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 spring structure in the prior art, a novel reinforcing layer structure is designed, one or more axial components are introduced into the reinforcing layer of the spring structure of the existing catheter, so that the axial modulus of the catheter is increased, axial deformation of the catheter caused by the fact that the pipe body of the catheter is subjected to an axial force is avoided, and the problem of fracture in a serious case is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a catheter reinforcement layer and a catheter comprising the catheter reinforcement layer. Background Art

[0002] Minimally invasive interventional surgery is a procedure that uses a catheter delivery system within a blood vessel with the support of a digital subtraction angiography (DSA) system to deliver implantable medical devices or therapeutic drugs to the site of the lesion with minimal trauma, for mechanical or chemical treatment. As an important component of the delivery system, the catheter has been widely used in various minimally invasive interventional treatments. Currently, such interventional surgeries usually use a puncture of a small blood vessel (such as the femoral artery or radial artery) as the entry point. The catheter passes through the entry point along the blood vessel and is delivered to the target lesion site with the assistance of a sheath and guidewire, serving as a passage for other devices (such as stents, coils, other catheters, etc.).

[0003] At present, in order to meet the demand that the catheter can be smoothly delivered to the lesion site during clinical use, the existing medical catheters are usually harder at the proximal end and softer at the distal end, and the hardness gradually decreases from the proximal end to the distal end. The catheter is composed of multiple segments with different hardness. In order to achieve the different softness of the proximal and distal ends of the catheter, the outer layer and / or the inner layer are usually spliced ​​with materials of different hardness. In addition, the distal end of the catheter needs to be as soft as possible, and the catheter as a whole needs a good softness transition. However, affected by the material and design characteristics, the axial modulus of the soft catheter is low, and the connection of the catheter segments (the splicing of the inner and outer layers or the transition position) and the thinner parts of the catheter body are prone to become weak points of stress, thereby causing the catheter to be axially deformed or even broken under the action of axial force during clinical surgery, which has a serious adverse effect on clinical surgery. Summary of the Invention

[0004] The object of the present invention is to provide a catheter reinforcement layer and a catheter, so as to solve the problem that the existing catheters have insufficient axial tensile strength and may fail in severe cases in the form of fracture.

[0005] To solve the above technical problems, the present invention provides a catheter reinforcement layer, comprising a spring component and at least one axial component, wherein each axial component extends along the spring component from the proximal end to the distal end and has at least one intersection with the spring component.

[0006] Optionally, the material of the axial component may be metal and / or polymer wire.

[0007] Optionally, the axial component may be a filamentous structure, and its shape may be one or a combination of a straight line, a wave or a spiral.

[0008] Optionally, the axial component is arranged parallel to the axial direction of the spring component;

[0009] Alternatively, the axial component is arranged at a certain angle to the axial direction of the spring component, and the angle is 0-45°;

[0010] Alternatively, at least a portion of the axial component is arranged at a certain angle to the axial direction of the spring component, wherein the angle is 0-45°, and the other portion of the axial component is arranged parallel to the axial direction of the spring component.

[0011] Optionally, there are 1-80,000 intersections between the axial component and the spring component.

[0012] Optionally, the axial component is attached to the inner surface or outer surface of the spring component in a straight line or spiral shape from the proximal end to the distal end along the spring component;

[0013] Alternatively, the axial component is alternately attached between the inner surface and the outer surface of the spring component in a wave-like manner from the proximal end to the distal end;

[0014] Alternatively, the axial component is arranged between the gaps of the spring component from the proximal end to the distal end along the spring component, and the axial component and the spring component are in the same plane.

[0015] Optionally, when there are multiple axial components, the multiple axial components are symmetrically or asymmetrically arranged along the circumference of the spring component;

[0016] and / or,

[0017] The axial components are sequentially spaced apart along the axial direction of the spring component.

[0018] Optionally, when there are multiple axial components, the multiple axial components are symmetrically or asymmetrically arranged along the circumference of the spring component at preset positions;

[0019] and / or,

[0020] The axial components are sequentially spaced apart at preset positions along the axial direction of the spring component.

[0021] Optionally, when there are multiple axial components, the multiple axial components are arranged in an axial spiral along the spring component.

[0022] Optionally, the axial spacings of the plurality of axial components are the same or different.

[0023] and / or,

[0024] The circumferential angular spacings of the plurality of axial components are the same or different.

[0025] Optionally, among the plurality of axial components, the axial spacing of the axial components at the proximal end is smaller than the axial spacing of the axial components at the distal end.

[0026] and / or,

[0027] 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.

[0028] Optionally, the number of the axial components may range from 1 to 16,000.

[0029] Optionally, when there are multiple axial components, the axial spacing between two adjacent axial components in the axial direction of the spring component may be in the range of 0.001 inch to 0.1 inch.

[0030] Optionally, the material of at least one of the axial components may be a developing material.

[0031] Optionally, the axial component may be a monofilament or a twisted wire composed of multiple monofilaments.

[0032] Optionally, the diameter of the monofilament may range from 0.0005 inch to 0.003 inch, and the number of monofilaments in the twisted wire may range from 1 to 20.

[0033] Optionally, the axial component can be connected to the spring component by gluing, polymerization, bonding, or laser welding, or the axial component and the spring component can be integrated by cutting and forming.

[0034] Optionally, the axial component may further include a control wire extending in the opposite direction along the side close to the catheter operator.

[0035] At the same time, based on the catheter reinforcement layer described above, the present invention also provides a catheter, which includes an inner layer, a reinforcement layer and an outer layer arranged in sequence from the inside to the outside and all in a tubular shape, wherein the reinforcement layer includes the catheter reinforcement layer described above.

[0036] Optionally, the catheter comprises a plurality of catheter segments connected in sequence, and the axial component may be arranged at a preset position;

[0037] The preset position is between the circumferential surface of the spring component or the gap between the spring wires corresponding to the inner layer splicing or outer layer splicing of adjacent catheter segments;

[0038] Alternatively, the preset position is between the circumferential surfaces of the spring components or the gaps between the spring wires corresponding to the catheter segments whose modulus values ​​are smaller than the modulus values ​​of the adjacent catheter segments on two sides or one side;

[0039] Alternatively, the preset position is between the circumferential surface of the spring component or the gap between the spring wires corresponding to the catheter segment where the thickness of the material of the inner layer or the outer layer is smaller, or between the circumferential surface of the spring component or the gap between the spring wires where the softness of the inner layer or the outer layer is higher;

[0040] Alternatively, the preset position is between the circumferential surfaces of the spring components or the gaps between the spring wires corresponding to the catheter segments whose radial diameters are smaller than the radial diameters of the catheter segments on two adjacent sides or one side.

[0041] Optionally, the axial component may further include a control wire extending in the opposite direction along a side close to the catheter operator, so that the catheter operator can adjust the rotation direction of the catheter through the control wire.

[0042] Optionally, the inner layer is made of a polymer material, and the thickness of the inner layer is 0.0001 inch-0.002 inch.

[0043] Optionally, the thickness of the inner layer is 0.0003 inch-0.0006 inch.

[0044] Compared with the prior art, the technical solution of the present invention has at least one of the following beneficial effects:

[0045] 1. In the catheter reinforcement layer and catheter provided by the present invention, compared to the purely spring-structured reinforcement layer design of the prior art, the present invention designs a novel reinforcement layer structure. By introducing one or more axial components into the existing catheter spring-structured reinforcement layer, the axial modulus of the catheter is increased, thereby avoiding axial deformation of the catheter due to axial forces on the catheter body, which may lead to fracture in severe cases.

[0046] 2. Arranging one or more axial components at the mechanically weak points of the catheter can prevent stress concentration points from being generated on the catheter and prevent the catheter from breaking during the delivery of the device or the pullback process.

[0047] 3. Introducing one or more axial components extending in the axial direction into the reinforcement layer of the catheter can improve the transmission efficiency of the axial force of the catheter and optimize the transmission performance of the catheter.

[0048] 4. When the inner layer of the catheter is particularly thin, one or more axial components extending in the axial direction are introduced into the reinforcing layer of the catheter, which can ensure the flexibility of the catheter and prevent the axial deformation and breakage of the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Figure 1 A schematic structural diagram of a catheter reinforcement layer and a catheter using the same in an embodiment of the present invention;

[0050] Figure 2a-2c A schematic view of a structure of a catheter reinforcing layer in another embodiment provided by the present application;

[0051] Figure 3 A schematic view of a structure of a catheter reinforcing layer in another embodiment provided by the present application;

[0052] Figure 4 A schematic view of a structure of a catheter reinforcing layer in another embodiment provided by the present application;

[0053] Figure 5 A schematic view of a structure of a catheter reinforcing layer in another embodiment provided by the present application;

[0054] Figure 6 A schematic view of a structure of a catheter reinforcing layer in another embodiment provided by the present application;

[0055] Figure 7 A schematic view of a structure of a catheter in an embodiment provided by the present application.

[0056] In the drawings, reference numerals:

[0057] 10 - catheter; 100 - catheter reinforcing layer;

[0058] 200 - outer layer; 110 - spring member;

[0059] 120 - axial member; 130 - control wire. DETAILED DESCRIPTION

[0060] A catheter reinforcing layer and a catheter 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 should be understood that those skilled in the art can modify the present application described herein while still implementing 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.

[0061] 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 one skilled in the art that the present application can be practiced without some or all of these specific details. In other instances, well known process operations have not been described in detail in order to not unnecessarily obscure the present application. It will be understood that the development of an actual implementation is necessarily carried out by a multitude of design choices but that only a small subset of the total number of possible implementations are described herein for the sake of brevity and clarity in understanding the present application. Furthermore, it is to be understood that the use of certain terms is intended to be illustrative and not to limit the scope or meaning of the present application.

[0062] As used in this specification, the singular forms "a", "an", and "the" include plural referents unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in a sense including "and / or", unless the context clearly indicates otherwise. The term "plurality" is generally used in a sense including two or more, unless the context clearly indicates otherwise. The term "several" is generally used in a sense including an indefinite quantity, unless the context clearly indicates otherwise. The term "proximal" generally refers to the end closest to the operator of a medical device, and "distal" generally refers to the end of the device that first enters the human body, unless the context clearly indicates otherwise.

[0063] As described in the background art, currently, in order to meet the demand that the catheter can be smoothly delivered to the lesion site during clinical use, the existing catheter is usually harder at the proximal end and softer at the distal end, and the hardness gradually decreases from the proximal end to the distal end. The catheter is composed of multiple segments with different hardness. In order to achieve the different softness of the proximal and distal ends of the catheter, the outer layer and / or the inner layer are usually spliced ​​with materials of different hardness. In addition, the distal end of the catheter needs to be as soft as possible, and the catheter as a whole needs a good softness transition. However, affected by the material and design characteristics, the axial modulus of the soft catheter is low, and the connection points of multiple catheter segments (the splicing points of the inner and outer layers or the transition positions) and the thinner parts of the catheter body are prone to become weak points under stress, thereby causing the catheter to deform axially under the action of axial force or even be pulled apart during clinical surgery, which has a serious adverse effect on clinical surgery.

[0064] To address the above issues, researchers have discovered that the overall mechanical properties of catheters are related to the modulus and hardness of the polymer material, as well as the strength and metal coverage of the reinforcement layer's metal wire. In the prior art, catheters primarily consist of three layers: an inner layer, a reinforcement layer, and an outer layer. While catheters with a spring-structured reinforcement layer can achieve high flexibility due to their unique structure, the spring-structured reinforcement layer contributes very little to the catheter's overall resistance to axial deformation. The axial tensile strength of catheters with spring-structured reinforcement layers depends primarily on the strength of the polymer materials in the inner and outer layers. When the inner and outer layers are made of lower-hardness polymer materials, or when there is a transitional structure between the inner and outer layers, the catheter's axial tensile strength is insufficient, and in severe cases, a fracture failure mode may occur.

[0065] To this end, the present invention provides a catheter reinforcement layer and a catheter including the catheter reinforcement layer to solve the problem that the existing catheter has insufficient axial tensile strength and may fail in severe cases in the form of fracture.

[0066] refer to Figure 1 , Figure 1A schematic view of a catheter reinforcement layer and a catheter using the catheter reinforcement layer according to an embodiment of the present application. 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 the present 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 delivery of the interventional instrument into the blood vessel in a neurointerventional operation, a cardiac interventional operation, an aortic interventional operation or a peripheral vascular interventional operation. In other embodiments, the diameter of the catheter can be modified according to actual needs.

[0067] As shown in Figure 1 The present application provides a catheter reinforcement layer and a catheter using the catheter reinforcement layer. The catheter includes an inner layer, a reinforcement layer and an outer layer which are sequentially arranged from inside to outside and are each in a tubular shape. The reinforcement layer of the catheter comprises the catheter reinforcement layer. The catheter reinforcement layer includes a spring member and at least one axial member. Each axial member is arranged along the spring member from the proximal end to the distal end and has at least one intersection with the spring member. Specifically, the axial direction can be arranged in parallel to the axial direction of the catheter, or at an angle to the axial direction of the catheter, wherein the angle is any angle within 0-45°, such as 3°, 5°, 10°, 15°, 30°, 45°, etc. Alternatively, at least part of the axial members can be arranged at an angle to the axial direction of the spring member, wherein the angle is within 0-45°, and the other part of the axial members is arranged in parallel to the axial direction of the spring member. The axial member can be in a wire-like structure, and the shape thereof can be linear, wavy or helical, or a combination thereof. For example, the spring member can be arranged in a clockwise helical manner between the inner layer and the outer layer of the catheter, or in an anticlockwise helical manner, or other curved shapes. The spring member can be arranged uniformly or non-uniformly along the axial direction of the catheter, which is not limited in the present application.

[0068] Specifically, the inner layer of the catheter can be made of any one or a combination of polymer materials such as polytetrafluoroethylene, polyurethane, polyamide, polyolefin, polyolefin elastomer, and thermoplastic elastomer, and the thickness of the inner layer can range from 0.0001 inch to 0.002 inch. Optionally, the thickness of the inner layer can range from 0.0003 inch to 0.0006 inch. The outer layer of the catheter can be made of any one or a combination of polymer materials such as polyurethane, polyolefin, polyolefin elastomer, thermoplastic elastomer, and polyamide. For example, in an embodiment of the present invention, both the inner and outer layers can be made of thermoplastic elastomer. The spring component of the reinforcement layer can be made of a metal, such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy, and tungsten; alternatively, the spring component can be made of a polymer filament, such as polyethylene, polyamide, or liquid crystal polymer filament; or alternatively, the spring component can be made of a combination of metal and polymer filament. Furthermore, the material of the axial component of the reinforcement layer can be metal and / or polymer filament. Specifically, the material of the axial component can be any one of metals such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy, tungsten, silver, and gold, and can also be any one of polymer filaments such as polyethylene, polyamide, and liquid crystal. Alternatively, the material of the axial component can also be a combination of the metal and the polymer filament. In the case of multiple axial components, some axial components can be made of metal, and some axial components can be made of polymer filament. Exemplarily, when there are multiple axial components, at least one of the axial components can be made of a developing material.

[0069] Optionally, there may be 1-80,000 intersections between the axial component and the spring component, for example, 1, 4, 10, 100, 200, 500, 1,000, 2,000, 5,000, 10,000, 20,000, 40,000, 60,000, or 80,000 intersections.

[0070] It should be noted that the catheter provided by the present invention maintains the same inner and outer layer materials as existing catheters, thus ensuring the catheter's flexibility. By disposing one or more axial components in the axial direction of the spring component within the existing catheter's reinforcement layer (catheter reinforcement layer), the axial modulus of the catheter is increased, thereby preventing axial deformation of the catheter due to axial forces acting on the catheter body, which can lead to fracture in severe cases. Therefore, any axial component disposed in any manner axially in the axial direction of the spring component can achieve the objectives of the present invention.

[0071] Since the main improvement point of the catheter of the present application is the catheter reinforcing layer (reinforcing layer) in its three-layer structure, the structure of the catheter reinforcing layer will be mainly introduced below, and the spring member is taken as an example of being arranged in a clockwise spiral winding manner between the inner layer and the outer layer of the catheter, and the various combinations of the spring member and the axial member in the reinforcing layer of the catheter provided by the present application are specifically described in combination with the drawings.

[0072] Embodiment one:

[0073] Referring to Figure 2a-2c , Figure 2a-2c the structure diagram of the catheter reinforcing layer of an embodiment of the present application is shown in Figure 2a-2c , and please refer to Figure 1 , the catheter reinforcing layer 100 includes a spring member 110 and an axial member 120 extending along the spring member 110 from the proximal end to the distal end and penetrating the spring member 110 as a whole. Specifically, as shown in Figure 2a , the axial member 120a can be attached between the spring member 110 and the inner layer (not shown) in a linear or spiral shape from the proximal end to the distal end. Alternatively, as shown in Figure 2b , the axial member 120b can be attached between the spring member 110 and the outer layer (not shown) in a linear or spiral shape from the proximal end to the distal end. Alternatively, as shown in Figure 2c , the axial member 120c can be attached between the inner surface and the outer surface of the spring member 110 in a wave shape from the proximal end to the distal end.

[0074] Embodiment two:

[0075] Referring to Figure 3 , Figure 3 the structure diagram of the catheter reinforcing layer of another embodiment of the present application is shown in Figure 3 , the catheter reinforcing layer 100 is a combination of the spring member 110 and the axial member 120d, the axial member 120d can be arranged between the spring member 100 from the proximal end to the distal end, and the axial member 120d and the spring member 110 are in the same plane. Compared with the catheter reinforcing layer 100 shown in Figure 2a-2c , Figure 3 the advantage of the catheter reinforcing layer 110 shown in is that the outer diameter size of the catheter including the catheter reinforcing layer will not increase due to the existence of the axial member 120.

[0076] It should be noted that, in addition to being combined with the spring component 110 to form the catheter reinforcement layer 100 in the manner described in the first and second embodiments above in which the axial component 120 is entirely passed through the spring component 110, the axial component 120 provided by the present invention can also be combined with the spring component 110 to form the catheter reinforcement layer 100 in a manner that partially passes through the spring component 110, and the present invention does not make specific limitations on this.

[0077] In addition, the number of the axial components 120 can be one or more. Preferably, the number of the axial components can range from 1 to 16,000, such as 1, 2, 4, 8, 20, 100, 800, 2,000, 5,000, 10,000, 12,000, or 16,000. Specifically, when there is one axial component 120, the axial component 120 can be arranged in a unilateral manner as described in the first and second embodiments above. When there are multiple axial components 120, the multiple axial components 120 can be arranged symmetrically or asymmetrically along the circumference of the spring component 110, and / or the axial components 120 can be arranged in sequence and spaced apart along the axial direction of the spring component 110. It should be emphasized that the spacing mentioned in this specification refers to the proximal ends of two adjacent axial components being arranged in a staggered manner, rather than being located at the same axial position. In some embodiments, the two adjacent axial components may not overlap at all; in other embodiments, the two adjacent axial components may partially overlap. "Overlap" here means that at the same axial position, a cross-section of the reinforcement layer at that position has the cross-sections of both adjacent axial components.

[0078] The following takes the example that the multiple axial components 120 can be symmetrically or asymmetrically arranged along the circumference of the spring component 110 to introduce the positional relationship between the axial components and the spring component 110 when there are multiple axial components. Please refer to the following embodiments for details.

[0079] Example 3:

[0080] See also Figure 4 , Figure 4 FIG. 1 is a schematic structural diagram of a catheter reinforcement layer according to another embodiment of the present invention. Figure 4As shown, preferably, the catheter reinforcement layer 100 includes a spring component 110 and a plurality of axial components 120e symmetrically arranged along the spring component 110 from the proximal end to the distal end thereof and integrally extending through the spring component 110. Since the axial components 120e are symmetrically arranged on the surface of the spring component 100, the structural stability of the catheter including the catheter reinforcement layer can be ensured. Simultaneously, similar to the first and second embodiments, when a device is delivered within the catheter body, axial deformation of the catheter caused by axial shear stress on the catheter body is avoided. In other words, the axial tensile strength of the catheter is improved, thereby reducing the elongation of the catheter, and ultimately avoiding the risk of fatigue failure of the catheter caused by axial stretching by an internal compatible device.

[0081] Optionally, the number of the axial components 120e may range from 2 to 10, for example, 2, 3, 5, 6, 8, or 10.

[0082] It is understandable that when there are multiple axial components 120, the multiple axial components 120 can be symmetrically or asymmetrically arranged at any position on the circumferential surface of the spring component 110. However, in the prior art, the catheter is usually harder at the proximal end and softer at the distal end, and the hardness gradually decreases from the proximal end to the distal end, and the catheter is composed of multiple segments with different hardness. In order to achieve the different softness of the proximal and distal ends of the catheter, the outer layer and / or the inner layer are usually spliced ​​with materials of different hardness. In addition, the distal end of the catheter needs to be as soft as possible, and the catheter as a whole needs a good softness transition. However, due to the influence of material and design characteristics, the axial modulus of the soft catheter is low, and the connection points of multiple catheter segments (the splicing points or transition positions of the inner and outer layers) and the thinner parts of the catheter body are prone to become weak points under stress, thereby causing the catheter to deform axially under the action of axial force or even be pulled apart during clinical surgery. Therefore, in an embodiment of the present invention, it is preferred that the plurality of axial components 120 are symmetrically or asymmetrically arranged at predetermined positions along the circumference of the spring component 110, and / or the axial components 120 are sequentially spaced apart at predetermined positions along the axial direction of the spring component 110. The predetermined positions may include the connection points of the plurality of catheter segments included in the catheter reinforcement layer (the junction of the inner and outer layers or the transition points), locations where the material of the inner or outer layer is relatively soft, locations where the material thickness of the inner or outer layer is relatively thin, locations where the catheter modulus is relatively small, and locations where the catheter body is relatively thin. For details, please refer to the following embodiments.

[0083] Example 4:

[0084] See also Figure 5 and Figure 6 , Figure 5 and Figure 6 FIG. 1 is a schematic structural diagram of a catheter reinforcement layer according to another embodiment of the present invention. Figure 5 or Figure 6 As shown, when there are multiple axial components 120, the multiple axial components 120g or axial components 120f can be spirally arranged along the circumferential direction of the spring component 110, and the multiple axial components 120g or axial components 120f can be located between the circumferential surfaces of the spring components 110 or the gaps between the spring wires at the inner layer connection or outer layer splicing of adjacent catheter segments, and the non-end points of each axial component 120g or 120f are connected to the circumferential surface of the spring component 110 or the spring wire corresponding to the splicing; or, the multiple axial components 120g or axial components 120f can be located Between the circumferential surface or spring wire gaps of the spring component 110 corresponding to the catheter segment whose modulus value is smaller than the modulus value of the adjacent catheter segments on both sides or one side, and between the circumferential surface or spring wire gaps of the spring component 110 corresponding to the catheter segment whose radial diameter is smaller than the radial diameter of the adjacent catheter segments on both sides or one side; alternatively, the multiple axial components 120g or axial components 120f can be located between the circumferential surface or spring wire gaps of the spring component corresponding to the catheter segment whose material thickness of the catheter inner layer or the catheter outer layer is smaller, or whose catheter inner layer or the catheter outer layer has higher softness.

[0085] Specifically, each axial component 120g or axial component 120f can be arranged between the spring component 110 and the inner layer of the catheter, or between the spring component 110 and the outer layer 200 of the catheter, or between the gaps of the spring component 110. In addition, the axial length of each axial component 120 can be a pitch between two adjacent single waves of the spring component 110 wound in a clockwise spiral, such as Figure 6 The axial component 120g shown may also be the pitch between multiple single waves of the sinusoidal spring component 110, such as Figure 5 The axial component 120f is shown, but the present invention does not make any specific limitation on this.

[0086] It is understood that when there are multiple axial components, the axial spacing between the multiple axial components 120 can be the same or different, and / or the circumferential angular spacing between the multiple axial components 120 can be the same or different. Alternatively, among the multiple axial components 120, the axial spacing between the axial components 120 at the proximal end is smaller than the axial spacing between the axial components at the distal end, and / or the circumferential angular spacing between the axial components at the proximal end is smaller than the axial spacing between the axial components at the distal end. When there are multiple axial components, the axial spacing between two adjacent axial components 120g (or two adjacent axial components 120f) in the axial direction of the spring component 110 can range from 0.001 inch to 0.1 inch.

[0087] It should be emphasized that the axial spacing mentioned in this specification refers to the spacing between the proximal ends of the two axial components parallel to the axial direction, such as Figure 5 D1 and D2 shown, and the arc corresponding to the circumferential angular spacing L between two adjacent axial components along the axial direction of the axial components.

[0088] Optionally, the axial component 110 is a monofilament or a twisted wire composed of multiple monofilaments, wherein the diameter of the monofilament ranges from 0.0005 inch to 0.003 inch, and the number of monofilaments in the twisted wire ranges from 1 to 20.

[0089] For example, the researchers of the present invention obtained the following table through experiments to explain the effects of the axial component provided by the present invention on various parameters of the catheter.

[0090] Table 1

[0091] Number of axial components Breaking force outer diameter Softness N＝1 +0.6％ +0.1％ -0.6％ N＝2 +2.4％ +0.2％ -1.1％ N＝3 +5.6％ +0.4％ -1.6％ N＝10 +49.9％ +0.41％ -6.43％ N＝15 +57.3％ +0.46％ -9.07％

[0092] As can be seen from Table 1 above, compared with a catheter without axial components, as the number of axial components increases, the axial tensile breaking force of the catheter gradually increases, but the outer diameter and softness of the catheter remain basically unchanged. That is, while the axial components added to the catheter effectively increase the tensile breaking force of the catheter, the effect on the outer diameter and softness of the catheter is small and can be ignored.

[0093] It is understandable that the axial component 120 described in the above figures can be connected to the spring component 100 by gluing, polymerization, bonding or laser welding. Alternatively, the axial component 120 and the spring component 110 can be combined into one body by cutting and forming, that is, the axial component 120 and the spring component 110 are integrally formed by cutting the tube.

[0094] Also, see Figure 7 7 is a schematic diagram of the overall structure of a catheter in an embodiment of the present invention. Figure 7 As shown, in any of the above-described embodiments, the axial component 120 may further include a control wire 130 extending in the opposite direction along the side closest to the catheter operator, so that the catheter operator can dynamically adjust the rotation direction of the catheter 10 via the control wire 130, thereby facilitating the catheter's passage through tortuous blood vessels. The length of the control wire 130 may be specifically set based on actual needs and is not specifically limited in the present invention.

[0095] In summary, the catheter reinforcement layer and catheter provided by the present invention utilize a novel reinforcement layer structure, compared to the prior art's purely spring-structured reinforcement layer design. By introducing one or more axial components into the existing spring-structured reinforcement layer, the axial modulus of the catheter is increased, thereby preventing axial deformation of the catheter body due to axial forces, which can lead to fracture in severe cases. Furthermore, by providing one or more axial components at mechanically weak points of the catheter, stress concentration points can be prevented, preventing fracture during device delivery or retraction.

[0096] Furthermore, introducing one or more axially extending axial components into the catheter's reinforcement layer can improve the efficiency of axial force transmission within the catheter and optimize the catheter's transmission performance. Furthermore, if the catheter's inner layer is particularly thin, introducing one or more axially extending axial components into the catheter's reinforcement layer can ensure the catheter's flexibility while preventing axial deformation and fracture.

[0097] It should be noted that although the present invention has been disclosed above with reference to preferred embodiments, the above embodiments are not intended to limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, the technical content disclosed above can be used to make many possible changes and modifications to the technical solution of the present invention, or to modify it into an equivalent embodiment with equivalent changes. Therefore, any simple modification, equivalent change, and modification made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of protection of the technical solution of the present invention.

[0098] It should also be understood that, unless otherwise specified or indicated, the terms "first", "second", "third", etc. in the specification are only used to distinguish the various components, elements, steps, etc. in the specification, and are not used to indicate the logical relationship or sequential relationship between the various components, elements, steps, etc.

[0099] It should also be understood that the terms described herein are intended to describe particular embodiments only and are not intended to limit the scope of the invention. It should be noted that the singular forms "a" and "an" as used herein and in the appended claims include plural references unless the context clearly indicates otherwise. For example, a reference to "a step" or "a device" means a reference to one or more steps or devices, and may include secondary steps as well as secondary devices. All conjunctions used should be understood in their broadest sense. Also, the word "or" should be understood to have the definition of a logical "or" rather than a logical "exclusive or" unless the context clearly indicates otherwise. Furthermore, implementation of the methods and / or apparatus in embodiments of the present invention may include performing selected tasks manually, automatically, or in combination.

Claims

1. A catheter reinforcement layer, characterized in that: The invention comprises a spring component and at least one axial component, wherein each axial component extends from the proximal end to the distal end of the spring component and has at least one intersection with the spring component; wherein, when there are multiple axial components, the multiple axial components are sequentially spaced and spirally arranged along the axial direction of the spring component, and the proximal ends of two adjacent axial components are not at the same axial position.

2. The catheter reinforcement layer according to claim 1, wherein: The material of the axial component is metal and / or polymer wire.

3. The catheter reinforcement layer according to claim 1, wherein: The axial component is a filamentous structure, and its shape is one or a combination of a straight line, a wave or a spiral.

4. The catheter reinforcement layer according to claim 1, wherein: The axial component is arranged parallel to the axial direction of the spring component; Alternatively, the axial component is arranged at a certain angle to the axial direction of the spring component, and the angle is 0-45°; Alternatively, at least a portion of the axial component is arranged at a certain angle to the axial direction of the spring component, wherein the angle is 0-45°, and the other portion of the axial component is arranged parallel to the axial direction of the spring component.

5. The catheter reinforcement layer according to claim 1, wherein: There are 1-80,000 intersections between the axial component and the spring component.

6. The catheter reinforcement layer according to claim 1, wherein: The axial component is attached to the inner surface or outer surface of the spring component in a straight line or a spiral shape from the proximal end to the distal end of the spring component; Alternatively, the axial component is alternately attached between the inner surface and the outer surface of the spring component in a wave-like manner from the proximal end to the distal end; Alternatively, the axial component is arranged between the gaps of the spring component from the proximal end to the distal end along the spring component, and the axial component and the spring component are in the same plane.

7. The catheter reinforcement layer according to claim 1, wherein: When there are multiple axial components, the multiple axial components are asymmetrically arranged along the circumference of the spring component at preset positions; and / or, The axial components are sequentially spaced apart at preset positions along the axial direction of the spring component.

8. The catheter reinforcement layer according to claim 1, wherein: The axial spacings of the plurality of axial components are the same or different, and / or, The circumferential angular spacings of the plurality of axial components are the same or different.

9. The catheter reinforcement layer according to claim 8, characterized in that: Among the plurality of axial components, the axial spacing of the axial components at the proximal end is smaller than the axial spacing of the axial components at the distal end. 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.

10. The catheter reinforcement layer according to claim 1, wherein: The number of the axial components ranges from 1 to 16,000.

11. The catheter reinforcement layer according to claim 1, wherein: When there are multiple axial components, the axial spacing between two adjacent axial components in the axial direction of the spring component ranges from 0.001 inch to 0.1 inch.

12. The catheter reinforcement layer according to claim 1, wherein: The material of at least one of the axial components is developer material.

13. The catheter reinforcement layer according to any one of claims 1 to 12, characterized in that: The axial component is a monofilament or a twisted wire composed of a plurality of monofilaments.

14. The catheter reinforcement layer according to claim 13, wherein: The diameter of the monofilament ranges from 0.0005 inch to 0.003 inch, and the number of monofilaments in the twisted wire ranges from 1 to 20.

15. The catheter reinforcement layer according to claim 1, wherein: The axial component is connected to the spring component by gluing, polymerization, bonding, or laser welding, or the axial component and the spring component are integrated into one by cutting and forming.

16. The catheter reinforcement layer according to claim 1, wherein: The axial member further includes a control wire extending in the opposite direction along a side close to the catheter operator.

17. A catheter, characterized in that The catheter comprises an inner layer, a reinforcement layer and an outer layer which are arranged in sequence from the inside to the outside and are all tubular, wherein the reinforcement layer comprises the catheter reinforcement layer according to any one of claims 1 to 16.

18. The catheter according to claim 17, wherein The catheter comprises a plurality of catheter segments connected in sequence, and the axial component is arranged at a preset position; The preset position is between the circumferential surface of the spring component or the gap between the spring wires corresponding to the inner layer splicing or outer layer splicing of adjacent catheter segments; Alternatively, the preset position is between the circumferential surfaces of the spring components or the gaps between the spring wires corresponding to the catheter segments whose modulus values ​​are smaller than the modulus values ​​of the adjacent catheter segments on two sides or one side; Alternatively, the preset position is between the circumferential surface of the spring component or the gap between the spring wires corresponding to the catheter segment where the thickness of the material of the inner layer or the outer layer is smaller, or between the circumferential surface of the spring component or the gap between the spring wires where the softness of the inner layer or the outer layer is higher; Alternatively, the preset position is between the circumferential surfaces of the spring components or the gaps between the spring wires corresponding to the catheter segments whose radial diameters are smaller than the radial diameters of the catheter segments on two adjacent sides or one side.

19. The catheter according to claim 17, wherein The axial component further includes a control wire extending in the opposite direction along a side close to the catheter operator, so that the catheter operator can adjust the rotation direction of the catheter through the control wire.

20. The catheter of claim 17, wherein The inner layer is made of polymer material, and the thickness of the inner layer is 0.0001 inch-0.002 inch.

21. The catheter according to claim 20, wherein The thickness of the inner layer is 0.0003 inch to 0.0006 inch.

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