Interventional catheter and interventional system

Abstract

The utility model relates to the field of medical instruments, and discloses an interventional catheter and an interventional system.The interventional catheter comprises an operation part, a sheathing canal and an elastic structure, the elastic structure is arranged at the end, away from the operation part, of the sheathing canal, the elastic structure is elastic, and the first end and the second end of the elastic structure are connected to the outer surface of the sheathing canal; the second end is located between the first end and the operation part, and the protruding radian of the sheath tube between the first end and the second end opposite to the elastic structure is variable. The interventional catheter can conveniently pass through the circuitous position of the blood vessel at low cost.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, and particularly relates to an interventional catheter and an interventional system. BACKGROUND

[0002] The interventional catheter is an important component of cardiovascular interventional medical devices, and belongs to the core tool of minimally invasive diagnosis and treatment technology. The interventional catheter enters the body through the natural cavity or blood vessel puncture of the human body, and is guided by an imaging device (such as DSA, CT) to perform diagnosis or treatment of medical devices. Its functions include drug delivery, implantation of devices (such as stents, occluders), and collection of physiological data.

[0003] However, the interventional catheter may encounter a detour of the blood vessel during pushing along the blood vessel, which affects the smooth arrival of the interventional catheter at the designated position. CONTENT OF THE UTILITY MODEL

[0004] Embodiments of the present application provide an interventional catheter and an interventional system, which can facilitate the low-cost passage of the interventional catheter through the detour position of the blood vessel.

[0005] In one aspect, some embodiments of the present application provide an interventional catheter, comprising: an operation part, a sheath tube and an elastic structure, the sheath tube being in communication with a chamber of the operation part, and the sheath tube being capable of bending; the elastic structure being arranged at one end of the sheath tube away from the operation part, the elastic structure comprising a first end and a second end along the length direction of the elastic structure, the first end and the second end being respectively connected to the outer surface of the sheath tube, the second end being located between the first end and the operation part, and the curvature of the sheath tube between the first end and the second end being variable away from the elastic structure.

[0006] In some optional embodiments of the present application, the curvature of the sheath tube between the first end and the second end away from the elastic structure corresponds to a central angle of a circle, and 15°≤β≤180°.

[0007] In some optional embodiments of the present application, the elastic structure comprises at least one elastic rope, and the end of the elastic rope along the length direction forms the first end and the second end; the sheath tube comprises a reference surface passing through an axis, and the elastic rope is arranged on one side of the reference surface.

[0008] In some optional embodiments of the present application, the elastic structure comprises a plurality of elastic ropes, the first end comprises a first clasp, the second end comprises a second clasp, the plurality of elastic ropes are distributed in a crisscross manner, and the two ends of each elastic rope are respectively connected to the first clasp and the second clasp.

[0009] In some optional embodiments of the present application, the first end is detachably connected to the sheath tube, and the second end is detachably connected to the sheath tube; or one of the first end and the second end is detachably connected to the sheath tube, and the other is fixedly connected to the sheath tube.

[0010] In some optional embodiments of the present application, the elastic structure comprises a pre-bent body and a pair of positioning members, the pre-bent body comprises an elastic rope and a pair of clamping rings, the elastic rope is connected to the pair of clamping rings, and the pair of clamping rings form the first end and the second end, respectively; the pair of positioning members are detachably mounted on the outer surface of the sheath tube in an axial direction, the pair of clamping rings are sleeved on the sheath tube and located on the side opposite to the pair of positioning members, and the elastic rope is located on one side of a reference surface passing through the axis of the sheath tube.

[0011] In some optional embodiments of the present application, at least one of the pair of positioning members comprises a developing material.

[0012] In some optional embodiments of the present application, the sheath tube comprises a distal port, a lumen and a proximal port arranged in sequence along the axial direction of the sheath tube, and the proximal port is connected to the operation part; the distance L between the first end and the distal port ranges from 5 mm to 200 mm; and / or the length W of the sheath tube between the first end and the second end ranges from 0.1 mm to 100 mm.

[0013] In some optional embodiments of the present application, the elastic modulus E of the elastic structure ranges from 0.1 MPa to 600 MPa.

[0014] In another aspect, some embodiments of the present application also provide an interventional system comprising the interventional catheter of the above-mentioned embodiments.

[0015] The interventional catheter and the interventional system of the embodiments of the present application connect the two ends of the elastic structure to the outer surface of the sheath tube, so that the sheath tube has a bending angle, which is convenient for passing through the detour position of the blood vessel, and the elasticity of the elastic structure can change with the stress state of the blood vessel and other tissues when the sheath tube enters the body, so as to be more fitted to the sheath tube, improve the compliance of the interventional catheter in the blood vessel, and the structure of the elastic structure is simple and has low cost. BRIEF DESCRIPTION OF DRAWINGS

[0016] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments of the present application will be briefly introduced below. Those skilled in the art can also obtain other drawings according to these drawings without creating any creative labor.

[0017] Figure 1 FIG. 1 is a structural schematic diagram of an interventional catheter according to some embodiments of the present application;

[0018] Figure 2 A partial view of an interventional catheter according to some embodiments of the present application in a first state;

[0019] Figure 3 Another partial view of an interventional catheter according to some embodiments of the present application in a second state;

[0020] Figure 4 A partial view of an interventional catheter according to some embodiments of the present application in a second state;

[0021] Figure 5 A structural view of an elastic structure in an interventional catheter according to some embodiments of the present application;

[0022] Figure 6 Another structural view of an elastic structure in an interventional catheter according to some embodiments of the present application;

[0023] Figure 7 A computational simulation state view of an elastic structure in an interventional catheter according to some embodiments of the present application.

[0024] Reference signs:

[0025] 100, operating part; 200, sheath; 201, distal port; 202, proximal port; 203, lumen; 300, elastic structure; 301, first end; 302, second end; 310, elastic string; 310a, pre-bent body; 320, first clasp; 330, second clasp; 340, positioning member; 400, blood vessel; X, axis. DETAILED DESCRIPTION

[0026] The embodiments of the technical solutions of the present application will be described in detail below with reference to the drawings. The following embodiments are only used to more clearly illustrate the technical solutions of the present application, and therefore only serve as examples, and cannot limit the protection scope of the present application.

[0027] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present application belongs; the terms used herein are only for the purpose of describing specific embodiments of the present application, and are not intended to limit the present application; the terms "include" and "have" and any variations thereof in the specification and claims of the present application and the above description of drawings are intended to cover not exclusive inclusion.

[0028] In the description of the embodiments of the present application, the technical terms "first", "second", etc. are only used to distinguish different objects, and cannot be understood as indicating or implying relative importance or implicitly indicating the number, specific order or primary and secondary relationship of the indicated technical features. In the description of the embodiments of the present application, the meaning of "a plurality of" is two or more, unless otherwise explicitly and specifically limited.

[0029] Reference within this document to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the application. The appearances of the phrase "in an embodiment" in various places in the specification are not necessarily all referring to the same embodiment, nor are they necessarily mutually exclusive of one another. It is expressly understood that any of the embodiments described herein can be combined with any of the other embodiments unless explicitly stated otherwise.

[0030] In the description of the embodiments of the present application, the term "and / or" is merely used to describe associated objects, and can represent that three conditions can exist, for example, A and / or B can mean that the three conditions of A alone, A and B, and B alone can exist. In addition, the character " / " in this document generally indicates that the preceding and following associated objects have an "or" relationship.

[0031] In the description of the embodiments of the present application, the term "a plurality of" refers to two or more (including two), and similarly, "a plurality of groups" refers to two or more groups (including two groups), and "a plurality of pieces" refers to two or more pieces (including two pieces).

[0032] In the description of the embodiments of the present application, the technical terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the embodiments of the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the embodiments of the present application.

[0033] In the description of the embodiments of the present application, unless otherwise explicitly specified and limited, the technical terms "mounting", "connection", "connection", "fixing", and the like should be understood broadly, for example, can be fixedly connected, or can be detachably connected, or can be integrated; can be mechanically connected, or can be electrically connected; can be directly connected, or can be indirectly connected through an intermediate medium; can be the internal communication of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the embodiments of the present application can be understood according to the specific circumstances.

[0034] Interventional catheters can include diagnostic catheters, therapeutic catheters, etc. Taking therapeutic catheters as an example, they can include balloon catheters, embolization catheters, radiofrequency ablation catheters, etc. Interventional catheters can be used for cardiovascular diseases, cerebrovascular diseases, tumor treatment, peripheral vascular diseases, etc. Taking coronary artery intervention as an example, it includes the process of puncture and access establishment, guidewire guidance, catheter insertion and positioning, treatment operation, and withdrawal and closure. Specifically, the interventional catheter is inserted as a channel through the femoral or radial artery puncture. Under X-ray fluoroscopy, the guidewire passes through the tortuous segment of the blood vessel to reach the distal end of the lesion, providing a path for the guiding catheter. The guiding catheter is advanced along the guidewire to the coronary artery ostium, and the guidewire is withdrawn; the angiography catheter injects contrast agent to confirm the location of the lesion. The balloon catheter is advanced along the guidewire to the stenosis, dilated, and then a stent is implanted; the drug-eluting balloon adheres to the vessel wall to release drugs. The catheter system is withdrawn, and a vascular closure device or compression is used to stop bleeding.

[0035] During interventional procedures, catheters may encounter vascular tortuosity, such as bends and curves, necessitating pre-bending of the distal end. Currently, pre-bending of interventional catheters is achieved through braided metal (nickel-titanium) tubing or heat setting. However, the elastic structure of heat-set catheters tends to spring back at a certain angle after prolonged placement, making it difficult to control and maintain a fixed angle. Pre-bending with braided metal tubing requires an external bending element fitted around the catheter, using external force to bend and deform the catheter itself, resulting in high cost and poor conformability.

[0036] In view of this, some embodiments of this application provide an interventional catheter, which has an elastic structure on the outer surface of the sheath, and the sheath is bent relative to the elastic structure by tightening the two ends of the elastic structure, which is low in cost and has good compliance. The interventional catheter can be an aspiration catheter.

[0037] like Figures 1 to 6 As shown, in some embodiments of this application, an interventional catheter is provided, including: an operating part 100, a sheath 200, and an elastic structure 300. The sheath 200 communicates with the chamber of the operating part 100 and is bendable. The elastic structure 300 is disposed at the end of the sheath 200 away from the operating part 100. The elastic structure 300 is elastic and includes a first end 301 and a second end 302 along its own length direction. The first end 301 and the second end 302 are connected to the outer surface of the sheath 200. The second end 302 is located between the first end 301 and the operating part 100. The curvature of the sheath 200 between the first end 301 and the second end 302 facing away from the elastic structure 300 is variable.

[0038] In one example, the operating part 100 has a chamber that communicates with the lumen 203 of the sheath 200.

[0039] Exemplarily, the elastic structure 300 is stretched to tighten the sheath tube 200 to realize the bending of the sheath tube 200. When the sheath tube 200 is subjected to an external force from the blood vessel 400 or other structures in the body, the bending curvature of the sheath tube 200 is reduced, and the elastic structure 300 is further stretched. When the external force from the blood vessel 400 or other structures on the sheath tube 200 disappears, the elastic structure 300 is retracted, the bending curvature of the sheath tube 200 is increased, and the sheath tube 200 returns to the initial bending curvature. In this case, the relative distance between the first end 301 and the second end 302 changes when the sheath tube 200 or the elastic structure 300 is subjected to an external force, and the elastic structure 300 is stretched or retracted.

[0040] It can be understood that the length of the sheath tube 200 between the first end 301 and the second end 302 is as follows: the position connected with the first end 301 on the sheath tube 200 is a first position, the position connected with the first end 301 on the sheath tube 200 is a second position, and the distance from the first position to the second position on the sheath tube 200 is the length of the sheath tube 200 between the first end 301 and the second end 302.

[0041] In this application, the operation part 100 is a core component for the operator to directly control the movement of the interventional catheter, and the operation part 100 is placed outside the body. Exemplarily, the operation part 100 includes an operation channel to facilitate the insertion of other catheters or guide wires.

[0042] Exemplarily, the operation part 100 can include a handle type structure and a mechanical control type structure. In one example, the handle type operation part 100 includes an integrated guide wire holder, a hemostatic valve, and a rotation adjustment device. The operator can adjust the fixation or release of the guide wire through the knob at the end of the handle, and at the same time control the blood backflow through the hemostatic valve. The front end of the handle is connected with the sheath tube 200, and the rear end is provided with a guide wire channel to facilitate the quick replacement of the catheter or guide wire placed in the sheath tube 200.

[0043] In this application, the sheath tube 200 is the main part of the interventional catheter, and is at least partially placed in the body. Exemplarily, the sheath tube 200 includes an interventional channel extending along the axial direction thereof, and the interventional channel can include one or more cavities. The sheath tube 200 includes an inner surface and an outer surface opposite in thickness direction, the inner surface defines the interventional channel, and the outer surface directly contacts with the outside.

[0044] Exemplarily, the outer surface of the sheath tube 200 is relatively smooth to reduce the friction between the catheter and the surrounding tissues when the catheter moves in the body, thereby reducing the risk of damage to the blood vessel 400 or other tissues. In one example, the outer surface of the sheath tube 200 is coated with a hydrophilic polymer. In another example, the sheath tube 200 can have a multi-layer structure.

[0045] In some examples, the sheath tube 200 can be a one-piece or multi-piece detachable structure.

[0046] Exemplarily, the intervention channel of the sheath tube 200 is in communication with the operation channel of the operation part 100.

[0047] In some examples, the sheath tube 200 has a bending property. For example, the sheath tube 200 can be made of PE (polyethylene), PTFE (polytetrafluoroethylene), or FEP (fluorinated ethylene propylene), or the like.

[0048] Exemplarily, the sheath tube 200 is divided into a proximal hard segment, a middle transition segment, and a distal soft segment, and the bending adaptation is achieved by combining materials with different hardness. In some embodiments of the present application, the first end 301 and the second end 302 of the elastic structure 300 are respectively connected to the distal soft segment.

[0049] In the present application, the elastic structure 300 realizes automatic rebound after deformation through the elastic modulus of the material itself. Exemplarily, the elastic structure 300 can be made of a high molecular material, and relies on the flexibility of the molecular chain to realize elastic deformation.

[0050] Exemplarily, the elastic structure 300 can be in the shape of a strip, a sheet, a net, or the like. The elastic structure 300 is connected to the outer surface of the sheath tube 200 through the first end 301 and the second end 302 in the length direction, thereby realizing the bending deformation of the sheath tube 200 under the tension of the elastic structure 300.

[0051] In an embodiment of the present application, the central angle β of the sheath tube 200 corresponding to the curvature of the elastic structure 300 is 15°≤β≤180°.

[0052] Exemplarily, the central angle β is 15°, 20°, 25°, 30°, 60°, 75°, 90°, 100°, 120°, 150°, 160°, 175°, or 180.

[0053] Exemplarily, the pre-bending central angle β of the sheath tube 200 can be 15° when the intervention catheter is not in the body. Alternatively, the pre-bending central angle β of the sheath tube 200 can be 80°, and the minimum bending central angle β of the sheath tube 200 in the body is 15°.

[0054] In an embodiment, the intervention catheter comprises a first state and a second state; in the first state, the length of the elastic structure 300 is less than the length of the sheath tube 200 between the first end 301 and the second end 302, and the sheath tube 200 between the first end 301 and the second end 302 has a curvature away from the elastic structure 300; in the second state, the length of the elastic structure 300 is equal to the length of the sheath tube 200 between the first end 301 and the second end 302.

[0055] The first state and the second state are not in any particular order and can be repeatedly switched between the two states. For example, after the first state to the second state, the state can be switched from the second state back to the first state.

[0056] In the present application, the first state can be the initial state of the sheath tube 200 or the state of the sheath tube 200 in the bypass position of the blood vessel 400, and in the first state, the sheath tube 200 has a tendency to bend to the side of the elastic structure 300 within the length range opposite to the elastic structure 300. The second state can be the state of the sheath tube 200 entering the straight section of the blood vessel 400, at this time, the elastic structure 300 is stretched to a state close to parallel with the sheath tube 200 under the elasticity of the elastic structure 300 itself, so that the elastic structure 300 is more fitted to the blood vessel 400 and the sheath tube 200, facilitating the passage through the straight section of the blood vessel 400.

[0057] In the present application, "equal" or "equivalent" or "parallel" can be understood as approximately equal or equal or parallel within a certain error or range, which will not be repeated below.

[0058] In some examples, in the first state, the elastic structure 300 can be in a tensioned state or a relaxed state.

[0059] In one example, as shown in Figure 1 and Figure 4 In the second state, when the elastic structure 300 is opposite to the pre-bending direction or has a bias angle, the sheath tube 200 can be rotated by the operation part 100, so that the elastic structure 300 is opposite to the pre-bending direction, and then the elastic structure 300 drives the sheath tube 200 to bend, facilitating the bending adjustment.

[0060] In the embodiments of the present application, the two ends of the elastic structure 300 are connected to the outer surface of the sheath tube 200, so that the sheath tube 200 has a bending angle in the first state, facilitating the passage through the bypass position of the blood vessel 400, and through the elasticity of the elastic structure 300, the elastic structure 300 is elongated in the second state to be consistent with the length of the sheath tube 200 inside the two ends of the elastic structure 300, and then more fitted to the sheath tube 200, improving the compliance of the interventional catheter in the blood vessel 400, the structure of the elastic structure 300 is simple and the cost is low.

[0061] Further, in some embodiments of the present application, the elastic structure 300 includes at least one elastic rope 310, the end of the elastic rope 310 in the length direction forms a first end 301 and a second end 302; in the second state, the sheath tube 200 includes a reference surface on one side of the sheath tube 200.

[0062] Exemplarily, the elastic structure 300 can include one elastic cord 310 or multiple elastic cords 310. The elastic cord 310 refers to a flexible linear structure with high resilience and deformation recovery capability in the interventional catheter. By being fixed in a specific position of the sheath tube 200 in a pre-stretched state, the elastic cord 310 provides controllable bending force when the interventional catheter passes through the tortuous section of the blood vessel 400, while maintaining the stability of the shape.

[0063] In some examples, the elastic cord 310 can be made of one or a combination of medical-grade silicone, polyurethane (PU) fiber, fluorinated ethylene propylene (FEP) coated wire. The elastic cord 310 can also be made of a soft film material such as thermoplastic polyurethane elastomer (TPU), polytetrafluoroethylene (PTFE), or an elastic cord such as silicone.

[0064] In other examples, the elastic cord 310 can be a single-strand braided or multi-strand spiral wound structure.

[0065] Exemplarily, the two ends of the elastic cord 310 can be connected to the outer surface of the sheath tube 200 by adhesion, welding, fastener connection, or the like.

[0066] In one example, the elastic structure 300 includes one elastic cord 310, and in the second state, the elastic cord 310 is parallel to the axis X, the elastic cord 310 passes through a reference plane of the axis X, and the first end 301 and the second end 302 both pass through the reference plane. That is, when the elastic cord 310 is connected to the sheath tube 200, the sheath tube 200 has no torsion around the axis X.

[0067] In the embodiments of the present application, the elastic structure 300 is simplified by using the elastic cord 310, the cost is reduced, and the elastic cord 310 is placed on one side of the reference plane to facilitate the pre-bending of the interventional catheter to one side.

[0068] In addition, in some optional embodiments of the present application, the elastic structure 300 includes multiple elastic cords 310, the first end 301 includes a first clasp 320, the second end 302 includes a second clasp 330, and the multiple elastic cords 310 are cross-connected to the first clasp 320 and the second clasp 330.

[0069] Exemplarily, the first clasp 320 and the second clasp 330 can be a closed ring or an open ring structure.

[0070] In one example, the elastic structure 300 includes multiple elastic cords 310, the first end 301 includes a first clasp 320 with a first opening, the second end 302 includes a second clasp 330 with a second opening, the first opening and the second opening are opposite along the length direction of the elastic structure 300, the multiple elastic cords 310 are cross-connected to the first clasp 320 and the second clasp 330, and the multiple elastic cords 310 are placed at one end of the first clasp 320 away from the first opening.

[0071] In the present application, the plurality of elastic ropes 310 are connected to the first and second clamping rings 320 and 330 and connected to the sheath 200 through the first and second clamping rings 320 and 330. In some examples, the elastic ropes 310 are connected to the first and second clamping rings 320 and 330 by bonding, welding, fastener connection, etc.

[0072] Exemplarily, the first and second clamping rings 320 and 330 are connected to the sheath 200 by bonding, welding, fastener connection, clamping, limiting connection, etc.

[0073] In some examples, the diameters of the first and second clamping rings 320 and 330 can be the same or different to match the outer diameter of the corresponding positions of the sheath 200. Among them, the opening sizes of the first and second openings can be the same or different.

[0074] In another example, the circumference of the first clamping ring 320 is L1, the circumference of the corresponding position of the sheath 200 where the first clamping ring 320 is arranged is K1, and the range of L1 / K1 is 20%-80%.

[0075] As an example, L1 / K1 is 20%, 30%, 50%, 60%, 70% or 80%. The range of L1 / K1 of the second clamping ring 330 is the same as that of the first clamping ring 320, which is not repeated here.

[0076] In some examples, the plurality of elastic ropes 310 are connected to the middle part of the first and second clamping rings 320 and 330, and when the first and second clamping rings 320 and 330 are installed on the sheath 200, the first and second openings are opposite, reducing the probability of torsion of the elastic structure 300 to the sheath 200.

[0077] As an example, the first and second openings overlap in the axial direction by a length greater than or equal to 80% of the length of the largest opening of the first and second openings.

[0078] Exemplarily, the plurality of elastic ropes 310 can be 2, 3, 4, 5, etc. In one example, when the plurality of elastic ropes 310 is even, they are symmetrically arranged about the axis X, and when the plurality of elastic ropes 310 is odd, one of them is opposite and parallel to the axis X, and the others are symmetrically arranged about the axis X.

[0079] In the embodiments of the present application, the pre-bending angle and the pre-bending stability of the sheath 200 are improved by the cross arrangement of the plurality of elastic ropes 310, and the plurality of elastic ropes 310 are connected to the sheath 200 by the clamping ring, improving the installation convenience and position alignment.

[0080] In some embodiments, one end of the elastic rope 310 is staggered left-right symmetrically along the sheath tube 200, and the other end of the elastic rope 310 extends to the right and left sides of the sheath tube 200 respectively and is fixedly connected, so as to realize the cross layout of the elastic rope 310.

[0081] In some embodiments of the present application, the elastic structure 300 is detachably connected to the sheath tube 200.

[0082] For example, the elastic structure 300 can be detachably connected to the sheath tube 200 by buckle connection, limiting connection, threaded connection and the like.

[0083] In some examples, the elastic structure 300 can be detachably connected at both the first end 301 and the second end 302, or can be detachably connected at one end.

[0084] For example, the elastic structure 300 includes the elastic rope 310, the first clasp 320 and the second clasp 330, the elastic rope 310 is connected to the sheath tube 200 through the first clasp 320 and the second clasp 330, the first clasp 320 and the second clasp 330 can be fixedly connected or detachably connected to the elastic rope 310, and the first clasp 320 and the second clasp 330 can be fixedly connected to the sheath tube 200. The stability of the pre-bending angle of the sheath tube 200 to the elastic structure 300 can be improved by replacing the elastic rope 310.

[0085] Through the detachable connection between the elastic structure 300 and the sheath tube 200, the elastic structure 300 can be replaced, the reliability of the pre-bending angle of the sheath tube 200 can be improved, and the pre-bending angle of the sheath tube 200 can be adjusted.

[0086] In some embodiments of the present application, one of the first end 301 and the second end 302 is detachably connected to the sheath tube 200, and the other is fixedly connected to the sheath tube 200.

[0087] In one example, the first end 301 is fixed to the sheath tube 200, and the second end 302 is detachably connected to the sheath tube 200. In another example, the first end 301 is detachably connected to the sheath tube 200, and the second end 302 is fixed to the sheath tube 200.

[0088] For example, the elastic structure 300 includes the elastic rope 310, the first clasp 320 and the second clasp 330, the elastic rope 310 is connected to the sheath tube 200 through the first clasp 320 and the second clasp 330, the first clasp 320 and the second clasp 330 can be fixedly connected or detachably connected to the elastic rope 310, the first clasp 320 is fixedly connected to the sheath tube 200, and the second clasp 330 is detachably connected to the sheath tube 200.

[0089] The detachable connection of the first end 301 or the second end 302 with the sheath 200 facilitates adjustment of the position installed on the sheath 200, and further adjustment of the pre-bending angle of the sheath 200 and the pre-bending range of the sheath 200, improves convenience and ensures the stability and applicability of the elastic structure 300, avoids falling into the body and causes safety hazards.

[0090] In one example, the elastic structure 300 includes a pre-bending body 310a and a pair of positioning members 340. The pre-bending body 310a includes an elastic rope 310 and a pair of clamping rings. The elastic rope 310 is connected to the pair of clamping rings. The pair of clamping rings respectively form the first end 301 and the second end 302. The pair of positioning members 340 are detachably mounted on the outer surface of the sheath 200 along the axial direction. The pair of clamping rings are sleeved on the sheath 200 and located on the side opposite to the pair of positioning members 340. The elastic rope 310 is located on one side of a reference surface of the axis X of the sheath 200.

[0091] In the present application, the positioning member 340 is used to limit the position of the clamping ring in the axial direction. For example, the positioning member 340 can be a threaded locking type positioning member 340, a buckle type positioning member 340, a magnetic positioning member 340, etc.

[0092] In some examples, the positioning member 340 protrudes from the outer surface of the sheath 200 and is used to limit the clamping ring. The inner diameter of the clamping ring is smaller than the outer diameter of the positioning member 340.

[0093] For example, the positioning member 340 can be made of medical-grade stainless steel, nickel-titanium alloy, biocompatible polymer, etc.

[0094] For example, the clamping ring can include a split type clamp and an elastic clamping ring. The pair of clamping rings includes a first clamping ring 320 and a second clamping ring 330. The first clamping ring 320 is the first end 301, and the second clamping ring 330 is the second end 302.

[0095] In the present application, the elastic rope 310 is connected to the clamping ring beyond the positioning member 340. The elastic rope 310 has a mutual approaching pulling force on the positioning member 340.

[0096] In one example, the clamping ring is slidably sleeved on the sheath 200.

[0097] For example, the positioning member 340 can be a positioning ring, a positioning column or other structures.

[0098] In the embodiments of the present application, the pre-bending body 310a is installed by the positioning member 340. Different pre-bending bodies 310a can be replaced to realize the pre-bending angle of the sheath 200, which has higher adaptability. The positioning member 340 is detachably connected to the sheath 200, which facilitates installation and replacement.

[0099] In some embodiments of the present application, at least one of the pair of positioning members 340 comprises a radiopaque material.

[0100] As an example, the positioning member 340 distal to the operating end comprises a radiopaque material.

[0101] As another example, both of the positioning members 340 comprise a radiopaque material.

[0102] As an example, the radiopaque material has a strong absorption characteristic to X-rays, and can be a nickel-titanium alloy, tungsten coating, barium sulfate, etc. For example, barium sulfate is added in the plastic.

[0103] Under the digital subtraction angiography (DSA) image, the positioning member 340 with the radiopaque material can provide real-time feedback to the operator, reminding the operator of the position of the interventional catheter at the moment.

[0104] In some embodiments of the present application, the elastic modulus E of the elastic structure 300 is 0.1-600 MPa.

[0105] As an example, the elastic modulus E is 0.1 MPa, 1 MPa, 2 MPa, 5 MPa, 10 MPa, 20 MPa, 40 MPa, 50 MPa, 100 MPa, 150 MPa, 200 MPa, 400 MPa, or 600 MPa.

[0106] The better the compliance of the elastic structure 300 with the elastic modulus of 0.1-10 MPa, the lower the hardness, and the lower the damage to the blood vessel 400. The elastic structure 300 with the elastic modulus of 10-600 MPa has better bending and stretching resistance, and is convenient for pre-bending the angle of the position sheath 200.

[0107] In addition, in some embodiments of the present application, the sheath 200 comprises a distal port 201, a lumen 203, and a proximal port 202 arranged in sequence along the axial direction of the sheath 200, and the proximal port 202 is connected with the operating part 100; the distance L between the first end 301 and the distal port 201, L is in the range of 5-200 mm. As an example, L is 5 mm, 6 mm, 8 mm, 10 mm, 30 mm, 50 mm, 80 mm, 100 mm, 110 mm, 150 mm, 180 mm, or 200 mm.

[0108] In some embodiments of the present application, the length W of the sheath 200 between the first end 301 and the second end 302, W is in the range of 0.1-100 mm.

[0109] As an example, W is 0.1 mm, 0.5 mm, 1 mm, 2 mm, 5 mm, 10 mm, 30 mm, 35 mm, 50 mm, 60 mm, or 100 mm.

[0110] As shown in FIG. 1, the sheath 200 is connected with the operating part 100, and the sheath 200 is connected with the elastic structure 300.Figure 7 As shown, in the embodiments of the present application, in the first state, i.e. the state of not entering the body, the relationship among the arc length W between the first end 301 and the second end 302 of the sheath tube 200, the length D of the elastic structure 300 and the pre-bending angle β is as follows:

[0111]

[0112] wherein β = 2α. r is the radius of the circle where the arc length is located.

[0113] Specifically, in the calculation process, based on the requirements of the in-vivo intervention position, the pre-bending angle β of the first end 301 and the second end 302 of the sheath tube 200 is determined, and the arc length W between the first end 301 and the second end 302 of the sheath tube 200 is determined, the first end 301 and the second end 302 of the sheath tube 200 are approximated to a circular arc of a circle based on β and W, β is the central angle of the circle, and the length D of the elastic structure 300 in the first state is calculated based on the above formula. Wherein the length D of the elastic structure 300 is the length value in the stretched state.

[0114] Exemplarily, the elastic structure 300 can be selected based on the length D of the elastic structure 300, combined with the elastic modulus, the bending strength of the sheath tube 200 and other parameters. The actual selected elastic structure 300 can also be verified based on the length D of the elastic structure 300 whether it meets the standard.

[0115] In some embodiments of the present application, an intervention system is provided, comprising the intervention catheter of the above-mentioned embodiments.

[0116] The above is only a specific implementation of the present application, and those skilled in the art can clearly understand that, for the convenience and brevity of description, the specific working process of the above-mentioned system, module and unit can refer to the corresponding process in the foregoing method embodiments, which will not be described here. It should be understood that the protection scope of the present application is not limited to this, and any skilled person in the art can easily think of various equivalent modifications or replacements within the technical range disclosed in the present application, and these modifications or replacements should be covered within the protection scope of the present application.

Claims

1. An interventional catheter, characterized in that, include: Operations Department; The sheath is connected to the chamber of the operating part and is bendable. An elastic structure is disposed at the end of the sheath away from the operating part. The elastic structure includes a first end and a second end along its own length direction. The first end and the second end are respectively connected to the outer surface of the sheath. The second end is located between the first end and the operating part. The curvature of the sheath protruding away from the elastic structure between the first end and the second end is variable.

2. The interventional catheter according to claim 1, characterized in that, The central angle corresponding to the arc of the sheath protruding away from the elastic structure between the first end and the second end is β, where 15°≤β≤180°.

3. The interventional catheter according to claim 1 or 2, characterized in that, The elastic structure includes at least one elastic rope, the ends of which along the length direction form a first end and a second end; The sheath includes a reference plane passing through the axis, and the elastic cord is positioned on one side of the reference plane.

4. The interventional catheter according to claim 3, characterized in that, The elastic structure includes multiple elastic ropes, with a first retaining ring at the first end and a second retaining ring at the second end. The multiple elastic ropes are distributed in a crisscross pattern, and the two ends of each elastic rope are respectively connected to the first retaining ring and the second retaining ring.

5. The interventional catheter according to claim 1 or 2, characterized in that, The first end is detachably connected to the sheath, and the second end is detachably connected to the sheath; Alternatively, one of the first end and the second end may be detachably connected to the sheath, while the other may be fixedly connected to the sheath.

6. The interventional catheter according to claim 5, characterized in that, The elastic structure includes a pre-bent body and a pair of positioning members. The pre-bent body includes an elastic rope and a pair of retaining rings. The elastic rope is connected to the pair of retaining rings, and the pair of retaining rings respectively form the first end and the second end. The pair of positioning members are detachably mounted on the outer surface of the sheath at an axial distance, the pair of retaining rings are sleeved on the sheath and positioned on the opposite side of the pair of positioning members, and the elastic rope is positioned on one side of a reference plane passing through the axis of the sheath.

7. The interventional catheter according to claim 6, characterized in that, At least one of the pair of positioning elements includes developing material.

8. The interventional catheter according to claim 1 or 2, characterized in that, The sheath includes a distal port, a lumen, and a proximal port arranged sequentially along its own axial direction, and the proximal port is connected to the operating part; The distance L between the first end and the distal end is in the range of 5mm to 200mm. And / or, the length W of the sheath between the first end and the second end, where W ranges from 0.1 mm to 100 mm.

9. The interventional catheter according to claim 1, characterized in that, The elastic modulus of the elastic structure is E = 0.1~600 MPa.

10. An intervention system, characterized in that, The interventional catheter included in any one of claims 1 to 9.

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