WO1982004398A1 - Agencement de poches plastiques en particulier pour les perfusions et procede de fabrication - Google Patents

Agencement de poches plastiques en particulier pour les perfusions et procede de fabrication Download PDF

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Publication number
WO1982004398A1
WO1982004398A1 PCT/SE1982/000209 SE8200209W WO8204398A1 WO 1982004398 A1 WO1982004398 A1 WO 1982004398A1 SE 8200209 W SE8200209 W SE 8200209W WO 8204398 A1 WO8204398 A1 WO 8204398A1
Authority
WO
WIPO (PCT)
Prior art keywords
channel portion
liquid
channel
sealing plug
sealing
Prior art date
Application number
PCT/SE1982/000209
Other languages
English (en)
Inventor
System Ab Fiab
Original Assignee
Niklasson Tage
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
Priority claimed from SE8104346A external-priority patent/SE8104346L/xx
Priority claimed from SE8106012A external-priority patent/SE8106012L/xx
Application filed by Niklasson Tage filed Critical Niklasson Tage
Publication of WO1982004398A1 publication Critical patent/WO1982004398A1/fr

Links

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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers

Definitions

  • the present invention relates to an arrangement for bags especially for infusion and made from at least two layers of plastic foil which are welded together along a continuous weld seam so. that a space is formed for a liquid, especially for infusion purposes, the said liquid space being arranged so that via one or more connection points it is connected to further arrangements such as a filling arrangement for filling it with liquid, a drain tube, an injection needle or the like, and where at least one connection point is designed as a channel section with firstly an inner connecting member for the liquid space in the bag, the said member comprising a pierc able parting wall located at some distance from the far end of the channel section and secondly an external connecting member which is designed to seal off the channel section also outside the said piercable parting wall and to be opened to permit the introduction of some of the said external arrangements through the outer end and through the pierc-able separating wall.
  • the present invention relates also to a method for manufacture in accordance with the preamble to patent claim 8.
  • the aim of the present invention is to rationalise the manufac ture of infusion bags and to reduce production costs by reducing the number of connection points to the bag interior.
  • the said objective is achieved by means of an arrangement in accordance with the present invention which is characterised in that the said piercable separating wall forms part of a separate connection plug, that the sealing plug and the said outer connecting members are arranged to be inserted in the said channel section only after the liquid has been poured in, that the said channel section is open during one filling stage and serves as inlet for liquid to the said liquid space and subsequently in an emptying stage functions as outlet after opening of the outer connecting member and piercing of the wall of the sealing plug by some of the said external arrangements.
  • the said objective is also achieved by means of a procedure in accordance with the present invention which is characterised in that the said channel section is provided, during the production of the bag, with a completely open through cavity, that the said channel section in one filling stage is employed as inlet and connected to the said filling arrangement, whereby liquid is poured in, and that a sealing plug having the said piercable separating wall is inserted in the said channel section, that the external sealing member is connected to the outer end of the channel section, as a result of which the filled bag is kept sealed until during an emptying stage the liquid space in the bag is made accessible by the opening of the outer sealing member and piercing of the piercable separating wall.
  • fig. 1 shows a partially broken view of an infusion bag in accordance with the invention
  • fig. 2 provides a partially broken side view of the bag
  • fig. 3 shows a view from the front of a connecting piece forming part of the bag having a sealing foil which seals off the connecting piece
  • fig. 4 shows a view of the connecting piece with an associated sealing plug prior to its assembly in the connection piece
  • fig. 5 gives a side view of the connecting piece illustrated in fig.4 with the sealing plug assembled in position
  • fig. 6 shows the said sealing foil separately.
  • Fig. 7 gives a partially broken view of the bag in a second embodiment, fig.
  • fig. 9 shows a variation of the bag in accordance with the invention, the view corresponding essentially with that in fig. 1, fig. 10 is a view from the front of the variant as in fig. 9, and fig. 11 shows an exploded view of a separate channel section forming part of the arrangement in accordance with the invention.
  • an Infusion bag 1 is formed by two plastic foils, made for example fromplasticised polyvinyl chloride or a tube shaped plastic foil which is welded together along a weld seam 3, so that two plastic foil layers are formed which are not connected with each other in a centre area so that a space 4 is formed for the bag contents.
  • the contents can for example be glucose or blood.
  • the edge portions at the ends are welded with double weld areas so that broader sections are formed for the attachment of supplementary items such as corner zones so as to facilitate the handling of the bag, holes 7 for hanging up the bag during its emptying stage, and a moulded connecting piece 8.
  • the connecting piece 8 has two connections in the form of two tubular channel sections, a first channel section 16 with a cavity 17 and a second channel section 18 with a cavity 19.
  • the two channel sections 16, 18 are united by means of a platform-like connecting portion 20 which holds the channel portions together so that these together with the connecting portion and a flange portion 21 which extends in front of the channel portions, form one piece of material.
  • This is made in a somewhat more rigid material than the remaining portions of the bag and is for example made from unplasticised polyvinyl chloride.
  • the inner tubular ends 22 of both channel portions 16, 18 extend for some distance inside the liquid space 4 of the bag.
  • the outer ends 23, 24 of both channel portions 16, 18 are sealed by a sealing foil 25 of plastic film, e.g. plasticised polyvinyl chloride.
  • the sealing foil covers the whole of the flange portion 21 which is common to the entire connecting piece 8 and extends beyond both ends of the flange portion by way of two tab sections 26. These are provided with fluted portions 27 so as to provide a safe grip for the user.
  • the sealing foil 25 has two V-shaped tear initiation points 28 facing each other, as also indicated in fig. 6, where the sealing foil 25 is shown separately prior to its attachment to the flange portion 21. As indicated in fig. 3 the sealing foil 25 has become somewhat deformed during attachment to the flange portion.
  • the sealing foil 25 is welded firmly to the flange portion 21 by high-frequency welding, the sealing foil being connected with the flange portion by means of a "half weld seam" 29 which runs in the manner shown in fig. 3 and extends along both long edge portions 30, 31 of the flange portion and beyond the outer ends 23 of both channel portions 16, 18.
  • a "half weld seam" 29 which runs in the manner shown in fig. 3 and extends along both long edge portions 30, 31 of the flange portion and beyond the outer ends 23 of both channel portions 16, 18.
  • the half veld seam 29 proceeds around both ends of the channel portions, thereby sealing these.
  • the half weld seam 29 is not completely welded to the flange along its entire length, but instead is more or less "spot welded" along a plurality of smaller areas,arranged at intervals, as shown in fig.3- Between these areas the foil is not completely welded to the flange but does adhere to this, but in such a way that a liquid-tight and high-quality sterile seal of both channel portions 16, 18 is obtained.
  • This type of weld facilitates the tearing off of both portions of the sealing foil 25 which are located beyond the tear initiation lines 28. However in a central veld zone 32 full welding is undertaken so as to completely separate the outer ends 23, 24 of both channel portions 16, 18 from each other.
  • the sealing plug 33 in accordance with the first embodiment furthermore is provided with a collar
  • the second channel portion 18 similarly has a membrane 38 in cavity 19 located at a distance from the outer end 23 of the cavity.
  • this membrane 38 can be arranged per manently in a conventional manner.
  • a plug 39 is inserted made of an elastic material such as rubber or the like. This plug 39 is intended to ensure self sealing after a hypodermic syringe has been introduced into the channel portion 18.
  • This connecting point which is formed by channel portion 18 is for example designed for the supply of medicaments by means of a hypodermic syringe or the like.
  • a ring-shaped portion 40 having a channel 41 is inserted in front of plug 39 and forms a guide for the inserted tip of the hypodermic syringe so that this is introduced in a fairly straight manner through the cavity 19 of channel portion 18.
  • the inner, inwardlyprojecting, ends 22 of both channel sections have recesses 42, more particularly two recesses for each channel portion. These recesses 42 extend from the inner ends 22 of the channel portions up to the edge portion 43 of the liquid space formed by the weld seam 3 which encloses the liquid space 4.
  • the two channel sections 16, 18 project inwardly for some distance into the liquid space 4, this prevents the tip of an inserted hypodermic needle from accidentally piercing a hole in the plastic foil 2, whilst at the same time the recesses 42 ensure that the liquid contents can be emptied completely through the connections.
  • the recesses 42 impart flexibility to the inwardly projecting ends 22 so that a smooth transition is obtained from the thicker connecting piece 8 to the thinner liquid space 4, as indicated by fig. 2.
  • a leak-proof seal around the connecting piece 8 is obtained by welding the two layers of plastic foil 2 to the connecting piece on both sides of the latter, firstly across a weld zone 44 which connects the layer of plastic foil with the connecting section 20 and secondly along a weld seam 45 which extends around the outside of each of the two channel sections 16, 18 on either side of the connecting piece, the weld seas 45 connecting up with weld seam 3 which proceeds around the liquid space 4.
  • Fig. 7 and 8 illustrate a second embodiment of the invention where the sealing plug, which in this example is designated as 46, is designed without a collar. Otherwise, in this example also the sealing plug has a tubular cylindrical portion 47 and bottom membrane 48. Instead of the collar, the cavity 17 of the channel portion is provided with a stage-wise reduction in diameter in the direction into the bag, so that a shoulder 49 is formed inside the cavity 17 against which the base of the sealing plug 46 can rest so as to keep the sealing plug in position. Thus in this example there is no shoulder on the flange portion 21.
  • each connection there are thus two sealing members in each connection, firstly the inner membrane 35, 38, 48 and secondly the outer sealing foil 25. Between these two sealing positions a chamber is formed in each cavity 17, 19 in both channel portions 16, 18, which are designated as expansion chambers 50 so as to form room for expansion during the sterilisation, known as autoclaving, of the infusion bag, during which the bag is subjected to relatively high temperatures.
  • this expansion chamber is formed by the cavity 51 which is present in the sealing plug 33, 46 and is thus confined by its bottom membrane 35 in the base of the plug and by the welded on sealing foil.
  • one of the connections to the infusion bag 1 thus has two main functions, which functions are utilised during two different stages of bag use, namely first of all a filling stage when the connection, i.e. the channel portion 16, is used for filling of liquid before any sealing member is applied, and secondly an emptying stage after the sealing member has been pierced or removed, when the connection is employed for draining off the liquid.
  • This consequently simplifies bag design and manufacture in that the sealing of the connection is combined with the provision of the requisite membrane in the connection.
  • Fig. 9, 10 and 11 illustrate a variation of the bag in accordance with the invention.
  • the channel portions 51, 52 comprise essentially cylindrical units with an inner, open end 55 and with an outer end 67 which, prior to use, is sealed by means of the tear-off sealing foil 56, This is connected to a flange portion 57 which is arranged separately for each channel portion.
  • both channel portions 51, 52 hare an insertable sealing plug 60 with bottom membrane 61.
  • the sealing plugs are of the type illustrated in fig. 7 and 8, i.e. they do not have their own flange and are inserted in a portion of the cavity 62, 63 of the channel portions which is enlarged by a shoulder.
  • Fig, 10 shows best the arrangement of the sealing foils 56 which are welded onto the flange portion 57 by an annular weld which surrounds the outer end 67 of the channel portions 51, 52 so that the cavities of the channel portions are protected against contamination before the bag is used.
  • the sealing foils are attached in such a way that the portion which covers the outer apertures of the cavities 62, 63 is opened up when the sealing foils are torn off. This is possible because these are welded against the flange portions 57 by means for example of a "half weld seam" so that the foils are released from the flange portions without the risk that only the tab portions 58 are torn off. It is also possible to provide here tongue-shaped tear initiation points which surround the outer ends 67 of the cavities.
  • an exploded view shows one channel portion 52.
  • This view also fig. 9, illustrates that the sealing plug 60 has a further plug 64 made of an elastic material such as rubber or the like.
  • This plug corresponds to the elastic plug described in conjunction with fig. 1 and ensures self-sealing after a hypodermic syringe is introduced into the channel portion.
  • an annular portion 65 is provided having a channel 66 which forms a guide for an inserted hypodermic needle tip so that this can be introduced fairly straight into and through, the cavity 63 of the channel portion 52.
  • both channel portions 51 , 52 are provided with sealing plugs 60 with bottommembranes 61 , either of the two channel portions can be employed for pouring in liquid, because filling takes place prior to attachment of the respective plug with bottom membrane.
  • a simplification from the production viewpoint is obtained in that the channel portion can be manufactured with a through cavity right from the outset.
  • the provision of channel portions in separate units, separated from each other, furthermore provides a production simplification and savings in material.
  • the invention is not restricted to the embodiments described above and illustrated on the drawings, but can be varied within the framework of the following patent claims.
  • the sealing plugs can be designed in a different way.
  • the sealing plug can be made slightly tapered, the cavity of the channel portion also being made slightly tapered at the corresponding location so as to form a seat for the sealing plug. Furthermore it is not absolutely essential that the membrane be located at the base of the plug, as this can be located somewhere inside the cylindrical portion of the sealing plug.
  • the number of connections can vary, dependent on the purpose of the bag. For example it is feasible that there be only one connection, which thus serves to some extent as an inlet for filling the bag and also as an outlet for emptying the bag. The number of connections can be either three or more.

Landscapes

  • Health & Medical Sciences (AREA)
  • Hematology (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)

Abstract

Agencement de poches plastiques (1) pour perfusions fabriquees a partir d'au moins deux couches (2) de feuille plastique. Celles-ci sont soudees selon un joint continu (3) de telle sorte qu'un espace (4) soit forme pour loger un liquide de perfusion. L'espace destine a contenir le liquide est dispose de facon a etre en communication, par l'intermediaire de points de communication (16, 18), avec des dispositifs exterieurs tels qu'un dispositif de remplissage par un liquide, un drain, une seringue hypodermique ou analogue. L'un des points de communication est concu comme une portion de canal pourvue d'un organe d'etancheite interne (35) pour l'espace destine a contenir le liquide dans la poche. Cet organe comprend une cloison de separation perforable situee a une certaine distance de l'extremite externe de la portion de canal. Un organe d'etancheite externe (25) isole la portion de canal qui est situee en deca de la cloison de separation perforable et est ouvert pour permettre l'introduction de certains des dispositifs exterieurs a travers la cloison. Cette cloison (25) fait partie d'un bouchon d'etancheite separe (33). Le bouchon et l'organe d'etancheite externe (25) ne sont fixes dans le canal (16) qu'apres remplissage avec le liquide de telle sorte que ce canal soit ouvert pendant une phase de remplissage et serve d'orifice d'admission du liquide vers l'espace (4) destine a recevoir ce liquide et ulterieurement serve, pendant une phase d'evacuation, d'orifice d'evacuation apres ouverture de l'organe d'etancheite externe et perforation de la cloison du bouchon a l'aide de certains des dispositifs exterieurs.
PCT/SE1982/000209 1981-06-12 1982-06-11 Agencement de poches plastiques en particulier pour les perfusions et procede de fabrication WO1982004398A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
SE8103693 1981-06-12
SE8103693 1981-06-12
SE8104346A SE8104346L (sv) 1981-06-12 1981-07-14 Anordning vid infusionspasar
SE8104346 1981-07-14
SE8106012811012 1981-10-12
SE8106012A SE8106012L (sv) 1981-06-12 1981-10-12 Anordning vid infusionspar och forfarande for deras framstellning

Publications (1)

Publication Number Publication Date
WO1982004398A1 true WO1982004398A1 (fr) 1982-12-23

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ID=27355250

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE1982/000209 WO1982004398A1 (fr) 1981-06-12 1982-06-11 Agencement de poches plastiques en particulier pour les perfusions et procede de fabrication

Country Status (2)

Country Link
EP (1) EP0094387A1 (fr)
WO (1) WO1982004398A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0113597A2 (fr) * 1983-01-08 1984-07-18 The Boots Company PLC Récipient
GB2214486A (en) * 1988-01-20 1989-09-06 John David Yair Container
FR2665633A1 (fr) * 1990-08-08 1992-02-14 Technoflex Perfectionnements aux recipients a contenu sterile, notamment aux poches souples a usage medical.

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3064652A (en) * 1960-02-11 1962-11-20 Baxter Don Inc Transfusion equipment
US3509879A (en) * 1967-11-24 1970-05-05 American Hospital Supply Corp Parenteral liquid container having frangible part structure
US3828779A (en) * 1972-12-13 1974-08-13 Ims Ltd Flex-o-jet
DE2501821A1 (de) * 1974-02-26 1975-08-28 American Hospital Supply Corp Behaelter fuer sterile medizinische fluessigkeiten, insbesondere mit verschweisster verschlusstruktur
US3905368A (en) * 1974-02-15 1975-09-16 Cutter Lab Pierceable access port assembly
US3915212A (en) * 1973-12-10 1975-10-28 Abbott Lab Flexible medical fluid container having a combined fill and administration port and reinforced hanger
US4187893A (en) * 1978-07-19 1980-02-12 Abbott Laboratories Combined additive and administration port for a container

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3064652A (en) * 1960-02-11 1962-11-20 Baxter Don Inc Transfusion equipment
US3509879A (en) * 1967-11-24 1970-05-05 American Hospital Supply Corp Parenteral liquid container having frangible part structure
US3828779A (en) * 1972-12-13 1974-08-13 Ims Ltd Flex-o-jet
US3915212A (en) * 1973-12-10 1975-10-28 Abbott Lab Flexible medical fluid container having a combined fill and administration port and reinforced hanger
US3905368A (en) * 1974-02-15 1975-09-16 Cutter Lab Pierceable access port assembly
DE2501821A1 (de) * 1974-02-26 1975-08-28 American Hospital Supply Corp Behaelter fuer sterile medizinische fluessigkeiten, insbesondere mit verschweisster verschlusstruktur
US4187893A (en) * 1978-07-19 1980-02-12 Abbott Laboratories Combined additive and administration port for a container

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0113597A2 (fr) * 1983-01-08 1984-07-18 The Boots Company PLC Récipient
EP0113597A3 (fr) * 1983-01-08 1985-05-22 The Boots Company PLC Récipient
US4596573A (en) * 1983-01-08 1986-06-24 The Boots Company P.L.C. Container
GB2214486A (en) * 1988-01-20 1989-09-06 John David Yair Container
FR2665633A1 (fr) * 1990-08-08 1992-02-14 Technoflex Perfectionnements aux recipients a contenu sterile, notamment aux poches souples a usage medical.

Also Published As

Publication number Publication date
EP0094387A1 (fr) 1983-11-23

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