JP2023120709A - Medical component and its manufacturing method - Google Patents

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

The present invention relates to a medical device and a manufacturing method thereof.

Conventionally, it is inserted into blood vessels, body cavities, or internal organs such as the bladder, urethra, trachea, esophagus, stomach, and large intestine to extract and discharge body fluids such as blood, or to inject drug solutions and contrast agents, and to cut and remove various parts. It is a tubular medical member for performing operations such as opening, dilating, and imaging, and medical devices that have a tubular structure at least in part, such as medical catheters, puncture needles, and endoscopes, are widely used. It is Medical devices of this type include those used in therapeutic medical devices (for example, surgical catheters) and those used in diagnostic medical devices (for example, endoscopes). In addition, medical members include not only those that are incorporated into medical equipment, but also those that are used alone.

The above medical device may have a joint structure for connecting other members to a flexible tube. In addition, it is necessary to secure the joint strength of the joint structure and to make the outer dimensions as compact as possible. As a medical member having such a joint structure, those described in Patent Documents 1 to 4 below are known.

JP 2008-188304 A Japanese Patent Publication No. 5-055139 Registration No. 3162588 International publication 2020/035919 specification

By the way, as a method for joining medical members as described above, the heat fusion method adopted in Patent Document 1 and the adhesion method using various adhesives are usually used. However, when the heat-sealing method is employed, there is a risk that the material will be degraded by heating, and that the durability of the bonding strength will be reduced, resulting in separation during use. Moreover, even when the bonding method is used, it is often the case that sufficient bonding strength cannot be ensured depending on the combination of resin materials, and bonding strength between resin and metal may further decrease. In addition, in many medical devices, restrictions are imposed on the external dimensions of various tubular members from the viewpoint of insertion into the body of a patient. Reduction in external dimensions is also required.

On the other hand, as shown in Patent Literatures 2 to 4, even in the case of medical members, when metal parts are used, caulking has been conventionally used in some cases. However, conventional caulking is not reliable, so it is difficult to use it safely as a medical component. There is also a problem that sufficient fixing strength cannot be ensured unless metals are fixed together.

The present invention solves the above problems, and its object is to meet the requirements imposed on the medical member, particularly the joint strength and sealing, in a medical member having a joint structure for connecting another member to a flexible tube. The object of the present invention is to provide a medical member that satisfies the requirements and a method for manufacturing the same.

The medical member of the present invention comprises a flexible tube configured in such a manner that the end portion expands toward the edge, and the tube is disposed on the outer peripheral side of the tube, and the end portion of the tube is connected to the tube. It comprises an end fitting provided with a receiving surface for receiving from the base end side, and a fastener provided on the inner peripheral side of the tube and provided with a tightening surface for tightening the end portion of the tube from the distal end side of the tube. Here, the end fitting and the tightening fitting are provided further toward the tip side than the edge of the tube in a state where the end of the tube is pressed between the receiving surface and the tightening surface. are fixed by crimping in the regions facing each other.

In the present invention, it is preferable that the fastener has a recess in the facing region, and a part of the end fitting facing the facing region is introduced into the recess by plastic flow due to caulking. Moreover, it is desirable that the recess is an annular groove.

In the present invention, the inclination angle of the receiving surface with respect to the axial direction is preferably larger than the inclination angle of the tightening surface with respect to the axial direction.

In the present invention, it is preferable that at least one of the receiving surface and the tightening surface has a surface with an uneven structure. In this case, it is desirable that the uneven structure of the surface is composed of a surface portion along the axial direction and a surface portion along a plane orthogonal to the axial direction. According to this, it is possible to achieve a good balance between the improvement of the joint strength and sealing performance between the end portion of the tube and the fitting and the suppression of breakage of the end portion, so that a medical member having high strength can be realized.

In the present invention, the end fitting has an end fitting side abutting surface facing the distal end side, the fastener has a fastening fitting side abutting surface facing the base end side, and the end fitting side contact surface faces the base end side. It is preferable that the distance between the receiving surface and the tightening surface is set by the contact surface and the fastener-side contact surface contacting each other.

In the present invention, it is preferable that the fastener has a through hole along the axis, and the inner diameter of the fastener is equal to or larger than the minimum inner diameter of the end of the tube.

Next, the method for manufacturing a medical device according to the present invention comprises a tube forming step of forming an end portion of a flexible tube so that its diameter is expanded toward an end edge; An end fitting having a receiving surface for receiving from the base end side is arranged on the outer peripheral side of the tube, and a fastener having a tightening surface for tightening the end portion of the tube from the distal end side of the tube is arranged on the inner peripheral side of the tube. The end fitting and the fastener respectively arranged are configured to have regions facing each other on the tip end side of the end of the tube, and the end fitting and the fastener are arranged in the axial direction and a fitting caulking step of caulking and fixing the facing regions in a state where the end portion of the tube is compressed by the receiving surface and the tightening surface by applying pressure to the tube. Here, the end fitting has an end fitting side abutting surface facing the distal end side, the fastener has a fastening fitting side abutting surface facing the base end side, and the pressure is applied in the axial direction. It is preferable that the fitting caulking step is performed in a state in which the end fitting-side abutment surface and the fastener-side abutment surface abut against each other.

According to the present invention, there is provided a medical member having a joint structure for connecting another member to a flexible tube, and a medical member capable of satisfying requirements imposed on the medical member, as well as a manufacturing method thereof. can be done. In particular, it is possible to increase the joint strength and sealability between the metal fitting and the tube, so that it is possible to manufacture a high-quality and safe medical member.

FIG. 4 is an enlarged partial cross-sectional view showing the vicinity of the end of the first embodiment of the medical member according to the present invention; It is explanatory sectional drawing which shows the 1st step of the manufacturing process of the said 1st Embodiment. It is explanatory sectional drawing which shows the 2nd stage of the manufacturing process of the said 1st Embodiment. It is an enlarged partial cross-sectional view showing the vicinity of the end of the tube of the first embodiment. FIG. 8 is an enlarged partial cross-sectional view showing the vicinity of the end of the tube of the second embodiment; FIG. 11 is an enlarged partial cross-sectional view showing the vicinity of the end of the tube of the third embodiment; FIG. 4A is a schematic schematic diagram of a catheter introducer, a dilator, and a catheter showing an example in which an embodiment of the medical member is used, and an enlarged perspective view (b) of the distal end portion of an endoscope showing another example.

Embodiments of the present invention will now be described in detail with reference to the accompanying drawings. First, with reference to FIGS. 1 to 4, a first embodiment of a medical device and a manufacturing method thereof according to the present invention will be described.

As will be described later, the medical member 10 of this embodiment can be used as various medical members having a tubular portion. It is exemplified for use in a catheter whose direction can be changed by manipulation. Examples of such catheters include catheters for administering tissues such as drugs and cells, catheters for performing various treatments such as tissue collection, vessel expansion, and stent placement. As shown in FIG. 1, the medical member 10 has a flexible tube 11, and an end fitting 12 and a fastener 13 made of metal such as stainless steel and attached to the tube 11. As shown in FIG. The tube 11 is made of a synthetic resin such as PTFE (polytetrafluoroethylene) or PFA (tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer), a resin material including a core material such as a braided metal wire material, or other flexible materials. of material.

The inner diameter or outer diameter of the tube 11 of this embodiment is preferably within the range of 0.05 mm to 10 mm, more preferably within the range of 0.5 to 3 mm. In the illustrated example, the inner diameter or the outer diameter of the tube 11 is about 1 mm because of its use as a catheter.

The end fitting 12 is formed with a mounting portion 12d to which a locking member 14 for locking the operation wires 15 and 16 is mounted. In the illustrated example, the mounting portion 12 d is formed on the base end outer peripheral portion of the end fitting 12 . The operation wires 15 and 16 connected to the locking member 14 are connected to an operation portion (not shown) provided in the base structure to which the tube 11 is connected, and are pulled in accordance with the operation of the operation portion, whereby the tube is pulled. It is configured such that the extension direction of the tip of 11 can be changed arbitrarily.

The end portion 11a of the tube 11 is deformed into a conical shape expanding in diameter toward the tip edge. The shape of the end portion 11a may be such that the end fitting 12 and the fastener 13 result in a conical expanded shape as shown in the drawing. It is preferable that the end portion 11a is pressed between the receiving surface 12a and the tightening surface 13a.

The end fitting 12 has a tubular shape with a through hole 12t, and has a proximal end 12A and a distal end 12B. The base end portion 12A is positioned on the base end side (the right side in FIG. 1, hereinafter simply referred to as the "base end ”). The base end portion 12A is provided with the mounting portion 12d. A receiving surface 12a is provided on the inner peripheral portion between the proximal end portion 12A and the distal end portion 12B. The receiving surface 12a is directed toward the distal side (the left side in FIG. 1, hereinafter simply referred to as "the distal side") in the axial direction so as to receive (support) the end portion 11a of the tube 11 from the proximal side. It has an inner diameter that expands conically.

The distal end portion 12B is provided with a facing inner peripheral portion 12b that faces the fastener 13 . A stepped contact surface 12c directed toward the distal end is formed between the facing inner peripheral portion 12b and the receiving surface 12a. In the illustrated example, the abutting surface 12c is formed in an annular shape by the difference in the inner diameters of the portions on both sides in the axial direction.

The fastener 13 is tubular with a through hole 13t. A tightening surface 13a facing the receiving surface 12a is provided on the base end side of the fastener 13. As shown in FIG. The tightening surface 13a has an outer diameter that expands toward the distal end side in the axial direction so as to tighten (hold) the end portion 11a of the tube 11 from the distal end side. In the illustrated example, the tightening surface 13a is formed in a conical shape from the proximal edge of the fastener 13 toward the distal end. The proximal edge of the fastener 13 is a narrow annular edge.

The fastener 13 has a facing outer peripheral portion 13b on the tip side of the fastening surface 13a. The facing outer peripheral portion 13b radially faces the facing inner peripheral portion 12b. A concave portion 13d is provided in the facing outer peripheral portion 13b. In this embodiment, the recess 13d is an annular groove formed around the axis. A portion of the facing inner peripheral portion 12b is introduced into the concave portion 13d by plastic deformation, whereby the end fitting 12 and the fastener 13 are crimped and fixed.

Between the tightening surface 13a of the fastener 13 and the facing outer peripheral portion 13b, there is formed a contact surface 13c directed toward the base end side. In the illustrated example, the stepped contact surface 13c is formed in an annular shape due to the difference in the outer diameters of the portions on both sides in the axial direction. In the crimped state shown in FIG. 1, the stepped contact surface 12c and the stepped contact surface 13c are in contact with each other in the axial direction. That is, the facing inner peripheral portion 12b and the facing outer peripheral portion 13b are caulked and fixed in a state where the stepped contact surfaces 12c and 13c corresponding to each other are in contact with each other. At this time, the abutting surfaces 12c and 13c abut against each other to position the end fitting 12 and the fastener 13 in the axial direction, and the distance between the receiving surface 12a and the tightening surface 13a, that is, the thickness of the end portion 11a of the tube 11 becomes is set. 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 tightening surface 13a.

FIG. 2 is an explanatory sectional view schematically showing the forming process (first process) of the end portion 11a of the tube 11. As shown in FIG. In the illustrated example, the end portion 11a of the tube 11 held by the female mold 21A is pressurized by the male mold 21B to be molded. Here, the end portion 11a of the tube 11 is heated by the mold or before molding. Here, the end portion 11a of the tube 11 is formed into an expanded conical shape by the expanding (conical) forming surface 21At of the female die 21A and the conical forming surface 21Bt of the male die 21B.

FIG. 3 is an explanatory cross-sectional view schematically showing the state of the caulking and fixing step (second step). The support die 22A supports the base end face 12As of the end metal fitting 12, and the pressure die 22B and pressure spring 22C pressurize the tip end face of the fastener 13, thereby tightening the receiving surface 12a of the end metal fitting 12 and the fastener 13. The end portion 11a of the tube 11 is compressed axially by the surface 13a. At this time, if the contact surfaces 12c and 13c are brought into contact with each other, the distance between the receiving surface 12a and the tightening surface 13a becomes a preset design value. and reproducibility can be improved. In this state, the distal end outer circumference 12Bs of the end fitting 12 is crimped and fixed by a crimping die 22D having a (annular) mold surface facing obliquely to the proximal side inner circumference. At this time, plastic flow is generated from the facing inner peripheral portion 12b into the concave portion 13d of the facing outer peripheral portion 13b, and the end fitting 12 and the fastener 13 are caulked and fixed as described above.

FIG. 4 is an enlarged partial cross-sectional view showing the vicinity of the end portion 11a of the tube 11 in the cross-sectional view of FIG. As described above, in the medical device 10, the end fitting 12 and the fastener 13 are caulked and fixed with the end portion 11a of the tube 11 being squeezed between the receiving surface 12a and the tightening surface 13a. At this time, the inclination angle θ of the receiving surface 12a with respect to the axis 11x is set larger than the inclination angle φ of the tightening surface 13a with respect to the axis 11x. By setting θ>φ, the end portion 11a is positioned closer to the proximal side than the portion (tip edge) on the distal side (left side in the figure) in a state of being pressed between the receiving surface 12a and the tightening surface 13a. Since the thickness of the portion (on the right side in the figure) is deformed into a narrowed shape, the pull-out resistance of the tube 11 from the end fitting 12 and the fastener 13 can be increased. Therefore, as a result, it is possible to improve the joint strength and sealing performance between the tube 11 and the end fitting 12 and the fastener 13 .

Although the inclination angle θ is not particularly limited, it is preferably in the range of 30-60 degrees, and more preferably in 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 in the range of 25-55 degrees, and more preferably in the range of 35-45 degrees. The angles of inclination θ and φ are preferably angles close to 45 degrees. , the tube 11 is more likely to break, and in any case, the bonding strength is lowered. Also, the angular difference θ-φ is preferably within the range of 3-15 degrees, and more preferably within the range of 5-10 degrees. If the angular difference is smaller than the above range, the effect of increasing the pull-out resistance is reduced. Even so, the bonding strength and sealing performance required for the medical member 10 are lowered.

In addition, when the fastener 13 has the through hole 13 t , the inner diameter IDb is preferably equal to or greater than the inner diameter IDa of the tube 11 . This is because the medical member 10 configured as a tubular body such as a catheter, a sheath, an endoscope, or the like needs to be configured so that a guide wire, a catheter, a sensor (examination tool), a treatment tool, or the like can be passed through and retracted. Because there is In particular, when IDa<IDb as shown in the figure, the proximal end of the fastener 13 (an annular proximal edge in the illustrated example) is likely to bite into the base of the end 11a of the tube 11. It is possible to further increase the resistance and improve the sealing performance.

Furthermore, it is preferable that the end fitting 12 and the fastener 13, which are crimped and fixed with the end portion 11a of the tube 11 pressed, are in a state where the contact surfaces 12c and 13c are in contact with each other as described above. . The abutment of the abutting surfaces 12c and 13c means that the distance between the receiving surface 12a and the tightening surface 13a, which pinches the end portion 11a of the tube 11, that is, the thickness of the end portion 11a becomes a preset value. , the joining structure of the tube 11 and the metal fittings 12, 13 can be obtained as designed, so that the desired joining strength and airtightness can be obtained. That is, the breakage of the end portion 11a of the tube 11 due to too small a distance between the receiving surface 12a and the tightening surface 13a, and the reduction in pull-out resistance of the tube 11 due to an excessively large distance between the receiving surface 12a and the tightening surface 13a. Since this is prevented, the required bonding strength and sealing performance can be stably and reliably obtained.

Next, a second embodiment according to the present invention will be described with reference to FIG. In this second embodiment, the only difference is the tightening surface 13a' of the fastener 13' from the tightening surface 13a of the first embodiment. The same reference numerals are given to the parts, and the description thereof is omitted. The tightening surface 13a' of this embodiment is not a continuous surface like the tightening surface 13a, but has an uneven shape. The concavo-convex structure of the tightening surface 13a' has a size (protrusion amount) within the range of 0.05-0.15 mm, preferably about 0.1 mm. The unevenness of the tightening surface 13a′ is not particularly limited, but in the illustrated example, the surface portion 13a-1 along the axis 11x (in the illustrated example, a ring band having a width in the axial direction around the axis 11x), It has a stepped surface structure including a surface portion 13a-2 along a plane orthogonal to the axis 11x (in the illustrated example, a ring band having a width in the radial direction around the axis 11x). It is preferable that the uneven structure is formed in a plurality of cycles (sets) on the clamping surface 13a', and it is desirable that 2 to 3 pieces (sets) of unevenness are formed as shown in the illustrated example.

In this embodiment, since the tightening surface 13a' is formed in an uneven shape, the uneven structure bites into the end portion 11a of the tube 11, thereby increasing the pull-out resistance of the tube 11 and improving the sealing performance. In particular, the concave-convex 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 fastener 13 is pushed into the end 11a of the tube 11 along the axis 11x, the position of the end 11a on the receiving surface 12a is not easily affected, and the tube 11 can be pulled out of the fittings 12 and 13. The resistance can be increased and the possibility of breakage of the end portion 11a of the tube 11 can be suppressed. This is because the surface portion of the uneven structure is composed of a surface portion along the axis 11x and a surface portion perpendicular to the axis 11x. This is because it is difficult to move 11a on the receiving surface 12a, and since the difference in angle between the two surfaces is 90 degrees, the end portion 11a is less likely to be torn due to the non-sharp concave-convex structure.

Also in the present embodiment, the inclination angle φ of the base surface (one-dot chain line in the figure) of the uneven structure of the tightening surface 13a′ is smaller than the inclination angle θ of the receiving surface 12a, so that the effects are similar to those of the first embodiment. can be played. Similarly, by setting the inner diameter IDb of the fastener 13' to be equal to or larger than the inner diameter IDa of the tube 11, particularly larger than IDa, similar effects as described above can be obtained. Furthermore, the contact between the abutment surfaces 12c and 13c determines the distance between the receiving surface 12a and the concavo-convex structure of the tightening surface 13a', so that the amount of engagement of the concavo-convex structure with respect to the end portion 11a of the tube 11 can be accurately and reproducibly set. Therefore, it is possible to satisfactorily obtain the effect of suppressing the pull-out resistance and the possibility of breakage.

Next, a third embodiment according to the present invention will be described with reference to FIG. This third embodiment differs from the receiving surface 12a of the first embodiment only in the receiving surface 12a' of the end fitting 12', and the rest of the structure can be constructed in the same manner as in the first embodiment. The same reference numerals are given to the parts, and the description thereof is omitted. The receiving surface 12a' of this embodiment is not a continuous surface like the receiving surface 12a, but has an uneven shape. The concave-convex structure of the receiving surface 12a' has a size (projection amount) within the range of 0.05-0.15 mm, preferably about 0.1 mm. The form of unevenness of the receiving surface 12a′ is not particularly limited, but in the case of the illustrated example, the surface portion 12a-1 along the axis 11x (in the illustrated example, a ring strip having a width in the axial direction around the axis 11x), It has a stepped surface structure including a surface portion 12a-2 along a plane perpendicular to the axis 11x (in the illustrated example, a ring band having a width in the radial direction around the axis 11x). It is preferable that the uneven structure is formed in a plurality of periods (sets) on the receiving surface 12a', and it is desirable that 2 to 3 pieces (sets) of unevenness are formed as shown in the illustrated example.

In the present embodiment, since the receiving surface 12a' is configured in an uneven shape, the uneven structure bites into the end portion 11a of the tube 11, thereby increasing the pull-out resistance of the tube 11 and improving the sealing performance. In particular, the concave-convex 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 fastener 13 is pushed into the end 11a of the upper tube 11 along the axis 11x, the position of the end 11a on the receiving surface 12a' is not easily affected, and the tube with respect to the metal fittings 12, 13 The pullout resistance of the tube 11 can be increased, and the possibility of the tube 11 being broken can be suppressed. The reason is the same as that of the tightening surface 13a' of the second embodiment.

Also in the present embodiment, since the inclination angle θ of the base surface (one-dot chain line in the drawing) of the concave-convex structure of the receiving surface 12a′ is larger than the inclination angle φ of the tightening surface 13a, It is possible to achieve similar effects. Similarly, by setting the inner diameter IDb of the fastener 13 to be equal to or larger than the inner diameter IDa of the tube 11, particularly larger than IDa, similar effects to those described above can be obtained. Furthermore, the contact between the abutment surfaces 12c and 13c determines the distance between the concavo-convex structure of the receiving surface 12a' and the tightening surface 13a, so that the amount of engagement of the concavo-convex structure with respect to the end portion 11a of the tube 11 can be accurately and reproducibly set. Therefore, it is possible to satisfactorily obtain the effect of suppressing the pull-out resistance and the possibility of breakage.

In addition, in the second embodiment and the third embodiment, either one of the receiving surface and the tightening surface is configured to be uneven, but both the receiving surface and the tightening surface are configured to be uneven as described above. You may do so. In this case, it is preferable that the concave-convex structure of the receiving surface and the concave-convex structure of the clamping surface are configured so that the concave-convex structures are fitted to each other with the end portion 11a of the tube 11 interposed therebetween. That is, the concave portion of the receiving surface faces the convex portion of the tightening surface with the end portion 11a interposed therebetween, and the convex portion of the receiving surface faces the concave portion of the tightening surface with the end portion 11a interposed therebetween. In this way, the end portion 11a is interposed between the receiving surface and the tightening surface in an uneven shape, so even if the height of the unevenness is to some extent comparable to the thickness of the end portion 11a, the above-described The pull-out resistance can be further increased, and the possibility of breakage of the end portion 11a can be suppressed. However, if the height of the unevenness is sufficiently lower than the thickness of the end portion 11a, such as 1/3 or less of the thickness of the end portion 11a, the uneven structure of the receiving surface and the uneven structure of the tightening surface correspond to each other. You don't have to.

FIG. 7 is a schematic diagram schematically showing the application of the medical device 10 according to the present invention. FIG. 7(a) shows a sheath introducer A, a dilator B, and a catheter D guided by a guide wire C used for catheter surgery. The medical device 10 can be applied to the sheath distal end Aa of the sheath introducer A. As shown in FIG. It can also be applied to the tubular distal end Ba of the dilator B. Furthermore, it can also be applied to the distal end portion Da of the catheter D.

FIG. 7(b) schematically shows the structure of the distal end portion of the endoscope E. As shown in FIG. A flexible tube Ea is used for the endoscope E, and a tip structure Eb having a metal part Eb attached to its tip is formed. This tip structure Eb can be composed of an end fitting 12 and a fastener 13 attached to the tip of the tube 11 described above.

It goes without saying that the medical device and its manufacturing method of the present invention are not limited to the illustrated examples described above, and that various modifications can be made without departing from the scope of the present invention. For example, in each of the above embodiments, the end portion 11a of the tube 11 has a conically widened shape toward the distal end side, but it is not particularly limited, and may have various shapes such as a curved shape. be able to. Also, the inclination angles θ and φ are set within the range of 40 to 60 degrees, but may be around 90 degrees or may exceed 90 degrees.

DESCRIPTION OF SYMBOLS 10... Medical member (catheter tube) 11... Flexible tube 11a... End part 12... End fitting 12A... Base end part 12As... Base end face 12B... Tip part 12Bs... Tip outer circumference 12a... Receiving surface 12b... Facing inner peripheral part 12c... Abutting surface (on the end fitting side) 13... Fastener 13A... Base end part 13B... Tip part 13a... Fastening surface 13b... Facing outer peripheral part 13c ... Abutment surface (on fastener side) 13d ... Recessed portion (annular groove) 14 ... Locking member 15, 16 ... 21 (21A ... female mold, 21B ... male type) ... Tube mold 22 (22A ... Support type, 22B...Pressure type, 22C...Pressure spring, 22D...Caulking type)...Caulking fixed type

Claims (8)

a flexible tube configured in such a way that the ends expand toward the edges;
an end fitting provided on the outer peripheral side of the tube and provided with a receiving surface for receiving the end portion of the tube from the base end side of the tube;
a clamping fitting disposed on the inner peripheral side of the tube and having a clamping surface that clamps the end of the tube from the tip side of the tube;
and
The end fitting and the clamping fitting are mutually provided further toward the distal end than the edge of the tube in a state where the end of the tube is pressed between the receiving surface and the clamping surface. A medical element that is crimped in the facing areas. said fasteners having recesses in said facing regions;
A portion of the end fitting facing the facing region is introduced into the recess by plastic flow due to caulking,
The medical device according to claim 1. the inclination angle of the receiving surface with respect to the axial direction is greater than the inclination angle of the tightening surface with respect to the axial direction;
The medical member according to claim 1 or 2. At least one of the receiving surface and the tightening surface comprises a surface with an uneven structure,
Medical device according to any one of claims 1-3. 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,
The medical device according to claim 4. The end fitting has an end fitting side contact surface facing the tip side,
The fastener has a fastener-side abutment surface facing the base end,
The distance between the receiving surface and the tightening surface is set by the contact surface on the end fitting side and the contact surface on the fastener side contacting each other.
Medical device according to any one of claims 1-5. The fastener has a through hole along the axis,
The inner diameter of the fastener is greater than or equal to the minimum inner diameter of the end of the tube.
Medical device according to any one of claims 1-6. a tube forming step of forming the end portion of the flexible tube so that the diameter is expanded toward the edge;
An end fitting having a receiving surface for receiving the end portion of the tube from the base end side of the tube is arranged on the outer peripheral side of the tube, and a tightening surface is provided for tightening the end portion of the tube from the distal end side of the tube. a fastener is arranged on the inner peripheral side of the tube, and the end fitting and the fastener arranged respectively have regions facing each other on the tip side from the end of the tube, a fitting crimping step of pressurizing the end fitting and the fastener in the axial direction to crimp and fix the facing regions in a state where the end portion of the tube is narrowed by the receiving surface and the tightening surface;
A method for manufacturing a medical component, comprising:

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