JP4007351B2 - Blood collection needle - Google Patents

Description

  The present invention relates to a blood collection needle. More specifically, one end of the blood collection needle is punctured into a subject's blood vessel, the other end is inserted into a vacuum blood collection tube, and the inside of the blood vessel communicates with the inside of the vacuum blood collection tube. The present invention relates to a blood collection needle used for collecting blood in an amount corresponding to negative pressure. The blood collection needle of the present invention further relates to a blood collection needle that can confirm so-called flashback that one end is punctured into a blood vessel of a subject before the other end is inserted into a vacuum blood collection tube.

2. Description of the Related Art Conventionally, a blood collection unit that uses a vacuum blood collection tube to collect blood multiple times with a single puncture has been used. This blood collection unit is attached so as to surround the needle punctured into the patient's skin, the needle punctured into the rubber stopper of the vacuum blood collection tube, the needle hub that can fix these needles, and the needle punctured into the vacuum blood collection tube The blood collection needle is provided with the elastic tip, the blood collection holder for fixing the blood collection needle and fitting with the vacuum blood collection tube, and the vacuum blood collection tube sealed with a rubber stopper.
When collecting blood, first, the blood collection needle is fixed to the blood collection tube holder, and the vacuum blood collection tube is fitted to the blood collection tube holder, so that the needle punctured in the vacuum blood collection tube is exposed from the elastic tip, and the rubber plug of the vacuum blood collection tube Blood sampling is started by penetrating through.

The blood collection needle in the blood collection unit is desired to be able to confirm the flashback before attaching the vacuum blood collection tube. Examples of such a blood collection needle include a substantially cylindrical hub and both axial ends of the hub. A needle tube having a sharp tip that extends, and a bottomed cylindrical elastic cap fitted to the hub so as to surround one end of the needle tube, and the inside and outside of the elastic cap communicate with the hub There is a blood collection needle in which an air permeable blood impermeable filter is provided in an external port portion of a ventilation hole provided at the distal end portion of the hub (for example, see Patent Document 1).
In order to confirm the flashback, such a blood collection needle is used to allow the blood to flow into the blood collection needle when the blood collection needle is punctured into the subject's vein, while the air escapes to the outside. Is provided with an air-permeable blood-impermeable filter so as not to leak outside. However, such a blood collection needle needs to form a vent hole that allows the inside and outside of the elastic cap to communicate with each other inside the hub, but its structure is complicated and it is very difficult to mold.

  In addition, in order to facilitate the formation of a ventilation hole inside the hub, a blood collection needle having a hub composed of two members has also been developed (see, for example, Patent Document 2). In this blood collection needle, a plate-like breathable filter is interposed in a gap between two hub members so that the flat surface has an angle of 70 to 110 degrees with respect to the hub axial direction. For such a blood collection needle, it is necessary to select a filter having a certain degree of strength, and it is difficult to fix the filter, and it takes time to manufacture the blood collection needle itself.

On the other hand, the present applicant has previously proposed a blood collection needle that is easy to manufacture, in which the hub is composed of two members and the filter is fitted between the members of the hub (Patent Document 3). This blood collection needle is to be fitted by inserting an elastic cap connecting member into a lumen provided at the proximal end of the hub, and when both members are fitted, a filter is sandwiched between the two members. Since the fixing method is simple without selecting a filter, there is an advantage that the blood collection needle can be manufactured in a short time.
However, since the hub and the elastic cap connecting member are fitted and fixed via a filter, there is a possibility that the two members may be disengaged when an unexpected external force is applied to the hub. There is room.

Japanese Patent Publication No. 7-32766 (prior art, FIG. 5) Japanese Patent No. 3086024 JP 2002-253535 A

  The present invention provides a blood collection needle that can be easily manufactured in all steps including the formation of an air passage and the fixing of a filter, and further, there is no risk of the hub consisting of two members being disassembled by an unexpected external force. With the goal.

  As a result of intensive studies, the inventor has formed a ventilation path when the hub and the elastic cap connecting member are joined, and the filter is sandwiched between the flange and the hub provided at the tip of the elastic cap connecting member. The present inventors have found that a blood collection needle obtained by joining a flange receiving portion provided at the base end can solve the above-mentioned problems, and have reached the present invention.

That is, the present invention
(1) A needle tube having a sharp cutting edge at the distal end and the proximal end, a hub that is a hollow tube externally inserted into the needle tube, the distal end of which is fixed to the needle tube, and a lumen into which the needle tube can be inserted An elastic cap connecting member that is a hollow tube joined to the proximal end side of the hub, and is hermetically attached to the proximal end side of the elastic cap connecting member, and can accommodate the cutting edge on the proximal end side of the needle tube An elastic cap, and the inside of the elastic cap communicates with an external atmosphere through a ventilation path formed by the hub and the elastic cap connecting member, and an air-permeable blood impermeable filter is provided in the ventilation path. A blood collection needle, an annular flange projecting outward is formed on the distal end side of the outer peripheral surface of the elastic cap connecting member, and the hub is a flange receiver that can be joined to the flange of the elastic cap connecting member Part A blood collection needle, characterized in that
(2) The blood collecting needle according to (1), wherein the flange and the flange receiving portion are arranged perpendicular to the axial direction and project in an annular shape outward.
(3) The blood receiving needle according to (2), wherein the flange receiving portion is further provided with an annular edge portion projecting toward the flange side at an outer end thereof, and the flange is disposed inside the edge portion. ,
(4) The air passage formed by the hub and the elastic cap connecting member communicates with the inside of the elastic cap, and communicates with the gap formed by the lumen of the elastic cap connecting member and the needle tube. And the gap formed by the hub and the elastic cap connecting member, and the ventilation path communicates with an external atmosphere through an external port provided in the elastic cap connecting member (1) to ( 3) the blood collection needle according to any one of
(5) The elastic cap connecting member has a groove that is arranged in parallel with a lumen into which the needle tube can be inserted and opens toward the distal end side, and the groove is a gap between the hub and the elastic cap connecting member. The blood collection needle according to (4), wherein the external mouth portion is formed so as to communicate with the proximal end portion of the annular groove.
(6) The blood-collecting needle according to (5), wherein the air-permeable blood-impermeable filter is fixed to the air passage by being inserted into the groove.
(7) The elastic cap connecting member has a threaded portion formed on an outer peripheral surface, the groove extends from the threaded portion to the proximal end side, and the external port portion is provided on the proximal end side of the threaded portion. A blood collection needle according to (5) or (6),
(8) The blood collecting needle according to any one of (5) to (7), wherein the hub has a protruding portion that can be inserted into a groove of the elastic cap connecting member on a proximal end side.
(9) The groove of the elastic cap connecting member is an annular groove that is concentric with a lumen into which a needle tube can be inserted, and is formed on the outer side in the circumferential direction of the lumen. A blood collection needle as described in
(10) The blood collection needle according to (9), wherein the protrusion of the hub is an annular protrusion that can be inserted into the annular groove of the elastic cap connecting member.
(11) The air permeable blood impermeable filter relates to a blood collection needle according to (9) or (10), which has a ring shape and is fitted into an annular groove of the elastic cap connecting member.

  In the blood collecting needle of the present invention, the gap formed when the hub and the elastic cap connecting member are joined is used as an air passage, and an air-permeable blood impermeable filter is fixed to the air passage by fitting. Simple and easy to mold and manufacture. In addition, since the hub of the blood collection needle of the present invention has two members, the hub and the elastic cap connecting member, joined by a flange, there is no possibility that the hub will be disassembled even when an unexpected external force is applied. Furthermore, the blood collection needle of the present invention includes an air permeable blood impermeable filter inserted into a groove provided in an elastic cap connecting member, and a hub protrusion inserted into the groove, and the hub and the elastic cap. By joining the connecting members, the blood collection needle can be more firmly and easily assembled.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings, but the present invention is not limited thereto. FIG. 1 is a longitudinal sectional view showing an example of a blood collection needle of the present invention. The blood collection needle 1 of the present invention includes a needle tube 2 having sharp cutting edges 21 and 22 at the distal end and proximal end, a hub 3 externally inserted into the needle tube 2, and an elastic cap joined to the proximal end side of the hub 3. It has a connecting member 4 and an elastic cap 5 attached to the elastic cap connecting member 4.
In the blood collection needle 1 of the present invention, the distal side is the side punctured by the patient (left side in the figure), and the proximal side is the side punctured by the vacuum blood collection tube (right side in the figure)

  The needle tube 2 in the blood collection needle 1 of the present invention is a hollow tube, and sharp cutting edges 21 and 22 are formed at the distal end and the proximal end thereof. The cutting edge 21 is inserted into a blood vessel through the patient's skin, and the cutting edge 22 is inserted into a rubber plug that seals the vacuum blood collection tube, but the cutting edges 21 and 22 are inclined at least one to reduce the puncture resistance. It has a blade surface (bevel). As the material of the needle tube 2, a metal material such as stainless steel, aluminum, titanium, or an alloy thereof is preferably used.

A hub 3 is externally attached to the needle tube 2 at an intermediate portion thereof. The hub 3 is a hollow tube, and the inner diameter of the tip is formed slightly larger than the outer diameter of the needle tube 2 so that the needle tube 2 can be inserted. After the needle tube 2 is inserted into the lumen of the hub 3, the needle tube 2 is hermetically fixed using, for example, an adhesive S. As the adhesive S, an epoxy curing agent, a UV curing adhesive, or the like is preferably used. The adhesive S may be used to fill a part of the gap between the hub 3 and the needle tube 2 as shown in FIG.
The hub 3 is preferably made of a transparent or translucent material so that flashback can be easily confirmed. Specifically, polypropylene, polyethylene, polystyrene, polyethylene terephthalate, polymethylpentene, polycarbonate, polyacrylonitrile, It is molded using a known molding technique such as injection molding using ABS resin or the like as a material.

The hub 3 of the present invention may be provided with a rib on the outer peripheral surface on the tip side. The rib engages with a needle cap attached before use to protect the cutting edge 21 on the distal end side of the needle tube 2, and is used to prevent the blood collection needle 1 from rotating within the needle cap. The It is preferable that two or more ribs are provided at equal intervals over the entire outer periphery of the hub 3.
The hub 3 is formed with a flange receiving portion 31 that can be joined to a flange 41 of an elastic cap connecting member 4 to be described later on the base end side. The flange receiving portion 31 is not particularly limited as long as it has a shape that follows the shape of the flange 41. However, the flange receiving portion 31 is arranged perpendicular to the axial direction and protrudes outward. Is preferred. More preferably, the flange receiving portion 31 is further provided with an annular edge 32 projecting toward the flange at the outer end thereof.

An elastic cap connection member 4 is joined to the proximal end side of the hub 3. The elastic cap connecting member 4 is also a hollow tube body into which the needle tube 2 can be inserted, and the inner diameter thereof is formed slightly larger than the outer diameter of the needle tube 2 so that the needle tube 2 can be inserted.
A screw portion 42 is provided on the outer peripheral surface of the elastic cap connecting member 4, and a mouth portion of a blood collection tube holder (not shown) capable of fitting and holding a vacuum blood collection tube is screwed into the screw portion 42. It has become so. Further, a locking portion 43 that can lock an elastic cap 5 to be described later in an airtight manner and cannot be detached may be formed on the proximal end side of the screw portion 42.
The elastic cap connecting member 4 is preferably made of a transparent or translucent material like the hub 3 so that flashback can be easily confirmed, and the same material as the hub 3 described above is used. The elastic cap connecting member 4 is molded by the same molding method as the hub 3 described above.

Further, a flange 41 protruding outward is provided on the distal end side of the outer peripheral surface of the elastic cap connecting member 4. By joining the flange 41 to the flange receiving portion 31 provided on the hub 3, the hub 3 and the elastic cap connecting member 4 are securely fixed. As the joining means, welding is used in addition to adhesion with an adhesive such as a UV curable adhesive such as sialic acrylate or acrylic resin, or an epoxy resin.
The flange 41 is not particularly limited as long as it has a shape that conforms to the shape of the flange receiving portion 31, but an annular flange 41 that is disposed perpendicular to the axial direction and projects outward is preferable. . It is also possible to confirm that the screwing of the blood collection needle 1 and the blood collection tube holder is completed by contacting the flange 41 with the mouth of the blood collection tube holder connected to the screw portion 42 by screwing. By joining the flange 41 and the flange receiving portion 31 as described above, the blood collection needle 1 of the present invention has a strong joint between the hub 3 and the elastic cap connecting member 4 and is not likely to be decomposed by an unexpected external force.
When the edge portion 32 is formed at the outer end of the flange receiving portion 31, the flange 41 is disposed inside the edge portion 32. By forming the edge portion 32 on the flange receiving portion 31, even if an unexpected external force is applied to the hub 3 or the elastic cap connecting member 4, the external force is not directly applied to the adhesive surface. It is more preferable that the joining of the cap connecting member 4 can be held more safely.

  The elastic cap 5 that is locked to the locking portion 43 of the elastic cap connecting member 4 has a bottomed cylindrical shape and can accommodate the cutting edge 22 on the distal end side of the needle tube 2 that is punctured by the rubber stopper. Have Examples of the material of the elastic cap 5 include natural rubber, synthetic rubber such as isoprene rubber and silicon rubber, and elastomer. The elastic cap 5 may also be at least partially transparent or translucent so that the flashback can be easily confirmed, like the hub 3.

  The blood collection needle 1 of the present invention is configured such that the inside of the elastic cap 5 communicates with the external atmosphere through a ventilation path 6 formed by the hub 3 and the elastic cap connecting member 4. The air passage 6 includes a gap 61 between the inner cavity of the elastic cap connecting member 4 and the needle tube 2 inserted into the inner cavity, and a gap 62 formed by the hub 3 and the elastic cap connecting member 4. . The inside of the elastic cap 5 and the gap 61 and the gap 61 and the gap 62 communicate with each other. The air passage 6 communicates with the external atmosphere through an external port 63 provided in the elastic cap connecting member 4.

  The gap 61 between the elastic cap connecting member 4 and the needle tube 2 constituting the ventilation path 6 may be provided in the entire outer periphery of the needle tube 2, but the inner cavity of the elastic cap connecting member 4 is formed in an elliptical shape. Thus, the gap 61 may be partially formed. Further, by changing the shape of the inner cavity of the elastic cap connecting member 4, one or more gaps 61 having various shapes and various dimensions can be formed. The gap 61 may be of a size that allows air and blood to pass by being pressed by venous pressure.

  The gap 62 between the hub 3 and the elastic cap connecting member 4 constituting the air passage 6 is a gap formed on the joint surface other than the flange 41 and the flange receiving portion 31 of the hub 3 and the elastic cap connecting member 4. . That is, when the flange 41 and the flange receiving portion 31 of the hub 3 are joined, the hub 3 and the elastic cap connecting member 4 do not join the portions other than the flange 41 and the flange receiving portion 31 and are slightly The gap 62 is formed. The gap 62 communicates with the gap 61 between the elastic cap connecting member 4 and the needle tube 2 described above, and is formed from the outer peripheral portion of the needle tube 2 to the joint portion of the flange 41 and the flange receiving portion 31. The external port 63 is formed in the elastic cap connecting member 4 so as to allow the gap 62 and the external atmosphere to communicate with each other. As a result, the inside of the elastic cap 5 communicates with the external atmosphere.

  An air permeable blood impermeable filter 7 is disposed in a ventilation path 6 provided in the blood collection needle 1 of the present invention and capable of communicating the inside of the elastic cap 5 with the external atmosphere. The air permeable blood impermeable filter 7 is preferably held in the gap 62 when the hub 3 and the elastic cap connecting member 4 are joined. The air permeable blood impermeable filter 7 is not particularly limited as long as it has pores that allow gas to pass but not liquid, such as a membrane filter and a sintered filter, but preferably polyethylene, polypropylene, polymethyl It is a sintered body made of methacrylate, polystyrene or the like, and more preferably contains a water-absorbing polymer that swells when contacted with blood and closes the pores of the sintered body. Examples of the water-absorbing polymer include starch and acrylate, and the content thereof is preferably 1 to 30% with respect to the total weight of the sintered filter.

As shown in FIG. 1, the blood collection needle 1 of the present invention is provided in the elastic cap connecting member 4 with a groove 44 that is arranged in parallel with the lumen into which the needle tube 2 can be inserted and that opens toward the distal end side. May be. The groove 44 communicates with the gap 62 between the hub 3 and the elastic cap connecting member 4 at the opening thereof and constitutes a part of the air passage 6. Therefore, the external port 63 only needs to be formed so that the groove 44 can communicate with the external atmosphere. Therefore, the external port 63 can be formed at a preferred position according to the shape of the outer peripheral surface of the elastic cap connecting member 4. it can.
For example, as shown in FIG. 1, when the threaded portion 42 is formed on the outer peripheral surface of the elastic cap connecting member 4, the needle tube 2 is formed when the external port 63 is provided on the proximal end side of the threaded portion 42. When the cutting edge 21 is punctured into the blood vessel of a patient, the inflow range of the blood flowing into the blood collection needle 1 is widened, and confirmation of flashback becomes easier. At this time, if the groove 44 is formed to extend to the base end side from the screw portion 63, the length of the external port portion 63 is minimized, which is preferable because the molding becomes easier.

At least one external port 63 may be formed, but as shown in FIG. 1, two or more external ports 63 may be provided according to the shape of the groove 44. As the number of the external ports 63 increases and the diameter of the external ports 63 increases, the air inside the needle tube 2 and the elastic cap 5 is quickly discharged to the outside. The inflow of ceased quickly and the time required for confirmation of flashback becomes shorter.
Further, by inserting the air permeable blood impermeable filter 7 into the groove 44, the air permeable blood impermeable filter 7 is disposed on the joint surface between the hub 3 and the elastic cap connecting member 4, Since the process of joining both members so that the filter 7 is sandwiched between both members is not necessary, the blood collection needle 1 can be manufactured more easily. At this time, it is more preferable that the shape of the air permeable blood impermeable filter 7 corresponds to the shape of the groove 44 in order to maintain the liquid tightness of the ventilation path 6.

Furthermore, the blood collection needle 1 of the present invention may be provided with a protrusion 33 that can be inserted into the groove 44 of the elastic cap connection member 4 on the proximal end side of the hub 3. The projecting portion 33 is disposed in parallel with a lumen into which the needle tube 2 of the hub 3 can be inserted, and projects to the proximal end side. The protruding portion 33 has the same cross-sectional shape as the groove 44 of the elastic cap connecting member 4 and has an outer diameter slightly smaller than the inner diameter of the elastic cap member 4 or the protruding portion 33. One or a plurality of ribs projecting toward the groove 44 are formed on the inner peripheral surface of the first and second ribs. Thereby, even when the protrusion 33 is inserted into the groove 44, it can serve as a ventilation path for the gap 62 between the hub 3 and the elastic cap connecting member 4. Further, since the groove 44 and the projecting portion 33 also serve as a guide when the hub 3 and the elastic cap connecting member 4 are joined, the blood collection needle 1 can be manufactured more easily.
Further, inside the hub 3, a gap 33 is provided between the gap 61 between the elastic cap connecting member 4 and the needle tube 2 and the gap 62 between the hub 3 and the elastic cap connecting member 4. May be. When blood flows into the gap 33, the inflow range of blood flowing into the blood collection needle 1 is widened, and flashback can be confirmed more quickly.

  The groove 44 of the elastic cap connecting member 4 may be an annular groove 44 that is concentric with a lumen into which the needle tube 2 can be inserted and is formed on the outer side in the circumferential direction of the lumen. In this case, the protrusion 33 provided on the hub 3 is also preferably an annular protrusion 33 that is concentric with the lumen into which the needle tube 2 can be inserted so that the protrusion 33 can be inserted into the annular groove 44. . The air permeable blood impermeable filter 7 fitted in the annular groove 44 preferably has a ring shape. In this way, the blood collection needle 1 can be more firmly and easily assembled by making the groove 44, the projecting portion 33 and the air permeable blood impermeable filter 7 all annular.

  The blood collection needle 1 of the present invention is used by piercing the patient's vein with the cutting edge 21 at the tip of the needle tube 2 in a state in which a blood collection holder (not shown) is screwed into the screw portion 42 of the elastic cap connecting member 4. Is done. At this time, the air in the needle tube 2 passes through the inside of the elastic cap 5, escapes from the external port 63 through the air passage 6 and the air permeable blood impermeable filter 7, and blood flows into the needle tube 2. . The blood fills the inside of the elastic cap 5, then flows into the gap 61 and the gap 62 constituting the ventilation path 6, flows into the groove 44, and is then blocked by the air permeable blood impermeable filter 7. Accordingly, blood does not leak outside through the external port 63. The medical staff can confirm the flashback by visually observing the blood flowing into the elastic cap 5, the air passage 6 or the groove 44, or the blood penetrating into the air permeable blood impermeable filter 7 from the outside. After the flashback is confirmed, a vacuum blood collection tube is inserted into the blood collection tube holder, and the cutting edge 22 of the proximal end of the needle tube 2 passes through a rubber stopper provided at the mouth of the vacuum blood collection tube, and the vacuum By being inserted into the blood collection tube, blood flows into the vacuum blood collection tube to collect blood.

It is a longitudinal cross-sectional view which shows an example of the blood collection needle | hook of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Blood collection needle 2 Needle tube 21, 22 Cutting edge 3 Hub 31 Flange receiving part 32 Edge part 33 Protrusion part 4 Elastic cap connection member 41 Flange 42 Screw part 44 Groove 5 Elastic cap 6 Air flow path 61 Gap 62 Gap 63 External port part 7 Air permeation | transmission Blood-impermeable filter

Claims (8)

A needle tube having a sharp cutting edge at the distal end and proximal end, a hollow tube body that is externally inserted into the needle tube, a distal end portion fixed to the needle tube, and a hollow tube having a lumen into which the needle tube can be inserted An elastic cap connecting member that is joined to the proximal end side of the hub, and an elastic cap that is hermetically attached to the proximal end side of the elastic cap connecting member and can store the cutting edge on the proximal end side of the needle tube The inside of the elastic cap is communicated with the external atmosphere through an air passage formed by the hub and the elastic cap connecting member and an external port provided in the elastic cap connecting member, and air permeable blood impermeability to the air passage An annular flange projecting outward is formed on the distal end side of the outer peripheral surface of the elastic cap connecting member, and the hub has a flange that can be joined to the flange of the elastic cap connecting member. A blood collection needle receiving portion is formed, the elastic cap connecting member is arranged in parallel with the lumen that can interpolate needle tube and has a groove open toward the tip side, groove Is in communication with the gap between the hub and the elastic cap connecting member, and the external port is formed so as to be in communication with the base end of the groove . The air passage formed by the hub and the elastic cap connecting member communicates with the inside of the elastic cap, and a gap formed by a lumen of the elastic cap connecting member and a needle tube, communicates with the gap, and The blood collection needle according to claim 1, wherein the blood collection needle comprises a gap formed by a hub and the elastic cap connecting member. The blood collection needle according to claim 1 or 2, wherein the air permeable blood impermeable filter is fixed to the air passage by being inserted into the groove. The elastic cap connecting member has a threaded portion formed on an outer peripheral surface, the groove is formed to extend from the threaded portion to the proximal end side, and the external port portion is provided on the proximal end side of the threaded portion. Item 4. The blood collecting needle according to any one of Items 1 to 3 . The blood collection needle according to any one of claims 1 to 4 , wherein the hub has a protruding portion that can be inserted into a groove of the elastic cap connecting member on a proximal end side. The blood collecting needle according to any one of claims 1 to 5 , wherein the groove of the elastic cap connecting member is an annular groove formed concentrically with a lumen into which a needle tube can be inserted and formed on the outer side in the circumferential direction of the lumen. . The blood collection needle according to claim 6 , wherein the protrusion of the hub is an annular protrusion that can be inserted into the annular groove of the elastic cap connecting member. The blood collection needle according to claim 6 or 7, wherein the air permeable blood impermeable filter has a ring shape and is fitted into an annular groove of the elastic cap connecting member.

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