WO2010054345A1

WO2010054345A1 - Patency check device

Info

Publication number: WO2010054345A1
Application number: PCT/US2009/063774
Authority: WO
Inventors: Frank M. Fago
Original assignee: Mallinckrodt Inc.
Priority date: 2008-11-10
Filing date: 2009-11-10
Publication date: 2010-05-14

Abstract

A patency check (100) device used in checking the patency of an intravenous catheter (201) is provided. The patency check device (100) may include a container member (101) operable to contain a volume of fluid. The container member (101) may also include a fluid port (102). The container member (101) may be in the form of a deformable pliable bag. A user (203) may squeeze the container member (101) to cause fluid to flow from the container member (101), through the fluid port (102) and into an intravenous catheter (201). Tactile feedback, in the form of a level of resistance to squeezing of the container member (101), may be evaluated by a user (203) to determine patency. The patency check device (300) may include a turbine (307) responsive to fluid flow into or out of the container member (301). Visual markings (308) on the turbine (307) may aid the user (203) in the patency determination.

Description

PATENCYCHECK DEVICE

REUTEDAPPLICATIQNS This application claims priority to US provisional application serial number 61/112,797 filed on 10

November 2008 entitled "PATENCY CHECK DEVICE".

FIELD OF THE IWENTION

The present invention generally relates to systems for checking the patency of medical fluid injection sites.

BACKGROUND

Intravenous delivery of fluids into a patient through a catheter is commonplace. Furthermore, checking for patency is commonplace for intravenous administration applications. Ensuring that an intravenous catheter is properly positioned in a patient's vein is particularly important with high flow rate injections such as those associated with delivering contrast media used in computed tomography and magnetic resonance imaging procedures. It may be difficult for a user to determine if a catheter is positioned inside the vein or adjacent to it in the subcutaneous tissue (a condition where fluid is injected into the subcutaneous tissue being commonly referred to as extravasation or infiltration) since the force to inject in each situation is not easily differentiated using conventional methods.

Many known methods of checking patency require the injection of fluids using a syringe. Such methods may be hampered by syringe actuation force variability and the difficulty in discerning the difference in the force required to inject fluids from a syringe into a patent intravenous catheter versus the force required to inject fluids from a syringe into a non-patent intravenous catheter.

SUMMARY

The first through fourth aspects of the present invention are each embodied by a patency check device. The patency check device includes a container member operable to contain an amount of fluid and a fluid port fluidly connected to the container member, As used herein, the phrase "fluidly connected" refers to two or more components or entities being connected (directly or indirectly) in a manner such that fluid can flow {e.g., undirectionally or bidirectionally) therebetween, For example, "a fluid port fluidly connected to the container member" describes a configuration where fluid is operable to flow between the container member, through any interconnecting devices (e.g., tubing, connectors), and the fluid port. The patency check device may be operable to interface with an intravenous catheter or any other appropriate device or combination of devices used to gain access to the vasculature (e.g., vein or artery) of a patient to check patency. As used herein, "intravenous catheter" includes a catheter or other medical device designed to be inserted into a patient to provide access to the vasculature of the patient to deliver fluids. Unless specified otherwise, an "intravenous catheter" referred to herein may be patent, partially patent, or non-patent.

In the case of the first aspect of the present invention, the container member of the patency check device includes a pliable bag operable to be deformed to discharge fluid from the container member through the fluid port. The pliable bag has a maximum internal volume of no more than about 15 milliliters (ml). Accordingly, a particular embodiment may include a pliable bag with a maximum volume of 15 ml, while another embodiment may include a pliable bag with a maximum volume of, for example, 5 ml or 10 ml. The pliable bag may, for example, be formed from two opposing sheets (e.g., polymer sheets) bonded or joined together along a periphery. The fluid port may include a portion of the periphery that is unbonded or unjoined. For example, a tube or other fluid conduit may be disposed between the polymer sheets, and the polymer sheets may be bonded to the tube or other fluid conduit in the region of the fluid port.

I n the case of the second aspect of the present invention, the fluid port of the patency check device is the only fluid inlet/outlet of the container member. In other words, the only fluid path into or out of the container member of the second aspect is the fluid port of the patency check device. The container member is operable to be deformed to discharge fluid therefrom through the single fluid port. The container member has a maximum internal volume of no more than about 15 ml.

In the case of the third aspect of the present invention, the patency check device includes a seal associated with the fluid port. This seal is removable by a user of the patency check device to facilitate discharging fluid contained in the container member through the fluid port. After the seal has been removed, the container member is operable to be deformed to discharge the fluid therefrom through the fluid port.

In aspects of the present invention where the patency check device includes a deformable container member, there may be little or no resistance from the container member itself to deformation and fluid discharge. Accordingly, resistance to the flow of fluid from the container member during a patency check may come primarily from the device whose patency is being checked (e.g., a non-patent intravenous catheter). This is unlike some devices used to check patency, such as syringes, where internal friction of components (e.g., friction between a plunger and a barrei) may significantly contribute to the resistance felt by a user during a patency check.

In the case of the fourth aspect of the present invention, the patency check device includes a movable indicator responsive to fluid flow into and/or out of the container member through the fluid port. The movable indicator may be observable by a user of the patency check device, who may evaluate patency based, at least in part, on observed movement of the movable indicator.

A number of feature refinements and additional features are separately applicable in relation to each of the above-noted first, second, third, and fourth aspects of the present invention. These feature refinements and additional features may be used individually or in any combination in relation to each of the first, second, third, and fourth aspects. That is, each of the following features that will be discussed is not required to be used with any other feature or combination of features unless otherwise specified.

The container member of some embodiments may be characterized as including at least one membrane that allows the container member to be deformed such that fluid may be discharged from the container member for purposes of providing a patency check. In one embodiment, the container member may be squeezed or compressed to discharge fluid from the container member in a manner that results in a shape change of the container member.

Embodiments of the first, second, and fourth aspects may further include a seal associated with the fluid port. This seal may be removable by a user of the patency check device so that, once the seal is removed, the container member may be operable to be deformed to discharge fluid therefrom through the fluid port thereof. In embodiments of the patency check device that include a seal, the seal may be removable from the container member by tearing the seal from the container member. In certain embodiments, the seal may be removed by twisting or pulling of a cap or Luer lock cover or any other appropriate sealing member type. Any such seal may be of any appropriate size, shape, configuration, and/or type, and may be "removed" from the patency check device in any appropriate manner.

In an embodiment, the container member of the patency check device may include a rigid base member and a resilient flexible member, The resilient flexible member may be operable to be deformed to discharge fluid from the container member through the fluid port thereof. The resilient flexible member may be operable to return toward an original shape after it has been deformed. In this regard, the resilient flexible member may be operable to draw fluid into the container member (e.g., through the fluid port) when returning toward the original shape.

An embodiment of the patency check device may include a movable indicator responsive to fluid flow into and/or out of the container member. The movable indicator may include a turbine designed to rotate in response to fluid flow into and/or out of the container member. The movable indicator may include markings and/or coloring to help a user to identify movement of the movable indicator.

The patency check device may include a connector fluidly connected to the fluid port and operable to fluidly connect to an external component. The external component may be an intravenous catheter or any other appropriate device to gain access to the vasculature of a patient. The external component may be a tube, tubing set, or other device that may be fluidly disposed between the patency check device and the intravenous catheter. In an embodiment, the patency check device may include an extension tube that is disposed between the connector and the container member and that is fluidly connected to the connector and the container member. The connector may be operable to fluidly connect the container member to the external component (e.g., intravenous catheter). The connector may be a Luer fitting or any other appropriate type of connector.

The patency check device may be configured such that fluid may be discharged from the container member using digital pressure from a user. For example, the user may place the patency check device between their thumb and index finger (more generally, between two portions of a single hand of the user, such as two different digits on the same hand) and squeeze or compress the patency check device to force fluid from the container member. Fluid may, for example, be operable to be discharged from the container member using a maximum force of less than about 1 pound of force. The container member of the patency check device may include fluid, for instance an appropriate liquid.

In this regard, the patency check device may be furnished to an operator with a fixed volume of liquid present within the container member. The container member may be partially or completely filled with liquid, Alternatively, the patency check device may be furnished to a user without liquid therein, and the user may partially or fully fill the patency check device with a liquid prior to performing a patency check. The liquid in the patency check device may be any appropriate medical liquid. For example, the medical liquid may include saline and/or any other appropriate biocompatible flushing media. The fluid port of the patency device may be sized to correspond to typical catheter access port sizes. In this regard, the fluid port may have an internal diameter (e.g., the diameter of a fluid path through the fluid port; the diameter of the lumen) of at least 0.5 millimeters (mm). In an arrangement, the fluid port may have an internal diameter corresponding to a typical Luer lock (about 2 mm). Accordingly, the fluid path through the fluid port may have a minimum cross-sectional area of at least about 0.78 square mm (e.g., a 0.5 mm bore). In an arrangement, the fluid port may have a cross-sectional area corresponding to a typical Luer lock (about 3.1 square mm). Such cross-sectional areas correspond to typical cross-sectional areas of connectors interconnected to typical catheters and allow for flow rates out of the container member that are conducive to receiving tactile feedback from the resistance to such flow due to the degree of patency of the catheter within the patient.

The patency device may include an outer package. The outer package may be sealed. The contents of the outer package may be sterile. For example, the outer package may be in the form of a sealable bag or other appropriate type of packaging where the outer package is operable to maintain the sterility of contents within the outer package. Furthermore, the container member sealed within the outer package may be partially or fully filled with fluid,

Fifth and sixth aspects of the present invention are each embodied by an injection system that includes an injection device (e.g., a power injector), a patency check device, a tubing set or other appropriate conduit, and an intravenous access device. The patency check device of the injection system includes a container member having a fluid port, The container member may include a pliable bag operable to be deformed to discharge fluid from the container member through the fluid port. The patency check device may be configured as described above with reference to any of the first through fourth aspects. The tubing set could provide a separate fluid connection for each of the injection device and the patency check device (e.g., such that each of the injection device and the patency check device could direct fluid to the intravenous access device through the tubing set without regard to whether or not the other of injection device and patency check device was fluidly interconnected with the intravenous access device), Alternatively, the tubing set could be configured so that only one of the injection device and the patency check device may be fluidly interconnected with the intravenous access device at any one time (e.g., the patency check device would need to be disconnected from the tubing set to allow the injection device to be connected to the tubing set, and vice versa).

Seventh through ninth aspects of the present invention are each embodied by a method of evaluating the patency of an intravenous access device, In each of these methods, a container member is fluidly interconnected to the intravenous access device, and a membrane is deformed to force at least some fluid from the container member into the intravenous access device. Furthermore, in each of the methods, patency of the intravenous access device is evaluated based on tactile feedback received as a result of deforming the membrane. In the case of the seventh aspect of the present invention, the method includes unsealing the container member. The container member may be sealed and contain a fluid prior to the unsealing step.

In the case of the eighth aspect of the present invention, the container member is in the form of a bag. As such, the deforming of the container member includes squeezing the bag. In the case of the ninth aspect of the present invention, medical fluid is deiivered into the intravenous access device after patency has been evaluated. In this regard, a fluid delivery apparatus (e.g., a power injector) may be interconnected to the intravenous access device, and the fluid delivery apparatus can be activated to deliver another fluid into the intravenous access device after the patency of that device has been evaluated. The fluid delivered via the fluid delivery apparatus may be same as or different from the fluid discharged from the patency check device. For example, the fluid delivered via the fluid delivery apparatus may be contrast media designed for use in a medical imaging process. In any case, the fluid delivery apparatus delivers fluid to the intravenous access device oniy after patency has been evaluated.

A number of feature refinements exist and additional features are separately applicable in relation to each of the above-noted seventh, eighth, and ninth aspects of the present invention. These feature refinements and additional features may be used individually or in any combination in relation to each of the seventh, eighth, and ninth aspects. That is, each of the following features that will be discussed is not required to be used with any other feature or combination of features unless otherwise specified.

In an embodiment, evaluating patency may include tearing off a seal member and/or removing a cap and/or removing a Luer lock cover from the container member to unseal the container member prior to fluidiy connecting the container member to the intravenous access device. Tearing off a seal member may include tearing, twisting, pulling or any other appropriate motion to remove the seal member from the container member. Removing a cap and/or Luer lock cover may include unscrewing, pulling or any other appropriate motion to remove the cap and/or Luer lock cover from the container member,

In an embodiment, evaluating patency may include opening an outer package containing the container member. In such an embodiment, the container member may be partially or fully filled with fluid prior to the opening of the outer package. The opening of the outer package may include breaking a seal of the outer package to gain access to the container member.

Methods of evaluating patency may include partially squeezing the container member to eject air from the container member prior to fluidiy interconnecting the container member with the intravenous access device, In an embodiment, the intravenous access device may include a heparin lock. The fluidiy interconnecting of the container member with the intravenous access device may include interconnecting a Luer fitting interconnected to the container member to a corresponding Luer fitting interconnected to the intravenous access device. in an embodiment, the deforming of the membrane may include a user squeezing or compressing the container member. The user may squeeze or compress the container member between a thumb and at least one other finger of the same hand. A user may evaluate the patency of the intravenous line based on a tactile feedback received during the squeezing or compressing of the container member. Methods of evaluating patency may include halting the deforming of the membrane and then drawing {or attempting to draw) fluid from within a patient into the patency check device and/or tubing interconnected to the patency check device. The drawing of fluid may be at least partially performed by the walls of the container member being biased toward returning to an original shape, and therefore creating a vacuum force within the container member upon release of the force used to deform the container member. The drawing of fluid may be at least partially due to fluid pressure (e.g., blood pressure) within the patient forcing fluid through the intravenous access device and into the container member.

In an embodiment, evaluating patency may include observing a movable indicator to determine a presence of flowing fluid (e.g., during the deforming of the membrane). The movable indicator may include a turbine responsive to fluid flow passing between the container member and the intravenous access device.

In embodiments of the seventh and eighth aspects of the present invention, the methods may include, after the deforming of the membrane, activating a fluid delivery apparatus to deliver another fluid into the intravenous access device. In relation to each of the seventh, eighth, and ninth aspects, the fluid delivery apparatus may be a power injector, although any appropriate fluid delivery apparatus could be utilized. The fluid that is delivered via the fluid delivery apparatus may be the same as or different from the fluid discharged from the patency check device. In other words, the fluid delivered via the fluid delivery apparatus may be of any appropriate type.

A patency check device and at least one other fluid source (e.g., a power injector) may be fluidly interconnected with the intravenous access device in any appropriate manner for each of the seventh, eighth, and ninth aspects, including without limitation sequentially (e.g., trie patency check device could be interconnected with the intravenous access device for performing a patency check, and thereafter removed to allow another fluid source to be interconnected with the intravenous access device). The patency check device and at least one fluid source (e.g., a power injector) could also be interconnected (e.g., physically) with the intravenous access device at overlapping times, For instance, an appropriate tubing set could allow each of the patency check device and at least one other fluid source to be interconnected with the intravenous access device at the same time, although it may be such that fluid is delivered to the intravenous access device from only one fluid source at a time (e.g., where the patency check device may be characterized as a fluid source).

A tenth aspect of the present invention is embodied by a device for determining patency of an injection site. This device includes a container member, a fluid port, and a connector. The container member includes a membrane and has a maximum internal volume of 20 milliliters. The connector is fiuidly connected to the fluid port and allows the device to be fluidiy connected with an external component. Deformation of the member via manually-applied pressure from a user (e.g., a user engaging the membrane and changing the shape thereof) discharges fluid from the container member through the fluid port.

A number of feature refinements exist and additional features are separately applicable in relation to the tenth aspect of the present invention. These feature refinements and additional features may be used individually or in any combination in relation to the tenth aspect. That is, each of the following features that will be discussed is not required to be used with any other feature or combination of features unless otherwise specified. Initially, the various features discussed above in relation to the patency check devices in accordance with each of the first, second, third, and fourth aspects may be used by the device of this tenth aspect, individually or in any combination. Moreover, the device of this tenth aspect may be used in place of the patency check device in the injection system of each of the fifth and sixth aspects of the present invention,

5

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is a perspective view of one embodiment of a patency check device. Figure 2 is a perspective view of the patency check device of Figure 1 interconnected to an intravenous catheter inserted into a patient. l o Figure 3A is a perspective view of another embodiment of a patency check device.

Figure 3B is a partial cross-sectional view of a portion of the patency check device of Figure 3A. Figure 4 is a perspective view of another embodiment of a patency check device. Figure 5 is a perspective view of the patency check device of Figures 3A and 3B within a package. Figure 6 is a schematic of one embodiment of a power injector.

15 Figure 7 is a schematic of one embodiment of an injection system that may use any of the patency check devices of Figures 1, 3A, and 4.

DETAILED DESCRIPTION Figure 1 is a perspective view of one embodiment of a patency check device 100. The patency check 0 device 10O may be used by a physician, nurse, technician, or other personnel (referred to herein as a "user") to check the patency of an intravenous access device inserted into a patient. The intravenous access device may be inserted into the vasculature of the patient such that a user may gain intravenous access to the patient through the intravenous access device. Generally, the following detailed description makes reference to patency check devices and methods to check the patency of intravenous catheters. It should be understood that the devices and 5 methods described herein may be used with any appropriate intravenous access device.

The patency check device 100 may include a container member 101. The container member 101 may be operable to contain a volume of fluid. The container member 101 may also include a fluid port 102. The fluid port 102 may be operable to allow fluid to pass therethrough to discharge fluid from the container member 101 and/or to fill the container member 101 with fluid. The container member 101 may be made from a transparent material. 0 In the illustrated embodiment, the fluid port 102 is the only access to the interior (e.g., the fluid-containing volume) of the container member 101. The fluid port 102 may be sized to correspond to typical catheter access port sizes. In this regard, the fluid port 102 may have an internal diameter (e.g., the diameter of a fluid path through the fluid port 102) of at least 0.5 mm. For example, the fluid port 102 may have an internal diameter corresponding to a typical Luer lock (about 2 mm). 5 The container member 101 may be deformable. For an example, an embodiment of the container member 101 may comprise a pliable bag. In such an embodiment, a user may squeeze or compress the container member 101 , thus collapsing the pliable bag and thereby raising the fluid pressure within the container member 101 and causing fluid to flow from the container member 101 through the fluid port 102. The container member 101 may, for example, be constructed from two thin layers of a polymer adjoining to each other around the perimeter of the container member 101 (e.g., via a heat seal on the like), thereby creating an internal volume operable to hold fluid. The container member 101, in the form of a pliable bag, may be configured such that upon the release of the container member 101, the container member 101 , absent any other forces (e.g., fluid pressure at the fluid port 102), remains in a collapsed state. The container member 101 may be characterized as being formed from one or more membranes, sheets, or the like.

In another embodiment, the container member 101 may be constructed such that it is capable of maintaining a predetermined shape. For example, the container member 101 illustrated in Figure 1 is shown with a bulbous central region surrounded by a flat perimeter region. The materia! used to construct the container member 101 may be configured to naturally take the shape as shown in Figure 1 (e.g., by being formed from a resilient or elastic material). In such an embodiment, a user may squeeze or compress the container member 101 to discharge fluid through the fluid port 102 of the container member 101, and upon release of the container member 101 the walls of the container member 101 may return at least toward the shape illustrated in Figure 1 (and including returning to the original, un-deformed shape). As the walls of the container member 101 return at least toward the shape illustrated in Figure 1 in this embodiment (e.g., by the elasticity of the container member 101 ; by the increase of the potential energy stored in the structure of the container member 101 from its deformation), a vacuum force may be created and fluid may be drawn into the container member 101 through the fluid port 102. As illustrated, the container member 101 may contain a single fluid outlet/inlet in the form of the fluid port

102. Fluidly interconnected to the fluid port 102 is a tube 103. The tube 103 may serve to fluidly connect the container member 101 to a connector 104 and which may be of any appropriate configuration. The connector 104 may be operable to fluidly connect to an external component such as an intravenous catheter or other device that has been inserted into a patient {e.g., including a tube leading to such an intravenous catheter). As illustrated in Figure 1, the connector 104 may take the form of a Luer fitting. The connector 104 may comprise other types of connectors used to fluidly connect to intravenous catheters. The connector 104 may be operable to interface with a heparin lock.

The patency check device 100 may include a sealing member 105. The sealing member 105 may be operable to block fluid flow out of or into the patency check device 100, to maintain sterility of the interior of the patency check device 100, or both. As illustrated in Figure 1, the sealing member 105 may be in the form of cap operable to fit over a portion of the connector 104 in embodiments where the connector 104 is a Luer fitting. The sealing member 105 may take other forms known to those skilled in the art. For example, the sealing member 105 may, for example, comprise a member that is integrally formed with the connector 104 and is operable to be twisted off by a user. Such an embodiment is illustrated in Figure 5, discussed below, where a removable sealing member5Q1 is shown interconnected to a port on a connector 104'. The sealing member 105 may be of any appropriate configuration (e.g., a removable film). In any case and returning to Figure 1, once the sealing member 105 is removed from the patency check device 100, fluid may then flow through the connector 104, tube 103 and fluid port 102 and fluid may be discharged from or passed into the container member 101.

Figure 2 is a perspective view of the patency check device 100 interconnected to an intravenous catheter 201 inserted into a patient 202. Methods of using the patency check device 100 will now be discussed with reference to Figures 1 and 2. After the intravenous catheter 201 has been inserted into a patient 202, the user may desire to check the patency of the intravenous catheter 201 prior to the patient 202 receiving a high volume injection of fluids such as, for example, contrast media used in various internal imaging methods.

The user may use the patency check device 100 to check the patency of the intravenous catheter 201. The patency check device 100 may come pre-filled with a fixed volume of fluid. "Fiiled" in this context does not require that the amount of fluid in the patency check device 100 corresponds with its maximum storage voiume. As addressed below, a relatively small volume of fluid may be retained with the container member 101 in order to enhance tactile feedback for undertaking a patency check. Any appropriate fluid may be stored in the container member 101 , for example liquid saline. The user may remove the sealing member 105 from the patency check device 100. As noted above, removal of the sealing member 105 may, for example, take the form of removing a cap or twisting off an end portion. The user may grasp the container member 101 of the patency check device 100 in the user's hand 203 between the user's thumb and index finger (e.g., more generally the container member 101 may be retained between 2 portions of the user's hand 203, such as between two digits). The user may squeeze or compress (e.g., gently) the container member 101 to eject a small amount of fluid out of the patency check device 100 to ensure that no unacceptable air bubbles are present within liquid contained in the patency check device 100. The user may then interconnect the connector 104 to the intravenous catheter 201 as illustrated in Figure 2 to fluidly interconnect the container member 101 to the intravenous catheter 201. The user may then deform the container member 101 (e.g., change the shape of the container member 101) to force a voiume of fluid from the container member 101 through the intravenous catheter 201 and into the patient 202. As noted above, such deformation may take the form of squeezing or compressing the container member 101 between the thumb and index finger of the user. This deformation may be characterized as a deflection of a membrane or sheet of the container member 101.

The patency of the intravenous catheter 201 may be evaluated based on the tactile feedback received by the user through the container member 101. In this regard, a properly installed intravenous catheter 201 will offer relatively little resistance to the flow of fluid from the container member 101 and into the body of the patient 202. For example, it may take about 1 pound of force or less on the container member 101 to discharge fluid from the container member 101 into the intravenous catheter 201 when the intravenous catheter 201 is properly patent. In contrast, an intravenous catheter 201 that has not been properly installed and that does not provide access to the vasculature of the patient 202 may take a detectably greater force to squeeze the container member 101 such that the fluid within the container member 101 is delivered into the patient 202. This greater force may be 4 pounds of force or more. Accordingly, the user should be able to discern the difference between the force required to discharge fluid from the container member 101 when the intravenous catheter 201 is patent versus the force required to discharge fluid from the container member 101 when the intravenous catheter 201 is not properly inserted.

The container member 101 may utilize any appropriate interna! volume to store fluid fora patency check. Generally, the maximum internal volume of the container member 101 may be selected such that a user of the patency check device 100 may be able to determine patency of the catheter 201 fluidly connected to the patency check device 100 through tactile feedback experienced during the patency check. If the maximum internal volume is too small, the user may be unable to discern fluid flow resistance due to a lack of patency (e.g., due to the fluid within the container member 101 being expelled from the container member 101 too quickly for a user to receive adequate tactile feedback to make a patency determination). If the maximum internal volume is too large, other factors (e.g., fluid movement within the container member 101, compression of any entrapped gasses within the container member 101 , stretching of the container member 101) may mask (e.g., the system may have a low signal-to-noise ratio) the effects of patency on the tactile feedback felt during container member 101 deformation. Accordingly, the container member 101 may have a maximum internal volume of less than about 20 ml. For example, in some embodiments, the container member 101 may have a maximum internal volume of about 15 ml or less. In some embodiments, the container member 101 may have an internal volume of about 10 ml. The container member 101 may have a maximum dimension of less than about 5 centimeters (cm).

In place of, or in addition to, checking patency by discerning the level of force required to force the fluid from the container member 101 into the intravenous catheter 201 (e.g., a tactile feedback for the user), the user may also check patency by releasing the container member 101 (after the user has caused fluid to be discharged from the container member 101 into the patient 202) and observing whether or not there is biood flow into the container member 101 and/or tube 103. For example, where the container member 101 is a pliable bag, blood pressure within the patient 202 may cause blood to flow into the tube 103 and container member 101 when the intravenous catheter 201 is patent (e.g., properly inserted into the vasculature of the patient). If the intravenous catheter 201 is not patent (e.g., not properly inserted into the vasculature), there may be little or no blood pressure operable to force blood into the tube 103 and container member 101. Accordingly, if upon release blood is observed to flow into the tube 103 and container member 101 , this may be taken as an indication of patency of the intravenous catheter 201.

!n another example, where the container member 101 is constructed such that upon release of the container member 101, the container member 101 walls rebound toward the shape as illustrated in Figure 1 (e.g., the "static" shape or condition), release of the container member 101 by the user may ailow the walls of the container member 101 to rebound and thus form a negative pressure within the container member 101 that may actively attempt to pull fluid into the container member 101 (e.g., via a vacuum or suction force), Similar to as above, if the intravenous catheter 201 is not patent, there may be little or no blood flow into the tube 103 and container member 101. If the intravenous catheter 201 is patent, blood may flow into the tube 103 and container member 101 , thereby indicating patency of the intravenous catheter 201.

After performing the patency check as described above, the connector 104 may be disconnected from the intravenous catheter 201 and the patency check device 100 may be discarded.

IO Figure 3A is a perspective view of another embodiment of a patency check device 300. The patency check device 300 may include a container member 301 that may be configured generally similar to the container member 101. The container member 301 may include a fluid port 302 operable to fluidly connect the container member 301 with a fluid port member 303. The fluid port member 303 may be a non-pliable member operable to fluidly connect the container member 301 with a connector 104', The connector 104¹ may be at least partially integrally formed with the fluid port member 303. The interface between the fluid port member 303 and the container member 301 may be sealed using any appropriate method such as through welding or an adhesive. In the illustrated embodiment, the fluid port 302 is the only access to the interior of the container member 301. Deforming, squeezing, or compressing the container member 301 discharges fluid through the fluid port 302. The fluid port 302 may be sized similarly to fluid port 102.

Generally, the maximum internal volume of the container member 301 may be selected such that a user of the patency check device 300 may be able to determine patency of a catheter fluidly connected to the patency check device 300 through tactile feedback experienced during the patency check, similar to as described above with respect to patency check device 100. The patency check device 300 may include an indicator 304 operable to provide a visual indication of fluid flow into or out of the container member 301. Figure 3B is a partial cross-sectional viewofthe patency check device 300 taken along a horizontal plane through section line 3B of Figure 3A. In Figure 3A₁ the arrows attached to the section line 3B indicate the direction of the view of Figure 3B. The fluid port member 303 may include a fluid passage 305 that fluidly connects the container member 301 with the connector 104'. As fluid flows from the container member 301 toward the connector 104' (or vice versa) along the fluid passage 305, the fluid may contact and impart a force on an indicator wheel 307 disposed in an indicator chamber 306. The indicator wheel 307 may be in the form of a turbine comprising a plurality of arms or blades 309 distributed around its periphery. A portion of the plurality of arms 309 may interact with the fluid stream to impart the force on the indicator wheel 307, thereby causing the indicator wheel 307 to rotate in response to the fluid movement. To assist in visual detection of the rotation of the indicator wheel 307, a visual indicator 308 may be disposed on top of the indicator wheel 307. The visual indicator 308 may be in the form of a line colored and/or shaped to contrast with the rest of the indicator wheel 307. A clear member may be disposed over the indicator wheel 307 to seal the indicator chamber 306. It should be appreciated that the flow indicator 304 could be incorporated by any appropriate patency check device. Figure 4 is a perspective view of another embodiment of a patency check device 400. The patency check device 400 includes a resilient or elastic member 401 and a rigid base member 402, The resilient member 401 may be in the shape of a dome or any other appropriate shape (e.g., an at least generally convex structure). Together, the resilient member 401 and a rigid base member 402 may form a chamber operable to contain a fluid. The patency check device 400 may further include a fluid port member 403 that fluidly connects the chamber with a connector 104". In the illustrated embodiment, the fluid port member 403 is the only access to the chamber. The fluid port member 403 may include a passage therethrough that is sized similarly to fluid port 102.

Upon deformation or deflection of the resilient member 401 by applying a downwardly-directed force to the top of the dome of the resilient member 401 in the view shown in Figure 4 (e.g., inwardly-directed in relation to the fluid-container chamber), fluid may be forced out of the chamber along the fluid port member 403, through the connector 104" and into a body of a patient through an intravenous catheter. Upon release of the downward force to the resilient member 401 , the resilient member 401 may attempt to return to its original shape (e.g., dome) and thus provide some vacuum force to draw fluids into the chamber to further assist in evaluating patency. The patency check device 400 may include an indicator 404 similar to the indicator 304 discussed above.

The patency check device 400 may be used in a similar fashion as the patency check device 300 described above. The connector 104" of the patency check device 400 may be directly fluidly connected to an intravenous catheter. The connector 104" of the patency check device 400 may be interconnected to a tube that in turn is connected to an intravenous catheter. Generally, the maximum internal volume of the patency check device 400 (e.g., the volume between the resilient member 401 prior to deformation and the rigid base 402) may be selected such that a user of the patency check device 400 may be able to determine patency of a catheter fluidly connected to the patency check device 400 through tactile feedback experienced during the patency check, similar to as described above with respect to patency check device 100 and patency check device 300. Figure 5 is a perspective view of the patency check device 300 of Figures 3A and 3B within an exemplary package 500. The package 500 may protect the patency check device 300 prior to use. The package 500 may be operable to maintain the sterility of the patency check device 300 while the patency check device 300 is sealed within the package 500. The package 500 may be formed in any appropriate manner. For example, the package 500 may be formed from an upper sheet 503 and a lower sheet 502 bonded (e.g., chemically) and/or sealed (e.g., heat-sealed) together to form an interior portion capable of housing the patency check device 300. One or both of the sheets 502, 503 may be transparent to aid in identification of the patency check device 300 therein. Other embodiments of patency check devices disclosed herein may be similarly packaged. The patency check device 300 within the package 500 may be pre-filled with a fluid such as, for example, saline.

Methods for delivering medical fluid into an intravenous catheter that include evaluating patency using the pre-filled patency check device 300 of Figures 3A and 5 will now be described. Similar steps may be used to check patency with the other patency check device embodiments described herein. Prior to delivering medical fluids into an intravenous catheter, a patency check may be performed to verify that the intravenous catheter is patent. This may be particularly beneficial where there is a high volume of medical fluids to be delivered, such as contrast media for an imaging procedure. A first step to the process may be to remove a patency check device 300 from an outer package 500.

This may include breaking a seal of the outer package 500 (e.g., tearing open the package 500). Alternatively, the patency check device 300 may be bulk packaged (e.g., not in individual packages). Where the patency check device 300 is bulk packaged or where the individual package does not maintain sterility, the interior portions of the patency check device 300 may be sterile and the sterility may be maintained by the sealing member 501 , The next step may be to remove the sealing member 501 by twisting off the sealing member 501 from the connector 104". Alternatively, as with the patency check device 100, the sealing member 105 may be in the form of a cap that may be pulled or twisted off of the connector 104. Returning to the embodiment of Figure 3A, the next step may be to attach a tube member to the connector 104'. The tube member may be in the form of a tube with a Luer connector on each end such that the tube member may be connected to the patency check device 300 on one end and the intravenous catheter on the other end. This step may not be needed where a tube is an integral part of the patency check device as with patency check device 100. Once the tube member is connected to the patency check device 300, the next step may be to force out any air within the patency check device 300 and tube member. This step may avoid forcing air into the intravenous catheter during the patency check. Once any air has been expelled from the patency check device 300 and attached tube member, the next step may be to attach the patency check device 300 to the intravenous catheter. This may be achieved by connecting the free end of the tube member to the intravenous catheter. The next step may be to deform the container member 301 of the patency check device 300 to force fluid out of the container member 301. This may be accomplished by squeezing or compressing the container member 301 and thus forcing fluid contained within the container member 301 into the intravenous catheter. The patency check device 300 may be squeezed between a thumb and index finger similar to as shown in Figure 2.

While deforming (e.g., squeezing or compressing) the patency check device 300, the user may evaluate patency based on the level of resistance to squeezing from the container member 301 in a manner similar to as previously described with respect to the patency check device 100 of Figures 1 and 2.

In addition to tactile feedback, while deforming the container member 301 , the user may observe the indicator 104 to determine if fluid is flowing from the container member 301 into the intravenous catheter. In this regard, the user may observe the visual indicator 308. If it is rotating, fluid flow is indicated. Furthermore, the rate of rotation may be indicative of the flow rate. Accordingly, for a given level of force applied by the user, the user may be able to discern (by observing the rate of rotation of the visual indicator 308) between a patent intravenous catheter, into which the fluid from the container member 301 may flow at a first rate causing the visual indicator 308 to rotate at a first speed, and a non-patent intravenous catheter, into which the fluid from the container member 301 may flow at a second rate causing the visual indicator 308 to rotate at a second speed, where the second speed is discernibly slower than the first speed.

In situations where the user is able to determine patency from tactile and/or visual feedback during deformation (e.g., squeezing) of the container member 301, the next step may be to disconnect the patency check device 300 from the intravenous catheter. Post-container member 301 disconnection steps are discussed below. in situations where the user is not able to satisfactorily determine patency from tactile and/or visual feedback during deformation (e.g., squeezing) of the container member 301 , the next step may be to remove the deformation force (e.g., stop squeezing) from the container member 301. After removal of the deformation force, the user may observe the container member 301 and any tubing attached thereto to see if any blood is flowing from the intravenous catheter toward/into the container member 301. Such flow may be a result of a fluid connection between the container member 301 and blood pressure associated with a patent intravenous catheter. The user may also observe the indicator 304 to see if fluid flow is occurring from the intravenous catheter toward the container member 301. In embodiments where the patency check device includes a resilient member capable of generating a vacuum force upon release, the user may assess patency based on the flow rate of blood into the container member. A relatively high flow rate may indicate patency, whereas a low flow rate or no flow may indicate that the intravenous catheter is not patent. After patency is thusly determined, the next step may be to disconnect the patency check device 300 from the intravenous catheter. With some tubing sets (e.g., a "Y" tubing set interconnected to the intravenous catheter, with the patency check device being interconnected to one branch of the "Y" tubing set, and with another fluid source (e.g., a power injector) being interconnected with another branch of the "Y" tubing set), physical disconnection of the patency check device 300 may not be required to thereafter deliver fluids to the intravenous catheter from another fluid source.

After disconnection of the patency check device 300 from the intravenous catheter, the next step may be to discard the patency check device 300. In situations where it has been determined that patency is not adequate, the next step may be to reposition the intravenous catheter and repeat the patency check procedure.

In situations where patency has been determined to be adequate, the next step may be to attach a device for delivering fluids to the intravenous catheter. For example, a medical fluid delivery apparatus may be fluidly interconnected to the intravenous catheter. The medical fluid to be delivered may, for example, include contrast media used in an imaging procedure. The next step may be to activate the medical fluid delivery apparatus to deliver the medical fluid to the intravenous catheter. In an embodiment, the medical fluid delivery device may be a power injector.

The patency check device 300, at least one other fluid source (e.g., a power injector), and an intravenous catheter may be fluidly interconnected in any appropriate manner, including where only one of the patency check device 300 or another fluid source is physically interconnected with the intravenous catheter at any one time. However and as previously noted, an appropriate tubing set could be utilized that would allow each of the patency check device 300 and another fluid source (e.g., a power injector) to remain physically interconnected with the intravenous catheter at the same time. For instance, the above-noted Y-type tubing set could be utilized. A tubing set could also be utilized that included an access port to which the patency check device 300 could be fluidly interconnected, and where the tubing set extends from the intravenous catheter to at least one other fluid source (e.g., a power injector).

Figure 6 presents a schematic of an injection device in the form of one embodiment of a power injector 600 having a powerhead 602. One or more graphical user interfaces or GUIs 601 may be associated with the powerhead 602. Each GUI 601 : 1) may be of any appropriate size, shape, configuration, and/or type; 2) may be operatively interconnected with the powerhead 602 in any appropriate manner; 3) may be disposed at any appropriate location; 4) may be configured to provide one or any combination of the following functions: controlling one or more aspects of the operation of the power injector 600; inputting/editing one or more parameters associated with the operation of the power injector 600; and displaying appropriate information (e.g., associated with the operation of the power injector 600); or 5) any combination of the foregoing. Any appropriate number of GUIs 601 may be utilized. In one embodiment, the power injector 600 includes a GUI 601 that is incorporated by a console that is separate from but which communicates with the powerhead 602. in another embodiment, the power injector 600 includes a GUI 601 that is part of the powerhead 602. In yet another embodiment, the power injector 600 utilizes one GUI 601 on a separate console that communicates with the powerhead 602, and also utilizes another GUI 601 that is on the powerhead 602. Each GUI 601 could provide the same functionality or set of functionalities, or the GUIs 601 may differ in at least some respect in relation to their respective functionalities. A syringe 610 may be installed on this powerhead 602 and, when installed, may be considered to be part of the power injector 600. Some injection procedures may result in a relatively high pressure being generated 5 within the syringe 610. In this regard, it may be desirable to dispose the syringe 610 within a pressure jacket 609. The pressure jacket 609 is typically associated with the powerhead 602 in a manner that allows the syringe 610 to be disposed therein as a part of or after installing the syringe 610 on the powerhead 602. The same pressure jacket 609 will typically remain associated with the powerhead 602, as various syringes 610 are positioned within and removed from the pressure jacket 609 for multiple injection procedures, The power injector 600 may eliminate i o the pressure jacket 609 if the power injector 600 is configured/utilized for low-pressure injections and/or if the syringe(s) 610 to be utilized with the power injector 600 is (are) of sufficient durability to withstand high-pressure injections without the additional support provided by a pressure jacket 609. In any case, fluid discharged from the syringe 610 may be directed into a conduit 615 of any appropriate size, shape, configuration, and/or type, which may be fluidly interconnected with the syringe 610 in any appropriate manner, and which may direct fluid to any

15 appropriate location (e.g., to a patient).

The powerhead 602 includes a syringe plunger drive assembly or syringe plunger driver 603 that interacts (e.g., interfaces) with the syringe 610 (e.g., a plunger 612 thereof) to discharge fluid from the syringe 610. This syringe plunger drive assembly 603 includes a drive source 604 (e.g., a motor of any appropriate size, shape, configuration, and/or type, optional gearing, and the like) that powers a drive output 605 (e.g., a rotatable drive 0 screw). A ram 606 may be advanced along an appropriate path (e.g., axial) by the drive output 605. The ram 606 may include a coupler 607 for interacting or interfacing with a corresponding portion of the syringe 610 in a manner that will be discussed below.

The syringe 610 includes the plunger or piston 612 that is movably disposed within a syringe barrel 611 (e.g., for axial reciprocation along an axis coinciding with the double-headed arrow B). The plunger 612 may 5 include a coupler 613. This syringe plunger coupler 613 may interact or interface with the ram coupler 607 to allow the syringe plunger drive assembly 603 to retract the syringe plunger 612 within the syringe barrel 611. The syringe plunger coupler 613 may be in the form of a shaft 614a that extends from a body of the syringe plunger 612, together with a head or button 614b. However, the syringe plunger coupler 613 may be of any appropriate size, shape, configuration, and/or type. 0 Generally, the syringe plunger drive assembly 603 of the power injector 600 may interact with the syringe plunger 612 of the syringe 610 in any appropriate manner (e.g., by mechanical contact; by an appropriate coupling (mechanical or otherwise)) so as to be able to move or advance the syringe plunger 612 (relative to the syringe barrel 611) in at least one direction (e.g., to discharge fluid from the corresponding syringe 610). That is, although the syringe plunger drive assembly 603 may be capable of bi-directional motion (e.g., via operation of the same 5 drive source 604), the power injector 600 may be configured such that the operation of the syringe plunger drive assembly 603 actually only moves each syringe plunger 612 being used by the power injector 600 in only one direction. However, the syringe plunger drive assembly 603 may be configured to interact with each syringe plunger 612 being used by the power injector 600 so as to be able to move each such syringe plunger 612 in each of two different directions (e.g. in different directions along a common axial path).

Retraction of the syringe plunger 612 may be utilized to accommodate a loading of fluid into the syringe barrel 611 for a subsequent injection or discharge, may be utilized to actually draw fluid into the syringe barrel 611 5 for a subsequent injection or discharge, or for any other appropriate purpose. Certain configurations may not require that the syringe plunger drive assembly 603 be able to retract the syringe plunger 612, in which case the ram coupler 607 and syringe plunger coupler 613 may not be desired. In this case, the syringe plunger drive assembly 603 may be retracted for purposes of executing another fluid delivery operation (e.g., after another pre- filled syringe 610 has been installed). Even when a ram coupler 607 and syringe plunger coupler 613 are utilized, i o it may such that these components may or may not be coupled when the ram 606 advances the syringe plunger 612 to discharge fluid from the syringe 610 (e.g., the ram 606 may simply "push on" the syringe plunger 612). Any single motion or combination of motions in any appropriate dimension or combination of dimensions may be utilized to dispose the ram coupler 607 and syringe plunger coupler 613 in a coupled state or condition, to dispose the ram coupler 607 and syringe plunger coupler 613 in an urt-coupled state or condition, or both.

15 The syringe 610 may be installed on the powerhead 602 in any appropriate manner. For instance, the syringe 610 could be configured to be installed directly on the powerhead 602, In the illustrated embodiment, a housing 608 is appropriately mounted on the powerhead 602 to provide an interface between the syringe 610 and the powerhead 602. This housing 608 may be in the form of an adapter to which one or more configurations of syringes 610 may be installed, and where at least one configuration fora syringe 610 could be installed directly on 0 the powerhead 602 without using any such adapter. The housing 608 may also be in the form of a faceplate to which one or more configurations of syringes 610 may be installed. In this case, it may be such that a faceplate is required to install a syringe 610 on the powerhead 602 - the syringe 610 could not be installed on the powerhead 602 without the faceplate. When a pressure jacket 609 is being used, it may be installed on the powerhead 602 in the various manners discussed herein in relation to the syringe 610, and the syringe 610 will then thereafter be 5 installed in the pressure jacket 609.

The housing 608 may be mounted on and remain in a fixed position relative to the powerhead 602 when installing a syringe 610. Another option is to movably interconnect the housing 608 and the powerhead 602 to accommodate installing a syringe 610. For instance, the housing 608 may move within a plane that contains the double-headed arrow A to provide one or more of coupled state or condition and an un-coupled state or condition 0 between the ram coupler 607 and the syringe plunger coupler 613.

The injection device in the form of the power injector 600 may be utilized with any of the above-described patency check devices 100, 300, 400 in an injection system. A method of delivering fluid into an intravenous access device may include using any of the above-described patency check devices 100, 300, 400 and associated methods to check the patency of an intravenous access device installed in a patient using a first fluid from the 5 patency check device 100, 300, 400. This may be followed by interconnecting the power injector 600 (or another appropriate injection device) to the intravenous access device. The power injector 600 may then be activated to deliver a second fluid (e.g., from the syringe 610) into the intravenous access device. The first and second fluids may be of the same type or of different types.

Figure 7 illustrates one embodiment of an injection system 700 that includes an injection device 710 of any appropriate type (e.g., a power injector), an intravenous access device 720 of any appropriate type (e.g., a catheter), and a patency check device 750 in accordance with any of the embodiments described herein (e.g., patency check devices 100, 300, 400). A tubing set or other appropriate conduit 730 includes a separate connection for each of the injection device 710 and the patency check device 750 (e.g., such that each may be fluidly connected with the tubing set 730 at the same time if desired), and extends to the intravenous access device 720. Valving 740 (e.g., a check valve) may be included in the tubing set 730 between the injection device 710 and the patency check device 750. Other components may be included in the tubing set 730.

When the patency check device 750 is connected with the tubing set 730 in the case of the injection system 700 of Figure 7, a fluid (e.g., a liquid) may be delivered by the patency check device 730 to the intravenous access device 720 via the tubing set 730. After patency has been confirmed and at a time when the injection device 710 is connected with the tubing set 730, a fluid (e.g., a liquid) may be delivered by the injection device 710 to the intravenous access device 720 via the tubing set 730. The fluids delivered by the patency check device 750 and the injection device 710 may be of the same type or of different types.

The foregoing description of the present invention has been presented for purposes of illustration and description. Furthermore, the description is not intended to limit the invention to the form disclosed herein. Consequently, variations and modifications commensurate with the above teachings, and skill and knowledge of the relevant art, are within the scope of the present invention. The embodiments described hereinabove are further intended to explain best modes known of practicing the invention and to enable others skilled in the art to utilize the invention in such, or other embodiments and with various modifications required by the particular application(s) or use(s) of the present invention. It is intended that the appended claims be construed to include alternative embodiments to the extent permitted by the prior art.

Claims

What is claimed:

1. A device for determining patency of an injection site, the device comprising: a container member comprising a membrane and having a maximum internal volume of no more than 20

5 a fluid port through which fluid discharged from the container member is designed to flow in response to the membrane being deformed via manual pressure from a user; and a connector fluidly connected to the fluid port and operable to fiuidiy connect the container member with an externa! component.

2. The device of claim 1, further comprising: l O a removable seal associated with the connector, wherein, after the seal is removed, the container member is operable to be deformed to discharge fluid therefrom through the fluid port and the connector.

3. The device of any of claims 1-2, wherein the fluid port is the only fluid path into or out of the container member.

4. The device of any of claims 1-3, wherein the container member comprises a rigid base 15 member, wherein the membrane is a resilient flexible member, and wherein the resilient flexible member is operable to be deformed to discharge fluid from the container member through the fluid port of the container member.

5. The device of claim 4, wherein the resilient flexible member is operable to return toward an original shape after it has been deformed, and wherein the resilient flexible member is operable to draw fluid 0 into the container member when returning toward the original shape.

6. The device of any of claims 1 -3, wherein the container member comprises a pliable bag, which in turn comprises the membrane,

7. The device of any of claims 1-6, further comprising: a movable indicator responsive to at least one of fluid flow into the container member and fluid flow out of 5 the container member.

8. The device of claim 7, wherein the movable indicator comprises a turbine disposed to rotate in response to at least one of fluid flow into the container member and fluid flow out of the container member.

9. The device of any of claims 1-8, further comprising: 0 a tube disposed between the connector and the fluid port of the container member, wherein the tube is fluidly connected to the connector and the fluid port of the container member.

10. The device of any of claims 1-9, wherein the connector is operable to fiuidiy connect the fluid port of the container member to a catheter.

11. The device of any of claims 1-10, wherein the connector comprises a Luer fitting. 5

12. The device of claim 11, further comprising: a Luer fitting cap disposed on the Luer fitting such that the container member is sealed.

13, The device of any of claims 1-12, wherein the container member has a maximum internal volume of no more than 15 ml.

14. The device of any of claims 1-13, wherein the container member has a maximum cross dimension of no more than 5 cm.

15. The device of any of claims 1-14, wherein the container member is designed to discharge fluid therefrom when exposed to a force of about 1 pound.

16. The device of any of claims 1-15, further comprising: fluid disposed within the container member.

17. The device of claim 16, wherein the fluid comprises saline.

18. The device of claim 16, wherein the fluid consists essentially of saline.

19. The device of any of claims 1-18, wherein the container member contains a fixed volume of fluid.

20. The device of any of claims 1 -19, wherein a fluid path through the fluid port has a minimum cross-sectional area of 0.78 square mm.

21. A patency check assembly comprising: an outer package; and the device of any of claims 1-20, wherein the device is sealed within the outer package.

22. An injection system comprising: an injection device; the device of any of claims 1-20; a tubing set compatible for being simultaneously fluidly connected with both the injection device and the device of any of claims 1-20; and an vascular access device fluidly connected with the tubing set.

23. A method for performing an injection procedure, the method comprising: evaluating patency of a vascular access device, the evaluating comprising: fluidly connecting a patency check device to the vascular access device; and deforming a membrane of the patency check device to force fluid therefrom through the vascular access device and into a patient; fluidly connecting a fluid delivery apparatus to the vascular access device; and activating the fluid delivery apparatus to deliver fluid through the vascular access device and into the patient, wherein the activating is executed after the evaluating if the patency of the vascular access device is determined to be satisfactory based, at least in part, on the evaluating.

24. The method of claim 23, further comprising: dissociating a seal from the patency check device prior to fluidly connecting the patency check device to the vascular access device.

25. The method of claim 23, further comprising: removing a cap from the patency check device prior to fluidly connecting the patency check device to the vascular access device.

26. The method of claim 23, further comprising: removing a Luer lock cover member from the patency check device prior to fluidly connecting the patency check device to the vascular access device.

27. The method of any of claims 23-26, further comprising: opening an outer package containing the patency check device, wherein the patency check device has fluid disposed therein prior to the opening.

28. The method of claim 27, wherein the opening comprises breaking a seal of the outer package to gain access to the patency check device.

29. The method of any of claims 23-28, further comprising: ejecting air from the patency check device prior to fluidly connecting the patency check device to the vascular access device.

30. The method of any of claims 23-29, wherein fluidly connecting the patency check device to the vascular access device comprises fluidly connecting the patency check device to a heparin lock.

31. The method of any of claims 23-29, wherein fluidly connecting the patency check device to the vascular access device comprises fluidly connecting a Luer fitting of the patency check device to a complimentary Luer fitting that is fluidly connected to the vascular access device,

32. The method of any of claims 23-31 , wherein the evaluating occurs while the fluid delivery apparatus is fluidly connected to the vascular access device.

33. The method of any of claims 23-32, wherein the deforming comprises a user squeezing the membrane.

34. The method of claim 33, wherein the squeezing is performed between a thumb and at least one other finger of a user.

35. The method of any of claims 23-34, further comprising: determining the patency of the vascular access device based, at least in part, on tactile feedback of a user of the patency check device.

36. The method of any of claims 23-35, further comprising: observing a movable indicator of the patency check device to determine at least a presence or an absence of fluid flow during the deforming.

37. The method of claim 36, wherein the movable indicator comprises a turbine responsive to fluid flow passing between the patency check device and the vascular access device.