. Figure 5 What is shown is along Figure 4 Sectional view of the middle BB line; Figure 6 What is shown is Figure 5 Enlarged view at point I. The cutting edge 170 is a horizontal cutting edge, positioned axially along the expander. The cross-section of the cutting edge 170 can be any suitable shape, such as rectangular, elliptical, square, or irregular. According to one embodiment of the present invention, as... Figure 4 , Figure 5 and Figure 6 As shown, the cross-sectional area of ​​the cutting opening 170 gradually decreases from its proximal end to its distal end, and then gradually increases again near the distal end face of the tube body 150. This shape ensures the support force at the distal end of the tube body 150. The cutting opening 170 is located in the direction perpendicular to the curved plane of the curved structure. The distal end of the cutting opening 170 can cut to the distal end face of the curved structure. The remaining structure of the three-dimensional atrial septal puncture dilator 100 is the same. Figures 2 to 3 As shown.

[0032] The embodiments of the present invention are not limited to those described above. Without departing from the spirit and scope of the present invention, those skilled in the art can make various changes and improvements to the present invention in form and detail, and these are all considered to fall within the protection scope of the present invention.

Claims

1. A dilator for three-dimensional atrial septal puncture, characterized in that... Includes a tube body, the tube body comprising a central chamber, a distal end, and a proximal end; The distal end of the tube is a curved structure; The distal end of the curved structure is provided with a cutting edge; The cutting edge is an inclined cutting edge; The inclined cutting edge has an arc-shaped cut perpendicular to the tube's axial direction and does not directly contact the tissue. The distance between the proximal edge of the cutting opening and the distal end face of the curved structure is 1-3 mm; The distal end of the central chamber of the tube is a stepped end face, which is an isosceles trapezoid with a shorter side near the cutting edge and a longer side near the joint, and there is no step transition at the connection between the two sides. The distance between the stepped end face and the distal end face of the curved structure is 8-9 mm; When the tip of the interventricular septal puncture needle moves to the cutting opening, the needle tip becomes electrically connected to the blood.

2. The dilator for three-dimensional atrial septal puncture according to claim 1, characterized in that... The cutting edge is a horizontal cutting edge, which is set upward along the axial direction of the expander.

3. The dilator for three-dimensional atrial septal puncture according to claim 2, characterized in that... The distal end of the cutting edge cuts into the distal end face of the curved structure.

4. The dilator for three-dimensional atrial septal puncture according to claim 2 or 3, characterized in that... The cross-section of the cutting edge is rectangular, elliptical, square, or irregular in shape.

5. The dilator for three-dimensional atrial septal puncture according to claim 4, characterized in that... The cross-sectional area of ​​the cutting opening gradually decreases from the near end to the far end, and then gradually increases again near the far end face of the tube body.

6. The dilator for three-dimensional atrial septal puncture according to claim 5, characterized in that... The cutting edge is located in the direction perpendicular to the curved plane of the curved structure.

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