Vascular access device assembly facilitating single-handed advancement of an introducer probe

Abstract

A vascular access device assembly is provided that facilitates one-handed patency probe advancement. The IV device assembly may include a lumen (102) forming a fluid channel within the IV device assembly. The lumen may be fluidly coupled to a vascular access device (VAD) interface via a funnel-type interface (106) and to an IV device assembly interface (108) at a proximal end of the lumen. The IV device assembly may also include one or more of: a collapsible sleeve (122) coaxially formed around a first portion of the lumen and mechanically coupled to the funnel-type interface; a patency instrument (112) formed within the collapsible sleeve along a second portion of the lumen and into the VAD interface; a translation handle (114) for translating the patency instrument out the distal end of the VAD interface; and a fixed grip (116) formed around the lumen for maintaining the position of the IV device assembly relative to the translation handle.

Description

Technical Field

[0001] The present invention relates to a vascular access device assembly that facilitates one-handed advancement of an introducer probe.

Background Art

[0002] By extending the patency of an intravenous (IV) device, longer-term placement can be made more possible, reducing the expense of unnecessary additional intervention procedures and the need to expose the patient to trauma. More specifically, during use of an IV device, the IV device is inserted into the patient's blood vessel, and in some cases, while the IV device remains in the patient's blood vessel, the needle is withdrawn from the IV device. Depending on the situation, the IV device may remain in the patient's blood vessel for up to 30 days. This is done to allow a clinician or another healthcare provider (HCP) to have fluid access to the patient's bloodstream during care. This continuous fluid access to the patient's bloodstream allows the clinician or another HCP to draw one or more blood samples when appropriate, or to administer one or more infusions such as saline, various drugs, and total parenteral nutrition.

[0003] However, while the IV device is inside the patient's blood vessel, the patency of the IV device may be impaired. Some interference may continuously disable the IV device, resulting in the need for another administration of the IV device into the patient's body. This can increase the trauma felt by the patient and lead to another medical problem such as inflammation of the blood vessel among other medical problems.

[0004] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or operate only in environments such as those described herein. Rather, this background is provided to describe the environment in which the embodiments described herein can operate.

Summary of the Invention

Means for Solving the Problems

[0005] The present disclosure generally relates to an intravenous (IV) device assembly for use in interacting with a vascular access device (VAD), such as a catheter. In some embodiments, the IV device assembly provides a fluid pathway to the VAD device while a needle and / or catheter is within a patient's blood vessel and also provides an existence device that is used to periodically check the existence of the VAD.

[0006] The IV device assembly may include a lumen that forms a fluid channel within the IV device assembly, the lumen being fluidly coupled to a VAD coupling at a distal end via a funnel-shaped junction and to an IV device assembly coupling at a proximal end of the lumen. In these embodiments, the IV device assembly may further include a collapsible sleeve coaxially formed around a first portion of the lumen and mechanically coupled to the funnel-shaped junction. In these embodiments, the IV device assembly includes an existence device formed into the VAD coupling along a second portion of the lumen within the collapsible sleeve by a translation handle that translates the existence device out from the distal end of the VAD coupling, and a fixed grip formed around the lumen that maintains the position of the IV device assembly relative to the translation handle. In these embodiments, the existence device may be a double-length existence device or a single-length existence device.

[0007] In embodiments where the access device is a twice-as-long access device, the first end of the access device can be mechanically coupled to the funnel-shaped coupling and passed through a channel formed in the translation handle, whereby the access device can be sent into the VAD coupling through a seal formed in the funnel-shaped coupling. In these embodiments, for example, when the translation handle is moved distally towards the VAD coupling, the access device may be expanded beyond the VAD coupling, and in some embodiments, by entering the catheter, the access device can inspect the patency of the catheter. Similarly, when the IV device assembly includes a once-as-long access device, the first end of the access device is fixed to the translation handle, and the translation of the translation handle towards the distal end of the IV device assembly thereby expands the access device beyond the VAD coupling as described.

[0008] In some embodiments, the lumen used for the fluid pathway through the IV device assembly may be offset from the central longitudinal axis. In these embodiments, the access device can enter the funnel-shaped coupling at the central longitudinal axis so that the access device can pass through the funnel-shaped coupling. Additionally, since the lumen is offset from the fluid axis of the VAD coupling to which the funnel-shaped coupling is mechanically coupled, the funnel-shaped coupling may include a coupling channel for completing the fluid channel from the lumen to the VAD coupling.

[0009] In some embodiments, the IV device assembly may include a catheter, such as, for example, a peripheral IV catheter (PIVC) or another suitable catheter, coupled to the VAD coupling. In some embodiments, the catheter may include a needle for accessing the patient's blood vessel. In some embodiments, the IV device assembly further includes a blood sample access device mechanically coupled to the IV device assembly coupling for receiving a blood sample through the IV device assembly.

[0010] In some embodiments, the introducer device may include a guide wire with a porous distal end. In certain examples, the porous distal end may include a winding of material around a central portion of the introducer guide wire.

[0011] In some embodiments, the collapsible sleeve includes a coil spring formed therein. The coil spring may be biased to expand the translation handle toward the proximal end of the IV device assembly. In some embodiments, the coil spring expands the translation grip to abut against the fixed grip.

[0012] This specification describes an IV device assembly, which is a lumen that forms a fluid channel inside the IV device assembly. The lumen is fluidly coupled to a vascular access device (VAD) junction at the distal end via a funnel-shaped junction and to an IV device assembly junction at the proximal end of the lumen. An introducer device is formed along the length of the lumen. The first end of the introducer device is mechanically coupled to the funnel-shaped junction. A translation handle that translates the introducer device out from the distal end of the VAD junction. The introducer device travels through a channel formed in the translation handle and enters the VAD junction. A fixed grip formed around the lumen that maintains the position of the IV device assembly relative to the translation handle. In these embodiments, the IV device assembly may include a collapsible sleeve coaxially formed around a first portion of the lumen and mechanically coupled to the funnel-shaped junction. In some embodiments, the lumen may be offset from the fluid axis of the VAD junction.

[0013] In some embodiments, the IV device assembly includes a catheter coupled to the VAD junction, the catheter including a needle for accessing a patient's blood vessel and a blood sample access device mechanically coupled to the IV device assembly junction for receiving a blood sample through the IV device assembly. In some embodiments, the cannula may include a guide wire coupled to a porous distal end formed at an end of the cannula.

[0014] The present disclosure further describes an IV device assembly, which includes a lumen forming a fluid channel within the IV device assembly, the lumen being fluidly coupled to a vascular access device (VAD) junction at a distal end via a funnel junction and to an IV device assembly junction at a proximal end of the lumen, an introducer device formed into the VAD junction along the length of the lumen, a translation handle for translating the introducer device out of the distal end of the VAD junction, a first end of the introducer device being mechanically coupled to the translation handle, and a fixed grip formed around the lumen for maintaining the position of the IV device assembly relative to the translation handle. In these embodiments, the IV device assembly may further include a catheter coupled to the VAD junction. In these embodiments, the lumen of the IV device assembly is offset from the fluid axis of the VAD junction. In these embodiments, the introducer device is a guide wire having a porous second end. In these embodiments, the IV device assembly may include a collapsible sleeve coaxially formed around a first portion of the lumen and mechanically coupled to the funnel-shaped junction. In these embodiments, the collapsible sleeve further includes a coil spring creating a space between the lumens and biasing the translation handle towards the proximal end of the IV device assembly.

[0015] It should be understood that both the foregoing general description and the following detailed description are by way of example and explanation, and are not intended to limit the claimed invention. It should be understood that the various embodiments are not limited to the configurations and means shown in the drawings. It should also be understood that embodiments may be combined or other embodiments may be utilized without departing from the scope of the various embodiments of the present invention, and structural changes may be made as long as they are not so described in the claims. The following detailed description should, therefore, not be construed in a limiting sense.

[0016] Exemplary embodiments are described and explained by additional features and details through the use of the following attached drawings.

Brief Description of the Drawings

[0017]

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DETAILED DESCRIPTION OF THE INVENTION

[0018] FIG. 1 is a perspective view of an IV device assembly 100 according to some embodiments of the present disclosure. In some embodiments, the IV device assembly 100 may be mechanically and fluidly coupled to a vascular access device (VAD), such as a catheter, coupled to a VAD junction 104. In these embodiments, the VAD may include a needle, a catheter, or a combination of a needle and a catheter used to access a patient's blood vessel. In embodiments where the VAD includes a needle and a catheter, the needle may be removed from inside the catheter when the VAD is inserted into the patient's blood vessel. In these embodiments, the catheter may remain within the blood vessel and may receive a patency check using the patency instrument 112 described in the present disclosure. In some embodiments, the catheter may include a peripheral IV catheter (PIVC), a peripherally inserted central catheter (PICC), or a midline catheter. In embodiments where the VAD includes a needle, the patency instrument 112 may also be used to inspect the patency of the needle.

[0019] In some embodiments, the IV device assembly 100 may be mechanically and fluidly coupled to a blood sample access device. In some embodiments, the blood sample access device may be mechanically coupled to an IV device assembly junction 108 to receive a blood sample via the IV device assembly 100. In some embodiments, the blood sample access device may include a BD VACUTAINER® LUER-LOK® Access Device manufactured by Becton, Dickinson and Company of Franklin Lakes, N.J., or another suitable blood sample access device.

[0020] In some embodiments, the IV device assembly 100 may include a lumen 102 that is fluidly coupled to the VAD junction 104 via a funnel-shaped junction 106 at the distal end of the IV device assembly 100. In these embodiments, the funnel-shaped junction 106 may include a funnel-shaped junction channel that completes a fluid channel between the lumen 102 and a fluid channel formed within the VAD junction 104. In some embodiments, the lumen 102 may be offset from a fluid channel formed within the VAD junction 104. In these embodiments, the lumen 102 may be offset from the fluid path of the VAD junction 104 because the longitudinal axis of the fluid path through the VAD junction 104 is not the same as the longitudinal axis of the fluid path of the lumen 102 at the location where the lumen 102 is fluidly coupled to the funnel-shaped junction 106. This offset with respect to the fluid channel is further described and shown in relation to FIG. 3. In some embodiments, the gauge of the lumen 102 may be optimized to minimize hemolysis and provide an appropriate flow rate for receiving a blood sample. In some embodiments, the lumen 102 may be made of polyvinyl chloride (PVC), thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), or another medical grade tubing material. As described in the present disclosure, in some embodiments, the lumen 102 may include markings formed thereon that describe the position or deployment of the access device 112 during use of the IV device assembly 100.

[0021] In some embodiments, the IV device assembly 100 may further include a collapsible sleeve 110 that is coaxially formed around a first portion of the lumen 102 and mechanically coupled to the funnel-shaped junction 106. In some embodiments, the collapsible sleeve 110 may be mechanically coupled to the funnel-shaped junction 106, for example, using an adhesive or by performing an ultrasonic welding process. In some embodiments, the collapsible sleeve 110 may be made of a bendable and flexible material that allows the collapsible sleeve 110 to be folded onto itself.

[0022] In some embodiments, the proximal end of the collapsible sleeve 110 may be mechanically coupled to the translation handle 114. In some embodiments, the collapsible sleeve 110 may be mechanically coupled to the translation handle 114, for example, using an adhesive or by performing an ultrasonic welding process. In some embodiments, during operation, the translation handle 114 may be allowed to move along the longitudinal axis of the lumen 102 such that the collapsible sleeve 110 abuts against the funnel-shaped junction 106 and is folded.

[0023] In some embodiments, the collapsible sleeve 110 may be made of an elastomer or a polymer film. The elastomer or polymer film may allow the collapsible sleeve 110 to be folded onto itself and returned to its unfolded state without damaging the elastomer or polymer film itself. In some embodiments, the collapsible sleeve 110 may include a coil spring 122 formed therein, and the coil spring expands the collapsible sleeve 110 (e.g., as shown in FIG. 1) when no force is applied to the translation handle 114 towards the distal end of the IV device assembly 100. In some embodiments, the coil spring 122 may be biased to return to the unexpanded state as shown in FIG. 1. In some embodiments, the collapsible sleeve 110 being translucent or fully transparent may allow a clinician or another HPC to view the lumen 102 and / or any measurement markings placed on or over the lumen 102.

[0024] In some embodiments, the IV device assembly 100 may include a grip 116. In some embodiments, the grip 116 may be any body formed and fixed around the lumen 102 to maintain the position of the IV device assembly 100 relative to the translational handle 114. In some embodiments, during operation of the IV device assembly 100, a clinician may grasp the grip 116 with one hand or multiple fingers and translate the translational handle 114 along the length of the translational handle 114 towards the distal end of the IV device assembly 100 with the other hand or other fingers. In some embodiments, in the ergonomics of the shape of the grip 116, the grip 116 and the translational handle 114 may be such that they can be operated with one hand.

[0025] In some embodiments, the patentable instrument 112 may be approximately twice the length of the collapsible sleeve 110. In these embodiments, the first end of the patentable instrument 112 is fixed to the funnel-shaped coupling 106. The patentable instrument 112 may then be passed through a channel 118 formed within the translational handle 114. The patentable instrument 112 may then be passed back towards the funnel-shaped coupling 106, through a hole formed through the funnel-shaped coupling 106, and into a fluid channel formed within the VAD coupling 104. In some embodiments, since the patentable instrument 112 may enter a fluid channel formed within the VAD coupling 104, the interface between the fluid channel formed within the VAD coupling 104 and the hole formed within the funnel-shaped coupling 106 for the patentable instrument 112 may include a seal (not shown). The seal may prevent blood and fluids such as infusions of saline, various medications, and total parenteral nutrition from exiting the funnel-shaped coupling 106 and passing into the collapsible sleeve 110.

[0026] In some embodiments, the access device 112 may include a device that enters the patient's blood vessel to improve access. In some embodiments, the device may be non-invasive. In some embodiments, the access device 112 may include a guide wire that is flexible enough to pass through the fluid channels described in this disclosure, yet elastic enough to remove material inside the VAD.

[0027] In some embodiments, the IV device assembly 100 may improve the access of the VAD that is mechanically and fluidly coupled to the VAD junction 104 for fluid delivery and sampling, as described in this disclosure. In some embodiments, since the IV device assembly 100 is mechanically coupled to a VAD inserted into the patient's body, the IV device assembly 100 can be selectively removed from and coupled to the VAD when the access of the VAD is to be examined. In some embodiments, the VAD may include separate ports for providing drugs to the patient's body and for receiving blood samples. In some embodiments, the IV device assembly 100 can be coupled to the VAD as long as the VAD is inserted into the patient's body. In some embodiments, the VAD may include a catheter having an unnecessary access connector (NAC) attached near the patient access point on the catheter. In these embodiments, the access device 112 may be sufficiently rigid yet flexible enough to bend when it advances from the VAD junction 104 and enters the VAD. In some embodiments, the IV device assembly 100 may be used to deliver a device into the VAD or the patient's vein, such as a sensor for monitoring the patient's vital signs. In these embodiments, the end of the access device 112 may be attached with this sensor.

[0028] The VAD coupling portion 104 shown in FIG. 1 is depicted as a blunt cannula - less snap - type connector in accordance with some embodiments. However, the present disclosure contemplates that other types of connectors may be used. In another embodiment, the IV device assembly 100 may include a threaded male luer connector, a crimp luer connector, a threaded male luer connector with a removably attached blunt cannula - less snap connector, or any other type of connector that mechanically and fluidly couples the IV device assembly 100 as described in the present disclosure to the VAD.

[0029] In some embodiments, the IV device assembly 100 may provide an integrated extension set having an optimized fluid resistance and improved patency with a relatively less traumatic open - access device 112 to the patient's vein. In some embodiments, the IV device assembly 100 may be used by a clinician with one hand, enabling the clinician to have a free hand. In some embodiments, the IV device assembly 100 may be compact and may include an extension set in the form of a lumen 102 that may be coupled to a blood sample access device to access a blood sample. In some embodiments, the IV device assembly 100 may also remain flexible by removing a rigid housing to reduce the likelihood of VAD complications when the VAD is inserted into the patient's vein. By using the IV device assembly 100, the workflow may be simplified, and by having an IV device assembly 100 coupled to a VAD that meets multiple objectives, the steps may be reduced. Since the IV device assembly 100 includes fewer and smaller components, medical waste can also be reduced by the use of the IV device assembly 100. By miniaturizing the IV device assembly 100, the IV device assembly 100 can more easily fit within a pointed container or medical waste container.

[0030] Figure 2 is a perspective view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 2 particularly shows the IV device assembly 100 together with a catheter 126 configured to couple to a blood sample access device 124 coupled to the IV device assembly 100 via a VDA coupling 104 and an IV device assembly coupling 108, according to some embodiments. Figure 2 shows the catheter 126 and the blood sample access device 124 coupled to the IV device assembly 100, but the present disclosure contemplates that the IV device assembly 100 may be coupled to any type of device that would benefit from the functions provided by the IV device assembly 100.

[0031] In some embodiments, the IV device assembly 100 may be coupled to the blood sample access device 124 via the IV device assembly coupling 108 at the proximal end of the IV device assembly 100. In some embodiments, the blood sample access device 124 may be any type of device that can selectively enable receiving a blood sample from the catheter 126 and the IV device assembly 100. The blood sample access device 124 may be, in some embodiments, a BD VACUTAINER® LUER-LOK™ Access Device manufactured by Becton, Dickinson and Company of Franklin Lakes, New Jersey. In some embodiments, the blood sample access device 124 may be coupled to the IV device assembly coupling 108 via threads formed inside the IV device assembly coupling 108 and on the blood sample access device 124. In some embodiments, during operation, the clinician may NeedleA blood sample can be taken by inserting a blood vial into the blood sample access device 124 when it is capable of piercing a septum on the blood vial to allow blood to flow from the lumen 102 into the blood vial. In some embodiments, the blood sample access device 124 may include a valve that allows blood flow therein only when the blood vial is inserted into the blood sample access device 124.

[0032] Also shown in FIG. 2 is a catheter 126 according to some embodiments. The catheter 126 is shown as being detached from the VAD coupling portion 104 of the IV device assembly 100. However, during use of the IV device assembly 100, it should be understood that the IV device assembly 100 is coupled to the catheter 126 to enable a fluid path to be coupled to the IV device assembly 100. In some embodiments, the catheter assembly 128 may include the catheter 126. In some embodiments, the catheter assembly 128 may include a needle and a catheter formed coaxially around the needle. During operation, the needle of the catheter assembly 128 may be removed, leaving the catheter for fluid transport within the patient's body.

[0033] In some embodiments, the catheter 126 may also include a port tube 132 and a port 130. In some embodiments, the port tube 132 and the port 130 can be used as separate access points for a clinician to introduce infusions such as saline, various drugs, and total parenteral nutrition into the blood vessels of the patient's body. In some embodiments, the port tube 132 may include a port clamp 134 to prevent backflow of blood into the port tube 132 and the port 130. In some embodiments, the port clamp 134 is clamped when the port 130 is not in use to prevent pressure within the port tube 132 from preventing blood flow therein.

[0034] FIG. 3 is a perspective cross-sectional view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 3 shows an IV device assembly 100 mechanically and fluidly coupled to a blood sample access device 124 according to some embodiments. In the cross-sectional view of the IV device assembly 100, the patentable instrument 112 is shown to be a double-pass patentable instrument such that the distance the distal end of the patentable instrument 112 moves is approximately twice the length of the collapsible sleeve 110.

[0035] In some embodiments, the patentable instrument 112 may be fixed to the funnel-shaped coupling portion 106 at the patentable instrument anchor 136. In these embodiments, the patentable instrument anchor 136 may be a hole formed within the funnel-shaped coupling portion 106, and the first end of the patentable instrument 112 is fixed within the patentable instrument anchor 136, for example, by an adhesive or a mechanical coupling device and held therein. The patentable instrument 112 may then be passed through a channel 118 formed within the translation handle 114. The channel 118 may be formed such that the entire length of the patentable instrument 112 can easily pass through the channel 118 so that the patentable instrument 112 can be moved out of the IV device assembly 100. After the patentable instrument 112 passes through the channel 118, the patentable instrument 112 may be passed through the VAD coupling portion 104 and the funnel-shaped coupling portion 106.

[0036] In some embodiments, the fluid path of the lumen 102 is offset from the fluid path of the VAD coupling portion 104 such that the fluid path of the lumen 102 is not the same as the mechanical path of the patentable instrument 112 when it enters the funnel-shaped coupling portion 106. In some embodiments, the mechanical port in the funnel-shaped coupling portion 106 occupied by the patentable instrument 112 may be coupled to the fluid paths of the VAD coupling portion 104 and the lumen 102. In some embodiments, the mechanical port may include a seal 120 that seals the mechanical port for the patentable instrument 112 so as not to allow fluid to leak out from the fluid paths of the VAD coupling portion 104 and the funnel-shaped coupling portion 106.

[0037] In some embodiments, during operation of the IV device assembly 100, a clinician or another HCP may translate the translation handle 114 towards the distal end of the IV device assembly 100. In doing so, the patentable device 112 can be pushed out from the VAD coupling 104. In some embodiments, in addition, when the translation handle 114 is moved to the distal end of the IV device assembly 100, the patentable device 112 can be passed through the channel 118 and the funnel coupling 106. In some embodiments, the first end of the patentable device 112 is fixed to the patentable device anchor 136 and passed through the channel 118, so that the patentable device 112 can be extended outward from the VAD coupling 104 by approximately twice the length of the distance between the translation handle 114 and the funnel-shaped coupling 106.

[0038] FIG. 4 is a perspective cross-sectional view of an IV device assembly 100 according to some embodiments of the present disclosure. The cross-sectional view of FIG. 4 is similar to that shown in FIG. 3, except that the IV device assembly 100 according to some embodiments is rotated by approximately 90 degrees about the longitudinal axis.

[0039] For example, as shown in FIG. 4, a funnel-shaped coupling channel 140 may be formed through the funnel-shaped coupling 106. In some embodiments, the fluid channel of the lumen 102 is formed in the funnel-shaped coupling 106 at a position offset from the fluid channel of the VAD coupling 104. In some embodiments, in order to fluidly couple the lumen 102 to the fluid channel formed through the VAD coupling 104, the funnel-shaped coupling 106 can fluidly connect these two fluid paths by having a funnel-shaped coupling channel 140 formed therethrough.

[0040] Again, during operation of the IV device assembly 100, a clinician or another HCP may translate the translation handle 114 towards the distal end of the IV device assembly 100. In doing so, the access device 112 may be pushed out of the VAD connection 104. In addition, when the translation handle 114 is moved to the distal end of the IV device assembly 100, the access device 112 may be passed through the channel 118 and the funnel connection 106. Since the first end of the access device 112 is fixed to the access device anchor 136 and passed through the channel 118, the access device 112 may be extended out from the VAD connection 104 by approximately twice the length of the distance between the translation handle 114 and the funnel-shaped connection 106. In some embodiments, when the access device 112 is extended beyond the VAD connection 104 and the translation handle 114 is translated towards the distal end of the IV device assembly 100, fluid may be allowed to flow through the lumen 102, the funnel-shaped connection channel 140, and the VAD connection 104. In some embodiments, fluid may not be allowed to flow until the access device 112 is in the retracted position shown in FIG. 4.

[0041] Figure 4 further shows the distal end of an implantable device 112, such as a porous distal end 138, in accordance with some embodiments. In some embodiments, the porous distal end 138 may be made porous by joining coil windings around the distal end of a guide wire forming the implantable device 112. In some embodiments, the coil windings may be in the form of, among other configurations, fixed coils, variable coils, iteratively variable coils, and open-ended expansion coils. In some embodiments, the coil windings of the porous distal end 138 may be covered with knobs. In some embodiments, the length of the porous distal end 138 may vary and may be longer or shorter than the distance between the distal end of the fluid channel formed within the VAD junction 104 and the distal end of the seal 220. In these embodiments, the diameter of the holes through the seal 220 may be smaller than the diameter of the porous distal end 138, and the porous distal end 138 may be prevented from entering the holes formed through the seal 220.

[0042] In some embodiments, the length of the lumen 102 may be selected based on one or more of a particular VAD gauge, a particular VAD assembly configuration, or a clinical setting. In some embodiments, the lumen 102 may include a length L from the grip 116 to the funnel-shaped junction 106. In some embodiments, the lumen 102 may include an inner diameter D.

[0043] When the lumen 102 is tubular, the flow of fluid within the fluid path through the lumen 102 can be analyzed using the following Poiseuille's equation.

Number

Number

[0044] In some embodiments, lumen 102 may have a plurality of sections having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), and the geometric coefficients are as follows. [Math.] In some embodiments, lumen 102 may have an inner diameter that varies along the length of lumen 102, and the geometric coefficients are as follows. [Math.] In some embodiments, lumen 102 may have a non-circular cross-section or may have a complex inner diameter profile. Next, the geometric coefficients can be determined as follows by measuring the flow rate (Q) at a given pressure (ΔP) using a known viscous (μ) fluid. [Math.]

[0045] The G f value of lumen 102 can be made below the maximum shear stress of the BD 21G VACUTAINER® UltraTouch™ push-button blood collection set (available from Becton, Dickinson and Company, Franklin Lakes, NJ), which was previously regarded as the absolute standard for blood collection, by being selected to reduce the maximum shear stress for each VAD. In some embodiments, the G fThe value may be selected to reduce it below the maximum shear stress for each VAD gauge and below the maximum shear stress of a BD 25G VACUTAINER® UltraTouch™ push-button blood collection set (available from Becton, Dickinson and Company, Franklin Lakes, NJ).

[0046] In some embodiments, the fluid path of the blood collection system may include one or more of the blood sample access devices 124, and the fluid path (which may include the lumen 102) within the IV device assembly 100, and the VAD (which may include the catheter assembly 128 and / or the extension tube) may include the entire blood collection path through which blood exits the blood vessel and flows into the blood collection device 124 during blood collection. The system geometric coefficient G for the fluid path of the blood collection system fs may be determined in a manner similar to the G of the lumen 102 as described above. In some embodiments, the system geometric coefficient G f may be determined in a manner similar to the value of G for the lumen 102 as described above. In some embodiments, the system geometric coefficient G fs may be 7.34E+06 (1 / in 3 ) or greater. In some embodiments, G fs may include another value. In some embodiments, the system geometric coefficient G fs may be 7.34E+06 (1 / in 3 ) or greater when the translation handle 114 is moved to the distal end of the IV device assembly 100. In some embodiments, the system geometric coefficient G fs may be 7.34E+06 (1 / in 3 ) ±10%, ±25%, ±50%, or ±75%. In some embodiments, G fs may include another value, which may be selected based on the gauge and / or length of the catheter.

[0047] FIG. 4 also shows the interconnection between the lumen 102 and the grip 116 according to some embodiments. In this example, the grip 116 may be used as a fluid path having a fluid aperture formed therethrough. In some embodiments, the grip 116 may include a number of threads that interact with the threads of the blood sample access device 124 such that they may be mechanically and fluidly coupled together. In another embodiment, the lumen 102 may be passed through a mechanical aperture formed through the grip 116, and the grip 116 may be coupled to the outer surface of the lumen 102 using an adhesive or another type of joining mechanism. In some embodiments, the fluid path of the lumen 102 may fluidly couple to the funnel-shaped junction channel 140 within the funnel-shaped junction 106 and to the blood sample access device 124. In some embodiments, the portion of the IV device assembly 100 between the funnel-shaped junction 106 and the grip 116 may be flexible such that the operation of the IV device assembly 100 does not interfere with the placement of a VAD coupled to the IV device assembly 100 via the VAD junction 104.

[0048] Again, in some embodiments, the collapsible sleeve 110 may include a coil spring (not shown). The coil spring may be able to expand the collapsible sleeve 110 to the state shown in FIG. 4 and bias the translation handle 114 to the proximal end of the IV device assembly 100. In this state, the introducer instrument 112 may remain in the undeployed state until the clinician translates the translation handle 114 towards the distal end of the IV device assembly 100.

[0049] FIG. 5 is a perspective view of an IV device assembly 100 according to some embodiments of the present disclosure. In FIG. 5, according to some embodiments, a translation handle 114 is translated a distance toward the distal end of the IV device assembly 100. By translating the translation handle 114 toward the distal end of the IV device assembly 100, numerous changes can occur to the IV device assembly 100. For example, the collapsible sleeve 110 may be collapsed and compressed between the translation handle 114 and the funnel coupling 106. As described in the present disclosure, the patency instrument 112 may also be passed through a channel 118 formed within the translation handle 114 and through the funnel coupling 106 and the VAD coupling 104. This expands the patency instrument 112 out of the VAD coupling 104 and into the fluid pathway formed within the VAD coupled to the IV device assembly 100 when coupled. The translation position of the translation handle 114 as shown in FIG. 5 may be an intermediate position such that the translation handle 114 can be further passed closer toward the funnel coupling 106. In some embodiments, the translation handle 114 slides along the lumen 102 and, in conjunction, the lumen 102 passes through a lumen aperture formed through the translation handle 114.

[0050] In some embodiments, by thus expanding the patency instrument 112, a clinician may inspect the patency of the VAD coupled to the IV device assembly 100. In some embodiments, the expansion of the patency instrument 112 and its porous distal end 138 into the VAD may move or displace something that may occlude the catheter of the VAD during blood sampling. Materials that may occlude the fluid pathway within the VAD may include fibrin material, thrombus, or vein wall. In some embodiments, the patency instrument 112 may be rigid enough to open a valve downstream of the IV device assembly 100 to allow backflow into the catheter.

[0051] FIG. 6 is a front view of an IV device assembly 100 according to some embodiments of the present disclosure. In some embodiments, the collapsible sleeve 110 is collapsed between the translation handle 114 and the funnel-shaped coupling 106 to expand the access device 112 to approximately its maximum or increased length. In these and other embodiments, the lumen 102 may include a number of measurement indicators 142 disposed along the length of the lumen 102. The indicators may be physical markings that indicate to the clinician the distance that the access device 112 has moved out from the VAD coupling 104 and into the VAD coupled to the IV device assembly 100. Any number of measurement indicators 142 may be marked along the lumen 102 between the access device 112 and the funnel-shaped coupling 106, and the present disclosure contemplates that these dimensions may be in any imperial or metric increment. During operation, the clinician may determine the length of the fluid path inside the VAD coupled to the IV device assembly 100 and use the measurement indicators 142 printed or marked on the lumen 102 to translate the translation handle 114 towards the distal end of the IV device assembly 100 in accordance with that length. This enables the clinician to accommodate shorter fluid path lengths in various VADs such that the access device 112 can be expanded inside and outside the VAD and, for example, within the wall of a blood vessel without damaging the blood vessel. The IV device assembly 100 maintains flexibility with respect to the VAD coupling 104 so that when the IV device assembly 100 is coupled to the VAD, the clinician can manipulate the translation handle 114 without removing or interfering with the placement of the VAD within the patient's arm. This prevents damage to the patient's body during the access examination and during blood sampling to the blood sample access device 124.

[0052] FIG. 7 is a front view of the access device 112 according to some embodiments of the present disclosure. In some embodiments, for example, as shown in FIG. 7, the access device 112 may extend through a catheter assembly 128 that is mechanically and fluidly coupled to the IV device assembly 100 of FIGS. 1 and 2. The access device 112 is shown as being extended slightly beyond the distal end of the catheter assembly 128 by a clinician passing the translation handle 114 toward the distal end of the IV device assembly 100, as described in the present disclosure. As also described in the present disclosure, the distal end of the access device 112 may include a porous distal end 138. In these embodiments, the access device 112 is narrowed to a smaller diameter, and the porous distal end 138 may include coil windings around the smaller diameter portion of the access device 112. The coil windings are merely an example of what the porous distal end 138 may be constructed from, and the present disclosure contemplates that other porous distal end 138 materials may be used.

[0053] In addition, the present disclosure contemplates that certain sensors may be placed inside the coil windings or right at the distal end of the access device 112 such that certain physiological characteristics of the patient, such as blood pressure, pH of the patient's blood, blood chemistry, peripheral capillary oxygen saturation (SPO2) level, blood flow rate, heart rate, and temperature, may be monitored.

[0054] The coil windings shown on the porous distal end 138 of the access device 112 are shown as having a constant pitch over the entire length of the porous distal end 138. However, the present disclosure contemplates that the pitch of the coil windings may vary along the length of the porous distal end 138. The variation in pitch may be a repetitive dispersion, a constant dispersion, or a random dispersion and may be adapted to a particular access inspection quality of the access device 112.

[0055] FIG. 8 is a perspective view of an IV device assembly 200 according to some embodiments of the present disclosure. The IV device assembly 200 shown in FIG. 8 is similar to that shown in FIG. 4 and includes a lumen 202 that fluidly couples a blood sample access device 224 to a funnel-shaped junction 206. As described in the present disclosure, the proximal end of the lumen 202 may be coupled to the blood sample access device 224 via an IV device assembly junction 208. In addition thereto, similar to FIG. 4, the IV device assembly 200 may include a collapsible sleeve 210 that is coaxially formed around a first portion of the lumen 202 and mechanically coupled to the funnel-shaped junction 206. During operation of the IV device assembly 200, a clinician may grip the grip 216 with one hand or multiple fingers and translate the translation handle 214 along the length of the translation handle 214 towards the distal end of the IV device assembly 200 with the other hand or multiple other fingers. In some embodiments, the ergonomics defining the shape of the grip 216 may be such that the grip 216 and the translation handle 214 can be operated with one hand. In some embodiments, the collapsible sleeve 210 may include a coil spring 222 formed therein to expand the collapsible sleeve 210 (e.g., as shown in FIG. 1) when force is not applied to the translation handle 214 towards the distal end of the IV device assembly 200. In some embodiments, the coil spring 222 may be biased to return to the unexpanded state as shown in FIG. 1.

[0056] Similar to FIG. 4, the distal end of the introducer instrument 212 may include a porous distal end 238. The porous distal end 238 may be made porous in some embodiments by coupling coil windings around the distal end of a guide wire forming the introducer instrument 212.

[0057] However, in FIG. 8, the access device 212 is shown as being a single-pass access device 212. That is, instead of the first end of the access device 212 being fixed to the funnel-shaped coupling portion 206, the first end of the access device 212 is fixed to the translation handle 214 at the access device anchor 236. Accordingly, the distance that the access device 212 can be translated out of the IV device assembly 200 is approximately half the distance as shown in FIG. 4. Instead, the distance that the access device 212 can be translated out of the IV device assembly 200 may be approximately equal to the length between the proximal face of the funnel-shaped coupling portion 206 and the distal face of the translation handle 214.

[0058] As described in the present disclosure, the funnel-shaped coupling channel 240 is shown as being formed through the funnel-shaped coupling portion 206. As described in the present disclosure, the fluid channel of the lumen 202 is formed in the funnel-shaped coupling portion 206 at a position offset from the fluid channel of the VAD coupling portion 204. To fluidly couple the lumen 202 to the fluid channel formed through the VAD coupling portion 204, the funnel-shaped coupling portion 206 may fluidly connect these two fluid paths by having a funnel-shaped coupling channel 240 formed therethrough.

[0059] The IV device assembly 200 shown in FIG. 8 may be used in connection with a VAD whose fluid path is relatively short compared to that used in the IV device assembly 100 shown in FIG. 4. In some embodiments, the distance between the distal ends of the VADs coupled to the IV device assembly 200 may be shorter than that shown in FIG. 4 due to the absence of an intervening length of an extension tube disposed between the VDA coupling portion 204 and the catheter assembly 128 of the VAD shown in FIG. 2. In some embodiments, the size of the VAD coupled to the IV device assembly 200 via the VAD coupling portion 204 may be shorter, such that the use of the two-fold longer access device 112 as shown in FIG. 4 may not be necessary.

[0060] In some embodiments, since the IV device assembly 200 of FIG. 8 does not have the patency device 212 pass through the translational handle 214, it may prevent the need to form a channel 118 (FIG. 1) inside the translational handle 214. Instead, the movement of the translational handle 214 toward the distal end of the IV device assembly 200 causes the patency device 212 to exit the VAD coupling 204.

[0061] FIG. 9 is a perspective view of an IV device assembly 300 according to some embodiments of the present disclosure. In these embodiments, the IV device assembly 300 may include a funnel-shaped coupling 306 that is mechanically and fluidly coupled to an indwelling catheter 346. The indwelling catheter 346 may include a catheter / needle assembly 328 that is fluidly and mechanically coupled to the funnel-shaped coupling 306.

[0062] In some embodiments, the IV device assembly 300 may include a patency device 312 that is fixed to the IV device assembly 300 at a patency device anchor 336. In some embodiments, the patency device 312 may then be passed through a channel (not shown) formed through the translational handle 314 and into the funnel-shaped coupling 306. Thus, the patency device 312 is shown to be a double-pass patency device 312 as described in the present disclosure.

[0063] FIG. 9 also shows that, in some embodiments, a grip 316 is formed alongside the IV device assembly coupling 308. In these embodiments, the space occupied by the grip 316 and the IV device assembly coupling 308 is reduced by the use of the grip 316 formed on the side of the IV device assembly coupling 308.

[0064] FIG. 9 also shows a lumen 302 that is also offset from a fluid pathway formed within an indwelling catheter 346. The components of the IV device assembly are of relatively higher stiffness than those shown and described in connection with FIG. 1, but the length of the IV device assembly 300 of FIG. 9 is reduced, which can reduce the materials used and the size of the IV device assembly 300.

[0065] FIG. 10A is a perspective cross-sectional view of an IV device assembly 400 according to some embodiments of the present disclosure. FIG. 10B is a perspective view of an IV device assembly 400 according to some embodiments of the present disclosure. The IV device assembly 400 of FIGS. 10A and 10B may be rigid or semi-rigid by using a solid lumen 448 that is of relatively higher stiffness than the lumens described in connection with FIG. 1. FIG. 10A shows a lumen 402 that is offset with respect to a fluid pathway formed within a VAD junction 404, along with a mechanical pathway of an access device 412 that is aligned with the fluid pathway formed within the VAD junction 404. FIG. 10B shows an access device 412 that is offset with respect to a fluid pathway formed within a VAD junction 404, along with the fluid pathway of a lumen 402 that is aligned with the fluid pathway formed within the VAD junction 404. This specification contemplates that any of these pathways (e.g., the mechanical pathway of the access device 412 and the fluid pathway of the lumen 402) can be aligned with or offset from a fluid pathway formed within the VAD junction 404.

[0066] In some embodiments, the solid lumen 448 can be made of a material that maintains the stiffness of the lumen 402 formed therethrough. In these embodiments, the lumen 402 can be fluidly coupled to a blood sample access device 424 via an IV device assembly junction 408 similar to that described in other embodiments of the present disclosure. In some embodiments, the solid lumen 448 may also include a channel 442 formed along the length of the solid lumen 448.

[0067] In one embodiment, the channel 442 is used to receive the cannula 412 therein and thereby translate it through the funnel-shaped junction 406 into the VAD junction 404 and out of the IV device assembly 400. In these embodiments, the solid lumen 448 includes a channel 442 formed therein such that the cannula 412 can pass from the cannula anchor 436 at the first end of the cannula 412 through a channel 418 formed in a portion of the translation handle 414 mechanically coupled to the channel 442 and into the VAD junction 404 through a hole formed therein. In some embodiments, the channel 442 may be semi-circular in shape.

[0068] In the embodiments described in this disclosure, the translation handle 414 includes a curved portion formed inside the channel 442 such that a channel 418 for the cannula 412 can be formed therein for the cannula 412 to pass through. This channel 418 used to pass the cannula 412 through the translation handle 414 can be formed within a portion of the translation handle 414 disposed inside the channel 442. In some embodiments, during operation, when the translation handle 414 is translated towards the distal end of the IV device assembly 400, the cannula 412 is passed through the channel 418 and into the VAD junction 404, thereby expanding the cannula 412 into the VAD coupled to the IV device assembly 400 via the VAD junction 404.

[0069] In some embodiments, the cannulating device 412 may include a porous distal end 438. The porous distal end 438 may be made porous in some embodiments by coupling coil windings around the distal end of a guidewire forming the cannulating device 412. The coil windings may be in the form of, among other configurations, fixed coils, variable coils, iteratively variable coils, and open-ended extension coils. In some embodiments, the coil windings of the porous distal end 438 may be capped by a knob. In some embodiments, the length of the porous distal end 438 may be variable and may be the same as or shorter than the distance between the distal end of a fluid path formed within the VAD junction 404 and the distal end of a seal (not shown) formed within the VAD junction 404 used to seal the cannulating device 412 aperture from the fluid path within the VAD junction 404 and the solid lumen 448. In these embodiments, the diameter of the aperture through the seal may be smaller than the diameter of the porous distal end 438, and the porous distal end 438 may be prevented from entering the aperture formed through the seal.

[0070] In some embodiments, the translational handle 414 may include a series of locking teeth 452 that interact with channel locking teeth 450 formed in an opening that leads to the channel 442. During operation, the translational handle 414 may be grasped by a clinician to disengage the locking teeth 452 formed on the translational handle 414 from those channel locking teeth 450 formed in the opening that leads to the channel 442. In this way, the clinician may fix the translational handle 414 at any distance along the solid lumen 448, whereby any portion or length of the cannulating device 412 extends out from the VAD junction 404 and, for example, into a PIVC coupled to the VAD junction 404.

[0071] In another embodiment, the translational handle 414 may include a spring mechanism (not shown) that abuts and is biased against the wall of an opening leading to channel 442 and that may include a semi-circular shape when no pressure is applied to the translational handle 414. When a clinician or another HCP applies a pinching pressure to the translational handle 414 at a location on the translational handle 414, the pressure compresses the biased spring mechanism and releases the translational handle 414, which may be slid along the longitudinal axis of the lumen 448, which may be rigid or semi-rigid. Again, by doing so, the clinician may fix the translational handle 414 at any distance along the solid lumen 448 such that any portion or length of the patent device 412 extends out from the VAD junction 404 and, for example, into the PIVC coupled to the VAD junction 404.

[0072] In the embodiment shown in FIG. 10B, a collapsible sleeve 410 may be formed around the solid lumen 448. In one embodiment, the collapsible sleeve 410 may be mechanically coupled to the distal side surface of the translational handle 414. Additionally, the collapsible sleeve 410 may be coupled to the distal end of the solid lumen 448. In these embodiments, the collapsible sleeve 410 may prevent contaminants from entering into the channel 442 and contacting the surface of the patent device 412 during operation.

[0073] Still further, the lumen 402 may be fluidly coupled to the blood sample access device 424 via the IV device assembly junction 408, similar to another embodiment described in the present disclosure. In these embodiments, a blood collection tube (not shown) may be inserted into the blood sample access device 424. In certain embodiments, a septum formed on the blood collection tube may be pierced by a needle inside the blood sample access device 424 when the blood collection tube is inserted into the blood sample access device 424. Blood may then be allowed to flow into the blood collection tube and a blood sample may be received.

[0074] Figure 10C is a side view of an IV device assembly 40 that can be rigid or semi-rigid, according to some embodiments of the present disclosure. To 0 Figure 10D is a side view of an IV device assembly 40 that can be rigid or semi-rigid, according to some embodiments of the present disclosure. To 0 Figure 10E is a side view of an IV device assembly 400 that can be rigid or semi-rigid, according to some embodiments of the present disclosure. Figure 10F is a side view of an IV device assembly 400 that can be rigid or semi-rigid, according to some embodiments of the present disclosure. Each of these figures shows possible shapes of a channel 442 formed through a rigid or semi-rigid solid lumen 448, as described in connection with FIGS. 10A and 10B.

[0075] Figure 10C shows that the channel 442 is in the form of a semi-circle as shown in FIG. 10B. In some embodiments, the lumen 402 may be centered within a fluid path formed within the VAD junction 404 as shown in FIG. 10A. In some embodiments, the lumen 402 may be offset with respect to a fluid path formed within the VAD junction 404 as shown in FIG. 10A.

[0076] Figure 10C also shows a translation handle 414 formed around the solid lumen 448. In this embodiment, the translation handle 414 includes a neck portion 454 and a crescent body 456. In this embodiment, the translation handle 414, the neck portion 454, and the crescent body 456 may be formed as a monolithic piece. Also shown in Figure 10C is a channel 418 formed through the crescent body 456 of the translation handle 414. As described in the present disclosure, when the access device 412 is passed through this channel 418, when the translation handle 414 is translated either distally or proximally along the longitudinal axis of the solid lumen 448, it can either expand the access device 412 from the solid lumen 448 or retract it therein. Although Figure 10C shows the channel 442 interacting with the translation handle 414 through the crescent body 456 and the neck portion 454, this specification assumes that any extension from the translation handle 414 can be used based on the shape and form of the solid lumen 448 such that the channel 418 is formed therethrough and the access device 412 can be passed therethrough as described.

[0077] FIG. 10D shows that, in accordance with some embodiments, one or more lumens 402 may be formed through the solid lumen 448 to correspond to one or more types of fluid passing through the solid lumen 448 or a single fluid passing through the lumen 402. In addition, in these embodiments, the channel 442 may be formed through the center of the solid lumen 448. In some embodiments, the cannula 412 may be passed through this channel 442 such that the cannula 412 passes within the lumen 402 at a position offset from the fluid path formed through the VAD junction 404. In addition, in some embodiments, the lumen 402 may be offset from the fluid path formed through the VAD junction 404. In FIG. 10D, the translational handle 414 includes an arm that intersects a channel 442 formed through the solid lumen 448. Again, the arm includes a channel 418 through which the cannula 412 may pass, as described herein.

[0078] FIG. 10E shows that, in accordance with some embodiments, the solid lumen 448 may include one or more lumens 402. The lumen 402 may correspond to one or more types of fluid passing through the solid lumen 448 or a single fluid passing through the lumen 402. The lumen 402 is also shown offset from the fluid path formed through the VAD junction 404. FIG. 10E also shows that, in accordance with some embodiments, the channel 442 may be formed through the solid lumen 448. In these embodiments, the channel 442 may include a number of dedicated channel portions through which the cannula 412 may pass, while at the same time a number of mating bumps may be used to maintain the alignment of the cannula 412 as it passes through the channel 442. In FIG. 10E, the translational handle 414 includes an arm that intersects a channel 442 formed through the solid lumen 448. In contrast to FIG. 10D, the arm meanders to the channel 442 through a channel 442 of a similar shape. Again, the arm includes a channel 418 through which the cannula 412 may pass, as described in the present disclosure.

[0079] Figure 10F shows that the solid lumen 448 includes one or more lumens 402. The lumen 402 may be adapted for one or more types of fluid passing through the solid lumen 448, or a single fluid via the lumen 402. The lumen 402 is also shown offset from the fluid path formed through the VAD junction 404. Figure 10F also shows a channel 442 that may be serpentine in shape. In this example, the channel 442 may include a number of dedicated channel portions through which the cannula 412 passes. In Figure 10F, the translational handle 414 includes an arm that intersects a channel 442 formed through the solid lumen 448. In contrast to Figure 10D, the arm snakes through a channel 442 of a similar shape to the channel 442. Again, the arm includes a channel 418 through which the cannula 412 may pass as described in the present disclosure.

[0080] In each of Figures 10C - 10F, the translational handle 414 may be wrapped around the outer surface of the solid lumen 448 and interact with the solid lumen 448 and the cannula 412 as described in connection with Figures 10A and 10B. The translational handle 414 may be formed of an elastically flexible material that returns to its original shape when a clinician is not applying a clamping force to the translational handle 414, thereby translating the translational handle 414 toward the distal end of the IV device assembly 400.

[0081] Figure 11 is a perspective view of a VAD junction 504 assembly according to some embodiments of the present disclosure. The VAD junction 504 may, in some embodiments, be a combination of a VAD junction 104 and a funnel junction 106 as shown in Figure 1.

[0082] As described in the present disclosure, the cannula 512 may be passed through the VAD junction 504 for a certain distance. The embodiment shown in Figure 11 shows that the cannula 512 may extend to the distal end of the VAD junction 504. In addition, the distal end of the cannula 512 may be a porous distal end.

[0083] The VAD coupling 504 may further include a coupling channel 540. The coupling channel 540 may funnel an output from one or more lumens fluidly coupled to the VAD coupling 504 to the fluid channel 550. The coupling portion channel 540 may receive fluid from one or more lumens as described in connection with FIG. 1.

[0084] The VAD coupling 504 may further include a seal 520. The seal 520 may prevent fluid within the coupling channel 540 and the fluid channel 550 from exiting at a location where the implantable device 512 interacts with the VAD coupling 504. The seal may prevent that fluid from entering, for example, within the collapsible sleeve described in connection with FIG. 1.

[0085] The VAD coupling 504 may further include a number of coupling grip arms 555. In this particular example of the VAD coupling 504, the coupling grip arms 555 are used to mechanically secure the VAD coupling 504 to the VAD, thereby fluidly coupling the fluid channel 550 to a fluid path formed within the coupled VAD. FIG. 11 shows a particular type of VAD coupling 504, but the present disclosure contemplates that any type of coupling may be used, including but not limited to blunt cannula-less snap connections (e.g., VAD coupling 504), threaded male luer caps, slip luer caps, and threaded male luer with a removably attached blunt cannula-less snap connector.

[0086] The IV device assembly described in the present disclosure may provide an integrated extension set in the form of the present IV device assembly having optimized fluid resistance, including an implantable improvement guidewire device that is relatively non-traumatic to the patient's blood vessels. The present IV device assembly described herein includes an implantable device that can be operated using one hand. The present IV device assembly described in the present disclosure may be more compact than another extension set and may combine the implantability test process with the blood sampling process through the use of a blood sample access device for an improved workflow, reducing steps and processes in implantability testing and blood sampling. By the form and components used in the present IV device assembly, the amount of waste can be reduced and that amount of waste is generated.

[0087] All examples and conditional statements described in the present disclosure are intended for educational purposes to assist the reader in understanding the present invention and the concepts contributed by the inventors to the advancement of the art and should be construed as not being limited to such specifically described examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alternatives can be made without departing from the spirit and scope of the disclosed embodiments.

Description of the Reference Numerals

[0088] 102 Lumen 106 Funnel-shaped junction 108 IV device assembly junction 112 Implantable device 114 Translation handle 116 Grip

Claims

**Claim 1** An IV device assembly, forming a fluid channel inside the IV device assembly, a lumen fluidly coupled to a vascular access device (VAD) coupling at a distal end via a funnel-shaped coupling and to an IV device assembly coupling at a proximal end, a collapsible sleeve formed around the lumen and mechanically coupled to the funnel-shaped coupling, an introducer extending along the lumen inside the collapsible sleeve and into the VAD coupling, a translation handle movable relative to the lumen for translating the introducer out from a distal end of the VAD coupling, a grip formed and fixed around the lumen to assist in gripping the lumen for operation of the translation handle, the IV device assembly comprising the above. **Claim 2** The IV device assembly according to claim 1, wherein a first end of the introducer is mechanically coupled to the funnel-shaped coupling. **Claim 3** The IV device assembly according to claim 2, wherein the introducer passes through a channel formed in the translation handle, through the funnel-shaped coupling, and into the VAD coupling. **Claim 4** The IV device assembly according to claim 1, wherein the lumen is offset from a fluid axis of the VAD coupling. **Claim 5** The IV device assembly according to claim 1, further comprising a catheter coupled to the VAD coupling. **Claim 6** The IV device assembly according to claim 1, further comprising a blood sample access device mechanically coupled to the IV device assembly coupling for receiving a blood sample through the IV device assembly. **Claim 7** The IV device assembly according to claim 1, wherein the introducer is a guide wire having a porous distal end. **Claim 8** The IV device assembly according to claim 1, wherein the introducer is mechanically coupled to the translation handle and passed out from the IV device assembly when the translation handle translates toward a distal end of the IV device assembly. **Claim 9** The IV device assembly according to claim 1, wherein the collapsible sleeve further comprises a coil spring creating a space between the lumens and biasing the translation handle toward a proximal end of the IV device assembly. **Claim 10** An IV device assembly, Form a fluid channel inside the IV device assembly, A lumen that is fluidly coupled to a vascular access device (VAD) coupling at a distal end via a funnel-shaped coupling and to an IV device assembly coupling at a proximal end; An indwelling device formed along the length of the lumen, wherein a first end of the indwelling device is mechanically coupled to the funnel-shaped coupling; A translation handle movable relative to the lumen that translates the indwelling device out from a distal end of the VAD coupling, the indwelling device advancing through a channel formed within the translation handle and entering into the VAD coupling; A grip formed and fixed around the lumen to assist in gripping the lumen for operation of the translation handle; An IV device assembly comprising the above. **Claim 11** The IV device assembly according to claim 10, further comprising a collapsible sleeve formed around the lumen and mechanically coupled to the funnel-shaped coupling. **Claim 12** The IV device assembly according to claim 10, wherein the lumen is offset from a fluid axis of the VAD coupling. **Claim 13** A catheter coupled to the VAD coupling; A blood sample access device mechanically coupled to the IV device assembly coupling for receiving a blood sample through the IV device assembly; The IV device assembly according to claim 10, further comprising the above. **Claim 14** The IV device assembly according to claim 10, wherein the indwelling device comprises a guide wire coupled to a porous distal end formed at an end of the indwelling device. **Claim 15** An IV device assembly, Form a fluid channel inside the IV device assembly, A lumen that is fluidly coupled to a vascular access device (VAD) coupling at a distal end via a funnel-shaped coupling and to an IV device assembly coupling at a proximal end; An indwelling device extending outside the lumen along the length of the lumen and into the VAD coupling; A translation handle movable relative to the lumen that translates the indwelling device out from a distal end of the VAD coupling, a first end of the indwelling device being mechanically coupled to the translation handle; For the operation of the translation handle, a grip formed and fixed around the lumen to assist in gripping the lumen, An IV device assembly comprising. **Claim 16** The IV device assembly according to claim 15, further comprising a catheter coupled to the VAD junction. **Claim 17** The IV device assembly according to claim 15, wherein the lumen is offset from the fluid axis of the VAD junction. **Claim 18** The IV device assembly according to claim 15, wherein the access device is a guide wire having a porous second end. **Claim 19** The IV device assembly according to claim 15, further comprising a collapsible sleeve formed around the lumen and mechanically coupled to the funnel-shaped junction. **Claim 20** The collapsible sleeve according to claim 19, further comprising a coil spring that creates a space between the lumens and biases the translation handle toward the proximal end of the IV device assembly.

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