Abstract:
A device for transferring fluids between an internal structure in a living body and an exterior thereof, comprises a housing including a pressure activated lumen extending to a distal end opening to a power injection lumen that extends to a distal port configured for connection to a fluid conduit extending to a target structure within the body and a pressure activated valve extending across the pressure activated lumen and controlling fluid flow therethrough, the pressure activated valve opening to permit fluid flow therethrough into the power injection lumen when a fluid pressure differential thereacross is at least a first predetermined threshold level and remaining sealed when the fluid pressure differential thereacross is less than the first threshold level in combination with a proximal port coupled to the housing for movement between a first position in which a proximal end of the power injection lumen opens to the proximal port and a second position in which a proximal end of the pressure activated lumen opens to the proximal port.

Description:
BACKGROUND 
     Procedures requiring the use of peripherally inserted central catheters (“PICC”) often employ pressure activated valves to seal these catheters when not in use. Such pressure activated valves are designed to remain closed during normal pressure fluctuations between uses to prevent leakage and backflow which may lead to occlusions and/or infections. However, these valves have often been unsuitable for the injection of fluids at high pressures or volumes. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a device for transferring fluids between an internal structure in a living body and an exterior thereof, comprises a housing including a pressure activated lumen extending to a distal end opening to a power injection lumen that extends to a distal port configured for connection to a fluid conduit extending to a target structure within the body and a pressure activated valve extending across the pressure activated lumen and controlling fluid flow therethrough, the pressure activated valve opening to permit fluid flow therethrough into the power injection lumen when a fluid pressure differential thereacross is at least a first predetermined threshold level and remaining sealed when the fluid pressure differential thereacross is less than the first threshold level in combination with a proximal port coupled to the housing for movement between a first position in which a proximal end of the power injection lumen opens to the proximal port and a second position in which a proximal end of the pressure activated lumen opens to the proximal port. 
     The present invention is further directed to a method for transferring fluids between a target internal structure of a living body and an exterior of the body, the method comprising connecting to a proximal end of a fluid conduit extending into the body to the target structure a distal port of a housing opening to a power injection lumen thereof, the housing including a pressure activated lumen extending to a distal end opening to the power injection lumen with a pressure activated valve opening to permit fluid flow therethrough into the power injection lumen when a fluid pressure differential thereacross is at least a first predetermined threshold level and remaining sealed when the fluid pressure differential thereacross is less than the first threshold level and moving a proximal port of the housing to a first position in which the proximal port is fluidly coupled to the power injection lumen in combination with supplying a first fluid to the proximal port at a power injection pressure greater than the first threshold level, moving the proximal port of the housing to a first position in which the proximal port is fluidly coupled to the pressure activated lumen and supplying a second fluid to the proximal port at a pressure greater than the first threshold level and less than the power injection pressure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawing illustrates the design of the present invention wherein: 
         FIG. 1  shows a first view of an apparatus according to a first embodiment of the present invention; 
         FIG. 2  shows an exploded view of the device of  FIG. 1 ; 
         FIG. 3  shows an internal view of the device of  FIG. 1 ; 
         FIG. 4  shows a side view of the device of  FIG. 1 ; 
         FIG. 5  shows a bottom view of the device of  FIG. 1 ; 
         FIG. 6  shows a top view of the device of  FIG. 1 ; 
         FIG. 7  shows a perspective view of the device of  FIG. 1  in a position permitting flow through a pressure activated valve; and 
         FIG. 8  shows a perspective view of the device of  FIG. 1  in a normal flow position. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention, which may be further understood with reference to the following description and the appended drawings, relates to a system and method for high pressure and high volume injection without damaging a pressure activated valve. In particular, the present invention relates to the selective engagement for high pressure and high volume injection of separate lumens within a device employed in conjunction with a catheter (e.g., a PICC catheter) with at least one of the lumens employing a pressure activated valve. 
     Presently available pressure activated valves are generally unable to sustain the high pressures and flow rates associated with power injection (e.g., of contrast media). An exemplary embodiment of the present invention seeks to alleviate this problem by incorporating with a pressure activated valve a bypass feature allowing power injection without damaging the pressure activated valve. 
     As shown in  FIGS. 1-8 , a port  100  according to a first embodiment of the invention includes two passages which may be selectively engaged to select either power injection or standard infusion/withdrawal of fluids. The port  100  comprises a base  110  and a cover  120  joined together, for example, via any known means such as bonding, welding, friction fit, etc. Protruding distally from the port  100  is an elongated tubular body  105  with a lumen  115  extending therethrough and into the base  110 , as will be described in greater detail below. It is noted that the term proximal as referred to herein refers to a direction approaching a user or point of user access to the device while distal refers to a direction toward an interior of the body of the patient. 
     The tubular body  105  is provided with a barbed fitting comprising a series of ridged portions  106  designed to frictionally engage a catheter disposed thereover. Specifically, the ridged portions  106  are formed with a diameter sized to frictionally engage inner walls of a catheter, thereby firmly securing the catheter to the port  100 . Accordingly, to mate to the port  100 , a catheter is guided over the tubular body  105  to a proximal-most position and frictionally retained thereon. In an alternate embodiment, the tubular body  105  may be insert molded on the catheter, as those skilled in the art will understand. 
     As shown in the exploded view of  FIG. 2 , a silicone disk  130  is provided in the port  100 , in engagement with a correspondingly sized recess  131  in the base  110  which opens to the lumen  115 . The silicone disk  130  effectively regulates the pressure and flow of fluids passing therethrough the port  100 . As would be understood by those skilled in the art, the disk  130  may be formed in any desired configuration to obtain desired flow configurations. For example, the disk  130  and a slot or slots therethrough may be formed as shown for any of slitted membranes disclosed in U.S. patent application Ser. No. 10/768,571 entitled “Pressure Activated Safety Valve With Anti-Adherent Coating” filed on Jan. 29, 2004 to Weaver, et al. (the &#39;571 app.); U.S. application Ser. No. 10/768,565 entitled “Pressure Activated Safety Valve With High Flow Slit” filed on even day herewith naming Karla Weaver and Paul DiCarlo as inventors, and U.S. application Ser. No. 10/768,629 entitled “Stacked Membrane For Pressure Actuated Valve” filed on even day herewith naming Karla Weaver and Paul DiCarlo as inventors, and U.S. application Ser. No. 10/768,855 entitled “Pressure Actuated Safety Valve With Spiral Flow Membrane” filed on even day herewith naming Paul DiCarlo and Karla Weaver as inventors, and U.S. application Ser. No. 10/768,479 entitled “Dual Well Port Device” filed on even day herewith naming Katie Daly, Kristian DiMatteo and Eric Houde as inventors. The entire disclosures of each of these applications are hereby incorporated by reference in this application. The silicone disk  130  is held in place over the recess  131  via a disk retainer  135  which engages a periphery thereof. When the cover  120  is mounted to the base  110 , a portion of the cover  120  engages the disk retainer  135  applying pressure against the disk  130  to hold the disk  130  against a periphery of the recess  131  and prevent the silicone disk  130  from being moved therefrom. 
     A rotating luer  150  engages a proximal end of the base  110  at a proximal end of the port  100 , as further shown in  FIG. 3 . The rotating luer  150  includes a lumen  155  extending therethrough from a proximal end  151  to a distal end  152  and at least two tabs  160  extending therefrom about a circumference of an end plate  158  of the luer  150  which preferably forms a substantially continuous surface with the portion of the port  100  (i.e., proximal ends of the base  110  and the cover  120  regardless of a rotational orientation of the luer  150 . The tabs  160  indicate an alignment of the lumen  155  in relation to the two lumens  115  and  125  of the port  100 , as will be described in greater detail below. The luer  150  also includes a disk-shaped mating projection  156  which is received within a correspondingly shaped and sized slot  154  to rotatably secure the luer  150  to the base  110 . 
     Two O-rings  140  are provided between the rotating luer  150  and the upper and lower body portions  120 ,  110  to provide a fluid seal therebetween. However, those skilled in the art will understand that any number of O-rings may be provided in the device and these O-rings may vary in thickness and size to obtain the desired seal. The O-rings may exhibit elastomeric properties and may, in an exemplary embodiment, be received in recesses formed on a proximal faces of the base  110  and the cover  120  around proximal openings to the lumens  115 ,  125 , respectively. 
     As shown in  FIG. 3 , when in a pressure activated position, the lumen  155  of the luer  150  is aligned with the lumen  125  of the cover  120  which opens to the disk  130 . As would be understood by those skilled in the art, when a pressure differential between the lumen  125  and the lumen  115  exceeds a predetermined threshold, edges of the slit(s) in the disk  130  are moved apart from one another and fluid will flow through the disk  130  into the lumen  115  to a catheter attached thereto. When the pressure differential remains below the predetermined threshold, the disk  130  remains sealed preventing fluid flow from the lumen  115  to the lumen  125 . 
     In order to configure the port  100  in the pressure activated position as also shown in  FIGS. 6 and 7 , a user of the port  100  rotates the luer  150  until the tabs  160  are aligned with corresponding projections (e.g., projections  161 ) on the port distal body of the port  100  (i.e., the base  110  and/or the cover  120 ) to an indicated pressure activated position. Specifically, the proximal portion of the port  100  may be labeled to indicate the locations of the lumens  115  and  125 , as shown in  FIGS. 5 and 6 . A physician may then rotate the proximal portion of the port  100  to align the tabs  160  with the projections  161 . Rotating the proximal portion of the port  100  in either a clockwise or counter-clockwise direction until the lumen  155  aligns with the desired lumen of the port  100  engages the desired one of the lumens  125  and  115 . It is further noted that, when the tabs  160  are not aligned with the projections  161 , the port  100  is in an off position with both of the lumens  115  and  125  sealed to prevent the flow of fluid into or out of the proximal portion of the device. 
     Once the pressure activated valve has been selected, the flow of fluid through the port  100  is guided through the pressure activated valve, as detailed above, with fluid entering the port  100  through an externally attached fluid source via an attachment means shown at the proximal end  151  of the rotating luer  150 . The fluid flows through the lumen  155  and into the lumen  125  and, when the pressure differential exceeds the predetermined threshold level, past the silicone disk  130  into the lumen  115  via the recess  131 . The fluid is passes through the lumen  115  toward the elongated tubular body  105  as flow toward the proximal end of the lumen  115  is prevented by the fluid-tight seal formed by the distal face of the rotating luer  150  which covers the proximal opening to the lumen  115  when the pressure activated valve has been selected. The fluid flows out of the distal opening of the elongated tubular body  105  to a targeted site in the body via a catheter or other device attached to the tubular body portion  105  as would be understood by those skilled in the art. 
     Alternatively, if the “&lt;5 mL/s” marker is selected, as shown in  FIGS. 5 and 8 , the lumen  155  is connected directly to the lumen  115  located inside the base  110  of the port  100 . An external high pressure or high volume fluid source may then be attached to a proximal end of the port  100  so that high pressure and/or high volume fluid (e.g., at flow rates and pressures suitable for the power injection of contrast media) supplied to the port  100  passes directly through the lumen  115  to the distal opening in the body  105  and into the catheter without passing through the disk  130 . It is further noted that the diameter of the lumen  155  may be substantially similar to the diameter of the lumen  115  to allow for an undeterred flow of fluid therethrough. 
     The present invention has been described with respect to particular designs and embodiments. However, those skilled in the art will understand that the described exemplary embodiments of the present invention may be altered without departing from the spirit or scope of the invention. For example, the port  100  may be altered in geometry, with the diameters of the either of the lumens  115 ,  125  and  155  increased or decreased to accommodate the requirements of a patient or procedure for which they are intended. Furthermore, a design may be incorporated with each of the lumens  115  and  125  identified by a different color or pattern of colors, eliminating the need for written markings on the outer body of the port  100 . 
     It is to be understood that these embodiments have been described in an exemplary manner and are not intended to limit the scope of the invention which is intended to cover all modifications and variations of this invention that come within the scope of the appended claims and their equivalents. The specifications are, therefore, to be regarded in an illustrative rather than a restrictive sense.