Inserter, guide wire kit, and catheter kit

Abstract

The present invention is an inserter for assisting insertion of a medical device, the inserter being provided with a flat part having a flat shape, and a long cylindrical part provided on the distal end side relative to the flat part. The cylindrical part has a base-end-side opening provided to the base end thereof and a distal-end-side opening provided to the distal end thereof. A slit that connects the base-end-side opening and the distal-end-side opening and that communicates between the interior and the exterior of the cylindrical part is provided to the side surface of the cylindrical part. The minimum width of the slit is 0.2-0.6 mm inclusive, and the thickness of the inserter is 0.2-0.5 mm inclusive.

Description

Technical Field

[0001] The present invention relates to an inserter, a guide wire kit, and a catheter kit.

Background Art

[0002] Conventionally, when inserting a medical device such as a guide wire into an insertion target, an inserter for assisting the insertion may be used. Such inserters include, for example, an inserter used for assisting when inserting a guide wire into a catheter that is the insertion target. Patent Document 1 discloses a catheter introduction device as an inserter used for assisting when inserting a catheter into a blood vessel. Patent Document 2 discloses an insertion assist device for an endoscope as an inserter used for assisting when inserting a tube into a channel of an endoscope.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0004] In the inserter disclosed in Patent Document 1, when the tip of the inserter is placed inside a blood vessel, a catheter is inserted into the blood vessel by inserting the catheter from the rear end of the inserter and feeding it out from the tip. Consider the case of inserting a medical device such as a guide wire into a catheter as the insertion target using an inserter with such a shape. Medical devices such as guide wires often have a small curved shape (hereinafter also referred to as a "curved portion") at the tip in order to improve blood vessel selectivity. In such a medical device having a curved portion, due to the curved portion being an obstacle, the operation of inserting the medical device from the rear end of the inserter becomes complicated, resulting in problems such as delays in the procedure and damage to the tip of the medical device. Note that in the inserter disclosed in Patent Document 2, since a tube is inserted into the inserter from the side surface of the inserter and used, no consideration is given to insertion from the rear end of the inserter.

[0005] The present invention has been made to solve the above-described problems, and an object thereof is to provide an inserter, a guide wire kit, and a catheter kit that can easily insert a medical device having a curved portion at the tip.

Means for Solving the Problems

[0006] The present invention has been made to solve at least a part of the above-described problems and can be realized in the following forms.

[0007] (1) According to one aspect of the present invention, an inserter is provided. This inserter is an inserter that assists in inserting a medical device, and includes a flat portion having a flat shape and a long cylindrical portion provided on the tip side of the flat portion. The cylindrical portion has a base end side opening provided at the base end and a tip side opening provided at the tip. A slit that connects the base end side opening and the tip side opening and communicates the inside and outside of the cylindrical portion is provided on the side surface of the cylindrical portion. The cross-sectional shape of the cylindrical portion at the base end portion transitions from a flat shape to a cylindrical shape from the base end side toward the tip side.

[0008] According to this configuration, a slit is provided on the side surface of the cylindrical portion of the inserter, which connects the proximal end side opening and the distal end side opening and communicates the inside and outside of the cylindrical portion. Therefore, as a medical device, for example, when inserting a guide wire having a curved portion at the tip into the inserter, the portion of the guide wire proximal to the curved portion (the straight portion that is not curved) is pressed against the entire length of the slit and inserted into the inserter, and then the guide wire is pulled toward the proximal end side, so that the curved portion can be corrected to a straight shape and stored in the inserter. Therefore, compared with the case of inserting a medical device such as a guide wire having a curved portion at the tip from the rear end of the inserter, the medical device can be easily inserted into the inserter. Further, according to this configuration, the inserter includes a flat portion having a flat shape, and the cross-sectional shape of the cylindrical portion at the proximal end portion transitions from a flat shape to a cylindrical shape from the proximal end side toward the distal end side. Therefore, before pressing a medical device such as a guide wire against the slit, the medical device can be placed on the flat portion and positioned by the proximal end portion of the cylindrical portion. Therefore, with the medical device positioned with respect to the inserter, by pressing the medical device against the slit from the proximal end portion to the distal end of the cylindrical portion, the slit is sequentially widened and the medical device can be inserted into the inserter. Also in this regard, according to the inserter of this configuration, the medical device can be easily inserted into the inserter.

[0009] (2) In the inserter of the above form, the flat portion may be curved in a direction away from the axis of the inserter from the distal end side toward the proximal end side. According to this configuration, when inserting the inserter into a cylindrical object, it is possible to prevent the entire inserter from being inserted into the object. Further, when holding the inserter by pinching the flat portion with two fingers, since the contact area between the curved surface of the surface of the flat portion facing away from the axial side and the curved surface of the finger surface (finger pad) becomes large, it is possible to easily hold the inserter. Further, when the inserter is placed on a flat surface, since it is highly likely that the periphery of the base end portion of the cylindrical portion of the inserter floats from the flat surface due to the curvature of the flat portion, by grasping the periphery of the base end portion, it is possible to easily pick up the inserter placed on the flat surface. Further, when the inserter is arranged on the mount having a curved surface formed on the surface thereof that receives the curvature of the flat portion, the inserter can be stably arranged.

[0010] (3) In the inserter of the above aspect, the cylindrical portion has a first end portion and a second end portion facing each other across the slit in any cross section, and the first end portion and the second end portion may be separated in the circumferential direction. According to this configuration, the first end portion and the second end portion are separated in the circumferential direction. For this reason, since it is easy for a medical device to fit into the slit from the outside of the inserter, it becomes easy to position the medical device by the slit. Further, it is possible to reduce the force required for widening the slit (the widening to such an extent that the medical device can be inserted into the inserter) by pressing the medical device.

[0011] (4) In the inserter of the above aspect, the cylindrical portion has a first end portion and a second end portion facing each other across the slit in any cross section, and the first end portion and the second end portion may overlap. According to this configuration, the first end portion and the second end portion overlap. For this reason, in a state where the medical device is inserted into the inserter, since the medical device is covered by the inserter over the entire circumference, it is possible to prevent the medical device from popping out of the inserter.

[0012] (5) In the inserter of the above-described form, the flat portion and the cylindrical portion may be formed from a single sheet member. According to this configuration, compared with the case where the inserter is manufactured by connecting the flat portion and the cylindrical portion formed from different members respectively, the manufacturing process of the inserter can be labor-saving. Further, since there is no connecting portion due to connecting the members, an inserter that is difficult to break can be realized.

[0013] (6) In the inserter of the above-described form, the sheet member may be formed of a uniaxially stretched PTFE resin, and the stretching direction of the PTFE resin may be parallel to the stretching direction of the slit extending from the base-end side opening to the tip-end side opening. According to this configuration, the sheet member is formed of a uniaxially stretched PTFE resin. In the manufacturing process of the inserter, the sheet member is cut out from the uniaxially stretched PTFE resin, and the inserter is formed from the sheet member. In the uniaxially stretched PTFE resin, since the molecules in the resin are oriented along the stretching direction, by cutting out the sheet member along the stretching direction, the cutting operation can proceed easily and quickly. Therefore, the manufacturing efficiency of the inserter can be improved. Further, according to this configuration, the stretching direction of the PTFE resin (in the sheet member) is parallel to the stretching direction of the slit extending from the base-end side opening to the tip-end side opening. For this reason, an inserter in which a tear in a direction orthogonal to the stretching direction of the slit is less likely to occur can be realized.

[0014] (7) Further, according to another aspect of the present invention, an inserter is provided. This inserter is an inserter that assists in the insertion of a medical device, and includes a flat portion having a flat shape and a long cylindrical portion provided on the tip side of the flat portion. The cylindrical portion has a proximal end side opening provided at the proximal end and a distal end side opening provided at the distal end. On the side surface of the cylindrical portion, a slit is provided that connects the proximal end side opening and the distal end side opening and communicates the inside and outside of the cylindrical portion. The minimum width of the slit is 0.2 mm or more and 0.6 mm or less, and the thickness of the inserter is 0.2 mm or more and 0.5 mm or less. According to this configuration, a slit that connects the proximal end side opening and the distal end side opening and communicates the inside and outside of the cylindrical portion is provided on the side surface of the cylindrical portion included in the inserter. Therefore, when inserting, for example, a guide wire having a curved portion at the tip as a medical device into the inserter, the portion on the proximal end side of the curved portion (the straight portion that is not curved) of the guide wire is pressed against the entire length of the slit and inserted into the inserter, and then the guide wire is pulled toward the proximal end side, so that the curved portion can be corrected to a straight shape and stored in the inserter. Therefore, compared with the case of inserting a medical device such as a guide wire having a curved portion at the tip from the rear end of the inserter, such a medical device can be easily inserted into the inserter. Further, according to this configuration, the minimum width of the slit is 0.2 mm or more and 0.6 mm or less, and the thickness of the inserter is 0.2 mm or more and 0.5 mm or less. Therefore, when assisting the insertion of a medical device such as a guide wire having a diameter of 0.6 mm or more and 0.9 mm or less, an inserter can be realized in which the medical device can be easily inserted into the inserter and the medical device can be easily removed from the inserter. Further, when assisting the insertion of a medical device having a curved portion at the tip, an inserter can be realized in which the curved portion is less likely to protrude from the slit.

[0015] (8) In the inserter of the above aspect, the minimum width of the slit may be 0.3 mm or more and 0.4 mm or less. According to this configuration, when assisting the insertion of a medical device having a diameter of 0.6 mm or more and 0.9 mm or less and having a curved portion at the tip, an inserter in which the curved portion is less likely to protrude from the slit can be realized.

[0016] (9) In the inserter of the above form, the length from the tip of the flat portion to the tip of the cylindrical portion may be 110 mm or more and 130 mm or less. According to this configuration, when assisting the insertion of a medical device having a curved portion at the tip, after inserting an inserter that houses the medical device with the curved portion corrected to a linear shape into a cylindrical object, the correction is released from a position 110 mm or more and 130 mm or less away from the tip of the flat portion (the tip of the cylindrical portion), and the curved portion can be sent out.

[0017] (10) In the inserter of the above form, the width of the slit may gradually narrow from the base - side opening toward the tip - side opening. According to this configuration, it is possible to make it more difficult for the medical device to protrude from the inside of the inserter toward the tip side of the cylindrical portion.

[0018] (11) Further, according to another aspect of the present invention, a guide - wire kit is provided. This guide - wire kit includes the inserter described in the above form and a guide wire as the medical device, and the diameter of the guide wire is 0.6 mm or more and 0.9 mm or less. According to this guide - wire kit, similar to the above inserter, a medical device such as a guide wire can be easily inserted.

[0019] (12) Further, according to another aspect of the present invention, a catheter kit is provided. This catheter kit includes the inserter described in the above form, a connector into which the inserter is inserted, and a catheter to which the connector is connected. The clearance width obtained by subtracting the maximum outer diameter of the cylindrical portion of the inserter from the maximum inner diameter of the insertion hole of the connector is 0.10 mm or more and 0.35 mm or less. According to this catheter kit, similar to the above inserter, a medical device having a curved portion at the tip can be easily inserted. Also, it is possible to facilitate the insertion of the inserter into the connector.

[0020] Note that the present invention can be realized in various modes. For example, it can be realized in the form of a guide wire set including an inserter and a guide wire, a catheter kit including an inserter and a catheter having a connector, a manufacturing method of the inserter, and the like.

Brief Description of the Drawings

[0021]

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Modes for Carrying Out the Invention

[0022] <First Embodiment> FIG. 1 is a plan view of the inserter 1 according to the first embodiment. FIG. 2 is a side view of the inserter 1. FIG. 3 is a cross-sectional view of the inserter 1. FIG. 3(A) shows a cross-section taken along line A - A of FIGS. 1 and 2. FIG. 3(B) shows a cross-section taken along line B - B of FIGS. 1 and 2.

[0023] The inserter 1 is a long instrument that assists in inserting a medical device such as a guide wire into an insertion target. In the present embodiment, the inserter 1 is used to assist in inserting a guide wire into a catheter that is the insertion target. The inserter 1 can be formed of, for example, polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, fluororesin, etc. In the present embodiment, the inserter 1 is formed of PTFE resin which is a fluororesin. The inserter 1 includes a flat portion 10 and a cylindrical portion 20.

[0024] In FIGS. 1 and 2, an axis passing through the center of the inserter 1 is represented by an axis O (dashed-dotted line). In FIGS. 1 and 2, for the sake of convenience of explanation, there are parts where the relative ratios of the sizes of the respective components are described as being different from the actual ones. Also, there are parts where a part of each component is exaggeratedly described. Further, in FIGS. 1 and 2, XYZ axes orthogonal to each other are illustrated. The X axis corresponds to the longitudinal direction of the inserter 1, the Y axis corresponds to the height direction of the inserter 1, and the Z axis corresponds to the width direction of the inserter 1. The left side (-X axis direction) of FIG. 1 is called the "base end side" of the inserter 1 and each component, and the right side (+X axis direction) of FIG. 1 is called the "tip side" of the inserter 1 and each component. Also, of the two ends of the inserter 1 and each component in the longitudinal direction (X axis direction), one end located on the tip side is called the "tip", and the other end located on the base end side is called the "base end". Also, the tip and its vicinity are called the "tip part", and the base end and its vicinity are called the "base end part". These points are common also in FIGS. 3 and later.

[0025] The flat part 10 is a part that constitutes the base end side of the inserter 1. The flat part 10 has a flat shape as shown in FIG. 3(A). Also, as shown in FIG. 2, the flat part 10 is curved in a direction away from the axis O of the inserter 1 from the tip side toward the base end side.

[0026] The cylindrical part 20 is an elongated part provided on the tip side of the inserter 1 rather than the flat part 10. The cross-sectional shape at a position closer to the tip than the base end part 21 of the cylindrical part 20 is cylindrical as shown in FIG. 3(B).

[0027] As shown in FIGS. 3(A) and 3(B), the cross-sectional shape of the inserter 1 at the A - A line is flat, and the cross-sectional shape of the inserter 1 at the B - B line is cylindrical. The cross-sectional shape of the cylindrical part 20 at the base end part 21 transitions from a flat shape to a cylindrical shape from the base end side toward the tip side. In other words, the cross-sectional shape of the cylindrical part 20 at the base end part 21 gradually rounds from a flat shape to a cylindrical shape as it goes from the base end side toward the tip side.

[0028] The cylindrical portion 20 has a proximal end opening 22 provided at the proximal end and a distal end opening 24 provided at the distal end. Further, on the side surface of the cylindrical portion 20, a slit 26 is provided that connects the proximal end opening 22 and the distal end opening 24 and communicates the inside and outside of the cylindrical portion 20. In the present embodiment, the width of the slit 26 (length in the Z-axis direction) is substantially constant at a position closer to the distal end than the proximal end portion 21. Note that the width of the slit 26 is designed to be shorter than the diameter of a medical device inserted into the inserter 1 (a medical device that is the target for assisting insertion into the insertion target).

[0029] As shown in FIG. 3(B), the cylindrical portion 20 has a first end portion 27 and a second end portion 28 facing each other across the slit 26 in any cross section. Further, the first end portion 27 and the second end portion 28 are separated in the circumferential direction. The first end portion 27 and the second end portion 28 here include the ends and the vicinity thereof in the circumferential direction of the cross section. Note that the thickness T and the maximum outer diameter Φ1 will be described later.

[0030] FIG. 4 is a perspective view for explaining the manufacturing process of the inserter 1. FIG. 4(A) is a perspective view of an intermediate product 1P. FIG. 4(B) is a perspective view of the inserter 1.

[0031] The intermediate product 1P is a cylindrical member. The intermediate product 1P is manufactured by joining a pair of opposite sides of a single sheet member and forming it into a cylindrical shape. This sheet member is a sheet member cut out along the stretching direction from a uniaxially stretched PTFE resin. The stretching direction of the PTFE resin is parallel to the direction in which the two sides joined when formed into a cylindrical shape extend. That is, the longitudinal direction of the intermediate product 1P and the stretching direction of the PTFE resin constituting the intermediate product 1P are parallel.

[0032] The manufacturing process of the inserter 1 will be described. First, along the longitudinal direction of the intermediate product 1P, a cut CT (shown by a broken line) is made in the side surface of the intermediate product 1P. At this time, the cut CT is made over the entire length of the intermediate product 1P. After making the cut CT, at one end of the intermediate product 1P, the intermediate product 1P is opened along the longitudinal direction with a certain width (corresponding to the width of the slit 26), and the cylindrical portion 20 is formed. On the other hand, from the other end of the intermediate product 1P, the intermediate product 1P is largely opened, and the flat portion 10 is formed. In the process of forming the flat portion 10, at the portion corresponding to the base end portion 21 of the cylindrical portion 20, the intermediate product 1P is opened so that the cross-sectional shape becomes a shape that transitions from a flat shape to a cylindrical shape. In the inserter 1 formed in this way, the flat portion 10 and the cylindrical portion 20 are formed from a single sheet member, and the sheet member is formed of uniaxially stretched PTFE resin. Since the PTFE resin of the material used for the inserter 1 of the present embodiment has relatively high plasticity, the shape after the manufacturing process is maintained even if the above-described manufacturing process is carried out without preheating. When the material used for the inserter 1 is a thermoplastic resin, the above-described manufacturing process is carried out after preheating.

[0033] As described above, the longitudinal direction of the intermediate product 1P and the stretching direction in the PTFE resin constituting the intermediate product 1P are parallel. Further, the slit 26 in the inserter 1 is formed along the longitudinal direction of the intermediate product 1P. Therefore, the stretching direction of the PTFE resin constituting the inserter 1 is parallel to the stretching direction of the slit 26 extending from the base end side opening 22 to the tip end side opening 24.

[0034] FIG. 5 and FIG. 6 are explanatory diagrams showing the process of attaching a guide wire GW, which is a medical device, to an inserter 1. FIGS. 5(A)-(C) are plan views showing a series of attachment processes. FIGS. 6(A)-(C) are side views showing a series of attachment processes. In FIGS. 5 and 6, the guide wire GW is a guide wire having a curved portion CV at its tip. Like the guide wire GW, medical devices such as guide wires often have a small curved shape (hereinafter also referred to as a "curved portion") at their tips in order to improve vascular selectivity.

[0035] As shown in FIGS. 5(A) and 6(A), first, the operator places the portion of the guide wire GW on the proximal side of the curved portion CV on the slit 26 provided in the inserter 1. Then, the guide wire GW is pressed against the inserter 1 (slit 26) in order from the proximal side to the distal side (the direction indicated by the white arrow). That is, the portion of the guide wire GW on the proximal side of the curved portion CV is pressed over the entire length of the slit 26. Since the width of the slit 26 is designed to be shorter than the diameter of the guide wire GW, the slit 26 corresponding to the position where the guide wire GW is pressed is widened in the width direction to sequentially take the guide wire GW into the inserter 1.

[0036] FIGS. 5(B) and 6(B) show a state in which the guide wire GW has been inserted into the inserter 1 through the slit 26 after the process described in FIGS. 5(A) and 6(A). The curved portion CV of the guide wire GW is exposed outside the inserter 1 from the distal opening 24. From such a state, as shown in FIGS. 5(C) and 6(C), the operator pulls the guide wire GW toward the proximal side to house the curved portion CV in the inserter 1 (the direction indicated by the white arrow). Along with this housing, the curved portion CV is corrected to a linear shape along the long inserter 1.

[0037] FIG. 7 is an explanatory view showing a state in which the inserter 1 is inserted into the connector 50. The state shown in FIG. 7 is a state in which the inserter 1 maintaining the states shown in FIGS. 5(C) and 6(C) is inserted into the connector 50, and then the guide wire GW is sent out from the tip-side opening 24 in the tip direction and inserted into the catheter CA. In FIG. 7, the portion of the inserter 1 inserted into the connector 50 is indicated by a broken line. Also, the portion of the guide wire GW inserted into the inserter 1 is not shown.

[0038] The connector 50 is a connector into which the inserter 1 is inserted. The connector 50 also includes a first port 51 having a hemostatic valve, a second port 52 for injecting a contrast agent or the like, and a connecting portion 53 that connects to the catheter hub HB. The catheter hub HB is connected to the connecting portion 53. The catheter CA is connected to the connector 50 via the catheter hub HB. The length L1 from the tip of the flat portion 10 to the tip of the cylindrical portion 20 in the inserter 1 is designed to be longer than the length L2 from the base end of the insertion hole of the connector 50 (the hole into which the cylindrical portion 20 is inserted into the connector 50) to the tip of the catheter hub HB. In FIG. 7, since the length L2 is 110 mm, the length L1 is preferably 110 mm or more and 130 mm or less. When the length L1 is designed to be within such a range, the cylindrical portion 20 can be exposed from the tip of the catheter hub HB and disposed in the catheter CA, and the correction can be released from the tip of the cylindrical portion 20 to send out the curved portion CV (not shown in FIG. 7) into the catheter CA.

[0039] FIGS. 8 and 9 are explanatory views showing the process when the guide wire GW is removed from the inserter 1. FIGS. 8(A) to (C) are plan views showing a series of removal processes. FIGS. 9(A) to (C) are side views showing a series of removal processes.

[0040] As shown in FIG. 7, after the inserter 1 is inserted into the connector 50 and the guide wire GW is inserted into the catheter CA, only the inserter 1 is removed from the connector 50 along the guide wire GW. As shown in FIGS. 8(A) and 9(A), the operator inserts a finger or the like between the flat portion 10 and the guide wire GW in the inserter 1 removed from the connector 50 and lifts the guide wire GW in a direction away from the flat portion 10 (the direction indicated by the white arrow).

[0041] Next, as shown in FIGS. 8(B) and 9(B), the operator moves a finger or the like inserted between the flat portion 10 and the guide wire GW along the surface of the inserter 1 toward the tip side (the direction indicated by the white arrow), thereby removing the guide wire GW taken into the inserter 1 from the inserter 1. FIGS. 8(C) and 9(C) show a state in which the guide wire GW has been removed from the inserter 1 through the slit 26 after the process described in FIGS. 8(B) and 9(B).

[0042] As described above, according to the inserter 1 of the first embodiment, on the side surface of the cylindrical portion 20, there is provided a slit 26 that connects the proximal end side opening 22 and the distal end side opening 24 and communicates the inside and outside of the cylindrical portion 20. Therefore, as a medical device, for example, when inserting a guide wire GW having a curved portion CV at the tip into the inserter 1 (see FIGS. 5 and 6), the portion of the guide wire GW on the proximal end side of the curved portion CV (the straight portion that is not curved) is pressed against the entire length of the slit 26 and inserted into the inserter 1, and then by pulling the guide wire GW toward the proximal end side, the curved portion CV can be corrected to a straight shape and stored in the inserter 1. Therefore, compared with the case of inserting a medical device such as a guide wire GW having a curved portion CV at the tip from the rear end of the inserter, such a medical device can be easily inserted into the inserter 1. Further, according to the inserter 1 of the first embodiment, the inserter 1 includes a flat portion 10 having a flat shape, and the cross-sectional shape of the cylindrical portion 20 at the proximal end portion 21 transitions from a flat shape to a cylindrical shape from the proximal end side toward the distal end side. Therefore, before pressing a medical device such as the guide wire GW against the slit 26, the medical device can be placed on the flat portion 10 and positioned by the proximal end portion 21 of the cylindrical portion 20 (see FIGS. 5(A) and 6(A)). Therefore, with the medical device positioned with respect to the inserter 1, by pressing the medical device against the slit 26 from the proximal end portion 21 to the distal end of the cylindrical portion 20, the slit 26 is sequentially widened and the medical device can be inserted into the inserter 1. Also in this regard, according to the inserter 1 having this configuration, a medical device such as the guide wire GW can be easily inserted into the inserter 1.

[0043] Also, according to the inserter 1 of the first embodiment, when inserting the inserter 1 into a cylindrical object (for example, the connector 50 in FIG. 7), it is possible to prevent the entire inserter 1 from being inserted into the object. Further, when holding the inserter 1 by sandwiching the flat portion 10 with two fingers, the contact area between the curved surface of the surface of the flat portion 10 facing the side opposite to the axial side (the -Y axis direction side in FIG. 2) and the curved surface (the belly of the finger) of the finger surface becomes large, so that the inserter 1 can be easily held. Further, when the inserter 1 is placed on a plane, since it is highly likely that the periphery of the base end portion 21 of the cylindrical portion 20 of the inserter 1 floats from the plane due to the curvature of the flat portion 10, by grasping the periphery of the base end portion 21, it is possible to easily pick up the inserter 1 placed on the plane. Further, when the inserter 1 is arranged on a mount having a curved surface formed on the surface for receiving the curvature of the flat portion 10, the inserter 1 can be stably arranged.

[0044] Also, according to the inserter 1 of the first embodiment, the first end portion 27 and the second end portion 28 are separated in the circumferential direction. For this reason, since it is easy for a medical device to fit into the slit 26 from the outside of the inserter 1, the medical device can be easily positioned by the slit 26. Further, the force required for the width of the slit 26 (the width to the extent that the medical device can be inserted into the inserter 1) due to the pressing of the medical device can be reduced.

[0045] Also, according to the inserter 1 of the first embodiment, compared with the case of manufacturing the inserter 1 by connecting the flat portion 10 and the cylindrical portion 20 formed from different members, the manufacturing process of the inserter 1 can be labor-saving. Further, since there is no connecting portion due to connecting the members to each other, an inserter 1 that is difficult to break can be realized.

[0046] Moreover, according to the inserter 1 of the first embodiment, the sheet member constituting the inserter 1 is formed of a uniaxially stretched PTFE resin. In the manufacturing process of the inserter 1, the sheet member is cut out from the uniaxially stretched PTFE resin, and the inserter 1 is formed from the sheet member. In the uniaxially stretched PTFE resin, since the molecules in the resin are oriented along the stretching direction, by cutting out the sheet member along the stretching direction, the cutting operation can be carried out easily and quickly. Therefore, the manufacturing efficiency of the inserter 1 can be improved. Further, according to this configuration, the stretching direction of the PTFE resin (in the sheet member) is parallel to the stretching direction of the slit 26 extending from the base end side opening to the tip end side opening. For this reason, an inserter 1 in which a tear in a direction orthogonal to the stretching direction of the slit 26 is less likely to occur can be realized.

[0047] FIG. 10 shows, in tabular form, the results of an evaluation test in which the usability when inserting a guide wire was evaluated for each of the inserters 1 (Examples 1 to 12 and Comparative Examples 1 to 5) created by adjusting various parameters. The various parameters referred to here include the minimum width W of the slit 26, the thickness T of the inserter 1 (see FIG. 3(B)), and the maximum outer diameter Φ1 of the cylindrical portion 20 (see FIG. 3(B)). The minimum width W is the width at the position where the width of the slit 26 is the smallest. The thickness T can also be said to be the thickness of the sheet member constituting the inserter 1. The maximum outer diameter Φ1 is the outer diameter at the position where the outer diameter is the largest in the cross section of the cylindrical portion 20. In Examples 1 to 12 and Comparative Examples 1 to 5, it is assumed that the width of the slit 26 and the outer diameter of the cylindrical portion 20 are manufactured to be generally constant.

[0048] In FIG. 10, "guide wire diameter" indicates the diameter of the guide wire inserted into the inserter 1. "Minimum width W" indicates the minimum width W of the slit 26. "Thickness T" indicates the thickness T of the inserter 1. "Maximum outer diameter Φ1" indicates the maximum outer diameter Φ1 of the cylindrical portion 20. "Clearance width C" indicates the clearance width C obtained by subtracting the maximum outer diameter Φ1 of the cylindrical portion 20 from the maximum inner diameter of the insertion hole of the connector 50 (the hole for inserting the cylindrical portion 20 into the connector 50). The maximum inner diameter is the inner diameter at the position where the inner diameter is the largest among the portions of the connector 50 into which the inserter 1 is inserted. In FIG. 10, it is 2.65 mm. The unit of the left numerical value among the numerical values indicating "guide wire diameter" is inch, and the numerical value within the parentheses on the right is the numerical value obtained by converting the left numerical value to millimeters, and its unit is millimeter. The units of the numerical values indicating "minimum width W", "thickness T", "maximum outer diameter Φ1", and "clearance width C" are millimeters.

[0049] FIG. 10 shows the evaluation items of the usability. "Connector insertability" indicates the ease of insertion when the inserter 1 is inserted into the connector 50. "Slit formability" indicates the ease of cutting when a cut CT is made on the side surface of the intermediate product 1P and cut during the manufacturing process of the inserter 1 (see FIG. 4(A)). "Slit escape" indicates the difficulty of the curved portion protruding from the slit 26 when a guide wire having a curved portion at the tip is inserted into the inserter 1 (see FIGS. 5 and 6). "Kink resistance" indicates the difficulty of the lumen of the inserter 1 being blocked when the inserter 1 is bent during the process of inserting the inserter 1 into the connector 50 (see FIG. 7). "Attachability / detachability" indicates the ease of inserting the guide wire into the inserter 1 and the ease of removing the guide wire from the inserter 1. Each of the evaluation items of the usability was evaluated in three levels: B, C, and D. Also, the "overall evaluation" is an overall evaluation considering each evaluation item of the usability, and was evaluated in four levels: A, B, C, and D. Note that the evaluation result means that A is the best and D is the worst.

[0050] In Comparative Examples 1 to 5, each "overall evaluation" was D. In Comparative Examples 1 to 3, the evaluation of each "connector insertability" was D, which is considered to be due to the fact that the numerical value of each "clearance width C" was 0.00 mm. In Comparative Example 4, the evaluation of "slit escape" was D, which is considered to be due to the fact that the numerical value of "minimum width W" was 0.7 mm. In Comparative Example 5, the evaluation of "kink resistance" was D, which is considered to be due to the fact that the numerical value of "clearance width C" was 0.55 mm.

[0051] On the other hand, in Examples 1 to 12, each "overall evaluation" had variations of A, B, and C, but there was no D. Therefore, from the results shown in FIG. 10, in the inserter 1 that assists the insertion of a guide wire having a diameter of 0.6 mm or more and 0.9 mm or less, the minimum width W of the slit is preferably 0.2 mm or more and 0.6 mm or less, and the thickness T of the inserter 1 is preferably 0.2 mm or more and 0.5 mm or less. According to this configuration, when assisting the insertion of a medical device such as a guide wire having a diameter of 0.6 mm or more and 0.9 mm or less, the guide wire can be easily inserted into the inserter 1, and an inserter from which the medical device can be easily removed can be realized. Also, when assisting the insertion of a medical device such as a guide wire having a curved portion at the tip, an inserter 1 in which the curved portion is less likely to protrude from the slit can be realized. That is, an inserter excellent in "detachability" and "slit escape" can be realized.

[0052] Regarding the minimum width W of the slit, it is more preferably 0.3 mm or more and 0.4 mm or less. According to this configuration, when assisting the insertion of a medical device such as a guide wire having a diameter of 0.6 mm or more and 0.9 mm or less and having a curved portion at the tip, an inserter 1 in which the curved portion is even less likely to protrude from the slit 26 can be realized.

[0053] Also, the clearance width C is preferably 0.10 mm or more and 0.35 mm or less. According to this configuration, it is possible to facilitate the insertion of the inserter 1 into the connector 50. That is, an inserter excellent in "connector insertability" and "kink resistance" can be realized.

[0054] Also, as described with reference to FIG. 7, when the length L2 is 110 mm, the length L1 from the tip of the flat portion 10 to the tip of the cylindrical portion 20 in the inserter 1 is preferably 110 mm or more and 130 mm or less. According to this configuration, when the inserter 1 assists in inserting a medical device such as a guide wire having a curved portion at the tip, after inserting the inserter 1 storing the medical device in a state where the curved portion is corrected to a straight shape into a cylindrical object (connector 50 in FIG. 7) (see FIGS. 5 to 7), the correction can be released from a position 110 mm or more and 130 mm or less away from the tip of the flat portion 10 (the tip of the cylindrical portion 20) to send out the curved portion. In FIG. 7, the correction can be released from the tip of the cylindrical portion 20 disposed in the catheter CA to send out the curved portion CV (not shown in FIG. 7).

[0055] <Second Embodiment> FIG. 11 is a plan view of the inserter 1A according to the second embodiment. FIG. 12 is a cross-sectional view of the inserter 1A. FIG. 12 shows a cross-section taken along line C - C of FIG. 11. The inserter 1A according to the second embodiment is different from the inserter 1 according to the first embodiment in that it has a cylindrical portion 20a different from the cylindrical portion 20 of the first embodiment.

[0056] As shown in FIG. 12, in the inserter 1A, in any cross section of the cylindrical portion 20a, the first end portion 27a and the second end portion 28a facing each other across the slit 26a overlap. Specifically, in the first embodiment, since the first end portion 27 and the second end portion 28 were separated in the circumferential direction (see FIG. 3(B)), the inside of the cylindrical portion 20 could be visually recognized in the plan view (FIG. 1). However, in the second embodiment, since the first end portion 27a and the second end portion 28a overlap (see FIG. 12), the inside of the cylindrical portion 20 cannot be visually recognized in the plan view (FIG. 11). Even in such a cylindrical portion 20a, when a medical device such as a guide wire is pressed against the periphery of the slit 26a, the slit 26a is widened, allowing the medical device to be inserted into the inserter 1A.

[0057] With the inserter 1A of the second embodiment as described above, similarly to the first embodiment, a medical device such as a guide wire can be easily inserted into the inserter 1A. Further, according to the inserter 1A of the second embodiment, in a state where the medical device is inserted into the inserter 1A, since the medical device is covered by the inserter 1A over the entire circumference, it is possible to prevent the medical device from protruding from the inserter 1A.

[0058] <Third Embodiment> FIG. 13 is a plan view of the inserter 1B of the third embodiment. The inserter 1B of the third embodiment is different from the inserter 1 of the first embodiment in that it has a cylindrical portion 20b different from the cylindrical portion 20 of the first embodiment.

[0059] As shown in Fig. 13, in the inserter 1B, the width (length in the Z-axis direction) of the slit 26b provided in the cylindrical portion 20b is substantially constant at positions closer to the tip than the base end portion 21 (excluding the tip portion), but gradually narrows toward the tip at the tip portion. Also, with the inserter 1B of the third embodiment as well, similar to the first embodiment, a medical device such as a guide wire can be easily inserted into the inserter 1B. Further, according to the inserter 1B of the third embodiment, since a medical device easily fits into the portion of the slit 26b where the width is substantially constant (excluding the tip portion) from the outside of the inserter 1B, it becomes easier to position the medical device by the slit 26b. Also, at the tip portion of the slit 26b, it is possible to prevent the medical device from popping out from inside the inserter 1B.

[0060] <Fourth Embodiment> Fig. 14 is a plan view of the inserter 1C of the fourth embodiment. The inserter 1C of the fourth embodiment is different from the inserter 1 of the first embodiment in that it has a cylindrical portion 20c different from the cylindrical portion 20 of the first embodiment.

[0061] As shown in Fig. 14, in the inserter 1C, the width (length in the Z-axis direction) of the slit 26c provided in the cylindrical portion 20c gradually narrows from the base end side opening 22 toward the tip end side opening 24. Also, with the inserter 1C of the fourth embodiment as well, similar to the first embodiment, a medical device such as a guide wire can be easily inserted into the inserter 1C. Further, it is possible to make it difficult for the medical device to pop out from inside the inserter 1C toward the tip end side of the cylindrical portion 20c.

[0062] <Fifth Embodiment> Fig. 15 is a plan view of the inserter 1D of the fifth embodiment. The inserter 1D of the fifth embodiment is different from the inserter 1 of the first embodiment in that it has a cylindrical portion 20d different from the cylindrical portion 20 of the first embodiment.

[0063] As shown in FIG. 15, in the inserter 1D, the width (length in the Z-axis direction) of the slit 26d provided in the cylindrical portion 20d gradually narrows from the proximal end opening 22 toward the distal end opening 24, similar to the fourth embodiment. In the fifth embodiment, at the tip of the slit 26d, similar to the second embodiment (FIGS. 11 and 12), the first end portion (not shown) and the second end portion (not shown) facing each other across the slit 26d overlap. Also with the inserter 1D of such a fifth embodiment, similar to the first embodiment, a medical device such as a guide wire can be easily inserted into the inserter 1D. Further, similar to the third and fourth embodiments, the slit 26d facilitates positioning of the medical device and can also prevent the medical device from protruding from within the inserter 1D.

[0064] <Sixth Embodiment> FIG. 16 is a plan view of the inserter 1E of the sixth embodiment. The inserter 1E of the sixth embodiment is different in that it has a cylindrical portion 20e different from the cylindrical portion 20 of the first embodiment compared to the inserter 1 of the first embodiment.

[0065] As shown in FIG. 16, in the inserter 1E, the slit 26e provided in the cylindrical portion 20e is provided with bridging portions 29 at regular intervals. In other words, the slit 26e does not connect the proximal end opening 22 and the distal end opening 24 on the side surface of the cylindrical portion 20e, but is alternately provided with the bridging portions 29 between the proximal end opening 22 and the distal end opening 24. Even in such a cylindrical portion 20e, when a medical device such as a guide wire is pressed against the slit 26e, the medical device can be inserted into the inserter 1E by the bridging portion 29 being broken and then the slit 26e being widened.

[0066] Even with the inserter 1E of the sixth embodiment as described above, similar to the first embodiment, a medical device such as a guide wire can be easily inserted into the inserter 1E. Further, according to the inserter 1E of the sixth embodiment, since the crosslinked portion 29 is provided, it is possible to prevent the cylindrical portion 20e from being deformed by an external force and the diameter of the cylindrical portion 20e (the width of the slit 26e) from shrinking from the completed inserter 1E. Further, after the medical device is inserted into the inserter 1E by destroying the crosslinked portion 29, if the remains of the crosslinked portion 29 remain at at least one of the ends in the width direction of the slit 26e (the Z-axis direction in FIG. 16), it is possible to prevent the medical device from popping out of the inserter 1E due to the remains.

[0067] <Seventh Embodiment> FIG. 17 is a plan view of the inserter 1F of the seventh embodiment. The inserter 1F of the seventh embodiment is different from the inserter 1 of the first embodiment in that it has a cylindrical portion 20f different from the cylindrical portion 20 of the first embodiment.

[0068] As shown in FIG. 17, in the inserter 1F, the width (length in the Z-axis direction) of the slit 26f provided in the cylindrical portion 20f gradually narrows from the proximal end opening 22 toward the distal end opening 24, similar to the fourth embodiment. Further, at the tip of the slit 26f, similar to the second embodiment (FIGS. 11 and 12) and the fifth embodiment, a first end portion (not shown) and a second end portion (not shown) facing each other across the slit 26f overlap. Further, in the sixth embodiment, the diameter of the cylindrical portion 20f decreases from the proximal end side toward the distal end side. Even with the inserter 1F of the seventh embodiment as described above, similar to the first embodiment, a medical device such as a guide wire can be easily inserted into the inserter 1F. Further, similar to the third to fifth embodiments, the slit 26d facilitates positioning of the medical device and can also prevent the medical device from popping out of the inserter 1F.

[0069] <Eighth Embodiment> FIG. 18 is a plan view of the inserter 1G of the eighth embodiment. The inserter 1G of the eighth embodiment is different from the inserter 1 of the first embodiment in that it has a cylindrical portion 20g different from the cylindrical portion 20 of the first embodiment.

[0070] As shown in FIG. 18, in the inserter 1G, the cylindrical portion 20g has a minimum diameter portion 23 at the tip end. The minimum diameter portion 23 is a portion having a smaller diameter than the portion on the proximal end side from the minimum diameter portion 23 in the cylindrical portion 20g. The minimum diameter portion 23 may be produced by extending the tip end portion of the cylindrical portion 20 along the axis O using the inserter 1 of the first embodiment. Further, the inserter 1G may be produced by press molding using a mold for molding the inserter 1G. Also, with such an inserter 1G of the eighth embodiment, similarly to the first embodiment, a medical device such as a guide wire can be easily inserted into the inserter 1G. Further, according to the inserter 1G of the eighth embodiment, since the cylindrical portion 20g has a reduced diameter portion 25, when guiding the inserter 1G (cylindrical portion 20g) into the catheter CA via the connector 50 (FIG. 7), the guiding can be performed smoothly.

[0071] <Ninth Embodiment> FIG. 19 is a plan view of the inserter 1H of the ninth embodiment. The inserter 1H of the ninth embodiment is different from the inserter 1G of the eighth embodiment in that it has a cylindrical portion 20h different from the cylindrical portion 20g of the eighth embodiment.

[0072] As shown in FIG. 19, in the inserter 1H, the cylindrical portion 20h has a reduced-diameter portion 25 at the base end portion of the narrowest-diameter portion 23. The reduced-diameter portion 25 is a portion where the diameter gradually decreases toward the distal end side of the cylindrical portion 20h. Similar to the eighth embodiment, the reduced-diameter portion 25 and the narrowest-diameter portion 23 may be formed by extending the distal end portion of the inserter 1 along the axis O. Alternatively, the inserter 1H may be manufactured by press molding using a mold for molding the inserter 1H. Also, with the inserter 1H of the ninth embodiment as well, similar to the first embodiment, a medical device such as a guide wire can be easily inserted into the inserter 1G. Further, according to the inserter 1H of the ninth embodiment, since the cylindrical portion 20h has the narrowest-diameter portion 23 and the reduced-diameter portion 25, when guiding the inserter 1H (cylindrical portion 20h) into the catheter CA via the connector 50 (FIG. 7), the guiding can be performed more smoothly.

[0073] <Modification Example of the Present Embodiment> The present invention is not limited to the above-described embodiments, and can be implemented in various aspects without departing from the gist thereof. For example, the following modifications are possible.

[0074] [Modification Example 1] In the above-described first to ninth embodiments, the configurations of the inserters 1, 1A to 1H have been exemplified. However, the configuration of the inserter can be variously changed. For example, in the first embodiment, the flat portion 10 is curved in a direction away from the axis O of the inserter 1 from the distal end side toward the base end side, but it is not limited to this, and the flat portion 10 may be along the axis O of the inserter 1. Further, the flat portion 10 and the cylindrical portion 20 do not have to be formed from a single sheet member, and the inserter 1 may be configured by connecting the flat portion 10 and the cylindrical portion 20 formed from separate members. Also, even if the flat portion 10 and the cylindrical portion 20 are formed from a single sheet member, the sheet member may be formed of a PTFE resin that has not been uniaxially stretched.

[0075] Also, in the sixth embodiment, as shown in FIG. 16, a plurality of cross - bridging portions 29 were provided, but the number of cross - bridging portions 29 may be one. Further, in the first embodiment, the inserter 1 was described as an inserter used for assisting when inserting a guide wire into a catheter. However, it is not limited to this, and it may be used for assisting when inserting any medical device (such as a catheter or a tube) into any cylindrical object (such as a blood vessel or the channel of an endoscope). Also, the color of the inserter is preferably set according to the cylindrical object into which the inserter is inserted and the surrounding situation assumed when using the inserter. For example, by making the color of the inserter different from the color of the sheet laid on the bed on which the patient lies or the color of the cylindrical object, the operator can be prevented from losing sight of the inserter.

[0076] [Modification Example 2] The configurations of the inserters 1, 1A - 1H in the first to ninth embodiments and each configuration of the above - mentioned modification example 1 may be combined as appropriate. For example, in the inserters 1B - D, G, H of the third to fifth, eighth, and ninth embodiments, as described in the sixth embodiment, a cross - bridging portion 29 may be added.

[0077] As described above, the present aspect has been explained based on the embodiments and modification examples. However, the embodiments of the above - described aspects are for facilitating the understanding of the present aspect and do not limit the present aspect. The present aspect can be changed and improved without departing from its spirit and the scope of the claims, and equivalents thereof are included in the present aspect. Also, if its technical features are not described as essential in this specification, they can be deleted as appropriate.

Explanation of Reference Numerals

[0078] 1, 1A - H... Inserter 1P... Intermediate Product 10... Flat Portion 20, 20a - h... Cylindrical Portion 21... Base End Portion 22... Base End Side Opening 23... Narrowest Diameter Portion 24... Tip Side Opening 25... Diameter Reduction Portion 26, 26a~f... Slit 27, 27a... First end 28, 28a... Second end 29... Bridging part 50... Connector 51... First port 52... Second port 53... Connecting part CA... Catheter CV... Curved part GW... Guide wire HB... Catheter hub O... Axis

Claims

1. An inserter for assisting the insertion of a medical device, comprising: a flat portion having a flat shape; a long cylindrical portion provided on the tip side of the flat portion; and the cylindrical portion has: a proximal end side opening provided at the proximal end, and a distal end side opening provided at the distal end; a slit is provided on the side surface of the cylindrical portion, connecting the proximal end side opening and the distal end side opening and communicating the inside and outside of the cylindrical portion; the minimum width of the slit is 0.2 mm or more and 0.6 mm or less; the thickness of the inserter is 0.2 mm or more and 0.5 mm or less; the maximum outer diameter of the cylindrical portion is 2.30 mm or more and 2.55 mm or less. Inserter.

2. The inserter according to claim 1, wherein the minimum width of the slit is 0.3 mm or more and 0.4 mm or less.

3. The inserter according to claim 1 or claim 2, wherein the length from the tip of the flat portion to the tip of the cylindrical portion is 110 mm or more and 130 mm or less.

4. The inserter according to any one of claims 1 to 3, wherein the width of the slit gradually narrows from the proximal end side opening toward the distal end side opening.

5. A guide wire kit, comprising: the inserter according to any one of claims 1 to 4; and a guide wire as the medical device. The diameter of the guide wire is 0.6 mm or more and 0.9 mm or less.

6. A catheter kit, comprising: the inserter according to any one of claims 1 to 4; a connector into which the inserter is inserted; and a catheter to which the connector is connected. The clearance width obtained by subtracting the maximum outer diameter of the cylindrical portion of the inserter from the maximum inner diameter of the insertion hole of the connector is 0.10 mm or more and 0.35 mm or less.

Images