Abstract:
A medical connector is described which is formed by a body having an inlet port, an outlet port through a male luer portion of the body, and a fluid path between the inlet port and the at least one outlet ports. A retractable post extends through the fluid path in the male luer sealing a tip of the male luer thereby closing the fluid path when the connector in not activated. Barbs extending along the exterior of the male luer and connected to the retractable post, wherein when the connector is activated, the barbs force the retractable post away from the tip of the male luer thereby opening the fluid path through the medical connector. A retention member applies force to the post to force the post to seal the tip of the male luer with the medical connector is not activated.

Description:
TECHNICAL FIELD 
     The present invention relates to medical connectors used in fluid delivery applications, and more specifically to connectors that minimize fluid leakage during connection and disconnection. 
     BACKGROUND OF THE INVENTION 
     Medical connections are widely used in fluid delivery systems such as those used in connection with intravenous fluid lines, blood access, hemodialysis, peritoneal dialysis, enteral feeding, drug vial access, etc. Many prior art aseptic medical connections have been designed to puncture an elastomeric diaphragm or septum, which has one side in contact with the fluid, with a sharpened hollow hypodermic needle. The use of such hypodermic needles has been gradually decreasing as a result of both safety and cost considerations associated with infectious disease acquired from needle sticks. These connectors have been replaced with luer activated connectors which don&#39;t require hypodermic needles, but instead use an activator such as a luer on the end of a syringe or IV line to create a fluid path though a valve in a connector. The removal of the connector causes the valve to close when the line is disconnected. Such a system is described in U.S. Pat. No. 5,569,235 to Ross et al. 
     Typical connectors and valves of this type, such as described by Ross, have many attributes that are not ideal in medical applications for delivery of fluids that could be harmful if contacted by the health care provider or the patient other than through the patient&#39;s intravenous (“IV”) connection. Oncology drugs such as chemotherapy are examples of fluids that while beneficial to the patient as part of a treatment regimen could be extremely harmful to the health care provider if the chemotherapy drug were to come into contact with the skin of the health care provider or patient. 
     Traditional medical connectors require the health care provider to exercise great care on connection or disconnection due to the likelihood of the drug remaining inside the connector or dripping, particularly on disconnection when the connectors are primed with fluid. Some female connectors are designed to push fluid in the throat of the connector to the surface during disconnection. While this is desirable for aseptic connectors to provide a swabbable surface, it can result in fluid drips from the device on disconnection. Other connectors use a membrane with a septum that can also allow fluids to escape the connector. 
     What is needed is a connector for medical fluids that has standardized connections for use with existing medical connectors and also minimizes or eliminates drips on connection or disconnection. 
     BRIEF SUMMARY OF THE INVENTION 
     Embodiments of the concepts described herein describe a medical connector which is formed by a body having an inlet port, an outlet port through a male luer portion of the body, and a fluid path between the inlet port and the at least one outlet ports. A retractable post extends through the fluid path in the male luer sealing a tip of the male luer thereby closing the fluid path when the connector in not activated. Barbs extending along the exterior of the male luer and connected to the retractable post, wherein when the connector is activated, the barbs force the retractable post away from the tip of the male luer thereby opening the fluid path through the medical connector. A retention member applies force to the post to force the post to seal the tip of the male luer when the medical connector is not activated. 
     In another embodiment of the concepts described herein a method for activating a medical connector is described. The medical connector includes a body having an inlet port and an outlet port the outlet port being part of a male luer. The connector further includes a post extending through a flow channel in the male luer and one or more barb arms connected to the post and adjacent to an outer surface of the male luer. The method includes inserting the male luer of the medical connector into a female luer of a secondary device, engaging the barb arms of the medical connector with a surface of the female luer, and retracting the post from the outlet port of the medical connector in response to the engagement of the barb arm with the female luer, wherein the retraction of the post from the outlet port opens a fluid path through the medical connector. 
     In another embodiment a closed male luer medical connector is described which includes a body formed by a top and a base, the body having an internal cavity and flow channels formed in walls of the internal cavity, the body further having an inlet port and an outlet port, the outlet port including a male luer, wherein the male luer defines a flow channel along its length. The connector also includes a body having a top in the internal cavity of the body; a post extending from the top and having a portion that extends the length of the flow channel, a tip of the post sized to seal the male luer thereby closing the flow channel when the post is fully extended into the male luer, the post further comprising one or more barb arms extending through vent holes in the body and adjacent to an external surface of the male luer, and an elastic cup, the elastic cup having a seating ring held in a fixed position by the body and a cup extending into the internal cavity and receiving the top of the post. Pressure applied to the barb arms in a direction parallel to the male luer and away from the outlet port results in the top of the body being forced up into the internal cavity and the post being drawn out of the outlet port, thereby unsealing the male luer, opening the flow channel through the medical connector. The elastic cup applies tension to the post body, the tension forcing the post back into the sealed position when the force on the barb arms is removed. 
     The foregoing has outlined rather broadly the features and technical advantages of the present invention in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the invention will be described hereinafter which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the invention as set forth in the appended claims. The novel features which are believed to be characteristic of the invention, both as to its organization and method of operation, together with further objects and advantages, will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a more complete understanding of the present invention, reference is now made to the following descriptions taken in conjunction with the accompanying drawing, in which: 
         FIG. 1  is a side view of an embodiment of a male luer medical connector for fluid delivery according to the concepts described herein; 
         FIG. 2  is an exploded view of the embodiment of a male luer medical connector shown in  FIG. 1 ; 
         FIGS. 3A and 3B  are side views of an embodiment of the base of the male luer medical connector shown in  FIG. 2   
         FIG. 3C  is a perspective view showing the outlet port of an embodiment of the base of the male luer connector shown in  FIG. 2 ; 
         FIG. 4  is a sectional view of an embodiment of the top of the male luer medical connector show in  FIG. 2 ; 
         FIG. 5  is a side view of an embodiment of the barb of the male luer medical connector shown in  FIG. 2 ; 
         FIG. 6A  is a section view of the male luer medical connector from  FIG. 1 ; 
         FIG. 6B  is a section view of the male luer medical connector shown in  FIG. 1  rotated 90° along its longitudinal axis from the view in  FIG. 6A ; 
         FIG. 7  is a sectional view of the male luer medical connector from  FIG. 1  illustrating the relationship between the male luer of the medical connector and a female luer connector and the fluid path through the connector; 
         FIGS. 8A and 8B  are sectional views of the male luer medical connector from  FIG. 1  illustrating the barb engaging the female luer connector and opening the fluid path through the connector; 
         FIG. 9  is a sectional view of the medical connector from  FIG. 1  illustrating an alternative mechanism for opening the fluid path through the connector; and 
         FIGS. 10A-10D  are alternate embodiments of a male luer medical connector according to the concepts described herein. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to  FIG. 1 , an embodiment of a medical connector  100  in accordance with the concepts described herein is shown. Medical connector  100  operates as a needleless access device and has a body  101  with a female access port  102  and a male lure  103 . The male luer  103  is ISO compatible and compliant and interfaces with standard needless access devices. Medical connector  100  differs from access devices in that male luer  103  is closed, thereby preventing any fluid flow or leakage until activated by being inserted into a female luer. While connector  100  is shown with a threaded female luer at its distal end any type of inlet port could be used while remaining within the concepts described herein. Such inlet ports could include know connections for any type of fluid delivery sources or devices such as IV fluid bags, pumps or the like. 
     As with traditional needleless medical connectors, male luer  103  of medical connector  100  is inserted into the female luer of another needleless access device to create a fluid path between a fluid delivery mechanism and a patient. In order to avoid drips and leakage of medical fluids that may be harmful to health care providers or patients, medical connector  100  is designed to minimize or eliminate fluid drips or leakage upon connection of medical connector  100  with another access device, or particularly upon disconnection from another access device with both devices are primed with fluid. 
     Referring now to  FIG. 2 , the embodiment of the medical connector  100  shown in  FIG. 1  is shown in an exploded view. Embodiments of the components that form medical connector  100  shown. The body of medical connector  100  includes top  204  having an inlet port  202  and a base  208 , which includes outlet port  203 . The medical connector also includes an elastic cup  205  formed from an elastic deformable material, a barb  206 , and a sealing ring  207 . 
     Top  204  can form a majority of the body of medical connector  100 . Top  204  includes threaded female luer  209  which connects to the male luer of any other compatible device. Female luer  209  can be threaded to maintain the connection between devices. While connector  209  is shown as having a threaded female luer type connector, any type of inlet port could be used, such as a bond pocket or other connector, while remaining within the scope of the concepts described herein. Top  100  can also include ridges  210  along the outer surface of top  204 . Ridges  204  provide for enhanced gripping surfaces when twisting forces are applied to medical connector  100  during connection and disconnection with other devices. Top  204  also includes cavity  223  which holds elastic cup  205  and barb  206  as will be described. 
     Elastic cup  205  is formed from an elastic deformable material allowing it to stretch and then return to its original state. Elastic cup  205  fits into cavity  223  of top  204  and includes cup cavity  224  for receiving top  212  of barb  206 . Seating ring  211  is used to hold elastic cup  205  between top  204  and base  208 . 
     Barb  206 , which may also be referred to as a post body, is used to open and close the fluid path through medical connector  100  as will be described. Additional reference is made to  FIG. 5  in the description of barb  206 . Barb  206  includes top  212  which fits into elastic cup  205 . Barb arms  213   a  and  213   b  extend downward from the radial edge of top  212  and engage a surface of an activating connector. Sealing ring seat  214  receives sealing ring  207 , which is held in place by flange  215 . Post  216  extend downward from the center of top  212  parallel to barb arms  213   a  and  213   b . Post  216  includes tapered end  217  which mates with the end outlet port  203  in base  208 . Bumps  218  arranged around the circumference of post  216  keep post  216  centered in base  208  and provide space for fluid to flow around post  216  of barb  206 . 
     Base  208  mates with top  204  thereby holding elastic cup  205 , barb  206  and sealing ring  207  in cavity  223  of top  204 . Top  204  is secured to the base  208  using conventional means, such as solvent bonding, ultrasonics, spin welding, etc. Base  208  includes channel  225  which receives post  216  of barb  206 . 
     Referring additionally to  FIGS. 3A and 3B  which show side views of an embodiment of base  208  from  FIG. 2 , base  208  will be described in greater detail. Base  208  includes channel  225  which receives post  216  of barb  206 . Sealing ring seat  219  engages the bottom surface of seating ring  211  to hold elastic cup  205  in place when medical connector  100  is assembled. Seating surface  221  mates with a corresponding surface (not shown) in top  204  to seal medical connector  100  except for the proscribed fluid path. Flow channels  220  allow for fluid flow through the base and into outlet port  203 . While two channels are shown in base  208 , any number of channels, including one or three or more, can be used without departing from the scope of the concepts described herein. Base  208  also includes male luer  226  and threaded connector  222 . 
       FIG. 3C  shows a perspective view of an embodiment of base  208  illustrating the outlet port end of base  208 . As described, male luer  226  extends down through threaded connector  222  and includes the outlet port  203  of the fluid path though the connector. Channels  334  are formed in the end of male luer  226  to aid in the suction characteristics and fluid retraction of the connector upon disconnection as will be described in greater detail below. Channels  334  assist in the retraction of fluid upon disconnect by directing fluid into tapered end  217  of outlet port  203  throughout the disconnection process. 
     Referring now to  FIG. 4 , an embodiment of top  204  is shown in a sectional view. As described, top  204  includes an inlet port  202  for receiving the male luer of another compatible device. As described with respect to  FIG. 2 , cavity  223  receives elastic cup and barb, and as will be discussed, provides room for barb  206  from  FIG. 2  to move longitudinally within cavity  223 . Cavity  223  also includes flow channels  327  molded into the internal walls of cavity  223 . While the flow channels  223  are shown symmetrically spaced around the internal wall of cavity  223 , any number, size, spacing or configuration of flow channels could be used without departing from the scope of the concepts described herein. 
     The internal surface of cavity  223  of top  204  also includes elastic cup seat  328  which works cooperatively with seating ring seat  219  of base  208 , shown in  FIGS. 3A and 3B  to hold seating ring  211  of elastic cup  205  in place when the medical connector is assembled. Base seat  329  mates with seat  221  from  FIGS. 3A and 3B  to assemble and seal top  204  to base  208 . 
     Referring now to  FIGS. 6A and 6B , an embodiment of a medical connector  100  is shown assembled in section view.  FIG. 6B  is a sectional view of the medical connector shown in  FIG. 6A  rotated 90° around its longitudinal axis. As has been described, a preferred embodiment of medical connector  100  is formed by the assembly of top  204  to base  208 . Within the cavity  223  formed by top  204  and base  208 , barb  206  and elastic cup  205  are housed. Sealing ring  207  fits into sealing ring seat  214 . 
     Top fluid path  650  communicates with junction fluid path  651  and base fluid path  652 , using channel  220 , before arriving at post fluid path  653  which is in communication with outlet port  203  in male luer portion  226  of connector  100 . Unlike other similar medical connectors in which the fluid path flows directly from an inlet port through a channel inside a post and out the end of the outlet port in a male luer, fluid paths  650 ,  651 ,  652 , through  653  channel flow around elastic cup  205 , through channel  220  in base  208  and around post  216  of barb  206 . This fluid path allows for the sealing of male luer  226  using tapered end  217  of post  216 . 
     Top  212  of barb  206  fits into the cavity created by elastic cup  205 . A ridge, or seating surface  328  formed in the inner wall of top  204  between the flow channels mates with the top surface of seating ring  211 , while the bottom surface of seating ring  211  mates with seating ring seat  219  in base  208 . When assembled seating ring  211  of elastic cup  205  is held firmly in place between top  204  and base  208 . Cup portion  648  of elastic cup  205  may deform or stretch up into cavity  223  of top  204 . 
     Cup portion  648  also acts to place tension on barb  206 , acting to force barb  206  toward base  208  which acts to force tapered end of post  216  into tapered channel  647  of male luer  226 . When tapered end  217  is pressed into tapered channel  647 , male luer  226  is blocked, thereby preventing fluid flow through medical connector  100 . 
     Referring specifically to  FIG. 6B , it can be seen that the embodiment of base  208  shown includes vent holes  646   a  and  646   b . Barb arms  213   a  and  213   b  extend downward through vent holes  646   a  and  646   b  and protrude into the cavity forming threaded connector  222 . Sealing ring  207  prevents fluid in fluid path  652  from flowing up and into vents  646   a  and  646   b.  As will be discussed below, barb arms  213   a  and  213   b  can be engaged by a surface of a male luer to push barb  206  and cup  648  up into cavity  223  extracting tapered end  217  of post  216  from tapered channel  647  of male luer  226  and thereby opening the flow path through medical connector  100 . 
     Referring now to  FIG. 7 , a sectional view of the embodiment of medical connector  100  shown in  FIG. 1  is described in relation to a complimentary connector  700 . Medical connector  100 , in accordance with the concepts described herein, includes a closed male luer that prevents fluid flow until activated by insertion into a complimentary female luer connector. As described, elastic cup  205  places a positive pressure on barb  206 , thereby keeping tapered end  217  of post  216  firmly seated in male luer  226  of base  208 . Barb arms  213   a  and  213   b  extend through vent holes  646   a  and  646   b , respectfully, and into the cavity form by connector  222 . 
     Female connector  700  includes female luer  703  which includes threaded connector  704  and top surface  701 . As can be seen, when female connector  700  is threaded onto medical connector  100  such that male luer  226  engages with female luer  703 , top surface  701  of female connector  700  will engage the bottom surfaces  702   a  and  702   b  of barb arms  213   a  and  213   b , respectively. As female connector  700  continues to be threaded into medical connector  100 , the engagement of top surface  701  with barb arms  213   a  and  213   b  will force barb  206  up into medical connector  100 , elongating elastic cup  205 . 
     Referring now to  FIGS. 8A and 8B , sectional views of the embodiment of medical connector  100  shown in  FIG. 1  are shown activated by the complimentary connector  700  of  FIG. 7 . The term activate or activated, as used herein has the same meaning a connected or engaged, while the term deactivated has the same meaning as disconnected or disengaged. As described with reference to  FIG. 7 , when male luer  226  is activated by female connector  700  by inserting male luer into female connector  700 , top surface  701  of female connector  700  engages barb arms  213   a  and  213   b  of barb  206 . As barb  206  is pushed upward into cavity  223  of top  204 , seating ring is held in place between the opposing surfaces of top  204  and base  208  while cup  648  of elastic cup  205  stretches to accommodate the rise of barb  206 . The rise of barb  206  results in the rise of post  216  causing tapered end  217  to disengage from tapered channel  647  creating an open fluid path from medical connector inlet port through outlet port  203  and into female connector  700 . The deformation of elastic cup  205  provides tension on barb  206  so that when female connector  700  is removed from male luer  226 , the force supplied by elastic cup  205  causes barb  206  to return to the closed position with tapered end of post  216  again sealing tapered channel  647  of male luer  226 . 
     The fluid path when medical connector  100  is engaged with female connector  700  can be seen clearly in  FIG. 8B  with reference to elements in  FIG. 8A . In the open fluid path configuration, fluid enters through inlet port  202  and flows into cavity  223  of top  204 . Fluid continues in top fluid path  650  which flows through flow channels  327  as described with respect to  FIG. 4 . Fluid continues through junction fluid path along flow channels  330  also described with respect to  FIG. 4  and then into channels  220  through base  208  into fluid path  652 . From channels  220  and fluid path  652 , the fluid continues through post fluid path  653  which extends the along the length of male luer  226  between the inner surface of the male luer and post  216  of barb  206 . Fluid then exits out of outlet port  203  through tapered channel  647  and flows into female connector  700 . 
     As can be seen from  FIGS. 8A and 8B , activation or connection of medical connector  100  to another device causes post  216  to push elastic cup  205  up into cavity  223  thereby decreasing the volume of cavity  223 . Upon deactivation or disconnection, the opposite occurs, cup  205  returns to its original state increasing the volume of cavity  223 . This increase in the volume of cavity  223  has advantageous effects on the operation of medical connector  100 . Namely, the increase in the fluid volume held by medical connector  100  at disconnection provides a suction force, or negative displacement force on the fluid on male luer  226 , thereby drawing the fluid out of male luer  226  and into medical connector  100 . Channels  334  in the end of male luer  226 , as shown in  FIG. 3C  provide a path for the suction force and fluid retraction into outlet port  203  as the connector is being disengaged. Without channels  334 , the tip of male luer  226  could be closed by the receiving device until the moment of complete separation possibly preventing the fluid retraction before that moment. 
     This suction acts to clean any fluid in the vicinity male luer opening, preventing leaks or drops escaping from the medical connector at disconnection, which is very important when working with blood or potentially harmful medicines such as those used in chemotherapy. Traditional connectors have required medical professionals to clamp a line in the system to prevent leakage upon disconnection. Such clamping, while potentially beneficial in that it would prevent the suction created by the increase in fluid volume at disconnection from drawing fluid from the source line, is not necessary with embodiments of connectors as described herein to prevent leakage or dripping. 
     Referring now to  FIG. 9 , and alternate embodiment of a female connector for activating a closed male luer medical connector  100  according to the concepts describe herein is shown. While  FIGS. 8A and 8B  demonstrate a closed male luer medical connector according to the concepts described herein being opened using the bard arms of barb  206  from  FIG. 2 , female connector  900  may also include a spike to cause activation of the closed male luer. Spike  901  engages bottom surface  902  of post  216  moving post  216  away from tapered channel  647 . Spike  901  includes inlet ports  903  which allow fluid from medical connector to flow into channel  904  in spike  901 . 
     While medical connector  100  shown in  FIGS. 2-9  uses the elastic nature of elastic cup  205  to force barb  206  into a closed position when not engaged with a female connector, other mechanisms may be used to accomplish the same purpose without departing from the concepts described herein.  FIGS. 10A-D  illustrate embodiments of other medical connectors that use other mechanisms to force the post into a sealing position. 
       FIG. 10A  shows an embodiment of a medical connector  1001  that replaces the elastic cup with a rigid cup  1002  and uses spring  1003  to provide the force against post  1004 . Connector  1001 , by using a rigid cup will providing a constant priming volume.  FIG. 10B  shows a connector  1010  that uses an inverted bellows valve  1011  to provide the elastic force on post  1012 . Slits  1014  in inverted bellows valve  1011  allow fluid to pass through and in to the fluid path. Additional seal  1013  is required to prevent fluid from flowing into the vent holes in the base. 
       FIG. 10C  shows a embodiment of a medical connector  1020  substantially as described with respect to  FIG. 10B  except that the inverted bellows valve is replaced with an inverted helix spring  1021 .  FIG. 10D  shows an alternate embodiment of a bellows valve. Medical connector  1030  uses a bellows valve  1031  as was described with respect to  FIG. 10B  to provide the elastic force on post  1033 . However, instead of using slits and passing the fluid through the bellows valve, connector  1030  includes a seal  1032  which directs the fluid over and around bellows valve  1031  and into the fluid path through connector  1030 . 
     The top, base and barb elements are preferably formed from polycarbonate plastic but could be formed from any number of materials appropriate for medical connectors. The elastic cup and the bellows described herein are preferably made from medical grade silicon, but can be made from any material that has the characteristics described with respect to those elements. The female connector used with a medical connector according to the concepts described herein may be any type of female connector such as those having a valve plug arrangement, bellows type plugs, devices with septums, or other configurations designed to accept standardized male luer connectors. 
     Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.