The present disclosure relates to a tubular body kit and a gasket that are usable for preparing a liquid containing a desired component by fractionating blood or the like.
Instruments for separating serum or plasma components from collected blood are known.
In an aspect of the present disclosure, a tubular body kit includes a tubular body and a gasket movable in a tube axial direction in the tubular body, the tubular body includes a storage chamber partitioned by the gasket, the storage chamber being configured to store a liquid, and the gasket includes a first surface facing the storage chamber, the first surface having a flat surface shape or a recessed surface shape, the first surface including a first recessed portion.
In an aspect of the present disclosure, a gasket includes a first surface and a second surface facing the first surface, and the gasket is movable in a tube axial direction in a tubular body configured to store a liquid, the liquid is stored in a storage chamber partitioned by the tubular body and the first surface, and the first surface has a flat surface shape or a recessed surface shape, the first surface including a first recessed portion.
Interest has been growing in techniques and methods for fractionating blood or the like collected from a patient to prepare a liquid containing a desired component. For example, in regenerative medicine, the usage of platelet rich plasma (hereinafter referred to as PRP) prepared from blood has been attracting attention.
Embodiments of the present disclosure will be described below by using the drawings. Hereinafter, a syringe system 100 configured to prepare platelet rich plasma (hereinafter, referred to as PRP) from blood will be described as an example.
The present disclosure is not limited to this example, and may be applied to the syringe system 100 to be used for preparing, for example, a liquid containing blood, bone marrow liquid, or platelets collected from a spleen or the like, a liquid containing platelets produced outside a living body (in vitro), a liquid containing an adipose tissue-derived stromal vascular fraction, a liquid containing white blood cells, or the like. Examples of the liquid containing white blood cells include a liquid containing bone marrow mononuclear cells, a liquid containing peripheral blood mononuclear cells, and a liquid containing polynuclear granular leukocytes.
Configuration of Syringe System 100 and Tubular Body Kit 110 Hereafter, a configuration of the syringe system 100 and a tubular body kit 110 according to a first embodiment of the present disclosure will be described based on the drawings.
As illustrated in
The first syringe 10 may include the first syringe tube 11 and the first gasket 13 as illustrated in
The first syringe tube 11 is formed in a substantially tubular shape, for example, and has a storage space forming a storage chamber configured to store a liquid such as blood therein. The first syringe tube 11 is constituted by a transparent or translucent member, and thus, the inside of the first syringe tube 11 can be visually recognized.
The first syringe tube 11 includes, at one end portion thereof, an opening portion 111 through which a first plunger 14, which will be described later, and the like are inserted and withdrawn. The first syringe tube 11 includes, at the other end portion thereof, a first port 12 having a substantially tubular shape and having a smaller diameter than that of a body of the first syringe tube 11. An inner bottom surface of the first syringe tube 11 may have, for example, a shape protruding toward the storage chamber in a substantially circular arc shape, a flat surface shape, or a shape protruding toward a side opposite to the storage chamber. In the present embodiment, an inner bottom surface of the first syringe tube 11 is configured in a flat surface shape, and follows a shape of a first surface 131 that is a bottom surface of the first gasket 13, which will be described later. The first surface 131 is a surface facing the storage chamber in the first syringe tube 11. The liquid is stored in the storage chamber partitioned by the first syringe tube 11 and the first surface 131.
The first port 12 may function as an attachment portion to which a blood collection tube, an injection needle (for example, a blood collection needle), or the like is to be attached. The storage chamber in the first syringe tube 11 and an internal space of the first port 12 communicate with each other, and a liquid such as blood can be stored in the storage chamber in the first syringe tube 11 through a blood collection tube or an injection needle attached to the first port 12. The first port 12 has a Luer lock type (ISO80369-7:2016) structure, and a blood collection tube, an injection needle, or the first cap 15, which will be described later, may be attached to the first port 12 with the structure.
The first gasket 13 can be detachably attached to a first plunger 14 that is movable in the first syringe tube 11. The first gasket 13 liquid-tightly seals the inside of the first syringe tube 11 together with the first cap 15, which will be described later. The first gasket 13 may reciprocate in the first syringe tube 11 in the tube axial direction. At this time, an outer peripheral surface of the first gasket 13 may slide on an inner wall surface of the first syringe tube 11 with liquid-tightness in the first syringe tube 11 being maintained. This makes it possible to liquid-tightly seal the inside of the first syringe tube 11 even when the first gasket 13 reciprocates in the first syringe tube 11.
The first syringe 10 may further include the first plunger 14 detachably attached to the first gasket 13. The first plunger 14 is attached at one end portion 141 thereof with an upper portion of the first gasket 13. The first plunger 14 and the first gasket 13 may be screwed together with screw grooves. The first plunger 14 may include, at the other end portion thereof, for example, a flange 142 that is used as an operation portion.
After the first gasket 13 is attached, the first plunger 14 is inserted into the first syringe tube 11 from the opening portion 111 described above. A user such as a medical professional may operate the flange 142 of the first plunger 14 to cause the first plunger 14 to reciprocate in the tube axial direction in the first syringe tube 11. Accordingly, as described above, the first gasket 13 attached to the first plunger 14 can be caused to reciprocate in the first syringe tube 11.
When blood is collected, the first plunger 14 is moved to pull out at least a part of the first plunger 14 from the inside of the first syringe tube 11, and the first gasket 13 is moved in a direction of the opening portion 111, whereby blood or the like can be stored in the storage chamber in the first syringe tube 11.
The first syringe 10 may further include the first cap 15 detachably attached to the first port 12. As described above, attaching the first cap 15 to the first port 12 allows the storage chamber in the first syringe tube 11 to be liquid-tightly sealed. Accordingly, a user can perform centrifugal separation processing with blood contained in the first syringe tube 11 after collecting the blood or the like.
To be specific, after collecting blood, the user attaches the first cap 15 to the first port 12, and then, the first syringe tube 11 is used as a centrifugation container to perform the centrifugal separation processing using a centrifugal force directed from the first gasket 13 side toward the first port 12 side. At this time, the user may detach the first plunger 14 from the first gasket 13 so as not to interfere with the centrifugal separation processing or does not need to detach the first plunger 14.
By using the centrifugal separation processing, the blood in the first syringe tube 11, that is, whole blood 50 (see
As will be described in detail later, at this time, the user extracts the third fraction 53 positioned at the uppermost layer into a second syringe 20 with the injection needle 26. Thus, the user can extract the third fraction 53 necessary for PRP preparation from the whole blood.
The structure of the first gasket 13 will be described in detail based on
As described above, the first gasket 13 liquid-tightly seals the inside of the first syringe tube 11 together with the first cap 15. The first gasket 13 can reciprocate in the first syringe tube 11 in the tube axial direction through the first plunger 14 with liquid-tightness in the first syringe tube 11 being maintained.
As illustrated in
As illustrated in the diagram on the left side of
The gasket 13a does not include the first recessed portion 133 from which the needle tip portion 27 of the injection needle 26 protrudes, unlike the first gasket 13 including the first recessed portion 133 in the first surface 131.
Here, extraction of the third fraction 53 by the known gasket 13a will be described. First, a user sticks the needle tip portion 27 of the injection needle 26 from the second surface 132a facing the first surface 131a of the gasket 13a, penetrates through the inside of the gasket 13a, and causes the needle tip portion 27 to protrude from a tip end 131b of the first surface 131a of the gasket 13a. Then, the user extracts the third fraction 53 positioned below the first surface 131a from the needle tip portion 27 into the second syringe 20. Here, the injection needle 26 may have a sufficient length to penetrate through the gasket 13a and to extract the third fraction 53 positioned below the first surface 131a of the gasket 13a.
At this time, a portion of the gasket 13a into which the needle tip portion 27 is stuck is pulled downward in the tube axial direction, and the first surface 131a extends downward in the tube axial direction by about 3 mm. When the needle tip portion 27 protrudes from the first surface 131a, the extended portion of the first surface 131a returns to its original position, and as a result, the needle tip portion 27 protrudes from the first surface 131a by about 3 mm. Thus, in order to cause the needle tip portion 27 to protrude from the first surface 131a, the injection needle 26 needs to have a length enough to cause the needle tip portion 27 to protrude from the first surface 131a by about 3 mm. For this reason, a protrusion length T2 from the tip end 131b of the needle tip portion 27 becomes long, and is about 3 mm.
As illustrated in the diagram on the left side of
Here, referring back to
As illustrated in
Extraction of the third fraction 53 by the first gasket 13 according to the first embodiment of the present disclosure will be described.
As illustrated in the diagram on the right side of
At this time, since a portion of the first gasket 13 stuck by the needle tip portion 27 is pulled downward and extended in the tube axial direction, the needle tip portion 27 protrudes from the bottom surface 134 of the first recessed portion 133 by about 3 mm. However, since the first recessed portion 133 is recessed from the first surface 131 by about 2 mm, a protrusion length T1 of the needle tip portion 27 from the first surface 131 is about 1 mm.
The user extracts the third fraction 53 positioned below the first surface 131 from the needle tip portion 27 into the second syringe 20.
At this time, the first surface 131 of the first gasket 13 is formed in a flat surface shape or a recessed surface shape, and as described above, positions of the first surface 131 and the needle tip portion 27 substantially coincide with each other. Thus, 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, which can reduce the portion L1 that cannot be extracted.
As described above, by using the first gasket 13, an amount and a concentration rate of PRP to be prepared can be increased.
Processing of preparing PRP by using the tubular body kit 110 will be described with reference to
As illustrated in a state <1> of
The user subjects the first syringe 10 to the centrifugal separation processing using a centrifugal force directed from the first gasket 13 side toward the first port 12 side. Conditions of the centrifugal separation processing may be, for example, weak centrifugation conditions in which a centrifugal acceleration is 600×g and a processing time is 7 minutes.
As illustrated in a state <2> of
As illustrated in a state <3> of
When the third fraction 53 is extracted, first, the user sticks the needle tip portion 27 of the injection needle 26 into the second surface 132 of the first gasket 13, causes the needle tip portion 27 to penetrate through the inside of the first gasket 13, and causes the needle tip portion 27 to protrude from the first recessed portion 133. Then, the user extracts the third fraction 53 positioned below the first surface 131 using the needle tip portion 27 out to the second syringe 20.
At this time, as described above, the first surface 131 of the first gasket 13 is formed in a flat surface shape or a recessed surface shape. Because of the first recessed portion 133, the positions of the first surface 131 and the needle tip portion 27 substantially coincide with each other, and therefore, 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. Furthermore, since resistance of the needle tip portion 27 being inserted 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 recessed portion 133 is not formed.
Thus, by using the syringe system 100, the third fraction 53 in the first syringe tube 11 can be effectively accommodated into the second syringe 20 without waste. This also makes it possible to increase the amount and the concentration rate of PRP to be prepared.
Although an example in which the third fraction 53 is extracted into the second syringe 20 has been described above, the user may extract the second fraction 52 and the third fraction 53 at the time of extracting the liquid in the first syringe tube 11 out to the second syringe 20. In this case, PRP having a higher leukocyte concentration than that of the whole blood can be prepared from the whole blood 50.
The configuration described in the first embodiment can be changed as appropriate. For example, although an example in which the tubular body kit for preparing PRP from blood is applied to a syringe tube has been described in the first embodiment, the tubular body kit may be applied to, for example, a vacuum blood collection tube.
Configuration of Blood Collection Tube System 300 and Tubular Body Kit 310
The vacuum blood collection tube 71 is used for collecting blood or the like and storing the collected blood or the like, for example. As will be described later, the vacuum blood collection tube 71 is used as a centrifugation container for subjecting collected blood or the like to centrifugal separation processing.
The vacuum blood collection tube 71 is formed in a substantially tubular shape, and includes a storage chamber therein, for example. The vacuum blood collection tube 71 includes an opening portion 711 at one end and a flange 712 around the opening portion 711. The vacuum blood collection tube 71 is a tubular container including a closed end and an open end.
The stopper 73 is a member that closes the open end of the vacuum blood collection tube 71. The stopper 73 is adhered to the flange 712 of the vacuum blood collection tube 71, and maintains and seals the storage chamber in the vacuum blood collection tube 71 in a vacuum state together with the gasket 72, which will be described later. The stopper 73 is made of, for example, metal, synthetic resin, or the like, and has a substantially disk-like shape. The stopper 73 includes the first member 74, which will be described later.
The gasket 72 is formed, for example, in a substantially columnar shape, and a first surface 721 that is a bottom surface of the gasket 72 is formed in a flat surface shape or a recessed surface shape. The gasket 72 includes the first recessed portion 723. The needle tip portion 761 protrudes from the first recessed portion 723 when the needle tip portion 761, which will be described later, is pierced through the first recessed portion 723. The gasket 72 may be detachably attachable to the stopper 73.
The gasket 72 is formed with an insertion hole into which the first member 74, which will be described later, is inserted.
The injection needle 76 is attached to the holder 75, which will be described later, and includes one needle tip portion 761 and the other needle tip portion 762 individually at both ends in a longitudinal direction.
The first member 74 is attached to the stopper 73, and a lower portion of the first member 74 is inserted into an insertion hole formed in the gasket 72.
The first member 74 may be made of a flexible material. For example, the first member 74 may be made of 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, fluor 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. Accordingly, when the needle tip portion 761 penetrates through the first member 74 and the gasket 72, the vacuum of a space surrounded by the stopper 73 and the gasket 72 can be maintained.
The first member 74 includes a guide hole 741 that guides one needle tip portion 761 of the injection needle 76 from the outside of the stopper 73 to the space surrounded by the stopper 73 and the gasket 72.
The holder 75 includes, at one end portion thereof, an opening portion 751 through which the vacuum blood collection tube 71 is inserted and withdrawn, and includes, at the other end portion thereof, a flange 752 to be used as, for example, an operation portion.
The holder 75 may further include a rubber sleeve 763 that covers the needle tip portion 761 over the entire length.
When blood is collected by 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 opening portion 751 described above. The user puts fingers on the flange 752 and pushes the vacuum blood collection tube 71 into the holder 75.
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 breaks through a bottom surface of the first member 74. Then, the needle tip portion 761 further penetrates through the gasket 72 and protrudes from the first recessed portion 723 of the gasket 72.
Accordingly, blood flows into the storage chamber of the vacuum blood collection tube 71 in a vacuum state through the injection needle 76.
Processing of preparing PRP by using the tubular body kit 310 will be described with reference to
State <1a>
As illustrated in a state <1a> in
State <2a>
As illustrated in a state <2a> of
State <3a>
As illustrated in a state <3a> in
State <4a>
As illustrated in a state <4a> of
State <5a>
As illustrated in a state <5a> of
The gasket 72 liquid-tightly seals the storage chamber of the vacuum blood collection tube 71 in which the whole blood 50 is stored. Accordingly, the user can perform centrifugal separation processing with the whole blood 50 stored in the vacuum blood collection tube 71.
State <6a>
As illustrated in a state <6a> of
Since the first surface 721 of the gasket 72 includes the first recessed portion 723 from which the injection needle 76 protrudes, in a similar manner 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 with each other. Thus, the user can extract a necessary fraction up to the vicinity of the interface.
In this way, as in the case where the first syringe 10 is used, the user can efficiently separate and extract the blood components or the like stored in the vacuum blood collection tube 71 without waste by using the vacuum blood collection tube 71. This also makes it possible to increase the amount and the concentration rate of PRP to be prepared.
A second embodiment of the present disclosure will be described below. For the sake of convenience of description, members having the same functions as those of the members described in the above-described embodiments are denoted by the corresponding reference signs, and descriptions thereof are not repeated. Also, in embodiments subsequent to the second embodiment, members having the same functions as those of the members described in the embodiment described above are denoted by the corresponding reference signs, and descriptions thereof are not repeated.
As illustrated in
The first syringe 10 according to the second embodiment has the same configuration as the configuration thereof described in the first embodiment. Thus, here, the description of the first syringe 10 is omitted, and the second syringe 20 and the third syringe 30 will be mainly described.
The second syringe 20 is used for extracting a part of liquid separated by the first syringe 10, for example. The injection needle 26 that extracts 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.
As will be described in detail later, the second syringe 20 is used as a centrifugation container for further subjecting a liquid extracted from the first syringe 10 to centrifugal separation processing.
Here, the liquid extracted from the first syringe 10 to the second syringe 20 may be a part of a liquid separated by the first syringe 10, and may be the third fraction 53, or may be the second fraction 52 and the third fraction 53, for example. In the present embodiment, the user extracts the third fraction 53 from the first syringe 10 into the second syringe 20.
The second syringe 20 is further used for preparing PRP in the second syringe tube 21 and administering the prepared PRP to a patient or the like. Here, the second syringe tube 21 is a tubular container including a closed end and an open end.
The second syringe 20 includes the second syringe tube 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.
The second syringe tube 21 is formed in, for example, a substantially tubular shape, and is formed with a storage chamber configured to store a liquid such as the third fraction 53 therein. The second syringe tube 21 is formed of a transparent or translucent member, and thus, the inside of the second syringe tube 21 can be visually recognized.
The second syringe tube 21 includes, at one end portion thereof, an opening portion 211 through which the second plunger 24 and the like are inserted and withdrawn. The second syringe tube 21 includes, at the other end portion thereof, a second port 22 having a substantially tubular shape. A diameter of the second port 22 is smaller than that of a body of the second syringe tube 21. An inner bottom surface of the second syringe tube 21 may have, for example, a shape protruding toward the storage chamber in a substantially circular arc shape, a flat surface shape, or a shape protruding toward a side opposite to the storage chamber. In the present embodiment, the inner bottom surface of the second syringe tube 21 is formed in a flat surface shape, and follows a shape of a first surface 231 that is a bottom surface of the second gasket 23, which will be described later. The first surface 231 is a surface facing the storage chamber in the second syringe tube 21.
The second port 22 may function as an attachment portion to which the injection needle 26 or the like is attached. An internal space of the second port 22 communicates with a storage space in the second syringe tube 21. Thus, the user can extract a liquid such as the third fraction 53 stored in the first syringe tube 11 through the injection needle 26 attached to the second port 22 and store the liquid in the storage chamber in the second syringe tube 21. As described above, the injection needle 26 has a length long enough to penetrate through the first gasket 13 and to extract the liquid positioned below the first surface 131 of the first gasket 13.
The second gasket 23 can be detachably attached to the second plunger 24 that is movable in the second syringe tube 21. The second gasket 23 liquid-tightly seals the inside of the second syringe tube 21 together with the second cap 25. The second gasket 23 may reciprocate in the second syringe tube 21 in the tube axial direction. At this time, an outer peripheral surface of the second gasket 23 may slide on an inner wall surface of the second syringe tube 21 with liquid-tightness in the second syringe tube 21 being maintained. Accordingly, even when the second gasket 23 reciprocates in the second syringe tube 21, the inside of the second syringe tube 21 can be liquid-tightly sealed.
The second gasket 23 is formed in, for example, a substantially columnar shape. The first surface 231 that is the bottom surface of the second gasket 23 is formed in a flat surface shape or a recessed surface shape, and includes a first recessed portion 233. The first recessed portion 233 may be positioned at a substantially central region of the first surface 231 of the second gasket 23. When the injection needle 36, which will be described later, is pierced through the first recessed portion 233, a needle tip portion 37 of the injection needle 36 protrudes from the first recessed portion 233.
The second plunger 24 may be attached with an upper portion of the second gasket 23 at one end portion 241, and may be provided with a flange 242 to be used as, for example, an operation portion at the other end portion.
After being attached with the second gasket 23, the second plunger 24 is inserted into the second syringe tube 21 from the opening portion 211. The user may operate the flange 242 of the second plunger 24 to cause the second plunger 24 to reciprocate in the tube axial direction in the second syringe tube 21. This allows the second gasket 23 attached to the second plunger 24 to reciprocate in the second syringe tube 21.
When a part of the liquid is extracted from the inside of the first syringe tube 11 by using 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 tube 21, and moves the second gasket 23. Accordingly, the user can store the part of the liquid in the first syringe tube 11 in the storage chamber in the second syringe tube 21. The liquid stored in the storage chamber in the second syringe tube 21 may be a part of the liquid separated by the first syringe 10, and may be the third fraction 53 or may be the second fraction 52 and the third fraction 53, for example. In the present embodiment, the user extracts the third fraction 53 from the first syringe 10 into the second syringe 20.
The second cap 25 is detachably attached to the second port 22. The user can liquid-tightly seal the storage chamber in the second syringe tube 21 by attaching the second cap 25 to the second port 22 and inserting the second gasket 23 into the second syringe tube 21. Accordingly, the user can accommodate, in the second syringe tube 21, a part of the liquid in the first syringe tube 11, and then, perform the centrifugal separation processing with the part of the liquid within the first syringe tube 11. In the present embodiment, after accommodating the third fraction 53 in the second syringe tube 21, the user performs the centrifugal separation processing with the third fraction 53 accommodated.
Specifically, after attaching the second cap 25 to the second port 22, the user uses the second syringe tube 21 as a centrifugation container to perform the centrifugal separation processing using a centrifugal force directed from the second gasket 23 side toward the second port 22 side. At this time, the user may detach the second plunger 24 from the second gasket 23 so as not to interfere with the centrifugal separation processing or does not need to detach the second plunger 24.
The centrifugal separation processing centrifugally separates the liquid in the second syringe tube 21 into respective layers of a fourth fraction 54 (see <5b> in
Although the details will be described later, at this time, the user extracts the fifth fraction 55 positioned at the uppermost layer into the third syringe 30 by the injection needle 36 of the third syringe 30, which will be described later. As such, the fifth fraction 55 unnecessary for PRP preparation from the third fraction 53 may be removed.
After the fifth fraction 55 is removed in such a manner, PRP with a high concentration of platelets (see <8b> in
Herein, as an index of the concentration of each type of blood cell component in the liquid, for example, the predetermined number of blood cell components per unit volume (pieces/μL) may be used. Each type of blood cell component in the liquid may be measured by, for example, 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 the concentration of each type of blood cell component is described to be high or low without specifying a subject to be compared with it means that the concentration of each type of blood cell component is high or low in comparison with whole blood. For example, the description “the concentration of platelets is high” means that the concentration of platelets is high in comparison with whole blood, and the description “the concentration of platelets is low” means that the concentration of platelets is low in comparison with whole blood. In the present disclosure, PRP refers to a liquid having a high concentration of platelets in comparison with whole blood.
In a similar manner to the first surface 131 of the first gasket 13, the first surface 231 of the second gasket 23 includes the first recessed portion 233 from which the injection needle 36 is protruded. This reduces the protrusion length of the needle tip portion 37 of the injection needle 36, and the positions of the first surface 231 and the needle tip portion 37 substantially coincide with each other. Accordingly, the user can extract the fifth fraction 55 up to the vicinity of an interface between the fourth fraction 54 and the fifth fraction 55 and can prepare PRP with a high concentration of platelets.
As described above, the second syringe 20 can be used for administering the PRP prepared in the second syringe tube 21 to a patient or the like.
In administering the PRP to the patient or the like, the user stirs the PRP as illustrated in <8b> in
The user attaches the second plunger 24 to the second gasket 23 and inserts the needle tip of the injection needle 28 into an affected area of the patient. Then, the user moves the second gasket 23 downward in the tube axial direction via the second plunger 24. Thus, the user can administer the prepared PRP to the affected area of the patient or the like.
The third syringe 30 is used for, for example, extracting the fifth fraction 55 separated by the second syringe 20 and storing the extracted fifth fraction 55 in the third syringe tube 31. Thus, the user can remove the fifth fraction 55 unnecessary for preparing PRP from the third fraction 53 stored in the second syringe tube 21. Here, the third syringe tube 31 is a tubular container including a closed end and an open end.
The third syringe 30 includes a third syringe tube 31 and a third gasket 33. The third syringe 30 may further include a third plunger 34 and the injection needle 36.
The third syringe tube 31 is formed in, for example, a substantially tubular shape, and is formed with a storage chamber configured to store the fifth fraction 55 therein. The third syringe tube 31 is formed of a transparent or translucent member, which allows the inside of the third syringe tube 31 to be visually recognized.
The third syringe tube 31 includes, at one end portion thereof, an opening portion 311 through which the third plunger 34 and the like are inserted and withdrawn. The third syringe tube 31 includes, at the other end portion thereof, a third port 32 having a substantially tubular shape. The third port 32 has a diameter smaller than that of a body of the third syringe tube 31.
A shape of an inner bottom surface of the third syringe tube 31 may be, for example, a shape protruding toward the storage chamber in a substantially circular arc shape, a flat surface shape, or a shape protruding toward a side opposite to the storage chamber. In the present embodiment, the inner bottom surface of the third syringe tube 31 may have a shape protruding in a substantially cone shape similar to that of a general syringe. In this case, when the third gasket 33 including the bottom surface 331 having a shape protruding in a substantially cone shape similar to that of a general gasket is used, the bottom surface 331 of the third gasket 33 can follow the inner bottom surface of the third syringe tube 31.
The third gasket 33 can be detachably attached to the third plunger 34 that is movable in the third syringe tube 31. Unlike the first gasket 13 and the second gasket 23, the third gasket 33 does not require insertion of the injection needle 36 to extract a substance stored in the third syringe tube 31. Thus, the third gasket 33 does not need to have a flat surface shape or a recessed surface shape, and may have a general gasket shape. Unlike the first gasket 13 and the second gasket 23, the first recessed portions 133 and 233 from which the injection needle 36 protrudes do not need to be provided.
The third port 32 may function as an attachment portion to which the injection needle 36 or the like is attached. A storage space in the third syringe tube 31 and an internal space of the third port 32 communicate with each other. Thus, the user can extract the fifth fraction 55 stored in the second syringe tube 21 through the injection needle 36 attached to the third port 32 and store the extracted fifth fraction 55 in the storage chamber in the third syringe tube 31.
The injection needle 36 is configured with a length sufficient to penetrate through the second gasket 23 to extract the fifth fraction 55 positioned below the first surface 231 of the second gasket 23.
The third plunger 34 may be attached with an upper portion of the third gasket 33 at one end portion 341 thereof, and may be provided with a flange 342 to be used as, for example, an operation portion, at the other end portion thereof.
After the third gasket 33 is attached, the third plunger 34 is inserted into the third syringe tube 31 from the opening portion 311. The user may operate the flange 342 of the third plunger 34 to cause the third plunger 34 to reciprocate in the third syringe tube 31 in the tube axial direction. Accordingly, the user can cause the third gasket 33 attached to the third plunger 34 to reciprocate in the third syringe tube 31.
When the user extracts the fifth fraction 55 from the second syringe tube 21 by using the injection needle 36, the user moves the third plunger 34 to pull out at least a part of the third plunger 34 from the inside of the third syringe tube 31 and moves the third gasket 33. Accordingly, the user can store the fifth fraction 55 in the storage space in the third syringe tube 31.
Processing of preparing PRP by using the syringe system 200 will be described with reference to
Since a state <1b> to a state <3b> in
State <4b>
As illustrated in a state <4b> in
State <5b>
The user subjects the second syringe 20 to centrifugal separation processing by using a centrifugal force directed from the second gasket 23 side toward the second port 22 side. The centrifugal separation processing conditions may be, for example, strong centrifugation conditions in which a centrifugal acceleration is 2000×g and a processing time is 5 minutes.
As illustrated in a state <5b> of
State <6b>
As illustrated in a state <6b> in
State <7b>
The user attaches the detached second plunger 24 again to the second gasket 23 inserted in the second syringe tube 21.
State <8b>
The user stirs the stored liquid remaining in the second syringe tube 21 to prepare PRP.
As described above, the second syringe 20 is used for administering the PRP in the second syringe tube 21 to a patient or the like. When administering the PRP to the patient or the like, the user first detaches the second cap 25 from the second port 22 and attaches the injection needle 28 or the like instead. The injection needle 28 is an injection needle having a typical length, unlike the injection needles 26 and 36 having a longer length than those of typical injection needles.
The user inserts a needle tip of the injection needle 28 into an affected area of the patient and moves the second gasket 23 downward in the tube axial direction via the second plunger 24. Thus, the user can administer the prepared PRP to the affected area of the patient or the like.
As described above, by using the syringe system 200, the user can efficiently perform PRP preparation processing including blood collection, two times of centrifugal separation processing, two times of extraction of necessary components, and PRP preparation.
Using the first gasket 13 and the second gasket 23 can improve an amount and a concentration rate of PRP to be prepared.
Various types of variations of the gaskets will be described. The structure of the gasket can be appropriately changed as will be described below.
A structure of a gasket 43a according to a second variation of the present disclosure will be described with reference to
As illustrated in
The first recessed portion 433 is a portion recessed from the first surface 431 of the gasket 43a, and is formed as, for example, a columnar hole portion whose peripheral wall surface is slightly inclined. The first recessed portion 433 may be a portion recessed from the first surface 431, and may be, for example, a hole portion having a cone shape, a rectangular parallelepiped shape, or the like, and the shape thereof is not particularly limited.
The gasket 43a further includes a second recessed portion 434 in a second surface 432 of the gasket 43a opposite to the first surface 431. In the present embodiment, the second recessed portion 434 is formed in a shape obtained by hollowing out the gasket 43a from the second surface 432 side in a columnar shape. The shape of the second recessed portion 434 is not particularly limited as long as the shape can reduce the thickness of the gasket 43a. The second recessed portion 434 may be a depression having, for example, a rectangular parallelepiped shape, a polygonal pillar shape, or a cone shape.
This makes the thickness of the gasket 43a at a portion into which the injection needles 26 and 36 are inserted thin, which reduces a resistance at the time of insertion. Thus, the user can more easily insert the needle tip portions 27 and 37 into the gasket 43a.
A width of an opening portion of the second recessed portion 434 may be larger than, equal to, or smaller than a width of an opening of the first recessed portion 433. In the present embodiment, the width of the opening portion of the second recessed portion 434 is formed to be larger than the width of the opening of the first recessed portion 433. However, the second recessed portion 434 may have the same width as that of the opening of the first recessed portion 433 or a width narrower than that of the opening of the first recessed portion. In this case, when the injection needles 26 and 36 are inserted into the gasket 43a, the needle tip portions 27 and 37 of the injection needles 26 and 36 can be effectively guided to the first recessed portion 433.
A structure of a gasket 43b according to a third variation of the present disclosure will be described with reference to
As illustrated in
For example, the third recessed portion 435 is formed in a shape obtained by hollowing out the gasket 43b from the first surface 431 side in a columnar shape so as to be wider than the opening portion of the first recessed portion 433. At this time, the first opening portion 433 may be positioned at a bottom surface of the third recessed portion 435. The third recessed portion 435 may be a depression having a rectangular parallelepiped shape, a polygonal pillar shape, a cone shape, or the like, and the shape thereof is not particularly limited.
This makes a thickness of the gasket 43b at a portion into which the injection needles 26 and 36 are inserted thinner. Thus, the user can more easily insert the needle tip portions 27 and 37 into the gasket 43b.
A structure of a gasket 43c according to a fourth variation of the present disclosure will be described with reference to
As illustrated in
A width of an opening portion of the second recessed portion 434 may be the same as a width of an opening of the first recessed portion 433 or may be narrower than the width of the opening of the first recessed portion. The second recessed portion 434 may be formed in a columnar shape whose peripheral wall is slightly inclined. The second recessed portion 434 may be a depression having, for example, a rectangular parallelepiped shape, a polygonal columnar shape, or a cone shape, and the shape thereof is not particularly limited thereto.
Thus, the gasket 43c is thickened to improve the strength of the gasket 43c, and the second recessed portion 434 is provided to easily insert the injection needles 26 and 36 into the gasket 43c.
By forming the second recessed portion 434 to be narrower than the opening portion of the first recessed portion 433, the needle tip portions 27 and 37 of the injection needles 26 and 36 can be effectively guided to the first recessed portion 433.
A third embodiment of the present disclosure will be described below. Although the example in which the recessed portion is formed in the gasket has been described above, a gasket according to the third embodiment is different from the above-described gasket in that the gasket according to the third embodiment is formed with a protruding portion.
The protruding portion 437 may have, for example, a columnar shape whose peripheral wall is slightly inclined, and may include a guide hole 437a at a substantially central portion. The guide hole 437a can guide the needle tip portions 27 and 37 of the injection needles 26 and 36. The protruding portion 437 may be positioned on the second surface 432 so as to surround a region of the second surface 432 facing the first recessed portion 433. In other words, an axis of the protruding portion 437 and an axis of the first recessed portion 433 are configured to be at substantially the same position, and the needle tip portions 27 and 37 of the injection needles 26 and 36 can be effectively guided. The shape of the protruding portion 437 is not particularly limited as long as the protruding portion 437 has the shape capable of guiding the needle tip portions 27 and 37 of the injection needles 26 and 36.
This makes it possible to effectively guide the needle tip portions 27 and 37 to the first recessed portion 433.
Various types of variations of the gasket according to the third embodiment will be described. The structure of the gasket can be appropriately changed as will be described below.
A structure of a gasket 43e according to a fifth variation of the present disclosure will be described with reference to
As illustrated in
The protruding portion 437 may have, for example, a columnar shape whose peripheral wall is slightly inclined, and may include a guide hole that guides each of the needle tip portions 27 and 37 of the injection needles 26 and 36 at a substantially central portion. The protruding portion 437 may be positioned on the second surface 432 so as to surround a region of the second surface 432 facing the first recessed portion 433. That is, an axis of the protruding portion 437 and an axis of the first recessed portion 433 may be formed to be at substantially the same position, and at this time, the needle tip portions 27 and 37 of the injection needles 26 and 36 can be effectively guided. The shape of the protruding portion 437 is not particularly limited as long as the protruding portion 437 has the shape capable of guiding the needle tip portions 27 and 37 of the injection needles 26 and 36.
This makes it possible to effectively guide the needle tip portions 27 and 37 to the first recessed portion 433.
A structure of a gasket 43f according to a sixth variation of the present disclosure will be described with reference to
As illustrated in
The second recessed portion 434 is formed in a columnar shape whose peripheral wall is slightly inclined so as to be narrower than an opening portion of the first recessed portion 433. The second recessed portion 434 may have a depression having a rectangular parallelepiped shape, a polygonal pillar shape, or a cone shape, or the like, and the shape thereof is not particularly limited.
Providing of the second recessed portion 434 can facilitate easier insertion of the injection needles 26 and 36 into the gasket 43f. Configuring the second recessed portion 434 to be narrower than the opening portion of the first recessed portion 433 makes it possible to more effectively guide the needle tip portions 27 and 37 to the first recessed portion 433.
The user may use guide members 80 and 90, which will be described later. The guide members 80 and 90 include through holes that guide the needle tip portions 27 and 37 of the injection needles 26 and 36, respectively. When the guide members 80 and 90 are used, axes of the guide members 80 and 90 and an axis of the first recessed portion 433 may be configured to be at substantially the same position. When the injection needles 26 and 36 are inserted into the guide members 80 and 90 with end portions of the guide members 80 and 90 being in contact with the second surface 432, the needle tip portions 27 and 37 are guided to the first recessed portion 433. In this way, the user can easily cause the needle tip portions 27 and 37 to protrude into the first recessed portion 433 by using the guide members 80 and 90.
A configuration of a syringe system 400 and a tubular body kit 410 according to a fourth embodiment of the present disclosure will be described using
As illustrated in
The guide members 80 and 90 respectively includes through holes 81 and 91 that guide the injection needles 26 and 36 penetrating through the gasket 43a. Providing the guide members 80 and 90 suppresses breaking or bending of the injection needles 26 and 36 that are longer than typical injection needles, and enables the injection needles 26 and 36 to be guided to the storage chamber when the injection needles 26 and 36 penetrate through the gasket 43a.
The syringe system 400 has the same configuration as the configuration described in the second embodiment except for the provision of the guide members 80 and 90 described above and the structure of the gasket 43a into which the guide members 80 and 90 are fitted. Thus, the guide members 80 and 90 and the gasket 43a will be mainly described here, and descriptions of the other configurations are omitted.
As illustrated in
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 tube axial direction. The through hole 81 includes one opening portion 81a and the other opening portion 81b individually at both ends in the tube axial direction.
The attachment portion 82 is formed in, for example, a substantially tubular shape having a smaller diameter than that of the body of the guide member 80, and a part of the through hole 81 including the other opening portion 81b is disposed inside the attachment portion 82. The guide member 80 is detachably attached to the gasket 43a by fitting the attachment portion 82 into the gasket 43a.
As described above, the gasket 43a is formed in a substantially columnar shape. The first surface 431 that is the bottom surface of the gasket 43a is formed in a flat surface shape or a recessed surface shape, and includes the first recessed portion 433 from which the needle tip portion 27 of the injection needle 26 protrudes. The first recessed portion 433 is formed as, for example, a columnar hole portion whose peripheral wall surface is slightly inclined, but may be a portion recessed from the first surface 431, and may be, for example, a hole portion having a cone shape, a rectangular parallelepiped shape, or the like, and the shape thereof is not particularly limited thereto.
The gasket 43a also includes the second recessed portion 434 in the second surface 432 of the gasket 43a opposite to the first surface 431. The second recessed portion 434 is formed in a shape obtained by hollowing out the gasket 43a from the second surface 432 side in a substantially columnar shape, and has a diameter slightly larger than that of the attachment portion 82 of the guide member 80.
Accordingly, 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 recessed portion 434 of the gasket 43a. At this time, the gasket 43a may be positioned inside the first syringe tube 11.
The guide member 80 is attached to the gasket 43a. In this case, an axis of the through hole 81 of the guide member 80 is at substantially the same position as those of axes of the second recessed portion 434 and the first recessed portion 433.
The user inserts the injection needle 26 (see
In this way, the guide member 80 can suppress breaking or bending of the injection needle 26 due to a resistance when the injection needle 26 penetrates through the gasket 43a by inserting the injection needle 26 longer than typical injection needles into the through hole 81. The guide member 90 can also suppress breaking or bending of the injection needle 36 due to a resistance when the injection needle 36 penetrates through the gasket 43a by inserting the injection needle 36 longer than typical injection needles into the through hole 91.
As illustrated in
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 centrifugal separation processing. The first syringe 10 may include the first syringe tube 11 and the gasket 43a.
The gasket 43a is detachably attached with the first plunger 14. The first port 12 of the first syringe tube 11 is attached with a blood collection needle when blood is collected, and is attached with the first cap 15 when the storage chamber is liquid-tightly sealed.
As described above, the second syringe 20 is used for extracting a part of liquid separated by the first syringe 10. The second syringe 20 may be used as a centrifugation container for subjecting the extracted liquid to centrifugal separation processing, and may be further used for administering the prepared PRP to a patient. The second syringe 20 includes the second syringe tube 21 and the gasket 43a.
The second plunger 24 is detachably attached to the gasket 43a of the second syringe 20. To the second port 22 of the second syringe tube 21, the second cap 25 is attached when the storage chamber is liquid-tightly sealed, and the injection needle 26 is attached when a part of liquid is extracted from the first syringe 10. When PRP is administered to a patient, the injection needle 28 is attached to the second port 22.
When extracting a part of liquid from the first syringe 10 by using the second syringe 20, the user detaches 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. Thus, when the injection needle 26 penetrates through the gasket 43a of the first syringe 10, breaking or bending of the injection needle 26 can be suppressed.
As described above, the third syringe 30 is used for extracting a part of liquid separated by the second syringe 20. The third syringe 30 includes the third syringe tube 31 and the third gasket 33.
The third plunger 34 is detachably attached to the third gasket 33, and the injection needle 36 is attached to the third port 32 of the third syringe tube 31 when a part of liquid is extracted from the second syringe 20.
When extracting a part of liquid from the second syringe 20 by using the third syringe 30, the user detaches 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.
Thereafter, the user inserts the injection needle 36 into the through hole 91 of the guide member 90. This allows the user to suppress breaking or bending of the injection needle 36 when the injection needle 36 penetrates through the gasket 43a of the second syringe 20.
Since each processing is similar to that of
Accordingly, when the user extracts a part of liquid from the first syringe 10 or the second syringe 20, breaking or bending of the injection needles 26 and 36 can be suppressed while the injection needles 26 and 36 are penetrating through the gasket 43a.
A structure of a joint portion between the attachment portion 82 of the guide member 80 and the second recessed portion 434 of the gasket 43a will be described in detail with reference to
As illustrated in
Thereby, the user can adjust a position of the needle tip portion 27 vertically in the tube axial direction, and can more accurately and stably extract blood components.
The attachment portion 82 of the guide member 80 may be joined to the gasket 43a having features like those of a gasket 43b, 43c, 43e, or 43f. That is, the gasket 43a may include the third recessed portion 435 in the first surface 431, like the gasket 43b. The second surface 432 may be a bottom surface of a recessed portion that opens to a bottom surface of the gasket 43c positioned on the opposite side to the first surface 431. The second surface 432 facing the first surface 431 may include the protruding portion 437 protruding from the second surface 432 in the tube axial direction.
A structure of a joint portion between the attachment portion 92 of the guide member 90 and the second recessed portion 434 of the gasket 43a may be configured in a similar manner to the structure of the joint portion between the attachment as in the attachment portion 82 of the guide member 80 and the second recessed portion 434. That is, the attachment portion 92 of the guide member 90 may be joined to the gasket 43a having features like those of the gasket 43b, 43c, 43e, or 43f.
The guide member 80 may be attached to the gasket 43e.
As illustrated in
As described above, the gasket 43e includes, on the second surface 432, the protruding portion 437 protruding from the second surface 432 in the tube axial direction. The protruding portion 437 has, for example, a columnar shape whose peripheral wall is slightly inclined, and includes a guide hole 487a that guides the needle tip portion 27 of the injection needle 26 at a substantially central portion thereof. The protruding portion 437 is positioned on the second surface 432 so as to surround a region facing the first recessed portion 433. An axis of the protruding portion 437 and an axis of the first recessed portion 433 are at substantially the same position.
The male screw 83b that is a screw groove may be formed on at least a part of an outer peripheral surface of the tubular portion 83 of the guide member 80, and a female screw 437b that is a screw groove may be formed on at least a part of an inner peripheral surface of the guide hole 437a of the protruding portion 437. When the male screw 83b and the female screw 437b are engaged each other, the guide member 80 can be engaged with the gasket 43e so as to be movable in the tube axial direction.
Thereby, the user can adjust a position of the needle tip portion 27 vertically in the tube axial direction, and can more accurately and stably extract blood components.
The tubular portion 83 of the guide member 80 may be fitted to the protruding portion 437 of each of the gaskets 43d and 43f. In this case, the male screw 83b that is a screw groove may be formed on at least a part of the outer peripheral surface of the tubular portion 83, and the female screw 437b that is a screw groove may be formed on at least a part of the inner peripheral surface of the guide hole 437a of the protruding portion 437. When the male screw 83b and the female screw 437b are engaged with each other, the guide member 80 can be joined to each of the gaskets 43d and 43f so as to be movable in the tube axial direction.
Also, for the guide member 90, by forming a tubular portion similar to the tubular portion 83 of the guide member 80 in the guide member 90, a joint portion having a configuration similar to the structure of the joint portion between the guide member 80 and the second recessed portion 434 can be provided.
As a result, the user can adjust the positions of the needle tip portions 27 and 37 vertically in the tube axial direction, and can more accurately and stably extract blood components.
In the present disclosure, the invention has been described above based on the various drawings and examples. However, the invention according to the present disclosure is not limited to each embodiment described above. That is, the embodiments of the invention according to the present disclosure can be modified in various ways within the scope illustrated 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, a person skilled in the art can easily make various variations or modifications based on the present disclosure. Note that these variations or modifications are included within the scope of the present disclosure.
Number | Date | Country | Kind |
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2021-072801 | Apr 2021 | JP | national |
Filing Document | Filing Date | Country | Kind |
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PCT/JP2022/012526 | 3/18/2022 | WO |