MXPA00000361A - Improvements related to medical containers - Google Patents

Abstract

The invention relates to a port system for establishing fluid communication with a container for storing medical fluids and a device for adding or withdrawing fluids from said container comprising at least one port having a sealed front end and a rear end open to the inside of said container and a base plate attachable to said container, wherein said port has a penetrable membrane serving as a barrier to the stored fluids. The port comprises a cap in its front end which axially extends into an essentially sleeve formed part provided with said penetrable membrane which is sealed from contamination by said cap and furthermore it is provided with means to expose said penetrable membrane when it is desired to establish fluid communication with the container.

Description

X? RELATED IMPORTS CO * N ** "REC MEDICAL FEES FIELD OF THE INVENTION The present invention relates to a port system suitable as an opening for flexible medical containers that admits repeated entries in the container with a penetration device to establish fluid communication. The novel port system has improved security against pollution, is highly convenient and is manufactured with a simplified method.

BACKGROUND OF THE INVENTION Efforts to create containers of polymeric materials for medical products that are parenterally administered to replace glass bottles are described in International Patent Application WO 95/08317 and in the still-unpublished Swedish Patent Application SE 9601348-7. In order to obtain the acceptance of the authorities regarding the approvals of the medical systems, said polymeric containers after having been filled, and finally sealed, must be capable of being sterilized by high pressure steam (i.e., by autoclaving) with a capacity of barrier maintained against the environment and security against the migration of potentially dangerous agents. In addition, the container must maintain an adequate aesthetic value and from an environmental protective point of view should be easy to recycle after use. A particular problem in the development of this type of container is to provide it with an adequate opening or port that allows the collection or administration of its stored fluids, as well as the supplementation of said complementary agents that are degradable during storage. The opening must admit repeated entries by means of devices to establish fluid communication with the container, such as syringes, cannulas and spigots of infusion equipment. In addition, the opening must be capable of supporting various types of sterilization and provide a contamination-free entry of said devices to establish fluid connection, so that container fluids are not wasted by microbial growth. The conventional bottle form or similar polymeric container comprises a penetrable rubber sealant sealingly secured to an upper portion of a neck formed opening having an edge in which a removable protective protective foil of metal or polymers is sealed. In the polymeric bags by infusion, a removable rubber cover protects a membrane that can be penetrated by a spike to an infusion set. A disadvantage of said arrangements is that the penetrable (outer) top surface of the obturator or the membrane can be contaminated before sealing with a thin sheet or lid and although the finally sealed and filled container is closed by autoclaving, this part will never be reached adequately by steam sterilization. In order to solve said problem and provide safer ports for the flexible polymer containers, means for temporarily introducing the sterilization steam to the aforementioned parts are described in the Swedish Patent Application No. 9601540-9. the openings or ports for the polymeric container also have the disadvantage that the rubber parts can not be recirculated together with the remaining plastic container, but must be collected separately, in order to improve the existing closure devices for containers, a novel two-color mold method is disclosed in Swedish Patent Application No. 9700597-9 for preparing the sealants of an elastomeric material with improved resealing characteristics.The openings or ports of the container described in the aforementioned documents suffer the complicated production procedures where the elastomer obturator It is molded or inserted into a carrier that must subsequently be placed in the mouthpiece of the port that is sealed by a lid or a thin sheet, wherein the port can be attached to the container or the flexible material to form a container. A reduction in production steps will allow a more economical procedure that can also provide more aseptic production conditions. EP 0 097 054 (Hantakki Oy) discloses a flexible bag for medical fluids provided with an injection port having a closure comprising a protected flexible penetrable pad which is to be sealed after penetration and which can also be protected with the fluids stored. This type of closure has the disadvantage that it requires complicated manufacturing and is difficult to maintain aseptic in all its parts. 5 The Patent of E.U.A. 4,303,067 (American Hospital Supply Corp.) describes an additive port for a medical bag through which drugs can be delivered by an injection device. The port has a penetrable, resealable plug made of an elastomer. Nothing has yet been described near the resealing capability or the ability to sterilization of the closure. The Patents of E.U.A. 4,975,308 and E.U.A. 5,247,015 disclose molded stoppers for blood tubes made of a halobutyl rubber dispersed in a mixture of polyolefins and thermoplastic elastomer. No descriptions are made in the present about your resealing capacity after penetration of the needle or its ability to be sterilized by heat. There are numerous citations in the literature about openings for pharmaceutical containers of various types, made of glass or polymeric materials that are described as suitable for sealing medical fluids stored. For fluids directed to parenteral fluids (ie, intravenous injection), there are requirements on the part of medical authorities that the openings are capable of maintaining a barrier against the environment, during steam sterilization and during the i ^ tj "^ - < aa, a tó? gggí = * Subsequent long-term storage This type of closure is also required to be able to reseal spontaneously and immediately after removal of the penetrating needle. they must be capable of resealing after multiple entries of the penetration needle, a cannula or a similar penetration device to collect the fluid from the container, or by the addition of a component to be mixed with the contents of the container. Improper resealing of the closure after penetration will potentially waste the integrity of the stored fluids by providing a channel for antimicrobial growth in the container. It is also a requirement that the container does not leak when its closure is penetrated during the connection of the fluid, for example, during the infusion to a patient through a cannula. In addition, the opening must be compatible with stored fluids and no migration of potentially dangerous agents is allowed from any part.

The opening must also withstand conventional sterilization procedures including the autoclave at 121 ° C or sterilization by irradiation without loss of sealing capacity. It is also a requirement for an amount of increase from the medical authorities that each authorized recipient can be re-circulated and therefore is a It demands that empty containers be disposed of without laborious dismantling and departure from the parties for individual recycling procedures. *? m > tZ ** a * áa? Í¿ ~ * k * > An object of the present invention is to provide a container port system that is manufactured with a technique sufficiently aseptic to separate the sterilization process and that is not required before joining the container or the intended flexible material to form the container. It is also an object of the present invention to limit the number of steps required of the process to manufacture the port. Another object of the invention is to provide a port having a resealing capability after being penetrated with a device to establish the fluid connection with the container. Another object of the present invention is to eliminate the final sealing step of the front end of the port with a thin sheet or lid. Another objective of the present invention is to provide a port with a low risk of migration of potentially dangerous agents from the port to the stored fluids, avoiding direct contact between said polymeric materials that have the risk of migrating said agents and the stored fluid or through the minimization of the usefulness of said materials. Still another object of the present invention is to provide a port that can be unloaded with the remaining container for recycling without separate dismantling and collection. These objects are achieved by the present invention as described in the following description and the appended claims.

BRIEF DESCRIPTION OF THE INVENTION A port system according to the present invention should establish fluid communication with a container for medical storage fluids and a device for adding or removing fluids from said container. Said device is typically a syringe, cannula, spigot connection for an infusion device or a device with a similar function. The port system comprises at least one port having a sealed front end and an open rear end for the interior of the container and a base plate that is attached to said container. In addition, the port has a penetrable membrane that serves as a barrier to stored fluids that can be penetrated by the device to establish the fluid connection with the container. At its front end, the port comprises a cap extending axially in a formed portion of sleeve provided with said penetrable membrane that serves as a partition for the stored fluids. The membrane is preferably placed at a given axial distance from the front end of the sleeve formed part that is shorter than its axial distance to the rear open end of said sleeve formed part. The cap seals the upper face of the penetrable membrane against contamination during handling and storage of the port system as well as during its engagement with the container or flexible film to be formed as a container. In addition, the lid seals a protected space above said membrane that can not be reached by microbial contamination. In order to open the port and make the available membrane penetrable to a device for establishing fluid communication, the port is provided with exposure means by which the user can easily uncover said membrane when it is desired to enter the container. Preferably, the exposure means removes partially or completely the cover and can consist of a zone, which extends totally or partially around the periphery of the port, having a predetermined weakening, so that the user, by means of a prescribed turning movement You can easily remove part of the port in that area. As will be described later in more detail, said area of preference may consist of a groove extending along the outer periphery with a reduced thickness of material that may be formed when the port system is molded. The alternative means of exposition can obviously be considered by the person skilled in the art to form the various fragile or breakable constructions in order to remove an adequate part of the port. An important aspect of the invention is that the port system is molded into a part of the polyolefin material. The front sealing cap will extend directly into the formed sleeve portion that extends directly into the base plate. By producing the port system in the sealed mold at a temperature above the sterilization temperature it is achieved that the upper surface of the membrane and the space closed above by the front cover are not reached Ifgígg ^ ggHg ^^^^ á ^^^^^^ i ^^^^ »- ^^^^^ !? easily by microbial contamination. The above is a great advantage, since part of the port system will not be reached by the sterilization steam during the autoclave process to which it is subjected when it is finally coupled to the filled container. According to a specific embodiment of the present invention, the penetrable and sealing membrane is connected to a sealant and an elastomeric material that can be considered as an extension of said membrane that is particularly adapted to said port to be introduced by needles. of conventional syringes. The elastomer seal totally takes a predetermined space between said membrane and the front end of the port sleeve formed part. As described later, the obturator is preferably introduced into said space by injection molding with an elastomer, heated, liquefied through an aperture in the formed part of sleeve having a size suitable for communication with a conventional injection nozzle, so that a penetrable elastomeric seal is formed where repeated entries with a penetrating needle are possible without any subsequent leakage of fluid. It is important that the obturator fill the predetermined space completely and that the opening be properly closed so that microbial transport channels are not formed unexpectedly after production. According to an alternative embodiment of the present invention, the port is provided with a membrane adapted to penetrate ^ ¿^^^^ with a spike of an infusion device. In this case, the membrane is designed to facilitate penetrating operation, for example by being provided with steering means for a correct penetration of the spike, so that the centrally intercepting slots are at the central point of penetration. In addition, the membrane has a certain thickness suitable to allow the sealing action of the membrane even when penetrating through the spike through the administration of the infusion fluid which intends for the port to remain flipped during the infusion of gravity supply. Preferably, the front end of the sleeve formed part is formed with a nozzle that is designed to fit the conventional pins. In order to easily distinguish the ports designed for the spikes of the ports designed for the syringes when they are part of the same port system, the spigot port can preferably have a longer sleeve formed part and its periphery can be provided with an annular projecting edge. In the aforementioned embodiments, the lid serves as an effective means of protection by sealing the penetrable front surface of the obturator or membrane against contamination during storage and handling of the port system. It is conceivable and within the scope of protection to design the port systems according to the present invention with different combinations of the mentioned ports. Any combination of the mentioned ports adapted to the syringes or spikes may be conceived, although a port system having a port of each category is exemplified below. The present invention also pertains to a method of manufacturing the port system for the medical flexible container of a polymeric material comprising at least one sealed port and a base plate, wherein the port system is made in one part in a mold closed by an injection molding step at a temperature greater than about 180 ° C, to form a port having a removable front cover at least in part that seals the front surface of a membrane in a formed part of sleeve extending axially from said lid to the base plate. Preferably a predetermined weakening zone or line in the material extending around the port is easily formed in said molding step in order to make the lid removable with a simple turning movement of the user. The mold is basically of a conventional closed design for the manufacture of hollow articles of polymeric materials by injection molding and allows the introduction of different materials (ie, two-color molding), as also described in Swedish Patent Application No. 9700597-9. Additionally, the mold is provided with means for removing the cores from the molded ports and with thermal sealing bars that serve to seal the front end of the port and to form its front in the form of a lid. The aforementioned additional features of the mold are capable of operating within its closed system and are now described in more detail, although it is appreciated * that it is within the ability of the person skilled in the art to design such mold equipment. Primarily, the inventive method of manufacturing the port system, as described above, after it was initially formed in the mold, includes the steps of: a) allowing the port system to reach its fixation temperature in the mold; b) remove the molded port cores within a core drive system; 10 c) still inside the closed mold, the front end of the port is sealed so that the sealed front cover is formed with the heated sealing rods; and finally d) release the port system from the mold. One aspect of the inventive method is that the molded port system 15 does not allow to reach a temperature below about 60 to 80 ° C from its fixing temperature, preferably not less than about 70 ° C. In order to manufacture a port having an elastomer plug connected to the upper surface of the protective membrane with In the inventive method, the liquefied elastomer can be introduced into the closed mold and in said predetermined space above said membrane, preferably by injection at high pressure. immse ttíu? ^ a ?? ^ jkeiz &? STz- In relation to what was mentioned above, the port system has then reached its fixation temperature and does not cools to less than around 60 to 80 ° C, preferably at not less than about 70 ° C, before the liquefied elastomer is introduced into the port in the closed mold, preferably by high pressure injection, to form a releasable elastomer sealant, wherein the port system is released of the mold. The above is achieved by injecting the liquefied elastomer through an opening above the front surface of the membrane in the port sleeve portion to completely fill a predetermined region of said sleeve formed part when the plug is formed. The injection of the elastomer into the port can be carried out before or after its front end is sealed with the heated bars (ie, before or after step c) above). However, even if both alternatives can be conceived by the person skilled in the art, it is preferred to inject the elastomer before sealing the lid in the mold. Preferably, said elastomer is made with injection molding at high pressure according to the method described in the aforementioned Swedish Patent Application No. 9700597-9, so that a membrane is formed with a resealing capability at least in accordance with the requirements of standard DIN 58 363. It is preferred to maintain a high sterilization temperature of the port system during its removal from the mold until the introduction of said heated elastomer completely fills the predetermined space above the membrane in the part «> M- * - -. ~ > formed from the port sleeve. It is preferred that a sterilization temperature (eg above 121 ° C) is maintained during the manufacture of the port system to achieve a reduced risk of microbial contamination of any of its parts that will be contacted in regular prescribed operations by a device to establish the fluid connection with the container. The above can be achieved if the liquefied elastomer introduced into the high pressure mold has a temperature higher than 180 ° C and if the remaining port is molded by a material that reaches its fixing temperature but has been liquefied at a higher temperature at 180 ° C. The port system formed in this way can then be attached to the container or flexible material to be formed in the container by welding. The container will then be filled with a technique described in Swedish Patent Application No. SE 9601348-7, finally sealed and sterilized, preferably with a high pressure steam (autoclave). The final sterilization will effectively sterilize the remaining surface of the formed sleeve part of the port between the membrane and its posterior opening which is in contact with the container fluid. The inventive production process allows an effective form of sealing of the surface of the port system that is normally at risk of contamination to be carried out and therefore provides port systems for the flexible containers with superior safety by reducing the number of production steps, in particular when compared to procedures where a thin sheet of sealing must finally be secured before a separate sterilization, usually with a gamma radiation. The port system of preference consists of medical grade polyolefins that can be mixed with a fraction of thermoplastic elastomer. The material of the port system must be able to be attached to the container, for example, by a simple welding procedure which aims to have compatibility with the material of the container. Preferably, the polyolefin is based on polypropylene or polyethylene, which means that it essentially consists of polypropylene or polyethylene, optionally with a copolymerized ethylene or propylene fraction. Various medical grades of polypropylene or pure polyethylene are also materials that can be conceived. The elastomer material for the production of the obturator preferably comprises a polyolefin compatible with the carrier and a thermoplastic elastomer. Suitable commercially available materials are Dynaflex® from GLS Corp., which contains polypropylene and SEBS (styrene-ethylene-butadiene-styrene), Santoprene®, which contains polypropylene and EPDM rubber, Evoprene® from Evode, and Craiwton®, as well as Various materials containing polyisobutylene (PIB). It is important that the obturator described in the present invention has a resealing capability that meets at least the requirements of standard DIN 58 363, Y ^^? & ..

Part 15, about which it should be releasable after a penetration with a 0.6 mm needle without any fluid leakage. The following detailed part of the description illustrates one embodiment of the present invention that should not be considered as a limitation of the invention as described in the claims.

DETAILED DESCRIPTION OF THE INVENTION Figure 1A describes a side view of a port system according to the present invention having a specific port for additives and a specific port for connection with a spike of an infusion set. Figure 1 B shows a side view of a port system according to the present invention. Figure 1 C shows a top view of a port system according to the present invention. Figure 2 shows a cross-sectional side view of a mode of a port according to the present invention. Figure 3A shows a cross-sectional side view of another embodiment of a port according to the present invention. Figure 3B shows a top view of the penetrable membrane of the port shown in Figure 3A.

Figure 1A shows an embodiment of a port system 10 according to the present invention comprising two different ports 20, 30 and a base plate 40 to be attached to a flexible container. Port 20 is an additive port through which additional agents are introduced to the fluids stored in the vessel. Port 30 is intended to be connected to a spike of an infusion set. The ports generally comprise a cover 21, 31 at its front end that extends into a formed portion of sleeve 22, 32 which is provided with a penetrable membrane 23, 33 closed at the front end of said sleeve formed part. In addition, the ports are provided with weakening in the form of slots 24, 34 of the material in which the user can remove the cover 21, 31 with a simple turning movement to expose a surface for penetration with device to establish the connection of fluid with the container. In the embodiment shown in Figure 1A, the two ports 20, 30 are easily distinguished by having characteristically different sizes and the spigot port 30 is also provided with an edge 35 that is clearly characterized to simplify the identification of the ports for the user and a container. As best shown in FIG. 2, the formed portion of sleeve 22 of port 20, for the addition of an agent complementary to the stored fluid, is provided with a penetrable membrane 23 which serves as a division between the stored fluid and the penetrable seal. made of an elastomer to prevent the migration of potentially dangerous agents eaat * ^ g * "- ~~ -. ~ -? from the elastomer to the fluid The plug 25 extends from the membrane to the front end of the formed sleeve and has a front surface which is protected with the cap against contamination In order to avoid contamination in said port region, the plug is introduced into the space between the membrane and the front end of the sleeve formed part by injection molding through an opening 26 in said sleeve formed part. , while maintaining the port system at a high sterilization temperature before and during the molding of the elastomer, for the same reason, it is also important that this space be completely and carefully filled with elastomer so that the opening is completely sealed and not No channel is formed in the shutter During storage of the container, the front surface of the elastomeric shutter is protected against contamination by the cover. side view of the front part of the formed portion of sleeve 32 of port 30 for connection with the pin device of a conventional infusion set. The membrane 33 is considerably thicker than the port of addition to allow a sealing capacity, although the comparatively thick penetration means of the spike device penetrates the membrane. The front part of the formed sleeve is formed as a nozzle 36 directed radially outward to achieve a convenient fit with the spike device. As shown in Figure 3B, the membrane 33 can be provided with slots to facilitate directing the spike to a central point suitable for the ffiWTfffrlf ^ rí penetration that is also capable of partial resealing after the spigot has been displaced.

Claims (20)

NOVELTY OF THE INVENTION CLAIMS

1. - A port system for establishing fluid communication with a container for storing medical fluids and a penetrating device for adding or removing fluids from said container comprising at least one port connected to an adjustable base plate with a container wall, said port is provided with a sealing membrane having (i) a sealed front surface protected against contamination; (ii) a back surface that serves as a barrier to the fluids stored in the container; and wherein said port further is provided with a removable front cover which seals said front surface of the membrane, wherein the port is an injection molded part which is molded at a temperature higher than the sterilization temperature part.

2. The port system according to claim 1, further characterized in that the port comprises, in one molded part made of a polyolefin material, the front sealing cap directly extending from a part generally formed of sleeve further extends on the base plate.

3. The port system according to claim 2, further characterized in that the sleeve formed part axially extends between an open front end, an open rear end and is provided with sealing membrane extended radially at a predetermined distance from said front end.

4. The port system according to claim 1, further characterized in that the port is provided with a weakening in the material, so that the lid can be at least partially removed to expose the penetrable front surface of the membrane.

5. The port system according to any of claims 1 to 4, further characterized in that the membrane is connected to an obturator of an elastomeric material.

6. The port system according to claim 4, further characterized in that the port is provided with an opening for introducing the elastomeric material.

7. The port system according to claim 6, further characterized in that the opening is located between the front end of the formed part of the sleeve and the sealing membrane.

8. The port system according to claim 6, further characterized in that the obturator is formed by injection molding at high pressure.

9. The port system according to claim 5, further characterized in that the obturator is releasable after multiple entrances into the container with a penetrating device.

10. - The port system according to claim 9, further characterized in that the obturator has flexible capacity at least of the requirements of standard DIN 58 363 (part 15).

11. The port system according to any of claims 1 to 10, which consists of polyolefin polymers to such an extent that it is possible to recycle them in a single process.

12. The port system according to claim 11, further characterized in that the polyolefin polymers comprise polypropylene or a copolymer thereof.

13. The port system according to claims 1 to 2, further characterized in that the second port is provided having a portion formed longer than said first port sleeve and is provided with an annular rim extending around the periphery of its formed part of sleeve. 14.- The port system in accordance with the claim 13, further characterized in that the front surface of the membrane of its second port is provided with grooves that are cut centrally. 15. The port system according to claim 13, further characterized in that the front end of the sleeve formed of the second part is formed with a nozzle directed radially outwardly. 16.- A method of manufacturing a port system for medical flexible container and a polymeric material comprising at least one sealed port and one phase plate, characterized in that the port has an at least partially removable front cover that seals the front surface of a membrane in a formed portion of sleeve extending axially from said cover to the base plate, characterized in that the port system is made in a part in a mold closed by an injection molding step at a temperature exceeding about 180 ° C. 17. The method according to claim 16, further characterized in that: (i) it allows the port system to reach its fixation temperature in the mold; (ii) although still in the closed mold, the front end of said port is sealed to form the front cover; (iii) the port system is released from the mold. 18. The method according to claim 17, further characterized in that although it is in the closed mold, injects the liquefied elastomer through an opening above the front surface of the membrane in the formed part of the sleeve and of this The shape completely fills a predetermined region of said sleeve formed part to form the obturator. 19. The method according to claim 16, further characterized in that it keeps the molded port system at a temperature greater than at least 121 ° C. 20. The method according to claim 16, further characterized in that the mold of a predetermined weakening zone of the material extends around the port, so that the lid is removable.