CA1327776C - Sliding reconstitution device with seal - Google Patents
Sliding reconstitution device with sealInfo
- Publication number
- CA1327776C CA1327776C CA 589888 CA589888A CA1327776C CA 1327776 C CA1327776 C CA 1327776C CA 589888 CA589888 CA 589888 CA 589888 A CA589888 A CA 589888A CA 1327776 C CA1327776 C CA 1327776C
- Authority
- CA
- Canada
- Prior art keywords
- sleeve
- container
- coupling device
- seal
- piercing
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1475—Inlet or outlet ports
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/2013—Piercing means having two piercing ends
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2065—Connecting means having aligning and guiding means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/10—Coring prevention means, e.g. for plug or septum piecing members
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T137/00—Fluid handling
- Y10T137/8593—Systems
- Y10T137/87917—Flow path with serial valves and/or closures
- Y10T137/87925—Separable flow path section, valve or closure in each
- Y10T137/87941—Each valve and/or closure operated by coupling motion
- Y10T137/87949—Linear motion of flow path sections operates both
- Y10T137/87957—Valves actuate each other
Abstract
ABSTRACT
A coupling device for establishing fluid communication between a first container and a second container is provided. The device includes a first sleeve member including at a first end thereof, a member for connecting and securing the first sleeve member to a first container. A second sleeve member is provided and is so constructed and arranged that it receives a portion of the first sleeve, and is operatively adapted for axial sliding engagement thereon, including at one axial end thereof a member for releasably engaging and securing the second sleeve member to a second container. Piercing members located within an area defined by the first and second sleeve, are provided for providing fluid flow from the first container to the second container. The coupling device includes a resilient seal for sealing an end of the second sleeve member, located in said second sleeve member at said end adapted to be connected to said second container.
A coupling device for establishing fluid communication between a first container and a second container is provided. The device includes a first sleeve member including at a first end thereof, a member for connecting and securing the first sleeve member to a first container. A second sleeve member is provided and is so constructed and arranged that it receives a portion of the first sleeve, and is operatively adapted for axial sliding engagement thereon, including at one axial end thereof a member for releasably engaging and securing the second sleeve member to a second container. Piercing members located within an area defined by the first and second sleeve, are provided for providing fluid flow from the first container to the second container. The coupling device includes a resilient seal for sealing an end of the second sleeve member, located in said second sleeve member at said end adapted to be connected to said second container.
Description
S P E C I F I C A T I O N
TITLE
"SLIDING RECONSTITUTION DEVICE WITH SEAL"
BACKGROUND OF THE INVENTION
The present invention relates generally to the delivery of a beneficial agent to a patient. More specifically, the present invention relates to a device for reconstituting a benef$cial agent to be delivered to a patient.
Many drugs are stored in a powdered state, to increase their shelf life for example. In order for powdered drugs to be given intravenously to a patient, the drugs must first be placed in liquid form. To this end, these drugs are mixed or reconstituted with a dlluent before being delivered intravenously to a patlent. The diluents may be, for example, a dextrose solution, a saline solution, or even water. Typically these drugs are stored in powdered form in glass vials or ampules.
Other drugs, although in a liquid state, must still be diluted before administration to a patient. For example, some chemotherapy drugs are stored in glass vials or ampules, in a liquid state, but must be diluted prior to use. As used herein, reconstitution means to place the powdered drug in a liguid state, as well as, inaludes the dilution of a liquid drug.
Typically, the powdered drug and diluent are packaged separ~tely. Drugs may be packaged separate from the dlluent for various reasons. One of the principal reasons is that many drugs do not retain their chemical and physical stability when mixed with a diluent and thus cannot be stored for any substantial period of time.
132777 ~ I
TITLE
"SLIDING RECONSTITUTION DEVICE WITH SEAL"
BACKGROUND OF THE INVENTION
The present invention relates generally to the delivery of a beneficial agent to a patient. More specifically, the present invention relates to a device for reconstituting a benef$cial agent to be delivered to a patient.
Many drugs are stored in a powdered state, to increase their shelf life for example. In order for powdered drugs to be given intravenously to a patient, the drugs must first be placed in liquid form. To this end, these drugs are mixed or reconstituted with a dlluent before being delivered intravenously to a patlent. The diluents may be, for example, a dextrose solution, a saline solution, or even water. Typically these drugs are stored in powdered form in glass vials or ampules.
Other drugs, although in a liquid state, must still be diluted before administration to a patient. For example, some chemotherapy drugs are stored in glass vials or ampules, in a liquid state, but must be diluted prior to use. As used herein, reconstitution means to place the powdered drug in a liguid state, as well as, inaludes the dilution of a liquid drug.
Typically, the powdered drug and diluent are packaged separ~tely. Drugs may be packaged separate from the dlluent for various reasons. One of the principal reasons is that many drugs do not retain their chemical and physical stability when mixed with a diluent and thus cannot be stored for any substantial period of time.
132777 ~ I
Furthermore, many companies that make the drug do not make the diluent, and vice versa.
It is necessary for the doctor, pharmacist, nurse, or other medical personnel to mix the drug with diluent prior to use. The reconstitution of the drug presents a number of problems. The reconstitution procedure is time consuming and requires aseptic technique.
Furthermore, the proper drug and diluent must be utilized or the product must be disposed of.
The reconstltution procedure should be performed under sterile conditions. In some procedures for reconstituting, maintaining sterile conditions is difficult. Moreover, some drugs, such as chemotherapy drugs, are toxic and exposure to the operator during the reconstitution procedure can be dangerous.
One way of reconstituting a powdered drug is to inJect the liguid diluent directly into the drug vial.
Thls can be performed by use of a combination syringe and syringe needle having diluent therein. In this regard, drug vlals typically lnclude a pierceable rubber stopper.
The rubber stopper of the drug vial is pierced by the needle, and liquid ln the syringe is then in~ected into the vial. The vial is shaken to mix the powdered drug wlth the liquid. After the liquid and drug are mixed, the resultant liquid is then withdrawn back into the syrlnge. The syringe i8 then withdrawn and the drug can then be inJected into the patient.
Another method of drug administration ls to ln~ect the reconstituted drug, contained in the syrlnge, into a parenteral solutlon container. Examples of such contalners lnclude the Minibag (TM) flexible parenteral solution container or VIAFLEX (R) flexible parenteral _ 3 _ solution container sold by Baxter Healthcare Corporation of Deerfield, Illinois. These parenteral solutlon containers may already have therein dextrose or saline solutions. The drug is inJected into the container, mixed with the solution in the parenteral solution container and delivered through an intravenous solution administration set to a veln access site of the patient.
Another method for reconstituting a powdered drug utillzes a reconstltution device sold by Travenol Laboratorles, product code No. 2B8064. That devlce includes a double pointed needle and guide tubes mounted around both ends of the needle. This reconstitution device is utilized to place the drug vial in flow communication with a flexible-walled parenteral solution container. Once the connection is made, liquid in the solution contalner may be forced lnto the drug vlal by squeezlng the solution container. The vial ls then shaken. The liquid in the vial is withdrawn by squeezing air from the solution contalner lnto the vial. When compression of the ~lexible walled solution container is stopped, the pressurized air in the vial acts as a pump to force the liquid in the vlal bacX lnto the solutlon contalner.
An lmprovement to thls product is the sub~ect of U.S. Patent No. 4,607,671 to Aalto et al., assigned to the assignee of the present invention. The device of that invention includes a series of bumps on the inside of a sheath to grip a drug vial. These bumps hlnder the lnadvertent d'sconnectlon of the devlce and the vial.
U.S. Patent No. 4,759,756 discloses a reconstltution devlce whereln, ln an embodiment, the reconstltutlon ~.
device includes an improved vial adaptor and bag adaptor that permit the permanent coupling of a vial and liquid container. The bag adaptor can be rotatable relative to the vial adaptor to operate the valve including a stem channel and a base post on the vial adaptor, a base segment channel and a cut out portion of a rim on the bag adaptor and a sealing segment disposed between the vial and the bag adaptor.
Another form of reconstitution device is seen in U.S. Patent No. 3,976,073 to Quick et al., assigned to the assignee of the present lnvention. Yet another type of reconstitution device is disclosed in U.S. Patent No.
4,328,802 to Curley et al., entitled "Wet-Dry Syringe Package" which lncludes a vlal adaptor having lnwardly dlrected retain~ng pro~ections to firmly grip the retaining cap lip of a drug vial to secure the vial to the vial adaptor. The package disclosed by Curley et al.
is directed to reconstituting a drug by use of a syringe.
Other methods $or reconstltutlng a drug are shown, for example, l,n U.S. Patent Nos. 4,410,321 to Pearson et al., entltled "Close Drug Dellvery System"; 4,411,662 and 4,432,755 to Pearson, both entltled "Sterlle Coupllng";
and 4,458,733 to Lyons entltled "Mlxlng Apparatus", all assigned to the assignee o$ the present invention.
Other related patents lnclude U.S. Patent No.
It is necessary for the doctor, pharmacist, nurse, or other medical personnel to mix the drug with diluent prior to use. The reconstitution of the drug presents a number of problems. The reconstitution procedure is time consuming and requires aseptic technique.
Furthermore, the proper drug and diluent must be utilized or the product must be disposed of.
The reconstltution procedure should be performed under sterile conditions. In some procedures for reconstituting, maintaining sterile conditions is difficult. Moreover, some drugs, such as chemotherapy drugs, are toxic and exposure to the operator during the reconstitution procedure can be dangerous.
One way of reconstituting a powdered drug is to inJect the liguid diluent directly into the drug vial.
Thls can be performed by use of a combination syringe and syringe needle having diluent therein. In this regard, drug vlals typically lnclude a pierceable rubber stopper.
The rubber stopper of the drug vial is pierced by the needle, and liquid ln the syringe is then in~ected into the vial. The vial is shaken to mix the powdered drug wlth the liquid. After the liquid and drug are mixed, the resultant liquid is then withdrawn back into the syrlnge. The syringe i8 then withdrawn and the drug can then be inJected into the patient.
Another method of drug administration ls to ln~ect the reconstituted drug, contained in the syrlnge, into a parenteral solutlon container. Examples of such contalners lnclude the Minibag (TM) flexible parenteral solution container or VIAFLEX (R) flexible parenteral _ 3 _ solution container sold by Baxter Healthcare Corporation of Deerfield, Illinois. These parenteral solutlon containers may already have therein dextrose or saline solutions. The drug is inJected into the container, mixed with the solution in the parenteral solution container and delivered through an intravenous solution administration set to a veln access site of the patient.
Another method for reconstituting a powdered drug utillzes a reconstltution device sold by Travenol Laboratorles, product code No. 2B8064. That devlce includes a double pointed needle and guide tubes mounted around both ends of the needle. This reconstitution device is utilized to place the drug vial in flow communication with a flexible-walled parenteral solution container. Once the connection is made, liquid in the solution contalner may be forced lnto the drug vlal by squeezlng the solution container. The vial ls then shaken. The liquid in the vial is withdrawn by squeezing air from the solution contalner lnto the vial. When compression of the ~lexible walled solution container is stopped, the pressurized air in the vial acts as a pump to force the liquid in the vlal bacX lnto the solutlon contalner.
An lmprovement to thls product is the sub~ect of U.S. Patent No. 4,607,671 to Aalto et al., assigned to the assignee of the present invention. The device of that invention includes a series of bumps on the inside of a sheath to grip a drug vial. These bumps hlnder the lnadvertent d'sconnectlon of the devlce and the vial.
U.S. Patent No. 4,759,756 discloses a reconstltution devlce whereln, ln an embodiment, the reconstltutlon ~.
device includes an improved vial adaptor and bag adaptor that permit the permanent coupling of a vial and liquid container. The bag adaptor can be rotatable relative to the vial adaptor to operate the valve including a stem channel and a base post on the vial adaptor, a base segment channel and a cut out portion of a rim on the bag adaptor and a sealing segment disposed between the vial and the bag adaptor.
Another form of reconstitution device is seen in U.S. Patent No. 3,976,073 to Quick et al., assigned to the assignee of the present lnvention. Yet another type of reconstitution device is disclosed in U.S. Patent No.
4,328,802 to Curley et al., entitled "Wet-Dry Syringe Package" which lncludes a vlal adaptor having lnwardly dlrected retain~ng pro~ections to firmly grip the retaining cap lip of a drug vial to secure the vial to the vial adaptor. The package disclosed by Curley et al.
is directed to reconstituting a drug by use of a syringe.
Other methods $or reconstltutlng a drug are shown, for example, l,n U.S. Patent Nos. 4,410,321 to Pearson et al., entltled "Close Drug Dellvery System"; 4,411,662 and 4,432,755 to Pearson, both entltled "Sterlle Coupllng";
and 4,458,733 to Lyons entltled "Mlxlng Apparatus", all assigned to the assignee o$ the present invention.
Other related patents lnclude U.S. Patent No.
3,872,867 to Klllnger entltled "Wet-Dry Addltlve A88embly": U.S. Patent No. 3,841,329 to Klllnger entitled "Compact Syringe"; U.S. Patent No. 3,826,261 to Killnger entltled "Vlal and Syringe Assembly"; U.S. Patent No.
3,826,260 to Klllnger entltled "Vlal and Syrlnge Combination"; U.S. Patent No. 3,378,369 to Killnger 132777~
entitled "Apparatus for Transferring Liquld Between a Container and a Flexible Bag"; and German specification DE OS 36 27 231.
In reconstituting a drug, contained in a drug vial, with a diluent, without the use of an intermediary syringe, several problems exist. In some cases, the drug must be packaged separate from the diluent because certain drug's efficacy, in the presence of moisture is short, sometimes as short as 24 hours. Accordingly, once the drug ls reconstituted, it must be used in a relatlvely short time period. Added to thls is the fact that drug prescriptions are often changed and therefore, if the drug ls reconstltuted by the pharmacists, the prescription may change prior to use of the drug. Due to the short efflcacy of some drugs, thls can result ln the drug having to be dlsposed of.
Because many drugs are very expenslve, lt would be highly deslrable to provlde a reconstltution devlce that would prevent dilution or reconstitution of erroneously selected drugs or diluent; once the drugs are reconstituted or diluted, they must be used.
Further, it can be appreclated that lt ls hlghly desirable to provide a device that prevents contamination of the drug in the vial and the puncturing members that puncture the parenteral bag and vial. Also, the connection between the vial and the parenteral bag must be effective-y sealed to prevent leakage of the connecting device.
SUMMARY OF THE INVENTION
The present invention provides an improved connector for a reconstitution device. To this end, there is provided a coupling device having a cooperating inner and outer sleeve operatively engaged so that the outer sleeve can slide relatively axially about the inner sleeve. The inner sleeve includes means, at one axial end, for being coupled to a first container, such as, for example, a flexible parenteral bag. The outer sleeve is adapted at one axial end to be releasably connect to a second container, such as, for example, a vial. Piercing means for providing fluid flow from the first and second containers is provided within one of the sleeves.
Preferably, the piercing means is located at a second axlal end of the lnner sleeve and includes oppositely axially directed first and second hollow piercing members that are in fluid communlcation with each other.
The outer sleeve further includes a seal member located at a position in ~uxtaposition to the axial end of the outer sleeve that is releasably connected to the second container. Preferably, the seal lncludes a disc-shaped gasket member, and a resilient sleeve member that pro~ects axially from a central portion of the gasket member, and that operatively seals about the second piercing member.
The seal functions to seal an end of the outer sleeve and prevent any fluid that may be contalned therein from leaking out of the outer sleeve. The seal also functions to prevent microbial ingress into the outer sleeve, as well as into the second container when the sleeve is secured to the second container.
In an embodiment, the inner and outer slceves include means for releasably securing the sleeve member in a first lnactivated position or a second activated position. Preferably, the first piercing member is adapted to plerce the receptacle whenever the inner sleeve is connected to the receptacle. Preferably, the second plercing member is adapted to pierce the second container when the inner and outer sleeves are moved from the first inactivated position to the second activated position.
In use, in a preferred embodiment, the inner sleeve, having means for engaging a receptacle, is secured to a port of, for example, a parenteral bag. When so secured, the first piercing member pierces a membrane covering the port. The other axial end of the device is secured to a container, for example, a vial. In the first inactivated position, the second plercing member is spaced apart from the gasket covering the vial, to which the outer sleeve is secured. In the second activated position, however, the second piercing member pierces and extends through the gasket member and into the vial to thereby establish fluid communication between the vial and the parenteral bag.
In an embodiment of the present invention, the second piercing member 18 received within a sleeve deflned by the seal and pierces a membrane enclosing an end of the sleeve prior to penetrating the vlal.
In an embodiment of the present invention, the means for releasably securing the inner and outer sleeve member in a first or second posltlon lncludes a bayonet socket arrangement.
In an embodlment, means are provided for releasably securing the ~nner and outer sleeves in either a first or second axial position.
In an embodlment, means are provlded for releasably securlng the inner and outer slQeves ln either a flrst or second rotational position with respect to each other.
In an embodiment, the means for coupling the first sleeve to the receptacle includes a barbed connection.
The barbed connection allows a port of the container to be easily received within the first sleeve but prevents same from being removed therefrom.
In an embodiment, the first piercing member includes a solid puncturing meanc.
In an embodiment, the second piercing member includes an oblique puncturing member.
Other aspects of this invention are as follows:
A coupling device for establishing fluid communication between a first container and a second container comprising:
a first sleeve member including at a first end thereof, means for connecting and securing said first sleeve member to a first container;
a second sleeve member, so constructed and arranged that it receives a portion of the first sleeve, and operatively adapted for axial sliding engagement thereon, including means at one axial end thereof for releasably engaging and securing said second sleeve member to a second container;
piercing means located within the first and second sleeves and secured to one of the sleeves for providing fluid flow from the first container to the second container; and a resilient seal means for sealing an end of the second sleeve member, located in said second sleeve member at said end adapted to be connected to said second container.
A coupling device for establishing fluid communication between a first container and a second container comprising:
a first sleeve member having a first end adapted to securely receive a portion of the first container;
~ .
~32777~
- 8a -a pair of oppositely extending first and second hollow piercing members located within said secured to the first sleeve, the piercing members including channels in fluid communication with each other, the first piercing member adapted to pierce the first container and the second piercing member adapted to pierce the second container;
a second sleeve member concentrically engaged about said first sleeve member and operatively adapted to axial sliding engagement thereon, the second sleeve including an end for releasably securing the second container;
said first and second sleeves cooperating to define means for releasably securing said first and second sleeves in a first or second axial position relative to each other; and a molded rubber seal member located within said second sleeve member in juxtaposition to the end of the second sleeve, said seal defining a seal between a first area within the second sleeve and a second area outside the sleeve.
A connector mixing two products comprising:
first and second sleeves operatively adapted for limited rotation and axial movement relative to each other, the second sleeve member concentrically located about the first sleeve member;
means formed at an axial end of the first sleeve for securing the first sleeve member to a container;
means formed at an axial end of the second sleeve for releasably connecting the second sleeve to a second container;
the first and second sleeves defining means for releasably securing the first and second sleeve members in a first axial position or a second axial position and securing the sleeves in a first rotational position or a second rotational position;
FA
, - 8b -first and second piercing members located within and secured to the first sleeve, the first piercing member adapted to pierce the first container when the first sleeve member is connected to the container, the second piercing member adapted to pierce the second container when the container is secured to the second sleeve and the sleeves are in a second axial position;
and a molded rubber seal member located in the second sleeve member and having a disc-shaped gasket member adapted to cover and seal the outer sleeve.
Additional features and advantages of the present invention will be apparent from the detailed description of the presently preferred embodiments and from the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is an elevational view of a reconstitution device including the connector device of the present invention.
Figure 2 is a cross-sectional view of the connector device of Figure 1 illustrating the connector in an inactivated position.
Figure 3 is a cross-sectional view of the connector device of Figure 1 illustrating the connector in an activated position.
Figure 4 is an end view of the connector device of Figure 1 taken along lines IV-IV of Figure 2.
Figure 5 is an end view of the connector device of Figure 1 taken along lines V-V of Figure 2.
FigUrQ 6 i8 a fragmentary cross-sectional view of the tip of a first piercing member utilized in the connector device of Figure 1.
. .:
A
Flgure 7 is a fragmentary elevatlonal view of the tlp of a second piercing member utilized in the connector device of Figure 1.
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED
_ _ EMBODIMENTS
. _ The present invention provides a connector for use in the proper mixing of two substances, and more particularly, to the reconstitution of drugs, which may be stored in a vial, with a diluent, that may be stored in a flexible medical solution container, and used for the intravenous delivery of a medicament. To this end, the present invention provides a connector that aan be secured, at one end to a drug vlal or the like, and at a second end, to a container, such as a parenteral contalnsr containing a solution, and allows the mixing of the diluent and the drug.
Referrins to Figure 1, the connector device 10 of the present invention ls illustrated. The device 10 is adapted to place a container, such as a flexible bag 12 contalning a fluid source thereln, in fluld communication wlth a container 14 containlng a drug to be reconstituted. The devlce 10 allows the mlxlng of the drug and diluent to be performed in an aseptic manner without a contamination of the resultant product.
The contalner illustrated in Figure 1 is a flexible bag 12, such as a parenteral bag, of the type normally used in intravenous delivery systems and/or reconstitutlon devlces. However, the bag 12 can be any container that wlll allow one to reconstitute a product.
The second container 14, that contalns the drug to be reconstituted, can be a vlal or ampule, or any other type of container for containing a product or beneflclal agent i0 --such as a drug in powdered or liquid form. As discussed above, the vial 14 is connected to the flexible bag 12 so that the agent in the vial 14 can be diluted or reconstituted, depending on whether the agent is in liquid or powdered form.
The connector device 10 includes two sleeve members, a first inner sleeve 20 and a second outer sleeve 22.
Preferably, the sleeves are made of a plastic material.
The inner and outer sleeves 20 and 22 are so constructed and arranged that they allow relative axial movement therebetween. The sleeves 20 and 22 are adapted to move from a first inactlvated position to a second activated position. In a first, inactivated position, illustrated in Figure 2, the connector device 10 i8 inactivated and fluid communication is not established between the bag 12 and the vial 14 even though the connector 10 is secured to the bag 12 and vial 14. In a second activated position, illustrated in Figure 3, the connector device 10 establishes fluid communication between the bag 12 and the vial 14 allowing a drug contalned in the vial 14 to be reconstituted.
Typically, the vial 14 will include a necX or proJection havlng an openlng that 18 covered by a rubber stopper or other means for preventlng contaminatlon of the drug. The outer sleeve 22 is constructed at one end 28 thereof, 80 that lt can recelve and engage the pro~ectlon or neck 24 of the vial 14. To secure the outer sleeve 22 to the vlal, the end 28 of the outer sleeve 22 includes a locking portion. The end 28 has a dlameter and length that is designed to recelve the neck 24 of the vial 14.
.
i - 132777~
As lllustrated in Figure 2, located on the inside surface of the end portion 28 of the outer sleeve member 22 are a plurallty of bumps or flange members 34 that function to releasably lock the end portlon 28 on the vial 14. Because the outer sleeve 22 is made of plastlc, it has some resiliency and therefore, the vial 14 can be securely engaged within the end portion 28 by urglng the rlm 32 portlon of the vlal 14 lnto the locklng end portlon 28 until the flange members 34 engage an underside 36 of the rlm 32 of the vial 14. During the insertion process, the wall 30 of the end portion 28 of the outer sleeve 22 wlll give slightly to permit entry of the rim 32 of the vial 14.
As previously stated, the inner sleeve 20 is slidlngly mounted within the outer sleeve 22 for relatlve axlal movement thereln and to cooperate therewith. To this end, the ~uter sleeve 22 and the inner sleeve 20 are constructed 80 as to form two bayonet socket arrangements. One bayonet socket arrangement secures the inner and outer sleeves 20 and 22, respectively, in a first, inactivated position. The other bayonet socket or mount arrangement secures the inner and outer sleeves 20 and 22 in the second, activated posltion.
To form the first bayonet socket, the outer sleeve 22, at an axial end 44 thereof, includes an inwardly pro~ecting flange 46 formed on an inside wall 48 of the outer sleeve 22. Additionally, the outer sleeve 22 includes a pair of ribs 47 that run axially along a portion of the inside wall 48. The ribs 47 do not extend fully to the flange 46 and define, with the flange 46, a gap 49 therebetween.
,.. ~.. ^ :
The lnner sleeve 20 includes an outwardly pro~ecting flange 50 at an axial end 51 that engages and cooperates with the inner ribs 47 and the flange 46 of the outer sleeve 22 to releasably secure the inner sleeve 20 and outer sleeve 22 in a first inactivated position.
The outwardly projecting flange 50 includes two gaps 53 therein that can received the ribs 47. It can be appreciated that as the sleeves 20 and 22 are moved axially relative to each other, the flange 50 will move axially over the ribs 47, with each of the ribs 47 appropriately belng received within a respective gap 53.
When the ribs 47 are received within the gaps 53, the inner sleeve 20 is prevented from rotating withln the outer sleeve 22 but can move axially with respect to the outer sleeve.
The inner sleeve 20 also includes a pair of ridges or ribs 55 that run axially along the sleeve on opposite sides of the outside wall of the inner sleeve 20. These ribs 55 are received within gaps 57 formed in the flange 46. The gaps 57 are sufflciently wlde so as to allow a llmlted amount of relative rotatlonal movement between the inner sleeve 20 and the outer sleeve 22. A detent 59 ls located ln a center portlon of each of the gaps 57 and serves to releasably lock the lnner and outer sleeves 20 and 22 ln a flrst or second rotatlonal posltlon. The detents 59 only hlnder the relatlve rotatlonal movement of the inner sleeve 20 by releasably engaging the rlbs 55 as they travel from one slde of the gaps 57 to the other. Due to the reslllency of the plastlc materlal, a sufficlent rotatlonal torque can be exerted to overcome the detents 59 allowlng the inner and outer sleeves 20 and 22 to rotate relative to each other.
1327771~
In a first rotational position, when the flange 50 is positioned within the gap 49 between the outer sleeve ribs 47 and the outer sleeve flange 46, and the gaps 53 are aligned with ribs 47, the inner sleeve 20 and outer sleeve 22 are free to travel axially relative to each other. Thus, 1n the first rotational position, the inner and outer sleeves 20 and 22 are not locked together.
However, by rotating the inner and outer sleeves 20 and 22 relative to each other, when the flange 50 is located within the gap 49, the gap 53 in the flange 50 is caused to rotate so as to no longer be aligned with the ribs 47.
When the gaps 53 are no longer aligned with the ribs 47, the inner and outer sleeves 20 and 22 are prevent from moving axially relative to each other because the axial end of the flange 50 abuts against the edges of the ribs 47. Thus, in the second rotatlonal position, the inner and outer sleeves 20 and 22 are locked in the first inactivated position.
A simllar, second bayonet socket arrangement i8 formed at ths opposite ends of the ribs 47. However, the top of the vial 14 and seal functions as the equlvalent of flange 46 ln this arrangement. The top of the vial 14 and ribs 47 define a gap 81 wlthin which flange 50 can be received. Accordingly, once the flange S0 i8 aligned wlth the ribs 47, the inner and outer sleeves 20 and 22 can move axially relative to each other until the flange S0 abuts against the seal 70 that is compressed against the top of the vial 14. At that point, the flange 50 is recelved wlthin a gap formed between the top side of the vial 14 and the edges of the ribs 47. As illustrated in Figure 3, relative rotatlon of the inner and outer sleeves 20 and 22 from the first rotational positlon to 132777~
the second rotational position again causes m$salignment of the gaps 53 relative to the ribs 47. Thus, the inner and outer sleeves ,20 and 22 are locked in a second activated position.
As is most clearly $11ustrated in Figure 1, in the embodiment of the invention illustrated, the outer sleeve 22 includes a pair of axially extending ribs 61 on the outside wall thereof. ~he ribs 61 function to provide a better gripping action for a person who is utilizing the connector 10. To this end, the ribs 61 provide a protrusion along what would otherwise be a smooth surface of the outside wall of the outer sleeve 22. The ribs 55 on the inner sleeve 20 also function to assist in gripplng the connector lO.
lS The inner sleeve 20 is partially closed by an end wall 52 located at or near an axial end 51. A $1rst hollow piercing member 54 and a second hollow piercing member 56 are centrally positioned on opposite sides of the end wall 52. As discussed in more detail below, the f~rst and second plercing members 54 and 56 functlon to pierce the bag 12 and vial 14, respectively, placing same in fluid communication. The first and second piercing members 54 and 56, respectlvely, extend axially therefrom along the axis of the first sleeve 20. The first and second piercing members 54 and 56, respectively, lnclude hollow interlors that deflne channels that are ln fluld communlcation wlth each other through the end wall 52.
~he pieroing members 54 and 56 are so formed that they do not core when piercing a protective cover that protects an opening of the container 12 or vial 14.
Accordingly, the pierclng members 54 and 56 provide a high flow rate therebetween. The sleeve members 20 and 22 function, in part, to provide a shroud about the piercing members 54 and 56 to prevent touch contaminatlon of the piercing members by a user.
As illustrated in Figure 6, in the embodiment of the invention illustrated, the first piercing member 54 is formed so that at the piercing end thereof, it includes a solid tip member 63 for piercing a port, or the like, of a container 12. Due to the construction of the tip member 63, coring by the piercing member 54 ls prevented.
Instead, the tlp member 63 pierces the port membrane of the bag 12 and fluid communicatlon ls establlshed via openlngs 65 located above the tip member 63.
Referrlng now to Figure 7, in the embodiment of the invention illustrated, the second piercing member 56 does not have a solid tip. Instead, the second piercing member 56 is hollow throughout and has an oblique end that includes a cut-out portion 67. The cut-out portion 67 allows for the discharge of any cored material.
In the embodiment of the present invention illustrated, ~he inner sleeve 20 includes at a second axlal end 60 means for engaging and securlng a receptacle or port 62 o$ the flexlble plastlc bag 12. To this end, located wlthln the lnside of the second axial end 60 of the lnner sleeve 20, are a plurallty of locklng barbs 64 that engage the port 62 of the flexlble plastlc bag 12.
It can be appreclated that the barbs 64 allow entry of the port 62 lnto the inner sleeve 20 but prevent retraction of the port 62 therefrom. Thus, the port 62 18 securely held wlthln the inner sleeve 20. Due to the constructlon of the lnner sleeve 20 and flrst plercing member 54, when the port 62 ls so recelved, the flrst 132777~
pierclng member pierces the membrane of the port allowing fluid flow into the connector 10, and more specifically, into the first and second piercing members 54 and 56, from the bag 12.
The connector 10, and more specifically, the outer sleeve 22, includes a seal 70. Preferably, the seal 70 is a resilient molded rubber member. The seal is located at an end 28 of the outer sleeve 22 and provides improved sealing about the second piercing member 56 and between the vial 14 and outer sleeve 22. The seal 70 functions to prevent the leakage of any fluid that may be contained within the connector out the end 28 of the container.
This ls especially important if toxic substances, such as some chemotherapy drugs, are being reconstituted. The seal member 70 also functions to reduce microbial ingress into the vial 14 or the connector 10. To this end, the seal 70 seals the end 28 of the outer sleeve 22 preventing microbial ingress into the connector 10.
Likewise, when the connector 10 is secured to the vial 14, the seal 70 prevents mlcroblal lngress lnto the lnJection site, or opening, of the vlal 14.
In the embodlment of the inventlon illustrated, the molded rubber seal member 70 lncludes a gasket portlon 72 ln the form of a dlsk that effectively covers an end of the outer sleeve 22. In use, when the end 28 is locked onto the vial 14, the gasket portion 72 rests against the top of the vial forming a seal between the openlng of the vlal 14 and the connector 10.
The seal member 70 further includes a sleeve 74 that ls located centrally along the gasket portion 72 and extends axially therefrom toward the second piercing member 56. As lllustrated, the sleeve 74 operatively 132777~
engages and surrounds the-second piercing member 56 to provide a seal around the second piercing member 56.
AS illustrated in Figure 2, the sleeve 74 terminates at an end 91 that ls enclosed by a portion 93 of the gasket.
This portion 93 of the gasket 72 forms a membrane that must be penetrated to provide fluid communicatlon between an area located on a f$rst side of the seal 70 and an area located cn a second side of the seal. Thus, until the piercing member 56 is inserted through the portion 93 of the gasket 72, the end of the connector 10 is completely sealed.
The sleeve member 74 has a sufflclently small cross-sectional circumference, vls-a-vls the plerclng member 56, that when the gasket member 72 ls pierced by the piercing member 56, the sleeve member 74 seals about the spike member 56 so that the seal member 70 continues to provlde a sea;~ between the vlal 14 and the outer sleeve 22.
In use, the connector 10 18 secured to a port 95 of a contalner 12 such as a flexlble bag. When 80 secured, the flrst plerclng member 54 of the connector 10 ls recelved wlthln the port 95 of the flexlble plastlc bag 12 and pierces the membrane 97. Due to the constructlon of the connector 10 of the present lnvention, although the flrst plerclng member 56 has plerced the bag 12 and is ln contact wlth the fluid in the bag 12, the connector and bag can be stored for later use. Thls is due to the fact that the lnner and outer sleeves 20 and 22 are ln the flrst locked rotatlonal posltlon. In fact, the end 28 of the outer sleeve 22 can be locked lnto the vlal 14 and the comblnation can be stored because the second plerclng member 56, ln this state, has not yet plerced 132777~
the gasket member 72 of the seal member 70. At this point, the vial 14 may still be removed or disengaged from the outer sleeve 22. Thus, if the agent within the vial 14 was incorrectly selected, the bayonet socket arrangement formed by the inner and outer sleeves 20 and 22, and specifically, the rib 46 and flange 50 prevents accidental activation, and the vial 14 can be removed and the agent can still be used.
Figure 3 illustrates the connector 10 in the actlvated position. This position is obtained by causing the outer sleeve 22 to slide axlally relative to the inner sleeve 20 by exerting a force on the vial 14. This force must be sufficient to pierce the gasket member 72.
Because the lnner and outer sleeves 20 and 22 are lS operatlvely mounted for slldlng engagement, the outer sleeve 22 wlll be caused to slide or to be displaced axially relatlve to the inner sleeve 20. Accordingly, because the second plercing member 56 ls flxedly mounted on the end wall of the inner sleeve 20, the opening of the vial 14 will also be caused to be dlsplaced axially relatlve to the second piercing member 56. As the opening advances toward the second piercing member 56, the second piercing member 56 will penetrate the gasket member 72 and any other seal over the opening. As stated earlier, once the inner and outer sleeves 20 and 22 are ln the second activated positlon, they are rotated relatlve to each other to secure or lock the sleeves 20 and 22 in the 8econd, act$vated state.
Figure 3 illustrates the second piercing member 56 after lt has fully penetrated through the portlon 93 of the gasket 72 of the seal member 70 and the openlng of the vial 14. It can be appreciated, as illustrated, that the sleeve 74 of the seal 70 wlll be in a slightly deformed state as the end wall of the inner sleeve 20 abuts agalnst the free end of the sleeve member 74 thereby causing it to compress. Addltionally, frlctional forces between the second piercing member 56 and the sleeve member 74 will cause such deformation.
In the fully activated position, the vial 14 and flexible plastic bag 12 are in fluid communication wlth each other. At this point, the fluid in the flexible bag 12 can be introduced into the vial 14 to thereby dilute or reconstitute the agent within the vial 14. Once the drug is diluted or reconstituted, the diluted or reconstltuted agent can then be used.
It should be understood that various changes and modiflcations to the presently preferred embodlments descrlbed herein wlll be apparent to those skllled in the art. Such changes and modlfications can be made wlthout departlng from the splrlt and scope of the present invention and wlthout diminishing its attendant advantages. It is therefore lntended that such changes and modlflcatlons be covered by the appended claims.
3,826,260 to Klllnger entltled "Vlal and Syrlnge Combination"; U.S. Patent No. 3,378,369 to Killnger 132777~
entitled "Apparatus for Transferring Liquld Between a Container and a Flexible Bag"; and German specification DE OS 36 27 231.
In reconstituting a drug, contained in a drug vial, with a diluent, without the use of an intermediary syringe, several problems exist. In some cases, the drug must be packaged separate from the diluent because certain drug's efficacy, in the presence of moisture is short, sometimes as short as 24 hours. Accordingly, once the drug ls reconstituted, it must be used in a relatlvely short time period. Added to thls is the fact that drug prescriptions are often changed and therefore, if the drug ls reconstltuted by the pharmacists, the prescription may change prior to use of the drug. Due to the short efflcacy of some drugs, thls can result ln the drug having to be dlsposed of.
Because many drugs are very expenslve, lt would be highly deslrable to provlde a reconstltution devlce that would prevent dilution or reconstitution of erroneously selected drugs or diluent; once the drugs are reconstituted or diluted, they must be used.
Further, it can be appreclated that lt ls hlghly desirable to provide a device that prevents contamination of the drug in the vial and the puncturing members that puncture the parenteral bag and vial. Also, the connection between the vial and the parenteral bag must be effective-y sealed to prevent leakage of the connecting device.
SUMMARY OF THE INVENTION
The present invention provides an improved connector for a reconstitution device. To this end, there is provided a coupling device having a cooperating inner and outer sleeve operatively engaged so that the outer sleeve can slide relatively axially about the inner sleeve. The inner sleeve includes means, at one axial end, for being coupled to a first container, such as, for example, a flexible parenteral bag. The outer sleeve is adapted at one axial end to be releasably connect to a second container, such as, for example, a vial. Piercing means for providing fluid flow from the first and second containers is provided within one of the sleeves.
Preferably, the piercing means is located at a second axlal end of the lnner sleeve and includes oppositely axially directed first and second hollow piercing members that are in fluid communlcation with each other.
The outer sleeve further includes a seal member located at a position in ~uxtaposition to the axial end of the outer sleeve that is releasably connected to the second container. Preferably, the seal lncludes a disc-shaped gasket member, and a resilient sleeve member that pro~ects axially from a central portion of the gasket member, and that operatively seals about the second piercing member.
The seal functions to seal an end of the outer sleeve and prevent any fluid that may be contalned therein from leaking out of the outer sleeve. The seal also functions to prevent microbial ingress into the outer sleeve, as well as into the second container when the sleeve is secured to the second container.
In an embodiment, the inner and outer slceves include means for releasably securing the sleeve member in a first lnactivated position or a second activated position. Preferably, the first piercing member is adapted to plerce the receptacle whenever the inner sleeve is connected to the receptacle. Preferably, the second plercing member is adapted to pierce the second container when the inner and outer sleeves are moved from the first inactivated position to the second activated position.
In use, in a preferred embodiment, the inner sleeve, having means for engaging a receptacle, is secured to a port of, for example, a parenteral bag. When so secured, the first piercing member pierces a membrane covering the port. The other axial end of the device is secured to a container, for example, a vial. In the first inactivated position, the second plercing member is spaced apart from the gasket covering the vial, to which the outer sleeve is secured. In the second activated position, however, the second piercing member pierces and extends through the gasket member and into the vial to thereby establish fluid communication between the vial and the parenteral bag.
In an embodiment of the present invention, the second piercing member 18 received within a sleeve deflned by the seal and pierces a membrane enclosing an end of the sleeve prior to penetrating the vlal.
In an embodiment of the present invention, the means for releasably securing the inner and outer sleeve member in a first or second posltlon lncludes a bayonet socket arrangement.
In an embodlment, means are provided for releasably securing the ~nner and outer sleeves in either a first or second axial position.
In an embodlment, means are provlded for releasably securlng the inner and outer slQeves ln either a flrst or second rotational position with respect to each other.
In an embodiment, the means for coupling the first sleeve to the receptacle includes a barbed connection.
The barbed connection allows a port of the container to be easily received within the first sleeve but prevents same from being removed therefrom.
In an embodiment, the first piercing member includes a solid puncturing meanc.
In an embodiment, the second piercing member includes an oblique puncturing member.
Other aspects of this invention are as follows:
A coupling device for establishing fluid communication between a first container and a second container comprising:
a first sleeve member including at a first end thereof, means for connecting and securing said first sleeve member to a first container;
a second sleeve member, so constructed and arranged that it receives a portion of the first sleeve, and operatively adapted for axial sliding engagement thereon, including means at one axial end thereof for releasably engaging and securing said second sleeve member to a second container;
piercing means located within the first and second sleeves and secured to one of the sleeves for providing fluid flow from the first container to the second container; and a resilient seal means for sealing an end of the second sleeve member, located in said second sleeve member at said end adapted to be connected to said second container.
A coupling device for establishing fluid communication between a first container and a second container comprising:
a first sleeve member having a first end adapted to securely receive a portion of the first container;
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~32777~
- 8a -a pair of oppositely extending first and second hollow piercing members located within said secured to the first sleeve, the piercing members including channels in fluid communication with each other, the first piercing member adapted to pierce the first container and the second piercing member adapted to pierce the second container;
a second sleeve member concentrically engaged about said first sleeve member and operatively adapted to axial sliding engagement thereon, the second sleeve including an end for releasably securing the second container;
said first and second sleeves cooperating to define means for releasably securing said first and second sleeves in a first or second axial position relative to each other; and a molded rubber seal member located within said second sleeve member in juxtaposition to the end of the second sleeve, said seal defining a seal between a first area within the second sleeve and a second area outside the sleeve.
A connector mixing two products comprising:
first and second sleeves operatively adapted for limited rotation and axial movement relative to each other, the second sleeve member concentrically located about the first sleeve member;
means formed at an axial end of the first sleeve for securing the first sleeve member to a container;
means formed at an axial end of the second sleeve for releasably connecting the second sleeve to a second container;
the first and second sleeves defining means for releasably securing the first and second sleeve members in a first axial position or a second axial position and securing the sleeves in a first rotational position or a second rotational position;
FA
, - 8b -first and second piercing members located within and secured to the first sleeve, the first piercing member adapted to pierce the first container when the first sleeve member is connected to the container, the second piercing member adapted to pierce the second container when the container is secured to the second sleeve and the sleeves are in a second axial position;
and a molded rubber seal member located in the second sleeve member and having a disc-shaped gasket member adapted to cover and seal the outer sleeve.
Additional features and advantages of the present invention will be apparent from the detailed description of the presently preferred embodiments and from the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is an elevational view of a reconstitution device including the connector device of the present invention.
Figure 2 is a cross-sectional view of the connector device of Figure 1 illustrating the connector in an inactivated position.
Figure 3 is a cross-sectional view of the connector device of Figure 1 illustrating the connector in an activated position.
Figure 4 is an end view of the connector device of Figure 1 taken along lines IV-IV of Figure 2.
Figure 5 is an end view of the connector device of Figure 1 taken along lines V-V of Figure 2.
FigUrQ 6 i8 a fragmentary cross-sectional view of the tip of a first piercing member utilized in the connector device of Figure 1.
. .:
A
Flgure 7 is a fragmentary elevatlonal view of the tlp of a second piercing member utilized in the connector device of Figure 1.
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED
_ _ EMBODIMENTS
. _ The present invention provides a connector for use in the proper mixing of two substances, and more particularly, to the reconstitution of drugs, which may be stored in a vial, with a diluent, that may be stored in a flexible medical solution container, and used for the intravenous delivery of a medicament. To this end, the present invention provides a connector that aan be secured, at one end to a drug vlal or the like, and at a second end, to a container, such as a parenteral contalnsr containing a solution, and allows the mixing of the diluent and the drug.
Referrins to Figure 1, the connector device 10 of the present invention ls illustrated. The device 10 is adapted to place a container, such as a flexible bag 12 contalning a fluid source thereln, in fluld communication wlth a container 14 containlng a drug to be reconstituted. The devlce 10 allows the mlxlng of the drug and diluent to be performed in an aseptic manner without a contamination of the resultant product.
The contalner illustrated in Figure 1 is a flexible bag 12, such as a parenteral bag, of the type normally used in intravenous delivery systems and/or reconstitutlon devlces. However, the bag 12 can be any container that wlll allow one to reconstitute a product.
The second container 14, that contalns the drug to be reconstituted, can be a vlal or ampule, or any other type of container for containing a product or beneflclal agent i0 --such as a drug in powdered or liquid form. As discussed above, the vial 14 is connected to the flexible bag 12 so that the agent in the vial 14 can be diluted or reconstituted, depending on whether the agent is in liquid or powdered form.
The connector device 10 includes two sleeve members, a first inner sleeve 20 and a second outer sleeve 22.
Preferably, the sleeves are made of a plastic material.
The inner and outer sleeves 20 and 22 are so constructed and arranged that they allow relative axial movement therebetween. The sleeves 20 and 22 are adapted to move from a first inactlvated position to a second activated position. In a first, inactivated position, illustrated in Figure 2, the connector device 10 i8 inactivated and fluid communication is not established between the bag 12 and the vial 14 even though the connector 10 is secured to the bag 12 and vial 14. In a second activated position, illustrated in Figure 3, the connector device 10 establishes fluid communication between the bag 12 and the vial 14 allowing a drug contalned in the vial 14 to be reconstituted.
Typically, the vial 14 will include a necX or proJection havlng an openlng that 18 covered by a rubber stopper or other means for preventlng contaminatlon of the drug. The outer sleeve 22 is constructed at one end 28 thereof, 80 that lt can recelve and engage the pro~ectlon or neck 24 of the vial 14. To secure the outer sleeve 22 to the vlal, the end 28 of the outer sleeve 22 includes a locking portion. The end 28 has a dlameter and length that is designed to recelve the neck 24 of the vial 14.
.
i - 132777~
As lllustrated in Figure 2, located on the inside surface of the end portion 28 of the outer sleeve member 22 are a plurallty of bumps or flange members 34 that function to releasably lock the end portlon 28 on the vial 14. Because the outer sleeve 22 is made of plastlc, it has some resiliency and therefore, the vial 14 can be securely engaged within the end portion 28 by urglng the rlm 32 portlon of the vlal 14 lnto the locklng end portlon 28 until the flange members 34 engage an underside 36 of the rlm 32 of the vial 14. During the insertion process, the wall 30 of the end portion 28 of the outer sleeve 22 wlll give slightly to permit entry of the rim 32 of the vial 14.
As previously stated, the inner sleeve 20 is slidlngly mounted within the outer sleeve 22 for relatlve axlal movement thereln and to cooperate therewith. To this end, the ~uter sleeve 22 and the inner sleeve 20 are constructed 80 as to form two bayonet socket arrangements. One bayonet socket arrangement secures the inner and outer sleeves 20 and 22, respectively, in a first, inactivated position. The other bayonet socket or mount arrangement secures the inner and outer sleeves 20 and 22 in the second, activated posltion.
To form the first bayonet socket, the outer sleeve 22, at an axial end 44 thereof, includes an inwardly pro~ecting flange 46 formed on an inside wall 48 of the outer sleeve 22. Additionally, the outer sleeve 22 includes a pair of ribs 47 that run axially along a portion of the inside wall 48. The ribs 47 do not extend fully to the flange 46 and define, with the flange 46, a gap 49 therebetween.
,.. ~.. ^ :
The lnner sleeve 20 includes an outwardly pro~ecting flange 50 at an axial end 51 that engages and cooperates with the inner ribs 47 and the flange 46 of the outer sleeve 22 to releasably secure the inner sleeve 20 and outer sleeve 22 in a first inactivated position.
The outwardly projecting flange 50 includes two gaps 53 therein that can received the ribs 47. It can be appreciated that as the sleeves 20 and 22 are moved axially relative to each other, the flange 50 will move axially over the ribs 47, with each of the ribs 47 appropriately belng received within a respective gap 53.
When the ribs 47 are received within the gaps 53, the inner sleeve 20 is prevented from rotating withln the outer sleeve 22 but can move axially with respect to the outer sleeve.
The inner sleeve 20 also includes a pair of ridges or ribs 55 that run axially along the sleeve on opposite sides of the outside wall of the inner sleeve 20. These ribs 55 are received within gaps 57 formed in the flange 46. The gaps 57 are sufflciently wlde so as to allow a llmlted amount of relative rotatlonal movement between the inner sleeve 20 and the outer sleeve 22. A detent 59 ls located ln a center portlon of each of the gaps 57 and serves to releasably lock the lnner and outer sleeves 20 and 22 ln a flrst or second rotatlonal posltlon. The detents 59 only hlnder the relatlve rotatlonal movement of the inner sleeve 20 by releasably engaging the rlbs 55 as they travel from one slde of the gaps 57 to the other. Due to the reslllency of the plastlc materlal, a sufficlent rotatlonal torque can be exerted to overcome the detents 59 allowlng the inner and outer sleeves 20 and 22 to rotate relative to each other.
1327771~
In a first rotational position, when the flange 50 is positioned within the gap 49 between the outer sleeve ribs 47 and the outer sleeve flange 46, and the gaps 53 are aligned with ribs 47, the inner sleeve 20 and outer sleeve 22 are free to travel axially relative to each other. Thus, 1n the first rotational position, the inner and outer sleeves 20 and 22 are not locked together.
However, by rotating the inner and outer sleeves 20 and 22 relative to each other, when the flange 50 is located within the gap 49, the gap 53 in the flange 50 is caused to rotate so as to no longer be aligned with the ribs 47.
When the gaps 53 are no longer aligned with the ribs 47, the inner and outer sleeves 20 and 22 are prevent from moving axially relative to each other because the axial end of the flange 50 abuts against the edges of the ribs 47. Thus, in the second rotatlonal position, the inner and outer sleeves 20 and 22 are locked in the first inactivated position.
A simllar, second bayonet socket arrangement i8 formed at ths opposite ends of the ribs 47. However, the top of the vial 14 and seal functions as the equlvalent of flange 46 ln this arrangement. The top of the vial 14 and ribs 47 define a gap 81 wlthin which flange 50 can be received. Accordingly, once the flange S0 i8 aligned wlth the ribs 47, the inner and outer sleeves 20 and 22 can move axially relative to each other until the flange S0 abuts against the seal 70 that is compressed against the top of the vial 14. At that point, the flange 50 is recelved wlthin a gap formed between the top side of the vial 14 and the edges of the ribs 47. As illustrated in Figure 3, relative rotatlon of the inner and outer sleeves 20 and 22 from the first rotational positlon to 132777~
the second rotational position again causes m$salignment of the gaps 53 relative to the ribs 47. Thus, the inner and outer sleeves ,20 and 22 are locked in a second activated position.
As is most clearly $11ustrated in Figure 1, in the embodiment of the invention illustrated, the outer sleeve 22 includes a pair of axially extending ribs 61 on the outside wall thereof. ~he ribs 61 function to provide a better gripping action for a person who is utilizing the connector 10. To this end, the ribs 61 provide a protrusion along what would otherwise be a smooth surface of the outside wall of the outer sleeve 22. The ribs 55 on the inner sleeve 20 also function to assist in gripplng the connector lO.
lS The inner sleeve 20 is partially closed by an end wall 52 located at or near an axial end 51. A $1rst hollow piercing member 54 and a second hollow piercing member 56 are centrally positioned on opposite sides of the end wall 52. As discussed in more detail below, the f~rst and second plercing members 54 and 56 functlon to pierce the bag 12 and vial 14, respectively, placing same in fluid communication. The first and second piercing members 54 and 56, respectlvely, extend axially therefrom along the axis of the first sleeve 20. The first and second piercing members 54 and 56, respectively, lnclude hollow interlors that deflne channels that are ln fluld communlcation wlth each other through the end wall 52.
~he pieroing members 54 and 56 are so formed that they do not core when piercing a protective cover that protects an opening of the container 12 or vial 14.
Accordingly, the pierclng members 54 and 56 provide a high flow rate therebetween. The sleeve members 20 and 22 function, in part, to provide a shroud about the piercing members 54 and 56 to prevent touch contaminatlon of the piercing members by a user.
As illustrated in Figure 6, in the embodiment of the invention illustrated, the first piercing member 54 is formed so that at the piercing end thereof, it includes a solid tip member 63 for piercing a port, or the like, of a container 12. Due to the construction of the tip member 63, coring by the piercing member 54 ls prevented.
Instead, the tlp member 63 pierces the port membrane of the bag 12 and fluid communicatlon ls establlshed via openlngs 65 located above the tip member 63.
Referrlng now to Figure 7, in the embodiment of the invention illustrated, the second piercing member 56 does not have a solid tip. Instead, the second piercing member 56 is hollow throughout and has an oblique end that includes a cut-out portion 67. The cut-out portion 67 allows for the discharge of any cored material.
In the embodiment of the present invention illustrated, ~he inner sleeve 20 includes at a second axlal end 60 means for engaging and securlng a receptacle or port 62 o$ the flexlble plastlc bag 12. To this end, located wlthln the lnside of the second axial end 60 of the lnner sleeve 20, are a plurallty of locklng barbs 64 that engage the port 62 of the flexlble plastlc bag 12.
It can be appreclated that the barbs 64 allow entry of the port 62 lnto the inner sleeve 20 but prevent retraction of the port 62 therefrom. Thus, the port 62 18 securely held wlthln the inner sleeve 20. Due to the constructlon of the lnner sleeve 20 and flrst plercing member 54, when the port 62 ls so recelved, the flrst 132777~
pierclng member pierces the membrane of the port allowing fluid flow into the connector 10, and more specifically, into the first and second piercing members 54 and 56, from the bag 12.
The connector 10, and more specifically, the outer sleeve 22, includes a seal 70. Preferably, the seal 70 is a resilient molded rubber member. The seal is located at an end 28 of the outer sleeve 22 and provides improved sealing about the second piercing member 56 and between the vial 14 and outer sleeve 22. The seal 70 functions to prevent the leakage of any fluid that may be contained within the connector out the end 28 of the container.
This ls especially important if toxic substances, such as some chemotherapy drugs, are being reconstituted. The seal member 70 also functions to reduce microbial ingress into the vial 14 or the connector 10. To this end, the seal 70 seals the end 28 of the outer sleeve 22 preventing microbial ingress into the connector 10.
Likewise, when the connector 10 is secured to the vial 14, the seal 70 prevents mlcroblal lngress lnto the lnJection site, or opening, of the vlal 14.
In the embodlment of the inventlon illustrated, the molded rubber seal member 70 lncludes a gasket portlon 72 ln the form of a dlsk that effectively covers an end of the outer sleeve 22. In use, when the end 28 is locked onto the vial 14, the gasket portion 72 rests against the top of the vial forming a seal between the openlng of the vlal 14 and the connector 10.
The seal member 70 further includes a sleeve 74 that ls located centrally along the gasket portion 72 and extends axially therefrom toward the second piercing member 56. As lllustrated, the sleeve 74 operatively 132777~
engages and surrounds the-second piercing member 56 to provide a seal around the second piercing member 56.
AS illustrated in Figure 2, the sleeve 74 terminates at an end 91 that ls enclosed by a portion 93 of the gasket.
This portion 93 of the gasket 72 forms a membrane that must be penetrated to provide fluid communicatlon between an area located on a f$rst side of the seal 70 and an area located cn a second side of the seal. Thus, until the piercing member 56 is inserted through the portion 93 of the gasket 72, the end of the connector 10 is completely sealed.
The sleeve member 74 has a sufflclently small cross-sectional circumference, vls-a-vls the plerclng member 56, that when the gasket member 72 ls pierced by the piercing member 56, the sleeve member 74 seals about the spike member 56 so that the seal member 70 continues to provlde a sea;~ between the vlal 14 and the outer sleeve 22.
In use, the connector 10 18 secured to a port 95 of a contalner 12 such as a flexlble bag. When 80 secured, the flrst plerclng member 54 of the connector 10 ls recelved wlthln the port 95 of the flexlble plastlc bag 12 and pierces the membrane 97. Due to the constructlon of the connector 10 of the present lnvention, although the flrst plerclng member 56 has plerced the bag 12 and is ln contact wlth the fluid in the bag 12, the connector and bag can be stored for later use. Thls is due to the fact that the lnner and outer sleeves 20 and 22 are ln the flrst locked rotatlonal posltlon. In fact, the end 28 of the outer sleeve 22 can be locked lnto the vlal 14 and the comblnation can be stored because the second plerclng member 56, ln this state, has not yet plerced 132777~
the gasket member 72 of the seal member 70. At this point, the vial 14 may still be removed or disengaged from the outer sleeve 22. Thus, if the agent within the vial 14 was incorrectly selected, the bayonet socket arrangement formed by the inner and outer sleeves 20 and 22, and specifically, the rib 46 and flange 50 prevents accidental activation, and the vial 14 can be removed and the agent can still be used.
Figure 3 illustrates the connector 10 in the actlvated position. This position is obtained by causing the outer sleeve 22 to slide axlally relative to the inner sleeve 20 by exerting a force on the vial 14. This force must be sufficient to pierce the gasket member 72.
Because the lnner and outer sleeves 20 and 22 are lS operatlvely mounted for slldlng engagement, the outer sleeve 22 wlll be caused to slide or to be displaced axially relatlve to the inner sleeve 20. Accordingly, because the second plercing member 56 ls flxedly mounted on the end wall of the inner sleeve 20, the opening of the vial 14 will also be caused to be dlsplaced axially relatlve to the second piercing member 56. As the opening advances toward the second piercing member 56, the second piercing member 56 will penetrate the gasket member 72 and any other seal over the opening. As stated earlier, once the inner and outer sleeves 20 and 22 are ln the second activated positlon, they are rotated relatlve to each other to secure or lock the sleeves 20 and 22 in the 8econd, act$vated state.
Figure 3 illustrates the second piercing member 56 after lt has fully penetrated through the portlon 93 of the gasket 72 of the seal member 70 and the openlng of the vial 14. It can be appreciated, as illustrated, that the sleeve 74 of the seal 70 wlll be in a slightly deformed state as the end wall of the inner sleeve 20 abuts agalnst the free end of the sleeve member 74 thereby causing it to compress. Addltionally, frlctional forces between the second piercing member 56 and the sleeve member 74 will cause such deformation.
In the fully activated position, the vial 14 and flexible plastic bag 12 are in fluid communication wlth each other. At this point, the fluid in the flexible bag 12 can be introduced into the vial 14 to thereby dilute or reconstitute the agent within the vial 14. Once the drug is diluted or reconstituted, the diluted or reconstltuted agent can then be used.
It should be understood that various changes and modiflcations to the presently preferred embodlments descrlbed herein wlll be apparent to those skllled in the art. Such changes and modlfications can be made wlthout departlng from the splrlt and scope of the present invention and wlthout diminishing its attendant advantages. It is therefore lntended that such changes and modlflcatlons be covered by the appended claims.
Claims (32)
1. A coupling device for establishing fluid communication between a first container and a second container comprising:
a first sleeve member including at a first end thereof, means for connecting and securing said first sleeve member to a first container;
a second sleeve member, so constructed and arranged that it receives a portion of the first sleeve, and operatively adapted for axial sliding engagement thereon, including means at one axial end thereof for releasably engaging and securing said second sleeve member to a second container;
piercing means located within the first and second sleeves and secured to one of the sleeves for providing fluid flow from the first container to the second container; and a resilient seal means for sealing an end of the second sleeve member, located in said second sleeve member at said end adapted to be connected to said second container.
a first sleeve member including at a first end thereof, means for connecting and securing said first sleeve member to a first container;
a second sleeve member, so constructed and arranged that it receives a portion of the first sleeve, and operatively adapted for axial sliding engagement thereon, including means at one axial end thereof for releasably engaging and securing said second sleeve member to a second container;
piercing means located within the first and second sleeves and secured to one of the sleeves for providing fluid flow from the first container to the second container; and a resilient seal means for sealing an end of the second sleeve member, located in said second sleeve member at said end adapted to be connected to said second container.
2. The coupling device of Claim 1 wherein the seal means includes a gasket that creates a seal between a first area located on one side of the gasket and a second area located on a second side of the gasket.
3. The coupling device of Claim 1 wherein the seal member includes a resilient sleeve member extending axially from a portion of the seal member.
4. The coupling device of Claim 1 including means for releasably securing the first and second sleeves in a first or second axial position.
5. The coupling device of Claim 4 wherein said means for releasably securing said first and second sleeve members includes a bayonet socket arrangement.
6. The coupling device of Claim 1 including means for releasably securing the first and second sleeves in a first or second rotational position.
7. The coupling device of Claim 1 wherein said means for connecting said first sleeve member to said container includes means for allowing a portion of the container to be received within said first sleeve member but preventing the portion from being released therefrom.
8. The coupling device of Claim 1 wherein said seal member is formed of a molded rubber and said first and second sleeve members are made of plastic.
9. The coupling device of Claim 1 wherein said piercing means includes two piercing members, one of which is so constructed and arranged that it can pierce the first container and a second of which that is so constructed and arranged that it can pierce the second container.
10. The coupling device of Claim 9 wherein said first and second piercing members are made of plastic and are integrally formed with said first sleeve member.
11. The coupling device of Claim 9 wherein the first sleeve includes at a second axial end an end wall and the piercing members extend outwardly from opposite sides of the end wall.
12. The coupling device of Claim 1 wherein the seal means prevents fluid contained in the second sleeve from leaking out of the coupling device.
13. The coupling device of Claim 1 wherein the seal means prevents microbial ingress into the second sleeve member via the second end.
14. A coupling device for establishing fluid communication between a first container and a second container comprising:
a first sleeve member having a first end adapted to securely receive a portion of the first container;
a pair of oppositely extending first and second hollow piercing members located within said secured to the first sleeve, the piercing members including channels in fluid communication with each other, the first piercing member adapted to pierce the first container and the second piercing member adapted to pierce the second container;
a second sleeve member concentrically engaged about said first sleeve member and operatively adapted to axial sliding engagement thereon, the second sleeve including an end for releasably securing the second container;
said first and second sleeves cooperating to define means for releasably securing said first and second sleeves in a first or second axial position relative to each other; and a molded rubber seal member located within said second sleeve member in juxtaposition to the end of the second sleeve, said seal defining a seal between a first area within the second sleeve and a second area outside the sleeve.
a first sleeve member having a first end adapted to securely receive a portion of the first container;
a pair of oppositely extending first and second hollow piercing members located within said secured to the first sleeve, the piercing members including channels in fluid communication with each other, the first piercing member adapted to pierce the first container and the second piercing member adapted to pierce the second container;
a second sleeve member concentrically engaged about said first sleeve member and operatively adapted to axial sliding engagement thereon, the second sleeve including an end for releasably securing the second container;
said first and second sleeves cooperating to define means for releasably securing said first and second sleeves in a first or second axial position relative to each other; and a molded rubber seal member located within said second sleeve member in juxtaposition to the end of the second sleeve, said seal defining a seal between a first area within the second sleeve and a second area outside the sleeve.
15. The coupling device of Claim 14 wherein the first piercing member includes a solid tip.
16. The coupling device of Claim 14 wherein the second piercing member includes an oblique-shaped end.
17. The coupling device of Claim 14 wherein the seal includes a gasket extending across a face of the end of the outer sleeve.
18. The coupling device of Claim 17 wherein the gasket prevents microbial ingress into the first area and into the second container when the sleeve is secured to the second container.
19. The coupling device of Claim 14 wherein the seal includes a sleeve, having a pierceable membrane at one end and an opening at a second end, the sleeve being so constructed and arranged that it receives a portion of the second piercing member.
20. The coupling device of Claim 14 wherein said first piercing member extends for a length sufficient to cause the piercing member to pierce a portion of the first container when the first sleeve is secured to the container.
21. The coupling device of Claim 14 wherein the means for releasably securing the first and second sleeves in a first or second position includes a flange circumscribing an outer portion of the first sleeve and a flange circumscribing an inner portion of the second sleeve and at least one rib located on the inner portion of the second sleeve.
22. The coupling device of Claim 21 wherein flange on the first sleeve includes at least one gap for receiving the rib.
23. The coupling device of Claim 21 wherein the flange on the second sleeve includes a gap therebetween for receiving the flange on the first sleeve.
24. The coupling device of Claim 23 wherein the gap on the first sleeve includes means for limiting the rotational movement of the first sleeve with respect to the second sleeve.
25. The coupling device of claim 14 including means for releasably securing the first and second sleeves in a first or second rotational position with respect to each other.
26. A connector mixing two products comprising:
first and second sleeves operatively adapted for limited rotation and axial movement relative to each other, the second sleeve member concentrically located about the first sleeve member;
means formed at an axial end of the first sleeve for securing the first sleeve member to a container;
means formed at an axial end of the second sleeve for releasably connecting the second sleeve to a second container;
the first and second sleeves defining means for releasably securing the first and second sleeve members in a first axial position or a second axial position and securing the sleeves in a first rotational position or a second rotational position;
first and second piercing members located within and secured to the first sleeve, the first piercing member adapted to pierce the first container when the first sleeve member is connected to the container, the second piercing member adapted to pierce the second container when the container is secured to the second sleeve and the sleeves are in a second axial position;
and a molded rubber seal member located in the second sleeve member and having a disc-shaped gasket member adapted to cover and seal the outer sleeve.
first and second sleeves operatively adapted for limited rotation and axial movement relative to each other, the second sleeve member concentrically located about the first sleeve member;
means formed at an axial end of the first sleeve for securing the first sleeve member to a container;
means formed at an axial end of the second sleeve for releasably connecting the second sleeve to a second container;
the first and second sleeves defining means for releasably securing the first and second sleeve members in a first axial position or a second axial position and securing the sleeves in a first rotational position or a second rotational position;
first and second piercing members located within and secured to the first sleeve, the first piercing member adapted to pierce the first container when the first sleeve member is connected to the container, the second piercing member adapted to pierce the second container when the container is secured to the second sleeve and the sleeves are in a second axial position;
and a molded rubber seal member located in the second sleeve member and having a disc-shaped gasket member adapted to cover and seal the outer sleeve.
27. The connector of Claim 26 wherein the seal includes a resilient sleeve extending axially from a center portion of the gasket that operatively surrounds and seals the second piercing member.
28. The connector of Claim 27 wherein the sleeve includes a pierceable membrane at an end thereof.
29. The connector of Claim 26 wherein the means for releasably securing the first and second sleeves in a first or second position includes a flange circumscribing an outer portion of the first sleeve and a flange circumscribing an inner portion of the second sleeve and at least one rib located on the inner portion of the second sleeve.
30. The connector of Claim 29 wherein the flange on the second sleeve includes a gap therebetween for receiving the flange on the first sleeve.
31. The connector of Claim 30 wherein the gap on the first sleeve includes means for limiting the rotational movement of the first sleeve with respect to the second sleeve.
32. The connector of Claim 26 wherein flange on the first sleeve includes at least one gap for receiving the rib.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/249,747 US4898209A (en) | 1988-09-27 | 1988-09-27 | Sliding reconstitution device with seal |
| US249,747 | 1988-09-27 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1327776C true CA1327776C (en) | 1994-03-15 |
Family
ID=22944819
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 589888 Expired - Lifetime CA1327776C (en) | 1988-09-27 | 1989-02-02 | Sliding reconstitution device with seal |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US4898209A (en) |
| EP (1) | EP0388457B1 (en) |
| JP (1) | JP2936273B2 (en) |
| AU (1) | AU613531B2 (en) |
| CA (1) | CA1327776C (en) |
| DE (1) | DE68908388T2 (en) |
| ES (1) | ES2015227A6 (en) |
| WO (1) | WO1990003536A1 (en) |
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-
1988
- 1988-09-27 US US07/249,747 patent/US4898209A/en not_active Expired - Lifetime
-
1989
- 1989-02-02 CA CA 589888 patent/CA1327776C/en not_active Expired - Lifetime
- 1989-09-14 DE DE1989608388 patent/DE68908388T2/en not_active Expired - Lifetime
- 1989-09-14 WO PCT/US1989/003915 patent/WO1990003536A1/en active IP Right Grant
- 1989-09-14 EP EP19890910522 patent/EP0388457B1/en not_active Expired - Lifetime
- 1989-09-14 JP JP50987089A patent/JP2936273B2/en not_active Expired - Lifetime
- 1989-09-14 AU AU43184/89A patent/AU613531B2/en not_active Ceased
- 1989-09-25 ES ES8903226A patent/ES2015227A6/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| EP0388457A4 (en) | 1991-04-03 |
| JP2936273B2 (en) | 1999-08-23 |
| ES2015227A6 (en) | 1990-08-01 |
| AU4318489A (en) | 1990-04-18 |
| EP0388457B1 (en) | 1993-08-11 |
| DE68908388T2 (en) | 1994-01-13 |
| AU613531B2 (en) | 1991-08-01 |
| WO1990003536A1 (en) | 1990-04-05 |
| DE68908388D1 (en) | 1993-09-16 |
| US4898209A (en) | 1990-02-06 |
| JPH03501456A (en) | 1991-04-04 |
| EP0388457A1 (en) | 1990-09-26 |
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