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WO2025099108A1 - Ensemble bouchon de piston pour seringue médicale - Google Patents

Ensemble bouchon de piston pour seringue médicale Download PDF

Info

Publication number
WO2025099108A1
WO2025099108A1 PCT/EP2024/081413 EP2024081413W WO2025099108A1 WO 2025099108 A1 WO2025099108 A1 WO 2025099108A1 EP 2024081413 W EP2024081413 W EP 2024081413W WO 2025099108 A1 WO2025099108 A1 WO 2025099108A1
Authority
WO
WIPO (PCT)
Prior art keywords
plunger stopper
plunger
barrel
side wall
coupling element
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.)
Pending
Application number
PCT/EP2024/081413
Other languages
English (en)
Inventor
Harry Pütter
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.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
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 Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of WO2025099108A1 publication Critical patent/WO2025099108A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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

Definitions

  • the invention relates to a plunger stopper assembly comprising a plunger stopper comprising an end wall and a side wall; and a plunger rod detachably connectable to the plunger stopper.
  • the invention also relates to a medical syringe comprising the plunger stopper assembly and to a method for inserting a plunger stopper assembly into a barrel of a medical syringe.
  • Syringe assemblies are used to hold, transport, and deliver liquids.
  • syringes are often utilized in medical environments to administer one or more medicinal components to a patient.
  • Syringes can be delivered to a user empty or prefilled. Empty syringes are intended to be filled by the user from a vial or other container, whereas prefilled syringes are supplied to the user with a liquid (e.g., medicament or diluent) provided therein by a manufacturer.
  • a liquid e.g., medicament or diluent
  • a plunger rod When using prefilled syringes, a plunger rod is often installed by the user to a plunger stopper assembly prior to use by inserting the plunger rod into the syringe barrel through a rear end, which can be also referred to as inlet end portion and bringing an end section of the plunger rod into engagement with the plunger stopper assembly.
  • a plunger stopper By sliding an end wall of the plunger stopper, which is attached to a forward end of the plunger stopper, and which can be referred to as plunger, down the syringe barrel from the rear end, drawing or dispensing of a medicament is performed.
  • EP 2 060 290 B1 describes a medical syringe comprising such a screw connection.
  • the plunger stopper comprises a coupling element configured to be transferable between an open position and a closed position, wherein the coupling element is adapted to receive at least part of an end section of the plunger rod in the open position, and to interlock the end section with the plunger stopper in the locked position.
  • the end section of the plunger rod can comprise a groove, undercut, or indentation, in particular a ring-shaped groove, in the material of the plunger rod which can extend fully or in part around the circumference of the end section, so that the coupling element or a part of the coupling element can engage with the groove when transferred from the open position into the locked position to interlock the end section with the plunger stopper.
  • the coupling element can also be referred to as push fitting element, quick connect fitting element, quick coupler, or just as coupler etc. and can be comprised within the plunger stopper, such as being realized by sections of the side wall of the plunger stopper that are moved to engage with the plunger rod, when the plunger stopper is pushed inside the barrel of a medical syringe.
  • the coupling element could be also provided separately for attaching it to the plunger stopper.
  • a prefilled syringe can be delivered with the plunger stopper in a back position, a so-called parking position, where the plunger stopper is arranged at the inlet end portion of the syringe, but still seals the liquid provided therein from an outside environment.
  • the coupling element is in an open position to receive the end section of the plunger rod.
  • the coupling element can be transferred from the open position into the closed position by moving the coupling element past the inner surface of the barrel, which has a cross section with a diameter being the same size or just slightly larger than the cross section of the plunger stopper.
  • the coupling element can comprise at least one locking element that automatically engages with the end section of the plunger rod if the plunger rod is pushed into the coupling element.
  • the plunger rod In the closed position, the plunger rod is safely coupled to the plunger stopper. Thereby, unintentionally disconnecting the plunger rod from the plunger stopper can be avoided and an accurate coupling of the plunger rod to the plunger stopper without clearance can be provided, which increases the flow rate accuracy of the syringe.
  • the plunger rod and plunger stopper can be pulled back into the back position. When the plunger stopper reaches the back position, the coupling element is transferred into the open position and the plunger rod can be removed again from the plunger stopper.
  • the coupling element can be automatically transferred into the open position, e.g. by means of an elastic material of the plunger stopper.
  • the coupling element can be manually transferred into the open position, e.g. by the user triggering a release mechanism of the coupling element.
  • the plunger stopper assembly as described herein allows to design plunger rod as a re-usable part to reduce material consumption.
  • the plunger rod can be reusable part since it does not come in contact with any substances within a syringe.
  • Packages containing numerous pre-filled syringes comprising plunger stopper assembly as previously described, and of the same kind might be equipped with a number of plunger rods, less than the number of pre-filled syringes to save parts and resources.
  • the plunger rod comprises a groove, in particular a ring-shaped groove, in the material of the plunger rod, which extends fully or in part around the circumference of the end section for engaging with the coupling element.
  • the term “groove” can be also understood as undercut, or as an indentation in the material of the plunger rod.
  • the groove (or multiple groves) can be arranged in the material of the plunger rod to form a triangular, conical, or a ball shaped end of the plunger rod that is at least in part encaseable by the coupling element in the locked position.
  • the coupling element is at least in part comprised within the side wall of the plunger stopper.
  • the plunger stopper can comprise an elastic material, such as a rubber or silicone material, and the coupling element can be formed at least in part from the side wall, or from side wall sections of the plunger stopper.
  • the coupling element is comprised by at least two side wall sections, in particular two circular segment sections, wherein each side wall section is foldably arranged on the end wall between the open position and the closed position.
  • the end wall can be the “actual plunger” or the plunger section that is in contact with the liquid inside the barrel of the syringe.
  • the actual plunger can be a separate part and the end wall can be in contact with the actual plunger.
  • the side wall can be attached to the rim of the end wall and extend from the rim of the end wall in an angle of approximately 90° and can enclose a void or an open space in which the end section of the plunger rod can pe pushed into.
  • the plunger stopper can be essentially shaped like a cup.
  • the at least two side wall sections can be formed by creating slots or incisions running through the material of the side wall separating the side wall in two or more side wall sections that are still attached to the end wall but can move about the point where the side wall sections are attached to the end wall, for example this point/these points can be realized as film hinge.
  • the material of the side wall sections can be in part displaced/moved outside by the material of the end section of the plunger rod, i.e. moved in a direction perpendicular, or essentially perpendicular, to an insertion direction of the plunger stopper into the syringe barrel.
  • the side wall sections are moved, e.g. squeezed, towards the inside by the inside of the perimeter wall of the barrel, so that the end section of the plunger rod is held tightly by the side wall sections forming the coupling element.
  • the at least two side wall sections of the side wall are configured to fold in a direction towards each other to engage with the end section of the plunger rod to interlock the end section with the plunger stopper in the closed position.
  • the end wall merges with the side wall sections into a first sealing ring, which extends around the circumference of the side wall.
  • the first sealing ring can seal against the inside of the barrel of the syringe when the plunger stopper is arranged inside the barrel.
  • the side wall comprises at least one further sealing ring extending around the circumference of the side wall.
  • the second sealing ring can be formed as protrusions on the respective side wall sections, can run parallel to the first sealing ring, and can seal against the inside of the barrel in addition to the fist sealing ring.
  • the plunger stopper is formed in one single part or formed in multiple parts.
  • the plunger stopper can be assembled from different parts comprising different materials.
  • the plunger stopper is formed in three parts, the end wall comprising a metal or plastic material, a body of the plunger stopper comprising a rubber or silicon material for sealing against a barrel of the syringe, and the coupling element comprising a plastic material.
  • the three parts can be assembled/mounted together to form the plunger stopper described herein.
  • the end wall is conically shaped in a distal direction.
  • distal direction refers to a direction towards an outlet portion of the syringe, i.e. where the needle is installed.
  • a conically shaped end forming the plunger allows to empty the entire liquid from the inside of the barrel through the outlet portion when the plunger stopper is moved inside the barrel towards the outlet portion.
  • the invention also relates to a medical syringe comprising a barrel configured to receive a liquid and a plunger stopper assembly, as described herein, wherein the plunger stopper of the plunger stopper assembly is slidably disposed within the barrel between an inlet end portion of the barrel and an outlet end portion of the barrel, located opposite to the inlet end portion.
  • the barrel comprises a retention element arranged at the inlet end portion, wherein the retention element is adapted to restrict a movement of the end wall of the plunger stopper beyond the inlet end portion out of the barrel, and to transfer the coupling element into the open position when the plunger stopper, or the end wall of the plunger stopper, contacts the retention element.
  • the retention element can be arranged at the inside of the inlet opening of the barrel.
  • the retention element can allow the plunger stopper to move partly out of the barrel, such as for example allowing the side walls or part of the side walls of the plunger stopper to move out of the barrel so that the side walls can move to the side releasing the grip from the plunger rod.
  • the retention element can be also referred to as barrel stop ring.
  • the retention element comprises a bulge element, adapted to at least partly reduce an inner diameter of the barrel.
  • the barrel is pre-filled with a medical liquid and sealed with the plunger stopper, and wherein the medical syringe is autoclaved in an outer package in which the medical syringe is disposed.
  • the invention also relates to a method for inserting a plunger stopper assembly, in particular a plunger stopper assembly as described herein, comprising a plunger stopper and a plunger rod into the barrel of a medical syringe, comprising: inserting at least part of an end section of a plunger rod into the plunger stopper arranged at an inlet opening of the barrel, and pushing the plunger stopper inside the barrel of the medical syringe from an inlet end portion of the barrel towards an outlet end portion, located opposite the inlet end portion, to transfer the coupling element into a locked position to interlock the end section of the plunger rod with the plunger stopper in the locked position.
  • Fig. 1 shows a side view of the plunger stopper assembly together with a medical syringe, wherein the coupling element is shown in an open position;
  • Figs. 2A, 2B show side views of the plunger stopper, wherein the coupling element is shown in the open position and in the closed position;
  • Fig. 3 shows a side view of the plunger stopper assembly together with a medical syringe, wherein the end section of the plunger rod being inserted into the coupling element, and the coupling element is shown in the open position
  • Fig. 4 shows a side view of the plunger stopper assembly together with a medical syringe, wherein the end section of the plunger rod is inserted into the coupling element, and the coupling element is shown in the closed position;
  • Fig. 5 shows steps of a method for inserting a plunger stopper assembly into a barrel of a medical syringe.
  • Figure 1 shows a plunger stopper assembly 1 and a medical syringe 100.
  • the plunger stopper assembly 1 according to the embodiment shown in figure 1 comprises a plunger stopper 3 which comprises an end wall 35 and a side wall 33A, 33B.
  • the shown plunger stopper assembly 1 also comprises a plunger rod 5.
  • the coupling element 31 of the plunger stopper 3 is comprised within the side wall 33A, 33B and is configured to be transferable between the open position shown in figures 1 and 2A and the closed position shown in figures 4 and 2B. In the open position, the coupling element can receive part of the end section 51 of the plunger rod 5 and interlock the end section 51 of the plunger rod 5 in the material of the plunger stopper 3 in the locked position, shown in figure 4.
  • the end section 51 of the shown plunger rod 5 comprises a groove 53 in the material of the plunger rod 5 which extends around the circumference of the end section 51 , so that the coupling element 31 can engage with the groove 53 when the coupling element 31 is transferred from the open position into the locked position.
  • the end section 51 of the plunger rod 5 has essentially a triangular cross section and is encased by the coupling element 31 in the locked position.
  • the end section 51 When encased by the coupling element 31 , the end section 51 is encased/enclosed in the space surrounded by the end wall 35 and side wall sections 33A, 33B, In the shown embodiment the space surrounded by the end wall 35 and side wall sections 33A, 33B comprises essentially a complementary cross section to the end section 51.
  • the coupling element 31 is comprised within the shown side wall sections 33A, 33B, which are shown in the present embodiment as two circular segment sections.
  • Each one of the side wall sections 33A, 33B is moveably, e.g. foldably, arranged on an end section 32 of the plunger stopper 3.
  • the shown end wall 35 can be understood as the actual plunger or plunger section that is in contact with the liquid inside the barrel 101 of the syringe 100, and which pushes the liquid towards the outlet portion when moved in insertion direction I, which is indicated by an arrow in figure 1.
  • the plunger element 5 is moved along the insertion direction I into the barrel 101.
  • the shown syringe 100 includes a tubular barrel 101 defining an elongated and generally cylindrical chamber having a first diameter. Extending outwardly in insertion direction I from the barrel 101 is the outlet portion which can terminate in a delivery port (not shown in figure 1). The barrel 101 terminates at its back end at the inlet portion, which can be also referred to as a rear port from which outwardly extend transverse and opposing barrel flanges 105. The inlet portion is sized to receive the elongated syringe plunger rod 5 on which the plunger stopper 3 is mounted, as is described in further detail below. The plunger stopper 3 having a second diameter that is the same or smaller than the first diameter of the barrel 101 when the elastic material of the plunger stopper 3 is compressed.
  • Figure 2A shows a side view of the plunger stopper 3 with the coupling element 31 in the open position
  • figure 2B shows a side view the plunger stopper 3 with the coupling element 31 in the closed position.
  • the side wall 33A, 33B is attached to the rim of the end wall 35 and extends from the rim of the end wall 35 in an angle of approximately 90° from the end wall 35 to enclose an open space in which the end section of the plunger rod can be pushed into.
  • the plunger stopper 3 is essentially shaped like a cup and is made from an elastic material, such as for example from a rubber or silicone material in a molding process.
  • the two side wall sections 33A, 33B are formed by separating a section of the side wall into the two shown side wall sections 33A, 33B that are attached to the end section 32 of the plunger stopper 3 which is located opposite to the end wall 35.
  • the side wall sections 33A, 33B can move, i.e. elastically move, about the point where the side wall sections 33A, 33B are attached to the end section 32 of the plunger stopper 3.
  • more than two side wall sections can be realized, such as for example four side wall sections can be realized.
  • two sealing rings 37A, 37B extend around the circumference of the plunger stopper 3.
  • Figure 3 shows a side view of the plunger stopper assembly 1 and a medical syringe 100, wherein the end section 51 of the plunger rod 5 is being inserted into the coupling element 31 .
  • the coupling element 31 is shown in the open position.
  • the plunger stopper assembly 1 of figure 1 is shown.
  • the plunger rod 5 in figure 3 is pushed further towards the barrel 101 in insertion direction I indicated by the arrow in figure 3.
  • the end section 51 of the plunger rod 5 is pushed into the open space or void enclosed by the end wall 31 and the side wall sections 33A, 33B.
  • the elastic material of the side wall sections 33A, 33B can be in part displaced/moved outside by the material of the end section 51 of the plunger rod 5 in a direction essentially perpendicular to the insertion direction I.
  • Figure 4 shows a side view of the plunger stopper assembly 1 and a medical syringe 100, wherein the end section 51 of the plunger rod 5 is inserted into the coupling element 31.
  • the coupling element 31 is shown in the closed position.
  • the side wall sections 33A, 33B are pushed towards the inside, i.e. towards the inserted end section 51 of the plunger rod 5. This is caused by pushing or squeezing the plunger stopper 3 into the barrel 101.
  • the inside of the perimeter wall of the barrel 101 constricts the lateral extension of the side wall sections 33A, 33B, when the side wall sections 33A, 33B are introduced in insertion direction I into the barrel 101 , so that the end section of the plunger rod 5 is held tightly by the side wall sections 33A, 33B forming the coupling element 3.
  • the first sealing ring 37A and the further sealing ring 37B seal against the inside of the barrel 101.
  • a retention element 103 a so-called “barrel stop ring”, arranged at the inside of the inlet end portion.
  • the retention element 103 is adapted to restrict a movement of the end wall 35 of the plunger stopper 3 against the insertion direction I out of the barrel 101
  • the shown retention element 103 reduces the inside diameter of a section of the barrel 101 and thereby restricts a movement of the end wall 35 of the plunger stopper 3 beyond the inlet end portion out of the barrel 100 in a direction opposite to the insertion direction I.
  • Figure 5 shows steps of a method 1000 for inserting a plunger stopper assembly into a barrel of a medical syringe.
  • the method comprises the following steps: Inserting 1002 at least part of an end section of a plunger rod into the plunger stopper arranged at an inlet opening of the barrel; and

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 bouchon de piston (1) pour une seringue médicale (100), l'ensemble bouchon de piston (1) comprenant un bouchon de piston (3) comprenant une paroi terminale (35) et une paroi latérale (33A, 33B) ; et une tige de piston (5), le bouchon de piston (3) comprenant un élément d'accouplement (31) conçu pour être transférable entre une position ouverte et une position fermée, l'élément d'accouplement (31) étant adapté à recevoir au moins une partie d'une section terminale (51) de la tige de piston (5) dans la position ouverte, et pour verrouiller la section terminale (51) de la tige de piston (5) avec le bouchon de piston (3) dans la position verrouillée. En outre, l'invention concerne une seringue médicale (100) et un procédé (1000) pour insérer un ensemble bouchon de piston (1) dans un cylindre (101) d'une seringue médicale (100).
PCT/EP2024/081413 2023-11-10 2024-11-07 Ensemble bouchon de piston pour seringue médicale Pending WO2025099108A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23208951 2023-11-10
EP23208951.6 2023-11-10

Publications (1)

Publication Number Publication Date
WO2025099108A1 true WO2025099108A1 (fr) 2025-05-15

Family

ID=88779873

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2024/081413 Pending WO2025099108A1 (fr) 2023-11-10 2024-11-07 Ensemble bouchon de piston pour seringue médicale

Country Status (1)

Country Link
WO (1) WO2025099108A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5947935A (en) * 1996-11-12 1999-09-07 Medrad, Inc. Syringes, syringe plungers and injector systems
US20040158205A1 (en) * 2000-07-10 2004-08-12 Savage Rodney Brian Medical injector systems
US20080082055A1 (en) * 2006-09-29 2008-04-03 Tyco Healthcare Group Lp Detachable plunger rod syringe
EP2060290B1 (fr) 2007-11-19 2011-02-02 Daikyo Seiko, LTD. Seringue et tige du piston d'injection

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5947935A (en) * 1996-11-12 1999-09-07 Medrad, Inc. Syringes, syringe plungers and injector systems
US20040158205A1 (en) * 2000-07-10 2004-08-12 Savage Rodney Brian Medical injector systems
US20080082055A1 (en) * 2006-09-29 2008-04-03 Tyco Healthcare Group Lp Detachable plunger rod syringe
EP2060290B1 (fr) 2007-11-19 2011-02-02 Daikyo Seiko, LTD. Seringue et tige du piston d'injection

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