WO2022044340A1 - ピストン - Google Patents

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Publication number
WO2022044340A1
WO2022044340A1 PCT/JP2020/032958 JP2020032958W WO2022044340A1 WO 2022044340 A1 WO2022044340 A1 WO 2022044340A1 JP 2020032958 W JP2020032958 W JP 2020032958W WO 2022044340 A1 WO2022044340 A1 WO 2022044340A1
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WO
WIPO (PCT)
Prior art keywords
annular
piston
annular projection
syringe barrel
apex
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2020/032958
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English (en)
French (fr)
Japanese (ja)
Inventor
洋司 須藤
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Daikyo Seiko Ltd
Original Assignee
Daikyo Seiko Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Daikyo Seiko Ltd filed Critical Daikyo Seiko Ltd
Priority to CN202080103654.0A priority Critical patent/CN116157169A/zh
Priority to PCT/JP2020/032958 priority patent/WO2022044340A1/ja
Priority to EP20951589.9A priority patent/EP4205784A4/en
Priority to KR1020237009979A priority patent/KR20230058099A/ko
Priority to JP2021542470A priority patent/JP7193887B2/ja
Priority to US18/020,524 priority patent/US20230293820A1/en
Priority to AU2020465340A priority patent/AU2020465340A1/en
Priority to CA3192018A priority patent/CA3192018A1/en
Priority to TW110132009A priority patent/TW202224714A/zh
Priority to JP2022019646A priority patent/JP2022062227A/ja
Publication of WO2022044340A1 publication Critical patent/WO2022044340A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding

Definitions

  • the present invention relates to a piston suitable for use in, for example, a pharmaceutical / medical syringe.
  • a medical syringe consists of a syringe barrel provided with a drug solution discharge port at the tip and a syringe plunger that moves a piston inserted from an opening at the other end in the axial direction.
  • Pistons for medical syringes need to have contradictory characteristics (performance) such as sealability and kinesis with the inner surface of the syringe barrel, as well as having no interaction with the internal liquid (chemical liquid) filled in the syringe barrel. It is said that.
  • pistons for prefilled syringes (containers and syringes) pre-filled with chemicals, which have been increasing in recent years, are required to have these characteristics at a higher level than ordinary pistons for syringes, and there is no change in quality for a long period of time. It is required to be able to be used safely over a period of time, to ensure hermeticity (safety) even for highly permeable chemicals, and to have sufficient agitation so that the chemicals can be smoothly administered.
  • the piston according to the present invention is a substantially columnar piston made of an elastic body used by being inserted into a syringe barrel, and when inserted into the syringe barrel, the upper surface and the plunger rod in contact with the internal liquid are. It has a bottom surface in contact and a side surface in contact with the inner surface of the syringe barrel.
  • the side surface has a plurality of annular projections in its axial direction, and the maximum diameter portion of the annular projection has an outer diameter that contacts the inner surface thereof when inserted into the syringe barrel.
  • the maximum diameter portion of the annular projection is characterized in that it is located closer to the bottom surface side than 1 ⁇ 2 of the axial length of the annular projection.
  • the side surface has a first annular projection, an annular recess, and a second annular projection in order from the upper surface side in the axial direction thereof, and the first annular projection is provided.
  • the maximum diameter of the second annular process has an outer diameter that contacts its inner surface when inserted into the syringe barrel, and the maximum diameter of the second annular process is axial to the second annular process. It is characterized in that it is located closer to the bottom surface side than 1/2 of the length.
  • the side surface has a first annular projection, an annular recess, and a second annular projection in order from the upper surface side in the axial direction thereof, and the first annular projection is provided.
  • the maximum diameter of the annular process and the second annular process has an outer diameter that contacts its inner surface when inserted into the syringe barrel, and the radius of curvature of the second annular process is the curvature of the first annular process. It is characterized by being smaller than the radius.
  • the shape of the first annular protrusion mainly ensures the sealing property
  • the shape of the second annular projection ensures the sealing property
  • the sliding resistance value is suitably reduced. It is possible to provide a piston for a syringe suitable for being easily manufactured by a mold.
  • the inclination of the surface from the annular recess toward the maximum diameter portion of the second annular projection with respect to the annular recess is the slope of the surface facing the bottom surface side from the maximum diameter portion. It is characterized by being smaller than the inclination with respect to the annular depression.
  • the contact area where the second annular projection contacts the inner surface of the syringe barrel is such that the first annular projection has a contact area. It is characterized by being smaller than the contact area in contact with the inner surface of the syringe barrel.
  • FIG. 1 It is the schematic which shows the structure of the piston by one Embodiment of this invention, the right half is a front view, and the left half is a sectional view. It is an enlarged view which shows the shape of the right end part of the piston shown in FIG. (A) is a view showing the right half of the piston shown in FIG. 1, and (B) is an enlarged view of a portion B shown by a broken line in (A).
  • A) is a schematic view showing the configuration of the piston of the comparative example, the right half thereof is a front view and the left half is a cross-sectional view.
  • B) is an enlarged view showing the shape of the right end portion of the piston shown in (A).
  • FIG. 1 is a diagram showing the right end portion of the piston according to the embodiment shown in FIG. 1, and (B) is an enlarged view of the portion B shown by the broken line in (A).
  • A) is a view showing the right end portion of the piston of the comparative example shown in FIG. 4, and (B) is an enlarged view of the portion B shown by the broken line in (A).
  • A) is a schematic view showing a state in which the piston according to the embodiment shown in FIG. 1 is inserted into the syringe barrel
  • (B) is a schematic view showing a state in which the piston of the comparative example shown in FIG. 4 is inserted into the syringe barrel. It is a figure.
  • FIG. 1 is a diagram showing the right end portion of the piston according to the embodiment shown in FIG. 1
  • FIG. 4 is an enlarged view of the portion B shown by the broken line in (A).
  • FIG. 1A is a diagram showing test results in which a piston according to the embodiment shown in FIG. 1 is inserted into a syringe barrel and the sliding resistance value is measured after 1 day
  • FIG. 4B is a comparative example shown in FIG. It is a figure which shows the test result which measured the sliding resistance value one day after inserting the piston into a syringe barrel.
  • (A) is a diagram showing the test results of inserting the piston according to the embodiment shown in FIG. 1 into the syringe barrel and measuring the sliding resistance value one month later
  • (B) is a diagram showing the comparison shown in FIG. It is a figure which shows the test result which measured the sliding resistance value one month after inserting an example piston into a syringe barrel.
  • (A) is a schematic view showing a change in the shape of the second annular protrusion before and during sliding of the piston according to the embodiment shown in FIG. 1
  • (B) is a schematic diagram showing a change in the shape of the second annular protrusion according to the embodiment shown in FIG. It is a schematic diagram which shows the change of the shape of the 2nd annular protrusion before and during sliding of a piston.
  • (A) to (F) are schematic views showing the shape of the right end portion of the piston according to another embodiment of the present invention.
  • FIG. 1 shows a configuration of a piston according to an embodiment of the present invention.
  • the piston 1 is a molded body made of a substantially columnar elastic material.
  • the material used for the piston constituting the syringe is preferably made of an elastic material or a flexible material in order to ensure hermeticity.
  • butyl rubber As elastic materials, for example, in synthetic rubber, butyl rubber (IIR), chlorinated butyl rubber (CIIR), brominated butyl rubber (BIIR), partially crosslinked IIR, polybutadiene rubber (BR), polyisoprene rubber (IR), ethylene-propylene- Diene ternary copolymer rubber (EPDM), styrene-butadiene copolymer rubber (SBR), acrylic rubber (ACM), acrylonitrile butadiene rubber (NBR), etc. are the main raw materials, and fillers, cross-linking agents, etc. are mixed. Can be used.
  • butyl rubber (IIR), chlorinated butyl rubber (CIIR), brominated butyl rubber (BIIR) and the like are preferable in terms of gas barrier properties, elution characteristics and the like.
  • thermoplastic elastomer can be used as the elastic material.
  • SEBS styrene-ethylene-butadiene copolymer
  • SBS styrene-butadiene copolymer
  • SIS styrene-isoprene copolymer
  • SIBS styrene-isobutylene copolymer
  • thermoplastic resins such as PE-based resin, PP-based resin, PC-based resin, ABS-based resin, polyamide-based resin, and polyester-based resin. Is preferably used as a mixture.
  • the piston 1 has an outer shape having a rotationally symmetric shape centered on the central axis A indicated by the alternate long and short dash line.
  • FIG. 1 the right side of the central axis A is shown in a front view and the left side thereof is shown in a cross-sectional view.
  • the piston 1 having an axial length La is formed so as to have an outer shape in which the bottom surface of a cone having an axial length Lc is joined to one end surface of a cylinder having an axial length Lb.
  • the side surface of the cone is the upper surface 2 of the piston 1, and this shape preferably corresponds to the shape of the inner surface of the tip of the syringe barrel into which the piston 1 is inserted.
  • the upper surface 2 may be a side surface of a perfect cone, but may be a curved surface in which the vicinity of the apex 21 is rounded.
  • a first annular protrusion 31, a first annular recess 32, a second annular protrusion 33, a second annular recess 34, a third annular protrusion 35, and A third annular recess 36 is formed on the side surface 3 of the piston 1, in order from the upper surface 2 side.
  • the third annular recess 36 is formed so as to be continuous with the bottom surface 4, which is the other end surface of the cylinder.
  • a screw hole 5 is formed in the central portion of the bottom surface 4 so as to be screwed with a screw thread at the tip portion of a plunger rod (not shown).
  • FIG. 2 is an enlarged view of the portion B surrounded by the dotted line in FIG.
  • the outer diameters at the apex of the first annular projection 31, the second annular projection 33, and the third annular projection 35 that is, the first annular projection 31, the second annular projection 33, and the third annular projection 35, respectively.
  • the maximum outer diameter of the third annular projection 35 is set to be equal. This maximum outer diameter corresponds to the maximum outer diameter D1 of the cylinder in FIG.
  • the depths of the first annular recess 32 and the second annular recess 34, that is, the difference between the bottom surface and the maximum diameter of these annular recesses 32 and 34 are set to be equal.
  • the first annular projection 31, the second annular projection 33, and the third annular projection 35 are extended from the extended bottom surface 37 extending so as to connect the bottom surfaces of the two annular recesses 32 and 34. , Each protrudes by height H.
  • the outer diameter of the extended bottom surface 37 is D2.
  • the intersection of the upper surface 2 and the extended bottom surface 37 is the starting point 31B of the first annular projection 31, and reaches the extended bottom surface 37 at a position axially downward by the length L1 from the starting point 31B, and reaches the extended bottom surface 37 of the first annular projection 31. It becomes the end point 31E.
  • the axial cross-sectional shape of the first annular protrusion 31 is an arc shape having a center inside the piston 1 except for the vicinity of the start point 31B and the vicinity of the end point 31E, and is a part of one circle or a plurality of different radii. It is a continuous connection of circular parts.
  • the vicinity of the end point 31E has an arc shape with a center outside the piston 1.
  • It has an arc shape with a center inside the piston 1, and is formed by continuously connecting a part of one circle or a plurality of circles having different radii.
  • the vicinity of the start point 33B and the vicinity of the end point 33E are arcuate with a center outside the piston 1.
  • the axial cross-sectional shape of the third annular protrusion 35 is almost straight except for the vicinity of the start point 35B and the vicinity of the apex 35T, and the portion after exceeding the apex 35T is inside the piston 1 except for the vicinity of the end point 35E. It has an arc shape with a center, and is a part of one circle or a continuous connection of parts of a plurality of circles having different radii. The vicinity of the start point 35B and the vicinity of the end point 35E are arcuate with a center outside the piston 1.
  • the shape of the side surface 3 of the piston 1 will be described with respect to its axial cross section.
  • the radius of curvature in the vicinity of the apex 31T of the first annular projection 31 is R
  • the radius of curvature in the vicinity of the apex 33T of the second annular projection 33 is 0.6R
  • the radius of curvature in the vicinity of the apex 33T of the second annular projection 33 is 0.6R. It is smaller than the radius of curvature R near 31T.
  • the radius of curvature in the vicinity of the apex 35T of the third annular projection 35 is 0.8R, which is smaller than the radius of curvature R in the vicinity of the apex 31T of the first annular projection 31.
  • the radius of curvature in the vicinity of each of the end point 31E, the start point 33B, the end point 33E, and the start point 35B is 0.6R
  • the first annular projection 31, the first annular recess 32, the second annular projection 33, and the second annular projection 31 have a radius of curvature of 0.6R.
  • the annular recess 34 and the third annular protrusion 35 are smoothly and continuously formed.
  • the radius of curvature in the vicinity of the apex 21 of the upper surface 2 shown in FIG. 1 is 8R.
  • the axial length from the start point 31B to the end point 31E of the first annular protrusion 31 is L1
  • the axial length of the first annular recess 32 is L2
  • the end point 33B from the start point 33B of the second annular protrusion 33 is L3
  • the axial length of the second annular recess 34 is L4
  • the axial length from the start point 35B to the end point 35E of the third annular protrusion 35 is L5
  • the third annular recess 35 is L6.
  • the axial length L31 from the start point 33B to the apex 33T of the second annular projection 33 is longer than the axial length L32 from the apex 33T to the end point 33E. Further, the axial length L51 from the start point 35B to the apex 35T of the third annular projection 35 is longer than the axial length L52 from the apex 35T to the end point 35E.
  • the apex (maximum diameter portion) 33T of the second annular projection 33 is located closer to the bottom surface 4 side than 1/2 of the axial length of the second annular projection 33. Further, the apex (maximum diameter portion) 35T of the third annular projection 35 is located closer to the bottom surface 4 side than 1/2 of the axial length of the third annular projection 35.
  • FIG. 3B is an enlarged view of a portion B surrounded by a broken line in FIG. 3A showing a part of the piston 1.
  • the angle of the line connecting the apex 31T and the end point 31E of the first annular projection 31 (indicated by a broken line in the figure) with respect to the extended bottom surface 37 is set to ⁇ 1.
  • An extended bottom surface 37 of a line connecting the start point 33B and the apex 33T of the second annular projection 33 (indicated by a broken line in the figure, the cross section of the second annular projection 33 almost overlaps with a substantially linear curved surface).
  • ⁇ 2 be the angle with respect to.
  • ⁇ 3 be the angle of the line connecting the apex 33T and the end point 33E of the second annular projection 33 (indicated by a broken line in the figure) with respect to the extended bottom surface 37.
  • the angle ⁇ 2 is set smaller than the angle ⁇ 1, and the surface between the start point 33B and the apex 33T of the second annular projection 33 is the apex 31T and the end point 31E of the first annular projection 31.
  • the inclination is smaller with respect to the extended bottom surface 37 than the surface between the two.
  • the angle ⁇ 2 is set to be smaller than the angle ⁇ 3, and the surface between the start point 33B and the apex 33T of the second annular projection 33 is an extension bottom surface 37 than the surface between the apex 33T and the end point 33E.
  • the slope is smaller than that.
  • FIG. 4 shows the configuration of the piston 1P according to the comparative example.
  • the piston 1P has an outer shape having a rotationally symmetric shape centered on the central axis A indicated by the alternate long and short dash line.
  • the right side of the central axis A is a front view and the left side thereof is a front view. It is shown in a cross-sectional view.
  • the piston 1P is formed so as to have an outer shape in which the bottom surface of a cone is joined to one end face of a cylinder.
  • the shapes of the side surfaces 3 and 3P are different between the piston 1 in FIG. 1 and the piston 1P in FIG. 4 (A), the axial length La of the entire piston and the axial length Lb of the columnar portion are different. , The axial length Lc of the conical portion, and the maximum outer diameter D1, and the outer diameter D2 of the extended bottom surface 37 of the annular recess are equal to each other.
  • FIG. 4B is an enlarged view of the side surface 3P of the piston 1P.
  • the side surface 3P has a first annular projection 31P, a first annular recess 32P, a second annular projection 33P, a second annular recess 34P, a third annular projection 35P, and the like, in order from the upper surface 2P to the bottom surface 4P.
  • a third annular recess 36P is formed.
  • the maximum outer diameter of the protrusion 35P is set to be equal.
  • the depths of the first annular recess 32P and the second annular recess 34P, that is, the difference between the bottom surface of these annular recesses 32P and 34P and the maximum outer diameter are set to be equal.
  • the first annular projection 31P, the second annular projection 33P, and the third annular projection 35P are extended from the extended bottom surface 37 extending so as to connect the bottom surfaces of the two annular recesses 32P and 34P. , Each protrudes by height H.
  • the intersection of the upper surface 2P and the extended bottom surface 37 is the starting point 31PB of the first annular projection 31P, reaches the extended bottom surface 37 at a position axially downward by the length LP1 from the starting point 31PB, and reaches the extended bottom surface 37 of the first annular projection 31P. It becomes the end point 31PE.
  • the apex 31PT of the first annular projection 31P has a flat portion, that is, the radius of curvature of the apex 31PT and its vicinity is infinite or very large.
  • the radius of curvature of the curved surface continuous from the start point 31PB to the flat portion is 0.5R
  • the radius of curvature of the curved surface from the flat portion toward the first annular recess 32P is R
  • the radius of curvature near the end point 31PE is 0.5R
  • the second annular projection 33P has a vertex 33PT as a vertex and has a curved surface having an arcuate cross section that is symmetrical above and below the apex. It reaches the extended bottom surface 37 at a position downward in the axial direction by the length LP3 from the start point 33PB, and becomes the end point 33PE of the second annular projection 33P.
  • the radius of curvature near the start point 33PB is 0.5R
  • the radius of curvature near the apex 33PT is R
  • the radius of curvature near the end point 33PE is 0.5R.
  • FIG. 5 (A) shows the right end portion of the piston 1 according to the embodiment of the present invention
  • FIG. 5 (B) shows the portion B of the second annular protrusion 33 shown by the broken line in FIG. 5 (A).
  • the axial length of the second annular projection 33 of the piston 1 according to the embodiment of the present invention is L3
  • the axial length L31 from the start point 33B to the apex 33T is from the apex 33T. It is set longer than the axial length L32 up to the end point 33E. That is, the maximum diameter portion 33T of the second annular projection 33 is located closer to the bottom surface 4 side than 1/2 of the axial length of the second annular projection 33.
  • the angle of the line connecting the start point 33B and the apex 33T of the second annular protrusion 33 (indicated by the broken line in the figure) with respect to the extended bottom surface 37 is ⁇ 2, and the line connecting the apex 33T and the end point 33E (dashed line in the figure).
  • the angle with respect to the extended bottom surface 37 is ⁇ 3.
  • the angle ⁇ 2 is set smaller than the angle ⁇ 3, and the curved surface from the start point 33B to the apex 33T is a slope having a smaller angle than the curved surface from the apex 33T to the end point 33E.
  • the radius of curvature in the vicinity of the start point 33B, the vicinity of the apex 33T, and the vicinity of the end point 33E are all 0.6R.
  • FIG. 6 (A) shows the right end portion of the piston 1P of the comparative example shown in FIG. 4, and FIG. 6 (B) shows the second annular protrusion 33P shown by the broken line in FIG. 6 (A). It is an enlarged view of a part B.
  • the axial length of the second annular projection 33P of the piston 1P of the comparative example is LP3
  • the axial length LP31 from the start point 33PB to the apex 33PT is from the apex 33PT to the end point 33PE. Equal to the axial length LP32.
  • the angle of the line connecting the apex 31PT on the bottommost side forming the maximum outer diameter portion of the first annular protrusion 31P and the end point 31PE with respect to the extended bottom surface 37 is ⁇ P1.
  • the angle of the line connecting the start point 33PB and the apex 33PT (indicated by the broken line in the figure) with respect to the extended bottom surface 37 is ⁇ P2
  • the line connecting the apex 33PT and the end point 33PE (dashed line in the figure).
  • the angle with respect to the extended bottom surface 37 (shown by) is ⁇ P3.
  • the angle ⁇ P2 is set to be smaller than the angle ⁇ P1, and the angle ⁇ P2 is set to be equal to the angle ⁇ P3. That is, the curved surface from the start point 33PB to the apex 33PT has the same shape as the curved surface from the end point 33PE to the apex 33PT.
  • the radius of curvature near the start point 33PB and the vicinity of the end point 33PE is 0.5R, and the radius of curvature near the apex 33PT is R.
  • the radius of curvature of the apex 33T of the second annular projection 33 according to the present embodiment is 0.6R, which is set smaller than the radius of curvature R of the apex 33PT of the second annular projection 33P of the comparative example.
  • the angle ⁇ 2 formed by the line connecting the start point 33B and the apex 33T and the extension bottom surface 37 is set smaller than the angle ⁇ P2 formed by the line connecting the start point 33PB and the apex 33PT and the extension bottom surface 37.
  • the distances to the starting points 33B and 33E intersecting the extended bottom surface 37 at the top and bottom of the apex 33T are different, and the shape is asymmetric.
  • the distances to the starting points 33PB and 33PE intersecting the extended bottom surface 37 above and below the apex 33PT are equal, and the shapes are symmetrical.
  • the curved surface from the vicinity of the start point 33B of the second annular protrusion 33 to the apex 33T has a gentle slope, whereas in the comparative example, there is a gentle slope.
  • the curved surface from the vicinity of the starting point 33PB of the annular projection 33P of 2 to the apex 33PT is a slope that rises with a relatively large gradient.
  • FIG. 7 (A) shows the piston 1 and the plunger rod 7 by screwing the threaded tip portion of the plunger rod 7 into the screw hole 5 of the piston 1 according to the embodiment of the present invention described with reference to FIGS. 1 to 3.
  • the state in which the syringe barrel 8 is pushed into the cylindrical portion 81 of the syringe barrel 8 made of glass or plastic through the opening of the flange portion 82 is shown.
  • the inner diameter of the cylindrical portion 81 is set to be slightly smaller than the maximum outer diameter of the piston 1, and the first annular protrusion 31, the second annular protrusion 33, and the third annular protrusion 35 are pressed against the inner surface 83. Then, the vertices 31T, 33T, and 35T are slightly crushed.
  • FIG. 7B shows the glass after connecting the piston 1P and the plunger rod 7 by screwing the threaded tip portion of the plunger rod 7 into the screw hole 5P of the piston 1P of the comparative example shown in FIG.
  • a state of being pushed into the cylindrical portion 81 of the syringe barrel 8 made of plastic through the opening of the flange portion 82 is shown.
  • the inner diameter of the cylindrical portion 81 is set to be slightly smaller than the maximum outer diameter of the piston 1P, and the first annular projection 31P, the second annular projection 33P, and the third annular projection 35P are pressed against the inner surface 83. As a result, the vertices 31PT, 33PT, and 35PT are slightly crushed.
  • the maximum outer diameters of the piston 1 and the piston 1P are set to be equal. That is, the maximum outer diameters of the first annular projection 31, the second annular projection 33, and the third annular projection 35, respectively, and the first annular projection 31P, the second annular projection 33P, and the third annular projection 31P.
  • the maximum outer diameter of each of the protrusions 35P is set to be equal.
  • the inner diameters of the cylindrical portions 81 are set to be the same.
  • Table 1 shows the results of measuring the width of the portion of the syringe barrel 8 in contact with the inner surface 83 of the piston 1 and the piston 1P of the comparative example according to the present embodiment.
  • the width W1 of the portion where the first annular projection 31 contacts the inner surface 83, the width W2 of the portion where the second annular projection 33 contacts the inner surface 83, and the third annular projection 35 contact the inner surface 83.
  • the width W3 of the portion to be used was measured on the left side and the right side of the cylindrical portion 81 of the syringe barrel 8 in FIG. 7 (A).
  • the width WP1 of the portion where the first annular projection 31P contacts the inner surface 83, the width WP2 of the portion where the second annular projection 33P contacts the inner surface 83, and the third annular projection 35P are the inner surface 83.
  • the width WP3 of the portion in contact with the syringe barrel 8 was measured on the left side and the right side of the cylindrical portion 81 of the syringe barrel 8 in FIG. 7 (B).
  • the contact area (proportional to the width W2) in which the second annular projection 33 contacts the inner surface 83 of the syringe barrel 8 is such that the first annular projection 31 is the syringe barrel 8. It is smaller than the contact area (proportional to the width W1) in contact with the inner surface 83 of the. Further, the contact area where the third annular protrusion 35 is in contact with the inner surface 83 of the syringe barrel 8 (proportional to the width W3) is the contact area where the first annular protrusion 31 is in contact with the inner surface 83 of the syringe barrel 8 (proportional to the width W1). Smaller than.
  • the contact area (proportional to the width W1) in which the first annular protrusion 31 of the piston 1 according to the present embodiment is in contact with the inner surface 83 of the syringe barrel 8 is such that the first annular protrusion 31P of the comparative example is the inner surface 83 of the syringe barrel 8. It is smaller than the contact area in contact with (proportional to the width WP1).
  • the contact area (proportional to the width W2) of the second annular projection 33 in contact with the inner surface 83 of the syringe barrel 8 according to the present embodiment is the contact area in which the second annular projection 33P of the comparative example is in contact with the inner surface 83 of the syringe barrel 8.
  • the contact area (proportional to the width W3) in which the third annular protrusion 35 according to the present embodiment is in contact with the inner surface 83 of the syringe barrel 8 is the contact in which the third annular protrusion 35P in the comparative example is in contact with the inner surface 83 of the syringe barrel 8. It is smaller than the area (proportional to the width WP3).
  • the general material properties required for medical pistons are low elution, low water content, and excellent barrier properties.
  • the hardness of the elastic body used for the piston 1 is preferably 40 to 70, which is the Shore A hardness of JISK6253-3 (2012). Further, it is desirable that the compression set of JIS K6262 (2013) is 40% or less, and more preferably 3% or more and 40% or less.
  • unlaminated rubber pistons 1 and 1P were assembled as a 100 mL syringe by applying silicone oil to the inner surface 83 of the syringe barrel 8.
  • Tables 2 and 3 show the results of a test in which water was used as the internal liquid and the piston was pushed in after one day using the precision universal testing machine "Autograph" manufactured by Shimadzu Corporation. Further, the measurement results in which the horizontal axis is the stroke (mm) and the vertical axis is the sliding resistance value (N) are shown in FIG. 8 (A) for the piston 1 according to the present embodiment and FIG. 8 (B) for the piston 1P of the comparative example. ).
  • the vicinity of the stroke of 0 mm corresponds to the initial movement of the pistons 1 and 1P and shows the maximum sliding resistance value, but the sliding resistance value sharply decreases and the piston.
  • 1, 1P starts to move, it shows the minimum sliding resistance value, and the pistons 1, 1P move toward the tip of the syringe barrel and are pushed to a predetermined position.
  • the piston 1 according to the present embodiment has either the average value or the maximum value of the sliding resistance value of the piston 1 according to the comparative example as compared with the piston 1P of the comparative example. Is also being reduced.
  • the test results shown in FIGS. 9A and 9B are the same as the test results of FIGS. 8A and 8B, and the vicinity of the stroke of 0 mm corresponds to the initial movement of the pistons 1 and 1P, which is the maximum.
  • the sliding resistance value is shown, but when the sliding resistance value suddenly decreases and the pistons 1 and 1P start to move, the minimum sliding resistance value is shown, and the pistons 1 and 1P move toward the tip of the syringe barrel. It is pushed to the specified position.
  • the sliding resistance value after one month has passed is larger than the sliding resistance value after one day has passed.
  • the piston 1 according to the present embodiment has a sliding resistance value higher than that of the piston 1P of the comparative example even after one month has passed. Both the average value and the maximum value are reduced. Further, after one month has passed, the piston 1 according to the present embodiment is designed to reduce the minimum sliding resistance value. Therefore, even when used for a prefilled syringe, according to the present embodiment, the sliding resistance value of the piston inserted in the syringe barrel can be suitably reduced.
  • FIG. 10A and 10 (B) are schematic views for explaining the shape of the second annular protrusion, which is considered to be one of the reasons why the sliding resistance value is reduced by this embodiment.
  • FIG. 10A when the second annular projection 33 according to the present embodiment is inserted into the syringe barrel and slid in the direction shown by the arrow, the apex 33T is displaced rearward by d in the sliding direction. ..
  • FIG. 10B when the second annular projection 33P of the comparative example is inserted into the syringe barrel and slid in the direction shown by the arrow, the apex 33PT is displaced backward by dp in the sliding direction. do.
  • the displacement d is smaller than the displacement dp, that is, the force that the piston 1 according to the present embodiment tries to return to the original position, that is, the force that the second annular projection 33 tries to return to the original shape.
  • the fact that the force of the piston 1P of the comparative example to return to the original position, that is, the force of the second annular projection 33P to return to the original shape is smaller than the force to return to the original shape contributes to the reduction of the sliding resistance value. it seems to do.
  • the sliding resistance value is reduced, but the sealing property cannot be guaranteed.
  • the sliding resistance value can be reduced and the sealing performance can be ensured without reducing the height H of the second annular projection 33 according to the present embodiment.
  • the first annular projection 31 has an arcuate curved surface in the axial direction, the radius of curvature of the apex 31T is R, and the radius of curvature of the apex 33T of the second annular projection 33. It is 0.6R, which is larger than the radius of curvature of 0.8R of the apex 35T of the third annular protrusion 35.
  • the shape of the first annular projection 31 mainly plays a role in ensuring the sealing property, and the shapes of the second annular projection 33 and the third annular projection 35 slide while ensuring the sealing property. It is thought that it is responsible for reducing the resistance value.
  • the maximum diameter portion 33T of the second annular projection 33 is located closer to the bottom surface 4 side than 1/2 of the axial length of the second annular projection 33.
  • the number of annular protrusions is not limited to three, and may be two or four or more, but is preferably two to three.
  • the maximum diameter of any annular projection may be located closer to the bottom surface side than 1/2 of the axial length of the annular projection, but the piston is preferable. It is desirable to provide at least one after the second counting from the tip side.
  • the piston is made of unlaminated rubber, but the surface that comes into contact with the chemical solution or the piston sliding surface is made of fluororesin, ultra-high molecular weight polyethylene, polyethylene, polypropylene, polyester, nylon, or the like. Those laminated with a plastic film (plastic laminated piston) can also be used. From the viewpoint of stability of the wetted portion of the piston, water repellency, and the like, the periphery of the piston may be coated with a fluororesin film.
  • the piston according to the present invention is (1) a piston not coated with a fluororesin film, (2) a piston whose periphery (upper surface and side surface) is coated with a fluororesin film, or (3) a peripheral (at least upper surface). It may be a piston in which only the wetted surface on the side) is covered with a fluororesin film.
  • PTFE polytetrafluoroethylene
  • ETFE ethylene-tetrafluoroethylene copolymer
  • PFE perfluoroalkoxy alkane
  • PFA perfluoroethylene propene copolymer
  • PVDF polyvinylidene fluoride
  • the piston used for the 100 mL syringe has been described, but the piston is not limited to this size, and the piston for a syringe having a larger capacity or a smaller capacity is used.
  • the present invention can also be applied to pistons for syringes.
  • the sealing performance is ensured by the first annular protrusion 31a having an arcuate cross section, the first annular recess 32a having a flat portion, and the second annular projection 33a.
  • the angle ⁇ 2 of the second annular projection is set smaller than the angle ⁇ 1 of the first annular projection, as in the embodiment shown in FIG. 3 (B).
  • the angle ⁇ 1 and the angle ⁇ 2 are not shown, they are angles of the same portions as those shown in FIG. 3 (B).
  • the first annular projection 31b which has a longer axial length than the first annular projection 31a of (A), has a flat portion.
  • the first annular recess 32b which is shorter than the first annular recess 32a of (A)
  • the second annular protrusion 33b it is possible to reduce the sliding resistance value while ensuring the sealing property. be.
  • the slope is slightly inclined from the apex of the first annular protrusion 31b toward the first annular recess 32b.
  • the angle ⁇ 2 of the second annular projection can be set to be the same as the angle ⁇ 1 of the first annular projection, or larger or smaller than the angle ⁇ 1 of the annular projection.
  • the first annular projection 31c having an arcuate cross section and a longer axial length than the first annular projection 31a of (A), the flat portion is (A).
  • the first annular recess 32c which is shorter than the first annular recess 32b, and the second annular protrusion 33c, it is possible to reduce the sliding resistance value while ensuring the sealing property.
  • the angle ⁇ 2 of the second annular projection can be set to be the same as the angle ⁇ 1 of the first annular projection, or larger or smaller than the angle ⁇ 1 of the annular projection.
  • the sealing performance is ensured by using the first annular protrusion 31d having an arcuate cross section, the first annular recess 32d having no flat portion, and the second annular projection 33d.
  • the angle ⁇ 2 of the second annular projection is set smaller than the angle ⁇ 1 of the first annular projection.
  • the first annular projection 31e has a flat portion having a longer axial length than the first annular projection 31a of (A), and the flat portion is the first of (A).
  • the first annular recess 32e and the second annular protrusion 33b which are shorter than the annular recess 32a of the above, it is possible to reduce the sliding resistance value while ensuring the sealing property.
  • the slope is slightly inclined from the flat portion of the first annular protrusion 31e toward the first annular recess 32e.
  • the angle ⁇ 2 of the second annular projection can be set to be the same as the angle ⁇ 1 of the first annular projection, or larger or smaller than the angle ⁇ 1 of the annular projection.
  • the first annular projection 31f having a flat portion having a longer axial length than the first annular projection 31a of (A) and the first annular recess having no flat portion.
  • the angle ⁇ 2 of the second annular projection is set smaller than the angle ⁇ 1 of the first annular projection.
  • the outer diameter of the apex portion of the second annular protrusions 33a, 33b, 33c, 33d, 33e, 33f is set to be equal.
  • the outer diameter of the bottom of the first annular recess 32a, 32b, 32c, 32e is set to be equal to the outer diameter of the bottom of the second annular recess 34a, 34b, 34c34e, but the first annular recess 32d,
  • the outer diameter of the bottom of the 32f can be set to a size different from the outer diameter of the bottom of the second annular recesses 34d and 34f.
  • the sliding resistance can be reduced and the liquid leakage can be further prevented. It is thought that the sliding pressure in the direction opposite to the sliding direction will increase, and the piston will not retract during sterility, storage, or transportation, and the sealing performance can be ensured. Further, the piston according to the present embodiment is suitable for a prefilled syringe assembled by pre-filling a syringe barrel with a chemical solution. When used for a prefilled syringe, the sliding pressure increases in the direction opposite to the sliding direction, and the piston does not retract during sterility, storage, or transportation, ensuring reliable sealing.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Pistons, Piston Rings, And Cylinders (AREA)
PCT/JP2020/032958 2020-08-31 2020-08-31 ピストン Ceased WO2022044340A1 (ja)

Priority Applications (10)

Application Number Priority Date Filing Date Title
CN202080103654.0A CN116157169A (zh) 2020-08-31 2020-08-31 活塞
PCT/JP2020/032958 WO2022044340A1 (ja) 2020-08-31 2020-08-31 ピストン
EP20951589.9A EP4205784A4 (en) 2020-08-31 2020-08-31 PISTONS
KR1020237009979A KR20230058099A (ko) 2020-08-31 2020-08-31 피스톤
JP2021542470A JP7193887B2 (ja) 2020-08-31 2020-08-31 ピストン
US18/020,524 US20230293820A1 (en) 2020-08-31 2020-08-31 Piston
AU2020465340A AU2020465340A1 (en) 2020-08-31 2020-08-31 Piston
CA3192018A CA3192018A1 (en) 2020-08-31 2020-08-31 A piston
TW110132009A TW202224714A (zh) 2020-08-31 2021-08-30 柱塞
JP2022019646A JP2022062227A (ja) 2020-08-31 2022-02-10 ピストン

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EP (1) EP4205784A4 (https=)
JP (2) JP7193887B2 (https=)
KR (1) KR20230058099A (https=)
CN (1) CN116157169A (https=)
AU (1) AU2020465340A1 (https=)
CA (1) CA3192018A1 (https=)
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Publication number Priority date Publication date Assignee Title
KR102794309B1 (ko) * 2023-05-10 2025-04-15 제이더블유생명과학 주식회사 주사기
EP4609898A1 (en) * 2024-02-28 2025-09-03 Becton, Dickinson and Company Method of manufacturing a laminated stopper, polymer blends for same and stoppers made therefrom

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2895773A (en) * 1956-10-22 1959-07-21 Robert K Mcconnaughey Variable diameter tensed ring piston
JPS5722766A (en) 1979-10-09 1982-02-05 Terumo Corp Syringe
US6511459B1 (en) * 2000-09-29 2003-01-28 Mallinckrodt Inc. Syringe plunger having an improved sealing ability
JP2006181027A (ja) 2004-12-27 2006-07-13 Daikyo Seiko Ltd 注射器用ピストン
JP2012205931A (ja) * 2012-07-26 2012-10-25 Terumo Corp シリンジ

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006519070A (ja) * 2003-02-27 2006-08-24 バクスター・インターナショナル・インコーポレイテッド 注射器のためのピストンアセンブリ
WO2008151239A2 (en) * 2007-06-04 2008-12-11 Becton, Dickinson And Company Positive displacement stopper for a pre-filled syringe
WO2014196056A1 (ja) * 2013-06-06 2014-12-11 テルモ株式会社 注射器およびプレフィルドシリンジ
WO2015150646A1 (fr) * 2014-04-02 2015-10-08 Aptar Stelmi Sas Ensemble de seringue anti-reflux
JP6478325B2 (ja) * 2015-05-08 2019-03-06 住友ゴム工業株式会社 プレフィルドシリンジ用ガスケットおよびプレフィルドシリンジ

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2895773A (en) * 1956-10-22 1959-07-21 Robert K Mcconnaughey Variable diameter tensed ring piston
JPS5722766A (en) 1979-10-09 1982-02-05 Terumo Corp Syringe
US6511459B1 (en) * 2000-09-29 2003-01-28 Mallinckrodt Inc. Syringe plunger having an improved sealing ability
JP2006181027A (ja) 2004-12-27 2006-07-13 Daikyo Seiko Ltd 注射器用ピストン
JP2012205931A (ja) * 2012-07-26 2012-10-25 Terumo Corp シリンジ

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4205784A4

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JP7193887B2 (ja) 2022-12-21
EP4205784A1 (en) 2023-07-05
TW202224714A (zh) 2022-07-01
EP4205784A4 (en) 2023-10-04
CA3192018A1 (en) 2022-03-03
JPWO2022044340A1 (https=) 2022-03-03
AU2020465340A1 (en) 2023-05-04
US20230293820A1 (en) 2023-09-21
JP2022062227A (ja) 2022-04-19
KR20230058099A (ko) 2023-05-02
CN116157169A (zh) 2023-05-23
AU2020465340A9 (en) 2024-06-06

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