Abstract:
Disclosed herein is a syringe comprising a syringe body with plunger and a multi-pronged actuator. The syringe can further include a male coupling member, an outer sheath, a valve member and a back plate.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of application Ser. No. 12/789,255, filed May 27, 2010, now U.S. Pat. No. 8,066,692 which is a continuation of application Ser. No. 10/584,920, filed Dec. 28, 2006, now U.S. Pat. No. 7,758,566, which is the National Stage Entry of International Application No. PCT/US04/42723, filed Dec. 21, 2004, which claims the benefit of U.S. Provisional Application No. 60/532,916, filed Dec. 30, 2003; the entire contents of all of which are hereby incorporated by reference herein and made a part of this specification. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to medical systems specific to syringes. 
     2. Description of the Related Art 
     Syringes are commonly used to deliver medications and other biological fluids to a patient. The syringe typically has a plunger which is sealingly engaged with an outer cylindrical chamber to form an inner fluid—receiving chamber. A ‘male’ luer fitting is usually provided at a delivery end of the chamber which receives a female luer fitting with a needle assembly or the like. The fluid channel joining the cavity to the luer fitting is usually open, so that when the needle is removed, the cavity is open to the environment. This is problematic since many medications and biological fluids are sensitive (or can degrade when exposed) to the environment. 
     It is therefore an object of the present invention to provide a novel valve assembly for use with a syringe or other medical dispensing devices, enabling the latter to be closed to the environment when in an unattached condition. 
     SUMMARY OF THE INVENTION 
     In one of its aspects, the present invention provides a valve assembly comprising a male luer end portion, a female luer end portion and a channel for the transfer of fluids between the male and female luer end portions, valve means movable between a closed position and an open position, biasing means for biasing the valve means toward the closed position, and actuating means extending into the male luer end portion and coupled to the valve means to actuate the valve means when a female luer end portion of a medical accessory is coupled with the male luer end portion. 
     In an embodiment the male luer end portion has an inner projection and outer threaded sheath which is spaced therefrom to receive the female luer end portion therebetween. The actuating means includes an actuating member positioned between the outer threaded sheath and the inner projection. 
     In an embodiment, the valve means includes a valve seat and a valve member moveable relative thereto. The channel includes a first channel portion adjacent the female luer end portion and the inner projection includes a second channel portion. The valve member has a valve channel portion in fluid communication with the first and second channel portions. The valve seat is formed in the second channel portion and the valve member is integrally formed with the female luer end portion. 
     In one embodiment, the valve member includes an anchor flange extending outwardly toward an inner surface of the housing portion. In this case, the housing portion is coupled to the male luer end portion for movement therewith relative to the valve member. The male luer end portion engages the anchor flange when the valve means is in the closed position and the male luer end portion is spaced from said anchor flange when the valve means is in the open position. The housing portion terminates at an end region adjacent the female luer end portion, the biasing means includes a compression spring located within the housing between the end region and the outer anchor flange. 
     In another of its aspects, the present invention provides a medical dispensing device comprising a body having a chamber therein to contain a fluid material, a valve assembly in fluid communication with the chamber, the valve assembly having a male coupling member for engaging a female coupling member on a medical accessory to form a fluid coupling between the medical dispensing device and the medical accessory, the valve assembly further comprising flow control means operable to control fluid flow through the male coupling member, the flow control means being operable to be displaced by the female coupling member to open the male coupling member when female coupling member is operatively connected therewith, the flow control means being operable to be displaced by the female coupling member to close the male coupling member when the female coupling member is disconnected therefrom. 
     In one embodiment, the male coupling member includes an inner male portion and an outer sheath portion spaced therefrom to form a passage there between for receiving the female coupling member, the flow control means including at least one valve actuating portion positioned in the passage to abut the female coupling member and to displace the valve member during the travel of the female coupling member along the passage. The valve assembly includes a valve member and a valve seat, wherein the valve member is positioned against the seat to close the male coupling member. The valve actuating portion includes a pair of abutment elements which are spaced from one another along the passage to receive the female coupling member there between, wherein the pair of abutment elements are operable to travel with the female coupling member along the passage. 
     In one embodiment, the actuating portion is longitudinally oriented relative to the passage and the abutment elements are positioned along the actuating portion. 
     The valve member includes a back plate and a plurality of actuating portions equally spaced on the back plate, each of the actuating portions having first and second abutment elements. 
     In one embodiment, the valve actuating portion includes a locking flange which is adjacent one of the abutment elements. The valve assembly includes a locking seat to receive the locking flange when the male coupling member is in the closed position. The actuating portion has a distal end region, the locking flange being located adjacent the distal end region and the locking seat is formed in the outer sheath portion. The actuating portion is thus arranged to flex in order to displace the locking flange from the locking seat. 
     In yet another aspect, the present invention provides a medical dispensing device comprising a body having a chamber therein to contain a fluid material, a valve assembly in fluid communication with the chamber, the valve assembly having a male coupling member for engaging a female coupling member on a medical accessory to form a fluid coupling between the medical dispensing device and the medical accessory, the male coupling member including a projection and an outer valve member movable relative to the projection, the projection and the outer valve member forming a fluid channel there between, a sheath portion encircling the projection and spaced therefrom to form a passage to receive the female coupling member, the valve member being engageable with the female coupling member and movable relative to the projection to open the fluid channel when the female coupling member is connected with the male coupling member. 
     In one embodiment, the valve member forms an outer surface of the male coupling portion. 
     In an embodiment, biasing means is provided to bias the valve member toward an engaged position with the projection to close the fluid channel In this particular case, the passage ends at an inner wall and the biasing means includes a spring located between the inner wall and the valve member. 
     In one embodiment, the projection is fixed to the body and includes an inner passage, the inner passage having one end which is open to the chamber and another end which is open to the fluid channel. The projection also includes an enlarged end portion, the valve member including an outer portion arranged to engage the enlarged end portion to close the fluid channel. In this case the enlarged end portion and the outer end portion on the valve member have mating bevelled surfaces. 
     In one embodiment, the female coupling member has a leading segment, the valve member being dimensioned to fit within the leading segment. 
     Preferably, the medical dispensing device includes such items as a syringe, an IV bottle, an IV line, a powder and/or atomized fluid and/or gas inhalant dispenser, an implant delivery dispenser, a ventilator, a syringe pump, an intubation tube, a gastrointestinal feeding tube or a plurality and/or a combination thereof. 
     Preferably, the medical material is in solid, liquid or gaseous form or a combination thereof and has beneficial properties to enhance life, to promote health, to cure and/or treat a disease, condition or ailment, to monitor and/or indicate a bodily function or a combination thereof. For example, the medical material may be useful for, among others, IV therapy, implantation, stem cell therapy, oncology therapy, blood transfusion and/or organ transplantation. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Several preferred embodiments of the present invention will now be described, by way of example only, with reference to the appended drawings in which: 
         FIG. 1  is a perspective view of a syringe assembly; 
         FIG. 2  is a sectional view of a portion of the assembly of  FIG. 1 ; 
         FIGS. 3 and 4  are sectional views of the assembly of  FIG. 1  in two alternate operative positions; 
         FIG. 5  is a fragmentary sectional perspective view of a portion of another syringe assembly; 
         FIGS. 6 and 7  are fragmentary perspective views of another syringe assembly; 
         FIGS. 8 to 12  are fragmentary sectional views of the syringe assembly of  FIG. 6 ; 
         FIG. 13  is a fragmentary perspective view of yet another syringe assembly; and 
         FIGS. 14 and 15  are fragmentary sectional views of the syringe assembly of  FIG. 13  or portions thereof. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring to the figures, and in particular  FIG. 1 , there is provided a syringe assembly  10  comprising a syringe  12  and a valve unit  14 . The syringe  12  has a chamber  20  containing a plunger  22  to form a cavity  24 . Referring to  FIG. 2 , the cavity has an outlet  26  and the valve unit  14  is located downstream of the outlet  26  for coupling the cavity  24  with a medical accessory such as a needle  30  (as shown in  FIGS. 3 and 4 ). The valve unit  14  has an outlet  32  and flow control means, as will be described, to control fluid flow through the outlet, the flow control means being operable to open the outlet when the coupling section is operatively connected with the medical accessory, the flow control means being operable to close the outlet when the valve unit is disconnected from the medical accessory and to remain closed until connected once again with a medical accessory. 
     In this case, the chamber  20  includes a first male luer end portion  34  adjacent the outlet  26  and the valve unit  14  includes a first female luer end portion  36  which is engageable with the first male luer end portion  34 . The valve unit  14  also includes a second male luer end portion  38  for coupling with the medical accessory  30 . 
     Although the chamber  20  and the valve unit  14  are separate from one another in this case, it will be understood that they may, alternatively, be integrally formed, for example by combining the first male luer end portion  34  with the female luer end portion  36 . 
     The valve unit  14  has a channel  42  for the transfer of fluids between the first female and second male luer end portions  36 ,  38 . A valve means, in the form of a valve member  44  is located in the valve unit  14  and is movable between a first position (as shown in  FIG. 2 ), in which the channel is closed, and a second position (as shown in  FIG. 3 ), in which the channel is open. An actuating means, in the form of an actuating member  46  (shown in  FIG. 2 ), extends outwardly from the valve member  44  and into the second male luer end portion  38 . The actuating member  46  is coupled to the valve member  44  to actuate it when a female luer end portion of the medical accessory  30  is engaged with the second male luer end portion  38 . 
     In the embodiment of  FIGS. 1 to 4 , the second male luer end portion  38  has an outer threaded sheath  50  which is spaced from an inner projection  52 . In this case, the actuating member  46  is positioned between the outer threaded sheath  50  and the inner projection  52 . The valve member  44  includes a valve plug portion  54  moveable relative to a valve seat portion  56 . The valve member  44  has an upper end which is integrally formed with the first female luer end portion  36 . An outer housing member  58  is slidably mounted on the valve member  44 . In this case, the outer housing member  58  is joined to the second male luer end portion  38 . The valve member  44  also has a valve channel  44   a  extending from the first female luer end portion  36  to the valve plug portion  42  where it terminates at one or more transverse flow openings  44   b  to join with the channel  42 . 
     The valve member  44  includes an anchor flange  60 , and the second male luer end portion  38  seats, directly or indirectly, against the anchor flange  60  when the valve is in the closed position as viewed in  FIG. 2 . Conversely, the second male luer end portion  38  is spaced from said anchor flange when the valve is in the open position as shown in  FIG. 3 . 
     The outer housing member  58  terminates at a radially inwardly directed end region  62  adjacent the first female luer end portion  36  and a biasing means in the form of a compression spring  64  is located within the outer housing between the end region  62  and the anchor flange  60  to bias the valve member toward the first position to close the valve unit. 
     An alternative arrangement is shown in  FIG. 5 . In this case, the valve unit  70  has a housing  72  which is integrally formed with the female luer end portion  74 . A first channel portion  76  is adjacent the female luer end portion  74  and a second channel portion  78  is adjacent a male luer end portion  80 . In this case, the valve means includes a valve member  82  having a valve channel  84  in fluid communication with the first and second channel portions  76  and  78 . In this case, the valve seat portion is formed at  90  in the second channel portion  78 . 
     The valve member  82  includes a plug portion  92  which is movable relative to and within the second channel portion  78  for engaging the seat portion  90  to close the second channel portion  78 . The first channel portion  76  includes a tubular projection  94  extending from the female luer end portion  74 . In this case, the valve channel  84  in the valve member  82  is coextensive with the first and second channel portions  76 ,  78 . In this case, the tubular projection  94  is slidably engaged with the valve member  82  within the valve channel  84  and sealed therein by way of seal  98 . Likewise, the valve member  82  is sealed within the second channel portion  78  by way of seal  100 . 
     The syringe assembly  10  is used as follows. First, the valve unit  14  is joined to the syringe  12  by engaging the corresponding first male luer end portion  34  with the first female luer end portion  36 . In this condition, the second male luer end portion  38  is unattached with a medical accessory such as the needle  30  and the actuating member  46  is fully extended into the second male luer end portion  38  as shown in  FIG. 2 . Consequently, the valve member  44  is biased to its closed position, thereby engaging the valve plug portion  54  against the valve seat portion  56 . 
     The needle  30  is then attached to the syringe by engaging the female luer end portion on the needle  30  with the second male luer end portion  38 . Doing so causes the female luer end portion on the needle  30  to abut and displace the actuating member  46 , thereby causing the valve member  44  to be displaced upwardly (as viewed in  FIG. 2 ) thereby releasing the valve plug portion  54  from its sealed abutment with the valve seat portion  56  to open the valve channel. The, plunger  22  may then be displaced outwardly to cause fluids in the proximity of the pointed end of the needle  30  to be drawn into the cavity  24 , by a path starting at the valve seat portion  56  through the channel  42  to the transverse flow openings  44   b , to the valve channel  44   a  and on through the female luer end portion and into the cavity  24 . The needle  30  may then be removed causing the actuating member  46  to be displaced downwardly (as viewed in  FIG. 2 ) causing the immediate displacement of the valve plug portion to abut the valve seat portion  56  and thereby close the valve. 
     Another device is shown at  120   FIGS. 6 to 12 , having a body  122  forming an inner chamber  124  therein to contain a fluid material. A valve assembly  126  is in fluid communication with the chamber  124  and has a male coupling member  128  for engaging a female coupling member  130  on a medical accessory (in this case a needle  132 ) to form a fluid coupling between the device  120  and the needle  132 . 
     The valve assembly  126  is operable to control fluid flow through the male coupling member  128  and more particularly to be in an open position when the male coupling member  128  is operatively connected with the female coupling member  130  and, conversely, to be in a closed position when the male coupling member  128  is disconnected from the female coupling member  130 . 
     In this case, the body  122  and the valve assembly  126  are integrally formed and, as seen in  FIG. 8 , the latter includes a valve member  134  and a valve seat  136 . The valve member  134  is shown in its position against the valve seat  136  to close the male coupling member  128 , but for a very minor gap there between for illustrative purposes only. 
     The male coupling member  128  includes an inner male portion  140  having an inner fluid channel  140   a  and an outer sheath portion  142  spaced from the inner male portion  140  to form a passage  144  there between for receiving the female coupling member  130 . At least one, in this case three, valve actuating portions  146  (two being shown in  FIG. 7 ) are positioned in the passage  144  to abut the female coupling member  130  and to displace the valve member during the travel of the female coupling member  130  along the passage  144 . In this case, each valve actuating portion  146  is integrally formed with the valve member  134 . As shown in  FIGS. 7 and 8 , the valve actuating portions  146  are prongs that extend from a back plate  160 . 
     Each valve actuating portion  146  includes a pair of abutment elements  150 ,  152  which are spaced from one another along the passage  144  to receive the female coupling member  130  there between and to travel with the female coupling member along the passage  144 . The abutment element  152  has a bevelled outer surface  152   a  for reasons to be described. Each valve actuating portion  146  is longitudinally oriented relative to the passage  144  and the abutment elements  150 ,  152  are positioned along the valve actuating portion  146 . 
     Each valve actuating portion  146  includes a locking flange  154  and the valve assembly includes a locking seat  156  to receive the locking flange  154  when the valve member  134  is in the closed position. In this case, the actuating portion  146  has a distal end region and the locking flange  154  is located in the distal end region, while the locking seat  156  is formed in the outer sheath portion  142 . As shown in  FIG. 8 , the locking seat  156  forms a shoulder in the outer sheath portion  142  having a first diameter closest to the end of the outer sheath portion  142  and a second diameter smaller than the first and spaced from the first diameter. As also shown in  FIG. 8  the locking flange  154  comprises a protrusion and can engage with the locking seat or shoulder  156 . 
     It will be seen by comparing  FIG. 9  and  FIG. 10 , each actuating portion  146  is arranged to flex in order to displace the locking flange  154  out of the locking seat or shoulder  156 . Thus the actuating portion or prong  146  can form a hinge between the actuating portion and the back plate  160 . As can be seen by comparing  FIGS. 9 and 10 , each of the prongs  146  is shown with a protrusion that moves along the outer sheath from the first inner diameter to the smaller second inner diameter, wherein the illustrated prongs are configured to rotate at the hinge when the valve member is moved to the open position from the closed position. 
     Referring to  FIG. 8 , the valve member  134  includes a back plate  160  and the valve actuating portions  146  are equally spaced on the back plate  160 : The back plate  160  has a central fluid channel  162  which is in fluid communication with the chamber  124  and the valve member  134  has a fluid channel  163  therein in fluid communication with the central fluid channel  162  and hence the chamber  124 . In addition, the fluid channel  163  has a lateral portion  163   a  which establishes fluid communication between the fluid channel  163  and an inner fluid channel  140   a  in the inner male portion. 
     The device  120  is thus used as follows. The valve assembly is set with the valve member in its closed position, that is with the valve member  134  in its position against the valve seat  136  as shown in  FIG. 8 . The female coupling member  130  on the needle  132  is aligned with the passage  144  and brought toward the male coupling member  128 . The bevelled outer or leading surface  152   a  on the abutment member  152  aids to centre the female coupling member on the mouth of the passage  144 . With the locking flange  154  in the locking seat  156 , the female coupling member  130  is able to pass the lowermost edge of the abutment element  152  and continue into the passage  144  until the female coupling member makes contact with the abutment element  150  as seen in  FIG. 9 . As seen in  FIG. 10 , continued inward force on the female coupling member is transferred to the abutment element  150  causing the valve actuating portion  146  to move inwardly along the passage and thus to draw the locking flange  154  from this locked position in the locking seat  156 , causing the valve actuating portion  146  to flex, until the locking flange  154  is removed from the locking seat  156 . At this position, it can be seen that the valve member  134  has moved from the valve seat  136  to open the fluid channel  163  to the needle  132 . 
     Referring to  FIG. 11 , as the female coupling member  130  is removed from the passage  144 , it makes contact with the abutment element  152  and causes the valve actuating portion  146  to move outwardly along the passage  144  and thus cause the valve member  134  to move toward the valve seat  136 . The locking flange  154  approaches, and finally enters, the locking seat  156  to coincide with the closure of the valve assembly. 
     Thus, the device  120  does not make use of a valve member which is biased to its closed position as with the earlier embodiment, but rather relies on the displacement of the female coupling member  130  to draw the valve assembly to its closed position when it is removed from the male coupling member  128 . 
     Another device is shown at  170  in  FIGS. 13 to 15 , having a body  172  providing a chamber  174  therein to contain a fluid material. A valve assembly  176  is in fluid communication with the chamber  174  and has a male coupling member  178  for engaging a female coupling member  180 , again on a needle  181 , to form a fluid coupling between the medical dispensing device  170  and the needle  181 . 
     The valve assembly  176  is operable to control fluid flow through the male coupling member and more particularly to actuate or open the male coupling member  178  when operatively connected with the female coupling member  180  and, conversely, to close the male coupling member  178  when disconnected from the female coupling member  180 . 
     In this case, the male coupling member  178  includes a projection  182  which is fixed to the body  172 . A sheath portion  184  encircles the projection  182  and is also fixed to the body  172 . The sheath portion  184  and is spaced from the projection  182  to form a passage  186  to receive the female coupling member  180 . 
     A valve member  190  is movable relative to the projection  182  and forms a fluid channel  192  there between and sealed by an inner seal  193 . The projection  182  includes an inner passage  194  which has one end  194   a  open to the chamber  174  and another end  194   b  which is open to the fluid channel  192 . 
     Referring to  FIGS. 14 and 15 , the projection includes an enlarged end portion  198  and the valve member  190  has an outer portion  200  arranged to engage the enlarged end portion  198  to close the fluid channel  192 . In this case, the passage  186  ends at an inner wall  202  and the valve member  190  is movable relative to the inner wall  202  under the action of a spring  203  which is positioned in the passage  186  between the valve member  190  and the inner wall  202  to bias the outer end portion  200  of the valve member  190  toward an engaged position with the enlarged end portion  198 . 
     As can be seen in  FIG. 15 , the enlarged end portion  198  and the outer end portion  200  on the valve member  190  have mating bevelled surfaces  198   a  and  200   a  respectively. 
     The valve member  190  is operable to engage the female coupling member  180  and to travel with the female coupling member  180  along the passage  186 . In this case, the female coupling member  180  has a leading segment  180   a  and the outer end portion  200  of the valve member  190  is dimensioned to fit within the leading segment  180   a.    
     In contrast to the device  120  of  FIG. 6 , the device  170  has a valve member  190  which is biased to the closed position. As the female coupling member  180  passes over the projection  182 , the leading segment  180   a  of the female coupling member  180  rides over the outer portion  200  of the valve member  190 . Continued inward displacement of the female coupling member  180  into the passage  186  thus causes the valve member to move relative to the projection  182  until the mating bevelled surfaces  198   a ,  202   a  separate to open the fluid channel  192  to the needle. The fluid coupling is thus fully operational when the female and male coupling members are tightly engaged. When the female coupling member  180  is removed from the male coupling member  178 , the valve member  190  is returned to its closed position against the projection  182  under the biasing action of the spring  203 , to close the male coupling member. 
     While the present invention has been described for what are presently considered the preferred embodiments, the invention is not so limited. To the contrary, the invention is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions. 
     The valve unit may be used with other medical fluid delivery devices, such as IV lines, catheters, infusion pumps and the like. The valve unit may also be used on syringes and other medical devices which do not employ the ubiquitous luer coupling arrangement.