MXPA98010577A - Cate package - Google Patents

Abstract

A catheter package (10; 110; 210) comprising a catheter (1; 101; 201) positioned within an internal container (2; 102, 202) permeable to a sterilizing agent, for example, an ethylene oxide gas. An external container (3; 103; 203) which prevents moisture access to the interior encloses the internal container and catheter assembly. Two or more catheters can be stored in individual internal containers inside the external container

Description

CATHETER PACKAGE TECHNICAL FIELD OF THE INVENTION The present invention relates to a catheter package, and to a method for packing catheters therein.

BACKGROUND OF THE INVENTION Catheters have exterior coatings that have been known for many years. Typically the liner is a hydrophilic layer designed to reduce the coefficient of friction in wet conditions, so that the catheter can be inserted relatively painlessly into the patient's urethra, and likewise removed from the urethra when required. Typical examples of such catheters are the facts of knowledge in European patent specifications EP-B-0093093 (Astra Meditec AB) and EP-B-0217771 (Astra Meditec AB). EP-B-0093093 describes a process for providing a polymeric surface / such as a urinary latex catheter, with a primary coating including an isocyanate compound, and a secondary coating including polyvinylpyrrolidone. EP-B-0217771 discloses a method for forming an improved hydrophilic coating to retain the sliding ability during a REF period. 28962 prolonged time on a substrate, such as a PVC urinary catheter, by application of a solution comprising a solvent having a compound that increases osmolality such as sodium chloride. The catheters are conventionally packaged in a paper package, to allow them to be sterilized before being used. Sterilization is typically performed at the time of manufacture, using methods well known in the art such as gamma radiation or fumigation with ethylene oxide gas. If ethylene oxide is used, it must be allowed to have access to the surface of the catheter, and a paper packet allows this to occur. The conventional method is to use a paper that is permeable to ethylene oxide, with a polyethylene lacquer mesh and welded around its edge to a sheet of, for example, polyethylene-polypropylene or polyethylene-polyethylene terephthalate, or possibly polyethylene- nylon. The Applicant has observed that a problem encountered with coated catheters is that the surface of the catheter becomes tacky and adheres to the paper of the package causing the coating of the catheter to be damaged, destroyed or mutilated. The insertion of a plastic material adjacent to the inner surface of the paper has been suggested, creating a loose paper-plastic sheet sealed just around its edges, so that the catheter is not in immediate contact with the paper. However, this has the disadvantage that a barrier is now placed which prevents the penetration of ethylene oxide into the package to come into contact with the surface of the catheter. Such a package could only be effectively sterilized by radiation, although an alternative is to provide a number of grooves in the plastic material, sufficiently thin to prevent the surface of the catheter from coming into direct contact with the paper and to be able to open a sufficiently wide opening for allow access of ethylene oxide at the required time. This clearly means that the manufacturing process becomes more complicated than would be desirable. In particular, the grooves in the plastic material have to be carefully regulated, so that they do not allow contact of the catheter surface with the paper, without in any way preventing sterilization with ethylene oxide.

Disclosure of the invention There is therefore a need for an improved catheter package and according to the present invention there is provided a catheter package comprising a catheter coated on its surface, for example a catheter coated with an external hydrophilic surface, and a container which encloses the catheter and allows the passage of a sterilizing agent for the catheter through, for example an ethylene oxide gas, characterized in that the container is an internal container and in that the catheter package further comprises an external container which encloses the internal container and prevents or substantially prevents the access of moisture to the interior thereof. Such a package can overcome the disadvantages inherent in the prior art and is even simpler to manufacture. It thus appears that the sticky surface of the catheter is caused by the gradual ingress of moisture to the package during storage. The outer container of the package can be formed from a single layer of a plastic material such as polyethylene or poly (vinylidene dichloride) (PVDC). However, a watertight barrier against moisture can be achieved even better by using a sheet including a metal layer such as aluminum. Typically an aluminum and polyethylene sheet could be used, with the polyethylene on the inside of the outer container. Such a material could be very brittle, but this can be compensated for by providing an external reinforcing layer of a plastic material such as oriented polyester or polypropylene, for example biaxially oriented polypropylene.

The Applicant has also found that a moisture-tight barrier can be obtained by using a silicon oxide, for example silicon dioxide, in the construction of the outer container. The silicon oxide can be supported on a matrix material such as polyester, polyethylene terephthalate (PET), nylon or polypropylene or as distributed by Mitsubishi under the trade name of Techbarrier-S and can also be used as a layer of a sheet used to build the external container. If necessary, an external reinforcing layer of plastic materials may be used again in the construction of the outer container. Alternatively, a metallized film such as a metallized PET film with aluminum oxide can be used. The metal content of this is very small, which is environmentally better, and the applicant has also found that it is a good barrier against moisture. Nylon and polypropylene are alternatives to polyethylene terephthalate in such films. The polychlorotrifluoroethylene (PCTFE) can also be mentioned as a possible barrier material for the construction of the outer container. A catheter can be stored in each package. However, since the catheters are generally used once or very rarely and then replaced, two or more catheters can be stored in individual internal containers within a single external container. In such a case, it would be advantageous if the outer container could be sealed again once an internal container containing a catheter has been removed. This can be achieved by providing means to close the outer container again, such as a zipper or a resealable tape. Even so, it is possible that small amounts of moisture may diffuse through the outer container into the cavity between the internal and external containers during prolonged storage, or enter when the catheter is removed if means are provided to close again. The Applicant has found that the diffusion of moisture can occur particularly when the outer container comprises a single polymeric layer such as polyethylene. This problem can be avoided by placing a desiccant in this cavity. A typical desiccant could comprise a bag of silica gel, or a molecular sieve or calcium chloride. The Applicant has found that sometimes the use of plasticizer, or solvents in the glue, during the manufacture of the catheter or the external container can cause malodorous fumes to be released in the cavity between the internal and external containers during prolonged storage. This can be avoided by placing a deodorant material in this cavity. A typical deodorant material could comprise a sack of activated carbon. The package is particularly, although not exclusively, suitable for use in combination with a catheter having a hydrophilic coating. Such a coating is always more or less sensitive to water. Examples of moisture-sensitive coatings are those of polyethylene oxide, poly (vinylpyrrolidone) (PVP) and cellulose polymers such as hydroxyethylcellulose or hydroxypropylcellulose. The coating may include a compound that increases osmolality such as sugar, urea or an inorganic salt. Typically such compounds are crystalline in form and readily soluble in water. Soluble inorganic salts include sodium and potassium chlorides, iodides, nitrates, citrates and benzoates. According to the invention there is further provided a method for manufacturing a catheter package comprising the steps of closing a catheter coated on the surface in an internal container which allows access of a sterilizing agent therethrough to the enclosed catheter and exposing the internal container and catheter assembly to the sterilizing agent sufficiently to sterilize the catheter, characterized in that the additional step of enclosing the internal container-and catheter assembly in an external container is provided which prevents or substantially prevents access of moisture to the interior of the same.

BRIEF DESCRIPTION OF THE DRAWINGS The embodiments of the invention will now be described, by way of example, with reference to the accompanying drawings in which - Figure 1 is a view of a catheter package according to a first embodiment of the present invention which comprises an internal container which encloses a catheter and an external container which encloses an internal container; Figure 2A is a cross-sectional view of the catheter package of Figure 1; Figure 2B is a cross-sectional view of the construction of the boundary wall of the inner container of Figure 1; Figure 2C is a cross-sectional view of the construction of the boundary wall of the external vessel of the catheter package of Figure 1; Figure 3 is a cross-sectional view of a catheter package according to a second embodiment of the invention comprising a plurality of catheters within the individual internal containers all enclosed within an external container; Figure 4 is a further view of the ostrasound catheter package in Figure Z; and FIG. C is a cross-sectional view of a catheter pack and outside a third wedge of the invention that comprises a plurality of catheters in the inner containers, all wrapped in an external container.

DETAILED DESCRIPTION OF THE MODES OF THE INVENTION Referring to Figure 1 and Figures 2A to 2C, a catheter pack 10 according to a first embodiment of the present invention comprises a catheter 1 placed inside an inner bag 2, which itself The same is placed inside an outer bag 3. The catheter 1 can, for example, be a unitary PVC catheter with a hydrophilic coating which includes a compound that increases osmolality such as sodium chloride, as described in EP. -B-U21 /// 1. The construction of the inner bag 2 is such that it is permeable to the ethylene oxide gas. Corao can be seen from Figure 2B, the inner bag 2 was formed from a first boundary wall section comprising a paper layer 10 with a lacquer mesh with a polyethylene layer 9 and a second boundary wall section comprising a sheet of, for example, a polyethylene layer 8 and a polypropylene layer 7 welded to the edge of the first section of the boundary wall. A polyethylene terephthalate sheet, or possibly polyethylene-nylon, could also be used for the second boundary wall section, and the edges could also be sealed by folding or bending. Instead of paper, Tyvek ", a non-woven material of polyethylene fibers distributed by DuPont in the first section of the boundary wall, could be used in this case, the additional layer of polyethylene 9 would be unnecessary while the non-woven material would be by itself capable of forming a good seal by welding The construction of the outer bag 3, on the other hand, is such that it prevents moisture from entering the inner bag 2. As shown in Figure 2C, the outer bag 3 it is formed of a sheet composed of an aluminum layer 5 and a polyethylene layer 6, with the polyethylene layer ß being on the inside of the outer bag 3. An outer layer of polyester 4 is supported on the aluminum layer 5 The edges of the outer bag 3 are sealed together by welding.The typical dimensions are 30 to 50 μm for the polyethylene layer, of 6, 8 to 10 μm for the aluminum layer 5 and 10 to 20 μm for the polyester layer 4 .. Alternatively, a layer comprising a silicon oxide can be replaced by the aluminum layer 5, for example a layer of silicon oxide barrier material sold by Mitsubishi under the trade name of Techbarrier-S. An aluminum oxide could also be used to form the barrier layer which could be PCTFE. The catheter package 10 is mounted first by enclosing the catheter 1 in the inner bag 2 and then exposing the inner bag 2 to ethylene oxide gas until the catheter 1 is sterilized. The inner bag 2 is then encased in the outer bag 3. It has been found that the catheter pack 10 gives a shelf life of at least one year without the surface of the catheter 1 becoming tacky. The problem of damage to the liner of the catheter 1 by adhesion thereof to the paper layer 10 of the inner bag 2 is therefore eliminated. In Figures 3 and 4 a catheter pack 110 according to a second embodiment of the present invention is shown. In this case a plurality of catheters 101 are stored in individual inner bags 102 within a single outer bag 103. The constructions of the inner and outer bags 102, 103 are as in the first embodiment described hereinabove with reference to Figures 1 and 2A to 2C. However, in this case the zipper closure 11 is integrally made with the outer bag 103 to open and close the outer bag 103 to allow both an inner bag 102 to be removed while reducing the contact of the inner bags at the same time. remaining 102 with the ambient air. A desiccant comprising a bag of silica gel 112 is also included in the cavity 113 between the outer bag 103 and the inner bags 102. A deodorant material comprising an activated carbon sack 114 in the same cavity 113 is also provided. The catheter pack 110 also gives a shelf life of at least one year without the surface of the catheters 101 becoming sticky. Furthermore, the user is not confronted with noxious fumes when opening the outer bag 103. The catheter pack 110 is manufactured by forming each inner bag 102 around the catheter 101 which contains and seals the edges of the inner bags 102 by welding them together. Ideally a number of inner bags 102 can be manufactured as a single unit, joined at the edges, so that they can be separated when required. The inner bags 102 are then sterilized by exposing them to ethylene oxide gas and ventilating to remove excess ethylene oxide. An optional irradiation step may be included. The inner bags 102 are collected together with the bags of silica gel 112 and activated carbon 114. The outer bag 103 is then formed around them. The most expeditious way to achieve this is to use • prefabricated bags 103 in which three of the four edges have already been sealed by welding. The contents are then inserted and the fourth edge of the outer bag 103 is also sealed, again with solder. Turning now to Figure 5, a catheter pack 210 according to a third embodiment of the present invention comprises several catheters 201 stored in individual inner bags 202 of the same construction as in the first embodiment described hereinabove with reference to Figures 1 and 2A to 2C which are in turn stored within a single outer bag 203. The outer bag 203 comprises a vacuum formed tray 215 with a flat lid 216. The tray 215 and the lid 216 are both made of a material of barrier that prevents moisture access to inner bags 202 and can be formed therefrom or different materials. It is thought that the use of the same material is convenient. As suitable materials herein may be mentioned polypropylene, poly (vinylidene dichloride) (PVDC), a metallized film and an aluminum foil with polyethylene, polyester, polystyrene, polypropylene or nylon. The need to form the vacuum tray 215 means that certain restrictions are imposed on its thickness, although any reasonable material thickness can be used for the lid 216. A typical thickness for the lid 215 would be in the range of 400 to 600 μm, although if a more rigid material is used, lower thicknesses of 100 to 200 μm are possible. The tray 215 could also be made of a foamed material, such as expanded polystyrene. A means is developed for opening and closing the bag -external 203 comprising a resealable tape 211 integral with the lid 216 of the bag 203. In this way the contact of the inner bags 202 with ambient air is minimized. The catheter pack 210 is manufactured by collecting the inner bags 202 after exposing them to a sterilizing agent such as ethylene oxide gas and forming the outer bag 203 around them. The most expedient way to achieve this is to place the inner bags 202 within the hollow of the vacuum-formed tray 215 of the outer bag 203 and then seal the edges of the lid 216 of the outer bag 203 on the tray 215 by welding. The depth of the tray 215 can, as shown, be selected so as to allow more than one layer of catheters 201 to be inserted.

It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention. Having described the invention as above, the property contained in the following is claimed as corao:

Claims (15)

1. A catheter package comprising a catheter coated on the surface and a container which encloses the catheter and allows the passage of a sterilizing agent for the catheter therethrough, characterized in that the container is in an internal container and because the package of The catheter further comprises an external container which encloses the internal container and substantially prevents or prevents access of moisture to the interior thereof.

2. The package according to claim 1, characterized in that the construction of the external container comprises a sheet which includes a metal layer.

3. The package according to claim 1, characterized in that the construction of the external container comprises a layer comprising a silicon oxide. The package according to claim 2 or * 3, characterized in that the external container comprises an external reinforcing layer of a plastic material. The packet according to any of the preceding claims, characterized in that the catheter and the inner container form a catheter pack subassembly and that the catheter pack comprises one or more additional catheter pack sub-assemblies within the outer container. The package according to claim 5, characterized in that means are provided for repeatedly opening and closing the external container. The package according to any of the preceding claims, characterized in that a desiccant is deposited between the internal and external containers. The package according to any of the preceding claims, characterized in that a deodorant is deposited between the internal and external containers. 9. The package according to any of the preceding claims, characterized in that the or each catheter is a catheter coated on the external hydrophilic surface. 10. The package according to any of the preceding claims, characterized in that the sterilizing agent is an ethylene oxide gas. The package according to claim 9 or claim 10, when dependent on claim 9, characterized in that the hydrophilic coating comprises a compound that increases osmolality. The package according to claim 9 or claim 10, when dependent on claim 9, or claim 11, characterized in that the hydrophilic coating comprises an inorganic salt selected from sodium chlorides, iodides, nitrates, citraters and benzoates and potassium. A method for manufacturing an atheter package comprising the steps of enclosing a surface-coated catheter in an internal container which allows access of a sterilizing agent therethrough for the enclosed catheter and exposing the internal container assembly and catheter to the sterilizing agent sufficient to sterilize the catheter, characterized in that it provides the additional step of enclosing the internal container and catheter assembly in an external container, which substantially prevents or prevents the access of moisture to the interior thereof. 1

4. The method according to the claim 13, characterized in that the catheter is a catheter coated with an external hydrophilic surface. 1

5. The method according to claim 13 or 14, characterized in that the sterilizing agent is an ethylene oxide gas.