Inserter

The inserter design with multiple cylindrical bodies and slits addresses guidewire protrusion and damage issues by enabling easy and damage-free attachment and detachment, using rotatable and flexible components to guide the guidewire.

JP2026005908APending Publication Date: 2026-01-16ASAHI INTECC CO LTD
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Patent Information

Application Number
JP2024104544
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-06-28
Publication Date
2026-01-16

AI Technical Summary

Technical Problem

Existing inserters for guidewires in medical devices face issues with guidewire protrusion or detachment during operation, and existing slits can cause damage to the guidewire due to interference with slit edges.

Method used

An inserter design comprising multiple cylindrical bodies with overlapping and non-overlapping slits allows easy attachment and detachment while minimizing guidewire damage, using rotatable and flexible components to guide the guidewire through the inserter.

Benefits of technology

The inserter facilitates easy and damage-free attachment and detachment of guidewires by preventing protrusion and interference, ensuring smooth guidewire removal and attachment processes.

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Abstract

To provide an inserter which is easily attached to and detached from an insertion object such as a guide wire and can reduce damage to the insertion object during attachment and detachment.SOLUTION: The inserter 100 of the present disclosure includes the inserter main body 200 having the first cylindrical body 1 having the first slit 11 extending from the distal end to the proximal end and the second cylindrical body 2 disposed inside the first cylindrical body 1, rotatable in the circumferential direction relative to the first cylindrical body 1, and having the second slit 21 extending from the distal end to the proximal end, and the third cylindrical body 3 detachably attached to the distal end portion of the inserter main body 200 and having the third slit 31 extending from the distal end to the proximal end.SELECTED DRAWING: Figure 3
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Description

[Technical Field]

[0001] The present disclosure relates to an inserter used to introduce an insert such as a guidewire into a tubular medical device such as a catheter. [Background technology]

[0002] Conventionally, guidewires have been used to guide medical devices, such as catheters, inserted into tubular organs of the human body, such as blood vessels and digestive organs, to target sites. Known guidewires have tip portions formed into a curved shape or the like depending on the application. When inserting such guidewires into tubular organs, catheters, or the like, doctors use an insertion aid called an inserter, which has a tubular portion through which the guidewire is inserted, so that the tip portion can be inserted in a substantially straight state (see, for example, Patent Document 1).

[0003] When a doctor or other user attaches an inserter to a guidewire, the tip of the guidewire is typically inserted from the proximal end of the inserter's tubular portion. When a user removes an inserter from a guidewire, if the tip of the guidewire is already inserted into a tubular organ, catheter, or the like, the user must move the inserter to the proximal end of the guidewire. After removing an inserter from a guidewire, the user may need to reattach the inserter. In this case, the user must also attach the inserter from the proximal end of the guidewire and then move the inserter to the distal end of the guidewire. Therefore, inserters with slits in the tubular portion have been used to allow users to easily attach and detach inserters from the distal end of the guidewire (e.g., Patent Documents 2 and 3). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2000-107297 [Patent Document 2] Japanese Patent Application Laid-Open No. 2004-242954 [Patent Document 3] Japanese Patent Application Laid-Open No. 2005-245514 Summary of the Invention [Problem to be solved by the invention]

[0005] Although providing a slit in the tubular portion of the inserter makes it easier to attach and detach the inserter to and from the guidewire, there is a risk that the tip of the guidewire may protrude from the slit during operation or that the inserter may unintentionally become detached from the guidewire. To prevent the guidewire from protruding or falling off from the slit, it is possible to form a slit that does not have an opening larger than the diameter of the guidewire, or to form the slit so that both ends of the slit touch (overlap). When a user attempts to remove a guidewire from a slit with a narrow opening or no opening, the outer surface of the guidewire may interfere with the edge of the slit, potentially damaging the guidewire or peeling off the coating formed on the outer surface of the guidewire.

[0006] The present disclosure has been made in consideration of the above circumstances, and aims to provide an inserter that can be easily attached and detached to an insert such as a guide wire, and that can reduce damage to the insert when attaching and detaching. [Means for solving the problem]

[0007] In order to achieve the above-mentioned object, the present disclosure provides an inserter comprising: an inserter body comprising a first cylindrical body having a first slit extending from the tip to the base end; a second cylindrical body arranged inside the first cylindrical body, rotatable circumferentially relative to the first cylindrical body, and having a second slit extending from the tip to the base end; and a third cylindrical body removably attached to the tip portion of the inserter body and having a third slit extending from the tip to the base end (Disclosure 1).

[0008] According to this disclosure (Disclosure 1), when a user removes the third cylindrical body from the inserter body while the inserter is attached to an insertable object such as a guidewire, inserts the tip of the inserter body into the third slit of the third cylindrical body, and slides it toward the tip. Even if the third slit has a narrow opening or no opening, the third cylindrical body can be removed from the insertable object without the insertable object interfering with the edge of the third slit. Next, with the inserter body still attached to the insertable object, the user rotates the second cylindrical body relative to the first cylindrical body so that the first slit of the first cylindrical body and the second slit of the second cylindrical body overlap. This allows the insertable object to be removed from the overlapping first and second slits, thereby removing the inserter body from the insertable object. An inserter with this structure facilitates attachment and detachment to an insertable object such as a guidewire and reduces damage to the insertable object during attachment and detachment.

[0009] In the above disclosure (Disclosure 1), the first end edge of the first slit may be separated from the second end edge of the first slit along its entire length, the first end edge of the second slit may be separated from the second end edge of the second slit along its entire length, and the first end edge of the third slit may be in contact with the second end edge of the third slit at least at the tip side (Disclosure 2).

[0010] According to this disclosure (Disclosure 2), because the first and second slits are open, the insert can be easily removed from the inserter body, and because the tip side of the third slit is not open, the tip of the insert can be prevented from flying out or falling off the inserter while the inserter is in use.

[0011] In the above disclosures (Disclosures 1 and 2), the third cylindrical body may comprise a first flexible tube and a hub member connected to the base end of the first flexible tube and attached to the tip end of at least one of the first cylindrical body and the second cylindrical body (Disclosure 3).

[0012] According to this disclosure (Disclosure 3), the portion inserted into the medical device is made flexible, and by providing a hub member, it is possible to easily attach and detach the third cylindrical body to and from the inserter body.

[0013] In the above disclosure (Disclosure 3), the first flexible tube may have a fourth slit extending from the tip to the base end, the hub member may have a fifth slit extending from the tip to the base end, and the third slit may include the fourth slit and the fifth slit (Disclosure 4).

[0014] According to this disclosure (Disclosure 4), the third slit provided in the third cylindrical body can be configured by two different slits: a fourth slit provided in the first flexible tube and a fifth slit provided in the hub member.

[0015] In the above disclosure (Disclosure 4), the first end edge of the fourth slit may be in contact with the second end edge of the fourth slit along its entire length, and the first end edge of the fifth slit may be separated from the second end edge of the fifth slit along its entire length (Disclosure 5).

[0016] According to this disclosure (Disclosure 5), the base end side of the third slit (i.e., the fifth slit) can be open to make it easier to insert the tip of the inserter body, and the tip end side of the third slit (i.e., the fourth slit) can be closed to prevent the tip of the insert from popping out or falling out.

[0017] In the above disclosures (Disclosures 4 and 5), a protrusion may be provided on the outer peripheral surface of the tip of the inserter body, and the third cylindrical body may be attached to the inserter body with the protrusion inserted into the fifth slit (Disclosure 6).

[0018] According to this disclosure (Disclosure 6), the protrusion on the inserter body and the fifth slit in the hub member of the third cylindrical body can be used as a guide for alignment when attaching the third cylindrical body to the inserter body.

[0019] In the above disclosure (Disclosure 6), the protrusion may be formed to have a width corresponding to the width of the opening of the fifth slit (Disclosure 7).

[0020] According to this disclosure (Disclosure 7), the third cylindrical body and the inserter main body can be aligned more precisely.

[0021] In the above disclosures (Disclosures 1-7), a second flexible tube may be provided at the tip of the inserter body (Disclosure 8).

[0022] According to this disclosure (Disclosure 8), a second flexible tube protrudes from the tip of the inserter body, and the user inserts the second flexible tube into the third slit of the third cylindrical body while bending the second flexible tube so that the second slit and the third slit do not overlap, allowing the second flexible tube to pass through the third slit while protecting the inserted object, thereby further reducing damage when removing the third cylindrical body from the inserted object.

[0023] In the above disclosure (Disclosure 8), a protrusion protruding outward from the outer circumferential surface of the tip of the second flexible tube may be formed (Disclosure 9).

[0024] According to this disclosure (Disclosure 9), the presence of a convex portion at the tip of the second flexible tube makes it difficult for the tip of the second flexible tube inserted into the third slit of the third cylindrical body to come out of the third slit.

[0025] In the above disclosures (Disclosures 1-9), when the inserter body is in a first state, the first cylindrical body and the second cylindrical body are combined so that the first slit and the second slit overlap, and when the inserter body is in a second state, the first cylindrical body and the second cylindrical body may be combined so that the first slit and the second slit do not overlap (Disclosure 10).

[0026] According to this disclosure (Disclosure 10), when removing the inserter body from the insert, the inserter body can be easily removed from the insert by maintaining the inserter body in the first state so that the first slit and the second slit overlap. During use of the inserter, the inserter body can be maintained in the second state so that the first slit and the second slit do not overlap, thereby preventing the insert from flying out or falling out of the slits of the first and second cylindrical bodies. [Brief explanation of the drawings]

[0027] [Figure 1] FIG. 1 is an explanatory diagram illustrating an inserter according to an embodiment of the present disclosure. [Figure 2] FIG. 2 is an explanatory diagram showing a cross-sectional structure of the inserter according to the embodiment. [Figure 3] FIG. 2 is an explanatory diagram showing an exploded state of the inserter according to the embodiment. [Figure 4] FIG. 10 is an explanatory diagram showing the state in which the third cylindrical body is attached to the inserter body. [Figure 5] FIG. 10 is an explanatory view showing the state in which the guide wire is removed from the third cylindrical body using the inserter body. [Figure 6] FIG. 1 is an explanatory diagram showing a first state of the inserter body. [Figure 7] FIG. 10 is an explanatory diagram showing a second state of the inserter body. DETAILED DESCRIPTION OF THE INVENTION

[0028] Hereinafter, embodiments of the present disclosure will be described with reference to 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. The shapes and dimensions shown in each drawing are shown merely to facilitate understanding of the contents of the present disclosure, and do not accurately reflect the actual shapes and dimensions.

[0029] As used herein, "distal" refers to the direction along the axial direction of the inserter (and the insert, such as a guidewire to which the inserter is attached) in which the inserter (and the insert, such as a guidewire) advances toward the target site. "Proximal" refers to the direction along the axial direction of the inserter (and the insert, such as a guidewire) in the opposite direction to the distal end. "Distal" refers to the distal end of any component or component. "Proximal" refers to the proximal end of any component or component.

[0030] FIG. 1 is an explanatory diagram showing the overall structure of an inserter 100 according to an embodiment of the present disclosure. FIG. 2 is an explanatory diagram (longitudinal cross-sectional view) showing the cross-sectional structure of the inserter 100 according to the embodiment. FIG. 3 is an explanatory diagram showing the inserter 100 according to the embodiment in an exploded state. The inserter 100 according to this embodiment includes an inserter main body 200 and a third cylindrical body 3 detachably attached to the distal end of the inserter main body 200. The inserter main body 200 includes a substantially cylindrical first cylindrical body 1 and a substantially cylindrical second cylindrical body 2 disposed inside the first cylindrical body 1 and configured to be rotatable in the circumferential direction relative to the first cylindrical body 1. The inserter 10 is an insertion aid used to insert an insert such as a guidewire or a thin-diameter catheter into a tubular organ, a catheter, or the like. In this embodiment, a guidewire GW will be used as an example of the insert.

[0031] The first cylindrical body 1 is one of the components that make up the inserter body 200, and has a substantially cylindrical shape, with an inner cavity 10 therein through which the guidewire GW and the second cylindrical body 2 are inserted.

[0032] The first cylindrical body 1 has a first slit 11 extending from the distal end 111 to the proximal end 112 along the axial direction (longitudinal direction). The first slit 11 is a cut formed along the axial direction of the first cylindrical body 1, and both end edges thereof, i.e., a first end edge 11a and a second end edge 11b, are open and separated from each other over the entire length. Because the first slit 11 is formed as an open part in the first cylindrical body 1, the guidewire GW can be inserted into and removed from the lumen 10 inside the first cylindrical body 1 from the side peripheral surface of the first cylindrical body 1.

[0033] Examples of materials for forming the first cylindrical body 1 include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer, and polyether block amide copolymer. The first cylindrical body 1 may be formed entirely from the same material, or may be formed partially using different materials. By forming the first cylindrical body 1 from a resin material, the first slit 11, the first locking portion 12 described below, the protrusion 13, and the like can be easily formed in the first cylindrical body 1.

[0034] The second cylindrical body 2 is one of the components constituting the inserter body 200, and comprises a substantially cylindrical main body 2A and a substantially cylindrical second flexible tube 22 attached to the tip of the main body 2A. The internal space of the main body 2A and the internal space of the second flexible tube 22 communicate with each other, forming a lumen 20 through which the guidewire GW is inserted.

[0035] The second cylindrical body 2 has a second slit 21 extending from the distal end 211 to the proximal end 212 along the axial direction (longitudinal direction). The second slit 21 is a cut formed along the axial direction of the second cylindrical body 2, spanning both the main body 2A of the second cylindrical body and the second flexible tube 22, and both end edges thereof, i.e., a first end edge 21a and a second end edge 21b, are open and separated over their entire length. Because the second slit 21 is open and formed in the second cylindrical body 2, the guidewire GW can be inserted into and removed from the inner lumen 20 inside the second cylindrical body 2 from the side circumferential surface of the second cylindrical body 2.

[0036] The second cylindrical body 2 is disposed inside the first cylindrical body 1 and configured to be rotatable in the circumferential direction relative to the first cylindrical body 1. In this embodiment, the outer diameter of the second cylindrical body 2 is formed to be slightly smaller than the inner diameter of the first cylindrical body 1. This is not limited to this as long as the second cylindrical body 2 is rotatable inside the first cylindrical body 1. For example, even if the outer diameter of the second cylindrical body 2 is approximately the same as the inner diameter of the first cylindrical body 1, the second cylindrical body 2 may be disposed inside the first cylindrical body 1 and configured to slide inside the first cylindrical body 1 by utilizing the first slit 11 formed in the first cylindrical body 1.

[0037] Examples of materials for forming the second cylindrical body 12 include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer, and polyether block amide copolymer. The entire second cylindrical body 2 may be formed from the same material, or the main body 2A and the second flexible tube 22 of the second cylindrical body 2 may be formed from different materials. By forming the second cylindrical body 2 from a resin material, the second slits 21, the protrusions 221, and the like can be easily formed in the second cylindrical body 2.

[0038] In this embodiment, the first slit 11 provided in the first cylindrical body 1 and the second slit provided in the second cylindrical body 2 are both open, which allows the guidewire GW to be easily removed from the inserter main body 200 formed by combining the first cylindrical body 1 and the second cylindrical body 2. By forming the first slit 11 and the second slit 12 wider than the diameter of the guidewire GW, the guidewire GW does not interfere with the edges of the slits when removing the guidewire GW from the inserter main body 200, and damage to the guidewire GW during attachment and detachment can be reduced.

[0039] The third cylindrical body 3 is a component that can be detachably attached to the distal end of the inserter body 200. It comprises a substantially cylindrical first flexible tube 32 and a substantially cylindrical hub member 33 that is connected to the proximal end of the first flexible tube 32 and attached to the distal end of the first cylindrical body 30. The internal space of the first flexible tube 32 and the internal space of the hub member 33 are in communication with each other, forming the lumen 30 of the third cylindrical body 3. The hub member 33 is a component for attaching the third cylindrical body 3 to the distal end of the inserter body 200, and therefore may be attached to the distal end of the second cylindrical body 2 rather than the distal end of the first cylindrical body 1. By having the first flexible tube 32 at the distal end and the hub member 33 at the proximal end, the portion of the inserter 100 that is inserted into the medical device is flexible, while the provision of the hub member 33 makes it easy to attach and detach the third cylindrical body 3 to and from the inserter body 200.

[0040] The third cylindrical body 3 has a third slit 31 extending in the axial direction (longitudinal direction) from the distal end 311 to the proximal end 312. The third slit 31 is a cut formed along the axial direction of the third cylindrical body 3, spanning both the first flexible tube 32 and the hub member 33 of the third cylindrical body 3, and both end edges thereof, i.e., the first end edge 31a and the second end edge 31b, are in contact at least on the distal end side and are not open. Because the distal end side of the third slit 31 is not open, the distal end of the guidewire GW can be prevented from jumping out or falling off the inserter 100 during use of the inserter 100.

[0041] The first flexible tube 32 has a fourth slit 321 that extends in the axial direction (longitudinal direction) from the tip 311 to the connecting point (base end) with the hub member 33, and the hub member 33 has a fifth slit 331 that extends from the connecting point (tip end) with the first flexible tube 32 to the base end 312. In this embodiment, the third slit 31 of the third cylindrical body 3 is thus formed by the fourth slit 321 and the fifth slit 331, and therefore the third slit 31 provided in the third cylindrical body 3 can be formed by two different slits.

[0042] The fourth slit 321 formed in the first flexible tube 32 has both end edges, i.e., the first end edge 321a and the second end edge 321b, in contact along the entire length and not open, while the fifth slit 331 formed in the hub member 33 has both end edges, i.e., the first end edge 331a and the second end edge 331b, separated along the entire length and open. With this configuration, the base end side of the third slit 31 (i.e., the fifth slit 331) can be open to facilitate insertion of the tip of the inserter body 200, and the tip side of the third slit 31 (i.e., the fourth slit 321) can be closed to prevent the tip portion of the guidewire GW from protruding or falling off.

[0043] Examples of materials for forming the third cylindrical body 3 include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer, and polyether block amide copolymer. The entire third cylindrical body 3 may be formed from the same material, or the first flexible tube 32 and the hub member 33 of the third cylindrical body 3 may be formed from different materials. By forming the third cylindrical body 3 from a resin material, the third slit 31, the second locking portion 332 (described later), and the like can be easily formed in the third cylindrical body 3.

[0044] In this embodiment, the second flexible tube 22 is disposed on the distal end side of the second cylindrical body 2. As a result, the second flexible tube 22 protrudes from the distal end of the inserter main body 200. The user inserts the second flexible tube 22 into the third slit 31 of the third cylindrical body 3 while bending the second flexible tube 22 so that the second slit 21 and the third slit 31 do not overlap. This allows the second flexible tube 22 to pass through the third slit 31 while protecting the inserted object. As a result, damage caused when the user removes the third cylindrical body 3 from the guidewire GW can be further reduced. When the second flexible tube 22 is provided in the inserter main body 200, it is sufficient that the second flexible tube 22 protrudes from the distal end of the inserter main body 200. Alternatively, the second flexible tube 22 may be attached to the distal end of the first cylindrical body 1 rather than the second cylindrical body 2.

[0045] A protrusion 221 protruding outward from the outer circumferential surface is formed at the tip of the second flexible tube 22. The presence of the protrusion 221 at the tip of the second flexible tube 22 makes it difficult for the tip of the second flexible tube 22 inserted into the third slit 31 of the third cylindrical body 3 to come out of the third slit 31.

[0046] FIG. 4 is an explanatory diagram showing the attachment state of the third cylindrical body 3 to the inserter body 200. To facilitate understanding of the structures of the inserter body 200 and the third cylindrical body 3, FIG. 4 illustrates the inserter body 200 and the third cylindrical body 3 shown in FIGS. 1-3 rotated 90 degrees counterclockwise as viewed from the distal end, and only the third cylindrical body 3 is shown in cross section. In this embodiment, the third cylindrical body 3 is detachably attached to the distal end of the first cylindrical body 1, and the distal end of the second cylindrical body 2 (including the second flexible tube 22) protruding distally from the distal end of the first cylindrical body 1 is disposed within the lumen 30 of the third cylindrical body 3. The third cylindrical body 3 may be attached to the distal end of the inserter body 200. For example, a structure in which the third cylindrical body 3 is attached to the distal end of the second cylindrical body 2 protruding distally from the distal end of the first cylindrical body 1 may be employed.

[0047] A first locking portion 12 that protrudes outward is provided on the outer peripheral surface of the tip of the first cylindrical body 1. A second locking portion 332 that protrudes inward is provided on the inner peripheral surface of the hub member 33 of the third cylindrical body 1. When the inserter body 200 and the third cylindrical body 3 are separated and the tip of the inserter body 200 is inserted into the lumen 30 from the base end 312 of the hub member 33 of the third cylindrical body 3, the first locking portion 12 of the first cylindrical body 1 abuts against and comes into contact with the second locking portion 332 on the inside of the hub member 33. When the tip of the inserter body 200 is further pushed into the third cylindrical body 3 from this state, the first locking portion 12 of the first cylindrical body 1 moves over the second locking portion 332 and is locked between the inner peripheral surface of the hub member 33 and the second locking portion 332.

[0048] A pair of flat protrusions 13 is provided on the outer peripheral surface of the tip of the first cylindrical body 1. The pair of protrusions 13 are arranged parallel to each other and sandwich the first slit 11 of the first cylindrical body 1. When the third cylindrical body 3 is attached to the inserter body 200, the pair of protrusions 13 are inserted into the fourth slit 321 of the hub member 33 of the third cylindrical body 3. This allows the third cylindrical body 3 to be attached to the inserter body 200 with the orientation of the first slit 11 of the first cylindrical body 1 aligned with the orientation of the third slit 31 of the third cylindrical body 3. In other words, the protrusions 13 of the inserter body 200 and the fourth slit 321 of the hub member 33 of the third cylindrical body 3 function as a guide for alignment when attaching the third cylindrical body 3 to the inserter body 200.

[0049] The protrusion 13 may be provided on the outer peripheral surface of the tip of the inserter body 200, and does not have to be provided on the outer peripheral surface of the first cylindrical body 1. As described above, in a structure in which the third cylindrical body 3 is attached to the tip of the second cylindrical body 2, the protrusion 13 may be formed on the outer peripheral surface of the tip of the second cylindrical body 2. The protrusions 13 do not have to be provided in pairs parallel to each other across the first slit 11; only one protrusion may be provided on the outer peripheral surface of the tip of the inserter body 200, regardless of the position of the slit.

[0050] In this embodiment, the width from the outer wall of one protrusion 13 to the outer wall of the other protrusion 13 is slightly narrower than the width of the opening of the fourth slit 321 formed in the hub member 33 of the third cylindrical body 3. In this way, by forming the protrusion 13 to have a width corresponding to the width of the opening of the fourth slit 321, it is possible to more precisely align the third cylindrical body 3 and the inserter body 200. When only one protrusion 13 is formed at the tip end of the inserter body 200, the size (circumferential width) of the protrusion 13 can be made slightly narrower than the width of the opening of the fourth slit 321.

[0051] 5 is an explanatory diagram showing the state in which the guidewire GW is removed from the third cylindrical body 3 using the inserter body 200. When the operator removes the third cylindrical body 3 from the inserter body 200 while the inserter 100 is still attached to the guidewire GW, the third cylindrical body 3 and the inserter body 200 are separated with the guidewire GW still inserted through them (the state shown in FIG. 5).

[0052] The operator inserts the tip of the second flexible tube 22 located at the tip of the inserter main body 200 into the fifth slit 331 of the hub member 33 of the third cylindrical body 3, and inserts the second flexible tube 22 into the lumen 30 of the third cylindrical body 3 while bending it so that the second slit 21 and the third slit 31 do not overlap (FIG. 5A). Next, the operator slides the inserter main body 200 in the direction of the tip of the third cylindrical body 3 (FIG. 5B). Even if the third slit 31 of the third cylindrical body 3 is formed as a slit with a narrow opening or as a slit without any opening, the second flexible tube 22 can pass through the third slit 31 while protecting the guidewire GW, and the third cylindrical body 3 can be removed from the guidewire GW without the guidewire GW interfering with the edge of the third slit 31.

[0053] With the inserter main body 200 still attached to the guidewire GW, the operator rotates the second cylindrical body 2 relative to the first cylindrical body 1 so that the first slit 11 of the first cylindrical body 1 and the second slit 21 of the second cylindrical body 2 overlap. The operator can then remove the guidewire GW from the overlapping first slit 11 and second slit 21. With an inserter 100 structured in this way, it is easy to attach and detach the inserter 100 to and from an insertion object such as a guidewire GW, and damage to the insertion object during attachment and detachment can be reduced.

[0054] In this embodiment, the inserter body 200 is configured to be switchable between a first state in which the first cylindrical body 1 and the second cylindrical body 2 are combined so that the first slit 11 and the second slit 21 overlap, and a second state in which the first cylindrical body 1 and the second cylindrical body 2 are combined so that the first slit 11 and the second slit 21 do not overlap. Fig. 6 is an explanatory diagram schematically showing the inserter body 200 in the first state, and Fig. 7 is an explanatory diagram schematically showing the inserter body 200 in the second state.

[0055] As shown in Fig. 6, when the inserter body 200 is in the first state, the second cylindrical body 2 is disposed within the lumen 10 of the first cylindrical body 1 so that the first slit 11 and the second slit 21 overlap. The inserter body 200 shown in Fig. 1 is in the first state, with the first slit 11 of the first cylindrical body 1 and the second slit 21 of the second cylindrical body 2 opening in the same direction.

[0056] As shown in Figure 7, when the inserter body 200 is in the second state, the second cylindrical body 2 is disposed within the lumen 10 of the first cylindrical body 1 so that the first slit 11 and the second slit 21 do not overlap. The inserter body 200 shown in Figure 5 is in the second state, with only the first slit 11 of the first cylindrical body 1 being visible.

[0057] When removing the inserter body 200 from the guidewire GW, the inserter body 200 can be easily removed from the guidewire GW by maintaining the inserter body 200 in the first state so that the first slit 11 and the second slit 21 overlap. During use of the inserter 100 (when the third cylindrical body 3 is attached to the inserter body 200 and the guidewire GW is inserted therethrough), the inserter body 200 can be maintained in the second state so that the first slit 11 and the second slit 21 do not overlap, thereby preventing the guidewire GW from jumping out or falling off the slits of the first cylindrical body 1 and the second cylindrical body 2.

[0058] In this embodiment, an expanded diameter section 23 whose outer diameter gradually expands is provided on the base end side of the main body 2A of the second cylindrical body 2. When the second cylindrical body 2 is inserted into the lumen 10 from the base end 112 of the first cylindrical body 1, the expanded diameter section 23 abuts against and comes into contact with the inner circumferential surface of the base end 112 of the first cylindrical body 1, thereby fixing the positional relationship between the first cylindrical body 1 and the second cylindrical body 2.

[0059] The inserter according to the present disclosure has been described above with reference to the drawings. The present disclosure is not limited to the above-described embodiment, and various modifications are possible. For example, by adjusting the size of each component of the inserter, the inserter according to the present disclosure can be applied to inserts other than guidewires, such as catheters.

[0060] The structure of the first cylindrical body 1 and the second cylindrical body 2 that realize the inserter main body 200 that is configured to be switchable between the first state and the second state, and the method of combining them, are not limited to the structure of this embodiment. For example, as one modified example, a structure may be employed in which a notch is formed from the base end 112 of the first cylindrical body 1 toward the tip, and a portion of the second cylindrical body 2 is folded back from the base end 212 of the second cylindrical body 2 toward the tip to form a plate-like folded portion, which is inserted into the notch of the first cylindrical body 1, thereby fixing the positional relationship between the first cylindrical body 1 and the second cylindrical body 2.

[0061] As another modified example, a structure may be adopted in which a substantially flat first gripping portion is provided at the base end 112 of the first cylindrical body 1, and a substantially flat second gripping portion is provided at the base end 212 of the second cylindrical body 1. With such a structure, when an attempt is made to rotate the second cylindrical body 2 in the circumferential direction inside the first cylindrical body 1, the first gripping portion of the first cylindrical body 1 and the second gripping portion of the second cylindrical body 2 interfere with each other, thereby restricting the relative rotational movement of the second cylindrical body 2 with respect to the first cylindrical body 1. With this structure, simply by switching the orientation of the second gripping portion of the second cylindrical body 2 with respect to the first gripping portion of the first cylindrical body 1, it is possible to switch between a state in which the first slit 11 and the second slit 21 overlap (a first state suitable for attachment / detachment) and a state in which the first slit 11 and the second slit 21 do not overlap (a second state suitable for use).

[0062] As yet another variant, a structure may be adopted in which a groove extending toward the tip is formed on the inner surface of the first cylindrical body 1, and a protrusion formed on the outer surface of the second cylindrical body 2 is fitted into the groove of the first cylindrical body 1, thereby fixing the positional relationship between the first cylindrical body 1 and the second cylindrical body 2.

Claims

1. an inserter body (200) including a first cylindrical body (1) having a first slit (11) extending from the distal end to the proximal end, and a second cylindrical body (2) arranged inside the first cylindrical body (1), rotatable in a circumferential direction relative to the first cylindrical body (1), and having a second slit (21) extending from the distal end to the proximal end; The inserter (100) comprises a third cylindrical body (3) that is detachably attached to the tip end of the inserter body (200) and has a third slit (31) that extends from the tip end to the base end.

2. The first end side of the first slit (11) is separated from the second end side of the first slit (11) over the entire length thereof, The first end side of the second slit (21) is separated from the second end side of the second slit (21) over the entire length thereof, The inserter (100) according to claim 1, wherein the first end edge of the third slit (31) is in contact with the second end edge of the third slit (31) at least on the tip side.

3. 3. An inserter (100) as described in claim 1 or 2, wherein the third cylindrical body (3) comprises a first flexible tube (32) and a hub member (33) connected to the base end of the first flexible tube (32) and attached to the tip end of the inserter body (200).

4. The first flexible tube (32) has a fourth slit (321) extending from the distal end to the proximal end, The hub member (33) has a fifth slit (331) extending from the distal end to the proximal end, The inserter (100) of claim 3, wherein the third slit (31) includes the fourth slit (321) and the fifth slit (331).

5. The first end edge of the fourth slit (321) is in contact with the second end edge of the fourth slit (321) over the entire length thereof, The inserter (100) of claim 4, wherein a first end edge of the fifth slit (331) is spaced apart from a second end edge of the fifth slit (331) over the entire length thereof.

6. A protrusion (13) is provided on the outer peripheral surface of the tip of the inserter body (200), The inserter (100) described in 4 or 5, wherein the third cylindrical body (3) is attached to the inserter main body (200) with the protrusion (13) inserted into the fifth slit (331).

7. 7. The inserter (100) according to claim 6, wherein the protrusion (13) is formed to have a width corresponding to the width of the fifth slit (331).

8. The inserter (100) according to any one of claims 1 to 7, wherein a second flexible tube (22) is provided at the distal end of the inserter body (200).

9. 9. The inserter (100) according to claim 8, wherein a protrusion (221) protruding outward from the outer circumferential surface of the second flexible tube (22) is formed at the tip end of the second flexible tube (22).

10. When the inserter body (200) is in a first state, the first cylindrical body (1) and the second cylindrical body (2) are combined together so that the first slit (11) and the second slit (21) overlap each other; An inserter (100) according to any one of claims 1 to 9, wherein when the inserter body (200) is in the second state, the first cylindrical body (1) and the second cylindrical body (2) are combined so that the first slit (11) and the second slit (21) do not overlap.

Citation Information

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