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MXPA97007012A - A transfer assembly for a medicinal container that has a valve without spark - Google Patents

A transfer assembly for a medicinal container that has a valve without spark

Info

Publication number
MXPA97007012A
MXPA97007012A MXPA/A/1997/007012A MX9707012A MXPA97007012A MX PA97007012 A MXPA97007012 A MX PA97007012A MX 9707012 A MX9707012 A MX 9707012A MX PA97007012 A MXPA97007012 A MX PA97007012A
Authority
MX
Mexico
Prior art keywords
membrane
bottle
fluid
luer
container
Prior art date
Application number
MXPA/A/1997/007012A
Other languages
Spanish (es)
Other versions
MX9707012A (en
Inventor
Grimard Jeanpierre
Jansen Hubert
Original Assignee
Grimard Jeanpierre
Jansen Herbert
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
Priority claimed from US08/713,581 external-priority patent/US5871110A/en
Application filed by Grimard Jeanpierre, Jansen Herbert filed Critical Grimard Jeanpierre
Publication of MX9707012A publication Critical patent/MX9707012A/en
Publication of MXPA97007012A publication Critical patent/MXPA97007012A/en

Links

Abstract

A resealable transfer assembly for a container such as a bottle or flask highlighting a membrane to selectively open or close a fluid passage between the bottle and a medical delivery device inserted into the assembly. The assembly includes a body disposed on the bottle, and a luer connector hub which can be provided separately with the body or formed integrally therewith. A free plug rests in a defined cavity inside the luer connector hub. The free plug includes a hole sized to accept a luer tip associated with the medical delivery device. A membrane, preferably formed of an elastomeric material, is secured through both the opposite end of the luer connector hub and the open top of the bottle, and can be retained between the upper surface of the bottle and the body. The membrane preferably includes a central area that seals the opposite end of the luer connector hub from the open top of the bottle, with one or more fluid openings defined in a portion of the membrane outside the central area. When the luer tip is inserted into the hole of the free plug, a force is exerted on the central area to divert the membrane towards the inside of the bottle, urging the membrane out of the sealing contact with the body and, therefore, opening the passage of fluid between the inside of the bottle and the medical delivery device. The membrane is resealed with the body before removing the luer tip from the hole to avoid splashing the fluid from the container.

Description

A TRANSFER ASSEMBLY FOR A MEDICINE CONTAINER THAT HAS A VALVE WITHOUT SPLASH I. Field of the Invention The invention relates to a transfer assembly for a medication container, and more particularly, to a transfer assembly for a medication container having a valve without splash. II. Background Dry medicaments such as powdered or lyophilized medicaments are typically stored in sealed jars. In practice, the medicine is accessed shortly before being used by breaking or piercing the seal. A solvent solution such as a saline solution is then introduced into the bottle to reconstitute the powdered or lyophilized medicament. Once reconstituted, the medicine solution is extracted from the bottle to be used. Some prior art bottles for powdered or lyophilized medicaments include a pierceable membrane secured through the open top of the prior art bottle. The membrane is usually perforated by a needle in communication with the solvent. However, care must be taken to avoid the detachment of membrane fragments when the seal is punctured, since these can be accidentally supplied to the patient. Typically, these seals must be punched each time you want access to the solvent, increasing the problems associated with it.
Other bottles of the prior art include rubber stoppers that are either removed from or pushed into the bottle when the solvent is supplied to reconstitute the medication. Although in general these assemblies work well to store the medication safely before use, a disadvantage of these plugs is that they can not be taken after they have fallen into the bottle. Therefore, the bottle can not be resealed using the cap originally provided. Consequently, the structure of these jars of the prior art is not suitably adapted to a bottle capable of opening and closing repeatedly. When a practitioner may not want or need to administer the full dose of reconstituted drug contained in the vial, the vial would typically need to be resealed against the surrounding environment to preserve the sterility of the drug remaining in the vial. The stopper employed with a particular medicament is typically formulated from a material compatible with the medicament contained in the vial. Although the stopper does not normally pose harm to the safety of the reconstituted medicament, there may be a perception-however unsuccessful-that the presence of the stopper inside the vial adversely affects in some way the medicament contained therein. Also, there may be a perception that the presence of the plug in the bottle may interfere with the subsequent flow of the medication solution. One way to deal with the foregoing matters is to employ a membrane construction as part of the transfer assembly. The membrane can highlight one or more openings for fluid which are selectively operated by a practitioner by attaching or removing a medicine transfer device to the transfer assembly. In such assemblies, the membrane is configured for self-sealing operation in the interim of repeated uses of the bottle. However, during use a slight overpressure can be created inside the bottle. A slight overpressure can cause some splashing of medication from the bottle as the medicine delivery device is removed from the transfer assembly. III. Resin of the Invention A transfer assembly is provided for a bottle or bottle for access of resealable fluid to and from the inside of the bottle or bottle. The assembly establishes a reclosable fluid passageway between a medical delivery device for introducing to or sucking fluid from the bottle and allowing the practitioner repeated access to the medicament contained in the bottle while at the same time preserving its sterility. Even more, the resealable transfer assembly is constructed to substantially avoid, if not otherwise eliminate, the splash out of the bottle by decoupling the medicine delivery device from the transfer assembly. The bottle includes an interior, an open upper part in fluid communication with the interior, and an upper surface disposed around portions of the bottle surrounding the open top. The upper surface may be formed, for example, as an annular rim around the open top.
The transfer assembly highlights a body disposed on the upper surface of the bottle. A fluid access device is disposed on the body to provide fluid access to and from the interior of the bottle. In one embodiment, the fluid access device may be configured as a luer connector hub. The luer connector hub defines a cavity to accept a free plug. A connector end of the luer connector hub is configured for access by a component of a medical delivery device, while an opposite end is arranged for fluid communication with the open top of the bottle. Body portions that surround the opposite end of the luer connector hub may be provided with a concave narrowing. Cato is noted earlier in the present, a free plug is provided within the cavity defined by the luer connector hub. The free plug includes an open distal end, a stranger proximal to the open, and an external wall defined therebetween for contact with the cavity of the luer connector hub. A hole is also provided between the open distal end and the open proximal end, the orifice sized to accept the tip luer inlet associated with a medical delivery device. The orifice may have a narrowing conforming to the shape associated with conventional luer tips. The free plug is disengaged for axial movement within the cavity between a sealed position, in which fluid access to or from the open top of the bottle is disabled, and an activated position, in which the fluid access is open to or from the open top of the jar. The outer wall of the free plug may be configured for slight friction fit with the cavity of the luer connector hub; alternatively, a threaded connection can be provided between them. Portions of the free plug adjacent the open proximal end may be configured to engage in fluid-tight relationship with the structure at the opposite end of the luer connector hub. A secondary seal structure can be incorporated between the free plug and the opposite end of the luer connector hub. If desired, the body and the luer connector hub can be provided as separate components, or they can be integrally formed as a component. The connector assembly further includes a membrane disposed between the open top of the bottle and the opposite end of the luer connector hub. The membrane can be supported between the body and the upper surface of the bottle. The membrane can be held in place, for example, by an annular clip retaining the body to the upper surface of the bottle. If desired, the body and the upper surface of the bottle can be formed as an integral component, with the membrane secured in the integral component to be disposed between the opposite end of the luer connector hub and the open top of the bottle. The membrane, which may be formed of an elastomeric material such as various thermoplastic elastomers, natural or synthetic rubbers, or similar materials, preferably includes an area eeable for contact with the open proximal end of the free cap. The central area can be elevated from the surface of the adjoining membrane. The central area also has a width at least equal to the width defined by the open proximal end of the free cap. One or more openings for fluid are preferably arranged on the membrane outside the central area. The openings form part of the resealable fluid passage between the open top of the bottle and the medical delivery device. One or more sealing ribs may be disposed in the body around the periphery of the open proximal end of the free plug. The sealing ribs are preferably arranged for sealing contact with the membrane in a location between the central area and one or more of the openings. If desired, the sealing ribs can be provided in the same membrane. The membrane is movable between a sealing position, wherein the membrane is arranged for sealing contact with the body to close the passage of fluid, and an activated position, wherein the membrane is moved away from the body to open the passage of fluid. If desired, one or more fluid channels can be defined in the central area of the membrane to facilitate the flow of fluid between the medical delivery device and the membrane as the membrane is displaced by the free cap to its activated position. If desired, a luer seal may be provided to seal the connector end of the luer connector hub. In one configuration, the seal of the luer lock can be provided with a separable membrane. In another configuration, the luer lock seal may be provided with a cover which is threadably engageable with the connector end of the luer connector hub. The luer lock seal prevents inadvertent access to the inside of the bottle until its use is finally desired. Also, if desired, a protective cap can be fitted around the outside of the bottle to protect the luer connector hub. The lid can be glued with an inviolable seal, as is conventional. In use, the luer seal seal (if provided) is removed by the practitioner, so that the connector end of the luer connector hub is positioned for access by the medical delivery device. The medical delivery device may have a male luer tip which is insertable into the hole of the free cap through the connector end of the luer connector hub, under such conditions that the male luer tip and the hole are placed in airtight relationship. -fluid one with another. The continued downward movement of the male luer tip will exert a force directed proximally against the central area of the membrane, under such conditions that the membrane will be moved to its activated position. The membrane will be displaced from its sealing contact with the sealing ribs, creating, therefore, a space between the membrane and the sealing ribs. The flow of fluid is, therefore, allowed between the medical delivery device and the interior of the bottle via one or more of the channels formed in the central area of the membrane and, via one or more of the openings in the membrane, the passage of fluid between the open top of the bottle and the medical delivery device. The concave narrowing of the body surrounding the opposite end of the luer connector hub contributes to the complete aspiration of the fluid from the bottle to the medical delivery device. Upon removal of the medical delivery device from contact with the central area, the membrane will re-deviate to its sealed position prior to disconnection of the luer tip from the free plug hole. The membrane will then be re-arranged for sealing contact with the ribs, closing the passage of the fluid. At the same time, splashing out is avoided, which could occur if the luer tip were disconnected from the hole before the membrane was resealed. IV. BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described in greater detail by reference to the accompanying drawings, wherein: Figure 1 is an exploded perspective view of a resealable transfer assembly attached to a bottle containing a medicament therein; with a medical supply device such short a syringe used to deliver the medication; Figure 2 is a cross-sectional view showing one embodiment of a resealable transfer assembly according to the present invention in its storage position; Figure 3 is a cross-sectional view of the resealable transfer assembly of Figure 2, illustrating the displacement of the free cap and the membrane to the open position by action of the medical delivery device, thereby opening the passage of fluid between the device medical supply and open top of bottle; Figure 4 is a cross-sectional view of another embodiment of a resealable transfer assembly according to the present invention; Figure 5 is a cross-sectional view showing another embodiment of a resealable transfer assembly according to the present invention; Figure 6 depicts one embodiment of the membrane illustrated in Figures 2-5; Figure 6a illustrates a variant of the membrane shown in Figure 6; Figure 6b illustrates another variant of the membrane illustrated in Figures 2-5; Figures 7a-7c depict several structures to improve the retention of the membrane between the body and the upper surface of the bottle; Figure 8 depicts another embodiment of a resealable transfer assembly. V. Detailed Description of the Preferred Modes Even though the description and the figures herein refer to a bottle or bottle, it will be understood and appreciated by the skilled artisan that any type of container normally employed in the field of attempt, such as capsules , jars or similar containers are easily adaptable to the advantages described herein. In addition, although described herein with respect to containers containing a quantity of dry drug or medicament for reconstitution by liquid obtained from an external source, it will be appreciated by the skilled artisan that the invention is not so limited. For example, the invention can be applied to containers containing therein a quantity of liquid medication, where repeated access is desired. Further, although the invention described herein is explained with reference primarily to fluid communication means illustrated as a luer connector hub, it will be apparent to the skilled artisan that the principles are equally applicable to other fluid communication means such as a needle or point. Turning now to the drawings, in which similar numerals represent similar components, Figures 2 and 3 represent a modality 20 of a resealable transfer assembly according to the present invention, and Figure 1 is an exploded perspective view of the assembly of resealable transfer 20 mounted in a bottle or bottle 10 containing therein a medicament 16. The medicament 16 may involve, for example, a medicament in powdered or granular form, such as a lyophilized medicament, intended to be reconstituted by a fluid introduced at the vial 10 by a medical delivery device such a syringe 60. Alternatively, it will be appreciated by the skilled artisan that the medicament 16 may involve a completely liquid medicament to which repeated access by the practitioner is desired. The syringe 60 may have, for example, a male luer tip 62 for introducing a liguid into the bottle 10 via a luer connector hub 32 associated with the resealable bottle assembly 20, as will be more fully described herein. The syringe 60 may also show a luer lock collar 64 surrounding the luer tip 62. Internal portions of the luer lock collar 64 may include a thread 65. The thread 65 is engageable with an edge 35 such as an associated luer wing. with the luer connector hub 32. Alternatively, the thread 65 is engageable with a lip 235 provided around a free plug 80 (see Fig. 4) cato will be described herein. Although the syringe 60 as depicted herein is preferably configured as a luer lock syringe, it will be apparent to the skilled artisan that the invention is equally applicable to luer slip syringes. It will be apparent It will also be apparent to the skilled artisan that the syringe 60 can serve to aspirate the reconstituted medicament 16 from the bottle 10. Preserving will be evident from the different drawings, the bottle 10 can include a neck portion 13 defining an open top portion 12 with an "X" width. The bottle 10 further preferably includes a top surface 14 arranged around the open top 12. In the configuration shown here, the upper surface 14 is defined by a higher portion of an annular edge 15 formed around the open top 12 of the bottle. It will be understood by the skilled artisan that the upper surface of the bottle may also be constituted by rings or other means glued around the open top 12 of the bottle. Turning now to Figures 2 and 3, the resealable transfer assembly 20 has a relatively disk-like body 22 provided on the top surface 14 of the bottle. Body 22 is characterized by an internally-directed face 23. As illustrated, the face 23 tapers concavely away from the open top 12 of the bottle. The body 22 can be formed separately from the bottle 10, and glued to the upper surface 14 of the bottle by securing the body to the annular rim 15 with a corrugated lid 48. It will also be apparent to the skilled artisan that instead of a body separately provided, the body 22 is unitarily formed with the bottle 10. For example, the body 22 can define contiguous extension of the annular edge 15. The resealable transfer assembly 20 includes means for communicating with the bottle 10, fluid or supplied by a device of medical supply, such as a syringe 60, or that will be aspirated out of the bottle 10. Such means of communication can take many forms, and need not be restricted to one type of structure. For example, the means for communicating fluids may be formed with a needle transfer assembly as taught, for example, in the U.S. Patent. No. 5,487,737. This may also involve a structure such as spikes as taught, for example, in the U.S. Patent. No. 5,358,501. As depicted herein, the means for communicating fluids is provided as a luer connector hub 32. Other means will be imagined by the skilled artisan. The luer connector hub has a connector end 34 configured for access by the luer tip 62 of the syringe, and an opposite end 36 adjacent to the open top 12 of the bottle. Here, the opposite end 36 is illustrated as part of the structure of the body 22. A cavity 37 is provided between the connector and opposite ends of the luer connector hub. A locking splice 39 may also be provided in the cavity adjacent the connector end 34, for purposes described below. As illustrated in Figure 2, the opposite end 36 of the luer connector hub can define a width "A" smaller than the width "X" of the open top 12 of the bottle. For purposes that will be described more fully below, a sealing rib 30 is preferably provided around the periphery of the opposite end 36 of the luer connector hub. The sealing rib 30 can be formed as part of the body 22, or it can form an extension of the opposite end 36 of the luer connector hub 32. It will be apparent to the skilled artisan that the luer connector hub 32 can be supplied separately from the body 22 and be glued to the body 22. same, for example, by means of adhesives, welding, or similar fixing methods. Also, it will be understood by the skilled artisan that, if desired, the luer connector hub 32 may be unitarily formed with the body 22. The resealable bottle assembly 20 preferably features a membrane 40 which is movable between an open position (FIG. ) and a closed position (Figures 2, 4, 5) relative to the body 22. As will be described here, when the membrane is disposed in its open position, a fluid passage 54 is established between the luer tip 62 and the upper part. open 12 of the bottle, allowing the flow of free fluid between the syringe 60 and the inside of the bottle 10. Similarly, the passage of fluid 54 is closed when the membrane 40 is returned to its closed position, preventing the flow of fluid to through the luer connector hub 32 and isolating the inside of the bottle 10 from the surrounding environment. As depicted in Figures 2-6, the membrane 40, which may be formed of an elastomeric material such as several thermoplastic elastomers, natural or synthetic rubbers, or the like, may be configured in a planar, roughly cylindrical manner. The membrane 40 includes an edge 46 that can be secured between the body 22 and the upper surface 14 of the bottle, for example, by the force exerted by the corrugated lid 48. The membrane 40 preferably includes a central area 42 having a width "N" at least equal to the width "A" of the opposite end 36 of the luer connector hub. As illustrated herein, the central area 42 is configured in a manner as a raised platform of the surrounding portions of the membrane 40. The membrane 40 is moved to its activated position (FIGS. 3) when the luer tip 62 is inserted through the end. 34 of the luer connector hub in a hole 86 of the free plug 80, as described below. Thus, when the membrane is secured to the bottle 10, the central area 42 is disposed completely through the opposite end of the luer connector hub 32. Several structures can be incorporated to assist in the retention of the membrane 40 between the body 22 and the body. upper surface of the bottle and to increase the sealing action between the body and the upper surface of the bottle. For example, the ribs 46a (Fig. 7a) can be incorporated on the edge 46 to provide extra grip between the body 22 and the annular edge 15. Similarly, the ribs 23 and / or ribs 15a (Fig.7b) can be incorporated on the body and / or the annular edge, respectively, for the same purpose. Alteratively, as seen in FIG. 7c, the membrane 40 may include a flap 247 which is blocked below the annular edge 15 by the action of the corrugated lid 48. Similarly, the membrane could include a portion 249 fitted in a slit. 25 defined in the body 22 (Fig. 7d), improving the clamping action of the corrugated lid. Other variations will be imagined by the skilled artisan. Fluid passages are provided in the membrane 40 to allow fluid communication between the open top of the bottle and the opposite end of the luer connector hub. In one configuration, the fluid passages are configured as one or more openings 44 preferably defined in the membrane 40 outside the central area 42. The openings 44 form part of the fluid passage 54 when the membrane 40 is disposed in its open position. The one or more openings 44 are positioned in the membrane 40 in such a way that when the membrane is disposed in its closed position (Figures 2, 4, 5), the sealing rib 30 will contact the membrane in a sealing area 43 located around it. of the membrane between the central area 42 and the one or more openings, sealing the luer connector hub 32 of the fluid communication with the open top part 12 of the bottle, thereby closing the fluid passage 54. It will be understood also that the membrane 40 may be designed or otherwise formed of an appropriate material such that when the membrane is in its closed position, the one or more openings 44 will rest level with the body 22 (not shown), further sealing the hub luer connector against fluid communication with the top open part of the bottle. It will be understood by the skilled artisan that instead of the openings 44, the fluid passages may be made with pre-punched slits 44a or pinpoint type perforations 44b (See Fig. 6a) formed or otherwise provided through the membrane 40. The openings 44a or perforations 44b are configured in such a way that when the membrane 40 is disposed in its open position, the openings / perforations will be stretched and opened to provide fluid access between the open top of the bottle and the cube luer sonector. Likewise, when the membrane is disposed in its closed position, the slits 44a or perforations 44b will close, thereby providing a self-sealing ability to improve the seal provided by the rib 30. To facilitate the flow of fluids between the luer tip 62 and the open top 12 of the bottle, one or more fluid channels can be provided. in the central area 42. The fluid channels 45, if provided, form part of the fluid passage 54 enabled to open between the luer tip 62 and the open top 12 of the bottle. As described herein, the fluid channels 45 may involve spaces that are defined between the ribs 47 formed in the central area. The fluid channels 45 effectively communicate the supplied or aspirated fluid via the luer tip 62 with portions of the membrane 40 out of the central area 42. The resealable transfer assembly 20 highlights a free plug 80 placed within the cavity 37 of the luer connector hub. . The free plug 80 is preferably formed of a suitable plastic material and includes an open distal weird 82, an open proximal end 84, and a hole 86 formed therebetween. The orifice 86 is designed to accept the male luer tip 62 of a medical delivery device such as the syringe 60. In this arrangement, the orifice 86 may be tapered between the distal end 82 and the proximal end 84 so that the male luer tip 62 and orifice 86 engage in fluid-tight contact when the male luer tip is inserted into the hole. The free plug 80 is arranged for axial movement within the cavity 37 between a storage position, wherein the membrane 40 is disposed in sealing contact with the body 22 (Figure 2), and an activated position, wherein the membrane 40 is arranged in an activated position, opening the fluid passage 54 (Fig. 3). The free plug 80 is securely retained within the luer hub 32 via the locking fitting 39. The free plug 80 can be configured with an external wall 88 frictionally retained against the cavity 37. One or more sealing ribs (not shown) can be disposed on the outer wall for sealing contact with the cavity 37. Preferably, the outer wall 88 (or, if provided, the sealing ribs) defines a diameter slightly larger than the internal diameter "Z" of the cavity 37 so that a substantially contacting Hermetic-to-fluid is established between the cavity 37 and the outer wall 88 of the free plug. The free plug 80 may be structured for sealing action with the opposite end 36, open, of the luer connector hub. To this end, the proximal end 84 of the free plug can be configured to seal sealant with the complementary structure on the body 22 and / or the luer hub 32. In one configuration, the free plug 80 can include a proximally directed neck 90 configured for extending through a cylindrical section 93 provided at the open opposite end 36 of the luer connector hub. One or more secondary sealing rings 92 may be provided around the periphery of the neck 90 so that the neck 90 is retained in a fluid-tight relationship with the cylindrical section 93 of the opposite end of the luer connector hub either in storage positions ( Figure 2) or activated (Figure 3). Note that a nozzle 94 is provided which communicates with the orifice 86 through the neck 90. The nozzle 94 is arranged for fluid communication with the fluid channels 45 provided in the central area 42 of the membrane. The resealable transfer assembly 20 may further include an external seal to preserve the sterility of the various components, including drug 16, until use. In one configuration, the seal may involve a membrane 100 of suitable material glued on the connector end 34 of the luer connector hub. The free end 102 of the membrane may be welded to the luer connector hub in a position 104 (see Fig. 4), to prevent its inadvertent detachment and to provide a visual indication of obvious violation. Alternatively, the external seal can be configured as a cover 70 disposed on the connector end 34 of the luer connector cube (see Fig.5). The lid 70 has an end circular wall 72, and a side cylindrical wall 74 with an internal thread 76 configured to threadably couple the edge 35 provided with the connector end 34 of the luer connector hub. A material 78 suitable for seal, such as a rubber seal, can be secured to the inner face of the end circular wall 72. Accordingly, the cover 70 can be threadably engaged on the connector hub luer 32 and tightened so that the sealant material 78 seal sealant with the open connector end 34 of the luer connector hub. Thus, a barrier is established against the passage of contaminants or other unwanted material through the connector end 34 of the luer cube which (if it is otherwise uncovered) would provide communication through the luer connector hub and, potentially, through open upper part 12 of the bottle 10. When a practitioner wishes to introduce fluid to the medicament 16 contained within the bottle 10, the luer seal 70 (or 100) is removed from the connector end 34 of the luer connector hub. The connecting end 34 is thus exposed for insertion of the luer tip 62 of the syringe 60 into the orifice 86 of the free plug. By manual force exerted by a user on the syringe 60 or, when the structure is provided, by threadably coupling the luer lock collar 64 with the edge 35 of the luer connector hub, the luer tip 62 is urged to a water-tight contact. -fluid with the orifice 86. The luer tip 62 urges the free plug 80 proximally into the cavity 37, such that the neck 90 will exert a force proximally directed against the central area 42 of the membrane. It will be seen that the neck 90 urges the membrane 40 into the interior of the bottle 10, displacing the membrane to its open position. A space 61 is created between the sealing rib 30 and the central area 42. With the opening of the space 61, the fluid passage 54 between the luer tip and the interior of the bottle 10 is completed. Via the fluid passage 54, the Fluid flow is allowed completely between syringe 60 and the inside of the bottle via: luer tip 62; the channels for fluid 45; space 61; and the one or more openings 44 provided in the membrane 40. A practitioner can now push a plunger (not shown) associated with the syringe 60, thereby supplying fluid to the interior of the bottle 10. Then, leaving the fluid passage 54 open by maintaining the connection between syringe 60 and luer connector hub 32, the practitioner can re-aspirate drug 16, now reconstituted, into syringe 60, causing reverse fluid flow-ie, drug 16 can flow inside the syringe 60 via: the opening or openings 44; space 61; the fluid channels 45; and tip luer 62. Drug 16 is thus ready for administration by the practitioner, as desired. When it is not desired or necessary to use all of the medicament 16 contained within the bottle 10, the practitioner can simply reseal the bottle 10 by decoupling the syringe 60 from the luer connector hub 32. Advantageously, the resealable transfer assembly 20 according to the present invention substantially avoids, if not otherwise, eliminates splashing fluid from the bottle, which could occur, for example, if the inside of the bottle is pressurized slightly during the reconstitution process. It will be appreciated that as the luer tip 62 is removed from the bottle, the frictional engagement between the luer tip 62 and the orifice 86 of the free plug will cause the free plug 80 to distend distally within the cavity 37 together with the luer tip 62. appreciated by the skilled artisan that the various components may be dimensioned or otherwise configured so that the frictional forces between the hole 86 and the luer tip 62 exceed the frictional forces between the cavity 37 and the outer wall 88 of the free plug. Thus, the free tip 62 remains fixed with the free plug 80 until the free plug 80 has been moved to the closing splice 39. At this point, it will be seen that the membrane 40 will have been elastically biased upwards towards its storage position. , closing the fluid passage 54 by sealing engagement between the membrane 40 and the sealing rib 30. Thus the further distal flow of fluid between the open top 12 of the bottle through the openings 44 is avoided. The luer tip 62 is withdrawal of the orifice 86 only after the membrane 40 has been restored to its storage position. Thus, splashing fluid from the bottle is considerably prevented if not eliminated because at no time will the orifice 86 be exposed to an optional unless the membrane 40 is restored in its sealed position. In addition, it will be appreciated by the skilled artisan that the sealing action of the secondary seals 92 with the opposite end 36 of the luer connector hub, together with the substantially hermetic-to-fluid contact between the cavity 37 of the luer connector hub and the outer wall 88 of the free plug, all act to prevent the possibility of splash fluid flow through the luer connector hub. Figure 4 illustrates an alternative embodiment 200 of a resealable transfer assembly according to the present invention. Here, the body 220 is provided with a cylindrical straight extension 222 containing therein a free plug 280. The cylindrical extension 222 includes a distal open end 224. The free plug 280 has a distal open end 284 extending beyond the end distal 224 of the cylindrical extension. Luer wings 235 may be provided on the free plug 280 around its distal open end 284. The luer wings 235 are separated from the distal end 224 by a space "B". Instead of frictional engagement with the cylindrical extension, the free plug 280 can have threads 245 configured to engage with the complementary threads 246 formed on internal portions of the cylindrical extension 222. One or more of the sealing rings 250 can be disposed on portions of the 280 free stopper for sliding contact, fluid-tight with internal portions of the cylindrical portion 222. The free plug 280 includes a proximal end 284 which may be configured for fluid-tight coupling with an opposite open end 236 of the cylindrical section 222 when the free plug it is propelled towards an activated position. In one configuration, the proximal end 284 of the free plug may include a tapered surface 285 which engages a nip provided to the opposite end 236 of the cylindrical extension when the free plug is positioned in an activated position. After the seal 100 has been removed from the free plug 280, a luer connector tip (not shown) is inserted into the hole 286. Internal portions of the luer lock collar 64 engage threadably with the luer wing 235 of the free plug, up to point where the syringe 60 is locked on the free cap 280. The continued rotation of the syringe will cause the free cap 280 to rotate within the cylindrical extension 222, and by the action of complementary threaded structures 245.246, the free cap is thus urged towards its activated position. The space "B" is greater than the distance traveled by the free plug 280 to reach its activated position, in such a way that the luer wings do not prevent the free plug from reaching its activated position. The proximal end 284 of the free plug will exert force against the central area 242 of the membrane 240, as previously described. Accordingly, a fluid passage will be opened between the luer tip and the interior of the bottle. When it is desired to re-seal the bottle, a reverse-reverse action on the syringe 60 will cause the free cap 280 and the luer tip of the medical delivery device to be withdrawn together upwardly within the vertical cylindrical section 222 toward its position of storage. As described above, the frictional forces between the luer tip and the luer wings 235 can be designed to slightly exceed the frictional forces between the free plug 280 and the cylindrical extension 222. The membrane 240 will be sealed against the ribs 230 before the luer tip is removed from the cavity 286. Accordingly, in the manner previously described, the splash is considerably avoided, if not eliminated from the bottle, because the cavity 286 is not exposed to the practitioner until the membrane 240 has been sealed Figure 5 illustrates a further variant 300 of the resealable transfer assembly according to the present invention. Coto was seen with the resealable transfer assembly 20, here, a cavity 337 is provided in the luer connector hub 332. Luer wings 335 are provided on the luer connector hub 332. The open distal end 382 of the free cap 380 is disposed within the cavity 337. The free plug 380 and the luer cube 332 are provided with a threaded connection 345, 346 as previously described in Figure 4. Also, one or more seal rings 350 may be disposed in outer portions of the free plug 380 for sealing, fluid-tight sealing contact with the cavity 337. As in the embodiment of Figure 4, the exit of the luer tip from the orifice 386 occurs at a time subsequent to the re-sealing of the membrane 340 with the body 320. Therefore, the splash of fluid is considerably avoided, if not eliminated. If desired, it will be apparent to the skilled artisan that instead of a sealing rib 30 formed with the body or cone an extension of the luer connector hub, a sealing rib 400 may be formed as part of the structure of the same membrane 40 (see Figure 6). The sealing rib 400 may be located between the one or more openings 40 and the central area 42. Thus, the rib 400 will be urged into sealing contact with the body 22 when the membrane 40 returns to its closed position. The various components associated with the luer connector cube or the body can be molded or formed from another node from plastics, glass or similar medical grade materials. Similarly, the bottle 10 can be either plastic or glass, cone is conventional. The free plug 80, 280, 380 can be formed of several rigid plastic materials such as various thermoplastic materials, thermoset materials or the like. Similarly, as illustrated in Fig. 6b, the membrane may be formed of non-elastoic material such as plastics, metals, composites or the like, while imparting elasticity to allow the central area 42 to move relative to the edge 46 retained between the body and the upper surface of the bottle. For example, the central area may be suspended by one or more flexible cantilevers 500 glued to the edge 46, with spaces 502 provided to allow fluid flow. In addition, it will be understood that the membrane does not need to be secured between the body and the upper surface of the bottle. For example, the membrane could be associated with the body itself and coupled through the open top of the bottle, for example, being secured in the neck of the bottle. Figure 8 illustrates a modality 600 of the resealable bottle assembly substantially as described above although configured to retain the membrane against the neck of the bottle. A body 622 is provided which has a portion 622b that extends down. A 632 luer connector hub with a free plug 680 is provided therein. The downwardly extending portion 622b is configured for insertion into a neck portion 613 of the bottle 610. The membrane 640 includes an annular bead 648 retained between the neck portion 613 and a complementary groove 660 formed on the portion 622b that is extends down. One or more annular ribs 649 may also be provided in the distal membrane 240 of the annular bead 648. While the body 622 may be secured to the annular rim 615 via a corrugated lid, as shown here, the body 622 is threadedly secured to the body. annular rim 615 via complementary threads 628, 626 formed on the annular rim and the side wall 627 of the body, respectively. Cone in the previously described embodiments, the membrane 40 rests between the proximal end of the free plug 680 (via the portion 622b that extends downwards) and the open top of the bottle to open and close the fluid passage. It will be understood that by this configuration the annular bill 648 and, if provided, the one or more annular ribs 649, may also act as a stopper for the bottle 610.

Claims (13)

  1. CLAIMS 1. A resealable transfer assembly accessible by a medical delivery device and providing a reclosable fluid passage between the medical delivery device and the container, comprising: a container having an open top and an upper surface disposed about of portions of the container surrounding said open top; a body disposed adjacent the upper surface of the container, the body including a concave narrowing adjacent the open top of the container; means for communicating fluids with the container, said means having a distal end configured to initiate fluid communication with the medical delivery device, an opposite end disposed on said body for fluid communication with the open top of the container and a defined cavity among them; a free stopper disposed within the cavity defined by the means for fluid communication, the free stopper sized for axial movement within the cavity, the free stopper defining a hole for accepting a medical delivery device, the free stopper including a proximal end arranged for sealing relationship with the opposite end of the means for communicating; a membrane disposed between the open top of said container and the opposite end of the means for communicating, said membrane having a central area arranged for contact with the proximal end of the free plug, the central area having a width at least equal to the width defined by the opposite end of the means for communicating, said membrane having one or more passages of fluid placed outside said central area for fluid communication between the opposite end of the means for communicating and the open top of the container, and said membrane defining a sealing portion between said central area and said one or more fluid passages for sealing contact with the body, wherein by insertion of the component of the medical delivery device into the orifice of the free cap, said membrane is displaced to an activated position , wherein said membrane is driven away from the sealing contact with the body to open the passage of fluid between the medical delivery device and the open top of the container, and where by a removal of the component from the orifice, the membrane will be returned to the sealing contact with the body before the component is uncoupled from the orifice separating the fluid splash from the recipient.
  2. 2. The resealable transfer assembly of claim 1, wherein said means for communicating comprises a luer connector hub.
  3. The resealable transfer assembly of claim 1, wherein said central area comprises one or more channels for fluid flow to facilitate the flow of fluid between said medical delivery device and said bottle.
  4. The resealable transfer assembly of claim 1, further comprising a sealing rib disposed around at least a portion of the periphery of said opposite end of the means for communicating, said sealing rib disposed for said sealing contact with said membrane when said membrane is in the closed position.
  5. The resealable transfer assembly of claim 4, wherein when said free cap moves said membrane to the activated position, said membrane is urged out of the sealing contact with said sealing rib to create a space between the membrane and the sealing rib, thereby opening the passage of fluid between the medical delivery device and the open top of the container.
  6. The resealable transfer assembly of claim 1, wherein the proximal end of the free stop comprises a proximally directed neck and the opposite end of the means for communicating comprises a cylindrical section, the neck directed proximally of the free plug disposed in sealing surface contact with the opposite end cylindrical section.
  7. The resealable transfer assembly of claim 6, wherein one or more sealing rings are disposed between the proximally directed neck of the free plug and the cylindrical section of the opposite end.
  8. The resealable transfer assembly of claim 1, wherein the orifice of the free plug is formed with a constriction that conforms to the shape associated with the luer tip of a medical delivery device.
  9. 9. The resealable transfer assembly of claim 2, further comprising an outer seal for sealing the connector end of the luer connector hub.
  10. The resealable transfer assembly of claim 9, wherein said outer seal comprises a luer connector seal having a top wall and an annular side wall projecting from said top wall, said annular side wall including a series of internal threads selectively engageable with the connector end of said luer connector hub, and a seal disposed between said upper wall and the connector end of the luer connector hub for sealingly coupling said connector end.
  11. The resealable transfer assembly of claim 9, wherein said outer seal comprises a removable membrane.
  12. 12. A resealable transfer assembly accessible by a medical delivery device and providing a reclosable fluid passageway between the medical delivery device and the container, comprising: a bottle having an open top and an upper surface disposed about portions of the container surrounding said open top; a body disposed adjacent the upper surface of the container, said body including a concave narrowing around the open top of the bottle; a luer connector hub for communicating fluids with the container, said luer connector hub having a connector end configured for the introduction of a luer tip associated with the medical delivery device and an opposite end disposed on said body for fluid communication with the upper part open of the container, a cavity defined between the connector and the opposite ends of the hub; and one or more ribs provided around the periphery of the opposite end; a free stopper disposed within the cavity defined by the luer connection hub, the free stopper dimensioned for axial movement within the cavity, the free stop having an open distal end, an open proximal end configured for sealing relationship with the opposite end of the luer connection hub, and defining a hole between the open proximal and distal ends to receive the luer tip associated with the medical delivery device; a membrane disposed between the open upper part of said container and the opposite end of said membrane, the membrane having a central area arranged for contact with the proximal end of the free stopper and having a width at least equal to the width defined by the end opposite of the luer connector hub, said membrane having one or more fluid passages positioned outside said central area for fluid communication between the opposite end of the luer connector hub and the open top of the container, and said membrane defining a sealing portion therebetween central area and said one or more passages of fluid for sealing contact with the one or more ribs provided at the opposite end of the luer connector hub, wherein by insertion of the luer tip of the medical delivery device into the hole of the free cap, the membrane is moved to an activated position, where said membrane is driven away from the sealing contact with the rpo to open the passage of fluid between the medical delivery device and the open top of the container while the luer tip is arranged in sealing contact with the hole, and where when removing the luer tip from the hole, the membrane is returned to the contact Sealant with the body before the luer tip is removed from the sealing contact with the body to avoid splashing fluid from the bottle. The resealable transfer assembly of claim 1, wherein said membrane comprises a non-elastomeric material. VII. Extract A resealable transfer assembly for a container such as a bottle or flask highlighting a membrane to selectively open or close a fluid passage between the bottle and a medical delivery device inserted into the assembly. The assembly includes a body arranged on the bottle, and a luer connector hub which can be provided separately with the body or formed integrally therewith. A free plug rests in a defined cavity inside the luer connector hub. The free plug includes a hole sized to accept a luer tip associated with the medical delivery device. A membrane, preferably formed of an elastomeric material, is secured through both the opposite end of the luer connector hub and the open top of the bottle, and can be retained between the upper surface of the bottle and the body. The membrane preferably includes a central area that seals the opposite end of the luer connector hub from the open top of the bottle, with one or more fluid openings defined in a portion of the membrane outside the central area. When the luer tip is inserted into the hole of the free plug, a force is exerted on the central area to divert the membrane towards the inside of the bottle, urging the membrane out of the sealing contact with the body and, therefore, opening the way of fluid between the inside of the bottle and the medical delivery device. The membrane is resealed with the body before removing the luer tip from the hole to prevent splashing fluid from the container.
MXPA/A/1997/007012A 1996-09-13 1997-09-12 A transfer assembly for a medicinal container that has a valve without spark MXPA97007012A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/713,581 US5871110A (en) 1996-09-13 1996-09-13 Transfer assembly for a medicament container having a splashless valve
US08713581 1996-09-13

Publications (2)

Publication Number Publication Date
MX9707012A MX9707012A (en) 1998-08-30
MXPA97007012A true MXPA97007012A (en) 1998-11-12

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