WO2015141365A1

WO2015141365A1 - Catheter assembly

Info

Publication number: WO2015141365A1
Application number: PCT/JP2015/054541
Authority: WO
Inventors: 石田昌弘
Original assignee: テルモ株式会社
Priority date: 2014-03-20
Filing date: 2015-02-19
Publication date: 2015-09-24
Also published as: JPWO2015141365A1

Abstract

A catheter assembly (10) is provided with: a catheter (12); a catheter hub (14) having a hollow part (22) which communicates with the lumen (12a) of the catheter (12); and an inner needle (16) which can be inserted into the lumen (12a) and the hollow part (22). A plug (30) and a hemostasis valve (24) are provided to the hollow part (22). The hemostasis valve (24) has an inner needle slit (52) through which the inner needle (16) is inserted, and a plug slit (53) through which the plug (30) is inserted.

Description

Catheter assembly

The present invention relates to a catheter assembly that enables infusion to a patient by being inserted and placed in a patient's blood vessel, for example.

When performing infusion to a patient, a catheter assembly including an outer needle (catheter), an inner needle penetratingly disposed in the catheter, and a hub that holds the proximal end side of the catheter is used. When constructing the infusion line, the catheter and the inner needle are punctured integrally into the blood vessel of the patient, and after the puncture, only the inner needle is withdrawn, the catheter and the hub are left on the patient side, and the hub and the infusion tube are connected.

This type of catheter assembly is provided with a hemostasis valve (valve element) for preventing blood leakage and a cylindrical insertion member in the hub in order to improve the connectivity of the infusion tube (for example, JP-A-2002-263197). See the official gazette). That is, when the infusion tube is connected, the insertion member is pushed by the connector of the infusion tube to penetrate the slit of the hemostasis valve, and the distal end side hollow portion and the proximal end side hollow portion are communicated with each other than the hemostasis valve. Thereby, the infusion agent supplied from the infusion tube flows into the patient via the catheter assembly.

By the way, in the case of infusion, the infusion tube connected to the catheter assembly may be replaced in order to infuse different types of infusion agents. For this reason, as shown in FIGS. 5 to 8 of Japanese Patent Application Laid-Open No. 2002-263197, the catheter assembly pushes back the insertion member with a coil spring provided in the hub after the infusion tube is removed, so that the slit of the hemostasis valve is formed. It is convenient to re-occlude. This is because when the hemostasis valve is re-occluded, blood leakage is suppressed when the infusion tube is replaced.

However, the insertion member is formed thicker than the inner needle in order to allow the infusion agent to flow reliably into the distal end side hollow portion. Therefore, once the insertion member passes through the hemostasis valve, the catheter assembly may not sufficiently re-slit the slit by the hemostasis valve. If the re-occlusion is insufficient, blood leaks from the proximal end of the hub, increasing the possibility of infection by blood, making it difficult to connect other infusion tubes, or poorly looking due to blood. Inconveniences such as become.

The present invention has been made in view of the above circumstances, and with a simple configuration, the slit of the valve body can be reclosed more reliably, blood leakage can be prevented, and tube replacement can be simplified. It is an object to provide a catheter assembly.

In order to achieve the above object, a catheter assembly according to the present invention comprises a catheter, a hub that holds the catheter and has a hollow portion that communicates with a hole portion of the catheter, the hole portion and the hollow portion. An inner needle that can be inserted; an insertion member that is displaceably disposed in the hollow portion; and a valve body that is provided in the hollow portion. The valve body includes an inner needle slit through which the inner needle is inserted. And an insertion member slit through which the insertion member is inserted.

According to the above, since the valve body of the catheter assembly has the two slits of the inner needle slit and the insertion member slit, the valve body slit can be reclosed more reliably. That is, since the valve body has the slit for the insertion member, the insertion member can be easily passed through and displaced, and the damage to the slit for the insertion member can be reduced. Further, even if the inner needle slit is formed to be small according to the diameter of the inner needle, the valve body is not forced to spread, and the valve body can maintain a strong closed state. Therefore, the catheter assembly can prevent the leakage of blood and simplify the replacement of the tube.

In this case, the insertion member includes a closing portion that closes the slit for the insertion member, and an opening portion that opens to the slit due to a different shape or phase with respect to the closing portion connected to the proximal end side of the closing portion, It is preferable that either one of the closing part or the opening part is always inserted into the insertion member slit.

In this way, either one of the blocking portion or the opening portion is always inserted into the insertion member slit, so that the valve body and the blocking portion cooperate with each other at a position where the blocking portion overlaps the insertion member slit. The hollow part is effectively blocked. Therefore, blood leakage can be prevented more reliably. Further, in a state where the opening portion overlaps the insertion member slit, the insertion member slit can be opened to allow the liquid to flow easily.

In addition to the configuration described above, the cross-sectional shape of the open portion may be substantially similar to the cross-sectional shape of the closed portion, and the phase may be shifted by about 90 ° around the axis of the insertion member with respect to the closed portion.

As described above, the phase of the cross-sectional shape of the open portion is shifted by approximately 90 ° relative to the closed portion, so that when the open portion is inserted into the insert member slit, the insert member slit extending in a predetermined direction can be sufficiently expanded. Can do. Therefore, the liquid can pass through the insertion member slit more easily.

The front opening may have a flow hole that is longer in the axial direction than the thickness of the blocking membrane provided with the insertion member slit of the valve body.

In this way, the opening portion has a flow hole that is longer in the axial direction than the thickness of the obstruction membrane, so that the liquid can be discharged from the valve body through the flow hole in a state where the flow hole is disposed at a position overlapping the slit. It can flow into the hollow portion on the tip side.

Furthermore, it is preferable that the closed portion and the open portion have the same thickness in the direction orthogonal to the extending direction of the insertion member slit.

Thus, when the thickness of the closing part and the opening part is the same, when the insertion member is displaced relative to the insertion member slit, the sliding resistance of the insertion member can be suppressed and moved smoothly. .

Alternatively, the insertion member may always be inserted into the insertion member slit, and the insertion member may have a deformable portion that is elastically deformable in a direction orthogonal to the extending direction of the insertion member slit.

As described above, the deforming portion of the insertion member that is always inserted into the insertion member slit can be elastically deformed in a direction orthogonal to the extending direction of the insertion member slit, so that the insertion member is deformed along with the deformation of the deformation portion. The slit can be easily opened.

Further, the deforming portion is formed in a plate shape and extends in the axial direction, and one end of the insertion member receives a pressing force from a connector connected to the hub in a curved manner connected to the deforming portion. It is preferable that the receiving part which can be formed is formed.

Thus, since the receiving portion is formed at one end of the insertion member, the plate-shaped deformation portion can be easily deformed by the pressing force from the connector, and the insertion member slit can be opened.

Furthermore, it is preferable that the inner needle slit and the insertion member slit are formed in parallel, and the cutting width of the insertion member slit is longer than the cutting width of the inner needle slit.

As described above, the slit width for the insertion member slit is longer than the slit width for the inner needle slit and is formed in parallel, so that the valve body may crack when the insertion member slit is opened. Even if it is generated, it is possible to suppress the crack from going to the inner needle slit. Therefore, the obstruction | occlusion by a valve body and an insertion member can be made still more reliable.

According to the catheter assembly of the present invention, it is possible to more easily reclose the slit of the valve body with a simple configuration, prevent blood leakage, and simplify tube replacement.

It is a perspective view showing the whole catheter assembly composition concerning a 1st embodiment of the present invention. FIG. 2 is an exploded perspective view showing a part of the catheter assembly of FIG. 1. 3A is a side sectional view showing a part of the catheter assembly of FIG. 1, and FIG. 3B is a sectional view taken along line IIIB-IIIB of FIG. 3A. It is a perspective view which shows the relationship between the hemostatic valve of FIG. 2, a sealing member, and a plug. 5A is a first perspective view showing the plug of the catheter assembly of FIG. 2, and FIG. 5B is a second perspective view showing the plug of the catheter assembly of FIG. FIG. 2 is a plan sectional view showing a part of the catheter assembly of FIG. 1. 7A is a plan sectional view showing a state where the connector of the infusion tube is connected to the catheter assembly of FIG. 6, and FIG. 7B is a sectional view taken along the line VIIB-VIIB in FIG. 7A. It is side surface sectional drawing which shows the valve mechanism of the conventional catheter assembly roughly. 9A is a plan sectional view showing a state where the connector of the infusion tube is detached from the catheter assembly of FIG. 7A, and FIG. 9B is a sectional view taken along line IXB-IXB in FIG. 9A. FIG. 10A is a side sectional view showing a part of the catheter assembly according to the second embodiment, and FIG. 10B is a plan sectional view showing a part of the catheter assembly of FIG. 10A. 11A is a first perspective view showing the plug of the catheter assembly of FIG. 10A, and FIG. 11B is a second perspective view showing the plug of the catheter assembly of FIG. 10A. 12A is a plan sectional view showing a state where the connector of the infusion tube is connected to the catheter assembly of FIG. 10A, and FIG. 12B is a sectional view taken along the line XIIB-XIIB of FIG. 12A. 13A is a plan sectional view showing a state where the connector of the infusion tube is detached from the catheter assembly of FIG. 12A, and FIG. 13B is a sectional view taken along line XIIIB-XIIIB in FIG. 13A. 14A is a side sectional view showing a part of the catheter assembly according to the third embodiment, and FIG. 14B is a sectional view taken along line XIVB-XIVB in FIG. 14A. 15A is a first perspective view showing the plug of the catheter assembly of FIG. 14A, and FIG. 15B is a second perspective view showing a state where the plug of the catheter assembly of FIG. 14A is elastically deformed. 16A is a plan sectional view showing a state where the connector of the infusion tube is connected to the catheter assembly of FIG. 14A, and FIG. 16B is a sectional view taken along the line XVIB-XVIB of FIG. 16A. 17A is a plan sectional view showing a state where the connector of the infusion tube is detached from the catheter assembly of FIG. 16A, and FIG. 17B is a sectional view taken along line XVIIB-XVIIB in FIG. 17A.

Hereinafter, preferred embodiments of the catheter assembly according to the present invention will be described and described in detail with reference to the accompanying drawings.

[First Embodiment]
As shown in FIG. 1, the catheter assembly 10 according to the first embodiment includes a catheter 12 (outer needle), a catheter hub 14 that connects and holds the proximal end of the catheter 12, and an inner portion that is disposed through the catheter 12. A needle 16 and an inner needle hub 18 that holds the proximal end of the inner needle 16 are provided.

A user such as a doctor or nurse grasps the inner needle hub 18 of the catheter assembly 10 and punctures the distal end portion of the blood vessel of the patient. The distal end portion of the catheter assembly 10 has the catheter 12 and the inner needle 16 overlapped at the time of puncturing (hereinafter also referred to as a puncturable state), and is inserted integrally into the blood vessel of the patient. In the puncture enabled state, the proximal end side of the catheter hub 14 and the distal end side of the inner needle hub 18 are connected, and the inner needle hub 18 supports the catheter hub 14.

After puncturing the patient, the user pulls out the inner needle hub 18 in the proximal direction (retreats), thereby detaching the inner needle hub 18 from the catheter hub 14. Along with this, the inner needle 16 held by the inner needle hub 18 is also pulled out and detached from the catheter 12 and the catheter hub 14. That is, the inner needle 16 is removed from the patient's blood vessel. Therefore, on the patient side, the distal end side of the catheter 12 is inserted into the blood vessel, and the proximal end side of the catheter 12 and the catheter hub 14 are placed on the skin. Thereafter, an infusion solution (medical solution) is administered from the infusion tube to the patient by connecting the connector 20 (see FIG. 7A) of the infusion tube to the proximal end side of the catheter hub 14. Hereinafter, the configuration of the catheter assembly 10 will be specifically described.

The catheter 12 is a tubular member that is flexible and has a predetermined length. A lumen 12 a extending in the axial direction is formed inside the catheter 12. The inner cavity 12a is set to an inner diameter through which the inner needle 16 can be inserted.

The constituent material of the catheter 12 is not particularly limited, but a resin material, particularly a soft resin material, is suitable. For example, polytetrafluoroetherene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE). ), Fluorinated resins such as bellfluoroalkoxy fluororesin (PFA), olefinic resins such as polyethylene and polypropylene, or mixtures thereof, polyurethane, polyester, polyamide, polyether nylon resin, the olefinic resin and ethylene-vinyl acetate Examples thereof include a mixture with a polymer.

Further, the catheter 12 may have transparency so that the whole or a part of the inside can be visually recognized. Accordingly, it is possible to visually confirm a phenomenon (also referred to as flashback) in which blood flows into the catheter hub 14 through the lumen 12a of the catheter 12 with the catheter 12 inserted into the blood vessel.

The proximal end portion of the catheter 12 is fixed to the distal end portion in the catheter hub 14 by an appropriate joining method such as caulking, fusion (thermal fusion, high frequency fusion, etc.), adhesion with an adhesive, or the like. The catheter assembly 10 according to the first embodiment holds the catheter 12 between the inner surface of the catheter hub 14 by a caulking pin (not shown).

The catheter hub 14 that holds the catheter 12 is formed in a cylindrical shape that tapers in the distal direction. The catheter hub 14 is interposed between the catheter 12 and the infusion tube so that both members can be connected (communicated) easily and reliably. An operation protrusion 14 a for pushing the catheter 12 into the blood vessel is formed on the upper portion of the catheter hub 14. The catheter hub 14 is exposed on the patient's skin in a state where the catheter 12 is punctured into a blood vessel, and is affixed with a tape or the like.

The catheter hub 14 is preferably made of a material harder than the catheter 12. The constituent material of the catheter hub 14 is not particularly limited. For example, a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer can be suitably used.

The inside of the catheter hub 14 is provided with a hollow portion 22 that is formed so as to penetrate in the axial direction and through which an infusion solution can flow. The hollow portion 22 communicates with the proximal end opening 14b of the catheter hub 14, and as shown in FIG. 2, the hemostasis valve 24 (valve element), the seal member 26, the spring 28 (elastic member), the plug 30 ( Insertion member) is accommodated. Each of these members will be described in detail later.

The inner needle 16 of the catheter assembly 10 is formed as a tubular member having rigidity capable of puncturing the patient's skin. Examples of the constituent material of the inner needle 16 include a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy. The inner needle 16 is formed to be sufficiently longer than the catheter 12, and is configured such that a sharp needle tip 16a protrudes from the distal end opening of the catheter 12 in a puncturable state. The posture of the inner needle 16 is such that the body portion passes through the hollow portion 22 of the catheter hub 14 and the proximal end portion connected to the body portion is fixed and held by an inner needle holding member (not shown) in the inner needle hub 18. Maintained.

In FIG. 2, the inner needle 16 is inserted from the proximal end side of the catheter hub 14. However, when the inner needle 16 is assembled, the distal end of the catheter 12 is opened before the inner needle hub 18 is connected. It is preferable to insert the proximal end of the inner needle 16 from the top. Thus, the needle tip 16a can be prevented from sticking into the catheter hub 14, the hemostasis valve 24, and the seal member 26, and the inner needle 16 can be assembled smoothly.

Returning to FIG. 1, the inner needle hub 18 that holds the inner needle 16 is formed in a long casing that can be gripped by the user and stably operate the double tube body of the catheter 12 and the inner needle 16. Yes. Inside the inner needle hub 18, a housing mechanism (not shown) that houses the inner needle 16 when the inner needle hub 18 is detached from the catheter hub 14 is provided.

In the catheter assembly 10 described above, the double structure of the catheter 12 and the inner needle 16, the catheter hub 14 and the inner needle hub 18 are sequentially connected from the distal end side in the axial direction so that they can be handled integrally. ing. When the catheter assembly 10 is puncturable, a spring 28, a hemostatic valve 24, a seal member 26, and a plug 30 are appropriately disposed in the hollow portion 22 of the catheter hub 14, as shown in FIG. 3A.

The hollow portion 22 of the catheter hub 14 includes a catheter connection portion 32, a guide portion 34, a valve placement portion 36, and a connector connection portion 38 from the distal end side toward the proximal end side. The catheter connection portion 32 is configured by an inner wall 32a that substantially matches the outer diameter of the catheter 12 at the distal end portion of the catheter hub 14. The proximal end portion of the catheter 12 is firmly fixed by the inner wall 32a of the catheter connection portion 32 and a caulking pin.

The guide portion 34 is formed so that the distal end side is connected to the catheter connecting portion 32 and the infusion agent supplied from the proximal end side is guided to the lumen 12 a of the catheter 12. The inner wall 34a constituting the guide portion 34 is formed in a tapered surface (funnel shape) in which the inner diameter on the distal end side becomes smaller toward the inner cavity 12a.

Further, a spring 28 is disposed in the guide portion 34. The spring 28 is formed in a spiral shape and is disposed so as to be sandwiched between the inner wall 34a of the catheter hub 14 (the tapered surface of the guide portion 34) and a plug 30 described later. The spring 28 is formed in a diameter that can be fitted into the tapered surface of the guide portion 34, and has a predetermined length in the axial direction (the length from the inner wall 34a that contacts one end to the front of the hemostasis valve 24). The spring 28 is contracted in the axial direction when the connector 20 is inserted into the hollow portion 22 and the plug 30 is pushed in the distal direction, and biases the plug 30 in the proximal direction. Therefore, when the connector 20 is detached from the hollow portion 22, the spring 28 pushes the plug 30 back in the proximal direction according to the total length.

On the other hand, the valve arrangement part 36 is connected to the guide part 34 at the tip side, and is constituted by an inner wall 36a having a slightly larger diameter than the inner wall 34a of the guide part 34. That is, a step is formed between the guide portion 34 and the valve placement portion 36. The hemostatic valve 24 and the seal member 26 are arranged in the valve arrangement portion 36.

The hemostasis valve 24 is an elastic member formed in a bottomed cylindrical shape and has a function of blocking blood circulation. The hemostasis valve 24 is disposed so as to divide the hollow portion 22 of the catheter hub 14 into a distal end side hollow portion 22a and a proximal end side hollow portion 22b. Examples of the elastic material constituting the hemostasis valve 24 include various rubber materials such as natural rubber, isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene rubber, urethane rubber, nitrile rubber, acrylic rubber, fluorine rubber, and silicone rubber ( In particular, those obtained by vulcanization), various elastomers such as urethane, polyester, polyamide, olefin, styrene, and other thermoplastic elastomers, or mixtures thereof. Since the hemostasis valve 24 is also related to the configuration of the plug 30 described later, a specific configuration will be described later.

A plurality of inner circumferential groove portions 40 are provided on the inner wall 36a of the valve arrangement portion 36 to which the hemostasis valve 24 is fixed. The inner circumferential groove portion 40 is formed such that the tip portion cuts out a stepped portion between the guide portion 34 and the valve placement portion 36, and extends in the axial direction along the inner wall 36 a of the valve placement portion 36 from the tip portion. Yes. The inner peripheral groove portion 40 moves the air present in the distal end side hollow portion 22a to the proximal end side hollow portion 22b.

Also, a seal member 26 is attached to the proximal end side of the hemostasis valve 24. As shown in FIG. 2, the catheter assembly 10 has a configuration in which the hemostasis valve 24 and the seal member 26 are fitted to each other so as not to rotate. Specifically, a plurality (three in FIG. 2) of fitting grooves 24a are formed on the outer peripheral surface of the hemostasis valve 24, and a plurality of fittings corresponding to the fitting grooves 24a are formed on the seal member 26. A protrusion 26a for insertion is formed.

The seal member 26 includes an insertion protrusion 26a, a proximal end tubular portion 44 that matches the inner diameter of the valve placement portion 36 on the proximal end side of the insertion protrusion 26a, and the proximal end tubular portion 44 in the axial direction. And a through hole 46 therethrough. The proximal end cylinder portion 44 is disposed so as to close the inner circumferential groove portion 40 and to be in close contact with the inner wall 36 a of the valve placement portion 36. Thereby, the hemostasis valve 24 and the seal member 26 are firmly fixed in the catheter hub 14.

The seal member 26 is made of a material that allows gas to pass but does not allow liquid to pass. As a material constituting the seal member 26, for example, a material formed of a porous body such as a polyethylene sintered body can be suitably used. That is, the seal member 26 blocks the blood that has moved through the inner circumferential groove 40 while allowing the air that has moved through the inner circumferential groove 40 to escape in the proximal direction.

As shown in FIG. 3A, the connector connecting portion 38 of the catheter hub 14 is connected to the valve placement portion 36 at the distal end side and extends to the proximal end opening portion 14b of the catheter hub 14. The connector connecting portion 38 is configured so that the connector 20 of the infusion tube can be fitted (inserted connection). The inner wall 38a on the proximal end side of the connector connecting portion 38 is formed in a tapered shape having a slightly smaller diameter toward the distal end direction in order to improve the connectivity with the connector 20.

In the state where puncturing is possible, the plug 30 is disposed in the valve placement portion 36 and the connector connection portion 38 so as to be displaceable. The plug 30 functions together with the hemostasis valve 24 as a valve mechanism that enables blocking of blood in the catheter assembly 10 and supply of an infusion solution. The catheter assembly 10 is configured by appropriately configuring this valve mechanism to improve fluidity of the infusion solution and facilitate replacement of the infusion tube. Hereinafter, the configuration of the hemostasis valve 24 and the plug 30 according to the first embodiment will be specifically described.

As shown in FIG. 4, the hemostasis valve 24 formed in a bottomed cylindrical shape includes a side peripheral portion 48 that is tightly fixed to the inner wall 36 a of the valve placement portion 36, and a bottom portion that continues to the distal end side of the side peripheral portion 48. And the occluding film 50 to be configured. The occlusion film 50 of the hemostasis valve 24 is formed thicker than the side peripheral portion 48 and is easily elastically deformed. An inner needle slit 52 for passing the inner needle 16 and a plug slit 53 for passing the plug 30 are formed in the closing film 50.

The inner needle slit 52 is located at the center of the occlusion membrane 50 and is formed with a sufficiently short cutting width that easily closes as the inner needle 16 is pulled out of the hemostasis valve 24. In addition, the inner needle slit 52 is formed in a single line so as to penetrate in the thickness direction of the occlusion film 50 and is self-occluded by the elastic force of the hemostasis valve 24.

Similarly to the inner needle slit 52, the plug slit 53 is also formed penetrating in the thickness direction of the blocking film 50. The plug slit 53 is provided so as to be parallel to the cutting direction (left-right direction) of the inner needle slit 52 at a position shifted from the center of the blocking film 50 (inner needle slit 52). For example, as shown in the illustrated example, the plug slits 53 are spaced apart from each other by a predetermined distance in the upward direction of the inner needle slit 52 and are formed to have a longer cut width than the inner needle slit 52.

In the catheter assembly 10, the plug 30 is always inserted into the hemostasis valve 24 as described later. Therefore, the slit 53 for plugs is not particularly limited in terms of the cut shape as long as the closing film 50 can be sealed in cooperation with the plug 30. For example, the plug slit 53 may be opened in a state where the plug 30 is not inserted.

Further, a lubricant that makes sliding of the inner needle 16 and the plug 30 good may be applied to the inner surface of the hemostasis valve 24 constituting the inner needle slit 52 and the plug slit 53. Further, the hemostasis valve 24 may be provided with breakage prevention means (for example, making the peripheral edge of the slit flexible, etc.) so that the plug slit 53 is not broken even when the plug 30 is inserted.

As described above, the plug 30 is pushed out by the connector 20 of the infusion tube and passes through the plug slit 53 of the hemostasis valve 24, thereby causing the infusion agent supplied from the infusion tube to flow into the distal end side hollow portion 22a. For this reason, the plug 30 is formed in a length that can exist over the guide portion 34, the valve placement portion 36, and the connector connection portion 38 of the catheter hub 14 in a state of penetrating the hemostasis valve 24 (see FIG. 3A).

As shown in FIGS. 5A and 5B, the plug 30 has a closed head portion 54 (closed portion), an open body portion 56 (open portion), and a flange portion 58 in this order from the distal end side toward the proximal end side. The closed head portion 54 and the open body portion 56 are provided at positions that are shifted radially outward with respect to the axial center of the plug 30 that passes through the center of the flange portion 58 and that their phases are shifted by 90 ° around the axial center.

The occlusion head 54 closes the plug slit 53 in the inserted state of the plug slit 53 of the hemostasis valve 24, that is, it can block the hollow portion 22 back and forth in cooperation with the hemostasis valve 24. The closed head 54 has a substantially semicircular shape in a cross-sectional view (see FIG. 3B), and is formed in an axial length slightly longer than the film thickness of the occluded film 50 in a side cross-sectional view (see FIG. 3A). . The cross-sectional area of the blocking head 54 may be set as appropriate according to the plug slit 53, but has a thickness that can push the plug slit 53 up and down to the extent that the blocking film 50 is not broken. Good.

As shown in FIGS. 5A and 5B, the distal end portion of the closed head portion 54 is provided with a retaining portion 54 a that protrudes outward from the side peripheral surface of the closed head portion 54. The retaining portion 54 a is prevented from being pulled out in the proximal direction by being caught by the mouth edge of the plug slit 53. In addition, the front end surface of the closed head 54 has a large area and is formed flat by the retaining portion 54 a, and functions as a seat for receiving one end of the spring 28. The configuration of the retaining portion 54a is not particularly limited. For example, a groove portion into which the lip of the plug slit 53 can enter can be formed on the surface of the closed head portion 54, or the closed head portion 54 itself. The same effect can be obtained by sufficiently increasing the cross-sectional area.

The open body portion 56 includes a connecting portion 64 that is continuous to the proximal end side of the closed head portion 54 and an extending portion 66 that is continuous to the proximal end side of the connecting portion 64 and extends to the flange portion 58. The connecting portion 64 is a portion that smoothly continues toward the closed head portion 54 whose phase is shifted by 90 ° around the axial center with respect to the open body portion 56 (extending portion 66). Specifically, the lower side of the connecting portion 64 is inclined upward from the extending portion 66 toward the distal end side, and the side on the side facing the axial center of the connecting portion 64 is extended from the extending portion 66. The closed head 54 is supported by inclining in the width direction toward the distal end side.

The extending portion 66 is formed in a semicircular shape that is substantially similar to the closed head portion 54 in a cross-sectional view, and its axial length is sufficiently longer than the connecting portion 64. The extending portion 66 extends in parallel with the axial center of the plug 30 to support the closed head 54, and when the plug 30 is pushed in the distal end direction, the direction (vertical direction) is perpendicular to the extending direction of the plug slit 53. The plug slit 53 is opened in the direction).

On the other hand, the flange portion 58 is formed in a disc shape that protrudes radially outward from the proximal side surface of the open body portion 56. The flange portion 58 includes a plate portion 68 having a predetermined plate thickness, and a protruding edge portion 70 slightly extending in the proximal direction at the periphery of the plate portion 68. At the center of the plate portion 68, there is provided a flow hole 72 that is formed to have a predetermined diameter and that circulates the infusion agent. The open body portion 56 is connected to a position adjacent to the flow hole 72 on the front end surface of the plate portion 68.

Also, the proximal end surface of the protruding edge 70 is a receiving portion that receives the distal end surface of the connector 20 of the infusion tube. Furthermore, a pair of hole portions 74 are formed in the flange portion 58 across the plate portion 68 and the protruding edge portion 70. The pair of holes 74 are formed in a substantially rectangular shape, and are provided at positions facing each other with the open body 56 interposed therebetween. The hole 74 acts to allow the infusion agent to flow into the proximal end side hollow portion 22b and to evacuate the air in the proximal end side hollow portion 22b during circulation of the infusate.

The plug 30 configured as described above is preferably formed of a relatively hard resin material so as to pass through the plug slit 53 of the hemostasis valve 24 by receiving the pushing force from the connector 20. Although the constituent material of the plug 30 is not specifically limited, For example, what was mentioned by the constituent material of the catheter hub 14 is applicable. Further, a lubricant may be applied to the outer peripheral surface of the plug 30 in order to improve the slidability of the plug 30 with respect to the hemostasis valve 24.

Furthermore, the catheter assembly 10 according to the first embodiment is configured to restrict the rotation of the plug 30 by the through hole 46 of the seal member 26. As shown in FIG. 4, the through-hole 46 is connected to the central hole 76 for passing the inner needle 16 and the cross-sectional shape of the closed head 54 and the open body 56 of the plug 30 connected to the central hole 76. And a peripheral hole 78 cut out. That is, the peripheral hole portion 78 is formed such that two semicircular shapes (the first semicircular portion 78a and the second semicircular portion 78b) are shifted by 90 ° in the circumferential direction and partially overlap when viewed from the front. .

When the catheter assembly 10 is assembled, the plug 30 is inclined in the circumferential direction so that the closed head portion 54 is opposed to the first semicircular portion 78a and the open body portion 56 is opposed to the second semicircular portion 78b. The plug 30 can be easily passed through the seal member 26. In the usable state of the catheter assembly 10, the extension portion 66 of the plug 30 is disposed in the first semicircular portion 78 a. Therefore, even if the plug 30 is pushed in the distal direction as the connector 20 is inserted and the extension 66 receives stress from the plug slit 53, the plug 30 is restricted from rotating counterclockwise in FIG. The

As shown in FIGS. 3A, 3B, and 6, the catheter assembly 10 accommodates the above-mentioned members in the catheter hub 14 by appropriately assembling the above members in order to configure a punctureable state. In this case, the insertion protrusion 26 a of the seal member 26 is inserted into the insertion groove 24 a of the hemostasis valve 24 to integrate the hemostasis valve 24 and the seal member 26, and the base of the spring 28 previously accommodated in the hollow portion 22. Place on the end side. Further, the plug 30 and the inner needle 16 are accommodated so as to penetrate the occlusion membrane 50 of the hemostasis valve 24.

That is, the plug 30 is inserted into the plug slit 53 and the plug slit 53 is closed by the closing head 54. In this state, the distal end surface of the closed head 54 comes into contact with the extended spring 28, and the extending portion 66 is accommodated in the through hole 46 (first semicircular portion 78 a) of the seal member 26.

The inner needle 16 is also inserted into the inner needle slit 52, but the inner needle slit 52 is closed without a gap because the closing film 50 is pressed downward with the closing head 54 inserted. The inner needle 16 constitutes a double tube with the catheter 12, and extends straight through the catheter hub 14 (parallel to the open body 56) and penetrates the flow hole 72. Then, it is firmly held by the inner needle holding member in the inner needle hub 18.

The catheter assembly 10 according to the first embodiment is basically configured as described above, and the operation and effect thereof will be described below.

When performing infusion to a patient, a user (doctor or nurse or the like) prepares the catheter assembly 10 in the above-described puncturable state. The user operates the inner needle hub 18 of the catheter assembly 10 to puncture the catheter 12 and the inner needle 16 into the blood vessel of the patient. After puncturing, the inner needle 16 and the inner needle hub 18 are pulled out from the catheter 12 and the catheter hub 14. The outer diameter of the inner needle 16 is sufficiently small, and the inner needle slit 52 is elastically closed when the inner needle 16 is pulled out from the inner needle slit 52 of the hemostasis valve 24. As the inner needle 16 is pulled out, the patient's blood flows into the distal end side hollow portion 22a through the lumen 12a of the catheter 12. At this time, the air present in the distal end side hollow portion 22a is pushed out to the proximal end side by the inflow of blood, moves in the proximal end direction through the inner peripheral groove portion 40, and further passes through the seal member 26 to the catheter hub 14. From the base end opening 14b. On the other hand, the blood is blocked from leaking in the proximal direction by the hemostasis valve 24 and the seal member 26 and stored in the distal end side hollow portion 22a.

Next, as shown in FIGS. 7A and 7B, an infusion tube connector 20 is inserted into the catheter hub 14 remaining on the patient's skin by pulling out the inner needle 16 and the inner needle hub 18. The distal end portion of the connector 20 is formed into a tapered cylinder along the inner wall 38a of the connector connecting portion 38 of the catheter hub 14, and when the predetermined amount of the connector 20 is inserted into the hollow portion 22, the catheter hub 14 and the connector 20 are fitted. Match.

When the connector 20 is inserted, the tip surface of the connector 20 contacts the flange portion 58 of the plug 30 to push the plug 30 in the tip direction. The spring 28 existing between the inner wall 34a of the catheter hub 14 (guide part 34) and the distal end surface of the closed head 54 is pushed by the plug 30 and contracts.

In addition, the plug 30 pushed in the distal direction is inserted into the slit 53 for the plug by inserting the connecting portion 64 on the proximal end side of the closed head 54 into the slit 53 for the plug along the shape of the side portion of the connecting portion 64. 53 is opened in the vertical direction. That is, in FIG. 3B, the closed head 54 having a semicircular cross section that is long in the left-right direction and short in the up-down direction is pushed out to the plug slit 53 extending in the left-right direction. Then, the connecting portion 64 that gradually changes in the left-right direction and gradually changes in the up-down direction is inserted into the plug slit 53. Since the plug 30 is restricted from rotating counterclockwise in FIG. 7B by the shape of the through hole 46 formed in the seal member 26, the plug 30 can move in the axial direction satisfactorily.

Further, when the connector 30 is pushed in and the plug 30 is inserted, as shown in FIG. 7B, the semicircular extension 66 having a 90 ° phase shift from the closed head 54 is inserted into the plug slit 53. Is done. As a result, the plug slit 53 formed linearly in the left-right direction is expanded so as to be short in the left-right direction and long in the up-down direction, and is opened with a relatively large channel cross-sectional area. As a result, the infusion agent supplied from the infusion tube easily passes through the plug slit 53.

Here, a conventional valve mechanism (the hemostasis valve 80 and the plug 82) will be described with reference to FIG. In the conventional valve mechanism, the tip of the plug 82 is formed in a cylindrical shape. For this reason, the plug 82 forms a region (retention region 84) in which liquid (blood or infusion) is likely to stay around the hemostasis valve 80 in a penetrating state. The infusate that flowed out from the plug 30 moved in the distal direction almost without going around the stay region 84, and the infusate and blood that flowed into the stay region 84 were stagnant and remained.

On the other hand, as shown in FIGS. 7A and 7B, the catheter assembly 10 has a semicircular cross section formed at the distal end side of the hemostasis valve 24. Allow the agent to wrap around to the side. As a result, it is possible to suppress the occurrence of the stay region 84 in the guide portion 34. The infusion agent is continuously supplied to the guide portion 34, so that it is easily guided to the lumen 12a of the catheter 12 and flows into the blood vessel of the patient.

Also, as described above, in the infusion, the connector 20 may be detached from the catheter hub 14 by exchanging the infusion agent or the like according to the patient's condition or the like. In this case, the user retracts the connector 20 relative to the catheter hub 14 and pulls out the infusion tube. The catheter assembly 10 is configured to automatically push back the plug 30 in the proximal direction as shown in FIGS. 9A and 9B as the connector 20 moves backward.

That is, when the connector 20 moves backward, the spring 28 compressed by the advancement of the plug 30 is elastically restored and pushes the plug 30 in the proximal direction. Accordingly, the extending portion 66 of the open body portion 56 is detached from the plug slit 53, and the connecting portion 64 is also detached from the plug slit 53. Since the connecting portion 64 is tapered, it can be removed relatively easily.

Then, at the stage where the spring 28 has been extended, the closed head 54 of the plug 30 is positioned in the plug slit 53. At this time, the retaining portion 54 a is caught by the obstruction film 50, so that the occlusion head 54 is prevented from coming off. As a result, the plug slit 53 is pushed and widened by the closing head 54 without a gap, and the hemostasis valve 24 is reliably closed. For example, even if the obstruction film 50 is torn due to the insertion of the plug 30, the obstruction film 50 is closed by the spread of the obstruction head 54. Accordingly, it is possible to favorably avoid blood from leaking into the proximal end side hollow portion 22b of the hemostasis valve 24.

As described above, according to the catheter assembly 10 according to the first embodiment, the hemostasis valve 24 has the two slits of the inner needle slit 52 and the plug slit 53, so that each slit of the hemostasis valve 24 is further layered. Re-occlusion can be ensured. That is, since the hemostasis valve 24 has the plug slit 53, the plug 30 can be easily passed through and displaced, thereby reducing the damage of the plug slit 53. Further, even if the inner needle slit 52 is formed to be small according to the diameter of the inner needle 16, the inner needle slit 52 is not forcibly expanded and the hemostasis valve 24 can maintain a strong closed state. Therefore, the catheter assembly 10 can prevent blood leakage and simplify replacement of the infusion tube.

In this case, either one of the closed head portion 54 or the open body portion 56 is always inserted into the plug slit 53, so that the hemostatic valve 24 and the closed head portion are positioned at a position where the closed head portion 54 overlaps the plug slit 53. 54 cooperate to effectively close the hollow portion 22. Therefore, blood leakage can be prevented more reliably. In the state where the open body 56 overlaps the plug slit 53, the plug slit 53 can be opened to allow the liquid to flow easily.

Further, since the phase of the cross-sectional shape of the open body portion 56 is shifted by approximately 90 ° relative to the closed head portion 54, the plug slit 53 extending in a predetermined direction when the open body portion 56 is inserted into the plug slit 53. Can be expanded sufficiently. Therefore, the infusion agent can pass through the plug slit 53 more easily. Furthermore, since the cut width of the plug slit 53 is longer than the cut width of the inner needle slit 52 and is formed in parallel, the hemostasis valve 24 is cracked when the plug slit 53 is opened. Even if it is generated, it is possible to suppress the crack from heading toward the inner needle slit 52. Therefore, the obstruction by the hemostasis valve 24 and the plug 30 can be further ensured.

It should be noted that the catheter assembly 10 according to the present invention is not limited to the first embodiment described above, and of course, various embodiments, modifications, and application examples can be taken. For example, in a state where the catheter assembly 10 can be punctured, the plug 30 may not be inserted into the plug slit 53 and may be in a standby state on the proximal end side of the hemostasis valve 24.

[Second Embodiment]
As shown in FIGS. 10A and 10B, the catheter assembly 10A according to the second embodiment is different from the catheter assembly 10 according to the first embodiment in the configuration of each member disposed in the hollow portion 22 of the catheter hub 14. . In the following description, the same reference numerals are given to the same configuration or the same function as the catheter assembly 10 according to the first embodiment, and the detailed description thereof is omitted. In the following, each configuration will be described with the inner needle hub 18 omitted, but of course the inner needle hub 18 according to the first embodiment can be applied.

Specifically, the plug 130 assembled to the catheter assembly 10A is integrally formed with an elastic portion (spring portion 132) for pushing the plug 130 back in the proximal direction. The hemostasis valve 24 in which the plug 130 is disposed can adopt the same configuration as the hemostasis valve 24 according to the first embodiment, and the inner needle slit 52 and the plug slit 53 are provided in the closing membrane 50. Yes. Further, unlike the seal member 26 according to the first embodiment, the seal member 150 can form the through hole 152 in a circular cross section, and does not restrict the rotation of the plug 130. That is, the plug 130 is basically continuously inserted into the plug slit 53 of the hemostasis valve 24, so that the rotation is regulated by the hemostasis valve 24. Of course, the seal member 26 may have a through hole corresponding to the cross-sectional shape of the inner needle 16 or the plug 130.

The plug 130 has a sufficient thickness as compared with the plug 30 according to the first embodiment, and has an axial length that is accommodated across the guide portion 34, the valve placement portion 36, and the connector connection portion 38 of the catheter hub 14. Have Specifically, a spring part 132, a closed head part 134, an open body part 136, and a flange part 138 are provided in order from the distal end side to the proximal end side.

As shown in FIGS. 11A and 11B, the spring portion 132 of the plug 30 has a predetermined elastic force by connecting a plurality of (in the illustrated example, five) rings 140 along the axial direction of the catheter hub 14. Configured. The ring 140 has a hole 140a penetratingly formed in the thickness direction, and is formed in an elliptical shape having a short axis in the axial direction and a long axis in the width direction in a plan view shown in FIG. 10B. When a pressing force is applied in the axial direction, the ring 140 acts to release the stress in the major axis direction (width direction) and to be elastically crushed. As the individual rings 140 are crushed elastically, the entire spring portion 132 is sufficiently shortened in the axial direction.

On the other hand, the closed head 134 is connected to the proximal end side of the spring portion 132 and has a flat plate shape wider than the spring portion 132. The occlusion head 134 has an axial length that is slightly longer than the film thickness of the occlusion membrane 50 in a side sectional view (see FIG. 10A). Further, on the upper surface of the closed head 134, a protruding portion 134 a (prevention portion) that prevents the plug 130 from coming out of the plug slit 53 is formed to protrude.

The open body portion 136 is connected to the proximal end side of the closed head portion 134 and has a flat plate shape extending in the proximal direction with the same width and thickness as the closed head portion 134. A flow hole 142 that penetrates in the thickness direction is formed on the flat plate surface of the open body portion 136. The flow hole 142 has a function of communicating the distal end side hollow portion 22 a and the proximal end side hollow portion 22 b in a state where the open body portion 136 is inserted into the plug slit 53.

The flow hole 142 is formed in a wide square shape on the front end side in a plan view, and is formed in a taper shape that gradually becomes narrower from the intermediate portion in the axial direction toward the base end side. Since the circulation hole 142 is wide on the distal end side, it is possible to sufficiently secure the circulation amount of the infusion agent. Moreover, the strength of the plug 130 can be increased because the flow hole 142 is narrow on the base end side.

The flange portion 138 is formed in a disk shape continuous to the proximal end side of the open body portion 136, and is configured to cause the infusion agent to flow up and down the open body portion 136 by further notching up and down. The open body 136 is connected to a front end surface that is shifted upward with respect to the center of the flange 138, and a notch 144 on the lower side of the open body 136 can pass the inner needle 16. It is formed to a depth. As a result, the inner needle 16 is arranged in parallel with the plug 130 through the notch 144.

Returning to FIGS. 10A and 10B, the catheter assembly 10A inserts the plug 130 into the plug slit 53 of the hemostasis valve 24 and closes the plug slit 53 with the closing head 134 in order to configure a punctureable state. State. In this state, the spring portion 132 on the tip side of the closed head 134 just abuts against the inner wall 34 a of the guide portion 34 of the catheter hub 14. The inner needle 16 is also inserted into the inner needle slit 52, but the inner needle slit 52 is closed without a gap because the closing film 50 is pressed downward with the closing head 134 inserted.

The catheter assembly 10A according to the second embodiment is basically configured as described above, and the operation and effect thereof will be described below.

The catheter assembly 10A is also operated in the same manner as the catheter assembly 10 according to the first embodiment. That is, in the puncture enabled state, the catheter assembly 10A is punctured by the patient with the catheter 12 and the inner needle 16 under the operation of the user, and then the inner needle 16 is withdrawn. When the inner needle 16 is pulled out, the plug 130 is inserted into the plug slit 53 of the hemostasis valve 24, so that the plug slit 53 is reliably closed and the inner needle slit 52 below the plug 130 is positively opened. Block. For this reason, even if blood flows into the hollow portion 22, the hemostasis valve 24 can satisfactorily block blood leakage.

Next, the infusion tube connector 20 is inserted into the catheter hub 14 as shown in FIG. 12A. When the connector 20 is inserted, the front end surface of the connector 20 comes into contact with the flange portion 138 of the plug 130 and pushes the plug 130 in the front end direction. As a result, the spring portion 132 of the plug 130 is elastically deformed and contracts in the axial direction, and the closing head 134 moves in the distal direction relative to the closing membrane 50.

Then, the plug 130 is pushed by the connector 20 until the tip end side of the flow hole 142 of the open body portion 136 exceeds the blocking membrane 50. In this state, as shown in FIG. 12B, the flow hole 142 overlaps the plug slit 53 and the plug slit 53 is opened. Here, the plug 130 is formed to be thicker than the plug 30 according to the first embodiment, and the plug slit 53 is largely opened according to the thickness of the opening body 136. The infusion agent supplied from the connector 20 can flow through the notch 144 into the proximal end side hollow portion 22b and further pass through the plug slit 53 through the flow hole 142.

In addition, on the tip side of the hemostasis valve 24, the infusion agent flows out above and below the flat open body 136. For this reason, the infusion agent can be easily wrapped around the plug 130, and the occurrence of the stay region 84 (see FIG. 8) in the distal end side hollow portion 22a can be suppressed. The infusate that has flowed into the distal end side hollow portion 22a is easily guided to the lumen 12a of the catheter 12 and flows into the blood vessel of the patient.

Furthermore, when the connector 20 is moved backward from the catheter hub 14 by exchanging an infusion solution or the like, as shown in FIGS. 13A and 13B, the spring portion 132 operates to return elastically. That is, the spring part 132 automatically pushes the plug 130 in the proximal direction, so that the open body part 136 comes out of the plug slit 53.

Then, when the spring 28 has been extended, the closed head 134 is positioned in the plug slit 53. In other words, the plug slit 53 is pushed open by the closing head 134 without a gap, and becomes sealed, and the hemostasis valve 24 and the plug 130 firmly close the hollow portion 22. For example, even if the obstruction film 50 is torn due to the insertion of the plug 130, the obstruction film 50 with the obstruction head 134 being pushed and expanded can close the torn part. Accordingly, it is possible to favorably avoid blood from leaking into the proximal end side hollow portion 22b of the hemostasis valve 24.

As described above, the catheter assembly 10A according to the second embodiment can achieve the same effects as those of the catheter assembly 10 according to the first embodiment. In particular, the catheter assembly 10 </ b> A has a flow hole 142 in which the open body 136 is longer in the axial direction than the thickness of the blocking membrane 50. Therefore, in a state where the open body 136 is inserted into the plug slit 53 and the flow hole 142 is overlapped with the plug slit 53, the proximal end side hollow portion 22 b and the distal end side hollow portion 22 a communicate with each other through the flow hole 142. Therefore, the infusion agent can easily flow into the distal end side hollow portion 22a through the circulation hole 142. In addition, the distribution mechanism of the infusion agent by the open trunk | drum 136 is not limited to the flow hole 142 penetrated up and down, For example, the groove | channel etc. which are long in the axial direction of the open trunk | drum 136 can also be employ | adopted.

Further, since the spring part 132 is integrally formed with the plug 130, the catheter assembly 10A can reduce the number of parts, and can reduce the manufacturing cost and the work man-hour. In short, the configuration of the elastic portion that pushes back the

plugs

30 and 130 of the

catheter assemblies

10 and 10A is not particularly limited. For example, the spring portion 132 according to the second embodiment may be provided in the plug 30 according to the first embodiment. Further, the member for integrally forming the elastic portion is not limited to the

plugs

30 and 130, and may be the catheter hub 14, the hemostasis valve 24, the

seal members

26 and 150, or the like. For example, when an elastic portion is provided on the catheter hub 14, an elastic piece (not shown) that protrudes from the inner wall 34 a of the guide portion 34 toward the distal end surface of the plug 30 may be used. Further, the elastic piece may be provided in the valve arrangement portion 36 or the connector connection portion 38 and elastically contact the flange portion 58 of the plug 30. For example, when providing an elastic part in the hemostatic valve 24 (seal member 26), an elastic piece may be protruded from the base end part of the hemostatic valve 24 toward the flange part 58 of the plug 30.

Further, the catheter assembly 10 </ b> A suppresses the sliding resistance of the plug 30 when the plug 30 is displaced relative to the plug slit 53 because the closed head 134 and the open body 136 have the same thickness. Can be moved smoothly.

[Third Embodiment]
As shown in FIGS. 14A and 14B, the catheter assembly 10B according to the third embodiment is configured such that the configuration of each member disposed in the hollow portion 22 of the catheter hub 14 is according to the first and second embodiments. Different from 10, 10A. Specifically, the plug 160 assembled to the catheter assembly 10B is configured as a plate-like elastic member (plate spring).

Further, since the plug 160 is configured as a leaf spring, the spring 28 (see FIG. 2) cannot be accommodated in the catheter hub 14. For this reason, for example, the hemostasis valve 24 according to the first embodiment and the seal member 150 according to the second embodiment are disposed at appropriate positions in the hollow portion 22 and penetrate through the hemostasis valve 24 and the seal member 150. Thus, the plug 160 is accommodated.

The plug 160 extends in a sufficiently thin state so as to be easily elastically deformed compared to the plug 30 according to the first embodiment, and has an axial length extending between the guide portion 34, the valve disposing portion 36, and the connector connecting portion 38. Have. Specifically, a distal end locking portion 162, an intermediate deformation portion 164, and a proximal end receiving portion 166 are provided from the distal end side toward the proximal end side. Further, the width in the left-right direction of the plug 160 is substantially equal to the width in the left-right direction (extending direction) of the plug slit 53, and the distal end locking portion 162, the intermediate deformation portion 164, and the base end receiving portion 166 are the same. It is formed in width.

The front end locking portion 162 is a portion that is locked to the inner wall 34a of the guide portion 34, and is formed to be bent downward as shown in FIGS. 15A and 15B. The degree of curvature (curvature radius) of the distal end locking portion 162 is formed larger than the round corner of the proximal end receiving portion 166. As a result, when the plug 160 is assembled into the catheter hub 14, the distal end locking portion 162 is easily inserted into the plug slit 53, and is smoothly inserted to the distal end side while being prevented from being caught in the catheter hub 14. be able to.

Further, the distal end locking portion 162 has a pair of leg portions 162a formed in the downward direction by notching the intermediate portion in the width direction. The tip ends of the pair of leg portions 162a are formed at an acute angle and are easily caught on the inner wall 34a formed in a tapered shape of the guide portion 34. A space between the pair of legs 162a is an inverted U-shaped valley 162b wider than the lumen 12a of the catheter 12, and the inner needle 16 and the infusion solution can be easily passed.

It should be noted that the shape of the tip locking portion 162 is not particularly limited as long as the plug 160 is locked so that the plug 160 is elastically deformed in a predetermined direction. For example, the distal end locking portion 162 may extend substantially linearly without being curved, and may be locked to the inner wall 34 a of the guide portion 34. Further, for example, the catheter hub 14 may be configured such that a locking projection (not shown) is projected (for example, integrally formed) in the distal end side hollow portion 22a so that the distal end locking portion 162 is hooked.

The intermediate deformation portion 164 is a portion that is connected to the proximal end side of the distal end locking portion 162 and has a shape memorized so as to draw a gentle arc shape in a side view. The intermediate deformation part 164 is elastically deformed relatively easily by being formed thin in the axial direction with a thin plate thickness. That is, the intermediate deformation portion 164 is deformed so as to bend downward in a direction perpendicular to the surface direction of the leaf spring.

The catheter assembly 10B is configured to open the plug slit 53 downward based on the elastic deformation of the intermediate deformation portion 164 of the plug 160. Specifically, it is inserted so that the vicinity of the top portion 164 a of the intermediate portion in the axial direction of the intermediate deformable portion 164 overlaps the occlusion membrane 50 of the hemostasis valve 24. In the punctureable state where the plug 160 is not elastically deformed, the inserted intermediate deformation portion 164 is disposed at a position where the plugging membrane 50 is closed (so as not to provide an opening action at the initial formation position of the plug slit 53). Has been. On the other hand, when the plug 160 is pushed in the distal direction, the intermediate deformation portion 164 becomes a bow, and the top portion 164a is displaced downward to push down the blocking membrane 50. As a result, the plug slit 53 is largely opened.

The proximal end receiving portion 166 is connected to the proximal end side of the intermediate deformable portion 164 and is a portion that receives the pressing force when the connector 20 of the infusion tube comes into contact with the

flange portions

58 and 138 according to the first and second embodiments. Equivalent to. The base end receiving portion 166 is bent by approximately 90 ° with respect to the base end side of the intermediate deformation portion 164. The connection portion 165 with the intermediate deformation portion 164 is formed in a rounded corner, but its radius of curvature is smaller than that of the tip locking portion 162.

Also, the base end receiving portion 166 has a pair of leg portions 166a formed in the downward direction by notching the intermediate portion in the width direction, similarly to the distal end locking portion 162. Between the pair of leg portions 166a, a wide inverted U-shaped valley portion 166b communicating with the inner cavity of the connector 20 in a state where the inner needle 16 is passed and the connector 20 is in contact with each other is formed.

Although the material constituting the plug 160 is not particularly limited, a metal material or a resin material may be applied. Examples of metal materials include pseudoelastic alloys (including superelastic alloys) such as Ni-Ti alloys, shape memory alloys, stainless steel, cobalt alloys, noble metals such as gold and platinum, tungsten alloys, carbon Examples thereof include system materials. Alternatively, the plug 160 may be made of a resin material that is harder than the hemostasis valve 24 and has a rubber property.

14A and 14B, the catheter assembly 10B is configured so that the plug 160 is inserted into the plug slit 53 of the hemostasis valve 24, and the vicinity of the top portion 164a of the intermediate deformable portion 164 is the plug slit in order to configure the punctureable state. It is arranged at a position overlapping 53. In this state, the front end locking portion 162 is just hooked on the inner wall 34a of the guide portion 34. Since the plug 160 and the hemostasis valve 24 are disposed without applying an excessive force to each other, the hollow portion 22 can be satisfactorily closed. The inner needle 16 is also inserted into the inner needle slit 52.

The catheter assembly 10B according to the third embodiment is basically configured as described above, and the operation and effect thereof will be described below.

The catheter assembly 10B is also operated in the same manner as the

catheter assemblies

10 and 10A according to the first and second embodiments. That is, in the puncture enabled state, in the catheter assembly 10B, the catheter 12 and the inner needle 16 are punctured by the patient under the operation of the user, and then the inner needle 16 is pulled out. When the inner needle 16 is pulled out, the plug slit 53 is reliably closed by inserting the plug 160 into the plug slit 53 of the hemostasis valve 24. For this reason, even if blood flows into the hollow portion 22, the hemostasis valve 24 can satisfactorily block blood leakage.

Next, the infusion tube connector 20 is inserted into the catheter hub 14 as shown in FIG. 16A. When the connector 20 is inserted, the distal end surface of the connector 20 contacts the proximal end receiving portion 166 of the plug 160 and pushes the plug 160 in the distal direction. As a result, the intermediate deformation portion 164 of the plug 160 is pushed in the axial direction, and the tip locking portion 162 is hooked, so that the plate surface of the intermediate deformation portion 164 is elastically deformed downward.

Then, at the position where the connector 20 is fitted to the connector connecting portion 38, as shown in FIG. 16B, the top portion 164a of the plug 160 is greatly displaced, and the plug slit pressed against the plate surface of the intermediate deformable portion 164. 53 greatly opens. Therefore, the infusion agent supplied from the connector 20 flows into the proximal end side hollow portion 22b through the valley portion 166b of the proximal end receiving portion 166, and further flows into the distal end side hollow portion 22a through the plug slit 53. .

Further, on the tip side of the hemostasis valve 24, the infusion solution is caused to flow around the flat intermediate deformation portion 164. For this reason, generation | occurrence | production of the retention area | region 84 (refer FIG. 8) in the front end side hollow part 22a can be suppressed. The infusate that has flowed into the distal end side hollow portion 22a is easily guided to the lumen 12a of the catheter 12 and flows into the blood vessel of the patient.

Furthermore, when the connector 20 is moved backward from the catheter hub 14 by exchanging an infusion solution or the like, as shown in FIGS. 17A and 17B, the intermediate deformable portion 164 is elastically restored. That is, the vicinity of the top portion 164a that has been displaced downward automatically returns upward, and the plug slit 53 is closed again.

The plug slit 53 is hermetically sealed by the intermediate deformation portion 164, and the hemostasis valve 24 and the plug 160 firmly close the hollow portion 22. Accordingly, it is possible to favorably avoid blood from leaking into the proximal end side hollow portion 22b of the hemostasis valve 24.

As described above, the catheter assembly 10B according to the third embodiment can achieve the same effects as those of the

catheter assemblies

10, 10A according to the first and second embodiments. In particular, since the intermediate deformation portion 164 of the plug 160 that is always inserted into the plug slit 53 can be elastically deformed in the vertical direction perpendicular to the left-right direction of the plug slit 53, the plug is deformed along with the deformation of the intermediate deformation portion 164. The slit 53 can be easily opened.

Further, since the base end receiving portion 166 is formed at the base end of the plug 160, the plate-shaped intermediate deformation portion 164 can be easily deformed by the pressing force from the connector 20 of the infusion tube, and the plug slit 53 is formed. Can be opened. In addition, the shape of the both ends of the plug 160 is not specifically limited, For example, you may weld the

flange parts

58 and 138 which concern on 1st or 2nd embodiment by welding etc.

In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Yes.

Claims

A catheter (12);
A hub (14) holding the catheter (12) and having a hollow portion (22) communicating with the hole (12a) of the catheter (12);
An inner needle (16) that can be inserted through the hole (12a) and the hollow portion (22);
An insertion member (30, 130, 160) disposed in the hollow portion (22) so as to be displaceable;
A valve body (24) provided in the hollow portion (22),
The valve body (24) includes an inner needle slit (52) through which the inner needle (16) is inserted, and an insertion member slit (53) through which the insertion member (30, 130, 160) is inserted. A catheter assembly (10, 10A, 10B).
The catheter assembly (10, 10A) according to claim 1,
The insertion member (30, 130) is connected to a closing portion (54, 134) that closes the slit (53) for the insertion member, and a base end side of the closing portion (54, 134). 134) and opening portions (56, 136) that open the slits (53) for the insertion member by being different in shape or phase,
One of the blocking portions (54, 134) and the opening portions (56, 136) is always inserted in the insertion member slit (53). The catheter assembly (10, 10A) ).
Catheter assembly (10) according to claim 2,
The cross-sectional shape of the open portion (56) is substantially similar to the cross-sectional shape of the closed portion (54), and the phase around the axis of the insertion member (30) is approximately 90 ° with respect to the closed portion (54). A catheter assembly (10) characterized in that it is displaced.
The catheter assembly (10A) according to claim 2,
The open part (136) has a flow hole (142) that is longer in the axial direction than the thickness of the blocking membrane (50) provided with the slit (53) for the insertion member of the valve body (24). Feature catheter assembly (10A).
The catheter assembly (10A) according to claim 4,
The catheter assembly (10A), wherein the blocking part (134) and the opening part (136) have the same thickness in a direction perpendicular to the extending direction of the insertion member slit (53).
The catheter assembly (10B) of claim 1,
The insertion member (160) is always inserted into the insertion member slit (53),
The insertion member (160) includes a deformable portion (164) that can be elastically deformed in a direction orthogonal to the extending direction of the insertion member slit (53). The catheter assembly (10B).
The catheter assembly (10B) according to claim 6,
The deformation part (164) is formed in a plate shape and extends in the axial direction,
At one end of the insertion member (160), a receiving portion (166) that is curved and connected to the deformable portion (164) and can receive a pressing force from a connector (20) connected to the hub (14). A catheter assembly (10B) characterized in that is formed.
The catheter assembly (10, 10A, 10B) according to claim 1,
The inner needle slit (52) and the insertion member slit (53) are formed in parallel, and the cut width of the insertion member slit (53) is larger than the cut width of the inner needle slit (52). A catheter assembly (10, 10A, 10B) characterized in that it is also long.