Exploration catheter

Abstract

The probing catheter comprises a catheter body, the near end of the catheter body is fixedly connected with a flushing valve, the far end of the catheter body is provided with a bent section, the curvature radius of the bent section ranges from 45mm to 65mm, the included angle alpha between the central axis of the far end of the bent section and the central axis of the catheter body is larger than or equal to 45 degrees and smaller than or equal to 60 degrees, and the included angle alpha is larger than or equal to 45 degrees and smaller than or equal to 60 degrees. And the vertical distance h from the far end of the bent section to the tube body is 40mm-60mm. According to the technical scheme provided by the invention, the success rate of foramen ovale exploration is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical instruments, in particular to an exploration catheter. Background Art

[0002] Patent foramen ovale (PFO) closure is a minimally invasive interventional procedure for the treatment of PFO-related diseases (such as PFO-related stroke and migraine) and is increasingly widely used in clinical practice. Patent foramen ovale is a congenitally unclosed gap structure between the left and right atria of the human heart (the primary septum and secondary septum should be tightly closed here after birth in normal people). It is located in the oval fossa of the atrial septum, similar to two doors that are not closed. The key technology for the success of this operation is to detect and pass the PFO with a guidewire during the operation. Failure of the guidewire to pass the PFO will directly lead to failure of the operation.

[0003] The guidewire catheter used in existing conventional exploration is relatively soft and lacks supporting force. The tip of the guidewire floats in the right atrium to search for the PFO opening gap. This is highly random and the direction is difficult to control, resulting in a high failure rate in exploring PFO.

[0004] The above contents are only used to assist in understanding the technical solution of the present application and do not constitute an admission that the above contents are prior art. Utility Model Content

[0005] The present application provides an exploration catheter to improve the success rate of exploring the foramen ovale.

[0006] The present application provides an exploration catheter, which includes a tube body, a flush valve fixedly connected to the proximal end of the tube body, a curved section provided at the distal end of the tube body, a curvature radius of the curved section of 45mm-65mm, an angle α between the central axis of the distal end of the curved section and the central axis of the tube body, wherein 45°≤α≤60°, and a vertical distance h from the distal end of the curved section to the tube body of 40mm-60mm.

[0007] In a possible implementation manner, the tube body and the curved section are made of the same material, and the tube body and the curved section are formed by an extrusion process, and the tube wall thickness of the tube body and the curved section is 0.3 mm-0.73 mm.

[0008] In a possible implementation manner, the pipe body and the curved section have the same structure, and the pipe body is a composite pipe.

[0009] In a possible implementation, the tube body is a three-layer tube, including an inner layer, a braided layer and an outer layer. The inner layer is made of a smooth material, and the braided layer is braided from an alloy with memory.

[0010] In a possible implementation, the braided layer is nickel-titanium wire, the wire diameter of the nickel-titanium wire is 0.07 mm-0.14 mm, and the longitudinal angle formed by the nickel-titanium wire is β, wherein 25°≤β≤45°.

[0011] In a possible implementation, the outer layer is made of PEBAX or TPU.

[0012] In a possible embodiment, the flexibility of the curved section is greater than the flexibility of the tube body, a fixing ring is provided at the distal end of the curved section, the exploration catheter also includes a traction wire connected to the fixing ring, and a traction wire channel for the traction wire to pass through is opened in the curved section and the tube body.

[0013] In a possible implementation manner, a U-shaped opening is opened on the peripheral wall of the fixing ring, and the traction wire is connected to the fixing ring through the U-shaped opening.

[0014] In a possible implementation manner, the fixing ring is provided with a fixing hole, and the traction wire is fixedly connected to the fixing ring through the fixing hole.

[0015] In a possible implementation, the exploration catheter further includes a bending adjustment section, a proximal end of the bending adjustment section is connected to a distal end of the curved section, and the bending adjustment section is a flexible section.

[0016] In the technical solution proposed in the present application, an exploration catheter is provided including a tube body, the proximal end of the tube body is fixedly connected with a flush valve, the distal end of the tube body is provided with a bending section, the curvature radius of the bending section is 45mm-65mm, the angle between the central axis of the distal end of the bending section and the central axis of the tube body is α, wherein 45°≤α≤60°, and the vertical distance h from the distal end of the bending section to the tube body is 40mm-60mm. By providing the bending section and limiting the shape of the bending section, when the exploration catheter explores the foramen ovale, because the foramen ovale is an irregular channel, the setting of the bending section enables the exploration catheter to quickly explore the foramen ovale, thereby improving the success rate of exploring the foramen ovale. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying any creative work.

[0018] Figure 1 The schematic diagram of the structure of the exploration catheter in some embodiments of the present application is schematically shown;

[0019] Figure 2 The schematic diagram of the structure of the pipe body and the bending section in some embodiments of the present application is schematically shown;

[0020] Figure 3 Schematically shows the internal structure of the pipe body and the curved section in some embodiments of the present application;

[0021] Figure 4 for Figure 3 A schematic diagram of the enlarged structure at A in the middle;

[0022] Figure 5 The schematic diagram of the structure of the exploration catheter in other embodiments of the present application is schematically shown;

[0023] Figure 6 The cross-sectional structure diagram of the exploration catheter in some embodiments of the present application is schematically shown;

[0024] Figure 7 The schematic diagram of the structure of the connection between the fixing ring and the traction wire in some embodiments of the present application is schematically shown;

[0025] Figure 8 Schematically showing the structural schematic diagram of the connection between the fixing ring and the traction wire in other embodiments of the present application;

[0026] Fig. 9 The schematic diagram of the structure of the connection between the fixing ring and the traction wire in some other embodiments of the present application is schematically shown;

[0027] Fig.10 The schematic diagram of the structure of the exploration catheter in some other embodiments of the present application is schematically shown;

[0028] Fig.11 The schematic diagram of the structure of the exploration catheter exploring the oval foramen in some embodiments of the present application is schematically shown.

[0029] Explanation of the accompanying drawings: 10-exploration catheter, 11-tube body, 111-inner layer, 112-braided layer, 113-outer layer, 114-guidewire cavity, 12-bend section, 13-fixing ring, 131-U-shaped opening, 132-fixing hole, 14-traction wire, 15-traction wire channel, 16-bend adjustment section, 17-flush valve, 20-superior vena cava, 30-inferior vena cava, 40-right atrium, 50-secondary septum, 60-primary septum, 70-foramen ovale. DETAILED DESCRIPTION

[0030] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0031] It should be noted that all directional indications in the embodiments of the present application are only used to explain the relative position relationship, movement status, etc. between the components in a certain specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0032] In addition, the descriptions of "first", "second", etc. in this application are only for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0033] In this application, unless otherwise clearly specified and limited, the terms "connection", "fixation", etc. should be understood in a broad sense. For example, "fixation" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0034] In addition, the technical solutions between the various embodiments of the present application can be combined with each other, but it must be based on the fact that ordinary technicians in the field can implement it. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such combination of technical solutions does not exist and is not within the scope of protection required by this application.

[0035] It should be noted that "distal" and "proximal" are used as directional terms, which are commonly used terms in the field of medical devices, where "distal" refers to the end away from the operator during surgery, and "proximal" refers to the end close to the operator during surgery. Axial refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device; radial refers to the direction perpendicular to the above axial direction.

[0036] See also Figure 1 , Figure 2 and Fig.11The present application proposes an exploration catheter 10 for exploring the foramen ovale 70, comprising: a tube body 11, a flush valve 17 fixedly connected to the proximal end of the tube body 11, a curved section 12 provided at the distal end of the tube body 11, the curvature radius of the curved section 12 is 45mm-65mm, the angle between the central axis of the distal end of the curved section 12 and the central axis of the tube body 11 is α, wherein 45°≤α≤60°, and the vertical distance h from the distal end of the curved section 12 to the tube body 11 is 40mm-60mm.

[0037] Among them, the proximal end of the flush valve 17 is provided with a 6% standard Luer connector for flushing and exhausting and / or passing a guide wire. The fixed connection method between the proximal end of the tube body 11 and the flush valve 17 is not limited, such as welding, gluing, fusion or interference sleeve, etc., as long as it can be fixedly connected. The specification of the tube body 11 can be 5F-10F, preferably 5F-6F. Here, the specification of the tube body 11 refers to the inner diameter of the tube body 11, where 1F=0.33mm. The lumen of the tube body 11 can be a single-lumen tube or a multi-lumen tube. The curvature radius of the curved section 12 can also be understood as the radius of the curved section, wherein the curvature radius ranges from 45mm to 65mm, which here refers to the values ​​including both ends, that is, the curvature radius of the curved section can be 45mm, 48mm, 49mm, 50mm, 52mm, 55mm, 58mm, 60mm, 61mm, 63mm, 65mm, etc., as long as it is within the numerical range of 45mm-65mm (including the values ​​at both ends), the curvature radius of the curved section 12 is set to ensure that the subsequent guide wire can smoothly pass through the inner cavity of the exploration catheter 10 and smoothly reach the oval foramen 70. For the same reason, please refer to Figure 2 , wherein the data range of the vertical distance h from the distal end of the curved section 12 to the tube body 11 also includes the values ​​at both ends, that is, h can be 40mm, 43mm, 46mm, 50mm, 52mm, 58mm, 59mm, 60mm, etc., as long as it is in the numerical range of 40mm-60mm (including the values ​​at both ends), by limiting h, when the distal end of the curved section 12 is at the mouth of the oval foramen 70, the exploration catheter 10 can be against the atrial wall, thereby stabilizing the exploration catheter 10 and preventing the exploration catheter 10 from swinging. The angle between the central axis of the distal end of the curved section 12 and the central axis of the tube body 11 is α, and the degree of α can be 45°, 48°, 50°, 53°, 57°, 60°, etc., and can be in the range between the two.

[0038] The present application provides the exploration catheter 10 with a tube body 11 and a curved section 12, and limits the curvature radius of the curved section 12 and the position shape between the curved section 12 and the tube body 11, that is, both h and α are limited, so that the curved section 12 can more easily find the oval foramen 70. Because the mouth of the inferior vena cava 30 and the mouth of the superior vena cava 20 are basically aligned, if the exploration catheter 10 is in a straight line or has insufficient hardness, the exploration catheter 10 is very easy to slide toward the superior vena cava 20, causing certain difficulties in finding the oval foramen 70. The exploration catheter 10 of the present application is provided with a curved section 12, which limits its shape and improves the success rate of exploring the oval foramen 70.

[0039] In one or more embodiments, the tube body 11 and the curved section 12 are made of the same material, and the tube body 11 and the curved section 12 are formed by an extrusion process, and the tube wall thickness of the tube body 11 and the curved section 12 is 0.3mm-0.73mm. The tube body 11 and the curved section 12 can be understood as being integrally formed, and both can also be formed by an extrusion process. The tube wall thickness of the tube body 11 and the curved section 12 can be 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.71mm, 0.73mm, etc., so as to ensure a certain thickness of the tube wall to improve the hardness of the exploration catheter 10, and then improve the support of the exploration catheter 10, so as to ensure that the guide wire does not swing when passing through the inner cavity of the exploration catheter 10 or under the flushing of the circulating blood in the right atrium 40, and is easy to position. Specifically, the forming process of the curved section 12 can be as follows: after the tube body 11 is extruded as a whole, it is bent by a certain fixture, and then kept in a baking furnace at 180° C.-220° C. for 50 min-75 min to complete the shaping of the curved section 12.

[0040] In one or more embodiments, see Figure 3 and Figure 4, the structure of the tube body 11 and the curved section 12 is the same, and the tube body 11 is a composite tube. The tube body 11 and the curved section 12 are made of the same material. The tube body 11 and the curved section 12 can be single-layer tubes, and can also be composite tubes. The composite tube can be a two-layer tube or a three-layer tube. Further, the tube body 11 is a three-layer tube, specifically including an inner layer 111, a braided layer 112 and an outer layer 113, wherein the inner layer 111 is made of a smooth material to reduce the resistance encountered when the subsequent guide wire passes through, and the material can be selected such as a PTFE tube; the braided layer 112 is located between the inner layer 111 and the outer layer 113, and the braided layer 112 is woven from an alloy with memory, such as a nickel-titanium alloy. The metal alloy has higher stability, which can extend the shelf life of the product and ensure that the product is not easy to fail. The material of the outer layer 113 can be PEBAX or TPU, etc., so that the exploration catheter 10 is more supportive. When the material is PEBAX, the hardness of PEBAX is preferably greater than or equal to 63D. When the braided layer 112 is made of nickel-titanium wire, the curved section 12 can maintain this shape for a long time after being shaped, and is not easily invalidated by the environment (ambient temperature, transportation). Preferably, the wire diameter of the nickel-titanium wire is preferably 0.07mm-0.14mm, and the longitudinal angle formed by the nickel-titanium wire is β, wherein 25°≤β≤45°, thereby ensuring that the nickel-titanium wire is in its length direction (such as Figure 4 The inability to stretch and retract (in the upper and lower numerical directions) and the stability of the length prevent the exploration catheter 10 from being shortened due to cold, thereby preventing the exploration catheter 10 from being shortened in the length direction and failing to reach the oval foramen 70 along the femoral vein.

[0041] In another embodiment, the flexibility of the curved section 12 is greater than the flexibility of the tube body 11. There are many ways to achieve different flexibility. The first is due to the different flexibility of the material itself. For example, TPU can be used for soft materials, and PA can be used for hard materials. The second is that the same material can be used but with different specifications, such as PEBAX. For hard materials, 60D-75D PEBAX can be used, and for soft materials, 30D-38D PEBAX can be used. The second can also be a tube body including a braided layer. The hard one can make the braided layer more densely woven, and the soft one can make the braided layer sparsely woven to achieve different degrees of hardness and softness. The flexibility of the curved section 12 is set to be greater than the flexibility of the tube body 11, so that the curved section 12 does not need to be bent and shaped, and the pushing performance along the femoral vein is better. Please refer to Figures 5 to 9At the same time, a fixing ring 13 is provided at the distal end of the curved section 12. The exploration catheter 10 also includes a traction wire 14 connected to the fixing ring 13. A traction wire channel 15 for the traction wire 14 to pass through is provided in the curved section 12 and the tube body 11. A guide wire cavity 114 for the guide wire to pass through is also provided in the exploration catheter 10. When it is necessary to approach the foramen ovale 70, only the proximal traction wire 14 needs to be pulled back, and the curved section 12 will bend and deform to approach the foramen ovale 70, thereby improving the success rate of exploring the foramen ovale 70. After the traction wire 14 passes along the traction wire channel 15, it is connected to the fixing ring 13 at the distal end of the curved section 12. The traction wire 14 and the traction wire channel 15 are loosely matched, and the traction wire channel 15 passes in a straight line along the direction of the exploration catheter 10 without twisting or bending with the exploration catheter 10. The fixing ring 13 is fixedly connected to the distal end of the curved section 12 by melting, welding or crimping. In addition, the fixing ring 13 is a metal fixing ring and has a certain development effect during the operation. Preferably, the fixing ring can be made of metal tantalum, which has a better development effect, making it easier to see the position of the curved section 12 during the operation, which is beneficial to adjusting the angle of the exploration catheter 10, and is more beneficial to exploring the position of the oval foramen 70, thereby improving the success rate of exploration.

[0042] There are many ways to connect the fixing ring 13 and the traction wire 14. In one or more embodiments, a U-shaped opening 131 is provided on the peripheral wall of the fixing ring 13, and the traction wire 14 is connected to the fixing ring 13 through the U-shaped opening 131. Figure 8 As shown, the traction wire 14 is wound around and then clamped at the U-shaped opening 131 and then connected to the fixing ring 13. Fig. 9 The winding method shown is to wind the traction wire 14 around and then clamp it at the U-shaped opening 131 and then connect it to the fixing ring 13 .

[0043] In another embodiment, see Figure 7 The fixing ring 13 may be provided with a fixing hole 132, and the traction wire 14 may be fixedly connected to the fixing ring 13 through the fixing hole 132. After the fixing hole 132 is provided so that the traction wire 14 and the fixing hole 132 have a certain overlap length, the traction wire 14 may be fixed to the fixing ring 13 by welding, crimping, screwing or other connection methods.

[0044] In one or more embodiments, see Figure 10-11 , the exploration catheter 10 also includes a bending section 16, the proximal end of the bending section 16 is connected to the distal end of the bending section 12, and the bending section 16 is a flexible section. In this embodiment, the bending section 12 is made of the same material as the tube body 11, and has a higher hardness. The bending section 16 is a flexible section. At this time, the fixing ring 13 can be set at the distal end of the bending section 16. The specific connection method can refer to the connection method in which the fixing ring 13 is fixed to the bending section 12 in the previous embodiment. In this way, when the traction wire 14 is pulled, the bending section 16 is completely deformed, and when the traction wire 14 is not pulled, the bending section 16 can be reset and straightened. Please refer to Fig.11 After the exploration catheter 10 is inserted through the femoral vein, in order to explore the oval foramen 70 formed between the secondary septum 50 and the primary septum 60, the curved section 12 of the exploration catheter 10 extends from the inferior vena cava 30 to the oval foramen 70, and the curved section 116 extends along the oval foramen 70 to the left atrium. At this time, the guide wire can smoothly enter the left atrium along the exploration catheter 10. Accordingly, the inner cavity of the exploration catheter 10 can be set to a size that matches the occluder, and the exploration catheter 10 can be used as a delivery catheter for the occluder, thereby eliminating the need to exchange the guide wire in the middle and reducing the operation time.

[0045] The above are only preferred embodiments of the present application, and are not intended to limit the patent scope of the present application. All equivalent structural changes made using the contents of the present application specification and drawings under the application concept of the present application, or direct / indirect application in other related technical fields are included in the patent protection scope of the present application.

Claims

1. A probing catheter for probing the foramen ovale, characterized in that: include: A pipe body, wherein the proximal end of the pipe body is fixedly connected with a flush valve, and the distal end of the pipe body is provided with a curved section, the curvature radius of the curved section is 45mm-65mm, and the angle between the central axis of the distal end of the curved section and the central axis of the pipe body is α, wherein 45°≤α≤60°, and the vertical distance h from the distal end of the curved section to the pipe body is 40mm-60mm.

2. The exploration catheter according to claim 1, characterized in that: The tube body and the curved section are made of the same material, and the tube body and the curved section are formed by an extrusion process, and the tube wall thickness of the tube body and the curved section is 0.3mm-0.73mm.

3. The exploration catheter according to claim 1, characterized in that: The pipe body and the curved section have the same structure, and the pipe body is a composite pipe.

4. The exploration catheter according to claim 3, characterized in that: The tube body is a three-layer tube, including an inner layer, a braided layer and an outer layer. The braided layer is located between the inner layer and the outer layer. The inner layer is made of a smooth material, and the braided layer is braided from an alloy with memory.

5. The exploration catheter according to claim 4, characterized in that: The braided layer is nickel-titanium wire, the wire diameter of the nickel-titanium wire is 0.07mm-0.14mm, and the longitudinal angle formed by the nickel-titanium wire is β, wherein 25°≤β≤45°.

6. The exploration catheter according to claim 4, characterized in that: The material of the outer layer is PEBAX or TPU.

7. The exploration catheter according to claim 1, characterized in that: The flexibility of the curved section is greater than that of the tube body. A fixing ring is provided at the distal end of the curved section. The exploration catheter also includes a traction wire connected to the fixing ring. A traction wire channel for the traction wire to pass through is provided in the curved section and the tube body.

8. The exploration catheter according to claim 7, characterized in that: A U-shaped opening is provided on the peripheral wall of the fixing ring, and the traction wire is connected to the fixing ring through the U-shaped opening.

9. The exploration catheter according to claim 7, characterized in that: The fixing ring is provided with a fixing hole, and the traction wire is fixedly connected to the fixing ring through the fixing hole.

10. The exploration catheter according to any one of claims 2 to 4, characterized in that: The exploration catheter further comprises a bending adjustment section, the proximal end of which is connected to the distal end of the curved section, and the bending adjustment section is a flexible section.

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