catheter

Abstract

We provide a catheter in which the shaft is less likely to come loose from the hub. [Solution] The catheter comprises a shaft having a first lumen and a shaft projection, and a cylindrical member having a second lumen into which the proximal end of the shaft is inserted. The cylindrical member has an inner circumferential surface that forms the second lumen, a tip projection that protrudes from the inner circumferential surface of the cylindrical member toward the outer circumferential surface of the shaft, and a proximal projection that protrudes from the inner circumferential surface of the cylindrical member toward the outer circumferential surface of the shaft, located on the proximal end side of the tip projection. Between the tip projection and the proximal projection, the shaft projection protrudes from the outer circumferential surface of the shaft toward the inner circumferential surface of the cylindrical member, and restricts the movement of the shaft by catching on at least one of the tip projection and the proximal projection.

Description

Technical Field

[0001] The present disclosure relates to a catheter.

Background Art

[0002] Catheters used in percutaneous coronary intervention are known. For example, Patent Document 1 discloses a catheter including a tube body and a tube hub fixed to the proximal end of the tube body. Patent Document 2 discloses a catheter including a shaft and a hub attached to the proximal end of the shaft. Patent Document 3 discloses a catheter including a flexible tube-shaped shaft, a sleeve, and a hub formed to cover the sleeve. The hub is also called a connector. Percutaneous coronary intervention is also called PCI.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0004] In some cases, a drug solution may be injected into the lumen of a catheter. The polyamide resin hubs described in Patent Documents 2 and 3 have low chemical resistance, and therefore, cracks or surface dissolution may occur in the hub when chemicals adhere to it. The same applies to polycarbonate resin hubs, which are also susceptible to damage due to chemical adhesion. The polyolefin resin hubs described in Patent Documents 1 and 2 have higher chemical resistance compared to polyamide resin hubs, thus avoiding damage to the hub due to chemical adhesion. The same applies to fluororesin hubs, which are also susceptible to damage due to chemical adhesion. However, polyolefin resins and fluororesins have low bonding strength with the adhesive used to bond the shaft and the hub. Therefore, when polyolefin resins or fluororesins are used as the material for the hub, there was a risk that the shaft would detach from the hub due to delamination between the hub and the adhesive during catheter use. [Means for solving the problem]

[0005] This disclosure is made to solve at least some of the problems described above and can be implemented in the following forms.

[0006] According to one embodiment of the present disclosure, a catheter is provided. The catheter comprises a shaft having a first lumen and a shaft projection, and a cylindrical member having a second lumen into which the proximal end of the shaft is inserted. The cylindrical member has an inner circumferential surface forming the second lumen, a tip projection protruding from the inner circumferential surface of the cylindrical member toward the outer circumferential surface of the shaft, and a proximal projection located on the proximal end side of the tip projection, protruding from the inner circumferential surface of the cylindrical member toward the outer circumferential surface of the shaft. Between the tip projection and the proximal projection, the shaft projection protrudes from the outer circumferential surface of the shaft toward the inner circumferential surface of the cylindrical member, and restricts the movement of the shaft by catching on at least one of the tip projection and the proximal projection. [Brief explanation of the drawing]

[0007] [Figure 1] This is an explanatory diagram illustrating the configuration of a catheter. [Figure 2] This is a longitudinal cross-section of a portion of the shaft. [Figure 3] This is a longitudinal cross-section of a portion of a catheter. [Figure 4] This is a longitudinal cross-sectional view showing only the cylindrical member extracted from Figure 3. [Figure 5] This is a longitudinal cross-sectional view of a portion of the catheter according to the second embodiment. [Figure 6] This is a longitudinal cross-sectional view of a portion of the catheter according to the third embodiment. [Figure 7] This is a longitudinal cross-sectional view of a portion of the catheter according to the fourth embodiment. [Figure 8] This is a longitudinal cross-sectional view of a portion of the catheter according to the fifth embodiment. [Figure 9] This is a longitudinal cross-sectional view of a portion of the catheter according to the sixth embodiment. [Figure 10] This is a longitudinal cross-sectional view of a portion of the catheter according to the seventh embodiment. [Figure 11] This is a longitudinal cross-sectional view of a portion of the catheter according to the eighth embodiment. [Figure 12] This is a longitudinal cross-sectional view of a portion of the catheter according to the ninth embodiment. [Figure 13] This is a longitudinal cross-sectional view of a portion of the catheter according to the 10th embodiment. [Figure 14] This is a longitudinal cross-sectional view of a portion of the catheter according to the 11th embodiment. [Modes for carrying out the invention]

[0008] <First Embodiment> Figure 1 is an explanatory diagram illustrating an example of catheter 1. Catheter 1 is a medical device used in percutaneous coronary intervention (PCI). Percutaneous coronary intervention is also called PCI. Catheter 1 can be used not only in PCI but also in all percutaneous procedures. Catheter 1 comprises a shaft 10 and a tubular member 20. The tubular member 20 includes a hub. The hub is also called a "connector".

[0009] Figure 1 includes some parts where the relative sizes of the components differ from reality for the sake of explanation. Figure 1 also includes parts where some of the components are exaggerated. Figure 1 illustrates mutually orthogonal XYZ axes. The X-axis corresponds to the longitudinal direction of catheter 1 and each component. The X-axis corresponds to the axial direction of catheter 1 and each component. The Y-axis corresponds to the width direction of catheter 1 and each component. The Z-axis corresponds to the height direction of catheter 1 and each component. The left side of Figure 1 (-X-axis direction) is called the "tip side" of catheter 1 and each component, and the right side of Figure 1 (+X-axis direction) is called the "proximal end side" of catheter 1 and each component. In Figure 1, of the two ends of catheter 1 and each component in the longitudinal direction (X-axis direction), the end located on the tip side is called the "tip," and the other end located on the proximal end side is called the "proximal end." In Figure 1, the tip and its vicinity are called the "tip portion," and the proximal end and its vicinity are called the "proximal end portion." The tip side is inserted into the body, and the proximal end is manipulated by a surgeon such as a physician. These points are also common to Figure 2 and beyond. In this embodiment, "same" and "equal" mean approximately the same, allowing for variations due to manufacturing errors, etc. In this embodiment, "constant" also includes being approximately constant, allowing for variations due to manufacturing errors, etc.

[0010] As shown in Figure 1, the catheter 1 has a shaft 10 and a marker 19. The shaft 10 is a hollow tubular body with an elongated outer shape. The marker 19 is attached to the tip of the shaft 10. The marker 19 is ring-shaped. The marker 19 can be formed from either a radiopaque resin material or a radiopaque metal material. As the radiopaque resin material, for example, a material can be used which is a mixture of at least one of polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, or fluororesin with a radiopaque material such as bismuth trioxide, tungsten, or barium sulfate. As the radiopaque metal material, for example, gold, platinum, tungsten, or alloys containing these elements can be used. If the marker 19 is formed from a radiopaque material, the operator can visually confirm the tip position of the catheter 1 under an X-ray image. The marker 19 does not have to be radiopaque. The marker 19 may be omitted.

[0011] Figure 2 is a longitudinal cross-sectional view of a portion OP1 of the shaft 10. The shaft 10 of the catheter 1 has a tube 101 and a liner 103. The tube 101 is a tubular body formed of a resin material. The tube 101 can be formed from at least one of the following: polyamide resin, polyamide elastomer resin, polyester resin, polyurethane resin, and polyurethane elastomer resin. The liner 103 is a tubular body formed of a resin material. The liner 103 is located inside the tube 101. The liner 103 can be formed from a material with high chemical resistance, such as a fluororesin such as PTFE. The lumen of the liner 103 is also called the first lumen 10L.

[0012] The shaft 10 may further include a braided body. The braided body is a member embedded inside the tube 101 for reinforcing the tube 101. The braided body is a mesh member formed by weaving strands in a mesh pattern. Examples of the cross-sectional shape of the strands include circular and rectangular. The shaft 10 may further include a coil body. The coil body is a member embedded inside the tube 101 for reinforcing the tube 101. The coil body is a single-strand coil formed by winding a single strand. As the coil body, a multi-strand coil formed by winding a plurality of strands can also be used. The braided body and the coil body can be formed of at least any one of a stainless alloy, a superelastic alloy, tungsten, and a hard resin material. Examples of the stainless alloy include SUS304. Examples of the superelastic alloy include nickel titanium and nickel titanium alloy. Examples of the hard resin material include reinforced plastics such as PEEK.

[0013] FIG. 3 is a longitudinal sectional view of a part OP₂ of the catheter ①. The part OP₂ is a joint portion between the shaft 10 and the cylindrical member 20. FIG. 4 is a longitudinal sectional view showing only the cylindrical member 20 extracted from FIG. 3. As shown in FIG. 3, the proximal end portion 10b of the shaft 10 is inserted into the second lumen 20L of the cylindrical member 20. As shown in FIG. 4, the cylindrical member 20 includes a first cylindrical body 25 and a second cylindrical body 200. The first cylindrical body 25 is also called a "protector". The second cylindrical body 200 is also called a "hub".

[0014] The first cylinder 25 is disposed on the tip side with respect to the second cylinder 200. The first cylinder 25 is a protective member that covers the base end portion 10b of the cylindrical member 20 and the tip portion of the second cylinder 200. The first cylinder 25 is a hollow cylindrical body. The first cylinder 25 can be formed of an arbitrary resin material having flexibility. As shown in FIG. 1, the tip portion 251 of the first cylinder 25 has a tapered outer shape. The tip portion 251 of the first cylinder 25 has an outer diameter that gradually decreases from the base end side toward the tip side. As shown in FIG. 3, a space SP1 is provided between the inner peripheral surface 25i and the outer peripheral surface 10o of the shaft 10 at the tip portion 251 of the first cylinder 25. This space SP1 allows the shaft 10 and the cylindrical member 20 to be coupled while maintaining the flexibility of the catheter 1.

[0015] As shown in FIG. 3, the base end portion 252 of the first cylinder 25 has a substantially constant outer diameter. Three protrusions 254 are provided on the base end portion 252 of the first cylinder 25. The protrusion 254 is a portion where a part of the first cylinder 25 protrudes from the inner peripheral surface 25i toward the outer peripheral surface 21o of the second cylinder 200. The protrusion 254 is ring-shaped. Each protrusion 254 is arranged apart in the X-axis direction. In other words, there is a gap between the protrusion 254 disposed on the most tip side and the second protrusion 254. There is a gap between the second protrusion 254 and the third protrusion 254.

[0016] A tip-side protruding portion 253 is provided at the boundary portion between the tip portion 251 and the base end portion 252 of the first cylinder 25. The tip-side protruding portion 253 is a portion where a part of the first cylinder 25 protrudes from the inner peripheral surface 25i toward the outer peripheral surface 10o of the shaft 10. The position of the tip-side protruding portion 253 in the X-axis direction can be arbitrarily determined. That is, the tip-side protruding portion 253 may be located on the tip side or the base end side with respect to the boundary between the tip portion 251 and the base end portion 252. The tip-side protruding portion 253 is provided over the entire circumferential direction on the inner peripheral surface 25i of the first cylinder 25. As shown in FIG. 3, the tip-side protruding portion 253 has an inner peripheral surface 253i that extends along the outer peripheral surface 10o of the shaft 10. The inner peripheral surface 253i of the tip-side protruding portion 253 is in contact with the outer peripheral surface 10o of the shaft 10.

[0017] As shown in Figure 1, the second cylindrical body 200 has a narrow diameter section 21, a wide diameter section 22, and a connecting section 23. The second cylindrical body 200 can be made of a resin material with high chemical resistance. For example, the second cylindrical body 200 can be made of a polyolefin resin or a fluororesin. The narrow diameter section 21 is located at the very tip of the second cylindrical body 200. The narrow diameter section 21 is a portion with a substantially constant outer diameter, except for the groove 214. The wide diameter section 22 is located closer to the base end than the narrow diameter section 21. In other words, the wide diameter section 22 is located between the narrow diameter section 21 and the connecting section 23. The wide diameter section 22 is a portion with a larger outer diameter than the narrow diameter section 21. As shown in Figure 1, the wide diameter section 22 can have any shape as long as it has a larger outer diameter than the narrow diameter section 21. In the example in Figure 1, the wide diameter section 22 has a cylindrical body and a wing-like portion. The cylindrical body is the part having a cylindrical shape. The wing portion is the part that protrudes from the outer surface of the cylindrical body in the ±Y axis direction. The connecting portion 23 is provided at the proximal end of the second cylindrical body 200. The connecting portion 23 has a cylindrical body and a tapered portion. The cylindrical body is the part having a cylindrical shape. The tapered portion is provided at the proximal end of the cylindrical body and has an outer diameter that gradually decreases from the proximal end to the tip end. When using the catheter 1, the operator attaches a syringe filled with drug solution, etc., to the connecting portion 23. The inner surface of the connecting portion 23 may be provided with a screw groove for fixing the syringe.

[0018] As shown in Figure 4, a step 215 is provided between the narrow diameter portion 21 and the wide diameter portion 22. The step 215 is a surface perpendicular to the axis O and extending outward. A step 225 is provided inside the wide diameter portion 22. The step 225 is a surface perpendicular to the axis O and extending toward the axis O. The inner circumferential surface 25i of the tip portion 251 of the first cylindrical body 25 and the inner circumferential surface 200i of the second cylindrical body 200 form the second lumen 20L.

[0019] As shown in Figure 4, the narrow-diameter portion 21 has a tip portion 211, an intermediate portion 212, and a base portion 213. The narrow-diameter portion 21 is provided with three grooves 214 and a base-side projection 216. The grooves 214 are recesses provided on the outer circumferential surface 21o of the narrow-diameter portion 21. The grooves 214 are ring-shaped. Each groove 214 is spaced apart in the X-axis direction. In other words, there is a gap between the furthest tip groove 214 and the second groove 214. There is also a gap between the second groove 214 and the third groove 214. In the assembled state of the catheter 1 shown in Figure 3, the projection 254 of the first cylindrical body 25 fits into the grooves 214 of the narrow-diameter portion 21. For this reason, the grooves 214 of the narrow-diameter portion 21 and the projection 254 of the first cylindrical body 25 are located at corresponding positions in the X-axis direction.

[0020] The base end projection 216 is a portion of the second cylindrical body 200 that protrudes from the inner circumferential surface 200i toward the outer circumferential surface 10o of the shaft 10. In the example in Figure 4, the base end projection 216 is provided in the range from the intermediate part 212 of the narrow diameter section 21 to the step 225. A tapered section 2161 is provided on the tip side of the base end projection 216. The tapered section 2161 is the portion where the inner diameter Φ216 of the base end projection 216 gradually increases from the base end side toward the tip side. In the example in Figure 4, the tapered section 2161 is located in the intermediate part 212 of the narrow diameter section 21. The inner circumferential surface of the tapered section 2161 is in contact with the base end surface 112 of the shaft projection 110. A straight section 2162 is provided on the base end side of the base end projection 216. The straight section 2162 is the portion of the base-end projection 216 that has a constant inner diameter Φ216b. In the example in Figure 4, the straight section 2162 is located in the range from the base end 213 of the narrow-diameter section 21 to the step 225. The inner circumferential surface of the straight section 2162 is in contact with the outer circumferential surface 10o of the shaft 10. The inner diameter Φ216a of the base-end projection 216 at its tip is larger than the inner diameter Φ216b of the base-end projection 216 at its base.

[0021] The base end projection 216 is provided on the inner circumferential surface 200i of the second cylindrical body 200, extending over its entire circumferential direction. In other words, the base end projection 216 is provided on the inner circumferential surface of the narrow diameter portion 21, extending over its entire circumferential direction. The base end projection 216 is located closer to the base end than the tip end projection 253 of the first cylindrical body 25. As shown in Figure 4, a recess SP2 is formed on the inner circumferential surface 200i side of the second cylindrical body 200, between the tip end projection 253 and the base end projection 216. The recess SP2 is located in the range from the tip end 211 to the middle part 212 of the narrow diameter portion 21. The recess SP2 is provided on the inner circumferential surface 200i of the second cylindrical body 200, extending over its entire circumferential direction. In other words, the recess SP2 is provided on the inner circumferential surface of the narrow diameter portion 21, extending over its entire circumferential direction.

[0022] As shown in Figure 4, the narrow-diameter portion 21 of the second cylindrical body 200 is inserted inside the base end portion 252 of the first cylindrical body 25. At this time, the projections 254 of the first cylindrical body 25 fit into the grooves 214 of the narrow-diameter portion 21, thereby fixing the first cylindrical body 25 and the second cylindrical body 200 together. Figure 4 illustrates an embodiment in which the cylindrical member 20 has three projections 254 and three grooves 214. The number of projections 254 and grooves 214 is not limited to three and can be changed as desired. The first cylindrical body 25 may be provided with grooves and the narrow-diameter portion 21 with projections. Instead of projections 254 and grooves 214, a spirally extending male thread portion and a female thread portion that fits into the male thread portion may be provided. The tip surface of the narrow-diameter portion 21 is in contact with the base end surface 2532 of the tip-side projection portion 253. The tip surface of the narrow-diameter portion 21 and the base end surface 2532 may be separated. The base end surface 255 of the first cylindrical body 25 is in contact with the step 215 of the second cylindrical body 200. The base end surface 255 and the step 215 may be separated.

[0023] As shown in Figure 3, the base end 10b of the shaft 10 is inserted into the cylindrical member 20. In other words, the base end 10b of the shaft 10 is inserted into the first cylindrical body 25 and the second cylindrical body 200. The base end surface of the shaft 10 is in contact with the step 225 of the large diameter portion 22. A shaft projection 110 is provided on the base end 10b of the shaft 10. The shaft projection 110 is the portion that protrudes from the outer circumferential surface 10o of the shaft 10 toward the inner circumferential surface of the cylindrical member 20. Specifically, the inner circumferential surface of the cylindrical member 20 refers to the inner circumferential surface 25i of the first cylindrical body 25 and the inner circumferential surface 200i of the second cylindrical body 200. The shaft projection 110 is provided between the tip-side projection 253 and the base-side projection 216 of the cylindrical member 20.

[0024] In the example shown in Figure 3, the shaft projection 110 has a shape that fits into the recess SP2 on the inner circumferential surface side of the cylindrical member 20. The tip surface 111 of the shaft projection 110 is in contact with the base end surface 2532 of the tip projection 253. The tip surface 111 of the shaft projection 110 is a surface that extends perpendicular to the axis O. The base end surface 112 of the shaft projection 110 is in contact with the tapered portion 2161 of the base projection 216. The base end surface 112 of the shaft projection 110 is a surface that extends inclined along the tapered portion 2161. The shaft projection 110 is formed from any adhesive, such as an epoxy adhesive.

[0025] Catheter 1 can be manufactured, for example, as follows: The worker prepares the second cylinder 200. The worker inserts the base end 10b of the shaft 10 into the second cylinder 200. At this time, the shaft 10 does not yet have the shaft projection 110. The worker pours adhesive around the outer surface 10o of the shaft 10 from the side of the narrow diameter portion 21 of the second cylinder 200. The worker places the first cylinder 25 over the shaft 10 and the second cylinder 200. The worker pushes the first cylinder 25 towards the second cylinder 200, fitting the projection 254 into the groove 214 and fixing the first cylinder 25 and the second cylinder 200 together.

[0026] Let's consider the first case in which, when using catheter 1, the operator grasps the cylindrical member 20 and pushes the shaft 10 toward the tip. In the first case, the position of the cylindrical member 20 remains fixed, and a force is applied to the shaft 10 to move in the D1 direction. In the first case, the tip surface 111 of the shaft projection 110 catches on the base end surface 2532 of the tip projection 253, thereby restricting the movement of the shaft 10 in the D1 direction. Let's consider the second case in which, when using catheter 1, the operator grasps the cylindrical member 20 and pulls the shaft 10 toward the base. In the second case, the position of the cylindrical member 20 remains fixed, and a force is applied to the shaft 10 to move in the D2 direction. In the second case, the base end surface 112 of the shaft projection 110 catches on the tapered portion 2161 of the base projection 216, thereby restricting the movement of the shaft 10 in the D2 direction. Furthermore, the base end face of the shaft 10 catches on the step 225 of the second cylindrical body 200, thereby restricting the movement of the shaft 10 in the D2 direction. In this way, the shaft projection 110 restricts the movement of the shaft 10 in the D1 and D2 directions by catching on at least one of the tip projection 253 and the base projection 216. The D1 and D2 directions can also be described as the front-back directions.

[0027] As described above, according to the catheter 1 of the first embodiment, the inner circumferential surface of the cylindrical member 20, which includes the second cylindrical body 200, is provided with a tip-side projection 253 and a proximal-side projection 216. The second cylindrical body 200 is a hub. The shaft 10 is provided with a shaft projection 110 that protrudes from the outer circumferential surface 10o of the shaft 10 toward the inner circumferential surface of the cylindrical member 20, between the tip-side projection 253 and the proximal-side projection 216. Therefore, when using the catheter 1, for example, even if the operator pushes / pulls the shaft 10 while grasping the cylindrical member 20, the shaft projection 110 can catch on at least one of the tip-side projection 253 and the proximal-side projection 216 of the cylindrical member 20, thereby restricting the movement of the shaft 10. As a result, when using the catheter 1, the occurrence of the shaft 10 coming out of the cylindrical member 20 can be avoided.

[0028] Furthermore, according to the catheter 1 of the first embodiment, the tip surface 111 of the shaft projection 110 is in contact with the base end surface 2532 of the tip-side projection 253. Therefore, the movement of the shaft 10 toward the tip side D1 relative to the cylindrical member 20 can be restricted.

[0029] Furthermore, according to the catheter 1 of the first embodiment, the shaft projection 110 has a shape that fits into a recess SP2 formed between the tip projection 253 and the proximal projection 216 on the inner circumferential surface side of the cylindrical member 20. Therefore, it is possible to restrict the shaft 10 from moving toward the tip side D1 relative to the cylindrical member 20, and also to restrict the shaft from moving toward the proximal side D2 relative to the cylindrical member 20.

[0030] Furthermore, according to the catheter 1 of the first embodiment, the shaft projection 110 is an adhesive provided on the outer circumferential surface 10o of the shaft 10, so the shaft projection 110 can be easily formed. Moreover, according to the catheter 1, the shaft projection 110 can be easily shaped to fit into the recess SP2 between the tip projection 253 and the proximal projection 216, and the joint strength between the shaft 10 and the cylindrical member 20 can be improved. Since the shaft projection 110 is fixed to the cylindrical member 20 when the adhesive is used, the movement of the shaft 10 relative to the cylindrical member 20 can be restricted. Even if the adhesive peels off from the cylindrical member 20, the shaft projection 110 will catch on at least one of the tip projection 253 and the proximal projection 216. Therefore, the movement of the shaft 10 relative to the cylindrical member 20 can be effectively suppressed. The second to eleventh embodiments, which will be described later, can achieve similar effects.

[0031] Furthermore, according to the catheter 1 of the first embodiment, the cylindrical member 20 has a cylindrical first cylindrical body 25 including a tip-side projection 253 and a cylindrical second cylindrical body 200 including a proximal end projection 216. Therefore, a catheter 1 can be easily manufactured in which the shaft projection 110 provided on the outer circumferential surface 10o of the shaft 10 is located between the tip-side projection 253 and the proximal end projection 216.

[0032] Furthermore, according to the catheter 1 of the first embodiment, the narrow-diameter portion 21 of the second cylindrical body 200 is inserted inside the base end portion 252 of the first cylindrical body 25. Therefore, even if the second cylindrical body 200, which corresponds to the hub, is formed using a polyolefin resin or a fluororesin that has high chemical resistance and low bonding strength with adhesives, it is possible to make it difficult for the second cylindrical body 200 to detach from the first cylindrical body 25.

[0033] Furthermore, according to the catheter 1 of the first embodiment, a ring-shaped projection 254 is provided on the inner circumferential surface 25i of the proximal end portion 252 of the first cylindrical body 25, and a ring-shaped groove 214 that fits into the projection 254 is provided on the outer circumferential surface of the narrow diameter portion 21 of the second cylindrical body 200. Therefore, the first cylindrical body 25 and the second cylindrical body 200 can be mechanically fixed using the groove and projection.

[0034] Furthermore, according to the catheter 1 of the first embodiment, since the proximal projection 216 is provided on the inner circumferential surface of the narrow diameter portion 21, the length between the tip projection 253 and the proximal projection 216 can be shortened. Therefore, when the shaft projection 110 is shaped to fit into the recess SP2, and the shaft projection 110 is formed with adhesive, the amount of adhesive required to form the shaft projection 110 can be reduced. Moreover, since the proximal projection 216 is provided over the entire circumferential direction, the area of ​​the portion where the shaft projection 110 and the proximal projection 216 catch can be increased. Therefore, when using the catheter 1, the occurrence of the shaft 10 coming out of the cylindrical member 20 can be further avoided.

[0035] Furthermore, according to the catheter 1 of the first embodiment, the inner diameter Φ216a of the proximal protrusion 216 at its tip is larger than the inner diameter Φ216b of the proximal protrusion 216 at its base. Therefore, when manufacturing the catheter 1, it is easier for the worker to insert the shaft 10 into the second cylindrical body 200. Furthermore, when forming the shaft protrusion 110 with adhesive, it is easier for the worker to place the adhesive in the recess SP2.

[0036] Furthermore, according to the catheter 1 of the first embodiment, the proximal projection 216 includes a tapered portion 2161 in which the inner diameter Φ216 of the proximal projection 216 gradually increases from the proximal end to the tip end. Therefore, when manufacturing the catheter 1, it is easier for the worker to insert the shaft 10 into the second cylindrical body 200. Furthermore, when forming the shaft projection 110 with adhesive, it is easier for the worker to place the adhesive into the recess SP2.

[0037] <Second Embodiment> Figure 5 is a longitudinal cross-sectional view of a portion OP2 of catheter 1A in the second embodiment. In catheter 1A of the second embodiment, the shaft 10 has a shaft projection 110A instead of a shaft projection 110.

[0038] The shaft projection 110A has a different shape from that of the first embodiment and does not have a shape that fits into the recess SP2. The tip surface 111 of the shaft projection 110A is the same as that of the first embodiment. The base end surface 112A of the shaft projection 110A is a surface that extends perpendicular to the axis O. The base end surface 112A of the shaft projection 110A does not contact the base end projection 216. A gap is provided between the base end surface 112A of the shaft projection 110A and the base end projection 216. The shaft projection 110A is ring-shaped.

[0039] As described above, the shape of the shaft projection 110A can be modified in various ways. The second embodiment described above can also achieve the same effects as the first embodiment. Specifically, in the first case, the tip surface 111 of the shaft projection 110A catches on the tip side projection 253, thereby restricting the movement of the shaft 10 toward the tip side D1. In the second case, the base end surface of the shaft 10 catches on the step 225 of the second cylindrical body 200, thereby restricting the movement of the shaft 10 toward the base end side D2. Therefore, in the catheter 1A of the second embodiment, the movement of the shaft 10 in the D1 and D2 directions can also be restricted. Furthermore, according to the catheter 1A of the second embodiment, the amount of adhesive required to form the shaft projection 110A can be reduced.

[0040] <Third Embodiment> Figure 6 is a longitudinal cross-sectional view of a portion OP2 of catheter 1B of the third embodiment. In catheter 1B of the third embodiment, the shaft 10 has a shaft projection 110B instead of a shaft projection 110.

[0041] The shaft projection 110B has a different shape from that of the first embodiment and does not have a shape that fits into the recess SP2. The tip surface 111B of the shaft projection 110B is a surface that extends perpendicular to the axis O. The tip surface 111B of the shaft projection 110B does not contact the tip-side projection 253. A gap is provided between the tip surface 111B of the shaft projection 110B and the tip-side projection 253. The base end surface 112 of the shaft projection 110B is the same as that of the first embodiment. The shaft projection 110B is substantially ring-shaped with a tapered base end.

[0042] As described above, the shape of the shaft projection 110B can be modified in various ways. The same effects as those of the first embodiment can be achieved in the third embodiment described above. Specifically, in the first case, the shaft 10 moves toward the tip side D1 until the tip surface 111B of the shaft projection 110B catches on the tip side projection 253. After the tip surface 111B catches on the tip side projection 253, the movement of the shaft 10 toward the tip side D1 is restricted, similar to the first embodiment. In the second case, the movement of the shaft 10 toward the tip side D2 is restricted by the base end surface 112 of the shaft projection 110B catching on the base end projection 216. Furthermore, according to the catheter 1B of the third embodiment, the amount of adhesive required to form the shaft projection 110B can be reduced.

[0043] <Fourth Embodiment> Figure 7 is a longitudinal cross-sectional view of a portion OP2 of the catheter 1C of the fourth embodiment. In the catheter 1C of the fourth embodiment, the shaft 10 has a 100C instead of a shaft projection 110.

[0044] The shaft projection 110C has a different shape from that of the first embodiment and does not have a shape that fits into the recess SP2. The tip surface 111C of the shaft projection 110C is a surface that extends perpendicular to the axis O. The tip surface 111C of the shaft projection 110C does not contact the tip-side projection 253. A gap is provided between the tip surface 111C of the shaft projection 110C and the tip-side projection 253. The base end surface 112C of the shaft projection 110C is a surface that extends perpendicular to the axis O. The base end surface 112C of the shaft projection 110C does not contact the base-side projection 216. A gap is provided between the base end surface 112C of the shaft projection 110C and the base-side projection 216. The shaft projection 110C is ring-shaped.

[0045] Thus, the shape of the shaft projection 110C can be modified in various ways. The fourth embodiment described above can also achieve the same effects as the first embodiment described above. Specifically, in the first case, the shaft 10 moves toward the tip side D1 until the tip surface 111C of the shaft projection 110C catches on the tip side projection 253. After the tip surface 111C catches on the tip side projection 253, the movement of the shaft 10 toward the tip side D1 is restricted, similar to the first embodiment. In the second case, the shaft 10 moves toward the base side D2 until the base end surface 112C of the shaft projection 110C catches on the base side projection 216. After the base end surface 112C catches on the base side projection 216, the movement of the shaft 10 toward the base side D2 is restricted, similar to the first embodiment. Furthermore, according to the catheter 1C of the fourth embodiment, the amount of adhesive required to form the shaft projection 110C can be reduced.

[0046] <Fifth Embodiment> Figure 8 is a longitudinal cross-sectional view of a portion OP2 of catheter 1D according to the fifth embodiment. In the embodiment described in the first embodiment, catheter 1D has a shaft 10D instead of shaft 10. Shaft 10D has a tube 101D instead of tube 101 and a shaft projection 110D instead of shaft projection 110.

[0047] The shaft projection 110D has the same shape as in the first embodiment. The shaft projection 110D is not formed by adhesive. The shaft projection 110D is a portion of the wall thickness of the tube 101D that protrudes outward at the base end 10b. The operator can create the catheter 1D by inserting the shaft 10D, which has the shape shown in Figure 8, into the second cylindrical body 200, and then covering it with the first cylindrical body 25.

[0048] Thus, the configuration of the shaft projection 110D can be modified in various ways. The shaft projection 110D does not have to be formed by adhesive. For example, the shaft projection 110D may be integrally molded with the tube 101D as illustrated in Figure 8. For example, the shaft projection 110D may not be formed by adhesive and may be a separate component from the tube 101D. In this case, for example, the shaft projection 110D can be an elastic body wrapped around the outer circumferential surface 10o of the tube 101D. The same effects as those of the first embodiment described above can be achieved in this fifth embodiment as well.

[0049] <Sixth Embodiment> Figure 9 is a longitudinal cross-sectional view of a portion OP2 of the catheter 1E of the sixth embodiment. The catheter 1E of the sixth embodiment has a first cylindrical body 25E instead of the first cylindrical body 25 as described in the first embodiment. The first cylindrical body 25E has a tip-side projection 253E instead of the tip-side projection 253.

[0050] The inner circumferential surface 253i of the tip-side projection 253E is not in contact with the outer circumferential surface 10o of the shaft 10. A gap is provided between the inner circumferential surface 253i of the tip-side projection 253E and the outer circumferential surface 10o of the shaft 10. In the sixth embodiment, as in the first embodiment, the base end surface 2532 of the tip-side projection 253E and the tip surface 111 of the shaft projection 110 are in contact.

[0051] Thus, the shape of the tip-side projection 253E can be modified in various ways. At least one of the tip surface and the base end surface 2532 of the tip-side projection 253E may be a surface inclined with respect to the axis O. In the sixth embodiment described above, as in the first case, the tip surface 111 of the shaft projection 110 catches on the base end surface 2532 of the tip-side projection 253E, thereby achieving the same effect as in the first embodiment.

[0052] <Seventh Embodiment> Figure 10 is a longitudinal cross-sectional view of a portion OP2 of the catheter 1F of the seventh embodiment. The catheter 1F of the seventh embodiment has a first cylindrical body 25F instead of the first cylindrical body 25 as described in the first embodiment. The first cylindrical body 25F has a tip-side projection 253F instead of the tip-side projection 253.

[0053] The tip-side projection 253F is provided on only a portion of the inner circumferential surface 25i of the first cylindrical body 25 in the circumferential direction. The range in which the tip-side projection 253F is provided can be set as appropriate. For example, the range in which the tip-side projection 253F is provided may be 180 degrees or 90 degrees. Furthermore, multiple tip-side projections 253F may be arranged on the inner circumferential surface 25i of the first cylindrical body 25 at intervals from each other. In the seventh embodiment described above, as in the first case, the tip surface 111 of the shaft projection 110 catches on the base end surface 2532 of the tip-side projection 253F, thereby achieving the same effect as in the first embodiment.

[0054] <Eighth Embodiment> Figure 11 is a longitudinal cross-sectional view of a portion OP2 of catheter 1G of the eighth embodiment. In the embodiment described in the first embodiment, catheter 1G has a second cylindrical body 200G instead of the second cylindrical body 200. The second cylindrical body 200G has a proximal protrusion 216G instead of the proximal protrusion 216.

[0055] Of the base end projection 216G, the inner circumferential surface of the straight portion 2162G does not contact the outer circumferential surface 10o of the shaft 10. A gap is provided between the inner circumferential surface of the straight portion 2162G and the outer circumferential surface 10o of the shaft 10. In the eighth embodiment, as in the first embodiment, the inner circumferential surface of the tapered portion 2161 of the base end projection 216G is in contact with the base end surface 112 of the shaft projection 110.

[0056] Thus, the shape of the base end projection 216G can be modified in various ways. In the eighth embodiment described above, as in the second case, the base end surface 112 of the shaft projection 110 catches on the tapered portion 2161 of the base end projection 216G, thereby achieving the same effect as in the first embodiment.

[0057] <Ninth Embodiment> Figure 12 is a longitudinal cross-sectional view of a portion OP2 of the catheter 1H of the ninth embodiment. The catheter 1H of the ninth embodiment has a second cylindrical body 200H instead of the second cylindrical body 200, and a shaft protrusion 110H instead of the shaft protrusion 110. The second cylindrical body 200H has a proximal protrusion 216H instead of the proximal protrusion 216.

[0058] The base-side projection 216H does not have the tapered portion 2161 described in the first embodiment. The tip surface 2161H of the base-side projection 216H is a surface that extends perpendicular to the axis O. The base-side projection 216H is provided in the range from the base end 213 of the small-diameter portion 21 to the step 225. The range of the base-side projection 216H can be arbitrarily changed. The base end surface 112H of the shaft projection 110H is in contact with the tip surface 2161H of the base-side projection 216H. The shaft projection 110H is ring-shaped. The inner diameter at the tip of the base-side projection 216H is equal to the inner diameter at the base end of the base-side projection 216H.

[0059] Thus, the shapes of the shaft projection 110H and the base end projection 216H can be modified in various ways. In the ninth embodiment described above, as well as in the second case, the base end surface 112H of the shaft projection 110H catches on the tip surface 2161H of the base end projection 216H, thereby achieving the same effect as in the first embodiment.

[0060] <Tenth Embodiment> Figure 13 is a longitudinal cross-sectional view of a portion OP2 of the catheter 1I of the tenth embodiment. The catheter 1I of the tenth embodiment has a second cylindrical body 200I instead of the second cylindrical body 200 as described in the first embodiment. The second cylindrical body 200I has a proximal protrusion 216I instead of the proximal protrusion 216.

[0061] The base end projection 216I is provided on only a portion of the inner circumferential surface 200i of the second cylindrical body 200I in the circumferential direction. The range in which the base end projection 216I is provided can be set as appropriate. For example, the range in which the base end projection 216I is provided may be 180 degrees or 90 degrees. Furthermore, multiple base end projections 216I may be arranged on the inner circumferential surface 200i of the second cylindrical body 200I at intervals from each other. In the tenth embodiment described above, as in the second case, the base end surface 112 of the shaft projection 110 catches on the tapered portion 2161 of the base end projection 216I, thereby achieving the same effect as in the first embodiment.

[0062] <Embodiment 11> Figure 14 is a longitudinal cross-sectional view of a portion OP2 of the catheter 1J of the 11th embodiment. The catheter 1J of the 11th embodiment has a first cylindrical body 25J instead of the first cylindrical body 25, a second cylindrical body 200J instead of the second cylindrical body 200, and a shaft protrusion 110J instead of the shaft protrusion 110.

[0063] The first cylindrical body 25J does not have the projection 254 described in the first embodiment. The second cylindrical body 200J does not have the narrow diameter portion 21 described in the first embodiment. The second cylindrical body 200J has a base end projection 216J. The base end projection 216J is the portion where the inner circumferential surface 200i of the cylindrical member 20 protrudes toward the outer circumferential surface 10o of the shaft 10. The base end projection 216J is a part of the inner circumferential surface side of the tip of the wide diameter portion 22. The base end surface 112J of the shaft projection 110J is in contact with the tip surface of the base end projection 216J. The shaft projection 110J is ring-shaped.

[0064] As described above, the shapes of the first cylindrical body 25J and the second cylindrical body 200J, and the shape of the shaft projection 110J can be modified in various ways. Figure 14 illustrates an embodiment in which the second cylindrical body 200J does not have a narrow diameter portion 21. The first cylindrical body 25J and the second cylindrical body 200J may be integrally molded. In other words, the cylindrical member 20 may not be divided into the first cylindrical body 25J and the second cylindrical body 200J, but may be integrally molded. When integrally molding the cylindrical member 20, the worker provides a through hole in a part of the first cylindrical body 25J that penetrates from the inside to the outside. After inserting the shaft 10, in which the shaft projection 110J has not yet been formed, the worker can form the shaft projection 110J by pouring adhesive from the through hole into the recess SP2. The same effects as the first embodiment can be achieved in the 11th embodiment as described above.

[0065] <Modified form of this embodiment> This disclosure is not limited to the embodiments described above, and can be implemented in various forms without departing from its essence, including, for example, the following modifications.

[0066] [Example 1] The first to eleventh embodiments described above show examples of catheters 1, 1A to 1J. Various modifications are possible to the configuration of catheters 1, 1A to 1J. For example, catheter 1 does not need to have the marker 19 described in Figure 1. For example, catheter 1 may have a shaft 10 in a different configuration than that shown in Figure 2. For example, shaft 10 does not need to have a liner 103. For example, shaft 10 may further have a coating layer covering its outer circumferential surface to improve the slipperiness of catheter 1 in the biological lumen. For example, shaft 10 may further have a coating layer covering its inner circumferential surface to improve the slipperiness of the combined device in the first lumen 10L. The coating layer may be formed from either a hydrophilic resin or a hydrophobic resin.

[0067] For example, catheter 1 may be a multi-lumen catheter. In this case, shaft 10 may be a multi-lumen tube. Shaft 10 may include a plurality of tubes extending side by side. For example, let us describe the case in which shaft 10 includes a first tube and a second tube. In this case, the second cylindrical body 200 of the cylindrical member 20 may have a branching portion on the proximal end side of the proximal end projection 216. At the branching portion, the second cylindrical body 200 may have a first portion that extends in a first direction when the first tube is inserted, and a second portion that extends in a second direction when the second tube is inserted.

[0068] [Differentiation 2] The first to eleventh embodiments described above show examples of the cylindrical member 20. The configuration of the cylindrical member 20 can be modified in various ways.

[0069] For example, the configuration of the first cylindrical bodies 25, 25E, 25F, and 25J can be modified in various ways. For example, the inside of the tip portion 251 of the first cylindrical body 25 may be solid and the space SP1 may not be provided. For example, the tip-side projection 253 may be a different member from the first cylindrical body 25 and fixed to the inner circumferential surface 25i. For example, the first cylindrical body 25 may not have a projection 254. In this case, a projection may be provided in place of a groove 214 in the narrow diameter portion 21 of the second cylindrical body 200. The first cylindrical body 25 is made of a flexible material. Therefore, the first cylindrical body 25 and the second cylindrical body 200 can be integrated by making the projection of the second cylindrical body 200 bite into the inner circumferential surface 25i of the first cylindrical body 25.

[0070] For example, the configuration of the second cylindrical body 200, 200G~200J can be modified in various ways. For example, the second cylindrical body 200 does not have to have at least a part of the small diameter portion 21, the large diameter portion 22, and the connecting portion 23. For example, the second cylindrical body 200 may have parts that are different from the small diameter portion 21, the large diameter portion 22, and the connecting portion 23. For example, there may not be a step 215 between the small diameter portion 21 and the large diameter portion 22. In this case, the small diameter portion 21 and the large diameter portion 22 as a whole may have a tapered shape in which the outer diameter gradually increases from the base end to the tip end.

[0071] [Difference 3] The shaft protrusions 110, 110A~110D, 110H, 110J, first cylindrical bodies 25, 25E, 25F, 25J, and second cylindrical bodies 200, 200G~200J of the above-described first to eleventh embodiments, and the shaft protrusions 110, 110A~110D, 110H, 110J, first cylindrical bodies 25, 25E, 25F, 25J, and second cylindrical bodies 200, 200G~200J of the above-described modified examples 1 and 2 may be combined as appropriate. For example, the catheter 1 may employ a combination of the shaft protrusions 110A~110D described in any of the second to fifth embodiments, the first cylindrical bodies 25E, 25F described in any of the sixth to seventh embodiments, and the second cylindrical bodies 200G~200I described in any of the eighth to tenth embodiments.

[0072] This embodiment has been described above based on embodiments and modifications. The embodiments described above are for the purpose of facilitating understanding of this embodiment and do not limit it. This embodiment can be modified and improved without departing from its spirit and the scope of the claims, and equivalents thereof are included in this embodiment. Technical features that are not described as essential in this specification may be deleted as appropriate.

Claims

1. Catheters (1, 1A to 1J), A shaft (10, 10D) having a first lumen (10L) and shaft protrusions (110, 110A to 110D, 110H, 110J), A cylindrical member (20) having a second lumen (20L) into which the base end of the shaft (10, 10D) is inserted, Equipped with, The cylindrical member (20) is The inner circumferential surface that forms the second lumen, The tip-side protrusions (253, 253E, 253F) extend from the inner circumferential surface of the cylindrical member (20) toward the outer circumferential surface of the shaft (10, 10D), The cylindrical member (20) has base-end protrusions (216, 216G to 216J) that protrude from the inner circumferential surface toward the outer circumferential surface of the shaft (10, 10D) at a base end side of the tip-end protrusions (253, 253E, 253F), The shaft protrusions (110, 110A to 110D, 110H, 110J) extend from the outer circumferential surface of the shaft (10, 10D) toward the inner circumferential surface of the cylindrical member (20) between the tip-side protrusions (253, 253E, 253F) and the base-side protrusions (216, 216G to 216J), and restrict the movement of the shaft (10, 10D) by catching on at least one of the tip-side protrusions (253, 253E, 253F) and the base-side protrusions (216, 216G to 216J), in the catheter (1, 1A to 1J).

2. A catheter (1, 1A, 1D to 1J) according to claim 1, The tip surfaces of the shaft projections (110, 110A, 110D, 110H, 110J) are in contact with the proximal end surfaces of the tip projections (253, 253E, 253F) of the catheter (1, 1A, 1D to 1J).

3. A catheter (1,1D to 1J) according to claim 2, The shaft protrusions (110, 110D, 110H, 110J) have a shape that fits into a recess formed on the inner circumferential surface side of the cylindrical member (20) between the tip protrusions (253, 253E, 253F) and the base protrusions (216, 216G to 216J), and are used as catheters (1, 1D to 1J).

4. A catheter (1, 1A to 1C, 1E to 1J) according to any one of claims 1 to 3, The shaft protrusions (110, 110A to 110C, 110H, 110J) are adhesives provided on the outer surface of the shaft (10), and the catheter (1, 1A to 1C, 1E to 1J).

5. A catheter (1,1A to 1I) according to any one of claims 1 to 4, The cylindrical member (20) is A cylindrical first cylindrical body (25, 25E, 25F) including the aforementioned tip-side protrusions (253, 253E, 253F), A catheter (1, 1A to 1I) having a tubular second tube (200, 200G to 200I) including the proximal end protrusions (216, 216G to 216I).

6. A catheter (1,1A to 1I) according to claim 5, The aforementioned second cylindrical bodies (200, 200G to 200I) are, The narrow diameter section, It has a larger diameter portion provided on the base end side of the smaller diameter portion, and having a larger outer diameter than the smaller diameter portion, The narrow diameter portion of the second cylindrical body (200, 200G to 200I) is inserted inside the proximal end of the first cylindrical body (25, 25E, 25F), and is a catheter (1, 1A to 1I).

7. A catheter (1,1A to 1I) according to claim 6, A ring-shaped projection (254) is provided on the inner circumferential surface of the base end of the first cylindrical body (25, 25E, 25F). A catheter (1, 1A to 1I) is provided, wherein the outer circumferential surface of the narrow diameter portion of the second cylindrical body (200, 200G to 200I) is provided with a ring-shaped groove (214) that fits into the projection (254).

8. A catheter (1, 1A to 1H, 1J) according to claim 6 or claim 7, The proximal end projections (216, 216G, 216H, 216J) are provided on the inner circumferential surface of the narrow diameter portion, extending over the entire circumferential direction, in the catheter (1, 1A to 1H, 1J).

9. A catheter (1, 1A to 1G, 1I) according to claim 8, A catheter (1, 1A to 1G, 1I) in which the inner diameter of the proximal projection (216, 216G, 216I) at its tip is larger than the inner diameter of the proximal projection (216, 216G, 216I) at its proximal end.

10. A catheter (1, 1A to 1G, 1I) according to claim 8 or claim 9, The proximal projection (216, 216G, 216I) includes a tapered portion (2161) in which the inner diameter of the proximal projection (216, 216G, 216I) gradually increases from the proximal end to the distal end, wherein the catheter (1, 1A to 1G, 1I) is provided.

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