阅读说明：本技术 三维房间隔穿刺组件 (Three-dimensional interatrial septum puncture assembly ) 是由 蔡衡 于 2018-05-30 设计创作，主要内容包括：本发明公开了一种三维房间隔穿刺组件,包括房间隔穿刺针和扩张器,其中所述扩张器包括扩张器管体,所述扩张器管体包括中心腔室、远端和近端,所述扩张器管体的远端上设有小孔,所述小孔内设有触点组件,所述触点组件包括弹性元件；所述扩张器管体的近端与鲁尔接头连接。本发明的三维房间隔穿刺组件,使得房间隔穿刺针针尖的位置可以在三维系统中实时显示,降低或消除了针尖对上腔静脉及心内膜组织造成损伤的风险。(The invention discloses a three-dimensional interatrial septum puncture assembly, which comprises an interatrial septum puncture needle and an expander, wherein the expander comprises an expander tube body, the expander tube body comprises a central cavity, a far end and a near end, the far end of the expander tube body is provided with a small hole, a contact assembly is arranged in the small hole, and the contact assembly comprises an elastic element; the proximal end of the dilator tube is connected with the luer connector. The three-dimensional interatrial septum puncture assembly enables the position of the needle point of the interatrial septum puncture needle to be displayed in a three-dimensional system in real time, and reduces or eliminates the risk that the needle point damages the superior vena cava and the endocardial tissue.)

1. the utility model provides a three-dimensional interatrial septum puncture assembly, its characterized in that includes interatrial septum pjncture needle and expander, wherein the expander includes the expander body, the expander body includes central cavity, distal end and near-end, be equipped with the aperture on the distal end of expander body, be equipped with the contact subassembly in the aperture, the contact subassembly includes elastic element.

2. the three-dimensional atrial septum puncture assembly of claim 1, wherein the cross-section of the aperture is circular or rectangular.

3. The three-dimensional atrial septum puncture assembly of claim 1 or 2, wherein the contact assembly further comprises a sliding element.

4. The three-dimensional atrial septal puncture assembly of claims 1, 2, or 3, wherein the contact assembly further comprises a frame and an end cap.

5. The three-dimensional atrial septal puncture assembly of the preceding claims, wherein the resilient member is a spring disposed within the frame and the sliding member is disposed on top of the resilient member.

6. The three-dimensional atrial septal puncture assembly of claim 5, wherein the sliding element is a sphere, a cylinder, or a combination of a sphere and a cylinder.

7. The three-dimensional atrial septum puncture assembly of claim 1, 2 or 3, wherein the elastic element is formed by bending a metal sheet.

8. The three-dimensional atrial septal puncture assembly of claim 7 wherein the resilient element comprises an arcuate portion of a tip and a body portion, one side of the body portion being secured to the frame and the other side being suspended.

9. The three-dimensional atrial septal puncture assembly of any of the preceding claims, wherein the center of the aperture is spaced from the distal end face of the dilator tube by a distance of 3-20 mm; preferably, the distance from the center of the hole to the distal end face of the dilator tube body is 5-15 mm.

10. the three-dimensional atrial septal puncture assembly of any of the preceding claims, wherein the small hole is disposed on one or both sides of the distal end of the dilator tube; preferably, both sides of the distal end of the dilator tube body are provided with small holes, and the two small holes are through holes.

11. The three-dimensional atrial septal puncture assembly of any of the preceding claims wherein an annular groove is further defined in the aperture and an annular protrusion is provided on the frame.

12. The three-dimensional atrial septum puncture assembly of claim 11, wherein the diameter of the small hole is 0.6-1.2mm when the small hole is a circular hole; preferably, the diameter of the hole is 0.85 mm.

13. The three-dimensional atrial septal puncture assembly of any of the preceding claims wherein the diameter of the distal end of the central lumen of the dilator tube is reduced from a larger diameter to a smaller diameter, and the length of the smaller diameter is 8-9 mm.

14. The three-dimensional atrial septal puncture assembly of any of the preceding claims wherein the distal end of the dilator tube is bilaterally provided with a contact assembly.

15. A method of performing atrial septal puncture using the three-dimensional atrial septal puncture assembly of claims 1-14 comprising the steps of,

Sending the long sheath into the superior vena cava through a catheter with a magnetic positioning device, then exchanging the long sheath into a dilator and a guide wire, and positioning the guide wire by using a three-dimensional system;

the guide wire is replaced by an interatrial puncture needle, when the side wall of the needle body of the needle point completely covers the hole or the side wall of the needle body of the needle point is contacted with the sliding element, the interatrial puncture needle is electrically conducted with blood through the contact assembly, and the interatrial puncture needle is displayed in a three-dimensional system in real time;

And (4) moving the interatrial septum puncture needle, and puncturing when the puncture needle slides to the position of the interatrial septum foramen ovale.

Technical Field

the invention relates to a three-dimensional interatrial septum puncture assembly.

Background

In China, more than 1200 million patients suffering from atrial fibrillation (atrial fibrillation) adopt a radio frequency ablation method under the guidance of a preferred three-dimensional system for radical atrial fibrillation. One of the important steps in performing this procedure is the atrial septal puncture of the heart.

At present, the interatrial septum puncture technique which is mainstream at home is still the interatrial septum puncture technique under the guidance of X-ray fluoroscopy, which is a technique developed before more than half century under a two-dimensional plane view angle, the accurate indication given by a three-dimensional space is lacked, the long-time clinical accumulation is needed for mastering the technique, the puncture difficulty is extremely high if the heart of a patient is mutated, and the puncture success rate and the puncture safety are more influenced when the definition of an over-fat patient and an X-ray machine is not high. The atrial septal puncture under the guidance of intracardiac ultrasound advocated abroad, particularly in the United states and other countries, is to add an intracardiac ultrasound (ICE) catheter on the basis of X-ray fluoroscopy, although the positioning accuracy is increased, the atrial septal puncture is also a two-dimensional plane technology on the whole, the real three-dimensional spatial sensation of the heart is difficult to be well reflected, and in addition, the equipment and technical thresholds are greatly improved in practice due to the need of corresponding heart ultrasonography knowledge and expensive ultrasound catheters.

In recent years, with the increasingly wide application of three-dimensional systems, a novel three-dimensional interatrial septum puncture method is derived, which is completely operated under a three-dimensional interface and does not need X-rays and contrast agents. Not only can improve the precision and success rate of the atrial septal puncture, but also can completely ensure the safety. The key step of the puncture method is the visualization of the guide wire and the interatrial septum puncture needle. Any good conductor, such as a guidewire or puncture needle, can be defined as a two-pole mapping catheter in a three-dimensional system and accessed into the three-dimensional mapping system through a two-pole connection tail. In puncturing, a guidewire and a long sheath are first introduced into the superior vena cava. The long sheath is delivered into the superior vena cava using a catheter with a magnetic positioning device, and then exchanged for an inner sheath plus guidewire. The guide wire is always kept outside the inner sheath, and when the far end of the guide wire extends out of the inner sheath by 2-3 mm, the head end of the guide wire can be displayed in the three-dimensional system. Then the guide wire is replaced by an interatrial puncture needle, and the relative position of the puncture needle and the long sheath is judged according to the length of the puncture needle handle remained outside the long sheath; thereby confirming the position of the transseptal needle.

And finally, visualizing the atrial septal puncture needle by using a three-dimensional mapping system. When the needle point is 2-3 mm out of the sheath, the display of the needle can be seen on the three-dimensional mapping system, and the position of the needle in the heart and the blood vessel can be judged. The puncture needle handle indicator and the long sheath point to the direction of 4 points, and the puncture needle is pulled down at the same time, so that the movement of the puncture needle can be seen in the three-dimensional system. When the puncture needle slides to the marked puncture point, namely the interatrial foramen ovale position, the falling feeling can be generally realized for trying on, and the breakthrough feeling can be generally realized when the puncture needle passes through the septum. At the moment, the puncture needle can be clearly seen in the three-dimensional system to enter the left atrium by 1-1.5 cm. If image fusion exists, the three-dimensional space relationship between the puncture needle and structures such as the left atrium, the right atrium and the aorta can be clearly seen.

The puncture method has the problems that the position of the puncture needle can be displayed in a three-dimensional system in real time only when the needle point is required to be exposed out of the inner sheath by 2-3 mm all the time, the needle point can damage the superior vena cava and the endocardial tissue when the atrial septal puncture needle is operated to slide from the superior vena cava to the puncture point of the oval foramen, a new dilator head structure is urgently needed, the puncture is completed under the conditions that X rays are reduced or not needed, and the echocardiogram guidance is not needed, and the damage of the needle point to the superior vena cava and the endocardial tissue is reduced or eliminated.

Accordingly, there is a need for a new three-dimensional atrial septum puncture assembly.

disclosure of Invention

a three-dimensional interatrial septum puncture assembly comprises an interatrial septum puncture needle and an expander, wherein the expander comprises an expander tube body, the expander tube body comprises a central cavity, a far end and a near end, the far end of the expander tube body is provided with a small hole, a contact assembly is arranged in the small hole, and the contact assembly comprises an elastic element; the proximal end of the dilator tube is connected with the luer connector.

The contact assembly includes a resilient member. The contact assembly also includes a sliding element.

The contact assembly also includes a frame and an end cap.

The elastic element is a spring and is arranged in the frame, and the sliding element is arranged at the top of the elastic element.

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

The elastic element is formed by bending a metal sheet.

The elastic member includes an arc-shaped portion of a tip end and a body portion having one side fixed to the frame and the other side floating.

The distance between the center of the small hole and the far end face of the dilator tube body is 3-20 mm; preferably, the distance from the center of the hole to the distal end face of the dilator tube body is 5-15 mm.

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

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

When the small holes are round holes, the diameter is 0.6-1.2 mm; preferably, the diameter of the hole is 0.85 mm.

The diameter of the far end of the central cavity of the dilator tube body is reduced from large to small, and the length of the section with the smaller diameter is 8-9 mm.

Contact assemblies are arranged on two sides of the far end of the dilator tube body.

A method for performing atrial septum puncture by using the three-dimensional atrial septum puncture assembly comprises the following steps:

Sending the long sheath into the superior vena cava through a catheter with a magnetic positioning device, then exchanging the long sheath into a dilator and a guide wire, and positioning the guide wire by using a three-dimensional system;

The guide wire is replaced by an interatrial puncture needle, when the side wall of the needle body of the needle point completely covers the hole or the side wall of the needle body of the needle point is contacted with the sliding element, the interatrial puncture needle is electrically conducted with blood through the contact assembly, and the interatrial puncture needle is displayed in a three-dimensional system in real time;

The interatrial septum puncture needle is moved, and when the puncture needle slides to the position of the interatrial septum foramen ovale, puncture can be carried out.

According to the three-dimensional interatrial septum puncture assembly in one embodiment of the invention, the part of the interatrial septum puncture needle close to the needle tip can be electrically conducted with blood by punching the side wall of the dilator head and placing the contact assembly, and when the needle tip is hidden in the dilator, the three-dimensional system can display the position of the needle tip in real time, so that the risk of damage of the needle tip to superior vena cava and endocardial tissue is reduced or eliminated.

Drawings

FIG. 1 is a schematic diagram of a three-dimensional atrial septum puncture assembly 10;

FIG. 2 shows a schematic view of the distal end of the dilator 30;

FIG. 3 is a cross-sectional view taken along line A-A of FIG. 2;

fig. 4 shows a top view of the contact assembly 13;

FIG. 5 is a sectional view taken along line B-B;

fig. 6 shows a cross-sectional view of the assembled contact assembly 13;

FIG. 7 is a schematic diagram illustrating the distal configuration of another embodiment of a three-dimensional atrial septum puncture assembly 10;

FIG. 8 is a cross-sectional view taken along line C-C of FIG. 7;

Fig. 9 shows a top view of the contact assembly 130;

FIG. 10 is a sectional view taken along line D-D of the drawing;

FIG. 11 is a partial enlarged view of one embodiment according to the present invention.

Detailed Description

The technical solution of the present invention is further described in detail below by way of examples, with reference to the accompanying drawings, but the present invention is not limited to the following examples.

FIG. 1 is a schematic diagram of a three-dimensional atrial septum puncture assembly 10; FIG. 2 illustrates a schematic distal end configuration of a dilator 30 according to one embodiment of the present invention; fig. 3 is a cross-sectional view taken along line a-a of fig. 2. As shown in fig. 1, 2 and 3, the three-dimensional transseptal puncture assembly 10 includes a transseptal needle 20 and a dilator 30 including a dilator tube 32, the dilator tube 32 including a central lumen, a distal end and a proximal end. The dilator tube 32 is provided with an aperture 33 at its distal end, and the cross-section of the aperture 33 may be any suitable shape, such as circular, oblong, rectangular or square. When the cross-section of the small hole 33 is a circular hole, the diameter thereof may be 0.6 to 1.2mm, preferably 0.85 mm. The distance between the center of the small hole 33 and the distal end face of the dilator tube 32 is 3-20mm, preferably 5-15 mm. The small hole 33 may be formed on one side of the distal end of the dilator tube 32 or on both sides thereof. When both sides are provided with holes, the two small holes can be communicated or not communicated. The apertures 33 include 1-3 sets of apertures, preferably two sets of apertures. A luer fitting 34 is attached to the proximal end of the dilator tube 32.

The dilator tube 32 may be passed through by a medical instrument, such as an atrial septum puncture needle. The diameter of the distal end of the central chamber of the dilator tube 32 is reduced from large to small, and the length of the section with the smaller diameter is 8-9 mm. The structure can limit the needle outlet length of the interatrial septum puncture needle, and avoid the danger caused by overlong needle outlet.

The transseptal needle 20 includes a distal end and a proximal end. The needle body of the puncture needle 20 can be formed by integrally forming a section of tube or formed by connecting two sections of tubes. 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 body of the needle 20 may be made of a metallic conductive material, such as stainless steel. The needle body can be coated with an insulating layer or sleeved with an insulating tube, and the needle point is exposed without an insulating layer or an insulating tube.

the proximal end of the puncture needle 20 is provided with a hemostatic valve 21, and a lead 22 is arranged on the hemostatic valve 21. The proximal end of the lead 22 is connected to a pin.

fig. 4 shows a top view of the contact assembly 33; FIG. 5 is a cross-sectional view taken along line B-B of FIG. 4; fig. 6 shows a cross-sectional view of the assembled contact assembly 33. As shown in fig. 4 to 6, the cross section of the small hole 33 is circular, and a contact assembly 35 is disposed in the small hole 33. The contact assembly 35 includes an elastic member 51 and a sliding member 52. The resilient element 51 may be a spring or other suitable element and the sliding element 52 may be a ball, a cylinder or a combination of a ball and a cylinder, among other suitable elements. The sliding element 52 can be brought into reliable contact with the needle body of the atrial septum puncture needle by the elastic force of the elastic element.

The contact assembly 35 may also include a frame 53 and an end cap 54, the end cap 54 being secured to the frame by any suitable means, such as welding. The elastic member 51 is disposed inside the frame 53, and the sliding member 52 is disposed on the top of the elastic member 51. The elastic member 51, the sliding member 52, the frame 53 and the end cap 54 are made of a conductive material. An annular groove (not shown) may be formed 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 locked in the annular groove and is relatively firm.

The contact assembly 35 is pre-embedded in the small hole 33 in a hot melting mode. The top of the sliding element 52 protrudes from the inner surface of the body of the expander 30. The amount of contact force between the distal end of the dilator 30 and the septal puncture needle is determined by the compressive force of the resilient element 51 as the septal puncture needle passes within the dilator 30. The contact assemblies 35 may also be disposed on either side of the distal end of the dilator 30.

When the side wall of the needle body of the atrial septal puncture needle completely covers the small hole 33 or the side wall of the needle body of the atrial septal puncture needle is contacted with the sliding element 52, the contact assembly 35 is electrically connected with blood, and the display of the needle can be seen on the three-dimensional mapping system and the position of the needle in the heart and the blood vessel can be judged.

In use, the three-dimensional atrial septum assembly 10 according to an embodiment of the present invention is first advanced into the superior vena cava using a catheter with a magnetic positioning device, and then exchanged for a dilator 30 and guidewire. When the far end of the guide wire extends out of the dilator 30 by 2-3 mm, the head end of the guide wire can be displayed in the three-dimensional system, so that the guide wire can be positioned through the three-dimensional system. Then, the guide wire is replaced by an interatrial puncture needle, when the side wall of the needle tip body completely covers the small hole 33 or the side wall of the needle tip body is contacted with the sliding element 51, the needle tip body is electrically conducted with blood through the contact assembly 35, and at the moment, the display of the interatrial puncture needle can be seen on the three-dimensional mapping system, so that the positions of the puncture needle in the heart and the blood vessel can be judged. The puncture needle handle indicator and the long sheath are pulled down to point to the 4 o' clock direction, and the movement of the puncture needle can be seen in the three-dimensional system. Since the needle tip is entirely located within the dilator 30, the needle tip does not damage the superior vena cava and endocardial tissue during movement. When the puncture needle slides to the marked puncture point, namely the interatrial septum foramen ovale position, the puncture needle generally has a falling feeling, can be used for trying on, and generally has a breakthrough feeling when passing through the septum. At the moment, the puncture needle can be clearly seen in the three-dimensional system to enter the left atrium by 1-1.5 cm. If image fusion exists, the three-dimensional space relationship between the puncture needle and structures such as the left atrium, the right atrium and the aorta can be clearly seen.

FIG. 7 is a schematic view of a distal end of another embodiment dilator 300; FIG. 8 is a cross-sectional view taken along line C-C of FIG. 7; fig. 9 shows a top view of the contact assembly 330; FIG. 10 is a sectional view taken along line D-D of the drawing; FIG. 11 illustrates a partial enlarged view of an embodiment according to the present invention. As shown in fig. 7 to 11, the cross section of the small hole 330 is rectangular, and a contact assembly 350 made of a material having an electrical conductivity is disposed in the small hole 330. The contact assembly 350 includes a spring element 510, and the spring element 510 may be formed by bending a metal sheet, or may be any other suitable element.

the contact assembly 350 may also include a frame 530 and an end cap 540, the end cap 540 may be secured to the frame by any suitable means, such as welding. If the elastic member 510 is formed by bending a metal sheet, as shown in fig. 10, the elastic member 510 includes a top arc portion and a body portion, one side of which may be welded to the frame 530 and the other side of which is not fixed and is in a floating state. The arcuate portion of the foil projects outside the frame. Since the foil is thin and one side is not fixed, the part of the foil where it is not fixed can move up and down when being pressed. When the side wall of the needle body of the atrial septal puncture needle completely covers the small hole 330 or the side wall of the needle body of the needle tip is contacted with the arc-shaped part of the elastic element 510, the contact assembly 350 is electrically connected with blood, and the display of the needle can be seen on the three-dimensional mapping system and the position of the needle in the heart and the blood vessel can be judged.

The rest of the construction of the dilator 300 is as shown in fig. 2-6, and the rest of the three-dimensional atrial septum puncture needle assembly 100 is as shown in fig. 1-7.

the embodiments of the present invention are not limited to the above-described examples, and various changes and modifications in form and detail may be made by those skilled in the art without departing from the spirit and scope of the present invention, and these are considered to fall within the scope of the present invention.