Novel guiding catheter for patent foramen ovale closure

Abstract

The utility model provides a novel guide catheter for patent foramen ovale closure, which comprises: a delivery tube segment and a distal arc-shaped tube segment connected together, a support part for dilating the atrial septum is arranged at the distal end of the distal arc-shaped tube segment, a guide wire outlet for the guide wire to pass through and enter the patent foramen ovale tunnel is arranged at the distal end of the support part, the support part is tapered from small to large, the guide wire outlet is an oblique cutting oval-shaped opening, or the support part is tapered from small to large and the tapered distal end is smooth, the guide wire outlet is two oblique cutting side holes symmetrically arranged on both sides of the distal end of the support part, or the support part is spherical, and the diameter of the support part is greater than the diameter of the distal end opening of the distal arc-shaped tube segment. The atrial septum is dilated by the support part, so that the guide wire can easily enter the patent foramen ovale tunnel through the guide wire outlet, thereby quickly and smoothly establishing the guide wire channel for PFO closure.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a novel guiding tube for sealing patent foramen ovale. Background Technology

[0002] Patent foramen ovale (PFO) is a common congenital heart defect, present in nearly one-quarter of adults. It is an abnormal passageway between the left and right atria, formed after birth when the two atrial septa fail to close tightly, resulting in overlapping of the myocardial membranes and creating an oblique tunnel. This long and narrow tunnel allows for slow blood flow, making it prone to thrombosis. Furthermore, this passage provides a pathway for emboli from the right heart and venous system to reach the left heart; if an embolus reaches the head, it can cause stroke, migraines, and other ailments. In recent years, with increased clinical awareness of PFO and advancements in preventative closure treatments, PFO closure has become a hot research topic.

[0003] Currently, in clinical practice, when performing interventional procedures to occlude PFO, a traditional guiding catheter is usually used to insert a guidewire into the PFO tunnel to establish a surgical access. However, some patients may have aortic root dilatation, and due to the torsion of the atrial septum, the catheter may not be able to get close to the foramen ovale region of the atrial septum. In addition, for PFO occlusion procedures with a small foramen ovale opening, it is difficult for a conventional MP catheter to pass through the atrial septum.

[0004] In clinical practice, in addition to using MP catheters, some cases in this situation require the use of a transseptal puncture sheath to open the PFO tunnel in order to insert a guidewire. However, because the tip of the existing transseptal puncture sheath is relatively sharp, it is easy to damage the transseptum. Furthermore, since the opening of the sheath and the contact point with the transseptum are at the same location, it is not easy for the guidewire to enter the PFO tunnel when the transseptum is opened.

[0005] Therefore, there is an urgent need for a catheter that can simultaneously open the PFO tunnel and insert a guidewire into it, while also meeting the requirements of strong support and easy guidewire passage.

[0006] It should be noted that the information disclosed in the background section above is only used to enhance the understanding of the background of this disclosure, and therefore may include information that does not constitute prior art known to those skilled in the art. Utility Model Content

[0007] The purpose of this utility model embodiment is to provide a novel guide tube for closure of patent foramen ovale (PFO). The interatrial septum is opened by a support portion located at the distal end of the arc-shaped tube segment of the guide tube, which provides sufficient space for the guide wire to move. After the guide wire passes through the guide wire outlet at the distal end of the support portion, it is easy to enter the PFO tunnel, thereby quickly and smoothly establishing the guide wire channel for PFO closure.

[0008] To solve the above-mentioned technical problems, this utility model provides a novel guide tube for sealing patent foramen ovale, comprising: a connected delivery tube section and a distal arc-shaped tube section, wherein the distal end of the distal arc-shaped tube section is provided with a support portion for opening the interatrial septum, and the distal end of the support portion is provided with a guide wire outlet for a guide wire to pass through and enter the foramen ovale tunnel.

[0009] As one embodiment, the support portion is a cone shape with a smaller diameter at the far end and a larger diameter at the near end, and the guide wire outlet is a slanted elliptical opening.

[0010] As one embodiment, the support portion is smoothly connected to the distal arc-shaped pipe section, and the obliquely cut elliptical opening is aligned with the distal end of the support portion.

[0011] As one embodiment, the support portion is a cone shape with a smaller distal end and a larger proximal end, and the distal end of the cone is rounded. The guide wire outlet consists of two obliquely cut side holes symmetrically arranged on both sides of the distal end of the support portion.

[0012] As one embodiment, the support portion is spherical, and the diameter of the support portion is larger than the diameter of the distal opening of the distal arc-shaped pipe segment.

[0013] As one embodiment, the guidewire opening is coaxially arranged with the guidewire channel.

[0014] As one embodiment, the spherical support portion is connected to the distal arc-shaped pipe segment by an arc transition.

[0015] As one embodiment, the guide tube further includes a Luer connector disposed near the proximal end of the delivery pipe section.

[0016] As one embodiment, the distal arc-shaped pipe section is made of TPU material.

[0017] As one embodiment, the conveying pipe section is made of PA material and lined with a metal braided tube.

[0018] As can be seen from the above technical solution, the embodiments of this utility model have at least the following advantages and positive effects:

[0019] The atrial septum is opened by a support portion located at the distal end of the arc-shaped section of the guidewire guide tube, providing ample space for the guidewire to move. After the guidewire exits through the guidewire outlet at the distal end of the support portion, it is easy to enter the foramen ovale tunnel. This effectively solves the problem of difficulty in catheter passage through the atrial septum or the difficulty in the guidewire entering the PFO tunnel when opening the atrial septum because the sheath opening and the contact point of the atrial septum are in the same position. Thus, the guidewire channel for PFO occlusion can be established quickly and smoothly. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. It is understood that the drawings described below are only embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0021] Figure 1a A schematic diagram of the overall structure of the novel guide tube for sealing unclosed orifices of ovum provided in Embodiment 1 of this utility model;

[0022] Figure 1b for Figure 1a An enlarged schematic diagram of the guide tube at point B shown;

[0023] Figure 1c for Figure 1a The front view of the guide tube is shown.

[0024] Figure 1d for Figure 1a The diagram shows an enlarged schematic of the guide wire outlet at the distal end of the guide tube.

[0025] Figure 2a This is a schematic diagram of the overall structure of the novel guide tube for sealing unclosed orifices of ovum provided in Embodiment 3 of this utility model;

[0026] Figure 2b for Figure 2a An enlarged schematic diagram of the guide tube at point B shown;

[0027] Figure 2c for Figure 2a A three-dimensional structural diagram of the guide tube from another angle;

[0028] Figure 2d for Figure 2c An enlarged schematic diagram of the guide tube at point C shown;

[0029] Figure 2e for Figure 2a A three-dimensional view of the guide tube at point B from another angle;

[0030] Figure 3a This is a schematic diagram of the overall structure of the novel guide tube for sealing unclosed orifices of ovum provided in Embodiment 2 of this utility model;

[0031] Figure 3b for Figure 3a A three-dimensional structural diagram of the guide tube from another angle;

[0032] Figure 3c for Figure 3a An enlarged schematic diagram of point A in the guide tube is shown;

[0033] Figure 3d for Figure 3b An enlarged schematic diagram of the guide tube at point B is shown.

[0034] In the diagram: 1. Luer connector; 2. Delivery pipe section; 3. Distal arc-shaped pipe section; 4. Support section; 5. Guide wire outlet. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the various embodiments of this utility model will be described in detail below with reference to the accompanying drawings. However, those skilled in the art will understand that many technical details have been provided in the various embodiments of this utility model to enable readers to better understand this utility model. However, the technical solutions claimed by this utility model can be implemented even without these technical details and with various changes and modifications based on the following embodiments.

[0036] In the description of this utility model, it should be noted that the terms "upper," "lower," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0037] It should be noted that, unless otherwise explicitly stated, the terms “connected” and “linked” should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components.

[0038] In the description of this utility model, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator. The above definitions are for convenience only and should not be construed as limiting the present utility model.

[0039] The following description, with reference to the accompanying drawings, describes a novel guiding catheter for patent foramen ovale (PFO) closure according to embodiments of this application. Addressing the issue mentioned in the background art—that existing MP catheters have difficulty passing through the atrial septum, and that the opening of existing atrial septal puncture sheaths is at the same location as the contact point with the atrial septum, making it difficult for the guidewire to enter the PFO tunnel when the atrial septum is opened—the inventors propose that the guiding catheter needs to have strong support to open the PFO tunnel for guidewire insertion. This support refers to its ability to reliably and stably connect to the PFO tunnel while maintaining good coaxiality, thus smoothly delivering interventional therapeutic instruments into the PFO tunnel. Based on this, this application provides a novel guiding catheter for patent foramen ovale (PFO) closure, comprising a connected delivery tube section and a distal arc-shaped tube section. The distal end of the distal arc-shaped tube section is provided with a support portion for opening the interatrial septum, and the distal end of the support portion is provided with a guidewire outlet for the guidewire to pass through and enter the PFO tunnel. While opening the interatrial septum through the support portion, it can provide sufficient space for the guidewire to move, facilitating the guidewire to enter the PFO tunnel through the guidewire outlet at the distal end of the support portion to establish a guidewire channel for closure. Therefore, it can effectively solve the problems of difficulty in catheter passage through the interatrial septum or difficulty in guidewire entry into the PFO tunnel when opening the interatrial septum due to the sheath opening and the contact point between the sheath opening and the interatrial septum being at the same location, and can quickly and smoothly establish a guidewire channel for PFO closure.

[0040] Please see Figures 1a to 1d As shown, Embodiment 1 of this utility model provides a novel guiding tube for occlusion of patent foramen ovale (PFO), which can be used to establish a guide wire channel for PFO occlusion. The novel guiding tube for PFO occlusion of this utility model includes: a Luer connector 1, a connected delivery tube section 2, and a distal arc-shaped tube section 3. The distal end of the distal arc-shaped tube section 3 is provided with a support portion 4 for opening the interatrial septum, and the distal end of the support portion 4 is provided with a guide wire outlet 5 for the guide wire (not shown) to pass through and enter the PFO tunnel.

[0041] In this embodiment, the support portion 4 is tapered, with a smaller diameter at the distal end and a larger diameter at the proximal end, and the guidewire outlet 5 is a beveled elliptical opening. Exemplarily, the support portion 4 smoothly transitions to the distal arc-shaped tube segment 3, and the beveled elliptical opening is aligned with the distal end of the support portion 4. In use, the tapered support portion 4 easily opens the interatrial septum, providing sufficient support. The beveled elliptical opening has a large area, facilitating guidewire passage, and after the tapered support portion 4 opens the interatrial septum, the beveled elliptical opening provides ample space for the guidewire to move, thus facilitating the guidewire's search for the foramen ovale tunnel.

[0042] Preferably, the distal arc-shaped pipe section 3 can be made of TPU (thermoplastic polyurethane elastomer) material, giving it good resilience and improving operational flexibility. The conveying pipe section 2 can be made of PA (polyurethane, also known as nylon) material, and can also be lined with a metal braided tube to give it the required rigidity. A Luer joint 1 is provided at the proximal end of the conveying pipe section 2.

[0043] Compared with the prior art, this embodiment of the utility model opens the interatrial septum by using a tapered support, allowing the guidewire to find the foramen ovale tunnel through an obliquely cut elliptical opening, thereby quickly and smoothly establishing a guidewire channel, improving surgical efficiency and safety.

[0044] This utility model provides a novel guide tube for sealing open foramen ovale in embodiment 2. The main difference between the guide tube in this embodiment and the guide tube in embodiment 1 is that the guide wire outlet in embodiment 1 is a slanted elliptical opening, while in this embodiment, the guide wire outlet is a symmetrically arranged slanted side hole on both sides of the far end of the support. The rest of the structure is the same as the corresponding structure in embodiment 1, and will not be described again here.

[0045] Please see Figures 2a-2e As shown, the support part 4 is tapered, with a larger diameter near the end and a smaller diameter at the distal end. The distal end of the support part 4 can be blunted to avoid damage to the atrial septum. There are two guidewire outlets 5, which are symmetrically arranged oblique side holes on both sides of the distal end of the support part 4. In use, the tapered support part 4 facilitates the opening of the atrial septum and provides sufficient support for the atrial septum. Both oblique side holes have a large area, which facilitates the passage of the guidewire. At the same time, after the tapered support part 4 opens the atrial septum, the oblique side holes provide a large range of motion for the guidewire, thus making it easier for the guidewire to find the foramen ovale tunnel.

[0046] Compared with the prior art, this embodiment of the utility model opens the interatrial septum by using a tapered support, and the guidewire can find the foramen ovale channel through the oblique side holes on both sides of the support to quickly and smoothly establish the guidewire channel, thereby improving surgical efficiency and safety.

[0047] This utility model provides a novel guide tube for sealing open foramen ovale in embodiment 3. The main difference between the guide tube in this embodiment and the guide tube in embodiment 1 is that the shape of the support part 4 and the guide wire outlet 5 are different. The rest of the structure is the same as the corresponding structure in embodiment 1, and will not be described again here.

[0048] Please see Figures 3a-3d As shown, the support part 4 is spherical, and its diameter is larger than the diameter of the distal opening of the distal arcuate tube segment 3. The guidewire opening 5 is coaxially arranged with the guidewire channel, that is, the guidewire opening 5 is located at the center of the distal end of the support part 4. The spherical support part 4 can open the atrial septum and provide strong support. The atrial septum is opened and stably supported at the atrial septum, while maintaining good coaxiality, making it easy to locate the foramen ovale tunnel after the guidewire is led out from the guidewire outlet at the distal end of the spherical support part 4. The support part 4 can be a standard sphere or an ellipsoid, without excessive restrictions. The spherical support part 4 and the distal arcuate tube segment 3 are connected by an arcuate transition.

[0049] The method of using the novel guiding tube for sealing patent foramen ovale according to this utility model embodiment is as follows:

[0050] like Figure 1a , 2a As shown in 3a, after successful puncture of the femoral vein, the guidewire is advanced into the superior vena cava, and the guiding catheter is introduced. That is, the Luer connector 1 is held and the guiding catheter is pushed along the guidewire. The left anterior oblique fluoroscopy is performed at 45°, and the delivery sheath tip is pointed to the left. The guiding catheter is withdrawn and falls from the superior vena cava into the right atrium and foramen ovale. The guidewire is pushed to find the patent foramen ovale passage. The right anterior oblique fluoroscopy is then performed at 30° to confirm that the guidewire is behind the atrioventricular groove, ruling out the possibility that the guidewire enters the left pulmonary artery through the right ventricular outflow tract. After confirming that it has passed through the interatrial septum, the guidewire is advanced into the left superior pulmonary vein, systemic heparinization is performed, and a stiffened guidewire is exchanged. The catheter is withdrawn, and the occluder delivery device is advanced along the stiffened guidewire to complete the release of the occluder umbrella.

[0051] Compared with the prior art, this embodiment of the utility model opens the interatrial septum by using a spherical support, and the guidewire can find the foramen ovale channel through the guidewire outlet at the distal end of the support to quickly and smoothly establish the guidewire channel, thereby improving surgical efficiency and safety.

[0052] Those skilled in the art will understand that the above embodiments are specific examples of implementing the present invention, and in practical applications, various changes can be made to them in form and detail without departing from the spirit and scope of the present invention.

Claims

1. A novel guiding tube for sealing patent foramen ovale, characterized in that, include: The connected delivery pipe section and the distal arc-shaped pipe section, wherein the distal end of the distal arc-shaped pipe section is provided with a support for opening the interatrial septum, and the distal end of the support is provided with a guide wire outlet for the guide wire to pass through and enter the orifice of ovum tunnel.

2. The novel guiding tube for sealing patent foramen ovale according to claim 1, characterized in that, The support portion is tapered, with the smaller portion at the far end and the larger portion at the near end, and the guide wire outlet is a slanted elliptical opening.

3. The novel guiding tube for sealing patent foramen ovale according to claim 2, characterized in that, The support portion is smoothly connected to the distal arc-shaped pipe section, and the obliquely cut elliptical opening is aligned with the distal end of the support portion.

4. The novel guiding tube for sealing patent foramen ovale according to claim 1, characterized in that, The support portion is a cone shape with a smaller distal end and a larger proximal end, and the distal end of the cone is rounded. The guide wire outlet consists of two obliquely cut side holes symmetrically arranged on both sides of the distal end of the support portion.

5. The novel guiding tube for sealing patent foramen ovale according to claim 1, characterized in that, The support portion is spherical, and the diameter of the support portion is larger than the diameter of the distal opening of the distal arc-shaped pipe section.

6. The novel guiding tube for sealing patent foramen ovale according to claim 5, characterized in that, The guidewire opening is coaxially arranged with the guidewire channel.

7. The novel guiding tube for sealing patent foramen ovale according to claim 5, characterized in that, The spherical support portion is connected to the distal arc-shaped pipe segment by an arc transition.

8. The novel guiding tube for sealing patent foramen ovale according to claim 1, characterized in that, The guide tube also includes a Luer connector located near the end of the delivery pipe section.

9. The novel guiding tube for sealing patent foramen ovale according to claim 1, characterized in that, The distal arc-shaped pipe section is made of TPU material.

10. The novel guiding tube for sealing patent foramen ovale according to claim 1, characterized in that, The conveying pipe section is made of PA material and lined with a metal braided pipe.

Images