Trans-valvular catheter

Abstract

The transvalvular catheter comprises a connector, a near-end catheter body and a far-end catheter body which are sequentially connected and communicated, the near-end catheter body and the far-end catheter body are each of a tubular structure, the far-end catheter body is in a bent shape, and the far-end catheter body comprises at least two unit sections which are sequentially and smoothly connected; and each unit section of the far-end tube body is arc-shaped or at least one unit section is linear. The far-end catheter body with the bent shape is designed according to the shape of the aorta, so that the catheter is suitable for heart structures of different patients, two or more valve-crossing catheters with different bent far-end catheter bodies can be designed, the lesion of different angles between the ascending aorta and the valve can be met, and the catheter is suitable for heart structures of different patients. More suitable catheters are selected according to the conditions of different patients, so that the transvalvular time of the operation is further shortened, and the operation risk is reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a transvalvular catheter. Background Art

[0002] With the increase in human life expectancy and the aggravation of population aging, aortic valve disease has now become one of the most common heart valve diseases. Patients with aortic valve disease have a long course of disease, and their early symptoms can be relatively non-specific, such as palpitations, dizziness, fatigue, etc. Once more severe symptoms (such as angina pectoris, syncope, and congestive heart failure) appear, if not treated actively in a timely manner, the prognosis is extremely poor.

[0003] In the prior art, surgical aortic valve replacement is the first-line treatment for symptomatic severe aortic stenosis. Compared with surgical operations, transcatheter aortic valve replacement has the advantages of less trauma and faster postoperative recovery. With the accumulation of evidence-based medicine, it has now become the first-line treatment for patients with aortic stenosis.

[0004] Taking the transcatheter aortic valve replacement (TAVR) surgery with a transfemoral approach self-expanding valve system as an example, the main operation process for establishing the access during TAVR is as follows: (1) Taking the conventional access through the right femoral artery as an example: First step, after puncturing the left femoral artery, implant a 6F sheath, and place a 6F JR4.0 catheter to bypass the iliac artery bifurcation and reach the proximal right iliac artery or femoral artery; under angiographic guidance, select the center of the blood vessel more than 1 cm above the femoral artery bifurcation as the puncture point for puncturing the right femoral artery. After successfully puncturing the right femoral artery, implant a 6F femoral artery sheath and pre-bury 2 Proglide TM vascular closure devices. With the assistance of a super-stiff guide wire, complete the implantation of a large sheath through the right femoral artery access (usually select 18F / 20F) to establish a vascular access. (2) Place a pigtail catheter retrograde to the bottom of the non-coronary sinus of the aortic root through the left femoral artery sheath for angiography of the root vessels. Refer to the preoperative cardiac CTA measurement and analysis results, adjust to the optimal projection angle, and observe the aortic root structure and the combined aortic valve regurgitation, etc. by placing the bottoms of the three aortic valve sinuses on the same plane; (3) Select a straight guide wire to cross the valve into the left ventricle. After the guide wire successfully crosses the aortic valve, the guiding catheter is sent into the left ventricle along with it, and then it is exchanged for a pigtail catheter to measure the pressure gradient between the aortic root and the left ventricle. After completing the pressure measurement, introduce a shaped super-stiff guide wire through the pigtail catheter to establish a complete access from the outside to the left ventricle. In this process, selecting a straight guide wire to cross the valve into the left ventricle and the guide wire successfully crossing the aortic valve are extremely important and critical steps.

[0005] However, in clinical practice, patients with aortic stenosis face anatomical challenges such as transverse heart position and severe valve calcification, and crossing the valve has become a technical difficulty and challenge.

[0006] For aortic valve lesions, currently, an angiographic catheter with an AL bend is mainly used to assist the guide wire to cross the aortic valve, which can solve some cases. However, depending on the patient, the aortic angle and the degree of valve damage are also different. Therefore, when using a single angiographic catheter with an AL bend, the following problems are often encountered: First, the catheter angle is incorrect and the guide wire cannot enter the valve; second, the blood flow impact velocity at the valve is very fast and the catheter support force is insufficient; third, even if the guide wire successfully crosses the valve, due to the excessive overlap between the guide wire and the catheter tip, the catheter cannot follow up and cross the valve; fourth, there is a gap between the catheter lumen and the guide wire, and when the catheter and the guide wire are used in combination, blood leaks at the catheter joint. Summary of the Invention

[0007] In view of the above problems existing in the prior art, the object of the present invention is to provide a transvalvular catheter. The distal tube body with a curved shape is designed according to the aortic morphology, so that the catheter is applicable to the cardiac structures of different patients, shortening the transvalvular time of the operation and reducing the operation risk. Two or more transvalvular catheters with different curved distal tube bodies can be designed, which can meet the lesions of different angles between the ascending aorta and the valve. According to the conditions of different patients, a more suitable catheter can be selected, further shortening the transvalvular time of the operation and reducing the operation risk, and covering more than 90% of the cases. For a specific case, just select the one that matches it best. The tip of the transvalvular catheter is designed with a tapered transition and has a high matching degree with the guide wire. When the guide wire crosses the valve, the catheter can smoothly pass through the valve along the guide wire.

[0008] In order to achieve the above object, the technical solution adopted by the present invention is:

[0009] A transvalvular catheter includes a connector, a proximal tube body, and a distal tube body that are sequentially connected and communicated. Both the proximal tube body and the distal tube body are tubular structures. The distal tube body is in a curved shape and includes at least two unit segments that are sequentially and smoothly connected. Each unit segment of the distal tube body is arc-shaped or at least one unit segment is linear.

[0010] As a further improvement of the above technical solution:

[0011] The distal tube body includes a coaxial segment, a support segment, and a push segment that are sequentially connected. When in use, the coaxial segment points to the aortic valve, part or all of the support segment is located in the ascending aorta and conforms to the trend of the ascending aorta, and part or all of the push segment is located in the aortic arch and conforms to the trend of the aortic arch.

[0012] The distal tube body includes a first arc, a second arc, and a third arc connected in sequence. The first arc is connected to the proximal tube body. The end of the third arc is provided with a tip. The first arc and the second arc are internally tangent, and the third arc and the second arc are externally tangent. The radius of the first arc is 12 - 16 mm, and the corresponding central angle is 55 - 60°; the radius of the second arc is 14 - 18 mm, and the corresponding central angle is 60 - 65°; the radius of the third arc is 16 - 19 mm, and the corresponding central angle is 57 - 62°.

[0013] The distal tube body includes a first arc, a second arc, a third straight portion, and a fourth arc connected in sequence. The first arc is connected to the proximal tube body. The end of the fourth arc is provided with a tip. The first arc and the second arc are internally tangent. The third straight portion is linear and is externally tangent to both the second arc and the fourth arc, and the centers of the second arc and the fourth arc are respectively located on both sides of the third straight portion. The radius of the first arc is 14 - 18 mm, and the corresponding central angle is 35 - 40°; the radius of the second arc is 14 - 18 mm, and the corresponding central angle is 68 - 72°; the radius of the fourth arc is 15 - 19 mm, and the corresponding central angle is 49 - 53°.

[0014] The axial length of the proximal tube body is 80 - 90 cm, the inner diameter is 1.15 - 1.32 mm, and the outer diameter is 1.70 - 2.10 mm.

[0015] The proximal tube body is a pre - shaped three - layer tubular structure, including an inner layer, a middle layer, and an outer layer sleeved in sequence from the inside to the outside. The material of the inner layer is a high - molecular polymer, the material of the middle layer is a metal braided mesh, and the material of the outer layer is a high - molecular polymer containing a developing material.

[0016] The hardness of each part of the outer layer decreases in sequence along the direction from the joint to the distal tube body.

[0017] The axial length of the distal tube body is 10 - 20 cm, the inner diameter is 1.15 - 1.32 mm, and the outer diameter is 1.70 - 2.10 mm.

[0018] The distal tube body is a pre - shaped single - layer tubular structure. The distal tube body is composed of at least two different - hardness high - molecular polymers. Along the direction from the joint to the distal tube body, the hardness of the distal tube body decreases in sequence.

[0019] The end of the distal tube body is a conical tip.

[0020] The trans - valve catheter further includes a hemostatic valve assembly for hemostasis. The hemostatic valve assembly is connected to the joint.

[0021] The hemostatic valve assembly includes a hemostatic valve, a hemostatic valve joint, and a hemostatic valve handle. The hemostatic valve handle, the hemostatic valve, and the hemostatic valve joint are connected in sequence. One end of the hemostatic valve joint is connected to a joint, and the other end is connected to the hemostatic valve. The hemostatic valve is used for hemostasis, and the hemostatic valve handle is used to adjust the hemostatic valve to open or close it.

[0022] The beneficial effects of the present invention are as follows:

[0023] (1) According to the morphology of the aorta, a distal tube body with a curved shape is designed. The distal tube body has multiple unit segments and functional segments with different curvatures, enabling the catheter to be applicable to the heart structures of different patients, shortening the surgical transvalvular time, and reducing the surgical risk.

[0024] (2) Two or more transvalvular catheters with different curved distal tube bodies can be designed, which can meet the lesions of different angles between the ascending aorta and the valve. According to the conditions of different patients, a more suitable catheter can be selected, further shortening the surgical transvalvular time and reducing the surgical risk. It can cover more than 90% of the cases. For a specific case, just select the one that best matches it.

[0025] (3) The tip of the transvalvular catheter is designed with a tapered transition, which has a high matching degree with the guide wire. After the guide wire crosses the valve, the catheter can smoothly pass through the valve along the guide wire.

[0026] (4) The three-layer structure of the proximal tube body makes the catheter have better anti-bending and anti-torsion performance, provides stronger support for the catheter, and has good maneuverability. The distal tube body is a single-layer polymer, which can maintain the curved shape of the distal tube body. The pure polymer has better ability to maintain the curved shape than the wire, and can better adapt to the direction of the aortic valve.

[0027] (5) A hemostatic valve assembly is provided at the joint for hemostasis. Description of the Drawings

[0028] Figure 1 It is a schematic structural diagram of an embodiment of the present invention.

[0029] Figure 2 It is a schematic radial cross-sectional structure diagram of the proximal tube body of an embodiment of the present invention.

[0030] Figure 3 It is a schematic axial cross-sectional structure diagram of the proximal tube body of an embodiment of the present invention.

[0031] Figure 4 It is a schematic radial cross-sectional structure diagram of the distal tube body of an embodiment of the present invention.

[0032] Figure 5 It is a schematic axial cross-sectional structure diagram of the distal tube body of an embodiment of the present invention.

[0033] Figure 6Schematic diagram of the tip and guide wire matching structure according to an embodiment of the present invention.

[0034] Figure 7 Schematic diagram of the structure of the distal tube body of the present invention.

[0035] Figure 8 Schematic diagram of the structure of the distal tube body of the first type of transvalvular catheter according to an embodiment of the present invention.

[0036] Figure 9 Schematic diagram of the structure of the distal tube body of the second type of transvalvular catheter according to an embodiment of the present invention.

[0037] Figure 10 Schematic diagram of the ascending aorta and valve shapes of a patient suitable for the first type of transvalvular catheter of the present invention.

[0038] Figure 11 Schematic diagram of the ascending aorta and valve shapes of a patient suitable for the second type of transvalvular catheter of the present invention.

[0039] Figure 12 Schematic diagram of the opened hemostatic valve assembly of the present invention.

[0040] Figure 13 Schematic diagram of the closed hemostatic valve assembly of the present invention. Detailed Description of the Invention

[0041] The following will describe in detail the specific embodiments of the present invention with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are only for the purpose of illustrating and explaining the present invention, and are not intended to limit the present invention.

[0042] For the sake of convenience of description, spatial relative terms such as "above...", "over...", "on the upper surface of...", "upper" etc. can be used here to describe the spatial positional relationship between a device or feature shown in the drawings and other devices or features. It should be understood that the spatial relative terms are intended to cover different orientations in use or operation in addition to the orientation shown in the drawings of the device. For example, if the device in the drawings is inverted, the device described as "above other devices or structures" or "over other devices or structures" will then be positioned "below other devices or structures" or "under other devices or structures". Thus, the exemplary term "above..." can include both the orientation of "above..." and "below...". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and corresponding interpretations should be made for the spatial relative descriptions used here.

[0043] A transvalvular catheter, such as Figures 1-9As shown, it includes a connector 1, a proximal tube body 2, and a distal tube body 3 that are sequentially connected and communicate with each other. Both the proximal tube body 2 and the distal tube body 3 are tubular structures. One end of the connector 1 away from the proximal tube body 2 is connected to a hemostatic valve assembly 6, which can effectively prevent blood from flowing out from the connector 1.

[0044] The axial length of the proximal tube body 2 is 80 - 90 cm, the inner diameter is 1.15 - 1.32 mm, and the outer diameter is 1.70 - 2.10 mm.

[0045] The proximal tube body 2 is a pre-shaped three-layer tubular structure, as Figure 2 and 3 shown, including an inner layer 21, a middle layer 22, and an outer layer 23 that are sequentially sleeved from the inside to the outside. The material of the inner layer 21 is a polymer; the material of the middle layer 22 is a metal braided mesh, which can be 16-strand or 32-strand stainless steel wire, nitinol wire, or cobalt-chromium alloy wire, etc.; the material of the outer layer 23 is a polymer containing a developing material. The hardness of each part of the outer layer 23 varies along the axis. The three-layer structure of the proximal tube body 2 makes the catheter have better anti-bending and anti-torsion performance, provides stronger support for the catheter, has good maneuverability, and a hydrophilic coating is applied on the polymer surface of the outer layer 23.

[0046] The proximal tube body 2 can provide a channel and support for the delivery of the guide wire 5, and can also be used for injecting contrast agent.

[0047] In this embodiment, the inner layer 21 is a nylon polymer, the middle layer 22 is a steel wire mesh reinforcement layer, and the outer layer 23 is a nylon polymer. It should be noted that since the middle layer 22 is a steel wire mesh with relatively large intermediate voids, these voids will be filled by the outer layer 23.

[0048] The axial length of the distal tube body 3 is 10 - 20 cm, the inner diameter is 1.15 - 1.32 mm, and the outer diameter is 1.70 - 2.10 mm.

[0049] The distal tube body 3 is a pre-shaped single-layer tubular structure, as Figure 4 and 5 shown. The distal tube body 3 is designed in a curved shape, as Figure 7 、 10 、11 shown, and the curved shape conforms to the trend of the aortic arch C and the ascending aorta B. In other words, the specific shape and size of the curvature of the distal tube body 3 are set according to the overall shape and angle of the ascending aorta B and the aortic valve A.

[0050] The distal tube body 3 includes a coaxial section 31, a support section 32, and a push section 33 that are sequentially connected. The coaxial section 31 is used for guiding, that is, for pointing and aligning with the aortic valve A; the support section 32 is located on the side wall of the ascending aorta, that is, it needs to conform to the trend of the ascending aorta B; the push section 33 is located in the aortic arch C, that is, it needs to conform to the trend of the aortic arch C.

[0051] It should be noted that the overall shape design of the supporting section 32 and the pushing section 33 is to conform to the overall trend of the ascending aorta B and the aortic arch C. Therefore, during use, it is not necessary to strictly limit that the supporting section 32 must be entirely located within the ascending aorta B and the pushing section 33 must be entirely located within the aortic arch C. Generally, most or all of the supporting section 32 is located within the ascending aorta B and most or all of the pushing section 33 is located within the aortic arch C. A part of the supporting section 32 can be located within the aortic arch C and a part of the pushing section 33 can be located within the ascending aorta B. The so-called "conformity" means that the shape of the corresponding part of the distal tube body 3 (such as the supporting section 32) is similar to the shape of the corresponding blood vessel (such as the ascending aorta B), so that the distal tube body 3 can move more smoothly within the blood vessel, and when the corresponding part of the distal tube body 3 is located within the corresponding blood vessel, it will not cause a large impact on the blood vessel wall due to the too large difference in shape.

[0052] The distal tube body 3 is composed of multiple single-layer polymer materials with different hardnesses. Specifically, the distal tube body 3 includes at least two unit segments that are smoothly connected in sequence. The unit segments are arc-shaped or linear, and the hardnesses of the unit segments are different. Specifically, in the direction from the proximal end to the distal end (i.e., from the joint 1 to the distal tube body 3), the distal tube body 3 gradually becomes softer, that is, the hardnesses of the unit segments decrease in sequence. The hardness range of the distal tube body 3 is 55D - 25D. The outer surface of the distal tube body 3 is pre-coated with a hydrophilic coating.

[0053] The material of the distal tube body 3 is a polymer, and the single-layer structure can maintain the bent shape of the distal tube body 3. The pure polymer has better shape retention ability than the wire and can better adapt to the direction of the aortic valve.

[0054] The end of the distal tube body 3 is a conical tip 4, as Figure 6 shown. When the guide wire 5 passes through the tip 4 of the distal tube body 3, the conical outer surface of the tip 4 can smoothly transition and cooperate with the outer surface of the guide wire 5, avoiding the inability to smoothly transition due to the too large difference in diameter between the guide wire 5 and the distal tube body 3. The tip 4 is composed of a polymer containing a radiopaque agent, with low material hardness and safety.

[0055] The distal tube body 3 can ensure that the catheter has good trackability during pushing in the blood vessel. At the same time, the pre-shaped bent shape can adapt to different blood vessel trajectories and angles, and the design of the tip 4 can better match the guide wire 5.

[0056] In this embodiment, two types of transvalvular catheters are provided, and the difference between the two types of transvalvular catheters lies in the different bent shapes of the distal tube body 3.

[0057] In this embodiment, the distal tube body 3 of the first type of transvalvular catheter is as Figure 8As shown, it includes a first arc, a second arc, and a third arc connected in sequence. The first arc is connected to the proximal tube body 2, and a tip 4 is provided at the end of the third arc. The first arc and the second arc are internally tangent, and the third arc and the second arc are externally tangent. The radius of the first arc is 14.4 mm, and the corresponding central angle is 57°; the radius of the second arc is 15.75 mm, and the corresponding central angle is 62°; the radius of the third arc is 17.5 mm, and the corresponding central angle is 59°.

[0058] In this embodiment, the first arc of the first type of transvalvular catheter is the pushing section 33, the second arc is the supporting section 32, and the third arc is the coaxial section 31.

[0059] The distal tube body 3 of the second type of transvalvular catheter is as Figure 9 shown, including a first arc, a second arc, a third straight section, and a fourth arc connected in sequence. The first arc is connected to the proximal tube body 2, and a tip 4 is provided at the end of the fourth arc. The first arc and the second arc are internally tangent, the third straight section is straight, the third straight section is externally tangent to both the second arc and the fourth arc at the same time, and the centers of the circle corresponding to the second arc and the fourth arc are located on both sides of the third straight section respectively. The radius of the first arc is 16.62 mm, and the corresponding central angle is 38°; the radius of the second arc is 15.7 mm, and the corresponding central angle is 70°; the radius of the fourth arc is 16.98 mm, and the corresponding central angle is 51°.

[0060] In this embodiment, the first arc and the second arc of the second type of transvalvular catheter as a whole are the pushing section 33, the third straight section is the supporting section 32, and the fourth arc is the coaxial section 31; or the first arc is the pushing section 33, and the second arc and the third straight section as a whole are the supporting section 32.

[0061] As can be seen from the above, compared with the second type of transvalvular catheter, the bent part of the distal tube body 3 of the first type of catheter is formed by connecting three arcs, and its length is slightly shorter than the length of the bent part of the distal tube body 3 of the second type of catheter. The curvature of the three arcs of the first type of catheter decreases in sequence, which is equivalent to the fact that this bent part becomes "gentler", and it is suitable for the relatively "gentle" situation of the ascending aorta B. The setting of the third straight section of the distal tube body 3 of the second type of catheter and the design of the shape and size of other parts enable the "turn" formed by the second arc to be extended by the third straight section and then taken over and corrected in the bending direction by the fourth arc, which is suitable for the situation where the ascending aorta B is more curved as a whole.

[0062] Through the analysis of existing cases and experiments, the two different types of transvalvular catheters manufactured in this embodiment can cover most cases.

[0063] The aortic valve A can be regarded as being located at the end of the ascending aorta B. As Figure 10 and 11 shown, the shape and angle of the overall ascending aorta B and the aortic valve A are represented by the included angle between the spinal direction F1 and the direction F2 pointing to the aortic valve A. The direction F2 is equivalent to the extension direction of the ascending aorta B. The spinal direction F1 is a reference. For different patients, the spinal direction F1 can be regarded as being determined. When a person stands, the spinal direction F1 is vertically downward, and the extension direction F2 of the ascending aorta B of different patients is different.

[0064] As a preferred solution, in this embodiment, when the included angle between the direction F1 and the direction F2 is relatively small, it is equivalent to that the arc of the ascending aorta B is relatively large and the overall is relatively flat, and the first type of transvalvular catheter is selected. When the included angle between the direction F1 and the direction F2 is relatively large, it is equivalent to that the arc of the ascending aorta B is relatively small and the overall is more curved, and the second type of transvalvular catheter is selected. As Figure 10 and Figure 11 shown respectively in the two cardiac morphological structures, Figure 10 the included angle formed by the direction F1 and the direction F2 in Figure 11 is relatively small, and Figure 10 the included angle formed by the direction F1 and the direction F2 in Figure 11 is relatively large. Therefore, in this embodiment,

[0065] the first type of catheter bend is selected for the cardiac morphology of

[0066] The connector 1 is communicated with the inner cavity of the proximal tube body 2. The connector 1 is a standard luer connector and can pass a guide wire 5.

[0067] The hemostatic valve assembly 6 is as Figure 12 and 13 shown, including a hemostatic valve 61, a hemostatic valve connector 62, and a hemostatic valve handle 63. The hemostatic valve handle 63, the hemostatic valve 61, and the hemostatic valve connector 62 are connected in sequence. One end of the hemostatic valve connector 62 is connected to the connector 1, and the other end is connected to the hemostatic valve 61. The hemostatic valve 61 is used for hemostasis and can adopt a hemostatic valve product in the prior art. The hemostatic valve handle 63 is used to adjust the hemostatic valve 61 to open or close the hemostatic valve 61. As Figure 12 and 13 shown in, the dotted arrow is the blood flow direction. When the hemostatic valve 61 is closed, the blood in the catheter cannot flow out.

[0068] The working principle of the present invention is as follows: A more suitable transvalvular catheter is selected according to the included angle between the extension direction F2 of the ascending aorta B and the spinal column direction F1. A guide wire 5 passes through the transvalvular catheter. The transvalvular catheter passes through the femoral artery and can reach the ascending aorta B directly along the guide wire 5. The transvalvular catheter is adjusted so that the axial direction of the tip 4 of the transvalvular catheter is aligned with the aortic valve opening A. Then, the guide wire 5 is extended so that the guide wire 5 passes through the valve at A, and the transvalvular catheter then passes through the valve along the guide wire 5. During the process, hemostasis is performed through the hemostatic valve assembly 6.

[0069] Finally, it is necessary to state here that the above embodiments are only used to further elaborate on the technical solution of the present invention and cannot be construed as a limitation on the protection scope of the present invention. Some non-essential improvements and adjustments made by those skilled in the art based on the above content of the present invention all fall within the protection scope of the present invention.

Claims

1. A transvalvular catheter, characterized in that, It includes a connector (1), a proximal tube body (2), and a distal tube body (3) that are sequentially connected and communicate with each other. Both the proximal tube body (2) and the distal tube body (3) are tubular structures. The distal tube body (3) is in a curved shape and includes at least two unit segments that are sequentially and smoothly connected. Each unit segment of the distal tube body (3) is arc-shaped or at least one unit segment is linear.

2. The cross-valve catheter according to claim 1, wherein: The distal tube body (3) includes a coaxial segment (31), a support segment (32), and a pushing segment (33) that are sequentially connected. During use, the coaxial segment (31) points to the aortic valve. Part or all of the support segment (32) is located within the ascending aorta (B) and conforms to the trend of the ascending aorta (B). Part or all of the pushing segment (33) is located within the aortic arch (C) and conforms to the trend of the aortic arch (C).

3. The cross-valve catheter according to claim 1 or 2, characterized in that: The distal tube body (3) includes a first arc, a second arc, and a third arc that are sequentially connected. The first arc is connected to the proximal tube body (2). A tip (4) is provided at the end of the third arc. The first arc and the second arc are internally tangent, and the third arc and the second arc are externally tangent. The radius of the first arc is 12 - 16 mm, and the corresponding central angle is 55 - 60°; the radius of the second arc is 14 - 18 mm, and the corresponding central angle is 60 - 65°; the radius of the third arc is 16 - 19 mm, and the corresponding central angle is 57 - 62°.

4. The cross-valve catheter according to claim 1 or 2, characterized in that: The distal tube body (3) includes a first arc, a second arc, a third straight portion, and a fourth arc that are sequentially connected. The first arc is connected to the proximal tube body (2). A tip (4) is provided at the end of the fourth arc. The first arc and the second arc are internally tangent. The third straight portion is linear and is externally tangent to both the second arc and the fourth arc at the same time. The centers of the circles corresponding to the second arc and the fourth arc are respectively located on both sides of the third straight portion. The radius of the first arc is 14 - 18 mm, and the corresponding central angle is 35 - 40°; the radius of the second arc is 14 - 18 mm, and the corresponding central angle is 68 - 72°; the radius of the fourth arc is 15 - 19 mm, and the corresponding central angle is 49 - 53°.

5. The transvalvular catheter according to claim 1 or 2, characterized in that: The axial length of the proximal tube body (2) is 80 - 90 cm, the inner diameter is 1.15 - 1.32 mm, and the outer diameter is 1.70 - 2.10 mm. The axial length of the distal tube body (3) is 10 - 20 cm, the inner diameter is 1.15 - 1.32 mm, and the outer diameter is 1.70 - 2.10 mm.

6. The transvalvular catheter according to claim 1 or 2, characterized in that: The proximal tube body (2) is a pre-shaped three-layer tubular structure, including an inner layer (21), a middle layer (22), and an outer layer (23) that are sequentially sleeved from the inside to the outside. The material of the inner layer (21) is a high molecular polymer, the material of the middle layer (22) is a metal braided mesh, and the material of the outer layer (23) is a high molecular polymer containing a developing material.

7. The transvalvular catheter according to claim 1 or 2, characterized in that: The distal tube body (3) is a pre-shaped single-layer tubular structure. The distal tube body (3) is composed of at least two high molecular polymers with different hardnesses. In the direction from the connector (1) to the distal tube body (3), the hardness of the distal tube body (3) decreases sequentially.

8. The cross-valve catheter according to claim 1 or 2, characterized in that: The end of the distal tube body (3) is a conical tip (4).

9. The transvalvular catheter according to claim 1 or 2, characterized in that: The transvalvular catheter further includes a hemostatic valve assembly (6) for hemostasis, and the hemostatic valve assembly (6) is connected to the joint (1).

10. The transvalvular catheter according to claim 9, wherein: The hemostatic valve assembly (6) includes a hemostatic valve (61), a hemostatic valve joint (62), and a hemostatic valve handle (63). The hemostatic valve handle (63), the hemostatic valve (61), and the hemostatic valve joint (62) are connected in sequence. One end of the hemostatic valve joint (62) is connected to the joint (1), and the other end is connected to the hemostatic valve (61). The hemostatic valve (61) is used for hemostasis, and the hemostatic valve handle (63) is used to adjust the hemostatic valve (61) to open or close it.

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