# Patent

## Title
Power injection valve

## 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, 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.

## Background
CROSS-REFERENCE TO PRIOR APPLICATIONS
This application is a continuation of, and claims priority to, U.S. application Ser. No. 12/362,004, filed on Jan. 29, 2009 now U.S. Pat. No. 8,083,721.


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 '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 “<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.

## Claims

1. A valve assembly for a catheter, comprising:
a housing defining first and second lumens therethrough;
a pressure activated valve disposed between the first and second lumens, the valve adapted to permit fluid to flow from the first lumen to the second lumen when acted upon by a fluid pressure in excess of a predetermined threshold;
an outlet fluidly coupled to the second lumen; and
an inlet moveable between a first position and a second position, wherein the inlet engages the first lumen when it is in the first position, and the inlet engages the second lumen when it is in the second position.

2. The valve assembly of claim 1, wherein the pressure activated valve prevents fluid flow from the second lumen to the first lumen.

3. The valve assembly of claim 1, wherein the inlet rotates between the first and second positions.

4. The valve assembly of claim 1, wherein the inlet includes a first alignment feature, the housing includes a second alignment feature, and each of said first and second alignment features align when the inlet is placed in at least one of the first and second positions.

5. The valve assembly of claim 4, wherein said first and second alignment features visibly align when the inlet is placed into at least one of the first and second positions.

6. The valve assembly of claim 1, wherein the inlet includes first and second tabs, the first tab positioned to contact a portion of the housing when the inlet is in the first position, the second tab positioned to contact a portion of the housing when the inlet is in the second position.

7. The valve assembly of claim 1, further comprising first and second sealing O-rings disposed at first and second fluid junctions between the moveable inlet and the first and second lumens, respectively.

8. The valve assembly of claim 1, wherein the first lumen includes a surface acutely angled relative to the pressure-activated valve.

9. A system for power injection of fluids into a patient, comprising:
a catheter having a distal end insertable into a patient, a proximal hub opposite the distal end, and defining a first lumen therethrough; and
a valve assembly, comprising:
a housing defining second and third lumens therethrough;
a pressure activated valve disposed between the second and third lumens, the valve adapted to permit fluid to flow from the second lumen to the third lumen when acted upon by a fluid pressure in excess of a predetermined threshold;
an outlet fluidly coupling the second lumen to the third lumen; and
an inlet moveable between a first position and a second position, wherein the inlet engages the second lumen when it is in the first position, and the inlet engages the third lumen when it is in the second position.

10. The system of claim 9, wherein the pressure activated valve prevents fluid flow from the third lumen to the second lumen.

11. The system of claim 9, wherein the inlet rotates between the first and second positions.

12. The system of claim 9, wherein the inlet includes a first alignment feature, the housing includes a second alignment feature, and each of said first and second alignment features align when the inlet is placed in at least one of the first and second positions.

13. The system of claim 12, wherein said first and second alignment features visibly align when the inlet is placed into at least one of the first and second positions.

14. The system of claim 9, wherein the inlet includes first and second tabs, the first tab positioned to contact a portion of the housing when the inlet is in the first position, the second tab positioned to contact a portion of the housing when the inlet is in the second position.

15. The system of claim 9, further comprising first and second sealing O-rings disposed at first and second fluid junctions between the moveable inlet and the second and third lumens, respectively.

16. A system for power injection of fluids into a patient, comprising:
a catheter having a distal end insertable into a patient, a proximal hub opposite the distal end, and defining a first lumen therethrough; and
a valve assembly, comprising:
a housing defining second and third lumens therethrough, the housing including, at one end, a wall having a circular aperture therethrough and, at an opposite end, an outlet fluidly connected to said catheter and said third lumen;
a pressure activated valve disposed between the second and third lumens, the valve adapted to permit fluid to flow from the second lumen to the third lumen when acted upon by a fluid pressure in excess of a predetermined threshold; and
a rotating luer assembly moveable between first and second positions, the luer assembly comprising a rotating luer tip moveable between first and second positions, wherein the luer, when in the first position, is fluidly connected to the second lumen and, when in the second position, is fluidly connected to the third lumen,

wherein the rotating luer is disposed within the circular aperture of the housing.

17. The system of claim 16, wherein the pressure activated valve prevents fluid flow from the third lumen to the second lumen.

18. The system of claim 16, wherein the rotating luer includes a first alignment feature, the housing includes a second alignment feature, and each of said first and second alignment features align when the rotating luer is placed in at least one of the first and second positions.

19. The system of claim 18, wherein said first and second alignment features visibly align when the inlet is placed into at least one of the first and second positions.

20. The system of claim 16, wherein said rotating luer includes first and second tabs, the first tab positioned to contact a portion of the housing when the luer is in the first position, the second tab positioned to contact a portion of the housing when the luer is in the second position.

21. The system of claim 16, further comprising first and second sealing O-rings disposed at first and second fluid junctions between the rotating luer and the second and third lumens, respectively.