Patent Publication Number: US-2021178144-A1

Title: High flow, needleless connector

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority of provisional application Ser. No. 62/948,546 filed Dec. 16, 2019, entitled HIGH FLOW, NEEDLELESS CONNECTOR, the details of which are incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present application relates to needleless connectors, also referred to as intermittent injection port assemblies, used to provide safe connections for infusion of IV fluids, antibiotics, lipids, blood, blood components or drug products and/or blood aspiration in intravenous and blood administration therapies. 
     2. Description of the Prior Art 
     One type of needleless connector that is known in the art uses an internal valve member having a hollow cannula which pierces a slit in a flexible valve member as the flexible valve member is axially compressed. One example of connectors of this type is seen in Ryan U.S. Pat. No. 9,925,365. 
     A second type of known needleless connector uses a flexible valve member that is laterally displaced when it is moved to an open position. One example of connectors of this type is seen in Werschmidt U.S. Pat. No. 5,782,816. 
     There is a continuing need in needleless connectors of both of these types for improvements that allow for improved performance, and for less expensive methods of construction. 
     SUMMARY OF THE INVENTION 
     In one embodiment an injection port assembly includes a body including a first mating structure and a second mating structure configured to be coupled to the first mating structure. The body has a central body axis extending from a distal body end defined on the first mating structure to a proximal body end defined on the second mating structure. The first mating structure includes an annular wall defining an open proximal end of the first mating structure facing toward the proximal body end. A male luer connection includes an axial passage extending from a distal end of the male luer connection toward the proximal body end. A base is centered on the body axis and at least partially blocks the axial passage. A plurality of circumferentially spaced ribs extend from the annular wall to the base and define a plurality of transverse passages between the circumferentially spaced ribs. The transverse passages communicate with the axial passage of the male luer connection. The second mating structure includes a female luer connection configured to receive a male luer fitting, such as a syringe or IV line. The second mating structure has an interior communicating the female luer connection with the open proximal end of the first mating structure. A flexible valve member is mounted on the base of the first mating structure and has a proximal valve end portion configured to be sealingly received in the female luer connection of the second mating structure when the flexible valve member is in a closed position. The flexible valve member is configured to be displaced relative to the central body axis upon entry of the male luer fitting into the female luer connection to thereby place the male luer fitting in communication with the interior of the second mating structure. 
     In another embodiment the injection port assembly includes a body including a first mating structure and a second mating structure configured to be coupled to the first mating structure. The body has a central body axis extending from a distal body end defined on the first mating structure to a proximal body end defined on the second mating structure. The first mating structure may include an outer wall defining an open proximal end of the first mating structure facing toward the proximal body end. An inner cylindrical surface may extend distally from the open proximal end of the first mating structure. The inner cylindrical surface may have a first inner diameter. A male luer connection may be connected to the outer wall and extend distally to a free end. The male luer connection may include an axial passage, the axial passage having a second inner diameter smaller than the first inner diameter. A base may span the body axis and be supported from the outer wall. The base may be located axially between the open proximal end of the first mating structure and the axial passage of the male luer connection. A plurality of transverse passages partially frusto-conical in shape tapering from the first inner diameter of the inner cylindrical surface to the second inner diameter of the axial passage of the male luer connection may bypass the base and communicate the inner cylindrical surface with the axial passage of the male luer connection. The second mating structure may include a female luer connection configured to receive a male luer fitting. The second mating structure may have an interior communicating the female luer connection with the open proximal end of the first mating structure. A flexible valve member may have a proximal end portion configured to be sealingly received in the female luer connection of the said second mating structure when the flexible valve member is in a closed position. The flexible valve member may be configured to be laterally displaced relative to the central body axis upon entry of the male luer fitting into the female luer connection to thereby place the male luer fitting in communication with the interior of the second mating structure. 
     In any of the above embodiments the first mating structure may include a centering recess defined in the base and facing the proximal body end. The flexible valve member may include a distal end having a central protrusion received in the centering recess. 
     In any of the above embodiments each rib may include a proximal end face sloping distally from a radially outer end of the rib to a radially inner end of the rib attached to the base, so that the proximal end faces of the ribs define a tapered guide for guiding a distal end of the flexible valve member into engagement with the base. 
     In any of the above embodiments the axial passage of the male luer connection may have an inside diameter, and the base may have an outside diameter substantially equal to the inside diameter of the axial passage of the male luer connection. 
     In any of the above embodiments the second mating structure may include an annular radially inner distally facing step. The open proximal end of the first mating structure may about the distally facing step of the second mating structure when the first and second mating structures are coupled together. One of the distally facing step of the second mating structure and the open proximal end of the first mating structure may include an annular groove, and the other of the distally facing step of the second mating structure and the open proximal end of the first mating structure may include an annular ridge received in the annular groove to provide a seal between the first and second mating structures. 
     In any of the above embodiments an O-ring seal may be provided between the first and second mating structures for additional sealing functionality. 
     In any of the above embodiments the first mating structure may include an inner cylindrical surface extending distally from the open proximal end of the first mating structure, the inner cylindrical surface having a first diameter. The axial passage of the male Luer connection may have a second inner diameter smaller than the first inner diameter. The transverse passages may be partially frusto-conical in shape tapering from the first inner diameter to the second inner diameter. 
     In any of the above embodiments the base may have a base outside diameter substantially equal to the second inside diameter. 
     In any of the above embodiments the first and second mating structures may be first and second integrally molded plastic parts, respectively. 
     In any of the above embodiments a threaded connection may be provided between the first and second mating structures, and a ratchet lock may be provided to prevent unthreading of the threaded connection after the first and second mating structures are coupled together by the threaded connection. 
     In another embodiment an injection port assembly includes a body including a first mating structure and a second mating structure configured to be coupled to the first mating structure. The body may have a central body axis extending from a distal body end defined on the first mating structure to a proximal body end defined on the second mating structure. The first mating structure may include a first mating structure proximal end, a radially outer proximally facing step, an external thread located between the first mating structure proximal end and the radially outer proximally facing step, and a first annular ratchet portion. The second mating structure may include an annular radially inner distally facing step, a second mating structure distal end, an internal thread located between the second mating structure distal end and the radially inner distally facing step, and a second annular ratchet portion. The first and second mating structures may be configured to be coupled together by engagement of the internal thread with the external thread such that the first and second annular ratchet portions prevent disengagement of the internal thread from the external thread after the first and second mating structures are coupled together. 
     The first mating structure proximal end may abut the annular radially inner distally facing step of the second mating structure when the first and second mating structures are coupled together. One of the annular radially inner distally facing step of the second mating structure and the first mating structure proximal end may include an annular groove, and the other may include an annular ridge received in the annular groove to provide a seal between the first and second mating structures. 
     In another embodiment an injection port assembly includes a body including a first mating structure and a second mating structure configured to be coupled to the first mating structure. The body has a central body axis extending from a distal body end defined on the first mating structure to a proximal body end defined on the second mating structure. The first mating structure includes an annular wall defining an open proximal end of the first mating structure facing toward the proximal body end. A male luer connection includes an axial passage extending from a distal end of the male luer connection toward the proximal body end. An internal passage communicates the open proximal end of the first mating structure with the axial passage of the male luer connection. The second mating structure includes a female luer connection configured to receive a male luer fitting, such as a syringe or IV line. The second mating structure has an interior communicating the female luer connection with the open proximal end of the first mating structure. A flexible valve member is mounted on the first mating structure and has a proximal valve end portion configured to be sealingly received in the female luer connection of the second mating structure when the flexible valve member is in a closed position. The flexible valve member includes an axially extending main body portion, a tapered distal end portion extending distally from the main body portion, and a tapered proximal portion extending proximally from the main body portion to the proximal valve end portion. The tapered distal end portion engages the first mating structure. The tapered proximal portion is axially longer than the tapered distal end portion. The flexible valve member further includes a plurality of stabilizing fins extending laterally outward from the main body portion toward the interior wall of the second mating structure. The tapered proximal portion is configured to buckle asymmetrically relative to the central body axis upon entry of the male luer fitting into the female luer connection to thereby place the male luer fitting in communication with the interior of the second mating structure. 
     The main body portion of the flexible valve member may be cylindrical in shape having a main body portion diameter. 
     The main body portion may have a main body portion length at least one-half an axial length of the flexible valve member. 
     The tapered proximal portion may taper from the main body portion diameter to a minimum outside diameter less than 60% of the main body portion diameter. 
     The tapered proximal portion may have an axial length greater than the main body portion diameter. 
     The tapered proximal portion may have an axial length greater than 125% of the main body portion diameter. 
     In another embodiment an injection port assembly includes a body including a first mating structure and a second mating structure configured to be coupled to the first mating structure. The body has a central body axis extending from a distal body end defined on the first mating structure to a proximal body end defined on the second mating structure. The first mating structure includes an annular wall defining an open proximal end of the first mating structure facing toward the proximal body end. A male luer connection includes an axial passage extending from a distal end of the male luer connection toward the proximal body end. An internal passage communicates the open proximal end of the first mating structure with the axial passage of the male luer connection. The first mating structure may include a radially outer proximally facing step, and a cylindrical outer wall surface located between the proximal end of the first mating structure and the radially outer proximally facing step. The second mating structure includes a female luer connection configured to receive a male luer fitting, such as a syringe or IV line. The second mating structure has an interior communicating the female luer connection with the open proximal end of the first mating structure. A flexible valve member is mounted on the first mating structure and has a proximal valve end portion configured to be sealingly received in the female luer connection of the second mating structure when the flexible valve member is in a closed position. The second mating structure may include an annular radially inner distally facing step defined in the interior wall. A cylindrical inner surface may be located on the second mating structure between a second mating structure distal end and the radially inner distally facing step. The cylindrical outer wall surface of the first mating structure may be closely received in and sonically welded to the cylindrical inner surface of the second mating structure. 
     The first mating structure may further include a proximally facing radially outward extending step located distally of the open proximal end of the first mating structure. The second mating structure distal end may engage and be sonically welded to the proximally facing radially outward extending step of the first mating structure. 
     The proximally facing radially outward extending step of the first mating structure further may include a proximally facing annular groove configured to receive weld slag generated during the sonic welding of the second mating structure distal end to the proximally facing radially outward extending step of the first mating structure. 
     Numerous objects, features and advantages of the embodiments set forth herein will be readily apparent to those skilled in the art upon reading of the following disclosure when taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a cross-section elevation view of the injection port assembly with the flexible valve member in a closed position. A male luer syringe tip is shown above the injection port assembly prior to engaging the flexible valve member. 
         FIG. 2  is a cross-section elevation view of the injection port assembly of  FIG. 1  showing the male luer syringe tip engaging the flexible valve member so that the flexible valve member is moved to an open position. 
         FIG. 3  is a cross-section elevation view of the first and second mating structures of the body of the injection port assembly, shown in an assembled position. The flexible valve member has been removed for clarity.  FIG. 3  is taken along line  3 - 3  of  FIG. 9 . 
         FIG. 4  is a cross-section elevation view like  FIG. 3  but rotated 90 degrees about the axis of the body.  FIG. 4  is taken along line  4 - 4  of  FIG. 5 . 
         FIG. 5  is an elevation view of the injection port assembly of  FIGS. 1-4 . 
         FIG. 6  is an enlarged view of the portion of the body circled in  FIG. 3 . 
         FIG. 7  is a top end view of the body of  FIG. 5 . 
         FIG. 8  is a cross-section view taken along line  8 - 8  of  FIG. 5 . 
         FIG. 9  is a bottom end view of the body of  FIG. 5 . 
         FIG. 10  is an enlarged view of the structure circled in  FIG. 8 . 
         FIG. 11  is a cross-section elevation view of the second mating structure or upper body part of the body of  FIG. 3 .  FIG. 11  is taken along line  11 - 11  of  FIG. 12 . 
         FIG. 12  is a bottom view of the second mating structure of  FIG. 11 . 
         FIG. 13  is an enlarged view of the structure circled in  FIG. 11 . 
         FIG. 14  is an enlarged view of the structure circled in  FIG. 12 . 
         FIG. 15  is a cross-section elevation view of the first mating structure or lower body part of the body of  FIG. 3 .  FIG. 15  is taken along line  15 - 15  of  FIG. 16 . 
         FIG. 15A  is a cross-section view taken along line  15 A- 15 A of  FIG. 15  showing details of the ratchet. 
         FIG. 16  is a top view of the first mating structure of  FIG. 15 . 
         FIG. 17  is an enlarged view of the structure circled in  FIG. 15  and identified as  17 . 
         FIG. 18  is an enlarged view of the structure circled in  FIG. 15  and identified as  18 . 
         FIG. 19  is an elevation view of the flexible valve member of the injection port assembly of  FIG. 1 . 
         FIG. 20  is another elevation view of the flexible valve member of  FIG. 19 , rotated 90 degrees about its axis. 
         FIG. 21  is a top end view of the flexible valve member of  FIG. 19 . 
         FIG. 22  is a bottom end view of the flexible valve member of  FIG. 19 . 
         FIG. 23  is a cross-section view of the flexible valve member of  FIG. 19  taken along line  23 - 23  of  FIG. 20 . 
         FIG. 24  is a cross-section elevation view of a second embodiment of an injection port assembly with the flexible valve member in a closed position. A male luer syringe tip is shown above the injection port assembly prior to engaging the flexible valve member. 
         FIG. 25  is a cross-section elevation view of the injection port assembly of  FIG. 24  showing the male luer syringe tip engaging the flexible valve member so that the flexible valve member is moved to an open position. The cross-section of  FIG. 25  is taken along line  25 - 25  of  FIG. 31 . 
         FIG. 26  is an elevation view of the second or upper mating structure of  FIG. 24 . 
         FIG. 27  is a cross-sectional elevation of the second mating structure or upper body part of the body of  FIG. 26 .  FIG. 27  is taken along line  27 - 27  of  FIG. 26 . 
         FIG. 28  is an elevation view of the first or lower mating structure of  FIG. 24 . 
         FIG. 29  is a cross-sectional elevation of the first mating structure or lower body part of the body of  FIG. 28 .  FIG. 29  is taken along line  29 - 29  of  FIG. 28 . 
         FIG. 30  is a top plan view of the first mating structure or lower body part of  FIG. 28 . 
         FIG. 31  is an elevation view of the injection port assembly of  FIG. 24 . 
         FIG. 32  is a top perspective view of the flexible valve member of the injection port assembly of  FIG. 24 . 
         FIG. 33  is a bottom perspective view of the flexible valve member of the injection port assembly of  FIG. 24 . 
         FIG. 34  is a side elevation view of the flexible valve member of the injection port assembly of  FIG. 24 . 
         FIG. 35  is a top plan view of the flexible valve member of  FIG. 34 , taken along line  35 - 35  of  FIG. 34 . 
         FIG. 36  is a bottom view of the flexible valve member of  FIG. 34 , taken along line  36 - 36  of  FIG. 34 . 
         FIG. 37  is an elevation section view of the flexible valve member of  FIG. 34 , taken along line  37 - 37  of  FIG. 34 . 
         FIG. 38  is a plan section view of the flexible valve member of  FIG. 34 , taken along line  38 - 38  of  FIG. 34 . 
     
    
    
     DETAILED DESCRIPTION 
     Embodiment of FIGS.  1 - 23   
     Referring now to the drawings and particularly to  FIG. 1  an injection port assembly is shown and generally designated by the number  30 . The injection port assembly  30  may also be referred to as an intermittent needleless connector  30 . The injection port assembly  30  includes a body  32  including a first mating structure  34  and the second mating structure  36  configured to be coupled to the first mating structure  34 . Each of the first and second mating structures  34  and  36  may be a separate integrally molded plastic part. 
     The body  32  has a central body axis  38  extending from a distal body end  40  defined on the first mating structure  34  to a proximal body end  42  defined on the second mating structure  36 . 
     The first mating structure  34  includes an annular wall  44  defining an open proximal end  46  of the first mating structure  34  facing toward the proximal body end  42 . A male luer connection  48  includes an axial passage  50  extending from a distal end  40  of the male Luer connection which is coincident with the distal end  40  of the body  30 . The open proximal end  46  may also be referred to as a first mating structure proximal end  46 . Annular wall  44  may also be referred to as an outer wall  44  and extends distally past a base  52  and includes an internal thread  45  concentric with the male luer connection  48 . 
     The base  52  is centered on the body axis  38  and at least partially blocks the axial passage  50 . As best seen in  FIG. 7  a plurality of circumferentially spaced ribs  54 ,  56 ,  58  and  60  extend from the annular wall  44  to the base  52  and define a plurality of transverse passages  62 ,  64 ,  66  and  68  between the circumferentially spaced ribs. The transverse passages are communicated with the axial passage  50  of the male luer connection  48 . The transverse passages may also be described as bypassing the base  52  to communicate an inner cylindrical surface  108  of the first mating structure  34  with the axial passage  50  of the male luer connection  48 . The base  52  may also be described as spanning the body axis  38  and being supported from the outer wall  44 . The base  52  may also be described as being located axially between the open proximal end  46  of the first mating structure  34  and the axial passage  50  of the male luer connection  48 . 
     The axial passage  50  has an inside diameter  51 . The base  52  has a base outside diameter  53  substantially equal to the inside diameter  51  of the axial passage  50  of the male luer connection  48 . 
     The use of the multiple transverse passages  62 ,  64 ,  66  and  68  provides a combined flow path from the open proximal end  46  to the axial passage  51  that is relatively unrestricted. The passages  62 ,  64 ,  66  and  68  have a combined cross-sectional flow area at least as great as, and preferably greater than, the cross-sectional area of the axial passage  51 . Also the passages  62 ,  64 ,  66  and  68  are preferably sloped in a range of from 40 to 60 degrees relative to the longitudinal axis  38 . In this manner the flow path through the passages  62 ,  64 ,  66  and  68  does not restrict the flow of fluids through the injection port assembly  30 , thus providing what may be referred to as a high fluid flow injection port assembly. The flow path is non-tortuous and the passages  62 ,  64 ,  66  and  68  are free of dead ends or spaces that are difficult to flush of blood and other fluids. 
     The second mating structure  36  includes a female luer connection  70  configured to receive a male luer fitting  72  (see  FIGS. 1 and 2 ). The second mating structure  36  has an interior  71  communicating the female luer connection  70  with the open proximal end  46  of the first mating structure  34 . The upper end of the second mating structure  36  carries an external thread  75  that can be engaged with a luer-lock connector (not shown). 
     A flexible valve member  76  is mounted on the base  52  of the first mating structure  34  and has a proximal valve end portion  78  configured to be sealingly received in the female luer connection  70  of the second mating structure  36  when the flexible valve member  76  is in a closed position as seen in  FIG. 1 . The flexible valve member  76  is configured to be displaced relative to the central body axis  38  upon entry of the male luer fitting  72  into the female luer connection  70  to thereby place the male luer fitting  72  in communication with the interior  71  of the second mating structure  36 . 
     The first mating structure  34  includes a centering recess  80  defined in the base  52  and facing the proximal body end  42 . The flexible valve member  76  includes a distal end  82  having a central protrusion  84  received in the centering recess  80 . 
     As is best seen in  FIGS. 3 and 4  each of the ribs  54 ,  56 ,  58  and  60  has a proximal end face such as  54   f ,  56   f ,  60   f  sloping distally from a radially outer end of the rib to a radially inner end of the rib attached to the base  52 , so that the proximal end faces of the ribs define a tapered guide  86  for guiding the distal end  82  of the flexible valve member  76  into engagement with the base  52 . 
     The second mating structure  36  includes an annular radially inner distally facing step  88 . The open proximal end  46  of the first mating structure  34  abuts the distally facing step  88  of the second mating structure  36  when the first and second mating structures  34  and  36  are coupled together as shown for example in  FIGS. 1  and  2 . One of the distally facing step  88  of the second mating structure  36  and the open proximal end  46  of the first mating structure  34  includes a groove  90 , and the other of the distally facing step  88  of the second mating structure  36  and the open proximal end  46  of the first mating structure  34  includes an annular ridge  92  received in the annular groove  90  to provide a seal between the first and second mating structures  34  and  36 . 
     The ridge  92  may be sized slightly larger than the groove  90 , and the second mating structure  36  may have sufficient flexibility about the groove  90  so that a somewhat resilient mating occurs between the ridge  92  and groove  90 . 
     The first mating structure  34  may also include a radially outer proximally facing step  94 . An external thread  96  may be located between the first mating structure proximal end  46  and the radially outer proximally facing step  94 . A first annular ratchet portion  98  may be located between the external thread  96  and the radially outer proximally facing step  94 . 
     The second mating structure  36  includes the previously mentioned distally facing step  88  and a second mating structure distal end  100 . An internal thread  102  may be located between the second mating structure distal end  100  and the radially inner distally facing step  88 . A second ratchet portion  104  may be located between the internal thread  102  and the second mating structure distal end  100 . 
     As best seen in  FIG. 15A , the first annular ratchet portion may include four external ratchet teeth  98 A,  98 B,  98 C and  98 D. And as best seen in  FIG. 8 , the second annular ratchet portion  104  may include four internal ratchet teeth  104 A,  104 B,  104 C and  104 D. 
     The first and second mating structures  34  and  36  may be coupled together by engagement of the internal thread  102  with the external thread  96 , such that the first and second annular ratchet portions  98  and  104  prevent disengagement of the internal thread  102  from the external thread  96  after the first and second mating structures  34  and  36  are coupled together. The threads  96  and  102  provide a threaded connection between the first and second mating structures  34  and  36 . The first and second ratchet portions  98  and  104  provide a ratchet lock configured to prevent unthreading of the threaded connection after the first and second mating structures  34  and  36  are coupled together by the threaded connection. 
     The threaded connection  96 ,  102  may provide a seal to prevent passage of any fluid that may pass the seal between groove  90  and ridge  92 . Additionally, and optionally, an O-ring seal  106  may be provided between the proximally facing step  94  and the distal end  100 . Such an O-ring seal  106  is schematically illustrated in  FIG. 2 . 
     As best seen in the enlarged view of  FIG. 6 , the first mating structure  34  includes an inner cylindrical surface  108  extending distally from the open proximal end  46 . The inner cylindrical surface  108  has a first inner diameter  110 . The axial passage  50  of the male luer connection  48  has a second inner diameter  51  smaller than the first inner diameter  110 . The transverse passages  62 ,  64 ,  66  and  68  are partially frusto-conical in shape tapering from the first inner diameter  110  to the second inner diameter  51 . 
     The details of the flexible valve member  76  are best seen in  FIGS. 19-23 . The proximal end portion  78  of flexible valve member  76  is configured to be sealingly received in the female luer connection  70  of the second mating structure  36 . Below the proximal end portion  78  is a segmented stop surface  112  configured to abut lower taper  73  of the second mating structure  36  to prevent the flexible valve member  76  from being pushed out of the second mating structure  36  due to internal pressure. The segmented stop surface may include four segments as seen in  FIG. 23 , separated by gaps such as  114 . Below segmented stop surface  112  a relatively large lateral notch  116  is formed in flexible valve member. Notch  116  is designed to cause the flexible valve member  76  to collapse in an asymmetrical manner as schematically represented in  FIG. 2  when the male luer fitting  72  pushes downward on the flexible valve member  76 . This causes the flexible valve member  76  to be displaced laterally relative to the longitudinal axis  38  when the flexible valve member  76  is moved from its closed position of  FIG. 1  to its open position of  FIG. 2 . The lowermost portion of flexible valve member  76  tapers at  118  to the distal end  82  and the centering protrusion  84 . 
     The injection port assembly  30  may be assembled from the first mating structure  34 , second mating structure  36  and flexible valve member  76  substantially as follows. The flexible valve member  76  may be placed in the second mating structure  36  with the proximal end portion of the flexible valve member  76  adjacent or received in the female luer connection  70  substantially as shown in  FIG. 1 . Then the external threads  98  of the first mating structure  34  may be engaged with the internal threads  102  of the second mating structure  36  and the threaded connection made up until the ridge  92  sealingly engages the groove  90  and the distal end  100  of second mating structure  36  bottoms out on the proximally facing step  94  of the first mating structure  34 . The ratchet lock provided by the first and second ratchet portions  98  and  104  will prevent the threads from disengaging. The first and second annular ratchet portions  98  and  104  are preferably arranged such that the second mating structure  36  bottoms out on the proximally facing step  94  of the first mating structure  34  just as the ratchet teeth have reached an engagement position as shown in  FIG. 8 . During the assembly of the first and second mating portions  34  and  36  the tapered guide  86  formed by the sloping faces of the ribs will guide the distal end portion  82  of the flexible valve  76  toward the base  52  so that the central protrusion  84  is received in the centering recess  82 . 
     The use of the injection port assembly  30  is best illustrated in  FIGS. 1 and 2 . In  FIG. 1  the injection port assembly is shown with the flexible valve member  76  in a closed position. A male luer fitting  72  is shown above the injection port assembly  30  in a position just prior to engaging the flexible valve member  76 . In  FIG. 2 , the male ler fitting  72  has been moved downward and engaged with the upper end of the flexible valve member  76  to displace the flexible valve member  76  relative to the central body axis  38  upon entry of the male luer fitting  72  into the female luer connection  70  thereby placing the male luer fitting  72 , and particularly the interior thereof, in communication with the interior  71  of the second mating structure  36 . 
     Embodiment of FIGS.  24 - 38   
       FIGS. 24-38  illustrate a second embodiment of an injection port assembly generally designated by the numeral  130 . The injection port assembly  130  differs from the injection port assembly  30  in two primary ways. First the manner in which the first and second mating structures are connected together has been changed to a welded connection. Second the design of the flexible valve member has been modified. 
     Referring now to the drawings and particularly to  FIG. 24  an injection port assembly is shown and generally designated by the number  130 . The injection port assembly  130  may also be referred to as an intermittent needleless connector  130 . The injection port assembly  130  includes a body  132  including a first mating structure  134  and the second mating structure  136  configured to be coupled to the first mating structure  134 . Each of the first and second mating structures  134  and  136  may be a separate integrally molded plastic part. 
     The body  132  has a central body axis  138  extending from a distal body end  140  defined on the first mating structure  134  to a proximal body end  142  defined on the second mating structure  136 . 
     The first mating structure  134  includes an annular wall  144  defining an open proximal end  146  of the first mating structure  134  facing toward the proximal body end  142 . A male luer connection  148  includes an axial passage  150  extending from a distal end  140  of the male luer connection which is coincident with the distal end  140  of the body  132 . The open proximal end  146  may also be referred to as a first mating structure proximal end  146 . Annular wall  144  may also be referred to as an outer wall  144  and extends distally past a base  152  and includes an internal thread  145  concentric with the male luer connection  148 . 
     The base  152  is centered on the body axis  138  and at least partially blocks the axial passage  150 . As best seen in  FIG. 30  a plurality of circumferentially spaced ribs  154 ,  156 ,  158  and  160  extend from the annular wall  144  to the base  152  and define a plurality of transverse passages  162 ,  164 ,  166  and  168  between the circumferentially spaced ribs. The transverse passages are communicated with the axial passage  150  of the male luer connection  148 . The transverse passages may also be described as bypassing the base  152  to communicate an inner surface  208  of the first mating structure  134  with the axial passage  150  of the male luer connection  148 . The base  152  may also be described as spanning the body axis  138  and being supported from the outer wall  144 . The base  152  may also be described as being located axially between the open proximal end  146  of the first mating structure  134  and the axial passage  150  of the male luer connection  148 . 
     The axial passage  150  has an inside diameter  151 . The base  152  has a base outside diameter  153  substantially equal to the inside diameter  151  of the axial passage  150  of the male luer connection  148 . 
     The use of the multiple transverse passages  162 ,  164 ,  166  and  168  provides a combined flow path from the open proximal end  146  to the axial passage  150  that is relatively unrestricted. The passages  162 ,  164 ,  166  and  168  have a combined cross-sectional flow area at least as great as, and preferably greater than, the cross-sectional area of the axial passage  150 . Also the passages  162 ,  164 ,  166  and  168  are preferably sloped in a range of from 40 to 60 degrees relative to the longitudinal axis  138 . In this manner the flow path through the passages  162 ,  164 ,  166  and  168  does not restrict the flow of fluids through the injection port assembly  130 , thus providing what may be referred to as a high fluid flow injection port assembly. The flow path is non-tortuous and the passages  162 ,  164 ,  166  and  168  are free of dead ends or spaces that are difficult to flush of blood and other fluids. 
     The second mating structure  136  includes a female luer connection  170  configured to receive a male luer fitting  72  (see  FIGS. 24 and 25 ). The second mating structure  136  has an inner wall  169  defining an interior  171  communicating the female luer connection  170  with the open proximal end  146  of the first mating structure  134 . The upper end of the second mating structure  136  carries an external thread  175  that can be engaged with a luer-lock connector (not shown). 
     A flexible valve member  176  is mounted on the base  152  of the first mating structure  134  and has a proximal valve end portion  178  configured to be sealingly received in the female luer connection  170  of the second mating structure  136  when the flexible valve member  176  is in a closed position as seen in  FIG. 24 . The flexible valve member  176  is configured to be displaced relative to the central body axis  138  upon entry of the male luer fitting  72  into the female luer connection  170  to thereby place the male luer fitting  72  in communication with the interior  171  of the second mating structure  136 . 
     The first mating structure  134  includes a centering recess  180  defined in the base  152  and facing the proximal body end  142 . The flexible valve member  176  includes a distal end  182  having a central protrusion  184  received in the centering recess  180 . 
     As is best seen in  FIG. 29  each of the ribs  154 ,  156 ,  158  and  160  has a proximal end face such as  154   f ,  156   f ,  160   f  sloping distally from a radially outer end of the rib to a radially inner end of the rib attached to the base  152 , so that the proximal end faces of the ribs define a tapered guide  186  for guiding the distal end  182  of the flexible valve member  176  into engagement with the base  152 . 
     The second mating structure  136  includes an annular radially inner distally facing step  188 . The open proximal end  146  of the first mating structure  134  abuts the distally facing step  188  of the second mating structure  136  when the first and second mating structures  134  and  136  are coupled together as shown for example in  FIGS. 24 and 25 . The second mating structure  136  may also include a cylindrical inner surface  300  located between the second mating structure distal end  200  and the radially inner distally facing step  188 . The distal end  200  of the second mating structure  136  may also include a radially outwardly extending lower end face  304 . 
     The first mating structure  134  may also include a radially outer proximally facing step  194  and a cylindrical outer wall surface  302  located between the proximal end  146  and the radially outer proximally facing step  194 . 
     The injection port assembly  130  may be assembled from the first mating structure  134 , second mating structure  136  and flexible valve member  176  substantially as follows. The flexible valve member  176  may be placed in the second mating structure  136  with the proximal end portion of the flexible valve member  176  adjacent or received in the female luer connection  170  substantially as shown in  FIG. 24 . Then the cylindrical outer wall surface  302  of the first mating structure  134  is closely received in the cylindrical inner surface  300  of the second mating structure  136  until the radially outwardly extending lower end face  304  of the distal end  200  of the second mating structure  136  abuts the radially outer proximally facing step  194  of the first mating structure  134 . During this assembly the tapered lower end  314  of the flexible valve member  176  is guided by guide  186  into engagement with the base  152 , so that center protrusion  184  is received in centering recess  180 . The assembly is then placed in a sonic welding machine and sonic energy is applied to cause the first and second mating structures  134  and  136  to be sonically welded together along the interface between surfaces  300  and  302  and along the engagement of the radially outwardly extending lower end face  304  of the distal end  200  of the second mating structure  136  with the radially outer proximally facing step  194  of the first mating structure  134 . Any weld slag or other debris generated during the sonic welding operation may be received in an annular groove  306  which is formed in the radially outer proximally facing step  194  of the first mating structure  134 . 
     As best seen in  FIG. 29 , the first mating structure  134  includes an inner surface  208  extending distally from the open proximal end  46 . The inner surface  208  has a first inner diameter  210  at its upper end. The axial passage  150  of the male luer connection  148  has a second inner diameter  151  smaller than the first inner diameter  210 . The transverse passages  162 ,  164 ,  166  and  168  are partially frusto-conical in shape tapering from the first inner diameter  210  to the second inner diameter  151 . 
     The details of the flexible valve member  176  are best seen in  FIGS. 32-38 . The proximal end portion  178  of flexible valve member  176  is configured to be sealingly received in the female luer connection  170  of the second mating structure  136 . Below the proximal end portion  178  is a segmented stop surface  212  configured to abut lower taper  173  of the second mating structure  136  to prevent the flexible valve member  176  from being pushed out of the second mating structure  136  due to internal pressure. The segmented stop surface may include four segments as seen in  FIG. 38 , separated by gaps such as  214 . 
     The flexible valve member  176  includes an axially extending main body portion  310  which is preferably cylindrical in shape having a main body portion diameter  312 . A tapered distal end portion  314  extends distally from the main body portion  310  and includes the distal end  182  and the protrusion  184 . A tapered proximal portion  316  extends proximally from the main body portion  310  and joins the proximal end portion  178 . 
     The flexible valve member  176  has an axial length  318 . Proximal end portion  178  has an axial length  320 . Tapered proximal portion  316  has an axial length  322 . Main body portion  310  has an axial length or main body portion length  324 . Tapered distal end portion  314  has an axial length  326 . 
     The main body portion length  324  may be at least one-half the axial length  318  of the flexible valve member  176 . 
     The axial length  322  of the tapered proximal portion  316  may be greater than the main body portion diameter  312 , and preferably may be greater than 125% of the main body portion diameter  312 . The tapered proximal portion  316  may taper from the main body portion diameter  312  at its junction with main body portion  310  to a minimum outside diameter  328  less than 60% of the main body portion diameter  312 . 
     The flexible valve member  176  includes a plurality of stabilizing fins  330 ,  332 ,  334  and  336  extending laterally, and preferably radially, outward from the main body portion  310  toward the interior wall  169  of the second mating structure  136 . As best seen in  FIG. 34  the fins may extend along a fin length  338  which is less than the axial length  324  of the main body portion  310 . 
     The flexible valve member  176  is constructed from a resilient elastomeric material such that the flexible valve member  176  can deflect as shown in  FIG. 25  when engaged by the male luer fitting  72 , and can rebound back to its original shape to reseal against the female luer connection  170  when the male luer fitting  72  is withdrawn. 
     The use of the injection port assembly  130  is best illustrated in  FIGS. 24 and 25 . In  FIG. 24  the injection port assembly is shown with the flexible valve member  176  in a closed position. A male luer fitting  72  is shown above the injection port assembly  130  in a position just prior to engaging the flexible valve member  176 . In  FIG. 25 , the male luer fitting  72  has been moved downward and engaged with the upper end of the flexible valve member  176  to displace the flexible valve member  176  relative to the central body axis  138  upon entry of the male luer fitting  72  into the female luer connection  170  thereby placing the male luer fitting  72 , and particularly the interior thereof, in communication with the interior  171  of the second mating structure  136 . 
     The function of the flexible valve member  176  when engaged by the male luer fitting  72  to move the flexible valve member  176  from the closed position of  FIG. 24  to the open position of  FIG. 25  is generally as follows. The stabilizing fins  330 - 336  keep the main body portion  310  centered in the body  132  even as the flexible valve member  176  begins to axially compress as the male luer fitting  72  begins to push downwardly on the proximal valve end portion  178 . Because the tapered proximal portion  316  has the smallest cross-section and is relatively long, the tapered proximal portion  316  will ultimately buckle and be displaced laterally relative to the center axis  138  as is schematically represented in  FIG. 25 . When the tapered proximal portion  316  buckles the male luer fitting  72  will be in fluid communication with the interior  171  of the second mating structure  136  and can then introduce fluid into or withdraw fluid from the interior  171 . 
     Thus it is seen that the apparatus and methods of the present invention readily achieve the ends and advantages mentioned as well as those inherent therein. While certain preferred embodiments of the invention have been illustrated and described for purposes of the present disclosure, numerous changes in the arrangement and construction of parts and steps may be made by those skilled in the art, which changes are encompassed within the scope and spirit of the present invention as defined by the appended claims.