WO2021090544A1

WO2021090544A1 - Medical device kit and medical tubular member

Info

Publication number: WO2021090544A1
Application number: PCT/JP2020/028835
Authority: WO
Inventors: 慧一藤野; 哲平久保木
Original assignee: 朝日インテック株式会社
Priority date: 2019-11-07
Filing date: 2020-07-28
Publication date: 2021-05-14
Also published as: JP2021074109A

Abstract

The present invention suppresses interference with a manipulation caused by an unintended movement of a tubular member along a shaft. This medical device kit comprises a medical device and a tubular member. The medical device includes a shaft and a protector fixed to the base end section of the shaft. The tubular member has a through-hole formed therein and through which the shaft of the medical device can be inserted. Furthermore, the tubular member has a holding part with which the protector is detachably held in the medical device inserted through the through hole.

Description

Medical device kits and medical tubular members

The technology disclosed herein relates to a medical device kit.

A method using a catheter is widely used as a method for treating or inspecting a stenotic part, an occluded part, an abnormal blood vessel, etc. (hereinafter referred to as "lesion part") in a blood vessel or the like. A catheter is an elongated medical device comprising a shaft and a protector fixed to the proximal end of the shaft. The catheter is inserted, for example, through a catheter insertion hole opened at the base end of a sheath that has been previously inserted into a blood vessel or the like.

Here, a tubular member may be used when inserting the catheter into the catheter insertion hole of the sheath. The tubular member is formed with a through hole through which the shaft of the catheter can be inserted. The through hole of the tubular member and the catheter insertion hole of the sheath are arranged so as to communicate with each other, and the tip of the catheter shaft is inserted into the through hole of the tubular member. As a result, for example, a shaft having a non-linear shape or a shaft having a high flexibility and cannot maintain a linear shape can be smoothly inserted into the catheter insertion hole of the sheath.

By the way, after inserting the tip of the catheter shaft into the catheter insertion hole of the sheath, the tubular member becomes unnecessary. For this reason, the tubular member may unintentionally move along the shaft during the procedure and interfere with the procedure. Therefore, conventionally, a technique for forming a slit extending over the entire length of a tubular member is known (see Patent Document 1). The tubular member can be removed from the shaft or a guide wire inserted into the shaft via the slit.

Japanese Unexamined Patent Publication No. 10-433309

In the above-mentioned conventional technique for forming a slit in a tubular member, when the tubular member is removed from the shaft or the like, a portion constituting the slit of the tubular member interferes with the surface of the shaft or the like, for example, the shaft is damaged or the surface of the shaft is damaged. There is a possibility that problems such as peeling of the coating formed on the slit may occur.

Such a problem is not limited to a catheter, but is a problem common to medical device kits including a long medical device to be inserted into a blood vessel or the like and a tubular member.

This specification discloses a technique capable of solving the above-mentioned problems.

(1) The medical device kit disclosed in the present specification is a medical device kit, the medical device including a shaft, a protector fixed to a base end portion of the shaft, and the medical device. A tubular member having a through hole through which the shaft of the device can be inserted is provided, and the tubular member has a holding portion that is detachably held by the protector in the medical device inserted through the through hole. Have.

In this medical device kit, for example, the tip of the shaft of the medical device is inserted into the inner cylinder of the sheath or the like via a tubular member. As a result, the tip of the shaft is smoothly inserted into the inner cylinder of the sheath in a state of being linearly straightened by the tubular member. After that, the unnecessary tubular member is detachably held by a protector attached to the base end portion of the medical device. As a result, after the medical device is inserted into the sheath, it is possible to prevent the tubular member from unintentionally and freely moving along the shaft during the procedure to interfere with the procedure. Further, unlike the configuration in which the tubular member can be removed while the medical device is inserted into the sheath, it is possible to prevent the tubular member from being lost.

(2) In the medical device kit, a convex or concave first spiral portion formed spirally around the axis of the protector is formed on the outer peripheral surface of the protector, and the tubular member. The inner peripheral surface may be configured to have a convex or concave second spiral portion formed spirally around the axis of the tubular member and screwable to the first spiral portion. Good. In this medical device kit, the tubular member can be easily held by the protector simply by screwing the tubular member into the protector. Further, for example, as compared with the configuration in which the protector is press-fitted into the tubular member to hold it, the tubular member can be held by the protector without requiring deformation of the tubular member or the protector.

(3) In the medical device kit, the first spiral portion is a spiral concave portion formed on the outer peripheral surface of the protector, and the second spiral portion is formed on the inner peripheral surface of the tubular member. It may be configured to be a formed spiral convex portion. In this medical device kit, since a spiral recess is formed on the outer peripheral surface of the protector, the protector is more flexible than a configuration in which the recess is not formed, and the protector is damaged by bending stress, for example. Can be suppressed. Further, since the spiral convex portion is formed on the inner peripheral surface of the tubular member, the diameter of the tubular member may be larger than that of the configuration in which the spiral concave portion is formed on the inner peripheral surface of the tubular member, for example. , Thinning is suppressed.

(4) The medical tubular member disclosed in the present specification is a medical tubular member, and has a through hole through which a shaft of a medical device can be inserted, and the through hole is inserted into the through hole. It has a holding portion that is detachably held by a protector provided at a base end portion of the shaft in a medical device. According to the present medical tubular member, after the medical device is inserted into the sheath or the like, it is possible to prevent the tubular member from unintentionally and freely moving along the shaft during the procedure to interfere with the procedure.

The techniques disclosed herein can be realized in various forms, such as a medical device kit, a catheter kit, a medical tubular member, a method of using a medical device, and the like. Can be done.

Perspective view showing the appearance configuration of the catheter kit 10 in the embodiment. Longitudinal section of strainer 100 Explanatory drawing which shows the insertion process of a catheter 200 Explanatory drawing which shows holding state of strainer 100

A. Embodiment:
A-1. Overall configuration of catheter kit 10:
FIG. 1 is a perspective view showing an external configuration of the catheter kit 10 according to the present embodiment. In FIG. 1, the Z-axis negative direction side (the side of the protector 220 described later) is the proximal end side (proximal side) operated by a technician such as a doctor, and the Z-axis positive direction side (opposite to the protector 220). The side) is the distal side that is inserted into the body.

As shown in FIG. 1, the catheter kit 10 includes a strainer 100 and a catheter 200. Although FIG. 1 shows a state in which the catheter 200 is in a straight line parallel to the Z-axis direction as a whole, the catheter 200 has flexibility to the extent that it can be curved. The catheter kit 10 is an example of a medical device kit within the scope of claims.

A-1-1. Configuration of catheter 200:
The catheter 200 is a medical device inserted into a blood vessel or the like for treating or inspecting a lesion portion in the blood vessel or the like. As shown in FIG. 1, the catheter 200 includes an elongated shaft 210, a protector 220 attached to the proximal end of the shaft 210, and a connector 230 attached to the proximal end of the protector 220. There is. The catheter 200 is an example of a medical device.

The shaft 210 is a tubular (for example, cylindrical) member having an open tip and base end, and has a lumen (not shown) through which a guide wire or the like can be inserted. In addition, in this specification, "cylindrical shape (cylindrical shape)" is not limited to a perfect cylindrical shape (cylindrical shape), but is substantially cylindrical (substantially cylindrical shape, for example, slightly conical shape or a part) as a whole. It may have an uneven shape, etc.). Further, in the present embodiment, the tip portion of the shaft 210 is shaped in a non-linear shape (for example, a hook shape) (see FIG. 1). Examples of the material for forming the shaft 210 include a thermoplastic resin, more specifically, polyethylene, polypropylene, polybutene, an ethylene-propylene copolymer, an ethylene-vinyl acetate copolymer, an ionomer, or a mixture of two or more thereof. Such as polyolefin, polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, thermoplastic polyurethane and the like.

The protector 220 has a cylindrical shape as a whole, and has a lumen (not shown) that communicates with the lumen of the shaft 210 and allows a guide wire or the like to be inserted, and a taper whose outer diameter decreases as it approaches the tip of the protector 220. It has a portion 222. The base end portion of the shaft 210 is inserted and fixed to the tip opening of the tapered portion 222 of the protector 220. A spiral groove 224 is formed on the outer peripheral surface of the tapered portion 222, and the spiral groove 224 is spirally formed around the axis of the protector 220. The protector 220 is made of, for example, a material harder than the shaft 210 (for example, a resin such as polyethylene or polypropylene). The spiral groove 224 is an example of the first spiral portion in the claims.

A-1-2. Strainer 100 configuration:
FIG. 2 is a vertical cross-sectional view of the strainer 100. The vertical cross section of the strainer 100 means a cross section (YZ cross section of FIG. 1) parallel to the axial direction of the strainer 100 (longitudinal direction in the Z-axis direction of FIGS. 1 and 2). FIG. 2 shows an enlarged cross-sectional structure of the X1 portion of the strainer 100. The strainer 100 is a tubular member within the scope of the claims.

As shown in FIGS. 1 and 2, the strainer 100 is a tubular member having a through hole 102 through which the shaft 210 of the catheter 200 can be inserted. The strainer 100 has a base end portion 110, an intermediate portion 120, and a tip end portion 130. The base end portion 110 is a portion having the same outer diameter having substantially the same outer diameter over the entire length of the base end portion 110. The intermediate portion 120 has substantially the same outer diameter over the entire length of the intermediate portion 120, and the outer diameter is smaller than the outer diameter of the base end portion 110. The tip portion 130 is a tapered portion whose outer diameter becomes continuously smaller as it approaches the tip of the tip portion 130 (strainer 100). The radial thickness of the base end portion 110 is thicker than that of the other portions (intermediate portion 120, tip portion 130). The diameter of the through hole 102 of the strainer 100 is larger than the outer diameter of the shaft 210 and smaller than the maximum outer diameter of the protector 220. The diameter of the through hole 102 is continuously reduced from the base end to the tip end of the strainer 100.

As shown in FIG. 2, a spiral rib 112 is formed on the inner peripheral surface of the base end portion 110 of the strainer 100, and the spiral rib 112 is spirally formed around the axis of the strainer 100. Specifically, the spiral ribs 112 are arranged so that a plurality of (a pair in FIG. 2) ribs are arranged along a virtual line (not shown) extending spirally around the axis of the strainer 100. The spiral rib 112 of the strainer 100 can be screwed into the spiral groove 224 of the catheter 200 (see FIG. 4 described later). The strainer 100 is made of, for example, a material harder than the shaft 210 (for example, a resin such as polyethylene or polypropylene). The spiral rib 112 is an example of a holding portion and a second spiral portion within the scope of claims.

The spiral rib 112 is formed only on the proximal end side (base end portion 110) having a relatively large inner diameter in the strainer 100. Therefore, when the tip of the shaft 210 of the catheter 200 is inserted into the through hole 102 of the strainer 100, it is possible to prevent the spiral rib 112 from interfering with the tip of the shaft 210. Further, the cross-sectional shape perpendicular to the extension direction (spiral direction) of the spiral rib 112 is an arc shape. Therefore, it is possible to prevent the shaft 210 from being damaged or the like due to the contact between the shaft 210 and the spiral rib 112.

A-2. Example of using strainer 100:
FIG. 3 is an explanatory view showing an insertion step of the catheter 200, and FIG. 4 is an explanatory view showing a holding state of the strainer 100. FIG. 3 schematically shows a state in which the sheath 300 is inserted into the blood vessel 2 of the body 1.

For example, the hook-shaped tip of the shaft 210 of the catheter 200 is inserted into the through hole 102 of the strainer 100. As a result, the tip end portion of the shaft 210 is in a state of being linearly straightened by the strainer 100. Then, as shown in FIG. 3A, the through hole 102 of the strainer 100 and the catheter insertion hole 302 formed at the base end of the sheath 300 are arranged so as to communicate with each other, and the tip end portion of the shaft 210 is arranged so as to communicate with the sheath 300. Push it to the side. As a result, the tip of the shaft 210 is smoothly inserted into the catheter insertion hole 302 of the sheath 300 in a linearly straightened state.

When the tip of the catheter 200 is inserted into the blood vessel 2 via the sheath 300, the strainer 100 ends its role and becomes unnecessary. The inner diameter of the strainer 100 is smaller than the outer diameter of the sheath 300 and smaller than the outer diameter of the protector 220 as described above. Therefore, the strainer 100 cannot be moved so as to overlap the sheath 300 or pulled out from the proximal end side of the catheter 200, and is in the middle of the shaft 210 or in the middle of the guide wire inserted into the shaft 210. Cannot be removed with. Further, the diameter of the through hole 102 of the strainer 100 is larger than the outer diameter of the shaft 210 so that the shaft 210 can be smoothly inserted into the through hole 102 of the strainer 100. As a result, as shown in FIG. 3B, the strainer 100 that is no longer needed moves freely along the shaft 210 unintentionally, which interferes with the procedure. It is conceivable that the tip of the strainer 100 is held in the catheter insertion hole 302 of the sheath 300. However, this configuration causes a problem that the sheath 300 becomes large and the structure becomes complicated.

On the other hand, in the present embodiment, the unnecessary strainer 100 can be held by the protector 220 attached to the base end portion of the shaft 210. Specifically, as shown in FIG. 4, the strainer 100 is moved toward the protector 220 along the shaft 210, and the spiral rib 112 of the strainer 100 and the spiral groove 224 of the protector 220 are screwed together. As a result, the strainer 100 is detachably held by the protector 220.

A-3. Effect of this embodiment:
In the catheter kit 10 according to the present embodiment, the hook-shaped tip portion of the shaft 210 of the catheter 200 can be smoothly inserted into the inner cylinder or the like of the sheath 300 via the strainer 100. After that, the strainer 100 that is no longer needed can be detachably held by the protector 220 attached to the proximal end portion of the catheter 200. As a result, after the catheter 200 is inserted into the sheath 300, it is possible to prevent the strainer 100 from unintentionally and freely moving along the shaft 210 during the procedure to interfere with the procedure. Further, unlike the configuration in which the strainer 100 can be removed while the catheter 200 is inserted into the sheath 300, it is possible to prevent the strainer 100 from being lost.

In the present embodiment, the strainer 100 can be easily held by the protector 220 simply by screwing the strainer 100 into the protector 220. Further, as compared with the configuration in which the protector 220 is press-fitted and held by the strainer 100, for example, the strainer 100 can be held by the protector 220 without requiring deformation of the strainer 100 and the protector 220.

In the present embodiment, since the spiral groove 224, which is a spiral recess, is formed on the outer peripheral surface of the protector 220, the protector 220 is more flexible than the configuration in which the recess is not formed, for example, bending stress. It is possible to prevent the protector 220 from being damaged. Further, since the spiral rib 112 which is a spiral convex portion is formed on the inner peripheral surface of the strainer 100, the strainer 100 has a structure in which a spiral concave portion is formed on the inner peripheral surface of the strainer 100, for example. It is possible to prevent the diameter from becoming large or thin.

B. Modification example:
The technique disclosed in the present specification is not limited to the above-described embodiment, and can be transformed into various forms without departing from the gist thereof. For example, the following modifications are also possible.

The configuration of the catheter kit 10 in the above embodiment is merely an example and can be variously modified. For example, in the above embodiment, the shaft 210 may be a solid member having no lumen. Further, the tip portion of the shaft 210 may have a structure having flexibility to the extent that a predetermined shape cannot be maintained. Further, the protector 220 may have a shape having substantially the same outer diameter over the entire length, for example, without having the tapered portion 222. Further, the shape of the protector 220 in the axial direction is not limited to a circular shape, and may be a rectangular shape or the like.

The diameter of the through hole 102 of the strainer 100 may be substantially the same over the entire length of the strainer 100. The strainer 100 may be a member having substantially the same outer diameter over the entire length.

In the above embodiment, the spiral groove 224 is exemplified as the first spiral portion and the spiral rib 112 is exemplified as the second spiral portion. However, the first spiral portion is a spiral convex portion and the second spiral portion. The portion may be a spiral recess. Further, although the spiral rib 112 may be formed over the entire length of the strainer 100, it is preferable that the spiral rib 112 is formed only on the proximal end side of the strainer 100. Further, the cross-sectional shape perpendicular to the extension direction of the spiral rib 112 may be, for example, a rectangular shape or a triangular shape.

In the above embodiment, the holding portion is realized by a structure in which the strainer 100 is screwed into the protector 220. For example, the protector 220 does not have the first spiral portion, and the strainer 100 has the second spiral portion. Even when the protector 220 is not provided, the maximum outer diameter of the protector 220 is larger than the maximum inner diameter of the strainer 100, and the protector 220 or the strainer 100 is made of an elastic material such as a resin to make the protector 220 the strainer 100. When inserted into, they can be fixed to each other by elastic force. As described above, it may be realized by a structure in which the protector 220 is press-fitted into the strainer 100, or may be realized by a structure in which the strainer 100 is engaged with the protector 220.

The material of each member in the strainer 100 and the catheter 200 of the above embodiment is merely an example and can be variously deformed.

In the above embodiment, the catheter 200 is exemplified as a medical device, but a guide wire or the like may be used. In short, the medical device may be a long medical device that is inserted into a blood vessel or the like.

1: Body 2: Blood vessel 10: Catheter kit 100: Strainer 102: Through hole 110: Base end 112: Spiral rib 120: Middle part 130: Tip part 200: Catheter 210: Shaft 220: Protector 222: Tapered part 224: Spiral Groove 230: Connector 300: Sheath 302: Catheter insertion hole

Claims

A medical device kit
A medical device comprising a shaft and a protector fixed to the proximal end of the shaft.
A tubular member having a through hole through which the shaft of the medical device can be inserted.
The tubular member has a holding portion that is detachably held by the protector in the medical device inserted through the through hole.
Medical device kit.
The medical device kit according to claim 1.
On the outer peripheral surface of the protector, a first spiral portion having a convex shape or a concave shape spirally formed around the axis of the protector is formed.
On the inner peripheral surface of the tubular member, a convex or concave second spiral portion formed spirally around the axis of the tubular member and screwable to the first spiral portion is formed. Yes,
Medical device kit.
The medical device kit according to claim 2.
The first spiral portion is a spiral concave portion formed on the outer peripheral surface of the protector.
The second spiral portion is a spiral convex portion formed on the inner peripheral surface of the tubular member.
Medical device kit.
It is a medical tubular member and
A through hole is formed through which the shaft of the medical device can be inserted.
It has a holding portion that is detachably held by a protector provided at a base end portion of the shaft in the medical device inserted through the through hole.
Medical tubular member.