WO2023084735A1

WO2023084735A1 - Inserter, guide wire kit, and catheter kit

Info

Publication number: WO2023084735A1
Application number: PCT/JP2021/041728
Authority: WO
Inventors: 昇太香山; 将内村
Original assignee: 朝日インテック株式会社
Priority date: 2021-11-12
Filing date: 2021-11-12
Publication date: 2023-05-19
Also published as: JPWO2023084735A1

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

Inserters, Guidewire Kits, and Catheter Kits

The present invention relates to inserters, guidewire kits, and catheter kits.

Conventionally, when inserting a medical device such as a guide wire into an insertion target, an inserter is sometimes used to assist the insertion. Such inserters include, for example, inserters used to assist in inserting a guidewire into a catheter to be inserted. Patent Literature 1 discloses a catheter introduction device as an inserter used to assist in inserting a catheter into a blood vessel. Patent Literature 2 discloses an endoscope insertion aid as an inserter used to assist in inserting a tube into a channel of an endoscope.

Japanese Utility Model Publication No. 61-010698 Japanese Utility Model Publication No. 54-012955

In the inserter disclosed in Patent Document 1, the catheter is inserted into the blood vessel by inserting the catheter from the rear end of the inserter and sending it out from the tip while the tip of the inserter is placed in the blood vessel. Consider a case where an inserter having such a shape is used to insert a medical device such as a guide wire into a catheter to be inserted. A medical device such as a guidewire is often provided with a small curved shape (hereinafter also referred to as a “curved portion”) at its tip in order to improve blood vessel selectivity. In a medical device having such a curved portion, the curved portion interferes with the operation of inserting the medical device from the rear end of the inserter. There was a problem of causing damage to the In addition, in the inserter disclosed in Patent Document 2, since the tube is inserted into the inserter from the side surface of the inserter for use, insertion from the rear end of the inserter is not considered at all.

SUMMARY OF THE INVENTION The present invention has been made to solve the above-described problems, and an object of the present invention is to provide an inserter, a guide wire kit, and a catheter kit that allow easy insertion of a medical device having a curved tip. do.

The present invention has been made to solve at least part of the above problems, and can be implemented as the following forms.

(1) According to one aspect of the present invention, an inserter is provided. This inserter is an inserter for assisting insertion of a medical device, and includes a flat portion having a flat shape, and an elongated cylindrical portion provided on the distal end side of the flat portion. The shaped portion has a proximal side opening provided at the proximal end and a distal side opening provided at the distal end, and the proximal side opening and the distal side opening are provided on the side surface of the cylindrical portion. and a slit that communicates the inside and outside of the tubular portion. and is transitioning.

According to this configuration, the side surface of the cylindrical portion of the inserter is provided with a slit that connects the proximal side opening and the distal side opening and that communicates the inside and outside of the cylindrical portion. Therefore, as a medical device, for example, when a guide wire having a curved portion at its distal end is inserted into an inserter, a portion of the guide wire on the proximal side of the curved portion (a linear portion that is not curved) is cut into a slit. After inserting the guide wire into the inserter while pressing it over its entire length, the curved portion can be straightened and stored in the inserter by pulling the guide wire toward the proximal end side. Therefore, the medical device can be easily inserted into the inserter as compared with the case where a medical device such as a guide wire having a curved portion at the distal end is inserted from the rear end of the inserter. In addition, 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 transitions from the flat shape to the cylindrical shape from the proximal end to the distal end. are doing. 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 base end portion of the cylindrical portion. Therefore, in a state where the medical device is positioned with respect to the inserter, by pressing the medical device against the slit from the base end portion to the tip end of the cylindrical portion, the width of the slit is widened in order to remove the medical device. It can be inserted into an inserter. In this respect as well, according to the inserter with this configuration, the medical device can be easily inserted into the inserter.

(2) In the inserter of the above aspect, the flat portion may be curved in a direction away from the axis of the inserter from the distal side to the proximal 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. Also, when holding the inserter by holding the flat portion between two fingers, the curvature of the surface of the flat portion facing the opposite side to the axis line side and the curved surface of the finger surface (finger ball) Since the contact area is increased, the inserter can be easily held. Also, when the inserter is placed on a flat surface, there is a high possibility that the periphery of the base end of the cylindrical portion of the inserter will be in a state of floating from the plane due to the curvature of the flat portion. As a result, the inserter placed on the flat surface can be easily picked up. In addition, when the inserter is placed on the backing paper having a curved surface that receives the curvature of the flat portion, the inserter can be stably placed.

(3) In the inserter of the above aspect, the cylindrical portion has a first end and a second end facing each other across the slit in any cross section, and the first end and the It may be circumferentially spaced apart from the second end.
According to this configuration, the first end and the second end are spaced apart in the circumferential direction. Therefore, the medical device can be easily fitted into the slit from the outside of the inserter, and the medical device can be easily positioned by the slit. In addition, it is possible to reduce the force required to widen the slit by pressing the medical device (widening to the extent that the medical device can be inserted into the inserter).

(4) In the inserter of the above aspect, the cylindrical portion has a first end and a second end facing each other across the slit in any cross section, and the first end and the It may overlap with the second end.
According to this configuration, the first end and the second end overlap each other. Therefore, when the medical device is inserted into the inserter, the entire periphery of the medical device is covered by the inserter, thereby preventing the medical device from popping out of the inserter.

(5) In the inserter of the above aspect, the flat portion and the cylindrical portion may be formed from one sheet member.
According to this configuration, the manufacturing process of the inserter can be labor-saving as compared with the case where the inserter is manufactured by connecting the flat portion and the cylindrical portion formed from separate members. In addition, since there is no connecting portion due to connecting members, it is possible to realize an inserter that is difficult to break.

(6) In the inserter of the above aspect, the sheet member is made of uniaxially stretched PTFE resin, and the stretching direction of the PTFE resin is the same as the stretching direction of the slit extending from the proximal opening to the distal opening. They may be parallel.
According to this configuration, the sheet member is made of uniaxially stretched PTFE resin. In the inserter manufacturing process, a sheet member is cut out from uniaxially stretched PTFE resin, and the inserter is formed from the sheet member. In a uniaxially stretched PTFE resin, the molecules in the resin are oriented along the stretching direction, so cutting out the sheet member along the stretching direction facilitates and speeds up the cutting operation. Therefore, it is possible to improve the manufacturing efficiency of the inserter. 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 side opening. Therefore, it is possible to realize an inserter in which cracks are less likely to occur in the direction orthogonal to the extending direction of the slit.

(7) According to another aspect of the invention, an inserter is provided. This inserter is an inserter for assisting insertion of a medical device, and includes a flat portion having a flat shape, and an elongated cylindrical portion provided on the distal end side of the flat portion. The shaped portion has a proximal side opening provided at the proximal end and a distal side opening provided at the distal end, and the proximal side opening and the distal side opening are provided on the side surface of the cylindrical portion. and connecting the inside and outside of the tubular 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. not less than 0.5 mm and not more than 0.5 mm.
According to this configuration, the side surface of the cylindrical portion of the inserter is provided with a slit that connects the proximal side opening and the distal side opening and communicates the inside and the outside of the cylindrical portion. Therefore, as a medical device, for example, when a guide wire having a curved portion at its distal end is inserted into an inserter, a portion of the guide wire on the proximal side of the curved portion (a linear portion that is not curved) is slit. After inserting the guide wire into the inserter by pressing it over the entire length of the guide wire, the curved portion can be straightened and stored in the inserter by pulling the guide wire toward the proximal end side. Therefore, such a medical device can be easily inserted into the inserter as compared with the case where a medical device such as a guide wire having a curved tip is inserted from the rear end of 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, the medical device can be easily inserted into the inserter, and the medical device can be removed from the inserter. It is possible to realize an inserter that is easy to remove. Further, when assisting the insertion of a medical device having a curved portion at its tip, an inserter in which the curved portion is less likely to protrude from the slit can be realized.

(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 distal end, it is possible to realize an inserter in which the curved portion is less likely to protrude from the slit. can be done.

(9) In the inserter of the above aspect, the length from the tip of the flat portion to the tip of the tubular 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 its distal end, the inserter housing the medical device with the curved portion corrected to a straight shape is inserted into the cylindrical object. After the insertion, the curved portion can be released from the position (tip of the cylindrical portion) separated from the tip of the flat portion by 110 mm or more and 130 mm or less.

(10) In the inserter of the above aspect, the width of the slit may gradually narrow from the proximal side opening toward the distal side opening.
According to this configuration, it is possible to make it more difficult for the medical device to protrude from the inserter toward the distal end side of the tubular portion.

(11) According to another aspect of the present invention, a guidewire kit is provided. This guidewire kit includes the inserter according to the above aspect and a guidewire as the medical device, and the guidewire has a diameter of 0.6 mm or more and 0.9 mm or less.
According to this guidewire kit, a medical device such as a guidewire can be easily inserted in the same manner as the inserter.

(12) Further, according to another aspect of the present invention, a catheter kit is provided. This catheter kit includes an inserter according to the above aspect, 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 portion is 0.10 mm or more and 0.35 mm or less.
According to this catheter kit, like the inserter, a medical device having a curved tip can be easily inserted. Also, the inserter can be easily inserted into the connector.

It should be noted that the present invention can be implemented in various ways, for example, a guide wire set comprising an inserter and a guide wire, a catheter kit comprising an inserter and a catheter having a connector, an inserter It can be realized in the form of a manufacturing method of

It is a top view of the inserter of 1st Embodiment. It is a side view of the inserter of the first embodiment. It is a cross-sectional view of the inserter of the first embodiment. It is a perspective view for explaining the manufacturing process of the inserter. It is the top view which showed a series of mounting|wearing processes. It is the side view which showed a series of mounting processes. FIG. 4 is an explanatory diagram showing a state in which the inserter is inserted into the connector; It is the top view which showed a series of extraction processes. It is the side view which showed a series of extraction processes. 1 is a table showing evaluations of Examples 1-12 and Comparative Examples 1-5. It is a top view of the inserter of 2nd Embodiment. It is a cross-sectional view of the inserter of 2nd Embodiment. FIG. 11 is a plan view of an inserter according to a third embodiment; It is a top view of the inserter of 4th Embodiment. FIG. 11 is a plan view of an inserter according to a fifth embodiment; FIG. 11 is a plan view of an inserter according to a sixth embodiment; FIG. 14 is a plan view of an inserter according to a seventh embodiment; FIG. 20 is a plan view of an inserter according to an eighth embodiment; FIG. 21 is a plan view of an inserter according to a ninth embodiment;

<First Embodiment>
FIG. 1 is a plan view of the inserter 1 of the first embodiment. FIG. 2 is a side view of the inserter 1. FIG. FIG. 3 is a cross-sectional view of the inserter 1. FIG. FIG. 3A shows a cross section taken along line A--A of FIGS. 1 and 2. FIG. FIG. 3B shows a cross section taken along line BB of FIGS. 1 and 2. FIG.

The inserter 1 is an elongated instrument that assists in inserting a medical device such as a guidewire into an insertion target. In this embodiment, the inserter 1 is used to assist in inserting a guidewire into a catheter to be inserted. The inserter 1 can be made of, for example, polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicon resin, fluorine resin, or the like. In this embodiment, the inserter 1 is made of PTFE resin, which is a fluorine resin. The inserter 1 has a flat portion 10 and a tubular portion 20 .

　In Figures 1 and 2, the axis passing through the center of the inserter 1 is represented by the axis O (chain line). For convenience of explanation, FIGS. 1 and 2 include portions in which the relative size ratios of the constituent members are different from the actual ones. In addition, it includes a portion exaggeratedly describing a part of each constituent member. 1 and 2 also show XYZ axes orthogonal to each other. 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 referred to as the “proximal side” of the inserter 1 and each component, and the right side (+X axis direction) of FIG. 1 is referred to as the “distal side” of the inserter 1 and each component. Further, of the longitudinal (X-axis) ends of the inserter 1 and each component member, one end located on the distal side is referred to as the "distal end", and the other end located on the proximal side is referred to as the "base end". Also, the distal end and the vicinity thereof are referred to as the "distal portion", and the proximal end and the vicinity thereof are referred to as the "basal end portion". These points are also common in FIG. 3 and subsequent figures.

The flat portion 10 is a portion that constitutes the base end side of the inserter 1 . The flat portion 10 has a flat shape as shown in FIG. 3(A). 2, the flat portion 10 is curved in a direction away from the axis O of the inserter 1 from the distal end side to the proximal end side.

The tubular portion 20 is an elongated portion of the inserter 1 provided on the distal end side of the flat portion 10 . The cross-sectional shape of the cylindrical portion 20 at a position closer to the distal end than the proximal end portion 21 is cylindrical, as shown in FIG. 3(B).

As shown in FIGS. 3(A) and 3(B), the cross-sectional shape of the inserter 1 taken along the line AA is flat, and the cross-sectional shape of the inserter 1 taken along the line BB is cylindrical. be. 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 to the distal end side. In other words, the cross-sectional shape of the cylindrical portion 20 at the proximal end portion 21 changes from a flat shape to a cylindrical shape that gradually curls from the proximal end side to the distal end side.

The tubular portion 20 has a proximal opening 22 provided at the proximal end and a distal opening 24 provided at the distal end. A slit 26 is provided on the side surface of the cylindrical portion 20 to connect the proximal side opening 22 and the distal side opening 24 and communicate the inside and the outside of the cylindrical portion 20 . In the present embodiment, the width (length in the Z-axis direction) of the slit 26 is substantially constant at a position closer to the distal end than the proximal end portion 21 . The width of the slit 26 is designed to be shorter than the diameter of the medical device to be inserted into the inserter 1 (the medical device whose insertion into the insertion target is assisted).

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

FIG. 4 is a perspective view for explaining the manufacturing process of the inserter 1. FIG. FIG. 4A is a perspective view of the intermediate product 1P. FIG. 4B is a perspective view of the inserter 1. FIG.

The intermediate product 1P is a cylindrical member. The intermediate product 1P is manufactured by joining a pair of opposing sides of one sheet member to form a tubular shape. This sheet member is a sheet member cut out along the stretching direction from uniaxially stretched PTFE resin. The direction in which the PTFE resin is stretched is parallel to the direction in which the two sides that are joined when being molded into a cylindrical shape extend. That is, the longitudinal direction of the intermediate product 1P is parallel to the stretching direction of the PTFE resin forming the intermediate product 1P.

The manufacturing process of the inserter 1 will be explained. First, along the longitudinal direction of the intermediate product 1P, a cut CT (illustrated 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 the incision CT is made, at one end of the intermediate product 1P, the intermediate product 1P is opened with a constant width (corresponding to the width of the slit 26) along the longitudinal direction to form the cylindrical portion 20. be done. On the other hand, from the other end of the intermediate product 1P, the intermediate product 1P is widely opened to form a flat portion 10. As shown in FIG. In the process of forming the flat portion 10, the portion of the cylindrical portion 20 corresponding to the base end portion 21 is opened so that the cross-sectional shape changes from the flat shape to the cylindrical shape. In the inserter 1 thus formed, the flat portion 10 and the tubular portion 20 are formed from a single sheet member, and the sheet member is formed from uniaxially stretched PTFE resin. Since the PTFE resin, which is 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 performed without applying heat in advance. When the material used for the inserter 1 is a thermoplastic resin, it is preliminarily heated and then the above manufacturing process is carried out.

As described above, the longitudinal direction of the intermediate product 1P is parallel to the stretching direction in the PTFE resin forming the intermediate product 1P. Also, the slit 26 in the inserter 1 is formed along the longitudinal direction of the intermediate product 1P. Therefore, the extending direction of the PTFE resin forming the inserter 1 is parallel to the extending direction of the slit 26 extending from the proximal side opening 22 to the distal side opening 24 .

5 and 6 are explanatory diagrams showing the process of attaching the guide wire GW, which is a medical device, to the inserter 1. FIG. 5A to 5C are plan views showing a series of mounting processes. 6A to 6C are side views showing a series of mounting processes. 5 and 6, the guide wire GW is a guide wire having a curved portion CV at its tip. Like the guidewire GW, medical devices such as guidewires are often provided with a small curved shape (hereinafter also referred to as a “curved portion”) at the tip in order to improve blood vessel selectivity.

As shown in FIGS. 5(A) and 6(A), first, the operator places the portion of the guide wire GW closer to the proximal side than the curved portion CV on the slit 26 provided in the inserter 1. do. Then, the guide wire GW is pressed against the inserter 1 (slit 26) in order from the proximal side to the distal side (in 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 so that the guide wire GW can be sequentially inserted into the inserter 1. take in.

5(B) and 6(B) show a state in which the guide wire GW is inserted into the inserter 1 through the slit 26 through the process described in FIGS. 5(A) and 6(A). It is shown. A curved portion CV of the guide wire GW is exposed to the outside of the inserter 1 through the distal opening 24 . From this state, as shown in FIGS. 5(C) and 6(C), the operator pulls the guide wire GW toward the proximal end side to house the bending portion CV inside the inserter 1 (white line). direction indicated by the open arrow). Along with this retraction, the curved portion CV is corrected into a straight shape along the elongated inserter 1 .

FIG. 7 is an explanatory diagram showing a state in which the inserter 1 is inserted into the connector 50. FIG. In the state shown in FIG. 7, after the inserter 1 maintaining the state shown in FIGS. It has been delivered and inserted into the catheter CA. In FIG. 7, the portion of the inserter 1 that is inserted into the connector 50 is indicated by a broken line. A portion of the guide wire GW that is inserted into the inserter 1 is omitted from the drawing.

The connector 50 is a connector into which the inserter 1 is inserted. Further, the connector 50 includes a first port 51 having a hemostasis valve, a second port 52 for injecting a contrast agent or the like, and a connecting portion 53 connected to the catheter hub HB. The catheter hub HB is connected to the connecting portion 53 . Catheter CA is connected to connector 50 via catheter hub HB. The length L1 from the distal end of the flat portion 10 to the distal end of the cylindrical portion 20 in the inserter 1 is from the proximal end of the insertion hole of the connector 50 (the hole for inserting the cylindrical portion 20 into the connector 50) to the distal end of the catheter hub HB. It is designed to be longer than the length L2. 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 tubular portion 20 can be exposed from the distal end of the catheter hub HB and placed in the catheter CA, and the tubular portion 20 can be placed inside the catheter CA. Curvature CV (not shown in FIG. 7) can be delivered into catheter CA by releasing the straightening from the tip.

8 and 9 are explanatory diagrams showing the process of removing the guide wire GW from the inserter 1. FIG. 8A to 8C are plan views showing a series of withdrawal processes. 9A to 9C are side views showing a series of withdrawal processes.

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

Next, as shown in FIGS. 8(B) and 9(B), the operator moves a finger or the like sandwiched between the flat portion 10 and the guide wire GW along the surface of the inserter 1 to the distal end side. The guide wire GW that has been taken into the inserter 1 is pulled out from the inserter 1 by moving (in the direction indicated by the white arrow). 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 through the process described in FIGS. 8(B) and 9(B). It is

As described above, according to the inserter 1 of the first embodiment, the proximal side opening 22 and the distal side opening 24 are connected to the side surface of the tubular section 20, and the inside and outside of the tubular section 20 are communicated. A slit 26 is provided. Therefore, for example, when a guide wire GW having a curved portion CV at its distal end is inserted into the inserter 1 as a medical device (see FIGS. 5 and 6), the portion of the guide wire GW on the proximal side of the curved portion CV After inserting the portion (non-curved linear portion) into the inserter 1 by pressing it over the entire length of the slit 26, the guide wire GW is pulled toward the proximal end side, thereby correcting the curved portion CV into a linear shape and inserting the inserter. 1 can be stored. Therefore, such a medical device can be easily inserted into the inserter 1 as compared with the case where a medical device such as a guide wire GW having a curved portion CV at its tip is inserted from the rear end of the inserter. Further, according to the inserter 1 of the first embodiment, the inserter 1 includes the flat portion 10 having a flat shape, and the cross-sectional shape of the cylindrical portion 20 at the base end portion 21 is oriented from the base end side to the tip end side. It transitions from a flat shape to a cylindrical shape. Therefore, before pressing a medical device such as a guide wire GW against the slit 26, the medical device is placed on the flat portion 10 and positioned by the base end portion 21 of the cylindrical portion 20. (See FIGS. 5A and 6A). Therefore, in a state in which the medical device is positioned with respect to the inserter 1, by pressing the medical device against the slit 26 from the proximal end portion 21 of the tubular portion 20 toward the distal end, the slit 26 is widened in order. The medical device can be inserted into the inserter 1 by using the In this respect as well, according to the inserter 1 having this configuration, a medical device such as a guide wire GW can be easily inserted into the inserter 1 .

Further, 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), the entire inserter 1 is inserted into the object. can be prevented. Also, when holding the inserter 1 with the flat portion 10 sandwiched between two fingers, the surface of the flat portion 10 facing the opposite side to the axis side (the -Y-axis direction side in FIG. 2) Since the contact area between the curve and the curved surface of the finger surface (the ball of the finger) is increased, the inserter 1 can be easily held. In addition, when the inserter 1 is placed on a flat surface, there is a high possibility that the periphery of the base end portion 21 of the cylindrical portion 20 of the inserter 1 will be in a state of floating from the flat surface due to the curvature of the flat portion 10. By gripping the periphery of the end portion 21, the inserter 1 placed on a flat surface can be easily picked up. In addition, when the inserter 1 is arranged on a mount having a surface formed with a curved surface for receiving the curvature of the flat portion 10, the inserter 1 can be stably arranged.

Further, according to the inserter 1 of the first embodiment, the first end portion 27 and the second end portion 28 are spaced apart in the circumferential direction. Therefore, the medical device can be easily fitted into the slit 26 from the outside of the inserter 1 , and the medical device can be easily positioned by the slit 26 . In addition, the force required to widen the width of the slit 26 by pressing the medical device (widening to the extent that the medical device can be inserted into the inserter 1) can be reduced.

In addition, according to the inserter 1 of the first embodiment, the manufacturing process of the inserter 1 can be labor-saving as compared with the case where the inserter 1 is manufactured by connecting the flat portion 10 and the cylindrical portion 20 which are formed of separate members. can be In addition, since there is no connecting portion due to connecting members, the inserter 1 that is difficult to break can be realized.

Further, according to the inserter 1 of the first embodiment, the sheet member constituting the inserter 1 is made of uniaxially stretched PTFE resin. In the manufacturing process of the inserter 1, a sheet member is cut out from uniaxially stretched PTFE resin, and the inserter 1 is formed from the sheet member. In a uniaxially stretched PTFE resin, the molecules in the resin are oriented along the stretching direction, so cutting out the sheet member along the stretching direction facilitates and speeds up the cutting operation. 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 slits 26 extending from the proximal side opening to the distal side opening. For this reason, it is possible to realize the inserter 1 in which cracks in the direction orthogonal to the extending direction of the slits 26 are less likely to occur.

FIG. 10 shows the results of an evaluation test that evaluated the feeling of use when a guidewire was inserted into each inserter 1 (Examples 1 to 12 and Comparative Examples 1 to 5) prepared by adjusting various parameters. is shown as a table. The various parameters referred to here include the minimum width W of the slit 26, the thickness T of the inserter 1 (see FIG. 3B), and the maximum outer diameter Φ1 of the tubular portion 20 (see FIG. 3B). , is included. The minimum width W is the width of the slit 26 at the minimum width. It can also be said that the thickness T is the thickness of the sheet member forming the inserter 1 . The maximum outer diameter Φ1 is the outer diameter at the position where the outer diameter is maximum in the cross section of the tubular portion 20 . In Examples 1 to 12 and Comparative Examples 1 to 5, the width of the slit 26 and the outer diameter of the tubular portion 20 are generally constant.

In FIG. 10, "guidewire diameter" indicates the diameter of the guidewire 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 tubular portion 20 . The “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 of the portion of the connector 50 where the inserter 1 is inserted, at the position where the inner diameter is the largest, and is 2.65 mm in FIG. The unit of the numerical value on the left side of the numerical values indicating "guidewire diameter" is inches, and the numerical value in parentheses on the right side is the numerical value obtained by converting the numerical value on the left side into millimeters, and the unit is millimeters. The unit of numerical values indicating the "minimum width W", "thickness T", "maximum outer diameter Φ1", and "clearance width C" is millimeters.

Fig. 10 shows evaluation items for usability. “Connector insertability” indicates ease of inserting the inserter 1 into the connector 50 . The "slit formability" indicates the easiness of cutting in the manufacturing process of the inserter 1, when the side surface of the intermediate product 1P is cut CT (see FIG. 4(A)). "Slit release" indicates how difficult it is for the curved portion to protrude from the slit 26 when a guide wire having a curved portion at its tip is inserted into the inserter 1 (see FIGS. 5 and 6). "Kink resistance" indicates the difficulty of clogging the lumen of the inserter 1 when the inserter 1 is bent during the process of inserting the inserter 1 into the connector 50 (see FIG. 7). “Detachability” indicates ease of inserting a guidewire into the inserter 1 and ease of removing the guidewire from the inserter 1 . Each evaluation item of feeling in use was evaluated in three grades of B, C, and D. In addition, the "comprehensive evaluation" is a comprehensive evaluation in consideration of the evaluation items of each usability, and was evaluated in four stages of A, B, C, and D. In addition, the evaluation result means that A is the best and D is the worst.

In Comparative Examples 1 to 5, each "overall evaluation" was D. In Comparative Examples 1 to 3, each "connector insertability" was evaluated as D, which is considered to be due to the numerical value of each "clearance width C" being 0.00 mm. In addition, in Comparative Example 4, the evaluation of "missing slit" was D, which is considered to be due to the numerical value of "minimum width W" being 0.7 mm. In Comparative Example 5, the evaluation of "kink resistance" was D, which is considered to be due to the numerical value of "clearance width C" being 0.55 mm.

On the other hand, in Examples 1 to 12, each "overall evaluation" varied from 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 guidewire having a diameter of 0.6 mm or more and 0.9 mm or less, the minimum width W of the slit is 0.2 mm or more and 0.9 mm or more. It is 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 It is possible to realize an inserter from which the medical device can be easily removed. Further, when assisting the insertion of a medical device such as a guide wire having a curved portion at its distal end, the inserter 1 can be realized in which the curved portion is less likely to protrude from the slit. That is, it is possible to realize an inserter excellent in "detachability" and "slit removal".

Also, the minimum width W of the slit 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 distal end, the curved portion is less likely to protrude from the slit 26. The inserter 1 can be implemented.

Also, the clearance width C is preferably 0.10 mm or more and 0.35 mm or less. This configuration makes it easier to insert the inserter 1 into the connector 50 . That is, it is possible to realize an inserter excellent in "connector insertability" and "kink resistance".

7, when the length L2 is 110 mm, the length L1 from the tip of the flat portion 10 to the tip of the tubular portion 20 in the inserter 1 is 110 mm or more and 130 mm or less. is preferred. According to this configuration, when the inserter 1 assists the insertion of a medical device such as a guide wire having a curved portion at its distal end, the inserter accommodates the medical device with the curved portion straightened. 1 is inserted into a cylindrical object (connector 50 in FIG. 7) (see FIGS. 5 to 7), a position (the tip of cylindrical portion 20) separated from the tip of flat portion 10 by 110 mm or more and 130 mm or less. The straightening can be released from and the curved portion can be delivered. In FIG. 7, the bending portion CV (not shown in FIG. 7) can be delivered from the distal end of the tubular portion 20 placed in the catheter CA with the straightening removed.

<Second embodiment>
FIG. 11 is a plan view of the inserter 1A of the second embodiment. FIG. 12 is a cross-sectional view of the inserter 1A. FIG. 12 shows a cross section taken along line CC of FIG. The inserter 1A of the second embodiment differs from the inserter 1 of the first embodiment in that it has a tubular portion 20a different from the tubular portion 20 of the first embodiment.

As shown in FIG. 12, in the inserter 1A, the tubular portion 20a has a first end portion 27a and a second end portion 28a that face each other with a slit 26a interposed therebetween and overlap each other in any cross section. Specifically, in the first embodiment, since the first end portion 27 and the second end portion 28 are spaced apart in the circumferential direction (see FIG. 3B), in the plan view (FIG. 1), the cylinder In the second embodiment, the first end 27a and the second end 28a overlap each other (see FIG. 12), so the plan view (FIG. 11 ), the inside of the cylindrical portion 20 cannot be visually recognized. Also in the cylindrical portion 20a, when a medical device such as a guide wire is pressed against the periphery of the slit 26a, the width of the slit 26a is widened so that the medical device can be inserted into the inserter 1A. be able to.

With the inserter 1A of the second embodiment as described above, it is possible to easily insert a medical device such as a guidewire into the inserter 1A as in the first embodiment. Further, according to the inserter 1A of the second embodiment, when the medical device is inserted into the inserter 1A, the entire periphery of the medical device is covered by the inserter 1A. can be prevented from popping out.

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

As shown in FIG. 13, in the inserter 1B, the width (the length in the Z-axis direction) of the slit 26b provided in the tubular portion 20b is approximately Although it has a constant width, it gradually narrows toward the tip at the tip. With such an inserter 1B of the third embodiment as well, a medical device such as a guide wire can be easily inserted into the inserter 1B as in the first embodiment. Further, according to the inserter 1B of the third embodiment, a medical device can be easily fitted from the outside of the inserter 1B into a portion of the slit 26b that has a substantially constant width (excluding the tip portion). device is easier to position. In addition, the tip of the slit 26b can prevent the medical device from popping out of the inserter 1B.

<Fourth Embodiment>
FIG. 14 is a plan view of the inserter 1C of the fourth embodiment. The inserter 1C of the fourth embodiment differs from the inserter 1 of the first embodiment in that it has a tubular portion 20c different from the tubular portion 20 of the first embodiment.

As shown in FIG. 14, in the inserter 1C, the width (the length in the Z-axis direction) of the slit 26c provided in the cylindrical portion 20c gradually narrows from the proximal side opening 22 toward the distal side opening 24. . With such an inserter 1C of the fourth embodiment as well, a medical device such as a guide wire can be easily inserted into the inserter 1C as in the first embodiment. In addition, it is possible to make it more difficult for the medical device to protrude from the inserter 1C toward the distal end side of the cylindrical portion 20c.

<Fifth Embodiment>
FIG. 15 is a plan view of the inserter 1D of the fifth embodiment. The inserter 1D of the fifth embodiment differs from the inserter 1 of the first embodiment in that it has a tubular portion 20d different from the tubular portion 20 of the first embodiment.

As shown in FIG. 15, in the inserter 1D, the width (the length in the Z-axis direction) of the slit 26d provided in the cylindrical portion 20d is the same as in the fourth embodiment, from the proximal side opening 22 to the distal side opening. 24 gradually becomes narrower. In the fifth embodiment, at the tip of the slit 26d, a first end (not shown) and a second end (not shown) overlap each other. With such an inserter 1D of the fifth embodiment as well, a medical device such as a guide wire can be easily inserted into the inserter 1D as in the first embodiment. Further, as in the third and fourth embodiments, the slit 26d facilitates positioning of the medical device and prevents the medical device from jumping out of the inserter 1D.

<Sixth embodiment>
FIG. 16 is a plan view of the inserter 1E of the sixth embodiment. The inserter 1E of the sixth embodiment differs from the inserter 1 of the first embodiment in that it has a tubular portion 20e different from the tubular portion 20 of the first embodiment.

As shown in FIG. 16, in the inserter 1E, bridge portions 29 are provided at regular intervals in the slits 26e provided in the cylindrical portion 20e. In other words, the slit 26e does not connect the proximal-side opening 22 and the distal-side opening 24 on the side surface of the cylindrical portion 20e, and a bridging portion is formed between the proximal-side opening 22 and the distal-side opening 24. 29 are provided alternately. Even in such a cylindrical portion 20e, when a medical device such as a guide wire is pressed against the slit 26e, the cross-linking portion 29 is destroyed and then the slit 26e is widened so that the medical device can be inserted into the inserter 1E.

With the inserter 1E of the sixth embodiment as described above, it is possible to easily insert a medical device such as a guidewire into the inserter 1E as in the first embodiment. In addition, according to the inserter 1E of the sixth embodiment, since the bridging portion 29 is provided, the cylindrical portion 20e is deformed by an external force, and the diameter of the cylindrical portion 20e (the width of the slit 26e) changes when manufacturing is completed. can be prevented from shrinking from the inserter 1E. Further, after the medical device is inserted into the inserter 1E by destroying the bridging portion 29, remnants of the bridging portion 29 remain on at least one end of the slit 26e in the width direction (the Z-axis direction in FIG. 16). When the medical device is inside the inserter 1E, it is possible to prevent the medical device from popping out of the inserter 1E due to the wreckage.

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

As shown in FIG. 17, in the inserter 1F, the width (the length in the Z-axis direction) of the slit 26f provided in the cylindrical portion 20f is the same as in the fourth embodiment, from the proximal side opening 22 to the distal side opening. 24 gradually becomes narrower. At the tip of the slit 26f, a first end (not shown) and a second end ( (not shown) overlap each other. Furthermore, in the sixth embodiment, the diameter of the cylindrical portion 20f is reduced from the proximal side to the distal side. With such an inserter 1F of the seventh embodiment as well, a medical device such as a guide wire can be easily inserted into the inserter 1F as in the first embodiment. Further, as in the third to fifth embodiments, the slit 26d facilitates the positioning of the medical device and prevents the medical device from jumping out of the inserter 1F.

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

As shown in FIG. 18, in the inserter 1G, the tubular portion 20g has the smallest diameter portion 23 at the tip. The smallest diameter portion 23 is a portion of the cylindrical portion 20g that has a smaller diameter than the portion on the base end side from the smallest diameter portion 23 . The smallest diameter portion 23 may be produced by extending the tip portion of the cylindrical portion 20 along the axis O using the inserter 1 of the first embodiment. Alternatively, the inserter 1G may be manufactured by press molding using a mold for molding the inserter 1G. With such an inserter 1G of the eighth embodiment as well, a medical device such as a guide wire can be easily inserted into the inserter 1G as in the first embodiment. Further, according to the inserter 1G of the eighth embodiment, since the tubular portion 20g has the reduced diameter portion 25, the inserter 1G (tubular portion 20g) can be inserted into the catheter CA via the connector 50 (FIG. 7). When providing guidance, the guidance can be performed smoothly.

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

As shown in FIG. 19, in the inserter 1H, the tubular portion 20h has a reduced diameter portion 25 at the base end portion of the smallest diameter portion 23. As shown in FIG. The reduced-diameter portion 25 is a portion of the cylindrical portion 20h whose diameter gradually decreases toward the distal end side. The reduced diameter portion 25 and the smallest diameter portion 23 may be produced by extending the tip portion of the inserter 1 along the axis O, as in the eighth embodiment. Alternatively, the inserter 1H may be manufactured by press molding using a mold for molding the inserter 1H. With such an inserter 1H of the ninth embodiment as well, a medical device such as a guide wire can be easily inserted into the inserter 1G like the first embodiment. Further, according to the inserter 1H of the ninth embodiment, since the cylindrical portion 20h has the smallest diameter portion 23 and the reduced diameter portion 25, the inserter 1H (cylindrical portion 20h) is connected via the connector 50 (FIG. 7). ) into the catheter CA, the guidance can be performed more smoothly.

<Modification of this embodiment>
The present invention is not limited to the above-described embodiments, and can be implemented in various aspects without departing from the scope of the invention. For example, the following modifications are possible.

[Modification 1]
In the first to ninth embodiments, the configurations of the

inserters

1, 1A to 1H are illustrated. However, the configuration of the inserter can be modified in various ways. 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 to the proximal end side. It may be along the axis O. The flat portion 10 and the tubular portion 20 may not be formed from a single sheet member, and the flat portion 10 and the tubular portion 20 formed from separate members are connected to form the inserter 1. You may have Further, even if the flat portion 10 and the cylindrical portion 20 are formed from one sheet member, the sheet member may be formed from PTFE resin that is not uniaxially stretched.

Also, in the sixth embodiment, as shown in FIG. 16, a plurality of bridging portions 29 are provided, but the number of bridging portions 29 may be one. In addition, in the first embodiment, the inserter 1 was described as an inserter used to assist in inserting a guide wire into a catheter, but the present invention is not limited to this, and any medical device (catheter, tube, etc.) can be used in any desired manner. It may also be used to aid insertion into tubular objects (blood vessels, endoscope channels, etc.). Moreover, it is preferable that the color of the inserter is set according to the cylindrical object into which the inserter is inserted and the surrounding conditions assumed when the inserter is used. For example, by setting the color of the inserter to be different from the color of the sheets spread on the bed on which the patient is lying or the color of the cylindrical object, it is possible to prevent the operator from losing sight of the inserter.

[Modification 2]
The configurations of the

inserters

1, 1A to 1H of the first to ninth embodiments and each configuration of the modified example 1 may be combined as appropriate. For example, in the inserters 1B to 1B to 1D, 1G and 1H of the third to fifth, eighth and ninth embodiments, the bridging portion 29 may be added as described in the sixth embodiment.

Although the present aspect has been described above based on the embodiments and modifications, the above-described embodiments are intended to facilitate understanding of the present aspect, and do not limit the present aspect. This aspect may be modified and modified without departing from the spirit and scope of the claims, and this aspect includes equivalents thereof. Also, if the technical features are not described as essential in this specification, they can be deleted as appropriate.

DESCRIPTION OF

SYMBOLS

1, 1A-H... Inserter 1P... Intermediate product 10...

Flat part

20, 20a-h... Cylindrical part 21... Base end part 22... Base end side opening 23... Smallest diameter part 24... Tip side opening 25...

Diameter reduction Part

26, 26a to

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

An inserter that assists insertion of a medical device,
a flat portion having a flat shape;
a long cylindrical portion provided on the distal end side of the flat portion;
with
The cylindrical portion is
having a proximal opening provided at the proximal end and a distal opening provided at the distal end,
A side surface of the cylindrical portion is provided with a slit that connects the proximal side opening and the distal 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,
The inserter, wherein the inserter has a thickness of 0.2 mm or more and 0.5 mm or less.
The inserter of claim 1, comprising:
The inserter, wherein the minimum width of the slit is 0.3 mm or more and 0.4 mm or less.
The inserter according to claim 1 or claim 2,
The inserter, 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.
The inserter according to any one of claims 1 to 3,
The inserter, wherein the width of the slit gradually narrows from the proximal side opening toward the distal side opening.
A guidewire kit,
an inserter according to any one of claims 1 to 4;
a guide wire as the medical device;
A guidewire kit, wherein the guidewire has a diameter of 0.6 mm or more and 0.9 mm or less.
A catheter kit comprising:
an inserter according to any one of claims 1 to 4;
a connector into which the inserter is inserted;
a catheter to which the connector is connected;
A catheter kit according to claim 1, wherein a 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.