MXPA97007025A - Assembly connector for sterile bottle for efficient transfer of liquid - Google Patents

Abstract

A connector assembly is provided for the efficient flow of liquid into and / or out of a vial, such as a vial containing a lyophilized drug. The connector assembly includes a barb and a cap sleeve, both slidably mounted on the open top of the bottle. The connector assembly includes a cap fixed to the cap sleeve and coupled in sealed form to the open top of the bottle. The plug moves slidably in response to axial movement of the plug sleeve. The movement of the cap sleeve relative to the bottle will move the stopper in and out of the seal coupling with the vial. The connector assembly further includes a spring to generate a small amount of axial movement of the prong, the cap sleeve and the cap, after the cap has been moved into the open position in the bottle. The movement of the barb, the cap sleeve and the stopper generated by the spring will cause a sufficient change in pressure to overcome the surface tension and initiate an efficient flow of fluid inside or outside the vessel.

Description

ASSEMBLY CONNECTOR FOR STERILE BOTTLE FOR THE EFFICIENT TRANSFER OF THE LIQUID DO BACKGROUND OF THE INVENTION Field of the Invention The subject invention relates to a connector assembly for a frame, and more particularly, to a connector connector for a bottle that allows an efficient transfer of a liquid inside or outside the bottle.

Description of the Previous Technique Many drugs are presented in dry form to obtain a longer storage life. One type of dry drug is a lyophilized drug. A selected dose of a lyophilized drug can be stored in a glass vial that is sealed to prevent deterioration or contamination of the drug. An liquid solvent can be mixed with the lyophilized drug just before use, and the drug solution can be administered to a patient. Some prior art bottles of lyophilized drugs are sealed with a membrane that can be pierced by a needle or barb to supply the liquid solvent to the bottle and to subsequently deliver the drug solution to a patient.

However, it has been found that fragments of the membrane can be separated when the seal is punctured, and thus can inadvertently be administered to a patient with the drug solution. Other prior art bottles include a rubber stopper that is pushed toward the patient. bottle through the barb, needle or other tubular structure that supplies the solvent to the bottle. These plugs do not have convenient access after they have fallen into the bottle to reliably seal the drug solution vial. However, the loose plug may unintentionally block the opening of the bottle to impede the flow of the drug solution.

A very effective bottle connector assembly is shown in the U.S.A. patent. No. 5, 358,501. which was issued to Gabriel eyer on October 25, 1994. Certain embodiments of the assembly shown in the patent of E. U.A. No. 3, 358, 501 include a tube with a near end in the bottle and a distant end outside the bottle. First and second channels extend axially through the tubes. The first channel ends in a first hole at the near end of the tube. The second channel ends in a second hole disposed distantly of the first hole. The portions of the tube defining the first hole prevent the plug from blocking the second hole. In this way, a drug solution in the bottle can be completely emptied to be administered to a patient. Other embodiments shown in the E patent. OR . TO . Do not . 5, 358, 501 connect the cap to the tubular structure that pushes the cap to the bottle. Thus, the stopper does not fall at the bottom of the bottle. This allows the bottle to be sealed again and further prevents the cap from inadvertently falling into a position where the cap can cause the flow of the drug solution from the bottle. In many situations, it is desirable to use a prong on the bottle connector to provide access to a solvent supply maintained in a container, such as a rigid container. It has been found that the surface tension in the adjoining gas / liquid surface and a pressure differential between the flask and the solvent container prevents the initial flow of solvent into the flask. Similar problems with pressure differential and surface tension can occur when the drug solution is released from the bottle. When the container is a flexible container, such as a flexible infusion bag, it may be possible to compress the infusion bag to initiate the flow of fluid. However, if the container is rigid, this aspect is not possible. Some medical practitioners overcome this problem by shaking the bottle after it has been connected to the solvent supply. However, this agitation can inadvertently separate the vial from the solvent supply and can lead to a loss or contamination of the drug or the drug solution. In addition, the agitation of an assembly with a pointed implement is an unsafe practice.

COMPENDIUM OF THE I NVENTION The subject of the invention is directed to a connector for use with a bottle. The bottle includes a bottom wall and a straight side wall. A shoulder extends inward from the upper end of the side wall and a tubular neck extends upwardly from the shoulder toward an open top. An annular edge may extend around portions of the neck that define the top to the top. The portions of the bottle between the tubular neck and the bottom wall define an enclosure in which a lyophilized drug or drug solution can be stored. The connector includes an elongated transfer tube slidably mounted in the tubular neck of the bottle for movement between the near and distant positions in the neck of the bottle. The transfer tube includes a closely spaced end inside the bottle and a distant end projecting from the bottle. The distal end may be sufficiently pointed to pierce through a seal in a separate fluid container, such as a rigid container containing a solvent. The near end of the transfer tube includes a mounting structure for coupling with a plug. Portions of the transfer tube remote from the locking structure include openings to allow transverse flow of fluid in and out of at least one of the canals that axially pass through the transfer tube.

The connector also includes a plug secured to a stop sleeve. The cap is dimensioned to seally seal the inner surface of the neck of the bottle, when the transfer tube is in its extreme remote position relative to the neck. Close movement of the cap sleeve pushes the cap closely beyond the neck of the bottle and places the transverse apertures through the transfer tube in communication with the inner portions of the bottle. The connector of the invention or any of the components of the connector can be configured so that they have a minimum of two positions, relative to the neck of the frame. In one configuration, a spring is provided near the transfer tube. The spring is dimensioned and arranged to deflect the transfer tube distantly as the transfer tube reaches its extreme near position. The spring can be unitarily molded as part of the transference tube. The spring effect can be imparted by bending or twisting a flexible material forming the spring, or by the flexibility of the spring material itself. The spring may be substantially annular, and may define a circumferentially extending wave that stretches elastically in response to an axially directed pressure thereon. The connector of the present invention may further include a mounting collar mounted to and surrounding the open top of the bottle and slidably receiving the transfer tube therein. The collar may include a plurality of collapsible closures arranged and sized to lockly engage the annular rim surrounding the upper part of the opening of the vial. A seal can be arranged on the adjoining surface of the jar and collar. During use, a dry drug such as a lyophilized drug is stored in the bottle and is sealed, protectedly, by the stopper. A solvent can be added to the lyophilized drug in the bottle by placing the distal end of the transfer tube in communication with a solvent container. The cap sleeve is then pushed very close relative to the collar and the bottle, so that the cap secured to the near end of the cap sleeve moves very close to the neck of the bottle. As the cap sleeve approaches its extreme near position, the cap will clear the neck of the vial to allow fluid communication between the solvent container and the vial. More particularly, a clear path for fluid communication will be defined by at least one of the axially extending channels through the transfer tube and the transverse openings disposed distally and adjacent to the plug. As noted above, the surface tension and the pressure differences between the bottle and the solvent supply usually prevent an efficient flow of solvent into the bottle. In the prior art, this problem has been addressed by agitating the flask, the connector assembly and the fluid container to initiate the flow. This agitation of the prior art was desirable for the reasons explained above. The connector of the subject invention overcomes the problems caused by the surface tension and pressure differentials, and generates a rapid flow of liquid into the bottle. More particularly, the transfer tube, cap sleeve and stopper will move closely relative to the bottle, in response to the movement generated by the health care worker attempting to add the solvent to the lyophilized drug. As the transfer tube leaves one of the extreme near positions, the spring will exert forces directed distantly on the transfer tube relative to the bottle. These forces can easily be overcome by the health care worker using the vial and connector assembly of the invention. However, after the transfer tube, tampon sleeve, and stopper reach their extreme near position and the connection forces are released by the health care worker, the forces exerted by the spring will push. to the transfer tube, plug cap and cap lightly and distantly relative to the bottle. That movement of the transfer tube relative to the bottle is sufficient to overcome the surface tension and to generate a favorable pressure differential that will immediately generate the flow of liquid through the transfer tube and into the bottle.

BRIEF D ESCRIPTION OF THE DRAWINGS Figure 1 is a longitudinal cross-sectional view of a connector assembly according to the invention mounted in a bottle. Figure 2 is a cross-sectional view of the collar of Figure 1. Figure 3 is a top plan view of the cap sleeve shown in the connector of Figure 1. Figure 4 is a cross-sectional view taken along line 4-4 in Figure 3. Figure 5 is a cross-sectional view taken along line 5-5 in Figure 3. Figure 6 is a side elevational view of the tine shown in Figure 1. Figure 7 is a cross sectional view 1 taken along line 7-7 in Figure 6. Figure 8 is a cross-sectional view taken along line 8-8 in Figure 7. Figure 9 is a top plan view of a barb guard shown in Figure 1. Figure 10 is a cross-sectional view taken along the line 11-15 in Figure 10. Figure 12 is an exploded perspective view, partially in section of a collar and spike.

Figure 13 is a cross-sectional view of the connector assembly similar to Figure 1, but showing the cap on the bottle and the spring bent. Figure 14 is a cross-sectional view similar to Figure 13, but showing the spring elastically returned to an undifferentiated condition. Figure 15 is a side elevational view of an alternative prong. Figure 16 is a cross-sectional view taken along line 16-16 in Figure 15. Figure 17 is a side elevation view of a collar for use with the prong of Figures 15 and 16. The Figure 18 is a cross-sectional view taken along line 18-18 in FIG. 17.

DESCRIPTION OF THE PREFERRED MODALITIES An assembly connector according to the present invention is generally identified with the number 10 in Fig. 1. The connector assembly 10 is used with a glass jar 12 having a bottom wall 14, a cylindrical side wall 16 extending upwardly from the bottom wall 14, a shoulder 18 extending inwardly and upwardly from the end of the wall. the cylindrical side wall 16 away from the bottom wall 14 and a cylindrical neck 20 of internal diameter "a", extending upwardly from the shoulder 18. The neck 20 terminates in an open upper part 22. The upper part 22 is characterized by an annular edge 24 interposing outwardly around it. The bottle 12 is provided with a lyophilized drug 26 stored therein. The connector assembly 10 functions to securely seal the lyophilized drug 26 in the bottle 1 2 and to allow a solvent to be added to the bottle 12 to mix with the lyophilized drug 26 and form a drug solution. The connector 10 further allows delivery of the drug solution to an IV set for delivery to a patient. Connector probe 10 includes a generally annular collar 30. As shown more clearly in Figure 2, the collar 30 has near and far opposite ends 32 and 34, respectively. The proximal end 32 of the collar 30 is defined by a plurality of collapsible closures 36, dimensioned for engagement engaged with the annular rim 24 of the frame 12. The portion of the collar 30 between the near and far ends 32 and 34 define an annular rim. 38, extending inward, having an internal diameter approximately equal to the internal diameter "a" of the neck 20 of the bottle 12. A pair of diametrically opposed spring pushers 40 extend distally from the annular flange 38 and terminate in a intermediate location flange 38 and the distal end 34 of collar 30. Collar 30 further includes a pair of positioning windows 42, diametrically opposite s, more or less aligned with spring pushers 40.

The connector probe 10 further includes an annular seal 44, as shown in Figure 1. The seal 44 has an internal diameter equal to or slightly greater than the internal diameter "a" of the neck 20 in the bottle 12, and an outer diameter selected to seal the coupling with the inner circumferential portions of the collar 30. The seal 44 is positioned between the upper end 22 of the bottle 12 and the annular rim 38 of the collar 30, when the seals 36 of the collar 30 are engagedly engaged with the annular edge 24 of the bottle 12, as is more clearly shown in Figure 1. The copector assembly 10 further includes a plug sleeve 46, generally tubular, as shown in Figures 3-5. The plug sleeve 46 has a near end 48, an opposite distant end 50 and a central passage extending axially therebetween. The distal portions of the cap sleeve 46 are characterized by having cylindrical walls 52 and 54, concentrically arranged, internally and externally, defining an annular space between them. The outer cylindrical wall 54 defines an external diameter slightly smaller than the internal diameter "a" of the neck 20 in the bottle 12, but large enough to slide the fluid-tight coupling with the seal 44. The inner and outer cylindrical walls 52 and 54 of the plug sleeve 46 are connected to one another through a transverse support wall 56. A plurality of collapsible clamping legs 58 extend very close to the transverse wall 56 towards the proximal end 48 of the second order. stopper 46. Slots 59 adapt to a fl ow of fluid as explained below. A bottle cap 60 is tightly coupled on the ends 58 of the stop sleeve 46, as illustrated in Figure 1. The plug 60 is dimensioned to slide the fluid-tight coupling with the inner surfaces of the neck 20 and the bottle 12. The plug 60 is sized to terminate at an axial distance selected from the transverse web 56 of the stop sleeve 46. As As a result, a hollow is provided between the plug 60 and the transverse wall 56 to allow fluid communication through the slots 59, between the plug 60 and the transverse wall 56, as explained more herein. The connector assembly 10 further includes a tubular prong 62 unitarily molded from a thermoplastic material, as shown in Figures 6-8. The prong 62 may be formed as an elongated structure having a near end 64, a pointed distant end 66 and a pair of axially extended passages 68 and 70, extending through and separated from one another by a septum 72. The prong 62 is formed so that the passages 68 and 70 have different axial terms to substantially eliminate any possibility that both passages are obstructed by the structure either in the bottle 12 or in a separate container with which the connector assembly 10 can commu nicarse. The portions of the tubular barb 62 near the proximal end 64 define an external diameter that allows the sliding coupling within the internal wall 52 of the cap sleeve 46. The barb 62 further includes an annular wall 74 fixed in a vertical position. at intermediate position through radial arms 75. The null wall r 74 defines an external diameter selected for slidable insertion within the distal end 34 of the collar 30. A pair of diametrically opposed projections 76 extend outward from the wall an ular 74 at sites intermediate to the length of the annular wall 74. The projections 76 are dimensioned and shaped to be received in locked form within the windows 42 in the collar 30. The tine 62 further includes two arcuately generated springs 78, arranged inside the annular wall 74 and di mensioned for the coupling by the spring pushers 40 of the ring nut 30. The springs 78 can be formed part go from any suitable material, such as ABS, POM, or any thermoplastic that exhibits the desired elasticity characteristics. The springs 78 are foldable in an axial direction in response to the forces generated thereon by the spring pushers 40. The connector assembly 10 further includes a barbed guard, generally tubular, having ends near and far 82 and 84, opposite, as shown in Figures 9-1 1. The slots 85 extend distally from the near end 82 and are dimensioned to receive the radial arms 75 from the prong 62. The near end 82 of the barb guard 80 can be retained, through frictional or mechanical means, in a remote position in the annular space between the inner and outer circumferential walls 52 and 54 of the cap sleeve 46. However, the barbed guard 80 moves slidably in the annular space between the inner and outer walls 52 and 54 of the sleeve of plug 46 in response to closely directed forces on the barb guard 80. The barb guard 80 defines a sufficient axial length for the distal end 84 to surround, in a protective manner, the pointed end 66 of the barb 62 The connector assembly 10 further includes a safety shield 86, as shown in Fig. 1, which is releasably engaged around the circumflex portions. external components of the collar 30 and dimensioned to enclose, in a protective manner, the barb guard 80 and the barb 62. The connector assembly 10 is employed by initially removing the safety shield 86. The bottle 12, with the connector assembly 10 mounted thereon , is pushed into a source of solvent held in a rigid container, so that the stationary end 84 of the barb guard 80 is aligned with and pushed against an appropriate fit in the rigid container. The continuous force exerted on the bottle 12 will cause the near end 82 of the barb guard 80 to slide close to the null space between the inner and outer walls 52 and 54 of the cap sleeve 46. This close movement of the guard barb 80 relative to the prong 62 will cause the radial arms 75 of the prong 62 to slide distantly in the slots 85 of the barb guard 80. Simultaneously, the distal tip 66 of the barb 62 will be exposed and will pass to the adjustment appropriate over in rigid container. The continuous force on the bottle 12 will generate two separate movements within the connector pack 10. First, the barb guard 80 will generate forces on the cap sleeve 46 and will cause the cap sleeve 46 and the plug 60 mounted it slides very close into the neck 20 of the bottle 12. Sufficient near movement will cause the plug 60 to slide sufficiently in a near direction to clear the neck 20 of the bottle 12 and to allow fluid communication through the bottle. the slots 59 between the plug 60 and the transverse wall 56 of the cap sleeve 46 towards the portions of the bottle 12 below the shoulder 18, as shown in Figure 13. Second, these forces on the bottle 12 will cause the spring pushers 40 exert forces on the spring 78 sufficient for the spring 78 to flex relative to the remaining portions of the pin 62. As a result, the remaining portions from the pin 62 will move in a close direction relative to the collar 30 and the bottle 12. The forces on the bottle 12 will be placed inside the bottle 12 in communication with the solvent in the rigid container. More particularly, fluid communication will be achieved through one of the passages 68 or 70 of the pin 62, through the near portions of the inner wall 52 of the cap sleeve 46 and through the slots 59 between the plug 60 and the transverse wall 56 of the cap sleeve 46. However, as explained above, the pressure conditions and the surface tension prevent the flow of solvent through the tine 62. This problem is overcome by the connector assembly 10. More particularly, by releasing the forces on the bottle 12, which have been generated to push the pin 62 into the solvent supply, the spring 78 will elastically return to a non-flexed condition. This elastic movement of the spring 78 will cause a corresponding small movement of the remaining portions of the prong 62, the cap sleeve 46 and the cap 60 relative to the collar 30 and frame 12, as shown in Figure 14. This small relative movement of the pin 62, the plug sleeve 46 and the plug 60, generated by the spring 78, will vary the volume sufficiently to cause a lower pressure change that will exceed the surface tension and the static pressure conditions that they could otherwise impede the flow of solvent. As a result, the solvent will flow through one of the channels 68 or 70 of the tine 62 and into the bottle 12 to be mixed with the lyophilized drug 26. An alternative tine is illustrated in Figures 15 and 16, and is generally identified with the number 162. The pin 162 includes opposite and distant ends 164 and 166, opposite, respectively. The channels 168 t 170 extend between the opposite ends and are separated from each other through a septum 172. The tine 162 includes a spring 178 that is structurally and functionally similar to the spring 78 on the tine 62, described and illustrated previously. However, the tine 162 does not include a null wall surrounding the spring 178 for the interlocking connection to a collar to prevent separation between the tine and the collar. Rather, the pin 162 is provided with plug ends 158 at the distal end 164. The plug ends 158 are structurally similar to the ends 58 of the plug sleeve described above and illustrated in Figures 1, 3, 4 and 5. In the embodiment of FIGS. 15 and 16, the plug is substantially identical to the plug 60 described above and illustrated in FIG. 1, is directly mounted to the plug ends 158 of the pin 162. The frictional coupling between The stopper and neck of the bottle function to maintain the pin 162 in a fixed relationship to the bottle. A collar 130 for use with the prong 162 is illustrated in Figs. 17 and 18. The collar 130 is structurally and functionally similar to the collar 30 described above and illustrated in Fig. 1. In particular, the collar 130 includes foldable closures 1 32 which are arranged and sized for engagement engaged with the annular rim 24 in the bottle 12, as described and illustrated above. The collar 130 is not provided with a width for the coupling engaged with the pin 162 and has no spring pusher. Rather, the spring 178 of the pin 162 will engage against the distal end 1 34 of the collar 130 to generate the small movement of the pin 162 which facilitates the initial flow of the solvent therethrough.

Claims (10)

1 .- A connector assembly for a bottle, said bottle having a tubular neck, said connector assembly comprising: a cap slidably mounted on the tubular neck of the bottle; a transfer tube having a near end functionally coupled to the stopper, a distal end placed outside said stopper and at least one passage of fluid extending axially from the distal end to a location in said stopper away from the stopper , the transfer tube being slidably movable between a distal position, wherein said stopper is in the neck and a near position, wherein the stopper is in a location in the bottle separate from the neck; and a spring disposed between the bottle and portions of the transfer tube outside the bottle to push said transfer tube away from the near position of the transfer tube in the bottle, whereby said movement of the transfer tube varies the pressure, enough to allow the efficient flow of fluid into the bottle.

2. The connector assembly according to claim 1, further comprising a collar rigidly connected to the frame, said transfer tube being slidably coupled with the collar.

3. The connector assembly according to claim 2, wherein the spring engages with the collar when the transfer tube is in the near position to push said transfer boundary away from the bottle and the collar.

4. - The connector sampler according to claim 2, wherein the transfer tube and the collar are engaged in a locked manner to prevent the separation of said transfer tube from the collar.

5. The connector assembly according to claim 1, wherein the transfer tube comprises a prong having a pointed distal end.

6. The connector assembly according to claim 5, further comprising a barb guard that surrounds with protection the distal end of the barb, the barb guard being slidable in a near direction relative to the barb in response to the barbs. forces exerted on it to allow selective exposure of the pointed end of the barb.

7. The connector assembly according to claim 5, wherein the functional coupling of said transfer tube with the cap comprises a cap sleeve in sliding telescopic coupling with the barb, said cap sleeve defining said near end of the barrel. of transfer, so that the cap is securely coupled to the cap sleeve.

8. The connector assembly according to claim 1, wherein said spring is unitarily formed with the transfer tube.

9. The connector assembly according to claim 8, wherein the spring is an annular spring.

10. A connector assembly for a bottle having an annular neck, said connector assembly comprising: a collar mounted securely around said tubular neck; a prong having a near end disposed in the bottle, a distant end projecting from the vial and at least one channel extending therebetween, said tine being slidably mounted to the collar for movement between the positions near and distant relative to the collar and to the bottle; a cap functionally coupled to the proximal end of the prong and slidably engaged in the tubular neck of the bottle, said prong being dimensioned to lock the tubular neck when the prong is in the distal position and to separate from the neck when said prong is in the position close; and spring means for pushing said barb away from the near position to facilitate the flow of liquid through said channel of the barb and into the bottle. SUMMARY A connector assembly is provided for the efficient flow of liquid into and / or out of a jar, such as a bottle containing a lyophilized drug. The connector assembly includes a barb and a cap sleeve, both slidably mounted on the open top of the bottle. The connector assembly includes a cap fixed to the cap sleeve and coupled in sealed form to the open top of the bottle. The stopper moves slidably in response to axial movement of the tapping sleeve. The movement of the plug sleeve relative to the bottle will move the plug in and out of the seal coupling with the vial. The connector assembly further includes a spring to generate a small amount of axial movement of the prong, the cap sleeve and the cap, after the cap has been moved into the open position in the bottle. The movement of the barb, the cap sleeve and the cap generated by the spring will cause a sufficient change in pressure to overcome the surface tension and initiate an efficient flow of fluid in or out of the bottle.