Medical components and methods for manufacturing the same

Abstract

To provide a medical component with a joint structure for connecting other components to a flexible tube, the medical component that can satisfy requirements placed on the medical component, particularly, joint strength and airtightness, and provide its manufacturing method.SOLUTION: A medical component 10 comprises: a flexible tube 11 where an end 11a is structured in a manner of increasing diameter toward an end edge; end fittings 12 arranged in an outer circumferential side of the tube, and including a receiving surface 12a for receiving an end of the tube from a base end side; and fasteners 13 arranged in an inner circumferential side of the tube, and including a fastening surface 13a for fastening the end of the tube from the tip side. The end fittings 12 and the fasteners 13 are fixed by caulking in mutually facing areas 12b, 13b provided at the tip side more further than the end edge of the tube, while the end 11a of the tube 11 is pressurized between the receiving surface 12a and the fastening surface 13a.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a medical member and a method for manufacturing the same.

Background Art

[0002] Conventionally, a tubular medical member for performing operations such as extraction or discharge of body fluids such as blood, or injection of a chemical solution or a contrast agent, cutting, removal, opening, dilation, imaging, etc. by inserting it into a blood vessel, a body cavity, or internal organs such as the bladder, urethra, trachea, esophagus, stomach, and large intestine has been widely used. Such medical members include those used for therapeutic medical devices (e.g., surgical catheters, etc.) and those used for diagnostic medical devices (e.g., endoscopes, etc.). In addition, as medical members, there are not only those incorporated into medical devices but also those used alone.

[0003] Among the above medical members, there may be a joint structure that connects another member to a flexible tube. However, since at least a part of it is introduced into the patient's body, it is necessary to ensure the overall stability including the joint structure and the joint strength of the joint structure. Moreover, it is also necessary to configure the outer dimensions as compact as possible. As a medical member having such a joint structure, those described in the following Patent Documents 1-4 are known.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Summary of the Invention

[0005] Incidentally, the joining methods used for medical components as described above typically include the heat fusion method adopted in Patent Document 1 and bonding methods using various adhesives. However, when the heat fusion method is used, the material may be altered by heating, which may reduce the durability of the joint strength and lead to separation during use. Furthermore, even when using bonding methods, sufficient bonding strength cannot often be ensured depending on the combination of resin materials, and the bonding strength may be even lower when bonding resin and metal. In addition, in medical components, from the perspective of being inserted into the patient's body, there are often constraints on the external dimensions of various tubular materials, and the joint structure that connects other components to these tubular materials also requires a reduction in external dimensions, similar to the tubular material itself.

[0006] On the other hand, as shown in Patent Documents 2-4, when metal parts are used in medical components, crimping has traditionally been used for fixing. However, conventional crimping has low reliability, making it difficult to use with confidence as a medical component. There are problems such as insufficient joint strength to prevent failure during surgery and inadequate sealing to prevent leakage of liquids, etc. Furthermore, there is the problem that sufficient fixing strength cannot be ensured unless metal is fixed to metal.

[0007] The present invention solves the above problem, and its objective is to provide a medical component having a joint structure for connecting other members to a flexible tube, which can satisfy the requirements imposed on medical components, particularly joint strength and airtightness, as well as a method for manufacturing the same. [Means for solving the problem]

[0008] The medical component of the present invention comprises a flexible tube configured such that its end expands in diameter toward the edge; an end fitting disposed on the outer circumference of the tube and having a receiving surface that receives the end of the tube from the base end side of the tube; and a fastening fitting disposed on the inner circumference of the tube and having a fastening surface that fastens the end of the tube from the tip side of the tube. Here, the end fitting and the fastening fitting are crimped and fixed in mutually facing regions located further toward the tip side than the edge of the tube, while the end of the tube is pressurized between the receiving surface and the fastening surface.

[0009] In the present invention, it is preferable that the fastening fitting has a recess in the opposing region, and that a portion of the end fitting facing the opposing region is introduced into the recess by plastic flow due to crimping. Furthermore, it is preferable that the recess is an annular groove.

[0010] In the present invention, it is preferable that the inclination angle of the receiving surface with respect to the axial direction is greater than the inclination angle of the clamping surface with respect to the axial direction.

[0011] In the present invention, it is preferable that at least one of the receiving surface and the clamping surface has a surface with an uneven structure. In this case, it is preferable that the uneven structure of the surface is composed of a surface portion along the axial direction and a surface portion along a plane perpendicular to the axial direction. This makes it possible to balance the improvement of the joint strength and sealing performance between the end of the tube and the fitting with the suppression of breakage of the end, thereby realizing a medical component with high strength.

[0012] In the present invention, it is preferable that the end fitting has an end fitting side contact surface facing the tip side, and the fastening fitting has a fastening fitting side contact surface facing the base end side, and that the distance between the receiving surface and the fastening surface is set by the end fitting side contact surface and the fastening fitting side contact surface contacting each other.

[0013] In the present invention, the fastening fitting is preferably provided with a through hole along the axis, and the inner diameter of the fastening fitting is preferably greater than or equal to the minimum inner diameter of the end of the tube.

[0014] Next, the method for manufacturing a medical component of the present invention comprises a tube forming step of forming the end of a flexible tube in such a manner that its diameter is expanded toward the edge, and a fitting crimping step of arranging an end fitting having a receiving surface that receives the end of the tube from the base end side of the tube on the outer circumference side of the tube, and a fastening fitting having a fastening surface that fastens the end of the tube from the tip side of the tube on the inner circumference side of the tube, wherein the respectively arranged end fitting and fastening fitting are configured to have areas facing each other toward the tip side of the end of the tube, and the end fitting and fastening fitting are pressed in the axial direction so that the end of the tube is compressed by the receiving surface and the fastening surface, and the facing areas are crimped and fixed. Here, it is preferable that the end fitting has an end fitting side contact surface facing the tip side, and the fastening fitting has a fastening fitting side contact surface facing the base end side, and that the fitting crimping process is carried out with the end fitting side contact surface and the fastening fitting side contact surface in contact with each other due to axial pressure. [Effects of the Invention]

[0015] According to this invention, it is possible to provide a medical component that has a joint structure for connecting other members to a flexible tube, which can satisfy the requirements imposed on medical components, as well as a method for manufacturing the same. In particular, since the joint strength and airtightness between the metal fitting and the tube can be improved, it becomes possible to manufacture high-quality and safe medical components. [Brief explanation of the drawing]

[0016] [Figure 1] This is an enlarged partial cross-sectional view showing the vicinity of the end portion of the first embodiment of the medical component according to the present invention. [Figure 2] This is an explanatory cross-sectional view showing the first stage of the manufacturing process of the first embodiment. [Figure 3]It is an explanatory cross-sectional view showing the second stage of the manufacturing process of the first embodiment. [Figure 4] It is an enlarged partial cross-sectional view showing the vicinity of the end of the tube of the first embodiment. [Figure 5] It is an enlarged partial cross-sectional view showing the vicinity of the end of the tube of the second embodiment. [Figure 6] It is an enlarged partial cross-sectional view showing the vicinity of the end of the tube of the third embodiment. [Figure 7] It is a schematic general view (a) of a catheter introducer, dilator, and catheter showing an example in which an embodiment of a medical member is used, and an enlarged perspective view (b) of the tip of an endoscope showing another example.

Embodiments for Carrying Out the Invention

[0017] Next, embodiments of the present invention will be described in detail with reference to the accompanying drawings. First, referring to FIGS. 1 to 4, a first embodiment of a medical member and its manufacturing method according to the present invention will be described.

[0018] As will be described later, the medical member 10 of the present embodiment can be used as various medical members having a tubular portion. In the illustrated example, it is exemplified as being used for a catheter called a tip movable catheter or a tip deflectable catheter, in which the extending direction of the tip portion can be changed by an operation. Examples of such catheters include catheters for administering tissues such as drugs and cells, catheters for performing various treatments such as tissue collection, blood vessel dilation, and stent placement. As shown in FIG. 1, the medical member 10 has a flexible tube 11, and end fittings 12 and clamping fittings 13 made of a metal such as stainless steel attached to the tube 11. The tube 11 is made of a synthetic resin such as PTFE (polytetrafluoroethylene) or PFA (tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer), a resin material containing a core material such as a braided material of metal wires, or other flexible materials.

[0019] In this embodiment, the tube 11 preferably has an inner or outer diameter within the range of 0.05 mm to 10 mm, and more preferably within the range of 0.5 mm to 3 mm. In the illustrated example, due to its use as a catheter, the inner or outer diameter of the tube 11 is approximately 1 mm.

[0020] The end fitting 12 has a mounting portion 12d to which a locking member 14 for securing the operating wires 15 and 16 is attached. In the illustrated example, the mounting portion 12d is formed on the outer circumference of the base end of the end fitting 12. The operating wires 15 and 16 connected to the locking member 14 are connected to an operating part (not shown) provided on the base structure to which the tube 11 is connected, and are configured to be able to change the direction of extension of the tip of the tube 11 arbitrarily by being pulled in response to operation on the operating part.

[0021] The end portion 11a of the tube 11 is deformed into a conical shape that expands in diameter towards the tip edge. The shape of this end portion 11a may be a conical, expanded shape as shown in the figure, as a result of the end fitting 12 and the fastening fitting 13, but as will be described later, it is preferable that the end portion 11a is formed in advance to have the expanded shape and then compressed between the receiving surface 12a and the fastening surface 13a.

[0022] The end fitting 12 is configured in a tubular shape with a through hole 12t and has a base end 12A and a tip end 12B. The base end 12A is positioned on the base end side (right side in Figure 1, hereinafter simply referred to as the "base end side") in the direction along the axis 11x (hereinafter simply referred to as the "axial direction") relative to the end 11a of the tube 11. The mounting portion 12d is provided on this base end 12A. A receiving surface 12a is provided on the inner circumference between the base end 12A and the tip end 12B. This receiving surface 12a has an inner diameter that expands conically toward the tip side (left side in Figure 1, hereinafter simply referred to as the "tip side") in the axial direction so as to receive (support) the end 11a of the tube 11 from the base end side.

[0023] The tip portion 12B is provided with an inner circumference portion 12b that faces the fastening fitting 13. Between this inner circumference portion 12b and the receiving surface 12a, a stepped contact surface 12c facing the tip is formed. In the illustrated example, the contact surface 12c is annular in shape due to the difference in the inner diameter of the portions on both sides in the axial direction.

[0024] The fastening fitting 13 is configured in a tubular shape with a through hole 13t. The base end of the fastening fitting 13 is provided with a tightening surface 13a that faces the receiving surface 12a. The tightening surface 13a has an outer diameter that widens towards the tip in the axial direction so as to tighten (press) the end 11a of the tube 11 from the tip side. In the illustrated example, the tightening surface 13a is formed in a conical shape from the base edge of the fastening fitting 13 toward the tip. The base edge of the fastening fitting 13 is a narrow, annular edge.

[0025] The fastening fitting 13 has an outer peripheral portion 13b facing the tip side of the fastening surface 13a. This outer peripheral portion 13b faces the inner peripheral portion 12b in the radial direction. A recess 13d is provided in the outer peripheral portion 13b. In this embodiment, the recess 13d is an annular groove formed around the axis. A part of the inner peripheral portion 12b is introduced into the recess 13d by plastic deformation, thereby crimping and fixing the end fitting 12 and the fastening fitting 13.

[0026] Between the clamping surface 13a and the opposing outer circumference 13b of the fastening fitting 13, a contact surface 13c facing the base end is formed. In the illustrated example, the stepped contact surface 13c is annular in shape due to the difference in outer diameter between the parts on both sides in the axial direction. In the crimped fixing state shown in Figure 1, the stepped contact surface 12c and the stepped contact surface 13c are in contact in the axial direction. That is, the opposing inner circumference 12b and the opposing outer circumference 13b are crimped and fixed in a state where the corresponding stepped contact surfaces 12c and 13c are in contact. At this time, the contact between the contact surfaces 12c and 13c positions the end fitting 12 and the fastening fitting 13 in the axial direction, and the distance between the receiving surface 12a and the clamping surface 13a, i.e., the thickness of the end 11a of the tube 11, is set. Furthermore, in this state, the end portion 11a of the tube 11 is pressurized (constricted) in the axial direction by the receiving surface 12a and the clamping surface 13a.

[0027] Figure 2 is a schematic explanatory cross-sectional view showing the molding process (first step) of the end 11a of the tube 11. In the illustrated example, the end 11a of the tube 11, held in the female mold 21A, is pressed and molded by the male mold 21B. Here, the end 11a of the tube 11 is heated by the mold or before molding. Here, the expanding (conical) molding surface 21At of the female mold 21A and the conical molding surface 21Bt of the male mold 21B mold the end 11a of the tube 11 into a conical expanding shape.

[0028] Figure 3 is a schematic explanatory cross-sectional view showing the crimping and fixing process (second process). The base end surface 12As of the end fitting 12 is supported by the support type 22A, and the tip surface of the fastening fitting 13 is pressed by the pressure type 22B and the pressure spring 22C, thereby narrowing the end 11a of the tube 11 in the axial direction between the receiving surface 12a of the end fitting 12 and the fastening surface 13a of the fastening fitting 13. At this time, if the contact surfaces 12c and 13c are in contact, the distance between the receiving surface 12a and the fastening surface 13a will be a preset design value, thereby improving the stability and reproducibility of the pressurization of the end 11a of the tube 11. In this state, the outer circumference 12Bs of the tip of the end fitting 12 is crimped and fixed by the crimping type 22D which has an annular mold surface facing diagonally inward towards the base end side. At this time, plastic flow occurs from the opposing inner circumference 12b into the recess 13d of the opposing outer circumference 13b, and as described above, the end fitting 12 and the fastening fitting 13 are crimped and fixed together.

[0029] Figure 4 is an enlarged section cross-sectional view showing the vicinity of the end 11a of the tube 11 in the cross-sectional view of Figure 1. As described above, in the medical component 10, the end fitting 12 and the fastening fitting 13 are crimped and fixed with the end 11a of the tube 11 compressed between the receiving surface 12a and the fastening surface 13a. At this time, the inclination angle θ of the receiving surface 12a with respect to the axis 11x is set to be greater than the inclination angle φ of the fastening surface 13a with respect to the axis 11x. This is because by setting θ > φ, when the end 11a is pressed between the receiving surface 12a and the fastening surface 13a, the thickness of the base end (right side in the figure) is narrowed compared to the tip end (left side in the figure), thereby increasing the resistance to pulling the tube 11 out from the end fitting 12 and the fastening fitting 13. As a result, the joint strength and sealing performance between the tube 11 and the end fitting 12 and the fastening fitting 13 can be improved.

[0030] Here, the inclination angle θ is not particularly limited, but it is preferably within the range of 30 - 60 degrees, and particularly preferably within the range of 40 - 50 degrees. In the illustrated example, θ = 45 degrees. On the other hand, since the inclination angle φ is smaller than θ, it is preferably within the range of 25 - 55 degrees, and particularly preferably within the range of 35 - 45 degrees. The inclination angles θ and φ are preferably angles close to 45 degrees. When they are smaller than the above range, the pulling resistance between the tube 11 and the fittings 12, 13 decreases. When they are larger than the above range, the tube 11 is likely to break. In any case, the joining strength decreases. Also, the angle difference θ - φ is preferably within the range of 3 - 15 degrees, and particularly preferably within the range of 5 - 10 degrees. When the angle difference is smaller than the above range, the effect of increasing the pulling resistance becomes weak. When the angle difference is larger than the above range, the end portion 11a of the tube 11 is likely to break. In any case, the joining strength and sealing performance required for the medical member 10 decrease.

[0031] Also, when the clamping fitting 13 has the through hole 13t, the inner diameter IDb is preferably not less than the inner diameter IDa of the tube 11. This is because in the medical member 10 configured as a tubular body such as a catheter, sheath, endoscope, etc., it is necessary to insert a guide wire, catheter, sensor (inspection tool), treatment tool, etc. inside and configure it to be able to extend and retract. Particularly, as in the illustrated example, when IDa < IDb, the base end portion of the clamping fitting 13 (the annular base end edge in the illustrated example) is likely to be wedged into the base of the end portion 11a of the tube 11, so that the pulling resistance can be further increased and the sealing performance can be improved.

[0032] Furthermore, as mentioned above, it is preferable that the end fittings 12 and 13, which are crimped and fixed to the end 11a of the tube 11 while being clamped, have their contact surfaces 12c and 13c in contact. The contact of the contact surfaces 12c and 13c means that the distance between the receiving surface 12a and the clamping surface 13a that clamp the end 11a of the tube 11, i.e., the thickness of the end 11a, is set to a predetermined value. This allows the joint structure of the tube 11 and the fittings 12 and 13 to be obtained as designed, resulting in the desired joint strength and airtightness. In other words, it prevents the end 11a of the tube 11 from breaking due to the distance between the receiving surface 12a and the clamping surface 13a being too small, and prevents a decrease in the pull-out resistance of the tube 11 due to the distance between the receiving surface 12a and the clamping surface 13a being too large, thus ensuring that the required joint strength and airtightness can be obtained stably and reliably.

[0033] Next, a second embodiment of the present invention will be described with reference to Figure 5. In this second embodiment, the only difference is that the clamping surface 13a' of the fastening fitting 13' is different from the clamping surface 13a of the first embodiment. Since the other components can be configured in the same way as in the first embodiment, the same reference numerals are used for the same parts, and their descriptions are omitted. The clamping surface 13a' of this embodiment is not a continuous surface like the clamping surface 13a, but is configured in an uneven manner. The uneven structure of the clamping surface 13a' has a size (protrusion amount) in the range of 0.05-0.15 mm, preferably about 0.1 mm. The manner of the unevenness of the clamping surface 13a' is not particularly limited, but in the illustrated example, it has a stepped (staircase) surface structure comprising a surface portion 13a-1 along the axis 11x (in the illustrated example, a ring-shaped strip with width in the axial direction around the axis 11x) and a surface portion 13a-2 along a plane perpendicular to the axis 11x (in the illustrated example, a ring-shaped strip with width in the radial direction around the axis 11x). The above-mentioned uneven structure is preferably formed in multiple periodic (set) patterns on the clamping surface 13a', and it is desirable that 2 to 3 uneven surfaces (sets) are formed as shown in the illustrated example.

[0034] In this embodiment, since the clamping surface 13a' is configured in an uneven shape, the uneven structure bites into the end 11a of the tube 11, increasing the resistance to pulling out the tube 11 and improving the sealing performance. In particular, since the uneven structure is composed of a surface portion 13a-1 along the axis 11x and a surface portion 13a-2 along a plane perpendicular to the axis 11x, when the clamping fitting 13 is pushed along the axis 11x against the end 11a of the tube 11 on the receiving surface 12a of the end fitting 12, it is less likely to affect the position of the end 11a on the receiving surface 12a, and the resistance to pulling out the tube 11 against the fittings 12 and 13 is increased, while suppressing the possibility of the end 11a of the tube 11 breaking. This is because the surface of the above-mentioned uneven structure is composed of a surface along the axis 11x and a surface perpendicular to the axis 11x, making it difficult to exert radial force on the end 11a. As a result, it is difficult to move the end 11a on the receiving surface 12a. Furthermore, because the angle difference between the two surfaces is 90 degrees, the uneven structure is not sharp, making it difficult to tear the end 11a.

[0035] In this embodiment as well, by making the inclination angle φ of the base surface (dotted line in the figure) of the uneven structure of the clamping surface 13a' smaller than the inclination angle θ of the receiving surface 12a, similar effects and advantages as in the first embodiment can be achieved. Similarly, by making the inner diameter IDb of the clamping fitting 13' greater than or equal to the inner diameter IDa of the tube 11, and especially greater than IDa, similar effects and advantages as described above can be obtained. Furthermore, since the contact between the contact surfaces 12c and 13c determines the distance between the receiving surface 12a and the uneven structure of the clamping surface 13a', the amount of penetration of the uneven structure into the end 11a of the tube 11 can be set accurately and reproducibly, thus providing a good suppression effect on pull-out resistance and the possibility of breakage.

[0036] Next, a third embodiment of the present invention will be described with reference to Figure 6. In this third embodiment, the only difference is that the receiving surface 12a' of the end fitting 12' differs from the receiving surface 12a of the first embodiment. Since the other components can be configured in the same way as in the first embodiment, the same reference numerals are used for the same parts, and their descriptions are omitted. The receiving surface 12a' of this embodiment is not a continuous surface like the receiving surface 12a, but is configured in an uneven manner. The uneven structure of the receiving surface 12a' has a size (protrusion amount) in the range of 0.05-0.15 mm, preferably about 0.1 mm. The manner of the unevenness of the receiving surface 12a' is not particularly limited, but in the illustrated example, it has a stepped (staircase) surface structure comprising a surface portion 12a-1 along the axis 11x (in the illustrated example, a ring-shaped strip with width in the axial direction around the axis 11x) and a surface portion 12a-2 along a plane perpendicular to the axis 11x (in the illustrated example, a ring-shaped strip with width in the radial direction around the axis 11x). The above-mentioned uneven structure is preferably formed in multiple periodic (set) patterns on the receiving surface 12a', and it is desirable that 2 to 3 (sets) of unevenness are formed as shown in the illustrated example.

[0037] In this embodiment, the receiving surface 12a' is configured with an uneven surface, which causes the uneven structure to bite into the end 11a of the tube 11, thereby increasing the resistance to pulling out the tube 11 and improving the sealing performance. In particular, since the uneven structure is composed of a surface portion 12a-1 along the axis 11x and a surface portion 12a-2 along a plane perpendicular to the axis 11x, when the fastening fitting 13 is pushed along the axis 11x against the end 11a of the tube 11 on the receiving surface 12a' of the end fitting 12', it is less likely to affect the position of the end 11a on the receiving surface 12a', and the resistance to pulling out the tube 11 from the fittings 12 and 13 is increased, while suppressing the possibility of the tube 11 breaking. The reason for this is the same as for the fastening surface 13a' in the second embodiment.

[0038] In this embodiment as well, by making the inclination angle θ of the base surface (dotted line in the figure) of the uneven structure of the receiving surface 12a' larger than the inclination angle φ of the clamping surface 13a, similar effects and advantages as in the first and second embodiments can be achieved. Similarly, by making the inner diameter IDb of the clamping fitting 13 greater than or equal to the inner diameter IDa of the tube 11, and especially greater than IDa, similar effects and advantages as described above can be obtained. Furthermore, since the contact between the contact surfaces 12c and 13c determines the distance between the uneven structure of the receiving surface 12a' and the clamping surface 13a, the amount of penetration of the uneven structure into the end 11a of the tube 11 can be set accurately and reproducibly, thus providing a good suppression effect on pull-out resistance and the possibility of breakage.

[0039] Furthermore, in the second and third embodiments described above, either the receiving surface or the clamping surface is configured with an uneven surface, but both the receiving surface and the clamping surface may be configured with an uneven surface as described above. In this case, it is preferable to configure the uneven structure of the receiving surface and the uneven structure of the clamping surface so that the patterns of the unevenness fit together with respect to the end 11a of the tube 11. That is, the recesses of the receiving surface face the protrusions of the clamping surface with respect to the end 11a, and the protrusions of the receiving surface face the recesses of the clamping surface with respect to the end 11a. In this way, the end 11a is interposed between the receiving surface and the clamping surface in an uneven manner, so even if the height of the unevenness is somewhat large, comparable to the thickness of the end 11a, the pull-out resistance can be further increased, and the possibility of the end 11a breaking can be suppressed. However, if the height of the unevenness is sufficiently low compared to the thickness of the end 11a, such as 1 / 3 or less of the thickness of the end 11a, it is not necessary for the uneven structure of the receiving surface and the uneven structure of the clamping surface to correspond to each other.

[0040] Figure 7 is a schematic diagram illustrating the applications of the medical component 10 according to the present invention. Figure 7(a) shows a sheath introducer A, a dilator B, and a catheter D guided by a guidewire C, all used in catheter surgery. The medical component 10 can be applied to the sheath tip Aa of the sheath introducer A. It can also be applied to the tubular tip Ba of the dilator B. Furthermore, it can be applied to the tip Da of the catheter D.

[0041] Figure 7(b) schematically shows the tip structure of the endoscope E. The endoscope E uses a flexible tube Ea, and a tip structure Eb is formed by attaching a metal component Eb to its tip. This tip structure Eb can be constructed by an end fitting 12 and a fastening fitting 13 attached to the tip of the aforementioned tube 11.

[0042] It should be noted that the medical component and its manufacturing method of the present invention are not limited to the illustrated examples described above, and various modifications can be made without departing from the spirit of the present invention. For example, in each of the above embodiments, the end 11a of the tube 11 is shaped to widen into a cone towards the tip, but this is not particularly limited, and it can be shaped in various ways, such as a curved shape. Also, although the inclination angles θ and φ are set within the range of 40-60 degrees, they may be around 90 degrees, or even angles exceeding 90 degrees. [Explanation of symbols]

[0043] 10...Medical component (catheter tube), 11...Flexible tube, 11a...End, 12...End fitting, 12A...Base end, 12As...Base end face, 12B...Tip, 12Bs...Tip outer circumference, 12a...Receiving surface, 12b...Opposite inner circumference, 12c...Contact surface (end fitting side), 13...Clamping fitting, 13A...Base end, 13B...Tip, 13a...Clamping surface, 13b...Opposite outer circumference, 13c...Contact surface (clamping fitting side), 13d...Recess (annular groove), 14...Locking member, 15,16...21 (21A...Female type, 21B...Male type)...Tube molding mold, 22 (22A...Support type, 22B...Pressure type, 22C...Pressure spring, 22D...Crimping type)...Crimping fixing type

Claims

1. A flexible tube configured such that its end expands in diameter towards the edge, An end fitting is provided which is arranged on the outer circumference of the tube and has a receiving surface that receives the end of the tube from the base end side of the tube, A fastening fitting is provided which is positioned on the inner circumference side of the tube and has a fastening surface that fastens the end of the tube from the tip side of the tube, It is equipped with, A medical component wherein the end fitting and the fastening fitting are crimped and fixed in mutually opposing regions located further towards the tip than the end edge of the tube, while the end of the tube is pressurized between the receiving surface and the fastening surface.

2. The fastening fitting has a recess in the opposing region, A portion of the end fitting facing the aforementioned region is introduced into the recess by plastic flow due to crimping and fixing. The medical component according to claim 1.

3. The inclination angle of the receiving surface with respect to the axial direction is greater than the inclination angle of the clamping surface with respect to the axial direction. The medical component according to claim 1 or 2.

4. At least one of the receiving surface and the clamping surface has a surface with an uneven structure. A medical component according to any one of claims 1 to 3.

5. The uneven structure of the surface is composed of a surface portion aligned with the axial direction and a surface portion aligned with a plane perpendicular to the axial direction. The medical component according to claim 4.

6. The end fitting has an end fitting side contact surface facing the tip side, The fastening fitting has a fastening fitting side contact surface facing the base end side, The contact surface on the end fitting side and the contact surface on the fastening fitting side come into contact with each other, thereby setting the distance between the receiving surface and the fastening surface. A medical component according to any one of claims 1 to 5.

7. The fastening fitting has a through hole along the axis, The inner diameter of the fastening fitting is greater than or equal to the minimum inner diameter of the end of the tube. A medical component according to any one of claims 1 to 6.

8. A tube forming process in which the end of a flexible tube is formed in such a manner that its diameter is expanded toward the edge, An end fitting having a receiving surface that receives the end of the tube from the base end side of the tube is arranged on the outer circumference side of the tube, and a fastening fitting having a fastening surface that fastens the end of the tube from the tip side of the tube is arranged on the inner circumference side of the tube, and the respective end fitting and fastening fitting are configured to have areas facing each other on the tip side of the tube from the end, and the end fitting and fastening fitting are pressed in the axial direction so that the end of the tube is compressed by the receiving surface and the fastening surface, and the facing areas are crimped and fixed, in a fitting crimping process, A method for manufacturing medical components, comprising the following:

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