A vascular access device assembly that utilizes support components to facilitate the forward movement of a single-handed probe.

Abstract

An intravenous device assembly may include a lumen forming a fluid passage within the intravenous device assembly. The lumen may be fluidly coupled to a vascular access device (vascular access device) connector via a funnel-shaped connector and an intravenous device assembly connector located proximal to the lumen. The intravenous device assembly may further 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-shaped connector; a probe formed along a second portion of the lumen within the collapsible sleeve and inserted into the vascular access device connector; a translation handle that translates the probe distally out of the vascular access device connector; and a retaining handle formed around the lumen to maintain the position of the intravenous device assembly relative to the translation handle.

Description

Background Technology

[0001] extend Intravenous ( I ntra v enous, IV) devices such as Vascular access device ( V ascular A ccess D The patency of the IV device (VAD) improves the feasibility of long-term placement and reduces the cost and trauma to patients due to unnecessary additional interventions. More specifically, during IV device use, the IV device is inserted into the patient's blood vessel, and in some cases, the needle is pulled out of the IV device while it remains in the patient's vessel. In some cases, the IV device remains in the patient's vessel for up to 30 days. This is done to allow clinicians or other... Health Health Provider ( H ealth C are P A rovider (HCP) is able to provide fluid access to a patient's bloodstream during care. This continuous fluid access to the patient's bloodstream allows clinicians or other HCPs to draw one or more blood samples or administer one or more infusion fluids, such as saline, various medications, and total parenteral nutrition, as appropriate.

[0002] However, when an IV device is inside a patient's blood vessel, its patency can be compromised. Any blockage can persist and cause the IV device to malfunction, requiring re-implantation. This can increase patient discomfort and lead to other medical problems, such as vascular inflammation and other complications.

[0003] The subject matter claimed herein is not limited to embodiments that address any drawbacks or operate only in environments such as those described herein. Rather, this background is provided to describe the environments in which the embodiments currently described may operate. Summary of the Invention

[0004] This disclosure generally relates to an intravenous (IV) device assembly for connection to, for example, a vascular access device (VAD) such as a catheter assembly. In some embodiments, the IV device assembly can provide probes for periodically checking or improving IV device patency when the needle and / or catheter is in a patient's blood vessel. The IV device assembly may include a vascular access device (VAD) connector located at the distal end of the IV device assembly, which can be mechanically coupled to the VAD, the VAD connector having a channel formed therethrough. In these embodiments, the IV device assembly may also include a probe having a length along the IV device assembly. In these embodiments, a translation handle may be mechanically coupled to the probe such that translation of the translation handle moves the probe along the channel formed in the VAD connector out of the distal end of the IV device assembly and into the VAD. The IV device assembly may also include a support member formed along the length of the probe, which mechanically supports the probe as the probe translates within the IV device assembly. The IV device assembly may also include a retaining grip formed at the proximal end of the support member, the retaining grip maintaining the position of the proximal end of the support member relative to the translation handle.

[0005] In these embodiments, the IV device assembly may further include a collapsible sleeve coaxially formed around a support member. In these embodiments, the collapsible sleeve may also include a coil spring 118 that creates space around the probe and biases the translation handle toward the proximal end of the IV device assembly.

[0006] In one embodiment, the probe can be coupled to a VAD connector, pass through a probe channel formed in a translation handle, and insert into the VAD connector. This arrangement allows the probe to be folded (doubled) within the IV device assembly. By doubling the probe length within the IV device assembly, the overall length of the IV device assembly can be shortened, or the length of the probe extending out of the IV device assembly can be increased.

[0007] IV device assembly may also include a support member channel through which the support member can pass, and wherein the support member is keyed to fit within the support member channel and to prevent the support member from rotating about the longitudinal axis of the support member.

[0008] In the embodiments described herein, the support member may take one or more forms, such as a bistable spring, a helical coil, a tube, a shell, a sleeve, or a combination of sleeves. Each of these embodiments can provide rigidity to the IV device assembly and probe during operation.

[0009] In some embodiments, the support members may include a first sleeve support member and a second sleeve support member arranged coaxially around the probe. The second sleeve support member is sized to slide coaxially within the first sleeve support member when the translation handle is translated along the length of the IV device assembly.

[0010] This specification also describes an IV device assembly comprising: a lumen forming a fluid passage within the IV device assembly, the lumen being fluidly coupled to a vascular access device (VAD) connector and an IV device assembly connector located proximal to the lumen, the VAD connector being connectable to a VAD and connectable to the lumen via a funnel-shaped connector; a probe having a length along the IV device assembly; a translation handle mechanically coupled to the probe, the translation handle translating the probe through a VAD connector channel formed in the VAD connector, exiting from the distal end of the IV device assembly and entering the IV device assembly, the translation handle including a lumen channel formed therethrough, through which the lumen passes as the translation handle translates toward the distal end of the IV device assembly; a support member formed along the length of the probe, the support member mechanically supporting the probe as the probe translates within the IV device assembly; and a retaining grip formed proximal to the support member, the retaining grip maintaining the position of the proximal end of the support member relative to the translation handle. A support member channel is formed in the translation handle, and the support member is keyed to fit within the support member channel and prevent rotation of the support member about its longitudinal axis. In one embodiment, the support member is a bistable spring that exits the VAD connector through a bistable spring channel and coils itself as the translation handle is translated toward the distal end of the IV device assembly. In another embodiment, the support member comprises a helical spring wound around the length of the probe.

[0011] This specification also describes an IV device assembly comprising: a vascular access device (VAD) connector at a distal end of the IV device assembly, mechanically connectable to the VAD, the VAD connector having a channel formed therethrough; a probe having a length along the IV device assembly; a translation handle mechanically connected to the probe via probe spokes, which, when the translation handle is translated, causes the probe to translate through the channel, exit from the distal end of the IV device assembly, and enter the IV device assembly; a support member formed along the length of the probe, which mechanically supports the probe when the probe is translated within the IV device assembly, the support member including a tube coaxially formed around the probe, the tube including a slit formed along the longitudinal length of the tube allowing the probe spokes to pass through; and a fixed grip formed at the proximal end of the support member, the fixed grip maintaining the position of the proximal end of the support member relative to the translation handle. In this embodiment, a lumen may be formed, creating a fluid passage within the IV device assembly. The lumen is fluidly coupled to a VAD connector at the distal end of the IV device assembly and to an IV device assembly connector at the proximal end. In this embodiment, the IV device assembly may further include a collapsible sleeve coaxially formed around the probe, tube, and lumen. In some embodiments, a support spring may be formed within the collapsible sleeve, creating a space between the collapsible sleeve and the probe, and biasing the translation handle towards the proximal end of the IV device assembly. In this embodiment, the IV device assembly may further include a blood sample acquisition device fluidly and mechanically coupled to the lumen via the IV device assembly connector. The probe in this example may be a guidewire including a porous distal end.

[0012] It should be understood that the foregoing summary description and the following detailed description are illustrative and explanatory, and not intended to limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that these embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so required. Therefore, the following detailed description is not restrictive. Attached Figure Description

[0013] The exemplary embodiments will be described and explained in additional specific detail using the accompanying drawings, in which:

[0014] Figure 1 This is a side front view of an intravenous (IV) device assembly according to some embodiments of the present disclosure;

[0015] Figure 2A This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0016] Figure 2BThis is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0017] Figure 3 This is an exploded perspective view of an IV device assembly and a catheter assembly according to some embodiments of the present disclosure;

[0018] Figure 4 This is a perspective cross-sectional view of an IV device assembly and a blood sample acquisition device according to some embodiments of the present disclosure;

[0019] Figure 5 This is a perspective cross-sectional view of an IV device assembly and a blood sample acquisition device according to some embodiments of the present disclosure;

[0020] Figure 6A This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0021] Figure 6B This is a front cross-sectional view of the translation handle of an IV device assembly according to some embodiments of the present disclosure;

[0022] Figure 6C This is a perspective view of a support member of an IV device assembly according to some embodiments of the present disclosure;

[0023] Figure 7A This is a side front view of an IV device assembly and a blood sample acquisition device according to some embodiments of the present disclosure;

[0024] Figure 7B This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0025] Figure 7C This is a perspective view of an IV device assembly and a blood sample acquisition device according to some embodiments of the present disclosure;

[0026] Figure 8A This is a perspective view of an IV device assembly according to some embodiments of the present disclosure;

[0027] Figure 8B This is a perspective view of an IV device assembly according to some embodiments of the present disclosure;

[0028] Figure 9A This is a perspective view of an IV device assembly according to some embodiments of the present disclosure;

[0029] Figure 9B This is a perspective view of the translation handle and support member of an IV device assembly according to some embodiments of the present disclosure;

[0030] Figure 10A This is a perspective view of an IV device assembly according to some embodiments of the present disclosure;

[0031] Figure 10B This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0032] Figure 10C This is a front cross-sectional view of the support member of the IV device assembly according to some embodiments of the present disclosure;

[0033] Figure 10D This is a front cross-sectional view of the support member of the IV device assembly according to some embodiments of the present disclosure;

[0034] Figure 10E This is a front cross-sectional view of the support member of the IV device assembly according to some embodiments of the present disclosure;

[0035] Figure 10F This is a front cross-sectional view of the support member of the IV device assembly according to some embodiments of the present disclosure;

[0036] Figure 10G This is a front cross-sectional view of the support member of the IV device assembly according to some embodiments of the present disclosure;

[0037] Figure 11A This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0038] Figure 11B This is a side front view of the translation handle of an IV device assembly according to some embodiments of the present disclosure;

[0039] Figure 12 This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0040] Figure 13A This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0041] Figure 13B This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0042] Figure 14 This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0043] Figure 15A This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0044] Figure 15B This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0045] Figure 15C This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0046] Figure 16A This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0047] Figure 16B This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0048] Figure 17A This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0049] Figure 17B This is a side front view of an IV device assembly according to some embodiments of the present disclosure;

[0050] Figure 18A This is a side front cross-sectional view of an IV device assembly according to some embodiments of the present disclosure;

[0051] Figure 18B This is a front cross-sectional view of the translation handle of an IV device assembly according to some embodiments of the present disclosure;

[0052] Figure 19 This is a side front view of an IV device assembly according to some embodiments of the present disclosure; and

[0053] Figure 20 This is a side front view of a probe according to some embodiments of the present disclosure. Detailed Implementation

[0054] Figure 1 This is a side front view of an intravenous (IV) device assembly 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, at a VAD connector 106. In these embodiments, the VAD may include a needle, catheter, or a combination of needle and catheter for accessing a patient's blood vessel. In this embodiment, the VAD includes a needle and catheter, and the needle can be removed from the catheter once the VAD has been inserted into the patient's blood vessel. In these embodiments, the catheter may remain in the blood vessel, and as described herein, the probe 102 may be used as a patency testing device to perform patency checks. In one embodiment, the probe 102 may include a wire, guidewire, tube, occluder, 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 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 probe 102 may also be used to check the patency of the needle.

[0055] In some embodiments, the IV device assembly 100 may be mechanically and fluidly coupled to the blood sample acquisition device 144. In some embodiments, the blood sample acquisition device 144 may be mechanically coupled to the IV device assembly connector 146 to receive a blood sample via the IV device assembly 100. In some embodiments, the blood sample acquisition device may include a BD VACUTAINER manufactured by Becton, Dickinson and Company of Franklin Lakes, New Jersey. ® The LUER-LOK™ blood sample collection device, or another suitable blood sample collection device. For this blood sample collection device 144, blood sample tubes are used, for example, BDVacutainer® manufactured by Becton, Dickinson and Company.

[0056] In one embodiment, the VAD connector 106 may include a channel formed therethrough, which in one embodiment allows the probe 102 to pass through and into the VAD as described herein during operation. In one embodiment, the channel formed through the VAD connector 106 may be both a mechanical and a fluid channel. In this embodiment, the probe 102 may be allowed to pass through the channel formed in the VAD connector 106, while fluid is allowed to flow through the channel formed in the VAD connector 106 and into a lumen formed along the length of the IV device assembly 100, and fluidly coupled to the blood sample acquisition device described herein. In one embodiment, the channel is formed through the VAD connector 106 such that the channel is fluidly coupled to port conduit 120 and port 122. Port 122 and its fluidly coupled port conduit 120 may allow the IV device assembly 100 to introduce the probe 102 into the VAD coupled to the VAD connector 106, and allow the aspiration of one or more blood samples or the administration of one or more infusion fluids, such as saline solution, various medications, and total parenteral nutrition, when appropriate. As described herein, the channel formed in the VAD connector 106 can be fluidly coupled to a lumen that extends along the length of the IV device assembly 100 and passes through the translation handle 110 to reach a fluid reservoir or blood sample acquisition device.

[0057] IV device assembly 100 also includes a support member 104. According to any embodiment 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 against itself during operation of the IV device assembly 100. Figure 1In the illustrated embodiment, the support member 104 is a tube extending along the length of the probe 102 and formed coaxially around the probe 102.

[0058] As described herein, in some embodiments, probe 102 is mechanically coupled to translation handle 110. Translation handle 110 can be selectively moved toward the distal or proximal end of IV device assembly 100 such that probe 102 passes through, exits from, or enters VAD connector 106, respectively. In one embodiment, support member 104 may be mechanically coupled to translation handle 110 to maintain the rigidity level of IV device assembly 100 during operation.

[0059] exist Figure 1 In the illustrated embodiment, the support member 104 passes through a support member channel formed in the translation handle 110 and may terminate at the proximal end of the support member 104 at the grip 112. As the translation handle 110 translates along the length of the IV device assembly 100, a clinician or other healthcare provider (HCP) can use the support member 104 to hold the IV device assembly 100 in place.

[0060] In some embodiments described herein, IV device assembly 100 may include a collapsible sleeve 114. The collapsible sleeve 114 may be formed coaxially around a portion of probe 102 and mechanically coupled to VAD connector 106. In some embodiments, the collapsible sleeve 114 may be made of a foldable and flexible material, allowing the collapsible sleeve 114 to collapse on itself. In the embodiments described herein, the collapsible sleeve 114 may be mechanically coupled to translation handle 110. In some embodiments, the collapsible sleeve 114 may be mechanically coupled to funnel-shaped connector 108, which is coupled to the proximal end of VAD connector 106. Funnel-shaped connector 108 may be coupled to VAD connector 106 via, for example, the use of an adhesive or by performing an ultrasonic welding process.

[0061] As described, in some embodiments, the IV device assembly 100 may include a funnel-shaped connector 108 that is coupled to the proximal side of the VAD connector 106. The funnel-shaped connector 108 may include mechanical channels formed therein to allow the probe 102 to pass through it. Additionally, the channels formed in the funnel-shaped connector 108 may include a seal 116. The seal 116 may prevent any fluid present at the distal end of the seal 116 from flowing out from the proximal side of the funnel-shaped connector 108.

[0062] During operation of the IV device assembly 100, a clinician or other HCP physician may mechanically connect the IV device assembly 100 to the VAD via a coupling device that mechanically connects the VAD connector 106 to the IV device. In the example where the probe 102 is a patency device, the clinician may choose to mechanically connect the IV device assembly 100 to the VAD at intervals or during any other patient monitoring. Although this specification describes the probe 102 as a patency device, it should be understood that, as described herein, any type of sensor or other device may be used to provide a variety of medical diagnostic or medical treatments.

[0063] With the IV device assembly 100 mechanically connected to the VAD at the VAD connector 106, the clinician can grasp the handle 112 with one hand and the translation handle 110 with the other. The clinician can then translate the translation handle 110 toward the distal end of the IV device assembly 100. Because, in connection with… Figure 1 In the described embodiment, a support member 104 passes through a translation handle 110 and is mechanically connected to a grip 112, the translation handle 110 sliding along the support member 104. When the translation handle 110 translates, the support member 104 maintains the rigidity level of the IV device assembly 100.

[0064] although Figure 1 The support member 104 is shown as a tube placed coaxially around the probe 102, but this specification contemplates the use of other types and forms of support members. In some embodiments, the support member 104 may be a bistable spring, a set of telescopic sleeves, a rail, and a coil spring. These support members will be described in more detail herein in conjunction with other embodiments.

[0065] Figure 2A This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 2B This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 2A An IV device assembly 100 is shown, wherein the probe 102 is in a retracted state or the probe 102 is placed within the IV device assembly 100, and the translation handle 110 is located at the proximal end of the IV device assembly 100. Figure 2B A probe 102 in a deployed state is shown, with a portion of the probe 102 extending through the distal end of the VAD connector 106. In these embodiments, as described above, the VAD connector 106 can be coupled to a VAD, and when the probe 102 is in the deployed state, the probe 102 can penetrate mechanical and / or fluid channels formed within the VAD.

[0066] Figure 2AAn example position of the clinician's or other HCP's finger 124 is shown. In this embodiment, the clinician may place his or her finger 124 at or around the translation handle 110 in preparation for translating the translation handle 110 toward the distal end of the IV device assembly 100, such as... Figure 2B As shown. In one embodiment, the clinician may also grip the handle 112, allowing the translation handle 110 to move relative to the handle 112. In one embodiment, due to the rigidity of the support member 104, the clinician can push the translation handle 110 with one hand without gripping the handle 112.

[0067] Figure 2B The diagram illustrates the state of the collapsible sleeve 114 as the translation handle 110 is moved toward the distal end of the IV device assembly 100. In one embodiment, the collapsible sleeve 114 may be in the form of a bellows, having one or more predetermined creases within it that allow the collapsible sleeve 114 to fold onto itself as the translation handle 110 moves distally. In another embodiment, the collapsible sleeve 114 may be flexible, such that... Figure 2B The folding of the collapsible sleeve 114 shown is not defined by any predetermined crease. In one embodiment, the collapsible sleeve 114 may include a vent port (not shown) that allows air to escape from the internal volume of the collapsible sleeve 114.

[0068] Figure 2A and Figure 2B The illustrated embodiment does not show the funnel-shaped connector 108 attached to the proximal side of the VAD connector 106. In this embodiment, as described herein, the VAD connector 106 may accommodate a seal 116. Similarly, when the IV device assembly 100 is mechanically connected to a VAD fluidly connected to a patient's blood vessel, this seal 116 prevents any fluid from leaving the proximal side of the VAD connector 106.

[0069] Figure 2BA porous distal end 126 formed at the tip of probe 102 is also shown. In this embodiment, probe 102 can be a patency device. The porous distal end 126 of probe 102 can be configured to clear any obstructions in any fluid channels within the VAD. As described herein, clinicians can check the patency of the VAD from time to time. During the use of a VAD, the VAD is inserted into a patient's blood vessel, and in some cases, the needle is pulled out of the VAD while the VAD remains in the patient's blood vessel. In some cases, the VAD may remain in the patient's blood vessel for up to 30 days. This is done to allow clinicians or other healthcare providers (HCPs) to provide fluid access to the patient's blood flow during medical care. This continuous fluid access to the patient's blood flow allows clinicians or other HCPs to draw one or more blood samples or administer one or more infusion fluids, such as saline solution, various medications, and total parenteral nutrition, when appropriate. However, the patency of the VAD may be obstructed within the fluid channels formed therein, and this obstruction may persist and cause the VAD to fail, requiring the VAD to be reinjected into the patient. This can increase the patient's sense of trauma and lead to other medical problems, such as vascular inflammation and other medical issues. By using probe 102, patency of the VAD can be checked and maintained without removing it from the patient's body.

[0070] As described herein, probe 102 can be another type of device that can be introduced into a patient's blood vessel for medical diagnosis or to provide other types of medical care. For example, probe 102 may include a thermometer formed at its distal end. This thermometer can be introduced into the patient's blood vessel when the translation handle 110 is translated toward the distal end of the IV device assembly 100. In another example, probe 102 may include a pressure sensor that detects the patient's blood pressure within the patient's blood vessel. Other types of sensors are also available for measuring any medical vital signs within a patient's blood vessel.

[0071] although Figure 2A and 2B A specific type of VAD connector 106 is shown, but this specification envisions that any type of connector can be used. Figure 2A and 2B A male Luer adapter is shown as VAD connector 106. However, this specification contemplates the use of any other suitable VAD connector 106, including any female Luer adapter. In some embodiments, VAD connector 106 may include a sliding or threaded female Luer adapter or a sliding or threaded male Luer adapter or any other suitable connector including a pinless connector.

[0072] Figure 3This is an exploded perspective 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 may include a VAD connector 106 for mechanically (in some embodiments, fluidly) coupling the IV device assembly 100 to the catheter assembly 128.

[0073] In some embodiments, catheter assembly 128 may include catheter 132. In some embodiments, catheter assembly 128 may include a needle and catheter 132 formed coaxially around the needle. During operation, the needle of catheter assembly 128 may be removed so that catheter 132 remains in the patient for fluid transfer.

[0074] In some embodiments, catheter assembly 128 may further include catheter port conduit 134 and catheter port 136. In some embodiments, catheter port conduit 134 and catheter port 136 may serve as separate access points for clinicians to introduce infusion fluids (e.g., saline solution, various medications, and total parenteral nutrition) into a patient's blood vessels. In some embodiments, to prevent blood backflow into catheter port conduit 134 and catheter port 136, catheter port conduit 134 may include a port clamp 138. In some embodiments, when catheter port 136 is not in use, port clamp 138 may be clamped such that pressure within catheter port conduit 134 prevents blood flow therein.

[0075] Figure 4 This is a perspective cross-sectional view of an IV device assembly 100 and a blood sample acquisition device 144 according to some embodiments of the present disclosure. As described herein, the IV device assembly 100 may include a VAD connector 106 located at a distal end of the IV device assembly 100. In some embodiments, the VAD connector 106 may be mechanically coupled to a funnel-shaped connector 108, and the VAD connector 106 and the funnel-shaped connector 108 may have a mechanical path formed therethrough for the probe 102 to pass through. Figure 4 In the example shown, the funnel-shaped connector 108 may also include a seal 116 that prevents any fluid that may enter the mechanical path from leaving the proximal side of the funnel-shaped connector 108.

[0076] In some embodiments, the IV device assembly 100 may further include a collapsible sleeve 114. As described herein, the collapsible sleeve 114 may be positioned coaxially around the probe 102 to limit physical contact with the probe 102. By limiting physical contact with the probe 102, the collapsible sleeve 114 can limit the possibility of any contaminants that may come into contact with the probe 102 coming into contact with the patient's bloodstream. Figure 4In the illustrated embodiments, the collapsible sleeve 114 can be mechanically connected to the funnel-shaped connector 108 and the translation handle 110 via an adhesive or ultrasonic welding process. In some embodiments, the collapsible sleeve 114 can be mechanically connected to the funnel-shaped connector 108 and the translation handle 110 using a press-fit process, a shrink-fit process, or any other type of joining process, and these different types of joining processes are considered in this specification. In some embodiments, air in the space volume formed within the collapsible sleeve 114, the funnel-shaped connector 108, and the translation handle 110 can be discharged via a vent (not shown) or via a gap formed between the support member 104 and the support member channel formed within the translation handle 110, as described herein.

[0077] exist Figure 4 In the illustrated embodiment, the IV device assembly 100 may further include a lumen 140. The lumen 140 allows fluid, such as blood, from the catheter assembly 128 coupled to the VAD connector 106 through the IV device assembly 100 and into a blood sample acquisition device 144 mechanically and fluidly coupled to the lumen 140 via the IV device assembly connector 146. Channels formed in the VAD connector 106 and / or the funnel-shaped connector 108 can serve both as mechanical channels for the probe 102 and as fluid channels for the lumen 140 to through which fluid passes.

[0078] In one embodiment, lumen 140 can be fluidly coupled to a channel formed in VAD connector 106 and / or funnel-shaped connector 108 via funnel-shaped connector channel 142. This allows fluid to be transferred from catheter assembly 128 to the channel formed in VAD connector 106, into the channel formed in funnel-shaped connector 108 for receiving probe 102, through funnel-shaped connector channel 142, into lumen 140, and in this embodiment, into blood sample acquisition device 144. Therefore, in Figure 4 In the illustrated embodiment, IV device assembly 100 can be used as a means of inserting probe 102 into catheter assembly 128 (e.g., to check the patency of catheter assembly 128) and as a means of collecting blood samples.

[0079] The blood sample acquisition device 144 can be any type of blood sample / collection device, and in a particular embodiment, it may include a BD VACUTAINER. ® LUER-LOK™ acquisition device. In this particular example, the blood sample acquisition device 144 may include a port for receiving a blood sample tube (e.g., BD Vacutainer®). The blood sample tube may include a diaphragm that generates negative pressure to draw blood into the blood sample tube when the diaphragm is punctured by a needle formed in the blood sample acquisition device 144.

[0080] In this embodiment, the lumen 140 is offset from the central axis of the IV device assembly 100, such that the funnel-shaped connector channel 142 allows the lumen to be fluidly connected to channels formed in the VAD connector 106 and / or the funnel-shaped connector 108. The probe 102 may engage with the channel formed through the VAD connector 106 and the funnel-shaped connector 108 at a central axis substantially the same as the central axis of the IV device assembly 100.

[0081] In some embodiments, the length of the lumen 140 may be selected based on one or more of the following: the specifications of a particular VAD, a particular VAD component configuration, or a clinical setting. In some embodiments, the lumen 140 may include a length L from the funnel-shaped connector channel 142 to the IV device assembly connector 146. In some embodiments, the fluid pathway of the lumen 140, which can be optimized, may include an inner diameter D.

[0082] The fluid flow rate in the fluid path of the tubular lumen 140 can be analyzed using the Poiseuille equation:

[0083]

[0084] in, It represents the pressure gradient change along the length of the fluid path, where D and L are the inner diameter and length of the fluid path, respectively, μ is the viscosity of the fluid, and R... f = This refers to fluid resistance. Since μ is the viscosity of the fluid, and not part of the extension tube geometry, a geometry factor G is defined. f This makes R f (fluid resistance) is G f G f = .

[0085] In some embodiments, the fluid pathway of the lumen 140 may have multiple segments having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), then the geometric factors are:

[0086] In some embodiments, the fluid path of the lumen 140 may have an inner diameter that varies along the length of the lumen 140, then the geometric factor is:

[0087]

[0088] In some embodiments, the fluid path of the lumen 140 may have a non-circular cross-section or a complex inner diameter profile. Then, the fluid with a known viscosity (μ) can be measured at a given pressure. The flow rate (Q) is used to determine the geometry factor:

[0089]

[0090] G of the fluid path in lumen 140 f The value can be selected to reduce the maximum shear stress of each VAD specification to be equal to or less than BD 21G VACUTAINER. ® UltraTouch ™ The maximum shear stress of the button blood collection kit (available from Becton, Dickinson & Company, Franklin Lake, New Jersey) was previously considered the gold standard for blood extraction. In some embodiments, the fluid pathway can be selected. f Values ​​to reduce the maximum shear stress of each VAD specification to be equal to or less than BD 25G VACUTAINER. ® UltraTouch ™ Maximum shear stress of the button blood collection kit (available from Becton, Dickinson & Company, Franklin Lake, New Jersey).

[0091] In some embodiments, the fluid path of the port conduit 120 lumen is G f The value can be determined by a value similar to the Gf value of the fluid pathway of lumen 140. In some embodiments, the fluid pathway of the blood collection system may include one or more fluid pathways of the blood sample acquisition device 144, the IV device assembly 100, and the catheter assembly 128 (which may include catheter port conduit 134), which may comprise the entire blood collection pathway through which blood flows after exiting the blood vessel and into or through the blood sample acquisition device 144 during blood collection. The system geometry factor G of the fluid pathway of the blood collection system. fs The fluid pathway of the lumen 140 described above can be G f The value is determined in a similar manner. In some embodiments, the system geometry factor G is... fs It can be equal to or greater than 7.34E+06 (1 / in) 3 In some embodiments, G fs It may include another value. In some embodiments, the system geometry factor G fs It could be 7.34E+06 (1 / in) 3 Add or subtract 10%, add or subtract 25%, add or subtract 50%, or add or subtract 75%. In some embodiments, G fs Another value may be included, which may be selected based on the specifications and / or length of the conduit 132.

[0092] As described herein, IV device assembly 100 may also include a support member 104 that provides a level of rigidity throughout IV device assembly 100. Additionally, as described, the support member 104 may support the probe 102 as it moves from the interior of IV device assembly 100 to the exterior. Because 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, because IV device assembly 100 includes a lumen 140 in this embodiment, 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 as the translation handle 110 is moved distally toward VAD connector 106 and funnel connector 108.

[0093] As described herein, in some embodiments, probe 102 is mechanically coupled to translation handle 110. Translation handle 110 can be selectively moved distally or proximally to IV device assembly 100 such that probe 102 passes through, exits from, or enters VAD connector 106, respectively. In some embodiments, probe 102 may include a porous distal end 126. The porous distal end 126 of probe 102 may be configured to clear any obstructions in any fluid passage within the VAD. As described herein, clinicians may periodically check the patency of the VAD. During VAD use, the VAD is inserted into a patient's blood vessel, and in some cases, the needle is pulled out of the VAD while the VAD remains in the patient's blood vessel. In some cases, the VAD may remain in the patient's blood vessel for up to 30 days. This is done to allow clinicians or other healthcare providers (HCPs) to provide fluid access to the patient's bloodstream during medical care.

[0094] Figure 5 This is a perspective cross-sectional view of an IV device assembly 100 and a blood sample acquisition device according to some embodiments of the present disclosure. As described herein, the IV device assembly 100 may include a VAD connector 106 located at a distal end of the IV device assembly 100. In some embodiments, the VAD connector 106 may be mechanically coupled to a funnel-shaped connector 108, and the VAD connector 106 and the funnel-shaped connector 108 may have a mechanical path formed therethrough for the probe 102 to pass through. Figure 4 In the example shown, the funnel-shaped connector 108 may also include a seal 116 that prevents any fluid that may enter the mechanical path from leaving the proximal side of the funnel-shaped connector 108.

[0095] In some embodiments, the IV device assembly 100 may further include a collapsible sleeve 114. As described herein, the collapsible sleeve 114 may be positioned coaxially around the probe 102 to limit physical contact with the probe 102. By limiting physical contact with the probe 102, the collapsible sleeve 114 can limit the possibility of any contaminants that may come into contact with the probe 102 coming into contact with the patient's bloodstream. Figure 4 In the illustrated embodiment, the collapsible sleeve 114 can be mechanically connected to the funnel-shaped connector 108 and the translation handle 110 via an adhesive or ultrasonic welding process. In some embodiments, air within the space volume formed within the collapsible sleeve 114, the funnel-shaped connector 108, and the translation handle 110 can be discharged via a vent (not shown) or via a gap formed between the support member 104 and the support member channel formed within the translation handle 110, as described herein.

[0096] exist Figure 5 In the illustrated embodiment, the IV device assembly 100 may further include a lumen 140. The lumen 140 allows fluid, such as blood, to pass from the catheter assembly 128 coupled to the VAD connector 106 through the IV device assembly 100 and into a blood sample acquisition device 144, which is mechanically and fluidly coupled to the lumen 140 via the IV device assembly connector 146. Channels formed in the VAD connector 106 and / or the funnel-shaped connector 108 can serve both as mechanical channels for the probe 102 and as fluid channels for the lumen 140 to through which fluid passes.

[0097] Figure 5 As shown, in some embodiments, with Figure 4 In contrast, the positions of lumen 140, probe 102, and support member 104 can be interchanged. Specifically, probe 102 is offset from the central axis of IV device assembly 100 such that probe 102 passes through probe channel 143, which allows probe 102 to pass through a channel formed in VAD connector 106 and / or funnel connector 108. Probe 102 may be made of a flexible material that allows probe 102 to pass through probe channel 143 and enter the channel formed in VAD connector 106 during operation of IV device assembly 100. In this embodiment, lumen 140 may engage with the channel formed through VAD connector 106 and funnel connector 108 at a central axis substantially the same as the central axis of IV device assembly 100.

[0098] As described herein, IV device assembly 100 may also include a support member 104 that provides a level of rigidity throughout IV device assembly 100. Additionally, as described, the support member 104 may support the probe 102 as it moves from the interior of IV device assembly 100 to the exterior. Because 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, because IV device assembly 100 includes a lumen 140 in this embodiment, 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 as the translation handle 110 is moved distally toward VAD connector 106 and funnel connector 108.

[0099] As described herein, in some embodiments, probe 102 is mechanically coupled to translation handle 110. Translation handle 110 can be selectively moved distally or proximally to IV device assembly 100 such that probe 102 passes through, exits from, or enters VAD connector 106, respectively. In some embodiments, probe 102 may include a porous distal end 126. The porous distal end 126 of probe 102 may be configured to clear any obstructions in any fluid passage within the VAD. As described herein, clinicians may periodically check the patency of the VAD. During VAD use, the VAD is inserted into a patient's blood vessel, and in some cases, the needle is pulled out of the VAD while the VAD remains in the patient's blood vessel. In some cases, the VAD may remain in the patient's blood vessel for up to 30 days. This is done to allow clinicians or other healthcare providers (HCPs) to provide fluid access to the patient's bloodstream during medical care.

[0100] Figure 6A This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 6B This is a front cross-sectional view of the translation handle 110 of the IV device assembly 100 according to some embodiments of the present disclosure (e.g., along...). Figure 6A (The section "A" shown). Figure 6C This is a perspective view of the support member 104 of the IV device assembly 100 according to some embodiments of the present disclosure. Figure 6A and 6B In the illustrated embodiment, probe 102 is shown in an offset position relative to the central longitudinal axis of IV device assembly 100, and similar to Figure 4 As shown.

[0101] exist Figure 6A , 6BIn the embodiment shown in 6C, the IV device assembly 100 may include a VAD connector (not shown) at its distal end. In some embodiments, the VAD connector may be mechanically coupled to a funnel-shaped connector (not shown), and the VAD connector and the funnel-shaped connector may have a mechanical path formed therethrough for the probe 102 to pass through. In one example, the IV device assembly 100 may also include a seal 116 that prevents any fluid that may enter the mechanical path from exiting from the proximal side of the VAD connector or the funnel-shaped connector.

[0102] In some embodiments, the IV device assembly 100 may further include a collapsible sleeve 114. As described herein, the collapsible sleeve 114 may be positioned coaxially around the probe 102 to limit physical contact with the probe 102. By limiting physical contact with the probe 102, the collapsible sleeve 114 can limit the possibility of any contaminants that may come into contact with the probe 102 coming into contact with the patient's bloodstream. Figure 4 In the illustrated embodiment, the collapsible sleeve 114 can be mechanically connected to the funnel-shaped connector 108 and the translation handle 110 via an adhesive or ultrasonic welding process. In some embodiments, air within the space volume formed within the collapsible sleeve 114, the funnel-shaped connector 108, and the translation handle 110 can be discharged via a vent (not shown) or via a gap formed between the support member 104 and the support member channel formed within the translation handle 110, as described herein. In one embodiment, the funnel-shaped connector 108 and / or the VAD connector may include a probe channel 143. The probe channel 143 may be formed in one or both of the VAD connector or the funnel-shaped connector 108, such that the probe 102 can enter and exit the IV device assembly 100 during operation.

[0103] As described herein, the translation handle 110 may include a lumen channel 148 and a support member channel 150. The lumen channel 148 may be formed through the translation handle 110 such that the translation handle 110 can be translated toward the distal end of the IV device assembly 100 while allowing the lumen 140 to remain connected to, for example, an IV device assembly connector 146 and a blood sample acquisition device (not shown).

[0104] The support member channel 150 also allows the support member 104 to pass through when the translation handle 110 is translated toward the distal end of the IV device assembly 100. However, for moving the probe 102 with the translation handle 110, the translation handle 110 may also include spokes 152. The spokes 152 may, for example, be an extension of the translation handle 110 that radially extends into the support member channel 150 and mechanically engages the probe 102. In another embodiment, the spokes 152 may be a single mechanical coupling device coupled to the translation handle 110, extending into the support member channel 150, and coupled to the probe 102 at a location proximal to or near the proximal side of the probe 102.

[0105] exist Figure 6A , 6B In the embodiment shown in 6C, the IV device assembly 100 includes a tubular support member 104 that extends along the length of the IV device assembly 100. In one embodiment, the support member 104 may be as long as or longer than the distance that the collapsible sleeve 114 and the translation handle 110 can extend, thereby allowing the support member 104 to extend past the proximal side of the translation handle 110. In this embodiment, the support member 104 may include a grip (not shown) for a clinician to grasp as they translate the translation handle 110 toward the distal end of the IV device assembly 100.

[0106] In one embodiment, the support member 104 may be as follows: Figure 6C The tube shown is in the form of a probe 102, which is coaxially positioned within the tubular 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 tubular support member 104 may be made of a flexible material such as plastic, which is allowed to bend elastically regardless of where the spoke 152 enters the support member 104 along the slit 154 formed in the support member 104. Thus, during the translation of the translation handle 110, at the location where the spoke 152 engages the probe 102 with the slit 154 of the translation handle 110, the spoke 152 can bend open the support member 104.

[0107] Figure 7A This is a side front view of an IV device assembly 100 and a blood sample acquisition device 144 according to some embodiments of the present disclosure. Figure 7B This is a side front view of an IV device assembly according to some embodiments of the present disclosure. Figure 7C This is a perspective view of an IV device assembly and a blood sample acquisition device according to some embodiments of the present disclosure. Figure 7A and 7BIn the illustrated embodiment, the IV device assembly 100 may include a distal needle / catheter 130 directly, fluidly, and mechanically coupled to the distal side of the funnel-shaped connector 108. However, this specification also contemplates the possibility of such coupling... Figure 1 Use the VAD connector (not shown) as described. Figure 7A and 7B In the illustrated embodiments, the IV device assembly 100 may include a probe 102 and a lumen 140, which is mechanically and fluidly coupled to the distal end 130 of the needle / catheter, respectively. The interface between the probe 102 and the support member 104 has been described herein using several embodiments. In these embodiments, the lumen 140 may be positioned adjacent to the probe 102 such that the points where the probe 102 and the lumen 140 enter the funnel-shaped connector 108 are relatively close. This allows the probe 102 to enter the fluid path of the lumen 140 within the funnel-shaped connector 108 with minimal deflection. In these embodiments, the funnel-shaped connector channel 142 or probe channel 143 may be used as described above to allow the two paths of the probe 102 and the lumen 140 to converge within the funnel-shaped connector 108. Furthermore, a seal (not shown) may be used to seal the point of entry of the probe 102 into the funnel-shaped connector 108 relative to the fluid, thereby preventing fluid leakage from the proximal side of the funnel-shaped connector 108.

[0108] The support member 104 described herein can provide rigidity to the IV device assembly 100. In this specific embodiment, the distal end of the support member 104 is mechanically coupled to the proximal side of the funnel-shaped connector 108. In an alternative embodiment, the support member 104 and the funnel-shaped connector 108 may be formed from a single integral piece. In either embodiment, the support member 104 may pass through the translation handle 110 and be formed to be coaxially connected around the lumen 140. In one embodiment, the support member 104 may include a ring at its distal end that allows the lumen 140 to pass through it during manufacturing. Because 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 be used as a grip 112 as described herein.

[0109] During operation, a clinician or other HCP can fluidly connect the blood sample acquisition device 144 to the proximal end of the lumen 140 to prepare for receiving a blood sample. Before or after receiving a blood sample, the clinician can check or maintain the patency of the distal end 130 of the needle / catheter by translating the translation handle 110 toward the distal end of the IV device assembly 100. The clinician can grasp the translation handle 110 and, for example, the blood sample acquisition device 144, and translate the translation handle 110 along the support member 104 and the lumen 140, thereby allowing the support member 104 and the lumen 140 to pass through the support member channel 150 and the lumen channel 148 formed within the translation handle 110, respectively. As the distal translation of the IV device assembly 100 occurs, the collapsible sleeve 114 can fold onto itself. In one embodiment, the distal translation of the translation handle 110 can end with the distal side of the translation handle 110 contacting the proximal side of the funnel-shaped connector 108. This translation causes probe 102 to extend beyond the distal end 130 of the needle / catheter, as Figure 7B As shown, it passes through the distal end of the needle / catheter 130. In the case where probe 102 is a patency testing device, the fluid pathway within the distal end of the needle / catheter 130 and the funnel-shaped connector 108 has been checked, and patency has been restored where it might not have been previously present. In the case where probe 102 is, for example, a thermometer, a clinician can obtain and record the patient's temperature. Other types of probe 102 may be present as described herein, and this specification envisions the use of these other types of probe 102.

[0110] Following the patency check, in this embodiment, the clinician can obtain a blood sample by inserting the blood sample tube 156 into the blood sample acquisition device 144, such as... Figure 7B As depicted. In one embodiment, the blood sample acquisition device 144 may be a BD VACUTAINER. ® The blood sample tube 156 can be a LUER-LOK™, and the blood sample tube 156 can be a BD Vacutainer®. In this specific example, when the blood sample tube 156 is inserted into the blood sample acquisition device 144, the acquisition device needle 158 can be allowed to puncture the septum formed at the distal end of the blood sample tube 156, causing the negative pressure formed within the blood sample tube 156 to be released, and a certain amount of blood to be drawn into the blood sample tube 156 via the lumen 140. When a sufficient amount of blood has been obtained, the clinician can remove the blood sample tube 156, causing the septum to be sealed. This blood acquisition process can be performed any number of times during the indwelling period of the needle / catheter distal 130, and when used as a patency device, the probe 102 can be used to maintain the patency of the needle / catheter distal 130.

[0111] In this embodiment, the IV device assembly 100 may further include fluid connection port conduit 120 and port 122. As described herein, fluid connection port conduit 120 and port 122 may be used to administer one or more infusion fluids, such as saline solution, various medications, and total parenteral nutrition, when appropriate during the patient's medical care.

[0112] Figure 8A This is a perspective view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 8B This 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 connector 106 located at a distal end and a translation handle 110 and a grip 112 formed at a proximal end, as described herein.

[0113] In this embodiment, the support member 104 may include a plurality of rings 160 coaxially positioned around the probe 102 and secured to each other using a rod or ridge mechanically coupled to each ring 160. Figure 8A In the illustrated embodiment, the rod or ridge can be made straight. In this embodiment, each ring 160 can support the collapsible sleeve 114 when the translation handle 110 is translated distally. Each ring 160 can also be slidably coupled to the rod or ridge such that each ring 160 can translate along the length of the rod or ridge.

[0114] exist Figure 8B In the illustrated embodiment, the rod or ridge of the support member 104 can be bent. A bent rod or ridge can provide greater support for the IV device assembly 100 during use. Similarly, each ring 160 can support the collapsible sleeve 114 when the translation handle 110 is translated distally. Each ring 160 can also be slidably coupled to the rod or ridge such that each ring 160 can translate along the length of the rod or ridge.

[0115] Figure 9A This is a perspective view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 9B This is a perspective view of the translation handle 110 and support member 104 of an IV device assembly 100 according to some embodiments of the present disclosure. In this embodiment, the IV device assembly 100 may include a VAD connector 106 disposed at the distal end of the IV device assembly 100. Figure 9A and 9B The IV device assembly 100 shown may also include other elements associated with the IV device assembly 100 and shown and described in conjunction with other embodiments described herein.

[0116] Figure 9AThe support member shown may include a track mechanically connected to the internal support structure 162. In this embodiment, the track may be mechanically connected to the translation handle 110, allowing the translation handle 110 to be moved along the track. Figure 6B As shown, a portion of the translation handle 110 can be mechanically coupled to the proximal end of the probe 102, and the translation handle 110 can partially surround the track during assembly. In this embodiment, the support member 104 can structurally and integrally support the IV device assembly 100, and can also prevent the probe 102 from bending when force is applied to the proximal end of the probe 102.

[0117] In some embodiments, probe 102 may include a porous distal end 126. The porous distal end 126 of probe 102 may be configured to clear any obstructions in any fluid channels within the VAD. As described herein, clinicians may periodically check the patency of the VAD. During the use of the VAD, the VAD is inserted into a patient's blood vessel, and in some cases, the needle is pulled out of the VAD while the VAD remains in the patient's blood vessel. In some cases, the VAD may remain in the patient's blood vessel for up to 30 days. This is done to allow clinicians or other HCPs to access the patient's blood flow during medical care.

[0118] Figure 10A This is a perspective view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 10B This is a side front 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, at a VAD connector 106. In these embodiments, the VAD may include a needle, catheter, or a combination of needle and catheter for accessing a patient's blood vessel. In this embodiment, the VAD includes a needle and catheter, and the needle can be removed from the catheter once the VAD has been inserted into the patient's blood vessel. In these embodiments, the catheter may remain in the blood vessel, and as described herein, the probe 102 may be used as a patency testing device to perform patency checks. In one embodiment, the probe 102 may include a wire, guidewire, tube, occluder, 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 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 probe 102 may also be used to check the patency of the needle.

[0119] In some embodiments, the IV device assembly 100 may be mechanically and fluidly coupled to a blood sample acquisition device (not shown). In some embodiments, the blood sample acquisition device may be mechanically coupled to an IV device assembly connector (not shown) to receive a blood sample via the IV device assembly 100. In some embodiments, the blood sample acquisition device may include a BD VACUTAINER manufactured by Becton, Dickinson and Company of Franklin Lake, New Jersey. ® The LUER-LOK™ blood sample collection device, or another suitable blood sample collection device. For this type of blood sample collection device, blood sample tubes are used, such as the BD Vacutainer® manufactured by Becton, Dickinson and Company.

[0120] In one embodiment, the VAD connector 106 may include a channel formed therethrough, which in one embodiment allows the probe 102 to pass through and penetrate the VAD as described herein during operation. In one embodiment, the channel formed through the VAD connector 106 may be both a mechanical and a fluid channel. In this embodiment, the probe 102 may be allowed to pass through the channel formed in the VAD connector 106 while fluid is allowed to flow through the channel formed in the VAD connector 106 and into a lumen formed along the length of the IV device assembly 100, and fluidly coupled to the blood sample acquisition device described herein.

[0121] In one embodiment, the channel is formed through the VAD connector 106 such that it is fluidly coupled to port conduit 120 and port 122. Port 122 and its fluidly coupled port conduit 120 allow the IV device assembly 100 to be used to introduce probe 102 into the VAD coupled to the VAD connector 106 and to allow the aspiration of one or more blood samples or the administration of one or more infusion fluids, such as saline, various medications, and total parenteral nutrition, when appropriate. In one embodiment, the channel formed in the VAD connector 106 may be fluidly coupled to a lumen extending along the length of the IV device assembly 100 and through a translation handle 110 to a fluid reservoir or blood sample acquisition device. In some embodiments, the lumen may correspond to lumen 140 (e.g., see...). Figure 4 In one embodiment, port 122 may be mechanically and fluidly coupled to blood sample acquisition device 144 to receive a blood sample at blood sample tube 156. In this embodiment, port 122 may be selectively coupled to either a blood sample acquisition device or a drug delivery device.

[0122] IV device assembly 100 also includes a support member 104. According to any embodiment 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 against itself during operation of the IV device assembly 100. Figure 10A and 10B In the illustrated embodiment, the support member 104 is a rigid shaft extending along the length of the probe 102 and passing through a support member channel formed in the translation handle 110.

[0123] As described herein, in some embodiments, probe 102 is mechanically coupled to translation handle 110. Translation handle 110 can be selectively moved toward the distal or proximal end of IV device assembly 100, such that probe 102 passes through, exits from, or enters VAD connector 106, respectively. In one embodiment, support member 104 may be mechanically coupled to translation handle 110 to maintain a rigid level of IV device assembly 100 during operation. Figure 10A and 10B In the specific embodiment shown, probe 102 is a double-length probe 102. The length of probe 102 is folded in half (or doubled) by mechanically attaching the proximal end of probe 102 to an anchor point 164 formed on the proximal side of VAD connector 106, or in some embodiments, on the proximal side of funnel-shaped connector. In this embodiment, probe 102 is able to pass through a channel 166 formed in translation handle 110 and be guided by IV device assembly 100 to the channel formed in VAD connector 106 and / or funnel-shaped connector. During operation, as IV device assembly 100 translates distally, probe 102 is forced through channel 166 and exits from VAD connector 106. In some embodiments, grip 112 can be held between the thumb and fingers 124 of the clinician's first hand. In these and other embodiments, while the fingers 124 and thumb of the first hand grip the grip 112, another finger 124, such as the index finger of the first hand, can be placed on translation handle 110. In these embodiments, the index finger of the first hand can move the probe 102 forward while the grip 112 remains between the fingers 124 and thumb of the first hand. In other embodiments, while the fingers 124 and thumb of the first hand pinch the grip 112, the fingers 124 of the clinician's second hand can be placed on the translation handle 110. In these embodiments, the fingers 124 of the second hand can move the probe 102 forward while the grip 112 remains between the fingers 124 and thumb of the first hand.

[0124] Doubling the length of the probe 102 within the IV device assembly 100, or in some examples tripling the length, can increase the travel distance of the probe 102. In examples where the probe 102 is a patency device, the porous distal end 126 of the patency device can be allowed to reach the junction along a relatively long fluid path. Figure 1 The catheter assembly 128 is described for checking its patency. Other devices may also be used that not only allow the probe 102 to extend beyond the catheter assembly 128 coupled to the IV device assembly 100, but also allow the probe 102 to enter and travel a distance through a patient's blood vessels to monitor vital signs or perform other medical procedures. In some embodiments, probes 102 of any length multiple may be placed within the IV device assembly 100 to increase the distance traveled by the probe 102 without increasing the length of the IV device assembly 100.

[0125] exist Figure 10A In the illustrated embodiment, the support member 104 passes through a support member channel formed in the translation handle 110 and may terminate at the proximal end of the support member 104 at the grip 112. The support member 104 can be used by clinicians or other HCPs to fix the position of the IV device assembly 100 as the translation handle 110 translates along the length of the IV device assembly 100.

[0126] In some embodiments described herein, IV device assembly 100 may include a collapsible sleeve 114. The collapsible sleeve 114 may be formed coaxially around a portion of probe 102 and mechanically coupled to VAD connector 106. In some embodiments, the collapsible sleeve 114 may be made of a foldable and flexible material, allowing the collapsible sleeve 114 to collapse on itself. In the embodiments described herein, the collapsible sleeve 114 may be mechanically coupled to translation handle 110. In some embodiments, the collapsible sleeve 114 may be mechanically coupled to funnel-shaped connector 108, which is coupled to the proximal end of VAD connector 106. Funnel-shaped connector 108 may be coupled to VAD connector 106, for example, using an adhesive or by performing an ultrasonic welding process.

[0127] As described above, in some embodiments, the IV device assembly 100 may include a funnel-shaped connector (not shown) that is coupled to the proximal side of the VAD connector 106. The funnel-shaped connector may include mechanical channels formed therein to allow the probe 102 to pass through it. Additionally, the channels formed in the funnel-shaped connector may include a seal 116. The seal 116 may prevent any fluid present at the distal end of the seal 116 from flowing out from the proximal side of the funnel-shaped connector.

[0128] During operation of the IV device assembly 100, a clinician or other HCP may mechanically connect the IV device assembly 100 to the VAD via a connection device that mechanically connects the VAD connector 106 to the VAD. In the example where the probe 102 is a patency device, the clinician may choose to mechanically connect the IV device assembly 100 to the VAD at intervals or during any other patient monitoring. Although this specification describes the probe 102 as a patency device, it should be understood that, as described herein, any type of sensor or other device may be used to provide a variety of medical diagnostic or therapeutic purposes.

[0129] With the IV device assembly 100 mechanically connected to the VAD at the VAD connector 106, the clinician can grasp the handle 112 with one hand and the translation handle 110 with the other. The clinician can then translate the translation handle 110 toward the distal end of the IV device assembly 100. Because, in connection with… Figure 1 In the described embodiment, a support member 104 passes through a translation handle 110 and is mechanically connected to a grip 112, the translation handle 110 sliding along the support member 104. When the translation handle 110 translates, the support member 104 maintains the rigidity level of the IV device assembly 100.

[0130] Figure 10C-10G This is a front cross-sectional view of the support member 104 of the IV device assembly 100 according to some embodiments of the present disclosure (in... Figure 10B (The cross-section at point "B" in the middle). As described in this article, in Figure 10A and 10B In the example shown, the support member 104 passes through the translation handle 110 and terminates in a grip 112 for a clinician to hold. The support member channel 150 formed through the translation handle 110 and the support member 104 itself can be keyed so that the support member 104 is fitted within the support member channel 150 at a specific position angle, and so as to prevent the translation handle 110 from rotating about the support member 104.

[0131] In the first example, Figure 10C A support member 104 with a circular cross-sectional view is shown. In this example, depending on the diameter of the support member channel 150 formed in the translation handle 110, the interference fit between the inner diameter of the support member channel 150 and the outer diameter of the support member 104 can be used to prevent the translation handle 110 from rotating about the support member 104.

[0132] In the second example, Figure 10DThe support member 104 is shown to have two crescent shapes, and a bracket formed in the translation handle 110 can pass between the two crescent shapes. By keying the support member 104 and the support member channel 150 in this way, rotation of the translation handle 110 about the support member 104 is prevented.

[0133] In the third example, Figure 10E The support member 104 is shown to include a notch cut therefrom, such that the notch engages with a finger extending from the inner surface of the support member channel 150. By keying the support member 104 and the support member channel 150 in this way, rotation of the translation handle 110 about the support member 104 is prevented.

[0134] In the fourth example, Figure 10F The support member 104 is shown to be formed with a "U-shaped" cross section, such that a portion of the translation handle 110 can be formed to extend downward into a hollow portion formed in the support member 104. By keying 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.

[0135] In the fifth example, Figure 10G The support member 104 is shown to have a square cross-section. The support member channel 150 formed in the translation handle 110 can also be square, allowing the support member 104 to pass through it. By keying the support member 104 and the support member channel 150 in this way, rotation of the translation handle 110 about the support member 104 is prevented.

[0136] Figure 11A This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 11B This is a side front view of the translation handle 110 of an IV device assembly 100 according to some embodiments of the present disclosure. This embodiment of the IV device assembly 100 shows that the translation handle 110 may include a protrusion having a channel 166 formed therethrough. As described herein, a double-length probe 102 can be mechanically coupled to the VAD connector 106 at an anchor point 164, such that the probe 102 can pass through the channel 166 and enter the channel formed in the VAD connector 106. This arrangement allows the length of the probe 102 to be doubled within the IV device assembly 100, such that the total length of the IV device assembly 100 can remain constant.

[0137] The channel 166 formed in the translation handle 110 can be configured 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 can be coated with a friction-reducing material such as polytetrafluoroethylene.

[0138] Figure 12 This is a side front view of an IV device assembly according to some embodiments of the present disclosure. Figure 12 The diagram illustrates that probe 102 can be allowed to pass through the interior of IV device assembly 100 three times. In this embodiment, anchor 164 can be positioned at translation handle 110, allowing probe 102 to loosely pass through IV device assembly 100 and propagate toward the distal end of IV device assembly 100. Then, probe 102 can be allowed to pass through channel 166, as in conjunction, before being guided distally back within IV device assembly 100 and through the channel formed in VAD connector 106. Figure 11A and 11B As described.

[0139] In this embodiment, the grip 112 may be formed adjacent to the translation handle 110, allowing the clinician to operate the IV device assembly 100 with one hand. Although some embodiments show specific shapes of various elements among the components of the IV device assembly 100, it should be understood that these are merely illustrative shapes and, in conjunction with... Figure 12 The grip 112, like the translation handle 110, is modifiable to accommodate any specific ergonomic fit. By allowing single-handed operation of the IV device assembly 100, clinicians can free up their hands to simultaneously handle other devices or instruments associated with patient care.

[0140] Figure 13A This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 13B This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. Similar to other examples described herein, Figure 13A The image shows the IV device assembly 100 with probe 102 in an undeployed state, while Figure 13B The image shows an IV device assembly 100 with probe 102 in a deployed or extended state.

[0141] exist Figure 13A and 13BIn the illustrated embodiment, 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, the clinician can use his or her finger 124 to move the translation handle 110 toward the distal end of the VAD connector 106. When this occurs, the second sleeve support member 170 is telescopically inserted into the first sleeve support member 168. Because the probe 102 is coaxially positioned within the first sleeve support member 168 and the second sleeve support member 170, the probe 102 moves forward while the first sleeve support member 168 and the second sleeve support member 170 maintain relative rigidity of the IV device assembly 100. By setting the inner diameter of the second sleeve support member 170, buckling of the probe 102 under the force applied by the movement of the translation handle 110 can also be prevented. This allows the probe 102 to move while preventing buckling. Although Figure 13A and 13B The illustrated support members include a first sleeve support member 168 and a second sleeve support member; however, this specification contemplates that the support members may include more than two sleeve support members. Therefore, in these embodiments, multiple sleeve members may be nested within each other, such that during operation, the overall length of the IV device assembly 100 is reduced, while the probe 102 extends from the distal end of the VAD connector 106 and enters the VAD.

[0142] In one embodiment, the IV device assembly 100 may further include a collapsible sleeve 114. The collapsible sleeve 114 may be positioned coaxially around a first sleeve support member 168, a second sleeve support member 170, and a probe 102. The collapsible sleeve 114 may also be mechanically coupled to the proximal side of a suitable VAD connector 106 and the distal side of a translation handle 110.

[0143] Figure 14 This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. In this embodiment, a second sleeve support member 170 may be formed outside 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 provide support for the IV device assembly 100 as described above.

[0144] Figure 15A This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 15B This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 15CThis is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. These embodiments may each include a suitable VAD connector 106 formed at the distal end of the IV device assembly 100 and a translation handle 110 for translating the probe 102 through and out of the IV device assembly 100.

[0145] 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 a straight or curved spring as shown in the embodiments. 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.

[0146] Figure 15A As shown, when the translation handle 110 is translated toward the distal end of the IV device assembly 100, the support member 104 in the form of a bistable spring 172 is forced through the bistable spring channel 178. The further the translation handle 110 is translated toward the appropriate VAD connector 106, the further the bistable spring 172 extends out of the IV device assembly 100. In some embodiments, due to the bistable nature of the bistable spring 172, the bistable spring 172 can coil itself. This prevents the bistable spring 172 from advancing toward other objects (e.g., the patient's body) near the IV device assembly 100. Figure 15B The IV device assembly 100 is shown in a compressed state, with the bistable spring 172 fully coiled on itself.

[0147] Figure 15C An embodiment is shown where the support member 104 includes two bistable springs 172. Similarly, each bistable spring 172 is capable of passing through its own bistable spring channel 178 and is allowed to curl onto itself when the translation handle 110 is translated toward the appropriate VAD connector 106.

[0148] Figure 16A This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 16B This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. In this embodiment, a suitable VAD connector 106 is formed at the distal end of the IV device assembly 100, and a translation handle 110 is coupled to a probe 102. The probe 102 can pass through a channel formed in the suitable VAD connector 106.

[0149] The support member in this embodiment may include a plurality of sleeve guides 174. Each sleeve guide 174 may be formed at a crease formed on the collapsible sleeve 114, such that when the translation handle 110 and the probe 102 move forward, the sleeve guide 174 guides the probe 102 through the IV device assembly 100 and increases the rigidity of the IV device assembly 100. The sleeve guide 174 may form a cover layer at the crease, which adds further structure to the IV device assembly 100.

[0150] Figure 17A This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 17B This is a side front view of an IV device assembly 100 according to some embodiments of the present disclosure. In this embodiment, a suitable VAD connector 106 is formed at the distal end of the IV device assembly 100, and a translation handle 110 is coupled to a probe 102. The probe 102 can pass through a channel formed in the suitable VAD connector 106.

[0151] Figure 17A and 17B The IV device assembly 100 is shown in both uncompressed and compressed states. In these embodiments, the support member 104 may consist of a solid wall integrally formed by a suitable VAD connector 106 and extend coaxially downward toward the proximal end of the IV device assembly 100. The length of the support member 104 may be sufficient to suit any purpose of the IV device assembly 100.

[0152] Figure 17A and 17B The illustrated IV device assembly 100 also shows a collapsible sleeve 114 coaxially formed around the probe 102. The collapsible sleeve 114 can be coupled to the inner surface within the support member 104 and is located on the proximal side of the suitable VAD connector 106 and the distal side of the translation handle 110.

[0153] Figure 18A This is a side front cross-sectional view of an IV device assembly 100 according to some embodiments of the present disclosure. Figure 18B This is a front cross-sectional view of the translation handle 110 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 suitable VAD connector 106 located at the distal end of the IV device assembly 100. The VAD connector 106 may include a fluid connection port conduit 120 and a port 122, the port 122 allowing selective connection of a blood sample acquisition device or a drug reservoir, as described herein.

[0154] Similar to Figure 17A and 17B , Figure 18A and 18BThe IV device assembly 100 includes a rigid support member 104 formed around the collapsible sleeve 114 and the probe 102. In this embodiment, the support member 104 extends the entire length of the IV device assembly 100 such that the translation handle 110 is coaxially positioned within the support member 104. Similarly, in some examples, the support member 104 may be integrally formed during the formation of a suitable VAD connector 106.

[0155] The collapsible sleeve 114 can be mechanically connected to the proximal side of the VAD connector 106 and the distal side of the translation handle 110. For operation of the translation handle 110, the translation handle 110 may have an extension extending from it through... Figure 18A and 18B The arm of the slot formed in the support member 104. In this embodiment, the probe 102 is completely sealed from the atmosphere via the collapsible sleeve 114, so that contaminants do not interact with the surface of the probe 102.

[0156] Figure 19 This is a side front 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 connector 106 for fluidly and mechanically coupling the IV device assembly 100 to a VAD. A translation handle may be mechanically coupled to a probe 102, which extends at least partially into a channel formed in the VAD connector 106.

[0157] In this embodiment, the support member may include a helical spring 176. The helical spring 176 may be wound coaxially around the probe 102 from the proximal side of the VAD connector 106 to the distal side of the translation handle 110. In one embodiment, the helical spring 176 may be mechanically coupled to the proximal side of the VAD connector 106 at its distal end. The helical spring 176 may also be mechanically coupled to the distal side of the translation handle 110 at its proximal end. In some examples, the helical spring 176 may be made of gauge wire, which provides sufficient rigidity to the IV device assembly 100 when the clinician moves the translation handle 110 distally using his or her finger 124 as described.

[0158] Figure 20 This is a side front view of probe 102 according to some embodiments of the present disclosure. In some embodiments, probe 102 may extend through catheter assembly 128, which is mechanically and fluidly coupled to, for example... Figure 1IV device assembly 100 and 2. As clinicians pass the translation handle 110 toward the distal end of IV device assembly 100 as described herein, probe 102 is illustrated to extend slightly beyond the distal end of catheter assembly 128 (and specifically catheter 132). Also as described herein, the distal end of probe 102 may include a porous distal end 126. In these embodiments, probe 102 may necked to a smaller diameter, and porous distal end 126 may include a coil winding wound around a smaller diameter portion of probe 102. The coil winding is merely one example of what porous distal end 126 may be composed of, and this disclosure contemplates the use of other porous distal end 126 materials.

[0159] Furthermore, this disclosure envisions that certain sensors can be placed within the coil windings or at the farthest end of the probe 102, thereby enabling the monitoring of certain physiological characteristics of the patient (e.g., vital signs), 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.

[0160] The coil winding shown at the distal end 126 of the aperture of probe 102 is depicted as having a constant pitch over the entire length of the distal end 126. However, this disclosure contemplates that the pitch of the coil winding may vary along the length of the distal end 126. The pitch variation may be repetitive, constant, or random, to suit certain unobstructedness inspection qualities or other qualities of probe 102.

[0161] The IV device assembly described herein provides an integrated extension kit in the form of this IV device assembly, featuring optimized fluid resistance and including a patency-improving guidewire device with relatively minimal vascular trauma to the patient. The IV device assembly currently described includes a probe that can be operated with one hand. The IV device assembly described herein can be more compact than other extension kits and can combine the patency testing process with the blood sampling process using a blood sample acquisition device to improve workflow and reduce the steps and procedures involved in patency testing and blood sampling. Due to the form and components used in this IV device assembly, the amount of waste can be reduced.

[0162] All examples and conditional language described herein are for educational purposes, to aid the reader in understanding the invention and the concepts contributed by the inventors to the field, and are to be construed as not being limited to these specifically enumerated examples and conditions. Although embodiments of this disclosure have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of the disclosed embodiments.

Claims

1. An intravenous device assembly comprising: A conduit, the conduit forming a lumen within the intravenous device assembly, the lumen being fluidly connected to: A vascular access device connector, capable of connecting to a vascular access device and to the conduit; and An intravenous device assembly connector located at the proximal end of the tubing; A probe having a certain length along the intravenous device assembly; A translation handle, mechanically connected to the probe, translates the probe through the vascular access device connector and out from the distal end of the intravenous device assembly. The translation handle includes a channel formed therethrough, through which the conduit passes as the translation handle translates toward the distal end of the intravenous device assembly. A support member formed along the length of the probe mechanically supports the probe as it translates within the intravenous device assembly. as well as A grip is formed at the proximal end of the support member, wherein the translation handle is slidable relative to the support member and the grip.

2. The intravenous device assembly of claim 1, further comprising a support member channel formed in the translation handle.

3. The intravenous device assembly according to claim 2, wherein, The support member is keyed to fit within the support member channel and to prevent the support member from rotating about the longitudinal axis of the support member.

4. The intravenous device assembly of claim 1 further includes a collapsible sleeve coaxially formed around the support member.

5. The intravenous device assembly according to claim 1, wherein, The probe passes through a probe channel formed in the vascular access device connector.

6. An intravenous device assembly comprising: A vascular access device connector at the distal end of the intravenous device assembly, which is mechanically connected to the vascular access device, the vascular access device connector having a channel formed therethrough; A probe having a certain length along the intravenous device assembly; A translation handle, which is mechanically connected to the probe via probe spokes, allows the probe to translate through the channel and out from the distal end of the intravenous device assembly when the translation handle is translated. A support member formed along the length of the probe mechanically supports the probe as it translates within the intravenous device assembly. The support member includes a tube formed coaxially around the probe, the tube including a slit formed along the longitudinal length of the tube, allowing the probe spokes to pass through the slit. A conduit forming a fluid channel within the intravenous device assembly, wherein the conduit passes through the translation handle such that the translation handle is slidable relative to the conduit, wherein the distal end of the conduit is attached to the vascular access device connector and in fluid communication with the channel, and the proximal end of the conduit is fluidly connected to the intravenous device assembly connector; and A grip is formed at the proximal end of the support member, wherein the translation handle is slidable relative to the support member and the grip.

7. The intravenous device assembly of claim 6, further comprising a collapsible sleeve coaxially formed around the probe, tube, and conduit.

8. The intravenous device assembly of claim 7, further comprising a support spring formed within the collapsible sleeve, the support spring forming a space between the collapsible sleeve and the probe, and biasing the translation handle toward the proximal end of the intravenous device assembly.

9. The intravenous device assembly of claim 6, further comprising a blood sample acquisition device fluidly and mechanically connected to the tubing via the intravenous device assembly connector.

10. The intravenous device assembly according to claim 6, wherein, The probe is a guidewire, which includes a porous distal end.

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