WO2012134430A1 - Tige de piston de seringue pharmaceutique - Google Patents

Tige de piston de seringue pharmaceutique Download PDF

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Publication number
WO2012134430A1
WO2012134430A1 PCT/US2011/029973 US2011029973W WO2012134430A1 WO 2012134430 A1 WO2012134430 A1 WO 2012134430A1 US 2011029973 W US2011029973 W US 2011029973W WO 2012134430 A1 WO2012134430 A1 WO 2012134430A1
Authority
WO
WIPO (PCT)
Prior art keywords
piston
profile
thread
barrel
piston rod
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/US2011/029973
Other languages
English (en)
Inventor
Heike GRUN
Jurgen Brinkhues
Klaus Krautgartner
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.)
West Pharmaceutical Services Deutschland GmbH and Co KG
Kyowa Kirin Services Ltd
West Pharmaceutical Services Inc
Original Assignee
West Pharmaceutical Services Deutschland GmbH and Co KG
West Pharmaceutical Services Drug Delivery and Clinical Research Center Ltd
West Pharmaceutical Services Inc
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 West Pharmaceutical Services Deutschland GmbH and Co KG, West Pharmaceutical Services Drug Delivery and Clinical Research Center Ltd, West Pharmaceutical Services Inc filed Critical West Pharmaceutical Services Deutschland GmbH and Co KG
Priority to PCT/US2011/029973 priority Critical patent/WO2012134430A1/fr
Publication of WO2012134430A1 publication Critical patent/WO2012134430A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61M5/31515—Connection of piston with piston rod
    • 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 is directed to a pharmaceutical syringe plunger rod and a method for forming the distal end of the plunger rod. More, particularly, the present invention is directed to a pharmaceutical syringe piston rod for moving a piston in a pharmaceutical syringe barrel, the piston having a cavity with an internal thread having a deformed thread profile deformed by a compressive force applied by the barrel to the piston.
  • one aspect of the invention is directed to a pharmaceutical syringe piston rod for moving a piston having an exterior surface in slidable contact with an interior surface of a pharmaceutical syringe barrel along a longitudinal axis of the barrel, the piston having a cavity with a first cavity profile including an internal thread having a first thread profile when no external forces are applied to the piston and a second thread profile when the piston is in the barrel and the interior surface of the barrel applies a radially inwardly directed reactive force to the exterior surface of the piston, the second thread profile different than the first thread profile.
  • the piston rod comprises a rod having a distal end with an external thread having an external thread profile substantially the same as the second thread profile of the piston, the interior surface of the barrel applying substantially no additional radially inwardly directed reactive force to the exterior surface of the piston when the external thread engages the internal thread.
  • Another aspect of the invention is a method for forming the distal end of a pharmaceutical syringe piston rod for moving a piston having an exterior surface in slidable contact with an interior surface of a barrel of a pharmaceutical syringe along a longitudinal axis of the barrel, the piston having a cavity with a cavity profile including an internal thread having a first thread profile when no external forces are applied to the piston and a second thread profile when the piston is in the barrel and the interior surface of the barrel applies a radially inwardly directed reactive force to the exterior surface of the piston, the second thread profile different than the first thread profile, comprising the steps of: determining the second thread profile; and forming a piston rod distal end with an external thread having an external thread profile corresponding to the second thread profile.
  • Another aspect of the invention is directed to pharmaceutical syringe piston rod for moving a piston having an exterior surface in slidable contact with an interior surface of a barrel of a pharmaceutical syringe along a longitudinal axis of the barrel, the piston having a cavity with an internal thread having a first thread profile when no external forces are applied to the piston and a second thread profile when the piston is in the barrel and the interior surface of the barrel applies a radially inwardly directed reactive force to the exterior surface of the piston, the first thread profile having a first profile major diameter (Dl maj ), a first profile minor diameter (Dl m i n ) and a first profile pitch (PI), the second thread profile having a second profile major diameter (D2 maj ), a second profile minor diameter (D2 m j n ) and a second profile pitch (P2).
  • the piston rod comprises a rod having a distal end with an external thread having an external thread profile having a external profile major diameter (DE maj ), a external profile major
  • Another aspect of the invention is directed to a pharmaceutical syringe piston rod for moving a piston in a pharmaceutical syringe barrel, the piston having a cavity with an internal thread having a deformed thread profile deformed by a compressive force applied by the barrel to the piston.
  • the piston rod comprises a rod with a distal end having an external thread with an external thread profile substantially the same as the deformed thread profile.
  • FIG. 1 is an exploded cross sectional view of a prior art piston having an internal thread with a first thread profile and a distal end portion of a prior art piston rod having an external thread with an external thread profile corresponding to the first thread profile;
  • FIG. 2 is a cross sectional view of the piston of Fig. 1 inserted in the proximal end portion of the barrel of a prior art pharmaceutical syringe and having an internal thread with a second thread profile;
  • FIGs. 3 and 4 are first and second examples of comparative dimensional analyses of a 1 ml standard piston and a 1 ml long piston in the uncompressed and compressed states;
  • FIG. 5 is a side cross sectional view of the casting of the cavity of the piston of Fig. 1 showing the first thread profile and the casting of the cavity of the piston of Fig. 2 showing the second thread profile in phantom;
  • Fig. 6 is a cross sectional view of the distal portion of a piston rod having an external thread with an external thread profile corresponding to the second thread profile of Fig. 2, in accordance with the present invention.
  • Fig. 7 is a functional flow diagram of a preferred embodiment of a method for forming the distal end of a pharmaceutical syringe piston rod in accordance with the present invention.
  • first, second, etc. are used herein to describe various elements, these elements should not be limited by these words. These words are only used to distinguish one element from another.
  • a first thread profile could be termed a second thread profile, and, similarly, a second thread profile could be termed a first thread profile, without departing from the scope of the present invention.
  • the words “if may be construed to mean “when” or “upon” or “in response to determining” or “in response to detecting,” depending on the context.
  • the phrase “if it is determined” or “if [a stated condition or event] is detected” may be construed to mean “upon determining” or “in response to determining” or “upon detecting [the stated condition or event]” or “in response to detecting [the stated condition or event],” depending on the context.
  • Fig. 1 an exploded view of a prior art piston 10 and a distal portion 12 of a prior art piston rod.
  • the piston 10 has an exterior surface 14.
  • a cavity 16 is in the proximal end 10a of the piston 10.
  • the cavity 16 has a first cavity profile 18 including an internal thread 20 having a first internal thread profile 22 when no external forces are applied to the piston 10.
  • the first internal thread profile 22 has a first internal profile major diameter (Dl maj), a first internal profile minor diameter (Dl m j n ), a first internal profile pitch (PI) and a first internal engagement length (LI).
  • the cavity 16 may also have a recess 24 with a recess profile 26.
  • the cavity 16 has a first cavity length (LCI), and the recess has a first recess length (LR1) and a first recess diameter (DR1).
  • the distal portion 12 of the prior art piston rod has a distal end 12b with a first external thread 28 with a first external thread profile 30 corresponding to the first internal thread profile 20.
  • the distal end 12b may also have a first protrusion 32 having a first protrusion length (LP1) and diameter (DPI) respectively corresponding to the first recess length (LR1) and diameter (DR1).
  • the piston 10 is shown in a proximal portion of pharmaceutical syringe barrel 34.
  • the exterior surface 14 of the piston is in slidable contact with an interior surface 36 of the barrel 34.
  • the piston may be moved along a longitudinal axis 38 of the barrel 34.
  • the interior surface 36 of the barrel 34 applies a radially inwardly directed reactive force to the exterior surface 14 of the piston 10.
  • the reactive force compresses the piston 10 causing the cavity 16 to deform and, in turn, the first internal thread 20 and the recess 24 to deform.
  • the deformed cavity 16' has a second cavity profile 40 with a second cavity length (LC2). Further, the deformed cavity 16' has a second (or deformed) thread 20' and a second (or deformed) recess 24'.
  • the second (or deformed) thread 20' has a second thread profile 42 having a second profile major diameter (D2 maj ), a second profile minor diameter (D2 m i n ) 5 a second profile pitch (P2) and a second engagement length (L2).
  • the deformed recess 24' has second recess profile 44 having a second recess length (LR2) and a second recess diameter (DR2).
  • a comparative dimensional analysis of a 1 ml standard piston was performed by making a first casting of the cavity of the piston in an uncompressed state in which no external forces are being applied to the piston and then making a second casting, of the cavity of the piston after the piston in a compressed state in which the piston has been inserted in the barrel of a pharmaceutical syringe and the interior surface of the barrel applies a radially inwardly directed reactive force to the exterior surface of the piston placing the piston in compression.
  • a two-component, dimensionally-stable silicone filler was used for the casting material.
  • the filler was allowed to cure for approximately fifteen minutes after which the first casting was removed from the piston and the second casting was removed from the cavity of the piston after the piston was removed from the barrel by pressurized air.
  • a shadow graph was used to measure pertinent features of each casting, such as: major and minor thread diameters, thread pitch, thread engagement length, cavity length and recess diameter.
  • the dimensions of the pertinent features for the piston in both the uncompressed and compressed states are reproduced in the table in Fig. 3. As the fourth row of the table indicates, the dimension of each pertinent feature changed when the uncompressed piston was placed in the syringe barrel.
  • the major and minor thread diameters and the recess diameter are smaller when the piston is inserted in and compressed by the syringe barrel as compared to the larger diameters in the uncompressed state.
  • the cavity length, engagement length and pitch increase in the compressed state as compared to the uncompressed state.
  • FIG. 5 there is shown a side cross sectional view of the first cavity profile 18 of the cavity 16 and the second cavity profile 40 of the deformed cavity 16' shown in phantom. Similar to the examples in Figs. 3 and 4, the major and minor thread diameters and the recess diameter are smaller when the piston is inserted in and compressed by the syringe barrel as compared to the larger diameters in the uncompressed state. In contrast, the cavity length, engagement length and pitch increase in the compressed state as compared to the uncompressed state.
  • a preferred embodiment of a pharmaceutical piston rod generally designated 50, and hereinafter referred to as the "piston rod” 50 having a distal end 52 in accordance with the present invention.
  • the piston rod 50 is for moving the piston 10 along the longitudinal axis 38 of the pharmaceutical syringe barrel 34. ⁇ See, Fig.
  • the exterior surface 14 of the piston 10 is in slidable contact with the interior surface 36 of the barrel 34.
  • the first cavity profile 18 of the cavity 16 of the piston 10 includes the internal thread 20 with the first internal thread profile 22.
  • the second cavity profile 40 of the deformed cavity 16' includes the second internal thread 20' with the second internal thread profile 42 that is different than the first internal thread profile 22.
  • the distal end 52 of the piston rod 50 has an external thread 54 having an external thread profile 56 substantially the same as the second internal thread profile 42 of the piston 10.
  • the interior surface 36 of the barrel 34 applies substantially no additional radially inwardly directed reactive force to the exterior surface 14 of the piston 10 when the external thread 54 engages the second internal thread 20'.
  • the distal end 52 of the piston rod 50 has a protrusion 58 configured to reduce a radially outwardly directed force applied to the inner surface 36 of the barrel 34 by the exterior surface 14 of the piston 10 when a longitudinally directed force is applied to the piston rod 50.
  • the protrusion 58 has a generally conical shape.
  • the protrusion 58 may have a rod-like shape the distal end of which has a generally planar surface of a surface with a wide variety of curvatures including but not limited to a hemisphere.
  • the distal end 52 of the piston rod 50 may be configured to elongate the piston 10 reducing the compressive force applied by the barrel 34 when an axial force is applied to the piston rod 10 while the external thread 54 engages the second internal thread 20'.
  • the piston rod 50 comprises a rod having a distal end with an external thread having an external thread profile having a external profile major diameter (DE,naj), a external profile minor diameter (DE m i n ) and a external profile pitch (PE), wherein
  • the external thread profile further comprises an external engagement length (LE), wherein L2 ⁇ LE ⁇ 0.99 * L2.
  • the distal end of the rod further comprises a protrusion having a protrusion diameter (DP) and a protrusion length (LP), wherein
  • Fig. 7 is a functional flow diagram of a preferred embodiment of a method, generally designated 100 and hereafter referred to as the "piston rod forming method" 100, for forming the distal end of a pharmaceutical syringe piston rod for moving a piston along a longitudinal axis of a pharmaceutical syringe barrel in accordance with the present invention.
  • the piston has an exterior surface in slidable contact with an interior surface of the barrel.
  • a cavity in the proximal end of the piston has a cavity profile including an internal thread having a first internal thread profile when no external forces are applied to the piston.
  • the internal thread has a second internal thread profile different than the first internal thread profile when the piston is in the barrel and the interior surface of the barrel applies a radially inwardly directed reactive force to the exterior surface of the piston.
  • the piston rod forming method 100 comprising a determining step 102 in which the second internal thread profile is determined and a forming step 104 in which the distal end of the piston rod is formed with an external thread having an external thread profile corresponding to the second internal thread profile.
  • the determining step 102 comprises an installing step 106 and a first casting step 108.
  • the piston is installed in the syringe barrel in a manner that causes the interior surface 36 of the barrel 34 to apply a radially inwardly directed reactive force to the exterior surface 14 of the piston 10.
  • the reactive force compresses the piston 10 causing the first cavity profile 18 of the cavity 16 to deform to the second cavity profile 40 of the deformed cavity 16' and, in turn, the first internal thread profile 22 to deform to the second internal thread profile 42 and the first recess profile 26 to deform to the second recess profile 44.
  • the first casting step 108 a cast of the deformed cavity 16' is created while the piston 10 remains in the syringe barrel 34.
  • the first casting step 108 may only create a cast of the second internal thread profile 42 as the cavity 16' may not have a recess.
  • a cast of both the second internal thread profile 42 and the second recess profile 44 may be created.
  • the first casting step 108 may comprise a filling step 110, in which the cavity 16' is filled with a casting material, such as a two component silicone filler, that is deformable and dimensionally stable after curing and removal from the mold, a conforming step 112 in which the casting material is worked in the cavity to assure the material completely fills all crevices in the cavity and conforms to the profile of the cavity, a curing step 114 typically lasting about fifteen minutes during which time the casting material is allowed to set and harden and a removing step 116 in which the piston 10 is removed from the syringe barrel 34 typically using pressurized air, and the cured filler, now a casting of the deformed cavity profile 40.
  • a casting material such as a two component silicone filler
  • the second internal thread profile 42 is determined by an imaging step 118 in which computed tomography (CT) is used to image the deformed cavity profile 40.
  • CT computed tomography
  • the imaging step is followed by a dimensioning step 120 in which the dimensions of the second (or deformed) cavity profile 42 are obtained using a dimensional analysis technique such as shadow graphing.
  • pertinent dimensions of the second internal thread profile are recorded, such as the major diameter (D2 maj ), minor diameter (D2 m j n ), pitch (P2) and
  • the determining step 102 may also include the dimensioning step 120.
  • the recorded data may be used to validate the dimensions of the external thread profile of the external thread formed on the distal end of the piston during the forming step 104.
  • the forming step 104 may comprise a molding step 122 and a second casting step 124.
  • a mold is made of the cast of the deformed cavity 16' created in the casting 108.
  • the mold that is formed includes a mold of the second internal thread profile 42 and may also include a mold of the deformed recess 24' if the cavity includes a recess.
  • the distal end 12b of the piston rod 10 is created using the mold created in the molding step 122.
  • the distal end 12b of the piston rod that is formed by the second casting step 124 has an external thread with an external thread profile corresponding to the second internal thread profile of the deformed cavity 16' and may also have a protrusion 58 corresponding to the deformed recess 24' if the cavity includes a recess.

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  • 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)

Abstract

L'invention concerne une tige de piston de seringue pharmaceutique et un procédé de fabrication de l'extrémité distale de la tige. Le piston possède une cavité qui présente un filetage interne ayant un premier profil de filetage (18) lorsqu'aucune force externe n'est appliquée au piston et un second profil de filetage (40), différent du premier profil de filetage, lorsque le piston est dans le corps de la seringue et que la surface interne du corps applique sur le piston une force de réaction dirigée radialement vers l'intérieur. La tige de piston possède une extrémité distale qui présente un filetage externe ayant un profil de filetage externe sensiblement identique au second profil de filetage du piston. Le filetage externe est formé par un moulage par coulée de la cavité. La surface intérieure du corps n'applique sensiblement aucune force de réaction supplémentaire, dirigée radialement vers l'intérieur, à la surface extérieure du piston lorsque le filetage externe vient en prise avec le filetage interne.
PCT/US2011/029973 2011-03-25 2011-03-25 Tige de piston de seringue pharmaceutique Ceased WO2012134430A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2011/029973 WO2012134430A1 (fr) 2011-03-25 2011-03-25 Tige de piston de seringue pharmaceutique

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2011/029973 WO2012134430A1 (fr) 2011-03-25 2011-03-25 Tige de piston de seringue pharmaceutique

Publications (1)

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WO2012134430A1 true WO2012134430A1 (fr) 2012-10-04

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103170034A (zh) * 2013-04-03 2013-06-26 山东威高集团医用高分子制品股份有限公司 一种预充式冲管注射器
EP2803377A1 (fr) * 2013-05-15 2014-11-19 Sumitomo Rubber Industries, Ltd. Joint médical
FR3011472A1 (fr) * 2013-10-09 2015-04-10 Aptar Stelmi Sas Bouchon-piston et dispositif de seringue comportant un tel bouchon-piston
JP2016077354A (ja) * 2014-10-10 2016-05-16 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
CN110325235A (zh) * 2017-02-27 2019-10-11 W.L.戈尔及同仁股份有限公司 具有低润滑注射器筒的医疗递送装置
JPWO2020203239A1 (fr) * 2019-03-29 2020-10-08

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2688325A (en) * 1952-09-12 1954-09-07 Compule Corp Piston plug withdrawal limiting means for hypodermic syringe devices and the like
US4180069A (en) * 1976-06-01 1979-12-25 The West Company Plunger rod and piston for a syringe
US5460617A (en) * 1994-07-28 1995-10-24 Abbott Laboratories Syringe plunger with intermediate pushing surface
WO2004075958A2 (fr) * 2003-02-27 2004-09-10 Baxter International Inc. Ensemble piston pour seringue
WO2009128265A1 (fr) * 2008-04-16 2009-10-22 味の素株式会社 Seringue
WO2010103919A1 (fr) * 2009-03-09 2010-09-16 テルモ株式会社 Joint et seringue

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2688325A (en) * 1952-09-12 1954-09-07 Compule Corp Piston plug withdrawal limiting means for hypodermic syringe devices and the like
US4180069A (en) * 1976-06-01 1979-12-25 The West Company Plunger rod and piston for a syringe
US5460617A (en) * 1994-07-28 1995-10-24 Abbott Laboratories Syringe plunger with intermediate pushing surface
WO2004075958A2 (fr) * 2003-02-27 2004-09-10 Baxter International Inc. Ensemble piston pour seringue
WO2009128265A1 (fr) * 2008-04-16 2009-10-22 味の素株式会社 Seringue
WO2010103919A1 (fr) * 2009-03-09 2010-09-16 テルモ株式会社 Joint et seringue

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103170034A (zh) * 2013-04-03 2013-06-26 山东威高集团医用高分子制品股份有限公司 一种预充式冲管注射器
EP2803377A1 (fr) * 2013-05-15 2014-11-19 Sumitomo Rubber Industries, Ltd. Joint médical
CN104162210A (zh) * 2013-05-15 2014-11-26 住友橡胶工业株式会社 医疗用密封垫
FR3011472A1 (fr) * 2013-10-09 2015-04-10 Aptar Stelmi Sas Bouchon-piston et dispositif de seringue comportant un tel bouchon-piston
WO2015052429A1 (fr) * 2013-10-09 2015-04-16 Aptar Stelmi Sas Bouchon-piston glissant et dispositif de seringue comportant un tel bouchon-piston
JP2016077354A (ja) * 2014-10-10 2016-05-16 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
CN110325235A (zh) * 2017-02-27 2019-10-11 W.L.戈尔及同仁股份有限公司 具有低润滑注射器筒的医疗递送装置
CN113521451A (zh) * 2017-02-27 2021-10-22 W.L.戈尔及同仁股份有限公司 具有低润滑注射器筒的医疗递送装置
JPWO2020203239A1 (fr) * 2019-03-29 2020-10-08
WO2020203239A1 (fr) * 2019-03-29 2020-10-08 テルモ株式会社 Kit de piston, kit de seringue, et seringue pré-remplie
JP7397065B2 (ja) 2019-03-29 2023-12-12 テルモ株式会社 プランジャーキット、シリンジキット及びプレフィルドシリンジ

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