Abstract:
A fluid connector system features a stopper and an extending section. Installable within an outlet of a fluid container, the stopper defines a passage therethrough. Defining air and fluid conduits, the extending section has a first abutment member threadably connectible thereto and a second abutment member affixed thereto. The extending section is adapted to be extended through the passage of the stopper when assembled thereto. When the first abutment member is tightened about the extending section, the first and second abutment members abut against the exterior and interior sides, respectively, of the stopper. With the stopper installed within the outlet and the extending section and the abutment members therewith assembled to the stopper thereby sealing the passage therein, fluid within the container may be extracted via the fluid conduit as air exterior to the container flows therein via the air conduct to displace the fluid being extracted from the container.

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates to fluid path connectors and container spikes for fluid delivery and, particularly, to fluid path connectors and container spikes for delivery of sterile, medical fluids. 
     The following information is provided to assist the reader to understand the invention disclosed below and the environment in which it will typically be used. The terms used herein and objectives described herein are not intended to be limited to any particular narrow interpretation unless clearly stated otherwise in this document. References set forth herein may facilitate understanding of the present invention or the background of the present invention. The disclosure of all references cited herein are incorporated by reference. 
     In many medical procedures, such as diagnostic and/or therapeutic drug delivery, it is desirable to inject a fluid into a patient. For example, numerous types of contrast media (often referred to simply as contrast) are injected into a patient for many diagnostic and therapeutic imaging procedures. In some medical procedures (for example, computed tomography (CT), angiography, and nuclear magnetic resonance/magnetic resonance imaging (MRI)) it is desirable to deliver a liquid such as contrast medium in a timed fashion under relatively high pressures. Such relatively high pressures and timed boluses are typically achieved through the use of powered injectors. 
     To, for example, optimize contrast volume delivery, minimize waste of contrast and facilitate injector procedures for operators, fluid delivery systems that are capable of delivering sufficient contrast for multiple injection procedures from a single source of contrast have recently been developed. Examples of such systems are described generally in U.S. Pat. Nos. 5,569,181, 5,806,519, 5,843,037 and 5,885,216, the disclosures of which are incorporated herein by reference. Typically, it is desirable that such fluid delivery systems include a fluid path with a disposable patient interface that is changed/discarded between each patient to reduce the potential for cross-contamination. 
     A fluid path connector to connect to a source of fluid is required to incorporate a removable/disposable patient interface in the fluid path of a fluid delivery or injector system. However, many fluid path connectors used in medical procedures exhibit a number of substantial drawbacks including, for example, difficulty of use and difficulty in maintaining sterility. Moreover, when such connectors are used at high pressures, leakage and failure also become substantial problems. 
     Often a piercing member of spike is used to form a fluid connection with a fluid source or container via puncturing of an elastomeric septum or stopper on an outlet of the container. In addition to problems associated with, for example, difficulty of use and difficulty in maintaining sterility, it is often difficult to provided a suitable flow rate for certain medical procedures (for example, delivery of a relatively viscous fluid such as a contrast medium) from spike connectors. The spike of such fluid connectors is typically of limited cross-sectional area to facilitate piercing, resulting in significant limits upon the size of the fluid line or channel passing through the spike. For example, even the largest fluid line in currently available spike fluid connectors have a cross-sectional area of approximately 0.08 in 2 , significantly limiting the flow rate of fluids therethrough. 
     It is desirable to develop improved fluid path connectors for fluid delivery that, for example, reduce or eliminate the above and/or other problems associated with currently available fluid path connector and spikes. 
     SUMMARY OF THE INVENTION 
     In one aspect, a fluid connector for use with a pierceable container port is provided. The fluid connector includes an extending section including a spiked end to pierce the container port. The extending section includes at least one air conduit and at least one fluid conduit therethrough. The extending section further includes a first abutment member and second abutment member. The first abutment member is adapted to abut a first or air side of the container port upon piercing of the container port. The second abutment member is spaced from the first abutment member and is adapted to abut a second or fluid side of the container port. The fluid connector can further include grasping members extending from the extending section to facilitate rotation (including twisting) of the extending section relative to the container port during piercing thereof. The fluid connector can also include a check valve in fluid connection with the air line. In several embodiments, the check valve is positioned within the extending section. 
     In another aspect, a fluid connector system includes a stopper including a first or air side, a second or fluid side and a passage therethrough from the first side to the second side. The fluid connector system further includes a connector including a base having at least one air conduit and at least one fluid conduit therethrough. The base further includes an extending section adapted to extend through the passage. The extending section includes a first abutment member adapted to abut the first side of the stopper and a second abutment member spaced from the first abutment member and adapted to abut the second side of the stopper and seal the passage. 
     In several embodiments, the first abutment member is operatively connectible to the base to maintain the second abutment member in compressive contact with the stopper. The first abutment member can, for example, include threading which cooperates with threading on the extending section of the base. 
     The second abutment member can, for example, include a wedge-shaped section, at least a portion of which enters the passage of the stopper. The second abutment member can alternatively include a radially outward extending flange to abut and apply compressive force to the second side of the stopper. 
     The fluid connector system can further include a filter in fluid connection with the air line. The fluid connector can also include a check valve in fluid connection with the air conduit on an end of the air conduit interior to the container. 
     The extending section can also include a cooperating connector adapted to place a fluid path element in fluid connection with the base. The cooperating connector can, for example, include a luer connector. 
     In several embodiments, at least a portion of the connector is sealed within the container. The connector can further include a pull tab section attached to an end of the extending section of the base and extending from the first side of the stopper to enable a user to pull the extending section of the base through the passage in the stopper so that the second abutment member abuts the stopper. In several embodiments, the first abutment member extends radially outward from the extending section of the base and is spaced from the second abutment member so that upon pulling a length of the extending section through the passage, the first abutment member contacts the first side of the stopper and maintains the second abutment member in compressive and sealing abutment with the stopper. The pull tab section can be removably attached to the extending section via a cooperating connector on the extending section. The cooperating connector can be adapted to place a fluid path element in fluid connection with the base. The cooperating connector can, for example, include a luer connector. 
     In another aspect, a system to connect to an outlet of a container includes a cap assembly including an annular cap member connected to a pierceable stopper. The cap member includes an opening to provide access to the pierceable stopper and a connector section removably connectible to the container. The system can further include a connector member attachable to the outlet of the container. The connector member includes a cooperating connector section to which the connector section of the cap assembly is removably attachable. The connector section can, for example, include threading, and the cooperating connector section can include cooperating threading. The connector and the cap assembly can, for example, form a removably sealed attachment to seal the outlet of the container. 
     In another aspect, a fluid connector includes a spike to pierce a pierceable section of a container and a flexible cover encompassing at least a portion of the spike. The flexible cover is penetrated by the spike when force is applied to the spike to pierce the pierceable section of the container. 
     In several embodiments, the spike includes a fluid line having a minimum cross-sectional area of at least 0.02 in 2 . 
     The flexible cover can, for example, be formed from a generally cylindrical layer or film of polymeric material which is sealed on an end thereof. 
     In several embodiments, the flexible cover includes a generally annular elastomeric member to maintain the flexible cover in encompassing connection with the spike. 
     In another aspect, a fluid delivery system includes a fluid bag including at least one pierceable port and a fluid connector including a spike. A fluid line in the spike has a minimum cross-sectional area of at least 0.02 in 2 . 
     In another aspect, a fluid delivery system includes a fluid connector including a fluid line and an vent line therethrough. A source of pressurized gas is in fluid connection with the vent line. 
     In a further aspect, a method of connecting a fluid connector to a pierceable container port, includes piercing the container port with an extending section including a spiked end. The extending section includes at least one air conduit and at least one fluid conduit therethrough. The extending section also includes a first abutment member and second abutment member spaced from the first abutment member. The method further includes extending the extending section through the container port so that the first abutment member abuts a first or air side of the container port and the second abutment member abuts a second or fluid sided of the container port. 
     In another aspect, a method of forming a fluid connection with a container, which includes an outlet, includes placing a stopper in connection with the outlet, the stopper including a first or air side, a second or fluid side and a passage therethrough from the first side to the second side. The method further includes providing a fluid connector in connection with the stopper. The connector includes a base which includes at least one air conduit and at least one fluid conduit therethrough. The base further includes an extending section. The extending section includes a first abutment member and a second abutment member spaced from the first abutment member. The extending section extends through the passage such that the first abutment member abuts the first side and the second abutment member abuts the second side and seals the passage. 
     In a number of embodiments, the method further includes pulling the extending section of the base through the passage in the stopper so that the second abutment member abuts the stopper. The first abutment member can, for example, extend radially outward from the extending section of the base and is spaced from the second abutment member so that upon pulling a length of the extending section through the passage, the first abutment member contacts the first side of the stopper and maintains the second abutment member in compressive and sealing abutment with the stopper. 
     In a further aspect, a method of providing fluid connection to a container, which includes an outlet, includes removably connecting a cap assembly to the outlet. The cap assembly includes an annular cap member connected to a pierceable stopper. The cap member includes an opening to provide access to the pierceable stopper and a connector section to removably connect the cap assembly to the outlet of the container. The method can further include attaching a connector member to the outlet of the container. The connector member includes a cooperating connector section to which the connector section is removably connectible. 
     In still a further aspect, a method of providing fluid flow from a connector, which includes a fluid line and an air vent line, includes connecting a source of pressurized gas to the air vent line to pressurize fluid with fluid source in fluid connection with the connector. 
     The present invention, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  illustrates an embodiment of a spike connector including a flexible and penetrable sterility cover, shield or protector packaged with a fluid container. 
         FIG. 1B  illustrates the spike connector of  FIG. 1A  removed from the package in alignment to pierce a septum of the fluid container. 
         FIG. 1C  illustrates the spiked connector of  FIG. 1A  in fluid connection with the fluid container. 
         FIG. 1D  illustrates the spiked connector of  FIG. 1A  in fluid connection with a transfer set to deliver fluid to, for example, a pumping device such as a syringe or continuous pumping device. 
         FIG. 1E  illustrates an enlarged view of the spike connector of  FIG. 1A . 
         FIG. 1F  illustrates a side view of the spiked connector of  FIG. 1A  with the flexible sterility cover removed from connection therewith. 
         FIG. 1H  illustrates another side view of the flexible sterility cover, rotated approximately 90° about its axis from the view of  FIG. 1F . 
         FIG. 1G  illustrates another enlarged view of the spiked connector of  FIG. 1A . 
         FIG. 2A  illustrates an embodiment of a system or kit including a transfer set, which includes a spike connector having a flexible and penetrable sterility shield or protector, packaged with a fluid container. 
         FIG. 2B  illustrates the system of  FIG. 2A  removed from the package with the spiked connector in alignment to pierce a septum of the fluid container. 
         FIG. 2C  illustrates the spiked connector and transfer set of  FIG. 2A  in fluid connection with the container, wherein the container is inverted to, for example, deliver fluid to a pumping device such as a syringe or continuous pumping device. 
         FIG. 2D  illustrates an enlarged view of the transfer set of  FIG. 2A . 
         FIG. 3A  illustrates an embodiment of a spike connector of the present invention including a spike having a fluid line of enlarged cross-sectional area, wherein the spike connector is in a disassembled or exploded state. 
         FIG. 3B  illustrates the spike connector of  FIG. 3A  in an assembled state. 
         FIG. 3C  illustrates the spike connector of  FIG. 3A  used in connection with a flexible and penetrable sterility cover, shield or protector. 
         FIG. 3D  illustrates the spike connector of  FIG. 3A  in alignment to penetrate a fluid container (fluid bag) and after connection with the fluid bag. 
         FIG. 4A  illustrates a container including a standard elastomeric stopper therein and two embodiments of replacement stoppers adjacent to the container. 
         FIG. 4B  illustrates an embodiment of a connector of the present invention including a sealing connector assembly which passes through a passage in an elastomeric stopper. 
         FIG. 4C  illustrates the connector of  FIG. 4B  in fluid connection with a container. 
         FIG. 4D  illustrates a fluid connector similar to that of  FIG. 4A  wherein the connector includes an exterior retainer to retain the stopper in sealing engagement with the container. 
         FIG. 5A  illustrates another embodiment of a fluid connector of the present invention in a partially disassembled state. 
         FIG. 5B  illustrates a partially transparent view of the fluid connector of  FIG. 5A  in an assembled or connected state. 
         FIG. 5C  illustrates a partially transparent view of the fluid connector of  FIG. 5A  in operative connection with a compressible stopper. 
         FIG. 5D  illustrates another view of the fluid connector of  FIG. 5A  in operative connection with the compressible stopper. 
         FIG. 5E  illustrates operation of the fluid connector of  FIG. 5A  to form a seal with an compress the compressible stopper. 
         FIG. 5F  illustrates the fluid connector of  FIG. 5A  in operative connection with a fluid container. 
         FIG. 6A  illustrates an embodiment of a fluid connector of the present invention wherein the fluid connector is positioned within a container in a non-deployed or storage state. 
         FIG. 6B  illustrates initial unsealing and deployment of the fluid connector of  FIG. 6A . 
         FIG. 6C  illustrates full deployment of the fluid connector of  FIG. 6A . 
         FIG. 6D  illustrates an enlarged disassembled or exploded view of the fluid connector of  FIG. 6A . 
         FIG. 7A  illustrates a perspective view of an embodiment of a fluid connector of the present invention. 
         FIG. 7B  illustrates a side view of the fluid connector of  FIG. 7A . 
         FIG. 7C  illustrates a rear or top view of the fluid connector of  FIG. 7A . 
         FIG. 7D  illustrates a forward or bottom view of the fluid connector of  FIG. 7A . 
         FIG. 7E  illustrates the fluid connector of  FIG. 7A  in fluid connection with a septum of stopper of a container. 
         FIG. 7F  illustrates a side, cross-sectional view of the fluid connector of  FIG. 7A . 
         FIG. 7G  illustrates another side, cross-sectional view of the fluid connector of  FIG. 7A . 
         FIG. 7H  illustrates a perspective, partially cutaway view of the fluid connector of  FIG. 7A . 
         FIG. 7I  illustrated another perspective view of the fluid connector of  FIG. 7A . 
         FIG. 7J  illustrates another side view of the fluid connector of  FIG. 7A . 
         FIG. 7K  illustrates another side view of the fluid connector of  FIG. 7A . 
         FIG. 8A  illustrates an embodiment of a system including a fluid connector and a source of pressurized gas in connection with the air line or vent of the fluid connector. 
         FIG. 8B  illustrates an embodiment of a system including a fluid connector and an gas/air compressor in connection with the air line or vent of the fluid connector. 
         FIG. 8C  illustrates an embodiment of a system including a fluid connector and a compressed gas cartridge in connection with the air line or vent of the fluid connector. 
         FIG. 9A  illustrates a side disassembled or exploded view of an embodiment of a system of the present invention including a combination container cap and stopper wherein an operator can either spike the stopper using a spiked connector or remove the cap to, for example, fill the syringe with a quick fill tube. 
         FIG. 9B  illustrates a side view of the system of  FIG. 9A  wherein threading of the system has been placed in connection with a standard container. 
         FIG. 9C  illustrates a side view of the system of  FIG. 9A  wherein the cap and stopper assembly has been placed in operative connection with the threading on the container. 
         FIG. 9D  illustrates a top view of the system of  FIG. 9A  wherein the cap and stopper assembly is in operative connection with the container and a protective covering has been removed. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     As used herein and in the appended claims, the singular forms “a,” “an”, and “the” include plural references unless the content clearly dictates otherwise. Thus, for example, reference to “a filter” includes a plurality of such filters and equivalents thereof known to those skilled in the art, and so forth, and reference to “the filter” is a reference to one or more such filters and equivalents thereof known to those skilled in the art, and so forth. 
       FIGS. 1A through 1H  illustrate an embodiment of a sterility cover, protector or shield  100  for use in connection with a fluid connector  200  (or spike connector). Fluid connector  200  includes a piercing spike  210  to pierce a septum or elastomeric stopper  310  of a fluid container or bottle  300  to place a fluid line or channel passing through spike  210  of fluid connector in fluid connection with container  200 . Fluid connector  200  also includes a check ball and air filter  220  in fluid connection with an air line or vent line passing through spike  210 . As used herein, the term “spike” refers generally to an extending section which tapers over at least a portion thereof to a generally pointed end suitable for piercing. 
     Fluid connector  200  further includes a swabable valve  230  to, for example, connect to a transfer set  400  as illustrated in  FIG. 1D . Suitable swabable valves are, for example, disclosed in U.S. Pat. No. 6,651,956 and are commercially available from Halkey-Roberts Corporation of Saint Petersburg, Fla. External surfaces in the proximity of a valve stem of swabable valve  230  are accessible to be wiped with a sterile swab. Valve  230  can, for example, connect to a first luer-type connector  410  on a first end of a transfer set  400 , which can further include flexible tubing  420  and a second luer-type connector  430  on a second end thereof. Second luer-type connector  430  can, for example, be connected to a pressurizing device  500  such as a syringe in operative connection with a powered injector (for example, a STELLANT injector available from Medrad, Inc. of Indianola, Pa.) or a continuous pump as, for example, described in U.S. Pat. Nos. 5,916,197 and 6,197,000 and illustrated in  FIG. 1D  (not to scale). 
     In the embodiment illustrated in  FIGS. 1A through 1H , flexible, protective covering or shield  100  is provided over spike  210 . Cover  100  includes a first, closed end  110  that is pierceable, tearable or breakable by spike  210 . First end  110  can, for example, be formed of a pierceable, tearable or breakable material such as a polymeric/elastomeric material or a paper material. A body or side section  112  can, for example, be formed from a flexible or collapsible material such as a polymeric film or a paper, which is connected to or formed integrally with first end  110 . As illustrated in  FIG. 1H , in one embodiment, body section was formed to be generally cylindrical and the forward end thereof (that is, the end proximate the tip of spike  210 ) was closed or sealed (for example, via heat sealing, adhesive etc.) to create closed, first end  112 . Cover  100  further includes a second end or base  120 . In several embodiments, second end  120  included a generally annular elastomeric member that attaches to spike  210  via compressive pressure applied by the elastomeric member. Cover  100  can, for example, be attached to or placed in connection with spike  210  in many different manners to retain cover  100  in connection with spike  210  (for example, via an adhesive). 
     In the embodiment of  FIGS. 1A through 1G , cover  100  is generally in the form of a closed sleeve having a diameter or cross-sectional areal only slightly larger than that of spike  210 . Forming cover  100  as a relatively close-fitting sleeve assists in ensuring that cover  100  does not interfere with the normal operation of connector  200 . 
     Protective cover  100  can be sterilized and distributed in operative connection with sterilized connector  200  in sterile packaging  600  (see  FIG. 1A ), which can, for example, also include sterilized container  300 . Protective cover  100  assists in maintaining the sterility of spike  210 , for example, after removal from package  600  and during piercing of/fluid connection with septum or stopper  310 . 
     As illustrated in  FIG. 1B , after connector  200  is removed from packaging  600 , spike  210  is aligned with septum  300  and contacted therewith. Application of force to connector  200  in a direction toward container  300  will cause spike  210  to pierce or otherwise open first end  110  of cover  100  and then pierce septum  310 . As spike  210  is forced through septum  310  and into container  300 , flexible body section  112  folds or collapses into a collapsed state as illustrated in  FIGS. 1C and 1D . During the insertion process, however, protective cover  100  maintains the sterility of spike  210 . As a further precaution, a sterilizing swab can, for example, be applied to at least second end  120  of protective cover  100  prior to contact with septum  310  if there is concern that protective cover  100  has contacted a non-sterile surface after removal from packaging  600 . 
       FIGS. 2A through 2D  illustrate another embodiment of a fluid delivery system including container  300 , a transfer set  400   a  and a fluid connector  200   a . In the embodiment illustrated in  FIGS. 2A through 2D , fluid connector  200   a  is permanently connected to or formed as an integral component of transfer set  400   a . In other respects, the fluid delivery system of  FIGS. 2A through 2D  is similar to that of  FIGS. 1A through 1G  and elements of the fluid delivery system of  FIGS. 2A through 2D  are numbered similarly to corresponding elements of the fluid delivery system of  FIGS. 1A through 1G  with the addition of the designation “a” thereto. As illustrated in  FIG. 2A , container  300 , a transfer set  400   a  and a fluid connector  200   a  can be packaged together in sterile packaging  600   a . In the illustrated embodiment, a band  450  is placed around coiled tubing  420   a  of transfer set  400   a  and tubing  420   a  is placed around the top of container  300  in packaging  600   a.    
       FIGS. 3A through 3D  illustrates another embodiment of a fluid connector  700  including a spike  710 . Spike  710  includes at least one fluid flow line, conduit or channel therethrough that has a larger diameter or cross-sectional area larger than found in currently available spiked fluid connectors. In several embodiments, spike  710  was a cannula formed from a relatively stiff material (for example, a metal, a polymeric material or other material) to facilitate a relatively thin wall and a relatively large fluid channel therein. Forming spike or cannula  710  from a metal can, for example, provide for suitable stiffness and a relatively thin wall to allow piercing of a container septum (for example, a septum of a port  310 ′ of a fluid bag  300 ′ as illustrated in  FIG. 3D ) with large diameter spike  710 . In the illustrated embodiment, a connector base  720  is in fluid connection with a male luer-type or luer connector  730  at a first end thereof. Connector base  720  is in fluid connection with spike  710  at a second end thereof. In the illustrated embodiment, a cylindrical or tubular section  740  (for example, a silicon tube section) encompasses spike  710  and acts as a guide in placing connector  700  in operative, fluid connection with port  310 ′ as illustrated in  FIG. 3D . As illustrated in  FIG. 3C , protective cover  100  can be used in connection with fluid connector  700 . 
     As described in connection with spike  710 , a number of fluid connectors of the present invention include at least one fluid flow line, conduit or channel therethrough that has a larger diameter or larger cross-sectional area than found in currently available spiked fluid connectors (for example, greater than 0.008 in 2 ). In several embodiments, the fluid line of the fluid connectors of the present invention has a minimum cross-sectional area of at least 0.010 in 2 , at least 0.016 in 2 , at least 0.020 in 2 , or at least 0.030 in 2 . The relatively large fluid line or lines can sustain flow rates of, for example, 30 mls/sec or higher using, for example, a heated (to approximately, 98.6° C.) contrast fluid having a viscosity in the range of approximately 10-12 centipoise. For example, one fluid connector of the present invention (that is, connector  1000  of  FIGS. 7A through 7K ) had a fluid line having a minimum cross-sectional area (the area in the vicinity of the fluid inlet ports) of approximately 0.038 in 2 . A sustained flow rate of greater than 30 ml/sec with a heated contrast fluid having a viscosity in the range of approximately 10-12 centipoise was achieved. A sustained flow rate of greater than 50 ml/sec with that fluid connector with water (having a viscosity of approximately 1 centipoise) was achieved. These flow rates were achieved in drawing the fluid from a container such as bottle container  300  or bag container  300 ′ under atmospheric pressure using three-valve continuous flow pump  500  (see  FIG. 1D ) as disclosed in U.S. Pat. Nos. 5,916,197 and 6,197,000, which was operated under power of a motor  510 . 
       FIGS. 4A through 4D  illustrate another embodiment of a fluid delivery system for delivery of a fluid from a container  300 . In the illustrated embodiment, container  300  includes a stopper  310  in the outlet thereof as described above. A fluid connector  800  includes a replacement stopper  810  including a passage or conduit  812  therethrough.  FIG. 4A  also illustrates an alternative stopper  810 ′ including a passage  812 ′ the generally conforms to the shape of a second abutment member  826  of fluid connector  800  discussed below. A base  820  of connector  800  can, for example, include a fluid flow line, conduit or channel (not shown) therethrough of relatively large cross-sectional area to accommodate relatively high flow rates. To place connector  800  in fluid connection with container  300 , stopper  310  is removed from container  300  and replaced with fluid connector  800 , including stopper  810 . 
     In assembling connector  800 , an extending section  822  of base  820  is passed through passage  812  in stopper  810  until a first abutment member in the form of a threaded compression sleeve  830  can form a threaded connection with threading  824  on base  820 . Connector  800  can then be placed in fluid connection with container  300  via stopper  810  with first abutment member  830  on a first or fluid side of stopper  810  and second abutment member  826  on a second or fluid side of stopper  810 . 
     In that regard, base  820  includes a wedge-shaped, lower or second abutment member  826 . The radius of base  810  increases over the length of second abutment member  826 . Rotation of threaded first abutment member  830  relative to base  820  draws second abutment member  826  within passage  812 , sealing passage  812 . The drawing of second abutment member  826  within passage  812  also causes compression of stopper  810  (which can, for example, be formed from a silicone rubber) against the inner diameter of the outlet of container  300 , thereby improving the sealed connection therewith and creating a generally leakproof seal. 
     Compression of stopper  810  by second abutment member  826  assists in retaining stopper  810  in sealing engagement with container  300  when, for example, container is inverted to deliver fluid. In an alternative embodiment illustrated in  FIG. 4D , a retainer or retaining cap  870  (including an opening  872  through which an upper potion of fluid connector  800  can pass) forms, for example, a snap fit with container  300  to assist in retaining stopper  810  in sealing engagement with container  300 , even when inverted. In the embodiment of  FIG. 4D , a second abutment member  830 ′ need only form a sealing engagement with stopper  810  (sealing passage  812 ) and need not (but may) compress stopper  810 . 
     An air filter  840  is in fluid connection with an air line (not shown) in the vicinity of and air side end of extending section  822 . An air check valve  850  is in fluid connection with the air line at an opposite end  828  (that is, the fluid side end) of the air or vent line. Inclusion of check valve  850  in air filter line reduces or eliminates the chances of liquid entering and clogging filter  840 , which can result in deterioration of the operation of connector  800 . The inclusion of check valve  850  can, for example, be beneficial if reuse of connector  800  is desired. 
     A connector  860  such as a luer-type connector is placed in fluid connection with the fluid line extending through base  820  at the end of extending section  822 . Connector  860  can, for example, be placed in fluid connection with a transfer set such as transfer set  400  described above. 
     Use of connector  800 , including replacement stopper  810 , facilitates the incorporation of relatively large fluid conduits within the connector. Such large (inner diameter) fluid conduits enable one to achieve relatively high flow rates as compared to currently available spiked fluid connectors. 
       FIGS. 5A through 5F  illustrate another embodiment of a fluid delivery system for delivery of a fluid from container  300 , which is similar in design and operation to the fluid delivery system of  FIGS. 4A through 4C . Elements of the fluid delivery system of  FIGS. 5A through 5F  are numbered similarly to corresponding elements of the fluid delivery system of  FIGS. 4A through 4C  with the addition of the designation “a” thereto. 
     Fluid connector  800   a  includes a replacement stopper  810   a  including a passage or conduit  812   a  therethrough. A base  820   a  of connector  800   a  can, for example, include a relatively large inner diameter passage, conduit or fluid line  821   a  therethrough. To place connector  800   a  in fluid connection with container  300 , stopper  310  is removed from container  300  and replaced with fluid connector  800   a , including stopper  810   a.    
     In assembling connector  800   a , an extending section  822   a  of base  820   a  is passed through passage  812   a  in stopper  810   a  until a threaded first abutment member  830   a  (which can include radially extending flanges or fins  832   a  to facilitate grasping) can form a threaded connection with threading  824   a  on base  820   a . Connector  800   a  can then be placed in fluid connection with container  300  via stopper  810   a.    
     Base  820   a  includes a second abutment member including a flange  826   a  which extends generally perpendicular to the longitudinal axis of base  820   a . As, for example, illustrated in  FIGS. 5D and 5E , rotation of first abutment member  830   a  (which abuts a first or air side of stopper  810 ) relative to base  820   a  draws second abutment member into sealing contact with stopper  810   a , further causing compression of stopper  810   a  (which can, for example, be formed from a silicone rubber) and forcing stopper  810   a  against the inner diameter of the outlet of container  300 , thereby improving the seal therewith and creating a generally leakproof seal. 
     An air filter  840   a  is in fluid connection with an air line  827   a  formed in base  820   a  in the vicinity of an end of extending section  822   a . An air check valve  850   a  is in fluid connection with air line  827   a  at an opposite end  828   a  of base  820   a . As described above, inclusion of check valve  850   a  in air filter line  827   a  reduces or eliminates the chances of liquid entering and clogging filter  840   a.    
     A connector  860   a  such as a luer-type connector or a swabable valve can be placed in fluid connection with fluid line  821   a  extending through base  820   a  at the end of extending section  822   a . Connector  860   a  can, for example, be placed in fluid connection with a transfer set such as transfer set  400  described above. 
       FIGS. 6A through 6D  illustrate another embodiment of a fluid delivery system or fluid connector for delivery of a fluid from a container such as container  300 . Similar to the fluid delivery systems or connectors of  FIGS. 4A through 5F , fluid connector  900  includes a stopper  910  including a passage or conduit  912  therethrough. A base  920  of connector  900  can, for example, include a relatively large inner diameter passage, conduit of fluid line (not shown) therethrough. To place connector  900  in fluid connection with container  300 , for example, stopper  310  can be removed from container  300  and replaced with fluid connector  900 , including stopper  910 . However, connector  900  is preferably used as the original stopper in connection with container  300  upon filling thereof with fluid, obviating the need for replacing stopper  310 . 
     In assembling connector  900 , a pull tab section  970 , which can extend through passage  912  in stopper  910 , is connected to an end of an extending section  922  of base  920 . For example, pull tab section  970  can include a connector  972  (for example, a male luer connector) and extending section  922  can include a cooperating connector  960  on an end thereof (for example, a female luer connector). Extending section  922  includes a first abutment member  925 . Base  920  further includes a second abutment member or wedge  926  which operates similarly to compression section  826  described above. In general, the radius of base  920  increases over the length of compression section  926  to generally form a wedge. 
     In deployment or activation of connector  900 , one first removes an optional sterile cover  905 . The user can then grasp a pull tab  974  of pull tab section  970  and pulls extending section  922  of base  920  through passage  912  in stopper  910 . Second abutment member  926  is thereby drawn within passage  912 , sealing passage  912  and causing compression of stopper  910  (which can, for example, be formed from a silicone rubber) against the inner diameter of the outlet of container  300 , thereby improving the seal therewith and creating a generally leakproof seal. Base  920  is drawn upward (in the orientation of  FIGS. 6A through 6C ) until first abutment member  925  is drawn through passage  912  and a lower (once again, in the orientation of  FIGS. 6A through 6C ) surface of first abutment member  925  abuts an upper surface of stopper  910 , thereby locking base  920  in the deployed or active position illustrated in  FIG. 6A . At this point, pull tab section  970  can be removed and a fluid line such as transfer set  400  can be attached to fluid connector  900  via connector  960 . 
     An air filter  940  is in fluid connection with an air line (not shown) formed in base  920  and is positioned on base  920  in the vicinity of an end of extending section  922 . An air check valve  950  is in fluid connection with the air line at an opposite end  928  of the air line. As described above, inclusion of check valve  950  in the air filter line reduces or eliminates the chances of liquid entering and clogging filter  940 . During storage of fluid connector  900  within container  300 , a removable, protective covering  942  can be placed over air filter  940  or an inlet thereto. Protective covering  942  can, for example, be formed from a polymeric film with an adhesive on one side there of to adhere to base  920  and prevents fluid from entering air filter  940  when fluid connector  900  is stored within container  300 . When fluid connector  900  is deployed (as illustrated in  FIG. 6C ), protective covering  942  is removed to allow air to enter container  300  during flow therefrom. 
       FIGS. 7A through 7K  illustrate another embodiment of a fluid connector  1000  including an extending section  1022  in the form of a tapered or pointed spike to pierce stopper  310  of container  300 . Extending section or spike  1022  includes a fluid line  1021  (see, for example,  FIG. 7F ) therethrough of relatively large cross-sectional area as described above to provide increased flow rates as compared to currently available spike connectors. Fluid line  1021  includes at least one inlet  1021   a  (two in the illustrated embodiment) via which fluid from a container such as container  300  enters the fluid line and an outlet  1060 , which can be formed as or can connect to a connector (for example, a luer connector) as described above. Extending section  1022  further includes an air or vent line  1027  (see, for example,  FIG. 7F ) therethrough including at least one outlet  1027   a.  Alternatively, a check valve  1050  can be incorporated into filter  1040  or extending section  1022 . A check valve  1050 , which is incorporated into extending section  1022 , is in fluid connection with air line  1027 . An air filter  1040  is in fluid connection with an inlet  1027   b  of air line  1027  (see, for example,  FIGS. 7C and 7F ). 
     In the illustrated embodiment, fluid line  1021  was of a generally circular cross-sectional shape. Just downstream (that is, toward outlet  1060 ) from the centerline of fluid line inlets  1021   a , extending section had an outer diameter of approximately 0.327 in. The wall thickness was approximately 0.30 in, resulting in an inner diameter D 1  of approximately 0.267 in (see  FIGS. 7G and 7H ). The cross-sectional area (that is, a minimal cross-sectional area) of fluid line  1021  at that point was calculated to be approximately 0.038 in 2 . The inner diameter of fluid line increased to a maximum inner diameter D 2  of approximately 0.375 in (see  FIG. 7G ) over the length of extending section  1022 , corresponding to a calculated maximum cross-sectional area of approximately 0.063 in 2 . The wall thickness remained generally constant at approximately 0.030 in. As described above, a sustained flow rate of greater than 30 ml/sec for a heated contrast fluid and a sustained flow rate of greater than 50 ml/sec for water were achieved through fluid connector  1000  in drawing the fluid from a container under atmospheric pressure using three-valve continuous flow pump  500 . 
     Connectors  1000  used in the above-described studies were formed from an epoxy resin in a stereolithography or SLA system. In general, connectors of the present invention can be made from a variety of material including, but not limited to, metals and/or polymeric materials. Suitable polymeric materials for connectors of the present invention include, but are not limited to, acrylonitrile butadiene styrene (ABS) and polyvinyl chloride (PVC). 
     Extending section  1022  includes a first abutment member  1030  to abut a first or air side of stopper  310  and a second abutment member  1025  spaced from first abutment member  1030  to abut a second of fluid side of a pierceable septum of stopper  310  to retain fluid connector  1000  in fluid connection with stopper  310  and container  300 . In that regard, enlargement of extending section  1022  (as compared to currently available fluid connector spikes) results is substantial force exerted by elastomeric stopper  300  upon extending section  1022  tending to push fluid connector out of connection with stopper  300 . The entrapment of a portion of stopper  310  between first abutment member  1030  and second abutment member  1025  prevents disengagement. To facilitate full connection of fluid connector  1000  with stopper  310 , wherein the pierceable portion of stopper  310  is engages on the first side thereof by first abutment member  1030  and on the second side thereof by second abutment member  1025 , fluid connector  1000  includes extending flanges  1032  to facilitate rotation or twisting of fluid connector  1000  during penetration of stopper  310 . An air side end  1060  of fluid connector  1000  can include a connector such as luer connector as described above to, for example, attach transfer set  400 . A filter (not shown) as described above can also be placed in fluid connection with the air side end of the air line. 
       FIG. 8A  illustrates the use of a source or reservoir  1100  of low pressure (but higher than atmospheric pressure) gas (for example, sterile air) in fluid connection with an air vent  1210  of a fluid connector  1200  to increase the flow rate of fluid through the fluid line (not shown) of fluid connector  1200  when fluid connector is in fluid connection with a container such as container  300 . Source  1100  can, for example, include a refill port  1110 . 
       FIG. 8B  illustrates a source of pressurized gas (for example, air) including a compressor  1100   a  in fluid connection with air vent  1210  of fluid connector  1200  to increase the flow rate of fluid through the fluid line of fluid connector  1200 . 
       FIG. 8C  illustrates a source of pressurized gas (for example, air or sterile air) including a cartridge  1100   b  in fluid connection with air vent  1210  (not shown in  FIG. 8C ) of fluid connector  1200  to increase the flow rate of fluid through the fluid line of fluid connector  1200 . Sources of pressurized gas such as described in connection with  FIGS. 8A through 8C  can be used in connection with virtually any fluid connector including an air vent line to increase fluid flow through the fluid line of the fluid connector. 
       FIGS. 9A through 9D  illustrate a system for converting a container such as bottle  300  to a container that can either be spiked using a spiked fluid connector (as, for example, illustrated in  FIGS. 1A through 3C  and  7 A through  7 D) or the cap can be removed to enable access to the fluid within bottle  300  via, for example, a quick fill tube to, for example, fill a syringe. In the illustrated embodiment, system  1300  includes a generally cylindrical or annular cap member  1310  (formed, for example, from a polymeric material) which forms a connection (for example, via a friction fit, snap fit and/or an adhesive or other bond) with a stopper member  1320 . System  1300  also includes a generally cylindrical or annular connector member  1330  (formed, for example, from a polymeric material) which includes a connection section such as a threading section that connects to the outlet section of container  300  (for example, via an overforming process or an adhesive or other bonding process) as illustrated in  FIG. 7B . An inner wall of cap member  1310  includes cooperating connecting section such as a cooperating threading section so that cap assembly  1340  (including cap member  1310  and attached stopper member  1320 ) is removably and sealingly attachable to connector member  1330 , which is attached to container  300 . System  1300  can also include a protective covering  1350  (for example, a polymeric film) to, for example, assist in maintaining sterility and to provide an indication of tampering. A pull tab  1352  can be provided to assist removal of covering  1350 . When cap assembly  1340  is attached to container  300 , and covering  1350  is removed, an upper surface of stopper member  1320  is accessible via an opening  1312  (see  FIG. 7D ) in an upper end of cap member  1310 . As described above, cap assembly  1340  can be removed from connection with container  300  by twisting cap assembly  1340  to disengage cap member  1310  from connection with connector member  1330 . 
     In many currently available containers for pharmaceuticals (such as contrast media) which include a pierceable stopper, a user can remove a metal tab from the container to remove the pierceable stopper, enabling pouring of fluid from the container or use of a fill tube (to, for example, fill a syringe). However, removal of metal tabs on currently available containers can cause a safety hazard as a result of remaining sharp metal edges. These edges can easily cut or pierce surgical gloves. In the case system  1300 , in which stopper  1320  is attached to removable cap  1310 , the stopper can be removed without worry of creating sharp metal edges. Further, if removal of cap assembly  1340  is not desirable, a user can spike stopper  1320  in the usual manner. 
     The foregoing description and accompanying drawings set forth the preferred embodiments of the invention at the present time. Various modifications, additions and alternative designs will, of course, become apparent to those skilled in the art in light of the foregoing teachings without departing from the scope of the invention. The scope of the invention is indicated by the following claims rather than by the foregoing description. All changes and variations that fall within the meaning and range of equivalency of the claims are to be embraced within their scope.