A catheter reinforcement layer and catheter

Abstract

The application provides a catheter reinforcing layer and a catheter, and is applied to the technical field of medical devices. In the catheter provided by the application, compared with the reinforcing layer design of a pure braided structure in the prior art, a new reinforcing layer structure is designed, one or more axial components are introduced into the reinforcing layer of the existing catheter, the modulus of the catheter in the axial direction is increased, and then when an instrument is conveyed in the lumen of the catheter, the axial deformation of the catheter caused by the axial shear stress of the catheter body is avoided, that is, the axial tensile capacity of the catheter is improved, the elongation of the catheter is reduced, and finally the risk of fatigue failure of the catheter caused by the axial stretching of the internal compatible instrument is avoided.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a catheter reinforcing layer and a catheter comprising the same. BACKGROUND

[0002] Minimally invasive interventional surgery is a kind of surgery that uses a catheter delivery system to deliver an implantable medical device or a therapeutic drug to a lesion site through a blood vessel under the support of a digital subtraction angiography (DSA) system, so as to mechanically or chemically treat the lesion. As an important component of the delivery system, the catheter has been widely used in various minimally invasive interventional treatments. At present, such interventional surgery usually uses a small blood vessel (such as the femoral artery or the radial artery) as an entry point, and the catheter is delivered to the target lesion site along the blood vessel through the entry point with the assistance of a sheath tube and a guide wire, serving as a passageway for other devices (such as a stent, a coil, another catheter, etc.).

[0003] At present, in order to meet the requirement of smoothly delivering the catheter to the lesion site in clinical use, the existing medical catheter is usually designed to have segments with different hardness, the proximal end being harder and the distal end being softer, and the hardness gradually decreases from the proximal end to the distal end. The design of the hardness of different segments needs to be determined according to the blood vessel anatomy. Although the soft distal end of the catheter is easier to pass through the tortuous blood vessel and reduces the risk of damaging the blood vessel, at the same time, due to the influence of the material properties of the catheter, the axial elongation rate of the soft catheter is high, and the catheter is prone to axial deformation under the action of the axial force, such as being stretched to be longer. Therefore, during the clinical surgery, when other devices are delivered in the catheter, the catheter body will be subjected to axial shear stress, and if the axial elongation rate of the catheter body is too high, the catheter body is more likely to be axially stretched under the action of the force of the device delivered in the catheter, and the catheter body may be deformed after being stretched, causing the problem that the device delivered in the catheter is difficult to release or recover, which has a serious adverse effect on the clinical surgery. SUMMARY

[0004] The purpose of the present application is to provide a catheter reinforcing layer and a catheter, so as to solve the problem that the catheter is axially stretched when the device is delivered in the catheter due to the high elongation rate of the existing catheter.

[0005] To solve the above technical problems, the present application provides a catheter reinforcing layer catheter, which comprises a braided component and at least one axial component, the braided component is a mesh tube structure formed by crossing braiding of wires, the axial component is arranged along the braided component from the proximal end to the distal end, and there is at least one intersection point between the axial component and the braided component.

[0006] Optionally, the material of the axial component can be metal and / or high molecular wire.

[0007] Optionally, the axial component can be in a shape of one or a combination of straight line, wave or spiral.

[0008] Optionally, the axial component can be arranged parallel to the axial direction of the braided component.

[0009] Alternatively, the axial component can be arranged at an angle to the axial direction of the braided component, and the angle can be 0-45°.

[0010] Alternatively, at least a part of the axial component can be arranged at an angle to the axial direction of the braided component, and the angle can be 0-45°, and the other part of the axial component can be arranged parallel to the axial direction of the braided component.

[0011] Optionally, there can be 1-45000 intersection points between the axial component and the braided component.

[0012] Optionally, the braided wires of the braided component are cross-braided to form a mesh, the positions of the cross-braided wires form mesh intersection points, and the intersection points between the axial component and the braided component coincide with the mesh intersection points.

[0013] Alternatively, the intersection points between the axial component and the braided component can coincide with part of the mesh intersection points.

[0014] Alternatively, the intersection points between the axial component and the braided component can not coincide with the mesh intersection points.

[0015] Optionally, the axial component can be attached to the inner surface or the outer surface of the braided component in a straight line or spiral shape from the proximal end to the distal end.

[0016] Alternatively, the axial component can be attached to the inner surface and the outer surface of the braided component in a wave shape from the proximal end to the distal end.

[0017] Alternatively, the axial component can be arranged in the mesh of the braided component from the proximal end to the distal end, and the axial component and the braided component are in the same plane.

[0018] Optionally, when the number of the axial components can be multiple, the multiple axial components can be arranged symmetrically or asymmetrically along the circumferential direction of the braided component.

[0019] and / or,

[0020] The axial components can be arranged sequentially and spaced apart along the axial direction of the braided component.

[0021] Optionally, when the number of the axial components can be multiple, the multiple axial components can be arranged in a spiral along the axial direction of the braided component.

[0022] Optionally, the axial distance between the plurality of axial components is the same or different, and / or,

[0023] Optionally, the circumferential angular distance between the plurality of axial components is the same or different.

[0024] Optionally, the axial distance between the proximal axial components is smaller than the axial distance between the distal axial components,

[0025] and / or,

[0026] Optionally, the circumferential angular distance between the proximal axial components is smaller than the axial distance between the distal axial components.

[0027] Optionally, the number of the axial components can range from 1 to 16000.

[0028] Optionally, the axial distance between two adjacent axial components in the axial direction of the braided component can range from 0.001 inch to 0.1 inch.

[0029] Optionally, the material of at least one of the axial components can be a radiopaque material.

[0030] Optionally, the axial component is a monofilament or a stranded wire composed of a plurality of monofilaments.

[0031] Optionally, the diameter of the monofilament can range from 0.0005 inch to 0.003 inch, and the number of monofilaments in the stranded wire can range from 1 to 20.

[0032] Optionally, the axial component is connected to the braided component by means of gluing, polymerization, welding, or heating, or is integrated with the braided component by braiding.

[0033] Based on the above-mentioned catheter reinforcing layer, the present application further provides a catheter comprising an inner layer, a reinforcing layer, and an outer layer arranged sequentially from inside to outside and each in a tubular shape, wherein the reinforcing layer is the above-mentioned catheter reinforcing layer.

[0034] Optionally, the catheter comprises a plurality of catheter segments connected sequentially, and the axial component can be arranged at a preset position.

[0035] The preset position is between the circumferential surface of the braided component or the gap of the braided wire of the adjacent inner layer joint seam or outer layer joint seam of the catheter segments.

[0036] Alternatively, the preset position is between the circumferential surface of the braided component or the gap of the braided wire of the catheter segment with a modulus value smaller than that of the adjacent two or one side catheter segments.

[0037] Or, the preset position is the gap between the circumferential surface of the woven part or the woven wire material corresponding to the catheter segment with a smaller thickness of the material of the inner layer or the outer layer, or the catheter segment with higher softness of the inner layer or the outer layer.

[0038] Or, the preset position is the gap between the circumferential surface of the woven part or the woven wire material corresponding to the catheter segment with a smaller radial diameter than the radial diameter of the catheter segment on the adjacent two sides or one side.

[0039] Optionally, the inner layer is a high polymer material, and the thickness of the inner layer can be 0.0001 inch-0.002 inch.

[0040] Optionally, the thickness of the inner layer can be 0.0003 inch-0.0006 inch.

[0041] Compared with the prior art, the technical scheme of the present application has at least the following beneficial effects:

[0042] 1. In the catheter reinforcing layer and the catheter provided by the present application, compared with the pure woven structure reinforcing layer design in the prior art, a new reinforcing layer structure is designed, an axial part is introduced into the reinforcing layer of the existing catheter, thereby increasing the axial modulus of the catheter, and further avoiding the axial deformation of the catheter caused by the axial shear stress of the catheter tube when the instrument is conveyed in the catheter tube, that is, the axial tensile capacity of the catheter is improved, thereby reducing the elongation of the catheter, and finally avoiding the risk of fatigue failure of the catheter caused by the axial stretching of the inner compatible instrument.

[0043] 2. One or more axial parts are arranged at the mechanical weak point of the catheter, which can prevent stress concentration points from occurring on the catheter, thereby preventing the catheter from deforming during the conveying of the instrument.

[0044] 3. The introduction of one or more axial parts extending in the axial direction in the catheter reinforcing layer can improve the transmission efficiency of the axial force of the catheter and optimize the transmission performance of the catheter. BRIEF DESCRIPTION OF DRAWINGS

[0045] Figure 1 The structure schematic diagram of the catheter reinforcing layer and the catheter using the catheter reinforcing layer in an embodiment provided by the present application;

[0046] Figure 2 The planar schematic diagram of the catheter reinforcing layer in an embodiment provided by the present application is unfolded along the axial direction;

[0047] Figures 3a-3c The structure schematic diagram of the catheter reinforcing layer in another embodiment provided by the present application;

[0048] Figure 4A schematic view of the structure of the conduit reinforcement layer in another embodiment provided by the present application;

[0049] Figure 5 A schematic view of the structure of the conduit reinforcement layer in another embodiment provided by the present application;

[0050] Figure 6 A schematic view of the structure of the conduit reinforcement layer in another embodiment provided by the present application;

[0051] Figure 7 A schematic view of the structure of the conduit reinforcement layer in another embodiment provided by the present application;

[0052] Figure 8 Another plan view of the conduit reinforcement layer in an embodiment provided by the present application, developed in the axial direction.

[0053] Wherein, the reference signs are as follows:

[0054] 100 - conduit reinforcement layer; 200 - outer layer;

[0055] 110 - braided structure; 120 - axial component. DETAILED DESCRIPTION

[0056] A conduit reinforcement layer and a conduit comprising the same according to the present application will be described in further detail below. The present application will be described in more detail below with reference to the accompanying drawings, in which the preferred embodiments of the present application are shown, it being understood that those skilled in the art can modify the present application described herein while still achieving the advantageous effects of the present application. Accordingly, the following description should be understood as a broad teaching to those skilled in the art, and not as a limitation on the present application.

[0057] For clarity, not all of the features of an actual implementation are described in this document. In the following description, numerous specific details are set forth to provide a thorough understanding of the present application. However, it will be apparent to those skilled in the art that the present application can be practiced without such specific details. In other instances, well-known methods have not been described in detail in order to avoid obscuring the present application. It will be appreciated that in the development of any such actual implementation, numerous implementation-specific decisions can be made to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill in the art having the benefit of this disclosure.

[0058] As used in this specification, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise. The term "plurality" is generally employed in its sense of two or more unless the content clearly dictates otherwise. The term "several" is generally employed in its sense of an indefinite number unless the content clearly dictates otherwise. The term "proximal" generally refers to the end closer to the operator of the medical instrument, and "distal" generally refers to the end further from the operator of the instrument, unless the context clearly dictates otherwise.

[0059] As described in the background, in order to meet the requirement of smooth delivery of catheter to the lesion site in clinical use, the existing catheter is usually designed to have different stiffness segments, the proximal end is harder, the distal end is softer, and the stiffness gradually decreases from the proximal end to the distal end. The design of different segment stiffness needs to be determined according to the vascular anatomy. Although the soft catheter is easier to pass through the tortuous blood vessels and reduces the risk of damaging the blood vessels, at the same time, due to the influence of the material properties of the catheter, the axial elongation rate of the soft catheter is high, and it is easy to be axially deformed under the action of axial force, such as being stretched to be longer. Therefore, in the clinical treatment process, when other instruments are delivered in the catheter, the catheter body will be subjected to axial shear stress, and if the axial elongation rate of the catheter body is too high, it is more likely to be axially stretched under the action force of the inner instrument delivery, and the catheter body may be deformed after being stretched, which causes the problem that the inner instrument is difficult to release or retrieve, and has a serious adverse effect on the clinical operation.

[0060] In view of the above problems, the researchers of the present application found that the overall mechanical properties of the catheter are related to the modulus and hardness of the high molecular material and the strength and metal coverage of the reinforcing layer. In the prior art, the catheter is mainly composed of three layers of inner layer, reinforcing layer and outer layer. For the catheter with a woven structure of the reinforcing layer, the axial breaking resistance is strong and it is not easy to be pulled off, and the axial elongation rate of the catheter depends on the high molecular material of the inner layer and the outer layer. Therefore, when the inner layer and the outer layer structure of the catheter are selected to be low-hardness high molecular materials such as thermoplastic elastomer (TPE), polyolefin or polyolefin elastomer, due to the characteristics of the material elastomer, the low hardness property of the catheter can be realized, but at the same time, the axial elongation rate of the catheter is high, and it is easy to be stretched and thinned under the action of axial force, which can easily cause the situation that the inner compatible instrument cannot be pushed, released or withdrawn in clinical use, affecting the operation effect.

[0061] To this end, the present application provides a catheter reinforcing layer and a catheter comprising the same to solve the problem that the existing catheter is elongated axially when an instrument is delivered in the catheter due to high elongation.

[0062] Reference Figure 1 , Figure 1 The structural diagram of the catheter reinforcing layer and the catheter using the same according to an embodiment of the present application is shown. As shown in Figure 1 , the present application provides a catheter which can be used as a delivery catheter and can also be used for other medical purposes. The catheter is, for example, a hollow tube. In this embodiment, the catheter is, for example, a delivery catheter which is used to provide a delivery path for an intravascular interventional instrument, release and recovery of the intravascular interventional instrument, etc. The diameter of the catheter includes but is not limited to between 6F and 12F so as to facilitate the catheter to deliver the interventional instrument into a blood vessel in a neurointerventional procedure, a cardiac interventional procedure, an aortic interventional procedure or a peripheral vascular interventional procedure. In other embodiments, the diameter of the catheter can be modified according to actual needs.

[0063] As shown in Figure 1 , the present application provides a catheter reinforcing layer and a catheter using the same, the catheter comprising an inner layer, a reinforcing layer and an outer layer which are sequentially arranged from inside to outside and are all tubular, the reinforcing layer of the catheter comprising a catheter reinforcing layer, the catheter reinforcing layer comprising a braided component and at least one axial component, the braided component being a mesh tube structure formed by crossing braiding of braided wires, and the mesh tube structure comprising a plurality of meshes formed by crossing braiding of braided wires, the crossing positions of the braided wires forming mesh intersection points. The axial component is arranged to extend from a proximal end to a distal end along the braided component, and there is at least one intersection point between the braided component and the axial component.

[0064] Specifically, referring to Figure 2 , Figure 2 The planar diagram of the catheter reinforcing layer according to an embodiment of the present application is shown. As shown in Figure 2As shown, the braided member 110 can comprise a plurality of braided wire intersections forming a mesh, and assume that the position of the braided wire intersections is mesh intersection a. The intersection between the axial member and the braided member 110 included in the braided member 110 can all coincide with the mesh intersection a thereof, such as the intersection b1 between the axial member 120a and the braided member 110; or, the axial member can not coincide with all the intersections between the braided member 110, such as the intersection b2 between the axial member 120b and the braided member 110; or, part of the intersections between the axial member and the braided member 110 can coincide with the mesh intersection a thereof, such as the intersection b3 between the axial member 120c and the braided member 110, and part of the intersections can not coincide with the mesh intersection a of the braided member 110, such as the intersection b4 between the axial member 120c and the braided member 110.

[0065] Optionally, in the embodiments of the present application, there can be 1-45000 intersections between the axial member and the braided member, and the number of intersections between each axial member and the braided member can be set according to actual needs, which is not specifically limited in the present application.

[0066] Continuing to refer to Figure 2 , assume that the Figure 2When the left side of the proximal end of the braided member 110 contains axial members extending from the proximal end to the distal end, the axial members can be arranged in parallel to the axial direction of the catheter, such as the axial members 120a and 120b, or at an angle to the axial direction of the catheter, such as the axial member 120c, and the angle can be any angle within the range of 0-45°. When the braided member 110 contains multiple axial members, some of the axial members can be arranged in parallel to the axial direction of the catheter, while others are arranged at an angle to the axial direction of the catheter, and the angle can include any angle within the range of 0-45°, such as 3°, 5°, 10°, 15°, 30°, 45°, etc. When part or all of the axial members are arranged at an angle to the axial direction of the catheter, the angle of the same axial member in the length direction can be the same or different, and the angle of different axial members can be the same or different. The braided member contains multiple braided meshes connected in sequence, and the vertex of the mesh is the intersection point of the wires in the braided member. At least one axial member passes through or partially passes through at least one braided mesh of the braided member, and / or at least one axial member completely passes through one or multiple continuous braided meshes of the braided member. The axial member can be a wire structure, which can be linear, wavy, or spiral, or a combination thereof. The braided member can be arranged uniformly or non-uniformly along the axial direction of the catheter, which is not limited in the present application.

[0067] The material of the inner layer of the catheter can be any one or a combination of polytetrafluoroethylene, polyurethane, polyamide, polyolefin, polyolefin elastomer and thermoplastic elastomer. The material of the outer layer of the catheter can be any one or a combination of polyurethane, polyolefin, polyolefin elastomer, thermoplastic elastomer and polyamide. Exemplarily, in the embodiments of the present application, the material of the inner layer and the material of the outer layer can both be preferably thermoplastic elastomer. The material of the braided member of the reinforcing layer of the catheter can be metal, such as any one or a combination of stainless steel, nickel-titanium alloy, cobalt-chromium alloy and tungsten; or the material of the braided member can also be polymer filament, such as any one or a combination of polyethylene, polyamide and liquid crystalline polymer filament; or the material of the braided member can be a combination of metal and polymer filament. Moreover, the material of the axial member of the reinforcing layer of the catheter can be metal and / or polymer filament. Specifically, the material of the axial member can be any one or a combination of metal, such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy, tungsten, silver and gold, and polymer filament, such as polyethylene, polyamide and liquid crystalline polymer filament; or the material of the axial member can also be a combination of the metal and the polymer filament. In the case of multiple axial members, the material of part of the axial members can be metal and the material of part of the axial members can be polymer filament. Exemplarily, the material of at least one of the axial members is radiopaque material.

[0068] It should be noted that the catheter provided by the present application is to maintain the materials of the inner layer and the outer layer of the existing catheter unchanged, i.e. to ensure the softness of the catheter, and to increase the axial modulus of the catheter by arranging one or more axial members in the axial direction of the braided member of the reinforcing layer of the existing catheter, thereby avoiding the axial deformation of the catheter caused by the axial shear stress of the tube body of the catheter when conveying the instrument in the tube body of the catheter, i.e. improving the axial tensile strength of the catheter, thereby reducing the elongation of the catheter, and finally avoiding the risk of fatigue failure of the catheter caused by the axial stretching of the instrument. Therefore, as long as the axial members arranged in various ways in the axial direction of the braided member, including the direction along the axial direction of the catheter and the direction at an angle to the axial direction of the catheter, can realize the purpose of the present application, and the angle includes any angle within the range of 0-45°.

[0069] The following will specifically illustrate the various combinations of the braided member and the axial member in the reinforcing layer of the catheter provided by the present application.

[0070] Embodiment I:

[0071] Referring to Figures 3a-3c , Figures 3a-3c is a schematic view of the structure of the reinforcing layer of the catheter according to an embodiment of the present application,Figures 3a-3c As shown in FIG. 1, the conduit reinforcement layer 100 comprises a braided member 110 and an axial member 120 extending along the axial direction of the braided member 110 from the proximal end to the distal end and penetrating the braided member 110 as a whole. Specifically, as shown in FIG. 2, the axial member 120d can be attached linearly or spirally between the braided member 110 and the inner layer (not shown) from the proximal end to the distal end. Alternatively, as shown in FIG. 3, the axial member 120e can be attached linearly or spirally between the braided member 110 and the outer layer (not shown) from the proximal end to the distal end. Further alternatively, as shown in FIG. 4, the axial member 120f can be attached in a wave shape between the inner surface and the outer surface of the braided member 110 from the proximal end to the distal end. Figure 1 Figure 3a Figure 3b Figure 3c

[0072] Embodiment II

[0073] As shown in FIG. 5, the conduit reinforcement layer 100 according to the present application comprises a braided member 110 and an axial member 120g extending along the axial direction of the braided member 110 from the proximal end to the distal end and arranged in the mesh of the braided member 110, and the axial member 120g is in the same plane as the braided member 110. In Embodiment II, the axial member 120g can be combined with the braided member 110 by welding, bonding or other means, or the axial member 120g can be woven with the braided member 110 as a whole by weaving. Compared with the conduit reinforcement layer 100 shown in FIG. 1, Figure 4 Figure 4 As shown in FIG. 6, the conduit reinforcement layer 100 according to the present application comprises a braided member 110 and an axial member 120g extending along the axial direction of the braided member 110 from the proximal end to the distal end and arranged in the mesh of the braided member 110, and the axial member 120g is in the same plane as the braided member 110. In Embodiment II, the axial member 120g can be combined with the braided member 110 by welding, bonding or other means, or the axial member 120g can be woven with the braided member 110 as a whole by weaving. Compared with the conduit reinforcement layer 100 shown in FIG. 1, Figure 4 Figures 3a-3c Figure 4

[0074] It should be noted that, in addition to the above-mentioned embodiments I and II, the axial member 120 can also be combined with the braided member 110 to form the conduit reinforcement layer 100 in a manner that the axial member 120 penetrates the braided member 110 partially, and the present application does not make specific limitations in this regard.

[0075] ​​​​​​​​Furthermore, the number of axial components 120 can be one or more. Specifically, when there is one axial component 120, it can be arranged in a single-sided manner as described in Embodiments 1 and 2 above; when there are multiple axial components 120, they can be arranged symmetrically or asymmetrically along the circumference of the braided component 110, and / or, the axial components 120 can be arranged alternately along the axial direction of the braided component 110. It should be emphasized that the alternate arrangement mentioned in this specification refers to the fact that the proximal ends of two adjacent axial components are not in the same axial position, but are staggered in the axial direction. In some embodiments, two adjacent axial components may have no "overlap" in the axial direction; in other embodiments, two adjacent axial components may have a partial "overlap" in the axial direction. The "overlap" mentioned here means that at the same axial position, the cross-section of the reinforcing layer at that position simultaneously contains the cross-section of the two adjacent axial components.

[0076] The following example illustrates the positional relationship between multiple axial components 120 and the braiding component 110 when there are multiple axial components. For details, please refer to the following embodiments.

[0077] Example 3:

[0078] See Figure 5 , Figure 5 This is a schematic diagram of the structure of the catheter reinforcement layer according to another embodiment of the present invention, as shown below. Figure 5 As shown, preferably, the catheter reinforcement layer 100 includes a braided component 110 and a plurality of axial components 120h symmetrically arranged from the proximal end to the distal end along the axial direction of the braided component 110 and extending integrally through the braided component 110. Since the axial components 120 are symmetrically placed on the surface of the braided component 100, the structural stability of the catheter containing this reinforcement layer can be ensured. Simultaneously, similar to Embodiments 1 and 2, when delivering instruments within the catheter, axial deformation of the catheter caused by axial shear stress on the catheter body is avoided, thereby reducing the catheter's elongation rate and ultimately avoiding the risk of fatigue failure caused by axial tension of the internally compatible instruments.

[0079] Optionally, the number of axial components in the embodiments of the present invention can range from 2 to 10, for example, 2, 3, 5, 6, 8, or 10.

[0080] It can be understood that when the number of the axial components 120 is multiple, the multiple axial components 120 can be symmetrically or asymmetrically arranged at any position on the surface along the circumference of the braided component 110. However, in the prior art, the catheter is usually composed of multiple catheter segments with different hardness and thickness, which are connected from the proximal end to the distal end, and the hardness gradually decreases from the proximal end to the distal end. The connection (joint or transition position) of the multiple catheter segments and the thinner part of the catheter tube are prone to be the weak points under stress, and thus the catheter may be axially deformed or even broken under the action of axial force in clinical operation. Therefore, in the embodiment of the present application, the multiple axial components 120 can also be symmetrically or asymmetrically arranged along the circumference of the braided component 110 at the preset positions, and / or the axial components 120 can be sequentially and spacedly arranged along the axis of the braided component 110 at the preset positions. The preset positions can be the connection (joint or transition position) of the multiple catheter segments included in the catheter reinforcing layer, the position with higher material softness of the inner layer or the outer layer, the position with smaller material thickness of the inner layer or the outer layer, the position with smaller modulus value of the catheter, and the thinner part of the catheter tube.

[0081] Embodiment four:

[0082] Referring to Figure 6 and Figure 7 , Figure 6 and Figure 7 is a structure schematic view of the catheter reinforcing layer of another embodiment of the present application, as Figure 6 or Figure 7 indicated, when the number of the axial components 120 is multiple, the multiple axial components 120k or the axial components 120j can be helically arranged along the circumferential direction of the braided component 110, and the multiple axial components 120k or the axial components 120j can be located between the circumferential surface of the braided component 110 corresponding to the joint of the adjacent catheter segments or the gap between the braided wires; or the multiple axial components 120k or the axial components 120j can be located between the circumferential surface of the braided component 110 corresponding to the catheter segment with modulus value smaller than that of the adjacent two or one side catheter segments, and the gap between the braided wires; or the multiple axial components 120k or the axial components 120j can be located at the position with smaller material thickness of the inner layer of the catheter or the outer layer of the catheter, or the position with higher softness of the inner layer of the catheter or the outer layer of the catheter.

[0083] Specifically, each of the axial members 120j or 120k can be arranged between the braided member 110 and the inner layer of the catheter, between the braided member 110 and the outer layer 200 of the catheter, partially between the braided member 110 and the inner layer of the catheter and partially between the braided member 110 and the outer layer of the catheter, or between the meshes of the braided member 110. The axial length of each of the axial members 120 can be the axial distance of one braided mesh of the braided member 110, as shown in the axial member 120k of FIG. 1, or the axial distance of a plurality of braided meshes of the braided member 110 (the plurality of braided meshes including a non-integer number of braided meshes), as shown in the axial member 120j of FIG. 1. The present application is not limited in this regard. Figure 7 Figure 6 The axial length of each of the axial members 120 can be the axial distance of one braided mesh of the braided member 110, as shown in the axial member 120k of FIG. 1, or the axial distance of a plurality of braided meshes of the braided member 110 (the plurality of braided meshes including a non-integer number of braided meshes), as shown in the axial member 120j of FIG. 1. The present application is not limited in this regard.

[0084] In this embodiment, the plurality of axial members 120k or 120j are arranged helically along the circumferential direction of the braided member 110. In other embodiments, the plurality of axial members 120k or 120j can be arranged in the same circumferential direction but spaced apart in the axial direction. In this embodiment, one or more axial members can be arranged at the mechanically weak points of the catheter, so as to prevent stress concentration points from being formed on the catheter and thus prevent the catheter from deforming during the delivery of the medical device. Furthermore, the introduction of one or more axial members extending in the axial direction into the reinforcing layer of the catheter can improve the transmission efficiency of the axial force of the catheter and optimize the transmission performance of the catheter.

[0085] Optionally, the number of axial members in the embodiments of the present application can range from 1 to 16000, such as 1, 2, 4, 8, 20, 100, 800, 2000, 5000, 10000, 12000, or 16000.

[0086] ​It should be noted that the proximal end of the braided component refers to the side close to the operator of the catheter containing the catheter reinforcing layer, i.e. the proximal end of the catheter is also the proximal end of the braided component, the catheter reinforcing layer and the axial component. Similarly, the distal end of the braided component refers to the side away from the operator of the catheter containing the catheter reinforcing layer.

[0087] Optionally, with reference to Figure 8 , Figure 8 Fig. 4 is another plan view of the catheter reinforcing layer in the axial direction according to an embodiment of the present application. As shown in the figure, assuming that the left side of the braided component 110 is the proximal end, the axial spacing D1 between the two adjacent axial components 120l and 120m in the axial direction of the braided component 110, or the axial spacing D2 between the adjacent axial components 120m and 120n, can range from 0.001 inch to 0.1 inch. Figure 8

[0088] wherein the axial spacing is the spacing between the proximal ends of the two axial components in parallel to the axial direction, and the circumferential angular spacing is the radian corresponding to L1.

[0089] Optionally, the axial component 120 can be a monofilament or a stranded wire composed of a plurality of monofilaments. The diameter of the monofilament can range from 0.0005 inch to 0.003 inch, and the number of monofilaments in the stranded wire can range from 1 to 20. Preferably, when the axial component 120 in the embodiment is a polyamide high molecular filament with a size of 0.001 inch, the effect on the soft catheter of the braided component 110 is excellent.

[0090] For example, the researchers of the present application obtained the following table through experiments to explain the effect of the axial component on the parameters of the catheter containing the catheter reinforcing layer according to the embodiments of the present application.

[0091] Table 1

[0092] Axial component number Extensibility Outer diameter Softness N＝1 -38.0％ +0.1％ -3.1％ N＝2 -44.0％ +0.2％ -4.0％ N＝3 -56.0％ +0.4％ -7.0％

[0093] As shown in Table 1 above, compared with the catheter without the axial component, as the number of axial components increases, the axial elongation of the catheter gradually decreases, but the outer diameter and softness of the catheter remain basically unchanged, i.e. the axial component added in the catheter effectively reduces the axial elongation of the catheter, while having little effect on the outer diameter and softness of the catheter, which can be ignored.

[0094] ​It can be understood that the axial components 120 described in the above figures can be connected with the braided components 100 by means of gluing, polymerization, welding or heating, or can also be integrated with the braided components 100 by means of braiding (some specific braiding methods, such as triaxial braiding).

[0095] In summary, in the catheter reinforcing layer and the catheter provided by the application, compared with the reinforcing layer design of the pure braided structure in the prior art, a new reinforcing layer structure is designed, the axial component is introduced into the reinforcing layer of the existing catheter, so that the modulus of the catheter in the axial direction is increased, and then when the instrument is conveyed in the pipe body of the catheter, the axial deformation of the catheter caused by the axial shear stress of the pipe body of the catheter is avoided, that is, the axial tensile capacity of the catheter is improved, and then the elongation of the catheter is reduced, and finally the risk of fatigue failure of the catheter caused by the axial stretching of the inner compatible instrument is avoided.

[0096] Further, the one or more axial components arranged at the mechanical weak points of the catheter can prevent stress concentration points from being generated on the catheter, so that the deformation of the pipe body of the catheter during the conveying of the instrument is prevented. Moreover, the introduction of the one or more axial components extending in the axial direction into the reinforcing layer of the catheter can improve the transmission efficiency of the axial force of the catheter and optimize the transmission performance of the catheter.

[0097] It should be noted that although the application has been disclosed as above with the preferred embodiments, the above embodiments are not intended to limit the application. For any person skilled in the art, many possible changes and modifications or equivalent embodiments of the above disclosed technical content can be made to the technical solution of the application without departing from the scope of the technical solution of the application. Therefore, any simple modification, equivalent change and modification of the above embodiments made according to the technical essence of the application, without departing from the content of the technical solution of the application, all still belong to the protection scope of the technical solution of the application.

[0098] It should also be understood that, unless specifically described or indicated, the terms "first", "second", "third" and the like in the specification are merely used to distinguish the components, elements, steps and the like in the specification, and are not intended to represent the logical relationship or sequence relationship between the components, elements, steps and the like.

[0099] It is also to be appreciated that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the scope of the present application. It must be noted that, as used herein, the articles "a", "an" and "the" are intended to include both singular and plural references unless the context clearly dictates otherwise. For example, the references "a step" or "an element" can mean one or more steps or elements, and so forth. All conjunctive words such as "or" are used in the sense that at least one, but potentially more, than one of the conjunctive words are intended. In addition, the recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless the context indicates otherwise. Furthermore, the making and using of embodiments of the present application are discussed in terms of methods and / or devices, compositions, and / or systems.

Claims

1. A catheter reinforcement layer, characterized in that, It includes a braided component and at least one axial component. The braided component is a mesh tube structure formed by cross-woven yarns. The axial component extends from the proximal end to the distal end along the braided component and has at least one intersection point with the braided component. The axial component has a filamentous structure; the axial component is arranged parallel to the axial direction of the braiding component; and when there are multiple axial components, the multiple axial components are spirally arranged along the axial direction of the braiding component, and the axial components are arranged at intervals along the axial direction of the braiding component.

2. The catheter reinforcement layer as described in claim 1, characterized in that, The axial component is made of metal and / or polymer filament.

3. The catheter reinforcement layer as described in claim 1, characterized in that, There are 1-45,000 intersection points between the axial component and the braided component.

4. The catheter reinforcement layer as described in claim 1, characterized in that, The braided filaments of the braided component are interwoven to form a grid, and the intersection of the braided filaments forms the grid intersection point. The intersection point between the axial component and the braided component coincides with the grid intersection point. Alternatively, the intersection between the axial component and the braiding component coincides with the mesh intersection; Alternatively, the intersection between the axial component and the braided component does not coincide with the intersection of the mesh.

5. The catheter reinforcement layer as described in claim 1, characterized in that, The axial component is attached to the inner or outer surface of the braided component in a straight line from the proximal end to the distal end; Alternatively, the axial component is attached in a wavy, staggered manner between the inner and outer surfaces of the braided component from the proximal end to the distal end; Alternatively, the axial component may be disposed in the mesh of the braided component from the proximal end to the distal end, and the axial component and the braided component may be on the same plane.

6. The catheter reinforcement layer as described in claim 1, characterized in that, The axial spacing of the plurality of axial components may be the same or different. and / or, The circumferential angular spacing of the plurality of axial components may be the same or different.

7. The catheter reinforcement layer as described in claim 6, characterized in that, Of the plurality of axial components, the axial spacing between the proximal axial components is smaller than the axial spacing between the distal axial components. and / or, The circumferential angular spacing of the axial components at the proximal end is smaller than the axial spacing of the axial components at the distal end.

8. The catheter reinforcement layer as described in claim 1, characterized in that, The number of axial components ranges from 1 to 16,000.

9. The catheter reinforcement layer as described in claim 1, characterized in that, The axial spacing between two adjacent axial components in the axial direction of the braided component ranges from 0.001 inch to 0.1 inch.

10. The catheter reinforcement layer as described in claim 1, characterized in that, At least one of the axial components is made of a developing material.

11. The catheter reinforcement layer according to any one of claims 1-10, characterized in that, The axial component is a single filament or a twisted wire composed of multiple single filaments.

12. The catheter reinforcement layer as described in claim 11, characterized in that, The diameter of the monofilament is in the range of 0.0005 inch to 0.003 inch, and the number of monofilaments in the twisted wire is in the range of 1 to 20.

13. The catheter reinforcement layer as described in claim 1, characterized in that, The axial component is connected to the braided component by means of adhesive bonding, polymerization, welding or heating, or it is integrated with the braided component by means of braiding.

14. A catheter, characterized in that, It includes an inner layer, a reinforcing layer, and an outer layer arranged sequentially from the inside out, all of which are tubular, and the reinforcing layer includes the catheter reinforcing layer according to any one of claims 1-13.

15. The catheter as claimed in claim 14, characterized in that, The catheter includes multiple catheter segments connected in sequence, and the axial component is positioned at a preset location; The preset position is between the circumferential surface of the braided component or the gap of the braided filaments corresponding to the inner or outer splice seam of the adjacent catheter segment. Alternatively, the preset position is between the circumferential surface of the braided component or the gap of the braided filaments corresponding to the catheter segment whose modulus value is less than that of the adjacent two sides or one side of the catheter segment; Alternatively, the preset position is where the thickness of the inner or outer layer material is small, or between the circumferential surface of the braided component or the gap of the braided filaments corresponding to the conduit segment with higher flexibility of the inner or outer layer. Alternatively, the preset position is between the circumferential surface of the braided component or the gap of the braided filaments corresponding to a catheter segment whose radial diameter is smaller than that of the adjacent two sides or one side of the catheter segment.

16. The catheter as claimed in claim 14, characterized in that, The inner layer is made of polymer material and has a thickness of 0.0001 inch to 0.002 inch.

17. The catheter as claimed in claim 14, characterized in that, The thickness of the inner layer is 0.0003 inch to 0.0006 inch.

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