A braided reinforced tearable sheath structure and manufacturing method

Abstract

The present invention discloses a braided reinforced tearable sheath structure and a manufacturing method, which includes a sheath tube body. The sheath tube body includes a sleeve portion and a guiding insertion portion provided at the head end of the sleeve portion, and a connecting member is provided at the tail end of the sleeve portion. The sleeve portion includes an inner layer tube, a braided tube, and an outer layer tube arranged in sequence from the inside to the outside. A plurality of tearing grooves are formed in the sheath tube body along the length direction, and both ends of each tearing groove extend to both ends of the sheath tube body. Moreover, at least one layer of tearable film is hermetically wrapped outside the sheath tube body. It has the effects of improving the strength of the tearable sheath structure and making the tearing process of the tearable sheath safer.

Description

Technical Field

[0001] The present invention relates to the technical field of medical sheaths, and particularly relates to a braided reinforced tearable sheath structure and a manufacturing method thereof. Background Art

[0002] A tearable sheath (also known as a tear sheath or cutting sheath) plays an important role in cardiovascular interventional surgeries. Especially in emergency situations where rapid access to blood vessels is required, the design of this sheath aims to provide fast and convenient operation and ensure the protection of blood vessels during the surgery.

[0003] Existing tearable sheaths usually consist of multiple-layer tube structure components, including an inner layer, an intermediate reinforcement layer, and an outer layer. Each layer has specific functions. For example, the inner layer provides lubricity, the intermediate layer provides support, and the outer layer provides protection. Commercially available tearable sheaths usually pre-embed tear lines in the tube wall of the sheath and perform low structural strength treatment near the tear lines. When it is necessary to urgently remove the interventional device in the sheath, the tear lines can be used to tear the sheath, thereby achieving the purpose of quickly removing the interventional device. For this reason, the inner layer, intermediate reinforcement layer, and outer layer of existing tearable sheaths are all made of low-strength polymer materials that can be torn to meet the purpose of rapid tearing. This will inevitably reduce the overall structural strength of the sheath, resulting in the sheath being prone to breakage during interventional surgeries. In addition, during the process of pulling the tear line to tear the sheath, the tear line is likely to cause skin injury, which is not safe enough and urgently needs improvement. Summary of the Invention

[0004] The purpose of the present invention is to provide a braided reinforced tearable sheath structure and a manufacturing method thereof, which have the effects of improving the structural strength of the tearable sheath and making the tearing process of the tearable sheath safer.

[0005] The above technical purpose of the present invention is achieved through the following technical solutions: A braided reinforced tearable sheath structure includes a sheath body. The sheath body includes a sleeve portion and a guiding insertion portion provided at the head end of the sleeve portion. A connector is provided at the tail end of the sleeve portion.

[0006] The sleeve portion includes an inner layer tube, a braided tube, and an outer layer tube sequentially arranged from the inside out. The sheath body is provided with a plurality of tear grooves along the length direction. Both ends of each tear groove extend to both ends of the sheath body, and at least one layer of tearable film is hermetically wrapped outside the sheath body.

[0007] By adopting the above technical solution, the sheath tube body can be smoothly inserted into a predetermined position through the guiding insertion part at its head, and then an external medical device is connected by a connecting piece, so that an interventional device can be inserted into the sheath tube body and accurately guided to the predetermined position. During the process of inserting the tearing sheath into the predetermined position, the tearing sheath may bend. At this time, the braided tube can improve the flexibility and anti-torsion performance of the tearing sheath, thereby improving the structural strength of the tearing sheath and preventing the tearing sheath from breaking due to excessive bending amplitude. At the same time, during the insertion process of the tearing sheath, the outermost film can prevent the skin from being scratched by the surface of the sheath tube; in addition, when it is necessary to quickly remove the interventional device from the tearing sheath in an emergency, the operator can directly tear the sheath tube body, so that the film can be gradually torn from the tail of the tearing sheath towards the head direction with the tearing groove as the dividing line, thereby directly exposing the interventional device. Different from the existing situation where the sheath tube is easily torn and the skin is strained by the tearing line, the present invention cancels the tearing line, and the user can directly tear the tearing sheath through the tearing groove, and the skin will not be strained by the tearing line during the tearing process, which is safer to use and has the effects of improving the structural strength of the tearing sheath and making the tearing process of the tearing sheath safer.

[0008] A further setting of the present invention is that the inner side of the tearing groove communicates with the inner cavity of the sleeve part, and the outer side of the tearing groove penetrates to the surface of the sheath tube body.

[0009] By adopting the above technical solution, the tearing groove that runs through makes the structural strength of the tearing sheath near the tearing groove lower, and it is easier for the operator to tear the tearing sheath along the tearing groove.

[0010] A further setting of the present invention is that the tearing groove is spirally formed around the surface of the sheath tube body.

[0011] By adopting the above technical solution, the spirally formed tearing groove enables the sheath tube body to have better anti-bending performance and can effectively prevent the tearing sheath from breaking due to excessive bending amplitude.

[0012] A further setting of the present invention is that the tearing groove is linearly formed on the surface of the sheath tube body.

[0013] By adopting the above technical solution, the operator can tear the sheath tube body into several straight strips through the linear tearing groove, which is convenient for removing the interventional device from the tearing sheath.

[0014] A further setting of the present invention is that the outer diameter of the guiding insertion part gradually decreases from the end close to the sleeve part towards the end far from the sleeve part.

[0015] By adopting the above technical solution, the end of the guiding insertion part is conically arranged, which can reduce the resistance when the tearing sheath is inserted, thereby reducing the damage to the skin tissue.

[0016] A further setting of the present invention is that the connecting piece is set as a locking cap for externally connecting an expander.

[0017] By adopting the above technical solution, the design of the locking cap can improve the firmness and sealing degree of the connection between the sheath body and the expander.

[0018] A further setting of the present invention is that the film is made of a tubular polymer heat-shrinkable film, and the material of the polymer heat-shrinkable film is any one of TPE, PO, PVC, PEBAX, PET or silicone rubber.

[0019] A further setting of the present invention is that the material of the inner layer tube is a self-lubricating polymer, such as any one of PTFE, PEEK, PE, POM or PI. The intermediate braided tube is three-dimensionally braided by a plurality of fiber filaments outside the inner layer tube. The material of the fiber filaments is any one of polymer threads or metal wires. The outer layer tube is made of a thermoplastic polymer material.

[0020] Another technical object of the present invention is to provide a manufacturing method of a braided reinforced tearable sheath structure, including the following steps:

[0021] S1: Preparation of the inner layer tube: Alkaline wash the surface of the inner layer tube to remove the oil stains on its surface;

[0022] S2: Preparation of the braided tube: Three-dimensionally braid a plurality of fiber filaments outside the inner layer tube through a three-dimensional braiding machine to form the braided tube;

[0023] S3: Preparation of the outer layer tube: Weld the outer layer tube to the outside of the inner layer tube braided with the braided tube by hot melting or heat shrinking, and composite to form the sheath body;

[0024] S4: Processing of the tear groove: Cut the tear groove on the surface of the sheath body by high-precision mechanical cutting technology or laser cutting technology;

[0025] S5: Film covering: Tightly wrap the film on the outside of the sheath body processed with the tear groove in S4 to form the final product.

[0026] By adopting the above technical solution, a tear groove is opened on the surface of the composite assembled sheath body, and then the film is tightly wrapped outside the sheath body with the tear groove opened. The film is used to radially limit the sheath body, so that the tearable sheath can have sufficient bending support in the radial direction.

[0027] A further setting of the present invention is that in step S5, the film is fixedly connected to the surface of the sheath body by any one of bonding, dip coating or welding.

[0028] In summary, the present invention has the following beneficial effects:

[0029] By providing a tear groove in the longitudinal direction of the sheath body, the sheath body includes an inner layer tube, an intermediate braided tube, and an outer layer tube, and the sheath body includes a sleeve portion and a guiding insertion portion provided at the head end of the sleeve portion. During use, the sheath body can be smoothly inserted into a predetermined position through the guiding insertion portion at its head end, and then an external medical device is connected using a connecting member. Thus, the interventional device can be inserted into the sheath body and accurately guided to the predetermined position. During the process of inserting the tear sheath into the predetermined position, the tear sheath may bend. At this time, the braided tube can improve the flexibility and anti-torsion performance of the tear sheath, thereby enhancing the structural strength of the tear sheath and preventing the tear sheath from breaking due to excessive bending amplitude. At the same time, during the insertion process of the tear sheath, the outermost coating film can prevent the surface of the sheath from scratching the skin; in addition, when it is necessary to quickly remove the interventional device from the tear sheath in an emergency, the operator can directly tear the sheath body, causing the coating film to gradually tear from the tail towards the head direction of the tear sheath with the tear groove as the dividing line, thereby directly exposing the interventional device. Different from the existing situation where it is easy to cause skin injury by tearing the sheath through a tear line, the present invention eliminates the tear line, and the user can directly tear the tear sheath through the tear groove, and no skin injury will occur during the tearing process, making it safer to use, and having the effects of improving the structural strength of the tear sheath and making the tearing process of the tear sheath safer. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is the overall view of the present invention.

[0031] Figure 2 is the overall structural diagram of the first specific embodiment of the present invention, where the coating film is not shown.

[0032] Figure 3 is the overall structural diagram of the second specific embodiment of the present invention, where the coating film is not shown.

[0033] Figure 4 is the present invention Figure 3 longitudinal sectional view.

[0034] Figure 5 is the present invention Figure 4 local enlarged view of area A in.

[0035] In the figure: 1. Sheath body; 2. Sleeve portion; 21. Inner layer tube; 22. Braided tube; 23. Outer layer tube; 3. Guiding insertion portion; 4. Connecting member; 5. Coating film; 6. Tear groove. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0036] The present invention will be further described below with reference to the accompanying drawings.

[0037] Embodiment 1: A braided and reinforced tearable sheath structure, as Figures 1 - 4 shown, comprising a sheath body 1. The sheath body 1 includes a sleeve portion 2 and a guiding insertion portion 3 provided at the head end of the sleeve portion 2. A connecting member 4 is provided at the tail end of the sleeve portion 2; the sleeve portion 2 includes an inner layer tube 21, a braided tube 22, and an outer layer tube 23 arranged in sequence from the inside to the outside. A plurality of tear slots 6 are provided along the length direction of the sheath body 1. Both ends of each tear slot 6 extend to both ends of the sheath body 1, and at least one layer of tearable film 5 is hermetically wrapped outside the sheath body 1. In this embodiment, the thickness of the film 5 is controlled between 0.1 - 2 mm, and the tear strength of the film 5 is controlled between 0.5 - 10 N / mm; the inner side of the tear slot 6 communicates with the inner cavity of the sleeve portion 2, and the outer side of the tear slot 6 penetrates to the surface of the sheath body 1. The tear slot 6 penetratingly opened makes the structural strength of the tearable sheath lower near the tear slot 6, and it is easier for the operator to tear the tearable sheath along the tear slot 6; the tear slot 6 is spirally wound around the surface of the sheath body 1, and the spiral tear line is arranged as a conical spiral line on the guiding insertion portion 3. The tear slot 6 spirally opened enables the sheath body 1 to have better anti-bending performance, and can effectively prevent the situation that the tearable sheath is broken due to excessive bending amplitude; the outer diameter of the guiding insertion portion 3 gradually decreases from the end close to the sleeve portion 2 towards the end away from the sleeve portion 2, so that the end of the guiding insertion portion 3 is conically arranged, which can reduce the resistance when the tearable sheath is inserted, thereby reducing the damage to the skin tissue; the connecting member 4 is set as a locking cap for externally connecting an expander. The design of the locking cap can improve the firmness and sealing degree of the connection between the sheath body 1 and the expander; the film 5 is a tubular high molecular heat-shrinkable film, and the material of the high molecular heat-shrinkable film is any one of TPE, PO, PVC, PEBAX, PET, or silicone rubber; the material of the inner layer tube 21 is a self-lubricating polymer, such as any one of PTFE, PEEK, PE, POM, or PI. The intermediate braided tube 22 is three-dimensionally braided by a plurality of fiber filaments outside the inner layer tube 21, and the material of the fiber filaments is any one of high molecular wires or metal wires. The outer layer tube 23 is made of a high molecular material with thermoplasticity.

[0038] The basic working principle of the present invention is as follows: A tearing groove 6 is opened in the length direction of the sheath tube body 1. The sheath tube body 1 includes an inner layer tube 21, an intermediate braided tube 22 and an outer layer tube 23, and the sheath tube body 1 includes a sleeve portion 2 and a guiding insertion portion 3 provided at the head end of the sleeve portion 2. During use, the sheath tube body 1 can be smoothly inserted into a predetermined position through the guiding insertion portion 3 at its head, and then an external medical device is connected by a connecting member 4, so that an interventional instrument can be inserted into the sheath tube body 1 and accurately guided to the predetermined position. During the process of inserting the tearing sheath into the predetermined position, the tearing sheath may bend. At this time, the braided tube 22 can improve the flexibility and anti-torsion performance of the tearing sheath, thereby improving the structural strength of the tearing sheath and preventing the tearing sheath from breaking due to excessive bending amplitude. At the same time, during the insertion process of the tearing sheath, the outermost film 5 can prevent the surface of the sheath tube from scratching the skin. In addition, when it is necessary to quickly remove the interventional instrument from the tearing sheath in an emergency, the operator can directly tear the sheath tube body 1, so that the film 5 can be gradually torn from the tail to the head direction of the tearing sheath with the tearing groove 6 as the dividing line, thereby directly exposing the interventional instrument. Different from the existing situation where it is easy to strain the skin by tearing the sheath tube through a tearing line, the present invention cancels the tearing line, and the user can directly tear the tearing sheath through the tearing groove 6, and the skin will not be strained by the tearing line during the tearing process, which is safer to use and has the effects of improving the structural strength of the tearing sheath and making the tearing process of the tearing sheath safer.

[0039] Embodiment 2: A braided reinforced tearable sheath structure, as Figure 5 shown. The difference between this embodiment and the specific Embodiment 1 is that the tearing groove 6 is linearly opened on the surface of the sheath tube body 1. Different from the spiral-shaped tearing groove 6, the linear tearing groove 6 is provided, so that the operator can tear the sheath tube body 1 into several straight strip-shaped fragments through the linear tearing groove 6, which is more convenient for the operator to take out the interventional instrument from the tearing sheath.

[0040] The other structures of this embodiment are the same as those of the specific Embodiment 1 and will not be described herein again.

[0041] Another technical object of the present invention is to provide a manufacturing method of a braided reinforced tearable sheath structure, including the following steps:

[0042] S1: Preparation of the inner layer tube 21: The surface of the inner layer tube 21 is alkali-washed to remove the oil stains on its surface;

[0043] S2: Preparation of the braided tube 22: A plurality of fiber filaments are three-dimensionally braided outside the inner layer tube 21 by a three-dimensional braiding machine to form the braided tube 22;

[0044] S3: Preparation of the outer layer tube 23: The outer layer tube 23 is welded to the outside of the inner layer tube 21 braided with the braided tube 22 by hot melting or heat shrinking, and a sheath tube body 1 is formed by compounding;

[0045] S4: Processing the tearing groove 6: Cutting the tearing groove 6 on the surface of the sheath body 1 by high-precision mechanical cutting technology or laser cutting technology;

[0046] S5: Wrapping the film: Tightly wrapping the film 5 around the outside of the sheath body 1 processed with the tearing groove 6 in S4 to form the final product.

[0047] A tearing groove 6 is opened on the surface of the assembled sheath body 1 in combination, and then the film 5 is tightly wrapped around the sheath body 1 with the tearing groove 6 opened. The film 5 is used to limit the sheath body 1 radially, so that the tearing sheath can have sufficient bending support in the radial direction. In step S5, the film 5 is fixedly connected to the surface of the sheath body 1 by any one of bonding, dip coating or welding. In this embodiment, the film is hot-melt wrapped around the outside of the sheath body 1 by welding; and the outer diameter of the locking cap is equal to the maximum outer diameter of the guiding insertion part 3. At the same time, the outer diameter of the tearing sheath wrapped with the film 5 is equal to the outer diameter of the locking cap, so that the tearing sheath maintains a high concentricity in the overall length direction, facilitating the smooth insertion of the tearing sheath.

[0048] The above description is only a preferred embodiment of the present invention. Therefore, any equivalent changes or modifications made according to the structures, features and principles described in the scope of this invention patent application are included in the scope of this invention patent application.

Claims

1. A braided reinforced tearable sheath structure, comprising a sheath tube body (1), characterized in that: The sheath tube body (1) includes a sleeve portion (2) and a guiding insertion portion (3) provided at the head end of the sleeve portion (2), and a connecting member (4) is provided at the tail end of the sleeve portion (2); The sleeve portion (2) includes an inner layer tube (21), a braided tube (22), and an outer layer tube (23) which are arranged in sequence from the inside to the outside. A plurality of tearing grooves (6) are formed in the sheath tube body (1) along the length direction. Both ends of each tearing groove (6) extend to both ends of the sheath tube body (1), and at least one layer of tearable film (5) is hermetically wrapped outside the sheath tube body (1); The inner side of the tearing groove (6) communicates with the inner cavity of the sleeve portion (2), and the outer side of the tearing groove (6) penetrates to the surface of the sheath tube body (1); The tearing groove (6) is spirally formed around the surface of the sheath tube body (1); Alternatively, the tearing groove (6) is linearly formed on the surface of the sheath tube body (1).

2. The braided reinforced tearable sheath structure according to claim 1, wherein: The outer diameter of the guiding insertion portion (3) gradually decreases from the end close to the sleeve portion (2) to the end away from the sleeve portion (2).

3. A woven reinforced tearable sheath structure according to claim 1, characterized in that: The connecting member (4) is provided as a locking cap for externally connecting an expander.

4. A braided reinforced tearable sheath structure according to claim 1, characterized in that: The film (5) is made of a tubular polymer heat-shrinkable film, and the material of the polymer heat-shrinkable film is any one of TPE, PO, PVC, PEBAX, PET, or silicone rubber.

5. A woven reinforced tearable sheath structure according to claim 1, characterized in that: The material of the inner layer tube (21) is a self-lubricating polymer, and the material of the self-lubricating polymer is any one of PTFE, PEEK, PE, POM, or PI. The braided tube (22) is three-dimensionally braided by a plurality of fiber filaments outside the inner layer tube (21), and the material of the fiber filaments is any one of polymer wires or metal wires. The outer layer tube (23) is made of a thermoplastic polymer material.

6. A manufacturing method of the braided reinforced tearable sheath structure according to any one of claims 1-5, characterized in that, Including the following steps: S1: Preparation of the inner layer tube (21): The surface of the inner layer tube (21) is alkali-washed to remove the oil stains on its surface; S2: Preparation of the braided tube (22): A plurality of fiber filaments are three-dimensionally braided outside the inner layer tube (21) by a three-dimensional braiding machine to form the braided tube (22); S3: Preparation of the outer layer tube (23): The outer layer tube (23) is welded to the outside of the inner layer tube (21) braided with the braided tube (22) by means of hot melting or heat shrinking, and the sheath tube body (1) is formed by compounding; S4: Processing of the tearing groove (6): The tearing groove (6) is formed on the surface of the sheath tube body (1) by high-precision mechanical cutting technology; S5: Film sleeving: The film (5) is tightly coated on the outside of the sheath tube body (1) processed with the tearing groove (6) in S4 to form the final product.

7. The manufacturing method of a braided reinforced tearable sheath structure according to claim 6, characterized in that: In step S5, the film (5) is fixedly connected to the surface of the sheath tube body (1) by any one of bonding, dip coating, or welding.

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