conduit

Abstract

This invention relates to a catheter comprising an inner layer and an outer layer sleeved on the inner layer; the catheter further comprising a first imaging structure located between the inner and outer layers, the first imaging structure comprising: a plurality of imaging units, the plurality of imaging units being arranged alternately or intersecting each other; the plurality of imaging units being divided along the circumference of the catheter into: at least two circumferential imaging modules arranged sequentially, wherein each circumferential imaging module includes at least one imaging unit; and / or, the plurality of imaging units being divided along the axial direction of the catheter into: at least two axial imaging modules arranged sequentially, wherein each axial imaging module includes at least one imaging unit. The aforementioned catheter balances the requirements of clear positioning and maintaining appropriate catheter rigidity. In particular, when the first imaging structure is provided at the distal end of the catheter, the requirements of clear positioning and maintaining appropriate rigidity at the distal end of the catheter can be balanced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to catheters. Background Technology

[0002] In clinical practice, endovascular interventional procedures typically require the use of catheters to deliver surgical instruments to the lesion site. For the safety and effectiveness of the procedure, the operator needs to position the catheter. This is usually done by observing and locating the catheter's position within the blood vessel under X-ray guidance; therefore, the catheter must be capable of being visualized under X-ray. The catheter body generally consists of an inner layer, a reinforcing layer, and an outer layer nested radially from the inside out. Currently, to enable X-ray visualization of the catheter, a ring-shaped radiopaque with a certain thickness and width, known as a radiopaque ring, is usually installed at the distal end of the catheter.

[0003] To achieve better visualization, the width of the visualization ring is significantly larger than the corresponding width of the metal wire used in the catheter reinforcement layer. Furthermore, the visualization ring is typically made of an alloy containing 90% platinum and 10% iridium by mass, resulting in a high density and elastic modulus. For safety, the catheter reinforcement layer is usually connected to the visualization ring via welding or crimping, causing the reinforcement layer and the visualization ring to overlap radially along the catheter. For these reasons, the visualization ring increases the overall rigidity of the distal catheter to some extent, thus hindering catheter insertion and positioning within the blood vessel. According to the inventors' catheter flexibility tests, the visualization ring increases the rigidity of the distal catheter by 20%.

[0004] To reduce the stiffness of the distal catheter, replacing the material of the contrast ring with a material with a lower elastic modulus and higher density, such as 100% platinum, would not significantly increase the stiffness of the distal catheter. However, this would make the distal catheter too easily deformable, hindering its passage through tortuous blood vessels. Reducing the width and thickness of the contrast ring could also reduce the increase in distal catheter stiffness caused by the ring itself; however, this would negatively impact the catheter's visibility under X-rays, making clear catheter positioning impossible. Furthermore, current catheters, simply installing a contrast ring of a certain width at the distal end for visualization and positioning, are sometimes limited by the ring's width and design, and cannot achieve clear positioning.

[0005] In summary, current catheters have the challenge of simultaneously achieving both precise positioning and appropriate rigidity. Summary of the Invention

[0006] Therefore, it is necessary to address the problem that current catheters cannot simultaneously meet the requirements of clear positioning and appropriate rigidity, and to provide a catheter that can simultaneously meet the requirements of clear positioning and appropriate rigidity.

[0007] One embodiment of this application provides a catheter, an inner layer and an outer layer sleeved on the inner layer; the catheter further includes a first imaging structure located between the inner layer and the outer layer, the first imaging structure including: a plurality of imaging units, the plurality of imaging units being arranged at intervals or crosses each other;

[0008] The plurality of imaging units are divided into at least two circumferential imaging modules arranged sequentially along the circumference of the catheter, wherein each circumferential imaging module includes at least one imaging unit;

[0009] And / or, the plurality of imaging units are divided along the axial direction of the catheter into at least two axial imaging modules arranged sequentially, wherein each of the axial imaging modules includes at least one of the imaging units.

[0010] In the aforementioned catheter, multiple imaging units are divided into at least two sequentially arranged circumferential imaging modules along the circumference of the catheter. This allows the imaging units to be observed from different angles along the circumference of the catheter, thus enabling clear positioning of the catheter circumferentially. Alternatively, multiple imaging units are divided into at least two sequentially arranged axial imaging modules along the axial direction of the catheter. These at least two axial imaging modules can image at at least two different positions along the axial direction of the catheter, thereby enabling clear positioning of the catheter along the axial direction. Compared to a single imaging ring in traditional catheters, the catheter in this embodiment has multiple image-producing positions in both the circumferential and / or axial directions, resulting in superior imaging effects and clearer positioning. Furthermore, compared to traditional catheters where the imaging rings are continuously arranged around the same circumference of the catheter, in this embodiment, multiple imaging units are spaced apart or intersecting each other, and are divided into at least two circumferential imaging modules arranged sequentially along the circumference of the catheter, and / or at least two axial imaging modules arranged sequentially along the axial direction of the catheter. Therefore, the positions of the multiple imaging units are dispersed rather than continuous, both axially and circumferentially, thus having a smaller impact on the hardness of the catheter and allowing it to maintain appropriate hardness. It is thus evident that the catheter in this embodiment balances the requirements of clear positioning and maintaining appropriate hardness. Especially when a first imaging structure is provided at the distal end of the catheter, both clear positioning and maintaining appropriate hardness at the distal end of the catheter can be achieved.

[0011] In one embodiment, at least one of the circumferential imaging modules includes a plurality of imaging units, wherein the plurality of imaging units in a single circumferential imaging module are arranged sequentially at intervals along the axial direction of the catheter and along the same straight line; and / or, at least one of the axial imaging modules includes a plurality of imaging units, wherein the plurality of imaging units in a single axial imaging module are arranged sequentially at intervals along the same circumference of the catheter.

[0012] In one embodiment, in two adjacent axial imaging modules, the first axial imaging module includes at least two imaging units, and the second axial imaging module includes at least two imaging units, wherein the at least two imaging units of the first axial imaging module are respectively offset from the at least two imaging units of the second axial imaging module in the circumferential direction of the catheter.

[0013] In one embodiment, multiple imaging units in a single axial imaging module are arranged at uniform intervals along the same circumference of the conduit.

[0014] In one embodiment, the catheter further includes a reinforcing layer disposed between the inner layer and the outer layer.

[0015] In one embodiment, a single developing unit is disposed on any one of the reinforcing layer, the outer peripheral surface of the inner layer, and the inner peripheral surface of the outer layer.

[0016] In one embodiment, the plurality of developing units are distributed on any one of: the reinforcing layer, the outer peripheral surface of the inner layer, and the inner peripheral surface of the outer layer; or,

[0017] The plurality of developing units are distributed on any two of the reinforcing layer, the outer peripheral surface of the inner layer, and the inner peripheral surface of the outer layer; or

[0018] The plurality of developing units are distributed on the outer peripheral surface of the reinforcing layer, the inner layer, and the inner peripheral surface of the outer layer.

[0019] In one embodiment, a single developing unit is:

[0020] The developing wire is wound around the reinforcing layer; or

[0021] Developed solder joints are soldered to the reinforcing layer; or

[0022] A developing layer is attached to any one of the following: the surface of the reinforcing layer, the outer peripheral surface of the inner layer, and the inner peripheral surface of the outer layer.

[0023] In one embodiment, the reinforcing layer includes a metal wire mesh; at least one developing unit is disposed at the weave junction of the metal wires of the metal wire mesh; and / or, at least one developing unit is disposed on the metal wires of the metal wire mesh and located between two adjacent weave junctions of the metal wires of the metal wire mesh.

[0024] In one embodiment, the reinforcing layer includes a spirally wound metal wire layer, and at least one of the developing units is disposed on the metal wire of the spirally wound metal wire layer.

[0025] In one embodiment, the reinforcing layer includes a laser-engraved metal tube; at least one developing unit is disposed on the skeleton unit of the laser-engraved metal tube; and / or, at least one developing unit is disposed at the intersection of the skeleton units of the laser-engraved metal tube.

[0026] In one embodiment, at least one of the developing units is the developing filament, and the developing filament corresponding to a single developing unit has at least three turns.

[0027] In one embodiment, the developing filament corresponding to a single developing unit is wound circumferentially around the reinforcing layer, the spacing between two adjacent turns of the developing filament is D1, the diameter or width of the developing filament is d1, and the ratio of D1 to d1 ranges from 1:100 to 10:1; or

[0028] The developing filament corresponding to a single developing unit is wound in a helical direction on the reinforcing layer. The helical pitch of the developing filament corresponding to a single developing unit is D1, and the diameter or width of the developing filament is d1. The ratio of D1 to d1 is in the range of 1:100 to 10:1.

[0029] In one embodiment, at least one of the developing units is the developing layer, and the developing layer corresponding to a single developing unit is attached to the outer peripheral surface of the inner layer and / or the inner peripheral surface of the outer layer, and is located in the gap of the reinforcing layer.

[0030] In one embodiment, the developing unit is the developing layer, which is attached to the surface of the reinforcing layer;

[0031] The plurality of imaging units are divided into first type imaging units and second type imaging units. The plurality of first type imaging units are arranged at intervals along the circumference of the conduit, and the plurality of second type imaging units are arranged at intervals along the circumference of the conduit. The first type imaging units and the second type imaging units correspond one-to-one, and the second type imaging units and their corresponding first type imaging units intersect each other.

[0032] In one embodiment, the reinforcing layer includes a proximal portion and a distal portion, the proximal portion being closer to the proximal end of the catheter than the distal portion, the proximal portion being divided into a wire braided mesh or a wire spiral wound layer, and the distal portion being divided into a wire braided mesh or a wire spiral wound layer.

[0033] Some of the metal wires in the proximal portion are developing metal wires; and / or

[0034] Some or all of the metal wires in the distal portion are developing metal wires.

[0035] In one embodiment, some of the metal wires in the proximal portion are developing metal wires, and some or all of the metal wires in the distal portion are developing metal wires, wherein at least one developing metal wire in the proximal portion and at least one developing metal wire in the distal portion are a continuous integral structure. Attached Figure Description

[0036] Figure 1 This is a schematic diagram of the internal structure of the catheter in the first embodiment;

[0037] Figure 2 This is a schematic diagram of the internal structure of the catheter in the second embodiment;

[0038] Figure 3 This is a schematic diagram of the structure of the third embodiment, showing the solder joints located on the main body of the metal wire.

[0039] Figure 4 This is a schematic diagram of the structure of the fourth embodiment, in which the developing wire is disposed on the main body of the metal wire.

[0040] Figure 5 This is a schematic diagram of the internal structure of the catheter in the fifth embodiment;

[0041] Figure 6 This is a schematic diagram of the internal structure of the catheter in the sixth embodiment;

[0042] Figure 7 This is a schematic diagram of the structure of the developing metal layer attached to the metal wire in the seventh embodiment;

[0043] Figure 8 This is a schematic diagram of the internal structure of the catheter in the eighth embodiment.

[0044] Explanation of icon numbers:

[0045] Catheter 100;

[0046] Reinforcing layer 110; Metal wire 111;

[0047] Outer layer 120;

[0048] Developing unit 131; circumferential developing module 130a; axial developing module 130b; first type developing unit 131'; second type developing unit 131”;

[0049] Developed metal layer 140;

[0050] Proximal portion 110a; distal portion 110b; ordinary metal wire 111a; developing metal wire 111b. Detailed Implementation

[0051] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0052] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0053] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0054] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0055] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first and second features are in direct contact, or that they are in indirect contact through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature. The term "distal end" refers to the end furthest from the medical staff's operation, and the term "proximal end" refers to the end closest to the medical staff's operation.

[0056] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0057] Please refer to Figure 1 The first embodiment of this application provides a catheter 100. The catheter 100 includes an inner layer (not shown) and an outer layer 120 sleeved on the inner layer. The catheter 100 also includes a first radiopaque structure located between the inner layer and the outer layer 120.

[0058] The specific structural forms of the inner layer (not shown) and the outer layer 120 can adopt existing technologies, and will not be described in detail here.

[0059] The first imaging structure includes multiple imaging units 131, which are spaced apart from each other. The imaging units 131 are made of at least one imaging metal, which is visible under X-rays. Therefore, the imaging units 131 can be visualized under X-rays, allowing for the positioning of the catheter 100 within the blood vessel using their imaging capabilities. Specifically, the imaging units 131 may be made of platinum and its alloys, palladium and its alloys, silver and its alloys, gold and its alloys, tantalum and its alloys, tungsten and its alloys, etc.

[0060] like Figure 1 As shown, in this embodiment, the number of imaging units 131 is three. The three imaging units 131 are arranged circumferentially along the conduit 100 (within the direction of...). Figure 1 From a vertical perspective, the catheter 100 is divided into three sequentially arranged circumferential imaging modules 130a, each including a imaging unit 131. Multiple imaging units 131 are arranged along the axial direction of the catheter 100 (within a vertical direction). Figure 1From a perspective that is, from left to right, the two axial developing modules 130b are arranged sequentially. One (left) axial developing module 130b includes one developing unit 131, and the other (right) axial developing module 130b includes two developing units 131.

[0061] In other embodiments, the number of imaging units can also be two, four, five, etc. The number of circumferential imaging modules can also be one, two, four, five, etc. A single circumferential imaging module can include two, three, or more imaging units. Different circumferential imaging modules can contain the same or different numbers of imaging units. The number of axial imaging modules can also be one, three, four, five, etc. A single axial imaging module can also include three, four, or other numbers of imaging units. Different axial imaging modules can contain the same or different numbers of imaging units. The distribution of imaging units in the circumferential and / or axial direction of the catheter can be uniform or non-uniform.

[0062] In endovascular interventional procedures, when catheter 100 travels through a blood vessel, its distal end enters the vessel first and reaches the lesion site first. Therefore, a first contrast-enhancing structure can be placed at the distal end of catheter 100 to visualize and locate the distal end. By determining the position of the distal end of catheter 100, the overall position of catheter 100 can be predicted in advance. Alternatively, the first contrast-enhancing structure can be placed at the proximal end and / or the middle portion of catheter 100 (the portion between the proximal and distal ends) to achieve clearer positioning of catheter 100.

[0063] Preferably, the first imaging structure is located in the region 1 mm to 100 mm (the distance along the axial direction of the catheter) from the farthest end of the catheter 100.

[0064] In the aforementioned catheter 100, multiple imaging units 131 are divided into at least two sequentially arranged circumferential imaging modules 130a along the circumference of the catheter 100. Thus, the imaging units 131 can be observed from different angles along the circumference of the catheter 100, thereby enabling clear positioning of the catheter 100 along its circumference. And / or, the multiple imaging units 131 are divided into at least two sequentially arranged axial imaging modules 130b along the axial direction of the catheter 100. These at least two axial imaging modules 130b can be imaging at at least two different positions along the axial direction of the catheter 100, thereby enabling clear positioning of the catheter 100 along its axial direction. Compared to a single imaging ring in traditional catheters, the catheter 100 in this embodiment has multiple imaging positions in both the circumferential and / or axial directions, resulting in superior imaging effects and clearer positioning. Furthermore, compared to the traditional method where the imaging rings are continuously arranged around the same circumference of the catheter, in this embodiment, because multiple imaging units 131 are spaced apart from each other and are divided into at least two circumferential imaging modules 130a arranged sequentially along the circumference of the catheter 100, and / or at least two axial imaging modules 130b arranged sequentially along the axial direction of the catheter 100, the positions of the multiple imaging units 131 are dispersed rather than continuous along both the axial and circumferential directions of the catheter 100. This results in a smaller impact on the hardness of the catheter 100, allowing the catheter 100 to maintain a suitable hardness. Therefore, the catheter 100 in this embodiment of the application balances the requirements of clear positioning and maintaining a suitable hardness. Especially when a first imaging structure is provided at the distal end of the catheter 100, the requirements of clear positioning and maintaining a suitable hardness at the distal end of the catheter 100 can be balanced.

[0065] In some embodiments, at least one axial imaging module includes multiple (i.e., two or more) imaging units. When a single axial imaging module includes multiple imaging units, these units are arranged sequentially at intervals along the same circumference of the catheter, thereby providing more imaging positions in the circumferential direction of the catheter and allowing the imaging units to be observed from more perspectives in the circumferential direction of the catheter. Figure 1 As shown, in this embodiment, two of the three imaging units 131 (on the right) are arranged sequentially at intervals along the same circumference. Since these two imaging units 131 are positioned identically along the axial direction of the conduit 100, they can form an axial imaging module 130b. The other imaging unit 131 is located to one side of the two imaging units 131 along the axial direction of the conduit 100, and functions as a separate axial imaging module 130b.

[0066] In other embodiments, two adjacent axial imaging modules are referred to as the first axial imaging module and the second axial imaging module, respectively. The first axial imaging module includes at least two imaging units (e.g., six), and these six imaging units are arranged sequentially at intervals along the same circumference of the catheter. The second axial imaging module includes at least two imaging units (e.g., three), and these three imaging units are arranged sequentially at intervals along the same circumference of the catheter. Moreover, the positions of the at least two imaging units of the first axial imaging module and the at least three imaging units of the second axial imaging module are staggered along the circumference of the catheter (i.e., their circumferential position coordinates are different). This arrangement allows for more imaging positions along the circumference of the catheter, thus enabling the imaging units to be observed from more angles along the circumference of the catheter. In addition, it also avoids the impact on the hardness of the catheter caused by the imaging units in the first and second axial imaging modules being too concentrated.

[0067] Preferably, the multiple imaging units in a single axial imaging module are evenly spaced along the same circumference of the catheter, which facilitates observation of the imaging units from multiple perspectives in the circumference of the catheter and avoids the impact on the hardness of the catheter caused by the excessive concentration of the multiple imaging units in a single axial imaging module.

[0068] In other embodiments, at least one circumferential imaging module includes multiple (i.e., more than two) imaging units. When a single circumferential imaging module includes multiple imaging units, these multiple imaging units are arranged sequentially at intervals along the axial direction of the catheter and in the same straight line, thereby providing more imaging positions along the axial direction of the catheter, and thus allowing the imaging units to be observed at more positions along the axial direction of the catheter.

[0069] Please refer to Figure 2 In the second embodiment, the three imaging units 131 can also be staggered relative to each other along the axial direction of the conduit, and further, the three imaging units 131 can be staggered relative to each other along the circumferential direction of the conduit. Thus, the three imaging units 131 can be divided into three axial imaging modules 130b along the axial direction and three circumferential imaging modules 130a along the circumferential direction. Each axial imaging module 130b includes only one imaging unit 131.

[0070] like Figure 1 and Figure 2 As shown, in some embodiments, the catheter 100 further includes a reinforcing layer 110. The reinforcing layer is disposed between the inner layer and the outer layer 120.

[0071] like Figure 1 and Figure 2 As shown, in some embodiments, a single developing unit 131 is disposed on the reinforcing layer 110.

[0072] In other embodiments, a single developing unit may also be disposed on the outer peripheral surface of the inner layer or the inner peripheral surface of the outer layer. That is, a single developing unit may be disposed on any one of the reinforcing layer, the outer peripheral surface of the inner layer, and the inner peripheral surface of the outer layer.

[0073] like Figure 1 and Figure 2 As shown, in some embodiments, all of the multiple developing units 131 are distributed on the reinforcing layer 110.

[0074] In other embodiments, the multiple developing units may be distributed entirely on the outer peripheral surface of the inner layer, or entirely on the inner peripheral surface of the outer layer. Alternatively, the multiple developing units may be distributed on any two of the reinforcing layer, the outer peripheral surface of the inner layer, and the inner peripheral surface of the outer layer. For example, the multiple developing units may be divided into two parts, with one part distributed on the reinforcing layer and the other part distributed on the outer peripheral surface of the inner layer; or, for another example, with one part distributed on the reinforcing layer and the other part distributed on the inner peripheral surface of the outer layer; or, for yet another example, with one part distributed on the outer peripheral surface of the inner layer and the other part distributed on the inner peripheral surface of the outer layer. Alternatively, the multiple developing units may be divided into three parts, with the first part distributed on the outer peripheral surface of the inner layer, the second part distributed on the inner peripheral surface of the outer layer, and the third part distributed on the reinforcing layer.

[0075] like Figure 1 and Figure 2 As shown, in some embodiments, the reinforcing layer 110 includes a wire mesh. The wire mesh comprises multiple interwoven wires 111, and the weaving method and structure can employ existing technology, which will not be described in detail here. In this embodiment, all of the multiple developing units 131 are disposed at the intersection of the wires 111 of the wire mesh.

[0076] Of course, among multiple developing units, only some developing units may be located at the intersection of the metal wires in the wire mesh.

[0077] like Figure 3 As shown, in the third embodiment, at least one developing unit 131 is disposed on the metal wire 111 of the metal wire mesh, and is located between two adjacent weave junctions of the metal wire 111. That is, the at least one developing unit 131 is disposed at a local position on the main body of the metal wire 111 of the metal wire mesh, rather than at a weave junction.

[0078] It is understood that, in some embodiments, the multiple developing units of the metal wire mesh disposed in the reinforcing layer can all be disposed at the weaving junctions of the metal wires in the metal wire mesh; or all of them can be disposed on the main body of the metal wire mesh; or some can be disposed at the weaving junctions of the metal wires in the metal wire mesh, while others are disposed on the main body of the metal wire mesh. When the developing units are disposed at the weaving junctions of the metal wires, they not only serve the function of developing but also serve to fix the metal wires at the weaving junctions, making the connection of the metal wires at the weaving junctions more reliable.

[0079] In other embodiments, the reinforcing layer includes a spirally wound metal wire layer. At least one developing unit is disposed on the metal wire of the spirally wound metal wire layer. The spirally wound metal wire layer includes metal wire spirally wound around the inner layer, and its specific structure and winding method can adopt existing technology, which will not be described in detail here.

[0080] In some embodiments, the reinforcing layer includes a laser-engraved metal tube. The structure of the laser-engraved metal tube is prior art and will not be described in detail here. It is understood that the laser-engraved metal tube has multiple skeleton units. Several skeleton units (e.g., three, four, etc.) can form a hollow opening in the laser-engraved metal tube. A single developing unit can be located at the intersection of the skeleton units of the laser-engraved metal tube, or at a local location within the main body of the skeleton unit (i.e., between two adjacent intersections, i.e., a non-intersection).

[0081] It is understood that, in some embodiments, the multiple developing units of the laser-engraved metal tube disposed on the reinforcing layer may all be disposed at the intersection of the skeleton units of the laser-engraved metal tube; or all may be disposed on the main body of the skeleton units of the laser-engraved metal tube; or a portion may be disposed at the intersection of the skeleton units of the laser-engraved metal tube, while another portion may be disposed on the main body of the skeleton units of the laser-engraved metal tube.

[0082] It is understood that the reinforcing layer may include any one, two, or three of the following: a spiral wound metal wire layer, a woven metal mesh, and a laser-engraved metal tube. Multiple developing units disposed in the reinforcing layer may be distributed among any one, two, or three of the following: the spiral wound metal wire layer, the woven metal mesh, and the laser-engraved metal tube.

[0083] like Figures 1 to 3 As shown, in some embodiments, a single developing unit 131 is a developing solder joint. The developing solder joint is soldered to the reinforcing layer 110. Moreover, in this embodiment, multiple developing units 131 are developing solder joints.

[0084] The shape of a single developed solder joint can be any of a sphere, ellipsoid, teardrop, or cylinder. The thickness or height of a single developed solder joint can range from 0.0005 inches to 0.01 inches, and the width or diameter can range from 0.005 inches to 0.5 inches. Here, the thickness or height direction of the developed solder joint refers to the direction in which it protrudes from the surface of the reinforcing layer. In one specific embodiment, a single developed solder joint can be an ellipsoid with a thickness of 0.0005 inches and a width of 0.015 inches.

[0085] In other embodiments, a single developing unit may also be either a developing filament or a developing layer.

[0086] In some embodiments, when a single developing unit is a developing filament, the developing filament corresponding to the single developing unit is wound around a reinforcing layer. When the reinforcing layer comprises a wire mesh, the developing filament corresponding to the single developing unit may be wound around the main body of the wires of the wire mesh or at the intersection of the weaves. When the reinforcing layer comprises a spirally wound layer of wires, the single developing unit may be wound around the wires of the spirally wound layer. When the reinforcing layer comprises a laser-engraved metal tube, the single developing unit may be wound around the main body or at the intersection of the skeleton unit of the laser-engraved metal tube.

[0087] The cross-sectional shape of the developing filament corresponding to a single developing unit can be circular, square, or other shapes. When the cross-section of the developing filament is circular, the diameter of the developing filament ranges from 0.001 inches to 0.01 inches. When the cross-section of the developing filament is square or other shapes, the thickness of the developing filament ranges from 0.001 inches to 0.01 inches. The total length of the developing filament corresponding to a single developing unit ranges from 0.003 inches to 10 inches.

[0088] like Figure 4 As shown, in the fourth embodiment, at least one developing unit 131 is a developing filament, and the developing filament corresponding to a single developing unit 131 has at least three turns, such as three, four, or five turns, thereby providing a more obvious developing effect. The number of turns here refers to the number of turns the developing filament corresponding to a single developing unit 131 makes when wound on the reinforcing layer. Examples include metal wire 111 wound on a metal wire mesh, metal wire in a spiral wound layer, and the skeleton unit of a laser-engraved metal tube.

[0089] In some embodiments, when the developing wire corresponding to a single developing unit 131 is wound on the reinforcing layer 110, it can be wound along the circumferential direction. In this case, the single developing unit 131 is divided into several segments, and each segment is wound once. The spacing between two adjacent turns of developing wire is D1, and the diameter (when the cross-section is circular) or width (when the cross-section is of other shapes) of the developing wire is d1. The ratio of D1 to d1 ranges from 1:100 to 10:1.

[0090] In other embodiments, when the developing filament corresponding to a single developing unit 131 is wound on the reinforcing layer 110, it may be wound in a helical direction. The helical pitch of the developing filament corresponding to a single developing unit 131 is D1, and the diameter (when the cross-section is circular) or width (when the cross-section is of other shapes) of the developing filament is d1. The ratio of D1 to d1 ranges from 1:100 to 10:1.

[0091] It is understood that, in some embodiments, among the multiple developing units, some developing filaments corresponding to the developing units may be wound around the reinforcing layer in a circumferential direction, and some developing filaments corresponding to the developing units may be wound around the reinforcing layer in a helical direction.

[0092] In some embodiments, when a single developing unit is a developing layer, the developing layer corresponding to the single developing unit is attached to any one of the surface of the reinforcing layer, the outer peripheral surface of the inner layer, and the inner peripheral surface of the outer layer.

[0093] The thickness of the developing layer corresponding to a single developing unit ranges from 0.001 mm to 0.5 mm, for example, 0.02 mm. Therefore, the thickness of the developing layer is small, which is a very thin layer and has little impact on the hardness of the catheter.

[0094] The attachment method for the developing layer to any of the surfaces of the reinforcing layer, the outer peripheral surface of the inner layer, and the inner peripheral surface of the outer layer can be, but is not limited to, electroplating, electroless plating, physical vapor deposition (PVD), plasma spraying, or ion sputtering. Furthermore, the developing layer can be prepared from developing metal powder. In some embodiments, the developing layer corresponding to the developing unit is prepared after the preparation steps of the inner layer and reinforcing layer in the normal fabrication process of the conduit, and before the outer layer coating.

[0095] The projection shape of the developing layer corresponding to a single developing unit on the surface of the inner or outer layer can be, but is not limited to, circular, square, rhomboid, elliptical, etc. The radial dimension (i.e., thickness or height) of the developing layer corresponding to a single developing unit is 0.0005 inches to 0.1 inches, and the axial dimension (i.e., width, length, or diameter) of the developing layer is 0.005 inches to 0.5 inches.

[0096] like Figure 5 As shown, in the fifth embodiment, at least one developing unit 131 is a developing layer. The developing layer corresponding to a single developing unit 131 is attached to the outer peripheral surface of the inner layer or the inner peripheral surface of the outer layer 120, and is located in the gap of the reinforcing layer 110. Figure 5 As shown, in this embodiment, the five developing units 131 are arranged into three sequentially arranged axial developing modules 130b and four sequentially arranged circumferential developing modules 130b.

[0097] Of course, the arrangement of the multiple developing units 131 can also adopt the arrangement described in any of the foregoing embodiments, and there is no limitation here.

[0098] Specifically, the developing layer corresponding to a single developing unit 131 can be attached to the outer peripheral surface of the inner layer or the inner peripheral surface of the outer layer 120. For example... Figure 5 As shown, in this embodiment, each developing unit 131 is a developing layer. Among the multiple developing units 131, a portion of the developing layer corresponding to the developing unit 131 may be attached to the outer peripheral surface of the inner layer, and a portion of the developing layer corresponding to the developing unit 131 may be attached to the inner peripheral surface of the outer layer 120.

[0099] The reinforcing layer 110 includes a metal wire mesh. The gaps in the mesh formed by the metal wires 111 of the metal wire mesh are the gaps in the reinforcing layer 110. The developing layer corresponding to the developing unit 131 is located in the gaps of the reinforcing layer 110 to prevent it from being blocked by the reinforcing layer 110, thus facilitating a clear developing effect.

[0100] like Figure 5 As shown, in this embodiment, the developing layer corresponding to a single developing unit 131 is a square with rounded corners, with a thickness of 0.003 inches, a length of 0.005 inches along the axial direction of the conduit, and a width of 0.008 inches.

[0101] It is understandable that when the reinforcing layer includes a spirally wound metal wire layer, the gaps between the metal wires in the spirally wound metal wire layer can also be the gaps in the aforementioned reinforcing layer 110, meaning the developing layer corresponding to the developing unit can also be located at the gaps between the metal wires in the spirally wound metal wire layer. When the reinforcing layer includes a laser-engraved metal tube, the hollowed-out areas of the laser-engraved metal tube can also be the gaps in the aforementioned reinforcing layer 110, meaning the developing layer corresponding to the developing unit can also be located at the hollowed-out areas of the laser-engraved metal tube.

[0102] In some embodiments, the plurality of developing units may all be developing wires or all be developing layers. The plurality of developing units may also include any two or three of developing solder joints, developing wires, and developing layers.

[0103] In the sixth embodiment, the reinforcing layer 110 has an outer surface facing the outer layer 120. It is understood that, along the radial direction of the conduit, the outer surface of the reinforcing layer 110 faces the outer layer 120 and towards the outside of the conduit, while the inner surface of the reinforcing layer 110 faces the inner layer and towards the inside of the conduit. The developing unit 131 is a developing layer, which is attached to the outer surface of the reinforcing layer 100 to facilitate developing. Of course, the developing layer can also be attached to both the outer and inner surfaces of the reinforcing layer 100.

[0104] like Figure 6As shown, in this embodiment, the developing unit 131 is divided into a first type of developing unit 131' and a second type of developing unit 131". Multiple first type developing units 131' are arranged sequentially at intervals along the circumference of the conduit 100, thereby forming multiple circumferential developing modules. Multiple second type developing units 131" are also arranged sequentially at intervals along the circumference of the conduit 100, thereby also forming multiple circumferential developing modules. The second type developing units 131" have different inclination directions than the first type developing units 131'; therefore, the second type developing units 131" intersect with their corresponding first type developing units 131'. A second type of imaging unit 131” may intersect with a first type of imaging unit 131', or multiple second type of imaging units 131” may intersect with a first type of imaging unit 131', or a second type of imaging unit 131” may intersect with multiple first type of imaging units 131'. Multiple circumferential imaging modules formed by multiple first type of imaging units 131' and multiple circumferential imaging modules formed by multiple second type of imaging units 131”, and because the second type of imaging units 131” intersect with their corresponding first type of imaging units 131', can further enhance the imaging effect of the catheter 100.

[0105] The reinforcing layer 110 includes a metal wire mesh, thus having a plurality of interlaced metal wires 111. The first type of developing unit 131' and the second type of developing unit 131" are respectively attached to the metal wires 111 of the reinforcing layer 110, thereby facilitating the formation of a plurality of first type of developing units 131' arranged sequentially at intervals along the circumference of the conduit 100, a plurality of second type of developing units 131" arranged sequentially at intervals along the circumference of the conduit 100, and a structure in which the second type of developing units 131" intersect with the corresponding first type of developing units 131'.

[0106] like Figure 7 As shown, in the seventh embodiment, a radiopaque metal layer 140 is attached to the outer surface of a portion of the reinforcing layer 110. The radiopaque metal layer 140 is made of at least radiopaque metals, and may include, but is not limited to, platinum and its alloys, palladium and its alloys, silver and its alloys, gold and its alloys, tantalum and its alloys, and tungsten and its alloys. Therefore, the radiopaque metal layer 140 can further improve the radiopaque effect of the catheter, thereby achieving clearer positioning of the catheter. Since the radiopaque metal layer 140 is attached to the outer surface of the reinforcing layer 110, it can be prevented from being blocked by the reinforcing layer 110, thus facilitating a clear radiopaque effect.

[0107] The developing metal layer 140 is disposed in the region from the farthest end of the conduit between 0 mm and 200 mm. Compared with the multiple dispersed developing layers corresponding to the multiple developing units in the fifth embodiment, the developing metal layer 140 in this embodiment can be continuously disposed on a length range of the outer surface of the reinforcing layer 110, rather than being presented in a dispersed form.

[0108] Preferably, the attachment range of the imaging metal layer 140 to the reinforcing layer 110 is the entire outer surface of the reinforcing layer 110 within 0 to 10 mm from the farthest end of the catheter, thereby enabling the distal end of the catheter to have a better imaging effect so as to achieve clear positioning.

[0109] The thickness of the developing metal layer 140 ranges from 0.001 mm to 0.5 mm, which is a very thin layer and has little impact on the hardness of the catheter.

[0110] The manner in which the developing metal layer 140 is attached to the reinforcing layer 110 includes, but is not limited to, electroplating, electroless plating, physical vapor deposition (PVD), plasma spraying, and ion sputtering.

[0111] In other embodiments, the entire outer surface of the reinforcing layer may be covered with a radiopaque metal layer 140, which would allow the catheter to exhibit better radiopaqueness in the blood vessel.

[0112] like Figure 8 As shown, in the eighth embodiment, the reinforcing layer 110 includes a proximal portion 110a and a distal portion 110b. It can be understood that the distal portion 110b is located at the distal end of the catheter relative to the proximal portion 110a.

[0113] In this embodiment, the proximal portion 110a is a braided metal wire mesh, and the distal portion 110b is a spirally wound metal wire layer. Of the metal wires in the proximal portion 110a, a portion is a radiopaque metal wire 111b, and the other portion is a regular metal wire 111a. Here, the regular metal wire 111a refers to a non-radiopaque metal wire, which may be, but is not limited to, stainless steel, nickel-titanium alloy, tungsten and its alloys, cobalt and its alloys, titanium and its alloys, iron and its alloys, magnesium and its alloys, and zinc and its alloys. Therefore, the radiopaque metal wire 111b can serve as part of the proximal portion 110a of the reinforcing layer 110, thus both reinforcing the proximal portion 110a of the catheter and utilizing the radiopaque ability of the radiopaque metal wire 111b for catheter positioning.

[0114] like Figure 8 As shown, in this embodiment, the distal portion 110b is entirely made of radiopaque metal wire 111b, which enables the distal end of the catheter to have a good radiopaque effect and achieve clear positioning of the distal end.

[0115] Furthermore, in the metal wires of the proximal portion 110a, the number of ordinary metal wires 111a is greater than the number of radiopaque metal wires 111b. This allows the high hardness of the ordinary metal wires 111a to be utilized as much as possible to ensure the force transmission requirements of the proximal portion 110a, as well as to ensure the supporting and reinforcing function of the reinforcing layer 110, and also to play a role in positioning the catheter.

[0116] Furthermore, the developing metal wires 111b in the metal wires of the proximal portion 110a and the developing metal wires 111b in the metal wires of the distal portion 110b are continuous developing metal wires, that is, they are an integral structure, not spliced ​​together, which facilitates assembly. Specifically, in this embodiment, when the metal wire mesh of the proximal portion 110a is woven, the ends of the ordinary metal wires 111a of the proximal portion 110a can be cut off and the excess parts removed, while the developing metal wires 111b of the proximal portion 110a are (temporarily not cut) continued to be wound towards the distal end to form a spiral winding layer of metal wires in the distal portion 110b.

[0117] In other embodiments, the proximal portion can also be entirely made of ordinary metal wire, which can better ensure the force transmission requirements of the proximal portion and guarantee the supporting and reinforcing functions of the reinforcing layer. Of course, the distal portion can also use a combination of ordinary metal wire and developing metal wire to meet the force transmission and developing requirements of the distal portion as much as possible.

[0118] In addition, in some other embodiments, the proximal portion may also be a spirally wound layer of metal wire. The distal portion may also be a woven wire mesh. Both the proximal and distal portions may also be spirally wound layers of metal wire or woven wire mesh.

[0119] In some embodiments, the length of the imaging wire 111b in the distal portion 110b along the axial direction of the catheter ranges from 0.5 mm to 50 mm to meet the imaging requirements of the distal end of the catheter.

[0120] In some embodiments, the cross-sectional shape of the developing wire 111b of the proximal portion 110a and / or the distal portion 110b is circular, square, or other shapes. When the cross-sectional shape of the developing wire 111b is circular, its diameter is 0.0005 inches to 0.01 inches. When the cross-sectional shape of the developing wire 111b is square or other shapes, its diameter is 0.0005 inches to 0.01 inches, for example, 0.002 inches.

[0121] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0122] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A catheter, characterized in that, The catheter includes: an inner layer, an outer layer sleeved on the inner layer, and a reinforcing layer disposed between the inner layer and the outer layer; the catheter also includes a first imaging structure located between the inner layer and the outer layer, the first imaging structure including: a plurality of imaging units, the plurality of imaging units being spaced apart from each other; The plurality of imaging units are divided into at least two circumferential imaging modules arranged sequentially along the circumferential direction of the catheter, wherein each circumferential imaging module includes at least one imaging unit, and at least one circumferential imaging module includes a plurality of imaging units, and the plurality of imaging units in a single circumferential imaging module are arranged sequentially at intervals along the axial direction of the catheter and along the same straight line. The plurality of imaging units are divided along the axial direction of the catheter into at least two axial imaging modules arranged sequentially, wherein each axial imaging module includes at least one imaging unit, and at least one axial imaging module includes a plurality of imaging units, and the plurality of imaging units in a single axial imaging module are evenly spaced along the same circumference of the catheter. In two adjacent axial imaging modules, the first axial imaging module includes at least two imaging units, and the second axial imaging module includes at least two imaging units, wherein the at least two imaging units of the first axial imaging module are respectively offset from the at least two imaging units of the second axial imaging module along the circumferential direction of the catheter. Wherein, a single developing unit is: The developing wire is wound around the reinforcing layer; or Developed solder joints are soldered to the reinforcing layer; or A developing layer is attached to the outer peripheral surface of the inner layer and / or the inner peripheral surface of the outer layer, and is located in the gap of the reinforcing layer.

2. The catheter according to claim 1, characterized in that, The reinforcing layer includes a metal wire mesh; at least one developing unit is disposed at the intersection of the metal wires of the metal wire mesh; and / or, at least one developing unit is disposed on the metal wires of the metal wire mesh and located between two adjacent intersections of the metal wires of the metal wire mesh.

3. The catheter according to claim 1, characterized in that, The reinforcing layer includes a spiral wound metal wire layer, and at least one of the developing units is disposed on the metal wire of the spiral wound metal wire layer.

4. The catheter according to claim 1, characterized in that, The reinforcing layer includes a laser-engraved metal tube; at least one of the developing units is disposed on the skeleton unit of the laser-engraved metal tube; and / or, at least one of the developing units is disposed at the intersection of the skeleton units of the laser-engraved metal tube.

5. The catheter according to claim 1, characterized in that, At least one of the developing units is the developing wire, and the developing wire corresponding to a single developing unit has at least three turns.

6. The catheter according to claim 5, characterized in that, The developing filament corresponding to a single developing unit is wound circumferentially around the reinforcing layer, the spacing between two adjacent turns of the developing filament is D1, the diameter or width of the developing filament is d1, and the ratio of D1 to d1 ranges from 1:100 to 10:1; or, The developing filament corresponding to a single developing unit is wound in a helical direction on the reinforcing layer. The helical pitch of the developing filament corresponding to a single developing unit is D1, and the diameter or width of the developing filament is d1. The ratio of D1 to d1 is in the range of 1:100 to 10:

1.

7. The catheter according to claim 1, characterized in that, At least one of the developing units is the developing layer.

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