3D Transseptal Puncture Kit

Abstract

The present invention discloses a three-dimensional atrial septal puncture assembly, comprising an atrial septal puncture needle and a dilator, wherein the dilator comprises a dilator tube body, the dilator tube body comprises a central chamber, a distal end and a proximal end, a small hole is provided on the distal end of the dilator tube body, a contact assembly is provided in the small hole, and the contact assembly comprises an elastic element; the proximal end of the dilator tube body is connected to a Luer connector. The three-dimensional atrial septal puncture assembly of the present invention enables the position of the atrial septal puncture needle tip to be displayed in real time in a three-dimensional system, reducing or eliminating the risk of the needle tip causing damage to the superior vena cava and endocardial tissue.

Description

Technical Field

[0001] The invention relates to a three-dimensional atrial septal puncture component. Background Art

[0002] There are more than 12 million patients suffering from atrial fibrillation in China. Radiofrequency ablation under the guidance of a three-dimensional system is the first choice for curing atrial fibrillation. One of the important steps to complete this operation is atrial septal puncture.

[0003] At present, the mainstream atrial septum puncture in China is still atrial septum puncture under the guidance of X-ray fluoroscopy. This is a two-dimensional plane perspective technology developed more than half a century ago. It lacks the precise instructions given by three-dimensional space. It takes a long time of clinical accumulation to master this technology. If the patient's heart is abnormal, the puncture is extremely difficult. The success rate and safety of the puncture are further affected by obese patients and when the X-ray machine has low clarity. The atrial septum puncture under the guidance of intracardiac ultrasound advocated by foreign countries, especially the United States, is to add an intracardiac ultrasound (ICE) catheter to the basis of X-ray fluoroscopy. Although it increases the accuracy of positioning, it is generally a two-dimensional plane technology, which is difficult to well reflect the real three-dimensional spatial feeling of the heart. In addition, due to the need for corresponding cardiac ultrasound knowledge and expensive ultrasound catheters, it actually greatly increases the threshold of equipment and technology.

[0004] In recent years, with the increasing application of three-dimensional systems, a new type of three-dimensional atrial septal puncture method has been derived, which is completely operated under the three-dimensional interface and does not require X-rays and contrast agents. It can not only improve the accuracy and success rate of atrial septal puncture, but also ensure safety. The key step of this puncture method is the visualization of the guidewire and the atrial septal puncture needle. In the three-dimensional system, any good conductor, such as a guidewire or a puncture needle, can be defined as a bipolar mapping catheter, and the conductor is connected to the three-dimensional mapping system through a bipolar connecting tail line. During puncture, the guidewire and the long sheath are first sent into the superior vena cava. The long sheath is sent into the superior vena cava using a catheter with a magnetic positioning device, and then replaced with an inner sheath plus a guidewire. The guidewire is always kept outside the inner sheath. When the distal end of the guidewire extends 2 to 3 mm outside the inner sheath, the tip of the guidewire can be displayed in the three-dimensional system. Then the guidewire is exchanged for the atrial septal puncture needle, and the relative position of the puncture needle and the long sheath is judged by the length of the puncture needle handle left outside the long sheath; in this way, the position of the atrial septal puncture needle is confirmed.

[0005] Finally, the atrial septal puncture needle is visualized using a three-dimensional mapping system. When the needle tip is 2 to 3 mm out of the sheath, the needle can be seen on the three-dimensional mapping system and the position of the needle in the heart and blood vessels can be determined. Point the direction of the puncture needle handle indicator and the long sheath to the 4 o'clock direction, and pull down at the same time. The movement of the puncture needle can be seen in the three-dimensional system. When the puncture needle slides to the marked puncture point, that is, the location of the oval foramen of the atrial septum, there will generally be a sense of failure and a trial puncture can be performed. There will generally be a sense of breakthrough when passing through the septum. At this time, the three-dimensional system can clearly see that the puncture needle has entered the left atrium 1 to 1.5 cm. If there is image fusion, 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.

[0006] The problem with this puncture method is that the needle tip must always be exposed 2 to 3 mm from the inner sheath so that the position of the puncture needle can be displayed in real time in the three-dimensional system. When the atrial septal puncture needle slides from the superior vena cava meridian to the foramen ovale puncture point, the needle tip may cause damage to the superior vena cava and endocardial tissue. Now, a new dilator head structure is urgently needed to complete the puncture with reduced or no need for X-rays or echocardiographic guidance, and to reduce or eliminate damage to the superior vena cava and endocardial tissue caused by the needle tip.

[0007] Therefore, a novel three-dimensional transseptal puncture assembly is needed. Summary of the invention

[0008] A three-dimensional atrial septal puncture assembly comprises an atrial septal puncture needle and a dilator, wherein the dilator comprises a dilator tube body, the dilator tube body comprises a central chamber, a distal end and a proximal end, a small hole is arranged on the distal end of the dilator tube body, a contact assembly is arranged in the small hole, and the contact assembly comprises an elastic element; the proximal end of the dilator tube body is connected to a Luer connector.

[0009] The contact assembly includes an elastic element and a sliding element.

[0010] The contact assembly also includes a frame and an end cover.

[0011] The elastic element is a spring, which is arranged in the frame, and the sliding element is arranged on the top of the elastic element.

[0012] The sliding element is a sphere, a cylinder or a combination of a sphere and a cylinder.

[0013] The elastic element is formed by bending a metal sheet.

[0014] The elastic element comprises an arc-shaped portion at the top and a main body portion, one side of the main body portion is fixed to the frame, and the other side is suspended.

[0015] The distance between the center of the small hole and the distal end surface of the dilator tube body is 3-20 mm; preferably, the distance between the center of the hole and the distal end surface of the dilator tube body is 5-15 mm.

[0016] The small holes are arranged on one side or both sides of the distal end of the dilator tube body; preferably, small holes are arranged on both sides of the distal end of the dilator tube body, and the two small holes are through holes.

[0017] The cross section of the small hole is circular or rectangular.

[0018] When the small hole is a circular hole, the diameter is 0.6-1.2 mm; preferably, the diameter of the hole is 0.85 mm.

[0019] The distal end diameter of the central chamber of the dilator tube body decreases from large to small, and the length of the section with a smaller diameter is 8-9 mm.

[0020] Contact assemblies are arranged on both sides of the distal end of the expander tube body.

[0021] A method for performing atrial septal puncture using the above-mentioned three-dimensional atrial septal puncture assembly comprises the following steps:

[0022] A long sheath is delivered into the superior vena cava through a catheter with a magnetic positioning device, then exchanged for a dilator and a guidewire, and the guidewire is positioned using a three-dimensional system;

[0023] The guide wire is replaced with an atrial septal puncture needle. When the needle tip and the side wall of the needle body completely cover the hole or the needle tip and the side wall of the needle body are in contact with the sliding element, the atrial septal puncture needle achieves electrical conduction with the blood through the contact assembly, which is displayed in real time in the three-dimensional system.

[0024] Move the atrial septal puncture needle. When the puncture needle slides to the position of the atrial septal foramen ovale, puncture can be performed.

[0025] According to the three-dimensional atrial septal puncture assembly described in one embodiment of the present invention, by punching a hole in the side wall of the dilator head and placing a contact assembly, the part of the atrial septal puncture needle close to the needle tip can be electrically connected with the blood. When the needle tip is hidden in the dilator, the three-dimensional system can display the needle tip position in real time, reducing or eliminating the risk of damage to the superior vena cava and endocardial tissue caused by the needle tip. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 Shown is a schematic structural diagram of a three-dimensional atrial septal puncture assembly;

[0027] Figure 2 Shown is a schematic diagram of the distal structure of the dilator;

[0028] Figure 3 Shown is along Figure 2Sectional view along line AA;

[0029] Figure 4 Shown is a top view of the contact assembly;

[0030] Figure 5 Shown is a cross-sectional view along line BB in the figure;

[0031] Figure 6 Shown is a cross-sectional view of the contact assembly after assembly;

[0032] Figure 7 Shown is a schematic diagram of the distal structure of a three-dimensional atrial septal puncture assembly according to another embodiment;

[0033] Figure 8 Shown is along Figure 7 Sectional view of the mid-CC line;

[0034] Fig. 9 Shown is a top view of the contact assembly;

[0035] Fig.10 Shown is a cross-sectional view along line DD in the figure;

[0036] Fig.11 It is a partial enlarged view according to an embodiment of the present invention. DETAILED DESCRIPTION

[0037] The technical solution of the present invention is further described in detail below through embodiments and in combination with the accompanying drawings, but the present invention is not limited to the following embodiments.

[0038] Figure 1 Shown is a schematic structural diagram of a three-dimensional atrial septal puncture assembly 10; Figure 2 Shown is a schematic diagram of the distal structure of a dilator 30 according to an embodiment of the present invention; Figure 3 Shown is along Figure 2 The cross-sectional view of the AA line. Figure 1 , Figure 2 and Figure 3As shown, the three-dimensional atrial septal puncture assembly 10 includes an atrial septal puncture needle 20 and a dilator 30, wherein the dilator includes a dilator body, and the dilator body includes a central chamber, a distal end, and a proximal end. A small hole 33 is provided on the distal end of the dilator body, and the cross section of the small hole 33 can be any suitable shape, such as a circle, an oblong, a rectangle or a square. When the cross section of the small hole 33 is a circular hole, its diameter can be 0.6-1.2 mm, preferably 0.85 mm. The distance between the center of the small hole 33 and the distal end face of the dilator body is 3-20 mm, preferably 5-15 mm. The small hole 33 can be arranged on one side of the distal end of the dilator body, or on both sides thereof. When holes are provided on both sides, the two small holes can be connected or not connected. The small hole 33 includes 1-3 groups of small holes, preferably, two groups of small holes are provided. The proximal end of the dilator body is connected with a Luer connector 34.

[0039] The dilator tube body can be used for medical devices, such as an atrial septal puncture needle. The diameter of the distal end of the central chamber of the dilator tube body changes from large to small, and the length of the section with a smaller diameter is 8-9 mm. This structure can limit the needle length of the atrial septal puncture needle and avoid the danger caused by the needle being too long.

[0040] The atrial septal puncture needle 20 includes a distal end and a proximal end. The needle body of the puncture needle 20 can be formed by one section of tube or two sections of tube. The diameter of the distal end of the needle body of the puncture needle 20 is smaller than the diameter of the proximal end. The needle body of the puncture needle 20 can be made of a metal conductive material, such as stainless steel. The exterior of the needle body can also be coated with an insulating layer or covered with an insulating tube, and the needle tip is exposed without an insulating layer or an insulating tube.

[0041] A hemostatic valve 21 is disposed at the proximal end of the puncture needle 20, and a guide wire 22 is disposed on the hemostatic valve 21. The proximal end of the guide wire 22 is connected to the insertion needle.

[0042] Figure 4 Shown is a top view of the contact assembly 35; Figure 5 Shown is along Figure 4 Sectional view along the midline BB; Figure 6 The figure shows a cross-sectional view of the contact assembly 35 after assembly. Figures 4 to 6 As shown, the cross section of the small hole 33 is circular, and a contact assembly 35 is arranged in the small hole 33. The contact assembly 35 includes an elastic element 51 and a sliding element 52. The elastic element 51 can be a spring or other suitable element, and the sliding element 52 can be a suitable element such as a sphere, a cylinder, or a combination of a sphere and a cylinder. The elastic force of the elastic element can make the sliding element 52 and the needle body of the atrial septal puncture needle achieve reliable contact.

[0043] The contact assembly 35 may also include a frame 53 and an end cap 54, and the end cap 54 may be fixed to the frame by any suitable means, such as welding. The elastic element 51 is arranged inside the frame 53, and the sliding element 52 is arranged on the top of the elastic element 51. The elastic element 51, the sliding element 52, the frame 53 and the end cap 54 are all made of conductive materials. An annular groove (not shown in the figure) may also be provided in the small hole 33, and the frame 53 may also be provided with a corresponding annular protrusion, so that the frame 53 can be snapped into the annular groove and is relatively firm.

[0044] The contact assembly 35 is pre-buried in the small hole 33 by hot melting. The top of the sliding element 52 protrudes from the inner surface of the tube body of the dilator 30. When the atrial septal puncture needle passes through the dilator 30, the contact force between the distal end of the dilator 30 and the atrial septal puncture needle is determined by the pressing force of the elastic element 51. The contact assembly 35 can also be arranged on both sides of the distal end of the dilator 30.

[0045] When the side wall of the needle tip and the needle body of the atrial septal puncture needle completely covers the small hole 33 or the side wall of the needle tip and the needle body contacts the sliding element 52, electrical conduction is achieved with the blood through the contact assembly 35. At this time, the needle display can be seen on the three-dimensional mapping system and the position of the needle in the heart and blood vessels can be determined.

[0046] When the three-dimensional atrial septum assembly 10 according to one embodiment of the present invention is used, the long sheath is first sent into the superior vena cava using a catheter with a magnetic positioning device, and then replaced with a dilator 30 and a guide wire. When the distal end of the guide wire extends 2 to 3 mm outside the dilator 30, the head end of the guide wire can be displayed in the three-dimensional system, so that the guide wire can be positioned by the three-dimensional system. Then the guide wire is replaced with an atrial septum puncture needle. When the side wall of the needle tip and the needle body completely covers the small hole 33 or the side wall of the needle tip and the needle body are in contact with the sliding element 51, the needle tip and the needle body are electrically connected with the blood through the contact assembly 35. At this time, the display of the atrial septum puncture needle can be seen on the three-dimensional mapping system, thereby judging the position of the puncture needle in the heart and blood vessels. Point the direction of the puncture needle handle indicator and the long sheath to the 4 o'clock direction, and pull down at the same time, and the movement of the puncture needle can be seen in the three-dimensional system. Since the needle tip is located in the dilator 30 as a whole at this time, the needle tip will not cause damage to the superior vena cava and endocardial tissue during the movement. When the puncture needle slides to the marked puncture point, that is, the location of the oval foramen of the atrial septum, there will generally be a sense of missing, and a trial puncture can be performed. When passing through the septum, there will generally be a sense of breakthrough. At this time, the 3D system can clearly see that the puncture needle has entered the left atrium 1 to 1.5 cm. If there is image fusion, the three-dimensional spatial relationship between the puncture needle and the left and right atria and aorta and other structures can be clearly seen.

[0047] Figure 7Shown is a schematic diagram of the distal structure of a dilator 300 according to another embodiment; Figure 8 Shown is along Figure 7 Sectional view of the mid-CC line; Fig. 9 Shown is a top view of the contact assembly 350; Fig.10 Shown is a cross-sectional view along line DD in the figure; Fig.11 The figure shows a partial enlarged view according to an embodiment of the present invention. Figures 7 to 11 As shown, the cross section of the small hole 330 is rectangular, and a contact assembly 350 made of a conductive material is disposed in the small hole 330. The contact assembly 350 includes an elastic element 510, which can be formed by bending a metal sheet or other suitable elements.

[0048] The contact assembly 350 may further include a frame 530 and an end cap 540. The end cap 540 may be fixed to the frame in any suitable manner, such as by welding. Fig.10 As shown, the elastic element 510 includes an arc-shaped portion at the top and a main body portion, one side of the main body portion can be welded to the frame 530, and the other side is not fixed and is in a suspended state. The arc-shaped portion of the metal sheet protrudes outside the frame. Since the metal sheet is relatively thin and one side is not fixed, when squeezed, the unfixed portion of the metal sheet can move up and down. When the side wall of the needle tip and needle body of the atrial septal puncture needle completely covers the small hole 330 or the side wall of the needle tip and needle body contacts the arc-shaped portion of the elastic element 510, electrical conduction is achieved with the blood through the contact assembly 350. At this time, the needle display can be seen on the three-dimensional mapping system and the position of the needle in the heart and blood vessels can be determined.

[0049] The rest of the structure of the expander is the same as Figures 2 to 6 As shown, the remaining structures of the three-dimensional atrial septal puncture needle assembly are the same as Figures 1 to 7 shown.

[0050] The implementation of the present invention is not limited to the above-mentioned embodiments. Without departing from the spirit and scope of the present invention, ordinary technicians in this field can make various changes and improvements to the present invention in form and detail, and these are considered to fall within the protection scope of the present invention.

Claims

1. A three-dimensional atrial septal puncture assembly, characterized in that It includes an atrial septal puncture needle and a dilator, wherein the dilator includes a dilator tube body, the dilator tube body includes a central chamber, a distal end and a proximal end, a small hole is provided on the distal end of the dilator tube body, a contact assembly is provided in the small hole, the contact assembly includes an elastic element, the contact assembly is used to contact the atrial septal puncture needle, the contact assembly is made of a material with conductive properties, and the needle tip and needle body of the atrial septal puncture needle are electrically connected to the blood through the contact assembly.

2. The three-dimensional atrial septal puncture assembly according to claim 1, characterized in that The cross section of the small hole is circular or rectangular.

3. The three-dimensional atrial septal puncture assembly according to claim 1 or 2, characterized in that The contact assembly also includes a sliding element.

4. The three-dimensional atrial septal puncture assembly according to claim 1 or 2, characterized in that The contact assembly also includes a frame and an end cover.

5. The three-dimensional atrial septal puncture assembly according to claim 4, characterized in that The elastic element is a spring, which is arranged in the frame, and the sliding element is arranged on the top of the elastic element.

6. The three-dimensional atrial septal puncture assembly according to claim 5, characterized in that The sliding element is a sphere, a cylinder or a combination of a sphere and a cylinder.

7. The three-dimensional atrial septal puncture assembly according to claim 1 or 2, characterized in that The elastic element is formed by bending a metal sheet.

8. The three-dimensional atrial septal puncture assembly according to claim 4, characterized in that The elastic element comprises an arc-shaped portion at the top and a main body portion, one side of the main body portion is fixed to the frame, and the other side is suspended.

9. The three-dimensional atrial septal puncture assembly according to claim 1, characterized in that The distance between the center of the small hole and the distal end surface of the dilator tube body is 3-20 mm.

10. The three-dimensional atrial septal puncture assembly according to claim 1, characterized in that The small holes are arranged on one side or both sides of the distal end of the expander tube body.

11. The three-dimensional atrial septal puncture assembly according to claim 4, characterized in that An annular groove is also arranged in the small hole, and an annular protrusion is arranged on the frame.

12. The three-dimensional atrial septal puncture assembly according to claim 11, characterized in that When the small hole is a circular hole, the diameter is 0.6-1.2 mm.

13. The three-dimensional atrial septal puncture assembly according to claim 1, characterized in that The distal end diameter of the central chamber of the dilator tube body decreases from large to small, and the length of the section with a smaller diameter is 8-9 mm.

14. The three-dimensional atrial septal puncture assembly according to claim 1, characterized in that Contact assemblies are arranged on both sides of the distal end of the expander tube body.

15. A method for performing atrial septal puncture using the three-dimensional atrial septal puncture assembly according to any one of claims 1 to 14, characterized in that The method comprises the following steps: delivering a long sheath into the superior vena cava through a catheter with a magnetic positioning device, then exchanging it for a dilator and a guide wire, and positioning the guide wire using a three-dimensional system; exchanging the guide wire for an atrial septal puncture needle, and when the needle tip and the side wall of the needle body completely cover the hole or the needle tip and the side wall of the needle body contact the sliding element, the atrial septal puncture needle achieves electrical conduction with the blood through a contact assembly, which is displayed in real time in the three-dimensional system; moving the atrial septal puncture needle, and performing puncture when the puncture needle slides to the position of the oval foramen of the atrial septum.

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