WO2010052517A1 - Récipient à médicaments amélioré - Google Patents

Récipient à médicaments amélioré Download PDF

Info

Publication number
WO2010052517A1
WO2010052517A1 PCT/IB2008/003703 IB2008003703W WO2010052517A1 WO 2010052517 A1 WO2010052517 A1 WO 2010052517A1 IB 2008003703 W IB2008003703 W IB 2008003703W WO 2010052517 A1 WO2010052517 A1 WO 2010052517A1
Authority
WO
WIPO (PCT)
Prior art keywords
adaptor
distal tip
respect
ring
annular gap
Prior art date
Application number
PCT/IB2008/003703
Other languages
English (en)
Inventor
Michel Vernizeau
Original Assignee
Becton Dickinson France
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 Becton Dickinson France filed Critical Becton Dickinson France
Priority to PCT/IB2008/003703 priority Critical patent/WO2010052517A1/fr
Publication of WO2010052517A1 publication Critical patent/WO2010052517A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/344Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3129Syringe barrels
    • A61M5/3134Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula

Definitions

  • the present invention relates to an assembly comprising an injection device and an adaptor, such as a Luer lock adaptor, allowing a safe connection of the adaptor on the injection device, in view of further connecting a connector element, such as an IV (Intra Venous) connector, to said injection device.
  • an adaptor such as a Luer lock adaptor
  • distal end of a component or of a device is to be understood as meaning the end furthest from the user's hand and the proximal end is to be understood as meaning the end closest to the user's hand.
  • distal direction is to be understood as meaning the direction of injection
  • proximal direction is to be understood as meaning the opposite direction to the direction of injection.
  • Various medical devices are known for transferring and/or, storing medical fluids, such as syringes, perfusion and transfusion devices and connectors. It is essential that these various medical devices can be assembled together correctly and securely.
  • a conventional injection device usually comprises a hollow body forming a container for a medical product : the distal end of the body forming the container usually comprises a tip in which an axial passageway is arranged through which the said product is ejected from the container.
  • the connectors like for example IV connectors, are usually connected to the injection device by means of intermediate elements such as adaptors.
  • these adaptors are first mounted on the distal tip of the injection device : the connector, such as an IV connector, is then mounted on the free end of the adaptor, for example by screwing.
  • the adaptors are friction forced on the distal tip and are supposed to remain immobile, thanks to friction forces, with respect to the distal tip while the connector is screwed on the adaptor.
  • a shoulder is present on the distal tip to prevent the adaptor to slide distally with respect to the distal tip.
  • an assembly 200 of the prior art comprising a distal tip 201 of a container 202 having a longitudinal axis AO and an adaptor 203.
  • the distal tip 201 comprises on its outer surface 204 a shoulder 205.
  • the adaptor 203 comprises a ring 206 and an annular ridge 207 defining a diameter DO in a rest position of said adaptor 203, as shown on figure 1.
  • the annular ridge 207 of the adaptor 203 is radially expandable upon forces exerted on its inner wall.
  • the adaptor 203 is intended to be friction forced on the distal tip 201 as shown on figure 2.
  • the annular ridge 207 overcomes the shoulder 205 and gets stuck between said shoulder 205 and the distal wall of the container 202.
  • the adaptor 203 in this position, is still in a stressed position of its annular ridge 207 and is supposed to be immobile with respect to the distal tip 201 thanks to friction forces present between the annular ridge 207 and the outer surface 204 of the distal tip 201.
  • the adaptor 203 is prevented from sliding distally with respect to the distal tip thanks to the shoulder 205.
  • the adaptor 203 does not remain immobile with respect to the distal tip 201. In particular, it may happen in cases that the adaptor 203 remains immObile and it also may happen in other cases that the friction forces are not important enough to prevent the adaptor 203 to rotate, although with friction, with respect to the distal tip 201 when the user tries to screw a connector on to the adaptor 203: it is therefore impossible for the user to determine whether the connector is well fitted in the adaptor or not and, as a consequence, whether the connector is well connected to the distal tip of the injection device. An incorrect connection between the injection device and the connector may cause leaks of product and therefore incorrect doses administered to the patient. There is therefore a need for an assembly that would allow the reproducible connection between said injection device and an adaptor, so that the user knows when the connector is correctly connected to the injection device via the adaptor.
  • One aspect of the present invention is an assembly comprising: an injection device comprising a container for a product, said container comprising a distal tip having a longitudinal axis A, said distal tip encompassing a channel aligned with said longitudinal axis A and providing a passageway for the transfer of said product, an adaptor comprising a ring provided with at least one inner projection, said adaptor being intended to be fitted on said distal tip, said distal tip being provided on its outer surface with a shoulder being capable of cooperating with said at least one inner projection when said adaptor is fitted on said distal tip, so as to prevent distal movement of said adaptor with respect to said distal tip, characterized in that said distal tip is further provided on its outer surface with at least one annular gap, proximally spaced with respect to said shoulder, said at least one annular gap being capable of cooperating with said at least one inner projection so as to allow said adaptor to rotate freely with respect to said distal tip around said longitudinal axis A.
  • the adaptor rotates with respect to the distal tip with minimal friction between the two surfaces which are in contact, ie the surface of the adaptor which is in contact with the surface of the distal tip : in particular, the friction force between the two surfaces in contact is less than 2 N.cm, measured with a classical torquemeter.
  • the resistance between the two surfaces is very low and the adaptor can rotate very easily with respect to the distal tip.
  • the adaptor is allowed to rotate freely with respect to the distal tip of the injection device but is prevented from moving distally with respect to said distal tip, then the user can simply screw the connector to the adaptor by grasping in his fingers the adaptor on one hand, and the connector on the other hand. The user does not need to bother anymore about the firmness of the friction connection of the adaptor to the injection device like in the prior art.
  • the adaptor and the distal tip are in high friction contact.
  • said adaptor is no more maintained coupled to the distal tip by friction forces. It is maintained coupled to the distal tip by means of said inner projection being engaged in said annular gap, said adaptor being able to rotate freely with respect to the distal tip but being prevented from moving distally with respect to said distal tip.
  • said ring is radially and outwardly expandable from a rest position, in which said one inner projection defines a first internal diameter Dr of said ring, and a stressed position, in which said one inner projection defines a second internal diameter Ds of said ring, said second internal diameter being greater than said first internal diameter, said ring being in its rest position when said at least one annular gap cooperates with said at least one inner projection, so as to allow said adaptor to rotate freely with respect to said distal tip.
  • said annular gap has a diameter D1 , D1 being strictly less than Dr.
  • D1 being strictly less than Dr.
  • said friction force is less than 2 N. cm.
  • the ring is therefore not in high friction contact with the distal tip. This allows the adaptor to rotate freely around the. longitudinal axis A with respect to the distal tip. Moreover, because of the shoulder, the adaptor is prevented from moving distally with respect to the distal tip.
  • said shoulder has a diameter D2, D2 being strictly more than Dr.
  • the adaptor is therefore being prevented from moving distally with respect to the distal tip.
  • D1 may be 4.25 mm and D2 may be 4.40 mm.
  • Ds may be up to 4.40 mm. The ring is therefore allowed to rotate freely with respect to the distal tip while being prevented from moving distally with respect to the distal tip.
  • FIGS. 3 and 4 are perspective view of an assembly of the invention respectively before mounting the adaptor on the injection device and once the adaptor is mounted on the distal tip of the injection device
  • - Figure 5 is a cross section view of the assembly of figures 3 and 4 before mounting the adaptor on the distal tip
  • FIG. 6 is a cross section view of the assembly of figure 5 during the step of mounting the adaptor on the distal tip, the adaptor being in its stressed condition
  • Figure 7 is a cross section view of the assembly of figure 5 once the adaptor is fitted on the distal tip.
  • an assembly 101 of the invention comprising an injection device 1 comprising a container 2 comprising a distal tip 3 having a longitudinal axis A.
  • the container 2 and the distal tip 3 are made of one single element.
  • the container 2 has a tubular shape and defines a reservoir for a product, for example a medical fluid.
  • the container 2 and the distal tip 3 are preferably made of glass material.
  • the container 2 may be sealed at its proximal end by a piston (not shown).
  • the distal tip 3 encompasses a channel 4 aligned with the longitudinal axis A and providing a passageway for the transfer of the product, either from the container 2 to a connector (not shown) such as an IV connector, or from a vial to the container 2.
  • the outer surface 3a of the distal tip 3 has a slightly tapered shape and it is provided in its proximal region with an annular gap 5.
  • the annular gap 5 defines at its distal end a shoulder 10. The annular gap 5 is therefore proximally spaced with respect to said shoulder 10.
  • an adaptor 6 comprising a ring 7.
  • the ring 7 is provided in its proximal region with an inner projection under the form of a discontinuous annular bulge 8 extending radially inwardly.
  • the inner projection may be a continuous bulge.
  • the inner wall of the ring 7 is provided with an internal thread 9 distally spaced from the discontinuous annular bulge 8.
  • the adaptor 6 in a first step, is fitted on the distal tip 3, and then, in a second step, the adaptor 6 is intended to be screwed on a connector (not shown), such as an IV connector, in order to connect safely the injection device 1 to the said connector so as to realize the transfer of the product from the injection device to the connector or vice-versa.
  • a connector such as an IV connector
  • the said connector is provided with an external thread intended to cooperate with the internal thread 9 of the adaptor in order to screw the adaptor on the connector.
  • the adaptor 6 is generally made in a material flexible enough to allow said adaptor 6 to adopt a rest position, shown on figure 5, in which the discontinuous bulge 8 defines a first internal diameter Dr, and a stressed position, shown on figure 6, in which the discontinuous bulge 8 defines a second internal diameter Ds, Ds being greater than Dr.
  • the ring 7 is therefore radially expandable upon a stress exerted on the inner wall of the bulge 8 in the outward and radial direction. As shown on figure 6, such a stress is exerted on the bulge 8 by the outer surface 3a of the distal tip 3 when the adaptor 6 is friction forced on the distal tip 3 during the step of mounting the adaptor 6 on the distal tip 3.
  • the ring 7 is made of plastic material.
  • the user is provided with an injection device 1 and an adaptor 6 as shown on figures 3 and 5.
  • the adaptor 6 is in its rest position as shown on figure 5.
  • the user grasps the injection device ⁇ with one hand and the adaptor 6 with the other hand. He forces the proximal end of the ring 7 on the distal end of the distal tip 3. Since the diameter of the outer surface 3a of the distal tip 3 is greater than the diameter Dr of the adaptor 6 in its rest position, the outer surface 3a of the distal tip 3 exerts a radial and outward force on the discontinuous bulge 8 of the adaptor 6, and the ring 7 deforms and expands radially, as shown on figure 6. In this stressed position of the adaptor 6, the discontinuous bulge 8 defines an internal diameter Ds greater than Dr and the adaptor 6 and the outer surface 3a of the distal tip 3 are in high friction contact.
  • the adaptor 6 continues to push the adaptor 6 in direction of the container 2 of the injection device 1 until the discontinuous bulge 8 reaches the annular gap 5 in which it becomes engaged, as shown on figure 7. Since the diameter D1 of the annular gap 5 is less than the diameter Dr defined by the discontinuous bulge 8, the adaptor 6 comes back to its rest position : in particular, the diameter D1 of the annular gap 5 is sufficiently less than Dr so that the discontinuous bulge 8 is no more in high friction contact with the outer surface of the annular gap 5 : as a consequence, the adaptor 6 is only in minimal friction contact with the outer surface 3a of the distal tip 3, as shown on figure 7. In particular, the friction force between the adaptor 6 and the outer surface of the annular gap 5 is less than 2 N. cm.
  • the adaptor 6 when it is fitted on the distal tip 3 as shown on figure 7, the adaptor 6 is free to rotate with respect to the distal tip 3 around the longitudinal axis A. Moreover, because of the shoulder 10, the adaptor 6 is prevented from moving distally with respect to the distal tip 3.
  • the diameter D1 of the annular gap 5 is 4.25 mm
  • the internal diameter Dr of the ring 7 defined by the discontinuous bulge 8 is 4.30 mm.
  • the ring 7, and therefore the adaptor 6, is therefore allowed to rotate freely with respect to the distal tip 3 while being prevented from moving distally with respect to the distal tip 3.
  • the diameter D2 of the shoulder may then be 4.40 mm and Ds may be up to 4.40 mm.
  • the user when the user wishes to proceed to the further step of connecting to the adaptor 6 a connector, such as an IV connector, he just has to grasp the adaptor 6 fitted on the distal tip 3 as shown on figure 7 in one hand and then to screw the connector on to the internal thread 9 of the adaptor, without bothering as to whether the adaptor 6 is immobile with respect to the distal tip 3 or not.
  • the external thread of the connector (not shown) is firmly screwed on the internal thread 9 of the adaptor 6, then the user knows that the injection device 1 and the connector are tightly connected without any risk of leakage of the product to be transferred from one piece to the other.
  • the assembly of the invention therefore allows connecting safely an injection device to a connector without having to check the tightness of the fixation between the injection device and the intermediate element formed by the adaptor.
  • the assembly of the invention renders the connection of an injection device to a connector, such as an IV connector, particularly simple, safe and reproducible.

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 un ensemble (101) qui comprend : un dispositif d'injection (1) qui contient un récipient (2) pour un produit, ledit récipient (2) présentant une pointe distale (3) qui présente un axe longitudinal A, ladite pointe distale (3) comprenant un canal (4) aligné sur ledit axe longitudinal A et offrant un passage pour le transfert dudit produit, un adaptateur (6) qui comprend un anneau (7) doté d'au moins une saillie intérieure (8), ladite pointe distale (3) étant dotée sur sa surface extérieure (3a) d'un épaulement (10) qui peut empêcher un déplacement distal dudit adaptateur (6) par rapport à ladite pointe distale (3), caractérisé en ce que la surface extérieure (3a) de ladite pointe distale (3) est dotée d'au moins un interstice annulaire (5) espacé en direction proximale par rapport audit épaulement (10), ledit ou lesdits interstices annulaires (5) pouvant coopérer avec ladite ou lesdites saillies (8) de manière à permettre audit adaptateur (6) de tourner librement par rapport à ladite pointe distale (3) autour dudit axe longitudinal A.
PCT/IB2008/003703 2008-11-06 2008-11-06 Récipient à médicaments amélioré WO2010052517A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2008/003703 WO2010052517A1 (fr) 2008-11-06 2008-11-06 Récipient à médicaments amélioré

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2008/003703 WO2010052517A1 (fr) 2008-11-06 2008-11-06 Récipient à médicaments amélioré

Publications (1)

Publication Number Publication Date
WO2010052517A1 true WO2010052517A1 (fr) 2010-05-14

Family

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Family Applications (1)

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Country Link
WO (1) WO2010052517A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016034779A1 (fr) 2014-09-05 2016-03-10 Guerbet Systeme de maintien d'un adaptateur sur un cone d'extremite d'une seringue, et ensemble comprenant un tel systeme de maintien
ITMI20150587A1 (it) * 2015-04-24 2016-10-24 Marchionni Marco Siringa ad elevata sicurezza di impiego.
WO2016198580A1 (fr) * 2015-06-12 2016-12-15 Becton Dickinson France Adaptateur pour dispositif d'administration de médicament et dispositif d'administration de médicaments
EP3900764A1 (fr) * 2020-04-21 2021-10-27 Becton Dickinson France Récipient médical, adaptateur de montage sur ledit récipient médical et dispositif d'administration de médicaments comprenant ledit récipient médical

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3491757A (en) * 1966-12-30 1970-01-27 Raul Olvera Arce Hypodermic syringe with non-turning tip connector
EP0707859A1 (fr) * 1994-09-28 1996-04-24 Schott Glaswerke Récipient pour le stockage et l'administration de préparations d'injections, d'infusion et de diagnostique
WO1999045985A1 (fr) * 1998-03-13 1999-09-16 Becton Dickinson And Company Procede d'assemblage et de conditionnement de dispositifs medicaux
FR2809316A1 (fr) * 2000-05-26 2001-11-30 Becton Dickinson France Dispositif de connexion etanche a usage medical, du type "luer-lock", et seringue incorporant un tel dispositif
WO2004012797A1 (fr) * 2002-06-26 2004-02-12 Schering Aktiengesellschaft Seringue contenant un liquide medical et liquide a usage medical contenu dans la seringue

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3491757A (en) * 1966-12-30 1970-01-27 Raul Olvera Arce Hypodermic syringe with non-turning tip connector
EP0707859A1 (fr) * 1994-09-28 1996-04-24 Schott Glaswerke Récipient pour le stockage et l'administration de préparations d'injections, d'infusion et de diagnostique
WO1999045985A1 (fr) * 1998-03-13 1999-09-16 Becton Dickinson And Company Procede d'assemblage et de conditionnement de dispositifs medicaux
FR2809316A1 (fr) * 2000-05-26 2001-11-30 Becton Dickinson France Dispositif de connexion etanche a usage medical, du type "luer-lock", et seringue incorporant un tel dispositif
WO2004012797A1 (fr) * 2002-06-26 2004-02-12 Schering Aktiengesellschaft Seringue contenant un liquide medical et liquide a usage medical contenu dans la seringue

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016034779A1 (fr) 2014-09-05 2016-03-10 Guerbet Systeme de maintien d'un adaptateur sur un cone d'extremite d'une seringue, et ensemble comprenant un tel systeme de maintien
AU2016251625B2 (en) * 2015-04-24 2021-02-18 Carlo Giuberchio Syringe with high safety in use
ITMI20150587A1 (it) * 2015-04-24 2016-10-24 Marchionni Marco Siringa ad elevata sicurezza di impiego.
WO2016170150A1 (fr) * 2015-04-24 2016-10-27 MARCHIONNI, Marco Seringue présentant une sécurité élevée lors de l'utilisation
US11266793B2 (en) 2015-04-24 2022-03-08 Aghetto S.R.L. Syringe with high safety in use
CN107810024A (zh) * 2015-04-24 2018-03-16 卡洛·朱贝基奥 在使用中具有高安全性的注射器
CN107810024B (zh) * 2015-04-24 2021-08-17 卡洛·朱贝基奥 在使用中具有高安全性的注射器
KR20180018529A (ko) * 2015-06-12 2018-02-21 벡톤 디킨슨 프랑스 약물 전달 디바이스를 위한 어댑터 그리고 약물 전달 디바이스
RU2713371C2 (ru) * 2015-06-12 2020-02-04 Бектон Дикинсон Франс Переходник для устройства доставки лекарственных средств и устройство доставки лекарственных средств
AU2016277481B2 (en) * 2015-06-12 2020-06-11 Becton Dickinson France Adaptor for a drug delivery device and drug delivery device
US10864331B2 (en) 2015-06-12 2020-12-15 Becton Dickinson France Adaptor for a drug delivery device and drug delivery device
EP3511041A1 (fr) * 2015-06-12 2019-07-17 Becton Dickinson France Adaptateur pour dispositif d'administration de médicaments et dispositif d'administration de médicaments
JP2018519044A (ja) * 2015-06-12 2018-07-19 ベクトン ディキンソン フランス 薬物送達デバイス用のアダプタおよび薬物送達デバイス
WO2016198580A1 (fr) * 2015-06-12 2016-12-15 Becton Dickinson France Adaptateur pour dispositif d'administration de médicament et dispositif d'administration de médicaments
EP4194036A1 (fr) * 2015-06-12 2023-06-14 Becton Dickinson France Adaptateur pour dispositif d'administration de médicament et dispositif d'administration de médicament
KR102549202B1 (ko) 2015-06-12 2023-06-30 벡톤 디킨슨 프랑스 약물 전달 디바이스를 위한 어댑터 그리고 약물 전달 디바이스
US11833339B2 (en) 2015-06-12 2023-12-05 Becton Dickinson France Adaptor for a drug delivery device and drug delivery device
EP3900764A1 (fr) * 2020-04-21 2021-10-27 Becton Dickinson France Récipient médical, adaptateur de montage sur ledit récipient médical et dispositif d'administration de médicaments comprenant ledit récipient médical
WO2021214011A1 (fr) 2020-04-21 2021-10-28 Becton Dickinson France Récipient médical, adaptateur pour montage sur ledit récipient médical, et dispositif d'administration de médicament comprenant ledit récipient médical

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