Container for Intravenous Administration to Field of the Invention *. The present invention relates to a device for storing and administering a medical fluid, comprising a sealed, generally flexible bottle-shaped container provided with an insert in its opening to which an injection element can be attached. Background of the Invention 10 It is a well established technique in the pharmaceutical industry to manufacture containers formed as pre-filled bottles for sterile fluids from blowing to mold a polymeric material, filling and sealing the container formed in a
continuous operation. This method of blowing-filling-sealing is described for example in U.S. Patent 4,342,184. In the specification of European Patent EP 0 670 709, a container made from a method comprising essentially
only a material based on a polyolefin to obtain a container highly friendly to the environment with a high compatibility for stored fluids that also meets the requirements that the sealed container can finally
sterilize with high pressure steam (ie, by
autoclave at around 120 ° C for more than 15 minutes). This container formed as a bottle is suitable for repeated collection of fluid with a syringe needle that stings its resistant sealing insert containing an elastomer. This type of containers can have so many advantages by its method of cheap and efficient production and will successfully replace glass bottles or ampoules in numerous applications. An obstacle with these containers is that it requires some skill and precision to correctly chop the insert to establish fluid communication between the bottle and the syringe to collect a desired quantity of the stored fluid for administration to a patient or to transfer to another container. EP 0 088 056 and EP 0326 391 disclose a plastic bottle vial having half thread heads and neck portions formed as a female luer tip to fit the male luer tip heads of a connected syringe when the fluids are transferred from the bottle to the syringe. In many applications, it would be advantageous to be able to directly use the container formed as a filled bottle to deliver its sterile fluid to the patient. The transfer step
using a dockable syringe results in an additional routine and therefore a risk of contamination and faulty handling. Patent FR 27 18 017 discloses a bottle for liquid pharmaceuticals made of a polymeric material that is sealed with a removable lid. The bottle has an upper part formed as a male luer tip as a connection to a cannula (or a similar device) with the corresponding shape. After the lid 6 is broken, a safety ring 11 engages on the flange 10 of the opening of the bottle. The safety ring will serve as a piece that connects securely and hermetically between the opening of the bottle and the cannula. European Patent Application 0 788 804 describes a flexible bottle of a polymeric material. The bottle may contain a rinsing fluid (sodium chloride solution) which for example can be used to rinse a catheter connected to a vein of a patient, just before the infusion of a drug or a parenteral nutrient. It generally comprises a part with a coupling element for a cannula that is inserted in the opening. The coupled device is ready to be used to administer the contents of the bottle to a patient, or to transfer the
fluid to another container. The device of EP 0 788 804 suffers from a number of obvious setbacks. Initially, the insertion procedure of the connector is inconvenient and results in additional handling for the hospital staff and will always include a risk of inadvertent fluid contamination. Secondly, the device, if used to rinse the vein can bring air bubbles with the fluid when the fluid is administered through crushing the flexible bottle. The introduction of air bubbles into the blood system can not be tolerated due to the risk of embolism. Also, patents US 4,259,095, EP 0 310 227 and FR 954 795 disclose plastic bottles filled with medical liquids having removable end portions that expose a neck portion of the male luer tip to be connected to a corresponding female part of the cannula. . These containers are intended to provide containers that can be directly transformed into a management tool for the injection of a liquid stored to a patient. However, as injection devices, these containers are in many ways inferior when compared to ordinary syringes that operate when a rod is operated
piston connected to a piston during fluid administration. Another obstacle with conventional shaped blow-fill-seal containers of this type is that the joints of the molding process, when connected to the parts of the container, remain and cause inability to adjust the luer connection between the top of the container and a cannula It is of additional importance that they do not admit safe routines when it comes to removing the air bubbles from the injection fluids, performed through a routine de-aeration step with conventional syringes in order to avoid air injection. Patent US 5,538,306 discloses a construction of the apachurrable containers formed as a bottle coupled to a cannula that is intended to overcome the problems, but is complicated in its construction and requires a prescribed handling that includes several steps. Obviously there is a demand for plastic containers formed as a bottle for storing medical fluids that can easily become a safe and convenient injection device with a minimum of complicated operations and therefore have the highest possible safety in terms of fluid contamination during the driving. This is
obtained through the present invention as will be explained below. DESCRIPTION OF THE INVENTION The present invention relates to a device for storing and administering a medical fluid, comprising a sealed flexible container that is generally formed as a bottle or a similar shape. At its front end, the container is provided with an opening part, in which an insert is sealably seated. In order to protect the insert during handling and storage before using the device, the container is formed during its manufacture so that it extends directly into the sealing cap on the insert. The lid is removable as it is provided with a weak line or a similar breakable area so that the user, when performing a simple twisting motion, removes the entire lid or a substantial part of it to expose the insert when the fluid in the container is to be used. and the fluid communication is established within the container and a dockable injection element, preferably with a conventionally formed cannula comprising a front needle part connected to a hollow rear part
generally conical This is achieved by the fact that the rear part of the cannula engages a generally tubular part of the insert with a conical shape usually in a transverse fitting with the hollow part of the cannula. Preferably, the tubular part of the insert and the hollow part of the cannula are cooperative luer accessories, so that the tubular part corresponds to the male luer fitting and the hollow part corresponds to the female luer fitting. In addition, in order to ensure that the injection element is securely coupled, the insert is provided with a latching element comprising an annular recess radially extended in the insert extending axially in the insert at a sufficient distance to ensure the coupling of a conventional cannula having a rear end in the form of a female luer fitting. To improve the engagement, the outer periphery of the annular recess is preferably provided with threaded screw slots, to form a luer lock coupling between the cannula and the insert of the device. An important feature of the device is that it only admits the flow of fluid in one direction when medical fluid is handled and administered. It will prevent the accidental entry of air into the
container and therefore an accidental administration of air bubbles that in the worst case can cause an embolism. Therefore, the insert is provided with elements such that it only admits fluid communication in one direction. further, the insert has the ability to be sealed in case the fluid passes from the injection device through the insert into the container. This is preferably achieved through the insert which is provided with a membrane in its fluid channel which moves between a first sealing position to a second open position if pressure is exerted on the flexible container. Preferably, the membrane moves axially between two predetermined positions in order to act as a check valve mechanism. The skilled person can easily select a suitable valve mechanism that does not have to be limited to the aforementioned membrane and find the proper opening pressures. Suitable opening pressures for the valves in the present invention are less than 2.5 mm H20 and preferably less than about 1 mm H2O. In order to provide a device that is safe to jet and flush a catheter connected intravenously with a sterile saline, for example from a
patient confined to parenteral nutrition, it is preferred that the membrane be moved to a sealing position through the patient's blood pressure, so that the blood is not inadvertently drawn into the device. It is appropriate that the opening pressure of the valve mechanism be greater than the patient's blood pressure. In certain applications, the container formed as a bottle of the device may be formed as a bellows to facilitate the movement of crushing required during the administration of its contents. The container formed as a bottle may also be provided with elements indicating the fluid levels and the size of the dose required to be administered. The inventive device can be manufactured with a conventional blow-fill-seal method as it is closer to the specifications of the aforementioned EP 0 670 709 and the US patent 4,342,184. This method includes blow molding a polymeric material in the form of a bottle which is filled with a medical fluid, where the insert is placed in the opening of the container which is finally sealed by forming a removable lid on the insert of a polymeric material. . The assembly device
it can finally be subjected to a sterilization step through high pressure steam (autoclave) or through irradiation elements before leaving the manufacturing plant. The inventive device will find a large number of applications in addition to jetting the infusion element with the sodium chloride solution. For example, it will be useful for the supplementation of a complementary fluid to an infusion bag when chopping one of its ports, just before the administration of the contents of the bag. The use of the device as a single or multiple dose syringe for direct administration to a patient by injection of for example antithrombotic agents such as heparin or low molecular weight heparins such as Fragmin® can also be conceived. DETAILED DESCRIPTION OF THE INVENTION Figure 1 shows a schematic view of the container with an axial split view of the insert. Referring to Figure 1, the device comprises a container body generally formed as a bottle 10 with an opening part 12 at its front end where an insert 20 is placed. The container extends directly into a lid
sealing 14 which is easily removed through a torsion movement made by the user. For this reason the lid is provided with a break line 16 that can be easily broken. The insert generally has a tubular portion 22 which may be in connection with the fluid with the body of the container. The front end of the tubular part is sealed with a plug 21 which is intended to be removed at the same time the lid is broken. The tubular part has a conical shape generally in a cross-section to fit a hollow-shaped part on the back correspondingly of the cannula. Therefore, the cannula can be attached to the tubular part with a luer fitting. To assist in this engagement, the insert is provided with an annular recess 24 extending at a suitable axial distance in the insert. The recess may be provided with threaded screw slots 25 to improve engagement with the cannula. The dimension of these parts is selected so that they comply with the ISO / DIN standards for male and female luer accessories. In order to achieve fluid communication in only one direction through the insert this is provided with a valve mechanism. The insert comprises two parts, a front part 20A with the tubular part before
mentioned and the annular recess capable of establishing a luer lock connection to a cannula and the rear part 20B. The parts of the insert are presently made of the same compatible polymeric material and are welded together tightly with conventional elements. The rear part of the insert is provided with a sealing membrane 26 accommodated in a box 27 which has fluid connection with the channel 23 which passes through the tubular part 22 and the channel 28. The membrane is a silicone membrane for sealing coupled in its box 27, where it moves axially between an open position and a sealed position. The membrane and the box are dimensioned to admit fluid communication with the channel 23 when a predetermined positive pressure is exerted on the container 10, for example, when crushing it, otherwise the mechanism remains in the sealed position. The back of the insert will then act as a check valve and has the ability to close and seal the device in case the coupled cannula is in intravenous contact with the patient and the blood pressure is exerted on the valve mechanism until a pressure that exceeds the blood pressure is exerted on the container when the medical fluid is administered to the patient. The insert
Correspondingly designed device will provide a device that is useful both as jet and rinsing elements for intravenous administration provisionally connected to a patient's vein and for conventional administration through the injection of a medical fluid dose without the risk of administering air accidentally to the patient who, for example, could be sucked into the device by inadvertent handling. The handling of the container will be extremely simple and reliable and is initially restricted for the measurements of the removal of the lid together with the rupture line made and coupling the cannula to the insert. Then, the container can, if necessary, be subjected to a de-aeration step by gently squeezing it in an upward position until the fluid is exhausted from the needle and / or no visible signs of air bubble debris are found. . The administration can from that be realized through simply crushing the container in a prescribed manner. The device is preferably made substantially of polymer materials that can be recycled together without unnecessary work of dismantling it and collecting the parts separately. A preferred material for the container are the
polyolefins, especially polypropylenes and copolymers thereof. The insert can be made of polypropylenes or polycarbonates. The minor contribution of the latex membrane of the valve will not interfere with normal recycling applications, since its weight represents less than 1% of the entire container.