Abstract:
A fluid delivery system includes a valve device, a pump system operable to pressurize a fluid and a patient interface. The valve device includes a sealing element and defines at least a first outlet and a second outlet. The first outlet includes a first member of a connector. The pump system is operably associated with the second outlet of the valve device. The patient interface includes a second member of the connector and a tube in fluid connection with the second member. The second member of the connector is adapted to be removably connected to the first member of the connector. The first member preferably includes a resilient septum, and the second member preferably includes a penetrating member. The connector further comprises a resilient sealing element that contacts the penetrating member and one of an inner wall of the first member and an inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application is a continuation of application Ser. No. 09/507,274, filed on Feb. 18, 2000, which is a continuation of application Ser. No. 09/015,175, filed on Jan. 29, 1998, now U.S. Pat. No. 6,096,011, the contents of which are hereby incorporated by reference. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    The present invention relates to an aseptic connector or coupler and to a fluid delivery system using such an aseptic connector, and, more particularly, to an aseptic connector and fluid delivery system for use in medical procedures in which a fluid is delivered at a relatively high pressure.  
           [0003]    Aseptic connectors are commonly used in the medical arts, but most aseptic connectors are limited to use at relatively low pressures. In some medical procedures, however, it is desirable to deliver a liquid under relatively high pressures. In radiological procedures such as computer tomography (CT), for example, a liquid contrast medium is injected into a patient at pressures of approximately 300 psi. Although, there are connectors currently used at high pressures in the medical arts, such “high-pressure” connectors generally rely upon a friction fit to create a high-pressure seal and are not aseptic.  
           [0004]    As a result, it is very desirable to develop aseptic connectors and delivery systems incorporating such aseptic connectors that are suitable for use at relatively high pressures.  
         SUMMARY OF THE INVENTION  
         [0005]    The present invention provides generally an aseptic connector comprising a first member and a second member. The first member preferably includes a resilient septum, and the second member preferably includes a penetrating member. Preferably, the septum is formed from an elastomeric material such as a silicone elastomer. The penetrating member preferably includes an extending penetrating element to penetrate the resilient septum. The aseptic connector further comprises a resilient sealing element that contacts the penetrating member and one of an inner wall of the first member and an inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.  
           [0006]    The seal formed between the penetrating member and the inner wall of the first member or the inner wall of the second member is suitable for use at relatively high pressures. In that regard, the seal is preferably suitable for use (that is, will maintain a seal and not leak) at pressures of at least 100 psi. More preferably, the seal is suitable for use at pressures of at least 150 psi. Most preferably, the seal is suitable for use at pressures of at least 300 psi.  
           [0007]    The resilient sealing element preferably comprises an annular, elastomeric member that is axially compressed when the first member and the second member are brought together. The axial compression of the annular, elastomeric member causes a radial expansion which exerts radial pressure upon the penetrating member and the inner wall of the first member or the inner wall of the second member to form the seal between the penetrating member and the inner wall of the first member or the inner wall of the second member.  
           [0008]    In one embodiment, the resilient septum preferably has at least one generally circular enclosed end, which is attached to the annular, elastomeric member. The generally circular enclosed end is preferably fabricated from an elastomer such as a silicone elastomer that is preferably suitable for repeated penetration by the penetrating element. Preferably, the circular enclosed end of the septum and the annular, elastomeric member are formed integrally from such a material. The annular, elastomeric member is preferably seated in a generally cylindrical seating chamber formed in the first member. This seating chamber preferably has an inner wall having a diameter slightly greater than an outside diameter of the annular, elastomeric member. The annular, elastomeric member preferably has an inner diameter slightly greater than the outer diameter of the penetrating element. Upon axial compression of the annular, elastomeric member, a seal is formed between the penetrating element and the inner wall of the seating chamber. Preferably, the annular, elastomeric member is extended in length to have a generally cylindrical shape.  
           [0009]    In the embodiment of the previous paragraph, the penetrating member preferably includes an abutment shoulder that axially compresses the annular, elastomeric member when the first member and the second member are brought together. This abutment shoulder is preferably a radially outward extending shoulder on the penetrating member.  
           [0010]    The first member of the aseptic connector preferably further includes a first threaded section and the second member of the aseptic connector preferably includes a second threaded section. The first threaded section and the second threaded section are adapted to cooperate to securely and releasably connect the first member to the second member. The first threaded connection and the second threaded connection also assist in enabling the user to axially compress the annular, elastomeric member as the first member and the second member are brought into releasable connection.  
           [0011]    The present invention also provides a fluid delivery system comprising at least a first aseptic connector as described above. The fluid delivery system further comprises a pump system in fluid connection with one of the first member and the second member of the aseptic connector. The other of the first member and the second member is in fluid connection with the patient.  
           [0012]    The fluid delivery system preferably further comprises a dual check valve. The other of the first member and the second member is connected to a first outlet of the dual check valve. The pump system is connected to a second outlet of the dual check valve, and a source of the fluid is connected to the inlet of the dual check valve. The fluid delivery system preferably further comprises a check valve in fluid connection between the patient and the other of the first member and the second member.  
           [0013]    The fluid delivery system preferably further comprises a second aseptic connector in which one of a first member of the second aseptic connector and a second member of the second aseptic is connected to the inlet of the dual check valve. The other of the first member of the second aseptic connector and the second member of the second aseptic connector is connected to the source of the fluid. Preferably, the second aseptic connector is designed as described above.  
           [0014]    The aseptic coupler or connector of the present invention is suitable for use at relatively high pressures while being relatively simple in design and operation. The aseptic connector of the present invention is also inexpensive to fabricate, making it (or one of its first and second members) suitable for disposal after only a single use, if desired. However, the unique design of the aseptic connector of the present invention also makes it suitable for repeated use at relatively high pressures. The aseptic connector of the present invention maintains a leak proof seal at high pressures after many such uses.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]    [0015]FIG. 1 is a cross-sectional view of one embodiment of a female member of an aseptic connector of the present invention.  
         [0016]    [0016]FIG. 2 is a cross-sectional view of one embodiment of a male member of an aseptic connector of the present invention.  
         [0017]    [0017]FIGS. 3A through 3D illustrated the cooperation of the female member of FIG. 1 and the male member of FIG. 2 to form a releasable aseptic connection.  
         [0018]    [0018]FIG. 4 is a cross-sectional view of another embodiment of an aseptic connector in which the male and female members are in a disconnected state.  
         [0019]    [0019]FIG. 5 is a cross-sectional view of the embodiment of the aseptic connector of FIG. 4 in which the male and female members are in a connected state.  
         [0020]    [0020]FIGS. 6A and 6B illustrate an embodiment of a fluid delivery system incorporating the aseptic connector of FIGS. 1 through 3D. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0021]    As illustrated in FIG. 1, a first or female member  10  preferably comprises a generally cylindrical base member  15  having a passage  20  therethrough. Passage  20  is preferably in fluid connection with a seating area or chamber  25  formed within base member  15 . Seating chamber  25  preferably comprises a generally cylindrical passage having a diameter larger than the diameter of passage  20 . Seating chamber  25  is adapted to seat a flexible or resilient septum  50  therein. Septum  50  preferably comprises a generally cylindrical side portion  55  and a generally circular end portion  60 . Generally cylindrical side portion  55  and generally circular end portion  60  are preferably formed integrally from an elastomeric material, such as a silicone elastomer. The outer diameter of side portion  55  is preferably slightly less than the diameter of seating chamber  25 . Base member  15  preferably further includes a retention member  70  to retain septum  50  within seating chamber  25 . In the embodiment of FIG. 1, retention member  70  extends radially inward (with respect to axis A) around the perimeter of seating chamber  25 .  
         [0022]    Base member  15  also preferably includes a mechanism, such as threaded portion  75 , on an outside wall thereof to form a releasable connection with a second member  100 . Base member  15  preferably also comprises an extending member  80  in fluid connection with passage  20  to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached. Base member  15  is preferably fabricated from a relatively rigid polymeric material.  
         [0023]    As illustrated in FIG. 2, the connector of the present invention also comprises second or male member  100 . Second member  100  comprises a penetrating member  110 . Penetrating member  110  comprises a generally cylindrical penetrating element  115  extending from a first end thereof. A passage  120  is formed through penetrating element  115  and the remainder of penetrating member  110 . The second end of penetrating member  110  preferably forms an extending member  122  in fluid connection with passage  120  to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached.  
         [0024]    Second member  100  also preferably includes a swivel member  125  rotatably connected to penetrating member  110 . In the embodiment of FIG. 2, swivel member  125  comprises a passage  130  through which penetrating member  110  passes. In the embodiment of FIG. 2, penetrating member  110  is rotatably connected to swivel member  125  through the cooperation of an annular depression  135  formed in penetrating member  110  and a radially inward extending flange  140  on swivel member  125 . Swivel member  125  preferably further includes a threaded portion  145  on an interior surface thereof to cooperate with threaded portion  75  of first member  10 . Preferably, penetrating member  110  and swivel member  125  are fabricated from a relatively rigid polymeric material.  
         [0025]    The cooperation of first element  10  and second element  100  to form an aseptic connection is illustrated in FIGS. 3A through 3D. First member  10  and second member  100  are first drawn axially together as illustrated in FIG. 3A. As penetrating element  115  pierces flexible septum  50  (see FIG. 3B), swivel member  125  is rotated relative to base member  15  to engage threaded portions  145  and  75 . As threaded portions  145  and  75  are tightened, bringing first member  10  and second member  100  in closer contact, an abutment shoulder  150  of penetrating member  110  exerts axial force upon septum  50 . Generally cylindrical side portion  55  of septum  50  (which preferably has an inner diameter slightly greater than the outer diameter of penetrating element  115 ) is thereby compressed and exerts force generally symmetrically around penetrating element  115  and against the inner wall of seating chamber  25  to create a tight and substantially leak proof seal therebetween. The substantial axial and radial forces upon septum  50  (and the resultant seal) enable use of the aseptic connector at relatively high pressures.  
         [0026]    Upon connection of first member  10  and second member  100 , passage  20  and passage  120  are in fluid connection to allow flow of a fluid through the aseptic connector. As best illustrated in FIG. 3C, penetrating element  115  is preferably sized such that it does not directly contact any portion of first member  10  other than septum  50 . As penetrating element  115  has been exposed to the exterior environment, contact of penetrating element  115  only with septum  50  assists in preventing cross contamination between first member  10  and second member  100 . Penetrating element  115  must also be of sufficient length to extend beyond septum  50  to ensure unobstructed flow through passage  120 .  
         [0027]    As set forth above, threaded portions  75  and  145  of first member and second member, respectively, cooperate to retain first member and second member together, and to thereby maintain the tight and substantially leak proof seal of the aseptic connector. The cooperation of threaded portions  75  and  145  also acts to maintain the interior of the aseptic connector in an aseptic condition, until disengagement as illustrated in FIG. 3D. Upon disengagement, septum  50  substantially prevents leakage of fluid from first member  10 .  
         [0028]    [0028]FIGS. 4 and 5 illustrate another embodiment of an aseptic connector  150  of the present invention. Aseptic connector  150  comprises a first or female member  155  and a second or male member  175 . First member  155  is preferably generally cylindrical in shape and comprises a septum  160  enclosing one end thereof. First member  155  also preferably comprises an extending member  162  to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached. Extending member  162  has a passage  164  formed therein, which is in fluid connection with an interior  166  of first member  155 . First member  155  also preferably comprises threading  170  on an exterior wall thereof.  
         [0029]    Second member  175  comprises a penetrating member  180 . Penetrating member  180  comprises a generally cylindrical penetrating element  182  extending from a first end thereof. A passage  184  is formed through penetrating element  182  and the remainder of penetrating member  180 . The second end of penetrating member  180  preferably forms an extending member  186  in fluid connection with passage  184  to which a conduit or connector (not shown), such as flexible tubing or a luer connection, can be attached.  
         [0030]    Second member  180  also preferably includes a swivel member  190  rotatably connected to penetrating member  180  as described above. Swivel member  190  preferably includes threading  192  on an interior surface thereof to cooperate with threading  170  on first member  155 . Second member  175  also preferably includes opposing wing elements  194  extending radially outward therefrom to facilitate rotation of second member  175  relative to first member  155  to form a threaded connection of first member  155  and second member  175 .  
         [0031]    The cooperation of first member  155  and second member  175  to form an aseptic connection is illustrated in FIGS. 4 and 5. As discussed above in connection with first member  10  and second member  100 , first member  155  and second member  175  are first drawn axially together. As penetrating element  182  pierces flexible septum  160 , swivel member  190  is rotated relative to first member  155  to engage threaded portions  170  and  192 . As threaded portions  170  and  192  are tightened, bringing first member  150  and second member  175  into closer contact, a forward surface  172  of first member  155  contacts an annular, elastomeric member  196  seated in a generally cylindrical interior chamber  198  of second member  175 . Annular, elastomeric member  196  is thereby compressed generally symmetrically around penetrating member  180  and against the inner wall of swivel member  190  to create a tight and substantially leak proof seal between penetrating member  180  and the interior wall of swivel member  190 . As discussed above, the substantial axial and radial forces upon annular, elastomeric member  196  (and the resultant seal) enable use of aseptic connector  150  at relatively high pressures.  
         [0032]    [0032]FIG. 6A illustrates an embodiment of a fluid (for example, contrast media) delivery system  200  incorporating an aseptic connector as described in FIGS. 1 through 3B. As recognized by one skilled in the art, aseptic connector  150  of FIGS. 4 and 5 is equally suitable for use in fluid delivery system  200 . Other fluid delivery systems in which the aseptic connector of the present invention can be used are discussed U.S. Pat. No. 5,569,181, the disclosure of which is incorporated herein by reference.  
         [0033]    Delivery system  200  preferably includes a disposable patient interface  300  in releasable fluid connection with an outlet  360  of a pumping system, such as a manual or injector-powered syringe  350 . An example of a powered injector and syringe suitable for use in the present invention is described in U.S. Pat. No. 5,383,585, the disclosure of which is incorporated herein by reference. Other pumping systems, such as rotary pumps and gear pumps, are also suitable for use in the present invention.  
         [0034]    In the embodiment of FIG. 6A, disposable patient interface  300  preferably comprises an IV catheter  310 . IV catheter  310  is preferably in fluid connection with a check valve  320  or other suitable means to ensure unidirectional flow of the medium into the patient. Check valve  320  is in fluid connection with flexible tubing  330 . Flexible tubing is preferably in fluid connection with extending member  122  of male member  100  of the aseptic connector.  
         [0035]    Female member  10  of the aseptic connector is preferably in fluid connection with powered syringe  350 . In the embodiment of FIG. 6A, female member  10  is in fluid connection with a first outlet  410  of dual check valve  400  via extending member  80  of female member  10 . A second outlet  420  of dual check valve  400  is preferably in releasable fluid connection with syringe  350  via, for example, a luer connection. Inlet  430  of dual check valve  400  is preferably in fluid connection with female member  10 ′ of a second aseptic connector of the present invention via extending member  80 ′ thereof.  
         [0036]    Female member  10 ′ is preferably in releasable fluid connection with a disposable source of contrast medium  500 . In that regard, a male member  100 ′ is preferably in fluid connection with a contrast container  505 . In the embodiment of FIGS. 6A and 6B, male member  100 ′ is in fluid connection with the first end of a length of conduit  510  via extending member  122 ′. The second end of conduit  510  is in fluid connection with a spike  520  designed to penetrate a septum (not shown) of container  505 , as known in the art.  
         [0037]    During an injection procedure, plunger  355  of syringe  350  is first drawn rearward (toward powered injector  360 ). The negative pressure created within syringe  355  causes a valve of inlet  430  of dual check valve  400  to open and contrast medium to flow into syringe  350  from contrast container  505  via second outlet  420 . Concurrently, the negative pressure within syringe  350  causes a valve of second outlet  410  to remain closed.  
         [0038]    After a desired amount of contrast medium is drawn into syringe  350 , plunger  355  is advanced forwardly (away from powered injector  360 ) to create a positive pressure within syringe  350  and thereby inject contrast medium into the patient. The positive pressure within syringe  350  causes the valve of inlet  430  of dual check valve  400  to close and the valve of second outlet  410  to open, thereby allowing the contrast medium to be injected into the patient via disposable patient interface  300 .  
         [0039]    As best illustrated in FIG. 6A, the releasable nature of the aseptic connector of the present invention allows male member  100  to be disconnected from female member  10  so that disposable patient interface  300  may be discarded, preferably after each injection procedure. The disposable nature of patient interface  300  assists in preventing cross contamination between patients.  
         [0040]    Likewise, male member  100 ′ is disconnectable from female member  10 ′. Fluid source  500 , including contrast container  505 , conduit  510  and male member  100 ′, can thus be discarded when contrast container  505  is emptied. Dual check valve  400  can be reused with a new contrast container  505  and a new male member  100 ′ if so desired.  
         [0041]    Syringe  350  can be released from dual check valve  400  so that syringe  350 , dual check valve  400  and female members  10  and  10 ′ attached thereto can be discarded periodically. For example, syringe  350 , dual check valve  400  and female members  10  and  10 ′ can be discarded daily or after a certain number of injection procedures, such as, for example, 6-8 procedures, have been completed during the day. When more than one injection procedure is performed before dual check valve  400  and female members  10  and  10 ′ are discarded, septums  50  and  50 ′ are preferably cleaned using an aseptic technique between procedures by, for example, wiping septums  50  and  50 ′ with alcohol to reduce the likelihood of contamination.  
         [0042]    As also clear to one skilled in the art, configurations other than set forth in FIGS. 6A and 6B are possible. For example, conduit  510  can be connected directly to inlet  430  of dual check valve  400  without an intermediate releasable aseptic connection. In that embodiment, container  505 , conduit  510 , dual check valve  400 , and female member  10  are preferably discarded periodically as a unit. For example, those components may be discarded daily or upon emptying of container  500 . Once again, septum  50  is preferably cleaned using an aseptic technique between injection procedures.  
         [0043]    Although the present invention has been described in detail in connection with the above examples, it is to be understood that such detail is solely for that purpose and that variations can be made by those skilled in the art without departing from the spirit of the invention. The scope of the invention is indicated by the following claims rather than by the foregoing description. All changes to the present invention that fall within the meaning and range of equivalency of the claims are to be embraced within their scope.