A stent introduction sheath and a manufacturing method thereof

By adopting frustoconical shape design and heat shrinkage rheology process in the stent introduction sheath, the problems of high production costs and low efficiency in the existing technology are solved, and the efficient use of materials and the improvement of production efficiency are achieved to meet the stent introduction Functional requirements of sheath.

CN118576385BActive Publication Date: 2024-12-17LELAND BIOTECH (SUZHOU) CO LTD
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Patent Information

Application Number
CN202411069066.6
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-08-06
Publication Date
2024-12-17
Estimated Expiration
2044-08-06

AI Technical Summary

Technical Problem

The production cost of the existing stent introduction sheath tube is high and inefficient, mainly due to the large amount of material used and material loss caused by the heat shrinkage rheology process, resulting in loss at both ends of the introduction sheath tube, increasing production costs.

Method used

The main body part and the outer shape are frustoconical in shape. By placing an inner lining layer and an outer support layer on the mandrel, and heat shrinkage rheology is carried out in the heating equipment to form a fixed connection to reduce the material. The amount of use is used, and the one-time processing of multiple sheaths is achieved through cutting and docking.

Benefits of technology

It significantly saves material costs, improves production efficiency, meets the needs of the stent introduction sheath tube, and reduces the risk of wear and tear of the stent in the stent and the drug coating shedding.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides a stent introduction sheath and a manufacturing method thereof, belonging to the technical field of medical device interventional equipment; the stent introduction sheath comprises a main body and a tip portion with an external shape of a truncated cone, the main body comprises a first section and a second section which are connected in sequence, the second section is used to connect the tip portion, the second section comprises an outer supporting layer and an inner lining layer, the outer supporting layer is fixedly sleeved on the inner lining layer, the first section has only an outer supporting layer, the outer supporting layer of the first section and the outer supporting layer of the second section are butted together as a whole; the invention is used to solve the technical problem of high production cost of existing introduction sheaths.
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Description

Technical Field

[0001] The present invention belongs to the technical field of medical device intervention equipment, and in particular relates to a stent introduction sheath and a manufacturing method thereof. Background Art

[0002] In the interventional treatment of cerebrovascular stenosis, it is often necessary to place a stent at the location of the vascular lesion. Before the stent is introduced into the lesion, it is necessary to first compress the stent and load it into the distal lumen of the stent introduction sheath, and then push the stent into the microcatheter through the push wire, and then deliver the stent to the lesion through the microcatheter. Figure 1 , Figure 2 As shown, the stent introduction sheath is composed of a main body 1 and a tip part 2. The main body 1 is usually a double-layer composite structure. The inner lining layer 1022 uses a smooth PTFE material as the inner lining, which can effectively reduce the friction between the stent and the tube body during the pressing and pushing process, especially for stents with drug coatings, which can reduce the wear of the drug coating and the shedding of particles. The outer support layer 1021 of the catheter body is a relatively hard polymer nylon material, which can provide good support. The main body 1 is usually made by hot-shrink rheology to fuse the outer support layer 1021 with the inner lining layer 1022 through hot melt extrusion to achieve fixation. The PTFE inner lining layer covers the entire stent introduction sheath, and then the tip part 2 is tip-formed by a tip forming machine or welded by welding.

[0003] At present, the manufacturing method of the stent introduction sheath catheter body is to insert the inner lining layer and the outer supporting layer into the core shaft in turn and then put on the heat shrink tube for heat shrinkage rheology. After the heat shrinkage rheology, the heat shrink tube is deformed and presses the nylon tube of the outer supporting layer. At the same time, the outer supporting layer and the inner lining layer are partially melted due to the high temperature during the heat shrinkage flow process, and a fusion-type fixed connection is achieved under the extrusion of the heat shrink tube.

[0004] Since the length of the tube body of the introduction sheath is usually more than 500mm, only one product can be flowed at a time during heat shrink flow, and the production efficiency is low. In terms of raw materials, due to the influence of the process, there will be a certain amount of loss at both ends of the introduction sheath. Therefore, the length of the PTFE liner, nylon tube and heat shrink tube required for the production of one product must be greater than the designed length of the tube body of the introduction sheath. In addition, the raw materials of the liner and heat shrink tube are expensive, accounting for 80% of the total product cost. Therefore, it takes a high material cost to make a tube body of an introduction sheath.

[0005] In addition, the stent introduced into the sheath is usually pressed into one end of the tip part, and then the tip is extended into the microcatheter, and the stent is pushed into the microcatheter from the other end of the introduction sheath. The smaller the depth of the stent pressed into the introduction sheath, the shorter the time it takes to push the stent into the microcatheter, and the more convenient it is for the doctor to push the stent. It can also reduce the wear of the stent in the introduction sheath and the risk of drug coating falling off. Therefore, the depth of the stent pressed into the sheath cavity is generally less than 100 mm. Therefore, the position of the introduction sheath that needs to be lined is only a section near the tip, and the existing method of lining the entire introduction sheath further increases the production cost.

[0006] Therefore, it is necessary to provide an improved technical solution to address the above-mentioned deficiencies in the prior art. Summary of the invention

[0007] The object of the present invention is to provide a stent introduction sheath tube, which is used to solve the technical problem of high production cost of existing introduction sheath tubes.

[0008] In order to achieve the above-mentioned purpose, the stent introduction sheath of the present invention provides the following technical solutions:

[0009] A stent introduction sheath comprises a main body and a tip portion with an external shape of a truncated cone, the main body comprising a first section and a second section which are connected in sequence, the second section being used to connect with the tip portion, the second section comprising an outer supporting layer and an inner lining layer, the outer supporting layer being fixedly sleeved on the inner lining layer, the first section comprising only an outer supporting layer, and the outer supporting layer of the first section and the outer supporting layer of the second section being butted together as a whole.

[0010] As a further optimized technical solution, the length of the second section is not less than 100 mm.

[0011] As a further optimized technical solution, the length of the second section is 100-150 mm.

[0012] Beneficial effects of the stent introduction sheath: The main part of the stent introduction sheath of the present invention has a first section and a second section, and the inner lining layer is installed only in the second section connected to the tip part, which not only meets the use requirements but also greatly saves material costs without reducing the use function.

[0013] The present invention also aims to provide a method for manufacturing a stent introduction sheath, so as to solve the technical problems of high cost and low efficiency in the existing introduction sheath manufacturing method.

[0014] The manufacturing method of the stent introduction sheath of the present invention provides the following technical solutions:

[0015] A method for manufacturing a stent introduction sheath as described in the above technical solution comprises the following steps:

[0016] Step 1, sleeve the inner lining layer on the mandrel, and the length between the mandrel and the inner lining layer is 200-1500mm;

[0017] Step 2, isolating rings and outer supporting layers are evenly and staggeredly arranged on the outer side of the inner lining layer;

[0018] Step 3, a heat shrink tube is sheathed on the outside of the isolation ring and the outer supporting layer, and the length of the heat shrink tube is not less than the length of the inner lining layer;

[0019] Step 4, placing the set heat shrink tube into a heating device for heating to shrink the heat shrink tube;

[0020] Step 5, after the shrunk heat shrink tube is cooled, first remove the heat shrink tube and the isolation ring, then pull out the mandrel, and cut it at the end of the position where the isolation ring is sleeved to obtain multiple second sections with an extended lining layer at one end;

[0021] Step 6, a tip portion is provided at one end of the second section having the extended inner lining layer, and the other end is connected to an outer support layer of a set length to form a whole, so as to obtain a stent introduction sheath.

[0022] As a further optimized technical solution, in step 6, the method of connecting the second section and the outer supporting layer into one body comprises the following steps:

[0023] Step 611, take a second section and a section of outer support layer, insert one end of the mandrel into one end of the second section, insert the other end of the mandrel into one end of the outer support layer, and align the second section with one end of the outer support layer;

[0024] Step 612, sleeve a heat shrink tube at the aligned position, the heat shrink tube simultaneously covering a portion of the outer support layer and a portion of the second section;

[0025] Step 613, heating the second section on which the heat shrink tube is sheathed and the outer support layer to shrink the heat shrink tube, so that the outer support layer and the second section are fused and fixedly connected during the shrinking process;

[0026] Step 614, after the shrunk heat shrink tube cools down, the heat shrink tube is first removed, and then the core shaft is pulled out.

[0027] As a further optimized technical solution, in S6, the method of setting the tip portion on the second segment includes directly placing the end of the second segment on a tip forming device for processing, or fixing a tip portion to the end of the second segment.

[0028] As a further optimized technical solution, the method for fixing and connecting the tip portion comprises the following steps:

[0029] Step 621, take a tip portion, insert the tip portion into the lining layer extending outside the second section, insert the mandrel into the lining layer, and align the tip portion with the outer support layer of the second section;

[0030] Step 622, a heat shrink tube is placed at the aligned position, the heat shrink tube simultaneously covering a portion of the outer support layer and the entire tip portion;

[0031] Step 623, heating the second section and the tip portion of the heat shrinkable tube to shrink the heat shrinkable tube, so that the tip portion and the second section are fixedly connected in a fusion manner during the shrinking process;

[0032] Step 624, after the shrunk heat shrink tube cools down, first remove the heat shrink tube and then pull out the core shaft.

[0033] As a further optimized technical solution, in S1, after the core shaft penetrates the inner lining layer, the single-side gap between the inner lining layer and the core shaft is 0.005-0.05mm.

[0034] As a further optimized technical solution, the isolation ring is made of heat shrinkable material, and the length of the isolation ring is 5-20 mm.

[0035] As a further optimized technical solution, in S4, the heat shrink tube needs to be preheated and shrunk before being placed in the heating device. The preheating and shrinking method is to use a hot air gun to heat both ends of the heat shrink tube at 150-200°C.

[0036] Beneficial effects of the method for manufacturing a stent introduction sheath: The method of the present invention can be used to realize the one-time processing of the second sections of multiple stent introduction sheaths, and an outer support layer and a tip portion are respectively arranged at both ends of the second section to form a stent introduction sheath, so that multiple stent introduction sheaths can be processed at one time, and the processed stent introduction sheath has only the second section with an inner lining layer, which can not only meet the use requirements but also effectively save material costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. Among them:

[0038] Figure 1 This is a schematic diagram of the overall structure of the stent introduction sheath of the present invention;

[0039] Figure 2 It is a cross-sectional schematic diagram of a stent introduction sheath tube in the prior art;

[0040] Figure 3 A schematic diagram of processing the second section according to an embodiment of the present invention;

[0041] Figure 4 A schematic diagram of the connection between the first section and the second section according to an embodiment of the present invention;

[0042] Figure 5 A schematic diagram of a first section and a second section connected to each other according to an embodiment of the present invention;

[0043] Figure 6 A schematic diagram of the connection between the second section and the tip portion of one embodiment of the present invention;

[0044] Figure 7 A schematic diagram of a second section after connecting the tip portion to an embodiment of the present invention;

[0045] Figure 8 An overall cross-sectional schematic diagram of a stent introduction sheath according to an embodiment of the present invention.

[0046] In the figure: 1. main body; 101. first section; 102. second section; 1021. outer support layer; 1022. inner lining layer; 2. tip part; 3. core shaft; 4. isolation ring; 5. heat shrink tube. DETAILED DESCRIPTION

[0047] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention belong to the scope of protection of the present invention.

[0048] In the description of the present invention, the terms "longitudinal", "lateral", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and do not require that the present invention must be constructed and operated in a specific orientation. Therefore, they should not be understood as limitations on the present invention. The terms "connected" and "connected" used in the present invention should be understood in a broad sense. For example, they can be fixed connections or detachable connections; they can be directly connected or indirectly connected through intermediate components. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0049] The present invention will be described in detail below with reference to the accompanying drawings and in combination with embodiments. It should be noted that the embodiments and features in the embodiments of the present invention can be combined with each other without conflict.

[0050] Embodiment of stent introduction sheath:

[0051] like Figure 1 , Figure 8As shown, the present invention provides a stent introduction sheath tube, which has a main body portion 1 and a tip portion 2 with an external shape of a truncated cone, wherein, as Figure 5 As shown, the main body 1 has a first section 101 and a second section 102 that are connected in sequence, and the end of the second section 102 away from the first section 101 is used to connect the tip part 2. It should be noted that the "connecting the tip part 2" here includes an integral fixed connection, that is, the tip part 2 is directly processed by the tip forming equipment at the end of the second section 102; and also includes an installed fixed connection, that is, the tip part 2 processed separately is installed at the end of the second section 102. The second section 102 has an outer support layer 1021 and an inner lining layer 1022, and the outer support layer 1021 is fixedly sleeved on the inner lining layer 1022. The first section 101 only has the outer support layer 1021, and the outer support layer 1021 of the first section 101 and the outer support layer 1021 of the second section 102 are connected to form an integral body. In one embodiment of the present invention, the connection to form an integral body can be glued together by gluing to form a fixed connection. In another embodiment of the present invention, the connection to form an integral body can be connected to form an integral body by thermoforming to form a fixed connection structure.

[0052] Because in actual use, the stent introduced into the sheath is pressed into the main body 1 from one end of the tip part 1, and the depth of the stent pressed into the inner cavity of the sheath is generally less than 100 mm, that is, only one section of the lining layer 1022 is actually used. As long as the section actually used has the lining layer 1022, the use function of the stent introduction sheath can be met. Because the first section 101 has no lining layer 1022, the inner diameter is larger. In this way, in the process of pushing the stent out, it is necessary to push the pushing piece into the stent introduction sheath from the end of the main body 1 away from the tip part. The first section 101 with a larger inner diameter is more convenient for the operation of the pushing piece.

[0053] In this embodiment, as long as the length of the second section 102 is not less than 100 mm, the design requirements can be met. However, in order to save raw materials by using a functional machine, it is preferred that the length of the second section 102 is 100-150 mm, preferably 100 mm.

[0054] Embodiment of the method for manufacturing the stent introduction sheath:

[0055] A method for manufacturing a stent introduction sheath comprises the following steps:

[0056] Step 1, sleeve a PTFE lining layer 1022 on a core shaft 3 with a diameter of 0.3-1.0 mm. The core shaft 3 is made of stainless steel or silver-plated copper. The core shaft 3 is mainly used to support the lining layer 1022, and the material can be selected as long as it can achieve support and is not easy to adhere to the lining layer 1022. The length of the core shaft 3 and the lining layer 1022 is 200-1500 mm.

[0057] After the mandrel 3 penetrates the inner lining layer 1022, the single-side gap between the inner lining layer 1022 and the mandrel 3 is 0.005-0.05mm. If the gap is too large, the inner lining layer 1022 is easy to fold in the subsequent heating process, and the smoothness of the side wall of the inner lining layer 1022 after processing cannot be guaranteed, which affects the pushing of the bracket. If the gap is too small, it is inconvenient to disassemble and assemble the mandrel 3. Therefore, this gap needs to ensure that the mandrel 3 is easy to disassemble and assemble, and the mandrel 3 can also play a good supporting role to maintain the shape stability of the inner lining layer 1022 during the processing process.

[0058] Step 2: Isolation rings 4 and outer support layers 1021 are evenly and staggeredly arranged on the outer side of the inner lining layer 1022 .

[0059] In this embodiment, the outer support layer 1021 is made of nylon tube, and the isolation ring 4 is made of heat shrink material. The function of the isolation ring 4 is to insulate and prevent the inner lining layer 1022 from deforming. Any material that can achieve heat insulation and protect the inner lining layer 1022 can be used. Specifically, during the processing, the nylon tube is cut into 100-150mm lengths, and the length of the isolation ring 4 is 5-20mm. Figure 3 As shown, nylon tubes and isolation rings 4 are staggered on the outside of the inner lining layer 1022 to achieve uniform staggered arrangement of the isolation rings 4 and the outer supporting layer 1021 .

[0060] Among them, the single-sided gap between the nylon tube and the inner lining layer 1022 is 0.005-0.5mm, the wall thickness of the nylon tube is 0.01-1mm, the wall thickness of the isolation ring 4 is 0.05-0.5mm, and the single-sided gap between the isolation ring 4 and the inner lining layer 1022 is 0.01-1.0mm. The specific number of nylon tubes inserted depends on the inner lining layer 1022, the core shaft 3 and the length of the nylon tube after cutting, and the number at a time ranges from 2 to 14.

[0061] Step 3, a heat shrink tube 5 is jointly sleeved on the outside of the isolation ring 4 and the outer support layer 1021. The length of the heat shrink tube 5 is 200-1500 mm, the wall thickness is 0.05-1.0 mm, the single-sided gap between the heat shrink tube 5 and the nylon tube is 0.05-2.0 mm, and the length of the heat shrink tube 5 is not less than the length of the inner lining layer 1022, and the inner lining layer 1022 needs to be completely covered.

[0062] Step 4, placing the sleeved heat shrink tube 5 into a heating device for heating to shrink the heat shrink tube 5.

[0063] Specifically, the heat shrink tube 5 needs to be preheated and shrunk before being placed in the heating device. The preheating and shrinking method is to use a hot air gun to heat both ends of the heat shrink tube 5 at 150-200° C. In this way, the heat shrink tube 5 is pre-shrunk at both ends, which can ensure the stability of the whole during the processing and prevent the heat shrink tube 5 from moving relative to the internal pipe fittings when the whole shrinks.

[0064] In this embodiment, the heating device is a heat shrinkable laminating machine, and the heat shrinkable tube 5 needs to be vertically hung in the heat shrinkable laminating machine for heat shrinkage rheology. The rheology temperature is 250-350° C. and the rheology speed is 0.5-2.0 mm / s.

[0065] Step 5, after the shrunk heat shrink tube 5 cools down, first remove the heat shrink tube 5 and the isolation ring 4 to release the restraint of the heat shrink tube 5 and the isolation ring 4 on the core shaft 3, then pull out the core shaft 3, and cut it at the end of the position where the isolation ring 4 is sleeved to obtain multiple second sections 102 with an extended lining layer 1022 at one end, and the length of the extended lining layer 1022 is 5-20mm.

[0066] Specifically, in the process of pulling out the mandrel 3 , a stretching machine or a core pulling machine needs to be used to apply force evenly to pull out the mandrel 3 .

[0067] Step 6, a tip portion 2 is provided at one end of the second section 102 having the extended inner lining layer 1022, and the other end is connected to an outer support layer 1021 of a set length to form a whole, so as to obtain a stent introduction sheath.

[0068] like Figure 4 As shown, the method of connecting the second section 102 and the outer support layer 1021 into one body comprises the following steps:

[0069] Step 611, take a second section 102 and an outer support layer 1021, insert one end of the core shaft 3 into one end of the second section 102, the length of the core shaft 3 is not less than 500mm, insert the other end of the core shaft 3 into one end of the outer support layer 1021, and align the opposite ends of the second section 102 and the outer support layer 1021. The single-sided gap between the core shaft 3 and the outer support layer 1021 is 0.05-2.0mm, and the single-sided gap between the core shaft 3 and the inner support layer 1022 of the second section 102 is 0.01-1.0mm.

[0070] Step 612, a heat shrink tube 5 is installed at the aligned position, the heat shrink tube 5 covers part of the outer support layer 1021 and part of the second section 102 at the same time, and the single-side gap between the heat shrink tube 5 and the outer support layer 1021 is 0.05-2.0 mm.

[0071] Step 613, heat and weld the second section 102 and the outer support layer 1021 with the heat shrink tube 5 at a temperature of 150-250°C to shrink the heat shrink tube 5. During the shrinking process, the outer support layer 1021 and the second section 102 are fused and fixedly connected, thereby achieving welding of the outer support layer 1021 and the second section 102.

[0072] Step 614, after the shrunk heat shrink tube 5 cools down, the heat shrink tube 5 is first removed to release the binding of the heat shrink tube 5 on the core shaft 3, and then the core shaft 3 is pulled out. Figure 5 .

[0073] In addition, the method of setting the tip portion 2 on the second segment 102 includes directly placing the end of the second segment 102 on a tip forming device for processing, or fixing a tip portion 2 on the end of the second segment 102 .

[0074] like Figure 6 As shown, the method for fixedly connecting the tip portion 2 comprises the following steps:

[0075] Step 621, take a tip portion 2, the tip portion 2 is a section of equal-diameter tube, and the outer diameter of the equal-diameter tube is smaller than the outer diameter of the outer support layer 1021, the length of the tip portion 2 is 5-10mm, and the tip portion 2 is inserted into the lining layer 1022 extending outside the second section 102. The inner diameter of the tip portion 2 is 0.01-1.0mm smaller than the size of the second section 102, and the single-sided gap between the tip portion 2 and the lining tube is 0.005-0.05mm.

[0076] The core shaft 3 is inserted into the inner lining layer 1022 , and the tip portion 2 is aligned and abutted against the outer supporting layer 1021 of the second section 102 .

[0077] Step 622, a heat shrink tube 5 is installed at the aligned position, the heat shrink tube 5 covers part of the outer support layer 1021 and the entire tip portion 2 at the same time, and the single-side gap between the tip portion 2 and the heat shrink tube 5 is 0.01-1.0 mm.

[0078] Step 623, the second section 102 and the tip portion 2 which are covered with the heat shrink tube 5 are heated at a heating temperature of 150-250°C to shrink the heat shrink tube 5. During the shrinking process, the outer support layer 1021 with different outer diameters wrapped by the heat shrink tube 5 and the equal-diameter tube are fused and fixedly connected under the action of the heat shrink tube 5 to form a truncated cone shape; the tip portion 2 and the second section 102 are welded, and at the same time, the tip portion 2 and the inner lining layer 1022 are fused and fixedly connected.

[0079] Step 624, after the shrunk heat shrink tube 5 cools down, the heat shrink tube 5 is first removed to release the binding of the heat shrink tube 5 on the mandrel 3, and then the mandrel 3 is pulled out. Figure 7 .

[0080] In summary, the stent introduction sheath and the manufacturing method thereof provided by the present invention can not only meet the original use requirements of the stent introduction sheath, but also greatly save material costs and improve production efficiency without reducing the use function.

[0081] It should be understood that the above description is merely exemplary and the embodiments of the present application do not limit this.

[0082] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention are within the scope of protection of the pending claims of the present invention.

Claims

1. A method for manufacturing a stent introduction sheath, characterized in that: The stent introduction sheath comprises a main body (1) and a tip portion (2) having an external shape of a truncated cone, the main body (1) comprising a first section (101) and a second section (102) which are connected in sequence, the second section (102) being used to connect the tip portion (2), the second section (102) comprising an outer supporting layer (1021) and an inner lining layer (1022), the outer supporting layer (1021) being fixedly sleeved on the inner lining layer (1022), the first section (101) having only the outer supporting layer (1021), the outer supporting layer (1021) of the first section (101) and the outer supporting layer (1021) of the second section (102) being butted together as a whole; The method for manufacturing the stent introduction sheath comprises the following steps: Step 1, sleeve an inner lining layer (1022) on the core shaft (3), wherein the length between the core shaft (3) and the inner lining layer (1022) is 200-1500 mm; Step 2, isolating rings (4) and outer supporting layers (1021) are evenly and staggeredly arranged on the outer side of the inner lining layer (1022); Step 3, a heat shrink tube (5) is sleeved on the outside of the isolation ring (4) and the outer support layer (1021), wherein the length of the heat shrink tube (5) is not less than the length of the inner lining layer (1022); Step 4, placing the sleeved heat shrink tube (5) into a heating device for heating to shrink the heat shrink tube (5); Step 5, after the shrunk heat shrink tube (5) cools down, first remove the heat shrink tube (5) and the isolation ring (4), then pull out the mandrel (3), and cut it at the end of the position where the isolation ring (4) is sleeved, to obtain a plurality of second sections (102) with an extended lining layer (1022) at one end; Step 6, a tip portion (2) is provided at one end of the second section (102) having the extended inner lining layer (1022), and the other end is connected to an outer support layer (1021) of a set length to form a whole, thereby obtaining a stent introduction sheath.

2. The method for manufacturing a stent introduction sheath according to claim 1, characterized in that: In step 6, the method of connecting the second section (102) and the outer supporting layer (1021) into one body comprises the following steps: Step 611, take a second section (102) and a section of outer supporting layer (1021), insert one end of the second section (102) into one end of the core shaft (3), insert the other end of the core shaft (3) into one end of the outer supporting layer (1021), and align the second section (102) with one end of the outer supporting layer (1021); Step 612, sleeve the heat shrink tube (5) at the aligned position, the heat shrink tube (5) simultaneously covering a portion of the outer support layer (1021) and a portion of the second section (102); Step 613, heating the second section (102) and the outer supporting layer (1021) on which the heat shrink tube (5) is sleeved, so as to shrink the heat shrink tube (5), and during the shrinking process, the outer supporting layer (1021) and the second section (102) are fused and fixedly connected; Step 614, after the shrunk heat shrink tube (5) cools down, first remove the heat shrink tube (5) and then extract the core shaft (3).

3. The method for manufacturing a stent introduction sheath according to claim 1, characterized in that: In S6, the method of setting the tip portion (2) on the second segment (102) includes directly placing the end of the second segment (102) on a tip forming device for processing, or fixing a tip portion (2) on the end of the second segment (102).

4. The method for manufacturing a stent introduction sheath according to claim 3, characterized in that: The method for fixedly connecting the tip portion (2) comprises the following steps: Step 621, take a tip portion (2), insert the tip portion (2) into the inner lining layer (1022) extending outside the second section (102), insert the core shaft (3) into the inner lining layer (1022), and align the tip portion (2) with the outer support layer (1021) of the second section (102); Step 622, sleeve a heat shrink tube (5) at the aligned position, the heat shrink tube (5) simultaneously covering a portion of the outer support layer (1021) and the entire tip portion (2); Step 623, heating the second section (102) and the tip portion (2) on which the heat shrink tube (5) is sleeved, so as to shrink the heat shrink tube (5), and during the shrinking process, the tip portion (2) and the second section (102) are fixedly connected in a fusion manner; Step 624, after the shrunk heat shrink tube (5) cools down, first remove the heat shrink tube (5) and then extract the core shaft (3).

5. The method for manufacturing a stent introduction sheath according to claim 1, characterized in that: In S1, after the core shaft (3) penetrates the inner lining layer (1022), the single-side gap between the inner lining layer (1022) and the core shaft (3) is 0.005-0.05 mm.

6. The method for manufacturing a stent introduction sheath according to claim 2, characterized in that: The isolation ring (4) is made of a heat shrinkable material, and the length of the isolation ring (4) is 5-20 mm.

7. The method for manufacturing a stent introduction sheath according to claim 1, characterized in that: In S4, the heat shrink tube (5) needs to be preheated and shrunk before being placed in the heating device. The preheating and shrinking method is to use a hot air gun to heat both ends of the heat shrink tube (5) at 150-200°C.

8. The method for manufacturing a stent introduction sheath according to claim 1, characterized in that: The length of the second section (102) is not less than 100 mm.

9. The method for manufacturing a stent introduction sheath according to claim 1 or 8, characterized in that: The length of the second section (102) is 100-150 mm.

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