WO2018079083A1

WO2018079083A1 - Catheter assembly and container

Info

Publication number: WO2018079083A1
Application number: PCT/JP2017/031961
Authority: WO
Inventors: 陽平黒瀬
Original assignee: 株式会社カネカ
Priority date: 2016-10-27
Filing date: 2017-09-05
Publication date: 2018-05-03
Also published as: JP2020000263A

Abstract

The present invention provides: a catheter assembly having a double tube structure configured such that an intertubular space can be sterilized; and a container therefor. The catheter assembly includes a catheter hub and a catheter, the catheter hub has a communication hole, and the catheter has one or a plurality of inner tubular members that form a lumen inside an outer tubular member that forms an outer shell, the inner tubular member and the outer tubular member having an intertubular space therebetween. The communication hole of the catheter hub is in communication with the inner tubular member lumen, and the base end and the distal end of the outer tubular member are closed. The catheter hub and/or the outer tubular member have a side hole, and the intertubular space is in communication with the outside through the side hole.

Description

Catheter assembly and storage

The present invention relates to a catheter assembly and a storage object storing the catheter assembly.

As a method of reducing diseases such as ischemic heart disease (angina, myocardial infarction, etc.), a balloon catheter is inserted into the blood vessel from the patient's arm or thigh root and passed through the blood vessel to reach the coronary artery of the heart There is a method in which a portion where a blood vessel is narrowed due to arteriosclerosis (coronary artery stenosis) is pushed out with a balloon.

By the way, in the case of a chronic total occlusion lesion in which the coronary artery stenosis is completely occluded by arteriosclerosis, the coronary artery stenosis is blocked by the occlusion, which makes it difficult to pass the guide wire to the coronary artery stenosis. The balloon catheter cannot be guided along the wire to the coronary artery stenosis. Therefore, conventionally, before inserting the balloon catheter into the coronary artery stenosis, the guide wire can pass through the coronary artery stenosis using a coronary artery penetration catheter (for example, Patent Document 1) different from the balloon catheter or the like in advance. In this way, the guide wire passes through the occluded portion of the coronary artery stenosis, and the guide wire can pass through the coronary artery stenosis. This makes it possible to guide the balloon catheter to the coronary artery stenosis along the guide wire.

This coronary artery penetrating catheter requires an operation of passing the guide wire through the lumen and removing clogging of the coronary artery stenosis at the distal end of the guide wire, so that improvement in the operability of the guide wire is desired.
Therefore, the coronary artery penetrating catheter of Patent Document 1 has a structure in which a proximal end shaft is provided in a coaxial double tubular shape of an outer tube and an inner tube, and a core wire is arranged in a space between the outer tube and the inner tube. Have taken. In patent document 1, it is supposed that it becomes difficult to kink by setting it as such a structure, and the operativity of a guide wire can be improved.

International Publication No. 2006/126642

By the way, even in the medical field, especially in the operating room, even a small amount of bacteria can cause infection. Therefore, the surgical instrument does not allow the presence of a slight amount of bacteria, and is used after being sterilized by being exposed to a sterilization gas (for example, EOG, ethylene oxide gas) in advance and strictly controlled.

However, even if the coronary artery penetrating catheter of Patent Document 1 is exposed to a sterilizing gas, the space between the outer tube and the inner tube is sealed, so that the sterilizing gas does not reach the space between the tubes. That is, in this coronary artery penetrating catheter, bacteria mixed in the space between the tubes at the time of manufacture are not killed by a normal sterilization process.

Although this coronary artery catheter does not break in principle, the outer tube or inner tube of the catheter does not necessarily break in the blood vessel in the case of initial failure or excessive bending against the bending strength. In such a case, if bacteria are present in the inter-tube space between the inner tube and the outer tube, the bacteria in the inter-tube space may migrate into the patient's body, and in the worst case, the patient may have complications.

Therefore, an object of the present invention is to provide an assembly of a catheter having a double tube structure and capable of easily sterilizing the inter-tube space, and a stored product thereof.

One aspect of the present invention for solving the above problems includes a catheter hub and a catheter, the catheter hub has a communication hole, and the catheter has a lumen in an outer tubular member constituting an outer shell. There is one or a plurality of inner tubular members, and an inter-tube space exists between the inner tubular member and the outer tubular member, and the communication hole of the catheter hub is formed of the inner tubular member. The outer tubular member communicates with the lumen, the proximal end portion and the distal end portion of the outer tubular member are closed, and the catheter hub and / or the outer tubular member has a lateral hole, and the inter-tube is separated by the lateral hole. A catheter assembly in which the space communicates with the outside.

According to this aspect, the proximal end portion and the distal end portion of the outer tubular member are closed, and the inter-tube space is a space in which the distal end portion and the proximal end portion are closed. And according to this aspect, since this inter-tube space communicates with the outside through a horizontal hole, it can be installed in a sterilizing gas atmosphere or by directly introducing a sterilizing gas from the horizontal hole. The inside space can be easily exposed to the sterilizing gas, and the bacteria in the intertube space can be substantially killed. Therefore, even if the catheter is broken in the blood vessel of the patient, it is possible to prevent bacteria in the inter-tube space from mixing with blood and causing complications.

In a preferred aspect, the catheter hub and the inner tubular member are joined, and the lateral hole is disposed on the inner tubular member side of the joint portion of the catheter hub with the inner tubular member. .

According to this aspect, since the lateral hole can be arranged away from the introduction part of the catheter into the body, it is possible to prevent blood from entering from the lateral hole and reducing the operability.

A preferred aspect is that there is a core wire in the inter-tube space, and the minimum included circle diameter of the lateral hole is larger than the maximum non-included circle diameter of the core wire.

Here, the “minimum inclusion circle diameter” refers to the diameter of the smallest virtual circle including all vertices or sides.
The “maximum non-inclusion circle diameter” herein refers to the diameter of the largest virtual circle that is centered inside the minimum inclusion circle and does not include all vertices or sides.

According to this aspect, even if the core wire overlaps the horizontal hole and blocks a part of the horizontal hole, an open part from the core wire can be secured in the horizontal hole, and an opening for introducing the sterilization gas can be maintained. .

In the aspect described above, a part of the core wire is in a state of facing the lateral hole, and in the state of facing the lateral hole, the area of the portion of the core wire facing the lateral hole is: It is preferable that the area is smaller than the area of the lateral hole.

A preferred aspect is that at least two side holes are provided.

横 According to this aspect, the horizontal hole is not easily blocked.

A preferred aspect is that the two lateral holes are arranged at positions shifted in the circumferential direction.

The “position shifted in the circumferential direction” herein refers to a position on the same circumference that surrounds the catheter assembly and does not overlap.

According to this aspect, even if one horizontal hole is blocked by the installation surface such as the floor surface or the mounting surface, the other horizontal hole can be opened depending on the installation posture of the catheter on the installation surface. Therefore, a sterilization gas introduction path can be secured during sterilization.

In a preferred aspect, the catheter hub has a protruding portion projecting in a direction orthogonal to the longitudinal direction, and the lateral hole is closer to the proximal end than the protruding portion, and the end of the protruding portion in the orthogonal direction. It is formed inside the part.

According to this aspect, even if the covering covers the horizontal hole and the protruding portion, the horizontal hole is not easily blocked because the protruding portion forms a step inward and outward.

A preferred aspect is that the inter-tube space is sealed at the tip side from the side hole.

According to this aspect, the intervascular space is not substantially exposed to blood in the blood vessel, so that blood in the blood vessel does not enter the intervascular space during normal use unless it is damaged due to initial failure or the like.

A preferred aspect is that there is a core wire in the inter-tube space, and the core wire protrudes from the proximal end portion of the catheter into the catheter hub.

According to this aspect, since the core wire extends to the inside of the catheter hub, the hand is difficult to bend and is easy to operate.

In a preferred aspect, there is a core wire in the inter-tube space, a proximal end portion of the outer tubular member is closed by the catheter hub, and an elastic body is provided between the core wire and the catheter hub. It is arranged.

According to this aspect, when the catheter is bent and bent, even if the core wire moves to the proximal end side, the elastic body is arranged between the core wire and the catheter hub. The pressing force from the core wire can be relaxed.

In a preferred aspect, the catheter includes a lumen region having at least two lumens, and the inner tubular member constitutes one of the two lumens.

According to this aspect, since the catheter includes a plurality of lumens, it is easy to pass the guide wire into the blood vessel.

One aspect of the present invention includes the above-described catheter assembly, a posture fixing member that fixes the catheter assembly in a predetermined posture, and a storage body that houses the catheter assembly and the posture fixing member therein. The posture fixing member has a catheter protection part for protecting the catheter and a hub holding part for holding the catheter hub, and the storage body is bag-like and is sterilized inside and outside in a closed state. Gas can be circulated, and the catheter assembly is a storage item in which the lateral hole is exposed from the hub holding portion in a state of being fixed to the posture fixing member.

According to this aspect, since the space between the tubes of the catheter assembly can be exposed to the sterilization gas in a state where the catheter assembly is stored in the storage body, the catheter assembly can be carried into an operating room or the like with very few bacteria. .

According to the assembly and storage of the catheter of the present invention, the inter-tube space between the inner tubular member and the outer tubular member can be easily sterilized.

It is a perspective view of the stored thing in 1st Embodiment of this invention. It is a cross-sectional perspective view of the storage body of FIG. It is a perspective view which shows the state which extracted a part of catheter assembly body in 1st Embodiment of this invention from the attitude | position fixing member. FIG. 4 is a perspective view of the catheter assembly of FIG. 3. It is an enlarged view of the front end side shaft part of the catheter assembly of FIG. It is a cross-sectional perspective view of the front end side shaft part of FIG. It is a longitudinal cross-sectional view of the front end side shaft part of FIG. It is a partially broken perspective view of the base end side shaft part of FIG. It is a cross-sectional perspective view of the base end side shaft part of FIG. FIG. 5 is a cross-sectional view of the base end side shaft portion of FIG. 4, (a) is a vertical cross-sectional view, and (b) is a cross-sectional view taken along line AA of (a). It is the enlarged view of the principal part of the catheter hub of FIG. 4, and is a figure which abbreviate | omitted the protection member. It is explanatory drawing showing an example of the treatment method using the catheter assembly of FIG. 4, (a) is the conceptual diagram which let the guide wire pass the obstruction | occlusion part of the blood vessel, (b) is a catheter along a guide wire. Is a conceptual diagram in which the blood vessel is passed through the vicinity of the occluded portion of the blood vessel, and FIG. It is a conceptual diagram which shows the state at the time of performing a sterilization process using the stored thing of FIG.

Hereinafter, embodiments of the present invention will be described in detail. In the catheter assembly 3, the proximal end side of the catheter hub 11 is a proximal end side (hand side), and the distal end side of the catheter 10 is a distal end side.

The stored item 1 according to the first embodiment of the present invention is one in which a catheter assembly 3 and a posture fixing member 5 are mainly stored in a storage body 2 as shown in FIG. The stored item 1 according to the present embodiment is characterized in that the internal catheter assembly 3 can be sterilized by being exposed to an atmosphere of sterilization gas 305 (see FIG. 13). One thing.

As shown in FIGS. 1 and 2, the storage body 2 is a bag-like member and includes a storage space 6 in which the catheter assembly 3 and the posture fixing member 5 can be stored. The sterilization gas 305 can be distributed between the two. The storage body 2 of the present embodiment is configured such that the two films 7 and 8 are bonded along the edge to form the storage space 6.
The film 7 constituting one surface of the container 2 is formed of a gas non-permeable film that does not pass through the sterilizing gas 305, and the film 8 constituting the other surface passes through the sterilizing gas 305. It is made of film. Therefore, the storage body 2 can pass the sterilization gas 305 from the outside through the film 8 into the storage space 6. In addition, as for the container 2, both the films 7 and 8 may be a gas passage film.

As shown in FIG. 12, the catheter assembly 3 is inserted into the patient's blood vessel 302 along the guide guide wire 200 a previously arranged in the patient's blood vessel 302, and an occlusion portion in which the obstruction in the blood vessel 302 is clogged. The guide wire 200b for penetration is made to penetrate through 301.
As shown in FIG. 4, the catheter assembly 3 includes a catheter 10 and a catheter hub 11 as main components.

The catheter 10 is a so-called catheter for coronary artery penetration, improves the operability of the guide wire 200 (200a, 200b) in the coronary artery stenosis part 300 in the blood vessel 302, and the guide wire 200 is attached to the occlusion part 301 of the coronary artery stenosis part 300. A catheter for penetrating.
The catheter 10 of this embodiment includes a rapid exchange lumen 15 (hereinafter also referred to as RX lumen 15) and an over-the-wire lumen 16 (hereinafter also referred to as OTW lumen 16), as can be seen from FIGS. This is a Lumen member axial penetration catheter.

The RX lumen 15 is a guide wire lumen for introducing the catheter 10 into the patient's blood vessel 302 along a guide wire 200a that is arranged in advance.
The OTW lumen 16 is a guide wire lumen for introducing the penetrating guide wire 200b into the coronary artery stenosis 300 along the catheter 10, and can inject a drug in addition to the guide wire 200b.

The catheter 10 is a long body extending linearly, and a part thereof has a double tube structure.
As can be seen from FIGS. 5, 7, and 8, the catheter 10 includes a first inner tubular member 20, a second inner tubular member 21, a first outer tubular member 22, a second

outer tubular member

23, 1 Alternatively, a plurality of core wires 25 are provided.

The first inner tubular member 20 is a tube having the RX lumen 15 as an internal space and allowing the guide wire 200a to be inserted through the RX lumen 15 as can be seen from FIGS. The first inner tubular member 20 is a resin tube that has a cylindrical shape and has a substantially circular or polygonal cross-sectional shape and is elastically deformable.

As can be seen from FIGS. 5 and 7, the second inner tubular member 21 is a tube that has the OTW lumen 16 as an internal space and allows the guide wire 200 b to be inserted through the OTW lumen 16. The second inner tubular member 21 is a resin tube that has a cylindrical shape and has a substantially circular or polygonal cross-sectional shape and is elastically deformable.
The second inner tubular member 21 of the present embodiment is a tubular member that has an inner wall constituting the OTW lumen 16 and is joined to the catheter hub 11. As shown in FIG. 10, the second inner tubular member 21 includes a diameter-expanded portion 27 that is diameter-expanded with respect to other portions at the proximal end portion of the OTW lumen 16.
The enlarged diameter portion 27 constitutes a part of the OTW lumen 16 and is a space communicating with the wire port portion 65 of the catheter hub 11 when the catheter assembly 3 is assembled.

As shown in FIG. 5, the first outer tubular member 22 is a resin tube that constitutes a part of the outline of the catheter 10.
As shown in FIG. 6, the first outer tubular member 22 covers the outer periphery of the inner

tubular members

20, 21 and integrates the inner

tubular members

20, 21. That is, the first outer tubular member 22 includes a plurality of insertion holes 28 and 29 into which the inner

tubular members

20 and 21 can be inserted.
As shown in FIG. 7, the insertion holes 28 and 29 are through holes penetrating in the longitudinal direction (axial direction X), and are attachment holes for attaching the inner

tubular members

20 and 21.
The material of the inner

tubular members

20 and 21 and the material of the outer tubular member 22 may be integrated without using the insertion holes 28 and 29.
In addition, the 1st outer side tubular member 22 can select the number of insertion holes according to the number of inner side tubular members. The first outer tubular member 22 may be integrated by inserting a plurality of inner tubular members into one insertion hole. The outer tubular member 22 and the inner

tubular members

20 and 21 can be integrated by heat welding, adhesion, or the like.

As shown in FIG. 7, the first outer tubular member 22 includes a plurality of radiation markers 26 (26a to 26d) on its inner surface.
The radiation marker 26 is a marker for confirming the current position of the catheter 10 when the catheter 10 is inserted into the blood vessel 302 while imaging the patient's blood vessel 302 using radiation such as X-rays. Specifically, the radiation marker 26 is a radiopaque marker that hardly transmits radiation during radiography of X-rays or the like, and is a radiopaque marker in the present embodiment.

The second outer tubular member 23 is a resin tube that forms the outer shell of the catheter 10 together with the first outer tubular member 22. In addition, the 1st outer side tubular member 22 and the 2nd outer side tubular member 23 may be integral, and the form to which the different tubular member was joined may be sufficient.
As shown in FIG. 8, the second outer tubular member 23 includes a space through which a part of the second inner tubular member 21 can pass, and is formed so as to surround the periphery. The second outer tubular member 23 has a rigidity that decreases from the proximal end side toward the distal end side, and is easily bent.

The core wire 25 is a member that reinforces the bending strength of the catheter 10 and the catheter hub 11 and is an elastically deformable wire. The core wire 25 is a wire having a circular or polygonal cross-sectional shape, and is disposed so as to support the catheter 10 over the entire length of the inter-tube space 50 in the inter-tube space 50.
The core wire 25 may have a length in the longitudinal direction shorter than the length of the inter-tube space 50.
As the core wire 25 moves from the base end side to the tip end side, the rigidity is reduced continuously or intermittently, and the core wire 25 is easily bent. The core wire 25 can be reduced in cross-sectional area from the proximal end side toward the distal end side or can be reduced in rigidity toward the distal end side by annealing or the like. The core wire 25 of the present embodiment has a tapered shape that gradually tapers from the proximal end side toward the distal end side, and the distal end side is more easily elastically deformed than the proximal end side.

The material of the core wire 25 is not particularly limited as long as it has an appropriate elasticity, and may be any of a metal material, an alloy material, and a resin material. As a material of the core wire 25, for example, a metal material such as stainless steel, nickel titanium, cobalt chrome, or an alloy material can be preferably used.

As shown in FIG. 7, the catheter 10 is roughly composed of a distal end side shaft portion 30 and a proximal end side shaft portion 31 in the longitudinal direction (axial direction X).
The distal end side shaft portion 30 is a portion on the distal end side from a portion including both the RX lumen 15 and the OTW lumen 16.
In the distal end side shaft portion 30, the distal end portion of the first inner tubular member 20 projects to the distal end portion side relative to the distal end portion of the second inner tubular member 21, and the first lumen region 35 to which only the RX lumen 15 belongs, and RX There is a second lumen area 36 (lumen area) to which both the lumen 15 and the OTW lumen 16 belong.
In the first lumen region 35, at least one radiation marker 26 (26 a, 26 b) is provided on the inner peripheral surface of the first outer tubular member 22. The second lumen region 36 is also provided with at least one radiation marker 26 (26c, 26d) on the inner peripheral surface of the first outer tubular member 22. The radiation marker 26 may be provided in a dot shape around the first inner tubular member 20, or may be provided in a ring shape covering the periphery of the first inner tubular member 20.

The proximal-side shaft portion 31 is a portion closer to the proximal-end portion (hand side) than the distal-end-side shaft portion 30 and occupies most of the catheter 10. The proximal shaft portion 31 occupies 80% or more and less than 100% of the total length of the catheter 10, and preferably occupies 90% or less.
As shown in FIG. 8, the second inner tubular member 21 passes through the inside of the second outer tubular member 23, and the second outer tubular member 23 surrounds the second inner tubular member 21. Is provided.

As shown in FIG. 10, there is a gap between the outer peripheral surface of the second inner tubular member 21 and the inner peripheral surface of the second outer tubular member 23, and an inter-tube space 50 exists.
In the inter-tube space 50, one or a plurality of core wires 25 (25a, 25b) are arranged, and in the present embodiment, two

core wires

25a, 25b are arranged.
The

core wires

25 a and 25 b are arranged around the second inner tubular member 21 with a predetermined interval, and the distal ends thereof are inserted into the base end surface of the first outer tubular member 22 and fixed.
The

core wires

25a and 25b are supported by the first outer tubular member 22 in a cantilevered manner at the distal ends, and the proximal ends are free ends. Therefore, when the catheter 10 is bent and bent, the ends of the

core wires

25a and 25b are movable in the axial direction X.

As shown in FIG. 7, the second inner tubular member 21 is disposed across the distal end side shaft portion 30 and the proximal end side shaft portion 31.
On the distal end side of the proximal end side shaft portion 31, the distal end portion of the second outer tubular member 23 is connected to the proximal end portion of the first outer tubular member 22 and is closed.
On the proximal end side (hand side) of the proximal end side shaft portion 31, the proximal end portion of the second inner tubular member 21 extends from the proximal end portion of the second outer tubular member 23 to the catheter assembly 3 as shown in FIG. 10. The proximal end portions of the

core wires

25 a and 25 b also project from the proximal end portion of the second outer tubular member 23 to the proximal end portion side of the catheter assembly 3. That is, the proximal end surface of the second inner tubular member 21 is located closer to the proximal end portion side of the catheter assembly 3 than the proximal end surface of the second outer tubular member 23.

The catheter hub 11 is a member that is joined to the second inner tubular member 21 of the catheter 10 and introduces the guide wire 200b into the OTW lumen 16 of the second inner tubular member 21. As shown in FIG. 9, the catheter hub 11 includes a hub main body portion 60, a hub connection portion 61, and a protection member 62.

The hub body 60 includes a communication hole 63 communicating with the OTW lumen 16 therein.
The communication hole 63 is a hole into which the guide wire 200b can be inserted, and guides the guide wire 200b into the OTW lumen 16 on the distal end side.
The communication hole 63 is a hole provided with a wire port portion 65 therein, and is a through-hole penetrating in the axial direction X of the hub main body portion 60. The communication hole 63 is also a hole that allows the OTW lumen 16 to communicate with the outside via the wire port portion 65.

The wire port portion 65 is a space whose base end portion (hand side portion) is opened and guides the guide wire 200b to the OTW lumen 16 side.
The wire port 65 has a space area that decreases from the base end side toward the tip end side, and the communication hole 63 constituting the outer shell also has an opening area on the tip end side compared to the opening area on the base end side. It is getting smaller.
As for the wire port part 65 of this embodiment, the space area gradually decreases in a part as it goes from the base end part side to the tip part side, and the communication hole 63 also partly goes from the base end part side to the tip part side. The gradual cross-sectional area decreases.

As can be seen from FIG. 11, the hub main body 60 includes a port forming portion 66 and wing-

like portions

67 and 68.
The port forming part 66 is a part provided with a wire port part 65 inside, and there is a part having a substantially conical outer shape. In the conical portion, the port forming portion 66 has a tapered outer peripheral surface, and the diameter of the port forming portion 66 decreases from the proximal end side toward the distal end side.

The port forming portion 66 includes an attachment portion 70 for attachment to another instrument or the like in the vicinity of the proximal end portion.
The attachment portion 70 is a ridge that is formed in a spiral shape on the outer peripheral surface of the port forming portion 66, and protrudes outward from the outer peripheral surface, and can be screwed into another instrument or the like.
As shown in FIG. 11, the wing-

like portions

67 and 68 are overhanging portions that project outward from the port forming portion 66 in the radial direction (inside and outside directions), and are also grasping portions that can be grasped by the practitioner.

The hub connection portion 61 is a connection portion of the catheter hub 11 for connecting the catheter hub 11 and the catheter 10, and as can be seen from FIGS. 10 and 11, a connection wall portion 71, a flange portion 72 (protrusion portion), and the like. , A locking portion 73 is provided.
As shown in FIG. 11, the connection wall portion 71 is a peripheral wall portion extending from the distal end portion of the port forming portion 66 so as to surround the distal end portion of the communication hole 63, and an enclosed space 74 is formed inside.
The surrounding space 74 is a space that is continuous with the wire port portion 65 and is open toward the distal end portion.

The connection wall portion 71 of the catheter hub 11 includes a proximal end side wall portion 75 and a distal end side wall portion 76 positioned on the distal end side (catheter 10 side) from the proximal end side wall portion 75. The proximal end side wall portion 75 is a wall portion that is annularly continuous along the distal end edge of the port forming portion 66 and is a wall portion that extends from the distal end surface of the port forming portion 66.

The proximal end side wall 75 of the catheter hub 11 includes at least two gas passage holes 80 (80a, 80b) (lateral holes) as shown in FIG.
The gas passage hole 80 is a horizontal hole formed in the outer peripheral surface of the proximal end side wall portion 75 and is a through hole that penetrates the proximal end side wall portion 75 in the thickness direction (radial direction). As shown in FIG. 10, the gas passage hole 80 is a communication hole that allows communication between the outside and the inter-tube space 50, and allows the sterilization gas 305 to flow from the outside.
The number of gas passage holes 80 that are horizontal holes may be one, but is preferably a plurality.
Since there are a plurality of gas passage holes 80, the gas passage property can be improved. Further, since there are a plurality of gas passage holes 80, even when some of the gas passage holes 80 are blocked, the sterilization gas 305 is passed from the other gas passage holes 80 to the inter-tube space as will be described later. 50 can be introduced or discharged.

The gas passage hole 80 can be selected from an arbitrary shape such as a circle or a polygon, but is preferably a circular hole.
The circumscribed circle diameter of the gas passage hole 80 is preferably larger than the inscribed circle diameter of the core wire 25. The circumscribed circle diameter of the gas passage hole 80 is preferably larger than the circumscribed circle diameter of the core wire 25, and more preferably 1.1 times or more and 1.5 times or less of the circumscribed circle diameter of the core wire 25.
The minimum inclusion circle diameter of the gas passage hole 80 is preferably larger than the maximum non-inclusion circle diameter of the core wire 25, more preferably larger than the minimum inclusion circle diameter of the core wire 25, and the minimum of the core wire 25 More preferably, it is 1.1 times or more and 1.5 times or less of the diameter of the inclusion circle.
If it is said range, even when the core wire 25 and the gas passage hole 80 overlap, the core wire 25 does not block the gas passage hole 80 completely, but an opening can be maintained.
The “circumferential circle diameter” here refers to the diameter of the virtual circumscribed circle. That is, “the circumscribed circle diameter of the gas passage holes 80a and 80b” refers to the diameter of a virtual circumscribed circle circumscribing the openings of the gas passage holes 80a and 80b which are horizontal holes.
The “inscribed circle diameter” here refers to a diameter in a virtual inscribed circle. That is, the “inscribed circle diameter of the core wire 25” refers to the diameter of a virtual inscribed circle inscribed in the outer shape (contour) of the cross section at a specific position of the core wire 25.

Similarly, the opening area of the gas passage hole 80 is preferably larger than the cross-sectional area of the base end portion of the core wire 25.
The arrangement of the plurality of gas passage holes 80 is not particularly limited, but each of the gas passage holes 80 is preferably arranged at a position shifted in the circumferential direction C. In the present embodiment, the gas passage holes 80a and 80b are arranged on a straight line in the radial direction (a direction orthogonal to the axial direction X). That is, when the catheter assembly 3 is assembled, the gas passage holes 80a and 80b are in a relationship of facing each other with the second inner tubular member 21 interposed therebetween.

As shown in FIG. 9, the distal end side wall portion 76 of the catheter hub 11 is a wall portion that is annularly continuous along the distal end edge of the proximal end side wall portion 75, and is erected from the distal end surface of the proximal end side wall portion 75. It is a wall.
The inner peripheral surface of the distal end side wall portion 76 is continuous with the inner peripheral surface of the proximal end side wall portion 75 via the distal end surface of the proximal end side wall portion 75 in a step shape.

The flange portion 72 is a portion that restricts the movement of the protective member 62 toward the proximal end portion.
The flange portion 72 is a flange projecting outward from the distal end portion of the proximal end side wall portion 75 or the vicinity thereof, and extends in the circumferential direction C. That is, the proximal end side wall portion 75 has a step difference from the projecting direction end surface of the flange portion 72 in the radial direction (inner and outer directions), and is located on the inner side of the projecting direction end surface of the flange portion 72.
The gas passage hole 80 (lateral hole) is preferably provided closer to the proximal end portion of the catheter assembly 3 than the flange portion 72 (protruding portion). In the protruding direction of the flange portion 72, that is, in the direction orthogonal to the axial direction X of the catheter 10, the flange portion 72 is preferably formed inside the end portion of the flange portion 72.

The locking part 73 is a part that locks the movement of the protective member 62 in the longitudinal direction (axial direction X).
The locking portion 73 is a protruding strip that protrudes outward from the longitudinal intermediate portion of the distal end side wall portion 76, and extends in the circumferential direction C.
Here, the “intermediate portion” is a portion other than the end portion between the end portions facing each other in a predetermined direction.

The hub body 60 and the hub connection 61 are preferably formed of a transparent resin such as a styrene-butadiene copolymer from the viewpoint of ensuring the visibility of the guide wire 200b.

The protection member 62 is a member that protects a boundary portion between the second outer tubular member 23 of the catheter 10 and the hub main body 60, and functions as a strain relief. The protection member 62 is elastically deformable, is cylindrical, and tapers from the proximal end side toward the distal end side.
As shown in FIG. 10, the protection member 62 includes a protection-side engagement portion 82 at the base end portion.
The protection-side engaging portion 82 is a protruding piece that protrudes further inward from the inner surface of the protection member 62 and extends in the circumferential direction C, and is a portion that can be engaged with the locking portion 73 of the catheter hub 11.

Subsequently, the positional relationship of each part of the catheter assembly 3 will be described.

In the distal end side shaft portion 30, the inner

tubular members

20, 21 are inserted into the insertion holes 28, 29 of the first outer tubular member 22 without a gap as shown in FIG. 6.
The

radiation markers

26 a and 26 b are provided in the insertion hole 28 and are located closer to the distal end side of the catheter assembly 3 than the distal end surface of the second inner tubular member 21. The

radiation markers

26 c and 26 d are provided in the insertion hole 28 and are located closer to the proximal end portion of the catheter assembly 3 than the distal end surface of the second inner tubular member 21.

In the proximal end side shaft portion 31, as shown in FIG. 10, the second inner tubular member 21 is arranged in the second outer tubular member 23, and the second inner tubular member 21 and the second outer tubular member 23 are interposed.

Core wires

25a and 25b are arranged in the inter-tube space 50, respectively.
The proximal end portion of the second inner tubular member 21 is inserted into the surrounding space 74 of the catheter hub 11. The proximal end portion of the second inner tubular member 21 and the distal end portion of the port forming portion 66 are joined, and the inner surface of the enlarged diameter portion 27 of the second inner tubular member 21 and the inner surface of the communication hole 63 are flush with each other. It has become.
The OTW lumen 16 of the second inner tubular member 21 communicates with the wire port portion 65 of the catheter hub 11.
An elastic adhesive 85 (elastic body) is disposed around the joint located at the port forming portion 66 of the second inner tubular member 21 and the catheter hub 11, and the second inner tubular member 21 is provided by the elastic adhesive 85. The catheter hub 11 is bonded. An elastic body may be arranged at a joint portion between the second inner tubular member 21 and the port forming portion 66 of the catheter hub 11, and these may be joined with an adhesive. As a result of the catheter 10 being bent by the bending of the catheter 10, even if the core wire 25 moves to the catheter hub 11 side, an elastic body is disposed between the core wire 25 and the catheter hub 11. Can relieve the pressing force by contacting the elastic body. Thereby, breakage of the catheter 10 can be prevented.

The gas passage hole 80 (lateral hole) of the catheter hub 11 is preferably disposed closer to the second inner tubular member 21 than the joint between the second inner tubular member 21 and the catheter hub 11. In the case of such an arrangement, the gas passage hole 80 (lateral hole) of the catheter hub 11 is located closer to the distal end side than the proximal end surface of the second inner tubular member 21. Thereby, the gas passage hole 80 is disposed closer to the proximal end portion of the catheter assembly 3 than the proximal end portion of the second outer tubular member 23, and the gas passage hole 80 is disposed away from the introduction portion of the catheter 10 into the body. it can.

The

core wires

25 a and 25 b protrude from the proximal end surface of the second outer tubular member 23 toward the proximal end side (catheter hub 11 side) of the catheter assembly 3, and a part of the

core wires

25 a and 25 b is in the surrounding space 74 of the catheter hub 11. Is located. In other words, the proximal end surfaces of the

core wires

25 a and 25 b are located closer to the proximal end portion side of the catheter assembly 3 than the distal end surface of the catheter hub 11. Specifically, the

core wires

25a and 25b protrude so as to overlap with the gas passage holes 80a and 80b, and the elastic adhesive 85 is located on the projection surface in the longitudinal direction.

The base end portion of the second outer tubular member 23 is fitted inside the distal end side wall portion 76 of the catheter hub 11, and the proximal end surface of the second outer tubular member 23 is in contact with the distal end surface of the proximal end side wall portion 75. ing.
There is a step between the outer surface of the second outer tubular member 23 and the outer surface of the distal end side wall portion 76, and an elastic adhesive 86 is disposed so as to fill the step. That is, the elastic adhesive 86 is disposed across the outer surface of the second outer tubular member 23 and the distal end surface of the distal end side wall 76, and the second outer tubular member 23 and the catheter hub 11 are joined by the elastic adhesive 86. ing.
The

elastic adhesives

85 and 86 are adhesives having elasticity, and a liquid elastic adhesive is solidified. The

elastic adhesives

85 and 86 are not particularly limited as long as they have elasticity and have an adhesive function. As the

elastic adhesives

85 and 86, for example, a urethane resin in which a urethane adhesive is solidified can be employed.

The joining of the second outer tubular member 23 and the catheter hub 11 is not limited to the

elastic adhesives

85 and 86, and various joining means such as general adhesive, fitting, and joining using a fixing member can be used.
The gas passage hole 80 (lateral hole) provided in the catheter hub 11 of the present embodiment can also be provided in the second outer tubular member 23. When the gas passage hole 80 (lateral hole) is provided in the second outer tubular member 23, it is preferably provided on the proximal end side. That is, it is preferable that the second outer tubular member 23 is provided at a position close to the base end portion.
Thereby, it is possible to prevent blood in the blood vessel 302 from entering the inter-tube space 50 from the gas passage hole 80 during the operation. If blood enters the inter-tube space 50, the blood may coagulate and the operability of the catheter 10 may be reduced.

Moreover, the gas passage hole 80 (lateral hole) may be provided in only one of the outer tubular member 23 or the catheter hub 11 or may be provided in both. When the gas passage hole 80 is provided in the outer tubular member 23, the gas passage hole is formed when the catheter 10 of the catheter assembly 3 is inserted into the protective tube 100 and the catheter assembly 3 is held by the hub holding portion 102 and the protective tube 100. 80 may be disposed inside the protective tube 100 or the hub holding portion 102. In that case, an opening is provided on the distal end side of the catheter 10 of the protective tube 100 or the hub holding portion 102, and the opening and the gas passage hole 80 of the catheter hub are communicated, whereby the sterilization gas 305 flows from the gas passage hole 80. Is possible. That is, in the state in which the protective tube 100 and the hub holding portion 102 are provided with through holes and the catheter assembly 3 and the posture fixing member 5 are stored in the storage body 2, the gas passage hole 80 communicates with the through hole and forms one You may arrange | position so that a communicating hole may be formed.
Alternatively, in the cross section perpendicular to the long axis of the catheter 10 (perpendicular cross section with respect to the longitudinal direction), the cross sectional shape of the catheter hub 11 is different from the cross sectional shape of the lumen of the protective tube 100 or the hub holding portion 102. By doing so, the sterilization gas 305 can be distributed from the gas passage hole 80. For example, in the cross section perpendicular to the long axis, the catheter hub 11 has a square cross section, and the hub holding section 102 has a circular cross section. The sterilization gas 305 can be circulated from the gas passage hole 80 without being blocked by the wall surface of the cavity.

As shown in FIG. 10, the protection member 62 is disposed across the distal end side wall portion 76 and the second outer tubular member 23 so as to cover the elastic adhesive 86. The protection member 62 has a proximal end abutting against the distal end surface of the flange portion 72, a protection-side engagement portion 82 is engaged with the locking portion 73, and is further bonded to the elastic adhesive 86. Therefore, the movement of the protective member 62 on the base end side is restricted by the flange portion 72, and the displacement in the longitudinal direction is prevented by the locking portion 73, and the second outer tubular member is further prevented by the elastic adhesive material 86. 23 and the catheter hub 11.

The inter-tube space 50 is sealed at the distal end and the proximal end. The inter-tube space 50 is closed on the distal end side and the proximal end side with respect to the gas passage hole 80. Specifically, the inter-tube space 50 is sealed at portions other than the gas passage holes 80a and 80b by the first outer tubular member 22, the second inner tubular member 21, the second outer tubular member 23, and the catheter hub 11. ing. The inter-tube space 50 is at least sealed at the tip side from the gas passage holes 80a and 80b.

The remaining part of the stored item 1 will be described.
As shown in FIG. 1, the posture fixing member 5 is a member that fixes the catheter assembly 3 in a predetermined posture, and includes a protective tube 100 (catheter protective portion) and tube fixing portions 101a to 101e as main components. is doing.
The protection tube 100 is a hollow body into which the catheter 10 can be inserted, and is a tube that protects the catheter 10 by inserting a part or all of the catheter 10 therein.
The protective tube 100 is made of resin and has a length that covers the entire catheter 10, and can be covered from the proximal end portion to the distal end portion of the catheter 10 in a state in which the stored item 1 is configured.

The tube fixing portions 101a to 101e are portions for fixing the intermediate portion of the protective tube 100 and fixing the protective tube 100 in a predetermined posture as can be seen from FIGS.
The tube fixing portions 101a to 101e of the present embodiment can be fixed in a posture in which the protective tube 100 extends in a spiral shape when seen in a plan view, and the radially parallel portions of the protective tube 100 can be fixed. ing.
Of the plurality of tube fixing portions 101a to 101e, one tube fixing portion 101a includes a hub holding portion 102.

As can be seen from FIGS. 1 and 3, the hub holding portion 102 is a portion that holds the catheter hub 11, and includes a hub insertion hole 103 into which the protective member 62 of the catheter hub 11 can be inserted.
The hub insertion hole 103 is a through hole extending in the extending direction of the protective tube 100, and the opening area gradually decreases in the insertion direction of the catheter 10 into the protective tube 100. That is, the hub insertion hole 103 has a tapered inner peripheral surface.

Subsequently, the positional relationship of each part of the stored item 1 will be described.

The stored item 1 is disposed in the storage body 2 in a state where the catheter assembly 3 is fixed to the posture fixing member 5.
In the catheter assembly 3, a part or all of the catheter 10 is inserted into the protective tube 100, and the catheter hub 11 is guided to the inner side surface of the hub insertion hole 103 of the hub holding portion 102 to enter the hub insertion hole 103. It is inserted.
In the present embodiment, the protective tube 100 covers the outer peripheral surface of the catheter 10 over the entire longitudinal direction of the catheter 10. A part of the catheter 10 may be exposed from the protective tube 100. For example, there may be a gap between the protective tube 100 and the hub holding portion 102, and a part of the catheter 10 may be exposed from the gap.
The protection tube 100 is bent in a spiral shape, and the distances between adjacent portions in the radial direction are evenly spaced by the tube fixing portions 101a to 101e.
The tube fixing portions 101a to 101e are arranged at predetermined intervals in the extending direction of the protective tube 100, and fix the intermediate portions of the protective tube 100, respectively.

Subsequently, an example of treatment using the catheter assembly 3 of the first embodiment will be briefly described.

As shown in FIG. 12A, the guide wire 200a for guidance is passed through the patient's blood vessel 302 in advance, and the proximal end portion of the guide wire 200a is inserted into the RX lumen 15 of the catheter assembly 3, The catheter 10 is inserted into the blood vessel 302 until the tip reaches the vicinity of the coronary artery stenosis 300. Then, as shown in FIG. 12B, when the distal end of the catheter 10 reaches the vicinity of the coronary artery stenosis 300, another guide wire 200b is inserted into the OTW lumen 16 from the communication hole 63 of the catheter hub 11, and the coronary artery stenosis is obtained. The penetration guide wire 200b is inserted to the vicinity of 300. Then, as shown in FIG. 12C, the occlusion portion 301 of the coronary artery stenosis portion 300 is shaved with the distal end portion of the guide wire 200b inserted into the OTW lumen 16, and the guide wire 200b removes the occlusion portion 301 of the coronary artery stenosis portion 300. When passing, the guide wire 200 a for guidance is left in the blood vessel 302, and the catheter 10 and the guide wire 200 b for penetration are pulled out from the blood vessel 302. Then, if necessary, a balloon catheter is inserted into the blood vessel 302 along the guide wire 200a, and the coronary artery stenosis 300 is expanded with the balloon.

Then, the sterilization method of the stored item 1 of 1st Embodiment is demonstrated.

As shown in FIG. 13, the stored item 1 is put in the sterilization chamber 201, the inside of the sterilization chamber 201 is depressurized, and the inter-tube space 50 in the catheter assembly 3 is set to a negative pressure with respect to the atmospheric pressure of the sterilization chamber 201. Then, the sterilization gas 305 is introduced into the sterilization chamber 201 to bring the sterilization chamber 201 into an atmosphere of the sterilization gas 305. By doing so, the sterilizing gas 305 passes through the permeable film 8 of the housing body 2 and enters the inter-tube space 50 from the gas passage hole 80 of the catheter assembly 3, and the air in the inter-tube space 50 becomes the sterilizing gas. Replaced with 305.
The sterilization gas 305 used here is not particularly limited as long as it can be sterilized. As the sterilization gas 305, for example, ethylene oxide gas, low-temperature steam formaldehyde gas, hydrogen peroxide gas, or the like can be employed.
After the sterilization by the above method, the sterilization gas 305 can be substantially removed from the inter-tube space 50 in the catheter assembly 3 by sucking the inside of the sterilization chamber 201 and reducing the pressure.

According to the storage 1 of the first embodiment, the inter-tube space 50 can be exposed to the sterilization gas 305 through the gas passage hole 80 in a state where the catheter assembly 3 is stored in the storage 2. Therefore, the catheter assembly 3 can be put in the storage body 2 and carried into the operating room in a state in which the space between the tubes 50 is sterilized.

According to the storage 1 of the first embodiment, the gas passage holes 80a and 80b of the catheter assembly 3 are located outside the hub holding portion 102 and are held in a state of being exposed from the hub holding portion 102. Therefore, the

gas holding holes

80a and 80b can be prevented from being blocked by the hub holding portion 102.

According to the stored item 1 of the first embodiment, the gas passage holes 80a and 80b are formed in the hub connection portion 61 located on the inner side with a step from the outer peripheral surface of the protective member 62. Therefore, when the protective member 62 is attached to the hub holding portion 102, the protective member 62 and / or the hub holding portion 102 is elastically deformed, and the openings of the gas passage holes 80a and 80b are covered by the hub holding portion 102. However, a step is generated in the inner and outer directions. As a result, it is possible to prevent the gas passage holes 80a and 80b from being blocked by the hub holding portion 102.

According to the catheter assembly 3 of the first embodiment, since the gas passage holes 80a and 80b are provided at positions facing each other with the second inner tubular member 21 interposed therebetween, one gas passage hole 80a is blocked by the installation surface. In addition, the sterilization gas 305 can be circulated from the other gas passage hole 80b.

According to the catheter assembly 3 of the first embodiment, since the diameters of the gas passage holes 80a and 80b are larger than the diameter of the core wire 25, the gas passage holes 80a and 80b can be prevented from being blocked by the core wire 25. .

According to the catheter assembly 3 of the first embodiment, the core wire 25 is a free end, and a part of the core wire 25 faces the gas passage hole 80 when the catheter 10 is bent. In the state where a part of the core wire 25 faces the gas passage hole 80, the area of the portion of the core wire 25 that faces the gas passage hole 80 is smaller than the area of the gas passage hole 80. Therefore, it is possible to prevent the core wires 25 from closing the 80a and 80b.

According to the catheter assembly 3 of the first embodiment, since the two

lumens

15 and 16 are provided and are independent of each other, the tangling of the

guide wires

200a and 200b in the

lumens

15 and 16 can be prevented.

In the above-described embodiment, the two-

axis lumens

15 and 16 extending in parallel are provided, but the present invention is not limited to this. The catheter may have one lumen or may have more than two lumens.

In the above-described embodiment, the gas passage hole 80 is formed in the hub body 60 of the catheter hub 11. However, if the portion where the gas passage hole 80 is formed is a portion that is not used for surgery, the present invention is not limited thereto. It is not limited. For example, the gas passage hole 80 may be provided in the second outer tubular member 23. In this case, it is preferable to provide the gas passage hole 80 in a range within 20 cm from the proximal end portion of the second outer tubular member 23. Within this range, even when the gas passage hole 80 is used outside the blood vessel 302, the distance from the hand to the blood vessel does not become too far, and the operability is unlikely to deteriorate.

In the above-described embodiment, the case where the catheter hub 11 is provided with the two gas passage holes 80a and 80b is illustrated, but the present invention is not limited to this. The number of gas passage holes 80a and 80b is not particularly limited. There may be one gas passage hole 80 or three or more.

In the above-described embodiment, the gas passage holes 80a and 80b are circular holes, but the present invention is not limited to this. The opening shape of the gas passage holes 80a and 80b is not particularly limited. Polygonal shape may be sufficient and elliptical shape may be sufficient. It may be a long hole or a groove.

In the above-described embodiment, the sterilization gas 305 can be circulated in and out of the storage body 2 by using one side of the storage body 2 as a gas permeable film, but the present invention is not limited to this. Both surfaces of the storage body 2 may be gas permeable films, or gas introduction holes may be provided in part.

In the above-described embodiment, the cross-sectional shape includes the

lumens

15 and 16 having a circular shape or an elliptical shape, but the present invention is not limited to this. The cross-sectional shapes of the

lumens

15 and 16 may be polygonal shapes, semicircular shapes, semielliptical shapes, or the like.

In the above-described embodiment, the gas passage holes 80a and 80b are arranged at the same position in the longitudinal direction X, but the present invention is not limited to this. The gas passage holes 80a and 80b may be shifted in the longitudinal direction X.

In the above-described embodiment, the case where the catheter assembly 3 is used to penetrate the guide wire 200b for penetration through the occlusion portion 301 of the coronary artery stenosis portion 300 has been described, but the present invention is not limited thereto. The catheter assembly 3 can be used in other applications. For example, the catheter assembly 3 may be used when the guide wire 200 is inserted into a side branch having a small angle at a branch portion where the blood vessel 302 branches into a plurality of portions, or the guide wire 200 is inserted between stent struts. May be used in some cases.

In the above-described embodiment, the case where the catheter assembly 3 is used with the gas passage holes 80a and 80b opened after the inter-tube space 50 is sterilized with the sterilizing gas 305 has been described, but the present invention is limited to this. It is not a thing. After sterilization, the gas passage holes 80a and 80b may be closed with other members.

As long as the above-described embodiments are included in the technical scope of the present invention, each constituent member can be freely replaced or added between the embodiments.

DESCRIPTION OF SYMBOLS 1 Storage object 2 Storage body 3 Catheter assembly 5 Posture fixing member 8 Film 10 Catheter 11 Catheter hub 15 RX lumen 16 OTW lumen 21 2nd inner tubular member (inner tubular member)
23 Second outer tubular member (outer tubular member)
25, 25a, 25b Core wire 31 Base end side shaft portion 36 Second lumen region 36 (lumen region)
50 Space between pipes 72 Flange (projection)
80, 80a, 80b Gas passage hole (horizontal hole)
85 Elastic adhesive (elastic body)
100 Protection tube (catheter protection part)
101a to 101e Tube fixing part 102

Hub holding part

200, 200a, 200b Guide wire

Claims

A catheter hub and a catheter;
The catheter hub has a communication hole,
The catheter has one or more inner tubular members that constitute a lumen in an outer tubular member that constitutes an outer shell,
Between the inner tubular member and the outer tubular member, an intertube space exists,
The communication hole of the catheter hub communicates with the lumen of the inner tubular member;
The proximal end portion and the distal end portion of the outer tubular member are closed,
A catheter assembly comprising a lateral hole in the catheter hub and / or the outer tubular member, and the inter-tube space communicates with the outside through the lateral hole.
The catheter hub and the inner tubular member are joined,
2. The catheter assembly according to claim 1, wherein the lateral hole is disposed on the inner tubular member side of a joint portion of the catheter hub with the inner tubular member.
There is a core wire in the inter-tube space,
The catheter assembly according to claim 1 or 2, wherein a minimum inclusion circle diameter of the lateral hole is larger than a maximum non-inclusion circle diameter of the core wire.
The catheter assembly according to any one of claims 1 to 3, wherein at least two of the lateral holes are provided.
The catheter assembly according to claim 4, wherein the two lateral holes are arranged at positions shifted in the circumferential direction.
The catheter hub has a protrusion protruding in a direction perpendicular to the longitudinal direction,
The said horizontal hole is a base end part side rather than the said protrusion part, Comprising: The said orthogonal hole is formed in the inner side rather than the edge part of the said protrusion part in the said orthogonal direction. The catheter assembly according to Item.
The catheter assembly according to any one of claims 1 to 6, wherein the inter-tube space is hermetically sealed at a portion closer to the tip than the lateral hole.
There is a core wire in the inter-tube space,
The catheter assembly according to any one of claims 1 to 7, wherein the core wire protrudes from the proximal end portion of the catheter into the catheter hub.
There is a core wire in the space between the tubes,
The proximal end of the outer tubular member is occluded by the catheter hub;
The catheter assembly according to any one of claims 1 to 8, wherein an elastic body is disposed between the core wire and the catheter hub.
The catheter comprises a lumen region comprising at least two lumens;
The catheter inner assembly according to any one of claims 1 to 9, wherein the inner tubular member constitutes one of the two lumens.
The catheter assembly according to any one of claims 1 to 10, a posture fixing member that fixes the catheter assembly in a predetermined posture, and a storage body that stores the catheter assembly and the posture fixing member therein. Have
The posture fixing member has a catheter protection part for protecting the catheter, and a hub holding part for holding the catheter hub,
The container is in a bag shape, and in a closed state, the sterilization gas can be distributed inside and outside,
The stored article, wherein the catheter assembly is fixed to the posture fixing member, and the lateral hole is exposed from the hub holding portion.