WO2009130147A1 - Dispositif de perforation et procédé de prélèvement d'un liquide dans une poche ou d'amenée d'une substance dans une poche - Google Patents

Dispositif de perforation et procédé de prélèvement d'un liquide dans une poche ou d'amenée d'une substance dans une poche Download PDF

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Publication number
WO2009130147A1
WO2009130147A1 PCT/EP2009/054462 EP2009054462W WO2009130147A1 WO 2009130147 A1 WO2009130147 A1 WO 2009130147A1 EP 2009054462 W EP2009054462 W EP 2009054462W WO 2009130147 A1 WO2009130147 A1 WO 2009130147A1
Authority
WO
WIPO (PCT)
Prior art keywords
bag
puncture
piercing
port
liquid
Prior art date
Application number
PCT/EP2009/054462
Other languages
German (de)
English (en)
Inventor
Stefan Puller
Original Assignee
Plümat Plate & Lübeck GmbH & Co.
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 Plümat Plate & Lübeck GmbH & Co. filed Critical Plümat Plate & Lübeck GmbH & Co.
Priority to EP09731471A priority Critical patent/EP2155140B1/fr
Priority to BRPI0903703-9A priority patent/BRPI0903703A2/pt
Priority to AT09731471T priority patent/ATE488212T1/de
Priority to DE502009000183T priority patent/DE502009000183D1/de
Priority to RU2010147044/15A priority patent/RU2519639C2/ru
Publication of WO2009130147A1 publication Critical patent/WO2009130147A1/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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • 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
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means

Definitions

  • the present invention relates to a puncturing device, i. a so-called transfer spike for opening and then withdrawing a liquid from a bag or supplying a powdery or liquid substance to the liquid in the bag via the piercing device.
  • the bag may for example be filled with an infusion solution for a patient and has a correspondingly formed closure at its opening and removal area.
  • the piercing device is inserted into the interior of the bag after opening the bag through the closure.
  • the piercing device has a snap closure for attachment to the closure of the bag. After the puncture device is attached to the pouch, a portion of the puncture device within the pouch is partially ruptured to create a passageway for withdrawing the fluid of the pouch or for mixing the fluid in the pouch with another substance. fen.
  • Such systems are primarily used in the medical field, for example when administering an infusion solution for a patient.
  • a hose attached to the puncture tube at the other end of the puncture tube, which is not in the interior of the bag, a hose attached to the puncture tube.
  • the bag with the infusion solution consists of a plastic element (port) and of plastic film layers, which are welded together accordingly.
  • the plastic element forms the liquid removal portion of the bag is often cylindrical and has on its outer surface a rubber membrane and, if necessary, a seal made of aluminum.
  • the bag is opened by piercing the seal by means of the pointed puncture tube.
  • the puncture tube is then passed through the port into the interior of the bag.
  • a gap between the outer surface of the puncture tube and the seal at the puncture site is sealed by the rubber membrane to prevent leakage of the liquid.
  • the puncture tube does not have a tight fit after insertion and insertion into the pouch, and therefore, does not have a tight fit, i.e., in the lateral direction. can move back and forth along the port or rotate within the port or bag.
  • the puncture tube will be withdrawn from the bag due to inadvertence by medical personnel or the patient, leaking fluid and exposing the puncture tube or through-bore of the puncture tube to germs.
  • various prior art solutions are previously known.
  • European Patent No. 0 820 777 B1 to Haemopharm Industry AG describes an infusion system having a tubular piercing device with a tip, the piercing device being connected to the tip for attachment in a penetrated, elastic plug of a bag to form a screw cap. Bond is provided with an external thread.
  • This prior art piercing device is therefore integrated into the plug by rotation, with the self-tapping external thread of the piercing device cutting into the material of the plug.
  • a port piercing apparatus ie, a closure, a bag for withdrawing a liquid from the bag, or for supplying another substance to the liquid in the bag.
  • the piercing device includes a snap closure for attaching the puncture device to the bag.
  • the snap closure on the piercing device can further ensure, for example, a simple and faster handling when mixing the liquid in the interior of the bag with a further, supplied substance.
  • the snap closure forms a secure unit with the closure or port of the bag.
  • the snap closure for example, also applied to ports of different sizes or shapes become. This allows, for example, the use of bags of different sizes and with different liquid fillings.
  • the snap fastener may comprise at least a first clip bracket.
  • the at least one clip bracket can for example be made elastic by either elastic material is used and / or the clip bracket is formed in terms of its geometric properties or its structure such that a certain elasticity is given.
  • elasticity is meant, for example, geometrically nonlinear elasticity.
  • the possible or reversible deformations of the at least one clip bracket are relatively large in terms of its dimensions, for example, greater than 5%.
  • the snap fastener may comprise at least one second clip bracket.
  • an at least second clip bracket may provide for improved attachment of the piercing device to the bag.
  • the puncturing device according to the present invention may also have a third and fourth bracket.
  • the at least first clip bracket and / or the at least second clip bracket having a first and / or a second handle member.
  • the first and / or second gripping element can, for example, be arranged on the outer surfaces, so that the handling of the puncturing device with the bag is improved in terms of ergonomics.
  • the first gripping element and / or the second gripping element can also be used to open the piercing device or the bag. The piercing device is already inserted into the bag through the closure or port and individual sections of the piercing device are rotated against each other to form an opening by means of the first and / or second grip element.
  • this aspect will be explained in more detail below.
  • the at least first clip bracket and / or the at least second clip bracket is hook-shaped.
  • the first and / or clamp bracket can be L-shaped and, in the sense of an arm, extend away from the puncture device to the outside.
  • the at least first clip bracket may be arranged opposite the at least second clip bracket on the piercing device.
  • the piercing device may comprise a contacting portion, wherein the contacting portion is arranged to contact a container with another substance and / or to connect the further substance of the container with the liquid in the bag.
  • the container with the further substance may, for example, be a glass vial, i. a small glass bottle or, for example, another bag.
  • the further substance may comprise, for example, a powdery substance or another liquid which is to be mixed via the piercing device with the liquid of that bag to which the piercing device is fastened by means of the snap closure.
  • the piercing device can be used together with the bag, to which the piercing device is attached, for example during infusions.
  • the puncture device may comprise a bag section.
  • the bag portion is arranged to be inserted through the port of the bag into the bag.
  • the piercing device can be securely fastened to the port of the bag by means of the snap closure.
  • the functional separation of the puncturing device into a contacting section and a bag section, wherein these sections are different in structure will not result in any errors in the handling of the puncturing device when, for example, medical personnel are in a hurry to use the puncturing device.
  • Both the bag section and the Kunststoffierabterrorism the puncture device can be provided or covered before use of the piercing device with protective caps.
  • the bag portion may include a bag piercing portion and a bag feeding / bag removing portion.
  • the bag puncture section may be configured to open the bag at the port and insert the piercing device into the bag through the structure of the port.
  • the bag supply / bag removal portion of the bag portion of the puncturing device may be configured to remove the liquid from the bag.
  • the bag supply / bag removal portion may alternatively serve to supply another substance to the liquid inside the bag. It can then take place a mixing of the liquid in the bag with the supplied further substance.
  • the bag section By separating the bag section into at least two function carriers or functional sections, as described, above all a defined handling of the piercing device can be achieved. Further, the piercing device may already be introduced into the bag without the liquid exiting the bag. In the case of a medical application during infusions, therefore, the pouch and puncture device can already be prepared in advance of a treatment.
  • a predetermined breaking point may be located between the bag piercing section and the bag feed / bag removal section.
  • the bag puncture portion may therefore be designed as separable.
  • the bag puncture portion can only be at least partially separable from the bag feed / bag removal portion.
  • the bag puncture portion remains in the interior of the bag after its complete separation or only partial separation from the bag feed / bag removal portion at the predetermined breaking point in any case.
  • a contact land portion of the contacting portion and / or a bag portion end of the bag portion or the bag piercing portion may be formed like an arrow.
  • the Beierabitessende and / or the bag section end barb-like may be formed like an arrow.
  • the Beierabitessende and / or the bag section end barb-like may be formed like an arrow.
  • a quick and easy opening of the bag can be achieved via the plastic element by means of piercing or piercing the bag section end by the plastic element.
  • the possibility of extracting the piercing device from the bag in addition to securing the piercing device to the bag by means of the snap closure is avoided.
  • the piercing device may at least partially have a channel, for example a bore.
  • the channel may lead the liquid inside the bag to the outside or another substance, as described in more detail below, lead to mixing with the liquid in the bag.
  • the channel or the bore can be designed as a through hole in the interior of the piercing device.
  • Both the bag feed / bag removal section and the contacting section may comprise the channel.
  • a passage formed in the contacting section and the bag section may serve to connect or mix together a powdery substance or further liquid with the fluid in the bag.
  • the powdery substance or other liquid is in such a case in a container which is contacted or connected to the contacting portion of the piercing device.
  • the container may, for example, as already described, be a glass bottle or another bag.
  • the channel which is designed for example as a bore, be offset with respect to a longitudinal axis and / or an axis of symmetry of the piercing device. This can be achieved, for example, that the devisierabitessende is formed with a tip.
  • the puncturing device may essentially, ie, in terms of essential parts and sections of plastic fabric be produced by die casting, injection molding, etc. This ensures, for example, a simple and inexpensive production.
  • individual sections of the piercing device may also have metal structures.
  • the snap closure, the bag section end and / or the Kunststoffierabêt- send may be formed with a metal sheet or an integrated metal layer.
  • a bag is provided with a port (closure) and a piercing device for removing a liquid from the bag.
  • the piercing device can have properties and features that are as described above.
  • a method for removing a liquid from a bag or supplying a further substance, for example a powder or another liquid, into the bag by means of a piercing device.
  • the piercing device can have the features and properties described above.
  • the method includes, in addition to other sections of the method not further described, attaching a bag portion end of a bag portion of the piercing device to a port of the bag; Opening the port by means of the bag portion end and inserting the booty portion end through the port into the bag, and opening the bag portion of the piercing device and forming a bag removal portion opening.
  • Opening the port by means of the bag section end may include, for example, puncturing, puncturing or piercing the bag section end into a seal on the port.
  • the seal may consist of a rubber material and / or be an integral part of the port.
  • opening the pouch portion of the puncture device may include, for example, severing or at least partially separating a puncture piercing portion from a pouch supply / bag removal portion at a predetermined breaking point.
  • the severing or at least partially severing may include twisting and / or buckling of the bag puncture portion opposite the bag feed / bag removal portion of the puncture device include.
  • the twisting can be accomplished, for example, by means of the first grip element and / or the second grip element. Further, then, removal or supply of the liquid from or in the bag may be provided via the formed bag supply / bag removal section opening.
  • attaching a container to a contacting portion end of a contacting portion of the piercing device and connecting the container to the piercing device or bag via the contacting portion may be provided his.
  • the container may include another substance, such as a powder or another liquid.
  • the powder or other liquid may then, after opening the piercing device as described above, enter and be mixed with the interior of the bag containing the liquid. This is especially relevant, for example, in the medical field, in particular when administering and administering infusions of relevance.
  • the opening of the bag portion may include twisting the bag puncture portion at least opposite to the bag feed / bag removal portion of the puncture device.
  • the invention provides a puncture device for a bag and a method for withdrawing a liquid from the bag or supplying a substance to the liquid in the bag which avoids the deficiencies of the prior art described above. It is further understood that the above disclosed features for achieving further designs of the bag according to the invention can be combined with each other as desired.
  • Fig. 1 is a schematic representation of an example of the piercing device according to the invention in a plan view (shown below in Figure 1), front view (shown in the middle of Figure 1) and a bottom view (shown above in Figure 1);
  • Fig. 2 is a schematic representation of the piercing device of Figure 1 in one
  • FIG. 3 is a schematic representation of the piercing device of FIGS. 1 and
  • Fig. 4 is a schematic illustration of the outer part of the bag puncture portion as shown in Fig. 2 in an enlarged side view;
  • Fig. 5 is a schematic illustration of the outer part of the contacting portion as shown in Fig. 2 in an enlarged side view
  • Fig. 6 is a schematic illustration of the predetermined breaking point between the bag feed / bag removal section and the bag puncture section, as shown in Fig. 3, in an enlarged side cross-sectional view;
  • Fig. 7 is a schematic representation of the piercing device with a port in a front view, wherein the piercing device is attached to the port by means of the snap closure.
  • the piercing device 100 is shown in a plan view, a side view and a bottom view.
  • the piercing device 100 has sections along its longitudinal axis XX a cylindrical shape.
  • the position of the longitudinal axis XX is defined by the pointed ends of the piercing device 100, which will be described in more detail below.
  • the piercing device 100 comprises a bag section 20 and a contacting section 30.
  • the piercing device 100 further includes a snap closure 10.
  • the snap closure 10 has a first clip bracket 11 and a second clip bracket 12.
  • the first bracket 11 and the second bracket 12 are integrally formed with the piercing device 100 between the bag portion 20 and the contacting portion 30 on the piercing device 100.
  • the bag portion 20 may also be positively and / or frictionally connected together with the Maisierabêt 30 and the snap closure 10 (for example, by screwing or pressing the bag portion 20 with the Druckierabêt 30 and the snap closure 10).
  • Both the first clip bracket 11 and the second clip bracket 12 of the snap fastener 10 have an L-shaped, i. angled shape and protrude from the longitudinal axis X-X of the puncture device 100 like extended, angled arms away. With respect to the longitudinal axis X-X, the first clip bracket 11 is opposite to the second clip bracket 12 in a plane mirror image.
  • the piercing device 100 thus has a symmetrical shape with respect to a plane.
  • the free first end 11.1 of the first clip bracket 11 and the free second end 12.1 of the second clip bracket 12 in the region of the bag section 20 are hook-shaped with a corresponding latching projection.
  • a snap closure 10 is realized on the piercing device 100, which with a correspondingly formed closure (plastic element) or port 200 of a bag (not shown in Figure 1) after insertion of the piercing device 100 engages in the bag so that secure attachment of the puncture device 100 to the bag (not shown in Figure 1) is provided.
  • the first clip bracket 11 has a first grip element 13 and the second clip bracket 12 has a second handle member 14 in the form of an outwardly directed, flat portion which is rounded at its corners and edges.
  • the puncture device 100 or the pouch section 20 of the puncturing device 100 is preferably guided into the interior of the bag by a linear, non-rotational movement through the port 200 (see FIG. 7).
  • the opening of the bag, and thus of the piercing device 100 is accomplished by forming an opening at a predetermined breaking point 23 on the bag section 20, preferably by twisting a bag piercing section 21 of the bag section 20 with respect to the remaining sections of the piercing device 100 with the aid of the first handle element 13 and the second handle element 14 Bag puncture portion 21 in the interior of the bag is thereby held either by the port 200 and / or manually from the outside.
  • this aspect will be described in more detail below.
  • the bag portion 20 is that portion of the puncture device 100 which is arranged to be in the interior of the bag after opening the bag at the port 200 (see Figure 7) and inserting the puncture device 100 into the bag (not shown in Figure 1).
  • the bag section 20 can also be subdivided into a bag puncture section 21 and a bag removal section 22.
  • a predetermined breaking point 23 at the same time includes a bag feed Z bag removal section opening 23.
  • the predetermined breaking point 23 represents a region with a cross-sectional and a material taper. This aspect will be explained in more detail in the context of the following detailed description.
  • Both the bag puncture portion 21 and the bag feed / bag removal portion 22 of the puncturing apparatus 100 have a substantially cylindrical shape.
  • the cross section of the bag puncture portion 21 as well as the pre-bag take-out portion 22 is substantially circular with respect to a plane perpendicularly intersecting the longitudinal axis X-X.
  • an oval, i. elliptical or polygonal cross-sectional area conceivable.
  • the bag portion 20 and the bag piercing portion 21 have at their outer end a bag portion end 29 and bag piercing portion end 29, respectively.
  • the bag portion end 29 is formed like a barb in the example of the piercing apparatus 100 shown in FIG.
  • the pouch section end 29 comprises a sharp pouch piercing tip 29.1 and outwardly projecting projections 29.2 circumferentially disposed in sections.
  • the bag portion 20 is arranged and / or adapted to be inserted through the port 200 (see Figure 7) of the bag into the bag (not shown in Figure 1).
  • the contacting section 30, like the bag section 20 or the bag piercing section 21, comprises a contacting section end 39.
  • the contacting section end 39 is arrow-shaped and therefore comprises a sharp contacting piercing tip 39.1 and arranged in sections around the circumference , outwardly projecting projections 39.2.
  • the contacting portion end 39 has a shape which is partially similar to a cone.
  • the contacting section 30 is arranged and / or configured to contact a container (not shown in FIGS. 1 to 7) with a further substance and / or to connect the further substance in the container with the liquid in the bag to bring together.
  • the container can for this purpose port or container closure have any shape.
  • the material connection of the bag with the container via the piercing device 100 takes place via a channel or a bore 40, which will be described in more detail below.
  • the container with the further substance may, for example, be a glass vial, i. a small glass bottle or, for example, another bag.
  • the further substance in the container may, for example, comprise a powdery substance or another liquid which is to be mixed via the piercing device 100 with the liquid of the bag to which the piercing device 100 is fastened by means of the snap closure 10.
  • the puncture device 100 can be optimally used together with the bag to which the puncture device 100 is attached, for example during infusions.
  • a bore 40 is located at the Kunststoffierabitessende 39.
  • the bore 40 is arranged offset or formed offset to the longitudinal axis X-X and may at least partially extend in the direction of the piercing device 10, along the longitudinal axis X-X.
  • the bore 40 forms a channel for withdrawing a liquid from the bag or for supplying a further substance to a liquid in the bag.
  • the puncture device 100 shown in Figure 1 is shown schematically in a further side view. It can be seen in particular from FIG. 2 that the bag section end 29 is not rotationally symmetrical. A conical or cone-like structure runs at the pouch section end 29 only up to half of the circumference. In other words, the bag section end 29 is flattened in a region towards the bag puncture tip 29. 1, while the contacting section end 39 is designed to be substantially rotationally symmetrical in the direction of the longitudinal axis X - X of the puncturing device 100.
  • Figure 3 shows a schematic representation of the puncture device 100 of Figures 1 and 2 in a side cross-sectional view.
  • the bore 40 extends continuously from the contacting section 30 into the bag feed / bag removal section 22 and ends at the predetermined breaking point 23, which is followed by the bag piercing section 21.
  • the bore 40 is offset with respect to the longitudinal axis XX, so that, as already described, a pointed piercing piercing tip 39.1 can be realized.
  • the predetermined breaking point 23 is a region with a locally tapering cross section and smaller wall thicknesses than at other regions of the sections 20 and 30.
  • the predetermined breaking point 23 is a region defined with respect to the position at the piercing opening 100, at which the bag puncture section 22 can be at least partially or completely separated from the puncture device 100 by twisting against the remaining portions or areas of the piercing device 100.
  • the bag puncture portion 22 is thereby separated or at least after the insertion of the piercing device 100 into the bag and attaching the piercing device 100 to the bag or the port 200 (see figure 7) by means of the snap closure from the bag feed / bag removal section partially separated (opened).
  • the predetermined breaking point 23 then forms a bag feed / bag removal section opening 23.
  • the liquid inside the bag can then be removed from the bag via the bag feed / bag removal section opening 23 and associated bore 40.
  • the bag is still considered to be closed since prior to being opened, i. Separation and partial separation of the bag piercing portion 21 from the bag feed / bag removal portion 21 still no liquid can flow out of the bag.
  • the bag puncture portion 21 often remains “suspended" in the port 200 (see Figure 7) and does not fall into the bag.
  • the predetermined breaking point 23 can be opened by kinking.
  • the bag or the port 200 is the Beutelzu wool- / bag removal portion 22 of the puncture 100th at least in sections taken in the direction of the longitudinal axis XX of the inner surfaces of the port 200 (not shown in Figure 3).
  • the lateral and lower outer surfaces of the port 200 are thereby encompassed by the first clip bracket 11 and the second clip bracket 12 to form a secure and durable attachment.
  • the port 200 can have a two-stage telescopic cylinder-like shape in sections. The first cylinder or cylindrical section with the smaller diameter protrudes directly from the bag to a certain distance.
  • a second cylinder or cylindrical area with a larger diameter adjoins the first cylinder and is dimensioned so that it can be received by the snap closure 10 by means of latching.
  • the piercing device 100 can be firmly fixed to the port 200 or bag. This aspect will be explained in more detail below with reference to FIG.
  • FIG. 4 is a schematic representation of the outer part of the bag-piercing section 21, as shown in FIG. 2, in an enlarged side view.
  • the bag section end 29 or the bag puncture from the cut end 29 with the bag puncture tip 29.1 is not formed symmetrically but up to a certain area, i. Depth flattened in the direction of the longitudinal axis X-X.
  • Figure 5 is a schematic representation of the outer part of the Kunststoffierabitess, as shown in Figure 2, shown in an enlarged side view.
  • the contacting portion end 39 has a piercing tip 39. 1 and is of a conical shape. Around the circumference are at least partially projections along the longitudinal axis X-X, which can act as barbs.
  • FIG. 6 is a schematic illustration of the predetermined breaking point 23 or bag feed / bag removal section opening 23 between the bag feed / bag removal section 22 and the bag puncture section 21, as shown in FIG. 3, in an enlarged side cross-sectional view.
  • the bore 40 protrudes in the direction of the longitudinal axis XX over the predetermined breaking point 23 up to a certain section or a certain length into the bag penetration section 21.
  • the puncture device 100 is shown schematically together with a port 200 in a front view.
  • the upper, essentially cylindrically shaped head region 210 of the port 200 is thereby partially covered by the first clip 11 and the second clip 12 of the snap closure 10.
  • the port 200 is further connected to portions of a bag (not shown in Figs. 1-7) which contain a liquid.
  • the height H210 of the upper cylindrical head portion 210 of the port 200 is dimensioned accordingly, so that after the insertion of the piercing device 100 through the port 200 in the direction of the port longitudinal axis YY, the head surface 211 of the head portion 210 and the bottom surface 212 of the head portion 210 of the first clip bracket 1 1 and the second clip bracket 12 is included.
  • the puncture device 100 is securely fastened to the port 200 and unwanted movement of the puncture device 100 with respect to the port 200 is avoided.
  • a method according to the invention for withdrawing a liquid from a bag by means of a puncture device 100 or for supplying a further substance, such as a powder or another liquid, to the liquid in the bag inter alia (in addition to other method sections not described) the following method sections are provided: attaching a bag section end 29 of a bag section 20 of the piercing device 100 to a port 200 of the bag (not shown in FIGS. 1 to 6); Opening the port 200 by means of the bag portion end 29; Inserting the bag portion end 29 through the port 200 into the bag; and opening the bag portion 20 of the puncture device 100 and forming the bag feed / bag removal portion opening 23.
  • the opening of the port 200 can be done by piercing, piercing or puncturing the puncture device 100 into the port 200.
  • the wall of a seal of the port 200 can first be punched through, then following a diaphragm wall made of elastic material which adjoins transitions or gaps (between the puncture device 100 and the port 200) and thus seals.
  • Opening of the bag portion 21 in this case comprises a separation or at least partial separation of the bag puncture portion 21 of the Beutelzu SMS- / bag removal portion 22 of the bag portion 20 of the puncture device 100 at the predetermined breaking point 23, preferably by rotating the bag puncture portion 21 by means of the first handle member 13 and the second handle member 14.
  • a bag feed / bag removal portion opening 23 is now formed at the predetermined breaking point 23, through which the liquid can be removed from the bag or the further substance of the liquid can be supplied in the bag.
  • the method may further include translationally inserting the piercing device 100 into the bag until the snap closure 10 engages with or includes the port 200 of the bag.
  • Another method section may be provided which includes attaching a container (not shown in FIGS. 1-7) to the contacting portion 39 of the contacting portion 30 of the puncturing apparatus 100 and connecting the container to the puncturing apparatus 100 and the FIG Bag over the Kunststoffierabites 30 includes.
  • a puncture device 100 as well as a bag with the puncture device 100 and a method for withdrawing a liquid from the bag or supplying another substance to the liquid in the bag by means of the puncture device 100 wherein the puncturing device 100 can be firmly fixed to the bag in a rapid and simple manner by means of latching and / or locking, and wherein the removal of the liquid from the bag or the supply of the further substance to the liquid in the bag only by opening the piercing device 100 can happen.

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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)
  • Sampling And Sample Adjustment (AREA)
  • Encapsulation Of And Coatings For Semiconductor Or Solid State Devices (AREA)
  • Perforating, Stamping-Out Or Severing By Means Other Than Cutting (AREA)

Abstract

La présente invention concerne un dispositif de perforation (100), c'est-à-dire une pointe dite de transfert qui sert à ouvrir une poche pour ensuite y prélever un liquide ou amener une substance pulvérulente ou liquide dans le liquide présent dans la poche, au moyen du dispositif de perforation. La poche peut par exemple être remplie d'une solution de perfusion pour un patient et dispose dans sa zone d'ouverture et de prélèvement d'une fermeture conçue de manière appropriée. Le dispositif de perforation est inséré à l'intérieur de la poche après ouverture de la poche en passant par la fermeture. Le dispositif de perforation présente une fermeture encliquetable (10) servant à le fixer à la fermeture de la poche. Après avoir fixé le dispositif de perforation sur la poche, on rompt partiellement une partie du dispositif de perforation à l'intérieur de la poche pour former un canal de passage qui permet de prélever le liquide présent dans la poche ou de mélanger une autre substance au liquide présent dans la poche.
PCT/EP2009/054462 2008-04-24 2009-04-15 Dispositif de perforation et procédé de prélèvement d'un liquide dans une poche ou d'amenée d'une substance dans une poche WO2009130147A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP09731471A EP2155140B1 (fr) 2008-04-24 2009-04-15 Dispositif de perforation et procédé de prélèvement d'un liquide dans une poche ou d'amenée d'une substance dans une poche
BRPI0903703-9A BRPI0903703A2 (pt) 2008-04-24 2009-04-15 Dispositvo de perfuração, bolsa com um "port" e processo para retirada de um líquido de uma bolsa por meio de um dispositivo de perfuração.
AT09731471T ATE488212T1 (de) 2008-04-24 2009-04-15 Durchstossvorrichtung und verfahren zum entnehmen einer flüssigkeit aus einem beutel oder zuführen einer substanz in einen beutel
DE502009000183T DE502009000183D1 (de) 2008-04-24 2009-04-15 Durchstossvorrichtung und verfahren zum entnehmen einer flüssigkeit aus einem beutel oder zuführen einer substanz in einen beutel
RU2010147044/15A RU2519639C2 (ru) 2008-04-24 2009-04-15 Устройство для прокола мешка и способ отбора жидкости из мешка или введения вещества в мешок с использованием устройства для прокола

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE200810020652 DE102008020652A1 (de) 2008-04-24 2008-04-24 Durchstoßvorrichtung und Verfahren zum Entnehmen einer Flüssigkeit aus einem Beutel oder Zuführen einer Substanz in einen Beutel
DE102008020652.0 2008-04-24

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WO2009130147A1 true WO2009130147A1 (fr) 2009-10-29

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Country Status (6)

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EP (1) EP2155140B1 (fr)
AT (1) ATE488212T1 (fr)
BR (1) BRPI0903703A2 (fr)
DE (2) DE102008020652A1 (fr)
RU (1) RU2519639C2 (fr)
WO (1) WO2009130147A1 (fr)

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EP2528574A1 (fr) * 2010-01-26 2012-12-05 Fresenius Kabi Deutschland GmbH Raccord pour récipients contenant un principe actif médicinal
US10420927B2 (en) 2015-12-04 2019-09-24 Icu Medical, Inc. Systems, methods, and components for transferring medical fluids
USD874644S1 (en) 2016-07-19 2020-02-04 Icu Medical, Inc. Medical fluid transfer system
US11007119B2 (en) 2009-07-29 2021-05-18 Icu Medical, Inc. Fluid transfer devices and methods of use
US11020541B2 (en) 2016-07-25 2021-06-01 Icu Medical, Inc. Systems, methods, and components for trapping air bubbles in medical fluid transfer modules and systems
US11439570B2 (en) 2011-12-22 2022-09-13 Icu Medical, Inc. Fluid transfer devices and methods of use
US11541171B2 (en) 2013-11-25 2023-01-03 Icu Medical, Inc. Methods and systems for filling IV bags with therapeutic fluid
US11590057B2 (en) 2020-04-03 2023-02-28 Icu Medical, Inc. Systems, methods, and components for transferring medical fluids
US11674614B2 (en) 2020-10-09 2023-06-13 Icu Medical, Inc. Fluid transfer device and method of use for same
US12023304B2 (en) 2022-08-04 2024-07-02 Icu Medical, Inc. Fluid transfer devices and methods of use

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CN102438683A (zh) * 2009-05-22 2012-05-02 弗雷泽纽斯卡比德国有限公司 用于输液装置的滴注器和设有滴注器的输液装置
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US11806308B2 (en) 2009-07-29 2023-11-07 Icu Medical, Inc. Fluid transfer devices and methods of use
US11007119B2 (en) 2009-07-29 2021-05-18 Icu Medical, Inc. Fluid transfer devices and methods of use
EP2528574A1 (fr) * 2010-01-26 2012-12-05 Fresenius Kabi Deutschland GmbH Raccord pour récipients contenant un principe actif médicinal
US8876790B2 (en) 2010-01-26 2014-11-04 Fresenius Kabi Deutschland Gmbh Connector for containers containing a medicinal active substance
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EP2528574B1 (fr) * 2010-01-26 2015-07-29 Fresenius Kabi Deutschland GmbH Connecteur pour récipient contenant un agent actif médical
US11439570B2 (en) 2011-12-22 2022-09-13 Icu Medical, Inc. Fluid transfer devices and methods of use
US11439571B2 (en) 2011-12-22 2022-09-13 Icu Medical, Inc. Fluid transfer devices and methods of use
US11541171B2 (en) 2013-11-25 2023-01-03 Icu Medical, Inc. Methods and systems for filling IV bags with therapeutic fluid
US10420927B2 (en) 2015-12-04 2019-09-24 Icu Medical, Inc. Systems, methods, and components for transferring medical fluids
USD948044S1 (en) 2015-12-04 2022-04-05 Icu Medical, Inc. Fluid transfer device
US11135416B2 (en) 2015-12-04 2021-10-05 Icu Medical, Inc. Systems, methods, and components for transferring medical fluids
USD1018849S1 (en) 2015-12-04 2024-03-19 Icu Medical, Inc. Fluid transfer device
US11865295B2 (en) 2015-12-04 2024-01-09 Icu Medical, Inc. Systems, methods, and components for transferring medical fluids
USD943732S1 (en) 2016-07-19 2022-02-15 Icu Medical, Inc. Medical fluid transfer system
USD905228S1 (en) 2016-07-19 2020-12-15 Icu Medical, Inc. Medical fluid transfer system
USD874644S1 (en) 2016-07-19 2020-02-04 Icu Medical, Inc. Medical fluid transfer system
US11020541B2 (en) 2016-07-25 2021-06-01 Icu Medical, Inc. Systems, methods, and components for trapping air bubbles in medical fluid transfer modules and systems
US11583637B2 (en) 2016-07-25 2023-02-21 Icu Medical, Inc. Systems, methods, and components for trapping air bubbles in medical fluid transfer modules and systems
US11951293B2 (en) 2016-07-25 2024-04-09 Icu Medical, Inc. Systems, methods, and components for trapping air bubbles in medical fluid transfer modules and systems
US11590057B2 (en) 2020-04-03 2023-02-28 Icu Medical, Inc. Systems, methods, and components for transferring medical fluids
US11674614B2 (en) 2020-10-09 2023-06-13 Icu Medical, Inc. Fluid transfer device and method of use for same
US12023304B2 (en) 2022-08-04 2024-07-02 Icu Medical, Inc. Fluid transfer devices and methods of use

Also Published As

Publication number Publication date
ATE488212T1 (de) 2010-12-15
DE102008020652A1 (de) 2009-12-31
BRPI0903703A2 (pt) 2015-06-30
RU2519639C2 (ru) 2014-06-20
DE502009000183D1 (de) 2010-12-30
RU2010147044A (ru) 2012-05-27
EP2155140B1 (fr) 2010-11-17
EP2155140A1 (fr) 2010-02-24

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