catheter

Abstract

To provide a catheter with enhanced bonding strength at the joint between the shaft and the connector. [Solution] The catheter 100 comprises a shaft 10 having a lumen 11 inside, and a connector 20 joined to the proximal end 10d of the shaft 10 by adhesive 31. The shaft 10 has an inner layer 12 forming the lumen 11, a reinforcing layer 13 covering the outside of the inner layer 12, an anchor member 14 positioned outside the reinforcing layer 13, and an outer layer 15 covering the outside of the reinforcing layer 13 and the anchor member 14. The connector 20 has an insertion portion 21 into which the proximal end 10d of the shaft 10 is inserted, and the adhesive 31 is filled between the outer peripheral surface 10s of the outer layer 15 and the inner peripheral surface 21s of the insertion portion 21. The outer layer 15 has a protruding portion 15a formed by the anchor member 14 to protrude radially outward from the shaft 10, at least at the proximal end 10d of the shaft 10 inserted into the insertion portion 21.

Description

[Technical Field]

[0001] The present disclosure relates to a catheter. [Background Art]

[0002] A known catheter includes a shaft having a lumen extending along an axial direction, and a connector (hub) connected to a proximal end of the shaft and gripped by an operator for operation. Generally, the shaft and the connector are connected by inserting the proximal end of the shaft into a space formed inside the connector from the distal end side of the connector (for example, Patent Document 1). [Prior Art Literature] [Patent Literature]

[0003] [Patent Document 1] Japanese Utility Model Publication No. Sho 63-17486 [Summary of the Invention] [Problem to be Solved by the Invention]

[0004] In a catheter as described in Patent Document 1, the proximal end side of the shaft is inserted into the internal space of the connector from the distal end side, and the outer peripheral surface of the shaft and the inner peripheral surface of the lumen of the connector are adhesively fixed via an adhesive, thereby joining the shaft and the connector. When a catheter with such a structure is used, a large load may be applied to the joint portion between the shaft and the connector when the operator performs a rotation operation, so high joint strength is required for the joint portion between the shaft and the connector.

[0005] The present disclosure has been made in view of the above circumstances, and provides a catheter in which the joint strength of the joint portion between a shaft and a connector is increased. [Means for Solving the Problem]

[0006] This disclosure provides a catheter comprising a shaft having a lumen inside, and a connector joined to the proximal end of the shaft by adhesive, wherein the shaft has an inner layer forming the lumen, a reinforcing layer covering the outside of the inner layer, an anchor member disposed outside the reinforcing layer, and an outer layer covering the outside of the reinforcing layer and the anchor member, the connector has an insertion portion into which the proximal end of the shaft is inserted, the adhesive is filled between the outer circumferential surface of the outer layer of the shaft and the inner circumferential surface of the insertion portion of the connector, and the outer layer has a projection formed by the anchor member to project radially outward from the shaft, at least at the proximal end of the shaft inserted into the insertion portion. [Brief explanation of the drawing]

[0007] [Figure 1] This is an overall side view showing an example of a catheter according to one embodiment of the present disclosure. [Figure 2] Figure 1 is a partial cross-sectional view of the catheter. [Figure 3] This is an enlarged view of section III in Figure 2. [Figure 4] This is an enlarged view of another example of part III in Figure 2. [Figure 5] This is a partial cross-sectional view showing a catheter related to a modified example. [Modes for carrying out the invention]

[0008] The embodiments of this disclosure will be described below with reference to the drawings. This disclosure is not limited to the embodiments described below, and the embodiments described are merely examples to illustrate the technical features of this disclosure. The shapes and dimensions shown in each drawing are shown only to facilitate understanding of the contents of this disclosure and do not accurately reflect the actual shapes and dimensions.

[0009] In this specification, "tip side" means the direction along the axial direction of the catheter, in which the catheter advances toward the target site. "Proximal side" means the direction along the axial direction of the catheter, in the opposite direction to the tip side. "Tip" refers to the tip end of any component or site, and "proximal end" refers to the proximal end of any component or site. In Figure 1, the left side of the illustration is the "tip side" that is inserted into the body, and the right side of the illustration is the "proximal side" that is manipulated by the operator.

[0010] Figure 1 is an overall side view showing an example of a catheter according to one embodiment of the present disclosure. Figure 2 is a partial cross-sectional view of the catheter 100 of Figure 1. The catheter 100 comprises a shaft 10 having a lumen 11 extending in the axial direction of the catheter 100, and a connector 20 connected to the shaft 10 and having a connector lumen 22 communicating with the lumen 11. The connector 20 is also called a hub. The shaft 10 has a tip 10a, a proximal end 10b, and an intermediate portion 10c located between the tip 10a and the proximal end 10b. The connector 20 is joined to the proximal end 10b of the shaft 10 by adhesive 31. In this embodiment, the axial direction of the catheter 100 is the direction along the central axis X of the catheter 100.

[0011] The shaft 10 has an inner layer 12 which is a hollow tubular member having a lumen 11 inside, a reinforcing layer 13 which covers the outside of the inner layer 12, an anchor member 14 which is positioned outside the reinforcing layer 13, and an outer layer 15 which covers the outside of the reinforcing layer 13 and the anchor member 14. The connector 20 has an insertion portion 21 on the tip 20a side into which the base end 10b of the shaft 10 is inserted. The adhesive 31 is filled between the outer circumferential surface 10s of the shaft 10 (of the outer layer 15) and the inner circumferential surface 21s of the insertion portion 21 of the connector 20.

[0012] The outer layer 15 of the shaft 10 has a projection 15a formed by the anchor member 14 so as to protrude radially outward from the shaft 10, at least at the base end 10b of the shaft 10 that is inserted into the insertion portion 21.

[0013] The connector 20 has an insertion portion 22 on the tip 20a side into which the base end 10b of the shaft 10 is inserted. The insertion portion 22 is configured to allow insertion of at least the base end 10b of the shaft 10. The insertion portion 22 may also be configured to allow insertion of the base end 10b and a portion of the intermediate portion 10c on the base end 10b side of the shaft 10.

[0014] In the catheter 100, the formation of a protrusion 15a on the outer layer 15 of the shaft 10 increases the contact area of ​​the shaft 10 with the adhesive 31 filled in the gap 30 between the shaft 10 and the connector 20, thereby improving the bonding strength of the joint between the shaft 10 and the connector 20. Furthermore, because the protrusion 15a is formed on the outer layer 15 so as to protrude radially outward from the shaft 10, the protrusion 15a exerts an anchoring effect on the adhesive 31, improving the effect of preventing the shaft 10 and the connector 20 from coming loose in the axial direction.

[0015] The insertion portion 21 of the connector 20 includes a tapered portion 211 whose inner diameter widens from the base end to the tip end, and a straight portion 212 located closer to the base end than the tapered portion 211, with a constant inner diameter. A connecting portion 213 is provided at the base end of the straight portion 21, which connects to the connector lumen 22. The protrusion 15a formed at the base end 10b of the shaft 10 is located in the region corresponding to the tapered portion 211 of the insertion portion 21. By providing the tapered portion 211 in the insertion portion 21, the amount of adhesive 31 that enters the gap 30 between the shaft 10 and the connector 20 can be increased, thereby further improving the bonding strength of the joint between the shaft 10 and the connector 20.

[0016] Figure 3 is an enlarged view of part III of Figure 2. As shown in Figure 3, the reinforcing layer 13 has a coil body 13a formed in a hollow spiral shape from metal wires 13w and a braided body 13b formed by weaving metal wires 13w together. The braided body 13b is arranged to cover the outside of the inner layer 12, and the coil body 13a is arranged to cover the outside of the braided body 13b. The reinforcing layer 13 may be formed only from the coil body 13a, and the reinforcing layer 13 may not have a braided body 13. By arranging at least the coil body 13a, formed in a hollow spiral shape from metal wires 13a, on the outside of the inner layer 12, the reinforcing layer 13 can be provided on the shaft 10. The coil body 13a and the braided body 13b may be formed from stranded wires formed by twisting multiple wires together.

[0017] The anchor member 14 is a spiral-shaped linear member 14a wound around the outside of the reinforcing layer 13. By winding the linear member 14a around the outside of the reinforcing layer 13, a protruding portion 15a with a large anchoring effect can be formed on the outer layer 15 of the shaft 10. The anchor member 14 may be welded to the outside of the coil body 13a of the reinforcing layer 13, or it may simply be wound around it. The anchor member 14 may be a single spiral-shaped linear member 14a, or it may be a plurality of spiral-shaped linear members 14a.

[0018] In this embodiment, the linear member 14a is formed of a round wire with a substantially circular cross-section. The shape of the linear member 14a is not limited to this. Figure 4 is an enlarged view of another example of part III of Figure 2. As shown in Figure 4, the anchor member 14 may be a linear member 14b formed of a flat wire with a substantially rectangular cross-section, or it may be a linear member having other cross-sectional shapes (substantially elliptical, substantially peanut-shaped, etc.).

[0019] The cross-sectional area of ​​the linear member 14a is larger than the cross-sectional area of ​​the metal wires 13w of the coil body 13a. By forming a projection 15a on the shaft 10 with the anchor member 14 of such a linear member 14a, a structure in which the projection 15a penetrates deeply into the adhesive 31 can be easily realized.

[0020] The outer layer 15 is formed so as to cover the outer sides of the reinforcing layer 13 and the anchor member 14. As shown in FIGS. 3 and 4, the outer layer 15 may be formed so as to penetrate into gaps between the inner layer 12 and the reinforcing layer 13, gaps between the coil body 13a and the braided body 13b of the reinforcing layer 13, and gaps between the reinforcing layer 13 and the anchor member 14.

[0021] As the adhesive 31, an adhesive generally used for medical devices such as catheters can be used.

[0022] The configuration of the catheter in the present embodiment is not limited to the catheter 100 shown in FIG. 1. Modified examples of the catheter will be described below.

[0023] (Modified Example) FIG. 5 is a partial cross-sectional view showing a catheter 101 according to a modified example. The catheter 101 according to the modified example includes an anchor member 141 disposed on the outer side of the reinforcing layer 13 at the proximal end portion 10b of the shaft 10. The anchor member 141 in the catheter 101 is an annular linear member. Except for the structure of the anchor member 141, the catheter 101 has the same configuration as the catheter 100 shown in FIGS. 1 and 2. Therefore, in the following description, the same reference numerals are used for components common to the catheter 100, and the description thereof is omitted.

[0024] With the catheter 101 as well, since the protruding portion 15a is formed on the outer layer 15 of the shaft 10 by the anchor member 141, the contact area of the shaft 10 with respect to the adhesive 31 filled in the gap 30 between the shaft 10 and the connector 20 increases, so that the bonding strength of the bonded portion between the shaft 10 and the connector 20 can be improved. Further, since the protruding portion 15a is formed on the outer layer 15 so as to protrude outward in the radial direction of the shaft 10, the protruding portion 15a exerts an anchoring effect on the adhesive 31, and the effect of preventing the shaft 10 and the connector 20 from coming off in the axial direction is improved.

[0025] In catheter 101, the anchor members 141 are three annular linear members. By simply winding these annular anchor members 141 around the outside of the reinforcing layer 15, a protruding portion 15a with a large anchoring effect can be formed on the outer layer 15 of the shaft 10. The number of annular anchor members 141 is not limited to three. Depending on the required specifications of catheter 101, there may be one or two annular anchor members 141, or four or more.

[0026] The cross-sectional area of ​​the linear member of the anchor member 141 is larger than the cross-sectional area of ​​the metal wire 13w of the coil body 13a. By forming a projection 15a on the shaft 10 with such an anchor member 141, a structure in which the projection 15a penetrates deeply into the adhesive 31 can be easily realized.

[0027] The present disclosure provides a catheter comprising a shaft having a lumen inside, and a connector joined to the proximal end of the shaft by adhesive, wherein the shaft has an inner layer forming the lumen, a reinforcing layer covering the outside of the inner layer, an anchor member disposed outside the reinforcing layer, and an outer layer covering the outside of the reinforcing layer and the anchor member, the connector has an insertion portion into which the proximal end of the shaft is inserted, the adhesive is filled between the outer circumferential surface of the outer layer of the shaft and the inner circumferential surface of the insertion portion of the connector, and the outer layer has a projection formed by the anchor member to project radially outward from the shaft, at least at the proximal end of the shaft inserted into the insertion portion (Disclosure 1).

[0028] According to the disclosure (Disclosure 1), the formation of protrusions on the outer layer of the shaft increases the contact area of ​​the shaft with the adhesive filled between the shaft and the connector, thereby improving the bonding strength of the joint between the shaft and the connector. Furthermore, because the protrusions are formed on the outer layer so as to protrude radially outward from the shaft, the protrusions exert an anchoring effect on the adhesive, improving the effect of preventing the shaft and connector from coming loose in the axial direction.

[0029] In the above disclosure (Disclosure 1), the anchor member may be a linear member wound around the outside of the reinforcing layer (Disclosure 2).

[0030] According to such disclosure (Disclosure 2), a projection can be formed on the outer layer of the shaft by winding a linear member around the outside of the reinforcing layer.

[0031] In the above disclosure (Disclosure 2), the anchor member may have a helical shape (Disclosure 3), or the anchor member may have an annular shape (Disclosure 4).

[0032] According to such disclosures (Disclosures 3 and 4), by winding a linear member spirally or annularly around the outside of the reinforcing layer, a protruding portion with a large anchoring effect can be formed on the outer layer of the shaft.

[0033] In the above disclosures (Disclosures 1-4), the reinforcing layer may include a coil body formed in a hollow spiral shape from metal wires (Disclosure 5).

[0034] According to such disclosure (Disclosure 5), a reinforcing layer can be provided on the shaft by arranging a coil body formed in a hollow spiral shape from metal wires on the outside of the inner layer.

[0035] In the above disclosure (Disclosure 5), the anchor member may be a linear member wound around the outside of the coil body (Disclosure 6).

[0036] According to such disclosure (Disclosure 6), a protrusion can be formed on the outer layer of the shaft by winding a linear member around the outside of the coil body.

[0037] In the above disclosure (Disclosure 6), the diameter of the linear member may be larger than the diameter of the metal wire (Disclosure 7).

[0038] According to such disclosure (Disclosure 7), a structure in which the protruding portion penetrates deeply into the adhesive can be easily realized.

[0039] In the above disclosure (Disclosure 1-7), the insertion portion may have a tapered portion whose inner diameter expands from the base end to the tip end, and the protruding portion may be located in a region corresponding to the tapered portion (Disclosure 8).

[0040] According to such disclosure (Disclosure 8), by providing a tapered portion, the amount of adhesive between the shaft and the connector can be increased, thereby further improving the bonding strength of the joint between the shaft and the connector.

[0041] The catheter relating to this disclosure has been described above with reference to the drawings. However, this disclosure is not limited to the embodiments described above, and various modifications are possible. The components of the above embodiments and modifications may be combined with each other, as long as they do not conflict with the technical specifications.

[0042] The anchor members positioned outside the reinforcing layer only need to be capable of forming protrusions on the outer layer of the shaft so as to project radially outward from the shaft. The anchor members may be formed by winding a linear member around the outside of the reinforcing layer along the circumferential direction, or by winding a linear member around the outside of the reinforcing layer for a portion of the circumferential direction (half a turn, one-third of a turn, one-quarter of a turn, etc.), or by fixing a linear member to the outside of the reinforcing layer along an inclined direction at an angle to the axial direction, or by fixing a granular member or a lump member to the outside of the reinforcing layer.

[0043] The catheter relating to this disclosure is applicable to various types of catheters, including cardiovascular, cerebrovascular, lower limb vascular, and digestive catheters, as well as microcatheters, balloon catheters, guiding catheters, and other types of penetrating catheters.

Claims

1. A shaft (10) having a lumen (11) inside, The shaft (10) is joined to the base end (10d) by an adhesive (31) and comprises a connector (20), The shaft (10) comprises an inner layer (12) forming the inner lumen (11), a reinforcing layer (13) covering the outside of the inner layer (12), anchor members (14, 141) positioned outside the reinforcing layer (13), and an outer layer (15) covering the outside of the reinforcing layer (13) and the anchor members (14, 141). The connector (20) has an insertion portion (21) into which the base end portion (10d) of the shaft (10) is inserted. The adhesive (31) is filled between the outer circumferential surface (10s) of the outer layer (15) of the shaft (10) and the inner circumferential surface (21s) of the insertion portion (21) of the connector (20). The catheter has an outer layer (15) having a projection (15a) formed by the anchor members (14, 141) so as to protrude radially outward from the shaft (10) at least at the base end (10d) of the shaft (10) which is inserted into the insertion portion (21).

2. The catheter (100) according to claim 1, wherein the anchor members (14, 141) are linear members (14a, 14b) wound around the outside of the reinforcing layer (13).

3. The catheter (100) according to claim 2, wherein the anchor members (14, 141) have a spiral shape.

4. The catheter (100) according to claim 2, wherein the anchor members (14, 141) have an annular shape.

5. The catheter (100) according to claim 1, wherein the reinforcing layer (13) includes a coil body (13a) formed in a hollow spiral shape from metal wires (13w).

6. The catheter (100) according to claim 5, wherein the anchor members (14, 141) are linear members (14a, 14b) wound around the outside of the coil body (13a).

7. The catheter (100) according to claim 6, wherein the cross-sectional area of ​​the linear members (14a, 14b) is larger than the cross-sectional area of ​​the metal wire (13w).

8. The insertion portion (21) has a tapered portion (211) whose inner diameter expands from the base end to the tip end. The catheter (100) according to claim 1, wherein the protruding portion (15a) is located in a region corresponding to the tapered portion (211).

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