JP2020000263A - Catheter assembly body and stored article - Google Patents

Abstract

To provide a catheter assembly body having a double pipe structure capable of performing sterilization treatment on an inter-pipe space and its stored article.SOLUTION: A catheter hub 11 and a catheter 10 are provided, wherein the catheter hub 11 has a continuous hole 63, the catheter 10 has a second inner tubular member 21 constituting an OTW lumen 16 within a second outer tubular member 23 that forms an outline, an inter-tube space 50 exists between the second inner tubular member 21 and the second outer tubular member 23, the continuous hole 63 of the catheter hub 11 communicates with the second inner tubular member 21, the base end part of the second outer tubular member 23 is blocked, a gas passage hole 80 is opened in the catheter hub 11, and the inter-tube space 50 communicates with the outside via the gas passage hole 80.SELECTED DRAWING: Figure 10

Description

  TECHNICAL FIELD The present invention relates to a catheter assembly and a storage item storing the catheter assembly.

  As a method to reduce ischemic heart disease (angina pectoris, myocardial infarction, etc.), a balloon catheter is inserted into the blood vessel from the patient's arm or base of the thigh, passes through the blood vessel, and reaches the coronary artery of the heart There is a method in which a portion of the blood vessel (coronary artery stenosis) that is narrowed due to arteriosclerosis is expanded with a balloon.

  By the way, in the case of a chronic complete occlusion where the coronary artery stenosis is completely occluded due to arteriosclerosis, the passage of the guide wire to the coronary artery stenosis becomes difficult because the coronary artery stenosis is blocked by the occlusion. The balloon catheter cannot be guided to the coronary stenosis along the wire. Therefore, conventionally, before inserting the balloon catheter into the coronary artery stenosis, a 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. Thus, the closed portion of the coronary artery stenosis is penetrated so that 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 a guide wire to remove clogging of a coronary artery stenosis. Therefore, improvement in operability of the guide wire is desired.
Therefore, the coronary artery penetration catheter disclosed in Patent Document 1 has a structure in which a proximal shaft is provided in a coaxial double tube 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. Has taken. Patent Literature 1 states that such a structure makes kink less likely to occur and improves the operability of the guide wire.

WO 2006/1266642

  By the way, in the medical field, especially in the operating room, even a small amount of bacteria may cause an infection to the patient. Therefore, the surgical instrument is used after being exposed to a sterilizing gas (for example, EOG or ethylene oxide gas) in advance.

  However, in the coronary artery penetration catheter disclosed in Patent Document 1, even if the catheter is exposed to the sterilizing gas, the sterilizing gas does not spread throughout the intervascular space because the space between the outer tube and the inner tube is sealed. Sterilization does not kill bacteria contaminated during production.

  Although the catheter does not break in principle, the outer tube or the 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 exist in the intertube space between the inner tube and the outer tube, the bacteria in the intertube space may migrate into the patient's body, and in the worst case, cause complications to the patient.

  Therefore, the present invention provides an assembly of a catheter having a double-tube structure and its storage, which can easily sterilize the space between tubes and its storage. The task is to

The present invention for solving the above-mentioned problems relates to the following (1) to (11).
(1) A catheter assembly having a catheter hub and a catheter, wherein the catheter hub has a communication hole, and the catheter has one or a plurality of inner tubular members forming a lumen in an outer tubular member forming an outer shell. There is an intertube space between the inner tubular member and the outer tubular member, the communication hole of the catheter hub communicates with the inner tubular member, and a proximal end and a distal end of the outer tubular member. A catheter assembly wherein the portion is occluded and the catheter hub and / or the outer tubular member has a lateral hole, the lateral hole communicating the intervascular space with the outside. .

  According to the configuration of the present invention, the proximal end and the distal end of the outer tubular member are closed, and the inter-tube space is a space in which the distal end and the proximal end are closed. According to the configuration of the present invention, since the space between the tubes is communicated with the outside by the horizontal hole, the space between the pipes can be installed in a sterilizing gas atmosphere or the sterilizing gas can be directly introduced from the horizontal hole. In addition, the space between the tubes can be easily exposed to the sterilizing gas, and the bacteria in the space between the tubes can be substantially killed. Therefore, even if the catheter is broken in the blood vessel of the patient, bacteria can be prevented from being mixed with blood and causing complications.

(2) In the catheter assembly of the present invention, the catheter hub and the inner tubular member are joined, and the lateral hole is closer to the inner tubular member than a joint portion of the catheter hub with the inner tubular member. Preferably, they are arranged.

  According to the configuration of the present invention, it is possible to dispose the lateral hole away from the introduction portion of the catheter into the body, so that it is possible to prevent blood from entering the lateral hole and lowering the operability.

(3) In the catheter assembly of the present invention, a core wire is preferably provided in the inter-tube space, and a circumscribed circle diameter of the lateral hole is preferably larger than an inscribed circle diameter of the core wire.

Here, the “circumscribed circle diameter” refers to the diameter of the virtual circumscribed circle. That is, the “circumscribed circle diameter of the horizontal hole” refers to the diameter of a virtual circumscribed circle with respect to the opening of the horizontal hole.
The “inscribed circle diameter” here refers to the diameter of the virtual inscribed circle. That is, the “inscribed circle diameter of the core wire” refers to the diameter of a virtual inscribed circle with respect to the outer shape of the cross section at a specific position of the core wire.

  According to the configuration of the present invention, even if the core wire overlaps the horizontal hole and blocks a part of the horizontal hole, a portion opened from the core wire can be secured in the horizontal hole, and the opening for introducing the sterilizing gas is provided. Can be maintained.

  In the above invention, a part of the core wire takes a state facing the lateral hole, and in a state facing the lateral hole, an area of a portion of the core wire facing the lateral hole is: Preferably, the area is smaller than the area of the lateral hole.

(4) The catheter assembly of the present invention is preferably provided with at least two lateral holes.

  According to the configuration of the present invention, since at least two horizontal holes are provided, the horizontal holes are not easily blocked.

(5) In the catheter assembly of the present invention, it is preferable that the two lateral holes are arranged at positions shifted in a circumferential direction.

  According to the configuration of the present invention, depending on the installation posture, even if one of the horizontal holes is blocked by the installation surface, the other horizontal hole can be opened, so that the sterilization gas introduction path is secured during sterilization. it can.

(6) In the catheter assembly of the present invention, the catheter hub has a protruding portion projecting in a direction perpendicular to the longitudinal direction, and the lateral hole is closer to the base end than the protruding portion, and is in the orthogonal direction. Is preferably formed inside the end of the protrusion.

  According to the configuration of the present invention, even when the covering material covers the lateral hole and the protruding portion, the protruding portion forms a step in the inward and outward directions, so that the lateral hole is not easily closed.

(7) In the catheter assembly of the present invention, it is preferable that a portion of the inter-tube space closer to the distal end than the lateral hole is sealed.

  According to the present invention, since the intervascular space is not substantially exposed to the blood vessel, blood does not enter the intervascular space.

(8) In the catheter assembly of the present invention, it is preferable that a core wire is provided in the inter-tube space, and the core wire projects from the proximal end of the catheter to the inside of the catheter hub.

  According to the configuration of the present invention, since the core wire extends to the inside of the catheter hub, the hand is hardly bent and the operation is easy.

(9) In the catheter assembly of the present invention, a core wire is provided in the inter-tube space, and a proximal end of the outer tubular member is closed by the catheter hub. It is preferable that an elastic body is disposed between them.

  According to the configuration of the present invention, when the catheter is bent by bending, even if the core wire moves to the proximal end side, since the elastic body is arranged between the core wire and the catheter hub, It is possible to reduce the pressing force from the core wire on the catheter hub.

(10) In the catheter assembly of the present invention, the catheter includes a lumen region including at least two lumens, and the inner tubular member constitutes one of the two lumens. Is preferred.

  According to the configuration of the present invention, since a plurality of lumens are provided, a guide wire can be easily passed through a blood vessel.

(11) The container according to the present invention includes the catheter assembly according to any one of (1) to (10), a posture fixing member that fixes the catheter assembly in a predetermined posture, and the catheter assembly. A storage body for storing the body and the posture fixing member therein, wherein the posture fixing member has a catheter protection portion for protecting the catheter, and a hub holding portion for holding the catheter hub; In the closed state, the sterilizing gas can flow inside and outside the closed state, and the catheter assembly is fixed to the posture fixing member, and the lateral hole holds the hub. It is a storage thing characterized by being exposed from a part.

  According to the configuration of the present invention, since the space between the tubes can be exposed to the sterilizing gas in a state in which the assembly of the catheter is housed, it can be carried into an operating room or the like in a state with extremely little bacteria.

  ADVANTAGE OF THE INVENTION According to the assembly and storage of the catheter of this invention, a sterilization process can be easily performed with respect to the space between pipes.

It is a perspective view of a storage thing in a 1st embodiment of the present invention. FIG. 2 is a cross-sectional perspective view of the housing of FIG. 1. It is a perspective view showing the state where a part of catheter assembly in a 1st embodiment of the present invention was pulled out from a posture fixing member. FIG. 4 is a perspective view of the catheter assembly of FIG. FIG. 5 is an enlarged view of a distal shaft portion of the catheter assembly of FIG. 4. FIG. 6 is a cross-sectional perspective view of a distal shaft portion of FIG. 5. FIG. 5 is a longitudinal sectional view of a distal shaft portion of FIG. 4. FIG. 5 is a partially broken perspective view of a proximal shaft portion of FIG. 4. FIG. 5 is a sectional perspective view of a proximal shaft portion of FIG. 4. It is sectional drawing of the base end side shaft part of FIG. 4, (a) is a longitudinal cross-sectional view, (b) is AA sectional drawing of (a). FIG. 5 is an enlarged view of a main part of the catheter hub of FIG. 4, with a protection member omitted. It is explanatory drawing showing an example of the treatment method using the catheter assembly of FIG. 4, (a) is a conceptual diagram which passed the guide wire near the obstruction part of a blood vessel, (b) is a catheter along a guide wire. FIG. 2 is a conceptual diagram showing a state in which a closed portion of a blood vessel is cut by a guide wire using a lumen of a catheter. It is a conceptual diagram which shows the state at the time of performing a sterilization process using the storage 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 defined as a proximal end (hand side), and the distal end side of the catheter 10 is defined as a distal end side.

  As shown in FIG. 1, the container 1 of the first embodiment of the present invention mainly contains a catheter assembly 3 and a posture fixing member 5 in a container 2, and contains sterilizing gas. One of the features is that the catheter assembly 3 inside can be sterilized by exposure to an atmosphere.

As can be seen from FIGS. 1 and 2, the storage body 2 is a bag-shaped member, and includes a storage space 6 capable of storing the catheter assembly 3 and the posture fixing member 5. The sterilization gas can be circulated between them.
In the storage body 2 of the present embodiment, two films 7 and 8 are adhered along an edge to form a storage space 6.
The film 7 forming one surface of the housing 2 is formed of a gas impermeable film that does not pass a sterilizing gas, and the film 8 forming the other surface is a gas passing film that passes a sterilizing gas. Is formed. Therefore, the storage body 2 can pass a sterilizing gas into the storage space 6 from the outside via the film 8. Both films 7, 8 may be gas passing films.

As shown in FIG. 12, the catheter assembly 3 is inserted into a patient's blood vessel along a guide wire 200a arranged in advance in the patient's blood vessel, and a guide wire is inserted into an obstruction where an obstruction in the blood vessel is clogged. 200b.
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, and is a catheter for improving the operability of the guidewire 200 (200a, 200b) in the coronary artery stenosis part and for penetrating the guidewire 200 in the occlusion part of the coronary artery stenosis part. .
As can be seen from FIGS. 5 and 7, the catheter 10 of the present embodiment includes a rapid exchange lumen 15 (hereinafter, also referred to as an RX lumen 15) and an over-the-wire lumen 16 (hereinafter, also referred to as an OTW lumen 16). It is a lumen member axial type penetration catheter.

The RX lumen 15 is a guide wire lumen for introducing the catheter 10 into a blood vessel of a patient along a guide wire 200a arranged in advance.
The OTW lumen 16 is a guide wire lumen for introducing the guide wire 200b into the coronary artery stenosis along the catheter 10. In addition to the guide wire 200b, a drug can be injected.

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 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, and one or more Core wire 25 is provided.

As can be seen from FIGS. 5 and 7, the first inner tubular member 20 is a tube having the RX lumen 15 as an internal space and through which the guide wire 200a can be inserted.
The first inner tubular member 20 is a resin tube having a tubular shape, a substantially circular or polygonal cross section, and being elastically deformable.

As can be seen from FIGS. 5 and 7, the second inner tubular member 21 is a tube having the OTW lumen 16 as an internal space, and through which the guide wire 200b can be inserted.
The second inner tubular member 21 is a resin tube having a tubular shape, a substantially circular or polygonal cross section, and being elastically deformable.
The second inner tubular member 21 of the present embodiment is an inner tubular member that forms the OTW lumen 16 and is joined to the catheter hub 10.
As shown in FIG. 10, the second inner tubular member 21 has an enlarged diameter portion 27 that is enlarged at the base end of the OTW lumen 16 with respect to other portions.
The enlarged diameter portion 27 is a space that forms a part of the OTW lumen 16 and communicates 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 molded body forming a part of the outer shell of the catheter 10.
The first outer tubular member 22 covers the outer periphery of the inner tubular members 20 and 21 and integrates the inner tubular members 20 and 21. That is, the first outer tubular member 22 has 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 mounting holes for mounting the inner tubular members 20 and 21.
The material of the inner tubular members 20, 21 and the material of the outer tubular member 22 may be integrated without interposing the insertion holes 28, 29.
The number of insertion holes can be selected according to the number of inner tubular members. Also, a plurality of inner tubular members may be inserted into one insertion hole to be integrated.
The outer tubular member 22 and the inner tubular members 20, 21 can be integrated by heat welding, bonding, or the like.

As shown in FIG. 7, the first outer tubular member 22 has 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 while imaging the inside of the blood vessel of the patient using radiation such as X-rays. Specifically, the radiation marker 26 is a radiopaque marker that is hard to transmit radiation during radiography of X-rays or the like, and in the present embodiment, is a radiopaque marker.

The second outer tubular member 23 is a resin tube that forms an outer shell of the catheter 10 together with the first outer tubular member 22.
As shown in FIG. 8, the second outer tubular member 23 has a space that can pass through a part of the second inner tubular member 21, and is formed so as to surround the periphery. The rigidity of the second outer tubular member 23 decreases from the base end toward the distal end, and the second outer tubular member 23 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 disposed so as to support the catheter 10 within the inter-tube space 50 over substantially the entire length of the inter-tube space 50.
The core wire 25 is a wire having a circular or polygonal cross-sectional shape, and may have a length in the longitudinal direction shorter than the length of the intertube space 50.
The core wire 25 has a reduced rigidity continuously or intermittently from the base end side toward the distal end side, and is easily bent. The core wire 25 can reduce the cross-sectional area from the base end side to the distal end side, or can decrease the 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 base end side toward the distal end side, and the distal end side is more easily elastically deformed than the base end side.

  The material of the core wire 25 is not particularly limited as long as it has appropriate elasticity. As a material of the core wire 25, for example, a metal material such as stainless steel, nickel titanium, and cobalt chrome can be adopted.

As shown in FIG. 7, the catheter 10 is roughly divided into a longitudinal direction (axial direction X) and includes a distal shaft portion 30 and a proximal shaft portion 31.
The distal side shaft portion 30 is a portion on the distal side from a portion including both the RX lumen 15 and the OTW lumen 16.
In the distal side shaft portion 30, the distal end portion of the first inner tubular member 20 projects more distally than the distal end portion of the second inner tubular member 21, and a first lumen region 35 to which only the RX lumen 15 belongs, and an RX lumen There is a second lumen region 36 (lumen region) to which both the 15 and the OTW lumen 16 belong.
In the first lumen region 35, at least one radiation marker 26 (26a, 26b) is provided on the inner peripheral surface of the first outer tubular member 22, and also in the second lumen region 36, the first outer tubular member 22 is provided. At least one radiation marker 26 (26c, 26d) is provided on the inner peripheral surface of the. 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 surrounding the first inner tubular member 20.

The proximal shaft portion 31 is closer to the proximal end (hand side) than the distal shaft portion 30 and occupies most of the catheter 10. The proximal shaft portion 31 preferably occupies 80% or more and 90% or less of the entire length of the catheter 10.
As shown in FIG. 8, the proximal side shaft portion 31 has the second inner tubular member 21 passing through the inside of the second outer tubular member 23, and has a second outer tubular member around the second inner tubular member 21. A member 23 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.
One or a plurality of core wires 25 (25a, 25b) are arranged in the inter-tube space 50. In the catheter 10 of the present embodiment, two core wires 25a and 25b are arranged in the space 50 between tubes.
The core wires 25a and 25b are arranged at predetermined intervals around the second inner tubular member 21, and the distal ends of the core wires 25a and 25b are inserted and fixed to the base end surface of the first outer tubular member 22. That is, the core wires 25a and 25b have cantilevered distal ends supported by the first outer tubular member 22 and have free proximal ends. Therefore, when the catheter 10 is bent and bent, the ends of the core wires 25a and 25b can move in the axial direction X.

As shown in FIG. 7, the second inner tubular member 21 is disposed across the distal shaft portion 30 and the proximal shaft portion 31.
On the distal end side of the proximal shaft portion 31, the distal end of the second outer tubular member 23 is connected to the proximal end of the first outer tubular member 22 and is closed. That is, the space 50 between the pipes is closed at the distal end.
On the proximal side (hand side) of the proximal side shaft portion 31, as shown in FIG. 10, the proximal end of the second inner tubular member 21 moves from the proximal end of the second outer tubular member 23 to the proximal side. The base ends of the core wires 25a, 25b also protrude from the base end of the second outer tubular member 23 to the base end side. That is, the base end surface of the second inner tubular member 21 is located closer to the base end than the base end surface of the second outer tubular member 23.

  The catheter hub 11 is joined to the second inner tubular member 21 of the catheter 10 and is a member for introducing the guide wire 200b into the OTW lumen 16 of the second inner tubular member 21. As shown in FIG. A main body 60, a hub connection 61, and a protection member 62 are provided.

The hub main body 60 has a communication hole 63 that communicates 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 having a wire port 65 therein, and is a through hole penetrating in the axial direction X of the hub body 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 in which a base end portion (hand side portion) is opened and guides the guide wire 200b to the OTW lumen 16 side.
In the wire port portion 65, the space area decreases from the base end side toward the tip end side, and the communication hole 63 forming the outer periphery also has a smaller opening area on the tip end side than the opening area on the base end side. I have.
The wire port portion 65 of the present embodiment has a gradually decreasing space area in a part thereof from the base end side toward the distal end side, and a gradually increasing sectional area in a part of the communication hole 63 from the base end side to the distal end side. is decreasing.

The hub main body 60 includes a port forming portion 66 and wings 67 and 68 as can be read from FIG.
The port forming part 66 is a part provided with the wire port part 65 therein, and has a part whose outer shape is substantially conical. The outer peripheral surface of the port forming portion 66 has a tapered surface in the conical portion, and the diameter thereof is reduced from the base end toward the distal end.

The port forming portion 66 includes a mounting portion 70 near the base end for mounting to another instrument or the like.
The mounting portion 70 is formed in a spiral shape on the outer peripheral surface of the port forming portion 66, is a convex ridge protruding outward from the outer peripheral surface, and can be screwed with another instrument or the like.
As shown in FIG. 11, the wing portions 67 and 68 are projecting portions that project outward from the port forming portion 66 in both radial directions (inward and outward directions), and are also gripping portions that can be gripped by a practitioner.

The hub connection portion 61 is a portion of the catheter hub 10 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 (projection portion), A locking portion 73 is provided.
As shown in FIG. 11, the connection wall portion 71 is a peripheral wall portion rising 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 forms a surrounding space 74.
The surrounding space 74 is a space that is continuous with the wire port portion 65 and that opens toward the distal end.

  The connection wall 71 of the catheter hub 10 includes a proximal side wall 75 and a distal side wall 76 located on the distal side (the side of the catheter 10) with respect to the proximal side wall 75. The base end 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 stands upright from the distal end surface of the port forming portion 66.

As shown in FIG. 10, the proximal side wall portion 75 of the catheter hub 10 has at least two gas passage holes 80 (80a, 80b) (lateral holes). The number of the gas passage holes 80 as the horizontal holes may be one, but is preferably plural. By having a plurality of gas passage holes 80, gas permeability is improved, and even when some of the gas passage holes 80 are closed, sterilization gas is supplied from other gas passage holes 80. It can be introduced or discharged into the interspace 50.
The gas passage hole 80 is a lateral hole formed in the outer peripheral surface of the base end wall portion 75 and is a through hole penetrating the base end wall portion 75 in the thickness direction (radial direction). The gas passage hole 80 allows a sterilizing gas to flow therethrough.
The gas passage hole 80 is a circular hole, and the circumscribed circle diameter of the gas passage holes 80a and 80b 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 to 1.5 times the circumscribed circle diameter of the core wire 25. Even when the core wire 25 and the gas passage hole 80 overlap, the opening can be maintained without the core wire 25 completely blocking the gas passage hole 80.
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 is preferably arranged at a position shifted in the circumferential direction. In the present embodiment, the gas passage holes 80a and 80b are arranged on a straight line in a 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 face each other with the second inner tubular member 21 interposed therebetween. Here, the “position shifted in the circumferential direction” means a position on the same circumference that does not overlap.

The distal side wall portion 76 of the catheter hub 10 is a wall portion that is annularly continuous along the distal end edge of the proximal side wall portion 75 and is a wall portion that stands upright from the distal end surface of the proximal side wall portion 75.
The inner peripheral surface of the distal side wall portion 76 is stepwise connected to the inner peripheral surface of the proximal side wall portion 75 via the distal end surface of the proximal side wall portion 75.

The flange portion 72 is a portion that restricts the movement of the protection member 62 to the proximal end side.
The flange portion 72 is a flange that protrudes outward from the distal end portion of the proximal end side wall portion 75 or its vicinity, and extends in the circumferential direction. That is, the base end wall portion 75 has a step in the radial direction (inward and outward directions) with respect to the protruding end surface of the flange portion 72, and is located inside the protruding end surface of the flange portion 72.
The gas passage hole 80 (lateral hole) is preferably provided on the base end side of the flange 72 (projection). It is preferable to be formed inside the end of the flange 72 in the projecting direction of the flange 72, that is, in the direction orthogonal to the axial direction X of the catheter 10.

The locking portion 73 is a portion for locking the movement of the protection member 62 in the longitudinal direction (axial direction X).
The locking portion 73 is a protruding strip that protrudes outward from an intermediate portion in the longitudinal direction of the distal end side wall portion 76, and extends in the circumferential direction.
The “intermediate portion” here refers to a portion other than the end portion.

  It is preferable that the hub main body 60 and the hub connecting part 61 are formed of a transparent resin such as a styrene-butadiene copolymer from the viewpoint of securing 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 is a member that functions as a strain relief. The protection member 62 is elastically deformable, has a cylindrical shape, and tapers from a base end toward a tip end.
As shown in FIG. 10, the protection member 62 includes a protection-side engagement portion 82 at a base end.
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, and is a portion that can be engaged with the locking portion 73 of the catheter hub 11.

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

6, the inner tubular members 20 and 21 are inserted into the insertion holes 28 and 29 of the first outer tubular member 22 without gaps.
The radiation markers 26 a and 26 b are provided in the insertion holes 28 and are located on the distal end side of the distal end surface of the second inner tubular member 21. The radiation markers 26c and 26d are provided in the insertion holes 28 and are located on the proximal side from the distal end surface of the second inner tubular member 21.

As shown in FIG. 10, in the proximal shaft portion 31, the second inner tubular member 21 is disposed in the second outer tubular member 23, and the core wires 25 a and 25 b are disposed in the inter-tube space 50. .
The proximal end of the second inner tubular member 21 is inserted into the surrounding space 74 of the catheter hub 11. The proximal end of the second inner tubular member 21 and the distal end 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. Has become.
An elastic adhesive 85 (elastic body) is disposed around the joint located between the second inner tubular member 21 and the port forming portion 66 of the catheter hub 10. And the catheter hub 11 are adhered. An elastic body may be arranged at the joint 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. Even if the core wire 25 moves toward the catheter hub 10 as a result of the catheter 10 being bent due to the bending of the catheter 10, since the elastic body is disposed between the core wire 25 and the catheter hub 11, the core wire 25 Can contact the elastic body to reduce the pressing force. Thereby, breakage of the catheter 10 can be prevented.

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

  The core wires 25 a and 25 b project from the base end surface of the second outer tubular member 23 to the base end side (the side of the catheter hub 11), and a part thereof is located in the surrounding space 74 of the catheter hub 10. In other words, the proximal end surfaces of the core wires 25a and 25b are located more proximally than the distal end surface of the catheter hub 10. More specifically, the core wires 25a, 25b protrude to the extent that they overlap the gas passage holes 80a, 80b, and the elastic adhesive 85 is located on the projection plane in the longitudinal direction.

The proximal end of the second outer tubular member 23 is fitted inside the distal sidewall 76 of the catheter hub 10, and the proximal surface of the second outer tubular member 23 contacts the distal surface of the proximal sidewall 75. ing.
There is a step between the outer surface of the second outer tubular member 23 and the outer surface of the tip side wall portion 76, and the elastic adhesive 86 is arranged to fill the step. That is, the elastic adhesive 86 is disposed over the outer surface of the second outer tubular member 23 and the distal end surface of the distal side wall 76, and the second outer tubular member 23 and the catheter hub 11 are joined by the elastic adhesive 86. ing.
The above-mentioned elastic adhesives 85 and 86 are adhesives having elasticity, and are solidified liquid elastic adhesives. The elastic adhesives 85 and 86 are not particularly limited as long as they have elasticity and an adhesive function. As the elastic adhesives 85 and 86, for example, urethane resin in which a urethane adhesive is solidified can be used.

The joining between 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 an adhesive in general, 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 preferable to provide the gas passage hole 80 on the base end side. That is, it is preferable to provide it at a position near the base end.
Thereby, it is possible to prevent blood from entering the intertube space 50 from the gas passage hole 80 during the operation. When blood enters the intertube space 50, the blood may coagulate and the operability of the catheter 10 may be reduced.

  The protection member 62 is disposed so as to cover the elastic adhesive material 86 and straddle the distal end side wall portion 76 and the second outer tubular member 23. The protection member 62 has its base end in contact with the distal end surface of the flange 72, the protection-side engagement portion 82 engages with the locking portion 73, and is further adhered to the elastic adhesive 86. Therefore, the movement of the protection member 62 on the proximal end side is restricted by the flange portion 72, the displacement in the longitudinal direction is prevented by the locking portion 73, and the second outer tubular member 23 is further protected by the elastic adhesive 86. And the catheter hub 11.

  The space 50 between the pipes is sealed at the distal end and also at the proximal end. Specifically, in the inter-tube space 50, portions other than the gas passage holes 80a and 80b are sealed 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. That is, the space between the pipes 50 is at least hermetically sealed at a portion closer to the distal end than the gas passage holes 80a and 80b.

The remaining part of the storage 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 protection tube 100 (catheter protection unit) and tube fixing units 101a to 101e as main components. have.
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 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. The protective tube 100 can cover from the base end to the distal end of the catheter 10 in a state where the storage article 1 is configured.

The tube fixing portions 101a to 101e are portions that fix the intermediate portion of the protection tube 100 and fix the protection tube 100 in a predetermined posture, as can be seen from FIGS.
The tube fixing portions 101a to 101e of the present embodiment can fix the protection tube 100 in a helically extending posture when viewed in a plan view, and can fix radially parallel portions of the protection tube 100. ing.
One of the tube fixing portions 101a to 101e has 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 has a hub insertion hole 103 into which the protection member 62 of the catheter hub 11 can be inserted.
The hub insertion hole 103 is a through hole extending in the direction in which the protection tube 100 extends, and has an opening area gradually decreasing in the direction in which the catheter 10 is inserted into the protection tube 100. That is, the inner peripheral surface of the hub insertion hole 103 is a tapered surface.

  Next, the positional relationship between the respective parts of the storage 1 will be described.

The container 1 is disposed in a container 2 with the catheter assembly 3 fixed to the posture fixing member 5.
In the catheter assembly 3, 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 and inserted into the hub insertion hole 103. .
The protective tube 100 is spirally bent, and the distance between the radially adjacent portions is made equal 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 protection tube 100, and fix the intermediate portions of the protection tube 100, respectively.

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

  As shown in FIG. 12A, a guide wire 200a is passed through a blood vessel of a patient in advance, the proximal end of the guide wire 200a is inserted into the RX lumen 15, and the distal end of the catheter 10 is placed near the coronary artery stenosis. Until the catheter 10 is reached. Then, as shown in FIG. 12B, when the distal end of the catheter 10 reaches the vicinity of the coronary artery stenosis, 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. Insert the guide wire 200b to the vicinity. Then, as shown in FIG. 12 (c), the occlusion of the coronary artery stenosis is cut with the guide wire 200b inserted into the OTW lumen 16, and when the guide wire 200b passes through the occlusion of the coronary artery stenosis, the guide With the wire 200b left, the catheter 10 and the guide wire 200a are withdrawn from the blood vessel.

  Next, a method of sterilizing the stored matter 1 according to the first embodiment will be described.

As shown in FIG. 13, the container 1 is placed in the sterilization chamber 201, the pressure in the sterilization chamber 201 is reduced, and the inter-tube space 50 in the catheter assembly 3 is set to a negative pressure. Then, a sterilizing gas is introduced into the sterilizing chamber 201 to bring the inside of the sterilizing chamber 201 into a sterilizing gas atmosphere. The gas enters the inter-tube space 50 through the gas passage hole 80, and the inside of the inter-tube space 50 is replaced with a sterilizing gas.
The sterilizing gas used here is not particularly limited as long as it can be subjected to a sterilization treatment. As the sterilizing gas, for example, ethylene oxide gas or the like can be adopted.
After sterilization by the above method, the pressure in the sterilization chamber 201 is reduced, so that the sterilizing gas can be removed from the intertube space 50 in the catheter assembly 3.

  According to the storage product 1 of the first embodiment, in a state where the catheter assembly 3 is stored in the storage body 2, the inside of the intertube space 50 can be exposed to the sterilizing gas through the gas passage hole 80, so that the storage body 2 The catheter assembly 3 can be put into the operating room with the intertube space 50 sterilized.

  According to the container 1 of the first embodiment, since 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, the hub The gas passage holes 80a and 80b can be prevented from being blocked by the holding portion 102.

  According to the stored article 1 of the first embodiment, the gas passage holes 80a and 80b are formed in the hub connection portion 61 located inside the outer peripheral surface of the protection member 62 with a step. Therefore, when the protection member 62 is attached to the hub holding portion 102, the protection member 62 and / or the hub holding portion 102 is temporarily elastically deformed, and the openings of the gas passage holes 80a and 80b are covered by the hub holding portion 102. However, since there is a step in the inward and outward directions, the gas passage holes 80a and 80b can be prevented from being closed 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 opposed to each other with the second inner tubular member 21 interposed therebetween, even if one gas passage hole 80a is closed, the other gas passage hole 80a is closed. The gas for sterilization can be distributed from the gas passage hole 80b.

  According to the catheter assembly 3 of the first embodiment, since the diameter of the gas passage holes 80a and 80b is larger than the diameter of the core wire 25, it is possible to prevent the core wires 25 from blocking the 80a and 80b.

  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. Then, in a state where a part of the core wire 25 faces the gas passage hole 80, the area of the part of the core wire 25 facing 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, 80b.

  According to the catheter assembly 3 of the first embodiment, since two lumens are provided and they are independent, the entanglement of the guide wires 200a and 200b can be prevented.

  In the embodiment described above, two lumens having two axes 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 main body portion 60 of the catheter hub 11, but the present invention is applicable to a case where the gas passage hole 80 is formed in a portion not used for surgery. It is not limited. For example, a 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 base end of the second outer tubular member 23.

  In the above-described embodiment, the case where two gas passage holes 80a and 80b are provided in the catheter hub 11 is illustrated, but the present invention is not limited to this. The number of the gas passage holes 80a and 80b is not particularly limited. The number of gas passage holes 80 may be one, 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 shapes of the gas passage holes 80a and 80b are not particularly limited. It may be polygonal or elliptical. It may be an elongated hole or a groove.

  In the above-described embodiment, the sterilization gas can be circulated inside and outside the housing 2 by making one side of the housing 2 a gas permeable film, but the present invention is not limited to this. Both sides of the housing 2 may be gas permeable films, or gas introduction holes may be provided in parts.

  In the above-described embodiment, the lumen has a circular or elliptical cross section, but the present invention is not limited to this. The cross-sectional shape of the lumen may be polygonal, semicircular, semielliptical, or the like.

  In the above-described embodiment, the case where the guide wire 200b penetrates the occluded portion of the coronary artery stenosis using the catheter assembly 3 has been described, but the present invention is not limited to this. 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 bifurcation where a blood vessel branches into a plurality, or when the guide wire 200 is inserted between stent struts. May be used.

DESCRIPTION OF SYMBOLS 1 Stuff 2 Stuff 3 Stator assembly 5 Posture fixing member 8 Film 10 Catheter 11 Catheter hub 15 RX lumen 16 OTW lumen 21 Second inner tubular member (inner tubular member)
23 2nd outer tubular member (outer tubular member)
25, 25a, 25b core wire 31 proximal shaft portion 36 second lumen region 36 (lumen region)
50 Space between pipes 72 Flange (projection)
80, 80a, 80b Gas passage hole (lateral hole)
85 Elastic adhesive (elastic body)
100 Protection tube (catheter protection part)
101a to 101e Tube fixing part 102 Hub holding parts 200, 200a, 200b Guide wire

Claims (11)

A catheter assembly having a catheter hub and a catheter,
The catheter hub has a communication hole,
The catheter has one or more inner tubular members constituting a lumen in an outer tubular member constituting an outer shell, and an intertube space exists between the inner tubular member and the outer tubular member,
The communication hole of the catheter hub communicates with the inner tubular member,
The proximal end and the distal end of the outer tubular member are closed,
A catheter assembly, wherein the catheter hub and / or the outer tubular member has a lateral hole, and the lateral hole communicates the intertube space with the outside. The catheter hub and the inner tubular member are joined,
2. The catheter assembly according to claim 1, wherein the lateral hole is located closer to the inner tubular member than a joint of the catheter hub with the inner tubular member. 3.   3. The catheter assembly according to claim 1, wherein a core wire is provided in the inter-tube space, and a circumscribed circle diameter of the lateral hole is larger than an inscribed circle diameter of the core wire. 4.   The catheter assembly according to any one of claims 1 to 3, wherein at least two lateral holes are provided.   The catheter assembly according to claim 4, wherein the two side holes are arranged at positions shifted in a circumferential direction. The catheter hub has a protrusion projecting in a direction perpendicular to the longitudinal direction,
The said horizontal hole is a base end side with respect to the said protrusion part, and is formed in the said orthogonal direction inside the edge part of the said protrusion part, The Claim 1 characterized by the above-mentioned. A catheter assembly according to claim 1.   The catheter assembly according to any one of claims 1 to 6, wherein a portion of the inter-tube space closer to the distal end than the lateral hole is sealed. There is a core wire in the space between the pipes,
The catheter assembly according to any one of claims 1 to 7, wherein the core wire projects from the proximal end of the catheter into the inside of the catheter hub. There is a core wire in the space between the pipes,
The proximal end of the outer tubular member is closed by the catheter hub,
The catheter assembly according to any one of claims 1 to 8, wherein an elastic body is provided between the core wire and the catheter hub. The catheter comprises a lumen region with at least two lumens;
The catheter assembly according to any one of claims 1 to 9, wherein the inner tubular member constitutes one of the two lumens. A catheter assembly according to any one of claims 1 to 10, a posture fixing member for fixing the catheter assembly in a predetermined posture, and a housing for housing the catheter assembly and the posture fixing member therein. Has,
The posture fixing member has a catheter protection portion for protecting the catheter, and a hub holding portion for holding the catheter hub,
The storage body is bag-shaped, and sterilization gas can be circulated inside and outside in a closed state,
The container, wherein the lateral hole is exposed from the hub holding portion when the catheter assembly is fixed to the posture fixing member.

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