Cylinder Kit and Gasket
The cylinder kit with a specially designed gasket addresses the inefficiencies in extracting PRP by optimizing the gasket's surface and recess design, resulting in improved PRP preparation efficiency and concentration.
Patent Information
- Application Number
- JP2023516350
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-04-22
- Filing Date
- 2022-03-18
- Publication Date
- 2025-06-23
- Estimated Expiration
- 2042-03-18
AI Technical Summary
Existing technologies for separating serum or plasma components from blood are inefficient in extracting the desired components, particularly platelet-rich plasma (PRP), due to the design of conventional gaskets which hinder complete extraction.
A cylinder kit comprising a syringe system with a gasket that has a planar or concave first surface with a recess, allowing for efficient extraction of PRP by reducing the protruding length of the injection needle and minimizing the non-extractable portion of the plasma.
The cylinder kit enhances the amount and concentration ratio of PRP prepared by allowing complete extraction of the plasma layer, improving the efficiency of the PRP preparation process.
Smart Images

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Abstract
Description
Technical Field
[0001] The present disclosure relates to a cylinder kit and a gasket that can be used to fractionate blood or the like to prepare a liquid containing a desired component.
Background Art
[0002] Instruments for separating serum or plasma components from collected blood are known.
Prior Art Documents
Patent Documents
[0003]
Patent Document 1
Patent Document 2
Summary of the Invention
[0004] A cylinder kit according to one aspect of the present disclosure includes a cylinder and a gasket that can move in the cylinder axis direction within the cylinder. The cylinder has a storage chamber that is partitioned by the gasket and can store a liquid. The gasket has a first surface facing the storage chamber. The first surface is planar or concave and has a first recess.
[0005] A gasket according to one aspect of the present disclosure has a second surface facing the first surface and is a gasket that can move in the cylinder axis direction within a cylinder capable of storing a liquid. The liquid is stored in a storage chamber partitioned by the cylinder and the first surface. The first surface is planar or concave and has a first recess.
Brief Description of the Drawings
[0006]
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Mode for Carrying Out the Invention
[0007] There is an increasing interest in technologies and methods for fractionating blood and the like collected from a patient to prepare a liquid containing a desired component. For example, in regenerative medicine, the use of platelet-rich plasma (hereinafter referred to as PRP) prepared from blood has attracted attention.
[0008] Hereinafter, an embodiment of the present disclosure will be described with reference to the drawings. Hereinafter, a syringe system 100 for preparing platelet-rich plasma (hereinafter referred to as PRP) from blood will be described as an example.
[0009] The present disclosure is not limited to this example. For example, it may be applied to a syringe system 100 used for preparing a liquid containing platelets collected from blood, bone marrow fluid, or spleen, etc., a liquid containing platelets prepared in vitro, a liquid containing adipose tissue-derived stromal vascular fraction, or a liquid containing white blood cells. Examples of the liquid containing white blood cells include a liquid containing bone marrow mononuclear cells, a liquid containing peripheral blood mononuclear cells, a liquid containing white blood cell multinuclear granulocytes, and the like.
[0010] 〔Embodiment 1〕 <Configuration of Syringe System 100 and Cylinder Kit 110> Hereinafter, the configuration of the syringe system 100 and the cylinder kit 110 according to Embodiment 1 of the present disclosure will be described in detail with reference to the drawings.
[0011] FIG. 1 is an example of an exploded view showing a configuration example of the syringe system 100 and the cylinder kit 110, and FIG. 2 is a figure showing an example of a cross-sectional view of the cylinder kit 110.
[0012] As shown in FIG. 1, the cylinder kit 110 includes a syringe system 100, a first plunger 14, and a first cap 15 (plug body). The syringe system 100 includes a first syringe 10 having a first syringe barrel (cylinder) 11 and a first gasket 13. Here, the first syringe barrel 11 is a cylindrical container having a closed end and an open end.
[0013] <First syringe 10> As shown in FIGS. 1 and 2, the first syringe 10 includes a first syringe barrel 11 and a first gasket 13. The first syringe 10 is used, for example, to collect blood or the like and store the collected blood or the like. Also, as will be described in detail later, the first syringe 10 is used as a centrifugation container for centrifuging the collected blood or the like.
[0014] The first syringe barrel 11 is configured, for example, in a substantially cylindrical shape and has an accommodation space that forms a storage chamber for storing a liquid such as blood inside. Also, the first syringe barrel 11 is made of a transparent or translucent member so that the inside of the first syringe barrel 11 can be visually recognized.
[0015] The first syringe barrel 11 is provided with an opening 111 at one end for inserting and removing the first plunger 14 and the like, which will be described later. Also, at the other end, it is provided with a substantially cylindrical first port 12 having a smaller diameter than the main body of the first syringe barrel 11. Also, the inner bottom surface of the first syringe barrel 11 may be, for example, in a shape that protrudes toward the storage chamber in a substantially arc shape, a flat shape, or a shape that protrudes toward the side opposite to the storage chamber. In the present embodiment, the inner bottom surface of the first syringe barrel 11 is configured in a flat shape so as to follow the shape of the first surface 131, which is the bottom surface of the first gasket 13 described later. The first surface 131 is a surface facing the storage chamber inside the first syringe barrel 11. The liquid is stored in the storage chamber partitioned by the first syringe barrel 11 and the first surface 131.
[0016] The first port 12 may function as an attachment portion for attaching a blood collection tube, an injection needle (e.g., a blood collection needle), or the like. The storage chamber in the first syringe barrel 11 communicates with the internal space of the first port 12, and a liquid such as blood can be stored in the storage chamber in the first syringe barrel 11 through the blood collection tube or injection needle attached to the first port 12. Further, the first port 12 has a Luer lock type (ISO80369-7:2016) structure, and a blood collection tube, an injection needle, or a first cap 15 described later may be attached by this structure.
[0017] The first gasket 13 can be detachably attached to the first plunger 14 that is movable within the first syringe barrel 11. The first gasket 13, together with the first cap 15 described later, seals the inside of the first syringe barrel 11 in a liquid-tight manner. The first gasket 13 may reciprocate in the first syringe barrel 11 in the axial direction of the barrel. At this time, the outer peripheral surface of the first gasket 13 may slide on the inner wall surface of the first syringe barrel 11 while maintaining liquid tightness inside the first syringe barrel 11. Thereby, even if the first gasket 13 reciprocates within the first syringe barrel 11, the inside of the first syringe barrel 11 can be sealed in a liquid-tight manner.
[0018] Further, the first syringe 10 may further include a first plunger 14 that is detachably attached to the first gasket 13. The upper part of the first gasket 13 is attached to one end portion 141 of the first plunger 14. The attachment of the first plunger 14 and the first gasket 13 may be screwed together with a screw groove. Further, the first plunger 14 may be provided with a flange 142 used as an operation portion, for example, at the other end portion.
[0019] After attaching the first gasket 13, the first plunger 14 is inserted into the first syringe barrel 11 through the above-described opening 111. A user such as a medical staff may operate the flange 142 of the first plunger 14 to reciprocate the first plunger 14 in the axial direction of the barrel within the first syringe barrel 11. Thereby, as described above, the first gasket 13 attached to the first plunger 14 can be reciprocated within the first syringe barrel 11.
[0020] When collecting blood, the first plunger 14 is moved so that at least a part of the first plunger 14 is pulled out from inside the first syringe barrel 11, and the first gasket 13 is moved in the direction of the opening 111, whereby blood or the like can be accommodated in the storage chamber inside the first syringe barrel 11.
[0021] Further, the first syringe 10 may further include a first cap 15 that is detachably attached to the first port 12. As described above, by attaching the first cap 15 to the first port 12, the storage chamber inside the first syringe barrel 11 can be sealed in a liquid-tight manner. Thereby, after collecting blood or the like, the user can perform a centrifugation process with the blood accommodated in the first syringe barrel 11.
[0022] Specifically, after collecting blood, the user attaches the first cap 15 to the first port 12, then uses the first syringe barrel 11 as a centrifugation container, and performs a centrifugation process using the centrifugal force from the first gasket 13 side toward the first port 12 side. At this time, the user may remove the first plunger 14 from the first gasket 13 so as not to interfere with the centrifugation process, or may not remove it.
[0023] By the centrifugation process, the blood inside the first syringe barrel 11, that is, whole blood 50 (see FIG. 5), is centrifuged into each layer of a first fraction 51 mainly containing red blood cells (see FIG. 5), a second fraction 52 mainly containing white blood cells (see FIG. 5), and a third fraction 53 that is plasma mainly containing platelets (see FIG. 5).
[0024] Although it will be described in detail later, at this time, the user extracts the third fraction 53 located in the uppermost layer into the second syringe 20 with the injection needle 26. Thereby, the user can extract the third fraction 53 necessary for PRP preparation from the whole blood.
[0025] <Structure of the first gasket 13> Next, the structure of the first gasket 13 will be described in detail with reference to FIGS. 2 and 3. FIG. 3 is a schematic diagram showing an example of the first gasket 13.
[0026] As described above, the first gasket 13, together with the first cap 15, hermetically seals the inside of the first syringe barrel 11. Further, the first gasket 13 can reciprocate in the axial direction of the first syringe barrel 11 while maintaining the liquid tightness inside the first syringe barrel 11 via the first plunger 14.
[0027] As shown in FIGS. 2 and 3, the first gasket 13 is configured to have a substantially cylindrical shape, for example. Further, the first surface 131, which is the bottom surface of the first gasket 13, is configured to be planar or concave, and has a first recess 133. The first recess 133 may be located in a substantially central region of the first surface 131 of the first gasket 13. When the injection needle 26 is pierced through the first gasket 13 as described later, the tip portion 27 of the injection needle 26 protrudes from the first recess 133.
[0028] (Conventional gasket 13a) FIG. 4 is a diagram for explaining the first gasket 13 in comparison with a conventional gasket 13a. The left diagram in FIG. 4 is a diagram for explaining the conventional gasket 13a, and the right diagram is a diagram for explaining the first gasket 13 according to Embodiment 1 of the present disclosure.
[0029] As shown in the left diagram of FIG. 4, the conventional gasket 13a is configured to have a substantially cylindrical shape similar to the first gasket 13, but the shape of the first surface 131a, which is the bottom surface, is different from the shape of the first surface 131 of the first gasket 13. The first surface 131a of the gasket 13a has a shape along the shape of the inner bottom portion of the first syringe barrel 11 in order to discharge all the contents of the first syringe barrel 11, and has, for example, a shape protruding in a substantially conical shape.
[0030] Further, the gasket 13a does not have the first recess 133 in which the tip portion 27 of the injection needle 26 protrudes, which the first gasket 13 has in the first surface 131.
[0031] Here, the extraction of the third fraction 53 by the conventional gasket 13a will be described. First, the user inserts the tip 27 of the injection needle 26 from the second surface 132a facing the first surface 131a of the gasket 13a, penetrates through the gasket 13a, and protrudes the tip 27 from the tip 131b of the first surface 131a of the gasket 13a. Then, the user extracts the third fraction 53 located below the first surface 131a from the tip 27 into the second syringe 20. Here, the injection needle 26 only needs to be configured to have a sufficient length to penetrate through the gasket 13a and extract the third fraction 53 located below the first surface 131a of the gasket 13a.
[0032] At this time, in the gasket 13a, the portion where the tip 27 of the needle is inserted is pulled downward in the cylinder axis direction, and the first surface 131a extends downward in the cylinder axis direction by about 3 mm. When the tip 27 of the needle protrudes from the first surface 131a, the extended portion of the first surface 131a returns to its original state. As a result, the tip 27 of the needle protrudes about 3 mm from the first surface 131a. Therefore, in order to protrude the tip 27 of the needle from the first surface 131a, the injection needle 26 needs to have a length such that the tip 27 of the needle protrudes about 3 mm from the first surface 131a. For this reason, the protruding length T2 from the tip 131b of the tip 27 of the needle becomes long, about 3 mm.
[0033] Also, as shown in the left figure of FIG. 4, the interface 61 between the third fraction 53 and the second fraction 52 is a substantially horizontal plane, but the first surface 131a of the gasket 13a protrudes in a substantially conical shape as described above. Further, since the tip 27 of the needle protrudes by T2 from the tip 131b, it is difficult to extract all of the third fraction 53, and a relatively large portion L2 that cannot be extracted occurs.
[0034] (First gasket 13) Here, referring to FIG. 3 again, we return to the description of the structure of the first gasket 13. As described above, the first gasket 13 has a first concave portion 133 where the shape of the first surface 131 is configured in a planar shape or a concave shape, and the tip 27 of the injection needle 26 protrudes.
[0035] As shown in FIG. 3, the first recess 133 is a portion recessed from the first surface 131 of the first gasket 13, and is formed, for example, as a columnar hole portion with a slightly inclined peripheral wall surface. The depth of the first recess 133, that is, the length from the first surface 131 to the bottom surface 134 of the first recess 133, is configured to be about 2 mm, for example. The first recess 133 only needs to be a portion recessed from the first surface 131, and may be, for example, a hole portion such as a trapezoidal cone shape, a cone shape, a column shape, or a rectangular parallelepiped, and the shape is not particularly limited.
[0036] Next, the extraction of the third fraction 53 by the first gasket 13 according to Embodiment 1 of the present disclosure will be described.
[0037] As shown in the right figure of FIG. 4, when extracting the third fraction 53 using the first gasket 13, first, the user pierces the tip portion 27 of the injection needle 26 from the second surface 132 facing the first surface 131 of the first gasket 13. Then, the user penetrates the tip portion 27 through the first gasket 13 and protrudes it from the first recess 133.
[0038] At this time, in the first gasket 13, since the portion where the tip portion 27 is pierced is pulled downward in the cylinder axis direction and extended, the tip portion 27 protrudes about 3 mm from the bottom surface 134 of the first recess 133. However, since the first recess 133 is recessed about 2 mm from the first surface 131, the protruding length T1 of the tip portion 27 from the first surface 131 is about 1 mm.
[0039] The user extracts the third fraction 53 located below the first surface 131 from the tip portion 27 into the second syringe 20.
[0040] At this time, the first surface 131 of the first gasket 13 is configured to be planar or concave, and as described above, the positions of the first surface 131 and the tip portion 27 substantially coincide. For this reason, the user can extract the third fraction 53 up to the vicinity of the interface 61 between the second fraction 52 and the third fraction 53 without disturbing the interface 61 between the second fraction 52 and the third fraction 53, and can reduce the non-extractable portion L1.
[0041] As described above, by using the first gasket 13, it is possible to improve the amount and concentration ratio of the PRP to be prepared.
[0042] <Method for preparing PRP using the cylinder kit 110> Next, the process of preparing PRP using the cylinder kit 110 will be described with reference to FIG. 5. FIG. 5 is a diagram showing an example of the flow of the process of preparing PRP from blood using the cylinder kit 110 shown in FIG. 1.
[0043] State <1> As shown in state <1> of FIG. 5, first, the first syringe 10 is used for blood collection such as blood. At the time of blood collection, the user first attaches a blood collection tube or a blood collection needle to the first port 12 of the first syringe 10, and moves the first plunger 14 attached to the first gasket 13 upward in the cylinder axis direction to collect blood. The collected blood is injected into the storage chamber of the first syringe barrel 11. This collected blood is whole blood 50 and contains red blood cells, white blood cells, platelets, and plasma. In order to suppress blood coagulation, before blood collection, a blood preservation solution may be injected into the storage chamber of the first syringe barrel 11 at about 10% of the blood collection volume. As the blood preservation solution, ACD-A solution (Anticoagulant Citrate Dextrose Solution, Solution A) or the like may be used.
[0044] After injecting a predetermined amount of blood into the first syringe barrel 11, the user removes the blood collection tube or the blood collection needle from the first port 12 and attaches the first cap 15 to the first port 12 instead. At this time, the user also removes the first plunger 14. The first cap 15, together with the first gasket 13, seals the inside of the first syringe barrel 11 in a liquid-tight manner. Thereby, the first syringe 10 can be used as a centrifugal separation container for centrifugally separating the collected blood and the like.
[0045] State <2> Next, the user performs a centrifugation process on the first syringe 10 using centrifugal force from the side of the first gasket 13 toward the first port 12. The centrifugation process conditions may be, for example, weak centrifugation conditions with a centrifugal acceleration of 600xg and a processing time of 7 minutes.
[0046] As shown in state <2> of FIG. 5, by the centrifugation process, the whole blood 50 in the first syringe barrel 11 is fractionated into each layer of a first fraction 51 mainly containing red blood cells, a second fraction 52 mainly containing white blood cells, and a third fraction 53 which is plasma mainly containing platelets.
[0047] State <3> Next, as shown in state <3> of FIG. 5, the injection needle 26 attached to the second syringe 20 penetrates the first gasket 13. The injection needle 26 extracts the third fraction 53 located in the uppermost layer into the second syringe 20 described later, leaving the second fraction 52 mainly containing white blood cells. Thereby, the user can extract the third fraction 53 necessary for preparing PRP with a lower white blood cell concentration than whole blood from the whole blood 50. Here, when the long injection needle 26 used for extraction penetrates the first gasket 13, since the injection needle 26 is likely to bend, the user may use a guide cylinder or the like to suppress the bending of the injection needle 26.
[0048] When extracting the third fraction 53, first, the user stabs the tip portion 27 of the injection needle 26 from the second surface 132 of the first gasket 13, penetrates through the first gasket 13, and protrudes the tip portion 27 from the first recess 133. Then, the user extracts the third fraction 53 located below the first surface 131 into the second syringe 20 from the tip portion 27.
[0049] At this time, as described above, the first surface 131 of the first gasket 13 is configured to be planar or concave. Since the first recess 133 is formed, the position of the first surface 131 and the needle tip portion 27 substantially coincides, and the third fraction 53 can be extracted up to the vicinity of the interface 61 between the second fraction 52 and the third fraction 53, and the portion L1 that cannot be extracted can be reduced. Further, since the resistance when inserting the needle tip portion 27 into the first gasket 13 is reduced, the needle tip portion 27 can be easily inserted as compared with a gasket in which the first recess 133 is not formed.
[0050] In this way, using the syringe system 100, the third fraction 53 in the first syringe barrel 11 can be efficiently accommodated in the second syringe 20 without waste. Further, thereby, the amount and concentration rate of the PRP to be prepared can be improved.
[0051] In the above, an example of extracting the third fraction 53 into the second syringe 20 has been shown. When extracting the liquid in the first syringe barrel 11 into the second syringe 20, the user may extract the second fraction 52 and the third fraction 53. In this case, PRP having a higher white blood cell concentration than whole blood can be prepared from whole blood 50.
[0052] 〔Modification Example 1〕 The configuration described in the above Embodiment 1 can be appropriately changed. For example, in Embodiment 1, an example in which a cylinder kit for preparing PRP from blood is applied to a syringe barrel has been described. However, for example, it may be applied to a vacuum blood collection tube.
[0053] <Configuration of Blood Collection Tube System 300 and Cylinder Kit 310> FIG. 6 is a diagram showing an example of a vacuum blood collection tube (cylinder) 71 according to Modification Example 1 of the present disclosure. As shown in FIG. 6, the cylinder kit 310 includes a blood collection tube system 300, a holder 75, and an injection needle 76. The blood collection tube system 300 includes a vacuum blood collection tube 71, a gasket 72, a stopper 73, and a first member 74. The user may previously fill the vacuum blood collection tube 71 with about 10% of the blood collection volume with an ACD-A solution or the like, which is a blood preservative, in order to suppress blood coagulation.
[0054] The vacuum blood collection tube 71 is used, for example, to collect blood or the like and store the collected blood or the like. Further, as will be described later, the vacuum blood collection tube 71 is used as a centrifugation container for centrifuging the collected blood or the like.
[0055] The vacuum blood collection tube 71 is configured, for example, in a substantially cylindrical shape having a storage chamber inside. Further, the vacuum blood collection tube 71 is provided with an opening 711 at one end, and a flange 712 is provided around the opening 711. The vacuum blood collection tube 71 is a cylindrical container having a closed end and an open end.
[0056] The stopper 73 is a member that closes the open end of the vacuum blood collection tube 71. The stopper 73 is attached to the flange 712 of the vacuum blood collection tube 71, and together with the gasket 72 described later, seals the storage chamber inside the vacuum blood collection tube 71 while maintaining it in a vacuum state. The stopper 73 is made of, for example, metal, synthetic resin, etc., and has a substantially disc-shaped shape. Further, the stopper 73 is provided with a first member 74 described later.
[0057] The gasket 72 is configured, for example, in a substantially cylindrical shape, and the first surface 721 which is the bottom surface of the gasket 72 is configured in a flat shape or a concave shape. Further, the gasket 72 has a first recess 723. When the tip portion 761 of the needle described later is pierced and penetrated through the first recess 723, the tip portion 761 protrudes. The gasket 72 may be detachably attachable to the stopper 73.
[0058] Further, an insertion hole into which the first member 74 described later is inserted is formed in the gasket 72.
[0059] The injection needle 76 is attached to a holder 75 described later, and is provided with one tip portion 761 and the other tip portion 762 at both ends in the longitudinal direction, respectively.
[0060] The first member 74 is attached to the stopper 73, and the lower part of the first member 74 is inserted into the insertion hole formed in the gasket 72.
[0061] The first member 74 only needs to be made of a flexible material. For example, the first member 74 may be a rubber material such as natural rubber, styrene-butadiene rubber, chloroprene rubber, acrylonitrile rubber, butyl rubber, ethylene-propylene rubber, isoprene rubber, urethane rubber, silicone rubber, fluorine rubber, elastomer, or styrene-based thermoplastic elastomer. Since the first member 74 has flexibility, the first member 74 and the gasket 72 are in close contact with each other. As a result, when the needle tip portion 761 penetrates the first member 74 and the gasket 72, the vacuum in the space surrounded by the plug body 73 and the gasket 72 can be maintained.
[0062] The first member 74 has a guide hole 741 for guiding one needle tip portion 761 of the injection needle 76 from the outside of the plug body 73 into the space surrounded by the plug body 73 and the gasket 72.
[0063] The holder 75 is provided with an opening 751 for inserting and removing the vacuum blood collection tube 71 at one end, and is provided with a flange 752 used as an operation portion, for example, at the other end.
[0064] The holder 75 may further have a rubber sleeve 763 that covers the entire length of the needle tip portion 761.
[0065] When collecting blood using the vacuum blood collection tube 71, the other needle tip portion 762 of the injection needle 76 is inserted into a blood vessel or the like. The vacuum blood collection tube 71 is inserted into the holder 75 from the above-described opening 751. The user places a finger on the flange 752 and pushes the vacuum blood collection tube 71 into the holder 75.
[0066] At this time, one needle tip portion 761 of the injection needle 76 attached to the holder 75 is inserted into the guide hole 741 of the first member 74 and penetrates the bottom surface of the first member 74. Then, further penetrating the gasket 72, the needle tip portion 761 protrudes from the first recess 723 of the gasket 72.
[0067] As a result, blood flows into the storage chamber of the vacuum blood collection tube 71 in a vacuum state through the injection needle 76.
[0068] <Method for preparing PRP using the cylinder kit 310> Next, the process of preparing PRP using the cylinder kit 310 will be described with reference to FIG. 7. FIG. 7 is a diagram showing an example of the flow of the process of preparing PRP from blood using the cylinder kit 310 shown in FIG. 6.
[0069] State <1a> As shown in state <1a> of FIG. 7, first, the vacuum blood collection tube 71 is used for blood collection such as blood. At the time of blood collection, first, the user inserts the other needle tip portion 762 of the injection needle 76 into a blood vessel or the like.
[0070] State <2a> As shown in state <2a> of FIG. 7, the vacuum blood collection tube 71 can be pushed into the holder 75. At this time, one needle tip portion 761 of the injection needle 76 is inserted into the guide hole 741 of the first member 74 and penetrates the bottom surface of the first member 74.
[0071] State <3a> As shown in state <3a> of FIG. 7, when one needle tip portion 761 of the injection needle 76 penetrates the gasket 72 and protrudes from the first recess 723 of the gasket 72, blood, that is, whole blood 50, flows into the storage chamber of the vacuum blood collection tube 71 in a vacuum state through the injection needle 76.
[0072] State <4a> As shown in state <4a> of FIG. 7, the user removes the vacuum blood collection tube 71 from the holder 75 and the injection needle 76. Thereafter, the user withdraws the other needle tip portion 762 of the injection needle 76 from a blood vessel or the like.
[0073] State <5a> As shown in state <5a> of FIG. 7, the user removes the plug body 73 attached to the flange 712 of the vacuum blood collection tube 71 together with the first member 74. As a result, the vacuum blood collection tube 71 is released to the atmosphere, and the gasket 72 is pushed down to the liquid level of the whole blood 50 accommodated by the external pressure.
[0074] The reservoir containing the whole blood 50 in the vacuum blood collection tube 71 is liquid-tightly sealed by a gasket 72. Thus, the user can perform a centrifugation process with the whole blood 50 contained in the vacuum blood collection tube 71.
[0075] State <6a> As shown in the state <6a> of FIG. 7, by the centrifugation process, the whole blood 50 is separated into components. Thus, similar to the case of using the first syringe 10, the user can insert the injection needle 76 through the gasket 72 and extract the necessary components.
[0076] Also, since the first surface 721 of the gasket 72 has a first recess 723 where the injection needle 76 protrudes, similar to the first surface 131 of the first gasket 13, the positions of the first surface 721 and the needle tip portion 761 substantially coincide. Thus, the user can extract the necessary fraction up to near the interface.
[0077] In this way, similar to the case of using the first syringe 10, the user can efficiently separate and extract the blood components and the like contained in the vacuum blood collection tube 71 without waste using the vacuum blood collection tube 71. Also, thereby, it is possible to improve the amount and concentration rate of the PRP to be prepared.
[0078] 〔Embodiment 2〕 Subsequently, Embodiment 2 of the present disclosure will be described below. For convenience of explanation, members having the same functions as those described in the above embodiment are denoted by corresponding reference numerals, and the description thereof will not be repeated. Also, for embodiments and the like after Embodiment 2, members having the same functions as those described in the above embodiment are denoted by corresponding reference numerals, and the description thereof will not be repeated.
[0079] FIG. 8 is a diagram showing a configuration example of a syringe system 200 and a cylinder kit 210 according to Embodiment 2 of the present disclosure.
[0080] As shown in FIG. 8, the syringe system 200 is different from the first embodiment in that, in addition to the first syringe 10, it further includes a second syringe 20 and a third syringe 30.
[0081] The first syringe 10 of the second embodiment is the same as the configuration described in the first embodiment. Therefore, here, the description of the first syringe 10 will be omitted, and mainly the second syringe 20 and the third syringe 30 will be described.
[0082] <The second syringe 20> The second syringe 20 is used, for example, to extract a part of the liquid separated by the first syringe 10. The injection needle 26 for extracting the third fraction 53 described in the first embodiment is the same as the injection needle 26 of the second syringe 20 in the second embodiment.
[0083] Also, as will be described in detail later, the second syringe 20 is used as a centrifugation container for further centrifuging the liquid extracted from the first syringe 10.
[0084] Here, the liquid extracted from the first syringe 10 to the second syringe 20 may be a part of the liquid separated by the first syringe 10. For example, it may be the third fraction 53, or it may be the second fraction 52 and the third fraction 53. In this embodiment, the user extracts the third fraction 53 from the first syringe 10 to the second syringe 20.
[0085] Furthermore, the second syringe 20 is used to prepare PRP in the second syringe barrel 21 and administer the prepared PRP to a patient or the like. Here, the second syringe barrel 21 is a cylindrical container having a closed end and an open end.
[0086] The second syringe 20 includes a second syringe barrel 21 and a second gasket 23. The second syringe 20 may further include a second plunger 24, a second cap 25, and an injection needle 26.
[0087] The second syringe barrel 21 is configured, for example, in a substantially cylindrical shape, and a storage chamber for storing a liquid such as a third fraction 53 is formed inside. Further, the second syringe barrel 21 is made of a transparent or translucent member so that the inside of the second syringe barrel 21 can be visually recognized.
[0088] The second syringe barrel 21 is provided with an opening 211 at one end for inserting and removing the second plunger 24 and the like. Further, at the other end, it is provided with a substantially cylindrical second port 22 having a smaller diameter than the main body of the second syringe barrel 21. Also, the inner bottom surface of the second syringe barrel 21 may be, for example, a shape that protrudes toward the storage chamber in a substantially arc shape, a flat shape, or a shape that protrudes toward the side opposite to the storage chamber. In the present embodiment, the inner bottom surface of the second syringe barrel 21 is configured to be flat so as to follow the shape of the first surface 231 which is the bottom surface of the second gasket 23 described later. The first surface 231 is a surface facing the storage chamber in the second syringe barrel 21.
[0089] The second port 22 may function as a mounting portion for mounting an injection needle 26 or the like. The accommodation space inside the second syringe barrel 21 and the internal space of the second port 22 communicate with each other. For this reason, the user can extract a liquid such as the third fraction 53 stored in the first syringe barrel 11 through the injection needle 26 attached to the second port 22 and store it in the storage chamber inside the second syringe barrel 21. As described above, the injection needle 26 is configured to have a sufficient length to penetrate the first gasket 13 and extract the liquid located below the first surface 131 of the first gasket 13.
[0090] The second gasket 23 can be detachably attached to the second plunger 24 that can move inside the second syringe barrel 21. The second gasket 23, together with the second cap 25, seals the inside of the second syringe barrel 21 in a liquid-tight manner. The second gasket 23 may reciprocate in the axial direction of the second syringe barrel 21. At this time, the outer peripheral surface of the second gasket 23 may slide on the inner wall surface of the second syringe barrel 21 while maintaining liquid tightness inside the second syringe barrel 21. Thereby, even if the second gasket 23 reciprocates inside the second syringe barrel 21, the inside of the second syringe barrel 21 can be sealed in a liquid-tight manner.
[0091] Further, the second gasket 23 is configured, for example, in a substantially cylindrical shape. The first surface 231, which is the bottom surface of the second gasket 23, is configured in a planar shape or a concave shape and has a first recess 233. The first recess 233 may be located in a substantially central region of the first surface 231 of the second gasket 23. When the injection needle 36 described later is pierced and penetrated, the tip portion 37 of the injection needle 36 protrudes from the first recess 233.
[0092] The second plunger 24 may have the upper portion of the second gasket 23 attached to one end portion 241 and, for example, a flange 242 used as an operation portion provided at the other end portion.
[0093] After attaching the second gasket 23, the second plunger 24 is inserted into the second syringe barrel 21 through the opening 211. The user may operate the flange 242 of the second plunger 24 to reciprocate the second plunger 24 in the second syringe barrel 21 in the axial direction of the barrel. Thereby, the second gasket 23 attached to the second plunger 24 can be reciprocated within the second syringe barrel 21.
[0094] When extracting a part of the liquid from the inside of the first syringe barrel 11 with the injection needle 26, the user moves the second plunger 24 to pull out at least a part of the second plunger 24 from the inside of the second syringe barrel 21 and move the second gasket 23. Thereby, the user can store a part of the liquid in the first syringe barrel 11 in the storage chamber in the second syringe barrel 21. The liquid stored in the storage chamber in the second syringe barrel 21 may be a part of the liquid separated by the first syringe 10, for example, the third fraction 53, or may be the second fraction 52 and the third fraction 53. In the present embodiment, the user is extracting the third fraction 53 from the first syringe 10 to the second syringe 20.
[0095] The second cap 25 is detachably attached to the second port 22. By attaching the second cap 25 to the second port 22 and inserting the second gasket 23 into the second syringe barrel 21, the user can hermetically seal the storage chamber in the second syringe barrel 21. Thus, after the user has accommodated a part of the liquid in the first syringe barrel 11 in the second syringe barrel 21, the user can perform a centrifugation process with a part of the liquid in the first syringe barrel 11 accommodated. In the present embodiment, the user performs a centrifugation process with the third fraction 53 accommodated in the second syringe barrel 21.
[0096] Specifically, after the user attaches the second cap 25 to the second port 22, the user uses the second syringe barrel 21 as a centrifugation container and performs a centrifugation process using the centrifugal force from the second gasket 23 side toward the second port 22 side. At this time, the user may or may not remove the second plunger 24 from the second gasket 23 so as not to interfere with the centrifugation process.
[0097] By the centrifugation process, the liquid in the second syringe barrel 21 is centrifuged into layers of a fourth fraction 54 (see FIG. 9<5b>) mainly containing platelets and a fifth fraction 55 (see FIG. 9<5b>) mainly being plasma.
[0098] Although it will be described in detail later, at this time, the user extracts the fifth fraction 55 located in the uppermost layer into the third syringe 30 by the injection needle 36 of the third syringe 30 described later. Thereby, the fifth fraction 55 unnecessary for PRP preparation can be removed from the third fraction 53.
[0099] Thus, after removing the fifth fraction 55, PRP (see FIG. 9<8b>) with a high platelet concentration is accommodated in the second syringe 20.
[0100] As an index of the concentration of each blood cell component in a liquid, for example, the number of a predetermined blood cell component per unit volume (cells / μL) can be used. Each blood cell component in the liquid may be measured, for example, by a flow cytometry method, a sheath flow DC detection method, an electrical resistance detection method, a cyanmethemoglobin method, a fluorescence method, or the like. In the present disclosure, when it is described that the concentration of each blood cell component is high or low without particularly mentioning a comparison target, it means that the concentration of each blood cell component is high or low compared to whole blood. For example, the description "the concentration of platelets is high" means that the concentration of platelets is high compared to whole blood, and the description "the concentration of platelets is low" means that the concentration of platelets is low compared to whole blood. In the present disclosure, PRP means a liquid having a high platelet concentration compared to whole blood.
[0101] Further, the first surface 231 of the second gasket 23 has a first recess 233 from which the injection needle 36 protrudes, similar to the first surface 131 of the first gasket 13. For this reason, the protruding length of the tip portion 37 of the injection needle 36 is reduced, and the positions of the first surface 231 and the tip portion 37 substantially coincide. As a result, the user can extract the fifth fraction 55 up to the vicinity of the interface between the fourth fraction 54 and the fifth fraction 55, and can prepare PRP having a high platelet concentration.
[0102] As described above, the second syringe 20 can be used to administer the PRP prepared in the second syringe barrel 21 to a patient or the like.
[0103] When administering PRP to a patient or the like, the user stirs the PRP as shown in FIG. 9<8b>. First, the user removes the second cap 25 from the second port 22 and attaches an injection needle 28 or the like instead. The injection needle 28 is configured to have the length of a general injection needle, unlike the injection needle 26 having a longer length than a normal injection needle.
[0104] The user attaches the second plunger 24 to the second gasket 23 and inserts the tip of the injection needle 28 into the affected part of the patient. Then, the user moves the second gasket 23 downward in the cylinder axis direction via the second plunger 24. Thereby, the user can administer the prepared PRP to the affected part of the patient or the like.
[0105] <The third syringe 30> The third syringe 30 is used, for example, to extract the fifth fraction 55 separated by the second syringe 20 and accommodate it in the third syringe barrel 31. Thereby, the user can remove the fifth fraction 55 unnecessary for the preparation of PRP from the third fraction 53 accommodated in the second syringe barrel 21. Here, the third syringe barrel 31 is a cylindrical container having a closed end and an open end.
[0106] The third syringe 30 includes a third syringe barrel 31 and a third gasket 33. Further, the third syringe 30 may further include a third plunger 34 and an injection needle 36.
[0107] The third syringe barrel 31 is configured, for example, in a substantially cylindrical shape, and a storage chamber for accommodating the fifth fraction 55 is formed inside. Further, the third syringe barrel 31 is made of a transparent or translucent member so that the inside of the third syringe barrel 31 can be visually recognized.
[0108] The third syringe barrel 31 is provided with an opening 311 for inserting and removing the third plunger 34 and the like at one end. Further, at the other end, it is provided with a substantially cylindrical third port 32 having a smaller diameter than the main body of the third syringe barrel 31.
[0109] Further, the shape of the inner bottom surface of the third syringe barrel 31 may be, for example, a shape that protrudes toward the storage chamber in a substantially arc shape, a flat shape, or a shape that protrudes toward the side opposite to the storage chamber. In the present embodiment, the inner bottom surface of the third syringe barrel 31 may have a shape that protrudes in a substantially conical shape similar to a general syringe. At this time, when the third gasket 33 having a bottom surface 331 with a shape that protrudes in a substantially conical shape similar to a general gasket is used, the bottom surface 331 of the third gasket 33 can be aligned with the inner bottom surface of the third syringe barrel 31.
[0110] The third gasket 33 can be detachably attached to a third plunger 34 that is movable within the third syringe barrel 31. Unlike the first gasket 13 and the second gasket 23, the third gasket 33 does not need to insert the injection needle 36 to extract the contents within the third syringe barrel 31. For this reason, the third gasket 33 does not need to be flat or concave, and may have the shape of a general gasket. Also, like the first gasket 13 and the second gasket 23, it does not need to have the first recesses 133 and 233 through which the injection needle 36 protrudes.
[0111] The third port 32 may function as an attachment portion for attaching the injection needle 36 or the like. The accommodation space within the third syringe barrel 31 and the internal space of the third port 32 communicate with each other. For this reason, the user can extract the fifth fraction 55 accommodated within the second syringe barrel 21 through the injection needle 36 attached to the third port 32 and accommodate it in the storage chamber within the third syringe barrel 31.
[0112] The injection needle 36 is configured to have a sufficient length to penetrate the second gasket 23 and extract the fifth fraction 55 located below the first surface 231 of the second gasket 23.
[0113] The third plunger 34 may have the upper part of the third gasket 33 attached to one end 341 and, for example, a flange 342 used as an operation part provided at the other end.
[0114] After the third plunger 34 has the third gasket 33 attached thereto, the third plunger 34 is inserted into the third syringe barrel 31 through the opening 311. The user may operate the flange 342 of the third plunger 34 to reciprocate the third plunger 34 in the third syringe barrel 31 in the cylinder axis direction. Thereby, the user can reciprocate the third gasket 33 attached to the third plunger 34 within the third syringe barrel 31.
[0115] When extracting the fifth fraction 55 from the second syringe barrel 21 with the injection needle 36, the user moves the third plunger 34 to pull at least a part of the third plunger 34 out of the third syringe barrel 31, thereby moving the third gasket 33. Thereby, the user can accommodate the fifth fraction 55 in the accommodation space within the third syringe barrel 31.
[0116] <Method for preparing PRP using the syringe system 200> Next, the process of preparing PRP using the syringe system 200 will be described with reference to FIG. 9. FIG. 9 is a diagram showing an example of the flow of the process of preparing PRP using the syringe system 200.
[0117] Since the states from <1b> to <3b> in FIG. 9 are the same as the states from <1> to <3> in FIG. 5, the description thereof will be omitted.
[0118] State <4b> As shown in the state <4b> of FIG. 9, after the user injects a predetermined amount of the third fraction 53 into the second syringe barrel 21 of the second syringe 20, the user removes the injection needle 26 from the second port 22 and instead attaches the second cap 25 to the second port 22. Also, at this time, the second plunger 24 is also removed. The second cap 25, together with the second gasket 23, seals the inside of the second syringe barrel 21 in a liquid-tight manner. Thereby, the second syringe 20 can be used as a centrifugation container for centrifuging the extracted third fraction 53.
[0119] State <5b> Next, the user performs a centrifugation process on the second syringe 20 using centrifugal force directed from the second gasket 23 side toward the second port 22 side. The centrifugation process conditions may be, for example, strong centrifugation conditions with a centrifugal acceleration of 2000xg and a processing time of 5 minutes.
[0120] As shown in the state <5b> of FIG. 9, by the centrifugation process, the third fraction 53 in the second syringe barrel 21 is centrifuged into layers of a fourth fraction 54 mainly containing platelets and a fifth fraction 55 mainly composed of plasma.
[0121] State <6b> Next, as shown in the state <6b> of FIG. 9, the user extracts the fifth fraction 55 located in the uppermost layer in the second syringe barrel 21 into the third syringe barrel 31 using the injection needle 36 of the third syringe 30. Thereby, the user can remove the fifth fraction 55 unnecessary for PRP preparation from the third fraction 53 stored in the second syringe barrel 21.
[0122] State <7b> The user reattaches the removed second plunger 24 to the second gasket 23 inserted in the second syringe barrel 21.
[0123] State <8b> The user stirs the remaining liquid stored in the second syringe barrel 21 to prepare PRP.
[0124] As described above, the second syringe 20 is used to administer the PRP in the second syringe barrel 21 to a patient or the like. When administering the PRP to a patient or the like, the user first removes the second cap 25 from the second port 22 and attaches an injection needle 28 or the like instead. The injection needle 28 is an injection needle of a general length, different from the injection needles 26 and 36 having a longer length than a normal injection needle.
[0125] The user inserts the tip of the injection needle 28 into the affected part of the patient and moves the second gasket 23 downward in the cylinder axis direction via the second plunger 24. Thereby, the user can administer the prepared PRP to the affected part of the patient or the like.
[0126] As described above, by using the syringe system 200, the user can efficiently perform the PRP preparation process from blood collection, two centrifugation processes, two extractions of necessary components, to the preparation of PRP. Further, by using the first gasket 13 and the second gasket 23, it is possible to improve the amount and concentration rate of the PRP to be prepared.
[0127] Next, various modifications of the gasket will be described. The structure of the gasket can be appropriately changed as shown below.
[0128] [Modification 2] The structure of the gasket 43a of Modification 2 of the present disclosure will be described with reference to FIG. 10. FIG. 10 is a schematic diagram showing an example of the gasket 43a according to Modification 2.
[0129] As shown in FIG. 10, the gasket 43a is generally configured in a cylindrical shape. Further, the first surface 431, which is the bottom surface of the gasket 43a, is configured in a planar shape or a concave shape, and is similar to the first gasket 13 and the like in that it has a first recess 433 in which the tip portions 27 and 37 of the injection needles 26 and 36 protrude.
[0130] The first recess 433 is a portion recessed from the first surface 431 of the gasket 43a, and is formed, for example, in a columnar hole portion whose peripheral wall surface is slightly inclined. The first recess 433 only needs to be a portion recessed from the first surface 431, and may be, for example, a hole portion such as a conical shape or a rectangular parallelepiped, and the shape is not particularly limited.
[0131] The gasket 43a further has a second recess 434 on the second surface 432 facing the first surface 431 of the gasket 43a. In the present embodiment, the second recess 434 is formed in a shape obtained by punching out the gasket 43a in a columnar shape from the second surface 432 side. The second recess 434 only needs to be a shape that thins the thickness of the gasket 43a, and the shape is not particularly limited. The second recess 434 may be, for example, a rectangular parallelepiped, a polygonal column, a conical depression, or the like.
[0132] As a result, the thickness of the gasket 43a at the portion through which the injection needles 26 and 36 are inserted becomes thinner, and the resistance during insertion is reduced. Therefore, the user can more easily insert the needle tips 27 and 37 into the gasket 43a.
[0133] The width of the opening of the second recess 434 may be larger, the same, or smaller than the width of the opening of the first recess 433. In the present embodiment, the width of the opening of the second recess 434 is formed to be larger than the width of the opening of the first recess 433. However, the second recess 434 may be configured to have the same width as the opening of the first recess 433 or to be narrower than the opening of the first recess. In this case, when inserting the injection needles 26 and 36 into the gasket 43a, the needle tips 27 and 37 of the injection needles 26 and 36 can be effectively guided into the first recess 433.
[0134] 〔Modification Example 3〕 The structure of the gasket 43b according to Modification Example 3 of the present disclosure will be described with reference to FIG. 11. FIG. 11 is a schematic diagram showing an example of the gasket 43b according to Modification Example 3.
[0135] As shown in FIG. 11, in addition to the structure of the gasket 43a, the gasket 43b further has a third recess 435 on the first surface 431.
[0136] The third recess 435 is configured, for example, to be columnar and hollowed out from the first surface 431 side of the gasket 43b so as to be wider than the opening of the first recess 433. At this time, the first recess 433 may be located on the bottom surface of the third recess 435. The third recess 435 may be a rectangular parallelepiped, a polygonal prism, a conical depression, etc., and the shape is not particularly limited.
[0137] As a result, the thickness of the gasket 43b at the portion through which the injection needles 26 and 36 are inserted becomes even thinner, and the user can more easily insert the needle tips 27 and 37 into the gasket 43b.
[0138] 〔Modification Example 4〕 The structure of the gasket 43c of Modification 4 of the present disclosure will be described with reference to FIG. 12. FIG. 12 is a schematic diagram showing an example of the gasket 43c according to Modification 4.
[0139] As shown in FIG. 12, the gasket 43c has a second recess 434 on the second surface 432 located at a position facing the first surface 431, similar to the gasket 43a described above. However, the gasket 43c is different from the gasket 43a in that the second surface 432 is the bottom surface of the recess that opens to the bottom surface of the gasket 43c located on the opposite side of the first surface 431. Also, the thickness between the first surface 431 and the second surface 432 of the gasket 43c may be greater than the thickness between the first surface 431 and the second surface 432 of the gasket 43a.
[0140] The width of the opening of the second recess 434 may be the same as the width of the opening of the first recess 433, or may be configured to be narrower than the opening of the first recess. Also, the second recess 434 may be configured in a cylindrical shape with a slightly inclined peripheral wall. The second recess 434 may be, for example, a rectangular parallelepiped, a polygonal prism, a conical depression, etc., and the shape is not particularly limited.
[0141] Thereby, while increasing the thickness of the gasket 43c and improving the strength of the gasket 43c, by providing the second recess 434, the insertion of the injection needles 26 and 36 into the gasket 43c can be facilitated.
[0142] Also, by configuring the second recess 434 to be narrower than the opening of the first recess 433, the tip portions 27 and 37 of the injection needles 26 and 36 can be effectively guided into the first recess 433.
[0143] 〔Embodiment 3〕 Subsequently, Embodiment 3 of the present disclosure will be described below. Above, an example in which a recess is formed in the gasket has been described, but the gasket of Embodiment 3 is different from the above gasket in that a convex portion is formed.
[0144] FIG. 13 is a schematic diagram showing an example of the gasket 43d according to Embodiment 3 of the present disclosure. As shown in FIG. 13, in addition to the structure of the first gasket 13 according to Embodiment 1, the gasket 43d further has a convex portion 437 protruding in the cylinder axis direction from the second surface 432 on the second surface 432 facing the first surface 431.
[0145] The convex portion 437 may be, for example, a cylindrical shape with a slightly inclined peripheral wall and may have a guide hole 437a at a substantially central portion. The guide hole 437a can guide the tip portions 27 and 37 of the injection needles 26 and 36. The convex portion 437 may be located on the second surface 432 so as to surround the region of the second surface 432 facing the first recess 433. That is, the axis of the convex portion 437 and the axis of the first recess 433 are configured to be at substantially the same position, and the tip portions 27 and 37 of the injection needles 26 and 36 can be effectively guided. The convex portion 437 may have any shape as long as it can guide the tip portions 27 and 37 of the injection needles 26 and 36, and the shape is not particularly limited.
[0146] Thereby, the tip portions 27 and 37 can be effectively guided to the first recess 433.
[0147] Next, various modifications of the gasket according to Embodiment 3 will be described. The structure of the gasket can be appropriately changed as shown below.
[0148] 〔Modification 5〕 The structure of the gasket 43e according to Modification 5 of the present disclosure will be described with reference to FIG. 14. FIG. 14 is a schematic diagram showing an example of the gasket 43e according to Modification 5.
[0149] As shown in FIG. 14, the gasket 43e has a convex portion 437 protruding in the cylinder axis direction from the second surface 432 on the second surface 432 located at a position facing the first surface 431, similar to the above-described gasket 43d. However, the gasket 43c is different from the gasket 43d in that the second surface 432 is the bottom surface of a recess that opens on the bottom surface of the gasket 43c located on the opposite side of the first surface 431.
[0150] The convex portion 437 may have, for example, a cylindrical shape with a slightly inclined peripheral wall, and may have a guide hole for guiding the tip portions 27, 37 of the injection needles 26, 36 at a substantially central portion. The convex portion 437 may be positioned on the second surface 432 so as to surround the region of the second surface 432 that faces the first concave portion 433. That is, the axis of the convex portion 437 and the axis of the first concave portion 433 may be configured to be at substantially the same position. At this time, the tip portions 27, 37 of the injection needles 26, 36 can be effectively guided. The convex portion 437 may have any shape as long as it can guide the tip portions 27, 37 of the injection needles 26, 36, and the shape is not particularly limited.
[0151] Thereby, the tip portions 27, 37 can be effectively guided to the first concave portion 433.
[0152] 〔Modification Example 6〕 The structure of the gasket 43f according to Modification Example 6 of the present disclosure will be described with reference to FIG. 15. FIG. 15 is a schematic diagram showing an example of the gasket 43f according to Modification Example 6.
[0153] As shown in FIG. 15, in addition to the structure of the gasket 43e, the gasket 43f further has a second concave portion 434 at a position facing the first concave portion 433 of the second surface 432.
[0154] The second concave portion 434 is configured to have a cylindrical shape with a slightly inclined peripheral wall so as to be narrower than the opening of the first concave portion 433. The second concave portion 434 may be a rectangular parallelepiped, a polygonal prism, a conical depression, or the like, and the shape is not particularly limited.
[0155] By providing the second concave portion 434, the insertion of the injection needles 26, 36 into the gasket 43f can be facilitated. Further, by configuring the second concave portion 434 to be narrower than the opening of the first concave portion 433, the tip portions 27, 37 can be more effectively guided to the first concave portion 433.
[0156] Alternatively, the user may use guide members 80 and 90 described below, which have through holes for guiding the tip portions 27 and 37 of the injection needles 26 and 36. When using the guide members 80 and 90, the axes of the guide members 80 and 90 and the axis of the first recess 433 may be configured to be in substantially the same position. In a state where the end portions of the guide members 80 and 90 are in contact with the second surface 432, if the injection needles 26 and 36 are inserted into the guide members 80 and 90, the tip portions 27 and 37 are guided to the first recess 433. In this way, by using the guide members 80 and 90, the user can easily project the tip portions 27 and 37 into the first recess 433.
[0157] 〔Embodiment 4〕 Subsequently, the configurations of the syringe system 400 and the cylinder kit 410 according to Embodiment 4 of the present disclosure will be described in detail with reference to FIG. 16.
[0158] FIG. 16 is a schematic diagram showing an example of the guide member 80, and FIG. 17 is a diagram showing an example of a configuration example of the syringe system 400 and the cylinder kit 410.
[0159] As shown in FIG. 17, the syringe system 400 is different from Embodiment 2 in that, in addition to the configuration of the syringe system 200, the guide members 80 and 90 may be further provided.
[0160] The guide members 80 and 90 have through holes 81 and 91 for guiding the injection needles 26 and 36 that penetrate the gasket 43a. By providing the guide members 80 and 90, when the injection needles 26 and 36 penetrate the gasket 43a, it is possible to prevent the injection needles 26 and 36, which are longer than normal injection needles, from breaking or bending, and to guide the injection needles 26 and 36 to the storage chamber.
[0161] The syringe system 400 has the same configuration as that described in Embodiment 2 except for the above-described guide members 80 and 90 and the structure of the gasket 43a into which the guide members 80 and 90 are fitted. Therefore, here, mainly the guide members 80 and 90 and the gasket 43a will be described, and the description of other configurations will be omitted.
[0162] As shown in FIG. 16, the guide member 80 is configured, for example, in a substantially cylindrical shape so as to be insertable into the first syringe barrel 11, and includes a through hole 81 and a mounting portion 82.
[0163] As described above, the through hole 81 is a hole that guides the injection needle 26 piercing through the gasket 43a, and is formed over substantially the entire length of the guide member 80 in the axial direction of the cylinder. The through hole 81 has one opening 81a and the other opening 81b at both ends in the axial direction of the cylinder, respectively.
[0164] The mounting portion 82 is configured, for example, in a substantially cylindrical shape with a smaller diameter than the main body of the guide member 80, and a part of the through hole 81 including the other opening 81b is disposed inside. The guide member 80 is detachably attached to the gasket 43a by fitting the mounting portion 82 into the gasket 43a.
[0165] As described above, the gasket 43a is configured in a substantially cylindrical shape. Further, the first surface 431, which is the bottom surface of the gasket 43a, is configured in a flat shape or a concave shape, and has a first concave portion 433 where the tip portion 27 of the injection needle 26 protrudes. The first concave portion 433 is formed, for example, in a columnar hole portion with a slightly inclined peripheral wall surface, but may be a portion recessed from the first surface 431, and may be, for example, a hole portion such as a conical shape or a rectangular parallelepiped shape, and the shape is not particularly limited.
[0166] Further, the gasket 43a has a second concave portion 434 on the second surface 432 facing the first surface 431 of the gasket 43a. The second concave portion 434 is formed in a shape obtained by punching out the gasket 43a in a substantially columnar shape from the second surface 432 side, and is configured to have a slightly larger diameter than the mounting portion 82 of the guide member 80.
[0167] Thus, as described above, the user can detachably attach the guide member 80 to the gasket 43a by inserting and fitting the attachment portion 82 of the guide member 80 into the second recess 434 of the gasket 43a. At this time, the gasket 43a may be located within the first syringe barrel 11.
[0168] Further, the guide member 80 is attached to the gasket 43a such that the axis of the through-hole 81 of the guide member 80 is located substantially at the same position as the axes of the second recess 434 and the first recess 433.
[0169] The user inserts the injection needle 26 (see FIG. 17) into the through-hole 81 from one opening 81a of the through-hole 81 formed in the guide member 80, and projects the tip portion 27 of the injection needle 26 from the other opening 81b. Thereafter, the tip portion 27 pierces the second recess 434 of the gasket 43a and projects from the first recess 433 through the gasket 43a.
[0170] In this way, when a longer injection needle 26 than a normal injection needle is inserted through the through-hole 81, the guide member 80 can prevent the injection needle 26 from being bent or broken due to the resistance when the injection needle 26 penetrates the gasket 43a. Similarly, when a longer injection needle 36 than a normal injection needle is inserted through the through-hole 91, the guide member 90 can prevent the injection needle 36 from being bent or broken due to the resistance when the injection needle 36 penetrates the gasket 43a.
[0171] As shown in FIG. 17, the cylinder kit 410 is configured to include a first syringe 10, a second syringe 20, and a third syringe 30.
[0172] As described above, the first syringe 10 is used as a centrifugation container for collecting blood or the like and subjecting the collected blood or the like to centrifugation processing. The first syringe 10 includes a first syringe barrel 11 and a gasket 43a.
[0173] The gasket 43a has the first plunger 14 detachably attached thereto. The first port 12 of the first syringe barrel 11 has a blood collection needle attached thereto when collecting blood, and a first cap 15 is attached thereto when hermetically sealing the storage chamber.
[0174] As described above, the second syringe 20 is used to extract a part of the liquid separated by the first syringe 10. Further, the second syringe 20 may be used as a centrifuge container for subjecting the extracted liquid to a centrifugation process, and may also be used to administer the prepared PRP to a patient. The second syringe 20 includes a second syringe barrel 21 and a gasket 43a.
[0175] The gasket 43a of the second syringe 20 has the second plunger 24 detachably attached thereto. The second port 22 of the second syringe barrel 21 has a second cap 25 attached thereto when hermetically sealing the storage chamber, and an injection needle 26 is attached thereto when extracting a part of the liquid from the first syringe 10. Further, an injection needle 28 is attached thereto when administering PRP to a patient.
[0176] Here, when the user extracts a part of the liquid from the first syringe 10 using the second syringe 20, the user removes the first plunger 14 from the gasket 43a of the first syringe 10 and attaches the guide member 80 to the gasket 43a. Thereafter, the user inserts the injection needle 26 into the through hole 81 of the guide member 80. Thereby, when the injection needle 26 penetrates the gasket 43a of the first syringe 10, it is possible to avoid the injection needle 26 from being bent or broken.
[0177] As described above, the third syringe 30 is used to extract a part of the liquid separated by the second syringe 20. The third syringe 30 includes a third syringe barrel 31 and a third gasket 33.
[0178] The third gasket 33 has the third plunger 34 detachably attached thereto. The third port 32 of the third syringe barrel 31 has an injection needle 36 attached thereto when extracting a part of the liquid from the second syringe 20.
[0179] Here, when the user extracts a part of the liquid from the second syringe 20 with the third syringe 30, the user removes the second plunger 24 from the gasket 43a of the second syringe 20 and attaches the guide member 90 to the gasket 43a of the second syringe 20.
[0180] Thereafter, the user inserts the injection needle 36 into the through-hole 91 of the guide member 90. Thereby, when the injection needle 36 penetrates the gasket 43a of the second syringe 20, the user can prevent the injection needle 36 from breaking or bending.
[0181] FIG. 18 is a diagram showing an example of the flow of a process for preparing PRP using the cylinder kit 310 using the guide members 80 and 90.
[0182] Since each process is the same as that in FIG. 9, the description thereof is omitted, but the guide members 80 and 90 are used in states <3c> and <6c>, respectively.
[0183] Thereby, when the user extracts a part of the liquid from the first syringe 10 or the second syringe 20, when the injection needles 26 and 36 penetrate the gasket 43a, the user can prevent the injection needles 26 and 36 from breaking or bending.
[0184] <Joint portion> Next, the structure of the joint portion between the attachment portion 82 of the guide member 80 and the second recess 434 of the gasket 43a will be described in detail with reference to FIG. 19. FIG. 19 is a diagram showing an example of the structure of the joint portion between the guide member 80 and the gasket 43a.
[0185] As shown in FIG. 19, a male screw 82b may be formed on at least a part of the outer peripheral surface of the attachment portion 82 of the guide member 80, and a female screw 434b may be formed on at least a part of the inner peripheral surface (inner side surface) of the second recess 434 of the gasket 43a. By screwing the male screw 82b and the female screw 434b together, the guide member 80 can be joined to the gasket 43a so as to be movable in the cylinder axis direction.
[0186] Accordingly, the user can adjust the position of the needle tip portion 27 vertically in the cylinder axis direction, and can extract blood components more accurately and stably.
[0187] Further, the mounting portion 82 of the guide member 80 may be joined to the gasket 43a having features such as the gaskets 43b, 43c, 43e, or 43f. That is, the gasket 43a may have a third recess 435 on the first surface 431, like the gasket 43b. Also, the second surface 432 may be the bottom surface of a recess that opens to the bottom surface of the gasket 43c located on the side opposite to the first surface 431. Further, the second surface 432 facing the first surface 431 may have a convex portion 437 protruding in the cylinder axis direction from the second surface 432.
[0188] Also, the structure of the joint portion between the mounting portion 92 of the guide member 90 and the second recess 434 of the gasket 43a may be configured in the same manner as the structure of the joint portion between the mounting portion 82 of the guide member 80 and the second recess 434. That is, the mounting portion 92 of the guide member 90 may be joined to the gasket 43a having features such as the gaskets 43b, 43c, 43e, or 43f.
[0189] Also, the guide member 80 may be attached to the gasket 43e. FIG. 20 is a diagram showing another example of the structure of the joint portion between the guide member 80 and the gasket 43e.
[0190] As shown in FIG. 20, the guide member 80 may be attached to the gasket 43e by the engagement of the cylindrical portion 83 of the guide member 80 and the convex portion 437 of the gasket 43e. A through hole 81 through which the injection needle 26 is inserted is formed inside the cylindrical portion 83 of the guide member 80.
[0191] As described above, the gasket 43e has a convex portion 437 that protrudes from the second surface 432 in the cylinder axis direction on the second surface 432. The convex portion 437 is, for example, in the shape of a cylinder with a slightly inclined peripheral wall, and has a guide hole 487a for guiding the tip portion 27 of the injection needle 26 at substantially the center. The convex portion 437 is located on the second surface 432 so as to surround the region facing the first concave portion 433, and the axis of the convex portion 437 and the axis of the first concave portion 433 are configured to be at substantially the same position.
[0192] A male thread 83b, which is a thread groove, may be formed on at least a part of the outer peripheral surface of the cylindrical portion 83 of the guide member 80, and a female thread 437b, which is a thread groove, may be formed on at least a part of the inner peripheral surface of the guide hole 437a of the convex portion 437. By screwing the male thread 83b and the female thread 437b together, the guide member 80 can be engaged with the gasket 43e so as to be movable in the cylinder axis direction.
[0193] Thereby, the user can adjust the position of the tip portion 27 up and down in the cylinder axis direction, and can extract blood components more accurately and stably.
[0194] Further, the cylindrical portion 83 of the guide member 80 may be fitted with the convex portions 437 of the gaskets 43d and 43f. In this case, a male thread 83b, which is a thread groove, may be formed on at least a part of the outer peripheral surface of the cylindrical portion 83, and a female thread 437b, which is a thread groove, may be formed on at least a part of the inner peripheral surface of the guide hole 437a of the convex portion 437. By screwing the male thread 83b and the female thread 437b together, the guide member 80 can be joined to the gaskets 43d and 43f so as to be movable in the cylinder axis direction.
[0195] Also, for the guide member 90, by forming a cylindrical portion similar to the cylindrical portion 83 of the guide member 80 on the guide member 90, a joint portion similar to the joint portion between the guide member 80 and the second concave portion 434 can be configured.
[0196] Thereby, the user can adjust the positions of the tip portions 27 and 37 up and down in the cylinder axis direction, and can extract blood components more accurately and stably.
[0197] The invention according to the present disclosure has been described above with reference to the drawings and examples. However, the invention according to the present disclosure is not limited to each of the above-described embodiments. That is, the invention according to the present disclosure can be variously modified within the scope shown in the present disclosure, and embodiments obtained by appropriately combining the technical means disclosed in different embodiments are also included in the technical scope of the invention according to the present disclosure. In other words, it should be noted that those skilled in the art can easily make various deformations or modifications based on the present disclosure. Also, it should be noted that these deformations or modifications are included in the scope of the present disclosure.
Explanation of Reference Numerals
[0198] 11 First syringe barrel (barrel body) 13 First gasket 14 First plunger 21 Second syringe barrel (barrel body) 23 Second gasket 24 Second plunger 26, 36 Hypodermic needle 31 Third syringe barrel (barrel body) 33 Third gasket 34 Third plunger 71 Vacuum blood collection tube (barrel body) 72 Gasket 73 Stopper 80, 90 Guide member 81, 91 Through hole 82b, 83b Male screw (thread groove) 110, 210, 310, 410 Barrel kit 131, 231, 331 First surface 132 Second surface 133, 233 First recess 433 First recess 434 Second recess 434b Female screw (thread groove) 437 Protrusion 437b Female screw (thread groove)
Claims
1. A first cylinder body, a gasket movable in the axial direction of the first cylinder body, a guide member having a through hole for guiding a needle piercing the gasket, and comprising the first cylinder body has a storage chamber partitioned by the gasket and capable of storing a liquid, the gasket has a first surface facing the storage chamber and a second surface facing the first surface, the first surface is planar or concave and has a first recess, the second surface has a second recess engaging with the guide member, at least a part of the inner surface of the second recess and at least a part of the guide member have screw grooves that are screwed together with each other, the guide member is movable in the axial direction from the gasket by the screw groove on the guide member side sliding along the screw groove on the inner surface side, the needle is attached to a second cylinder body capable of accommodating a predetermined liquid extracted from the liquid in the first cylinder body by the needle, the second cylinder body to which the needle is attached is disposed above the guide member when the needle pierces the gasket, and by moving in the axial direction together with the guide member from the gasket, the position of the tip of the needle piercing the gasket can be adjusted in the axial direction, A cylinder kit for preparing platelet-rich plasma from the liquid.
2. A first cylinder body, a gasket movable in the axial direction of the first cylinder body, a guide member having a through hole for guiding a needle piercing the gasket, and comprising the first cylinder body has a storage chamber partitioned by the gasket and capable of storing a liquid, the gasket It has a first surface facing the storage chamber and a second surface facing the first surface, The first surface is planar or concave and has a first recess, The second surface has a convex portion that engages with the guide member, At least a part of the convex portion and at least a part of the guide member have screw grooves that are screwed together, The guide member is movable in the cylinder axis direction from the gasket by the screw groove on the guide member side sliding along the screw groove on the convex portion side, The needle is attached to a second cylinder that can accommodate a predetermined liquid extracted from the liquid in the first cylinder by the needle, The second cylinder to which the needle is attached is disposed above the guide member when the needle penetrates the gasket, and by moving in the cylinder axis direction together with the guide member from the gasket, the position of the tip of the needle penetrating the gasket can be adjusted in the cylinder axis direction, A cylinder kit for preparing platelet-rich plasma from the liquid.
3. The convex portion surrounds a region of the second surface facing the first recess and protrudes in the cylinder axis direction from the second surface. The cylinder kit according to claim 2.
4. The second surface has a second recess at a position facing the first recess The convex portion surrounds the second recess and protrudes in the cylinder axis direction from the second surface. The cylinder kit according to claim 2 or 3.
5. The first recess is provided in a central region of the first surface. The cylinder kit according to any one of claims 1 to 4.
6. The first cylinder and the second cylinder are syringe barrels, The gasket can be detachably attached to a plunger movable in the syringe barrel by the screw groove. The cylinder kit according to any one of claims 1 to 5.
7. The first cylindrical body and the second cylindrical body are cylindrical containers having a closed end and an open end. The cylindrical body kit according to any one of claims 1 to 6.
8. Further comprising a plug body for closing the open end, The gasket can be detachably attached to the plug body. The cylindrical body kit according to claim 7.
9. A gasket having a second surface facing the first surface and movable in the axial direction of the first cylindrical body capable of storing a liquid, The liquid is stored in a storage chamber defined by the first cylindrical body and the first surface, The first surface is planar or concave and has a first recess, The second surface has a second recess at a position facing the first recess, The second recess engages with a guide member having a through hole for guiding a needle piercing the gasket, At least a part of the inner surface of the second recess has a thread groove that engages with a thread groove formed in at least a part of the guide member, The guide member is movable in the axial direction from the gasket by sliding the thread groove on the guide member side along the thread groove on the inner surface side. The needle is attached to a second cylindrical body capable of accommodating a predetermined liquid extracted from the liquid in the first cylindrical body by the needle, When the needle is attached, the second cylindrical body is disposed above the guide member when the needle pierces the gasket, and by moving in the axial direction together with the guide member from the gasket, the position of the tip of the needle piercing the gasket can be adjusted in the axial direction. A gasket for preparing platelet-rich plasma from the liquid.
10. A gasket having a second surface facing the first surface and movable in the axial direction of the first cylindrical body capable of storing a liquid, The liquid is stored in a storage chamber defined by the first cylinder and the first surface. The first surface is planar or concave and has a first recess. The second surface has a convex portion. The convex portion engages with a guide member having a through-hole for guiding a needle that penetrates the gasket. At least a part of the convex portion has a thread groove that engages with a thread groove formed in at least a part of the guide member. The guide member is movable in the cylinder axis direction from the gasket by sliding the thread groove on the guide member side along the thread groove on the convex portion side. The needle is attached to a second cylinder that can accommodate a predetermined liquid extracted from the liquid in the first cylinder by the needle. When the needle penetrates the gasket, the second cylinder to which the needle is attached is disposed above the guide member and can adjust the position of the tip of the needle penetrating the gasket in the cylinder axis direction by moving in the cylinder axis direction together with the guide member from the gasket. A gasket for preparing platelet-rich plasma from the liquid.
Citation Information
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