Inserter

Abstract

An inserter 100, 200 according to the present disclosure is provided with: a cylindrical main body 1, 10 that includes a first slit 1S, 10S extending from the distal end toward the proximal end in the axial direction, and includes, in the outer circumferential surface thereof, a circumferential slit 1C, 122 extending from the first slit 1S, 10S in a direction intersecting the first slit 1S, 10S to a position on a virtual line opposite from the first slit 1S, 10S; and an cylindrical insertion body 2, 20 having an opening 2S, 20S. The opening 2S, 20S extends from the distal end of the cylindrical insertion body 2, 20 toward the proximal end thereof, and the cylindrical main body 1, 10 is provided with an internal cavity into which the cylindrical insertion body 2, 20 can be inserted in a state in which the opening 2S, 20S does not overlap the first slit 1S, 10S. By using the inserter 100, 200 according to the present disclosure, protrusion or detachment of an inserted object from the slit can be prevented, and the inserted object can easily be housed.

Description

Inserter

[0001] The present disclosure relates to an inserter used to introduce a guidewire, a catheter such as a microcatheter through which a guidewire has been inserted, or an insert such as a catheter into a tubular medical device such as a catheter.

[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 target sites. Known guidewires have distal ends formed into a curved shape or the like depending on the application. When inserting such guidewires into tubular organs, catheters, or the like, physicians use an insertion aid called an inserter, which has a tubular portion through which the guidewire is inserted, so that the distal end can be inserted in a substantially straight state (see, for example, Patent Document 1).

[0003] When a physician or other operator attaches an inserter to a guidewire, the distal end of the guidewire is typically inserted into the proximal end of the inserter's tubular portion. When the operator removes the inserter from the guidewire, if the distal end of the guidewire is already inserted into a tubular organ, catheter, or the like, the operator must move the inserter to the proximal end of the guidewire. After removing the inserter from the guidewire, the operator may need to reattach the inserter. In this case, the operator 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 the operator to easily attach and detach the inserter from the distal end of the guidewire (e.g., Patent Documents 2 and 3).

[0004] Japanese Patent Application Laid-Open No. 2000-107297 Japanese Patent Application Laid-Open No. 2004-242954 Japanese Patent Application Laid-Open No. 2005-245514

[0005] Although providing a slit in the tubular portion of the inserter makes it easier for the operator to attach and detach the inserter to the guidewire, there is a risk that the tip of the guidewire may protrude from the slit during manipulation, or that the inserter may become unintentionally detached from the guidewire.In particular, if the tip of the guidewire is formed into a curved shape, storing the guidewire in an inserter even with a slit may be cumbersome.

[0006] The present disclosure has been made in consideration of the above circumstances, and aims to provide an inserter that can prevent an inserted item from popping out or falling out of a slit and can easily store the inserted item.

[0007] In order to achieve the above-mentioned object, the present disclosure provides an inserter comprising: a tubular body having a first slit extending from the tip to the base along the axial direction and a circumferential slit extending on the outer peripheral surface from the first slit to a position on an imaginary line opposite the first slit along a direction intersecting the first slit; and an insertion tubular body having an opening, wherein the opening extends from the tip to the base of the insertion tubular body, and the tubular body has an inner cavity into which the insertion tubular body can be inserted without the opening overlapping the first slit.

[0008] In the present invention, the insert may be a guidewire, a catheter such as a microcatheter through which a guidewire is inserted, or a catheter. According to this disclosure, first, with the tubular main body and the insertion tube separated, the operator clamps the middle portion of the insert, such as a guidewire, in a circumferential slit in the tubular main body from the radially outer side. Next, the operator inserts the insertion tube into the tubular main body from the proximal end side of the tubular main body. The insert is then wound into the interior of the insertion tube through the opening of the insertion tube and is accommodated in the closed internal space formed by the tubular main body and the insertion tube. As a result, the insert easily fits into the inserter in a straight state. At this time, the insertion tube is inserted into the lumen of the tubular main body so that the first slit in the tubular main body and the opening of the insertion tube do not overlap. This prevents the insert from popping out or falling out of the slit after being accommodated in the inserter. In this way, an inserter is realized that can prevent the insert from jumping out or falling out of the slit and that can easily store the insert.

[0009] 1 is an explanatory diagram showing the overall structure of an inserter according to a first embodiment; FIG. 2 is a plan view of the inserter according to the first embodiment; FIG. 3 is an explanatory diagram showing a state in which the cylindrical main body and the insertion cylindrical body of the inserter according to the first embodiment are separated; FIG. 4 is an explanatory diagram showing a cross-sectional structure of a portion of the cylindrical main body according to the first embodiment where a first slit is formed; FIG. 5 is an explanatory diagram showing a cross-sectional structure of a portion of the cylindrical main body according to the first embodiment where a first slit and a circumferential slit are formed; FIG. 6 is an explanatory diagram showing a state in which an insertion cylindrical body is inserted into the cylindrical main body of FIG. 3; FIG. 7 is an explanatory diagram showing a state in which an insertion cylindrical body is inserted into the cylindrical main body of FIG. 4; FIG. 8 is an explanatory diagram showing a state in which a guidewire is sandwiched in the circumferential slit of the cylindrical main body according to the first embodiment; FIG. 9 is an explanatory diagram showing a state in which an insertion cylindrical body is inserted into the cylindrical main body with a guidewire sandwiched in the circumferential slit; FIG. 10 is an explanatory diagram showing a cross-sectional structure in which the insertion cylindrical body is inserted into the cylindrical main body and the guidewire is stored; FIG. 11 is an explanatory diagram showing the overall structure of an inserter according to a second embodiment; 10 is an explanatory diagram showing a state in which the cylindrical main body and the insertion cylindrical body of the inserter of the second embodiment are separated. FIG. 11 is an explanatory diagram showing the structure of the expanded diameter portion of the cylindrical main body of the second embodiment. FIG. 12 is an explanatory diagram showing the structure of the handle portion of the insertion cylindrical body of the second embodiment. FIG. 13 is an explanatory diagram showing a state in which a guide wire is sandwiched in a circumferential slit of the cylindrical main body of the second embodiment. FIG. 14 is an explanatory diagram showing a state in which the insertion cylindrical body is inserted into the cylindrical main body with the guide wire sandwiched in the circumferential slit.

[0010] 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.

[0011] As used herein, "distal" refers to the direction along the axial direction of the inserter and the guidewire to which the inserter is attached, in the direction in which the inserter and the guidewire advance toward the target site. "Proximal" refers to the direction along the axial direction of the inserter and the guidewire, in the direction opposite the distal end. "Distal" refers to the distal end of any component or part. "Proximal" refers to the proximal end of any component or part.

[0012] <First Embodiment> Fig. 1 is an explanatory diagram showing the overall structure of an inserter 100 according to a first embodiment of the present disclosure. Fig. 2 is a plan view of the inserter 100. The inserter 100 according to this embodiment includes a tubular main body 1 and an insertion tubular body 2 that is inserted into the tubular main body 1. The inserter 100 is an insertion aid used to insert an insert such as a guidewire, a catheter such as a microcatheter with a guidewire inserted therethrough, or a catheter into a tubular organ or catheter. In each drawing used to explain this embodiment, a guidewire is illustrated as an example of an insert.

[0013] 3 is an explanatory diagram showing the state in which the tubular main body 1 and the insertion tube 2 of the inserter 100 according to the first embodiment are separated. The tubular main body 1 has a generally cylindrical shape and an inner cavity 1L through which the insert OJ and the insertion tube 2 are inserted. The tubular main body 1 has a first slit 1S extending from the distal end to the proximal end along the axial direction (longitudinal direction), and a circumferential slit 1C extending from the first slit 1S to a position on an imaginary line Li opposite the first slit 1S along the circumferential direction.

[0014] The first slit 1S is a cut formed along the axial direction of the cylindrical main body 1, and both end edges thereof are open and do not contact each other over the entire length. In this embodiment, the first slit 1S is formed only up to an intermediate portion midway from the tip to the base end of the cylindrical main body 1. The first slit 1S may also be formed over the entire length of the cylindrical main body 1, from the tip to the base end. Figure 4 is an explanatory diagram showing the cross-sectional structure of the location where the first slit 1S of the cylindrical main body 1 is formed (the position indicated by line A-A in Figure 2).

[0015] The circumferential slit 1C is a cut formed on the outer peripheral surface of the cylindrical main body 1 in a direction intersecting the first slit 1S, and both end edges are open and not in contact along their entire length. The circumferential slit 1C is formed to extend a certain length in the circumferential direction of the cylindrical main body 1. In this embodiment, the circumferential slit 1C is formed to extend from the first slit 1S to a position on an imaginary line Li facing the first slit 1S. The imaginary line Li is a line parallel to the axis of the cylindrical main body 1 and the center line of the first slit 1S, and is a line facing the first slit 1S (the center line) on the side peripheral surface of the cylindrical main body 1. FIG. 5 is an explanatory diagram showing the cross-sectional structure of the cylindrical main body 1 at the location where the first slit 1S and the circumferential slit 1C are formed (the position indicated by line B-B in FIG. 2). The imaginary line Li is displayed on the cylindrical main body 1 in FIG. 3, and FIGS. 4 and 5 also show where the imaginary line Li is set on the side peripheral surface of the cylindrical main body 1.

[0016] Examples of materials that can be used to form the cylindrical body 1 include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer, and metal materials such as stainless steel alloys (SUS304, SUS316, and the like), nickel-titanium alloys, and cobalt-chromium alloys. The entire cylindrical body 1 may be made of the same material, or portions may be made of different materials.

[0017] The insertion cylindrical body 2 has a substantially cylindrical shape and an inner cavity 2L through which the insertion object OJ is inserted. The insertion cylindrical body 2 has an opening 2S extending from the distal end to the proximal end along the axial direction (longitudinal direction). The opening 2S is a notch formed along the axial direction of the insertion cylindrical body 2, and both end edges thereof are open and do not contact each other along their entire length. In this embodiment, the opening 2S is formed along the entire length of the tubular main body 1, from the distal end to the proximal end of the insertion cylindrical body 2. The opening 2S may also be formed only to an intermediate portion midway between the distal end and the proximal end of the insertion cylindrical body 2.

[0018] The insertion tube 2 is inserted into the cylindrical main body 1 so that the opening 2S overlaps with the circumferential slit 1C but does not overlap with the first slit 1S. Fig. 6 is an explanatory diagram showing a radial cross section of the inserter 100 with the insertion tube 2 inserted into the cylindrical main body 1, at a location where only the first slit 1S of the cylindrical main body 1 is formed (the location indicated by line A-A in Fig. 2), and Fig. 7 is an explanatory diagram showing a radial cross section of the inserter 100 at a location where the first slit 1S and the circumferential slit 1C of the cylindrical main body 1 are formed (the location indicated by line B-B in Fig. 2). As shown in Fig. 6, because the first slit 1S of the cylindrical main body 1 does not overlap with the opening 2S of the insertion tube, the lumen 2L of the insertion tube 2 cannot be visually observed through the first slit 1S of the cylindrical main body 1 from outside the inserter 100. As shown in Figure 7, the circumferential slit 1C of the tubular body 1 overlaps with the opening 2S of the insertion tube, so that the inner cavity 2L of the insertion tube 2 can be visually observed from outside the inserter 100 through the circumferential slit 1C of the tubular body 1.

[0019] Examples of materials that can be used to form the insertion cylinder 2 include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer, and metal materials such as stainless steel alloys (SUS304, SUS316, and the like), nickel-titanium alloys, and cobalt-chromium alloys. The entire insertion cylinder 2 may be made of the same material, or portions may be made of different materials.

[0020] The insertion cylindrical body 2 is inserted into the cylindrical main body 1 from its base end and disposed inside it, and in this embodiment, the outer diameter of the insertion cylindrical body 2 is formed slightly smaller than the inner diameter of the cylindrical main body 1. This is not limiting as long as the insertion cylindrical body 2 is capable of moving back and forth inside the cylindrical main body 1. For example, even if the outer diameter of the insertion cylindrical body 2 is substantially the same as the inner diameter of the cylindrical main body 1, the insertion cylindrical body 2 may be disposed inside the cylindrical main body 1 by utilizing the first slit 1S formed in the cylindrical main body 1, and the insertion cylindrical body 2 may slide inside the cylindrical main body 1.

[0021] In this embodiment, the length of the insertion cylindrical body 2 is longer than the cylindrical body 1 so that the insertion cylindrical body 2 can be easily inserted and pulled into and out of the cylindrical main body 1. However, this is not limiting as long as the insertion cylindrical body 2 can be inserted and pulled into and out of the cylindrical main body 1 and the insert OJ can be stored inside the inserter 100. For example, the length of the insertion cylindrical body 2 may be approximately the same as the length of the cylindrical main body 1, or the length of the insertion cylindrical body 2 may be shorter than the cylindrical main body 1.

[0022] The procedure for placing the insert OJ in the inserter 100 will be described. First, with the tubular main body 1 and the insertion tube 2 separated, the operator sandwiches the middle portion of the insert OJ into the circumferential slit 1C of the tubular main body 1 from the radially outer side. FIG. 8 is an explanatory diagram showing the state in which the insert OJ is sandwiched in the circumferential slit 1C of the tubular main body 1, and FIG. 9 is an explanatory diagram showing the cross-sectional structure of the tubular main body in that state. The circumferential slit 1C formed in the tubular main body 1 allows a portion (middle portion) of the insert OJ to be positioned from the side circumferential surface of the tubular main body 1 into the lumen 1L inside the tubular main body 1.

[0023] 10 is an explanatory diagram showing the insertion of the insertion tube 2 into the cylindrical main body 1 with the insert OJ sandwiched in the circumferential slit 1C. When the operator inserts the insertion tube 2 into the cylindrical main body 1 from the proximal end side of the cylindrical main body 1, the insert OJ is rolled up into the inner cavity 2L of the insertion tube 2 through the opening 2S of the insertion tube 2. Because the cylindrical main body 1 has a first slit 1S, when the insert OJ falls toward the inner cavity 1L of the cylindrical main body 1 as the insertion tube 2 advances toward the distal end, the insert OJ is introduced into the inner cavity 1L through the first slit 1S. As a result, the insert OJ is accommodated in the closed internal space formed by the cylindrical main body 1 and the insertion tube 2, and the insert OJ is accommodated in the inserter 100 in a straight state.

[0024] Because the circumferential slit 1C is formed to extend from the first slit 1S to a position on the imaginary line Li opposite the first slit 1S, when the insert OJ is sandwiched in the circumferential slit 1C (the state shown in FIG. 9 ), the insert OJ is arranged in the inner cavity 1L so as to pass near the central axis of the cylindrical main body 1. Because the insert OJ is located near the central axis of the cylindrical main body 1, the insert OJ is likely to be caught in the inner cavity 2L of the insertion cylindrical body 2 when the insertion cylindrical body 2 is inserted into the cylindrical main body 1.

[0025] 11 is an explanatory diagram showing the cross-sectional structure of the cylindrical main body 1 with the insertion tube 2 inserted and the insert OJ housed therein. The insertion tube 2 is inserted into the cylindrical main body 1 so that the circumferential slit 1C of the cylindrical main body 1 and the opening 2S of the insertion tube 2 overlap. As a result, the base end of the insert OJ is not sandwiched between the cylindrical main body 1 and the insertion tube 2, and is positioned outside the inserter 100 through the position where the circumferential slit 1C and the opening 2S overlap. At this time, the insertion tube 2 is inserted into the cylindrical main body 1 so that the first slit 1S of the cylindrical main body 1 and the opening 2S of the insertion tube 2 do not overlap. As a result, the insert OJ is prevented from popping out or falling out of the slit after being housed in the inserter 100.

[0026] When removing the inserter 100 from the insert OJ, the middle portion of the insert OJ can be easily removed from the first slit 1S and circumferential slit 1C of the cylindrical main body 1 by simply pulling out the insertion cylindrical body 2 from the base end of the cylindrical main body 1.

[0027] Second Embodiment Fig. 12 is an explanatory diagram showing the overall structure of an inserter 200 according to a second embodiment of the present disclosure. Fig. 12 is a partial cross-sectional view in which the distal end and a portion of the proximal end of a tubular main body 10 included in the inserter 200 are broken away. The inserter 200 according to this embodiment includes the tubular main body 10 and an insertion tubular body 20 that is inserted into the tubular main body 10. The inserter 200 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, an insert OJ will also be described as an example of the insert.

[0028] 13 is an explanatory diagram showing the tubular main body 10 and the insertion tube 20 of the inserter 200 of this embodiment in a separated state. The tubular main body 10 has a generally cylindrical shape and an inner cavity 10L through which the insertion object OJ and the insertion tube 20 are inserted. The tubular main body 10 has a first slit 10S extending axially from the distal end toward the proximal end and a circumferential slit 122 extending circumferentially from the first slit 10S to a position on an imaginary line opposite the first slit 10S. The insertion tube 20 has a generally cylindrical shape and an inner cavity 20L through which the insertion object OJ is inserted. The insertion tube 20 has an opening 20S extending from the distal end toward the proximal end. The insertion cylindrical body 20 is inserted into the cylindrical body 10 so that the opening 20S overlaps with the circumferential slit 122 of the cylindrical body 10, but so that the opening 20S does not overlap with the first slit 10S.

[0029] The cylindrical main body 10 comprises a tubular portion 11 and an expanded diameter portion 12 that is disposed on the proximal side of the tubular portion 11 and has a larger diameter than the tubular portion 11. The expanded diameter portion 12 only needs to have a shape in which at least a portion thereof is expanded in diameter compared to the tubular portion 11 connected to its distal side. The presence of the expanded diameter portion 12 in the cylindrical main body 10, which has a larger diameter than the tubular portion 11, makes it easier for the operator to grasp the cylindrical main body 10. The internal space of the tubular portion 11 and the internal space of the expanded diameter portion 12 are continuous, and the two together form an inner cavity 10L of the cylindrical main body 10.

[0030] The tubular portion 11 is a tube member having a substantially cylindrical shape, and has a tubular portion slit 111 formed therein so as to extend over its entire length from the tip to the base end. The tubular portion slit 111 is a cut formed along the axial direction of the tubular portion 11, and both end edges thereof are open and do not contact each other over the entire length.

[0031] The distal end of the tubular portion 11 has a tapered shape that gradually reduces in diameter toward the distal end. Because the distal end of the tubular portion 11 has a tapered shape, the distal end of the tubular main body 10, which has the tubular portion 11 on the distal side, gradually reduces in diameter toward the distal end. This can improve the insertion performance of the inserter 200 when, with the insertion cylindrical body 20 inserted into the tubular main body 10 and the insert object OJ housed in the inserter 200, the insert object OJ is inserted into a tubular organ, a catheter, or the like.

[0032] 14 is an explanatory diagram showing the structure of the expanded diameter portion 12 of the cylindrical main body 10. The expanded diameter portion 12 has a generally truncated cone shape with an outer diameter that gradually increases, and a flattened shape with a generally elliptical radial cross section. The internal space (lumen) of the expanded diameter portion 12 is formed so that the cross-sectional area of ​​its radial cross section gradually increases toward the proximal end, making it easier to insert the insertion cylindrical body 20 into the cylindrical main body 10. The flattened shape of the expanded diameter portion 12 makes it easier for the operator to grasp the expanded diameter portion 12 and allows the operator to fix the orientation of the cylindrical main body 10 so that the operator can hold it stably, thereby limiting the position and opening direction of the first slit 10S when the operator holds the cylindrical main body 10.

[0033] The enlarged diameter portion 12 has an enlarged diameter portion slit 121 formed therein, extending from its tip to approximately the center in the axial direction. The enlarged diameter portion slit 121 is a cut formed along the axial direction of the enlarged diameter portion 12, and both end edges thereof are open and do not contact each other over the entire length. In this embodiment, the enlarged diameter portion slit 121 is formed only to the intermediate portion midway from the tip to the base end of the enlarged diameter portion 12. The enlarged diameter portion slit 121 may also be formed over the entire length of the enlarged diameter portion 12, from the tip to the base end of the enlarged diameter portion 12.

[0034] The enlarged diameter portion slit 121 is arranged so as to be continuous with the tubular portion slit 111 of the tubular portion 11 attached to the tip of the enlarged diameter portion 12. The tubular portion slit 111 of the tubular portion 11 and the enlarged diameter portion slit 121 of the enlarged diameter portion 12 form a first slit 10S of the cylindrical main body 10.

[0035] A circumferential slit 122 connected to the enlarged diameter portion slit 121 is formed in the vicinity of the approximate axial center of the enlarged diameter portion 12. By forming the circumferential slit 122 in the enlarged diameter portion 12, which has a larger space than the tubular portion 11, it becomes easier to place the insert OJ in the circumferential slit 122 of the cylindrical main body 10 when storing the insert OJ in the inserter 200.

[0036] The circumferential slit 122 is a cut formed along the circumferential direction of the expanded diameter portion 12 of the cylindrical main body 10 so as to intersect (connect) with the expanded diameter portion slit 121 that constitutes the first slit 10S, and both end edges are open and do not contact each other over their entire length. The circumferential slit 122 is formed to extend a certain length in the circumferential direction of the cylindrical main body 10. In this embodiment, the circumferential slit 122 is formed to extend from the first slit 10S to a position on an imaginary line facing the first slit 10S. The imaginary line is a line parallel to the axis of the cylindrical main body 10 and the center line of the first slit 10S, and is a line facing the first slit 10S (center line) on the side circumferential surface of the cylindrical main body 10. In this embodiment, the second slit 123 described later is formed along the virtual line on the base end side of the enlarged diameter portion 12, so that the circumferential slit 122 is formed to extend from the enlarged diameter portion slit 121 that constitutes the first slit 10S to the second slit 123.

[0037] In this embodiment, the circumferential slits 122 are formed obliquely on the outer peripheral surface of the expanded diameter portion 12 that constitutes the cylindrical main body 10. This configuration makes it easier to sandwich the middle portion of the insert OJ in the circumferential slits 122 of the cylindrical main body 10 from the radially outer side, allowing the insert OJ to be smoothly stored in the inserter 200. Specifically, the connection position between the circumferential slits 122 and the expanded diameter portion slits 121 that constitute the first slits 10S is located closer to the tip of the cylindrical main body 10 than the position on the imaginary line of the circumferential slits 122. In other words, the connection position between the circumferential slits 122 and the expanded diameter portion slits 121 is located closer to the tip of the cylindrical main body 10 than the connection position between the circumferential slits 122 and the second slits 123. By forming the circumferential slits 122 obliquely in this direction on the outer peripheral surface of the expanded diameter portion 12, when the middle portion of the insert OJ is sandwiched between the circumferential slits 122 of the cylindrical body 10 from the outside in the radial direction, the portion distal to the middle portion naturally lies toward the distal end of the cylindrical body 10, and the portion proximal to the middle portion naturally lies toward the proximal end of the cylindrical body 10. As a result, the insert OJ can be more smoothly stored in the inserter 200.

[0038] The expanded diameter section 12 has a second slit 123 extending from the circumferential slit 122 toward the base end along the aforementioned imaginary line. With the intermediate portion of the insert OJ sandwiched from the radially outer side in the circumferential slit 122 of the cylindrical main body 10, the portion distal to the intermediate portion is introduced into the cylindrical main body 10 through the expanded diameter section slit 121, and the portion proximal to the intermediate portion is introduced into the cylindrical main body 10 through the second slit 123. As a result, the insert OJ can be aligned along the axial direction of the cylindrical main body 10. With the expanded diameter section 12 having this structure, the insert OJ can be smoothly stored in the inserter 200 when the insertion cylindrical body 20 is inserted into the cylindrical main body 10.

[0039] The enlarged diameter section 12 has an insertion path 124 through which the insertion tubular body 20 is inserted from its base end into the lumen 10L. The insertion path 124 is formed in a shape corresponding to the outer shape of a handle portion 22 of the insertion tubular body 20, which will be described later, and into which the handle portion 22 fits when the insertion tubular body 20 is inserted.

[0040] Two protrusions 125 are formed on the inner wall of the insertion path 124 of the enlarged diameter portion 12, protruding in the central axis direction of the enlarged diameter portion 12. In this embodiment, the protrusions 125, each having a substantially hemispherical shape, are formed on both side surfaces of the inner wall of the insertion path 124.

[0041] A partition plate 126 is disposed inside the base end side of the expanded diameter section 12, between the insertion path 124 and the second slit 123. The partition plate 126 has a generally flat plate shape and is bridged between the inner walls of the expanded diameter section 12 so as to separate the space that functions as the insertion path 124 from the space on the side where the second slit 123 is disposed. The presence of the partition plate 126 prevents the insert OJ inserted into the cylindrical main body 10 through the second slit 123 from entering the insertion path 124 into which the insertion cylindrical body 20 is inserted, making it easier to insert the insertion cylindrical body 20 into the cylindrical main body 10.

[0042] The partition plate 126 of the expanded diameter portion 12 is provided with a convex portion 127 that protrudes toward the insertion path 124. In this embodiment, the convex portion 127 is formed in a generally trapezoidal columnar shape whose width gradually decreases toward the base end.

[0043] Examples of materials that can be used to form the cylindrical body 10 include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer, and metal materials such as stainless steel alloys (SUS304, SUS316, and the like), nickel-titanium alloys, and cobalt-chromium alloys. The entire cylindrical body 10 may be made of the same material, or portions may be made of different materials.

[0044] The insertion tubular body 20 includes a tube 21 and a handle portion 22 that is disposed on the proximal end side of the tube 21 and has a larger diameter than the tube 21. The insertion tubular body 20 has the handle portion 22 that has a larger diameter than the tube 21, making it easier for the operator to grip the insertion tubular body 20.

[0045] The tube 21 is a substantially cylindrical tube member having a tube opening 211 formed so as to extend over its entire length from the tip to the base end. The tube opening 211 is a cut formed along the axial direction of the tube 21, and both end edges thereof are open without contacting over the entire length.

[0046] 15 is an explanatory diagram showing the structure of the handle portion 22 of the insertion cylindrical body 20. The handle portion 22 has a distal end portion 221 having a shape obtained by cutting a generally truncated cone in half along the axial direction, with the outer diameter gradually decreasing toward the distal end, and a proximal end portion 222 having a generally cylindrical shape with a generally elliptical cross section cut in half along the axial direction. A handle portion opening 223 is formed on the flat surfaces of the distal end portion 221 and the proximal end portion 222, extending from the distal end of the distal end portion 221 to the proximal end of the proximal end portion 222. The handle portion opening 223 is a cut formed along the axial direction of the handle portion 22, and both end edges thereof are open without touching along their entire length.

[0047] The handle opening 223 is arranged to be continuous with the tube opening 211 of the tube 21 attached to the tip of the handle 22. The tube opening 211 of the tube 21 and the handle opening 223 of the handle 22 form an opening 20S of the insertion cylindrical body 20.

[0048] The outer shape of the handle portion 22 is formed to fit into the shape of the lumen 10L at the base end of the expanded diameter portion 12 of the cylindrical main body 10. Specifically, an insertion path 124 is formed at the base end of the expanded diameter portion 12, and the inner shape of the insertion path 124 is formed into a tapered shape in which the cross-sectional area gradually decreases toward the tip, so that the tip portion 221 of the handle portion 22 fits into the insertion path 124 of the expanded diameter portion 12. When inserting the insertion cylindrical body 20 from the base end side of the cylindrical main body 10, the operator is guided to fit the handle portion 22 of the insertion cylindrical body 20 into the expanded diameter portion 12 of the cylindrical main body 10, and therefore, the opening direction of the opening 20S when inserting the insertion cylindrical body 20 into the cylindrical main body 10 can be controlled.

[0049] Two grooves 224 are formed on the outer surface of the handle 22, into which the protrusions 125 formed on the inner wall of the enlarged diameter section 12 fit. Specifically, a groove 224 is formed on each of the two side surfaces at a position closest to the base end 222 of the tip 221 of the handle 22. By fitting the two protrusions 125 of the enlarged diameter section 12 into the two grooves 224 of the handle 22, respectively, it is possible to prevent the insertion cylindrical body 20 from coming off the cylindrical main body 10 after the insertion of the insertion cylindrical body 20.

[0050] When inserting the insertion tubular body 20 from the proximal end side into the tubular main body 10, the convex portion 127 provided on the enlarged diameter portion 12 fits into the tube opening 211 of the tube 21 and the handle opening 223 of the handle portion 22. In this state, the operator can be guided to slide the insertion tubular body 20 toward the distal end, thereby controlling the opening direction of the opening 20S when inserting the insertion tubular body 20 into the tubular main body 10. In particular, since the width of the convex portion 127 gradually decreases toward the proximal end, the convex portion 127 can easily fit into the opening 20S of the insertion tubular body 20 when inserting the insertion tubular body 20 from the proximal end side into the tubular main body 10. In this embodiment, the width of the opening 20S at the distal end of the insertion tubular body 20 is gradually increased toward the distal end. Specifically, the opening width of the tube opening 211 at the distal end of the tube 21 is gradually increased toward the distal end. This makes it easier for the protrusion 127 to enter the opening 20S of the insertion cylindrical body 20 when the insertion cylindrical body 20 is inserted from the base end side of the cylindrical main body 10.

[0051] Examples of materials that can be used to form the insertion cylinder 20 include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer, and metal materials such as stainless steel alloys (SUS304, SUS316, and the like), nickel-titanium alloys, and cobalt-chromium alloys. The entire insertion cylinder 20 may be made of the same material, or portions may be made of different materials.

[0052] The insertion cylindrical body 20 is inserted into the cylindrical main body 10 from its base end side and disposed inside it, and in this embodiment, the outer diameter of the insertion cylindrical body 20 is formed to be slightly smaller overall than the inner diameter of the cylindrical main body 10. However, this is not limiting as long as the insertion cylindrical body 20 is capable of moving back and forth inside the cylindrical main body 10.

[0053] In this embodiment, the length of the insertion cylindrical body 20 is longer than the cylindrical body 10 so that the insertion cylindrical body 20 can be easily inserted and pulled into and out of the cylindrical main body 10. However, as long as the insertion cylindrical body 20 can be inserted and pulled into and out of the cylindrical main body 10 and the insert OJ can be stored inside the inserter 200, the present invention is not limited to this.

[0054] The procedure for accommodating the insert OJ in the inserter 200 will now be described. First, with the tubular main body 10 and the insertion tube 20 separated, the operator sandwiches the middle portion of the insert OJ in the circumferential slit 122 of the tubular main body 10 from the radially outer side. Figure 16 is an explanatory diagram showing the state in which the insert OJ is sandwiched in the circumferential slit 122 of the tubular main body 10. The circumferential slit 122 formed in the tubular main body 10 allows a portion (middle portion) of the insert OJ to be positioned in the lumen 10L inside the tubular main body 10 from the side circumferential surface of the tubular main body 10.

[0055] 17 is an explanatory diagram showing the insertion of the insertion tube 20 into the cylindrical main body 10 with the insert OJ sandwiched in the circumferential slit 122. When the operator inserts the insertion tube 20 into the cylindrical main body 10 from the proximal end side of the cylindrical main body 10, the insert OJ is rolled up into the lumen 20L of the insertion tube 20 through the opening 20S of the insertion tube 20. Because the cylindrical main body 10 has a first slit 10S, when the insert OJ tilts toward the lumen 10L of the cylindrical main body 10 as the insertion tube 20 advances toward the distal end, the insert OJ is introduced into the lumen 10L from the first slit 10S. As a result, the insert OJ is accommodated in the closed internal space formed by the cylindrical main body 10 and the insertion tube 20, and the insert OJ is accommodated in the inserter 200 in a straight state.

[0056] In this embodiment, the expanded diameter section 12 of the cylindrical main body 10 has an expanded diameter section slit 121 extending distally from a circumferential slit 122 and a second slit 123 extending proximally from the circumferential slit 122. After the middle portion of the insert OJ is sandwiched from the radially outer side in the circumferential slit of the cylindrical main body, the insert OJ is tilted along the cylindrical main body 10, so that the portion distal to the middle portion can be inserted into the cylindrical main body 10 through the expanded diameter section slit 121, which constitutes the first slit 10S, and the portion proximal to the middle portion can be inserted into the cylindrical main body 10 through the second slit 123. As a result, the insert OJ can be aligned along the axial direction of the cylindrical main body, so that the insert OJ can be smoothly stored in the inserter 200 when the insertion cylinder 20 is inserted into the cylindrical main body 10.

[0057] When the insertion cylinder 20 is inserted into the cylindrical main body 10 so that the circumferential slit 122 of the cylindrical main body 10 and the opening 20S of the insertion cylinder 20 overlap, the base end side of the insert OJ is not sandwiched between the cylindrical main body 10 and the insertion cylinder 20, but is positioned outside the inserter 200 through the position where the circumferential slit 122 and the opening 20S overlap. At this time, the insertion cylinder 20 is inserted into the cylindrical main body 10 so that the first slit 10S of the cylindrical main body 10 and the opening 20S of the insertion cylinder 20 do not overlap, so that the insert OJ is prevented from flying out of the slit or falling out after being stored in the inserter 200.

[0058] When removing the inserter 200 from the insert OJ, the middle portion of the insert OJ can be easily removed from the first slit 10S, the circumferential slit 122, and the second slit 123 of the tubular body 10 by simply pulling out the insertion cylindrical body 20 from the base end of the tubular body 10.

[0059] The same picture, mark, color, or pattern may be applied to one surface of the expanded diameter portion 12 of the cylindrical main body 10 where the circumferential slit 122 is located, and to one surface of the base end 22 of the insertion cylindrical body 20. When the operator inserts the insertion cylindrical body 20 into the cylindrical main body 10 with the circumferential slit 122 of the cylindrical main body 10 and the opening 20S of the insertion cylindrical body 20 overlapping, the one surface of the expanded diameter portion 12 of the cylindrical main body 10 with the picture, mark, color, or pattern applied thereto and the one surface of the base end 22 of the insertion cylindrical body 20 are positioned in the same radial direction. The same picture, mark, color, or pattern may be applied to the outer circumferential portion of the expanded diameter portion 12 where the insertion path 124 provided in the cylindrical main body 10 is located, and to one surface of the base end 22 of the insertion cylindrical body 20, and a different picture, mark, color, or pattern may be applied to the outer circumferential portion of the expanded diameter portion 12 where the insertion path 124 provided in the cylindrical main body 10 is not located.

[0060] 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 such as microcatheters through which guidewires are inserted, or other inserts such as catheters.

[0061] The present disclosure provides an inserter (Disclosure 1) comprising: a tubular body having a first slit extending axially from the tip to the base end and a circumferential slit extending on the outer peripheral surface from the first slit to a position on an imaginary line opposite the first slit along a direction intersecting the first slit; and an insertion tubular body having an opening, the opening extending from the tip to the base end of the insertion tubular body, and the tubular body having an inner cavity into which the insertion tubular body can be inserted without the opening overlapping the first slit.

[0062] In the present invention, the insert may be a guidewire, a catheter such as a microcatheter through which a guidewire is inserted, or a catheter. According to this disclosure (Disclosure 1), first, the operator separates the tubular main body and the insertion tube, and then clamps the middle portion of the insert, such as a guidewire, in the circumferential slit of the tubular main body from the radially outer side. Next, the operator inserts the insertion tube into the tubular main body from the base end side of the tubular main body. The insert is then wound into the interior of the insertion tube through the opening of the insertion tube and is accommodated in the closed internal space formed by the tubular main body and the insertion tube. As a result, the insert is easily accommodated in the inserter in a straight state. At this time, the insertion tube is inserted into the lumen of the tubular main body so that the first slit of the tubular main body and the opening of the insertion tube do not overlap. This prevents the insert from popping out or falling out of the slit after being accommodated in the inserter. In this way, an inserter is realized that can prevent the insert from jumping out or falling out of the slit and that can easily store the insert.

[0063] In the above disclosure (Disclosure 1), the opening may overlap the circumferential slit when the insertion cylindrical body is inserted into the inner cavity of the cylindrical main body (Disclosure 2).

[0064] According to the above disclosure (Disclosure 2), the opening and the circumferential slit are continuous with each other, thereby forming a passage for the insert that connects the outside of the inserter to the internal space of the inserter.

[0065] In the above disclosures (Disclosures 1 and 2), the cylindrical main body may include a tubular portion and an expanded diameter portion that is arranged on the base end side of the tubular portion and has a larger diameter than the tubular portion (Disclosure 3).

[0066] According to this disclosure (Disclosure 3), the cylindrical body has an expanded diameter portion that is larger than the tubular portion, making it easier for the operator to hold the cylindrical body.

[0067] In the above disclosure (Disclosure 3), the first slit may be formed to extend from the tip of the tubular portion to the expanded diameter portion, and the circumferential slit may be formed in the expanded diameter portion (Disclosure 4).

[0068] According to this disclosure (Disclosure 4), the circumferential slit can be formed in a space larger than the tubular portion, making it easier to place the insert in the circumferential slit of the tubular body when storing the insert in the inserter.

[0069] In the above disclosures (Disclosures 3 and 4), the enlarged diameter portion may have a flat shape (Disclosure 5).

[0070] According to this disclosure (Disclosure 5), if the expansion portion has a flat shape, it becomes easier for the operator to grasp the expansion portion and the operator can fix the orientation in which the tubular body can be held stably, thereby limiting the position and opening direction of the first slit when the operator holds the tubular body.

[0071] In the above disclosures (Disclosures 3-5), the radial cross-sectional area of ​​the lumen of the enlarged diameter portion may gradually increase toward the base end (Disclosure 6).

[0072] According to this disclosure (Disclosure 6), it becomes easier to insert the insertion cylindrical body into the cylindrical main body.

[0073] In the above disclosures (Disclosures 3-6), a handle portion that fits into the inner cavity of the enlarged diameter portion may be provided at the base end of the insertion cylindrical body (Disclosure 7).

[0074] According to this disclosure (Disclosure 7), the operator can be guided to insert the insertion cylindrical body from the base end side of the cylindrical body so that the handle portion of the insertion cylindrical body fits into the expanded diameter portion of the cylindrical body, thereby making it possible to control the opening direction of the opening when inserting the insertion cylindrical body into the cylindrical body.

[0075] In the above disclosure (Disclosure 7), a groove may be formed on the outer surface of the handle, into which a protrusion formed on the inner wall of the enlarged diameter portion fits (Disclosure 8).

[0076] According to this disclosure (Disclosure 8), it is possible to prevent the insertion cylindrical body from coming off from the cylindrical main body after the insertion of the insertion cylindrical body.

[0077] In the above disclosures (Disclosures 3-8), the expanded diameter portion may have a second slit extending from the circumferential slit toward the base end along the imaginary line (Disclosure 9).

[0078] In the above disclosure (Disclosure 3-8), the expanded diameter portion may have a second slit extending from the circumferential slit to the base end of the expanded diameter portion (Disclosure 10).

[0079] According to these disclosures (Disclosures 9 and 10), with the middle portion of the insert clamped from the radially outer side between the circumferential slits of the cylindrical body, the operator can insert the distal portion of the insert into the cylindrical body through the first slit and the proximal portion of the insert into the cylindrical body from the radially outer side into the second slit, thereby aligning the insert along the axial direction of the cylindrical body. As a result, the insert can be smoothly stored in the inserter when the insertion cylindrical body is inserted into the cylindrical body.

[0080] In the above disclosures (Disclosures 9 and 10), the expanded diameter portion may have an insertion passage into which the insertion cylindrical body is inserted from its base end, and a partition plate may be arranged between the insertion passage and the second slit (Disclosure 11).

[0081] According to this disclosure (Disclosure 11), the insert inserted into the tubular main body through the second slit is prevented from entering the insertion path through which the insertion tubular body is inserted, making it easier to insert the insertion tubular body into the tubular main body.

[0082] In the above disclosure (Disclosure 11), the partition plate may be provided with a convex portion that protrudes toward the insertion path (Disclosure 12).

[0083] According to this disclosure (Disclosure 12), when inserting the insertion cylindrical body from the base end side of the tubular main body, the operator can be guided to slide the insertion cylindrical body toward the tip end while the convex portion is engaged with the opening of the insertion cylindrical body, thereby making it possible to control the opening direction of the opening when inserting the insertion cylindrical body into the tubular main body.

[0084] In the above disclosure (Disclosure 12), the width of the convex portion may gradually decrease toward the base end (Disclosure 13).

[0085] According to this disclosure (Disclosure 13), when the insertion cylindrical body is inserted from the base end side of the cylindrical main body, the base end side of the convex portion is narrowed, making it easier for the convex portion to enter the opening of the insertion cylindrical body.

[0086] In the above disclosures (Disclosures 12 and 13), the width of the opening at the distal end of the insertion cylindrical body may gradually increase toward the distal end (Disclosure 14).

[0087] According to this disclosure (Disclosure 14), when the insertion cylindrical body is inserted from the base end side of the cylindrical main body, the width of the opening on the tip side is wider, making it easier for the convex portion to enter the opening of the insertion cylindrical body.

[0088] In the above disclosure (Disclosure 1-14), the circumferential slit may be formed obliquely on the outer peripheral surface of the cylindrical main body (Disclosure 15).

[0089] According to this disclosure (Disclosure 15), it becomes easier to clamp the middle portion of the insert into the circumferential slit of the cylindrical body from the radially outside, allowing the insert to be smoothly stored in the inserter.

[0090] In the above disclosures (Disclosures 1-15), the connection position between the circumferential slit and the first slit may be located closer to the axial tip of the cylindrical main body than the position on the imaginary line of the circumferential slit (Disclosure 16).

[0091] According to this disclosure (Disclosure 16), when the operator clamps the middle portion of the insert into the circumferential slit of the tubular body from the radial outside, the portion distal to the middle portion naturally positions toward the tip of the tubular body, and the portion proximal to the middle portion naturally positions toward the base of the tubular body, allowing the insert to be stored more smoothly in the inserter.

[0092] In the above disclosures (Disclosure 1-16), the distal end portion of the cylindrical body may have a gradually reduced diameter toward the distal end (Disclosure 17).

[0093] According to this disclosure (Disclosure 17), when the insertion tube is inserted into the cylindrical main body and an insert is stored in the inserter, the insertion performance of the inserter can be improved when the insert is inserted into a tubular organ, a catheter, etc.

Claims

1. An inserter (100, 200) comprising: a cylindrical body (1, 10) having a first slit (1S, 10S) extending axially from the tip to the base end; and a circumferential slit (1C, 122) extending on the outer peripheral surface from the first slit (1S, 10S) along a direction intersecting the first slit (1S, 10S) to a position on an imaginary line opposite the first slit (1S, 10S); and an insertion cylindrical body (2, 20) having an opening (2S, 20S), wherein the opening (2S, 20S) extends from the tip to the base end of the insertion cylindrical body (2, 20), and the cylindrical body (1, 10) has an inner cavity into which the insertion cylindrical body (2, 20) can be inserted without the opening (2S, 20S) overlapping the first slit (1S, 10S).

2. An inserter (100, 200) as described in claim 1, wherein when the insertion cylindrical body (2, 20) is inserted into the inner cavity of the cylindrical main body (1, 10), the opening (2S, 20S) overlaps with the circumferential slit (1C, 122).

3. An inserter (200) as described in claim 1 or 2, wherein the cylindrical body (10) comprises: a tubular portion (11); and an enlarged diameter portion (12) arranged on the base end side of the tubular portion (11) and having a larger diameter than the tubular portion (11).

4. An inserter (200) as described in claim 3, wherein the first slit (10S) is formed to extend from the tip of the tubular portion (11) to the enlarged diameter portion (12), and the circumferential slit (122) is formed in the enlarged diameter portion (12).

5. An inserter (200) according to claim 3 or 4, wherein the enlarged diameter portion (12) has a flattened shape.

6. An inserter (200) according to any one of claims 3 to 5, wherein the radial cross-sectional area of ​​the lumen of the enlarged diameter portion (12) gradually increases in the proximal direction.

7. An inserter (200) according to any one of claims 3 to 6, wherein the base end of the insertion tube (20) is provided with a handle portion (22) that fits into the inner cavity of the enlarged diameter portion (12).

8. An inserter (200) as described in claim 7, wherein a groove (224) is formed on the outer surface of the handle portion (22) into which a protrusion (125) formed on the inner wall of the enlarged diameter portion (12) fits.

9. An inserter (200) according to any one of claims 3-8, wherein the enlarged diameter portion (12) has a second slit (123) extending proximally from the circumferential slit (122) along the imaginary line.

10. An inserter (200) according to any one of claims 3-8, wherein the enlarged diameter portion (12) has a second slit (123) extending from the circumferential slit (122) to the base end of the enlarged diameter portion (12).

11. An inserter (200) as described in claim 9 or 10, wherein the enlarged diameter portion (12) has an insertion passage (124) into which the insertion cylindrical body (20) is inserted from its base end, and a partition plate (126) is arranged between the insertion passage (124) and the second slit (123).

12. The inserter (200) according to claim 11, wherein the partition plate (126) is provided with a protrusion (127) that protrudes toward the insertion path (124).

13. The inserter (200) according to claim 12, wherein the width of the convex portion (127) gradually decreases in the proximal direction.

14. An inserter (200) according to claim 12 or 13, wherein the width of the opening (20S) at the tip of the insertion tube (20) gradually increases towards the tip.

15. An inserter (200) according to any one of claims 1 to 12, wherein the circumferential slit (122) is formed obliquely on the outer circumferential surface of the tubular body (10).

16. An inserter (200) according to any one of claims 1 to 15, wherein the connection position between the circumferential slit (122) and the first slit (10S) is located closer to the axial tip of the cylindrical main body (10) than the position of the circumferential slit (122) on the imaginary line.

17. An inserter (200) according to any one of claims 1 to 16, wherein the distal end of the tubular body (10) gradually tapers in diameter towards the distal end.

Images