Medical tubular device and method for manufacturing the same

Abstract

To provide a medical tubular device in which a tubular body formed of polytetrafluoroethylene can be easily and firmly fixed to a hand part and leakage from a gap between the hand part and the tubular body can be suppressed, and to provide a method for manufacturing the same.SOLUTION: A medical tubular device 10 includes: a tubular body 20 having an outer diameter of 7 mm or more and a wall thickness of 0.5 mm or more and formed of polytetrafluoroethylene; and a hand part 30 fixed to a proximal end of the tubular body 20 and formed of a resin harder than polytetrafluoroethylene; wherein the hand part 30 has a housing portion 32 having a helical protrusion 34 formed in at least a portion of the inner cavity, and an apex 36 of the helical protrusion 34 is in close contact with the outer circumferential surface of the proximal end part of the tubular body 20, so that the tubular body 20 fits into the housing portion 32.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to medical tubular devices and methods for their manufacture. [Background technology]

[0002] In the treatment of a biological lumen such as a blood vessel, a medical tubular device to be inserted into the biological lumen is used. For example, Patent Document 1 discloses an introducer to be percutaneously inserted into a blood vessel for vascular treatment. The introducer has a long sheath tube and a proximal portion that is fixed to the base end of the sheath tube and can be grasped and operated by the surgeon.

[0003] Incidentally, since the sheath tube needs to have high slipperiness, it is preferable that the sheath tube be made of a material with a low coefficient of friction, such as polytetrafluoroethylene (hereinafter sometimes referred to as PTFE). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 5,700,253 Summary of the Invention [Problem to be solved by the invention]

[0005] The sheath tube is fixed to the proximal portion by crimping with a metal member or by adhesive. When the sheath tube is fixed to the proximal portion by crimping with a metal member, a metal member is required, which makes manufacturing complicated. When the sheath tube is fixed to the proximal portion by adhesive, it is difficult to fix the sheath tube with a high adhesive strength if the sheath tube is made of a material with a low friction coefficient.

[0006] The present invention has been made to solve the above-mentioned problems, and aims to provide a medical tubular device and a manufacturing method thereof, in which a tubular body formed of polytetrafluoroethylene can be easily and firmly fixed to a proximal portion and leakage from the gap between the proximal portion and the tubular body can be suppressed. [Means for solving the problem]

[0007] The above object can be achieved by the invention described in (1) below.

[0008] (1) The medical tubular device of the present invention comprises a tubular body having an outer diameter of 7 mm or more and a wall thickness of 0.5 mm or more and formed of polytetrafluoroethylene, and a proximal portion fixed to a base end of the tubular body and formed of a resin harder than polytetrafluoroethylene, the proximal portion having a storage portion in at least a part of an inner cavity where a helical protrusion is formed, the apex of the helical protrusion being in intimate contact with the outer peripheral surface of the base end of the tubular body so that the tubular body fits into the storage portion. Effect of the Invention

[0009] In the medical tubular device described in (1) above, the tubular body is less likely to deform, so that the tubular body can be fitted into the housing while being in close contact with the spiral convex portion of the proximal portion, which is harder than the tubular body. Therefore, the medical tubular device can easily and firmly fix the tubular body made of polytetrafluoroethylene to the proximal portion. In addition, since the proximal portion is made of resin rather than metal, damage to the tubular body when fixing the tubular body to the proximal portion can be suppressed, and leakage from the gap between the proximal portion and the tubular body can be suppressed.

[0010] (2) In the medical tubular device described in (1) above, the resin forming the proximal portion may be an acrylonitrile-butadiene-styrene copolymer, which allows the proximal portion to be strongly attached to the tubular body while suppressing damage to the tubular body and suppressing leakage from the gap between the proximal portion and the tubular body.

[0011] (3) In the medical tubular device described in (1) or (2) above, the outer peripheral surface of the tubular body with which the top of the helical protrusion is in intimate contact may be smooth, thereby eliminating the need for processing the tubular body to form a screw thread or the like, thereby reducing costs.

[0012] (4) The medical tubular device according to any one of (1) to (3) above may have a valve body disposed in the lumen of the proximal portion. This allows the medical tubular device to prevent leakage of blood or the like by the valve body while allowing another long device to be inserted into the lumen of the proximal portion. Even in applications requiring a valve body, the medical tubular device can effectively prevent leakage from a gap between the proximal portion and the tubular body by fitting the proximal portion and the tubular body together.

[0013] (5) The method for manufacturing a medical tubular device according to the present invention is a method for manufacturing a medical tubular device in which a proximal portion is fixed to a proximal portion of a long tubular body, and is characterized in that a tubular body having an outer diameter of 7 mm or more and a wall thickness of 0.5 mm or more and made of polytetrafluoroethylene and a housing portion made of a resin harder than polytetrafluoroethylene and having a helical convex portion formed in at least a part of the lumen are prepared, and the proximal portion of the tubular body is screwed into the housing portion, and the top of the helical convex portion is brought into close contact with the outer circumferential surface of the proximal portion of the tubular body to fit the tubular body to the housing portion. In this way, the method for manufacturing a medical tubular device fits the proximal portion of the tubular body, which is difficult to deform, to the housing portion having the helical convex portion of the proximal portion, which is harder than the tubular body, and therefore the tubular body can be easily and firmly fixed to the proximal portion. In addition, since the proximal portion is made of resin rather than metal, damage to the tubular body when fixing the tubular body to the proximal portion can be suppressed, and leakage from the gap between the proximal portion and the tubular body can be suppressed. [Brief description of the drawings]

[0014] [Figure 1] FIG. 1 is a plan view showing a medical tubular device according to an embodiment. [Diagram 2] FIG. 2 is a cross-sectional view showing a proximal end of a medical tubular device according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. Note that the dimensional ratios in the drawings may be exaggerated for convenience of explanation and may differ from the actual ratios. In the following description, the side of the medical tubular device 10 that is operated will be referred to as the "base end side," and the side that is inserted into the living body will be referred to as the "distal end side."

[0016] The medical tubular device 10 according to the embodiment of the present invention is a venous introducer to be inserted into a femoral, knee, or more peripheral vein in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). The blood vessel to be treated is a vein more peripheral than the inferior vena cava (e.g., iliac vein, femoral vein, popliteal vein, etc.). The blood vessel diameter of a vein is generally larger than that of an artery. For example, the inner diameter of an artery into which a medical tubular device is inserted is usually about 3 Fr to 8 Fr, whereas the inner diameter of a vein into which the medical tubular device 10 according to the present embodiment is inserted is about 6 Fr to 24 Fr. For this reason, the medical tubular device 10 has a long tubular body 20 with a large outer diameter.

[0017] As shown in Figures 1 and 2, the medical tubular device 10 has a long, flexible tubular body 20, a proximal portion 30 fixed to the base end of the tubular body 20, a port 40 communicating with the inner cavity of the proximal portion 30, and a valve body 50 positioned on the base end side of the position communicating with the port 40 in the inner cavity of the proximal portion 30.

[0018] The valve body 50 is a member arranged to close the opening on the base end side of the proximal portion 30, and seals the inner cavity of the tubular body 20 and the proximal portion 30 to suppress backflow of blood. The valve body 50 is made of rubber, elastomer, resin, etc., and is flexibly deformable, and is arranged on the inner circumferential surface of the inner cavity of the proximal portion 30. The valve body 50 is, for example, cylindrical, but the shape of the valve body 50 is not limited. The valve body 50 has a hole 51 formed therein through which the medical elongated body can be inserted. The shape of the hole 51 is not particularly limited, but is formed, for example, in a slit shape. When the medical elongated body is not inserted, the hole 51 of the valve body 50 is closed by the opposing surfaces inside the hole 51 coming into close contact with each other to prevent blood leakage.

[0019] The port 40 is connected to the proximal portion 30 and communicates with the inner cavity of the tubular body 20 via the inner cavity of the proximal portion 30. The port 40 has a connection part 41 such as a three-way stopcock at the end opposite to the side connected to the proximal portion 30. By connecting a syringe or the like to the connection part 41, the inner cavity of the tubular body 20 can be primed.

[0020] The proximal portion 30 is a member to which the base end of the tubular body 20 is fixed, and can be grasped and operated by the surgeon. The proximal portion 30 has a proximal portion lumen 31 that communicates with the lumen of the tubular body 20 and the lumen of the port 40. The proximal portion 30 has a housing portion 32 on the distal end side that forms a part of the distal end side of the proximal portion lumen 31. The housing portion 32 is a portion that houses the proximal end of the tubular body 20 and is engaged with the tubular body 20.

[0021] The storage section 32 has a helical groove 33 and a helical protrusion 34 formed along the helical groove 33 on the inner circumferential surface. The helical groove 33 has a valley 35 at the most recessed position. The helical protrusion 34 has a peak 36 at the most protruding position. A side surface 37 is formed between the peak 36 and the valley 35. The valley 35 is formed with a substantially constant inner diameter along the long axis direction X of the tube 20. The peak 36 is also formed with a substantially constant inner diameter along the long axis direction X of the tube 20. That is, the peak 36 is formed smoothly. The inner diameter of the valley 35 is larger than the outer diameter of the tube 20. Therefore, the base end of the tube 20 can easily enter the storage section 32. The inner diameter of the peak 36 is substantially constant with the outer diameter of the tube 20. Therefore, the peak 36 can be in close contact with the outer circumferential surface of the tube 20. The pitch of the helical groove 33 and the helical protrusion 34 is preferably constant along the longitudinal axis direction X of the tubular body 20. Note that the outer peripheral surface of the tubular body 20 to which the apex 36 of the helical protrusion 34 is in intimate contact is smooth and does not have a male thread that meshes with the helical protrusion 34, so that the inner diameter of the apex 36 and the pitch of the helical protrusion 34 may vary along the longitudinal axis direction X.

[0022] At least the storage portion 32 in which the spiral groove 33 is formed is made of a resin harder than PTFE. Examples of resins harder than PTFE include acrylonitrile-butadiene-styrene copolymers (hereinafter sometimes referred to as ABS resins), polystyrene, polyolefins, polyurethane, polyester, polyamide, etc. The storage portion 32 is not made of a metal material.

[0023] The tube 20 is a long member that can be inserted into a living body. The tube 20 is made of PTFE and has a constant outer diameter and inner diameter along the long axis direction X of the tube 20. The tube 20 may have a portion in which the outer diameter and / or inner diameter changes along the long axis direction X. It is preferable that the outer circumferential surface of at least the base end of the tube 20 has a constant outer diameter along the long axis direction X of the tube 20 so that the tube 20 is appropriately accommodated in the accommodation portion 32. The outer circumferential surface of at least the base end of the tube 20 is formed smoothly. That is, no helical convex or concave portion is formed on the outer circumferential surface of the base end of the tube 20 that is in close contact with the apex 36 of the helical convex portion 34.

[0024] The outside diameter D of the base end of the tube 20 is 7 mm or more, preferably 9 mm or more, and more preferably 10 mm or more. As the outside diameter D of the base end of the tube 20 is smaller, the wall thickness T of the tube 20 becomes thinner and the strength decreases, so that the tube 20 becomes more easily deformed and it becomes difficult to maintain the fixing strength by the close contact with the spiral convex portion 34 of the proximal portion 30. Therefore, as the outside diameter D of the base end of the tube 20 is larger, the wall thickness T of the tube 20 can be appropriately set so that the tube 20 is less likely to deform, and the base end of the tube 20 can be firmly fixed to the spiral convex portion 34 of the proximal portion 30.

[0025] The wall thickness T of the base end of the tube 20 is 0.5 mm or more, preferably 1.0 mm or more, and more preferably 2.0 mm or more. The smaller the wall thickness T of the base end of the tube 20, the lower the strength of the base end of the tube 20 and the easier it is to deform, making it more difficult to maintain the fixing strength due to close contact with the spiral convex portion 34 of the proximal portion 30. Therefore, the larger the wall thickness T of the base end of the tube 20, the less the tube 20 deforms, and the more firmly the base end of the tube 20 can be fixed to the spiral convex portion 34 of the proximal portion 30.

[0026] When the tube body 20 is fixed to the proximal portion 30, the base end of the tube body 20 having a smooth outer peripheral surface is screwed into the housing portion 32 having the helical protrusion 34 of the proximal portion 30 while rotating the tube body 20 and the proximal portion 30 relative to each other. At this time, since the outer diameter D of the base end of the tube body 20 is 7 mm or more and the wall thickness T is 0.5 mm or more, the base end of the tube body 20 is not easily deformed. Therefore, even if the smooth apex 36 of the helical protrusion 34 of the proximal portion 30, which is made of a material harder than the tube body 20 and hardly deforms, comes into contact with the base end, the outer peripheral surface of the base end of the tube body 20 is hardly depressed and maintains a smooth state. Therefore, even if the apex 36 of the helical protrusion 34 of the proximal portion 30, which is made of a material harder than the tube body 20 and hardly deforms, comes into contact with the base end, the tube body 20 hardly deforms and does not escape inward, so the tube body 20 is firmly fitted to the housing portion 32 of the proximal portion 30. Furthermore, by forming the helical protrusion 34 and the helical groove 33 in the proximal portion 30, even if the proximal portion 30 and the tube 20 are made of a hard material, a mechanically strong fit can be achieved by screwing. The portion of the outer surface of the tube 20 that comes into contact with the helical protrusion 34 is hardly dented, but a negligible dent may occur for an outer diameter of the tube 20 of 0.1 mm or less. The portion of the outer surface of the tube 20 that comes into contact with the helical protrusion 34 is hardly dented or damaged, but abrasion marks may occur. The abrasion marks have almost no effect on leakage between the proximal portion 30 and the tube 20.

[0027] The side surface 37 of the helical protrusion 34 from the apex 36 to the valley 35 does not contact the outer circumferential surface of the tube 20. In a typical female screw and male screw engagement, the apex of the female screw thread does not contact the male screw thread, but the side surface of the female screw thread contacts the side surface of the male screw thread. Therefore, the engagement of the helical protrusion 34 and the outer circumferential surface of the tube 20 in this embodiment is clearly different from the engagement of a typical female screw and male screw. Note that the medical tubular device 10 according to this embodiment is not used for administering a contrast medium, and therefore does not require high pressure resistance.

[0028] As described above, the medical tubular device 10 according to this embodiment has a tubular body 20 having an outer diameter of 7 mm or more and a wall thickness of 0.5 mm or more, which is made of polytetrafluoroethylene, and a proximal portion 30 which is fixed to the proximal end of the tubular body 20 and is made of a resin harder than polytetrafluoroethylene, the proximal portion 30 having a storage portion 32 in which a helical convex portion 34 is formed in at least a part of the lumen, and the apex 36 of the helical convex portion 34 is in close contact with the outer circumferential surface of the proximal end of the tubular body 20 to fit the storage portion 32. This makes the tubular body 20 of the medical tubular device 10 less likely to deform, and therefore the tubular body 20 can be fitted to the storage portion 32 while the helical convex portion 34 of the proximal portion 30, which is harder than the tubular body 20, is in close contact with the outer circumferential surface of the proximal end of the tubular body 20. Therefore, in the medical tubular device 10, the tubular body 20 made of polytetrafluoroethylene can be easily and firmly fixed to the proximal portion 30. Furthermore, since the proximal portion 30 is made of resin rather than metal, damage to the tubular body 20 when fixing the tubular body 20 to the proximal portion 30 can be suppressed, and leakage from the gap between the proximal portion 30 and the tubular body 20 can be suppressed. Furthermore, since the medical tubular device 10 does not require adhesion, fusion, or the like to fix the tubular body 20 to the proximal portion 30, costs can be reduced.

[0029] The resin forming the grip portion 30 is an acrylonitrile-butadiene-styrene copolymer. This allows the grip portion 30 to be attached to the tube body 20 with a strong fixing force while suppressing damage to the tube body 20 and suppressing leakage from the gap between the grip portion 30 and the tube body 20.

[0030] The outer peripheral surface of the tube 20 with which the apex 36 of the helical protrusion 34 comes into close contact is smooth. This eliminates the need for processing the tube 20 to form a screw thread or the like, thereby reducing costs.

[0031] The medical tubular device 10 has a valve body 50 disposed in the inner cavity of the proximal portion 30. This allows the medical tubular device 10 to prevent leakage of blood and the like by the valve body 50 while allowing other long devices to be inserted into the inner cavity of the proximal portion 30. Even in applications requiring the valve body 50, the medical tubular device 10 can effectively prevent leakage from a gap between the proximal portion 30 and the tubular body 20 by the strong engagement between the proximal portion 30 and the tubular body 20.

[0032] The manufacturing method of the medical tubular device 10 according to the present embodiment is a manufacturing method of the medical tubular device 10 in which a proximal portion 30 is fixed to a proximal portion of a long tubular body 20, and includes the steps of: preparing a tubular body 20 having an outer diameter of 7 mm or more and a wall thickness of 0.5 mm or more, made of polytetrafluoroethylene; and a housing portion 32 made of a resin harder than polytetrafluoroethylene and having a helical convex portion 34 formed in at least a part of the lumen; screwing the proximal portion of the tubular body 20 into the housing portion 32, and bringing the apex 36 of the helical convex portion 34 into close contact with the outer circumferential surface of the proximal portion of the tubular body 20 to fit the tubular body 20 to the housing portion 32. In this way, in this manufacturing method, the proximal portion of the tubular body 20, which is difficult to deform, is fitted to the housing portion 32 having the helical convex portion 34 of the proximal portion 30, which is harder than the tubular body 20, so that the tubular body 20 can be easily and firmly fixed to the proximal portion 30. In addition, since the grip portion 30 is formed from resin rather than metal, damage to the tube body 20 when fixing the tube body 20 to the grip portion 30 is suppressed, and leakage from the gap between the grip portion 30 and the tube body 20 is suppressed.

[0033] The present invention is not limited to the above-described embodiment, and various modifications may be made by those skilled in the art within the technical concept of the present invention. For example, the medical tubular device 10 may be an introducer for an artery. In addition, the medical tubular device 10 is not limited to an introducer, and may be, for example, a catheter for other uses, an endoscope, an insertion tube for the airway or digestive tract, or an evacuation tube. [Explanation of symbols]

[0034] 10 Medical tubular devices 31 Hand lumen 34 Spiral convexity 30 Hand section 40 Ports 41 Connection 32 Storage unit 33 Spiral groove 20 Body 50 Valve body 35 Valley 36 Top 37 Side 51 holes D Outside diameter of tube T Body thickness X Long axis direction

Claims

1. A tube having an outer diameter of 7 mm or more and a wall thickness of 0.5 mm or more and made of polytetrafluoroethylene; a proximal portion fixed to the proximal end of the tubular body and made of a resin harder than polytetrafluoroethylene; The medical tubular device is characterized in that the proximal portion has a accommodating portion having a helical protrusion formed in at least a part of the inner cavity, and the apex of the helical protrusion is in close contact with the outer peripheral surface of the base end of the tubular body so that the tubular body fits into the accommodating portion.

2. 2. The medical tubular device according to claim 1, wherein the resin forming the proximal portion is an acrylonitrile-butadiene-styrene copolymer.

3. 3. The medical tubular device according to claim 1, wherein the outer peripheral surface of the tubular body with which the top of the helical protrusion is in intimate contact is smooth.

4. 3. The medical tubular device according to claim 1, further comprising a valve disposed in the lumen of the proximal portion.

5. A method for manufacturing a medical tubular device having a proximal end portion fixed to a proximal end portion of a long tubular body, comprising the steps of: A tube having an outer diameter of 7 mm or more and a wall thickness of 0.5 mm or more and made of polytetrafluoroethylene, and a container portion made of a resin harder than polytetrafluoroethylene and having a helical convex portion formed in at least a part of the inner cavity are prepared; A method for manufacturing a medical tubular device, characterized in that the base end of the tubular body is screwed into the accommodating portion and the apex of the helical convex portion is brought into close contact with the outer peripheral surface of the base end of the tubular body to engage the tubular body with the accommodating portion.

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