Vascular access device assembly that facilitates advancement of a probe with one hand using a support member

Abstract

The IV device assembly can include a lumen forming a fluid channel within the IV device assembly. The lumen can be fluidly coupled to a vascular access device (VAD) interface via a funnel interface and to the IV device assembly interface at a proximal end of the lumen. The IV device assembly can also include one or more of the following: a collapsible sleeve coaxially formed around a first portion of the lumen and mechanically coupled to the funnel interface; a probe formed along a second portion of the lumen within the collapsible sleeve and extending into the VAD interface; a translation handle for translating the probe from the distal end of the VAD interface; and a stationary grip formed around the lumen for maintaining the position of the IV device assembly relative to the translation handle.

Description

Technical Field

[0001] The present disclosure relates to a vascular access device assembly that uses a support member to facilitate one-handed advancement of a probe.

Background Art

[0002] Extending the patency of an intravenous (IV) device, such as a vascular access device (VAD), can improve the feasibility of long-term indwelling and reduce the need to subject the patient to the cost and trauma of unnecessary additional invasive procedures. More specifically, during use of an IV device, the IV device is inserted into a patient's blood vessel, and in some cases, while the needle is withdrawn from the IV device, the IV device remains in the patient's blood vessel. Depending on the situation, the IV device may remain in the patient's blood vessel for more than 30 days. This allows a clinician or other healthcare provider (HCP) to fluidly access the patient's bloodstream during care. This continuous fluid access to the patient's bloodstream allows the clinician or other HCP to collect one or more blood samples or administer one or more infusions, such as saline, various drugs, and total parenteral nutrition as needed.

Summary of the Invention

Problems to be Solved by the Invention

[0003] However, the patency of an IV device can be compromised while the IV device is in the patient's blood vessel. Continued occlusion can render the IV device defective and may require administration of another IV device into the patient's body. This can increase the trauma felt by the patient and may lead to other medical problems, such as, among other medical problems, particularly blood vessel inflammation.

[0004] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in the environments as described above. Rather, this background is provided only to show an environment in which some of the embodiments described herein may be implemented.

Means for Solving the Problem

[0005] The present disclosure generally relates to an intravenous (IV) device assembly for interfacing with a vascular access device (VAD), such as a catheter assembly for example. In some embodiments, the IV device assembly provides a probe that can be used to periodically check or improve the patency of the VAD while the needle and / or catheter is within the patient's blood vessel. The IV device assembly may include a vascular access device (VAD) coupling at the distal end of the IV device assembly, which is mechanically couplable to the VAD, and the VAD coupling has a channel formed therethrough. The IV device assembly may further include a probe having a length along the IV device assembly in these embodiments. In these embodiments, a translation handle may be mechanically coupled to the probe such that translation of the translation handle translates the probe from the distal end of the IV device assembly into the VAD along the channel formed in the VAD coupling. The IV device assembly may further include a support member formed along the length of the probe, and the support member mechanically supports the probe as it translates within the IV device assembly. The IV device assembly may also include a fixed grip formed at the proximal end of the support member, and the fixed grip maintains the position of the proximal end of the support member relative to the translation handle.

[0006] In these embodiments, the IV device assembly may further include a collapsible sleeve coaxially formed around the support member. In these embodiments, the collapsible sleeve may further include a coil spring 118 that creates a space around the probe and biases the translation handle towards the proximal end of the IV device assembly.

[0007] In one embodiment, the probe is coupled to the VAD junction and can pass through a probe channel formed through the translation handle and through the VAD junction. This arrangement allows the probe to be folded in half within the IV device assembly. By folding the length of the probe in half within the IV device assembly, the overall length of the IV device assembly can be shortened or the length of the probe extending from the IV device assembly can be increased.

[0008] The IV device assembly may further include a support member channel through which the support member can pass, where the support member is sized to fit within the support member channel and prevents the support member from rotating about the longitudinal axis of the support member.

[0009] In the embodiments described herein, the support member can take one or more forms, such as, among other things, a bistable spring, a helical coil, a tube, a shell, a sleeve, or a combination of sleeves. Each of these embodiments can also provide rigidity to the IV device assembly and the probe during operation.

[0010] In some embodiments, the support member can include a first sleeve support member coaxially disposed around the probe and a second sleeve support member coaxially disposed around the probe, where the second sleeve support member is sized to slide coaxially within the first sleeve support member as the translation handle is translated along the length of the IV device assembly.

[0011] This specification also describes an IV device assembly, the IV device assembly including a lumen that forms a fluid channel within the IV device assembly, a vascular access device (VAD) coupling that is connectable to a VAD and connectable to the lumen via a funnel-shaped junction, and a lumen that is fluidly coupled to an IV device assembly coupling at a proximal end of the lumen; a probe having a length along the IV device assembly; a translation handle mechanically coupled to the probe and translatable through a VAD coupling channel formed in the VAD coupling from a distal end of the IV device assembly into the IV device assembly, the translation handle including a lumen channel formed therethrough for the lumen to pass through when the translation handle is translated toward the distal end of the IV device assembly; a support member formed along the length of the probe and mechanically supporting the probe as the probe is translated within the IV device assembly; and a fixed grip formed at a proximal end of the support member and maintaining the position of the proximal end of the support member relative to the translation handle. A support member channel formed in the translation handle is sized to receive the support member therein and prevent the support member from rotating about its longitudinal axis. In one embodiment, the support member is a bistable spring that exits the VAD coupling through a bistable spring channel and curls itself as the translation handle is translated toward the distal end of the IV device assembly. In another embodiment, the support member includes a coil spring that wraps around the length of the probe.

[0012] This specification also describes an IV device assembly, the IV device assembly including a vascular access device (VAD) coupling at a distal end of the IV device assembly, the VAD coupling being mechanically couplable to a VAD and having a channel formed therethrough; a probe having a length along the IV device assembly; a translation handle mechanically coupled to the probe via a probe spoke, the translation handle when translated causing the probe to translate into the IV device assembly from the distal end of the IV device assembly through the channel; a support member formed along the length of the probe and mechanically supporting the probe as the probe is translated within the IV device assembly, the support member including a tube coaxially formed about the probe, the tube including a slit formed along a longitudinal length of the tube through which the probe spoke can pass; and a fixed grip formed at a proximal end of the support member and maintaining the position of the proximal end of the support member relative to the translation handle. In this embodiment, a lumen can be formed within the IV device assembly to form a fluid channel, the lumen being fluidly coupled to the VAD coupling at the distal end of the IV device assembly and fluidly coupled to an IV device assembly coupling at the proximal end of the lumen. In this embodiment, the IV device assembly can also include a collapsible sleeve coaxially formed about the probe, the tube, and the lumen. In some embodiments, a support spring can be formed within the collapsible sleeve, creating a space between the collapsible sleeve and the probe and biasing the translation handle toward the proximal end of the IV device assembly. The IV device assembly can also include, in this embodiment, a blood sample access device fluidly and mechanically coupled to the lumen via the IV device assembly coupling. The probe in this example can be a guide wire including a porous distal end.

[0013] 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 invention as claimed. 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 the embodiments may be combined, or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless otherwise claimed. Accordingly, the following detailed description should not be construed in a limiting sense.

[0014] Exemplary embodiments are described and explained with additional specificity and detail by using the accompanying drawings.

Brief Description of the Drawings

[0015]

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DETAILED DESCRIPTION OF THE INVENTION

[0016] FIG. 1 is a side view of an intravenous (IV) device assembly according to some embodiments of the present disclosure. In some embodiments, the IV device assembly 100 can be mechanically and fluidly coupled at a VAD coupling 106 to a vascular access device (VAD), such as a catheter. In these embodiments, the VAD can 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 within the catheter when the VAD is inserted into the patient's blood vessel. In these embodiments, the catheter can remain within the blood vessel and, as described herein, the probe 102 can be used as the patency device described herein to receive a patency check. In one embodiment, the probe 102 can include a wire, a guide wire, a tube, an occluder, a sensor, or any other device that can be at least partially passed through a patient's blood vessel via a catheter. In some embodiments, the catheter can include a peripheral IV catheter (PIVC), a peripherally inserted central catheter (PICC), or a median catheter. In embodiments where the VAD includes a needle, the probe 102 can be used to check the patency of the needle.

[0017] In some embodiments, the IV device assembly 100 can be mechanically and fluidly coupled to the blood sample access device 144. In some embodiments, the blood sample access device 144 can be mechanically coupled to the IV device assembly coupling portion 146 to receive a blood sample via the IV device assembly 100. In some embodiments, the blood sample access device can include a BD VACUTAINER® LUER-LOK™ access device, or another suitable blood sample access device, manufactured by Becton, Dickinson and Company of Franklin Lakes, New Jersey. Along with this blood sample access device 144, a blood sample tube such as a BD Vacutainer® manufactured by Becton, Dickinson and Company may include .

[0018] In one embodiment, the VAD junction 106 includes a channel formed therethrough, and in one embodiment, as described herein, the probe 102 passes through the channel and, during operation, is enabled to pass through and through the VAD. In one embodiment, the channel formed through the VAD junction 106 can be both a mechanical channel and a fluid channel. In this embodiment, the probe 102 can pass through the channel formed in the VAD junction 106, and the fluid can flow through the channel formed in the VAD junction 106 into the lumen formed along the length of the IV device assembly 100, which is fluidly coupled to the blood sample access device described herein. In one embodiment, the channel is formed through the VAD junction 106 and is fluidly coupled to the port tubing 120 and the port 122. The port 122 and its fluid-coupled port tubing 120 not only enable the introduction of the probe 102 into the VAD coupled to the VAD junction 106 using the IV device assembly 100, but also, if necessary, allow for the extraction of one or more blood samples or the administration of one or more infusions, such as saline, various drugs, and total parenteral nutrition. As described herein, the channel formed within the VAD junction 106 can be fluidly coupled to the lumen, which extends along the length of the IV device assembly 100, through the translation handle 110, to the fluid reservoir or the blood sample access device.

[0019] The IV device assembly 100 further includes a support member 104. According to any of the embodiments described herein, the support member 104 can be any rigid, semi-rigid, or selectively rigid device that adds a support structure to the IV device assembly 100. In one embodiment, the support member 104 can also support the probe 102 such that the probe 102 does not bend or buckle under itself during the operation of the IV device assembly 100. In the embodiment shown in FIG. 1, the support member 104 is a tube that extends along the length of the probe 102 and is coaxially formed around the probe 102.

[0020] As described herein, in some embodiments, the probe 102 is mechanically coupled to the translation handle 110. The translation handle 110 is selectively moved toward the distal or proximal end of the IV device assembly 100, such that the probe 102 passes through the VAD junction 106 and enters and exits the VAD junction 106, respectively. In one embodiment, the support member 104 may be mechanically coupled to the translation handle 110 and provide a level of rigidity to the IV device assembly 100 during operation.

[0021] In the embodiment shown in FIG. 1, the support member 104 may pass through a support member channel formed through the translation handle 110 and terminate at the proximal end of the support member 104 at the grip 112. The support member 104 may be used by a clinician or other healthcare provider (HCP) to fix the position of the IV device assembly 100 while the translation handle 110 is being translated along the length of the IV device assembly 100.

[0022] In some embodiments described herein, the IV device assembly 100 may include a collapsible sleeve 114. The collapsible sleeve 114 may be coaxially formed around a portion of the probe 102 and may be mechanically coupled to the VAD junction 106. In some embodiments, the collapsible sleeve 114 may be made of a collapsible and flexible material, allowing the collapsible sleeve 114 to fold itself. In the embodiments described herein, the collapsible sleeve 114 may be mechanically coupled to the translation handle 110. In some embodiments, the collapsible sleeve 114 may be mechanically coupled to a funnel-shaped junction 108 coupled to the proximal end of the VAD junction 106. The funnel-shaped junction 108 may be coupled to the VAD junction 106, for example, using an adhesive or by performing an ultrasonic welding process.

[0023] As described, in some embodiments, the IV device assembly 100 may include a funnel-shaped coupling 108 coupled proximal to the VAD coupling 106. The funnel-shaped coupling 108 may include a mechanical channel formed therein to allow the probe 102 to pass therethrough. Additionally, the channel formed in the funnel-shaped coupling 108 may include a seal 116. The seal 116 may prevent fluid present at the distal end of the seal 116 from flowing out from the proximal side of the funnel-shaped coupling 108.

[0024] During operation of the IV device assembly 100, a clinician or other HCP can mechanically couple the IV device assembly 100 to the VAD, which is by mechanically coupling the VAD coupling 106 to the VAD's coupling device. In an example where the probe 102 is a patency device, the clinician can choose to mechanically couple the IV device assembly 100 to the VAD at specific intervals or during any other patient monitoring process. Although the probe 102 is described herein as a patency device, it should be understood that any type of sensor or other device can be used as described herein to provide a number of medical diagnostics or medical treatments.

[0025] With the IV device assembly 100 mechanically coupled to the VAD at the VAD coupling 106, a clinician can hold the grip 112 in one hand and the translation handle 110 in the other hand. Next, the clinician can translate the translation handle 110 towards the distal end of the IV device assembly 100. In the embodiment described in relation to FIG. 1, the support member 104 passes through the translation handle 110 and is mechanically coupled to the grip 112, and the translation handle 110 slides along the support member 104. The support member 104 maintains a certain level of rigidity in the IV device assembly 100 as the translation handle 110 translates.

[0026] FIG. 1 shows the support member 104 as a tube coaxially disposed around the probe 102, but this specification contemplates that other types and forms of support members may be used. In some embodiments, the support member 104 may be a bistable spring, a set of nested sleeves, rails, and coil springs. These support members are described in more detail herein in connection with other embodiments.

[0027] FIG. 2A is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 2B is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 2A shows the IV device assembly 100 with the probe 102 in a retracted state or with the probe 102 disposed within the IV device assembly 100 and the translation handle 110 at the proximal end of the IV device assembly 100. FIG. 2B shows the probe 102 in a deployed state, with a portion of the probe 102 extending beyond the distal end of the VAD coupling 106. In these embodiments, the VAD coupling 106 may be coupled to the VAD as described, and in the case of the probe 102 in the deployed state, the probe 102 may pass through mechanical and / or fluid channels formed within the VAD.

[0028] FIG. 2A shows an exemplary position of the finger 124 of a clinician or other HCP. In this embodiment, the clinician may place his or her finger 124 on or around the translation handle 110 and be prepared to translate the translation handle 110 toward the distal end of the IV device assembly 100 as shown in FIG. 2B. In one embodiment, the clinician may also hold the grip 112, and the translation handle 110 may be moved relative to the grip 112. In one embodiment, due to the rigidity of the support member 104, the clinician can use one hand to push the translation handle 110 without gripping the grip 112.

[0029] Figure 2B shows the state of the collapsible sleeve 114 as the translational handle 110 passes toward the distal end of the IV device assembly 100. In one embodiment, the collapsible sleeve 114 may have one or more predetermined folds in a bellows configuration within the collapsible sleeve 114, enabling the collapsible sleeve 114 to collapse upon itself as the translational handle 110 moves in the distal direction. In one embodiment, the collapsible sleeve 114 may be flexible, such that the collapse of the collapsible sleeve 114 as shown in Figure 2B is not defined by predetermined folds. In one embodiment, the collapsible sleeve 114 may include a vent (not shown) that allows air to escape from the interior volume of the collapsible sleeve 114.

[0030] The embodiments shown in Figures 2A and 2B do not show a funnel-shaped coupling 108 coupled proximal to the VAD coupling 106. In this embodiment, the VAD coupling 106 may house a seal 116 as described herein. Again, this seal 116 may prevent fluid from exiting proximal to the VAD coupling 106 when the IV device assembly 100 is mechanically coupled to a VAD that is fluidly coupled to the patient's blood vessel.

[0031] FIG. 2B also shows the porous distal end 126 formed at the end of the probe 102. In this embodiment, the probe 102 may be a patent device. The porous distal end 126 of the probe 102 may be formed to remove obstructions from the fluid channels within the VAD. As described herein, the patency of the VAD may be checked from time to time by a clinician. During use of the VAD, the VAD is inserted into a patient's blood vessel and, in some cases, while the needle is withdrawn from the VAD, the VAD remains within the patient's blood vessel. Depending on the situation, the VAD may remain within the patient's blood vessel for more than 30 days. This allows a clinician or other healthcare provider (HCP) to have fluid access to the patient's bloodstream during medical care. This continuous fluid access to the patient's bloodstream allows the clinician or other HCP to take one or more blood samples or administer one or more infusions, such as saline, various medications, and total parenteral nutrition, as needed. However, the patency of the VAD may have an obstruction within the fluid channels formed therein, which may continuously malfunction the VAD and require the administration of another VAD into the patient's body. This can increase the trauma felt by the patient and lead to other medical problems, such as, among other medical problems, blood vessel inflammation in particular. Using the probe 102, the patency can be checked and maintained without removing the VAD from the patient's body.

[0032] As described herein, the probe 102 may be another type of device and may be introduced into a patient's blood vessel to medically diagnose the patient or provide other types of medical care. By way of example, the probe 102 may include a thermometer formed at the distal end of the probe 102. This thermometer may be introduced into the patient's blood vessel as the translation handle 110 translates towards the distal end of the IV device assembly 100. In another example, the probe 102 may include a pressure sensor that detects the patient's blood pressure within the patient's blood vessel. Other types of sensors also exist and may be used to measure any medical vital within the patient's blood vessel.

[0033] Figures 2A and 2B show a particular type of VAD junction 106, but this specification contemplates that any type of junction may be used. Figures 2A and 2B show a male luer adapter as the VAD junction 106. However, this specification contemplates that any other suitable VAD junction 106 may be used, including any female luer adapter. In some embodiments, the VAD junction 106 may include a slip or threaded female luer adapter, or a slip or threaded male luer adapter, or any other suitable connector including a needleless connector.

[0034] Figure 3 is a perspective exploded view of an IV device assembly 100 and a catheter assembly 128 according to some embodiments of the present disclosure. As described herein, the IV device assembly 100 includes a VAD junction 106 that can be used to mechanically and, in some embodiments, fluidly couple the IV device assembly 100 to the catheter assembly 128.

[0035] In some embodiments, the catheter assembly 128 may include a catheter 132. In some embodiments, the catheter assembly 128 may include a needle and a catheter 132 coaxially formed around the needle. During operation, the needle of the catheter assembly 128 may be removed and the catheter 132 may remain in the patient's body for fluid transfer.

[0036] In some embodiments, the catheter assembly 128 may also include a catheter port tubing 134 and a catheter port 136. In some embodiments, the catheter port tubing 134 and the catheter port 136 may be used as separate access points for a clinician to introduce infusions, such as saline, various medications, and total parenteral nutrition, into the blood vessels of a patient's body. In some embodiments, to prevent backflow of blood into the catheter port tubing 134 and the catheter port 136, the catheter port tubing 134 may include a port clamp 138. In some embodiments, the port clamp 138 may be clamped when the catheter port 136 is not in use, such that the pressure within the catheter port tubing 134 prevents the flow of blood therein.

[0037] FIG. 4 is a perspective cross-sectional view of an IV device assembly 100 and a blood sample access device 144, according to some embodiments of the present disclosure. As described herein, the IV device assembly 100 may include a VAD coupling 106 at the distal end of the IV device assembly 100. In some embodiments, the VAD coupling 106 may be mechanically coupled to a funnel-shaped coupling 108, and the VAD coupling 106 and the funnel-shaped coupling 108 may have a mechanical path formed therethrough for the probe 102 to pass. In the example shown in FIG. 4, the funnel-shaped coupling 108 may also include a seal 116, which prevents fluid that may enter the mechanical path from exiting from the proximal side of the funnel-shaped coupling 108.

[0038] In some embodiments, the IV device assembly 100 may further include a collapsible sleeve 114. As described herein, the collapsible sleeve 114 may be coaxially disposed around the probe 102 and may limit physical contact with the probe 102. By limiting physical contact with the probe 102, the collapsible sleeve 114 can limit contaminants that may come into contact with the probe 102 that can be in fluid contact with the patient's blood stream. In the embodiment shown in FIG. 4, the collapsible sleeve 114 may be mechanically coupled to the funnel-shaped junction 108 and the translation handle 110 via an adhesive or an ultrasonic welding process. In some embodiments, the collapsible sleeve 114 may be mechanically coupled to the funnel-shaped junction 108 and the translation handle 110 using a press-fit process, a shrink-fit process, or any other type of joining process, and this specification contemplates these different types of joining processes. In some embodiments, air within the volume of the space formed within the collapsible sleeve 114, the funnel-shaped junction 108, and the translation handle 110 may be vented through a vent hole (not shown) or, as described herein, through a gap formed between the support member 104 and a support member channel formed in the translation handle 110.

[0039] In the embodiment shown in FIG. 4, the IV device assembly 100 may further include a lumen 140. The lumen 140 may enable a fluid such as blood to pass from a catheter assembly 128 coupled to the VAD junction 106, through the IV device assembly 100, and into a blood sample access device 144 that is mechanically and fluidly coupled to the lumen 140 via an IV device assembly junction 146. The channels formed in the VAD junction 106 and / or the funnel-shaped junction 108 may be both a mechanical channel for the probe 102 and a fluid channel for the lumen 140 to pass fluid therethrough.

[0040] In one embodiment, the lumen 140 can be fluidly coupled via a funnel-shaped coupling channel 142 to a channel formed in the VAD junction 106 and / or the funnel-shaped junction 108. Thereby, fluid can enter from the catheter assembly 128 into a channel formed in the VAD junction 106, enter a channel formed through the funnel-shaped junction 108 used to house the probe 102, enter into the lumen 140 through the funnel-shaped coupling channel 142, and in this embodiment, can enter into the blood sample access device 144. Thus, in the embodiment shown in FIG. 4, the IV device assembly 100 can be used as a device for inserting the probe 102 into the catheter assembly 128 (e.g., for checking the patency of the catheter assembly 128), as well as a device for collecting a blood sample.

[0041] The blood sample access device 144 can be any type of blood sample / collection device and, in certain embodiments, can include a BD VACUTAINER® LUER-LOK™ access device. In this particular example, the blood sample access device 144 includes a receptacle and can receive a blood sample tube such as a BD Vacutainer®. The blood sample tube can include a septum that, when punctured by a needle formed in the blood sample access device 144, creates a negative pressure to draw blood into the blood sample tube.

[0042] In this embodiment, the offset of the lumen 140 from the central axis of the IV device assembly 100 allows the funnel-shaped coupling channel 142 to fluidly couple the lumen to a channel formed in the VAD junction 106 and / or the funnel-shaped junction 108. The probe 102 can interface with a channel formed through the VAD junction 106 and the funnel-shaped junction 108 along generally the same central axis as the central axis of the IV device assembly 100.

[0043] In some embodiments, the length of the lumen 140 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 140 may include a length L from the funnel-shaped coupling channel 142 to the IV device assembly coupling portion 146. In some embodiments, the fluid path of the lumen 140 that may be optimized may include an inner diameter D.

[0044] The flow of fluid within the fluid path of the lumen 140, which is tubular, can be analyzed using Poiseuille's equation.

Number

[0045] In some embodiments, the fluid path of the lumen 140 may have a plurality of sections having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), and the geometric coefficients are as follows.

Number

Number

Number

[0046] The G of the fluid pathway of lumen 140 f value is selected to reduce the maximum shear stress for each VAD gauge and can be made below the maximum shear stress of the BD21G VACUTAINER® UltraTouch™ push-button blood collection set (available from Becton, Dickinson and Company, Franklin Lakes, NJ), which was previously considered the absolute standard for blood collection. In some embodiments, the G f value of the fluid pathway is selected to reduce the maximum shear stress of each VAD gauge and can be made below the maximum shear stress of the BD25G VACUTAINER® UltraTouch™ push-button blood collection set (available from Becton, Dickinson and Company, Franklin Lakes, NJ).

[0047] In some embodiments, the G of the fluid pathway of the lumen of the port tubing 120 f value can be determined in the same manner as the G f value of the fluid pathway of lumen 140. In some embodiments, the fluid pathway of the blood collection system can include one or more of the fluid pathways of the blood sample access device 144, the IV device assembly 100, and the catheter assembly 128 (which may include the catheter port tubing 134), and can include the entire blood collection pathway through which blood flows out of a blood vessel and then into or through the blood sample access device 144 during blood collection. The system geometric coefficient G for the fluid pathway of the blood collection system fs is the G of the fluid pathway of lumen 140 as described above fIt can be determined in a similar manner as the value. In some embodiments, the system geometric coefficient G fs can be 7.34E+06 (1 / in 3 ). In some embodiments, G fs may include another value. In some embodiments, the system geometric coefficient G fs can be 7.34E+06 (1 / in 3 ) ±10%, ±25%, ±50%, or ±75%. In some embodiments, G fs may include another value, which can be selected based on the gauge and / or length of the catheter 132.

[0048] As described herein, the IV device assembly 100 may also include a support member 104, which provides a certain level of rigidity throughout the IV device assembly 100. Additionally, the support member 104 can support the probe 102 as the probe 102 moves as described so as to extend from the inside of the IV device assembly 100 to the outside of the IV device assembly 100. Since the translation handle 110 translates along the support member 104, the translation handle 110 may include a support member channel that allows the support member to pass through the translation handle 110 during operation. Similarly, in this embodiment, since the IV device assembly 100 includes a lumen 140, the translation handle 110 may also include a lumen channel formed therethrough. The lumen channel may also allow the lumen 140 to pass through the translation handle 110 when the translation handle 110 passes distally towards the VAD junction 106 and the funnel-shaped junction 108.

[0049] As described herein, in some embodiments, the probe 102 is mechanically coupled to the translation handle 110. The translation handle 110 can be selectively moved towards the distal or proximal end of the IV device assembly 100, such that the probe 102 passes through the VAD junction 106 and enters and exits the VAD junction 106, respectively. The probe 102 can include a porous distal end 126 in some embodiments. The porous distal end 126 of the probe 102 can be formed to remove obstructions from the fluid channels within the VAD. As described herein, the patency of the VAD can be checked from time to time by a clinician. During use of the VAD, the VAD is inserted into a patient's blood vessel and, in some cases, while the needle is withdrawn from the VAD, the VAD remains within the patient's blood vessel. Depending on the situation, the VAD can remain within the patient's blood vessel for more than 30 days. This enables a clinician or other healthcare provider (HCP) to have fluid access to the patient's bloodstream during medical care.

[0050] FIG. 5 is a perspective cross-sectional view of an IV device assembly 100 and a blood sample access device, according to some embodiments of the present disclosure. As described herein, the IV device assembly 100 can include a VAD junction 106 at the distal end of the IV device assembly 100. In some embodiments, the VAD junction 106 may be mechanically coupled to a funnel-shaped junction 108, and the funnel-shaped junction 108 may have a mechanical path formed for the probe 102 to pass through. In the example shown in FIG. 4, the funnel-shaped junction 108 may also include a seal 116 to prevent fluid that may enter the mechanical path from exiting from the proximal side of the funnel-shaped junction 108.

[0051] In some embodiments, the IV device assembly 100 may further include a collapsible sleeve 114. As described herein, the collapsible sleeve 114 may be coaxially disposed around the probe 102 and may limit physical contact with the probe 102. By limiting physical contact with the probe 102, the collapsible sleeve 114 can limit contaminants that may come into contact with the probe 102, which may be in fluid contact with the patient's bloodstream. In the embodiment shown in FIG. 4, the collapsible sleeve 114 may be mechanically coupled to the funnel-shaped junction 108 and the translation handle 110 via an adhesive or an ultrasonic welding process. In some embodiments, air within the volume of the space formed within the collapsible sleeve 114, the funnel-shaped junction 108, and the translation handle 110 may be vented through a vent hole (not shown) or through a gap formed between the support member 104 and a support member channel formed in the translation handle 110, as described herein.

[0052] In the embodiment shown in FIG. 5, the IV device assembly 100 may further include a lumen 140. The lumen 140 may enable a fluid, such as blood, to pass from a catheter assembly 128 coupled to the VAD junction 106, through the IV device assembly 100, and into a blood sample access device 144 mechanically and fluidly coupled to the lumen 140 via an IV device assembly junction 146. Channels formed in the VAD junction 106 and / or the funnel-shaped junction 108 may be both a mechanical channel for the probe 102 and a fluid channel used for the lumen 140 to pass fluid therethrough.

[0053] FIG. 5 shows that, in some embodiments, the positions of the lumen 140, the probe 102, and the support member 104 can be exchanged compared to FIG. 4. In particular, the probe 102 is offset from the central axis of the IV device assembly 100 such that the probe 102 passes through the probe channel 143, which enables the probe 102 to be passed into a channel formed in the VAD junction 106 and / or the funnel-shaped junction 108. The probe 102 can be made of an elastically flexible material such that, during operation of the IV device assembly 100, the probe 102 is enabled to pass through the probe channel 143 and into a channel formed in the VAD junction 106. In this embodiment, the lumen 140 can interface with a channel formed through the VAD junction 106 and the funnel-shaped junction 108 generally along the same central axis as the central axis of the IV device assembly 100.

[0054] As described herein, the IV device assembly 100 can also include a support member 104, which provides a level of rigidity throughout the IV device assembly 100. Additionally, the support member 104 can support the probe 102 as the probe 102 moves such that it extends from the inside of the IV device assembly 100 to the outside of the IV device assembly 100 as described. Since the translation handle 110 translates along the support member 104, the translation handle 110 can include a support member channel that enables the support member to pass through the translation handle 110 during operation. Similarly, in this embodiment, since the IV device assembly 100 includes the lumen 140, the translation handle 110 can also include a lumen channel formed therethrough. The lumen channel can also enable the lumen 140 to pass through the translation handle 110 as the translation handle 110 passes distally towards the VAD junction 106 and the funnel-shaped junction 108.

[0055] As described herein, in some embodiments, the probe 102 is mechanically coupled to the translational handle 110. The translational handle 110 is selectively moved toward the distal or proximal end of the IV device assembly 100 such that the probe 102 passes through the VAD coupling 106 and enters and exits the VAD coupling 106, respectively. The probe 102 may include a porous distal end 126 in some embodiments. The porous distal end 126 of the probe 102 may be configured to remove obstructions from the fluid channels within the VAD. As described herein, the patency of the VAD may be checked from time to time by a clinician. During use of the VAD, the VAD is inserted into a patient's blood vessel and, in some cases, while the needle is withdrawn from the VAD, the VAD remains within the patient's blood vessel. In some situations, the VAD remains within the patient's blood vessel for 30 days or more. Thereby, a clinician or other healthcare provider (HCP) is able to access the patient's bloodstream fluidly during healthcare.

[0056] FIG. 6A is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 6B is a front cross-sectional view of the translational handle 110 of the IV device assembly 100 (e.g., along section “A” shown in FIG. 6A) according to some embodiments of the present disclosure. FIG. 6C is a perspective view of the support member 104 of the IV device assembly 100 according to some embodiments of the present disclosure. In the embodiments shown in FIGS. 6A and 6B, the probe 102 is shown to be in an offset position relative to the central longitudinal axis of the IV device assembly 100 and is similar to that shown in FIG. 4.

[0057] In the embodiments shown in FIGS. 6A, 6B, and 6C, the IV device assembly 100 may include a VAD coupling (not shown) at the distal end of the IV device assembly 100. In some embodiments, the VAD coupling may be mechanically coupled to a funnel-shaped coupling (not shown), and the VAD coupling and the funnel-shaped coupling may have a mechanical path formed for the probe 102 to pass through. In one example, the IV device assembly 100 may also include a seal 116, which prevents fluid that may enter the mechanical path from exiting proximal to the VAD coupling or the funnel-shaped coupling.

[0058] In some embodiments, the IV device assembly 100 may further include a collapsible sleeve 114. As described herein, the collapsible sleeve 114 may be coaxially disposed around the probe 102 and may limit physical contact with the probe 102. By limiting physical contact with the probe 102, the collapsible sleeve 114 can limit contaminants that may come into contact with the probe 102, which may be in fluid contact with the patient's blood flow. In the embodiment shown in FIG. 4, the collapsible sleeve 114 may be mechanically coupled to the funnel-shaped coupling 108 and the translation handle 110 via an adhesive or an ultrasonic welding process. In some embodiments, air within the volume of the space formed within the collapsible sleeve 114, the funnel-shaped coupling 108, and the translation handle 110 may be exhausted via a vent (not shown) or, as described herein, via a gap formed between the support member 104 and a support member channel formed in the translation handle 110. In one embodiment, the funnel-shaped coupling 108 and / or the VAD coupling may include a probe channel 143. The probe channel 143 may be formed in one or both of the VAD coupling or the funnel-shaped coupling 108, and the probe 102 may be able to enter and exit the IV device assembly 100 during operation.

[0059] As described herein, the translational handle 110 may include a lumen channel 148 and a support member channel 150. The lumen channel 148 may be formed through the translational handle 110 such that the lumen 140 can remain connected, for example, to the IV device assembly coupling 146 and a blood sample access device (not shown) while the translational handle 110 translates toward the distal end of the IV device assembly 100.

[0060] The support member channel 150 may also be possible as a channel through which the support member 104 can pass when the translational handle 110 translates toward the distal end of the IV device assembly 100. However, in order to move the probe 102 using the translational handle 110, the translational handle 110 may include spokes 152. The spokes 152 may be, in an example, extensions of the translational handle 110 that pass radially through the support member channel 150 and are mechanically coupled to the probe 102. In another embodiment, the spokes 152 may be a single mechanical coupling device that couples to the translational handle 110, extends within the support member channel 150, and may be coupled to the probe 102 at a proximal or near-proximal location along the probe 102.

[0061] In the embodiments shown in FIGS. 6A, 6B, and 6C, the IV device assembly 100 includes a tube-shaped support member 104 that extends along the length of the IV device assembly 100. In one embodiment, the support member 104 may be the same length as or longer than the distance that the folding sleeve 114 and the translational handle 110 can extend, thereby allowing the support member 104 to extend beyond the proximal side of the translational handle 110. In this embodiment, the support member 104 may include a grip (not shown) and the clinician translates the translational handle 110 toward the distal end of the IV device assembly 100 while gripping the grip.

[0062] In one embodiment, the support member 104 may be in the form of a tube as shown in FIG. 6C. The probe 102 is coaxially disposed within the tube-shaped support member 104. In this embodiment, the tubular support member 104 may include a slit 154 along the length of the support member 104, allowing the spoke 152 to translate through the support member 104. In one embodiment, the tube-shaped support member 104 may be made of a flexible material such as plastic, enabling it to elastically bend at any location along the slit 154 made in the support member 104 wherever the spoke 152 enters the support member 104. Thus, during the translation of the translation handle 110, the spoke 152 can bend and open the support member 104 at the location of the slit 154 where the spoke 152 couples the probe 102 to the translation handle 110.

[0063] Figure 7A is a side view of an IV device assembly 100 and a blood sample access device 144 according to some embodiments of the present disclosure. Figure 7B is a side view of an IV device assembly according to some embodiments of the present disclosure. Figure 7C is a perspective view of an IV device assembly and a blood sample access device according to some embodiments of the present disclosure. In the embodiments shown in Figures 7A and 7B, the IV device assembly 100 may include a needle / catheter distal end 130 that is fluidly and mechanically coupled directly to the distal side of the funnel-shaped junction 108. However, this specification also contemplates that a VAD junction (not shown) may be used as described in connection with Figure 1. In the embodiments shown in Figures 7A and 7B, the IV device assembly 100 may include a probe 102 and a lumen 140 that are mechanically and fluidly coupled to the needle / catheter distal end 130, respectively. The interface between the probe 102 and the support member 104 has been described using multiple embodiments herein. In these embodiments, the lumen 140 may be disposed along the probe 102 such that the points where the probe 102 and the lumen 140 enter the funnel-shaped junction 108 are relatively close to each other. Thereby, when the probe 102 enters the fluid path of the lumen 140 within the funnel-shaped junction 108, the deflection of the probe 102 can be reduced. In these embodiments, either the funnel-shaped junction channel 142 or the probe channel 143 can be used as described to converge the two paths of the probe 102 and the lumen 140 within the funnel-shaped junction 108. Further, a seal (not shown) can be used to fluid-tightly seal the entry point of the probe 102 into the funnel-shaped junction 108, thereby preventing fluid from leaking out from the proximal side of the funnel-shaped junction 108.

[0064] The support member 104 described herein can provide rigidity to the IV device assembly 100. In this particular embodiment, the distal end of the support member 104 is mechanically coupled proximal to the funnel-shaped junction 108. In alternative embodiments, the support member 104 and the funnel-shaped junction 108 may be formed from a single monolithic piece. In any embodiment, the support member 104 can be made to pass through the translation handle 110 and coaxially couple around the lumen 140. The support member 104, in one embodiment, includes a ring at the distal end to enable passage through the lumen 140 during manufacture. Since the lumen 140 can be made of a flexible material such as plastic, the support member can support the lumen 140 and other elements of the IV device assembly 100 during operation. In one embodiment, this ring of the support member 104 formed around the lumen 140 can function as the grip 112 described herein.

[0065] During operation, a clinician or other HCP may fluidly couple a blood sample access device 144 to the proximal end of the lumen 140 in preparation for receiving a blood sample. Either before or after receiving the blood sample, the clinician may check or maintain the patency of the needle / catheter distal end 130 by translating the translation handle 110 distally toward the distal end of the IV device assembly 100. The clinician may grasp the translation handle 110 and, for example, the blood sample access device 144, and translate the translation handle 110 along the support member 104 and the lumen 140 such that the support member 104 and the lumen 140 can each pass through a support member channel 150 and a lumen channel 148 formed within the translation handle 110. When distal translation of the IV device assembly 100 occurs, the collapsible sleeve 114 may be collapsed onto itself. Distal translation of the translation handle 110 may end, in one embodiment, when the distal side of the translation handle 110 contacts the proximal side of the funnel-shaped coupling 108. This translation causes the probe 102 to extend from the needle / catheter distal end 130 and pass through the distal end of the needle / catheter distal end 130, as shown in FIG. 7B. If the probe 102 is a patency device, the fluid channels within the needle / catheter distal end 130 and the funnel-shaped coupling 108 are checked and areas where patency may have been absent are restored. If the probe 102 is, for example, a thermometer, the patient's body temperature may be measured and recorded by the clinician. As described herein, other types of probes 102 may be present and this specification contemplates the use of these other types of probes 102.

[0066] After checking patency, in this embodiment, a clinician may collect a blood sample by inserting a blood sample tube 156 into a blood sample access device 144 as shown in FIG. 7B. In one embodiment, the blood sample access device 144 may be a BD VACUTAINER LUER-LOK and the blood sample tube 156 may be a BD Vacutainer. In this particular example, when the blood sample tube 156 is inserted into the blood sample access device 144, the needle 158 of the access device can pierce a septum formed at the distal end of the blood sample tube 156, releasing the negative pressure formed within the blood sample tube 156 and drawing a quantity of blood into the blood sample tube 156 via the lumen 140. When a sufficient quantity of blood has been collected, the clinician may remove the blood sample tube 156 and seal the septum. This blood collection process can be performed any number of times during the placement of the needle / catheter distal end 130, and the probe 102 may be performed to maintain the patency of the needle / catheter distal end 130 when used as a patency device.

[0067] In this embodiment, the IV device assembly 100 may also include a fluid coupling port tubing 120 and a port 122. As described herein, the fluid coupling port tubing 120 and port 122 may be used to administer one or more infusions, such as saline, various medications, and total parenteral nutrition, if needed during a patient's medical care.

[0068] FIG. 8A is a perspective view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 8B is a perspective view of an IV device assembly 100 according to some embodiments of the present disclosure. In these embodiments, the IV device assembly 100 may include a VAD coupling 106 at the distal end and a translation handle 110 and a grip 112 formed at the proximal end, as described herein.

[0069] In this embodiment, the support member 104 may include a plurality of rings 160 coaxially disposed around the probe 102, and the rings 160 are fixed to each other using rods or spines mechanically coupled to each ring 160. In the embodiment shown in FIG. 8A, the rods or spines may be straight. In this embodiment, each ring 160 may support the collapsible sleeve 114 when the translation handle 110 translates in the distal direction. Each ring 160 may also be slidably coupled to the rod or spine such that each ring 160 may be translated along the length of the rod or spine.

[0070] In the embodiment shown in FIG. 8B, the rod or spine of the support member 104 may be bent. The bent rod or spine may provide greater support to the IV device assembly 100 in use. Also in this case, each ring 160 may support the collapsible sleeve 114 when the translation handle 110 translates in the distal direction. Each ring 160 may also be slidably coupled to the rod or spine such that each ring 160 may be translated along the length of the rod or spine.

[0071] FIG. 9A is a perspective view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 9B is a perspective view of the translation handle 110 and the support member 104 of the IV device assembly 100 according to some embodiments of the present disclosure. In this embodiment, the IV device assembly 100 may include a VAD coupling portion 106 disposed at the distal end of the IV device assembly 100. Other elements related to the IV device assembly 100 and shown and described in connection with other embodiments herein may also be included in the IV device assembly 100 shown in FIGS. 9A and 9B.

[0072] Figure 9A shows that the support member can include rails mechanically coupled to the internal support structure 162. In this embodiment, the rails can be mechanically coupled to the translation handle 110, and the translation handle 110 can pass along the rails. As shown in Figure 6B, a portion of the translation handle 110 can be mechanically coupled to the proximal end of the probe 102 and can partially wrap around the rails during assembly. The support member 104, in this embodiment, structurally supports the entire IV device assembly 100 while preventing the probe 102 from bending when a force is applied to the proximal end of the probe 102.

[0073] The probe 102 can include a porous distal end 126 in some embodiments. The porous distal end 126 of the probe 102 can be formed to remove obstructions from fluid channels within the VAD. As described herein, the patency of the VAD can be checked by a clinician from time to time. During use of the VAD, the VAD is inserted into a patient's blood vessel, and in some cases, while a needle is withdrawn from the VAD, the VAD remains within the patient's blood vessel. Depending on the situation, the VAD can remain within the patient's blood vessel for 30 days or more. This allows a clinician or other healthcare provider (HCP) to fluidly access the patient's bloodstream during medical care.

[0074] FIG. 10A is a perspective view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 10B is a side view of the IV device assembly 100 according to some embodiments of the present disclosure. In some embodiments, the IV device assembly 100 can be mechanically and fluidly coupled to a vascular access device (VAD), such as a catheter, at a VAD coupling 106. In these embodiments, the VAD can 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 within the catheter when the VAD is inserted into the patient's blood vessel. In these embodiments, the catheter can remain within the blood vessel and, as described herein, the probe 102 can receive a patency check using the patency device described herein. In one embodiment, the probe 102 can include a wire, a guide wire, a tube, an occluder, a sensor, or any other device that passes through the catheter and at least partially enters the patient's blood vessel. In some embodiments, the catheter can include a peripheral IV catheter (PIVC), a peripherally inserted central catheter (PICC), or a median catheter. In embodiments where the VAD includes a needle, the patency of the needle can also be checked using the probe 102.

[0075] In some embodiments, the IV device assembly 100 can be mechanically and fluidly coupled to a blood sample access device (not shown). In some embodiments, the blood sample access device is mechanically coupled to an IV device assembly coupling portion (not shown) to receive a blood sample through the IV device assembly 100. In some embodiments, the blood sample access device can include a BD VACUTAINER LUER-LOK access device, manufactured by Becton, Dickinson and Company of Franklin Lakes, New Jersey, or another suitable blood sample access device. Along with this blood sample access device, a blood sample tube such as a BD Vacutainer manufactured by Becton, Dickinson and Company may include .

[0076] In one embodiment, the VAD coupling portion 106 includes a channel formed therethrough, and in one embodiment, the probe 102 passes through the channel and, during operation, passes through and is enabled to pass into the VAD as described herein. In one embodiment, the channel formed through the VAD coupling portion 106 can be both a mechanical channel and a fluid channel. In this embodiment, the probe 102 can pass through the channel formed in the VAD coupling portion 106, and fluid can flow through the channel formed in the VAD coupling portion 106 into a lumen formed along the length of the IV device assembly 100, which is fluidly coupled to the blood sample access device described herein.

[0077] In one embodiment, the channel is formed through the VAD junction 106 and is fluidly coupled to the port tubing 120 and the port 122. The port 122 and its fluidly coupled port tubing 120 enable the use of the IV device assembly 100 to introduce the probe 102 into the VAD coupled to the VAD junction 106 and, if necessary, to withdraw one or more blood samples or to administer one or more infusions, such as saline, various drugs, and total parenteral nutrition. In one embodiment, the channel formed within the VAD junction 106 may be fluidly coupled to a lumen that extends along the length of the IV device assembly 100, through the translation handle 110, to a fluid reservoir or a blood sample access device. In some embodiments, the lumen may correspond to the lumen 140 (see, e.g., FIG. 4). In one embodiment, the port 122 may be mechanically and fluidly coupled to the blood sample access device 144, and a blood sample may be received in the blood sample tube 156. In this embodiment, the port 122 may be selectively coupled to one of a blood sample access device or a drug introduction device.

[0078] The IV device assembly 100 further includes a support member 104. According to any of the embodiments described herein, the support member 104 may be any rigid, semi-rigid, or selectively rigid device and adds a support structure to the IV device assembly 100. In one embodiment, the support member 104 can also support the probe 102 such that the probe 102 does not bend or buckle under its own weight during operation of the IV device assembly 100. In the embodiments shown in FIGS. 10A and 10B, the support member 104 is a rigid shaft that extends along the length of the probe 102 and passes through a support member channel formed in the translation handle 110.

[0079] As described herein, in some embodiments, the probe 102 is mechanically coupled to the translation handle 110. The translation handle 110 is selectively moved toward the distal or proximal end of the IV device assembly 100, such that the probe 102 passes through the VAD junction 106 and enters and exits the VAD junction 106, respectively. In one embodiment, the support member 104 can be mechanically coupled to the translation handle 110 to provide a certain level of rigidity to the operating IV device assembly 100. In the particular embodiment shown in FIGS. 10A and 10B, the probe 102 is a double-length probe 102. Doubling the length of the probe 102 can be achieved by mechanically coupling the proximal end of the probe 102 to the point of the anchor 164 formed proximal to the VAD junction 106 or, in some embodiments, proximal to the funnel-shaped junction. In this embodiment, the probe 102 can pass through a channel 166 formed in the translation handle 110 and be oriented through a channel formed through the IV device assembly 100, through the VAD junction 106 and / or the funnel-shaped junction. During operation, when the IV device assembly 100 translates in the distal direction, the probe 102 is pushed out of the VAD junction 106 through the channel 166. In some embodiments, the grip 112 may be sandwiched between the thumb and the finger 124 of the clinician's first hand. In these and other embodiments, another finger 124, such as the index finger of the first hand, may be placed on the translation handle 110 while the index finger and thumb of the first hand sandwich the grip 112. In these embodiments, the index finger of the first hand can advance the probe 102 while the grip 112 is held between the index finger and thumb of the first hand. In another embodiment, the finger 124 of the clinician's second hand may be placed on the translation handle 110 while the index finger and thumb of the first hand sandwich the grip 112. In these embodiments, the finger 124 of the second hand can advance the probe 102 while the grip 112 is held between the index finger and thumb of the first hand.

[0080] Doubling the length of the probe 102 within the IV device assembly 100, or in some instances tripling it, can increase the travel distance of the probe 102. In an example where the probe 102 is a patency device, the porous distal end 126 of the patency device can pass along a relatively long fluid path to the catheter assembly 128 described in connection with FIG. 1 and check the patency of the catheter assembly 128. Another device can also be used, and the probe 102 can not only extend from the catheter assembly 128 coupled to the IV device assembly 100, but also move a distance within and through the patient's blood vessels to monitor vital signs or complete other medical procedures within the patient's body. In some embodiments, any multiple-length probe 102 can be disposed within the IV device assembly 100, and the distance the probe 102 travels can be increased without increasing the length of the IV device assembly 100.

[0081] In the embodiment shown in FIG. 10A, the support member 104 can pass through a support member channel formed through the translation handle 110 and terminate at the proximal end of the support member 104 at the grip 112. The support member 104 can be used by a clinician or other HCP to fix the position of the IV device assembly 100 while the translation handle 110 is translated along the length of the IV device assembly 100.

[0082] In some embodiments described herein, the IV device assembly 100 may include a collapsible sleeve 114. The collapsible sleeve 114 may be coaxially formed around a portion of the probe 102 and may be mechanically coupled to the VAD junction 106. In some embodiments, the collapsible sleeve 114 may be made of a collapsible and flexible material, allowing the collapsible sleeve 114 to fold itself. In the embodiments described herein, the collapsible sleeve 114 may be mechanically coupled to the translation handle 110. In some embodiments, the collapsible sleeve 114 may be mechanically coupled to a funnel-shaped junction 108 coupled to the proximal end of the VAD junction 106. The funnel-shaped junction 108 may be coupled to the VAD junction 106, for example, using an adhesive or by performing an ultrasonic welding process.

[0083] As described, in some embodiments, the IV device assembly 100 may include a funnel-shaped junction (not shown) coupled to the proximal side of the VAD junction 106. The funnel-shaped junction may include a mechanical channel formed therein, allowing the probe 102 to pass through. Additionally, the channel formed in the funnel-shaped junction may include a seal 116. The seal 116 may prevent fluid present at the distal end of the seal 116 from flowing out from the proximal side of the funnel-shaped junction.

[0084] During operation of the IV device assembly 100, a clinician or other HCP can mechanically couple the IV device assembly 100 to the VAD, which is by mechanically coupling the VAD junction 106 to the coupling device of the VAD. In an example where the probe 102 is a patency device, the clinician may choose to mechanically couple the IV device assembly 100 to the VAD at specific intervals or during any other patient monitoring process. Although the probe 102 is described herein as a patency device, it should be understood that any type of sensor or other device may be used as described herein to provide a number of medical diagnoses or medical treatments.

[0085] With the IV device assembly 100 mechanically coupled to the VAD at the VAD coupling 106, a clinician can grasp the grip 112 with one hand and the translation handle 110 with the other hand. Next, the clinician can translate the translation handle 110 toward the distal end of the IV device assembly 100. In the embodiment described in connection with FIG. 1, since the support member 104 passes through the translation handle 110 and is mechanically coupled to the grip 112, the translation handle 110 slides along the support member 104. The support member 104 maintains a certain level of rigidity in the IV device assembly 100 when the translation handle 110 is translated.

[0086] FIGS. 10C - 10G are front cross-sectional views of the support member 104 (in the cross-sectional view at "B" of FIG. 10B) of the IV device assembly 100 according to some embodiments of the present disclosure. As described herein, the support member 104 passes through the translation handle 110 and, in the examples shown in FIGS. 10A and 10B, can terminate at a grip 112 for a clinician to grasp. The support member channel 150 formed through the translation handle 110 and the support member 104 itself can be mated such that the support member 104 fits within the support member channel 150 at a specific positional angle to prevent the translation handle 110 from rotating around the support member 104.

[0087] In a first example, FIG. 10C shows a support member 104 having a circular cross-section. Depending on the diameter of the support member channel 150 formed in the translation handle 110, rotation of the translation handle 110 around the support member 104 can, in this example, be prevented using the degree of interference fit between the inner diameter of the support member channel 150 and the outer diameter of the support member 104.

[0088] In a second example, FIG. 10D shows that the support member 104 has two semi-circular shapes and that a brace formed in the translation handle 110 can pass between the two semi-circular shapes. By mating the support member 104 and the support member channel 150 in this way, rotation of the translation handle 110 around the support member 104 is prevented.

[0089] In a third example, FIG. 10E shows that the support member 104 may include a notch from which it is removed, and the notch contacts a finger extending from the inner surface of the support member channel 150. By aligning the support member 104 and the support member channel 150 in this way, the translational handle 110 is prevented from rotating around the support member 104.

[0090] In a fourth example, FIG. 10F shows that the support member 104 may be formed to have a "U-shaped" cross-section, and a portion of the translational handle 110 may be formed to extend downward into a hollow portion formed in the support member 104. By aligning the support member 104 and the support member channel 150 in this way, the translational handle 110 is prevented from rotating around the support member 104.

[0091] In a fifth example, FIG. 10G shows that the support member 104 has a square cross-section. The support member channel 150 formed in the translational handle 110 may also be square and the support member 104 may pass through it. By aligning the support member 104 and the support member channel 150 in this way, the translational handle 110 is prevented from rotating around the support member 104.

[0092] FIG. 11A is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 11B is a side view of the translational handle 110 of the IV device assembly 100 according to some embodiments of the present disclosure. This embodiment of the IV device assembly 100 shows that the translational handle 110 may include a protruding portion having a channel 166 formed therethrough. As described herein, the doubled probe 102 may be mechanically coupled to the VAD coupling portion 106 at the point of the anchor 164, such that the probe 102 may be passed through the channel 166 into a channel formed within the VAD coupling portion 106. With such a configuration, the length of the probe 102 can be doubled within the IV device assembly 100, and the overall length of the IV device assembly 100 can remain the same.

[0093] The channel 166 formed in the translational handle 110 can be formed such that the double-length probe 102 can pass through the channel 166 relatively easily. In some embodiments, the inner surface of the channel 166 may be coated with a friction-reducing material such as polytetrafluoroethylene.

[0094] FIG. 12 is a side view of an IV device assembly according to some embodiments of the present disclosure. FIG. 12 shows that the probe 102 can pass through the interior of the IV device assembly 100 three times. In this embodiment, the anchor 164 may be on the translational handle 110, and the probe 102 passes loosely through the IV device assembly 100 toward the distal end of the IV device assembly 100. Next, the probe 102 can pass through the channel 166 as described in connection with FIGS. 11A and 11B, and then return distally within the IV device assembly 100 and pass through the channel formed in the VAD junction 106.

[0095] In this embodiment, the grip 112 can be formed adjacent to the translational handle 110 so that a clinician can operate the IV device assembly 100 with one hand. The embodiments show specific shapes of any of the elements of the IV device assembly 100, but these are merely exemplary shapes and it is understood that they can be modified to facilitate a particular ergonomic fit, such as the grip 112 and translational handle 110 described in connection with FIG. 12. By enabling one-handed operation of the IV device assembly 100, the clinician's other hand is freed up to simultaneously address other devices or instruments related to patient care.

[0096] FIG. 13A is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 13B is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. Similar to another example described herein, FIG. 13A shows the IV device assembly 100 with the probe 102 not deployed, and FIG. 13B shows the IV device assembly 100 with the probe 102 in a deployed or extended state.

[0097] In the embodiments shown in FIGS. 13A and 13B, the support member 104 may include a first sleeve support member 168 and a second sleeve support member 170. In this embodiment, the inner diameter of the first sleeve support member 168 may be larger than the outer diameter of the second sleeve support member 170. During operation, a clinician may pass the translation handle 110 with his or her finger 124 towards the distal end of the VAD coupling 106. Thereby, the second sleeve support member 170 can be coaxially inserted into the first sleeve support member 168. Since the probe 102 is coaxially disposed within the first sleeve support member 168 and the second sleeve support member 170, the first sleeve support member 168 and the second sleeve support member 170 hold the IV device assembly 100 relatively rigid while the probe 102 advances. The probe 102 can also be prevented from buckling under the applied force by sizing the inner diameter of the second sleeve support member 170 by the movement of the translation handle 110. Thereby, it may be possible to prevent buckling while moving the probe 102. FIGS. 13A and 13B show that the support member includes the first sleeve support member 168 and the second sleeve support member, but this specification contemplates that the support member may include three or more sleeve support members. Thus, in these embodiments, the plurality of sleeve members may be nested within each other, and during operation, the overall length of the IV device assembly 100 is shortened while the probe 102 extends from the distal end of the VAD coupling 106 into the VAD.

[0098] In one embodiment, the IV device assembly 100 may also include a collapsible sleeve 114. The collapsible sleeve 114 may be coaxially disposed around the first sleeve support member 168, the second sleeve support member 170, and the probe 102. The collapsible sleeve 114 may also be mechanically coupled to the proximal side of the appropriate VAD coupling 106 and the distal side of the translation handle 110.

[0099] FIG. 14 is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. In this embodiment, the second sleeve support member 170 may be formed on the outside of the collapsible sleeve 114, the first sleeve support member 168, and the probe 102. In this orientation, the collapsible sleeve 114 can hermetically seal the surface of the probe 102, while the second sleeve support member 170 and the first sleeve support member 168 support the IV device assembly 100 as described.

[0100] FIG. 15A is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 15B is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 15C is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. Each of these embodiments may include an appropriate VAD coupling 106 formed at the distal end of the IV device assembly 100 and a translation handle 110 used to pass the probe 102 through the IV device assembly 100 and translate it therefrom.

[0101] In these embodiments, the support member 104 includes one or more bistable springs 172. The bistable spring 172 can be any spring having two stable equilibrium states, such as straight or bent, in the illustrated embodiment. In each of these embodiments, the proximal end of the bistable spring 172 can be mechanically coupled to the distal side of the translation handle 110.

[0102] Figure 15A shows that when the translation handle 110 translates towards the distal end of the IV device assembly 100, the support member 104 in the form of the bistable spring 172 is pushed through the bistable spring channel 178. As the translation handle 110 further translates towards the appropriate VAD coupling 106, the bistable spring 172 extends further from the IV device assembly 100. In some embodiments, due to the bistable nature of the bistable spring 172, the bistable spring 172 can curl upon itself. This prevents the bistable spring 172 from advancing towards other objects near the IV device assembly 100, such as the patient's body. Figure 15B shows the IV device assembly 100 in a compressed state where the bistable spring 172 is fully curled upon itself.

[0103] Figure 15C shows an embodiment where the support member 104 includes two bistable springs 172. Also in this case, each bistable spring 172 can pass through its own bistable spring channel 178 and can curl upon itself when the translation handle 110 is translated towards the appropriate VAD coupling 106.

[0104] Figure 16A is a side view of the IV device assembly 100 according to some embodiments of the present disclosure. Figure 16B is a side view of the IV device assembly 100 according to some embodiments of the present disclosure. In this embodiment, an appropriate VAD coupling 106 is formed at the distal end of the IV device assembly 100, and the translation handle 110 is coupled to the probe 102. The probe 102 can pass into a channel formed in the appropriate VAD coupling 106.

[0105] The support member in this embodiment may include a plurality of sleeve guides 174. Each sleeve guide 174 may be formed at a fold formed in the collapsible sleeve 114 such that as the translation handle 110 and the probe 102 advance, the sleeve guide 174 guides the probe 102 through the IV device assembly 100 and adds rigidity to the IV device assembly 100. The sleeve guide 174 assumes the shape of an overlay at the fold and may add more structure to the IV device assembly 100.

[0106] FIG. 17A is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 17B is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. In this embodiment, a suitable VAD coupling 106 is formed at the distal end of the IV device assembly 100 and the translation handle 110 is coupled to the probe 102. The probe 102 may pass into a channel formed in the suitable VAD coupling 106.

[0107] FIGS. 17A and 17B relatively show the IV device assembly 100 in a non-compressed state and a compressed state. In these embodiments, the support member 104 may consist of a solid wall which is formed monolithically from the suitable VAD coupling 106 and extends coaxially downwardly towards the proximal end of the IV device assembly 100. The length of the support member 104 may be sufficient to conform to any use of the IV device assembly 100.

[0108] The IV device assembly 100 shown in FIGS. 17A and 17B also shows a collapsible sleeve 114 formed coaxially around the probe 102. The collapsible sleeve 114 may be coupled to the inner surface within the support member 104 and to the proximal side of the suitable VAD coupling 106 and the distal side of the translation handle 110.

[0109] FIG. 18A is a side cross-sectional view of an IV device assembly 100 according to some embodiments of the present disclosure. FIG. 18B is a front cross-sectional view of a translation handle 110 of the IV device assembly 100 according to some embodiments of the present disclosure. In these embodiments, the IV device assembly 100 may include a suitable VAD coupling 106 disposed at the distal end of the IV device assembly 100. The VAD coupling 106 may include a fluid coupling port tubing 120 and a port 122, and may enable selective coupling of a blood sample access device or a drug reservoir as described herein.

[0110] Similar to FIGS. 17A and 17B, the IV device assembly 100 of FIGS. 18A and 18B includes a rigid support member 104 formed around a collapsible sleeve 114 and a probe 102. In this embodiment, the support member 104 extends along the entire length of the IV device assembly 100, and the translation handle 110 is coaxially disposed inside the support member 104. Again, in some examples, the support member 104 may be formed monolithically during the formation of a suitable VAD coupling 106.

[0111] The collapsible sleeve 114 may be mechanically coupled proximal to the VAD coupling 106 and distal to the translation handle 110. To operate the translation handle 110, the translation handle 110 may have an arm that extends therefrom through a slot formed in the support member 104 as shown in FIGS. 18A and 18B. In this embodiment, the probe 102 is completely sealed from the atmosphere through the collapsible sleeve 114 so that contaminants do not interact with the surface of the probe 102.

[0112] FIG. 19 is a side view of an IV device assembly 100 according to some embodiments of the present disclosure. Again, the IV device assembly 100 may include a suitable VAD coupling 106 used to fluidly and mechanically couple the IV device assembly 100 to a VAD. The translation handle is mechanically coupled to the probe 102, and the probe 102 may extend at least partially into a channel formed through the VAD coupling 106.

[0113] In this embodiment, the support member may include a coil spring 176. The coil spring 176 may be coaxially wound around the probe 102 from the proximal side of the VAD coupling portion 106 to the distal side of the translation handle 110. In one embodiment, the coil spring 176 may be mechanically coupled to the proximal side of the VAD coupling portion 106 at its distal end. The coil spring 176 may also be mechanically coupled to the distal side of the translation handle 110 at the proximal end of the coil spring 176. The coil spring 176 may, in some examples, be made of a gauge wire and, as described, provide sufficient rigidity to the IV device assembly 100 when a clinician uses their finger 124 to move the translation handle 110 distally.

[0114] FIG. 20 is a side view of a probe 102 according to some embodiments of the present disclosure. In some embodiments, the probe 102 may extend through a catheter assembly 128 that is mechanically and fluidly coupled to the IV device assembly 100 of FIGS. 1 and 2, for example. As described herein, the probe 102 is shown to extend slightly beyond the distal end of the catheter assembly 128 (and, in particular, the catheter 132) as a clinician passes the translation handle 110 towards the distal end of the IV device assembly 100. Also, as described herein, the distal end of the probe 102 may include a porous distal end 126. In these embodiments, the probe 102 may be narrowed to a smaller diameter and the porous distal end 126 may include coil windings around the smaller diameter portion of the probe 102. The coil windings are merely one example of what may constitute the porous distal end 126, and the present disclosure contemplates that other materials for the porous distal end 126 may be used.

[0115] In addition, the present disclosure contemplates that a particular sensor may be disposed within the coil winding or at the most distal end of the probe 102, and that particular physiological characteristics of a patient (such as vital signs), for example, blood pressure, pH of the patient's blood, blood chemistry, peripheral capillary oxygen saturation (SP02) level, blood flow rate, heart rate, and body temperature, etc., are monitored.

[0116] The coil winding shown at the porous distal end 126 of the probe 102 is shown as having a constant pitch over the entire length of the porous distal end 126. However, the present disclosure contemplates that the pitch of the coil winding may vary along the length of the porous distal end 126. The pitch variation may be repetitive variation, constant variation, or random variation, and may be adapted to a particular patency check quality or other quality of the probe 102.

[0117] The IV device assembly described herein may provide an integrated extension set in the form of the present IV device assembly having optimized fluid resistance, and includes a guidewire device that improves patency with relatively less trauma to the patient's blood vessels. The present IV device assembly described herein includes a probe that can be operated with one hand. The present IV device assembly described herein may be more compact than other extension sets, and uses a blood sample access device for an improved workflow to combine the patency check process with the blood sampling process, and may reduce the steps and processes of patency checking and blood sampling. The shape and components used in the present IV device assembly may reduce the amount of waste.

[0118] All examples and conditional language set forth herein are intended, for pedagogical purposes, to assist the reader in understanding the concepts contributed by the inventors for the advancement of the invention and the art, and are to be construed as not being limited to such specifically recited 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 Symbols

[0119] 100 IV Device Assembly 102 Probe 104 Support Member 106 VAD Coupling Port, and 108 Funnel-Shaped Coupling Port 110 Translation Handle 112 Grip 114 Foldable Sleeve 116 Seal 128 Catheter Assembly 132 Catheter 134 Catheter Port Tubing 136 Catheter Port 138 Port Clamp

Claims

1. An IV device assembly, comprising: a vascular access device (VAD) coupling portion at a distal end of the IV device assembly, the VAD coupling portion being mechanically couplable to a VAD and having a channel formed therethrough; a probe fixed along a length of the IV device assembly with a proximal end proximal to the VAD coupling portion; a translation handle mechanically coupled to the probe, the translation handle translating the probe along the channel formed in the VAD coupling portion from the distal end of the IV device assembly into the VAD; a support member formed along a length of the probe to mechanically support the probe when the probe is translated within the IV device assembly; a grip formed at a proximal end of the support member; The IV device assembly further comprising the translation handle being slidable relative to the support member and the grip.

2. The IV device assembly according to claim 1, further comprising a collapsible sleeve coaxially formed around the support member.

3. The collapsible sleeve is a coil spring that creates a space around the probe and biases the translation handle toward a proximal end of the IV device assembly. The IV device assembly according to claim 2, further comprising the coil spring.

4. The IV device assembly according to claim 1, wherein the probe passes through a probe channel formed in the VAD coupling portion.

5. The IV device assembly according to claim 1, further comprising a support member channel formed through the translation handle and through which the support member can pass, wherein the support member is adapted to fit within the support member channel to prevent the support member from rotating about its longitudinal axis.

6. The IV device assembly according to claim 1, wherein the support member is a bistable spring and the bistable spring passes through a bistable spring channel formed in the VAD coupling portion.

7. The support member includes a first sleeve support member coaxially disposed around the probe and a second sleeve support member coaxially disposed around the probe, and the second sleeve support member is sized to slide coaxially within the first sleeve support member when the translation handle translates along the length of the IV device assembly. The IV device assembly according to claim 1.

8. The probe is a guide wire including a porous distal end. The IV device assembly according to claim 1.

9. The IV device assembly according to claim 1, further comprising a funnel-shaped coupling mechanically coupled to the proximal end of the VAD coupling, wherein the funnel-shaped coupling includes a seal that prevents fluid from exiting the proximal end of the funnel-shaped coupling.

10. An IV device assembly, tubing forming a lumen within the IV device assembly, wherein the lumen is fluidly coupled to a VAD coupling connectable to a vascular access device (VAD) and connected to the tubing and an IV device assembly coupling at the proximal end of the tubing, a probe along the length of the IV device assembly, a translation handle mechanically coupled to the probe, the translation handle translating the probe through the VAD coupling from the distal end of the IV device assembly, and including a tubing channel formed such that the tubing passes through when the translation handle translates toward the distal end of the IV device assembly. a support member formed along the length of the probe to mechanically support the probe when the probe is translated within the IV device assembly, a grip formed at the proximal end of the support member, The IV device assembly is provided with the translation handle being slidable relative to the support member and the grip.

11. The IV device assembly according to claim 10, further comprising a support member channel formed in the translation handle.

12. The support member is adapted to fit within the support member channel to prevent the support member from rotating about the longitudinal axis of the support member. The IV device assembly according to claim 11.

13. The support member is a bistable spring that exits the VAD coupling through the bistable spring channel and curls itself as the translation handle is translated toward the distal end of the IV device assembly. The IV device assembly according to claim 10.

14. The IV device assembly according to claim 10, wherein the support member includes a coil spring that wraps around the length of the probe.

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