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 containers with sterile content and more particularly to flexible bags for medical use and relates to a nozzle more specifically intended for the sites of infusion of such flexible bags.
• Soft bags for medical use are made from various materials, in particular from polyolefins such as, for example, materials from the polypropylene family.
• the invention particularly relates to flexible bags using polyolefins as a constituent material.
• the infusion site usually consists of a chimney, part of which is sandwiched between the two faces of the plastic sheath from which the flexible bag is made, the chimney thus being welded to the pocket in a sealing strip closing the pocket.
• the chimney is separated internally by a thin perforable partition delimiting an upstream chamber in permanent communication with the inside of the pocket and a downstream chamber accessible from the external orifice of the chimney, an orifice which is advantageously closed by a removable element preserving sterility from the chimney until it is used at the site of administration, for example an infusion.
• Such a device is known and illustrated for example by patent FR 2,665,633 in the name of the present Applicant.
• the present invention aims to improve this type of infusion site by proposing a more practical infusion nozzle, adaptable to different communication structures between the inside and the outside of flexible bags, in particular polyolefins, and this, under optimal conditions. tightness to the right of the junction zone between the nozzle and the flexible pouch thus equipped.
• the subject of the invention is a perfusion nozzle for a flexible bag for medical use, of the type comprising a chimney formed by two coaxial tubular parts separated by a transverse transverse membrane, characterized in that said chimney is provided on its external periphery of an annular projection, continuous or not, delimiting a part of upstream nozzle intended to be introduced and fixed by welding in a part integral with the flexible bag to be equipped and a part of downstream nozzle capable of receiving an infusion line and in that it further comprises, on the one hand, a ring engaged inside said upstream part and able, due to its hardness, to act as a mandrel during the execution of said welding between the periphery of the upstream part and the pocket part into which this upstream part has been introduced and, on the other hand, a cap coming to cap said downstream part and capable of ensuring the preservation of the sterility of the chimney while allowing access to the latter
• the tubular end of the downstream part of the chimney has a diameter and a thickness which tapers
• the cap covering the downstream part also advantageously consists of a tubular part surrounding said downstream part extended by a part connected to said tubular part by a zone of least resistance, which can be broken to give access to the chimney of the 'tip
• the tip according to the invention is adaptable to different types of flexible pockets Thus it can be directly welded to the pocket during its manufacture, the ring inserted in the upstream part of the chimney serving as a rigid mandrel when welding said upstream part between the two walls of the sealed sheath to constitute one of the pocket closure bands.
• the end piece can also, in another context, be force-fitted inside an outlet tube forming an integral part of the flexible bag and welded to this tube in excellent sealing conditions thanks to the presence of said mandrel ring
• - Figure 1 is a coaxial sectional view of a perfusion nozzle according to the invention
• - Figure 2 is an axial sectional view of the single chimney
• FIG. 3 is a coaxial sectional view of the single ring acting as a mandrel
• - Figure 4 is an axial sectional view of the cap's cap alone
• - Figure 5 illustrates the integration of the tip of Figure 1 on a conventional flexible bag
• the complete end piece 1 shown in FIG. 1 comprises a tubular chimney 2 partly capped by a cap 3 and internally provided in its part opposite to that receiving the cap 3, with an annular ring 4
• the chimney 2 constitutes the percutable element the tip, that is to say capable of being pierced when the time comes, when using the flexible pocket (not shown) equipped with the tip 1, using a trocar (not represents) of an infusion line
• the chimney 2 is, in known manner, formed of a tubular conduit with a relatively thin wall, provided with a transverse separating membrane 5 substantially in its median zone.
• the membrane 5 has a thickness in the order of a few tenths of millimeters and divides the interior of the chimney into an upstream space 6 in communication with the interior of the flexible bag and a downstream space 7.
• the part of the latter delimiting the downstream space 7 has a wall thickness which tapers towards the downstream orifice 8 of the chimney.
• the conical profile and thinned thickness of the downstream part of the chimney gives a certain elasticity to the end of the chimney 2 and ensures a good seal on the trocar of the perfusion line introduced to pierce the membrane 5.
• the part of the chimney delimiting the upstream space 6 has a constant wall thickness for example of the order of a millimeter, the end of the chimney, at the height of the orifice 8, having for comparison a wall thickness of the order of half a millimeter.
• the chimney 2 is provided on its external periphery, substantially in its median zone and opposite the upstream space 6 in the embodiment illustrated by the drawings, a continuous projection in the form of annular bead 9 of rectangular section, delimiting in the chimney 2 an upstream part 1 0 intended to be introduced into a tubular part integral with the flexible bag.
• This tubular part can be for example a tubular section 1 1 ( Figure 5) formed during the production of a flexible bag 1 2, more precisely during the execution of the welding strip 1 3 closing one of the ends of the plastic sheath from which the pocket is made.
• the chimney 2 of the nozzle is shown with its upstream part 1 0 completely inserted into said tubular section 1 1 formed by pressing the walls of the sheath around said part 1 0.
• the bead 9 abuts against the extreme edge of the weld strip 1 3.
• the end piece 1 can also be introduced through its part 1 0 into a pocket outlet tube, itself welded to the body of the latter.
• the part 2 is preferably produced by molding from a grade of flexible polypropylene for reasons of compatibility with the material of the bags and their tubes.
• the downstream part 1 4 of the chimney 2 is capable of being capped by the cap 3 which is of generally frustoconical shape with a first part covering the part 1 4 of the chimney and extended by a part 1 5 of reduced diameter, with a wall thinner, the annular zone 1 6 of connection between these two parts constituting a zone of less resistance which one can break to give access to the orifice 8 of the chimney 2.
• the cap 3 which is of generally frustoconical shape with a first part covering the part 1 4 of the chimney and extended by a part 1 5 of reduced diameter, with a wall thinner, the annular zone 1 6 of connection between these two parts constituting a zone of less resistance which one can break to give access to the orifice 8 of the chimney 2.
• step 1 7 intended to come into abutment against the bead 9 at the end of insertion of the cap on the chimney 2.
• the cap 3 is advantageously produced by molding from a grade of rigid brittle polypropylene.
• the purpose of the cap 3 is to protect the fragile part 1 4 of the nozzle during the sterilization phase of the bag and its solution. On the other hand, it preserves the sterility of the chimney 2 until it is used.
• the reinforcing ring 4 is a simple cylindrical element of constant thickness of the same order as that of the part 1 0 of the chimney into which it is introduced.
• the internal end of the ring 4 is however slightly thinned in diameter and in thickness at 1 8 to facilitate its insertion into the chimney 2, while the other end is provided with a small peripheral projection 1 9 for retaining, coming in stop (figure 1) on the end of the chimney 2.
• the length of the ring 4 corresponds substantially to that of the upstream part 1 0 of the chimney
• the ring 4 is preferably made of rigid polypropylene
• the device of the invention it is possible to have a very good weld thanks to the presence of the ring 4 which acts as a rigid mandrel preventing the collapse of the chimney 2 at during welding.
• the ring 4 which acts as a rigid mandrel preventing the collapse of the chimney 2 at during welding.
• the end piece 1 is mounted on an outlet tube secured to a flexible pocket, it will be possible to ensure perfect sealing by welding the tube to the end piece in line with the part 1 4 of the chimney, the ring 4 then, HERE also, acting as a rigid mandrel inside said part 1 4
• the invention is obviously not limited to the embodiment shown and described above, but on the contrary covers all its variants, in particular as regards the shapes and dimensions of the elements 2, 3 and 4 constituting the 'end piece, as well as the material which can be used for their production II should also be noted that the bead 9 can be discontinuous or replaced by any other means capable of the same effect of driving in both the cap 3 on the chimney 2 and of the latter in any receiving tubular element

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)
• Bag Frames (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Applications Claiming Priority (3)

Publications (1)

Family

ID=8870568

Family Applications (1)

Country Status (6)

Families Citing this family (5)

Family Cites Families (10)

• 2001
  • 2001-12-17 FR FR0116299A patent/FR2833483B1/fr not_active Expired - Fee Related
• 2002
  • 2002-12-17 AU AU2002364922A patent/AU2002364922A1/en not_active Abandoned
  • 2002-12-17 CA CA002470224A patent/CA2470224A1/fr not_active Abandoned
  • 2002-12-17 WO PCT/FR2002/004379 patent/WO2003051270A2/fr not_active Application Discontinuation
  • 2002-12-17 US US10/499,062 patent/US20050035149A1/en not_active Abandoned
  • 2002-12-17 EP EP02802536A patent/EP1458326A2/de not_active Withdrawn

Non-Patent Citations (1)

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