JP2013070870A - Catheter assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To improve hemostasis performance and penetrating properties of a valve mechanism of a catheter assembly.SOLUTION: The catheter assembly 10 includes a tubular external needle 12, an external needle hub 14 having a flow channel 26 communicating with the inside of the external needle 12 in the inside, a hemostasis valve 46 having a blocking membrane 58 interrupting the circulation of a fluid and a slit 60 partially opening and closing the blocking membrane 58, and a plug 50 provided closer to a proximal end side than the blocking membrane 58 and inserted into the slit 60 by the movement toward the tip. The plug 50 includes a pair of notch parts 70 extending in the axial direction from the distal end, and a pair of insertion piece parts 72 divided by the notch parts 70 abut on the blocking membrane 58 with the movement of the plug 50 in the tip direction and deform elastically to get close to the slit 60.

Description

  The present invention relates to a catheter assembly that is placed in, for example, a patient's blood vessel and on the skin, and enables infusion to the patient.

  Usually, when infusion is performed on a patient, the indwelling needle is punctured (inserted) into the patient's blood vessel and placed, and the distal end of the infusion tube is connected to the proximal end of the indwelling needle exposed on the skin. Connect the lines. Therefore, the indwelling needle is configured as a catheter assembly so that the connection with the infusion tube can be quickly performed and the connection portion can be easily placed on the patient's skin (for example, see Patent Document 1).

  The catheter assembly disclosed in Patent Document 1 includes a tubular outer needle (catheter), an outer needle hub connected to a proximal end portion of the outer needle, an inner needle having a sharp needle tip, An inner needle hub connected to the proximal end portion of the inner needle. In addition, a valve mechanism including a hemostasis valve that prevents blood from flowing out and a plug (pusher) that passes through the slit of the hemostasis valve is disposed inside the outer needle hub.

  When using the catheter assembly, the outer needle and the inner needle are punctured into the blood vessel integrally, and then only the inner needle is withdrawn to place the outer needle in the blood vessel. In this state, blood flows into the flow path in the outer needle hub on the proximal end side via the outer needle, but the blood is prevented from flowing out by the hemostasis valve accommodated in the outer needle hub. Then, a plug is inserted into the opening / closing part of the hemostasis valve, and the infusion tube is connected to the proximal end side of the outer needle hub, thereby communicating the infusion line to the blood vessel of the patient.

US Patent Application Publication No. 2010/0204648

  As described above, it is desirable that the valve mechanism of the catheter assembly blocks the blood flowing in through the outer needle with high accuracy, while easily and reliably connecting the catheter assembly and the infusion tube. . That is, it is required to simultaneously satisfy the hemostatic properties of blood and the penetrability (including ease, quickness, reliability, etc.) when the plug is inserted through the hemostatic valve.

  However, the valve mechanism constituted by the hemostasis valve and the plug makes it difficult to insert the plug so as not to easily open the slit of the hemostasis valve when the hemostasis is to be improved, and the penetrability is lowered. . On the contrary, when trying to improve penetrability, the opening / closing part of the hemostasis valve is easily opened to facilitate the insertion of the plug, and the hemostasis is lowered. That is, it is difficult for the valve mechanism of the catheter assembly to satisfy both hemostasis and penetrability.

  The present invention has been made in view of the above circumstances, and can improve the hemostasis and penetrability of the valve mechanism with a simple configuration, thereby reducing the outflow of blood from the valve mechanism. An object of the present invention is to provide a catheter assembly that can improve the efficiency of the connection work of the infusion tube.

  In order to achieve the above object, the present invention provides a tubular insertion portion, a holding portion that is connected to a proximal end side of the insertion portion and communicates with the insertion portion, and has a flow passage on the flow passage. And a valve body having an occlusion membrane for blocking fluid flow, an opening / closing portion capable of partially opening and closing the occlusion membrane, and a proximal end side than the occlusion membrane, and moving in a distal direction A catheter assembly including an insertion member that passes through the opening / closing portion, and a distal end portion of the insertion member is formed into a plurality of insertion piece portions that are elastically deformable by a plurality of cutout portions extending in an axial direction. It is divided.

  According to the above, the distal end portion of the insertion member is divided into the plurality of insertion piece portions that can be elastically deformed by the plurality of cutout portions extending in the axial direction, thereby moving the insertion member in the distal direction. When abutting against the blocking film, the plurality of insertion piece portions are bent inward and the tip end side is reduced in diameter, and can be easily entered into the opening / closing portion. That is, the catheter assembly can improve the penetrability of the insertion member. Moreover, since the opening / closing part through which the insertion piece part is inserted can be formed small by operating so that the tip part of the plurality of insertion piece parts is reduced in diameter, the opening / closing part is prevented from flowing out blood. can do. That is, the catheter assembly can improve the hemostatic property of the blood by the valve body.

  Moreover, it is preferable that the said insertion piece part has a taper part diameter-expanded toward the base end direction from the outer periphery of a front-end | tip part.

  As described above, since the distal end portion of the insertion piece portion has the tapered portion, the distal end portion of the insertion piece portion can be easily reduced in diameter along the tapered portion when the insertion piece portion contacts the occlusion membrane of the hemostasis valve. You can be guided to do so.

  Further, the opening / closing part is formed to penetrate the blocking membrane in a single slit shape, and at least two of the insertion piece parts are disposed to face each other in a direction orthogonal to the extending direction of the opening / closing part in a front view. Good.

  Thus, since the opening / closing part is formed through the obstruction membrane in a single slit shape, the opening / closing part can be made smaller, and the hemostasis of blood can be further improved. In addition, the two insertion pieces are opposed to each other in a direction orthogonal to the extending direction of the opening / closing portion in a front view, so that the slit-like opening / closing is performed along the elastic deformation direction of the two insertion pieces. The part can be easily opened, and the penetrability can be further improved.

  In this case, it is preferable that the said notch part is extended in the base end side rather than the said taper part.

  As a result, the plurality of insertion pieces divided by the notches are easily elastically deformed, and each insertion piece can be easily entered into the opening / closing part.

  The catheter assembly includes an inner needle that is inserted into the insertion portion, and an inner needle hub that is fixed to the proximal end side of the inner needle and is connectable to the proximal end side of the holding portion. Also good.

  Thereby, when using a catheter assembly, an insertion part and an inner needle can be punctured easily by grasping and operating an inner needle hub.

  According to the present invention, it is possible to improve the hemostasis and penetrability of the valve mechanism constituted by the valve body and the insertion member with a simple configuration, thereby reducing the outflow of blood from the valve mechanism, It is possible to improve the efficiency of connecting the infusion tube.

It is a whole perspective view which shows the catheter assembly which concerns on this Embodiment. FIG. 2 is an exploded perspective view of the catheter assembly of FIG. 1. FIG. 2 is a side cross-sectional view of the catheter assembly of FIG. 1. FIG. 4 is a partial side cross-sectional view showing a state in which an inner needle and an inner needle hub are pulled out from the catheter assembly of FIG. 3. It is sectional drawing of the VV line of FIG. FIG. 5 is a partial side cross-sectional view showing a state where the plug is advanced halfway from the catheter assembly of FIG. 4. FIG. 7 is a partial side cross-sectional view showing a state where the plug is advanced from the catheter assembly of FIG. 6 and the hemostasis valve is inserted. It is a partial side sectional view showing the modification of the catheter assembly concerning the present invention.

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

  1 is an overall perspective view showing a catheter assembly 10 according to the present embodiment, FIG. 2 is an exploded perspective view of the catheter assembly 10 of FIG. 1, and FIG. 3 is a catheter assembly of FIG. FIG. In the following description, based on the illustration of the catheter assembly 10 in FIG. 1, the left side in the drawing is referred to as the distal end (front), and the right side in the drawing is referred to as the proximal end (rear).

  The catheter assembly 10 according to the present embodiment includes a tubular outer needle 12 (insertion portion), an outer needle hub 14 (holding portion) connected to the proximal end portion of the outer needle 12, and a sharp needle at the distal end. An inner needle 16 having a tip 16a and an inner needle hub 18 connected to a proximal end portion of the inner needle 16 are provided. The catheter assembly 10 punctures a patient's vein (blood vessel) in a state where the outer needle 12 and the inner needle 16 are overlapped (the outer needle 12 is covered with the outer needle 12), and then the inner needle 16 is Pull out with needle hub 18. Thus, the proximal end side of the outer needle 12 and the outer needle hub 14 are placed on the patient's skin with the distal end side of the outer needle 12 inserted into the vein. Then, by connecting an infusion tube (not shown) to the proximal end side of the outer needle hub 14, an infusion solution (medicine solution) can be supplied to the patient from the infusion tube. Prior to use of the catheter assembly 10, a protector 20 (see FIG. 2) is attached to prevent inadvertent puncture of the outer needle 12 and the inner needle 16.

  The outer needle 12 of the catheter assembly 10 is configured as a tubular (tubular) member (catheter) having flexibility. As a constituent material of the outer needle 12, a resin material, in particular, a soft resin material is suitable. In this case, for example, a fluororesin such as polytetrafluoroetherene (PTFE), an ethylene / tetrafluoroetherene copolymer (ETFE), or a belfluoroalkoxy fluororesin (PFA), an olefin resin such as polyethylene or polypropylene, or These mixtures, polyurethanes, polyesters, polyamides, polyether nylon resins, mixtures of the olefin resins and ethylene-vinyl acetate copolymers, and the like can be mentioned.

  Moreover, it is preferable that the outer needle 12 is comprised with resin which has transparency so that all or one part can visually recognize an inside. Thereby, when the outer needle 12 is inserted and indwelled in a vein, a phenomenon (also referred to as flashback) in which blood flows into the outer needle hub 14 through the lumen 22 (see FIG. 3) of the outer needle 12 is prevented. It can be confirmed visually.

  Moreover, the contrast function can also be given by mix | blending X-ray contrast agents, such as barium sulfate, barium carbonate, bismuth carbonate, and tungstic acid, in the constituent material of the outer needle 12, for example.

  As shown in FIG. 2, the proximal end portion of the outer needle 12 is attached to the distal end portion of the outer needle hub 14 by a method such as caulking, fusing (thermal fusing, high frequency fusing, etc.), bonding with an adhesive, or the like. It is fixed liquid-tight. In the catheter assembly 10 according to the present embodiment, the outer needle 12 is fixedly held on the outer needle hub 14 by using a caulking pin 24 (see also FIGS. 3 and 4).

  As shown in FIGS. 1 to 3, the outer needle hub 14 is formed into a cylindrical shape that is tapered in the distal direction by a resin material made of a material harder than the outer needle 12. The outer needle hub 14 fixes and holds the proximal end portion of the outer needle 12 to facilitate operation (puncture) of the outer needle 12 and facilitate communication between the outer needle 12 and the infusion tube. The outer needle hub 14 includes a tab 14a protruding outward on the outer peripheral surface of the intermediate portion in the axial direction in order to facilitate the advancement procedure (puncture) of the outer needle 12 into the vein.

  Further, the inside of the outer needle hub 14 functions as a flow path 26 through which the infusion solution can flow. The flow path 26 opens at the proximal end portion of the outer needle hub 14 and is fixed to the distal end portion of the outer needle hub 14. Connected (communication) to the inner cavity 22 of the outer needle 12 to be performed. Specifically, the flow path 26 of the outer needle hub 14 includes an outer needle connection portion 28, a distal end guide portion 30, a valve element arrangement portion 32, and a connector connection portion 34 from the distal end side toward the proximal end side (see FIG. 3).

  The outer needle connecting portion 28 has a wall portion 36 (inner diameter) that substantially matches the outer diameter of the outer needle 12 at the distal end portion of the outer needle hub 14. The proximal end portion of the outer needle 12 is inserted into the outer needle connecting portion 28.

  Further, the distal end guide portion 30 has a function of guiding the infusion agent supplied from the proximal end side to the outer needle 12 by connecting the distal end side to the outer needle connecting portion 28. The wall portion 38 constituting the distal end guide portion 30 has a tapered surface 38a whose inner diameter near the distal end gradually increases in the proximal direction, and is formed substantially in parallel from the intermediate portion connected to the tapered surface 38a to the proximal end. The

  The valve body arranging portion 32 is configured by a wall portion 40 having a distal end side continuous with the distal end guide portion 30 and having a diameter larger than the wall portion 38 of the distal end guide portion 30. Accordingly, a stepped portion is formed between the tip guide portion 30 and the valve element arrangement portion 32. A hemostatic valve 46 and a seal member 48, which will be described later, are disposed in the valve body arranging portion 32.

  The connector connecting portion 34 is connected to the valve element arranging portion 32 at the distal end side and extends in the proximal direction. A connector 44 (see FIGS. 6 and 7) of an infusion tube can be fitted into the connector connecting portion 34. In FIG. 3, the wall portion 42 constituting the connector connecting portion 34 is formed in parallel with the axial direction, but the inner diameter of the wall portion 42 of the connector connecting portion 34 gradually increases toward the proximal direction. It may have a tapered shape. Accordingly, the distal end portion of the connector 44 is formed into a corresponding tapered shape (taper angle), so that the distal end portion of the connector 44 can be easily inserted and connected to the proximal end side of the connector connecting portion 34. . By connecting in this way, the adhesion between the wall portion 42 of the connector connecting portion 34 and the outer peripheral surface of the connector 44 is increased, and a more liquid-tight connection is possible.

  4 is a partial side sectional view showing a state in which the inner needle 16 and the inner needle hub 18 are pulled out from the catheter assembly 10 in FIG. 3, and FIG. 5 is a sectional view taken along the line VV in FIG.

  As shown in FIGS. 2 to 4, the caulking pin 24, the hemostasis valve 46 (valve element), the seal member 48, and the plug 50 (insertion member) are accommodated in this order in the flow path 26 of the outer needle hub 14. The Among these, the hemostasis valve 46 and the plug 50 function as a valve mechanism 45 that enables blocking of blood and supply of an infusion in the catheter assembly 10.

  As described above, the caulking pin 24 is a member for connecting and fixing the outer needle 12 and the outer needle hub 14, and has a tubular circular pipe portion 52 on the distal end side, and from the circular pipe portion 52 toward the proximal end side. And a tapered portion 54 whose diameter gradually increases. In the caulking pin 24, the circular pipe portion 52 is accommodated in the outer needle connecting portion 28 of the outer needle hub 14 (flow path 26), and the tapered portion 54 is accommodated on the distal end side of the distal end guide portion 30 of the outer needle hub 14. .

  The circular pipe part 52 is formed so that the outer diameter substantially coincides with the lumen 22 of the outer needle 12, and is extended in the axial direction by a predetermined length. The catheter assembly 10 is caulked by inserting the circular tube portion 52 into the outer needle connecting portion 28 in a state where the outer needle 12 is inserted into the outer needle connecting portion 28 of the outer needle hub 14. As a result, the outer needle 12 is pinched by the wall portion 36 of the outer needle connecting portion 28 and the circular tube portion 52 of the caulking pin 24, and the outer needle 12 is fixedly held on the outer needle hub 14. The caulking pin 24 is preferably made of metal or hard resin in order to caulk the outer needle 12 and the outer needle hub 14 at the circular pipe portion 52.

  Further, the tapered portion 54 of the caulking pin 24 is formed so that the outer diameter gradually increases from the distal end side toward the proximal end side, corresponding to the tapered surface 38 a of the distal end guide portion 30 of the outer needle hub 14. Therefore, the caulking pin 24 is accommodated in the flow path 26 in a state where the tapered portion 54 and the tapered surface 38a are in close contact with each other. When the infusion agent is introduced from the proximal end side, the tapered portion 54 can smoothly flow out toward the outer needle 12.

  Of course, when the outer needle 12 and the outer needle hub 14 are fixed by fusion or an adhesive, the caulking pin 24 need not be used. In this case, since the distal end guide portion 30 of the outer needle hub 14 is formed on the tapered surface 38a, the infusion agent smoothly flows out toward the outer needle 12 when the infusion agent flows in from the proximal end side. Can be made.

  The hemostasis valve 46 is a member disposed so as to block the flow path 26 of the outer needle hub 14 and has a function of blocking outflow of fluid (blood). Specifically, the hemostasis valve 46 is formed in a bottomed cylindrical shape, and the side peripheral wall 56 is arranged in close contact with the wall portion 40 of the valve element arrangement portion 32 of the outer needle hub 14. Further, the hemostasis valve 46 is configured as a blocking film 58 whose bottom portion blocks the flow of the infusion agent, and a slit 60 (opening / closing section) penetrating the blocking film 58 is formed at the center of the blocking film 58.

  The blocking film 58 has a predetermined film thickness and functions as a valve that receives blood flowing into the flow path 26. That is, the blocking film 58 is configured with a predetermined elastic force so that the slit 60 can be easily opened and blood does not flow into the proximal end side of the hemostatic valve 46.

  The slit 60 is formed so as to exist in one planar shape by penetrating the blocking film 58 as a single line in a front view. Specifically, the slit 60 is cut and formed in a relatively short range in the width direction passing through the center point of the blocking film 58 in a front view (see FIG. 5). The slit 60 is formed so that the inner needle 16 and the plug 50 can be inserted and removed, and is self-closed when the inner needle 16 and the plug 50 are not inserted. In this way, the hemostasis valve 46 is formed by shortening one slit 60, so that the occlusion force is increased and blood can be blocked more reliably.

  It is preferable that the hemostasis valve 46 is comprised with the elastic material which has the hardness which the slit 60 does not open easily by blood flow (blood pressure). By configuring the hemostasis valve 46 with an elastic material, the slit 60 can be easily inserted through the plug 50. Examples of the elastic material constituting the hemostasis valve 46 include various rubber materials such as natural rubber, isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene rubber, urethane rubber, nitrile rubber, acrylic rubber, fluorine rubber, and silicone rubber ( Especially those vulcanized), various elastic materials such as urethane-based, polyester-based, polyamide-based, olefin-based, styrene-based various thermoplastic elastomers or mixtures thereof, among these elastic materials, In particular, it is preferable to use isoprene rubber. When isoprene rubber is used as the constituent material of the valve body, there is an advantage that the compression set is small and the usable period of the product becomes long.

  As shown in FIGS. 3 to 5, the distal end guide portion 30 of the outer needle hub 14 and the proximal end side of the valve body placement portion 32 are provided on the wall portion 40 of the valve body placement portion 32 where the hemostasis valve 46 is disposed. A plurality of inner peripheral groove portions 66 are provided for communication. The inner circumferential groove 66 is formed such that the tip thereof cuts out the stepped portion between the tip guide portion 30 and the valve body placement portion 32, and extends along the wall portion 40 of the valve body placement portion 32 from this tip portion. It extends in the axial direction.

  The inner circumferential groove 66 prevents gas (air) from remaining in the distal end guide portion 30 of the outer needle hub 14 after the outer needle 12 and the inner needle 16 are punctured into the patient's vein and the inner needle 16 is removed. It is provided for the purpose. That is, when the inner needle 16 is removed, the air located on the distal end side from the hemostasis valve 46 is pushed by the blood flowing into the flow path 26 and passes through the inner peripheral groove portion 66 and is guided to the proximal end side. In addition, the shape of the inner peripheral groove portion 66 may be formed not only in a straight line shape on the wall portion 40 of the outer needle hub 14 from the distal end side to the proximal end side, but may be formed so as to draw a waveform or a spiral, for example. Moreover, although the depth of the inner peripheral groove part 66 is based on the shape of the outer needle hub 14 and the hemostatic valve 46, it is suitable to set to about 5-20 micrometers, for example. Further, the inner peripheral groove 66 may be formed not only on the wall 40 (inner peripheral surface) of the outer needle hub 14 but also on the side peripheral wall 56 of the hemostasis valve 46.

  In the catheter assembly 10 according to the present embodiment, the seal member 48 is disposed on the proximal end side of the hemostasis valve 46 so as to close the inner peripheral groove 66. The seal member 48 is formed in a cylindrical shape, has a sealing property that allows gas to pass therethrough and does not allow liquid to pass through, and is disposed so as to be in close contact with the hemostasis valve 46 and to block the inner peripheral groove 66. . The seal member 48 is formed with a cylindrical convex portion 48 a fitted at the proximal end opening of the hemostasis valve 46 in order to improve the adhesion with the hemostasis valve 46. Further, the seal member 48 can be fixed to the wall portion 40 of the outer needle hub 14 (valve element arrangement portion 32) by a method such as fusion or adhesive. The hemostasis valve 46 and the seal member 48 are restrained from being displaced on the distal end side and the proximal end side by the valve element arranging portion 32 of the outer needle hub 14. Therefore, even when the inner needle 16 and the plug 50 are inserted / removed, the arrangement position of the hemostasis valve 46 is maintained, so that the opening / closing operation of the slit 60 can be performed smoothly.

  The seal member 48 is made of a material that allows gas to pass but does not allow liquid to pass. As such a sealing member 48, what was formed with porous bodies, such as a sintered compact made from polyethylene, for example can be used conveniently. The porous sealing member 48 is preferable because it is easy to manufacture and can be manufactured with high accuracy.

  On the other hand, the plug 50 which comprises the valve mechanism 45 with the hemostatic valve 46 is formed in a substantially cylindrical shape with a resin material having rigidity. The plug 50 is disposed on the base end side of the blocking film 58 on the flow path 26 of the outer needle hub 14 and can be advanced in the axial direction of the outer needle hub 14. The lumen 68 of the plug 50 functions as a flow path for circulating the infusion agent. The plug 50 is advanced and moved in the distal direction of the outer needle hub 14 by a predetermined operation (the pushing operation of the connector 44 when the infusion tube is connected), thereby inserting the slit 60 of the hemostasis valve 46 and the outer needle hub 14. The distal end guide portion 30 (flow path 26) and the lumen 68 are communicated.

  As shown in FIGS. 2 and 4, the plug 50 according to the present embodiment has a pair of cutout portions 70 cut out in the axial direction from the tip portion. The notch 70 is cut out with a relatively large width (for example, about 0.2 mm to 2 mm) in the circumferential direction of the plug 50 and extends a predetermined length (for example, about 2 to 3 mm) in the axial direction. The distal end portion of the plug 50 is divided into a pair of insertion piece portions 72 extending in the axial direction by the pair of cutout portions 70. The pair of insertion piece portions 72 can be elastically deformed so as to be close to each other toward the cutout portion 70 side. That is, the pair of insertion piece portions 72 are inclined from the split portion on the base end side (the connecting portion with the body portion 73) by the pair of notch portions 70 therebetween, and approach the axial center side of the plug 50 ( The tip of the plug 50 can be deformed so that the diameter thereof is reduced).

  Further, on the outer peripheral surface of the distal end portion of the pair of insertion piece portions 72, there are two flange portions (a first flange portion 72a and a second flange portion 72b) that protrude outward in the radial direction and extend in the circumferential direction in the axial direction. Are lined up. In this case, the 1st and 2nd collar parts 72a and 72b are formed in the taper shape (taper part) which increases gradually toward a base end direction from a front-end | tip part.

  Since the first flange 72b is tapered, when the plug 50 comes into contact with the blocking film 58, the first flange 72b receives the pressing force from the blocking film 58 from an oblique direction, and the distal end of the insertion piece 72 Can be reduced in diameter.

  Further, the second flange 72 b functions as an engaging portion that engages with the slit 60 of the hemostasis valve 46 in a state where the plug 50 penetrates (inserts) the slit 60. That is, the second flange 72b of the plug 50 is engaged with the slit 60 of the hemostasis valve 46, whereby the plug 50 is prevented from inadvertently moving in the proximal direction. The communication state with the inner cavity 68 of the plug 50 is reliably maintained. In addition, in this Embodiment, although two collar parts (1st and 2nd collar parts 72a, 72b) were shown, one or three or more may be sufficient.

  Further, the plug 50 includes a body portion 73 that is continuous with the cutout portion 70 and the insertion piece portion 72, and a proximal end diameter-expanded portion 74 that is continuous with the body portion 73. The trunk portion 73 extends a predetermined length in the proximal direction, and is disposed from the valve body placement portion 32 to the connector connection portion 34 in a state of being accommodated in the flow path 26 of the outer needle hub 14.

  The proximal end enlarged diameter portion 74 is arranged on the connector connecting portion 34 of the outer needle hub 14 by being provided continuously to the proximal end side of the body portion 73. A flange portion 74 a that protrudes radially outward and extends in the circumferential direction may be formed on the outer peripheral surface near the base end of the base end enlarged diameter portion 74, and the flange portion 74 a is formed on the outer needle hub 14. The outer diameter of the connector connecting portion 34 is substantially the same as the wall portion 42 (inner diameter). Therefore, when the plug 50 moves forward, the flange portion 74a slides on the wall portion 42 of the connector connecting portion 34, and the movement is performed stably.

  Before the advancement of the plug 50, the plug 50 is on the proximal end side with respect to the slit 60, so that the slit 60 is closed by self-occlusion and the flow path 26 is blocked. Then, when the plug 50 moves forward, the distal end portion passes through the slit 60 and moves further toward the distal end side than the hemostasis valve 46, and the inner cavity 68 of the plug 50 and the flow path 26 are connected. That is, the catheter assembly 10 advances the plug 50 along the axial direction of the flow path 26 and inserts the distal end portion into the slit 60 of the hemostasis valve 46, whereby the flow path 26 and the lumen 68 of the plug 50 are (See FIG. 7).

  Here, as shown in FIG. 5, in the plug 50 according to the present embodiment, a pair of insertion piece portions 72 are disposed to face each other in a direction orthogonal to the extending direction of the slit 60 in a front view. As a result, the insertion piece 72 is elastically deformed in a direction orthogonal to the slit 60, and the direction in which the slit 60 is easy to open (the direction orthogonal to the extending direction) matches the direction of elastic deformation. it can.

  Returning to FIG. 3, the inner needle 16 of the catheter assembly 10 has a proximal end fixed to the inner needle hub 18, and is a length that can penetrate the outer needle 12 and the outer needle hub 14 from the proximal end toward the distal end. Formed. In the assembled state of the catheter assembly 10, the inner needle 16 is inserted through the outer needle 12, the outer needle hub 14, the hemostasis valve 46 and the plug 50. As a result, the sharp needle tip 16a of the inner needle 16 is projected from the distal end opening of the outer needle 12, and the surface of the living body can be easily punctured by the needle tip 16a. Examples of the constituent material of the inner needle 16 include a metal material such as stainless steel, aluminum or an aluminum alloy, titanium or a titanium alloy.

  A groove (not shown) may be provided on the outer peripheral portion of the inner needle 16 along the axial direction of the inner needle 16. This groove can function as an introduction path for introducing blood into the lumen 22 of the outer needle 12 when the outer needle 12 and the inner needle 16 are punctured into the blood vessel. The blood introduced from the groove flows into the gap between the outer needle 12 and the inner needle 16. Thereby, the flashback of blood can be reliably confirmed from an early stage.

  The inner needle hub 18 has a case 76 capable of operating the inner needle 16 on the proximal end side, and a fixing block 78 for fixing and holding the inner needle 16 is provided inside the case 76. The case 76 is formed into an elongated shape that can be easily held with one hand. The inner needle hub 18 can be connected to the proximal end side of the outer needle hub 14. Thereby, the puncture of the outer needle 12 and the inner needle 16 can be easily performed by operating the inner needle hub 18.

  As described above, in the catheter assembly 10, after the outer needle 12 and the inner needle 16 are punctured into a patient's vein, an operation of pulling out (withdrawing) the inner needle 16 inserted into the outer needle 12 is performed. . The user of the catheter assembly 10 can easily remove the inner needle 16 from the outer needle 12 by gripping and pulling the inner needle hub 18 (case 76) when the inner needle 16 is pulled out.

  Examples of the constituent material of the outer needle hub 14 and the inner needle hub 18 include various resin materials such as polyolefin, such as polyethylene, polypropylene, and ethylene-vinyl acetate copolymer, polyurethane, polyamide, polyester, polycarbonate, polybutadiene, and polyvinyl chloride. can give. Further, the plug 50 is also made of the same material, so that the manufacturing cost can be reduced.

  6 is a partial side cross-sectional view showing a state in which the plug 50 is advanced halfway from the catheter assembly 10 in FIG. 4, and FIG. 7 is a hemostasis valve in which the plug 50 is advanced from the catheter assembly 10 in FIG. FIG. 6 is a partial side cross-sectional view showing a state where 46 is inserted.

  As shown in FIGS. 6 and 7, in the catheter assembly 10, the tubular connector 44 is inserted into the connector connecting portion 34 of the outer needle hub 14 after the inner needle 16 is removed. The connector 44 is formed to have an outer diameter substantially coinciding with the wall portion 42 (inner diameter) of the connector connecting portion 34. The connector 44 is fitted into the outer needle hub 14 by being inserted into the connector connecting portion 34, and the connected state is maintained. Is done. In a state where the connector 44 is connected to the outer needle hub 14, the distal end surface of the connector 44 abuts on the base end enlarged diameter portion 74 of the plug 50, and the inner cavity 68 of the plug 50 and the inner cavity 44 a of the connector 44 communicate with each other.

  A distal end portion of an infusion tube (not shown) is connected in advance to the proximal end portion of the connector 44, and an infusion bag (not shown) filled with an infusion agent is connected to the proximal end portion of the infusion tube. . Therefore, the catheter assembly 10 is supplied with the infusion agent via the infusion bag, the infusion tube, and the connector 44, and further passes through the lumen 68 of the plug 50 to the flow path 26 of the outer needle hub 14 and the lumen 22 of the outer needle 12. The infusion can be guided.

  In order to reliably supply the infusion agent, the outer needle hub 14 and the connector 44 may be provided with a lock mechanism (not shown) for maintaining the connection state. Moreover, the front-end | tip part of the connector 44 may be formed in the taper shape which the outer diameter increases gradually toward a base end direction. Thereby, when connecting the connector 44, it can insert easily in the base end side of the outer needle hub 14, and can be made to detach | leave from the outer needle hub 14 easily after supplying an infusion agent.

  Further, the plug 50 may be set such that the inner diameter of the base end enlarged diameter portion 74 is the same as or larger than the inner diameter of the connector 44. In this way, when the connector 44 is connected to the proximal end portion of the outer needle hub 14, the infusion agent can be easily and reliably made to flow from the connector 44 to the plug 50.

  The catheter assembly 10 according to the present embodiment is basically configured as described above. Next, operations and effects when the catheter assembly 10 is used will be described.

  The catheter assembly 10 is provided with the members shown in FIG. 2 assembled before use. That is, as shown in FIG. 3, the proximal end portion of the outer needle 12 is fixed to the outer needle hub 14 and protrudes in the distal direction, and the caulking pin 24 is disposed inside the outer needle hub 14 (the flow path 26). The hemostasis valve 46, the seal member 48, and the plug 50 are disposed at predetermined positions. Further, the proximal end portion of the inner needle 16 is fixed to the inner needle hub 18, is inserted through the outer needle hub 14, is further inserted through the lumen 22 of the outer needle 12, and the needle tip 16 a is the outer needle 12. It is exposed from the tip. The inner needle 16 is connected to the inner needle hub 18 through the slit 60 of the hemostasis valve 46 and the inner cavity 68 of the plug 50 in the flow path 26 of the outer needle hub 14. The catheter assembly 10 is mounted with a protector 20 (see FIG. 2) so as to cover the outer needle 12 and the inner needle 16 from the tip of the outer needle hub 14.

  Therefore, in using the catheter assembly 10, the protector 20 is first removed, and the catheter assembly 10 is positioned at a desired position (puncture position) of the patient. Next, the inner needle hub 18 is grasped, and the inner needle 16 and the outer needle 12 are punctured into the patient's vein. When the outer needle 12 and the inner needle 16 are inserted into the vein, blood flows between the outer needle 12 and the inner needle 16 in the proximal direction due to blood pressure. At this time, since the outer needle 12 or the outer needle hub 14 is formed of a transparent material, the inflow of blood can be visually recognized.

  The blood that has flowed into the outer needle hub 14 flows into the distal end guide portion 30 of the flow path 26 and is blocked from further flowing into the proximal end side by the hemostasis valve 46. In this blood inflow, the air existing in the distal end guide portion 30 passes through the inner peripheral groove portion 66 and is exhausted to the proximal end side of the outer needle hub 14 through the seal member 48 that can transmit gas.

  After visually confirming the inflow of blood, the catheter assembly 10 is further advanced toward the distal end by a minute distance. Specifically, a finger is applied to the tab 14a of the outer needle hub 14, and the outer needle 12 and the inner needle 16 are advanced by a predetermined amount relative to the vein. After the outer needle 12 is advanced, the outer needle 12 or the outer needle hub 14 is fixed with one hand, the inner needle hub 18 is grasped with the other hand and pulled toward the proximal end, and the inner needle 16 is pulled to the outer needle. Remove from 12. Thereby, the catheter assembly 10 is in a state in which the outer needle 12 and the outer needle hub 14 are indwelled in the patient. In addition, since the extracted inner needle 16 becomes unnecessary, it is used for disposal.

  As shown in FIGS. 4 and 5, the catheter assembly 10 is in a state in which the slit 60 of the hemostasis valve 46 is closed when the inner needle 16 is removed, and flows into the flow path 26 (tip guide 30). It is possible to prevent blood from flowing out (leakage) from the proximal end side of the outer needle hub 14 to the outside. In this case, since the slit 60 is formed with a short width, even when a pressing force (blood pressure) is applied from the blood flowing into the flow path 26 of the outer needle hub 14, the blood can be Outflow to the proximal side is suppressed. That is, the hemostasis valve 46 can reliably hold (block) the blood by the occlusion film 58.

  After the inner needle 16 is removed, the outer needle hub 14 is fixed on the patient's skin with an adhesive tape or the like, and an infusion tube connector 44 is inserted from the proximal end side of the outer needle hub 14 as shown in FIG. . As the connector 44 is inserted, the plug 50 housed in the flow path 26 of the outer needle hub 14 is pressed by the connector 44 and moves in the distal direction, and the plug 50 pushes the occlusion membrane 58 of the hemostasis valve 46. Go.

  Here, the plug 50 according to the present embodiment extends as a pair of insertion piece portions 72 whose tip portions are divided by the pair of notch portions 70. When the pair of insertion pieces 72 are pressed against the occlusion film 58, the central portion of the occlusion film 58 is displaced in the distal direction and is bent in a bow shape at the same time. It will be deformed in the axial direction by receiving the reaction force (pressing force). As a result, the slits 60 formed in the blocking film 58 are opened, and the pair of insertion piece portions 72 are close to each other. As a result, the distal end portions of the pair of insertion piece portions 72 are reduced in diameter, approaching the slit 60, and the pair of insertion piece portions 72 can easily enter the slit 60.

  As a result, as shown in FIG. 7, the insertion piece 72 of the plug 50 can be inserted into the slit 60 of the blocking film 58. Therefore, the plug 50 can be inserted into the slit 60 at a stage where the amount of pressing of the plug 50 (the amount of deformation of the blocking film 58) is small, and the pressing force (insertion force) applied to the connection of the infusion tube can be reduced. it can. As a result, the connection operation of the infusion tube can be performed in a short time, and the plug 50 can be more reliably penetrated through the hemostasis valve 46. Further, the burden on the hemostasis valve 46 that is elastically deformed is also reduced.

  Thus, the valve mechanism 45 improves the penetrability in the insertion of the plug 50 and prevents the blood from flowing out to the proximal end side of the occlusion film 58 by smoothly inserting the plug 50 into the hemostasis valve 46. Can do. That is, the catheter assembly 10 also improves hemostasis when the plug 50 is inserted.

  When the plug 50 is inserted through the slit 60 of the hemostasis valve 46 to the second collar 72b, the second collar 72b is caught on the edge of the slit 60, and the plug 50 is prevented from being detached. Thereby, the flow path 26 (tip guide portion 30) of the outer needle hub 14 and the inner cavity 68 of the plug 50 communicate with each other, and the infusion can be guided from the infusion tube to the outer needle 12.

  Next, the supply of the infusion agent is started from the infusion bag. The infusate that has passed through the infusion tube and the connector 44 in this order flows out from the opening of the lumen 68 of the plug 50 and fills the entire flow path 26 (primed). Further, the infusion agent is guided from the flow path 26 of the outer needle hub 14 into the patient's vein via the lumen 22 of the outer needle 12.

  As described above, according to the catheter assembly 10 according to the present embodiment, the plug 50 includes the two notches 70 extending in the axial direction from the distal end portion, and the plug 50 moves in the distal end direction. Accordingly, the pair of insertion piece portions 72 divided by the notch portion 70 abuts against the blocking film 58 and elastically deforms so that the distal end side thereof is reduced in diameter, whereby the pair of insertion piece portions 72 are It is possible to easily enter the slit 60. That is, the catheter assembly 10 can improve the penetrability of the plug 50. Moreover, since the slit 60 of the hemostasis valve 46 can be formed small by operating so that the distal end portions of the pair of insertion piece portions 72 are reduced in diameter, it is possible to prevent the slit 60 from flowing out blood. it can. That is, the catheter assembly 10 can improve blood hemostasis by the hemostasis valve 46.

  Further, the insertion piece 72 has the first flange 72a (tapered portion) at the tip, so that when the insertion piece 72 comes into contact with the occlusion film 58 of the hemostasis valve 46, the insertion piece 72 extends along the first flange 72a. Thus, the insertion piece 72 can be easily guided toward the slit 60.

  Furthermore, the notch part 70 is extended longer to the base end side than the collar parts 72a and 72b. Accordingly, the pair of insertion piece portions 72 divided by the notch portions 70 are easily elastically deformed, and the pair of insertion piece portions 72 can be easily entered into the slit 60.

  Furthermore, the pair of insertion piece portions 72 are disposed to face each other in a direction orthogonal to the extending direction of the slit 60 in a front view, thereby reducing the diameter of the distal end portions of the pair of insertion piece portions 72 (slits). If it is elastically deformed so as to be close to 60, the slit 60 can be easily opened along the elastic deformation direction of the pair of insertion piece portions 72, and the penetrability can be further improved.

  Note that the slit 60 formed in the hemostasis valve 46 is not limited to a single line, but is sufficient to ensure blood hemostasis sufficiently, such as a cross shape or a Y-shape (卜 -shape). It is good. In this case, the cutout portion 70 of the plug 50 may be formed in accordance with the shape of the slit 60.

  Of course, the notches 70 formed in the plug 50 are not only provided in pairs (two) in the width direction but may be formed in more than two. For example, three notches 70 may be formed at 120 ° intervals in the circumferential direction of the plug 50, and four notches 70 may be formed at 90 ° intervals in the circumferential direction of the plug 50. In this way, by forming the plurality of cutout portions 70 at equal intervals, the plurality of insertion piece portions 72 divided by the cutout portions 70 can be formed in the same shape and deformed when elastically deformed. The amount is made uniform and can be easily inserted into the slit 60. Of course, the plurality of cutout portions 70 may not be formed at equal intervals, and the plurality of insertion piece portions 72 may not be formed in the same shape.

[Modification]
FIG. 8 is a partial side sectional view showing a modification of the catheter assembly 10A according to the present invention. In addition, in the catheter assembly 10A according to the modified example, the same reference numerals are given to the same configuration or the same function as the catheter assembly 10 according to the above embodiment, and the detailed description thereof will be given. Omitted.

  The catheter assembly 10A according to the modified example includes a plug 90 in which a pair of cutout portions 80 extending in the axial direction is formed longer than the cutout portion 70 of the plug 50 of the catheter assembly 10. Further, the plug 90 is formed so that the pair of insertion piece portions 82 extend along with the cutout portions 80. Further, in the plug 90, an infusion discharge portion 86 penetrating the inside and outside of the plug 90 is formed at or near the base end portion (base end enlarged diameter portion 84). The infusion discharge portion 86 communicates the inner cavity 88 of the plug 90 and the flow path 26 (connector connection portion 34) of the outer needle hub 14 with the plug 90 disposed in the connector connection portion 34 of the outer needle hub 14. .

  The operation of the catheter assembly 10A according to the present modification from the time when the outer needle 12 and the inner needle 16 are punctured into the patient's vein, the inner needle 16 is removed, and the infusion tube connector 44 is connected is described above. This can be done in the same process as the catheter assembly 10. That is, when the catheter assembly 10A and the connector 44 are connected, the plug 90 is pushed by the connector 44 so that the pair of insertion piece portions 82 abut against the occlusion membrane 58 of the hemostasis valve 46, and the occlusion membrane 58 is deformed in the distal direction. To go. The pair of insertion piece portions 82 are elastically deformed so as to approach the slit 60 by the pressing force from the blocking film 58 at this time, and easily enter the slit 60. Therefore, even in the catheter assembly 10A according to the modification, the penetrability of the plug 90 can be improved. Further, the hemostasis of the catheter assembly 10A can be improved by applying the same hemostasis valve 46 as that of the catheter assembly 10.

  When the infusion agent is supplied from the infusion tube via the connector 44 in a state where the flow path 26 of the outer needle hub 14 and the lumen 88 of the plug 90 communicate with each other, the catheter assembly 10A according to the modification example While taking the first route R1 passing through the inner cavity 88 of the plug 90, the fluid can be discharged from the infusion discharge part 86 to the flow path 26 (connector connection part 34) of the outer needle hub 14. The infusate that has flowed out of the infusion discharge part 86 flows into the cylinder of the hemostasis valve 46 from the connector connection part 34 through the inside of the seal member 48, and returns to the inner cavity 88 from the notch part 80 of the plug 90. Two routes R2 can be taken.

  As described above, by using the plug 90 of the modified example, the infusion agent can be supplied through the two routes of the first and second routes R1 and R2, and the supply power of the infusion agent can be improved. The infusion agent that passes through the second route R2 is, for example, an infusion agent that flows out (leaks out) blood to the proximal end side of the outer needle hub 14 via the inner peripheral groove 66 (see FIG. 5) and the seal member 48. At the same time, it can be guided to the tip side of the flow path 26. Thereby, it is avoided that blood adheres in the outer needle hub 14, and when the catheter assembly 10A is visually recognized, blood is not visually recognized even if the outer needle hub 14 has transparency. That is, the appearance of the catheter assembly 10A can be improved.

  Needless to say, the catheter assemblies 10 and 10A according to the present invention are not limited to the above-described embodiments, and various configurations can be adopted without departing from the gist of the present invention.

DESCRIPTION OF SYMBOLS 10 ... Catheter assembly 12 ... Outer needle 14 ... Outer needle hub 16 ... Inner needle 18 ... Inner needle hub 26 ... Flow path 44 ... Connector 45 ... Valve mechanism 46 ... Hemostasis valve 50, 90 ... Plug 58 ... Occlusion membrane 60 ... Slit 70, 80 ... Notch 72, 82 ... Insertion piece 72a, 82a ... 1st collar 72b, 82b ... 2nd collar

Claims (5)

A tubular insert,
A holding portion that is connected to a proximal end side of the insertion portion and has a flow channel communicating with the insertion portion;
A valve body that is disposed on the flow path and that shuts off the flow of fluid, and a valve body having an opening and closing part that can partially open and close the closure film;
A catheter assembly provided on the proximal side of the occlusive membrane and inserted through the opening / closing part by movement in the distal direction,
The distal end portion of the insertion member is divided into a plurality of insertion pieces that can be elastically deformed by a plurality of notches extending in the axial direction. The catheter assembly of claim 1.
The insertion piece portion has a tapered portion whose diameter increases from the outer peripheral edge of the distal end portion toward the proximal direction. The catheter assembly of claim 2,
The opening / closing part is formed through the obstruction film in a slit shape,
The at least two insertion piece portions are disposed to face each other in a direction orthogonal to the extending direction of the opening / closing portion in a front view. The catheter assembly according to claim 2 or 3,
The catheter assembly, wherein the cutout portion extends to a proximal end side with respect to the tapered portion. The catheter assembly according to any one of claims 1 to 4,
An inner needle inserted through the insertion portion;
An inner needle hub fixed to the proximal end side of the inner needle and connectable to the proximal end side of the holding portion.

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