JP5267870B2 - Disposable blood collection device - Google Patents

Description

  The present invention relates to a blood collecting device used to puncture the skin and collect a small amount of blood, and more particularly to a disposable blood collecting device discarded after one use.

  For medical purposes, it may be necessary to self-collect a small amount of blood. For example, a diabetic patient needs to collect his / her own blood in order to periodically check the blood glucose level (blood glucose self-measurement: SMBG). Conventionally, blood collection instruments have been used so that such blood self-collection can be performed safely and reliably.

  Such a blood collection device generally has a structure in which a lancet having a puncture needle and a spring member are accommodated in a housing. Then, the lancet is urged by the spring member and the tip of the puncture needle protrudes from the housing, so that a small amount of blood is exuded by puncturing the skin surface. In particular, in recent years, disposable blood collection devices that are discarded after one-time use have been widely used in order to prevent infection with HIV, hepatitis B virus, and the like through the puncture needle after use.

  By the way, in such a blood collection device, it is necessary to prevent contamination of the puncture needle and erroneous puncture to ensure safety, and by adjusting the puncture depth according to the difference in the patient and the puncture site, etc. It is necessary to be able to stably collect a large amount of blood.

  For the former purpose, International Publication WO2005 / 110225 (Patent Document 1) proposes a structure in which a puncture needle is covered with a protective cap. For the latter purpose, US Pat. No. 4,895,147 (Patent Document 2) proposes a mechanism for adjusting the protruding amount of the puncture needle.

  However, the conventional blood collection device has a problem that it is difficult to employ both the protective cap of the puncture needle and the protrusion amount adjustment mechanism of the puncture needle. That is, the protective cap of the puncture needle and the protrusion amount adjustment mechanism of the puncture needle originally have different purposes and configurations, and are configured with different parts. Therefore, if both are used together, an increase in the number of parts and a complicated structure are inevitable. In addition, particularly in a disposable blood collection device in which a plurality of blood collection devices must be carried, if the size of the disposable blood collection device increases with an increase in the number of parts or a complicated structure, there is a problem in that it is easily disturbed during carrying and the convenience is lowered.

International Publication WO2005 / 110225 Pamphlet US Pat. No. 4,895,147

  The present invention has been made in the background of the above-mentioned circumstances, and the problem to be solved is to ensure the safety by protecting the needle tip of the puncture needle and the mechanism for adjusting the puncture depth of the puncture needle. An object of the present invention is to provide a disposable blood collection device having a novel structure that can be realized with a simple structure and the number of parts.

  Hereinafter, embodiments of the present invention made to solve the above-described problems will be described. In addition, the component employ | adopted in each aspect as described below is employable by arbitrary combinations as much as possible.

  That is, according to the present invention, a lancet having a puncture needle and a spring member are accommodated in a housing, the lancet is urged by the spring member, and the tip of the puncture needle projects from the housing to perform a puncture operation. In the puncture operation, a protective cap is provided to cover the needle tip of the puncture needle, and the protective cap is detached from the puncture needle and supported by the housing at a position off the protruding path of the puncture needle. The puncture needle is formed by changing the position of the moving end of the lancet defined by the contact with the stopper portion in the protruding direction of the puncture needle, while forming a stopper portion against which the lancet strikes. The amount of protrusion from the housing can be adjusted.

  According to the present invention, the stopper that strikes the lancet is formed by the protective cap that protects the needle tip of the puncture needle. As a result, it is possible to achieve the safety ensuring by the protection of the needle tip and the adjustment mechanism of the puncture depth of the puncture needle with a small number of parts and a simple configuration. In addition, it is possible to reduce the manufacturing cost and size of the disposable blood collection device.

  In particular, in the present invention, the above-mentioned problems are solved by focusing attention on the special relationship between the “protection cap for the puncture needle” and the “lancet stopper” which are two independent configurations that have absolutely no relation to the purpose and action. It was possible to solve. That is, these protective caps and stoppers are conventionally provided as separate structures that are not related to each other in order to achieve a completely different purpose. However, the present inventor has noted that there is a relationship in which the former protective cap is required and functions only before the puncture operation, while the latter stopper is required and functions only during the puncture operation. In short, when the protective cap is required and functions, the stopper is not required and does not function. On the contrary, when the stopper is required and functions, the protective cap is not required and does not function. As described above, the present invention has been completed by finding a special relationship between the protective cap and the stopper, which have been conventionally recognized as two independent structures that are completely unrelated, and paying attention to them. Thus, in the present invention, the needle tip protection function is based on the new idea that the stopper is configured by skillfully using the protective cap required before the puncture operation at the time of the puncture operation where it is unnecessary. The needle tip protrusion amount adjusting function at the time of puncture can be realized with a simple structure with common parts.

  In the present invention, the mode of changing the position of the moving end of the lancet in the protruding direction of the puncture needle is, for example, by displacing the position of the contact surface between the lancet and the stopper portion with respect to the housing in the protruding direction of the puncture needle. It is realized with. More specifically, at least one of the contact surface on the lancet side and the contact surface on the stopper portion side can be adjusted in the protruding direction of the puncture needle, so that the position of the moving end of the lancet can be adjusted. It is possible to change in direction.

  In the present invention, the housing includes a pressing member that is pressed against the skin surface of the blood collection unit and an operation member that is movably combined with the pressing member, and the spring member When the operation member releases the locked state of the lancet urged by the lancet, the puncture needle protrudes from the pressing member and is punctured. A mode in which the stopper is configured by the cap being supported by the pressing member can also be adopted.

  In this way, by moving the operating member relative to the pressing member, the locked state of the lancet can be released and the puncture operation can be performed. Therefore, it is possible to perform the puncturing operation with only one hand having the operation member, and excellent operability is exhibited.

  Further, when the above aspect is adopted, the pressing member and the operation member are both formed in a bottomed cylindrical shape, and are fitted to each other on the opening side and combined so as to be relatively movable in the axial direction. The housing is formed with a hollow structure, the lancet is accommodated so as to be movable in the axial direction of the housing, and the puncture needle of the lancet projects toward the bottom of the pressing member. In addition, a puncture hole is formed at the bottom of the pressing member, and the operation member is pressed against the pressing member while the bottom of the pressing member is pressed against the skin surface of the blood collection unit. Thus, the locked state of the lancet with respect to the pushing member is released, and the lancet is applied to the bottom of the pushing member by the biasing force of the spring member disposed between the housing and the lancet. Heading Move, the manner in which the tip of the puncture needle protrudes outside from the puncture hole of the pressing those members adapted to puncture operation, together can be employed.

  According to this aspect, puncture can be performed by a simple operation of pushing the operating member toward the skin surface against the pressing member while the pressing member is pressed against the skin surface. Further, during the puncturing operation, the pressing member is prevented from separating from the skin surface, and stabilization of the puncture depth is achieved.

  When the housing includes the pressing member and the operation member, the operation member releases an engagement state of the lancet biased by the spring member with respect to the pressing member. An aspect provided with a safety lock mechanism for blocking can also be suitably employed. By providing the safety lock mechanism, it is possible to prevent the cap from being removed and the needle tip of the puncture needle to protrude even if the pressing member is pushed unexpectedly, and erroneous puncture is avoided.

  In the case where the housing includes the pressing member and the operating member, the operating member is supported by the pressing member by rotating the operating member relative to the pressing member around a central axis. As the lancet supported by the protective cap and the operating member is relatively rotated, the contact position between the stopper portion formed on the protective cap and the lancet changes, and the stopper portion is moved to the stopper portion. A mode in which the position of the moving end of the lancet defined by hitting is changed can be suitably employed.

  In this aspect, since the protrusion amount of the puncture needle can be adjusted by the relative rotation operation of the pressing member and the operation member constituting the main part of the housing, the appearance of the instrument can be simplified and easy to operate. Become. In addition, since the operation direction of the pressing member and the operation member when adjusting the protrusion amount of the puncture needle is a relative rotation direction, the operation of the pressing member and the operation member during the puncturing operation of the puncture needle is different. It is also possible to reliably operate both operations without making a mistake.

  In the present invention, an aspect in which the position of the contact surface with which the lancet contacts the stopper portion can be changed in the protruding direction of the puncture needle may be employed. Here, the change of the position of the contact surface can be adjusted stepwise as a plurality of step surfaces in the protrusion direction of the puncture needle, or the position of the stopper portion can be adjusted by the screw feed mechanism in the protrusion direction of the puncture needle. It may be possible to adjust it steplessly or the like.

  Further, when the operation member is used, the stopper is configured to disengage the protection cap from the puncture needle by transmitting an operation force exerted on the operation member during the puncture operation to the protection cap. A mode in which an interlocking mechanism that leads to a position is provided can also be suitably employed. In this way, the protective cap can be detached from the puncture needle and the stopper portion can be formed automatically using the operating force during the puncture operation, and the protective cap can be removed and the stopper portion can be formed. A series of puncture operations including can be performed more easily and quickly.

  According to the present invention, it is possible to achieve safety ensuring by protecting the needle tip of the puncture needle and a mechanism for adjusting the puncture depth of the puncture needle with a small number of parts and a simple configuration.

The side view of the disposable blood-collecting device as one embodiment of the present invention. The side view of the direction different from FIG. 1 of the disposable blood collection instrument. III-III sectional drawing in FIG. IV-IV sectional drawing in FIG. FIG. 2 is an exploded perspective view of the disposable blood collection device shown in FIG. 1. The cross-sectional perspective view of the operation member which comprises the same disposable blood-collecting instrument. The front view of the cap member which comprises the disposable blood-collecting instrument. The perspective view of the cap member. Explanatory drawing for demonstrating the puncture operation | movement of the disposable blood-collecting instrument shown in FIG.

  Hereinafter, in order to clarify the present invention more specifically, embodiments of the present invention will be described in detail with reference to the drawings.

  First, FIG. 1 to FIG. 5 show a disposable blood collection device (hereinafter abbreviated as “blood collection device” as appropriate) 10 as one embodiment of the present invention. The blood collection device 10 includes a housing 16 in which an operation member 12 and a pressing member 14 are combined. A lancet 18 and a protective cap 20 are accommodated in the housing 16. In the following description, unless otherwise specified, the front means the right direction in FIG. 1, the rear means the left direction in FIG. 1, and the axial direction means the left and right direction in FIG.

  More specifically, the operation member 12 has a substantially cylindrical shape with a bottom. An engagement hole 24 is formed in the bottom portion 22 so as to penetrate the central portion in the axial direction.

  In addition, a housing cylinder portion 26 that protrudes inward in the axial direction from the bottom portion 22 is integrally formed inside the operation member 12. An engagement hole 24 of the bottom portion 22 is opened at the rear side end portion of the accommodating cylinder portion 26. On the other hand, the front side end portion of the accommodation tube portion 26 is opened in the operation member 12.

  Furthermore, a locking protrusion 28 that protrudes on the inner peripheral surface and extends in the circumferential direction is provided at the end of the operation member 12 on the opening 27 side. An end surface on the inner side in the axial direction of the locking protrusion 28 is a removal step surface 29 protruding on the inner peripheral surface of the operation member 12.

  Further, the accommodating cylinder portion 26 is formed with a pair of slit-like insertion grooves 30 and 30 on the peripheral wall portion thereof. The pair of slit-like insertion grooves 30, 30 extend in the axial direction of the housing cylinder part 26 and open to the distal end side of the housing cylinder part 26. In addition, the accommodating cylinder portion 26 has a thick wall structure that is partly integrated with the peripheral wall portion of the operation member 12 on the circumference. That is, a pair of connecting portions 31, 31 that integrally connect the accommodating cylinder portion 26 and the peripheral wall portion of the operation member 12 are partially formed on the circumference. Note that the opposing direction of the pair of insertion grooves 30 and 30 and the opposing direction of the pair of connecting portions 31 and 31 are both perpendicular to the axis of the housing tube portion 26 and are orthogonal to each other.

  A plurality of indicators 32, 34 a, 34 b, 34 c made of protrusions are formed on the outer peripheral surface of the operation member 12. One of the initial indicators 32 is provided near the edge on the opening 27 side, and indicates an initial rotation position of the pressing member 14 described later with respect to the operation member 12. Each of the first index 34a, the second index 34b, and the third index 34c is for selecting and setting a protruding amount of a puncture needle 62 described later, and is an edge of the operation member 12 on the opening 27 side. It is comprised from the linear protrusion extended in an axial direction from a part.

  The first index 34a is composed of one linear protrusion, the second index 34b is composed of two linear protrusions, and the third index 34c is composed of three linear protrusions, which can be distinguished from each other. Yes. In particular, as the first index 34a, the second index 34b, and the third index 34c, the linear protrusions are gradually lengthened, so that it is possible to visually imagine that the protruding amount of the puncture needle 62 is gradually increased. ing. The initial indicator 32 and the first to third indicators 34a, 34b, 34c are provided at a substantially constant interval in the circumferential direction of the operation member 12.

  Further, as shown in FIG. 6, a plurality of grooves 36, 38 a, 38 b, 38 c are formed on the inner peripheral surface of the operation member 12. All of these grooves 36, 38 a, 38 b, and 38 c are constituted by concave grooves that extend in the axial direction from the edge of the operation member 12 on the opening 27 side. One of the initial fitting grooves 36 is located on the inner peripheral surface of the initial indicator 32. The first guide groove 38a is located on the inner peripheral surface of the first indicator 34a, the second guide groove 38b is located on the inner peripheral surface of the second indicator 34b, and the third guide groove 38c is the second guide groove 38c. It is located on the inner peripheral surface of the 3 index 34d.

  Further, the axial lengths of the first to third guide grooves 38 a to 38 c are substantially the same, and extend within the operation member 12 to the vicinity of the opening end portion of the accommodation tube portion 26. On the other hand, the initial fitting groove 36 is shorter than the first to third guide grooves 38a to 38c.

  On the other hand, the pressing member 14 has a substantially cylindrical shape with a bottom. The outer diameter dimension of the cylindrical wall portion is a size that can be inserted into the operation member 12. Further, a puncture hole 42 penetrating the center portion is formed in the bottom portion 40 of the pressing member 14.

  A pair of support grooves 44 and 44 are formed in the cylindrical wall portion of the pressing member 14. Each support groove 44 has a slit shape penetrating the cylindrical wall portion, and extends in the axial direction from the end portion on the opening 45 side of the pressing member 14 to the vicinity of the bottom portion 40. Further, the width dimension of each support groove 44 changes in the middle portion in the length direction. In other words, an inclined portion 46 is provided at one side wall of each support groove 44 in the middle portion in the longitudinal direction. The inclined portion 46 has a large portion 48 on the opening 45 side of the inclined portion 46. The bottom 40 side is a narrow portion 50.

  The pair of support grooves 44 and 44 are formed to face each other in the radial direction of the cylindrical wall portion of the pressing member 14. Further, the inclined portions 46, 46 in the pair of support grooves 44, 44 overlap each other in a side view of the pressing member 14 (see FIG. 2).

  Further, a projecting rib 52 is formed on the outer peripheral surface of the pressing member 14, and extends in the axial direction between the pair of support grooves 44, 44 in the circumferential direction. As will be described later, the rib 52 displays the operating state of the blood collection device 10 in cooperation with the indicators 32, 34a, 34b, and 34c of the operation member 12.

  A thick wall portion having a large outer diameter is provided at the opening side end of the pressing member 14. And the outer peripheral surface of this thick part is made into the taper surface 53 which became small diameter toward the opening part 45 side. Further, the axial end surface on the large diameter side of the thick wall portion is a locking step surface 54 protruding on the outer peripheral surface of the pressing member 14.

  The tapered surface 53 facilitates the insertion of the pressing member 14 into the operation member 12. Further, when the tapered surface 53 of the pressing member 14 exceeds the locking projection 28 of the operation member 12 during insertion, the locking step surface 54 of the pressing member 14 is locked to the retaining step surface 29 of the operation member 12. As a result, the pressing member 14 is prevented from coming off from the operation member 12.

  On the other hand, the lancet 18 includes a lancet hub 60 and a puncture needle 62. The lancet hub 60 is made of a synthetic resin such as polypropylene, polyethylene, polycarbonate, ABS resin, acrylic resin, and the like. The lancet hub 60 includes a disc portion 64 and a cylindrical needle holding portion 66 that projects on the central axis of the disc portion 64. Have. In addition, a pair of contact portions 68 and 68 are integrally formed on the protruding surface of the needle holding portion 66 in the disc portion 64. The pair of abutting portions 68 and 68 are formed so as to protrude in a fan shape symmetrically in the radial direction of the disc portion 64. The proximal end portion of the puncture needle 62 is fixed to the needle holding portion 66 of the lancet hub 60 by insert molding or adhesion, and the needle tip 69 of the puncture needle 62 is outward on the central axis of the lancet hub 60. It protrudes.

  A pair of outer peripheral walls 70, 70 are formed on the outer peripheral portion of the disc portion 64, and project from the disc portion 64 toward the axial direction opposite to the needle holding portion 66. Further, a locking claw 72 is formed on the outer peripheral surface of each outer peripheral wall 70. The outer peripheral surface of the locking claw 72 is a tapered surface 73 that gradually increases in diameter in the protruding direction of the puncture needle 62.

  Further, a spring portion 74 as a spring member is integrally formed with the disc portion 64. The spring portion 74 of the present embodiment is configured by a resin plate spring having a bent-like bent shape, and one end portion thereof is connected to the disc portion 64. The spring portion 74 protrudes from the disc portion 64 in the axial direction opposite to the needle holding portion 66. A mounting plate portion 76 is integrally formed at the other end of the spring portion 74. A pair of engaging claws 78, 78 project from the mounting plate portion 76 on the surface opposite to the spring portion 74.

  Further, the spring portion 74 and the mounting plate portion 76 are formed with a plurality of insertion pins 80 protruding on both sides in the width direction of the spring portion 74. Each of these insertion pins 80 protrudes on a straight line that intersects the center line of the disc portion 64 and extends in the width direction of the spring portion 74 and the mounting plate portion 76. The protruding dimension of the insertion pin 80 formed on the mounting plate portion 76 is larger than that of the insertion pin 80 formed on the spring portion 74. These insertion pins 80 are formed by aligning and arranging the middle part of the ridge line and the valley line of the spring part 74 having a bent-like bent shape on a straight line extending in the bending direction of the spring part 74.

  Further, as shown in FIGS. 7 and 8, the protective cap 20 has a thick and substantially cylindrical shape (the inner diameter is substantially constant over the entire length, but the outer diameter changes toward one side in the axial direction. A cap body 86). A needle insertion hole 87 is formed by the center hole of the cap body 86. Further, the outer peripheral surface of the cap body 86 is gradually reduced in diameter from one end portion in the axial direction toward the other end portion, and has a substantially hemispherical curved outer peripheral surface. Further, a pair of support shafts 88, 88 projecting in a direction perpendicular to the axis are integrally formed at the large diameter side end portion of the cap body 86. Further, a needle housing hole 92 is formed on the outer peripheral surface near the large-diameter end of the cap body 86, and reaches the needle insertion hole 87 in a direction perpendicular to the protruding direction of the pair of support shafts 88, 88. There is no extension. That is, in the protective cap 20, the support shafts 88, 88, the needle insertion hole 87, and the needle accommodation hole 92 extend in the orthogonal three-axis direction.

  Further, a stopper portion 94 is formed on the axial end surface of the cap body 86 on the small diameter side. The stopper portion 94 includes first to third stopper surfaces 96a, 96b, and 96c that protrude in the axial direction of the cap body 86. Each of the first to third stopper surfaces 96a, 96b, 96c is formed by the distal end surfaces of a pair of fan-shaped protrusions that face each other in the radial direction of the cap body 86 when the needle insertion hole 87 is viewed in the axial direction. Each of the first to third stopper surfaces 96a, 96b, 96c in the present embodiment has a fan shape with a central angle of about 45 °. The first to third stopper surfaces 96a, 96b, and 96c are different from each other in the protruding height of the cap main body 86 in the axial direction, and the first stopper surface 96a, the second stopper surface 96b, In the order of the third stopper surface 96c, the protruding dimension is gradually reduced.

  In addition, the pair of support shafts 88 and 88 have an outer diameter dimension that can be inserted into the small width portion 50 in the support grooves 44 and 44 of the pressing member 14. Further, guide protrusions 98 that protrude from the support shafts 88 toward the stopper portions 94 are formed on the portions of the support shafts 88 on the cap body 86 side. The protruding height of the guide protrusion 98 is such that the support shaft 88 can be inserted into the large portion 48 of the support groove 44 in a state in which the protrusion direction is directed in the width direction of the support groove 44 of the pressing member 14. However, it is set so that it cannot be inserted into the narrow portion 50.

  The protective cap 20 can be integrally formed with the lancet 18 by insert molding using a molding cavity in which the puncture needle 62 is set. Thereby, the needle tip 69 of the puncture needle 62 is protected by the protective cap 20, and the needle accommodation hole 92 is formed in the protective cap 20.

  Then, a lancet structure 99 configured by attaching the puncture needle 62 to the needle holding portion 66 of the lancet 18 is inserted into the accommodating cylinder portion 26 of the operation member 12, and the engaging claw 78 is engaged with the operation member 12. Engage with the joint hole 24. As a result, the lancet structure 99 is assembled to the operation member 12 in a state where the mounting plate 76 is overlapped and fixed to the inner surface of the bottom 22 of the operation member 12. Further, the insertion pin 80 protruding from the spring portion 74 is inserted into the insertion groove 30 of the housing cylinder portion 26. Thus, the elastic elastic deformation is allowed while preventing the inclination of the spring portion 74 and the intended elastic deformation is stabilized.

  The protective cap 20 may be formed separately from the lancet 18 in addition to being integrally formed with the lancet 18 by insert molding as described above. In the latter case, the protective cap 20 may be attached to the puncture needle 62 before or after the lancet structure 99 is assembled to the operation member 12. Further, when the protective cap 20 is attached to the puncture needle 62, the distal end portion of the needle holding portion 66 that holds the puncture needle 62 is placed in the needle accommodation hole 92 of the protective cap 20 in order to maintain a sterilized state to be described later. It is preferable to insert until it is inserted.

  Thereafter, the pressing member 14 is fitted and assembled from the opening of the operation member 12. At that time, the support shaft 88 of the protective cap 20 is inserted into the support groove 44 of the pressing member 14. Then, the pressing member 14 is pushed into the operation member 12 until the tapered surface 53 of the pressing member 14 is positioned rearward in the axial direction from the retaining step surface 29 of the operation member 12. As a result, the locking step surface 54 of the pressing member 14 is locked to the retaining step surface 29, and the pressing member 14 is assembled in a state where it cannot be pulled out on the concentric shaft with respect to the operation member 12.

  The lancet structure 99 and the protective cap 20 are accommodated in the housing 16 of the blood collection device 10 assembled in this way. In such an assembled state, the needle tip 69 of the puncture needle 62 is directed toward the bottom portion 40 of the pressing member 14, and the spring portion 74 is disposed between the bottom portion 22 of the operation member 12 and the lancet 18.

  The blood collection device 10 is processed so that at least the needle tip 69 of the puncture needle 62 and the cap body 86 that protects it are in a sterilized state. Specifically, for example, before or after mounting the cap body 86 on the puncture needle 62, sterilization is performed by radiation, high-pressure steam sterilization, or the like. The lancet 18 and the protective cap 20 may be integrally molded using a molding cavity in which the puncture needle 62 is set, so that the needle tip 69 of the puncture needle 62 may be held in a sterilized state.

  The operation member 12 and the pressing member 14 are assembled so as to be rotatable around a central axis. As shown in FIGS. 1 to 4, the blood collection device 10 according to the present embodiment is configured such that the rib 52 of the pressing member 14 is positioned so as to overlap the initial indicator 32 in the circumferential direction of the operation member 12. The state fitted with the groove 36 is provided to the user as an initial state.

  In such an initial state, the protective cap 20 has the support shaft 88 and the guide protrusion 98 inserted into the large portion 48 of the support groove 44 in the pressing member 14, and the support groove 44 extends in the protruding direction of the guide protrusion 98. It is accommodated in a state directed in a direction (vertical direction in FIG. 2) orthogonal to the ejection direction. The guide protrusion 98 has a protruding tip from the support shaft 88 in the large portion 48 and is positioned on the inclined portion 46 side. Accordingly, the protective cap 20 is positioned in a state where the needle accommodation hole 92 is positioned on the puncture needle 62 side with respect to the support shaft 88 and extends on the central axis of the pressing member 14. The protruding portion of the puncture needle 62 from the needle holding portion 66 is inserted into the needle accommodation hole 92 and the needle tip 69 is positioned in the needle accommodation hole 92 so as to be covered and protected by the protective cap 20. .

  Further, in the initial state, the axial rear end surface of the rib 52 is locked to the axial rear end surface of the initial fitting groove 36, thereby preventing the operation member 12 from being pushed in the pressing member 14 in the axial direction. The rib 52 and the initial fitting groove 36 constitute a safety lock mechanism.

  The blood collection device 10 having such a structure has a slightly reduced diameter in the axially rearward direction of the pressing member 14 because the support groove 44 is formed in the pressing member 14 with a notch shape that opens rearward in the axial direction. The direction can be deformed, and the rotation of the pressing member 14 around the central axis with respect to the operation member 12 is allowed. When using the blood collection instrument 10, first, as shown in FIGS. 9A-1 and 9A-2, the pressing member 14 is rotated around the central axis with respect to the operation member 12. Then, the rib 52 is overlapped with any one of the first to third indicators 34a, 34b, 34c to fit the rib 52 into any of the first to third guide grooves 38a, 38b, 38c. FIG. 9 shows a state in which the rib 52 is fitted in the second guide groove 38b in accordance with the second index 34b.

  With this turning operation, the protective cap 20 together with the pressing member 14 is turned around the central axis with respect to the lancet 18. Further, the first to third guide grooves 38a, 38b, and 38c extend rearward in the axial direction of the operation member 12 with respect to the initial fitting groove 36 formed at the position of the initial indicator 32, whereby the rib 52 is formed. An axial relative displacement of the operating member 12 with respect to the pressing member 14 is allowed in a state where the operating member 12 is fitted in any of the first to third guide grooves 38a, 38b, and 38c.

  Next, as shown in FIGS. 9 (b-1) and 9 (b-2), the operating member 12 is pushed while pressing the bottom 40 of the pressing member 14 against the skin surface 100 of the blood collection portion schematically shown. It is pushed toward the member 14 in the axial direction. In this case, the protective cap 20 is configured such that the support shaft 88 protrudes from the support groove 44 of the pressing member 14 outward in the radial direction of the pressing member 14 and abuts against the opening end surface 102 of the operation member 12. A pressing force is exerted from the operation member 12, and is moved forward in the axial direction of the pressing member 14 along the support groove 44. On the other hand, in the lancet 18, the locking state of the locking claw 72 with respect to the axial rear end surface of the pressing member 14 is maintained. As a result, the protective cap 20 is moved forward in the protruding direction of the puncture needle 62 with respect to the lancet 18 and detached from the puncture needle 62, and the compression deformation of the spring portion 74 is started.

  Subsequently, as shown in FIGS. 9 (c-1) and (c-2), when the operation member 12 is further pushed, the guide protrusion piece 98 of the protective cap 20 contacts the inclined portion 46 of the support groove 44. Touched. The position of the inclined portion 46 in the axial direction of the pressing member 14 is set so that the contact of the guide protrusion 98 with the inclined portion 46 is performed after the protective cap 20 is detached from the puncture needle 62. The When the guide protrusion 98 is guided by the inclined portion 46, the support shaft 88 and the guide protrusion 98 are rotated around the central axis of the support shaft 88 so as to enter the small width portion 50, and the protective cap 20. However, it is rotated by approximately 90 ° around the support shaft 88 (in FIG. 9, counterclockwise in the figure). Accordingly, the needle insertion hole 87 is positioned on the protruding path of the puncture needle 62 in the axial direction, and the protective cap 20 is penetrated on the protruding path of the puncture needle 62 through the needle insertion hole 87, thereby the protective cap 20. Is supported by the pressing member 14 at a position deviating from the protruding path of the puncture needle 62. At the same time, the stopper portion 94 is opposed to the contact portion 68 of the lancet 18 in the displacement direction of the lancet 18.

  Here, the contact portion 68 of the lancet 18 has substantially the same shape as each of the first to third stopper surfaces 96a, 96b, 96c of the protective cap 20, and the rotation of the pressing member 14 relative to the operation member 12 is performed. Depending on the movement position, the position is opposed. Specifically, the abutment portion 68 of the lancet 18 has the first stopper surface 96a and the rib 52 as the second index at a position where the rib 52 is fitted to the first guide groove 38a in alignment with the first index 34a. The second stopper surface 96b is positioned at the position where the second guide groove 38b is fitted to 34b and the third stopper is positioned at the position where the rib 52 is fitted to the third guide groove 38c so as to be aligned with the third index 34c. The face 96b and the puncture needle 62 are opposed to each other in the protruding direction. In FIG. 9, since the rib 52 is aligned with the second index 34 b, the abutting portion 68 is positioned to face the second stopper surface 96 b in the protruding direction of the puncture needle 62.

  In addition, in the present embodiment, the first to third stopper surfaces 96a, 96b, and 96c have a smaller distance from the contact portion 68 in the protruding direction of the puncture needle 62 as the protruding amount increases. When the first stopper surface 96 a having the largest protrusion amount is opposed to the contact portion 68, the separation distance from the lancet 18 is the smallest, and the third stopper surface 96 c having the smallest protrusion amount is the contact portion 68. When facing each other, the distance from the lancet 18 is maximized.

  In addition, the spring portion 74 is smoothly deformed in the protruding direction of the puncture needle 62 by the insertion pin 80 being sequentially inserted into the insertion groove 30 of the accommodating tube portion 26 along with the compression deformation, and the compression deformation. Even at times, the housing 16 is positioned stably.

  When the operation member 12 is further pushed in, the pressing member 14 is moved further axially rearward of the operation member 12, whereby the tapered surface 73 of the lancet 18 is guided by the connecting portion 31 of the operation member 12 and the lancet. 18 is deformed in the direction of diameter reduction. Thereby, the engagement state between the locking claw 72 of the lancet 18 and the axial rear end surface of the pressing member 14 is released, and the lancet 18 is applied to the bottom portion 40 of the pressing member 14 by the elastic restoring force of the spring portion 74. The puncture needle 62 is moved forward in the axial direction on the central axis of the housing 16.

  As shown in FIGS. 9 (d-1) and (d-2), the spring portion 74 is instantaneously extended beyond the free length by the elastic restoring force, and the lancet 18 biased by the spring portion 74 The contact portion 68 is in contact with any one of the first to third stopper surfaces 96a, 96b, and 96c that are opposed to each other in the protruding direction of the puncture needle 62, thereby preventing the forward movement in the axial direction. As a result, the needle tip 69 protrudes from the housing 16 by a predetermined amount through the needle insertion hole 87 of the protective cap 20 and the puncture hole 42 of the pressing member 14 to puncture the skin surface 100.

  In this case, the amount of protrusion of the puncture needle 62 defined by the forward movement end position of the lancet 18 is set according to the amount of protrusion of the first to third stopper surfaces 96a, 96b, 96c. In other words, in the present embodiment, the contact with the first stopper surface 96a is the smallest, and the contact with the third stopper surface 96c is the largest. In FIG. 9, since the contact portion 68 is in contact with the second stopper surface 96b, it is larger than that in contact with the first stopper surface 96a and is in contact with the third stopper surface 96c. The amount of protrusion is smaller than that of the case.

  Then, as shown in FIGS. 9E-1 and 9E-2, the lancet 18 whose forward movement is blocked by the stopper portion 94 is returned to the natural length by the spring portion 74 returning to the natural length. 69 is accommodated again in the housing 16. As a result, exposure of the needle tip 69 to the outside of the housing 16 and erroneous puncture are prevented, and the blood collection device 10 cannot be reused, and the blood collection device 10 after use is discarded.

  According to blood collection instrument 10 having such a structure, by providing stopper portion 94 on protective cap 20, the protection mechanism for puncture needle 62 and the mechanism for adjusting the amount of protrusion of puncture needle 62 can be reduced in the number of parts. It can be realized with a simple structure. Thereby, reduction of manufacturing cost and size reduction of the blood collection instrument 10 can be achieved.

  Furthermore, in this embodiment, the support shaft 88 and the guide protrusion 98 provided on the protective cap 20, the opening end surface 102 of the operation member 12, the support groove 44 and the inclined portion 46 provided on the pressing member 14 are included. The interlocking mechanism is configured to disengage the protective cap 20 from the puncture needle 62 and position the stopper portion 94 to face the lancet 18 in the projecting direction of the puncture needle 62. It is possible to automatically perform the operation by a single operation of pressing against 100, and it is possible to realize better operability.

  Further, in the present embodiment, the amount of protrusion can be accurately and stably set by adjusting the protrusion amount of the puncture needle 62 stepwise by forming the stopper portion 94 into a plurality of stepped surface shapes. Safety can also be improved. Further, the amount of protrusion of the puncture needle 62 can be adjusted by a simple operation of rotating the pressing member 14 relative to the operation member 12.

  As mentioned above, although one Embodiment of this invention was explained in full detail, this is an illustration to the last, Comprising: This invention is not limited at all by the specific description in this Embodiment.

  For example, in the above-described embodiment, the stopper portion 94 of the protective cap 20 has a stepped surface shape, but the stopper portion 94 has the same shape as the contact portion 68 formed on the lancet hub 60, while the lancet hub The contact portion 68 in 60 may have the same stepped surface shape as the stopper portion 94. Moreover, when setting the protrusion amount of a puncture needle in steps, the number of steps can be set as appropriate, and may be larger or smaller than in the above embodiment. Further, for example, the protrusion amount of the puncture needle may be adjusted steplessly by moving the protective cap back and forth steplessly in the protruding direction of the puncture needle by adjusting a screw or the like.

  Moreover, in the said embodiment, although the lancet hub 60 and the spring part 74 as a spring member were integrally formed, these can also be shape | molded separately, and metal leaf | plate springs and coils can be used as a spring member. A spring or the like may be employed. Furthermore, in the above-described embodiment, the spring portion 74 is fixed to the operation member 12, but the spring member is not necessarily fixed to the operation member.

  Further, an interlocking mechanism for separating the protective cap from the puncture needle and guiding it to the position constituting the stopper portion is not necessarily required. For example, after the protective cap is detached from the puncture needle by a manual operation different from the puncture operation, the protective cap is not required. May be manually set as a stopper.

10: Blood collection instrument, 12: Operation member, 14: Pushing member, 16: Housing, 18: Lancet, 20: Protection cap, 62: Puncture needle, 68: Abutment part, 69: Needle tip, 74: Spring part, 94: stopper portion, 96a: first stopper surface, 96b: second stopper surface, 96c: third stopper surface

Claims (7)

In a disposable blood collection device in which a lancet having a puncture needle and a spring member are accommodated in a housing, the lancet is urged by the spring member, and the tip of the puncture needle protrudes from the housing to perform a puncture operation.
A protective cap is provided to cover the needle tip of the puncture needle, and the protective cap is detached from the puncture needle and supported by the housing at a position off the protruding path of the puncture needle, whereby the lancet While the stopper portion that strikes is formed, the position of the moving end of the lancet defined by the contact with the stopper portion is changed in the protruding direction of the puncture needle, whereby the puncture needle A disposable blood collection device characterized in that the amount of protrusion from the housing can be adjusted.   The lancet that includes a pressing member that is pressed against the skin surface of the blood collection unit and an operation member that is movably combined with the pressing member and is biased by the spring member. The locking state of the pressing member is released by the operating member, so that the puncture needle projects from the pressing member and is punctured, and the protective cap is formed by the pressing member. The disposable blood collection device according to claim 1, wherein the stopper portion is configured by being supported.   The pressing member and the operating member are both cylindrical with a bottom, and the housing is formed in a hollow structure by being fitted to each other on the opening side and combined so as to be relatively movable in the axial direction. The lancet is accommodated so as to be movable in the axial direction of the housing, and the puncture needle of the lancet projects toward the bottom of the pressing member, and the bottom of the pressing member is punctured The pressing member of the lancet is formed by pressing the operating member against the pressing member in a state where a hole is formed and the bottom of the pressing member is pressed against the skin surface of the blood collection unit Is released, and the lancet moves toward the bottom of the pressing member by the urging force of the spring member disposed between the housing and the lancet, and the tip of the puncture needle is moved. The pressing member Disposable type blood collecting device according to claim 2 from the puncture hole to protrude to the outside is adapted to puncture operation.   The disposable blood collection device according to claim 2 or 3, further comprising a safety lock mechanism that prevents an operation of releasing the locking state of the lancet biased by the spring member with respect to the pressing member.   By rotating the operation member relative to the pressing member about the central axis, the protective cap supported by the pressing member and the lancet supported by the operating member are rotated relative to each other, and the protection is performed. As the contact position between the stopper portion formed on the cap and the lancet changes, the position of the moving end of the lancet defined by the contact with the stopper portion is changed. The disposable blood collection device according to any one of claims 2 to 4.   The disposable blood collection device according to any one of claims 1 to 5, wherein a position of an abutting surface with which the lancet abuts in the stopper portion can be changed in a protruding direction of the puncture needle.   3. An interlocking mechanism is provided, wherein an operating force exerted on the operating member during the puncturing operation is transmitted to the protective cap, thereby detaching the protective cap from the puncture needle and guiding it to a position constituting the stopper portion. The disposable blood collection device according to any one of -6.

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