JP6735024B2 - Indwelling needle - Google Patents

Description

The present invention relates to an indwelling needle that is punctured and indwelled in a blood vessel when performing infusion, blood collection, hemodialysis or the like.

Traditionally, an indwelling device with a cannula that can be used for percutaneous puncture of blood vessels during long-term blood sampling such as dialysis or infusion (including blood transfusion) or multiple blood sampling or infusion for inpatients Needles are used. As such an indwelling needle, as described in, for example, Japanese Unexamined Patent Application Publication No. 2003-199822 (Patent Document 1), a cannula that is percutaneously inserted into a blood vessel is provided on the distal end side, and an external flow is provided. There is known a structure in which a connection connector that can be connected to a passage is provided on the proximal end side, and a valve body is arranged in an internal flow path from the cannula to the connection connector.

By the way, when connecting the internal flow path of the punctured indwelling needle to an external infusion flow path or the like, it is desirable to avoid mixing of air into the body. Therefore, Japanese Patent Laying-Open No. 2015-136524 (Patent Document 2) proposes an adapter structure that opens a valve body to promote air discharge when introducing reverse blood.

However, in the adapter structure described in Patent Document 2, the valve (9) in the catheter (3) is always kept open by the adapter (15) mounted in advance. Therefore, in the indwelling needle (1) provided on the market with the adapter (15) attached, there is a risk that the valve (9) may have an initial shape squeezed into the open state, resulting in insufficient closure when shutting off. there were. In addition, since the valve (9) in the catheter (3) is opened in the initial state by the adapter (15), reverse blood is generated at the same time when the inner needle (17) is removed, and the reverse blood is introduced. There was a problem that it was difficult to control.

JP, 2003-199822, A JP, 2005-136524, A

Here, the present invention has been made in view of the circumstances as described above, and the problem to be solved is to easily control the reverse blood introduction without adversely affecting the closing property at the time of shutting off the valve body. Accordingly, it is an object of the present invention to provide an indwelling needle having a novel structure, which can discharge residual air when connecting to an external flow path with good workability.

Hereinafter, embodiments of the present invention made to solve such problems will be described. The constituent elements used in each of the following aspects can be used in any combination as much as possible. The aspects and technical features of the present invention are not limited to those described below, but are described in the entire specification and the drawings, or the invention idea that can be understood by those skilled in the art from those descriptions. It should be understood that it is recognized based on.

A first aspect of the present invention has a cannula that is percutaneously inserted into a blood vessel on the distal end side and a connection connector on the proximal end side, and an internal flow from the cannula to the connection connector is provided. In the indwelling needle in which the passage is formed and the valve body is arranged in the internal flow path, the valve body can be held in a non-communication state in a state of being attached to the connection connector, and by an external operation. An air bleeding member that switches the valve body to a communicating state and bleeds air from the internal flow passage through the valve body in the communicating state is provided, and a part or the whole of the air bleeding member flows through the internal flow passage. By moving the valve body to the tip side in the road direction and pushing the valve body open to switch to the communication state, it is possible to bleed the internal flow passage through which the air does not escape to the outside through the valve body in the communication state. The valve body is restored to and held in the non-communication state by moving a part or the whole of the air bleeding member toward the base end side in the flow path direction.

According to the indwelling needle having the structure according to this aspect, since the valve body is held in the non-communication state even when the air bleeding member is attached to the connection connector, for example, the air bleeding member is attached to the connection connector. Even when the valve body is provided on the market in a closed state, the valve body can be prevented from being urged to the open state, and the shutoff performance of the valve body during use can be stably obtained.

Also, with the air bleeding member attached to the connector, the valve body can be switched between communication and cutoff by an external operation, so that the valve body can be communicated at any time to introduce reverse blood. In addition, it is possible to bleed air in the internal flow path, which makes it easy to control the operation of introducing reverse blood and bleeding air.

A second aspect of the present invention is the indwelling needle according to the first aspect, wherein the air bleeding member is attachable to and detachable from the connection connector.

According to the indwelling needle having the structure according to this aspect, since the air bleeding member can be attached to and detached from the connection connector, after the air bleeding, the air bleeding member is removed from the connection connector to the connection connector. The external flow path can be directly connected. Thereby, the internal flow path and the external flow path can be more reliably communicated with each other.

A third aspect of the present invention is the indwelling needle according to the first or second aspect, wherein a removable inner needle is inserted from the proximal end side to the distal end side of the internal flow path. ..

According to the indwelling needle having the structure according to the present aspect, even when the inner needle is withdrawn after the inner needle is inserted into the cannula (outer needle) and punctured, the valve body is substantially closed in advance, By preventing or suppressing back blood that occurs at the same time as the removal of the inner needle, it becomes easy to control the back blood introduction together with air removal.

A fourth aspect of the present invention is the indwelling needle according to the third aspect, wherein the inner needle is detachably inserted into the internal flow path in a state where the air bleeding member is attached to the connection connector. There is something.

With the indwelling needle having the structure according to the present aspect, the inner needle is inserted into the internal flow path with the air bleeding member attached to the connection connector, so that the indwelling needle is punctured without the air bleeding member attached. Then, troublesome work such as mounting an air bleeding member after removing the inner needle can be omitted.

A fifth aspect of the present invention is the indwelling needle according to any one of the first to fourth aspects, wherein the air bleeding member is movable with respect to the base cap attached to the connection connector. And an operating cap assembled to the base cap. By operating the operating cap from the outside to move the operating cap, the valve body can be switched between a communication state and a non-communication state. Is what

According to the indwelling needle having the structure according to the present aspect, the air bleeding member is configured to include the base cap and the operation cap, and by moving only the operation cap with respect to the base cap, the valve body is brought into the communication state. Since it is switched to the non-communication state, it is possible to more easily perform operations such as air bleeding. As a mechanism for moving the operation cap with respect to the base cap, in addition to the screw feeding mechanism described in the sixth aspect below, the operation cap may be pushed into the base cap.

A sixth aspect of the present invention is the indwelling needle according to the fifth aspect, wherein a screw feed mechanism is provided between the operation cap and the base cap, and the operation cap is rotationally operated from the outside. Thus, the base cap is moved toward the distal end side in the flow direction of the internal flow path to push and open the valve body to switch to the communication state.

According to the indwelling needle having the structure according to the present aspect, the valve body can be brought into the communicating state only by rotating the operation cap with respect to the base cap, and therefore the operation such as air bleeding can be performed more easily. it can. Further, by adopting the screw feeding mechanism as in the present aspect, the operation cap can be moved forward with respect to the base cap gently, and the risk that the valve body is damaged or falls off can be avoided.

A seventh aspect of the present invention is the indwelling needle according to the fifth or sixth aspect, wherein the operation cap is provided with an air vent hole penetrating in a flow direction of the internal flow path. The vent hole is adapted to be communicated with the internal flow path in the communication state of the valve body.

According to the indwelling needle having the structure according to this aspect, since the air vent hole is formed in the operation cap and the air vent hole is communicated with the internal flow passage in the communication state of the valve body, The air in the internal flow path can be efficiently discharged. In particular, by combining with the fourth aspect, it is possible to use, for example, the air vent hole as an insertion hole for the inner needle.

An eighth aspect of the present invention is the indwelling needle according to any one of the first to seventh aspects, wherein a sleeve-like pusher is provided in the flow passage direction on the proximal end side of the valve body in the internal flow passage. The pusher is arranged movably, and the pusher is moved toward the valve body by operating the air bleeding member from the outside, and the pusher moves toward the valve body, and the valve body is moved. Is pushed open to establish a communication state.

According to the indwelling needle having the structure according to this aspect, the pusher moves by operating the air bleeding member from the outside to bring the valve body into a communicating state, so that the air bleeding member is unnecessarily lengthened, etc. It is possible to improve the operability because it is possible to reduce the portion of the air bleeding member that enters the inside of the connection connector.

A ninth aspect of the present invention is the indwelling needle according to the eighth aspect, wherein the pusher is moved toward the valve body by connecting an external flow path to the connection connector. At the same time, when the pusher moves toward the valve body, the valve body is pushed open and brought into a communication state.

According to the indwelling needle having the structure according to the present aspect, even when the external flow path is connected to the connection connector, the pusher moves to bring the valve element into a communicating state, so that the portion that enters the connection connector in the external flow path. Can be made as small as the length of the pusher, and the connection and removal of the external flow path can be facilitated.

A tenth aspect of the present invention is the indwelling needle according to any one of the first to ninth aspects, wherein a needle base is provided at a proximal end of the cannula, and the needle base and the connection connector are provided. A soft tube is provided between them.

According to the indwelling needle having the structure according to the present aspect, since the soft tube is provided, the indwelling needle can be easily deformed at the portion of the soft tube, and the indwelling needle can be placed along the patient's skin. It can be fixed more stably. Further, by closing not only the valve body but also the soft tube with a clamp or the like, it becomes possible to control the timing of reverse blood more accurately.

With the indwelling needle having the structure according to the present invention, the valve body can be blocked more reliably, and the control of reverse blood introduction can be facilitated, so that the air bleeding in the internal flow path can be stably realized. ..

The perspective view which shows the whole indwelling needle as one Embodiment of this invention. The top view of the indwelling needle shown by FIG. The longitudinal cross-sectional view of the indwelling needle shown in FIG. FIG. 4 is a vertical cross-sectional view showing an enlarged main part in FIG. 3. FIG. 2 is an enlarged vertical cross-sectional view showing a main part in a state immediately after an inner needle is pulled out from the indwelling needle shown in FIG. 1. FIG. 3 is a vertical cross-sectional view showing a state in which the inner cap is pulled out from the indwelling needle shown in FIG. 1 and the operation cap is operated. FIG. 7 is a vertical cross-sectional view showing an enlarged main part in FIG. 6. FIG. 2 is a vertical cross-sectional view showing a state in which an air bleeding member is removed from the indwelling needle shown in FIG. 1 and an external flow path is connected.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.

First, FIGS. 1 to 4 show an indwelling needle assembly 13 including an outer needle unit 12 as one embodiment of an indwelling needle according to the present invention. The indwelling needle assembly 13 is configured by inserting the inner needle unit 14 into the outer needle unit 12. Further, the outer needle unit 12 has an outer needle 16 as a cannula on the distal end side and a connecting connector 18 on the proximal end side. Inside the outer needle unit 12, the outer needle 16 is connected to the connecting connector. An internal flow path 20 reaching 18 is formed. An air bleeding member 22 is attached to the proximal end of the connection connector 18, the indwelling needle assembly 13 is punctured, the inner needle unit 14 is pulled out from the outer needle unit 12, and the outer needle unit 12 is turned into a blood vessel of a patient. After the indwelling and before connecting the connector 18 and the external flow path such as the syringe, the air in the internal flow path 20 is discharged by operating the air bleeding member 22 from the outside. In the following description, the needle axis direction refers to the left-right direction in FIG. 2 in which the outer needle 16 extends, and the tip side refers to the side to be punctured by the patient on the left side in FIG. The side refers to the right side in FIG. 2, which is the side operated by the user.

More specifically, the inner needle unit 14 includes an inner needle 26 having a sharp needle tip 24 at the tip, an inner needle hub 28 attached to the proximal end of the inner needle 26, and a needle axial direction with respect to the inner needle 26. And a needle tip protector 30 movably attached to the needle tip protector 30.

In the present embodiment, the inner needle 26 is a hollow needle and is made of a known material such as stainless steel, aluminum, titanium or alloys thereof. The needle tip 24 provided at the tip of the inner needle 26 is formed with an inclined surface that is inclined with respect to the needle axis direction, so that the living body can be punctured easily and with low stimulation. A large-diameter portion (not shown) having a large outer diameter is formed on the outer peripheral surface of the tip portion of the inner needle 26. The large-diameter portion may be formed partially or entirely in the circumferential direction by subjecting the inner needle 26 to crushing or by manufacturing the inner needle 26 by centerless processing. The inner needle may be a solid needle.

On the other hand, the inner needle hub 28 attached to the base end of the inner needle 26 has a substantially cylindrical pedestal portion 32 to which the base end of the inner needle 26 is fixed in an embedded state, and a pedestal portion 32 from the tip of the pedestal portion 32. A substantially cylindrical cap accommodating portion 34 protruding with a larger outer diameter dimension and a substantially cylindrical connecting portion 36 protruding from the base end of the pedestal portion 32 are integrally molded of synthetic resin. It should be noted that the cap accommodating portion 34 is adapted to accommodate an operation cap 86 of the air bleeding member 22 described later.

Further, an inner needle cap 38 is removably attached to the proximal end side opening of the connecting portion 36. The inner needle cap 38 is a substantially stepped cylindrical synthetic resin member having a stepped portion at an intermediate portion in the needle axis direction. A ventilation filter (not shown) is provided inside the inner needle cap 38, and the ventilation filter has a property of transmitting gas but blocking liquid. By assembling the inner needle cap 38 to the connecting portion 36, the base end side opening of the inner needle hub 28 is covered in a liquid-tight manner so that reverse blood through the inner needle 26 does not leak to the outside. ing. Further, since the inner needle hub 28 and the inner needle cap 38 are made of a transparent material, it is possible to easily confirm reverse blood (flashback).

The needle tip protector 30 of the inner needle unit 14 is configured to include a protector body 40 having a substantially cylindrical shape with a distal end portion having a larger diameter than the proximal end portion, and a proximal end side opening portion of the protector body 40. Is closed by a bottom wall 42 extending in the direction perpendicular to the axis. A base end side needle insertion hole 44 penetrating in the needle axis direction is formed at the center of the bottom wall 42, and a metal locking ring 46 is fixed to the tip end side end surface of the bottom wall 42. There is. The inner diameter dimensions of the proximal needle insertion hole 44 and the locking ring 46 are smaller than the outer diameter dimension of the large diameter portion of the inner needle 26, and at the portions other than the large diameter portion of the inner needle 26. It is larger than the outer diameter.

On the other hand, the front end side opening of the protector main body 40 is closed by assembling a lid 48 having a substantially flat plate shape as a whole. An intermediate part needle insertion hole 50 is formed penetrating in the proximal direction of the lid body 48 in the needle axis direction, and a tip side needle insertion hole 52 is formed penetrating in the needle axis direction in the distal end side. The intermediate part needle insertion hole 50 and the tip side needle insertion hole 52 are provided with a predetermined distance from each other in the needle axis direction. The inner diameters of the intermediate portion needle insertion hole 50 and the tip side needle insertion hole 52 are made larger than the outer diameter dimension of the large diameter portion of the inner needle 26. Further, the length dimension in the needle axis direction from the proximal end side needle insertion hole 44 to the intermediate partial needle insertion hole 50 is made larger than the length dimension from the large diameter portion to the tip of the inner needle 26. Then, the proximal end side of the large diameter portion of the inner needle 26 is inserted into the proximal end side needle insertion hole 44, the intermediate portion needle insertion hole 50, and the distal end side needle insertion hole 52 of the needle tip protector 30, so that the needle tip protector 30. Is attached to the inner needle 26 so as to be movable in the needle axis direction.

Further, a shielding member 54 and a fixing member 56 are provided on the tip side of the intermediate portion needle insertion hole 50 in the lid 48, and the shielding member 54 and the fixing member 56 are housed and arranged in the needle tip protector 30. Has been done. The shielding member 54 and the fixing member 56 are respectively block-shaped and are provided on both sides of the inner needle 26 in the direction perpendicular to the axis, and the shielding member 54 is provided above the inner needle 26 in FIGS. On the other hand, the fixing member 56 is provided below the inner needle 26 in FIGS. Further, the shielding member 54 is displaceable in the direction perpendicular to the axis, while the fixing member 56 is fixedly attached to the lid 48. One of the shield member 54 and the fixing member 56 is a magnet, and the other is a magnet or a ferromagnetic material such as iron, so that magnetic attraction is exerted on each other. As a result, the shielding member 54 is constantly subjected to an urging force that approaches the fixing member 56, and the displacement of the shielding member 54 in the direction of approaching the fixing member 56 is limited by contacting the inner needle 26. ing.

The protector body 40 and the lid 48 can be preferably formed of, for example, a hard synthetic resin.

The proximal end of the inner needle 26 having the above structure is fixed to the inner needle hub 28, and the needle tip protector 30 is externally attached to the inner needle 26, whereby the inner needle unit 14 of the present embodiment is provided. It is configured.

Next, in the outer needle unit 12, in the present embodiment, the outer needle 16 has a hollow needle shape and has appropriate flexibility. The outer needle 16 can be made of various soft resins such as ethylene-tetrafluoroethylene copolymer (ETFE), polyurethane, polyether nylon resin, and polypropylene. For the same reason as the needle tip 24 of the inner needle 26, the outer peripheral surface at the tip of the outer needle 16 may be tapered so that the outer diameter gradually decreases toward the tip. Further, at the tip of the outer needle 16, one or more through holes may be provided in the peripheral wall, if necessary, so that the fluid can efficiently flow to the outer needle 16.

An outer needle hub 58 as a substantially cylindrical needle base is liquid-tightly fixed to the proximal end of the outer needle 16 so that the inner cavity of the outer needle 16 and the inside of the outer needle hub 58 communicate with each other. .. Further, a soft tube 60 made of a soft synthetic resin is liquid-tightly fixed to the base end of the outer needle hub 58. In the present embodiment, the distal end of the soft tube 60 is sandwiched between the overlapping surfaces of the proximal end of the outer needle 16 and the proximal end of the outer needle hub 58 in the axis-perpendicular direction, and adhesion or welding is performed as necessary. By being applied, it is fixed while maintaining liquid tightness. The connector 18 is liquid-tightly fixed to the base end of the soft tube 60. In other words, the outer needle hub 58 (needle base) is provided at the proximal end of the outer needle 16 (cannula), and the soft tube 60 is provided between the outer needle hub 58 and the connection connector 18. There is.

The connector 18 has a substantially cylindrical shape as a whole. That is, an intermediate wall portion 62 that protrudes from the inner peripheral surface in the axis-perpendicular direction and expands in an annular shape is provided inside the intermediate portion of the connector 18 in the needle axis direction, and the outer end surface of the tip end side of the intermediate wall portion 62 is provided. A cylindrical fixed cylinder portion 64 extends from the peripheral portion toward the tip side. On the other hand, from the outer peripheral edge of the base end side end surface of the intermediate wall portion 62, the accommodating cylinder portion 66 extends toward the base end side with an outer diameter dimension substantially the same as that of the fixed cylinder portion 64. Then, the proximal end portion of the soft tube 60 is inserted into the distal end side opening portion of the fixed tubular portion 64, and adhesion or welding is performed as necessary, so that the connection connector 18 is attached to the proximal end of the soft tube 60. It is fixed. An insertion hole 68, through which the inner needle 26 is inserted, is formed in the center of the intermediate wall portion 62 with an inner diameter larger than that of the large diameter portion of the inner needle 26. A male screw 72 is provided on the outer peripheral surface of the base end side opening 70 of the housing cylinder 66. Thereby, as will be described later, the external flow path 110 such as a luer lock syringe can be connected to the base end side opening 70 of the connection connector 18.

The inner hole of the outer needle 16, the inner hole of the outer needle hub 58, the inner hole of the soft tube 60, and the inner hole of the connector 18 (specifically, the inner hole 79 of the pusher 80 described later) communicate with each other. Due to these inner holes, the internal flow path 20 of the present embodiment is configured to extend in the left-right direction in FIG.

Here, in the internal flow path 20, the hemostatic valve mechanism 74 is housed inside the housing cylinder portion 66. That is, on the proximal end side of the intermediate wall portion 62, an elastic valve body 76 as a substantially disc-shaped valve body made of rubber or elastomer is disposed in contact with the intermediate wall portion 62, and the elastic valve The body 76 is formed with a substantially constant thickness dimension.

In the present embodiment, the central portion of the elastic valve body 76 serves as the valve main body portion 76a, and the slits 78 (see FIG. 5) extending at equal intervals (every 120°) in the three directions from the center are formed therethrough. The shape of the slit is not limited to any particular shape, and may be a single letter shape, a cross shape, or a radial shape extending from the center in a plurality of directions. The slit 78 of the elastic valve body 76 is in a closed state in a state in which the elastic valve body 76 is not acted upon from the outside, and the distal end side and the proximal end side of the elastic valve body 76 are not in communication with each other. It is said that. In addition, a cylindrical holding portion 76b that projects toward the base end side is integrally formed on the outer peripheral edge portion of the elastic valve body 76. Further, the holding portion 76b has a tapered inner peripheral surface 76c whose inner diameter gradually increases toward the base end side. Furthermore, a concave groove 76d that extends in the circumferential direction on the inner peripheral surface of the holding portion 76b is formed on the end surface of the elastic valve body 76 on the base end side. The recessed groove 76d allows elastic deformation that opens the slit 78 when the pusher 80 is pressed, which will be described later, relatively easily, and also improves durability due to stress relaxation.

A sleeve-shaped pusher 80 having an inner hole 79 is arranged on the proximal end side of the elastic valve body 76, and a substantially cylindrical pusher guide 82 is accommodated on the outer peripheral side of the pusher 80. It is fixedly attached to the inner peripheral surface of the tubular portion 66 by concave-convex fitting. The inner peripheral surface of the pusher guide 82 is a guide surface 82a extending in the needle axis direction with a substantially constant inner diameter.

It should be noted that the proximal end portion of the pusher guide 82 is provided with a cylindrical retaining portion 82b that protrudes toward the inner circumference by making the inner diameter slightly smaller. On the other hand, at the tip of the pusher guide 82, a pressing protrusion 82c having an outer diameter gradually reduced is integrally formed. The pressing projection 82c is fitted into the holding portion 76b of the elastic valve body 76 so that the tapered inner peripheral surface 76c and the outer peripheral surface of the pressing projection 82c are overlapped with each other, and the tip of the pressing projection 82c is elastic valve body. The groove 76d of the base end surface of the groove 76 is inserted. As a result, the holding portion 76b of the elastic valve body 76 is fluid-tightly sandwiched in the radial direction between the housing cylinder portion 66 and the pusher guide 82, and the outer peripheral portion of the elastic valve body 76 is arranged in the needle axis direction. It is sandwiched between the intermediate wall portion 62 and the pusher guide 82.

Further, the distal end portion of the pusher 80 is provided with a penetrating portion 80a having a tapered outer peripheral surface whose outer diameter gradually decreases toward the tip end side, and the base end portion of the penetrating portion 80a is a shaft of the pusher 80. It is a step portion 80b protruding on the outer peripheral surface at the intermediate portion in the direction. The stepped portion 80b is locked to the retaining portion 82b of the pusher guide 82, so that the tip end portion of the pusher 80 is assembled while preventing the pusher guide 82 from being pulled out. The tip of the pusher 80 is axially opposed to a portion on the inner peripheral side of the concave groove 76d on the base end side end surface of the valve body portion 76a. In the present embodiment, the pusher 80 has a distal end. The tip end and the base end side end surface of the valve body portion 76a are in contact with each other. On the other hand, the proximal end side of the step portion 80b of the pusher 80 extends in a substantially straight cylindrical shape.

In the penetrating portion 80a of the pusher 80 having such a shape, the outer peripheral surface of the base end portion having the maximum outer diameter is in sliding contact with the guide surface 82a of the pusher guide 82, and is closer to the base end side than the step portion 80b of the pusher 80. When the pusher 80 is guided by the pusher guide 82, the pusher 80 is guided by the pusher guide 82 in the needle axis direction (the length direction of the internal flow path 20) by the outer peripheral surface of the pusher guide 82 slidingly contacting the cylindrical inner peripheral surface of the retaining portion 82b. Relative movement is possible.

Then, the pusher 80 moves toward the tip end side in the axial direction by the operation force applied from the outside and is pressed against the elastic valve body 76, so that the slit 78 of the valve body portion 76a is pushed open so that the communication state is established. Has become. On the other hand, when the operating force is released, the elastic force of the elastic valve body 76 restores the pusher 80 to the initial position on the base end side, and the slit 78 is automatically restored to the closed state. I'm supposed to get it.

Since the connector 18 and the soft tube 60 accommodating the hemostatic valve mechanism 74 are made of transparent members, reverse blood (flashback) and opening/closing of the elastic valve body 76 can be easily confirmed.

The air bleeding member 22 is attached to the base end side opening 70 of the connection connector 18 having the above structure. The air bleeding member 22 includes a base cap 84 attached to the connector 18, and an operation cap 86 movably assembled to the base cap 84.

The base cap 84 includes a tubular protrusion 88 having a center hole 87 extending in the needle axis direction. The tubular projection 88 has an outer peripheral surface having a shape corresponding to the inner peripheral surface of the base end side opening 70 of the connector 18, and extends toward the distal end side in the needle axis direction. Further, on the outer peripheral side of the tubular protrusion 88, an annular peripheral wall 92 having an internal thread 90 formed on the inner peripheral surface thereof is provided. The tubular projections 88 and the peripheral wall 92 are connected to each other at their base ends by an annular bottom wall 94. Further, from the outer peripheral edge of the bottom wall 94, a tubular holding cylinder portion 96 is located at the base end side. Has been extended to. A male screw 97 is provided on the inner peripheral surface of the central hole 87 of the tubular protrusion 88.

On the other hand, the operation cap 86 includes a substantially annular plate-shaped tip wall portion 98, and a pushing cylinder portion 100 extending in the needle axis direction from the center of the tip end surface of the tip wall portion 98 is concentric with the tip wall portion 98. Is extended to the tip side. As a result, the inner hole of the distal end wall portion 98 and the inner hole of the pushing cylinder portion 100, which have substantially the same inner diameter, are communicated with each other, and these inner holes form the central through hole 102 extending in the needle axis direction. ing. The inner diameter of the central through hole 102 is larger than that of the large diameter portion of the inner needle 26, while the outer diameter of the pushing tube portion 100 is substantially equal to or slightly smaller than the inner diameter of the tubular protrusion 88. There is. Further, the outer diameter dimension of the tip wall portion 98 is substantially equal to or slightly smaller than the inner diameter dimension of the holding cylinder portion 96. A female screw 103 is formed on the outer peripheral surface of the pushing cylinder portion 100. Further, the length dimension of the pushing cylinder portion 100 in the needle axis direction is set larger than the length dimension of the tubular protrusion 88 in the needle axis direction.

Further, a cylindrical protector accommodating portion 104 extends from the outer peripheral edge portion of the proximal end side surface of the distal end wall portion 98 toward the proximal end side in the needle axis direction. The length dimension of the protector accommodating portion 104 in the needle axis direction is substantially equal to that of the needle tip protector 30, and the inner diameter dimension of the protector accommodating portion 104 is substantially equal to the maximum outer diameter dimension of the tip portion of the needle tip protector 30. It has been made slightly larger. Further, the outer diameter dimension of the protector housing portion 104 is substantially equal to or slightly smaller than the inner diameter dimension of the cap housing portion 34.

Furthermore, a recess 106 is formed on the proximal end surface of the distal end wall portion 98 on the inner peripheral side of the protector accommodating portion 104, and a block-shaped magnetic body 108 is fixed in the recess 106. There is. The magnetic body 108 is formed of a magnet or a ferromagnetic body such as iron, and when assembled with the indwelling needle assembly 13, the magnetic body 108 and the shield member 54 or the fixing member 56 are magnetic in the needle axis direction. The suction power is generated.

The pushing cylinder portion 100 of the operation cap 86 is inserted into the center hole 87 of the tubular projection 88 of the base cap 84 having such a structure, the male screw 97 and the female screw 103 are screwed together, and the holding cylinder portion 96 of the base cap 84 is also inserted. The air bleeding member 22 is configured by inserting the tip wall portion 98 of the operation cap 86 and the tip portion of the protector housing portion 104 into the. In the initial state shown in FIGS. 3 and 4, a predetermined facing distance is provided between the bottom wall 94 of the base cap 84 and the tip wall portion 98 of the operation cap 86 in the needle axis direction. Further, in the initial state, the tip of the pushing cylinder portion 100 projects from the tip of the tubular projection 88, but it does not have to project.

Then, the tubular protrusion 88 of the air bleeding member 22 is inserted into the base end side opening 70 of the housing tubular portion 66 of the connection connector 18, and the female screw 90 provided on the inner peripheral surface of the peripheral wall 92 of the base cap 84 is formed. The air bleeding member 22 is detachably attached to the connection connector 18 by screwing a male screw 72 provided on the outer peripheral surface of the base end of the housing tubular portion 66. At this time, the tip of the push-in cylinder portion 100 of the air bleeding member 22 may come into contact with the base end of the pusher 80 disposed inside the accommodating cylinder portion 66 in the needle axis direction or be slightly separated. Accordingly, the elastic valve body 76 is held in a closed state (non-communication state) without an external force moving to the tip side being applied to the pusher 80 when the air bleeding member 22 is attached. However, to the extent that the elastic valve body 76 is held in the closed state, the distal end of the pushing cylinder portion 100 and the proximal end of the pusher 80 abut, and the pushing cylinder portion 100 pushes the pusher 80 toward the tip end side. You may stay.

As described above, when the air bleeding member 22 is attached to the connection connector 18, the inner needle unit 14 (inner needle 26) is inserted into the outer needle unit 12, so that the indwelling needle assembly 13 of the present embodiment is provided. It is configured.

That is, the needle tip protector 30 is accommodated from the proximal end side in the protector accommodating portion 104 (operation cap 86) of the air bleeding member 22, and the operation cap 86 accommodating the needle tip protector 30 is accommodated in the cap of the inner needle hub 28. It is inserted into the portion 34 from the tip side. In the present embodiment, when the needle tip protector 30 is accommodated in the protector accommodating portion 104, the shield member 54 accommodated in the needle tip protector 30 and the magnetic body 108 fixed to the distal end wall portion 98 of the operation cap 86 are provided. They are arranged to face each other in the needle axis direction via the lid body 48. Here, since a magnetic attraction force is generated in the magnetic member 108 with respect to the shield member 54 or the fixing member 56 in the needle axis direction, the needle tip protector 30 is operated by the operation cap 86 (the protector housing portion 104). ) Is detachably accommodated and held. By adjusting the sizes and shapes of the shielding member 54, the fixing member 56, and the magnetic body 108, respectively, the shielding member 54 and the fixing member 56 are stronger than the mutual attraction force between the magnetic body 108 and the shielding member 54 or the fixing member 56. The mutual attraction with and is larger.

In addition, the inner needle 26 inserted into the needle tip protector 30 is inserted into the central through hole 102 of the air bleeding member 22 and the internal flow path 20 provided inside the outer needle unit 14 is inserted from the proximal end side. It is inserted toward the tip side. That is, the inner needle 26 penetrates the hemostatic valve mechanism 74, and specifically, the inner needle 26 is inserted into the inner hole 79 of the pusher 80 and the slit 78 of the elastic valve body 76. .. Here, since the elastic valve body 76 is in close contact with the inner needle 26, the elastic valve body 76 is held in a substantially closed state (non-communication state). The tip of the inner needle 26 inserted into the outer needle unit 14 projects from the tip of the outer needle 16.

The indwelling needle assembly 13 of the present embodiment having the above-described structure is punctured into the skin of a patient with the inner needle unit 14 inserted into the outer needle unit 12 shown in FIGS. Thereafter, by pulling out the inner needle unit 14 (inner needle 26) from the outer needle unit 12 to the proximal end side, the outer needle 16 of the outer needle unit 12 is percutaneously inserted and left in the blood vessel of the patient. It

At this time, the inner needle 26 is pulled out to the proximal end side, and the needle tip 24 of the inner needle 26 reaches the proximal end side with respect to the shielding member 54, so that the contact between the inner needle 26 and the shielding member 54 is released. Then, the shielding member 54 is displaced in the direction of approaching the fixed member 56 according to the biasing force. As a result, the shielding member 54 is displaced on the needle shaft of the inner needle 26, and the needle tip 24 of the inner needle 26 is protected by the needle tip protector 30. Then, by further pulling out the inner needle 26 toward the proximal end side, the large diameter portion of the inner needle 26 and the locking ring 46 (bottom wall 42) provided at the proximal end portion of the needle tip protector 30 are engaged. As the inner needle 26 is pulled out, the needle tip protector 30 is also displaced proximally with respect to the outer needle unit 12 and the air bleeding member 22. As a result, the needle tip protector 30 is removed from the protector accommodating portion 104 of the operation cap 86 while the needle tip 24 of the inner needle 26 is protected, and the inner needle unit 14 is removed from the outer needle unit 12. By providing the locking ring 46 at the base end portion of the needle tip protector 30, the engagement force between the large diameter portion of the inner needle 26 and the needle tip protector 30 can be improved.

When the inner needle 26 is removed, the inner needle 26 passes through the elastic valve body 76, so that the elastic valve body 76 is deformed based on the restoring action as shown in FIG. The slit 78 of the body 76 is closed to maintain the non-communication state. Therefore, even if the inner needle 26 is removed from the indwelling needle assembly 13, back blood does not occur.

After removing the inner needle unit 14, as shown in FIGS. 6 and 7, by rotating the operation cap 86 from the outside with respect to the base cap 84 of the air bleeding member 22 and moving the operation cap 86 toward the distal end side, the tubular protrusion 88 is formed. The tip of the push-in cylinder 100 further projects from the tip of the. Since the male screw 97 provided on the inner peripheral surface of the central hole 87 of the tubular protrusion 88 and the female screw 103 provided on the outer peripheral surface of the pushing cylinder portion 100 are screwed together, the operation cap 86 is attached to the base cap. The screw can be efficiently screw-fed to the tip side with respect to 84. In this way, by moving the pushing cylinder portion 100 toward the tip side, the pusher 80 located on the tip side of the pushing cylinder portion 100 is pushed toward the elastic valve body 76 and pushes the slit 78 of the elastic valve body 76. When opened, the elastic valve body 76 can be switched to the communicating state. Therefore, in this embodiment, the male screw 97 provided on the inner peripheral surface of the central hole 87 of the tubular protrusion 88 and the female screw 103 provided on the outer peripheral surface of the pushing cylinder portion 100 constitute a screw feeding mechanism. The movement end of the operation cap 86 toward the tip end in the needle axis direction with respect to the base cap 84 can be defined by the bottom wall 94 of the base cap 84 and the tip wall portion 98 of the operation cap 86 contacting each other.

In this way, the operation cap 86 moves toward the tip side so that the central through hole 102 of the air bleeding member 22 and the inner hole 79 of the pusher 80 communicate with each other, and the elastic valve body 76 is brought into a communication state. By doing so, the internal flow path 20 and the central through hole 102 are communicated with each other. Therefore, the internal flow path 20 extending from the blood vessel of the patient is opened to the outside through the inner hole 79 of the pusher 80 and the central through hole 102 of the air bleeding member 22, and the reverse blood flow is started. Then, the blood in the internal flow path 20 is pushed out by backflowing the blood of the patient into the internal flow path 20, and is discharged to the outside through the internal hole 79 of the pusher 80 and the central through hole 102 of the air bleeding member 22. It That is, in the present embodiment, the air vent hole is formed by the central through hole 102.

After the inner needle 26 is removed, the soft tube 60 may be closed with a clamp or the like before operating the operation cap 86. Then, the operation cap 86 may be operated to bring the elastic valve body 76 into a communication state, and the clamp may be gradually opened to start reverse blood flow.

Then, when the blood flowing back through the internal flow path 20 approaches the elastic valve body 76, the operation cap 86 is operated from the outside to move to the proximal end side. The elastic valve body 76 is deformed to the initial shape, the slit 78 is closed, the elastic valve body 76 is switched to the non-communication state, and the pusher 80 is pushed back to the proximal end side of the elastic valve body 76. The operation cap 86 may be moved to the base end side by rotating the operation cap 86 in the reverse direction with respect to the base cap 84, or by rotating the base cap 84 in the reverse direction with respect to the accommodating cylinder portion 66. 86 may be moved to the base end side together with the base cap 84.

After the air bleeding of the internal flow path 20 is completed in this manner, the base cap 84 of the air bleeding member 22 is reversely rotated with respect to the housing tubular portion 66, and the air bleeding member 22 is detached from the connection connector 18. Thereafter, as shown in FIG. 8, by connecting an external flow path 110 such as a syringe to the proximal end side opening 70 of the connection connector 18, the pusher 80 is pushed toward the distal end side by a male luer of the syringe, The slit 78 of the elastic valve body 76 is pushed open to bring the elastic valve body 76 into a communication state. Thereby, the internal flow path 20 and the external flow path 110 are communicated with each other, and blood collection and infusion can be performed.

In the indwelling needle assembly 13 having the above structure, even when the air bleeding member 22 is attached to the connecting connector 18, the pusher 80 is not pushed to the tip side, so that the elastic valve body 76 may be retained in a disconnected state. As a result, the elastic valve body is not squeezed in the open state, and the closing operation of the elastic valve body 76 when the inner needle 26 is removed can be stably realized.

In addition, the reverse blood does not occur until the inner needle 26 is removed from the initial state and the air bleeding member 22 is operated, and the blood bleeding member 22 is operated at the user's arbitrary timing to start the reverse blood bleeding. Therefore, the control of confirmation of reverse blood can be performed more accurately. Furthermore, by sealing the soft tube 60 with a clamp or the like, it is possible to control the timing of reverse blood with higher accuracy.

Furthermore, since the central through hole 102 is formed in the air bleeding member 22, it can be used as an insertion hole for the inner needle 26 when the inner needle 26 is inserted, while it can be used as an air bleed hole after the inner needle 26 is removed. The structure of the air bleeding member 22 can be skillfully utilized, and it is possible to prevent the structure from becoming complicated by separately providing an air bleeding hole.

Furthermore, since the screw feed mechanism is adopted between the base cap 84 and the operation cap 86, the operation cap 86 can be gently moved to the tip side with respect to the base cap 84, and the elasticity can be improved. It is possible to avoid the risk that the valve body 76 and the like are damaged or fall off.

Further, since the soft tube 60 is provided between the outer needle hub 58 and the connection connector 18, the outer needle unit 12 can be easily deformed and can be stably fixed to the patient's skin or the like. You can

Although the embodiments of the present invention have been described above, the present invention should not be limitedly interpreted by the specific description of the embodiments, and various changes, modifications, improvements, etc. based on the knowledge of those skilled in the art. Can be implemented in a mode in which is added.

For example, in the above embodiment, the indwelling needle assembly 13 in which the inner needle unit 14 is inserted into the outer needle unit 12 as the indwelling needle according to the present invention is shown, but the structure of the inner needle unit 14 is limited. Not a thing. However, the inner needle unit is not essential in the present invention. When the inner needle unit is not provided, the cannula (outer needle) is preferably a hollow needle made of metal or hard synthetic resin, which is easily punctured.

Further, the structure of the needle tip protector is not limited to that described in the above embodiment. That is, in the needle tip protector 22 described in the above-described embodiment, in addition to exerting the biasing force by the magnetic force, a spring or the like may be adopted to exert the biasing force by the elastic force, and it is described in JP-A-2014-108113. A needle tip protector including such an arm-shaped protection part may be adopted. However, in the present invention, the needle tip protector is not essential.

Further, in the above embodiment, the inner needle 26 can be inserted while the air bleeding member 22 is attached to the connection connector 18, but it is not necessary that the inner needle can be inserted into the air bleeding member. .. That is, after puncturing the indwelling needle assembly in which the inner needle unit is inserted into the outer needle unit, the inner needle unit may be removed and the air bleeding member may be attached to the connection connector of the left outer needle unit. Therefore, when providing the indwelling needle according to the present invention to the market, the air bleeding member may be provided separately from the connection connector, for example, the air bleeding member is attached to the conventional indwelling needle or indwelling needle assembly. It is also possible to sell it.

Furthermore, in the above-described embodiment, the air bleeding member 22 is configured to include the base cap 84 and the operation cap 86, but these may be one member. That is, in the above-described embodiment, the screw feeding mechanism is provided between the base cap 84 and the operation cap 86 to move the operation cap 86 forward or backward with respect to the base cap 84 in the needle axis direction. The entire air bleeding member may be moved forward or backward. In such a case, for example, a screw feed mechanism including a female screw 90 and a male screw 72 may be employed between the air bleeding member and the connector. However, the method of connecting the connection connector 18 and the external flow path is not limited to the luer lock type, and may be, for example, the slip lock type. Therefore, the male screw 72 provided at the base end of the connection connector 18 is not essential. When the male screw is not provided at the base end of the connection connector and the air bleeding member is composed of one member, an air bleeding member such as a groove or a ridge is provided between the air bleeding member and the connection connector. A mechanism for advancing or retracting the member may be provided separately.

The operation cap is not limited to the one that moves forward or backward with respect to the base cap by the screw feeding mechanism as in the above embodiment. That is, for example, the base cap and the operation cap may be provided with a groove or a ridge extending in the needle axis direction, respectively, so that the operation cap is slidably displaced in the needle axis direction with respect to the base cap.

Further, the residual air in the internal flow path is not limited to the mode in which it is discharged from the central through hole (air bleeding hole) 102 of the air bleeding member 22 as in the above-described embodiment, and for example, the base cap is moved backward. Thus, it may be discharged from the gap between the base cap and the connector. That is, an air vent passage constituted by a gap between members or a through hole for allowing residual air to escape to the external space is appropriately provided. Further, in order to prevent blood from leaking into the air bleeding passage, a ventilation filter having a property of allowing gas to permeate but blocking liquid can be appropriately provided.

Further, the shapes of the elastic valve body 76, the pusher 80, and the pusher guide 82 in the hemostatic valve mechanism 74 are not limited in any way. That is, for example, the pusher 80 and the pusher guide 82 may have a cylindrical shape or a cylindrical shape having a polygonal cross section. Further, in the present invention, the pusher 80 and the pusher guide 82 are not essential. If a pusher is not provided, increase the length of the push-in cylinder of the operation cap in the needle axis direction so that the push-in cylinder can directly open the slit of the elastic valve body or connect the external flow path. Also when performing, the slit of the elastic valve body may be directly opened by a male lure such as a syringe.

Furthermore, in the present invention, the outer needle hub 58 and the soft tube 60 are not essential. That is, the cannula (outer needle) may be directly connected to the connection connector, and in such a case, it is understood that the connection connector also has a function as an outer needle hub.

12: outer needle unit (indwelling needle), 16: outer needle (cannula), 18: connection connector, 20: internal flow path, 22: air bleeding member, 26: inner needle, 58: outer needle hub (needle base), 60: soft tube, 76: elastic valve body (valve body), 80: pusher, 84: base cap, 86: operation cap, 97: male screw (screw feed mechanism), 102: central through hole (air vent hole), 103: female screw (screw feed mechanism), 110: external flow path

Claims (10)

It has a cannula that is percutaneously inserted into a blood vessel on the distal end side and a connection connector on the proximal end side, and an internal flow path from the cannula to the connection connector is formed, and In the indwelling needle in which the valve element is arranged in the internal flow path,
The valve body can be held in a non-communication state in a state of being attached to the connection connector, and the valve body can be switched to a communication state by an external operation to bleed air from the internal flow path through the valve body in the communication state. There is an air bleeding member to get
By moving a part or the whole of the air bleeding member toward the distal end side of the internal flow path in the flow direction and pushing the valve body to switch to the communication state, the internal flow path in which air does not escape to the outside can be formed. Air can be released through the valve body in the communication state ,
An indwelling needle characterized in that the valve body is restored to the non-communication state and held by moving a part or the whole of the air bleeding member toward the proximal end side in the flow path direction. The indwelling needle according to claim 1, wherein the air bleeding member is attachable to and detachable from the connection connector. The indwelling needle according to claim 1 or 2, wherein a removable inner needle is inserted from the proximal end side of the internal flow path toward the distal end side. The indwelling needle according to claim 3, wherein the inner needle is removably inserted into the internal flow path in a state where the air bleeding member is attached to the connection connector. The air bleeding member includes a base cap attached to the connection connector, and an operation cap movably assembled to the base cap, and the operation cap is external to the base cap. The indwelling needle according to any one of claims 1 to 4, wherein the valve body can be switched between a communication state and a non-communication state by operating the valve body to move the valve body. A screw feed mechanism is provided between the operation cap and the base cap, and the operation cap is rotated from the outside to move toward the distal end side of the internal flow path with respect to the base cap. The indwelling needle according to claim 5, wherein the valve body is pushed open and switched to a communication state. The operation cap is provided with an air vent hole penetrating in the flow path direction of the internal flow path, and the air vent hole is communicated with the internal flow path in the communication state of the valve body. The indwelling needle according to claim 5 or 6. A sleeve-shaped pusher is movably arranged in the flow passage direction on the proximal end side of the valve body in the internal flow passage, and the pusher is moved to the valve body by operating the air bleeding member from the outside. 8. The valve body is moved toward the valve body while being moved toward the valve body so that the valve body is pushed open and brought into a communication state. The indwelling needle described. By connecting an external flow path to the connection connector, the pusher is moved toward the valve body, and the pusher moves toward the valve body so that the valve body is The indwelling needle according to claim 8, wherein the indwelling needle is pushed open to be in a communication state. The indwelling needle according to claim 1, wherein a needle base is provided at a proximal end of the cannula, and a soft tube is provided between the needle base and the connection connector. ..