EP2712603B1 - Récipient médical - Google Patents

Récipient médical Download PDF

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Publication number
EP2712603B1
EP2712603B1 EP13177471.3A EP13177471A EP2712603B1 EP 2712603 B1 EP2712603 B1 EP 2712603B1 EP 13177471 A EP13177471 A EP 13177471A EP 2712603 B1 EP2712603 B1 EP 2712603B1
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EP
European Patent Office
Prior art keywords
connection
closure cap
connection sleeve
medical container
particle
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.)
Active
Application number
EP13177471.3A
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German (de)
English (en)
Other versions
EP2712603A1 (fr
Inventor
Matthias Wesseler
Kerstin Dr. Schöttler
Willy Orszullok
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.)
B Braun Avitum AG
Original Assignee
B Braun Avitum AG
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Publication date
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Publication of EP2712603A1 publication Critical patent/EP2712603A1/fr
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Publication of EP2712603B1 publication Critical patent/EP2712603B1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1431—Permanent type, e.g. welded or glued

Definitions

  • the present invention relates to a medical container, in particular a dialysis infusion fluid container according to the preamble of claim 1.
  • sterile substance also referred to as Fuid
  • the connecting or joining region in the production of a connection of two parts of the container by means of a friction welding method, the connecting or joining region must Particle-tight (fabric-tight) to be completed inside the container to prevent contamination of the substance.
  • a container filled with such a substance often has one or more terminals or ports for removal of the substance, which often have a connector in the form of a screw thread connection.
  • the connectors are usually sealed, for example, by a breakable cap (so-called Orgin Rundsver gleich) sterile.
  • Orgin Rundsver gleich breakable cap
  • the firm connection of this cap to the port is advantageously carried out by means of a friction welding process, as already mentioned above, for example with a rotary friction welding process. In this process, particles of material are formed which are not allowed to enter the interior of the container via the connector, since the substance contained therein would be contaminated, which could lead to unpredictable consequences for a patient to whom this substance is to be supplied (or applied).
  • WO 2010/105775 describes a closure for a fluid space which is formed from two closure parts welded together. It is thus the object of the present invention to keep these particles away from the bag contents (the substance) on the one hand and the connection area of the port on the other hand.
  • a medical container preferably a dialysis infusion container / bag at least one in the container wall integrally integrated connection nozzle, in particular a container outlet nozzle, in the preferably forming a front-side connection-nozzle annular surface a connection sleeve axially protruding inserted, and a closure cap (Orgin Rundsver gleichkappe), which is welded to the connection piece and / or the connecting sleeve that surrounds the connection sleeve material-tight / closes.
  • the medical container according to the invention has a particle trap in the form of a particle collecting chamber for collecting generated in the production of the welded joint radially between the connection sleeve (the free outer surface) and the cap (radial cap inside) and axially between an annular surface of the connection sleeve or the end-piece-annular surface (end face) and a radially spaced therefrom radial projection between the connection sleeve and the closure cap extends, wherein the radial projection protrudes either radially from the connection sleeve radially outwardly or from the closure cap and preferably rests against the respective other component.
  • the medical container according to the invention is preferably a container which can be used in the medical field, in particular a dialysis infusion bag in which a medicinal substance can be taken up in a sterile manner, and ensures the sterility and integrity of the substance by means of the particle barrier when used correctly, the "substance" being used according to the invention an either liquid or solid and free-flowing substance, in particular a medical solution such as an infusion solution or a blood bank or the like is understood.
  • the connection piece is preferably a part of a wall of the container which is formed into a connection piece.
  • the connecting sleeve is inserted / pressed / glued axially projecting into the connecting piece, wherein the axial direction is defined by a longitudinal axis of the connecting piece, which preferably coincides with the longitudinal axes of the connecting sleeve and the closure cap, so that
  • a "radial direction" is a direction perpendicular to the longitudinal direction, which is directed from the longitudinal axis, ie, from the inside to the outside.
  • both parts are material and / or frictionally connected with each other.
  • both parts can be connected to each other by a clearance fit, but this makes an additional seal (see claim 8) mandatory.
  • the connecting sleeve serves to connect the medical container according to the invention to an external device, preferably a tube, which establishes a connection to a patient who is the recipient of the substance.
  • the connecting sleeve is "material-tight" surrounded by the closure cap, so that it is ensured that, in particular, the space bounded by the closure cap and the connecting sleeve is not contaminated by contaminants, in particular germs, which penetrate from the outside. Since the particle collecting chamber according to the invention "to capture produced during the production of the welded joint particles", a contact surface (weld / weld) between the cap and the connection stub to the particle collecting chamber or is substantially in the form of a contact line part of its boundary.
  • the closure cap is welded to the end-side connection-nozzle-annular surface and / or the annular surface of the connection sleeve. That is, according to the invention, the closure cap has a closure cap ring surface which corresponds to the end-side connection-spigot annular surface and is welded thereto, which is aligned with the end side of the connection spout.
  • the connection stub-ring surface is in the form of a flat annular surface whose points are all in a single radial plane.
  • the weld surface is a face-flat surface.
  • the cap and the connection piece can also on non-frontal, radially inside or outside be welded surfaces located.
  • the closure cap may have a sleeve-shaped continuation extending between the connection sleeve and the connection stub and being welded to at least part of its outer surface with a corresponding inner surface of the connection stub.
  • the front-side connection-nozzle-ring surface projects axially from the end-connection-end face. That is, according to this advantageous embodiment, the welding surface does not form a planar annular surface, but preferably forms an annular or band-shaped portion of a lateral surface of a fictitious straight circular cone. Preferably, this surface may be oriented to be generated by the circular cone when its axis of symmetry or center coincides with the longitudinal axis and the tip of which is directed either towards the closure cap or away from the closure cap. According to this advantageous embodiment, a portion of a surface line of the circular cone forms a straight line in the longitudinal section of the connection nozzle. Alternatively, this line may also be curved, preferably in the form of a circle segment.
  • an annular gap forms between the closure cap and the connection piece or the connection sleeve, in particular the radial projection preferably formed on the connection sleeve, and the closure cap, which opens axially into the particle collection chamber.
  • the annular gap has a gap width which is suitable for retaining the particles with the expected particle size.
  • the radial projection may also rest radially on the inside of the closure cap
  • At least one, preferably circumferential, projection protrudes axially from the closure cap and / or the connecting nozzle end face into the particle collecting chamber such that a labyrinth-shaped sealing device acting in the radial direction results within the particle collecting chamber
  • the labyrinth-shaped sealing device in short labyrinth seal, basically serves in particular, to lengthen a gap by interlocking or intersecting shaped elements (protrusions) so as to form a meander-shaped inhibiting structure; a perfect sealing effect is not achieved.
  • the projections are formed and arranged such that in the particle collecting chamber compartments are formed, in which the particles are pressed and molded, so that the transport of further particles is hindered by them.
  • the at least one axial projection is "preferably circumferential" and thus forms an arc of a circle whose center lies on the longitudinal axis, or a complete circle.
  • the closure cap has a first part, which is welded to the connection piece, and a second part with the first material-tightly connected second part, wherein the first and the second part, in particular according to Art a tamper-evident, on a side opposite the particle chamber side of the radial projection are separably connected to each other.
  • the separable connection is preferably designed in the form of a peripheral predetermined breaking point, so that the closure cap for the use of the medical bag according to the invention can be broken off by hand.
  • the first part of the closure cap encloses / surrounds an end portion of the connection nozzle.
  • the connection sleeve is a screw connection sleeve, in particular a Luer lock connection sleeve.
  • the screw connection sleeve preferably has a thread along its outer circumference, which can be connected to a corresponding internal thread of a connection, in particular a connection of a hose or the like.
  • the screw connection sleeve according to the invention is designed as a Luer lock connection sleeve, wherein the external thread is well defined, in particular has a large pitch, and the bushing has the known Luer cone.
  • the connecting sleeve according to the invention may have an internal thread instead of an external thread.
  • the connecting sleeve according to the invention can be threaded, with a smooth outer and inner peripheral surface, so that a rubber hose or the like can be easily attached.
  • the welded joint is a friction-welded joint, in particular a rotary friction-welded joint.
  • the closure cap and the connection stub are rotated relative to each other, wherein they touch each other at their contact surfaces.
  • the resulting friction causes heating and plasticization of the material in the area of the intended weld.
  • At least one or more axially spaced annular seals is arranged between the connection piece and the connecting sleeve.
  • this seal (s) prevents "particles produced during the production of the welded joint" (claim 1) from entering the container, the seal (s) according to this advantageous embodiment preventing the seal generated particles, despite the tightness of the connection sleeve in the connection piece, along the contact surface between the two into the container.
  • Each of these seals is preferably an O-ring or similar seal made of elastic plastic.
  • the radial projection protrudes from the connecting sleeve radially outward and the closure cap has a ring which projects axially into the particle collecting chamber and together with the radial projection and the boundaries of the particle collecting chamber through the connecting sleeve and the Closure cap forms a vertically acting labyrinth-shaped sealing device.
  • the ring also functions as part of a "labyrinth-shaped sealing device acting in the radial direction".
  • the ring interacts with the radial projection in such a way that a meander-shaped channel is formed in the axial direction.
  • the cap has an outer lid, which rests sealingly in the welded state on the free end face of the connection sleeve.
  • an annular seal can be arranged between the closure cap cover and the connection sleeve end face, which is pressed onto the closure cap during the welding process with the axial force applied for this purpose.
  • Fig. 1 is a schematic view in longitudinal section of a part of a medical container according to a preferred embodiment of the present invention, showing in particular a particle barrier according to the invention.
  • connection nozzle 100 the medical container (dialysis infusion container), only a part of which is shown in section.
  • the medical container 10 has a one-piece connection nozzle 100, an external connection sleeve 200, and an external closure cap 300, which are joined together in such a way that their longitudinal axes coincide to form a longitudinal axis A.
  • the connecting piece 100 has an outer diameter d1 and an inner diameter d2 and has a cylindrical recess 102 with a diameter d3 and a depth t, through which an outwardly facing inner shoulder annular surface 104 and an outer connection-socket annular surface (end face ) 106 are formed.
  • the ferrule 200 has an axially three-step lead-through 202 which penetrates longitudinally thereof and is divided into a large-diameter lower portion 204, a small-diameter upper portion 206, and an intermediate-diameter portion 208 interposed therebetween.
  • the lower portion 204 and the middle portion 208 are each formed substantially as a straight circular cylinder, while the upper portion 206 is formed on the inside in the form of a truncated cone, which widens slightly upwards.
  • connection sleeve 200 can be divided functionally and thus structurally into three sections, which correspond in their spatial extent along the longitudinal axis A approximately to the sections 204, 206, 208 of the bushing 202.
  • connection sleeve 200 has a lower insertion section 210, an upper connection section 212 and a middle or particle chamber section 214 arranged therebetween.
  • the insertion portion 210 has an outer diameter that is substantially equal to the diameter d3 of the recess 102 and a height that is substantially equal to the depth t of the recess 102.
  • the ferrule 200 is inserted into the recess 102 so that its lower end is in abutment with the inner shoulder annular surface 104.
  • the insert portion 210 is bounded at the top by a particle chamber annular surface 218, which forms a lower boundary of a particle collection chamber 220 and merges (flush) radially outward into the connection nozzle annular surface 106.
  • the particle chamber portion 214 further includes an outer and circumferential radial projection 222 at an axial distance to the particle chamber annular surface 218, which forms an upper boundary of the particle collecting chamber 220.
  • An axial portion of the outer circumferential surface of the particle chamber portion 214 arranged between the particle chamber annular surface 218 and the radial projection 222 forms a radially inner boundary of the particle collection chamber 220.
  • the terminal portion 212 of the ferrule 200 which extends above the radial projection 222, has an external thread 224.
  • the closure cap 300 has a first part 302 and a second part 304, which are connected to each other in a fluid-tight but separable manner by a circumferential predetermined breaking point or seam 306.
  • the second part 304 forms a connecting piece 100 encompassing sleeve portion which is closed at its upper end by a centrally-perforated lid 308, which is preferably formed integrally with it.
  • the first part 302 forms through the lid 306 a radial inner shoulder (axial annular projection on the lid 306), which is welded along an annular welding surface 310 by rotational friction welding to the connection-nozzle annular surface 106.
  • a radial inner shoulder axial annular projection on the lid 306
  • the materials of the first part 302 and the connection piece 100 in the region of the welding surface 310 are softened and plastically deformable, connecting under axial external pressure on the cap and so form a weld, which is adjacent to the particle trap chamber 220 directly.
  • a ring is arranged on the perforated lid, which protrudes axially from above into the particle collecting chamber 220 and thus represents a flow obstacle for a particle flow from radially outside to radially inside.
  • annular gap 304 is formed, which forms a close connection between the particle-collecting chamber 220 and between the second part 304 and the second Connecting sleeve 200 formed space 308 manufactures.
  • the second part 304 of the closure cap forms a sleeve which encloses the connection sleeve 200 and is connected to the first part 302 via the predetermined breaking point above the radial projection 222.
  • the space 308 is necessary to exert no forces on the ferrule 200 when breaking off / twisting off the second part 304, which is usually slightly deformed during this process.
  • another ring element 312 is inserted at the inner radial shoulder of the first part 302, such that it protrudes axially into the collecting chamber in the direction of the connecting piece annular surface or to the annular surface of the connecting sleeve.
  • the second part 304 of the closure cap finally has an upper sealing plate, which bears sealingly against the free end face of the connecting sleeve, with a seal between, for example, in the form of an O-ring being inserted therebetween.
  • the particle barrier according to the invention is thus formed by the particle collecting chamber 220, in particular by the outer contour of the particle chamber section 214 and the inner contour of the first part 302.
  • a particle created during the manufacture of the weld would have to travel a tortuous path that winds around the ring 312 and the radial projection 222 to escape from the Weld seam into the room 308 and from there finally to get inside the medical container.
  • the particulate collection chamber 220 may further include, in addition to the shown ring 312, a plurality of axial protrusions (not shown) projecting from above and below, which together with the ring 312 create a labyrinth seal effect in a radial plane.
  • At least one seal 314 or a plurality of axially spaced seals is disposed between the fitting 100 and the fitting sleeve 200, more specifically, between an outer surface of the fitting portion 210 and an inner peripheral surface of the recess 102.
  • the second part 304 of the closure cap 300 is broken off its first part 302 and the connection sleeve 200, for example, connected to a tube which is connected at its other end, for example, with a cannula, via the one in the Container 10 received substance, for example, an infusion solution, supplied to a patient (or applied) is.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)

Claims (10)

  1. Récipient médical comprenant une tubulure de raccordement (100), en particulier une tubulure d'évacuation de récipient, dans laquelle est insérée, en formant une surface annulaire de tubulure de raccordement (106) côté frontal, une douille de raccordement (200), laquelle dépasse axialement de celle-ci, et comprenant un bouchon (300), qui est soudé sur la tubulure de raccordement (100) et/ou sur la douille de raccordement (200) de telle manière qu'il entoure de manière étanche aux matières la douille de raccordement (200), caractérisé par une barrière antiparticules se présentant sous la forme d'une chambre de collecte de particules (220) servant à collecter des particules générées lors de la production de la liaison par soudure, qui s'étend radialement entre la douille de raccordement (200) et le bouchon (300) et axialement entre une surface annulaire (218) de la douille de raccordement (200) et/ou la surface annulaire de tubulure de raccordement (106) et une portion faisant saillie radiale (222) espacée axialement de celle-ci, laquelle portion faisant saillie radiale dépasse soit radialement vers l'extérieur depuis la douille de raccordement (200) soit radialement vers l'intérieur depuis le bouchon (300).
  2. Récipient médical selon la revendication 1, caractérisé en ce que le bouchon (300) est soudé sur la surface annulaire de tubulure de raccordement (106) côté frontal et/ou sur la surface annulaire de la douille de raccordement (200).
  3. Récipient médical selon la revendication 2, caractérisé en ce qu'est réalisée, entre la portion faisant saillie radiale (222) et le bouchon (300) ou la douille de raccordement (200), une fente annulaire, qui présente une largeur de fente ayant un effet de retenue de particules, de sorte que les particules y restent coincées.
  4. Récipient médical selon l'une quelconque des revendications 1 à 3, caractérisé en ce qu'au moins une portion faisant saillie (312), de préférence périphérique, dépasse axialement dans la chambre de collecte de particules de telle manière qu'il en résulte, à l'intérieur de la chambre de collecte de particules, un dispositif d'étanchéité sous forme de labyrinthe ayant un effet dans la direction radiale.
  5. Récipient médical selon l'une quelconque des revendications 1 à 4, caractérisé en ce que le bouchon de fermeture (300) présente une première partie (302), qui est soudée sur la tubulure de raccordement (100), et une deuxième partie (304) reliée de manière étanche aux matières à la première partie (302), la première et la deuxième partie (302, 304) étant reliées l'une à l'autre de manière séparable, en particulier à la manière d'une fermeture inviolable, sur un côté de la portion faisant saillie radiale (222) opposé axialement à la chambre de particules.
  6. Récipient médical selon la revendication 5, caractérisé en ce que la première partie (302) du bouchon de fermeture (300) entoure de manière étanche aux fluides une portion d'extrémité libre de la tubulure de raccordement (100).
  7. Récipient médical selon l'une quelconque des revendications 1 à 6, caractérisé en ce que la douille de raccordement (200) est une douille de raccordement par vissage, en particulier une douille de raccordement Luer-Lock.
  8. Récipient médical selon l'une quelconque des revendications 1 à 7, caractérisé en ce que la liaison par soudage est une liaison par soudage à friction, en particulier une liaison par soudage à friction en rotation.
  9. Récipient médical selon l'une quelconque des revendications 1 à 8, caractérisé en ce qu'est disposé, entre la tubulure de raccordement (100) et la douille de raccordement (200), un joint d'étanchéité (314) de forme annulaire ou plusieurs joints d'étanchéité espacés axialement.
  10. Récipient médical selon l'une quelconque des revendications 1 à 9, caractérisé en ce que la portion faisant saillie radiale (222) dépasse radialement vers l'extérieur de la douille de raccordement (200), et en ce que le bouchon (300) présente une bague (312), qui dépasse dans la chambre de collecte de particules depuis un épaulement du bouchon (300) et qui forme, conjointement avec la portion faisant saillie radiale (222) et les délimitations de la chambre de collecte de particules par la douille de raccordement (200) et le bouchon (300), un système d'étanchéité d sous forme de labyrinthe ayant un effet dans la direction verticale.
EP13177471.3A 2012-09-28 2013-07-22 Récipient médical Active EP2712603B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE201210109199 DE102012109199A1 (de) 2012-09-28 2012-09-28 Medizinischer Behälter

Publications (2)

Publication Number Publication Date
EP2712603A1 EP2712603A1 (fr) 2014-04-02
EP2712603B1 true EP2712603B1 (fr) 2015-06-24

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Application Number Title Priority Date Filing Date
EP13177471.3A Active EP2712603B1 (fr) 2012-09-28 2013-07-22 Récipient médical

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EP (1) EP2712603B1 (fr)
DE (1) DE102012109199A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102016116098A1 (de) 2016-08-30 2018-03-01 B. Braun Avitum Ag Verschlusskappe für einen kartuschenförmigen Behälter

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10223560B4 (de) * 2002-05-27 2006-01-19 Fresenius Kabi Deutschland Gmbh Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten
DE102004033205A1 (de) * 2004-07-09 2006-02-09 Fresenius Kabi Deutschland Gmbh Steriler Port
EP2408571B1 (fr) * 2009-03-17 2015-09-16 Boehringer Ingelheim International GmbH Reservoir et pulverisateur

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DE102012109199A1 (de) 2014-04-03
EP2712603A1 (fr) 2014-04-02

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