Woven reinforced tearable sheath structure and manufacturing method

Abstract

The invention discloses a woven reinforced tearable sheath structure and a manufacturing method, the woven reinforced tearable sheath structure comprises a sheath tube body, the sheath tube body comprises a cannula part and a guide insertion part arranged at the head end of the cannula part, and a connecting piece is arranged at the tail end of the cannula part; the sleeve part comprises an inner-layer tube, a braided tube and an outer-layer tube which are sequentially arranged from inside to outside, a plurality of tearing grooves are formed in the sheath tube body in the length direction, the two ends of each tearing groove extend to the two ends of the sheath tube body, and the sheath tube body is further wrapped with at least one layer of tearable covering film in a sealed mode. The structure strength of the tearing sheath is improved, and the tearing process of the tearing sheath is safer.

Description

Technical Field

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

[0002] Tearaway sheaths (also called tearaway sheaths or cutting sheaths) play an important role in cardiovascular interventional procedures, especially in emergency situations where rapid access to and from blood vessels is required. Tearaway sheaths are designed to provide fast and convenient operation and ensure protection of blood vessels during surgery.

[0003] Existing tearable sheaths are usually composed of a multi-layer tube structure component, including an inner layer, a middle reinforcement layer and an outer layer, and each layer has a specific function, such as the inner layer provides lubricity, the middle layer provides support, and the outer layer provides protection. Tearable sheaths on the market usually have a tear line pre-buried on the tube wall of the sheath, and at the same time, low structural strength treatment is performed near the tear line. When the interventional device in the sheath needs to be urgently removed, the sheath can be torn open using the tear line, thereby achieving the purpose of quickly removing the interventional device. For this reason, the inner layer, middle reinforcement layer and outer layer of the existing tearable sheath are all made of tearable low-strength polymer materials to meet the purpose of rapid tearing, which is bound to reduce the overall structural strength of the sheath, resulting in the sheath being easily broken during the interventional surgery; in addition, in the process of pulling the tear line to tear the sheath, the tear line is likely to tear the skin, which is not safe and needs to be improved urgently. Summary of the invention

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

[0005] The above technical objectives of the present invention are achieved through the following technical solutions: a braided reinforced tearable sheath structure, comprising a sheath body, the sheath body comprising a sleeve portion, a guide insertion portion provided at the head end of the sleeve portion, and a connector provided at the tail end of the sleeve portion; The sleeve portion includes an inner tube, a braided tube and an outer tube which are arranged in sequence from the inside to the outside. 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. The sheath body is also sealed and wrapped with at least one layer of tearable coating.

[0006] By adopting the above technical scheme, the sheath body can be smoothly inserted into the predetermined position through the guide insertion part at its head, and then the external medical device can be connected by the connector, so that the interventional device can be inserted into the sheath body and accurately introduced into the predetermined position. In the process of placing the tear sheath into the predetermined position, the tear sheath may bend. At this time, the braided tube can improve the flexibility and torsion resistance of the tear sheath, thereby improving the structural strength of the tear sheath, and preventing the tear sheath from breaking due to excessive bending. At the same time, during the insertion of the tear sheath, the outermost coating can prevent the surface of the sheath from scratching the skin; in addition, in an emergency, when the interventional device needs to be quickly removed from the tear sheath, the operator can directly tear the sheath body, so that the coating can be gradually torn from the tail of the tear sheath toward the head direction with the tear groove as the dividing line, thereby directly exposing the interventional device. Different from the existing situation that the sheath is easily torn by tearing the skin by tearing the sheath through the tear line, the present invention cancels the tear line, and the user can directly tear the tear sheath through the tear groove. The tearing process will not cause the tear line to tear the skin, which is safer to use and has the effect of improving the structural strength of the tear sheath and making the tearing process of the tear sheath safer.

[0007] The present invention is further configured as follows: the inner side of the tear groove is communicated with the inner cavity of the sleeve portion, and the outer side of the tear groove penetrates to the surface of the sheath body.

[0008] By adopting the above technical solution, the tear groove is opened through the tear sheath, so that the structural strength of the tear sheath near the tear groove is lower, and it is easier for the operator to tear the tear sheath along the tear groove.

[0009] The present invention is further configured as follows: the tearing groove is spirally arranged on the surface of the sheath body.

[0010] By adopting the above technical solution, the spirally opened tear groove makes the sheath body have better bending resistance, which can effectively prevent the tear sheath from breaking due to excessive bending.

[0011] The present invention is further configured as follows: the tear groove is linearly opened on the surface of the sheath body.

[0012] By adopting the above technical solution, the operator can tear the sheath body into a plurality of straight strips through the linear tearing groove, so as to facilitate the removal of the interventional instrument from the tearing sheath.

[0013] The present invention is further configured such that the outer diameter of the guide insertion portion gradually decreases from an end close to the sleeve portion toward an end away from the sleeve portion.

[0014] By adopting the above technical solution, the end of the guide insertion part is set in a tapered shape, which can reduce the resistance when the tear sheath is inserted, thereby reducing damage to skin tissue.

[0015] The present invention is further configured as follows: the connecting piece is configured as a locking cap for an external expander.

[0016] By adopting the above technical solution and the design of the locking cap, the firmness and sealing degree of the connection between the sheath body and the dilator can be improved.

[0017] The present invention is further configured as follows: the coating is a polymer heat shrinkable film that is arranged in a tubular shape, and the material of the polymer heat shrinkable film is any one of TPE, PO, PVC, PEBAX, PET or silicone rubber.

[0018] The present invention is further configured as follows: 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 formed by three-dimensionally weaving a number of fiber filaments outside the inner layer tube; the material of the fiber filaments is any one of polymer wires or metal wires; and the outer layer tube is made of a thermoplastic polymer material.

[0019] Another technical purpose of the present invention is to provide a method for manufacturing a braided reinforced tearable sheath structure, comprising the following steps: S1: preparing the inner tube: washing the inner tube surface with alkali to remove oil stains on the surface; S2: preparing the braided tube: three-dimensionally braiding a plurality of fiber filaments outside the inner tube through a three-dimensional braiding machine to form the braided tube; S3: preparing the outer tube: welding the outer tube to the outer side of the inner tube braided with the braided tube by heat melting or heat shrinking, and forming the sheath tube body by compounding; S4: processing the tear groove: cutting the tear groove on the surface of the sheath body by high-precision mechanical cutting technology or laser cutting technology; S5: Coating: The coating is tightly wrapped around the outer portion of the sheath tube body with the tear groove formed in S4 to form a final product.

[0020] By adopting the above technical scheme, a tear groove is opened on the surface of the composite assembled sheath body, and then the coating is tightly wrapped around the sheath body with the tear groove, and the sheath body is radially limited by the coating, so that the tear sheath can have sufficient bending support in the radial direction.

[0021] The present invention is further configured as follows: in step S5, the coating is fixedly connected to the surface of the sheath body by any one of bonding, dipping or welding.

[0022] In summary, the present invention has the following beneficial effects: A tear groove is provided in the length direction of the sheath body, the sheath body includes an inner tube, an intermediate braided tube and an outer tube, and the sheath body includes a sleeve part and a guide insertion part arranged at the head end of the sleeve part. When in use, the sheath body can be smoothly inserted into a predetermined position through the guide insertion part at its head, and then the external medical device is connected by a connector, so that the interventional device can be inserted into the sheath body and accurately guided into the predetermined position. In the process of placing the tear sheath into the predetermined position, the tear sheath may bend. At this time, the braided tube can improve the flexibility and torsion resistance of the tear sheath, thereby improving the structural strength of the tear sheath, preventing the tear sheath from breaking due to excessive bending, and at the same time During the insertion of the tear sheath, the outermost coating can prevent the surface of the sheath from scratching the skin. In addition, in an emergency situation where the interventional instrument needs to be quickly removed from the tear sheath, the operator can directly tear the sheath body so that the coating can be gradually torn from the tail to the head of the tear sheath with the tear groove as the dividing line, thereby directly exposing the interventional instrument. Different from the existing situation where the sheath is torn through the tear line and the skin is easily injured, the present invention eliminates the tear line, and the user can directly tear the tear sheath through the tear groove. The tearing process will not cause the tear line to scratch the skin, and it is safer to use, with the effect of improving the structural strength of the tear sheath and making the tearing process of the tear sheath safer. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is an overall diagram of the present invention.

[0024] Figure 2 It is an overall structural diagram of a specific embodiment of the present invention, wherein the coating is not shown.

[0025] Figure 3 It is an overall structural diagram of the second specific embodiment of the present invention, wherein the coating is not shown.

[0026] Figure 4 The present invention Figure 3 Longitudinal section view of .

[0027] Figure 5 The present invention Figure 4 A partial enlarged view of area A.

[0028] In the figure: 1, sheath body; 2, sleeve part; 21, inner tube; 22, braided tube; 23, outer tube; 3, guide insertion part; 4, connector; 5, coating; 6, tear groove. DETAILED DESCRIPTION

[0029] The present invention will be further described below in conjunction with the accompanying drawings.

[0030] Embodiment 1: A braided reinforced tearable sheath structure, such as Figure 1-Figure 4As shown, the sheath body 1 includes a sleeve part 2, a guide insertion part 3 arranged at the head end of the sleeve part 2, and a connector 4 is arranged at the tail end of the sleeve part 2; the sleeve part 2 includes an inner tube 21, a braided tube 22 and an outer tube 23 arranged in sequence from the inside to the outside, and the sheath body 1 is provided with a plurality of tear grooves 6 along the length direction, and the two ends of each tear groove 6 extend to the two ends of the sheath body 1, and the outer side of the sheath body 1 is also sealed and wrapped with at least one layer of tearable coating 5, and the thickness of the coating 5 in this embodiment is controlled to be 0.1- 2mm, the tear strength of the coating 5 is controlled between 0.5-10N / mm; the inner side of the tear groove 6 is connected to the inner cavity of the sleeve part 2, and the outer side of the tear groove 6 penetrates to the surface of the sheath body 1. The tear groove 6 penetrates, so that the structural strength of the tear sheath near the tear groove 6 is lower, and the operator can tear the tear sheath along the tear groove 6 more easily; the tear groove 6 is spirally opened on the surface of the sheath body 1, and the spiral tear line is set in a conical spiral line on the guide insertion part 3, and the spirally opened tear groove 6 , so that the sheath body 1 has better anti-bending performance, which can effectively prevent the tear sheath from breaking due to excessive bending; the outer diameter of the guide insertion part 3 gradually decreases from the end close to the sleeve part 2 to the end away from the sleeve part 2, so that the end of the guide insertion part 3 is set in a cone, which can reduce the resistance when the tear sheath is inserted, thereby reducing damage to skin tissue; the connecting piece 4 is configured as a locking cap for an external dilator, and the design of the locking cap can improve the firmness and sealing degree of the connection between the sheath body 1 and the dilator; the coating 5 adopts a polymer heat shrinkable film in a tubular shape, and the material of the polymer heat shrinkable film is any one of TPE, PO, PVC, PEBAX, PET or silicone rubber; the material of the inner tube 21 is a self-lubricating polymer, such as any one of PTFE, PEEK, PE, POM or PI, and the middle braided tube 22 is formed by three-dimensional weaving of a number of fiber filaments outside the inner tube 21, and the material of the fiber filaments is any one of polymer wire or metal wire, and the outer tube 23 is made of a thermoplastic polymer material.

[0031] The basic working principle of the present invention is as follows: a tear groove 6 is provided in the length direction of the sheath body 1, the sheath body 1 comprises an inner tube 21, an intermediate braided tube 22 and an outer tube 23, and the sheath body 1 comprises a sleeve portion 2 and a guide insertion portion 3 arranged at the head end of the sleeve portion 2. When in use, the sheath body 1 can be smoothly inserted into a predetermined position through the guide insertion portion 3 at its head, and then the external medical device is connected by a connector 4, so that the interventional device can be inserted into the sheath body 1 and accurately introduced into the predetermined position. In the process of placing the tear sheath into the predetermined position, the tear sheath may bend. At this time, the braided tube 22 can improve the flexibility and torsion resistance of the tear sheath, thereby improving the structural strength of the tear sheath and preventing the tear sheath from bending too much. In addition, in an emergency situation where the interventional device needs to be quickly removed from the tear sheath, the operator can directly tear the sheath body 1, so that the coating 5 can be gradually torn from the tail to the head of the tear sheath with the tear groove 6 as the dividing line, thereby directly exposing the interventional device. Different from the existing situation where the sheath is torn by the tear line and the skin is easily injured, the present invention eliminates the tear line, and the user can directly tear the tear sheath by the tear groove 6. The tearing process will not cause the tear line to injure the skin, so it is safer to use, and has the effect of improving the structural strength of the tear sheath and making the tearing process of the tear sheath safer.

[0032] Embodiment 2: A braided reinforced tearable sheath structure, such as Figure 5 As shown, the difference between this embodiment and the specific embodiment 1 is that the tear groove 6 is linearly opened on the surface of the sheath body 1. Different from the spiral tear groove 6, the linear tear groove 6 is set so that the operator can tear the sheath body 1 into a plurality of straight strips through the linear tear groove 6, which makes it more convenient for the operator to remove the interventional instrument from the tear sheath.

[0033] The other structures of this embodiment are the same as those of the first embodiment and will not be described again.

[0034] Another technical purpose of the present invention is to provide a method for manufacturing a braided reinforced tearable sheath structure, comprising the following steps: S1: preparing the inner tube 21: washing the surface of the inner tube 21 with alkali to remove oil stains on the surface; S2: preparing the braided tube 22: three-dimensionally braiding a plurality of fiber filaments outside the inner tube 21 through a three-dimensional braiding machine to form the braided tube 22; S3: preparing the outer tube 23: welding the outer tube 23 to the outer surface of the inner tube 21 braided with the braided tube 22 by heat melting or heat shrinking, and compounding to form the sheath tube body 1; S4: Processing the tear groove 6: Cutting the tear groove 6 on the surface of the sheath body 1 by high-precision mechanical cutting technology or laser cutting technology; S5: Coating: The coating 5 is tightly wrapped around the outside of the sheath tube body 1 with the tear groove 6 formed in S4 to form a final product.

[0035] A tear groove 6 is opened on the surface of the composite assembled sheath body 1, and then the coating 5 is tightly wrapped around the outside of the sheath body 1 with the tear groove 6, and the coating 5 is used to radially limit the sheath body 1, so that the tear sheath can have sufficient bending support in the radial direction. In step S5, the coating 5 is fixedly connected to the surface of the sheath body 1 by any of bonding, dipping or welding. In this embodiment, the coating is hot-melted and 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 guide insertion part 3, and the outer diameter of the tear sheath wrapped with the coating 5 is equal to the outer diameter of the locking cap, so that the tear sheath maintains a high concentricity in the overall length direction, which facilitates the smooth insertion of the tear sheath.

[0036] The above description is only a preferred embodiment of the present invention, so all equivalent changes or modifications made according to the structure, characteristics and principles described in the scope of the patent application of the present invention are included in the scope of the patent application of the present invention.

Claims

1. A braided reinforced tearable sheath structure, comprising a sheath body (1), characterized in that: The sheath tube body (1) comprises a sleeve portion (2), a guide insertion portion (3) arranged at the head end of the sleeve portion (2), and a connecting piece (4) is arranged at the tail end of the sleeve portion (2); The sleeve portion (2) comprises an inner tube (21), a braided tube (22) and an outer tube (23) which are arranged in sequence from the inside to the outside. The sheath body (1) is provided with a plurality of tear grooves (6) along the length direction. Both ends of each tear groove (6) extend to both ends of the sheath body (1). The sheath body (1) is also sealed and wrapped with at least one layer of tearable coating (5).

2. A braided reinforced tearable sheath structure according to claim 1, characterized in that: The inner side of the tear groove (6) is connected to the inner cavity of the sleeve part (2), and the outer side of the tear groove (6) penetrates to the surface of the sheath body (1).

3. A braided reinforced tearable sheath structure according to any one of claims 1-2, characterized in that: The tearing groove (6) is spirally arranged on the surface of the sheath body (1).

4. A braided reinforced tearable sheath structure according to any one of claims 1-2, characterized in that: The tear groove (6) is linearly opened on the surface of the sheath tube body (1).

5. The braided reinforced tearable sheath structure according to claim 1, characterized in that: The outer diameter of the guide insertion portion (3) gradually decreases from an end close to the sleeve portion (2) toward an end away from the sleeve portion (2).

6. The braided reinforced tearable sheath structure according to claim 1, characterized in that: The connecting piece (4) is configured as a locking cap for an external expander.

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

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

9. A method for manufacturing a braided reinforced tearable sheath structure according to any one of claims 1 to 8, characterized in that: The following steps are involved: S1: preparing the inner layer tube (21): performing alkaline washing on the surface of the inner layer tube (21) to remove oil stains on the surface; S2: preparing the braided tube (22): three-dimensionally braiding a plurality of fiber filaments outside the inner tube (21) through a three-dimensional braiding machine to form the braided tube (22); S3: preparing the outer tube (23): welding the outer tube (23) to the outer side of the inner tube (21) braided with the braided tube (22) by heat melting or heat shrinking, and forming the sheath tube body (1) by compounding; S4: processing the tear groove (6): cutting the tear groove (6) on the surface of the sheath tube body (1) by high-precision mechanical cutting technology or laser cutting technology; S5: Coating: The coating (5) is tightly wrapped around the outside of the sheath tube body (1) on which the tear groove (6) is formed in S4, to form a final product.

10. The method for manufacturing a braided reinforced tearable sheath structure according to claim 9, characterized in that: In step S5, the coating (5) is fixedly connected to the surface of the sheath tube body (1) by any one of bonding, dipping or welding.

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