WO2012020633A1

WO2012020633A1 - Indwelling needle and indwelling needle assembly

Info

Publication number: WO2012020633A1
Application number: PCT/JP2011/066658
Authority: WO
Inventors: 秀憲田邊; 図師　泰伸; 崇王安齋
Original assignee: テルモ株式会社
Priority date: 2010-08-10
Filing date: 2011-07-22
Publication date: 2012-02-16

Abstract

An indwelling needle (11) is provided with: a hollow outer needle (2); a hub (3) which is provided to the base end of the outer needle (2), has an flow path (31) communicating with the inside of the outer needle (2), and allows a tube body to be connected to the flow path (31); a valve element (7) which is provided at an end or in the middle of the flow path (31) so as to close the flow path (31) and which has an opening-closing section (71) which can be opened and closed; a groove (9) for connecting the portion of the flow path (31) which is on one side of the valve element (7) and the portion of the flow path (31) which is on the other side of the valve element (7); and a polymer layer (10) formed on the inner surface of the groove (9). The polymer layer (10) deforms or transforms by contact with liquid which flows into the groove (9), thereby preventing the passage of the liquid.

Description

Indwelling needle and indwelling needle assembly

The present invention relates to an indwelling needle and an indwelling needle assembly including the same.

When performing infusion for a patient, etc., an indwelling needle assembly connected to the infusion line is punctured into the patient's blood vessel and placed in place.

Such an indwelling needle assembly includes a hollow outer needle, an outer needle hub fixed to the proximal end of the outer needle, an inner needle inserted into the outer needle and having a sharp needle tip, and an inner needle. It is comprised with the inner needle hub fixed to the base end (for example, refer patent document 1). The outer needle hub houses a valve body (hemostatic valve) and an operation member (pusher) for opening and closing the valve body.

The valve element housed in the outer needle hub has a function of preventing leakage of blood flowing into the flow path in the outer needle hub via the outer needle that secures the blood vessel. In particular, in the indwelling needle assembly of Patent Document 1, the valve body has a groove formed on the outer peripheral surface thereof, and is confined between the blood flowing into the flow path and the valve body through the groove. The air can escape. This prevents bubbles from remaining in the flow path and improves the safety of the indwelling needle assembly.

However, in the valve body of the indwelling needle assembly of Patent Document 1 and such an indwelling needle assembly, the air trapped between the blood flowing into the flow path and the valve body can be released as described above. Even the blood flowing into the passage enters the proximal end side of the valve body through the groove.

JP 2002-263197 A

An object of the present invention is to allow air trapped between a liquid flowing in the flow path from one side of the valve body and the valve body to escape to the other side of the valve body, and the liquid is It is an object of the present invention to provide an indwelling needle and an indwelling needle assembly that can prevent entry into the other side.

To achieve the above object, the present invention comprises a hollow outer needle,
A hub provided at a base end portion of the outer needle, having a flow channel communicating with the inside of the outer needle, and capable of connecting a tubular body to the flow channel;
A valve body that is provided so as to close the flow path at an end portion or in the middle of the flow path, and has an openable / closable portion;
A groove portion communicating the flow path on the one side of the valve body and the other side;
A polymer layer formed on the inner surface of the groove,
The indwelling needle is characterized in that the polymer layer is configured to prevent passage of the liquid by being deformed or altered by contact with the liquid flowing into the groove.

In the indwelling needle of the present invention, it is preferable that the polymer layer absorbs the liquid flowing into the groove and swells to block the groove and prevent the liquid from passing therethrough.

In the indwelling needle of the present invention, it is preferable that the polymer layer is dissolved by contact with the liquid flowing into the groove and the volume is increased, thereby closing the groove and preventing the liquid from passing therethrough.

In the indwelling needle of the present invention, it is preferable that the polymer layer is dissolved by contact with the liquid flowing into the groove and the viscosity of the liquid is increased to prevent the liquid from passing therethrough.

In the indwelling needle of the present invention, the groove is preferably formed in the valve body.

In the indwelling needle of the present invention, the valve body has a plate-like plate-like portion in which the opening / closing portion is formed, and a cylindrical tube-like portion formed to protrude from an edge of the plate-like portion. Cylindrical,
The groove is preferably formed on the outer peripheral surface of the valve body.

In the indwelling needle of the present invention, it is preferable that the groove portion is extended from the outer peripheral surface to the surface of the plate-like portion.

In the indwelling needle of the present invention, the flow path has a step portion,
The valve body is disposed so that an edge of the plate-like portion contacts the stepped portion,
The groove is preferably extended on the surface of the plate-like portion so as to be exposed from the stepped portion.

In the indwelling needle of the present invention, it is preferable that the groove is formed on the inner surface of the hub so as to face the flow path.

In the indwelling needle of the present invention, it is preferable that the groove portion extends along the extending direction of the flow path.

In the indwelling needle of the present invention, it is preferable that the groove has a bent or curved portion in the middle.

In the indwelling needle of the present invention, it is preferable that the groove has a portion whose cross-sectional area changes along the extending direction.

In the indwelling needle of the present invention, the depth of the groove is preferably 5 μm to 100 μm.

In the indwelling needle of the present invention, it is preferable that a plurality of the groove portions are formed along the circumferential direction of the flow path.

In the indwelling needle of the present invention, the polymer layer is preferably composed of a hydrophilic polymer.

In the indwelling needle of the present invention, the polymer layer is formed by dropping a liquid containing the hydrophilic polymer into the groove, and drying the dropped liquid after wetting and spreading on the inner surface of the groove. Preferably it is done.

In order to achieve the above object, the present invention comprises an indwelling needle of the present invention,
An inner needle inserted through the outer needle,
In the indwelling needle assembly, blood flows into the flow path through the outer needle when the living body surface is punctured with the inner needle.

FIG. 1 is a longitudinal sectional view showing a first embodiment of an indwelling needle assembly (indwelling needle) of the present invention. FIG. 2 is a longitudinal cross-sectional view sequentially showing the use state of the indwelling needle assembly shown in FIG. FIG. 3 is a longitudinal cross-sectional view sequentially illustrating usage states of the indwelling needle assembly shown in FIG. FIG. 4 is a longitudinal cross-sectional view sequentially illustrating usage states of the indwelling needle assembly shown in FIG. FIG. 5 is a longitudinal cross-sectional view sequentially illustrating usage states of the indwelling needle assembly shown in FIG. 6 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly shown in FIG. FIG. 7 is a perspective view showing a valve body of the indwelling needle shown in FIG. 8 is a cross-sectional view of the valve body shown in FIG. 7 (a cross-sectional view taken along line AA in FIG. 7). FIG. 9 is a longitudinal sectional view of the valve body shown in FIG. 7 (a sectional view taken along line BB in FIG. 7). 10 is a plan view of the valve body shown in FIG. FIG. 11 is a perspective view showing a valve body included in the indwelling needle assembly according to the second embodiment of the present invention. FIG. 12 is a perspective view showing a valve body included in the indwelling needle assembly according to the third embodiment of the present invention. FIG. 13: is a perspective view which shows the valve body which the indwelling needle assembly of this invention concerning 4th Embodiment has. FIG. 14: is a longitudinal cross-sectional view which shows the valve body which the indwelling needle assembly of this invention concerning 5th Embodiment has. FIG. 15 is a longitudinal sectional view showing an indwelling needle assembly of the present invention according to a sixth embodiment.

Hereinafter, the indwelling needle and the indwelling needle assembly of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

<First Embodiment>
Hereinafter, an indwelling needle assembly to which the indwelling needle of the present invention is applied (an indwelling needle assembly of the present invention) will be described.

FIG. 1 is a longitudinal sectional view showing a first embodiment of the indwelling needle assembly of the present invention, FIGS. 2 to 6 are longitudinal sectional views sequentially showing usage states of the indwelling needle assembly shown in FIG. 1, and FIG. 1 is a perspective view showing the valve body of the indwelling needle shown in FIG. 1, FIG. 8 is a cross-sectional view of the valve body shown in FIG. 7 (cross-sectional view taken along line AA in FIG. 7), and FIG. FIG. 10 is a plan view of the valve body shown in FIG. 7. FIG. 10 is a longitudinal sectional view of the valve body shown in FIG. In the following, for convenience of explanation, the right side of FIGS. 1 to 6 is referred to as “base end” and the left side is referred to as “tip”. 1 to 7, illustration of the water-soluble polymer layer formed in the groove is omitted for convenience of explanation.

The indwelling needle assembly 1 shown in FIG. 1 includes an indwelling needle 11 and a puncture needle 12. The indwelling needle assembly 1 includes an assembled state in which the indwelling needle 11 and the puncture needle 12 are assembled (the state shown in FIGS. 1 and 2), and an extracted state in which the puncture needle 12 is removed from the indwelling needle 11 (FIGS. 3 to 5). 6). The indwelling needle assembly 1 can puncture the living body surface in the assembled state. Then, the indwelling needle 11 can be indwelled on the surface of the living body by setting it in the extracted state. In addition, the connector 20 can be connected to the indwelling needle 11 placed on the surface of the living body (see FIGS. 4 to 6).

Before describing the indwelling needle assembly 1, the connector 20 will be described.
As shown in FIGS. 4 to 6, the connector 20 is connected to the proximal end portion of the indwelling needle 11. The connector 20 includes a tubular connector main body 201 and a lock portion 202 provided on the outer peripheral side of the connector main body 201.

The connector main body 201 has a tapered shape in which the outer diameter gradually decreases in the distal direction. Thereby, when connecting the connector 20, the connector main body 201 can be easily inserted in the base end part of the indwelling needle 11, Therefore The connection operation can be performed easily.

The lock part 202 has a cylindrical shape arranged concentrically with the connector main body 201. A female screw 203 is formed on the inner peripheral portion of the lock portion 202. The female screw 203 can be screwed with the male screw 32 of the outer needle hub 3 of the indwelling needle 11 described later. The connection state between the connector 20 and the indwelling needle 11 is reliably maintained by screwing these screws. In the configuration shown in the figure, the lock portion 202 is formed integrally with the connector main body 201, but is not limited thereto, and may be configured separately from the connector main body 201.

Also, the distal end of a tube (not shown) is connected to the proximal end of the connector 20. A bag (not shown) filled with the infusion agent Q is connected to the proximal end of the tube. The infusion needle 11 is supplied with the infusion agent from the bag in a connected state where the connector 20 is connected (see FIGS. 5 and 6).

Next, the indwelling needle assembly 1 will be described.
As shown in FIGS. 1 to 6, the indwelling needle 11 blocks the hollow outer needle 2, the outer needle hub 3 fixed to the proximal end portion of the outer needle 2, and the flow path 31 of the outer needle hub 3. And a valve mechanism 6 to be opened.

As the outer needle 2, one having a certain degree of flexibility is preferably used. The constituent material of the outer needle 2 is preferably a resin material, in particular, a soft resin material. Specific examples thereof include fluorine resins such as PTFE, ETFE, and PFA, olefin resins such as polyethylene and polypropylene, and these. And the like, polyurethane, polyester, polyamide, polyether nylon resin, a mixture of the olefin resin and ethylene-vinyl acetate copolymer, and the like.

It is preferable that all or part of the outer needle 2 has internal visibility. That is, the outer needle 2 is preferably composed of a transparent (colorless and transparent), colored transparent or translucent resin. Thereby, when the outer needle 2 secures a blood vessel, a phenomenon (flashback) in which the blood R flows into the transparent outer needle hub 3 through the hollow portion 45 of the inner needle 4 can be visually confirmed.

In addition, the constituent material of the outer needle 2 may be mixed with an X-ray contrast agent such as barium sulfate, barium carbonate, bismuth carbonate, and tungstic acid to have a contrast function.

As shown in FIG. 1 (the same applies to FIGS. 2 to 6), for example, caulking, fusion (thermal fusion, high frequency fusion, etc.), adhesion with an adhesive, etc. The outer needle hub 3 is fixed in a liquid-tight manner by the method.

The outer needle hub 3 is formed of a tubular member, and its inner cavity functions as the flow path 31. The flow path 31 communicates with the lumen 21 of the outer needle 2. Further, the valve mechanism 6 is housed and disposed in the flow path 31. As described above, the lumen portion of the outer needle hub 3 is also used as a storage portion for storing the valve mechanism 6 in addition to the flow path 31.

A tapered portion 312 is formed at the distal end of the flow channel 31 in which the inner diameter of the wall 311 that defines the flow channel 31 gradually decreases in the distal direction. As a result, the infusion agent Q that has flowed down the flow path 31 in the distal direction is easily introduced into the outer needle 2.

As shown in FIG. 4 (the same applies to FIGS. 5 and 6), the base end portion of the flow path 31 has a tapered shape in which the inner diameter of the wall portion 311 gradually increases in the base end direction. The connector body 201 of the connector 20 can be inserted into the proximal end portion of the tapered flow path 31. When the connector main body 201 is inserted into the flow path 31, the wall portion 311 of the flow path 31 and the outer peripheral portion 204 of the connector main body 201 are brought into close contact with each other, thereby maintaining liquid tightness. Further, a male screw 32 that is screwed with the female screw 203 of the lock portion 202 of the connector 20 is formed on the outer periphery of the proximal end of the outer needle hub 3. Thus, the proximal end portion of the outer needle hub 3 is a connection portion to which the connector 20 is connected.

In the middle of the flow path 31, a stepped portion 35 having a distal end with a diameter reduced with respect to the proximal end is formed. A plurality of protrusions 36 are formed along the circumferential direction so as to protrude toward the center of the flow path 31 in the middle of the flow path 31 and on the base end side of the step portion 35. Yes. A valve body 7 to be described later is positioned so as to be sandwiched between the step portion 35 and the plurality of protrusions 36.

The valve mechanism 6 is accommodated in the outer needle hub 3. The valve mechanism 6 shuts and opens the flow path 31 and includes a valve body 7 and an operation member 8 that opens and closes the valve body 7.

As shown in FIGS. 1 to 6, the valve body 7 is installed in the middle of the flow path 31 so as to close the flow path 31. Specifically, the valve body 7 is provided so as to come into contact with the stepped portion 35 formed in the flow path 31 from the proximal end side, thereby preventing displacement toward the distal end side in the flow path 31. Has been. Further, the valve body 7 is prevented from being displaced toward the proximal end in the flow path 31 by a stepped portion 723 (described later) of the valve body 7 being hooked on the protrusion 36. Thus, by preventing the displacement of the valve body 7 in the flow path 31, the valve body 7 can be opened and closed smoothly.

As shown in FIGS. 7 and 8, the valve body 7 has a bottomed cylindrical shape, and has an opening / closing part 71 constituting a bottom part and a fixing part 72 constituting a side wall. The valve body 7 is fixed to the flow path 31 when the outer peripheral surface of the fixing portion 72 is in close contact with the wall portion 311 of the flow path 31.

Further, the valve body 7 is made of an elastic material. By configuring the valve body 7 with an elastic material, the opening / closing part 71 can be opened and closed smoothly.

The opening / closing part 71 has a disk shape, and is composed of a plate-like part 712 in which a through hole 711 is formed in the central part. The plate-like portion 712 has a surface that is perpendicular to the longitudinal direction of the flow path 31. Moreover, the through-hole 711 is comprised by the slit penetrated in the thickness direction of the plate-shaped part 712, for example. The shape of the slit is not particularly limited, and examples thereof include a single character shape, a cross shape, and a Y shape (t-shape). With such a configuration, the opening / closing part 71 is surely a part having a self-closing property.

The fixing portion 72 is formed integrally with the opening / closing portion 71. The fixing portion 72 is a cylindrical portion that is formed to project from the edge of the opening / closing portion 71 (plate-like portion 712) toward the proximal direction. The valve body 7 is fixed to the flow path 31 by fitting the outer peripheral portion of the fixing portion 72 to the wall portion 311 of the flow path 31.

In the present embodiment, the fixing portion 72 has a first part 721 located on the distal end side and a second part 722 located on the proximal side relative to the first part 721, The outer diameter of the part 721 is formed larger than the outer diameter of the second part 722. A step 723 is formed at the boundary between the first part 721 and the second part 722.

The elastic material constituting the valve body 7 is not particularly limited, and examples thereof include natural rubber, isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene rubber, urethane rubber, nitrile rubber, acrylic rubber, fluorine rubber, and silicone rubber. Various elastic materials such as various rubber materials (especially those vulcanized), various thermoplastic elastomers such as urethane, polyester, polyamide, olefin, and styrene, or mixtures thereof. Among the elastic materials, it is particularly preferable to use isoprene rubber. When isoprene rubber is used as the constituent material of the valve body 7, there is an advantage that the compression set is small and the expiration date of the product becomes long.

A plurality of groove portions 9 are formed in such a valve body 7. The plurality of grooves 9 are formed on the outer peripheral surface (side surface) 7 a of the valve body 7. As shown in FIG. 1, each groove 9 communicates the distal end side and the proximal end side with respect to the valve body 7 of the flow path 31. By forming such a groove portion 9, as will be described later, for example, a plurality of air trapped between the blood R flowing into the flow path 31 from the lumen 21 of the outer needle 2 and the valve body 7 is contained. It is possible to escape from the valve body 7 to the base end side through the groove portion 9. Therefore, it is possible to perform more reliable priming, that is, it is possible to prevent air from remaining in a region on the tip side of the valve body 7 in the flow path 31. Thereby, safe treatment can be performed.

In the present embodiment, eight groove portions 9 are formed, and these eight groove portions 9 are formed at equiangular intervals (that is, 45 ° intervals) along the circumferential direction of the valve body 7. In this way, by forming the plurality of groove portions 9 at different positions in the circumferential direction of the side surface 7 a, the blood R flowing into the flow path 31 and the valve body 7 can be interposed between the indwelling needle 11 in any posture. The trapped air can be released to the proximal end side of the valve body 7 through any of the grooves 9.

Specifically, as shown in FIGS. 1 to 6, when the indwelling needle 11 is turned sideways, the blood R flowing in the flow path 31 is closed in order from the groove portion 9 positioned on the lower side in the vertical direction. However, the groove 9 located on the upper side in the vertical direction is not blocked by the blood R until the flow path 31 (the region on the tip side of the valve body 7) is filled with the blood R. Therefore, almost all of the air trapped between the blood R and the valve body 7 can be more reliably released to the proximal end side of the valve body 7 via any one of the plurality of groove portions 9. .

Particularly, by forming the plurality of groove portions 9 at equiangular intervals along the circumferential direction of the valve body 7, there is no bias in the arrangement of the groove portions 9, and the above effects become more remarkable. In addition, since the indwelling needle 11 (indwelling needle assembly 1) is normally primed (bleeded out) in a lateral state, the indwelling needle 11 (indwelling needle assembly) is arranged according to the arrangement of the groove portion 9 as in this embodiment. 1) Regardless of the posture of 1), at the time of priming, almost all of the air confined between the blood that flows back into the flow path 31 and the valve body 7 is more reliably supplied to the proximal end side of the valve body 7 through the groove 9. Can escape.

Each groove portion 9 extends linearly along the axial direction of the valve body 7 (longitudinal direction of the flow path 31). Thereby, the air can smoothly pass through the groove 9.

Moreover, the front-end | tip part 91 of each groove part 9 is extended from the side surface 7a of the valve body 7 to the bottom face 7b (surface of the plate-shaped part 712) so that it may not contact with the through-hole 711. Further, as shown in FIG. 10, the tip end portion 91 of each groove portion 9 is exposed from the stepped portion 35 formed in the flow channel 31 when viewed in a cross section having the longitudinal direction of the flow channel 31 as a normal line. Is formed. By configuring each groove portion 9 in such a configuration, it is possible to prevent the groove portions 9 from being blocked by the stepped portion 35, and to ensure that each groove portion 9 exhibits the above-described effects.

On the other hand, the base end portion of each groove portion 9 is open to the step portion 723 of the valve body 7. Accordingly, the distal end side and the proximal end side communicate with each other from the valve body 7 of the flow path 31 through each groove portion 9. Here, in this embodiment, as described above, the plurality of protrusions 36 are formed in the flow path 31, and these protrusions 36 are engaged with the valve body 7. The shape and arrangement are set so as not to block the proximal opening.

The depth of each groove 9 is not particularly limited, but is preferably about 5 μm to 100 μm, and more preferably about 50 μm. As a result, the groove 9 has a sufficient cross-sectional area to allow air trapped between the blood R and the valve body 7 to escape to the proximal end side of the valve body 7. Moreover, the groove part 9 can be more reliably plugged by swelling of the hydrophilic polymer layer 10 as will be described later.

A hydrophilic polymer layer (polymer layer) 10 is formed on the inner surface of each groove 9. The hydrophilic polymer layer 10 has a function of blocking the passage of the liquid in the groove portion 9 by absorbing the liquid (blood) flowing into the groove portion 9 and swelling, etc., thereby closing the groove portion 9. Yes.

8 and 9, the hydrophilic polymer layer 10 is formed on the inner surface of the region 9a formed on the side surface 7a of the valve body 7 of each groove portion 9. As shown in FIG. In other words, in the present embodiment, the hydrophilic polymer layer 10 is not formed in a portion (tip portion 91) extended to the bottom surface 7 b of the valve body 7. Since the distal end portion 91 is a portion that comes into contact with the blood R at a relatively early stage, the hydrophilic polymer layer 10 is not formed in such a portion, so that it is trapped between the blood R and the valve body 7. It is possible to effectively prevent the groove portion 9 from being blocked by swelling or the like of the hydrophilic polymer layer 10 before letting air through the groove portion 9.

In the present embodiment, the hydrophilic polymer layer 10 is formed on the bottom surface and both side surfaces of each groove 9, but is not limited thereto, and may be formed only on the bottom surface of the groove 9, for example. However, it may be formed only on both side surfaces.

The hydrophilic polymer layer 10 is deformed or denatured by contact with a liquid (blood). Specifically, the hydrophilic polymer layer 10 is dissolved in the process of <1> swelling by absorbing liquid, and <2> the polymer material constituting the hydrophilic polymer layer 10 being dissolved. It has at least one of the property of increasing its volume by <3> and the property of increasing (increasing) the viscosity of the liquid by dissolution.

The hydrophilic polymer layer 10 having the <1> or <2> property has the following functions. That is, as described above, each groove portion 9 is formed to release the air trapped between the blood R flowing into the flow path 31 and the valve body 7 to the proximal end side of the valve body 7. The blood R may enter the proximal end side of the valve body 7 through the groove 9. The blood R that has entered the proximal end side of the valve body 7 is retained between the valve body 7 and the operation member 8, and the retained blood may become a bacterial growth source or cause thrombus formation. There is.

The hydrophilic polymer layer 10 swells by absorbing blood flowing into the groove 9 and closes the groove 9 by increasing the volume due to dissolution, so that the blood R passes through the groove 9 and is valved. It has a function of preventing entry into the base end side of the body 7. That is, by having such a hydrophilic polymer layer 10, air trapped between the blood R and the valve body 7 can be released to the proximal end side of the valve body 7 through the groove portion 9. It is possible to prevent blood R from entering the proximal end side of the valve body 7 through the groove 9.

The hydrophilic polymer layer 10 having the property <3> deteriorates the fluidity of the blood R by increasing the viscosity of the blood R flowing into the groove 9, and the blood R passes through the groove 9. And has a function of preventing the valve body 7 from entering the base end side.

Such a hydrophilic polymer layer 10 is composed of a hydrophilic polymer. Thereby, the structure of the hydrophilic polymer layer 10 becomes simple.

Further, the hydrophilic polymer is preferably soluble in various aqueous solvents or non-aqueous organic solvents. Thereby, formation of the hydrophilic polymer layer 10 becomes easy. Specifically, first, a coating solution obtained by dissolving the hydrophilic polymer in the various organic solvents is dropped into the groove 9 (region 9a), and the dropped coating solution is applied to the groove 9 using a capillary phenomenon. Wet and spread inside. Then, after the coating liquid wets and spreads on the inner surface of the groove 9, the hydrophilic polymer layer 10 can be formed on the inner surface of the groove 9 by drying the coating liquid and volatilizing the solvent. According to such a manufacturing method, the thin film-like hydrophilic polymer layer 10 can be easily formed. However, the formation method of the hydrophilic polymer layer 10 is not limited to this, For example, you may form by vapor deposition.

Furthermore, it is preferable that the hydrophilic polymer is constructed with a crosslinked structure by being given external energy such as heat, light, radiation (electron beam, gamma ray, etc.). Among these, in particular, when a material that builds a crosslinked structure by electron beam irradiation is used as the hydrophilic polymer, it is advantageous when sterilization by electron beam sterilization is performed. By using such a material, dissolution of the hydrophilic polymer layer 10 into blood is prevented, the safety of the indwelling needle 11 is ensured, and blood is more reliably absorbed by the hydrophilic polymer layer 10. can do.

The hydrophilic polymer constituting the hydrophilic polymer layer 10 is not particularly limited, and examples thereof include acrylamide-acrylates such as polyvinylpyrrolidone, methyl vinyl ether-maleic anhydride copolymer, dimethylacrylamide-glycidyl methacrylate copolymer, and the like. Water-soluble synthetic polymers such as copolymers, sodium polyacrylate, polyacrylamide, polystyrene sulfonate, polyvinyl alcohol, polyethylene osidide, and polyethyleneimine, and water-soluble semi-polymers such as carboxymethyl starch, dialdehyde starch, carboxymethyl cellulose, and hydroxyethyl cellulose. Examples include rigid polymers, water-soluble natural polymers such as tannin, lignin, alginic acid, gum arabic, guar gum, tragacanth gum, gelatin, casein, and collagen. Door can be.

Among the hydrophilic polymer layers 10 formed using these materials, those having a crosslinked structure by being given external energy such as heat, light, and radiation absorb <1> liquid. On the contrary, in the process in which the polymer material constituting the hydrophilic polymer layer 10 is dissolved, the material that does not substantially form the crosslinked structure is dissolved. The property of increasing the volume by dissolution or the property of increasing (increasing) the viscosity of the liquid by <3> dissolution can be exhibited.

Thus, even if the constituent material of the hydrophilic polymer layer 10 is the same, the properties of the hydrophilic polymer layer 10 change depending on the presence or absence of crosslinking.

The thickness (average thickness) of the hydrophilic polymer layer 10 is not particularly limited as long as it does not block the groove 9 in a state where liquid is not absorbed and can close the groove 9 in a state where liquid is absorbed. Although not limited, for example, it is preferably about 0.1 μm to 1 μm.

The operation member 8 is a member for opening / closing the opening / closing part 71 of the valve body 7. The operation member 8 is supported so as to be movable along the longitudinal direction of the flow path 31. Therefore, in the indwelling needle 11, the operation member 8 is moved in the distal direction from the first state (see FIGS. 1 to 3) in which the operation member 8 is located on the proximal end side with respect to the opening / closing part 71. Thus, a second state (see FIGS. 4 to 6) that penetrates the opening / closing part 71 and protrudes from the opening / closing part 71 can be taken.

In the first state, the opening / closing part 71 is closed by self-occlusion. Thereby, the flow path 31 is interrupted | blocked. On the other hand, in the second state, the opening / closing part 71 is forcibly opened by the penetration of the operation member 8. Thereby, the front end side and the base end side of the flow path 31 are opened via the valve mechanism 6.

The operation member 8 is configured by a tubular member. When the operation member 8 moves, the outer peripheral portion of the operation member 8 may slide on the wall portion 311 of the flow path 31. Thereby, the movement is performed stably.

The base end enlarged portion 84 whose inner diameter is increased is formed on the outer peripheral portion of the base end of the operation member 8. The inner diameter of the base end enlarged diameter portion 84 is larger than the inner diameter of the connector main body 201 of the connector 20. Thereby, the infusion agent Q can easily and reliably flow into the operation member 8 from the connector main body 201 in the connected state (see FIG. 5).

The outer peripheral portion of the distal end of the operation member 8 is formed with two enlarged-end portions (protrusions) 81a and 81b whose outer diameter is increased, that is, projecting along the circumferential direction. As shown in FIG. 4, the tip enlarged portion 81b of these tip enlarged

portions

81a and 81b functions as an engaging portion that engages with the opening / closing portion 71 of the valve body 7 in the second state. . By engaging the distal end enlarged diameter portion 81b with the opening / closing portion 71 of the valve body 7, the operation member 8 is prevented from unintentionally moving in the proximal direction, and the second state is reliably maintained.

Further, the tip enlarged

diameter portions

81a and 81b are each tapered. Thereby, when the operating member 8 penetrates the opening / closing part 71 of the valve body 7, the tip diameter-

enlarged parts

81a and 81b can surely spread the opening / closing part 71 outward in this order, and thus the penetration Is easily done. And the part (front-end | tip

enlarged diameter part

81a and 81b) which penetrated the opening / closing part 71 of the operation member 8 protrudes from the said opening / closing part 71 concerned. Hereinafter, this protruding portion is referred to as a “protruding portion 82”.

Now, as described above, when the indwelling needle assembly 1 in the assembled state is punctured and the outer needle 2 secures a blood vessel, the blood R flows from the distal end opening 22 of the outer needle 2 to the flow path 31. Come (see FIG. 2). This inflowing blood R remains in the flow path 31 even in a decomposed state (see FIG. 3). And if the connector 20 is connected to the indwelling needle 11, the indwelling needle 11 will be in a 2nd state (refer FIG. 4), and administration of the infusion agent Q to a biological body will be attained (refer FIG. 5, FIG. 6).

As shown in FIG. 1, the puncture needle 12 includes an inner needle 4 and an inner needle hub 5 fixed to the proximal end portion of the inner needle 4. In the assembled state, the inner needle 4 is inserted through the outer needle 2, and the distal end portion of the inner needle hub 5 is inserted and fitted into the proximal end portion of the outer needle hub 3. At this time, the indwelling needle 11 is in the first state, and the inner needle 4 is inserted through the valve body 7 and the operation member 8 all together.

The inner needle 4 has a sharp needle tip 41 at the tip. The length of the inner needle 4 is set to such a length that at least the needle tip 41 protrudes from the distal end opening 22 of the outer needle 2 when in the assembled state. The surface of the living body can be punctured by the needle tip 41.

The inner needle 4 may be a solid needle, but is preferably a hollow needle. When the inner needle 4 is a hollow needle, the blood flows into the hollow portion 45 of the inner needle 4 when the inner needle 4 punctures a blood vessel, so that the flashback of the blood R can be confirmed.

Further, when the inner needle 4 is a solid needle, it is possible to ensure a sufficient strength while reducing the outer diameter. Further, by making the inner needle 4 a solid needle, when the puncture needle 12 is discarded after the operation is finished, there is no risk that blood remains in the inner needle 4 or the blood flows out, High safety.

In addition, the inner needle 4 has a structure having both a hollow portion and a solid portion, for example, by filling a part of the lumen of the hollow needle, the distal end side is hollow and the proximal end side is solid. Although it can also be set as a structure etc., the cost of the inner needle 4 can be aimed at by comprising the whole with one member.

Further, a groove 44 is formed in the outer peripheral portion of the inner needle 4 so as to be recessed along the longitudinal direction of the inner needle 4. The groove 44 functions as an introduction path for introducing the blood R into the lumen 21 of the outer needle 2 when the blood vessel is punctured. The blood R introduced from the groove 44 flows into the gap between the inner needle 4 and the outer needle 2. Thereby, the flashback of blood R can be confirmed reliably from an early stage. Then, the blood R passes through the lumen 21 of the outer needle 2 and flows into the flow path 31 of the outer needle hub 3 (see FIG. 2).

Examples of the constituent material of the inner needle 4 include metal materials such as stainless steel, aluminum or an aluminum alloy, titanium or a titanium alloy.

The inner needle hub 5 is fixed (fixed) to the proximal end portion of the inner needle 4. The inner needle hub 5 has a tubular shape, and an air filter (not shown) is installed at the base end opening.

The inner needle hub 5 and the outer needle hub 3 described above are each preferably made of a transparent (colorless and transparent), colored transparent or translucent resin to ensure internal visibility. Thereby, when the outer needle 2 secures a blood vessel, the flashback of the blood R flowing in through the groove 44 of the inner needle 4 described above can be visually confirmed.

The constituent materials of the outer needle hub 3, the inner needle hub 5, and the operation member 8 are not particularly limited, and for example, polyolefins such as polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyurethane, polyamide, polyester, polycarbonate, respectively. And various resin materials such as polybutadiene and polyvinyl chloride.

Next, the use state of the indwelling needle assembly 1 will be described.
[1] The indwelling needle assembly 1 is brought into the assembled state shown in FIG.
In addition, an infusion bag filled with the infusion agent Q is connected to the connector 20 in advance, so that the infusion agent Q can be supplied.

[2] Next, the indwelling needle assembly 1 in an assembled state is grasped, and the patient's blood vessel is punctured. When a blood vessel is secured by the outer needle 2, the blood R flows into the proximal direction of the lumen 21 of the outer needle 2 through the groove 44 of the inner needle 4 due to blood pressure. This can be confirmed in the outer needle hub 3 (see FIG. 2). After confirming this, the indwelling needle assembly 1 is further advanced toward the distal end by a minute distance.

Further, as shown in FIG. 2, the blood R that has flowed in reaches the place where the valve element 7 of the flow path 31 is located. At this time, the air trapped between the blood R and the valve body 7 escapes to the proximal end side of the valve body 7 through the groove 9, and then the blood R flows into the groove 9, The hydrophilic polymer layer 10 formed on the inner surface absorbs blood R and swells, and the groove 9 is closed. Thereby, it is possible to prevent air from remaining on the distal end side of the valve body 7 of the flow path 31 and to prevent blood R from entering the proximal end side of the valve body 7. Can do.

[3] When a blood vessel is secured by the outer needle 2, the outer needle 2 or the outer needle hub 3 is fixed with one hand, and the inner needle hub 5 is grasped with the other hand and pulled toward the proximal end. Is removed from the outer needle 2 (see FIG. 3). Thereby, the indwelling needle assembly 1 will be in a disassembled state. At this time, in the indwelling needle 11, since the valve body 7 is closed, the blood R in the flow path 31 is prevented from leaking to the outside. Moreover, since the extracted puncture needle 12 becomes unnecessary, it is subjected to disposal.

[4] Next, the outer needle hub 3 of the indwelling needle 11 is fixed to the skin with an adhesive tape or the like. Then, the connector 20 is connected to the outer needle hub 3 (see FIG. 4). With this connection, in the indwelling needle 11 in the first state, the operation member 8 is pressed by the connector main body 201 of the connector 20 and moves in the distal direction, and penetrates the valve body 7. Thereby, the indwelling needle 11 will be in a 2nd state.

[5] Next, supply of the infusion solution Q is started. As a result, the infusate Q that has passed through the connector body 201 and the operation member 8 in this order flows out from the tip opening 85 of the operation member 8, and the entire flow path 31 is filled (primed) with the infusion agent Q. (See FIG. 6).

Second Embodiment
FIG. 11 is a perspective view showing a valve body included in the indwelling needle assembly according to the second embodiment of the present invention.

Hereinafter, the second embodiment of the indwelling needle and the indwelling needle assembly of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do. Moreover, in FIG. 11, illustration of the hydrophilic polymer layer formed in the inner surface of a groove part is abbreviate | omitted for convenience of explanation.

This embodiment is the same as the first embodiment except that the shape of the groove formed in the valve body is different.

In the configuration shown in FIG. 11, each groove 9 A has a bent portion 93 A in the middle of the extending direction. As described above, by having the bent portion 93A, the total length of each groove portion 9A can be extended as compared with the case of a straight line as in the first embodiment, for example, while suppressing the total length of the valve body 7. Thereby, the blood flowing into each groove 9 A can be more reliably absorbed by the hydrophilic polymer layer 10. That is, it is possible to more reliably prevent blood from entering the proximal end side of the valve body 7 through the groove 9A without absorbing the blood by the hydrophilic polymer layer 10 in time.

<Third Embodiment>
FIG. 12 is a perspective view showing a valve body included in the indwelling needle assembly according to the third embodiment of the present invention.

Hereinafter, a third embodiment of the indwelling needle and the indwelling needle assembly of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do. Moreover, in FIG. 12, illustration of the hydrophilic polymer layer formed in the inner surface of a groove part is abbreviate | omitted for convenience of explanation.

In the configuration shown in FIG. 12, each groove 9B has a curved shape so as to meander. Thus, by making each groove part 9B into a curved shape, it is possible to extend the entire length of each groove part 9B from, for example, the linear form as in the first embodiment, while suppressing the overall length of the valve body 7. . Thereby, the blood flowing into each groove part 9B can be more reliably absorbed by the hydrophilic polymer layer 10. That is, it is possible to more reliably prevent blood from entering the proximal end side of the valve body 7 through the groove portion 9B without absorbing blood by the hydrophilic polymer layer 10 in time.

<Fourth embodiment>
FIG. 13: is a perspective view which shows the valve body which the indwelling needle assembly of this invention concerning 4th Embodiment has.

Hereinafter, the fourth embodiment of the indwelling needle and the indwelling needle assembly of the present invention will be described with reference to this figure. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted. To do. Moreover, in FIG. 13, illustration of the hydrophilic polymer layer formed in the inner surface of a groove part is abbreviate | omitted for convenience of explanation.

In the configuration shown in FIG. 13, the cross-sectional area of each groove 9C changes along the extending direction. Specifically, each groove 9 C has a constant depth and a width that gradually decreases from the distal end side to the proximal end side of the flow path 31. Thereby, the groove 9 C can be more reliably closed by the swelling of the hydrophilic polymer layer 10.

Specifically, the blood that has flowed through the flow path 31 is gradually absorbed by the hydrophilic polymer layer 10 when it flows into the groove 9C. Therefore, the amount of blood flowing in the groove 9C decreases from the distal end side to the proximal end side of the groove portion 9C. Therefore, by gradually decreasing the width (cross-sectional area) of the groove 9C from the distal end side toward the proximal end side, it is possible to balance the width of the groove portion 9C and the amount of blood flowing therethrough. By adopting such a configuration, the region having a smaller amount of blood absorbed by the hydrophilic polymer layer 10 can be filled with the groove 9C with less swelling of the hydrophilic polymer layer 10. Swelling of the molecular layer 10 can block the groove 9C as a whole, and can block blood more reliably.

<Fifth Embodiment>
FIG. 14: is a longitudinal cross-sectional view which shows the valve body which the indwelling needle assembly of this invention concerning 5th Embodiment has.

Hereinafter, the fifth embodiment of the indwelling needle and the indwelling needle assembly of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do.

In the configuration shown in FIG. 14, the cross-sectional area of each groove portion 9 D changes along the extending direction. Specifically, each groove 9 D has a constant width, and the depth gradually decreases from the distal end side to the proximal end side of the flow path 31. Thereby, for the same reason as the above-described fourth embodiment, the groove 9D can be more reliably closed by the swelling of the hydrophilic polymer layer 10.

That is, blood that has flowed back through the flow path 31 is gradually absorbed into the hydrophilic polymer layer 10 when flowing into the groove 9D. Accordingly, the amount of blood flowing in the groove 9D decreases from the distal end side to the proximal end side of the groove portion 9D. Therefore, by gradually decreasing the depth (cross-sectional area) of the groove 9D from the distal end side toward the proximal end side, it is possible to balance the depth of the groove portion 9D and the amount of blood flowing therethrough. By adopting such a configuration, the region having a smaller amount of blood absorbed by the hydrophilic polymer layer 10 can fill the groove 9D with less swelling of the hydrophilic polymer layer 10. Swelling of the molecular layer 10 can block the groove 9D as a whole, and can block blood more reliably.

<Sixth Embodiment>
FIG. 15 is a longitudinal sectional view showing an indwelling needle assembly of the present invention according to a sixth embodiment.

Hereinafter, the sixth embodiment of the indwelling needle and the indwelling needle assembly of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do.

This embodiment is the same as the first embodiment except that the groove portion formed in the valve body in the above-described embodiment is formed in the outer needle hub.

15, a plurality (eight) grooves 9E are formed on the inner peripheral surface of the outer needle hub 3 so as to open to the flow path 31. The plurality of grooves 9E are formed at equal intervals along the circumferential direction of the outer needle hub 3 as in the above-described embodiment.

Each of the plurality of grooves 9E extends along the axial direction of the outer needle hub 3 (longitudinal direction of the flow path 31), and has a distal end side and a proximal end side with respect to the valve body 7 of the flow path 31. Is communicated. Specifically, each groove 9 E has a distal end extending to the distal end side with respect to the valve body 7 of the flow path 31, and a proximal end portion extending to the proximal end side with respect to the valve body 7 of the flow path 31. ing.

Each groove 9E has the same function as the grooves 9-9D of the first to fifth embodiments described above. That is, by forming the groove 9E, the air trapped between the blood R flowing into the flow path 31 from the lumen 21 of the outer needle 2 and the valve body 7 is allowed to flow from the valve body 7 through the groove 9E. Can also escape to the proximal side. Therefore, it is possible to perform more reliable priming, that is, it is possible to prevent air from remaining in a region on the tip side of the valve body 7 in the flow path 31. Thereby, safe treatment can be performed.

Further, in the present embodiment, since the plurality of groove portions 9E are formed at equal intervals along the circumferential direction of the outer needle hub 3, regardless of the posture of the outer needle hub 3, More reliable priming can be performed.

The depth of each groove 9E is not particularly limited, but is preferably about 5 μm to 100 μm, and more preferably about 50 μm. As a result, it is possible to configure the groove 9E having a sufficient cross-sectional area for allowing air trapped between the blood R and the valve body 7 to escape to the proximal end side of the valve body 7. Further, the groove 9E can be more reliably closed by the swelling of the hydrophilic polymer layer 10.

As shown in FIG. 15, a hydrophilic polymer layer 10 is formed on the inner surface of each groove 9E. In the present embodiment, the hydrophilic polymer layer 10 is formed on the bottom surface and both side surfaces of each groove 9E, but is not limited to this, for example, may be formed only on the bottom surface of the groove 9E, It may be formed only on both side surfaces.
The indwelling needle assembly of this embodiment has been described above.

In the present embodiment, the eight groove portions 9E are formed in the outer needle hub 3, but the number of the groove portions 9E is not limited to this, and may be one or two to seven. 9 or more. In the present embodiment, each groove 9E has a linear shape extending in the axial direction of the outer needle hub 3. However, the shape of each groove 9E is not limited to this, and for example, the first described above As in the groove portion 9A of the second embodiment, it may have at least one bent portion in the extending direction, or like the groove portion 9B of the third embodiment described above, it is curved to meander. It may be. In addition, each groove 9E may have a constant depth and a width gradually decreasing from the distal end side to the proximal end side of the flow path 31 as in the groove portion 9C of the fourth embodiment described above. Like the groove portion 9D of the fifth embodiment, the width may be constant and the depth may gradually decrease from the distal end side to the proximal end side of the flow path 31. By adopting such a shape, the same effects as those described in the second to fifth embodiments can be exhibited.

As mentioned above, although the indwelling needle and indwelling needle assembly of this invention were demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises an indwelling needle and an indwelling needle assembly is the same. It can be replaced with any structure that can perform its function. Moreover, arbitrary components may be added.

Further, the indwelling needle and the indwelling needle assembly of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

The indwelling needle assembly (indwelling needle) of the present invention is used by being inserted into a blood vessel, for example, inserted into an abdominal cavity, thoracic cavity, lymphatic vessel, spinal canal, etc. It can also be applied to.

In the indwelling needle and the indwelling needle assembly of the present invention, the number of grooves is not limited to 8, and may be 1 to 7 or 9 or more. For example, when one groove portion is formed, it is preferable to form a mark indicating the position where the groove portion is formed on the outer surface of the indwelling needle. Thereby, since an indwelling needle can be used in the state where the groove part was located in the perpendicular direction upper side, the same effect as the case where a plurality of groove parts are formed can be exhibited. Further, when the valve body is arranged in a posture in which the plate-like portions are orthogonal to each other in the vertical direction, the same effect as in the case of forming a plurality of groove portions can be exhibited even if the number of groove portions is one.

Moreover, in the indwelling needle and the indwelling needle assembly of the present invention, the groove portion may be formed in both the valve body and the outer needle hub.

Further, in the indwelling needle and the indwelling needle assembly of the present invention, the opening / closing part of the valve body is not limited to the illustrated configuration, and may be configured by a duckbill valve, for example.

Further, in the indwelling needle and the indwelling needle assembly of the present invention, the valve body may not be disposed in the middle of the channel, and may be disposed, for example, at the end of the channel.

According to the present invention, the air trapped between the blood (liquid) flowing into the valve body from the outer needle and the valve body can be released to the other side of the valve body through the groove portion. , Blood can be prevented from entering the other side of the valve body. Therefore, bubbles (air) can be prevented from remaining in the flow path on one side of the valve body, and more reliable priming can be performed. Moreover, it is possible to prevent blood from leaking through the groove. Therefore, it has industrial applicability.

Claims

A hollow outer needle,
A hub provided at a proximal end portion of the outer needle, having a flow channel communicating with the inside of the outer needle, and capable of connecting a tubular body to the flow channel;
A valve body that is provided so as to close the flow path at an end portion or in the middle of the flow path, and has an openable / closable portion;
A groove portion communicating the flow path on the one side of the valve body and the other side;
A polymer layer formed on the inner surface of the groove,
The indwelling needle, wherein the polymer layer is configured to prevent passage of the liquid by being deformed or deformed by contact with the liquid flowing into the groove.
The indwelling needle according to claim 1, wherein the polymer layer absorbs the liquid flowing into the groove and swells to block the groove and prevent the liquid from passing therethrough.
The indwelling needle according to claim 1, wherein the polymer layer is dissolved by contact with the liquid flowing into the groove and increases in volume, thereby closing the groove and preventing the liquid from passing therethrough.
The indwelling needle according to claim 1, wherein the polymer layer is dissolved by contact with the liquid flowing into the groove and increases the viscosity of the liquid, thereby preventing the liquid from passing therethrough.
The indwelling needle according to any one of claims 1 to 4, wherein the groove is formed in the valve body.
The valve body has a bottomed cylindrical shape having a plate-like plate-like portion in which the opening / closing portion is formed, and a cylindrical tube-like portion protruding from an edge of the plate-like portion,
The indwelling needle according to claim 5, wherein the groove is formed on an outer peripheral surface of the valve body.
The indwelling needle according to claim 6, wherein the groove portion is extended from the outer peripheral surface to the surface of the plate-like portion.
The flow path has a stepped portion,
The valve body is disposed so that an edge of the plate-like portion contacts the stepped portion,
The indwelling needle according to claim 7, wherein the groove portion is extended on the surface of the plate-like portion so as to be exposed from the stepped portion.
The indwelling needle according to any one of claims 1 to 4, wherein the groove is formed on an inner surface of the hub so as to face the flow path.
The indwelling needle according to any one of claims 1 to 9, wherein the groove portion extends along an extending direction of the flow path.
The indwelling needle according to any one of claims 1 to 10, wherein the groove has a portion whose cross-sectional area changes along the extending direction.
12. The indwelling needle according to claim 1, wherein the depth of the groove is 5 μm to 100 μm.
The indwelling needle according to any one of claims 1 to 12, wherein the polymer layer is made of a hydrophilic polymer.
The said polymer layer is formed by dripping the liquid containing the said hydrophilic polymer in the said groove part, and drying after drip-spreading the dripped liquid on the inner surface of the said groove part. Indwelling needle.
An indwelling needle according to any of claims 1 to 14,
An inner needle inserted through the outer needle,
An indwelling needle assembly, wherein blood flows into the flow path via the outer needle when the living body surface is punctured with the inner needle.