WO2015114381A1 - Seringue pour dispositif d'auto-injecteur comprenant une couche extérieure souple le long d'une tige de piston allongée - Google Patents

Seringue pour dispositif d'auto-injecteur comprenant une couche extérieure souple le long d'une tige de piston allongée Download PDF

Info

Publication number
WO2015114381A1
WO2015114381A1 PCT/GB2015/050275 GB2015050275W WO2015114381A1 WO 2015114381 A1 WO2015114381 A1 WO 2015114381A1 GB 2015050275 W GB2015050275 W GB 2015050275W WO 2015114381 A1 WO2015114381 A1 WO 2015114381A1
Authority
WO
WIPO (PCT)
Prior art keywords
plunger rod
outer layer
resilient outer
syringe
barrel
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/GB2015/050275
Other languages
English (en)
Inventor
Neil CAMMISH
Ian Anderson
Matt EKMAN
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.)
Consort Medical Ltd
Original Assignee
Consort Medical 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 Consort Medical Ltd filed Critical Consort Medical Ltd
Publication of WO2015114381A1 publication Critical patent/WO2015114381A1/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
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • 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
    • 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
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer

Definitions

  • This invention relates to an improved syringe, and in particular to an improved syringe for use in an autoinjector device that improves the reliability and safety of the autoinjector device.
  • Syringes are known and offer a convenient means of delivering a dose of medicament. Syringes may be hand operated, where a user applies a direct force to a plunger rod, to expel medicament. Alternatively, and increasingly commonly, syringes may form part of an autoinjector device where a driving means acts on a plunger rod of the syringe to expel medicament from the syringe and into a delivery site (e.g. via a needle).
  • Syringes used in autoinjectors are often so-called "standard syringes" that are prevalent in the industry and are both proven to be generally safe and reliable.
  • standard syringes that are prevalent in the industry and are both proven to be generally safe and reliable.
  • damage or breakage may lead to a partially or fully incomplete dose of medicament being delivered to a patient and this may have serious, or possibly fatal, consequences.
  • a syringe for use in an autoinjector comprising:
  • a barrel having a front outlet, an open rear end, and a tubular body extending between the front outlet and open rear end, wherein the tubular body has an internal diameter and defines a volume for containing medicament, and the open rear end has a diameter
  • a polymeric elongate plunger rod having a stopper at a forward end and a resilient outer layer along the length of the elongate plunger rod, the elongate plunger rod being disposable within the barrel such that the stopper seals against the inside of the tubular body of the barrel and is slidable therein by axial translation of the plunger rod in the barrel.
  • said resilient outer layer comprises a sleeve surrounding the circumference of the elongate plunger rod.
  • said resilient outer layer comprises a coating surrounding the circumference of the elongate plunger rod.
  • said resilient outer layer may comprise an overmoulded layer.
  • said resilient outer layer may comprise an elastomeric material, and optionally comprises silicone.
  • the resilient outer layer may extend along at least 50% of the length of the elongate plunger rod, extend along at least 75% of the length of the elongate plunger rod, or extend along at least 90% of the length of the elongate plunger rod.
  • the elongate plunger rod has a radially outwardly projecting flange at a rear end.
  • one or more of the elasticity, resilience and deformability of the resilient outer layer may be greater than that of the plunger rod.
  • substantially no axial movement of the resilient outer layer may be permitted relative to the plunger rod.
  • the plunger rod may be connected to the stopper.
  • the resilient outer layer may extend out of the open rear end of the barrel in at least one position of the plunger rod relative to the barrel.
  • an autoinjector device including:
  • a syringe according to the first aspect of the present invention; and a driving member for moving the plunger rod axially forwardly in the barrel.
  • an autoinjector device including:
  • a housing for receiving a syringe
  • a polymeric elongate plunger rod for insertion into a barrel of a received syringe and for connection to a stopper disposed in the barrel, the elongate plunger rod having a resilient outer layer along the length of the elongate plunger rod;
  • a driving member for moving the plunger rod axially forwardly in the barrel.
  • Said resilient outer layer may comprise a sleeve surrounding the circumference of the elongate plunger rod.
  • Said resilient outer layer may comprise a coating surrounding the circumference of the elongate plunger rod.
  • Said resilient outer layer may comprise an overmoulded layer.
  • Said resilient outer layer may comprise an elastomeric material.
  • Said elastomeric material may comprise silicone.
  • said resilient outer layer may extend along at least 50%, at least 75% or at least 90% of the length of the elongate plunger rod.
  • the elongate plunger rod may have a radially outwardly projecting flange at a rear end.
  • one or more of the elasticity, resilience and deformability of the resilient outer layer may be greater than that of the plunger rod.
  • substantially no axial movement of the resilient outer layer may be permitted relative to the plunger rod.
  • the plunger rod may be connected to the stopper.
  • the autoinjector device may further comprise a syringe received in the housing, wherein the syringe comprises a barrel having a front outlet, an open rear end, a tubular body extending between the front outlet and the open rear end, and a stopper disposed in the barrel, wherein the elongate plunger rod is disposed in the barrel and is connected to the stopper in the syringe.
  • the resilient outer layer may extend out of the open rear end of the barrel in at least one position of the plunger rod relative to the barrel.
  • Figure 1 is a cross-sectional view of a syringe in accordance with an embodiment of the present invention.
  • FIG. 1 shows a syringe 10 according to an embodiment of the present invention.
  • the syringe 10 includes a barrel 12 having a front outlet 12a, an open rear end 12b and a tubular body 12c extending therebetween.
  • the tubular body 12c has a generally constant cross section in an axial direction and has an internal diameter D1.
  • An elongate plunger rod 16 is disposed in the barrel 12 and is axially moveable therein.
  • the plunger rod 16 has a screw thread 16a at a front end that engages with a corresponding screw thread 18a of a stopper 18.
  • the stopper 18 may be connected to the plunger rod 16 by different means other than a screw thread 16a.
  • the stopper 18 may be connected to the plunger rod 16 by a ball and socket joint or a snap fit joint.
  • the stopper 18 is sized and configured to seal against the inside of the tubular body 12c when disposed in the barrel 12. Axial translation of the plunger rod 16 results in axial translation of the stopper 18 in the tubular body 12c.
  • a chamber 13 is defined in the barrel 12 between the stopper 18 and the front outlet 12a, where the chamber 13 may contain a medicament. Due to the sealing between the stopper 18 and the tubular body 12c, forward axial translation of the stopper 18 causes pressurization of the chamber 13 so that any medicament contained therein is expelled from the barrel via front outlet 12a.
  • the open rear end 12b of the barrel 12 has a diameter D2 that is either substantially equal to or greater than the internal diameter D1 of the tubular body 12c. This is required to permit assembly of the plunger rod 16 with stopper 18 into the barrel 12. As a result of this arrangement, there is an annular space around the plunger rod 16, between the plunger rod 16 and the barrel 12. In reality, the open rear end 12b may include radially inward deformations of the order of 1 mm due to the manufacturing process. However, even with such irregularities, the open rear end 12b of the barrel 12 may still be considered to have a diameter D2 that is substantially equal to the internal diameter D1 of the tubular body 12c in accordance with the present invention. When assembling such a syringe 10, the stopper 18 may deform to pass the minor deformations at the open rear end 12b and enter the tubular body 12c.
  • the syringe 10 is suitable for use in an autoinjector device where a driving member acts on the plunger rod 16 to translate the stopper 18 axially forward in the barrel 12 to expel a medicament contained in the chamber 13.
  • the axially forward force may be provided in the autoinjector by a spring or other suitable power source.
  • the rear end of the plunger rod 16 includes a radially extending flange 16b which may facilitate better engagement of the driving member with the plunger rod 16.
  • the finger flange 16b may not be present.
  • the plunger rod 16 of the present invention is constructed from a polymeric material that is preferably suitably strong enough to transmit axial load from the driving member to the stopper 18 and ultimately pressurize the chamber 13.
  • the force provided by the driving member is particularly large.
  • a large driving force may be used to minimize the risk that the whole dose of medicament is not delivered, or to expel a particularly viscous medicament in a defined time.
  • the large driving force acting on the plunger rod 16 may result in radial deformation or displacement of the plunger rod 16 which may consequently cause the plunger rod 16 to contact the barrel 12.
  • any contact between the plunger rod 16 and the barrel 12 is likely to occur around the rear open end 12b of the barrel 12 where a shoulder of the barrel 12 is formed.
  • the plunger rod 16 is liable to bending and there is the risk that a radially deformed part of the plunger rod 16 (e.g.
  • the plunger rod 16 according to the present invention is provided with a resilient outer layer 20 along its length.
  • the resilient outer layer cushicns any force between the plunger rod 16 and the barrel Yi and increases the time that any force applied by the plunger rod 16 acts on the barre 12, the eby increasing the impulse, / (since, for a force, F, appiied over time interval, z3 ⁇ 4, I ⁇ FAt).
  • the cushioning effect created by the presence of tfie resilient outer layer 20 minimizes the risk of breakage of the barrel 12 during movement of the plunger rod 16 therein.
  • the resilient outer layer 20 may be a sleeve that surrounds plunger rod 16 or may alternatively be a coating applied to the plunger rod 16.
  • the sleeve may be formed tightly around the plunger rod 16 so that axial movement of the sleeve relative to the plunger rod 16 is limited.
  • the sleeve may be otherwise fixed to the plunger rod 16 so as to prevent or limit axial movement of the sleeve relative to the plunger rod 16.
  • the resilient outer layer 20 may be formed from any suitably resilient material that provides an adequate cushioning effect.
  • the resilient outer layer 20 is made of an elastomeric material.
  • the resilient outer layer 20 may be made of a material incorporating or consisting of silicone.
  • the impact between the plunger rod 16 and the barrel 12 may occur at any time when the driving member is acting on the plunger rod 16.
  • the resilient outer layer 20 is provided along substantially all of the exposed length of the plunger rod 16, i.e. between the stopper and the rear end of the plunger rod (or radially extending flange 16b, if present).
  • the resilient outer layer 20 may extend along at least 50%, 75% or 90% of the exposed length of the plunger rod 16.
  • the resilient outer layer 20 may extend along the front 50%, 75% or 90% of the exposed length of the plunger rod 16, the rear 50%, 75% or 90% of the exposed length of the plunger rod 16, or an intermediate 50%, 75% or 90% of the exposed length of the plunger rod 16. Larger coverage by the resilient outer layer 20 is preferable as this minimizes breakage most effectively by providing protection in the event of unpredictable deformation or deflection of the plunger rod 16.
  • the resilient outer layer 20 may have a greater elasticity and/or resilience and/or deformability relative to the plunger rod 16.
  • the resilient outer layer 20 is arranged on the plunger rod 16 such that substantially no movement (e.g. axial movement) of the resilient outer layer 20 is permitted relative to the plunger rod.
  • the plunger rod 16 forms a connection with the stopper 18 and the resilient outer layer 20 may or may not be additionally connected to the stopper 18.
  • the resilient outer layer 20 is arranged on the plunger rod 16 such that there is substantially no radial gap between the resilient outer layer 20 and the plunger rod 16.
  • the resilient outer layer 20 extends out of the open rear end 12b of the barrel 12 in at least one position of the plunger rod 16. For example, in at least the initial position of the plunger rod 16 (i.e. prior to a dose of medicament being delivered), the resilient outer layer 20 may extend out of the open rear end 12b of the barrel 12.
  • an autoinjector device that includes a housing configured to receive a syringe.
  • the autoinjector device may include a plunger rod in accordance with that described above such that a syringe (without a plunger rod) may be installed in the autoinjector device and the plunger rod of the autoinjector device may be used to expel medicament from the syringe.
  • the autoinjector device may be provided with a syringe and plunger rod installed.

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)

Abstract

L'invention concerne une seringue devant être utilisée dans un auto-injecteur, la seringue comprenant un tube ayant une sortie avant, une extrémité arrière ouverte et un corps tubulaire s'étendant entre la sortie avant et l'extrémité arrière ouverte. Le corps tubulaire possède un diamètre interne et délimite un volume pour contenir un médicament, et le diamètre de l'extrémité arrière ouverte est sensiblement égal ou supérieur au diamètre interne du corps tubulaire. La seringue comprend en outre une tige de piston allongée polymère ayant une bouchon à une extrémité avant et une couche extérieure souple le long de la tige de piston allongée, la tige de piston allongée pouvant être disposée dans le tube de telle sorte que le bouchon scelle l'intérieur du corps tubulaire du tube et peut coulisser à l'intérieur de ce dernier par une translation axiale de la tige de piston dans le tube.
PCT/GB2015/050275 2014-01-31 2015-02-02 Seringue pour dispositif d'auto-injecteur comprenant une couche extérieure souple le long d'une tige de piston allongée Ceased WO2015114381A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1401677.8A GB2522656A (en) 2014-01-31 2014-01-31 Improved syringe for autoinjector device
GB1401677.8 2014-01-31

Publications (1)

Publication Number Publication Date
WO2015114381A1 true WO2015114381A1 (fr) 2015-08-06

Family

ID=50344184

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2015/050275 Ceased WO2015114381A1 (fr) 2014-01-31 2015-02-02 Seringue pour dispositif d'auto-injecteur comprenant une couche extérieure souple le long d'une tige de piston allongée

Country Status (2)

Country Link
GB (2) GB2522656A (fr)
WO (1) WO2015114381A1 (fr)

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2679246A (en) * 1952-07-22 1954-05-25 Miljam Instr Corp Hypodermic syringe
US3150801A (en) * 1960-09-06 1964-09-29 Clark H Hamilton Syringe
US3628523A (en) * 1968-12-05 1971-12-21 Othel L Pirtle Jr Syringe
US3958570A (en) * 1974-09-03 1976-05-25 Vogelman Joseph H Syringes and syringe capsules
DE3604826A1 (de) * 1985-02-14 1986-10-16 Technische Hochschule Karl-Marx-Stadt, DDR 9010 Karl-Marx-Stadt Vorrichtung mit tagesmedikamentdepot zur schmerzarmen injektion
US5000994A (en) * 1987-04-13 1991-03-19 The West Company, Incorporated Pharmaceutical elastomeric coating
EP0443227A1 (fr) * 1990-02-19 1991-08-28 Ito Corporation Microseringue analytique
JPH0999077A (ja) * 1995-10-09 1997-04-15 Shiseido Co Ltd カートリッジ式注射器のストッパー機構
US20070148326A1 (en) * 2005-12-28 2007-06-28 Hastings Mitchell R Syringe

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KR0149603B1 (ko) * 1995-12-07 1998-08-17 박경조 천연고무를 사용한 주사기용 흡자, 밀대 및 그 제조방법
US6368303B1 (en) * 1999-10-15 2002-04-09 Becton, Dickinson And Company Retracting needle syringe
US6413237B1 (en) * 2000-08-31 2002-07-02 Becton, Dickinson And Company Hypodermic syringe with selectively retractable needle
US6409701B1 (en) * 2000-09-29 2002-06-25 Becton, Dickinson And Company Hypodermic syringe with selectively retractable needle
CA2578365C (fr) * 2004-08-13 2013-07-16 Becton, Dickinson And Company Ensemble de seringue a aiguille retractable
FR2890316B1 (fr) * 2005-09-02 2007-10-05 Aguettant Soc Par Actions Simp Seringue destinee a etre remplie puis sterilisee par autoclavage a la vapeur.
CN2824966Y (zh) * 2005-10-23 2006-10-11 曹振军 一次性防污染注射器
CN201189335Y (zh) * 2008-03-20 2009-02-04 陈庆强 一种内置式防污染注射器
GB0910681D0 (en) * 2009-06-19 2009-08-05 Ucb Pharma Sa Auto-injector
US8530536B2 (en) * 2009-10-01 2013-09-10 Momentive Performance Materials Inc. Self-lubricating pharmaceutical syringe stoppers
CN201719629U (zh) * 2010-07-02 2011-01-26 李丰忠 一种无菌注射器
US20130060204A1 (en) * 2011-09-02 2013-03-07 Kuo-Cheng Wu Syringe with prevention of backflow of blood
PT2812051T (pt) * 2012-02-06 2017-01-09 Unitract Syringe Pty Ltd Subconjuntos de êmbolo e auto-injetores que têm baixa força de ativação de retração
CN202505900U (zh) * 2012-04-02 2012-10-31 张显水 疾病预防接种装置

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2679246A (en) * 1952-07-22 1954-05-25 Miljam Instr Corp Hypodermic syringe
US3150801A (en) * 1960-09-06 1964-09-29 Clark H Hamilton Syringe
US3628523A (en) * 1968-12-05 1971-12-21 Othel L Pirtle Jr Syringe
US3958570A (en) * 1974-09-03 1976-05-25 Vogelman Joseph H Syringes and syringe capsules
DE3604826A1 (de) * 1985-02-14 1986-10-16 Technische Hochschule Karl-Marx-Stadt, DDR 9010 Karl-Marx-Stadt Vorrichtung mit tagesmedikamentdepot zur schmerzarmen injektion
US5000994A (en) * 1987-04-13 1991-03-19 The West Company, Incorporated Pharmaceutical elastomeric coating
EP0443227A1 (fr) * 1990-02-19 1991-08-28 Ito Corporation Microseringue analytique
JPH0999077A (ja) * 1995-10-09 1997-04-15 Shiseido Co Ltd カートリッジ式注射器のストッパー機構
US20070148326A1 (en) * 2005-12-28 2007-06-28 Hastings Mitchell R Syringe

Also Published As

Publication number Publication date
GB2522656A (en) 2015-08-05
GB201501698D0 (en) 2015-03-18
GB2523655B (en) 2021-03-24
GB201401677D0 (en) 2014-03-19
GB2523655A (en) 2015-09-02

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