A flexible support catheter

By designing a flexible support catheter, combined with a flexible lining pipeline, a rigid support layer and an adhesive layer, the limitations of existing catheters in complex blood vessels are solved, the flexible adjustment and stability of the catheter in tortuous blood vessels are achieved, and the treatment effect is improved.

CN116139388BActive Publication Date: 2025-09-30SHANGHAI EASY-FLOW MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202211718121.0
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-12-29
Publication Date
2025-09-30
Estimated Expiration
2042-12-29

AI Technical Summary

Technical Problem

When dealing with complex CTO lesions, the conventional heat-setting method of existing support catheters is difficult to meet the needs of various usage scenarios, resulting in the need to prepare catheters with multiple bending angles. They are also prone to wrinkling or falling off during use, affecting the treatment effect.

Method used

A flexible support catheter is designed. The practicality of the catheter is improved by the arrangement of a flexible lining core in conjunction with a support member, a sheath member, a first connecting member and a second connecting member, allowing doctors to adjust the curvature according to clinical conditions. The combined design of a flexible lining pipeline, a rigid support layer, an adhesive layer and a braided layer enhances the support and torque.

Benefits of technology

It achieves flexible adjustment of the catheter in tortuous blood vessels, improves the effect of treating complex vascular occlusive diseases, reduces the phenomenon of catheter falling off and wrinkling during use, and enhances support and operability.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides a bendable support catheter, comprising a support member, a sheath member, a first connecting member, a second connecting member, and a liner core. One end of the sheath member is sleeved over one end of the support member, and the other end of the sheath member is detachably connected to the first connecting member. One end of the liner core is detachably connected to the second connecting member, and the other end is inserted into the support member. The liner core is bendable. In the present invention, the support catheter provided improves its practicality by combining the bendable liner core with the support member, sheath member, first connecting member, and second connecting member. Doctors can adjust the curvature of the catheter according to actual clinical conditions, making it particularly suitable for the treatment of tortuous vascular occlusive diseases.
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Description

Technical Field

[0001] The invention belongs to the technical field of medical catheter design and relates to a bendable supporting catheter. Background Art

[0002] In the treatment of occlusive diseases caused by thrombosis, embolism, atherosclerosis, etc., it is often difficult to pass the lesion using a guidewire alone, especially in complex CTO lesions. Support catheters provide good support and puncture resistance for the guidewire and are often used to establish good vascular access to facilitate subsequent treatments such as guidewire exchange, balloon and stent placement.

[0003] Currently, existing support catheters are typically heat-set to pre-adjust their curvature to meet the needs of specific scenarios. If a wide range of clinical scenarios arise, it will be necessary to prepare support catheters with different angles and specifications. Given the complex and tortuous blood vessels in the lower limbs and the numerous branching vessels, conventional support catheters with specific angles are quite limited and inconvenient to use. Therefore, there is an urgent need to design and develop a flexible support catheter that overcomes the shortcomings of existing technologies while meeting practical needs. Summary of the Invention

[0004] In view of the shortcomings of the existing technology, the purpose of the present invention is to provide a flexible support catheter. In the present invention, the provided support catheter improves the practicality of the support catheter by configuring a flexible liner core in conjunction with a support member, a sheath member, a first connecting member and a second connecting member. Doctors can adjust the curvature according to actual clinical conditions, and it is particularly suitable for the treatment of tortuous vascular occlusive diseases.

[0005] To achieve this object, the present invention adopts the following technical solutions:

[0006] The present invention provides a bendable support conduit, which includes a support member, a sheath member, a first connecting member, a second connecting member and a lining core. One end of the sheath member is sleeved on one end of the support member, and the other end of the sheath member is detachably connected to the first connecting member. One end of the lining core is detachably connected to the second connecting member, and the other end is inserted into the support member, and the lining core is bendable.

[0007] In the present invention, the support catheter provided improves the practicality of the support catheter by configuring a bendable liner core in conjunction with a support member, a sheath member, a first connecting member, and a second connecting member. Doctors can adjust the curvature according to actual clinical conditions, and the catheter is particularly suitable for the treatment of tortuous vascular occlusive diseases.

[0008] It should be noted that the support catheter of the present invention can be used to treat occlusive diseases caused by thrombosis, embolism, atherosclerosis and the like.

[0009] As a preferred technical solution of the present invention, the support member is a tubular structure, and the support member includes a main member, one end of the main member is connected to the first connecting member, and the other end is sequentially provided with a plastic member and a head end member in a direction away from the first connecting member.

[0010] Preferably, the main component includes a pipeline and a composite layer arranged on the outer surface of the pipeline.

[0011] Preferably, the plastic component is sleeved on the surface of the composite layer, and a coating layer is provided on the surface of the plastic component away from the composite layer.

[0012] It should be noted that the coating layer in the present invention can provide a smooth surface and natural rheology.

[0013] Preferably, the head end member includes a developing component, and the developing component is sleeved on the surface of the composite layer.

[0014] Preferably, the pipeline is a flexible lined pipeline.

[0015] Preferably, the composite layer is any one or a combination of two or more of a first adhesive layer, a rigid support layer, a second adhesive layer, a braided layer, a longitudinal support wire and a polymer packaging material.

[0016] It should be noted that conventional support catheters are pre-bent by heat setting, which can only meet specific vascular usage scenarios. Multiple usage scenarios require the preparation of support catheters with multiple bending angles. The plastic component of the support catheter in the present invention adopts a coating design to visualize the treatment process. Different from the existing support catheter, the support catheter of the present invention adds a rigid support layer in addition to the braided layer, which has stronger support performance and is easier to pass through the CTO lesion part. Furthermore, the conventional support catheter consists of an inner lining + braided layer + polymer outer layer. The inner lining is only etched, and the connection strength with the outer layer is weak. During the guidewire process, the inner layer often wrinkles or even falls off, resulting in the need to replace the instrument during surgery. The support catheter of the present invention has an adhesive layer added between the polymer outer layer, the rigid support layer and the flexible inner lining pipeline. The adhesive layer has excellent bonding performance and is not easy to wrinkle or fall off. The support and torque of the support catheter are also greatly improved.

[0017] Preferably, the material of the coating layer is the same as the material of the polymer packaging material.

[0018] As a preferred technical solution of the present invention, the length of the main component is 60 to 160 cm, for example, it can be 60 cm, 70 cm, 80 cm, 90 cm, 100 cm, 110 cm, 120 cm, 130 cm, 140 cm, 150 cm, 160 cm, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0019] The present invention limits the main member length to 60 to 160 cm because this range allows for various catheter access methods to the lesion. Outside this range, there is a risk of insufficient catheter length during surgery, preventing treatment and delaying treatment. It should be noted that the main member of the present invention can possess a certain degree of flexibility and support. The specific structure and material are not specifically limited in this invention, and those skilled in the art can adapt the design based on actual circumstances.

[0020] Preferably, the material of the flexible lining pipe is any one of polytetrafluoroethylene, polyetheretherketone, fluorinated ethylene propylene copolymer and ethylene-tetrafluoroethylene copolymer, more preferably polytetrafluoroethylene.

[0021] It should be noted that the flexible lining pipe in the present invention is preferably made of polytetrafluoroethylene because the surface friction coefficient is low and does not allow debris to be generated.

[0022] Preferably, the surface of the flexible lining pipeline is modified.

[0023] Preferably, the modification treatment includes sodium naphthalene etching and plasma treatment.

[0024] It should be noted that the surface of the flexible lined pipe in the present invention needs to be modified when in use, mainly to make the treated lining have good hydrophilic properties.

[0025] Preferably, the material of the first adhesive layer is any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber, nylon and fluorine-containing adhesive.

[0026] It should be noted that the first adhesive layer in the present invention can effectively combine the flexible lining pipe with the rigid support layer. The fluorine-containing adhesive in the present invention can specifically be polyvinylidene fluoride, fluorine-containing polyacrylate, etc.

[0027] Preferably, the rigid support layer is made of polyimide or stainless steel.

[0028] It should be noted that the rigid support layer in the present invention can further enhance the overall support strength of the supporting conduit.

[0029] Preferably, the second adhesive layer is made of any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber and nylon, more preferably nylon.

[0030] It should be noted that the second adhesive layer in the present invention can tightly bond the rigid support layer, the braided layer and the polymer packaging material, so that the pipe is not easily delaminated during use. Nylon hot melt adhesive can be used for bonding.

[0031] Preferably, the braided layer is made of any one of stainless steel, nickel titanium and polymer monofilament.

[0032] It should be noted that the braided layer in the present invention can adjust the support and torque-related parameters according to actual conditions, and those skilled in the art do not impose any special restrictions on its structure, shape and material.

[0033] Preferably, the braided layer comprises braided wires, and the braided wires are in the shape of round wires or flat wires.

[0034] It should be noted that the shape of the handle of the braided wire in the present invention is limited to round wire or flat wire. As long as it can be used for preparing the braided layer in this application, it is within the protection scope of the present invention, and those skilled in the art should know it.

[0035] Preferably, the braiding density of the braided layer is 60 to 120 PPI, for example, it can be 60 PPI, 70 PPI, 80 PPI, 90 PPI, 100 PPI, 110 PPI, 120 PPI, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0036] Preferably, the number of longitudinal support wires is 1 to 8, for example, 1, 2, 3, 4, 5, 6, 7, or 8, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0037] Preferably, the longitudinal support wires are evenly arranged circumferentially.

[0038] Preferably, the polymer packaging material is made of any one of nylon-11, nylon-12 and polyetheramide.

[0039] It should be noted that the material of the polymer packaging material in the present invention can be selected from materials of different hardness. The above-mentioned nylon-11, nylon-12 and polyetheramide are only preferred examples in the present invention. Those skilled in the art can make adaptive adjustments according to actual conditions.

[0040] As a preferred technical solution of the present invention, the thickness of the flexible lining pipe is 15 to 20 μm, for example, it can be 15 μm, 15.5 μm, 16 μm, 16.5 μm, 17 μm, 17.5 μm, 18 μm, 18.5 μm, 19 μm, 19.5 μm, 20 μm, but it is not limited to the listed values, and other unlisted values ​​within this numerical range are also applicable.

[0041] In the present invention, the thickness of the flexible lining pipe is preferably 15 to 20 μm. Within this range, the operation effect can be better. The thickness is not limited to this range, and those skilled in the art can make adaptive adjustments according to actual conditions.

[0042] Preferably, the thickness of the first adhesive layer is 5 to 10 μm, for example, it can be 5 μm, 5.5 μm, 6 μm, 6.5 μm, 7 μm, 7.5 μm, 8 μm, 8.5 μm, 9 μm, 9.5 μm, or 10 μm, but is not limited to the listed values, and other unlisted values ​​within this numerical range are also applicable.

[0043] In the present invention, the thickness of the first adhesive layer is preferably 5 to 10 μm. Within this range, the operation effect can be better. The thickness is not limited to this range, and those skilled in the art can make adaptive adjustments according to actual conditions.

[0044] Preferably, the thickness of the rigid support layer is 40 to 50 μm, for example, it can be 40 μm, 41 μm, 42 μm, 43 μm, 44 μm, 45 μm, 46 μm, 47 μm, 48 μm, 49 μm, or 50 μm, but is not limited to the listed values, and other unlisted values ​​within this numerical range are also applicable.

[0045] In the present invention, the preferred thickness of the rigid support layer is 40 to 50 μm. Within this range, the operation effect can be better. The thickness is not limited to this range, and those skilled in the art can make adaptive adjustments according to actual conditions.

[0046] Preferably, the inner diameter of the longitudinal support wire is 0.01-0.1 mm, for example, it can be 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, but is not limited to the listed values, and other unlisted values ​​within this numerical range are also applicable.

[0047] Preferably, the thickness of the polymer packaging material is 50 to 150 μm, for example, it can be 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, or 150 μm, but is not limited to the listed values. Other unlisted values ​​within this numerical range are also applicable.

[0048] In the present invention, the thickness of the polymer packaging material is preferably 50 to 150 μm. Within this range, the operation effect can be better. The thickness is not limited to this range, and those skilled in the art can make adaptive adjustments according to actual conditions.

[0049] Preferably, the thickness of the coating layer is 20 to 30 μm, for example, it can be 20 μm, 21 μm, 22 μm, 23 μm, 24 μm, 25 μm, 26 μm, 27 μm, 28 μm, 29 μm, or 30 μm, but is not limited to the listed values, and other unlisted values ​​within this numerical range are also applicable.

[0050] As a preferred technical solution of the present invention, the plastic component is bendable.

[0051] Preferably, the bending angle of the plastic component is 0 to 60°, for example, it can be 0°, 1°, 5°, 10°, 20°, 30°, 40°, 50°, 60°, but is not limited to the listed values. Other values ​​not listed within this numerical range are also applicable.

[0052] It should be noted that the plastic component in the present invention needs to have a certain degree of flexibility, can be bent at 0 to 60 degrees without folding, and can be bent repeatedly multiple times in order to achieve the technical effect of this application. Therefore, the plastic component of this application also needs to undergo necessary annealing treatment.

[0053] Preferably, the plastic component is made of any one of stainless steel, titanium and nickel.

[0054] Preferably, the plastic component needs to be annealed.

[0055] Preferably, the annealing temperature is 500-1100°C, for example, 500°C, 600°C, 700°C, 800°C, 900°C, 1000°C, 1100°C, but is not limited to the listed values, and other unlisted values ​​within this range are also applicable.

[0056] Preferably, the surface of the plastic component is provided with a plating layer.

[0057] It should be noted that the coating on the surface of the plastic component of the present invention can make the plastic component more flexible and make the treatment process more visual, thereby improving operability.

[0058] Preferably, the material of the coating is any one of gold, platinum-iridium and tantalum.

[0059] Preferably, the thickness of the plastic component is 40-50 μm, for example, it can be 40 μm, 41 μm, 42 μm, 43 μm, 44 μm, 45 μm, 46 μm, 47 μm, 48 μm, 49 μm, or 50 μm, but is not limited to the listed values, and other unlisted values ​​within this numerical range are also applicable.

[0060] In the present invention, the thickness of the plastic component is preferably 40 to 50 μm. Within this range, the operation effect can be better. The thickness is not limited to this range, and those skilled in the art can make adaptive adjustments according to actual conditions.

[0061] As a preferred technical solution of the present invention, the material of the developing component includes an organic polymer and a doped material doped in the organic polymer.

[0062] It should be noted that the developing component in the present invention must have a certain developing property so that the advancement of the bent supporting catheter in the blood vessel can be seen.

[0063] Preferably, the doping amount of the doped material is 20-40%, for example, it can be 20%, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, but it is not limited to the listed values, and other unlisted values ​​within this numerical range are also applicable.

[0064] In the present invention, the doping amount of the doped material is preferably 20-40%. Within this range, the operation effect can be better. The present invention is not limited to this range, and those skilled in the art can make adaptive adjustments according to actual conditions.

[0065] Preferably, the doping material is any one of tungsten, bismuth oxide and BaSO4.

[0066] Preferably, the material of the organic polymer is the same as that of the coating layer.

[0067] Preferably, one end of the head end member away from the sheath member is a tapered structure.

[0068] It should be noted that the head end component in the present invention is flexible and can avoid damaging the blood vessels when tortuous blood vessels.

[0069] Preferably, the cone angle of the conical structure is 3 to 30°, for example, it can be 3°C, 5°C, 7°C, 10°C, 14°C, 16°C, 18°C, 20°C, 22°C, 24°C, 26°C, 28°C, 30°C, but it is not limited to the listed values. Other unlisted values ​​within this numerical range are also applicable, and it is more preferably 10 to 20°.

[0070] In the present invention, the cone angle of the conical structure is preferably 3 to 30 degrees. Within this range, the operation effect can be better. The present invention is not limited to this range. Those skilled in the art can make adaptive adjustments according to actual conditions.

[0071] As a preferred technical solution of the present invention, the material of the sheath component is any one of nylon-11, nylon-12 and polyetheramide.

[0072] Preferably, the sheath member is a hollow cylindrical structure.

[0073] It should be noted that the sheath component of the present invention is combined with one end of the support component by melt reflow welding or bonding process, so that the support conduit as a whole has greater stability.

[0074] As a preferred technical solution of the present invention, the first connecting member is a Luer connector, one end of the first connecting member is used to be connected to the instrument, and the other end is detachably connected to the supporting member.

[0075] It should be noted that the detachable connection in the present invention can be a bolt connection, a bayonet connection, etc. Those skilled in the art should know that any detachable connection method that meets the requirements of the present invention is within the scope of protection of the present invention.

[0076] Preferably, the first connecting member is made of any one of polyetheramide, polyethylene, polycarbonate and polypropylene.

[0077] As a preferred technical solution of the present invention, the material of the liner core is any one of nylon-11, nylon-12 and polyetheramide.

[0078] Preferably, one end of the lining core away from the second connecting member is a tapered structure or is provided with a cutout.

[0079] Preferably, the conical angle of the conical structure is 30 to 45°, for example, it can be 30°C, 31°C, 32°C, 33°C, 34°C, 35°C, 36°C, 37°C, 38°C, 39°C, 40°C, 42°C, or 45°C, but is not limited to the listed values, and other unlisted values ​​within this numerical range are also applicable.

[0080] In the present invention, the preferred cone angle of the cone structure is 30-45°. Within this range, the operation effect can be better. The invention is not limited to this range, and those skilled in the art can make adaptive adjustments according to actual conditions.

[0081] As a preferred technical solution of the present invention, the second connecting member and the lining core are bonded.

[0082] It should be noted that the reason why the second connecting member and the liner core are combined by bonding in the present invention is to facilitate the movable connection between the two, and the movable connection can be the extension and withdrawal between the two.

[0083] Preferably, the second connecting member is made of any one of polyetheramide, polyethylene, polycarbonate and polypropylene.

[0084] Compared with the prior art, the present invention has the following beneficial effects:

[0085] In the present invention, the support catheter provided improves the practicality of the support catheter by configuring a bendable liner core in conjunction with a support member, a sheath member, a first connecting member, and a second connecting member. Doctors can adjust the curvature according to actual clinical conditions, and the catheter is particularly suitable for the treatment of tortuous vascular occlusive diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0086] Figure 1 A schematic structural diagram of a support conduit provided in accordance with a specific embodiment of the present invention;

[0087] Figure 2 A schematic structural diagram of the connection between the second connecting member and the liner core in a support conduit provided in a specific embodiment of the present invention;

[0088] Figure 3 A schematic structural diagram of a support member in a support conduit provided in a specific embodiment of the present invention;

[0089] Figure 4 A cross-sectional view of a support conduit provided in accordance with one embodiment of the present invention;

[0090] Figure 5 A schematic diagram of the structure of a plastic component provided in a specific embodiment of the present invention Figure 1 ;

[0091] Figure 6 A schematic diagram of the structure of a plastic component provided in a specific embodiment of the present invention Figure 2 ;

[0092] Among them, 1-support member; 11-main member; 12-plastic member; 13-coating layer; 14-head end member; 111-flexible lining pipe; 112-first bonding layer; 113-rigid support layer; 114-second bonding layer; 115-braided layer; 116-polymer packaging material; 117-longitudinal support wire;

[0093] 2-sheath member; 3-first connecting member; 4-core liner; 5-second connecting member. DETAILED DESCRIPTION

[0094] It should be understood that, in the description of the present invention, the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, features defined as "first", "second", etc. may explicitly or implicitly include one or more of such features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0095] It should be noted that, in the description of the present invention, unless otherwise expressly specified or limited, the terms "disposed," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integral connections; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0096] Those skilled in the art should understand that the present invention must include necessary pipelines, conventional valves and general pump equipment for realizing a complete process, but the above content does not belong to the main invention point of the present invention. Those skilled in the art can add layouts on their own based on the process flow and equipment structure selection, and the present invention does not make special requirements and specific limitations on this.

[0097] The technical solution of the present invention will be further described below with reference to the accompanying drawings and through specific implementation methods.

[0098] The present invention provides a flexible support conduit, such as Figures 1 to 6As shown, the supporting conduit includes a supporting member 1, a sheath member 2, a first connecting member 3, a second connecting member 5 and a lining core 4. One end of the sheath member 2 is sleeved on one end of the supporting member 1, and the other end of the sheath member 2 is detachably connected to the first connecting member 3. One end of the lining core 4 is detachably connected to the second connecting member 5, and the other end is inserted into the supporting member 1, and the lining core 4 is bendable.

[0099] In the present invention, the support catheter provided by the invention utilizes a flexible core 4 in conjunction with a support member 1, a sheath member 2, a first connecting member 3, and a second connecting member 5, thereby enhancing its practicality. Physicians can adjust the curvature of the catheter based on clinical needs, making it particularly suitable for treating occlusive diseases of tortuous vessels. It should be noted that the support catheter of the present invention can be used to treat occlusive diseases caused by thrombosis, embolism, atherosclerosis, and other causes.

[0100] The support member 1 is a tubular structure comprising a main member 11, one end of which is connected to the first connecting member 3, and the other end of which is provided with a plastic member 12 and a head end member 14 in sequence in a direction away from the first connecting member 3. The main member 11 comprises a pipeline and a composite layer provided on the outer surface of the pipeline. The plastic member 12 is sleeved on the surface of the composite layer, and a coating layer 13 is provided on the surface of the plastic member 12 away from the composite layer. It should be noted that the coating layer 13 in the present invention can provide a smooth surface and natural rheology. The head end member 14 comprises a developing component, which is sleeved on the surface of the composite layer. The pipeline is a flexible lining pipeline 111. The composite layer is any one or a combination of two or more of a first adhesive layer 112, a rigid support layer 113, a second adhesive layer 114, a braided layer 115, a longitudinal support wire 117, and a polymer coating material 116. The coating layer 13 is made of the same material as the polymer coating material 116.

[0101] The main body member 11 has a length of 60 to 160 cm. The flexible lining pipe 111 is made of any one of polytetrafluoroethylene, polyetheretherketone, fluorinated ethylene propylene copolymer, and ethylene-tetrafluoroethylene copolymer, preferably polytetrafluoroethylene. The surface of the flexible lining pipe 111 is modified by etching with sodium naphthalene and plasma treatment. It should be noted that the surface of the flexible lining pipe 111 in the present invention is modified during use, primarily to impart good hydrophilic properties to the treated lining.

[0102] The material of the first adhesive layer 112 can be any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber, nylon, and a fluorine-containing adhesive. It should be noted that in the present invention, the first adhesive layer 112 effectively connects the flexible liner 111 to the rigid support layer 113; the material of the rigid support layer 113 can be polyimide or stainless steel. It should be noted that in the present invention, the rigid support layer 113 can further enhance the overall support strength of the catheter.

[0103] The material of the second adhesive layer 114 is any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber and nylon, and further nylon. The material of the braided layer 115 is any one of stainless steel, nickel titanium and polymer monofilament. The braided layer 115 includes braided wire, and the shape of the braided wire is round wire or flat wire. It should be noted that the shape of the handle of the braided wire in the present invention is limited to round wire or flat wire. As long as it can be used for the preparation of the braided layer in this application, it is within the scope of protection of the present invention, and those skilled in the art should know it. The braiding density of the braided layer 115 is 60 to 120 PPI, and there are 1 to 8 longitudinal support wires 117, which are evenly arranged in a circle. The material of the polymer packaging material 116 is any one of nylon-11, nylon-12 and polyetheramide.

[0104] The thickness of the flexible lining pipe 111 is 15-20 μm, the thickness of the first adhesive layer 112 is 5-10 μm, the thickness of the rigid support layer 113 is 40-50 μm, the inner diameter of the longitudinal support wire 117 is 0.01-0.1 mm, the thickness of the polymer packaging material 116 is 50-150 μm, and the thickness of the coating layer 13 is 20-30 μm.

[0105] The plastic component 12 is bendable, and the bending angle of the plastic component 12 is 0 to 60 degrees. The material of the plastic component 12 is any one of stainless steel, titanium and nickel. The plastic component 12 needs to be annealed, and the annealing temperature is 500 to 1100°C. The surface of the plastic component 12 is provided with a coating, and the material of the coating is any one of gold, platinum iridium and tantalum. The thickness of the plastic component 12 is 40 to 50 μm.

[0106] The material of the developing component includes an organic polymer and a doped material doped in the organic polymer. It should be noted that the developing component in the present invention must have a certain degree of developing properties to allow visualization of the advancement of the support catheter within the blood vessel after bending. The doping level of the doped material is 20-40%. The doped material is any one of tungsten, bismuth oxide, and BaSO4. The organic polymer is made of the same material as the coating layer 13. The end of the head end member 14 away from the sheath member 2 has a conical structure. The cone angle of the conical structure is 3-30°.

[0107] The sheath member 2 is made of any of nylon-11, nylon-12, and polyetheramide and has a hollow cylindrical structure. The first connecting member 3 is a Luer connector, one end of which is used to connect to the device and the other end is detachably connected to the support member 1. It should be noted that the detachable connection in the present invention can be a bolt connection, a bayonet connection, or other methods. Those skilled in the art will recognize that any detachable connection method that meets the requirements of the present invention is within the scope of protection of the present invention.

[0108] The first connecting member 3 is made of any one of polyetheramide, polyethylene, polycarbonate, and polypropylene. The core liner 4 is made of any one of nylon 11, nylon 12, and polyetheramide. The end of the core liner 4 facing away from the second connecting member 5 has a tapered structure or a cutout, with the tapered angle ranging from 30 to 45 degrees. The second connecting member 5 is bonded to the core liner 4 and is made of any one of polyetheramide, polyethylene, polycarbonate, and polypropylene.

[0109] Example 1

[0110] This embodiment provides a bendable support conduit, wherein:

[0111] The supporting catheter includes a supporting member 1, a sheath member 2, a first connecting member 3, a second connecting member 5 and a lining core 4. One end of the sheath member 2 is sleeved on one end of the supporting member 1, and the other end of the sheath member 2 is detachably connected to the first connecting member 3. One end of the lining core 4 is detachably connected to the second connecting member 5, and the other end is inserted into the supporting member 1, and the lining core 4 is bendable.

[0112] The support member 1 is a tubular structure. The support member 1 includes a main member 11. One end of the main member 11 is connected to the first connecting member 3, and the other end is provided with a plastic member 12 and a head end member 14 in sequence in a direction away from the first connecting member 3. The main member 11 includes a pipeline and a composite layer provided on the outer surface of the pipeline. The plastic member 12 is sleeved on the surface of the composite layer, and a coating layer 13 is provided on the surface of the plastic member 12 away from the composite layer. The head end member 14 includes a developing component, which is sleeved on the surface of the composite layer. The pipeline is a flexible lining pipeline 111. The composite layer is, in sequence, a first adhesive layer 112, a rigid support layer 113, a second adhesive layer 114, a braided layer 115, a longitudinal support wire 117, and a polymer packaging material 116. The material of the coating layer 13 is the same as that of the polymer packaging material 116.

[0113] The length of the main component 11 is 60 cm. The material of the flexible lining pipe 111 is polytetrafluoroethylene. The surface of the flexible lining pipe 111 is modified by sodium naphthalene etching.

[0114] The first adhesive layer 112 is made of ethylene-vinyl acetate copolymer. The rigid support layer 113 is made of polyimide. The second adhesive layer 114 is made of ethylene-vinyl acetate copolymer. The braided layer 115 is made of stainless steel and includes round braided wires. The braiding density of the braided layer 115 is 60 PPI. Three longitudinal support wires 117 are provided, evenly spaced around the circumference. The polymer packaging material 116 is made of nylon 11.

[0115] The thickness of the flexible lining pipe 111 is 15 μm, the thickness of the first adhesive layer 112 is 5 μm, the thickness of the rigid support layer 113 is 40 μm, the inner diameter of the longitudinal support wire 117 is 0.01 mm, the thickness of the polymer packaging material 116 is 50 μm, and the thickness of the coating layer 13 is 20 μm.

[0116] The plastic member 12 is bendable with a bending angle of 20°. The plastic member 12 is made of stainless steel and needs to be annealed at a temperature of 1100° C. The surface of the plastic member 12 is provided with a gold coating with a thickness of 40 μm.

[0117] The developing component is made of an organic polymer and a doped material doped in the organic polymer. The doping level of the doped material is 20%. The doped material is tungsten. The organic polymer is made of the same material as the coating layer 13. The end of the head member 14 away from the sheath member 2 has a conical structure. The cone angle of the conical structure is 3°.

[0118] The sheath member 2 is made of nylon-11 and is a hollow cylindrical structure. The first connecting member 3 is a Luer connector, one end of which is used to connect to the instrument, and the other end is detachably connected to the support member 1.

[0119] The first connecting member 3 is made of polyetheramide. The core liner 4 is made of nylon 11. The end of the core liner 4 facing away from the second connecting member 5 is tapered at a 30° angle. The second connecting member 5 is bonded to the core liner 4 and is made of polyetheramide.

[0120] Example 2

[0121] This embodiment provides a bendable support conduit, wherein:

[0122] The supporting catheter includes a supporting member 1, a sheath member 2, a first connecting member 3, a second connecting member 5 and a lining core 4. One end of the sheath member 2 is sleeved on one end of the supporting member 1, and the other end of the sheath member 2 is detachably connected to the first connecting member 3. One end of the lining core 4 is detachably connected to the second connecting member 5, and the other end is inserted into the supporting member 1, and the lining core 4 is bendable.

[0123] The support member 1 is a tubular structure. The support member 1 includes a main member 11. One end of the main member 11 is connected to the first connecting member 3, and the other end is provided with a plastic member 12 and a head end member 14 in sequence in a direction away from the first connecting member 3. The main member 11 includes a pipeline and a composite layer provided on the outer surface of the pipeline. The plastic member 12 is sleeved on the surface of the composite layer, and a coating layer 13 is provided on the surface of the plastic member 12 away from the composite layer. The head end member 14 includes a developing component, which is sleeved on the surface of the composite layer. The pipeline is a flexible lining pipeline 111. The composite layer is a first adhesive layer 112, a rigid support layer 113, a braided layer 115, a longitudinal support wire 117 and a polymer packaging material 116 in sequence. The material of the coating layer 13 is the same as that of the polymer packaging material 116.

[0124] The length of the main component 11 is 100 cm. The material of the flexible lining pipe 111 is polyetheretherketone. The surface of the flexible lining pipe 111 is modified by plasma treatment.

[0125] The first adhesive layer 112 is made of thermoplastic polyurethane elastomer rubber. The rigid support layer 113 is made of stainless steel. The braided layer 115 is made of nickel-titanium and includes flat braided wires. The braid density of the braided layer 115 is 100 PPI. Five longitudinal support wires 117 are provided, evenly spaced around the circumference. The polymer packaging material 116 is made of nylon-12.

[0126] The thickness of the flexible lining pipe 111 is 18 μm, the thickness of the first adhesive layer 112 is 8 μm, the thickness of the rigid support layer 113 is 45 μm, the inner diameter of the longitudinal support wire 117 is 0.05 mm, the thickness of the polymer packaging material 116 is 100 μm, and the thickness of the coating layer 13 is 25 μm.

[0127] The plastic component 12 is bendable, and the bending angle of the plastic component 12 is 30°. The material of the plastic component 12 is titanium. The plastic component 12 needs to be annealed, and the annealing temperature is 550°C. The surface of the plastic component 12 is provided with a coating, and the material of the coating is platinum-iridium. The thickness of the plastic component 12 is 45μm.

[0128] The developing component is made of an organic polymer and a doped material doped in the organic polymer. The doping level of the doped material is 30%. The doped material is bismuth oxide. The organic polymer is made of the same material as the coating layer 13. The end of the head member 14, away from the sheath member 2, has a conical structure. The cone angle of the conical structure is 20°.

[0129] The sheath member 2 is made of nylon-12 and is a hollow cylindrical structure. The first connecting member 3 is a Luer connector, one end of which is used to connect to the instrument, and the other end is detachably connected to the support member 1.

[0130] The first connecting member 3 is made of polyethylene. The liner core 4 is made of nylon-12. A notch is provided at one end of the liner core 4 away from the second connecting member 5. The second connecting member 5 is bonded to the liner core 4 and is made of polyethylene.

[0131] Example 3

[0132] This embodiment provides a bendable support conduit, wherein:

[0133] The supporting catheter includes a supporting member 1, a sheath member 2, a first connecting member 3, a second connecting member 5 and a lining core 4. One end of the sheath member 2 is sleeved on one end of the supporting member 1, and the other end of the sheath member 2 is detachably connected to the first connecting member 3. One end of the lining core 4 is detachably connected to the second connecting member 5, and the other end is inserted into the supporting member 1, and the lining core 4 is bendable.

[0134] The support member 1 is a tubular structure. The support member 1 includes a main member 11. One end of the main member 11 is connected to the first connecting member 3, and the other end is provided with a plastic member 12 and a head end member 14 in sequence in a direction away from the first connecting member 3. The main member 11 includes a pipeline and a composite layer provided on the outer surface of the pipeline. The plastic member 12 is sleeved on the surface of the composite layer, and a coating layer 13 is provided on the surface of the plastic member 12 away from the composite layer. The head end member 14 includes a developing component, which is sleeved on the surface of the composite layer. The pipeline is a flexible lining pipeline 111. The composite layers are, in sequence, a first adhesive layer 112, a rigid support layer 113, a second adhesive layer 114, and a polymer packaging material 116. The material of the coating layer 13 is the same as that of the polymer packaging material 116.

[0135] The length of the main component 11 is 160 cm. The material of the flexible lining pipe 111 is fluorinated ethylene propylene copolymer. The surface of the flexible lining pipe 111 is modified by plasma treatment.

[0136] The first adhesive layer 112 is made of nylon, the rigid support layer 113 is made of polyimide, the second adhesive layer 114 is made of nylon, and the polymer packaging material 116 is made of polyetheramide.

[0137] The thickness of the flexible lining pipe 111 is 20 μm, the thickness of the first adhesive layer 112 is 10 μm, the thickness of the rigid support layer 113 is 50 μm, the thickness of the polymer packaging material 116 is 150 μm, and the thickness of the coating layer 13 is 30 μm.

[0138] The plastic component 12 is bendable, and the bending angle of the plastic component 12 is 60°. The material of the plastic component 12 is stainless steel. The plastic component 12 needs to be annealed, and the annealing temperature is 1100°C. The surface of the plastic component 12 is provided with a coating, and the material of the coating is tantalum. The thickness of the plastic component 12 is 50μm.

[0139] The developing component is made of an organic polymer and a doped material doped in the organic polymer. The doping level of the doped material is 40%. The doped material is BaSO4. The organic polymer is made of the same material as the coating layer 13. The end of the head end member 14, away from the sheath member 2, has a conical structure. The cone angle of the conical structure is 30°.

[0140] The sheath member 2 is made of polyetheramide and is a hollow cylindrical structure. The first connecting member 3 is a Luer connector, one end of which is used to connect to the instrument, and the other end is detachably connected to the support member 1.

[0141] The first connecting member 3 is made of polypropylene. The core liner 4 is made of polyetheramide. The end of the core liner 4 facing away from the second connecting member 5 is tapered at a 45° angle. The second connecting member 5 is bonded to the core liner 4 and is made of polypropylene.

[0142] Example 4

[0143] This embodiment provides a bendable support conduit. The difference from the first embodiment is that the thickness of the plastic component 12 is 30 μm. Other parameters and conditions are the same as those of the first embodiment.

[0144] Example 5

[0145] This embodiment provides a bendable support conduit. The difference from the first embodiment is that the thickness of the plastic component 12 is 55 μm. Other parameters and conditions are the same as those of the first embodiment.

[0146] The flexibility of the supporting catheter in Examples 1-3 is better than that in Examples 4 and 5 because the thickness of the plastic component 12 in the present invention is 40 to 50 μm, and the shaping component is less than 40 μm, so the shaping component is easily bent under force; if the shaping component is greater than 50 μm, the maximum outer diameter of the pipe will be too large, affecting the passability of the catheter.

[0147] The above description is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention fall within the protection scope and disclosure scope of the present invention.

Claims

1. A flexible support catheter, characterized in that: The support conduit comprises a support member, a sheath member, a first connecting member, a second connecting member and a liner core, wherein one end of the sheath member is sleeved on one end of the support member, and the other end of the sheath member is detachably connected to the first connecting member; one end of the liner core is detachably connected to the second connecting member, and the other end is inserted into the support member, and the liner core is bendable; The support member is a tubular structure, comprising a main body member, one end of the main body member being connected to the first connecting member, and the other end of the main body member being provided with a plastic member and a head end member in sequence in a direction away from the first connecting member. The main body member comprises a pipeline and a composite layer provided on the outer surface of the pipeline, the plastic member being sleeved on the surface of the composite layer, and a coating layer being provided on the surface of the plastic member away from the composite layer. The head end component includes a developing component, and the developing component is sleeved on the surface of the composite layer; The plastic component is bendable, and a bending angle of the plastic component is 0-60°.

2. The support catheter according to claim 1, wherein: The pipeline is a flexible lined pipeline.

3. The support catheter according to claim 2, characterized in that The composite layer is any one or a combination of two or more of a first bonding layer, a rigid support layer, a second bonding layer, a braided layer, a longitudinal support wire and a polymer packaging material.

4. The support catheter according to claim 3, characterized in that The material of the coating layer is the same as that of the polymer packaging material.

5. The support catheter according to claim 3, characterized in that The length of the main component is 60 to 160 cm.

6. The support catheter according to claim 5, characterized in that The material of the flexible lining pipe is any one of polytetrafluoroethylene, polyetheretherketone, fluorinated ethylene propylene copolymer and ethylene-tetrafluoroethylene copolymer.

7. The support conduit according to claim 6, characterized in that The material of the flexible lining pipeline is polytetrafluoroethylene.

8. The support catheter according to claim 5, characterized in that The surface of the flexible lining pipeline is modified.

9. The support catheter according to claim 8, characterized in that The modification treatment includes sodium naphthalene etching and plasma treatment.

10. The support catheter according to claim 5, characterized in that The material of the first adhesive layer is any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber, nylon and fluorine-containing adhesive.

11. The support catheter according to claim 5, characterized in that The rigid support layer is made of polyimide or stainless steel.

12. The support catheter according to claim 5, characterized in that The second adhesive layer is made of any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber and nylon.

13. The support catheter according to claim 5, characterized in that The second adhesive layer is made of nylon.

14. The support catheter according to claim 5, characterized in that The material of the braided layer is any one of stainless steel, nickel titanium and polymer monofilament.

15. The support catheter according to claim 5, characterized in that The braided layer includes braided wires, and the braided wires are in the shape of round wires or flat wires.

16. The support catheter according to claim 15, characterized in that The braiding density of the braided layer is 60-120 PPI.

17. The support catheter according to claim 5, characterized in that There are 1 to 8 longitudinal support wires.

18. The support catheter according to claim 17, characterized in that The longitudinal support wires are evenly arranged in a circumference.

19. The support catheter according to claim 5, characterized in that The polymer packaging material is made of any one of nylon-11, nylon-12 and polyetheramide.

20. The support catheter according to claim 3, characterized in that The thickness of the flexible lining pipeline is 15 to 20 μm.

21. The support catheter according to claim 3, characterized in that The thickness of the first adhesive layer is 5 to 10 μm.

22. The support catheter according to claim 3, characterized in that The thickness of the rigid support layer is 40-50 μm.

23. The support catheter according to claim 3, characterized in that The inner diameter of the longitudinal support wire is 0.01-0.1 mm.

24. The support catheter according to claim 3, characterized in that The thickness of the polymer packaging material is 50 to 150 μm.

25. The support catheter according to claim 3, characterized in that The coating layer has a thickness of 20 to 30 μm.

26. The support catheter according to claim 1, characterized in that The plastic component is made of any one of stainless steel, titanium and nickel.

27. The support catheter according to claim 1, wherein The plastic component needs to be annealed.

28. The support catheter according to claim 27, characterized in that The temperature of the annealing treatment is 500-1100°C.

29. The support catheter according to claim 1, wherein The surface of the plastic component is provided with a plating layer.

30. The support catheter according to claim 29, wherein The material of the coating is any one of gold, platinum, iridium and tantalum.

31. The support catheter according to claim 1, wherein The plastic component has a thickness of 40 to 50 μm.

32. The support catheter according to claim 1, wherein The material of the developing component includes an organic polymer and a doped material doped in the organic polymer.

33. The support catheter according to claim 32, characterized in that The doping amount of the doping material is 20-40%.

34. The support catheter according to claim 33, wherein: The doping material is any one of tungsten, bismuth oxide and BaSO4.

35. The support catheter according to claim 34, characterized in that The material of the organic polymer is the same as that of the coating layer.

36. The support catheter according to claim 35, characterized in that One end of the head end component away from the sheath component is a tapered structure.

37. The support catheter according to claim 36, characterized in that The cone angle of the conical structure is 3 to 30 degrees.

38. The support catheter according to claim 37, characterized in that The cone angle of the conical structure is 10-20 degrees.

39. The support catheter according to claim 1, wherein The material of the sheath component is any one of nylon-11, nylon-12 and polyetheramide.

40. The support catheter according to claim 39, wherein The sheath component is a hollow cylindrical structure.

41. The support catheter according to claim 1, wherein The first connecting member is a Luer connector, one end of the first connecting member is used to be connected to the instrument, and the other end is detachably connected to the supporting member.

42. The support catheter according to claim 41, characterized in that The first connecting member is made of any one of polyetheramide, polyethylene, polycarbonate and polypropylene.

43. The support catheter according to claim 1, characterized in that The material of the lining core is any one of nylon-11, nylon-12 and polyetheramide.

44. The support catheter according to claim 43, characterized in that One end of the lining core away from the second connecting member is a tapered structure or is provided with a cutout.

45. The support catheter according to claim 44, characterized in that The tapered angle of the tapered structure is 30-45°.

46. ​​The support catheter according to claim 1, characterized in that The second connecting member is bonded to the lining core.

47. The support catheter according to claim 46, characterized in that The second connecting member is made of any one of polyetheramide, polyethylene, polycarbonate and polypropylene.

Citation Information

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