EP1044670A1 - Beutelsystem mit integrierter Sicherheitsvorrichtung - Google Patents

Beutelsystem mit integrierter Sicherheitsvorrichtung Download PDF

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Publication number
EP1044670A1
EP1044670A1 EP00401053A EP00401053A EP1044670A1 EP 1044670 A1 EP1044670 A1 EP 1044670A1 EP 00401053 A EP00401053 A EP 00401053A EP 00401053 A EP00401053 A EP 00401053A EP 1044670 A1 EP1044670 A1 EP 1044670A1
Authority
EP
European Patent Office
Prior art keywords
pocket
injection
site
injection site
pocket system
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.)
Granted
Application number
EP00401053A
Other languages
English (en)
French (fr)
Other versions
EP1044670B1 (de
Inventor
Sylvie Demay
Thierry Verpoort
Francis Goudaliez
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.)
Maco Pharma SAS
Original Assignee
Maco Pharma SAS
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 Maco Pharma SAS filed Critical Maco Pharma SAS
Publication of EP1044670A1 publication Critical patent/EP1044670A1/de
Application granted granted Critical
Publication of EP1044670B1 publication Critical patent/EP1044670B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A61J1/1406—Septums, pierceable membranes
    • 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 invention relates to the pocket system for medical use.
  • pocket systems for medical use of the type comprising on a pocket at least one sterile injection site, allowing the injection of a certain product in the pocket using a needle and syringe injection.
  • Such a sterile injection site is in fact provided to be able to be crossed by an injection needle and close itself once the needle is removed.
  • Document DE-U-295 15 682 describes such a system in which a cover snap-in is intended to be placed on the injection site so that shut it off once an injection is made.
  • the invention therefore aims to remedy these drawbacks by proposing a system pocket comprising a security means associated with it in a set unitary, said safety means cannot be dissociated from the injection site after mounting to irreversibly prevent another injection.
  • the invention proposes a pocket system for medical use, of the type comprising on a pocket at least one site sterile injection, further comprising at least one safety means, the safety means and the injection site being arranged so that the means can be mounted - in particular by simply pressing it in - on the injection site by preventing injection by the site, the safety means and the pocket can not be separated by manual action, the means of safety being integrated into the pocket system to be, at least before mounting at the injection site, associated with it in a unitary assembly.
  • the injection site can be protected by a tearable envelope intended to be broken prior to injection of the product.
  • the security means is associated by means of frangible means, broken up with a view to mounting the security means on site sterile injection, and / or by non-frangible means, both before and view of the mounting of the safety device on the sterile injection site.
  • the security means is associated by means either essentially rigid or flexible, in particular elastic.
  • Flexible means of association, particularly elastic are suitable, in particular by their length and their flexibility, to allow the safety device to be associated with the injection site sterile.
  • the means of association of the security means are in one embodiment associated on the one hand with the pocket proper, or with a tab or a border depending on the bag or at the sterile injection site; on the other hand to the face external of the safety means, on the skirt or the transverse end face, especially in an essentially rigid manner.
  • the means of association of the security means with the pocket system are by example a material bridge, a frangible line, a leg, a cord or analogous, a band.
  • the safety means can be in two extreme positions, one before mounting on the sterile injection site, in particular in a fixed position and against or in the vicinity of the pocket and the other on the site itself.
  • the invention relates to an implementation method of a pocket system of the invention, in which one starts from a system with pocket in which the security means, although associated with the system, is removed the sterile injection site and thus leaves its free access for injection; when necessary a certain product is injected into the pocket through the site injection; once the injection has been carried out, the safety means are mounted on the injection site thereby irreversibly preventing any further injection through the site in question.
  • Figure 1 is an elevational and flat view of a first embodiment of the pocket system according to the invention in which the security means is in position before mounting on the sterile injection site.
  • Figure 2 is a partial view similar to Figure 1 in which the means safety device is mounted on the injection site.
  • Figure 3 is a partial elevational and flat view of a second embodiment realization of the pocket system according to the invention.
  • a pocket system for medical use 1 will now be described with reference in a normal position of use in which the contents of bag 2 go be distributed, for example to a patient.
  • the pocket 2 is suspended by its upper extremity. This situation allows you to define the qualifiers “upper”, “lower” and “lateral”.
  • the pocket system 1 first comprises a closed envelope 3, then a injection site 4 and finally a distribution site 5, the two sites 4 and 5 being mounted on said envelope 3.
  • the envelope 3 is intended to receive a content C such as a solute, a powder, blood, a serum or a blood component.
  • a content C such as a solute, a powder, blood, a serum or a blood component.
  • the injection site 4 allows the injection of a certain product P, for example a drug, or a solvent in pocket 2 using a needle and a injection syringe.
  • a certain product P for example a drug, or a solvent in pocket 2 using a needle and a injection syringe.
  • the distribution site 5 is designed to deliver the C + P content from the bag 2, for example to a patient through an infusion device conventional.
  • the bag system 1 can be packaged under a film flexible and waterproof plastic to ensure its sterility. The film is then broken before using the bag system 1.
  • the pocket system 1 which has just been described constitutes an elementary assembly which can be incorporated into a more complex system which includes example of other bags, tubing, clamps or filters, which elements will not be described further.
  • the pocket system 1 comprises an envelope 3 in the form of a flattened tube in flexible plastic material whose transverse end portions 6, 7 have been transversely welded.
  • the envelope 3 has two orifices 8, 9 located on the same transverse side of the envelope, namely lower 7.
  • the upper side 6 includes an eyelet 10 which allows the attachment of the bag system 1, for example on an infusion stand.
  • the pocket system 1 according to the invention may comprise more than two holes arranged differently on the casing 3.
  • the two orifices 8, 9 are of generally cylindrical shape and are each provided a portion of tube 11, 12 ensuring fluid communication with outside of envelope 3.
  • the site is tightly mounted Injection 4.
  • the injection site 4 is formed by an end piece hollow 13 of cylindrical shape made of rigid plastic material (see figure 1).
  • the injection site can be protected by an envelope tearable intended to be broken prior to the injection of the product P. This arrangement allowing, when the tearable envelope is intact, to show that no product P was injected into bag 2.
  • the nozzle 13 of the injection site 4 has two parts 14, 15, one intended for be introduced in a leaktight manner into the tube portion 11 projecting from the envelope 3 while the other, of slightly larger diameter, remains at outside in the extension of said portion of tube 11.
  • the diameter of the second part 15 being provided to form a circular flat 16 of low thickness at the junction between the end piece 13 and the protruding tube portion 11 of the envelope 3.
  • a pad 17 of elastomer, rubber or the like is arranged inside the second part 15 of the end piece 13 to form the site 4. This is provided so that it can be crossed by a needle and close itself once the needle is removed.
  • a tubing system 18 is tightly mounted to deliver the contents of pocket 2, for example to a patient via a conventional infusion (not shown).
  • the pocket system 1 also includes, in an integrated manner, a security means 19 intended, once the product P has been introduced into the bag 2, to obstruct the injection site 4 so as to prevent, so irreversible, a second injection.
  • the security means 19 is integrated into the pocket system 1 so that before mounting it is associated with it in a unitary whole.
  • system is meant unitary the fact that the pocket system 1 and the security means 19 are stored, sold, handled and used together.
  • the security means 19 is formed by a plug 21 made of rigid plastic material intended to obstruct the site 4 to prevent a second injection.
  • the plug 21 can be brightly colored in order to also visualize the realization of a injection.
  • the means of association of the security means 19 with the pocket system 1 can be the subject of several variants.
  • frangible means 22 consisting for example of a thinned material bridge or a point of glue formed between the safety means 19 and the pocket system 1.
  • frangible means 22 are broken during use, the safety means 19 then dissociated from the envelope 3 can be associated with the injection site 4.
  • the means 23 provide a connection security means 19 to the envelope 3.
  • the safety means 19 is associated with the pocket system 1 by a flexible cord 23 and by frangible means 22.
  • This variant ensures a connection security means 19 to the envelope 3 while benefiting from the advantages of frangible means 22.
  • the means of association of the security means 19 with the pocket system 1 are associated on the one hand with the external face of the security means 19 and on the other hand, either to the envelope 3 of the bag 2 (see Figure 1) near the injection site 4 but wide enough to allow free access either directly to the site injection 4 (see Figure 3).
  • the plug 21 and the safety means 19 are produced, for example by molding, in a single piece formed of the same material.
  • the safety means are formed by a thinned material bridge having sufficient flexibility and length to allow mounting the plug 21 on the injection site 4.
  • the combination of plug 21 to the pocket system can be produced by arranging and welding a part of the material bridge around the tube portion 11 so as to form a ring whose diameter is less than that of part 15.
  • the flat 16 prevents the sliding of the ring so that the security means 19 and the pocket system 1 forms a unitary assembly.
  • association means comprise frangible means 22, these are broken manually to allow the mounting of the safety means 19 at the injection site 4.
  • the safety means 19 is then mounted by forced insertion on the part lower 15 of the nozzle 13, the safety means 19 coming to engage on the flat 16 to lock it irreversibly (see Figure 2). Inviolability of the injection site 4 is then ensured by irreversible locking of the security 19.
  • the arrangement is provided so that the pocket system 1 and safety means 19 cannot be separated by manual action once said safety means 19 has been mounted on the injection site 4.
  • the security means 19 has a small size (around 1 cm in diameter) and a surface smooth outer so it has little grip to be removed manually.
  • the skirt of the plug 21 is slightly tightened at the level of the opening part so that this part comes to lock on the flat part 16.
  • the plug 21 is forced into the injection site 4 up to the flat 16 and the opening part of the plug 21 is locked on said flat 16 so as to prevent any removal of the plug 21 from on the site injection 4.
EP00401053A 1999-04-15 2000-04-14 Beutelsystem mit integrierter Sicherheitsvorrichtung Expired - Lifetime EP1044670B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR9904739 1999-04-15
FR9904739A FR2792209B1 (fr) 1999-04-15 1999-04-15 Systeme a poche avec moyen de securite integre

Publications (2)

Publication Number Publication Date
EP1044670A1 true EP1044670A1 (de) 2000-10-18
EP1044670B1 EP1044670B1 (de) 2010-06-02

Family

ID=9544449

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00401053A Expired - Lifetime EP1044670B1 (de) 1999-04-15 2000-04-14 Beutelsystem mit integrierter Sicherheitsvorrichtung

Country Status (4)

Country Link
EP (1) EP1044670B1 (de)
AT (1) ATE469629T1 (de)
DE (1) DE60044476D1 (de)
FR (1) FR2792209B1 (de)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8091727B2 (en) 2007-11-08 2012-01-10 Hospira, Inc. Snap-over clamshell protective port cap

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2749045A1 (de) * 1976-11-19 1978-06-01 Baxter Travenol Lab Zusaetzliche sicherheitskappe fuer den einlasstutzen eines behaelters o.dgl., insbesondere fuer behaelter mit medizinischen fluessigkeiten
US4126167A (en) * 1976-12-06 1978-11-21 Patient Care Products, Inc. Gastric tube drainage bag
EP0096115A2 (de) * 1982-06-07 1983-12-21 U.S. Clinical Products, Inc. Flexibles und steriles Verschlusssystem für Behälter
EP0126473A2 (de) * 1983-05-23 1984-11-28 Union Carbide Corporation Behälter für Chemikalien
DE9205801U1 (de) * 1992-04-30 1993-03-25 B. Braun Melsungen Ag, 3508 Melsungen, De
DE29515682U1 (de) 1995-10-02 1995-12-07 Braun Melsungen Ag Portsystem für einen Beutel

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2749045A1 (de) * 1976-11-19 1978-06-01 Baxter Travenol Lab Zusaetzliche sicherheitskappe fuer den einlasstutzen eines behaelters o.dgl., insbesondere fuer behaelter mit medizinischen fluessigkeiten
US4126167A (en) * 1976-12-06 1978-11-21 Patient Care Products, Inc. Gastric tube drainage bag
EP0096115A2 (de) * 1982-06-07 1983-12-21 U.S. Clinical Products, Inc. Flexibles und steriles Verschlusssystem für Behälter
EP0126473A2 (de) * 1983-05-23 1984-11-28 Union Carbide Corporation Behälter für Chemikalien
DE9205801U1 (de) * 1992-04-30 1993-03-25 B. Braun Melsungen Ag, 3508 Melsungen, De
DE29515682U1 (de) 1995-10-02 1995-12-07 Braun Melsungen Ag Portsystem für einen Beutel

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8091727B2 (en) 2007-11-08 2012-01-10 Hospira, Inc. Snap-over clamshell protective port cap

Also Published As

Publication number Publication date
ATE469629T1 (de) 2010-06-15
DE60044476D1 (de) 2010-07-15
FR2792209B1 (fr) 2001-09-21
FR2792209A1 (fr) 2000-10-20
EP1044670B1 (de) 2010-06-02

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