Interventional operation sheathing canal capable of automatically adjusting bending and preparation method

By using a combination of worm and gear in the interventional sheath, the independent bending function of the sheath is achieved, solving the problem of difficult control of the existing sheath bend, and improving the accuracy and efficiency of the surgery.

CN119770827APending Publication Date: 2025-04-08HUNAN BANTUO MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202411328479.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-09-23
Publication Date
2025-04-08

AI Technical Summary

Technical Problem

The existing interventional sheath is difficult to control during the operation, which affects the accuracy and safety of the operation.

Method used

An interventional surgery can automatically bend the sheath. Through the precise fit of the worm and gear, doctors can accurately control the bending angle and length of the sheath to accommodate different anatomical structures.

Benefits of technology

It improves the accuracy and success rate of the surgery, reduces the number of times the sheath is replaced during the surgery, shortens the operation time, and reduces medical costs.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention provides an interventional operation sheathing canal capable of automatically adjusting bending and a preparation method, the interventional operation sheathing canal comprises a sheathing canal, the sheathing canal comprises a canal body, a traction system and a handle, the canal body is composed of an inner layer, a middle layer and an outer layer, the middle layer is provided with a metal reinforcing layer, the traction system comprises a traction wire, a far-end connecting piece and a near-end connecting piece, the preparation of the sheath tube comprises the following steps: S1, selecting block polyether amide as a raw material to prepare an inner layer material, a traction guide wire material and an outer layer material, and preparing a tube body through an injection molding process; s2, assembling the handle and the tube body; s3, connecting a traction wire pre-embedded in the sheath tube body in advance with the traction part of the handle; and S4, testing the performance of the product. The sheath tube capable of automatically adjusting the bending has the capability of adjusting the deviation angle in real time, and a doctor can carry out immediate adjustment according to the actual condition of a patient in an operation, so that the optimal operation effect is achieved.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an interventional surgery sheath tube that can be automatically adjusted to bend, and also to a method for preparing an interventional surgery sheath tube that can be automatically adjusted to bend. Background Art

[0002] Interventional sheaths are mainly used to guide guidewires and catheters into blood vessels or other body channels and provide a temporary path for subsequent catheter operations. Interventional sheaths can help doctors perform operations more safely, reduce damage to the blood vessel wall, and provide additional support when needed.

[0003] Existing interventional sheaths are difficult to control during surgery because of their bending. For example, when inserting a catheter, doctors need to constantly adjust the catheter's bending state to adapt to the direction of the diseased tissue, which affects the accuracy and safety of the surgery. Therefore, developing a technology that can autonomously control the sheath's bending is of great significance to the success rate of interventional surgery and the patient's recovery speed. Summary of the invention

[0004] In view of the deficiencies in the prior art, the purpose of the present invention is to provide an interventional surgery sheath that can be automatically bent, which has a simple structure, is widely used, is suitable for a variety of interventional surgeries, and increases the adaptability of the surgery; the curvature of the sheath can be autonomously adjusted through in vitro operation to make it better adapt to the patient's anatomical structure, thereby improving the accuracy and success rate of the surgery; the number of times the sheath needs to be replaced during surgery is reduced, the operation time is shortened, and the operation efficiency is improved.

[0005] Another object of the present invention is to provide a method for preparing an interventional surgery sheath tube that can be automatically bent. The method is easy to implement, convenient to operate, simple in design, easy to produce and maintain, and simplifies the surgical operation process; reduces medical costs and alleviates the economic burden on patients. To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0006] A self-bending sheath tube for interventional surgery comprises a tube body, a connecting module, a handle shell, a worm, a gear, a limiting pressure rod, a gear grip, and a negative pressure sliding device. The tube body has a hard section at one end close to the connecting module and a soft section at the other end. The tube body is provided with an inner wall inside and an outer wall outside. An upper end traction guide wire passage is provided between the outer wall and the inner wall. The connecting module is fixedly connected to the handle shell, the hard section of the tube body is fixedly connected to the handle shell, the worm is arranged in the handle shell and connected to the traction wire, there are two gears which are arranged in the handle shell and mesh with each other, one of the gears meshes with the worm, and the other gear is fixedly connected to the gear grip, the limiting pressure rod is fixedly connected to the inside of the handle shell, and the negative pressure sliding device is arranged in the gear grip.

[0007] Among them, the key components include: ① Tube body: divided into a hard section and a soft section, the hard section provides support, and the soft section allows bending to adapt to different vascular paths; ② Connection module: connects the tube body and the handle shell to ensure the stability of the overall structure; ③ Worm: connected to the traction wire, the bending of the sheath is adjusted by rotating the worm; ④ Gear: There are two gears, which mesh with each other, one meshes with the worm, and the other is fixedly connected to the gear handle for transmitting torque.

[0008] Through the precise coordination of the worm and gear, doctors can precisely control the bending angle and length of the sheath to adapt to different anatomical structures;

[0009] While ensuring that the traction system has sufficient tensile strength and fatigue strength, the wall thickness of the sheath should be reduced as much as possible to reduce damage to the blood vessels;

[0010] Plastic materials of different hardness are combined together through hot melt lamination technology to ensure the overall performance and durability of the sheath.

[0011] A method for preparing a sheath tube capable of automatically adjusting the bending direction for interventional surgery, the preparation of the sheath tube comprising the following steps:

[0012] S1. Use block polyetheramide as raw material to prepare the inner layer, traction guide wire and outer layer material, and prepare the tube body by injection molding process;

[0013] S2. Assemble the handle and the tube body;

[0014] S3. Connect the traction wire pre-buried in the sheath tube body to the traction part of the handle;

[0015] S4.Perform performance tests on products.

[0016] Preferably, in step S1, block polyetheramide is selected as the raw material to prepare the inner layer, the traction guide wire and the outer layer material, and the tube body is prepared by injection molding. The specific preparation process is as follows:

[0017] 1) Drying the block polyether amide in a vacuum oven at a temperature between 60 and 80° C. for 8 to 12 hours;

[0018] 2) feeding the block polyether amide into an injection molding machine, and the injection molding parameters are: residence time less than 10 minutes, injection volume per mold 20%-80%, and compression ratio 2-2.8;

[0019] 3) The stainless steel wire is prepared into a closely wound constant pitch spring by mechanical processing, wherein the quenching heating temperature is between 800 and 850° C., the tempering temperature is between 330 and 520° C., and the hardness after heat treatment is finally maintained between HRC45 and 49;

[0020] 4) Select nickel-titanium alloy wire to prepare the traction wire, perform pretreatment of cleaning and annealing on the traction wire, and in the process of manufacturing the tube body, use a co-extrusion process to embed the traction wire into the tube body while extruding the tube body, so that the traction wire is embedded in the tube body;

[0021] 5) During the injection molding process, the position of the densely wound constant pitch spring on the sheath is accurately controlled, placed between the inner and outer layers of the sheath, and the passage of the traction wire is kept unobstructed;

[0022] 6) Use according to Figure 1 The standard design mold shown, the parting line difference must be controlled within 0.02mm. The size range of the adjustable bending sheath tube is 6.5F~25F, and the wall thickness is 0.45~0.7mm.

[0023] Pretreatment of the traction wire can ensure its compatibility with the sheath material and biocompatibility.

[0024] Preferably, the handle and the tube body are assembled in step S2, and the specific assembly process is as follows:

[0025] 1) According to Figure 1 Assemble the handle as shown;

[0026] 2) Use a hot plate welding machine to weld the handle and sheath tube body. The heating temperature is about 230-250°C and the heating time is 1-2 hours to ensure that the material is completely melted and the welding interface reaches a viscous flow state. After heating at 230°C for 30 minutes, a certain amount of pressure needs to be applied to the welding interface to ensure that the materials are fully in contact and bonded in the molten state. The pressure is about 200MPa. After that, it needs to be cooled to room temperature to solidify from the molten state. The curing time is about 5-8 hours;

[0027] 3) Connect with the proximal part to ensure that all parts fit well.

[0028] Preferably, in step S3, the traction wire pre-buried in the sheath body is connected to the traction part of the handle, and the specific connection process is as follows:

[0029] One end of the traction wire is usually fixed to the distal soft section of the tube body, and the other end needs to be connected to a worm inside an operating handle, in the middle at the connection between the handle and the sheath body; wherein, the diameter of the traction wire is between 0.01mm and 0.5mm, depending on the length and diameter of the sheath body. The length of the traction wire is about 40 to 50cm, and the length inside the sheath body is 30cm.

[0030] A limit pressure rod is used at the connection between the handle and the sheath tube body to adjust the telescopic length of the traction wire so as to perform precise angle control during surgery.

[0031] The performance test of the product in step S4 includes the test of tensile strength, fatigue strength and bending properties.

[0032] The quality of medical device products can be ensured by performing performance testing on the products.

[0033] The tube body is differentiated into multiple sections of hardness, that is, the front end of the tube body is a soft section, and the rear end of the tube body is a hard section.

[0034] The material used for the inner layer includes one or a mixture of two or four (or more) of PTFE, PEBAX, PA, and TPU, and the material for the outer layer is one or a mixture of two or four (or more) of PTFE, PEBAX, PA, and TPU.

[0035] The handle cooperates with the proximal connecting piece, which enables the user to quickly and accurately apply force to the traction system, thereby achieving control and bending of the distal end of the tube body.

[0036] The traction wire is made of any one of stainless steel wire, titanium alloy wire, cobalt-chromium alloy wire and polytetrafluoroethylene wire. The material of the traction wire is selected to have strength and not significantly increase the wall thickness of the sheath tube.

[0037] Among them, the key steps are: Material selection and processing: Block polyetheramide and specially pretreated traction wire are used to improve the performance of the product. Traction wire embedding and connection structure design: While ensuring the thinnest sheath wall thickness, the connection structure design at both ends of the traction wire is completed to improve the efficiency of the traction system. Gear coordination of the handle: The original worm and gear position coordination conforms to the ergonomic design and is easy to use. Connection method between the handle and the tube body: Hot plate welding technology is used to improve the firmness and sealing of the connection.

[0038] The technical effects of the above key steps are:

[0039] 1. Use block polyetheramide as raw material: It is the key to ensure that the tube body has appropriate hardness and flexibility. At the same time, the preparation of the tube body through injection molding process ensures the efficiency and consistency of production.

[0040] 2. Pretreatment and embedding of traction wire: Select appropriate materials (such as nickel-titanium alloy wire) and perform cleaning and annealing pretreatment to ensure compatibility and biocompatibility with the sheath material, and embed it into the tube body through a co-extrusion process. This is the core to achieve effective traction and bending functions.

[0041] 3. Assembly of handle and tube body: Use hot plate welding machine to weld the handle part and sheath tube body to ensure the firmness and sealing of the connection.

[0042] 4. Determination of the bending angle and length range of the bending section: Through precise design and material selection, ensure that the sheath can adapt to different anatomical structures.

[0043] 5. Balance between the strength of the traction system and the wall thickness of the sheath: While ensuring that the traction system has sufficient tensile strength and fatigue strength, the wall thickness of the sheath should be reduced as much as possible to reduce damage to the blood vessels.

[0044] 6. Hot-melt cladding technology for multi-layer pipes: through precise process control, ensure the firm bonding between different material layers.

[0045] 7. Welding technology between plastics of different hardness: Ensure that the welding between plastic materials of different hardness is firm to maintain the structural integrity of the sheath during use.

[0046] An interventional surgery sheath that can autonomously bend is used in cardiovascular interventional surgery, neurointerventional surgery, various endoscopic operations, and precise treatment under the guidance of classified imaging.

[0047] The physical performance data of the self-bending sheath tube for interventional surgery of the present invention mainly include the following aspects:

[0048] project Domestic leading brand performance Product performance Bending angle range (°) 45~120 45~180 Push force(N) 102.90 110.15 Twist control response time(s) 9.25 9.15 Catheter torque (N) - distal end 1.45 1.86 Catheter torque (N) - proximal 4.15 4.59 Fatigue resistance generally excellent

[0049] Working principle: The hardness of the tube body is differentiated into multiple sections. By changing the hardness of different sections, the pushability and anti-bending properties of the sheath can be optimized; the original pull wire and traction system requires the installation of a traction wire or pull wire system inside the sheath, which can be used to adjust the bending angle of the sheath through in vitro operation; the sheath can be autonomously adjusted by the surgeon outside the body, so that the distal end of the catheter can be accurately targeted according to the patient's lesion location, thereby improving the accuracy and safety of the operation.

[0050] Compared with the prior art, the present invention has the following advantages and effects:

[0051] 1. The innovative traction wire pretreatment and embedding technology of the present invention improves the compatibility between the traction wire and the sheath and enhances the effectiveness of the bending adjustment function; the uniquely designed handle driving mode realizes the autonomous bending of the sheath through the precise matching of the worm and the gear; the optimized connection process between the handle and the tube body improves the firmness and reliability of the connection through hot plate welding technology.

[0052] 2. The anatomical structure of each patient may be different, and the advantage of the self-adjustable sheath is that it can be customized according to the individual differences of the patient. The doctor can adjust the sheath according to the patient's specific situation to make it more suitable for the patient's anatomical structure, thereby improving the accuracy of the operation; by precisely controlling the position of the sheath.

[0053] 3. The sheath can be adjusted to bend automatically and can navigate accurately according to the doctor's instructions, guiding the sheath to the target area and reducing damage to surrounding tissues. The doctor can precisely control the sheath by manipulating the controller or using the intelligent navigation system, so that it can be accurately positioned during the operation, reducing damage to surrounding tissues and thus improving the safety of the operation.

[0054] 4. It simplifies the surgical process, reduces the number of times the sheath needs to be replaced during surgery, and shortens the operation time; by providing more precise and controllable surgical tools, it promotes the development and application of minimally invasive surgical techniques. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] Figure 1 This is a schematic diagram of a sheath structure that can be automatically bent during interventional surgery;

[0056] Figure 2 The present invention is a schematic diagram of the tube structure of a sheath tube that can be bent autonomously during interventional surgery.

[0057] Figure 3 This is a schematic diagram of a connection module for an interventional surgery sheath tube that can be automatically bent.

[0058] Figure 4 This is a schematic diagram of a negative pressure sliding device that can automatically adjust the bending sheath tube during interventional surgery.

[0059] Among them, 1. tube body; 101. soft section; 102. hard section; 103. outer wall; 104. inner wall; 105. upper end traction guide wire passage; 2. connection module (product model BT-DYQ-01); 3. handle housing; 4. worm; 5. gear; 6. limit pressure rod; 7. gear grip; 8. negative pressure sliding device (product model BT-DYQ-02). DETAILED DESCRIPTION

[0060] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0061] Embodiment 1:

[0062] like Figure 1-2As shown, an interventional surgery sheath tube with self-bending function is composed of a tube body 1, a connecting module 2, a handle shell 3, a worm 4, a gear 5, a limiting pressure rod 6, a gear handle 7, and a negative pressure sliding device 8. The end of the tube body 1 close to the connecting module 2 is a hard section 102, and the other end of the tube body 1 is a soft section 101. The inside of the tube body 1 is provided with an inner wall 104, and the outside of the tube body 1 is an outer wall 103. An upper end traction guide wire passage 105 is provided between the outer wall 103 and the inner wall 104. The connecting module 2 and the handle shell 3 are fixedly connected. The hard section 102 of the tube body 1 is fixedly connected in the handle shell 3. The worm 4 is arranged in the handle shell 3 and connected to the traction wire. There are two gears 5, which are arranged in the handle shell 3 and meshed with each other. One of the gears 5 is meshed with the worm 4, and the other gear 4 is fixedly connected to the gear handle 7. The limiting pressure rod 6 is fixedly connected to the inside of the handle shell 3, and the negative pressure sliding device 8 is arranged in the gear handle 7.

[0063] Embodiment 2:

[0064] A method for preparing an interventional surgery self-bending sheath tube, comprising a sheath tube, a traction system and a handle, wherein the sheath tube comprises an inner layer, a middle layer and an outer layer, the middle layer has a metal reinforcement layer, the traction system comprises a traction wire, a distal connector and a proximal connector, the handle cooperates with the proximal connector, and the sheath tube preparation comprises the following manufacturing steps:

[0065] S1. Use block polyetheramide as raw material to prepare the inner layer, traction guide wire and outer layer material, and prepare the tube body by injection molding process;

[0066] S2. Assemble the handle and the tube body;

[0067] S3. Connect the traction wire pre-buried in the sheath tube body to the traction part of the handle;

[0068] S4.Perform performance tests on products.

[0069] Reinforcement ribs and traction wires are added to the sheath body design to improve its structural stability and bending performance. The layout and tension of the traction wires are precisely designed to achieve precise bending control. The traction wires can slide freely axially in the tube body.

[0070] The tube body adopts multi-section hardness differentiation, that is, the front end of the tube body is a soft section, and the rear end of the tube body is a hard section.

[0071] The material used for the inner layer includes one or a mixture of two or four (or more) of PTFE, PEBAX, PA, and TPU; the material used for the outer layer is one or a mixture of two or four (or more) of PTFE, PEBAX, PA, and TPU; and the traction wire is made of any one of stainless steel wire, titanium alloy wire, cobalt-chromium alloy wire, and polytetrafluoroethylene wire.

[0072] In step 1, block polyetheramide is selected as the raw material to prepare the inner layer, the traction guide wire and the outer layer material, and the tube body is prepared by injection molding. The specific preparation process is as follows:

[0073] 1) drying the block polyether amide in a vacuum oven at a temperature between 60, 65, 70, 76 or 80° C. for 8, 10, 11 or 12 hours;

[0074] 2) feeding the block polyether amide into an injection molding machine, wherein the injection molding parameters are: residence time less than 10 minutes, injection volume per mold 20 or 30 or 40 or 50 or 60 or 70 or 80%, and compression ratio 2 or 2.4 or 2.8;

[0075] 3) The stainless steel wire is prepared into a close-wound constant pitch spring by mechanical processing, wherein the quenching heating temperature is 800 or 820 or 830 or 840 or 845 or 850° C., the tempering temperature is between 330 or 350 or 390 or 410 or 450 or 480 or 505 or 520° C., and the hardness after heat treatment is finally maintained between HRC45 or 49;

[0076] 4) Select nickel-titanium alloy wire to prepare the traction wire, perform pretreatment of cleaning and annealing on the traction wire, and in the process of manufacturing the tube body, use a co-extrusion process to embed the traction wire into the tube body while extruding the tube body, so that the traction wire is embedded in the tube body;

[0077] 5) During the injection molding process, the position of the densely wound constant pitch spring on the sheath is accurately controlled, placed between the inner and outer layers of the sheath, and the passage of the traction wire is kept unobstructed;

[0078] 6) Use according to Figure 1 The standard design mold shown, the parting line difference must be controlled within 0.02mm. The size range of the adjustable bending sheath tube is 6.5F or 8 or 11 or 16 or 19 or 23 or 25F, and the wall thickness is 0.45 or 0.55 or 0.65 or 0.7mm.

[0079] In step 2, the handle and the tube body are assembled. The specific assembly process is as follows:

[0080] 1) According to Figure 1 Assemble the handle as shown;

[0081] 2) Use a hot plate welding machine to weld the handle and sheath tube body. The heating temperature is about 230, 240, 246 or 250°C. The heating time is 1 or 2 hours to ensure that the material is completely melted and the welding interface reaches a viscous state. After heating to 230°C for 30 minutes, a certain pressure needs to be applied to the welding interface to ensure that the materials are fully in contact and bonded in the molten state. The pressure is about 200MPa. After that, it needs to be cooled and solidified at room temperature to solidify it from the molten state. The curing time is about 5, 6, 7 or 8 hours;

[0082] 3) Connect with the proximal part to ensure that all parts fit well.

[0083] Connect the traction wire pre-buried in the sheath tube body in step 3 to the traction part of the handle. The specific connection process is as follows:

[0084] One end of the traction wire is usually fixed to the distal soft section of the tube body, and the other end needs to be connected to a worm screw inside an operating handle, in the middle of which is the connection between the handle and the sheath body; wherein, the diameter of the traction wire is between 0.01mm and 0.5mm, depending on the length and diameter of the sheath body, the length of the traction wire is approximately 40 or 44 or 48 or 50cm, and the length inside the sheath body is 30cm.

[0085] The performance tests of the product in step 4 include tests of tensile strength, fatigue strength and bending properties.

[0086] An interventional surgery sheath with self-adjustable bending is widely used in cardiovascular interventional surgery, neurointerventional surgery, various endoscopic operations, and precise treatment under the guidance of classified imaging.

[0087] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An interventional surgery sheath tube capable of self-bending, comprising a tube body (1), a connection module (2), a handle housing (3), a worm (4), a gear (5), a limit pressure rod (6), a gear handle (7), and a negative pressure sliding device (8), characterized in that: One end of the tube body (1) connecting module (2) is a hard section (102), and the other end of the tube body (1) is a soft section (101). An inner wall (104) is arranged inside the tube body (1), and an outer wall (103) is arranged outside the tube body (1). An upper end traction wire passage (105) is arranged between the outer wall (103) and the inner wall (104). The connecting module (2) and the handle shell (3) are fixedly connected. The hard section (102) of the tube body (1) is fixedly connected to the handle shell (3). The worm (4) is arranged in the handle shell (3) and connected to the traction wire. There are two gears (5) arranged in the handle shell (3) and meshed with each other. One of the gears 5 meshes with the worm (4), and the other gear (4) is fixedly connected to the gear handle (7). The limit pressure rod (6) is fixedly connected to the inside of the handle shell (3), and the negative pressure sliding device (8) is arranged in the gear handle (7).

2. The method for preparing the self-bending sheath tube for interventional surgery according to claim 1, comprising the following steps: S1. Use block polyetheramide as raw material to prepare the inner layer, traction guide wire and outer layer material, and prepare the tube body by injection molding process; S2. Assemble the handle and the tube body; S3. Connect the traction wire pre-buried in the sheath tube body to the traction part of the handle; S4.Perform performance tests on products.

3. The method for preparing the self-bending sheath tube for interventional surgery according to claim 1, characterized in that: In the step (1), block polyetheramide is selected as the raw material to prepare the inner layer, the traction guide wire and the outer layer material, and the tube body is prepared by injection molding. The specific preparation process is: 1) Drying the block polyether amide in a vacuum oven at a temperature between 60 and 80° C. for 8 to 12 hours; 2) feeding the block polyether amide into an injection molding machine, and the injection molding parameters are: residence time less than 10 minutes, injection volume per mold 20%-80%, and compression ratio 2-2.8; 3) The stainless steel wire is prepared into a closely wound constant pitch spring by mechanical processing, wherein the quenching heating temperature is between 800 and 850° C., the tempering temperature is between 330 and 520° C., and the hardness after heat treatment is maintained between HRC45 and 49; 4) Select nickel-titanium alloy wire to prepare the traction wire, perform pretreatment of cleaning and annealing on the traction wire, and in the process of manufacturing the tube body, use a co-extrusion process to embed the traction wire into the tube body while extruding the tube body, so that the traction wire is embedded in the tube body; 5) During the injection molding process, the position of the densely wound constant pitch spring on the sheath is controlled and placed between the inner layer and the outer layer of the sheath to keep the passage of the traction wire unobstructed; 6) Use the mold designed according to the standard, the parting line difference must be controlled within 0.02mm, the size range of the adjustable bending sheath tube is 6.5F-25F, and the wall thickness is 0.45-0.7mm.

4. The method for preparing the self-bending sheath tube for interventional surgery according to claim 1, characterized in that: In step (2), the handle and the tube body are assembled, and the specific assembly process is as follows: 1) Assemble the handle; 2) Use a hot plate welding machine to weld the handle and the sheath tube body at a heating temperature of 230-250°C for 1 to 2 hours to ensure that the material is completely melted and the welding interface reaches a viscous state. After heating at 230°C for 30 minutes, apply a certain pressure to the welding interface to ensure that the materials are fully in contact and bonded in the molten state. The pressure is 200MPa, and then cool to room temperature to solidify, so that it solidifies from the molten state. The curing time is 5 to 8 hours; 3) Connect with the proximal part to ensure that all parts fit well.

5. The method for preparing the self-bending sheath tube for interventional surgery according to claim 1, characterized in that: In the step (3), the traction wire pre-buried in the sheath body is connected to the traction part of the handle, and the connection process is as follows: One end of the traction wire is usually fixed to the distal soft section of the tube body, and the other end needs to be connected to a worm inside an operating handle, in the middle at the connection between the handle and the sheath body; wherein, the diameter of the traction wire is between 0.01mm and 0.5mm, depending on the length and diameter of the sheath body. The length of the traction wire is 40 to 50cm, and the length inside the sheath body is 30cm.

6. The method for preparing the self-bending sheath tube for interventional surgery according to claim 1, characterized in that: The performance tests on the product in step (4) include tests on tensile strength, fatigue strength and bending properties.

7. The method for preparing the self-bending sheath tube for interventional surgery according to claim 1, characterized in that: The tube body is differentiated into multiple sections of hardness, that is, the front end of the tube body is a soft section, and the rear end of the tube body is a hard section.

8. The method for preparing the self-bending sheath tube for interventional surgery according to claim 1, characterized in that: The material used for the inner layer includes one or a mixture of two or four of PTFE, PEBAX, PA, and TPU, and the material for the outer layer is one or a mixture of two or four of PTFE, PEBAX, PA, and TPU.

9. The method for preparing the self-bending sheath tube for interventional surgery according to claim 1, characterized in that: The handle cooperates with the proximal connecting piece.

10. The method for preparing the self-bending sheath tube for interventional surgery according to claim 1, characterized in that: The traction wire is made of any one of stainless steel wire, titanium alloy wire, cobalt-chromium alloy wire and polytetrafluoroethylene wire.

Citation Information

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