Inserter

Abstract

To provide an inserter capable of preventing, while a slit for facilitating attachment / detachment to / from the guide wire is formed, a guide wire from jumping out or falling off from the slit.SOLUTION: An inserter 10 includes: an outer cylinder 11 having a first slit 11s extending from a distal end to a proximal end; an inner cylinder 12 disposed inside the outer cylinder 11 and configured to be rotatable in a circumferential direction relative to the outer cylinder 11 and has a second slit 12s extending from the tip end to the base end; and restriction mechanisms 11k, 12k that restrict the relative movement of the inner cylinder 12 with respect to the outer cylinder 11. The restriction mechanisms 11k, 12k regulate the movement of the inner cylinder 12 with respect to the outer cylinder 11 while maintaining a state in which the first slit 11s and the second slit 12s do not overlap each other.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates to an inserter used to introduce a guidewire into a catheter or the like. [Background technology]

[0002] Conventionally, guidewires have been used to guide medical instruments such as catheters inserted into tubular organs of the human body, such as blood vessels and digestive organs, to a target site. Some guidewires have a tip portion formed into a curved shape or the like according to their application, and when such a guidewire is inserted into a tubular organ, catheter, or the like, an insertion aid called an inserter having a tubular portion through which the guidewire is inserted is used so that the tip portion can be inserted in a substantially straight state (for example, Patent Document 1).

[0003] When an inserter is attached to a guidewire, the tip of the guidewire is usually inserted from the proximal end side of the tubular part of the inserter. However, when removing the inserter from the guidewire, if the tip of the guidewire is already inserted into a tubular organ, catheter, etc., the inserter must be moved to the proximal end of the guidewire. In addition, after removing the inserter from the guidewire, it may be necessary to attach the inserter again. In this case, too, the inserter must be attached from the proximal end of the guidewire and moved to the tip of the guidewire. Therefore, an inserter having a slit in the tubular part of the inserter is used so that the inserter can be easily attached and detached from the tip side of the guidewire (for example, Patent Documents 2 and 3). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2000-107297 A [Patent Document 2] JP 2004-242954 A [Patent Document 3] JP 2005-245514 A Summary of the Invention [Problem to be solved by the invention]

[0005] Providing a slit in the tubular portion of the inserter makes it easier to attach and detach it from the guidewire, but there is a risk that the tip of the guidewire may come out of the slit during operation, or that the inserter may become unintentionally detached from the guidewire.

[0006] The present disclosure has been made in consideration of the above circumstances, and aims to provide an inserter that has a slit that makes it easy to attach and detach the guidewire, yet prevents the guidewire from jumping out or falling off the slit. [Means for solving the problem]

[0007] In order to achieve the above-mentioned objective, the present disclosure provides an inserter comprising: an outer tube having a first slit extending from the tip to the base end; an inner tube disposed inside the outer tube and configured to be rotatable circumferentially relative to the outer tube, the inner tube having a second slit extending from the tip to the base end; and a regulating mechanism that regulates the relative movement of the inner tube with respect to the outer tube (Disclosure 1).

[0008] According to this disclosure (Disclosure 1), when the inner tube is positioned inside the outer tube so that the first slit of the outer tube and the second slit of the inner tube overlap, the inserter can be easily attached to and detached from the guidewire. Meanwhile, the regulating mechanism can prevent the inner tube from moving relative to the outer tube when the first slit and the second slit do not overlap, thereby preventing the guidewire from popping out of the slit or falling off during use.

[0009] In the above disclosure (Disclosure 1), the regulating mechanism maintains a state in which the first slit and the second slit do not overlap, and regulates the movement of the inner cylinder relative to the outer cylinder (Disclosure 2).

[0010] In the above disclosures (Disclosures 1 and 2), the regulating mechanism may be composed of a first locking portion provided on the outer tube and a second locking portion provided on the inner tube that locks with the first locking portion (Disclosure 3).

[0011] According to this disclosure (Disclosure 3), by engaging a first locking portion provided on the outer tube with a second locking portion provided on the inner tube, the positional relationship between the outer tube and the inner tube is fixed, thereby restricting the relative movement of the inner tube with respect to the outer tube.

[0012] In the above disclosure (Disclosure 3), the first locking portion may be formed as a notch in the base end of the outer tube, and the second locking portion may be formed as a plate-like piece formed by folding back a portion of the base end of the inner tube in the axial direction (Disclosure 4).

[0013] According to this disclosure (Disclosure 4), the positional relationship between the outer tube and the inner tube is fixed by inserting the plate-shaped second locking portion into the notched first locking portion, thereby regulating the relative movement of the inner tube with respect to the outer tube.

[0014] In the above disclosures (Disclosures 1 and 2), the regulating mechanism may be composed of a first gripping portion connected to the base end of the outer tube and a second gripping portion connected to the base end of the inner tube (Disclosure 5).

[0015] According to this disclosure (Disclosure 5), when an attempt is made to rotate the inner tube circumferentially inside the outer tube, the first gripping portion of the outer tube and the second gripping portion of the inner tube interfere with each other, thereby restricting the relative rotational movement of the inner tube with respect to the outer tube.

[0016] In the above disclosure (Disclosure 5), it is preferable that the radial length of the second gripping portion is greater than the inner diameter of the outer cylinder (Disclosure 6).

[0017] According to this disclosure (Disclosure 6), when an attempt is made to move the inner tube toward the axial tip relative to the outer tube, the second gripping portion abuts against the base end surface of the tubular outer tube main body that constitutes the outer tube, thereby restricting the relative axial movement of the inner tube with respect to the outer tube.

[0018] In the above disclosure (Disclosure 5), it is preferable that the first gripping portion and the second gripping portion are each formed in an approximately flat plate shape, and when the inner tube is placed inside the outer tube so that the first surface of the first gripping portion faces the first surface of the second gripping portion, the first slit and the second slit do not overlap, and when the inner tube is placed inside the outer tube so that the first surface of the first gripping portion faces the second surface of the second gripping portion, the first slit and the second slit overlap (Disclosure 7).

[0019] According to this disclosure (Disclosure 7), by simply switching the orientation of the second gripping portion of the inner tube relative to the first gripping portion of the outer tube, it is possible to switch between a state in which the first slit and the second slit do not overlap (a state suitable for use) and a state in which the first slit and the second slit overlap (a state suitable for attachment and detachment).

[0020] In the above disclosure (Disclosure 1), the first slit may be formed at a first angle with respect to the long axis of the outer tube, and the second slit may be formed at a second angle with respect to the long axis of the inner tube (Disclosure 8).

[0021] In the above disclosure (Disclosure 8), the first angle and the second angle may be substantially the same (Disclosure 9).

[0022] In the above disclosures (Disclosures 1 and 2), the regulating mechanism may be realized by the inner diameter of the outer tube being formed to be approximately the same as the outer diameter of the inner tube, so that the inner tube fits into the outer tube (Disclosure 10). Effect of the Invention

[0023] According to the present disclosure, a slit is formed in the inserter to facilitate attachment and detachment of the guidewire, while preventing the guidewire from jumping out or falling off the slit of the inserter. [Brief description of the drawings]

[0024] [Figure 1] FIG. 2 is an explanatory diagram showing the overall structure of an inserter according to the first embodiment of the present disclosure. [Diagram 2] 2A and 2B are explanatory diagrams showing the structures of the outer tube and the inner tube that constitute the inserter of FIG. 1, in which (a) shows the structure of the outer tube and (b) shows the structure of the inner tube. [Diagram 3] 1A and 1B are explanatory diagrams showing how the inner tube and outer tube are attached to a guide wire when assembled, where (a) shows the state with the slit positions aligned, and (b) shows the state with the slit positions shifted. [Figure 4] FIG. 11 is an explanatory diagram showing the overall structure of an inserter according to a second embodiment of the present disclosure. [Diagram 5] 5A and 5B are explanatory diagrams showing the structures of the outer tube and the inner tube which constitute the inserter of FIG. 4, in which (a) shows the structure of the outer tube and (b) shows the structure of the inner tube. [Figure 6] 5A and 5B are explanatory diagrams showing the state in which the inner and outer cylinders are assembled, in which (a) shows the state in which the slit positions are aligned, and (b) shows the state in which the slit positions are shifted. FIG. [Figure 7] FIG. 13 is an explanatory diagram showing the overall structure of an inserter according to a third embodiment of the present disclosure. [Figure 8] 8A and 8B are explanatory diagrams showing the structures of the outer tube and the inner tube which constitute the inserter of FIG. 7, in which (a) shows the structure of the outer tube and (b) shows the structure of the inner tube. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] Hereinafter, embodiments of the present disclosure will be described based on the drawings. The present disclosure is not limited to the embodiments described below, and the described embodiments are merely examples for explaining the technical features of the present disclosure. In addition, the shapes and dimensions shown in each drawing are shown only to facilitate understanding of the contents of the present disclosure, and do not accurately reflect the actual shapes and dimensions.

[0026] In this specification, the term "distal side" refers to the direction along the axial direction of the inserter (and the guidewire to which the inserter is attached) in which the inserter (and the guidewire) advances toward the target site. The term "base side" refers to the direction along the axial direction of the inserter (and the guidewire) in the opposite direction to the distal side. Furthermore, the term "distal" refers to the distal end of any member or site, and the term "base end" refers to the proximal end of any member or site. In each figure, the left side of the figure is the "distal side" that is inserted into the body, and the right side is the "base side" that is operated by the operator.

[0027] First Embodiment 1 is an explanatory diagram showing the overall structure of an inserter 10 according to a first embodiment of the present disclosure. The inserter 10 according to this embodiment includes a substantially cylindrical outer tube 11, a substantially cylindrical inner tube 12 that is disposed inside the outer tube 11 and configured to be rotatable in the circumferential direction relative to the outer tube 11, and a restricting mechanism that restricts the relative movement of the inner tube 12 with respect to the outer tube 11. The restricting mechanism will be described later.

[0028] 2(a), the outer tube 11 has a first slit 11s extending from the tip 111 to the base end 112 along the axial direction (longitudinal direction). The first slit 11s is a cut formed along the axial direction of the outer tube 11, and a gap may be formed between both ends of the first slit 11s, or the both ends may overlap. The formation of the first slit 11s in the outer tube 11 of the inserter 10 allows the guidewire GW to be introduced into the inside of the outer tube 11 from the side peripheral surface of the outer tube 11.

[0029] The outer tube 11 is provided with a first locking portion 11k, which is one of the components of the restriction mechanism. The first locking portion 11k is formed in a notch shape by cutting out a part of the outer tube 11 (the base end portion of the outer tube 11) in a substantially rectangular shape from the base end 112 toward the axial tip side. The first locking portion 11k may be formed integrally with and adjacent to the first slit 11s, or may be formed at a position away from the first slit 11s.

[0030] The material for forming the outer tube 11 is not particularly limited, and examples thereof include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer. The outer tube 11 may be entirely made of the same material, or may be partially made of different materials. By forming the outer tube 11 from a tube made of a resin material, the first slit 11s and the first locking portion 11k can be easily formed in the outer tube 11.

[0031] As shown in Fig. 2(b), the inner tube 12 has a second slit 12s extending from the tip 121 to the base end 122 along the axial direction (longitudinal direction). The first slit 12s is a cut formed along the axial direction of the inner tube 12, and a gap may be formed between both ends of the second slit 12s, or the both ends may overlap. Since the second slit 12s is formed in the inner tube 12 of the inserter 10, the guidewire GW can be introduced into the inner tube 12 from the side peripheral surface of the inner tube 12.

[0032] The inner cylinder 12 is disposed inside the outer cylinder 11 and configured to be rotatable in the circumferential direction relative to the outer cylinder 11. In this embodiment, the outer diameter of the inner cylinder 12 is formed to be slightly larger than the inner diameter of the outer cylinder 11, but this is not limited as long as the inner cylinder 12 is rotatable inside the outer cylinder 11. For example, even if the outer diameter of the inner cylinder 12 is substantially the same as the inner diameter of the outer cylinder 11, the inner cylinder 12 may be disposed inside the outer cylinder 11 and configured to slide inside the outer cylinder 11 by utilizing the first slits 11s formed in the outer cylinder 11.

[0033] The inner tube 12 is provided with a second locking portion 12k, which is one of the components of the regulating mechanism. The second locking portion 12k is engaged with the first locking portion 11k provided on the outer tube 11, and is formed in a plate shape by folding back a part of the inner tube 12 (the base end portion of the inner tube 12) from the base end 122 toward the axial tip side. Specifically, two cuts are formed approximately parallel to each other from the base end 122 of the inner tube 12, and the portion between the cuts is folded back, thereby forming the second locking portion 12k formed in a plate shape.

[0034] By inserting such a plate-shaped second locking portion 12k into the notched first locking portion 11k formed in the outer tube 11, the positional relationship between the outer tube 11 and the inner tube 12 is fixed, so that the relative movement of the inner tube 12 with respect to the outer tube 11 can be restricted. In order to firmly lock the first locking portion 11k and the second locking portion 12k, it is preferable that the width (circumferential length) of the second locking portion 12k is not extremely narrower than the width of the notch of the first locking portion 11k. In addition, if the axial length of the second locking portion 12k is extremely short, it will easily come off from the first locking portion 11k, so it is preferable that the second locking portion 12k is formed to have a certain degree of axial length.

[0035] The inner tube 12 is preferably formed so that its axial length is longer than the axial length of the outer tube 11. With the base end 112 of the outer tube 11 and the base end 122 of the inner tube 12 aligned by the first locking portion 11k and the second locking portion 12k (regulation mechanism), the tip 121 of the inner tube 12 protrudes further toward the tip side than the tip 111 of the outer tube 11, thereby preventing interference between the tip of the guidewire GW and the inserter 10 when the inserter 10 is attached to the guidewire GW.

[0036] The material for forming the inner tube 12 is not particularly limited, and examples thereof include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer. The inner tube 12 may be entirely made of the same material, or may be partially made of different materials. By forming the inner tube 12 from a tube made of a resin material, the second slit 12s and the second locking portion 12k can be easily formed in the inner tube 12.

[0037] In addition, the shape of the first locking portion 11k formed on the outer tube 11 and the shape of the second locking portion 12k formed on the inner tube 12 are not limited to these, and for example, a hook member may be placed on the base end 122 of the inner tube 12 and the hook member may be locked into a locking hole formed in the outer tube 11, or a protrusion formed on the outer peripheral surface of the inner tube 11 may be fitted into a recess formed on the inner peripheral surface of the outer tube 11 to lock the inner tube 11 to the outer tube 11.

[0038] 3 shows how the inserter 10 is attached to the guidewire GW with the inner tube 12 disposed inside the outer tube 11. As shown in FIG. 3(a), if the inner tube 12 is disposed inside the outer tube 11 so that the first slit 11s of the outer tube 11 and the second slit 12s of the inner tube 12 are overlapped, the guidewire GW can be pushed into the inserter 10 from the side peripheral surface of the inserter 10 (the outer tube 11 and the inner tube 12). As shown in FIG. 3(b), with the guidewire GW introduced inside the inserter 10, the inner tube 12 is rotated in the circumferential direction with respect to the outer tube 11, and the second locking portion 12k of the inner tube 12 is inserted into the first locking portion 11k of the outer tube 11, thereby restricting the relative movement of the inner tube 12 with respect to the outer tube 11. In this state, the inner tube 12 is restricted from rotating in the circumferential direction relative to the outer tube 11, and is also restricted from moving in the axial direction relative to the outer tube 11. In this locked state, the first slit 11s of the outer tube 11 and the second slit 12s of the inner tube 12 do not overlap, but when the lock is released, the first slit 11s of the outer tube 11 and the second slit 12s of the inner tube 12 can return to an overlapping state.

[0039] According to the inserter 10 described above, when the inner tube 12 is positioned inside the outer tube 11 so that the first slit 11s of the outer tube 11 and the second slit 12s of the inner tube 12 overlap, the inserter 10 can be easily attached to and detached from the guidewire GW. Meanwhile, the first locking portion 11k of the outer tube 11 and the second locking portion 12k of the inner tube 12, which constitute the regulating mechanism, can prevent the inner tube 12 from moving relative to the outer tube 11 when the first slit 11s and the second slit 12s do not overlap, thereby preventing the guidewire GW from popping out or falling off through the first slit 11s and the second slit 12s during use.

[0040] <Second embodiment> 4 is an explanatory diagram showing the overall structure of an inserter 20 according to a second embodiment of the present disclosure. The inserter 20 according to this embodiment includes a substantially cylindrical outer tube 21, a substantially cylindrical inner tube 22 that is disposed inside the outer tube 21 and configured to be rotatable in the circumferential direction relative to the outer tube 21, and a restriction mechanism that restricts the relative movement of the inner tube 22 with respect to the outer tube 21. The restriction mechanism will be described later.

[0041] As shown in FIG. 5(a), the outer tube 21 has an outer tube body 21m having a substantially cylindrical shape, and the outer tube body 21m has a first slit 21s extending from the tip 211 to the base end 212 along the axial direction (longitudinal direction). The first slit 21s is a cut formed along the axial direction of the outer tube body 21m, and a gap may be formed between both ends of the first slit 21s, or the both ends may overlap. Since the first slit 21s is formed in the outer tube 21 (of the outer tube body 21m) of the inserter 20, the guide wire GW can be introduced into the inside of the outer tube 21 from the side peripheral surface of the outer tube 21.

[0042] The outer tube 21 is provided with a first gripping portion 21h, which is one of the components of the regulating mechanism. The first gripping portion 21h is substantially flat and connected to the base end 212 of the outer tube body 21m. The first gripping portion 21h may be formed integrally with the outer tube body 21m, or may be connected to the outer tube body 21m as a separate member. When the first gripping portion 21h is formed integrally with the outer tube body 21m, for example, a single cylindrical body may be prepared, one end of which may be cut in the axial direction to open it, and the end may be the substantially flat first gripping portion 21h.

[0043] The material forming the outer tube 21 (outer tube main body 21m and first gripping portion 21h) is not particularly limited, and examples thereof include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer. The outer tube 21 may be entirely formed of the same material, or may be partially formed of a different material (for example, only the first gripping portion 21h). By forming the outer tube 21 from a tube made of a resin material, the first slit 21s and the first gripping portion 21h can be easily formed in the outer tube 21.

[0044] As shown in FIG. 5(b), the inner tube 22 has a substantially cylindrical inner tube body 22m, which has a second slit 22s extending from the tip 221 to the base end 222 along the axial direction (longitudinal direction). The second slit 22s is a cut formed along the axial direction of the inner tube body 22m, and a gap may be formed between both ends of the second slit 22s, or the both ends may overlap. The second slit 22s is formed in the inner tube 22 (the inner tube body 22m) of the inserter 20, so that the guidewire GW can be introduced into the inner tube 22 from the side peripheral surface of the inner tube 22.

[0045] The inner cylinder 22 (the inner cylinder body 22m) is disposed inside the outer cylinder 21 (the outer cylinder body 21m), and the inner cylinder 22 is configured to be rotatable in the circumferential direction relative to the outer cylinder 21. In this embodiment, the outer diameter of the inner cylinder body 22m is formed to be slightly larger than the inner diameter of the outer cylinder body 21m, but this is not limited as long as the inner cylinder body 22m is rotatable inside the outer cylinder body 21m. For example, even if the outer diameter of the inner cylinder body 22m is substantially the same as the inner diameter of the outer cylinder body 21m, the inner cylinder body 22m may be disposed inside the outer cylinder body 21m by utilizing the first slit 21s formed in the outer cylinder body 21m, and the inner cylinder body 22m may be configured to slide inside the outer cylinder body 21m.

[0046] The inner tube 22 is provided with a second gripping portion 22h, which is one of the components of the regulating mechanism. The second gripping portion 22h is generally flat and connected to the base end 222 of the inner tube main body 22m. The second gripping portion 22h may be formed integrally with the inner tube main body 22m, or may be connected to the inner tube main body 22m as a separate member. When the second gripping portion 22h is formed integrally with the inner tube main body 22m, for example, a single cylindrical body may be prepared, one end of which may be cut in the axial direction to open it, and the end may be the generally flat second gripping portion 22h.

[0047] In this way, a regulating mechanism is formed by connecting a first gripping portion 21h to the base end 212 of the outer tube body 21m of the outer tube 21 and connecting a second gripping portion 22h to the base end 222 of the inner tube body 22m of the inner tube 22.When an attempt is made to rotate the inner tube 22 (its inner tube body 22m) in a circumferential direction inside the outer tube 21 (its outer tube body 21m), the first gripping portion 21h of the outer tube 21 and the second gripping portion 22h of the inner tube 22 interfere with each other, so that the relative rotational movement of the inner tube 22 with respect to the outer tube 21 can be regulated. In this embodiment, the radial length of the second gripping portion 22h is greater than the inner diameter of (the outer tube body 21m of) the outer tube 21, and by configuring in this manner, when the inner tube 22 is moved toward the axial tip side relative to the outer tube 21, the second gripping portion 22h abuts against the base end surface 212 of the tubular outer tube body 21m constituting the outer tube 21, so that the relative axial movement of the inner tube 22 with respect to the outer tube 21 can be restricted. Therefore, by forming a restriction mechanism with the first gripping portion 21h of the outer tube 21 and the second gripping portion 22h of the inner tube 22, the positional relationship between the outer tube 21 and the inner tube 22 is fixed, and the relative movement of the inner tube 22 with respect to the outer tube 21 can be restricted.

[0048] The inner tube 22 is preferably formed so that its axial length is longer than the axial length of the outer tube 21. With the base end 212 of the outer tube body 21m of the outer tube 21 and the base end 222 of the inner tube body 22m of the inner tube 22 aligned by the first gripping portion 21h and the second gripping portion 22h (regulating mechanism), the tip 221 of the inner tube 22 protrudes further toward the tip side than the tip 211 of the outer tube 21, thereby preventing interference between the tip of the guidewire GW and the inserter 20 when the inserter 20 is attached to the guidewire GW.

[0049] The material forming the inner tube 22 (the inner tube main body 22m and the second gripping portion 22h) is not particularly limited, and examples thereof include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer. The inner tube 22 may be entirely formed of the same material, or may be partially formed of a different material (for example, only the second gripping portion 22h). By forming the inner tube 22 from a tube made of a resin material, the second slit 22s and the second gripping portion 22h can be easily formed in the inner tube 22.

[0050] The shapes of the first gripping portion 21h formed on the outer tube 21 and the second gripping portion 22h formed on the inner tube 22 are not limited to these, and may be any shapes that cause the first gripping portion 21h of the outer tube 21 and the second gripping portion 22h of the inner tube 22 to interfere with each other when an attempt is made to rotate the inner tube 22 (the inner tube main body 22m) circumferentially inside the outer tube 21 (the outer tube main body 21m).

[0051] FIG. 6 shows how the inserter 20 is attached to the guidewire GW with the inner tube 22 disposed inside the outer tube 21. As shown in FIG. 6(a), if the inner tube 22 (the inner tube main body 22m) is disposed inside the outer tube 21 (the outer tube main body 21m) so that the first slit 21s of the outer tube 21 and the second slit 22s of the inner tube 22 are overlapped, the guidewire GW can be pushed into the inserter 20 from the side peripheral surface of the inserter 20 (the outer tube 21 and the inner tube 22). As shown in FIG. 6(b), if the inner tube 22 is rotated 180° in the circumferential direction relative to the outer tube 21 with the guidewire GW introduced inside the inserter 20, the first slit 21s of the outer tube 21 and the second slit 22s of the inner tube 22 do not overlap. In other words, simply by switching the orientation of the second gripping portion 22h of the inner tube 22 relative to the first gripping portion 21h of the outer tube 21, it is possible to switch between a state in which the first slit 21s and the second slit 22s do not overlap (a state suitable for use) and a state in which the first slit 21s and the second slit 22s overlap (a state suitable for attachment and detachment).

[0052] In other words, in the inserter 20 of this embodiment, when the inner tube 22 is positioned inside the outer tube 21 so that the first surface of the first gripping portion 21h (the front surface shown in FIG. 5(a)) faces the first surface of the second gripping portion 22h (the front surface shown in FIG. 5(b)), the first slit 21s and the second slit 22s do not overlap, and when the inner tube 22 is positioned inside the outer tube 21 so that the first surface of the first gripping portion 21h faces the second surface of the second gripping portion 22h (the back surface not shown in FIG. 5(b)), the first slit 21s and the second slit 22s overlap.

[0053] According to the inserter 20 described above, when the inner tube 22 is positioned inside the outer tube 21 so that the first slit 21s of the outer tube 21 and the second slit 22s of the inner tube 22 overlap, the inserter 20 can be easily attached to and detached from the guidewire GW. Meanwhile, the first gripping portion 21h of the outer tube 21 and the second gripping portion 22h of the inner tube 22, which constitute the regulating mechanism, can prevent the inner tube 22 from moving relative to the outer tube 21 when the first slit 21s and the second slit 22s do not overlap, thereby preventing the guidewire GW from popping out or falling off through the first slit 21s and the second slit 22s during use.

[0054] <Third embodiment> 7 is an explanatory diagram showing the overall structure of an inserter 30 according to a third embodiment of the present disclosure. The inserter 30 according to this embodiment includes a substantially cylindrical outer tube 31, a substantially cylindrical inner tube 32 that is disposed inside the outer tube 31 and configured to be rotatable in the circumferential direction relative to the outer tube 31, and a restriction mechanism that restricts the relative movement of the inner tube 32 with respect to the outer tube 31. The restriction mechanism will be described later.

[0055] As shown in FIG. 8(a), the outer tube 31 has a generally cylindrical outer tube body 31m, and the outer tube body 31m has a first slit 31s that extends in a spiral shape from the tip 311 to the base end 312. The first slit 31s is a cut formed at a first angle θ1 with respect to the long axis X1 of the outer tube 31 (the axial direction of the outer tube body 21m), and a gap may be formed between both ends of the first slit 31s, or the both ends may overlap. The first slit 31s is formed in the outer tube 31 (outer tube body 31m) of the inserter 30, so that the guidewire GW can be introduced into the inside of the outer tube 31 from the side peripheral surface of the outer tube 31.

[0056] The material for forming the outer cylinder 31 (outer cylinder main body 31m) is not particularly limited, and examples thereof include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer. The outer cylinder 31 may be entirely made of the same material, or may be partially made of different materials. By forming the outer cylinder 31 from a tube made of a resin material, the first slit 31s can be easily formed in the outer cylinder 31.

[0057] As shown in FIG. 8(b), the inner tube 32 has a substantially cylindrical inner tube body 32m, and the inner tube body 32m has a second slit 32s that extends in a spiral shape from the tip 321 to the base end 322. The second slit 32s is a cut formed at a second angle θ2 with respect to the long axis X2 of the inner tube 32 (the axial direction of the inner tube body 22m), and a gap may be formed between both ends of the second slit 32s, or the both ends may overlap. Since the second slit 32s is formed in the inner tube 32 (the inner tube body 32m) of the inserter 30, the guide wire GW can be introduced into the inner tube 32 from the side peripheral surface of the inner tube 32.

[0058] The material forming the inner tube 32 (the inner tube main body 32m) is not particularly limited, and examples thereof include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer. The inner tube 32 may be entirely formed of the same material, or may be partially formed of different materials. By forming the inner tube 32 from a tube made of a resin material, the second slit 32s can be easily formed in the inner tube 32.

[0059] The inner cylinder 32 (its inner cylinder body 32m) is disposed inside the outer cylinder 31 (its outer cylinder body 31m), and the inner cylinder 32 is configured to be rotatable in the circumferential direction relative to the outer cylinder 31. In this embodiment, the outer diameter of the inner cylinder body 32m is formed to be approximately the same as the inner diameter of the outer cylinder body 31m. By utilizing the fact that a first slit 31s is formed in the outer cylinder body 31m, the inner cylinder body 32m can be disposed inside the outer cylinder body 31m, and the inner cylinder body 32m slides inside the outer cylinder body 31m, so that the inner cylinder 32 can be rotatable in the circumferential direction relative to the outer cylinder 31.

[0060] On the other hand, in the inserter 30, the restriction mechanism for restricting the relative movement of the inner tube 32 with respect to the outer tube 31 is realized by fitting the inner tube 32 into the outer tube 31, since the outer diameter of the inner tube 32 is formed to be substantially the same as the inner diameter of the outer tube 31. When the inner tube 32 is fitted into the outer tube 31, the inner tube 32 does not rotate in the circumferential direction inside the outer tube 31 unless a sufficiently strong force is intentionally applied, so that the relative rotational movement of the inner tube 32 with respect to the outer tube 31 can be restricted. In other words, by fitting the inner tube 32 into the outer tube 31, the positional relationship between the outer tube 31 and the inner tube 32 is fixed, and the relative movement of the inner tube 32 with respect to the outer tube 31 can be restricted.

[0061] The inner tube 32 may be formed so that its axial length is longer than the axial length of the outer tube 31. Even if the base end 322 of the inner tube main body 32m of the inner tube 32 is inserted from the tip 311 side of the outer tube main body 21m of the outer tube 31 and the base end 312 of the outer tube 31 and the base end 322 of the inner tube 32 are aligned in a state in which the tip 321 of the inner tube 32 protrudes toward the tip side beyond the tip 311 of the outer tube 31, so that when the inserter 30 is attached to the guidewire GW, interference between the tip of the guidewire GW and the inserter 30 can be prevented.

[0062] When the inserter 30 is attached to the guidewire GW with the inner tube 32 disposed inside the outer tube 31, if the inner tube 32 (the inner tube main body 32m) is disposed and fitted inside the outer tube 31 (the outer tube main body 31m) so that the first slit 31s of the outer tube 31 and the second slit 32s of the inner tube 32 overlap, the guidewire GW can be pushed into the inserter 30 from the side peripheral surface of the inserter 30 (the outer tube 31 and the inner tube 32). With the guidewire GW introduced inside the inserter 30, if the inner tube 32 is rotated even slightly in the circumferential direction relative to the outer tube 31, the first slit 31s of the outer tube 31 and the second slit 32s of the inner tube 32 do not overlap.

[0063] According to the inserter 30 described above, when the inner tube 32 is arranged inside the outer tube 31 so that the first slit 31s of the outer tube 31 and the second slit 32s of the inner tube 32 overlap, the inserter 30 can be easily attached to and detached from the guidewire GW. Meanwhile, by fitting the inner tube 22, which constitutes the regulating mechanism, into the outer tube 31, the inner tube 32 can be prevented from moving relative to the outer tube 31 when the first slit 31s and the second slit 32s do not overlap, thereby preventing the guidewire GW from popping out or falling off through the first slit 31s and the second slit 32s during use.

[0064] In this embodiment, the inclination of the spiral of the first slit 31s formed in the outer tube 31 (first angle θ1) and the inclination of the spiral of the second slit 32s formed in the inner tube 32 (second angle θ2) are made substantially the same. By making them substantially the same, the outer tube 31 and the inner tube 32 can be fitted together with the first slit 31s and the second slit 32s overlapping, which makes it easy to attach the inserter 30 to the guidewire GW. As long as the inserter 30 can be attached to the guidewire GW, the first angle θ1 and the second angle θ2 may be different angles.

[0065] In this embodiment, the outer tube 31 has a first slit 31s extending spirally from the tip 311 to the base end 312, but the first slit 31s may be a cut formed at a first angle θ1 with respect to the long axis of the outer tube 31 (the axial direction of the outer tube main body 21m); for example, the first angle θ1 may change between the tip 311 and the base end 312, or the first slit 31s may be a wavy slit extending from the tip 311 to the base end 312. Similarly, the inner tube 32 has a second slit 32s extending spirally from the tip 321 to the base end 322, but the second slit 32s may be a cut formed at a tilt at a second angle θ2 with respect to the long axis of the inner tube 32 (the axial direction of the inner tube main body 22m); for example, the second angle θ2 may change between the tip 321 and the base end 322, or the second slit 32s may be a wavy slit extending from the tip 321 to the base end 322.

[0066] The inserter according to the present disclosure has been described above with reference to the drawings, but the present disclosure is not limited to the above embodiment and various modifications are possible. For example, the outer tubes 11, 21, 31 and the inner tubes 12, 22, 32 constituting the inserters 10, 20, 30 may have partially varying diameters, for example, tapered shapes. In addition, the widths (slit gap distances) of the slits formed in the outer tubes 11, 21, 31 and the inner tubes 12, 22, 32 constituting the inserters 10, 20, 30 may be varied, for example, by making the gaps of the slits on the base end side wider than those on the tip end side to improve attachment to the guidewire. [Explanation of symbols]

[0067] 10 Inserter 11 Outer cylinder 11s First slit 11k 1st locking part 111 Tip 112 Proximal end 12 Inner cylinder 12s 2nd slit 12k 2nd locking part 121 Tip 122 Proximal end 20 Inserter 21 Outer cylinder 21m outer cylinder body 21s 1st slit 21h 1st grip part 211 Tip 212 Proximal end 22 Inner cylinder 22m outer cylinder body 22s 1st slit 22h 1st grip part 221 Tip 222 Proximal end 30 Inserter 31 Outer cylinder 31m outer cylinder body 31s 1st slit 311 Tip 312 Proximal end 32 Inner cylinder 32m outer cylinder body 32s 1st slit 321 Tip 322 Proximal end

Claims

1. an outer cylinder having a first slit extending from a distal end to a proximal end; an inner cylinder disposed inside the outer cylinder and configured to be rotatable in a circumferential direction relative to the outer cylinder, the inner cylinder having a second slit extending from a tip end to a base end; and a restricting mechanism that restricts relative movement of the inner tube with respect to the outer tube.

2. The inserter according to claim 1 , wherein the regulating mechanism maintains a state in which the first slit and the second slit do not overlap, thereby regulating movement of the inner tube relative to the outer tube.

3. The regulatory mechanism is A first locking portion provided on the outer cylinder; The inserter according to claim 1 or 2, further comprising: a second locking portion provided on the inner tube and configured to lock with the first locking portion.

4. The first locking portion is formed in a notch shape at a base end portion of the outer cylinder, The inserter according to claim 3 , wherein the second locking portion is formed in the shape of a plate obtained by folding back a portion of a base end portion of the inner tube in the axial direction.

5. The regulatory mechanism is A first gripping portion connected to a base end of the outer cylinder; The inserter according to claim 1 or 2, further comprising: a second gripping portion connected to a base end of the inner cylinder.

6. The inserter of claim 5 , wherein a radial length of the second gripping portion is greater than an inner diameter of the outer barrel.

7. The first gripping portion and the second gripping portion are each formed in a flat plate shape, When the inner tube is disposed inside the outer tube such that the first surface of the first gripping portion faces the first surface of the second gripping portion, the first slit and the second slit do not overlap with each other.

6. The inserter of claim 5, wherein when the inner tube is positioned inside the outer tube so that the first surface of the first gripping portion faces the second surface of the second gripping portion, the first slit and the second slit overlap.

8. The first slit is formed at a first angle with respect to a major axis of the outer cylinder, The inserter of claim 1 , wherein the second slit is inclined at a second angle relative to a longitudinal axis of the inner barrel.

9. The inserter of claim 8 , wherein the first angle and the second angle are substantially the same.

10. 3. The inserter according to claim 1, wherein the restriction mechanism is realized by fitting the inner tube to the outer tube such that an outer diameter of the inner tube is substantially the same as an inner diameter of the outer tube.

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