Intravenous device assembly

Abstract

This disclosure relates to an intravenous device assembly that may include an endometrium forming a fluid passage within the intravenous device assembly. The endometrium may be fluidly coupled to a vascular access device connector via a funnel-shaped connector, and fluidly coupled to an intravenous device assembly connector at a proximal end of the endometrium. The intravenous device assembly may further include one or more of the following: a collapsible sleeve coaxially formed around a first portion of the endometrium and mechanically coupled to the funnel-shaped connector; a patency device formed within the collapsible sleeve along a second portion of the endometrium; a translation handle that translates the patency device distal to the vascular access device connector; and a retaining grip formed around the endometrium to maintain the position of the intravenous device assembly relative to the translation handle.

Description

Technical Field

[0001] This disclosure relates to the field of medical devices, and more particularly, to an intravenous device assembly. Background Technology

[0002] Ensuring the patency of extended intravenous (IV) devices improves the feasibility of long-term placement and reduces the cost and trauma associated with unnecessary additional interventions for patients. More specifically, during the use of an IV device, the device is inserted into the patient's blood vessel, and in some cases, the needle is removed from the device while the device remains in the patient's blood vessel. In some cases, the IV device may remain in the patient's blood vessel for up to 30 days. This is done to provide the clinician or other healthcare provider (HCP) with a continuous flow of blood to the patient during care. This continuous flow of blood allows the clinician or other HCP to draw one or more blood samples or administer one or more infusions (e.g., saline solutions, various medications, and total parenteral nutrition) as appropriate.

[0003] However, when an intravenous device is in a patient's blood vessel, its patency can be compromised. Any blockage can persist and cause the intravenous device to malfunction, necessitating the placement of another device. This increases the trauma experienced by the patient and can lead to other medical problems, such as inflammation of the blood vessels and other medical issues.

[0004] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described herein. Rather, this background art is provided to describe the environments in which the embodiments currently described may operate. Summary of the Invention

[0005] This disclosure generally relates to an intravenous (IV) device assembly for interfacing with a vascular access device (VAD), such as a catheter. In some embodiments, the intravenous device assembly provides a fluid pathway to the vascular access device while also providing a patency device for periodically checking the patency of the vascular access device while the needle and / or catheter is in a patient's blood vessel.

[0006] The intravenous device assembly may include an inner lumen forming a fluid passage within the intravenous device assembly, the lumen being fluidly coupled distally to a vascular access device connector via a funnel-shaped connector, and fluidly coupled to an intravenous device assembly connector proximal to the lumen. In these embodiments, the intravenous device assembly may further include a collapsible sleeve coaxially formed around a first portion of the lumen and mechanically coupled to the funnel-shaped connector. In these embodiments, the intravenous device assembly may further include a patency device formed along a second portion of the lumen within the collapsible sleeve and inserted into the vascular access device connector, the vascular access device connector having: a translation handle for translating the patency device distally out of the vascular access device connector; and a retaining grip formed around the lumen to maintain the position of the intravenous device assembly relative to the translation handle. In these embodiments, the patency device may be a dual-length patency device or a single-length patency device.

[0007] In embodiments where the patency device is a dual-length patency device, the first end of the patency device is mechanically coupled to a funnel-shaped connector and passes through a channel formed in a translation handle, allowing the patency device to be guided through a seal formed in the funnel-shaped connector and into a vascular access device connector. In these embodiments, as the translation handle moves distally toward the vascular access device connector, the patency device can extend beyond the vascular access device connector and, in some embodiments, enter a catheter, for example, allowing the patency device to check the catheter's patency. Similarly, in cases where the intravenous device assembly comprises a single-length patency device, the first end of the patency device is anchored to a translation handle, and the translation handle translates distally toward the intravenous device assembly, thereby extending the patency device beyond the vascular access device connector, as described.

[0008] In some embodiments, the lumen for the fluid path through the intravenous device assembly may be offset from the central longitudinal axis. In these embodiments, the patency device may enter the funnel-shaped connector at the central longitudinal axis, allowing the patency device to pass through the funnel-shaped connector. Additionally, because the lumen is offset from the fluid axis of the vascular access device connector to which the funnel-shaped connector is mechanically connected, the funnel-shaped connector may include connector channels to complete the fluid path from the lumen to the vascular access device connector.

[0009] In some embodiments, the intravenous device assembly may include a catheter (e.g., a peripheral intravenous catheter (PIVC) or other suitable catheter) coupled to a vascular access device connector. In some embodiments, the catheter may include a needle for accessing a patient's blood vessel. In some embodiments, the intravenous device assembly may also include a blood sample access device mechanically coupled to the intravenous device assembly connector to receive a blood sample via the intravenous device assembly.

[0010] In some embodiments, the patency device may include a guidewire, the guidewire including a porous distal end. In one specific example, the porous distal end may include a material winding surrounding a central portion of the patency guidewire.

[0011] In some embodiments, the collapsible sleeve includes a helical spring formed therein. The helical spring can be biased to cause the translation handle to extend toward the proximal end of the intravenous device assembly. In some embodiments, the helical spring causes the translation handle to extend against a fixed grip.

[0012] This specification describes an intravenous device assembly comprising: an endometrium forming a fluid passage within the intravenous device assembly, the endometrium being distally fluidly coupled to a vascular access device (VAD) connector via a funnel-shaped connector; an intravenous device assembly connector at a proximal end of the endometrium; a patency device formed along the length of the endometrium, wherein a first end of the patency device is mechanically coupled to the funnel-shaped connector; a translation handle for translating the patency device distally out of the vascular access device connector, wherein the patency device passes through a channel formed in the translation handle and downward through and into the vascular access device connector; and a retaining grip formed around the endometrium to maintain the position of the intravenous device assembly relative to the translation handle. In these embodiments, the intravenous device assembly may include a collapsible sleeve coaxially formed around a first portion of the endometrium and mechanically coupled to the funnel-shaped connector. In some embodiments, the endometrium may be offset from the fluid axis of the vascular access device connector.

[0013] In some embodiments, the intravenous device assembly may include a catheter coupled to a vascular access device connector, the catheter including a needle for accessing a patient's blood vessel and a blood sample access device mechanically coupled to the intravenous device assembly connector to receive a blood sample via the intravenous device assembly. In some embodiments, the patency device may include a guidewire coupled to a porous distal end formed at the tip of the patency device.

[0014] This disclosure further describes an intravenous device assembly comprising: an endometrium forming a fluid passage within the intravenous device assembly, the endometrium being fluidly coupled via a funnel-shaped connector to a vascular access device (VAD) connector at a distal end and to an intravenous device assembly connector at a proximal end of the endometrium; a patency device formed along the length of the endometrium and inserted into the vascular access device connector; a translation handle for translating the patency device out of the distal end of the vascular access device connector, wherein a first end of the patency device is mechanically coupled to the translation handle; and a retaining grip formed around the endometrium to maintain the position of the intravenous device assembly relative to the translation handle. In these embodiments, the intravenous device assembly may further include a catheter coupled to the vascular access device connector. In these embodiments, the endometrium of the intravenous device assembly is offset from the fluid axis of the vascular access device connector. In these embodiments, the patency device is a guidewire including a porous second end. In these embodiments, the intravenous device assembly may include a collapsible sleeve coaxially formed around a first portion of the lumen and mechanically coupled to a funnel-shaped connector. In these embodiments, the collapsible sleeve also includes a helical spring that forms a space between the lumens and biases a translation handle toward the proximal end of the intravenous device assembly.

[0015] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and apparatus shown in the drawings. It should also be understood that these embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless such requirements are specified. Therefore, the following detailed description should not be considered limiting. Attached Figure Description

[0016] With the aid of the accompanying drawings, exemplary embodiments will be described and illustrated with additional features and details, wherein:

[0017] Figure 1 This is a perspective view of an intravenous (IV) device assembly according to some embodiments of the present disclosure;

[0018] Figure 2 This is a perspective view of an intravenous device assembly according to some embodiments of the present disclosure;

[0019] Figure 3 This is a perspective cross-sectional view of an intravenous device assembly according to some embodiments of the present disclosure;

[0020] Figure 4 This is a perspective cross-sectional view of an intravenous device assembly according to some embodiments of the present disclosure;

[0021] Figure 5 This is a perspective view of an intravenous device assembly according to some embodiments of the present disclosure;

[0022] Figure 6 This is a front view of an intravenous device assembly according to some embodiments of the present disclosure;

[0023] Figure 7 This is a front view of a patency device according to some embodiments of the present disclosure;

[0024] Figure 8 This is a perspective cross-sectional view of an intravenous device assembly according to some embodiments of the present disclosure;

[0025] Figure 9 This is a perspective view of an intravenous device assembly according to some embodiments of the present disclosure;

[0026] Figure 10A This is a perspective cross-sectional view of a rigid or semi-rigid intravenous device assembly according to some embodiments of the present disclosure;

[0027] Figure 10B This is a perspective view of a rigid or semi-rigid intravenous device assembly according to some embodiments of the present disclosure;

[0028] Figure 10C This is a side view of a rigid or semi-rigid intravenous device assembly according to some embodiments of the present disclosure;

[0029] Figure 10D This is a side view of a rigid or semi-rigid intravenous device assembly according to some embodiments of the present disclosure;

[0030] Figure 10E This is a side view of a rigid or semi-rigid intravenous device assembly according to some embodiments of the present disclosure;

[0031] Figure 10F This is a side view of a rigid or semi-rigid device assembly according to some embodiments of this disclosure; and

[0032] Figure 11 This is a perspective view of a vascular access device (VAD) connector assembly according to some embodiments of the present disclosure. Detailed Implementation

[0033] Figure 1This is a perspective view of an intravenous device assembly 100 according to some embodiments of the present disclosure. In some embodiments, the intravenous device assembly 100 may be mechanically and fluidly coupled to a vascular access device (VAD), such as a catheter coupled to a vascular access device connector 104. In these embodiments, the vascular access device may include a needle, a catheter, or a combination of a needle and a catheter for accessing a patient's blood vessel. In embodiments where the vascular access device includes a needle and a catheter, the needle can be withdrawn from the catheter once the vascular access device has been inserted into the patient's blood vessel. In these embodiments, the catheter may remain in the blood vessel and may undergo patency checks using the patency device 112 described in this disclosure. In some embodiments, the catheter may include a peripheral intravenous catheter (PIVC), a peripherally inserted central catheter (PICC), or a midline catheter. In embodiments where the vascular access device includes a needle, the patency device 112 may also be used to check the patency of the needle.

[0034] In some embodiments, the intravenous device assembly 100 may be mechanically and fluidly coupled to a blood sample access device. In some embodiments, the blood sample access device may be mechanically coupled to an intravenous device assembly connector 108 to receive a blood sample via the intravenous device assembly 100. In some embodiments, the blood sample access device may include a BD manufactured by Beckton Dickinson, Inc. of Franklin Lake, New Jersey. LUER-LOK TM Access devices or other suitable blood sample access devices.

[0035] In some embodiments, the intravenous device assembly 100 may include a lumen 102 fluidly connected at the distal end of the intravenous device assembly 100 to a vascular access device connector 104 via a funnel-shaped connector 106. In these embodiments, the funnel-shaped connector 106 may include a funnel-shaped connector channel that completes a fluid passage between the lumen 102 and a fluid passage formed within the vascular access device connector 104. In some embodiments, the lumen 102 may deviate from the fluid passage formed within the vascular access device connector 104. In these embodiments, the lumen 102 may deviate from the fluid path of the vascular access device connector 104 because the longitudinal axis of the fluid path through the vascular access device connector 104 differs from the longitudinal axis of the fluid path through the lumen 102 at the location where it is fluidly connected to the lumen 102 of the funnel-shaped connector 106. This deviation of the fluid passage will be further described and incorporated into... Figure 3The lumen 102 is shown. In some embodiments, the specifications of the lumen 102 may be optimized to minimize hemolysis and provide sufficient flow rate for receiving blood samples. In some embodiments, the lumen 102 may be made of polyvinyl chloride (PVC), thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), or other medical-grade tubing. As described in this disclosure, in some embodiments, the lumen 102 may include markings formed thereon that describe the location or extension of the patency device 112 during use of the intravenous device assembly 100.

[0036] In some embodiments, the intravenous device assembly 100 may further include a collapsible sleeve 110, which is coaxially formed around a first portion of the lumen 102 and mechanically coupled to a funnel-shaped connector 106. In some embodiments, the collapsible sleeve 110 may be mechanically coupled to the funnel-shaped connector 106, for example, using an adhesive or by performing an ultrasonic welding process. In some embodiments, the collapsible sleeve 110 may be made of a collapsible and flexible material that allows the collapsible sleeve 110 to fold itself.

[0037] In some embodiments, the proximal end of the foldable sleeve 110 may be mechanically coupled to the translation handle 114. In some embodiments, the foldable sleeve 110 may be mechanically coupled to the translation handle 114 via, for example, the use of an adhesive or by performing an ultrasonic welding process. In some embodiments, during operation, the translation handle 114 may be allowed to move along the longitudinal axis of the cavity 102 such that the foldable sleeve 110 can be folded against the funnel-shaped connector 106.

[0038] In some embodiments, the foldable sleeve 110 may be made of an elastomer or polymer film. The elastomer or polymer film allows the foldable sleeve 110 to fold itself and return to its folded state without damaging the elastomer or polymer film itself. In some embodiments, the foldable sleeve 110 may include a helical spring 122 formed therein to extend the foldable sleeve 110 toward the distal end of the intravenous device assembly 100 when no force is applied to the translation handle 114 (e.g., as shown in the image). Figure 1 (As shown). In some embodiments, the helical spring 122 can be biased to return to, as shown Figure 1 The non-expanded state is shown. In some embodiments, the foldable sleeve 110 may be translucent or completely transparent, thereby allowing clinicians or other HCPs to view the lumen 102 and / or any measurement markers placed on the lumen 102.

[0039] In some embodiments, the intravenous device assembly 100 may include a grip 116. In some embodiments, the grip 116 may be any body fixed and formed around the lumen 102 to maintain the position of the intravenous device assembly 100 relative to the lumen 102. In some embodiments, during operation of the intravenous device assembly 100, a clinician may grasp the grip 116 with one hand or more fingers and use another hand or other fingers to translate the translation handle 114 along its length toward the distal end of the intravenous device assembly 100. In some embodiments, the ergonomics defining the shape of the grip 116 allow the grip 116 and the translation handle 114 to be operated with one hand.

[0040] In some embodiments, the length of the patency device 112 may be approximately twice the length of the collapsible sleeve 110. In these embodiments, a first end of the patency device 112 is anchored to the funnel-shaped connector 106. The patency device 112 can then pass through a channel 118 formed within a translation handle 114. The patency device 112 can then return toward the funnel-shaped connector 106 and pass through an orifice formed through the funnel-shaped connector 106 and into a fluid channel formed in a vascular access device connector 104. In some embodiments, because the patency device 112 can enter the fluid channel formed in the vascular access device connector 104, the interface between the fluid channel formed in the vascular access device connector 104 and the orifice formed in the funnel-shaped connector 106 for the patency device 112 may include a seal (not shown). The seal prevents fluids such as blood and infusion fluids (e.g., saline solutions, various medications, and total parenteral nutrition) from leaving the funnel-shaped connector 106 and entering the collapsible sleeve 110.

[0041] In some embodiments, the patency device 112 may include a device that advances into a patient's blood vessel to provide improved patency. In some embodiments, the device may be non-invasive. In some embodiments, the patency device 112 may include a guidewire that is flexible enough to pass through the fluid channels described in this disclosure while still having sufficient resilience to expel material within the vascular access device.

[0042] In some embodiments, as described in this disclosure, the intravenous device assembly 100 can improve the patency of a vascular access device mechanically and fluidly coupled to the vascular access device connector 104 for fluid delivery and sampling. In some embodiments, because the intravenous device assembly 100 is mechanically coupled to a vascular access device inserted into a patient, the intravenous device assembly 100 can be selectively removed from and coupled to the vascular access device when the patency of the vascular access device needs to be checked. In some embodiments, the vascular access device may include separate ports for delivering medication into the patient and receiving blood samples. In some embodiments, the intravenous device assembly 100 can be coupled to the vascular access device as soon as the vascular access device is inserted into the patient. In some embodiments, the vascular access device may include a catheter having a needleless access connector (NAC) attached to the catheter near a patient access point. In these embodiments, the patency device 112 may be rigid enough yet flexible enough to bend as it advances from the vascular access device connector 104 and into the vascular access device. In some embodiments, the intravenous device assembly 100 may be used to deliver an instrument, such as a sensor for monitoring a patient's vital organs, into the vascular access device or into the patient's vein. In these embodiments, the sensor may be mounted on one end of the patency device 112.

[0043] According to some embodiments, Figure 1 The illustrated vascular access device connector 104 is depicted as a blunt-fit cannula snap-fit ​​connector. However, this disclosure contemplates the use of other types of connectors. In one alternative embodiment, the intravenous device assembly 100 may include a threaded male Luer connector, a clip-on Luer connector, a threaded male Luer connector with a removably attached blunt-fit cannula snap-fit ​​connector, or any other type of connector that mechanically and fluidly connects the intravenous device assembly 100 to the vascular access device described in this disclosure.

[0044] In some embodiments, the intravenous device assembly 100 may be provided via a patency device 112 with an integrated extension kit that has optimized fluid resistance and improved patency, the patency device 112 causing less trauma to the patient's vein. In some embodiments, the intravenous device assembly 100 can be used by a clinician with one hand, thereby allowing the clinician to have a free hand. In some embodiments, the intravenous device assembly 100 may be compact and include an extension kit in the form of a lumen 102 that can be coupled to a blood sample access device to access blood samples. In some embodiments, the intravenous device assembly 100 may also eliminate a rigid housing and remain flexible to reduce the likelihood of vascular access device complications when the vascular access device is inserted into a patient's vein. By using the intravenous device assembly 100, workflows can be streamlined and steps can be reduced by enabling the intravenous device assembly 100 to be coupled to vascular access devices that serve multiple purposes. Because the intravenous device assembly 100 includes fewer and smaller components, medical waste can also be reduced by using the intravenous device assembly 100. As the size of the intravenous device assembly 100 is reduced, the intravenous device assembly 100 can be more easily fitted into sharp containers or medical waste containers.

[0045] Figure 2 This is a perspective view of an intravenous device assembly 100 according to some embodiments of the present disclosure. According to some embodiments, Figure 2 Specifically shown are an intravenous device assembly 100, a catheter 126 configured to be connected to a vascular access device connector 104, and a blood sample access device 124 connected to the intravenous device assembly 100 via an intravenous device assembly connector 108. Although Figure 2 The catheter 126 and blood sample access device 124 are shown connected to the intravenous device assembly 100, but this disclosure contemplates that the intravenous device assembly 100 can be connected to any type of device that would benefit from the functionality provided by the intravenous device assembly 100.

[0046] In some embodiments, the intravenous device assembly 100 can be coupled to the blood sample access device 124 via an intravenous device assembly connector 108 located proximally at the intravenous device assembly 100. In some embodiments, the blood sample access device 124 can be any type of device that selectively allows blood samples to be received from the catheter 126 and the intravenous device assembly 100. In some embodiments, the blood sample access device 124 can be a BD product manufactured by Beckton Dickinson, Inc., Franklin Lake, New Jersey. LUER-LOK TMAccess device. In some embodiments, the blood sample access device 124 may be threaded to the intravenous device assembly connector 108 within and on the blood sample access device 124. In some embodiments, a clinician may obtain a blood sample during operation by inserting a blood bottle into the blood sample access device 124, wherein there is a need for the blood sample access device 124 to puncture a septum on the blood bottle and allow blood to flow from the lumen 102 into the blood bottle. In some embodiments, the blood sample access device 124 may include a valve that allows blood to flow therein only when a blood bottle is inserted into the blood sample access device 124.

[0047] According to some embodiments, Figure 2 The diagram also shows catheter 126. Catheter 126 is shown disconnected from the vascular access device connector 104 of the intravenous device assembly 100. However, it should be understood that during use of the intravenous device assembly 100, the intravenous device assembly 100 can be connected to catheter 126 to allow a fluid pathway to be coupled to the intravenous device assembly 100. In some embodiments, catheter assembly 128 may include catheter 126. In some embodiments, catheter assembly 128 may include a needle and a catheter coaxially formed around the needle. During operation, the needle of catheter assembly 128 can be withdrawn to leave the catheter in the patient for fluid delivery.

[0048] In some embodiments, conduit 126 may further include port tube 132 and port 130.

[0049] In some embodiments, port tube 132 and port 130 can be used as separate access points for clinicians to introduce infusion fluids (e.g., saline solutions, various medications, and parenteral nutrition) into a patient's blood vessels. In some embodiments, port tube 132 may include a port clamp 134 to prevent blood backflow into port tube 132 and port 130. In some embodiments, when port 130 is not in use, port clamp 134 may be clamped such that pressure within port tube 132 prevents blood from flowing within the port tube.

[0050] Figure 3 This is a perspective cross-sectional view of an intravenous device assembly 100 according to some embodiments of the present disclosure. Figure 3 An intravenous device assembly 100 is shown, mechanically and fluidly coupled to a blood sample access device 124 according to some embodiments. A cross-sectional view of the intravenous device assembly 100 shows that the patency device 112 can be a two-pass patency device, such that the distal end of the patency device 112 can travel a distance that is approximately twice the length of the collapsible sleeve 110.

[0051] In some embodiments, the patency device 112 may be anchored to the funnel-shaped connector 106 at the patency device anchor 136. In these embodiments, the patency device anchor 136 may be a hole formed in the funnel-shaped connector 106, wherein a first end of the patency device 112 is secured in the patency device retainer 136 and held in the patency device retainer 136 by, for example, an adhesive or mechanical coupling device. The patency device 112 may then pass through a channel 118 formed in the translation handle 114. The channel 118 may be configured such that the length of the patency device 112 can easily pass through the channel 118, allowing the patency device 112 to be moved outside the intravenous device assembly 100. After the patency device 112 passes through the channel 118, the patency device 112 may pass into the vascular access device connector 104 and the funnel-shaped connector 106.

[0052] In some embodiments, the fluid path of the lumen 102 may deviate from the fluid path of the vascular access device connector 104, such that the fluid path of the lumen 102 differs from the mechanical path of the patency device 112 as it enters the funnel-shaped connector 106. In some embodiments, the mechanical port at the funnel-shaped connector 106 occupied by the patency device 112 may be connected to the fluid paths of the vascular access device connector 104 and the lumen 102. In some embodiments, the mechanical port may include a seal 120 that seals the mechanical port for the patency device 112 to prevent fluid leakage from the fluid paths of the vascular access device connector 104 and the funnel-shaped connector 106.

[0053] In some embodiments, during operation of the intravenous device assembly 100, a clinician or other HCP may translate the translation handle 114 toward the distal end of the intravenous device assembly 100. In doing so, the patency device 112 may be pushed outside the vascular access device connector 104. In some embodiments, additionally, as the translation handle 114 moves to the distal end of the intravenous device assembly 100, the patency device 112 may pass through the channel 118 and through the funnel-shaped connector 106. In some embodiments, because the first end of the patency device 112 is anchored at the patency device anchor 136 and passes through the channel 118, the patency device 112 may extend from the vascular access device connector 104 approximately twice the length of the distance between the translation handle 114 and the funnel-shaped connector 106.

[0054] Figure 4 This is a perspective cross-sectional view of an intravenous device assembly 100 according to some embodiments of the present disclosure. According to some embodiments, the intravenous device assembly 100 has been rotated approximately 90 degrees about its longitudinal axis. Figure 4 cross-sectional view and Figure 3 The cross-sectional views shown are similar.

[0055] For example, such as Figure 4 As shown, a funnel-shaped connector channel 140 can be formed by the funnel-shaped connector 106. In some embodiments, a fluid passage for the lumen 102 is formed at the funnel-shaped connector 106, at a location offset from the vascular access device connector 104. In some embodiments, in order to fluidly connect the lumen 102 to the fluid passage formed by the vascular access device connector 104, the funnel-shaped connector 106 may have a funnel-shaped connector channel 140 formed therethrough, so as to fluidly connect the two fluid paths.

[0056] Additionally, during operation of the intravenous device assembly 100, a clinician or other HCP may translate the translation handle 114 toward the distal end of the intravenous device assembly 100. Doing so allows the patency device 112 to be displaced from the vascular access device connector 104. Furthermore, as the translation handle 114 moves to the distal end of the intravenous device assembly 100, the patency device 112 can pass through the channel 118 and through the funnel-shaped connector 106. Because the first end of the patency device 112 is anchored at the patency device retainer 136 and passes through the channel 118, the patency device 112 can extend from the vascular access device connector 104 approximately twice the length of the distance between the translation handle 114 and the funnel-shaped connector 106. In some embodiments, when the patency device 112 extends beyond the vascular access device connector 104 and the translation handle 114 is translated toward the distal end of the intravenous device assembly 100, fluid flow is permitted through the lumen 102, the funnel-shaped connector channel 140, and the vascular access device connector 104. In some embodiments, until the patency device 112 is in Figure 4 Fluid flow is only permitted when it is in its retracted position as shown.

[0057] Figure 4 Further illustration shows the distal end of a porous distal end 138 of the patency device 112 according to some embodiments. In some embodiments, the porous distal end 138 may be made porous by connecting a spring winding around the distal end of the guidewire forming the patency device 112. In some embodiments, the spring winding may be in the form of a fixed coil, a variable coil, a repeating variable coil, and an open-end extension coil, and other configurations. In some embodiments, the spring winding of the porous distal end 138 may be covered by a knob. In some embodiments, the length of the porous distal end 138 may be varied and may be as long as or shorter than the distance between the distal end of the fluid passage formed in the vascular access device connector 104 and the distal end of the seal 220. In some embodiments, the diameter of the hole through the seal 220 may be smaller than the diameter of the porous distal end 138, and the porous distal end 138 may be prevented from entering the hole formed through the seal 220.

[0058] In some embodiments, the length of the lumen 102 may be selected based on one or more of the following: the specifications of a particular vascular access device, a particular vascular access device component configuration, or a clinical setting. In some embodiments, the lumen 102 may include a length L from the grip 116 to the funnel-shaped connector 106. In some embodiments, the lumen 102 may include an inner diameter D.

[0059] When the inner cavity 102 is tubular, the Poisson equation can be used to analyze the fluid flow rate in the fluid path through the inner cavity 102:

[0060]

[0061] Where ΔP is the change in pressure gradient along the length of the fluid path, D and L are the inner diameter and length of the fluid path, respectively, and μ is the viscosity of the fluid. This is fluid resistance. Since μ is the viscosity of the fluid rather than part of the extension tube geometry, a geometry factor G is defined. f So that R f (fluid resistance) is in

[0062] In some embodiments, the inner cavity 102 may have multiple segments with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), then the geometric factor is:

[0063]

[0064] In some embodiments, the cavity 102 may have an inner diameter that varies along the length of the cavity 102, then the geometric factor is:

[0065]

[0066] In some embodiments, the cavity 102 may have a non-circular cross-section or a complex inner diameter profile. The geometric factors can then be determined by measuring the flow rate (Q) using a fluid of known viscosity (μ) at a given pressure (ΔP):

[0067]

[0068] You can choose G with an inner cavity of 102. f Values ​​were set to reduce the maximum shear stress for each vascular access device specification to be equal to or less than BD 21G. UltraTouch TM The maximum shear stress of the push-button blood collection kit (available from Beckton Dickinson, Franklin Lake, New Jersey), which was previously considered the gold standard for blood collection. In some embodiments, the G of the lumen 102 can be selected.f Values ​​were set to reduce the maximum shear stress for each vascular access device specification to be equal to or less than BD 25G. UltraTouch TM Maximum shear stress of the push-button blood collection kit (available from Beckton Dickinson, Franklin Lake, New Jersey).

[0069] In some embodiments, the fluid path of a blood collection system (which may include one or more blood sample access devices 124), the fluid path within an intravenous device assembly 100 (which may include a lumen 102), and the vascular access device (which may include a catheter assembly 128 and / or an extension tube) may comprise the entire blood collection path through which blood flows after exiting a blood vessel and enters the blood collection device 124 during blood collection. The system geometry factor G for the fluid path of the blood collection system. fs It can be compared with the previously described inner cavity 102 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 Other values ​​may be included. In some embodiments, when the translation handle 114 is moved to the distal end of the intravenous device assembly 100, the system geometry factor G... fs It can be equal to or greater than 7.34E+06(1 / in) 3 In some embodiments, the system geometry factor G fs It can be equal to or greater than 7.34E+06(1 / in) 3 Add or subtract 10%, 25%, 50%, or 75%. In some embodiments, G fs Other values ​​may be included, which may be selected based on the catheter's specifications and / or length.

[0070] According to some embodiments, Figure 4The interconnection between the lumen 102 and the grip 116 is also shown. In this example, the grip 116 can serve as a fluid path having a fluid orifice formed therethrough. In some embodiments, the grip 116 may include a plurality of threads that threadedly engage with the blood sample access device 124, such that they can be mechanically and fluidly coupled together. In other embodiments, the lumen 102 may pass through a mechanical orifice formed through the grip 116, and the grip 116 may be coupled to the outer surface of the lumen 102 using adhesives or other types of coupling mechanisms. In some embodiments, the fluid path of the lumen 102 may be fluidly coupled to the blood sample access device 124 and to the funnel-shaped connector channel 140 in the funnel-shaped connector 106. In some embodiments, the portion of the intravenous device assembly 100 between the funnel-shaped connector 106 and the grip 116 may be flexible, such that movement of the intravenous device assembly 100 does not interfere with the placement of the vascular access device coupled to the intravenous device assembly 100 via the vascular access device connector 104.

[0071] Additionally, in some embodiments, the foldable sleeve 110 may include a helical spring (not shown). The helical spring can cause the foldable sleeve 110 to expand to... Figure 4 The device is positioned as shown, and the translation handle 114 can be biased towards the proximal end of the intravenous device assembly 100. In this position, the patency device 112 can remain in an undeployed state until the clinician translates the translation handle 114 towards the distal end of the intravenous device assembly 100.

[0072] Figure 5 This is a perspective view of an intravenous device assembly 100 according to some embodiments of the present disclosure. According to some embodiments, in... Figure 5 In this configuration, the translation handle 114 has been translated a distance toward the distal end of the intravenous device assembly 100. By translating the translation handle 114 toward the distal end of the intravenous device assembly 100, numerous modifications can be made to the intravenous device assembly 100. For example, the collapsible sleeve 110 can be folded and compressed between the translation handle 114 and the funnel-shaped connector 106. As described in this disclosure, the patency device 112 can also pass through the channel 118 formed in the translation handle 114 and through the funnel-shaped connector 106 and the vascular access device connector 104. This extends the patency device 112 beyond the vascular access device connector 104 and, when connected, into the fluid path formed in the vascular access device connected to the intravenous device assembly 100. Figure 5 As shown, the translation position of the translation handle 114 can be an intermediate position, allowing the translation handle 114 to move further downward toward and closer to the funnel-shaped connector 106. In some embodiments, the translation handle 114 slides along the inner cavity 102 within the inner cavity 102, thereby passing through the inner cavity hole formed through the translation handle 114.

[0073] In some embodiments, by extending the patency device 112 in this manner, a clinician can check the patency of the vascular access device coupled to the intravenous device assembly 100. In some embodiments, the extension of the patency device 112 and its porous distal end 138 into the vascular access device can move or push aside any object that may obstruct the catheter of the vascular access device during blood draw. Substances that may obstruct the fluid passage within the vascular access device may include fibrinous material, thrombus formation, or even the vein wall. In some embodiments, the patency device 112 may be rigid enough to open a valve downstream of the intravenous device assembly 100 to allow backflow into the catheter.

[0074] Figure 6 This is a front view of an intravenous device assembly 100 according to some embodiments of the present disclosure. In some embodiments, the collapsible sleeve 110 folds between the translation handle 114 and the funnel-shaped connector 106 to extend the patency device 112 to nearly its maximum or increased length. In these and other embodiments, the lumen 102 may include a plurality of measuring indicators 142 positioned along the length of the lumen 102. The indicators may be physical markers indicating to a clinician the distance the patency device 112 has moved out of the vascular access device connector 104 and into the vascular access device coupled to the intravenous device assembly 100. Any number of measuring indicators 142 may be marked along the lumen 102 between the patency device 112 and the funnel-shaped connector 106, and the present disclosure takes into account that these measurements may be incremented using any imperial or metric system. During operation, the clinician can determine the length of the fluid path within the vascular access device coupled to the intravenous device assembly 100 using a measuring indicator 142 printed or marked on the lumen 102, and translate the translation handle 114 toward the distal end of the intravenous device assembly 100 accordingly. This allows the clinician to accommodate shorter fluid path lengths within various vascular access devices, ensuring that the patency device 112 does not extend into or out of the vascular access device and does not extend into, for example, the wall of a blood vessel, thus preventing damage to the vessel. Because the intravenous device assembly 100 remains flexible relative to the vascular access device connector 104, the clinician will not dislodge or otherwise interfere with the placement of the vascular access device in the patient's arm when manipulating the translation handle 114 when the intravenous device assembly 100 is coupled to the vascular access device. This prevents injury to the patient during patency testing and during blood draws to the blood sample access device 124.

[0075] Figure 7 This is a front view of a patency device 112 according to some embodiments of the present disclosure. In some embodiments, such as... Figure 7 As shown, the patency device 112 can be extended to, for example, mechanically and fluidly connected to... Figure 1 and 2 The catheter assembly 128 of the intravenous device assembly 100. Because the clinician advances the translation handle 114 toward the distal end of the intravenous device assembly 100 as described in this disclosure, the patency device 112 is shown extending slightly beyond the distal end of the catheter assembly 128. Also as described in this disclosure, the distal end of the patency device 112 may include a porous distal end 138. In these embodiments, the patency device 112 may be necked to a smaller diameter, and the porous distal end 138 may include a coil winding surrounding the smaller diameter portion of the patency device 112. The coil winding is merely one example of how the porous distal end 138 may be constructed, and this disclosure contemplates the use of other porous distal end 138 materials.

[0076] In addition, this disclosure anticipates that certain sensors can be placed within the coil windings or at a very distal end of the patency device 112 in order to monitor certain physiological characteristics of the patient, such as blood pressure, pH of the patient's blood, blood chemistry, peripheral capillary oxygen saturation (SPO2) level, blood flow rate, heart rate, and temperature.

[0077] The coil winding shown at the distal end 138 of the patency instrument 112 is depicted as having a constant pitch over the entire length of the distal end 138. However, this disclosure contemplates that the pitch of the coil winding may vary along the length of the distal end 138. The pitch variation may be a repetitive variation, a constant variation, or a random variation to suit certain patency inspection qualities of the patency instrument 112.

[0078] Figure 8 This is a perspective cross-sectional view of an intravenous device assembly 200 according to some embodiments of the present disclosure. Figure 8 The intravenous device assembly 200 shown is similar to Figure 4 The intravenous device assembly shown includes a lumen 202 that fluidly connects a blood sample access device 224 to a funnel-shaped connector 206. As described in this disclosure, the proximal end of the lumen 202 can be connected to the blood sample access device 224 via an intravenous device assembly connector 208. Additionally, similar to... Figure 4The intravenous device assembly 200 may include a collapsible sleeve 210, which is coaxially formed around a first portion of the lumen 202 and mechanically coupled to a funnel-shaped connector 206. During operation of the intravenous device assembly 200, a clinician may grasp the grip 216 with one or more fingers and use another hand or other fingers to translate the translation handle 214 along its length toward the distal end of the intravenous device assembly 200. In some embodiments, the ergonomics defining the shape of the grip 216 allow for single-handed operation of the grip 216 and the translation handle 214. In some embodiments, the collapsible sleeve 210 may include a helical spring 222 formed therein to extend the collapsible sleeve 210 toward the distal end of the intravenous device assembly 200 when no force is applied to the translation handle 214 (e.g., as shown in the image). Figure 1 (As shown). In some embodiments, the helical spring 222 can be biased to return to, as shown Figure 1 The non-expanded state is shown.

[0079] Similar to Figure 4 The distal end of the patency device 212 may include a porous distal end 238. In some embodiments, the porous distal end 238 may be made porous by attaching a spring winding around the distal end of the guide wire forming the patency device 212.

[0080] However, in Figure 8 In this diagram, the patency device 212 is shown as a single-pass patency device 212. That is, instead of anchoring the first end of the patency device 212 to the funnel-shaped connector 206, the first end of the patency device 212 is anchored to the translation handle 214 at the patency device anchor 236. Therefore, the patency device 212 can be moved from the intravenous device assembly 200 by approximately [distance missing]. Figure 4 The distance shown is half of the distance. However, the distance that the patency device 212 can be removed from the intravenous device assembly 200 can be approximately equal to the length between the proximal side of the funnel-shaped connector 206 and the distal side of the translation handle 214.

[0081] As described in this disclosure, a funnel-shaped connector channel 240 formed by a funnel-shaped connector 206 is shown. As described in this disclosure, a fluid passage for the lumen 202 is formed at the funnel-shaped connector 206, at a location offset from the fluid passage of the vascular access device connector 204. To fluidly connect the lumen 202 to the fluid passage formed by the vascular access device connector 204, the funnel-shaped connector 206 may have a funnel-shaped connector channel 240 formed therethrough to fluidly connect the two fluid paths.

[0082] and Figure 4 Compared to the fluid path used by the intravenous device assembly 100 shown, Figure 8The illustrated intravenous device assembly 200 can be used in conjunction with those vascular access devices with relatively short fluid paths. In some embodiments, due to the lack of placement... Figure 2 The distance between the vascular access device connector 204 and the catheter assembly 128 of the illustrated vascular access device may be greater than any intermediate length of the extension tube, and therefore the distance between the distal ends of the vascular access device connected to the intravenous device assembly 200 may be greater than Figure 4 As shown in the diagram, the vascular access device connected to the intravenous device assembly 200 via the vascular access device connector 204 can be smaller, making it possible to eliminate the need for devices such as... Figure 4 The double-length patency device 112 is shown.

[0083] In some embodiments, because the patency device 212 does not pass through the translation handle 214, Figure 8 The intravenous device assembly 200 can prevent the formation of channel 118 in the translation handle 214. Figure 1 The need for ) is met. Instead, movement of the translation handle 214 toward the distal end of the intravenous device assembly 200 causes the patency device 212 to exit the vascular access device connector 204.

[0084] Figure 9 This is a perspective view of an intravenous device assembly 300 according to some embodiments of the present disclosure. In these embodiments, the intravenous device assembly 300 may include a funnel-shaped connector 306 that is mechanically and fluidly coupled to an indwelling catheter 346. The indwelling catheter 346 may include a catheter / needle assembly 328 that is fluidly and mechanically coupled to the funnel-shaped connector 306.

[0085] In some embodiments, the intravenous device assembly 300 may include a patency device 312 anchored to the intravenous device assembly 300 at a patency device anchor 336. In some embodiments, the patency device 312 may then pass through a channel (not shown) formed by a translation handle 314 and enter a funnel-shaped connector 306. Thus, the patency device 312 is shown as a two-way patency device 312 as described in this disclosure.

[0086] Figure 9 A grip portion 316, according to some embodiments, is also shown formed along the side of the intravenous device assembly connector 308. In these embodiments, the space occupied by the grip portion 316 and the intravenous device assembly connector 308 is reduced by using the grip portion 316 formed on the side of the intravenous device assembly connector 308.

[0087] According to some embodiments, Figure 9 The lumen 302 is also shown, which deviates from the fluid path formed in the indwelling catheter 346. Although the components of the intravenous device assembly are more integrated... Figure 1 The components shown and described are relatively more rigid, but Figure 9 The length of the intravenous device assembly 300 can be reduced, thereby eliminating the need for materials and the volume of the intravenous device assembly 300.

[0088] Figure 10A This is a perspective cross-sectional view of an intravenous device assembly 400 according to some embodiments of the present disclosure. Figure 10B This is a perspective view of an intravenous device assembly 400 according to some embodiments of the present disclosure. Due to the use of comparison... Figure 1 The described internal cavity is relatively more rigid than the internal cavity of a solid 448, therefore Figure 10A and 10B The intravenous device assembly 400 can be rigid or semi-rigid. Figure 10A A cavity 402 is shown offset relative to the fluid path formed in the vascular access device connector 404, wherein the mechanical path of the patency device 412 is aligned with the fluid path formed in the vascular access device connector 404. Figure 10B A patency device 412 is shown offset relative to a fluid path formed in a vascular access device connector 404, wherein the fluid path of the lumen 404 is aligned with the fluid path formed in the vascular access device connector 404. This specification contemplates that either of these paths (e.g., the mechanical path of the patency device 412 and the fluid path of the lumen 402) may be aligned with or deviated from the fluid path formed in the vascular access device connector 404.

[0089] In some embodiments, the solid lumen 448 may be made of a material that maintains rigidity to the lumen 402 formed therethrough. In these embodiments, similar to other embodiments described in this disclosure, the lumen 402 may be fluidly coupled to the blood sample access device 424 via an intravenous device assembly connector 408. In some embodiments, the solid lumen 448 may also include a channel 442 formed along the length of the solid lumen 448.

[0090] In one embodiment, channel 442 may be used to receive patency device 412 therein, allowing the patency device to be translated through funnel-shaped connector 406 into vascular access device connector 404 and out of intravenous device assembly 400. In these embodiments, solid lumen 448 may include channel 442 formed therein to allow patency device 412 to pass from patency device anchor 436 at a first end of patency device 412 through channel 418 formed in a portion of translation handle 414 mechanically coupled to channel 442 and through a hole formed in vascular access device connector 404 into vascular access device connector 404. In some embodiments, channel 442 may be quarter-moon shaped.

[0091] In the embodiments described in this disclosure, the translation handle 414 may include a bend formed within the channel 442, such that a channel 418 for the patency device 412 can be formed therein for the patency device 412 to pass through. The channel 418 for allowing the patency device 412 to pass through the translation handle 414 may be formed in a portion of the translation handle 414 located within the channel 442. In some embodiments, during operation, as the translation handle 414 is translated toward the distal end of the intravenous device assembly 400, the patency device 412 passes through the channel 418 and enters the vascular access device connector 404 to extend the patency device 412 into a vascular access device connected to the intravenous device assembly 400 via the vascular access device connector 404.

[0092] In some embodiments, the patency device 412 may include a porous distal end 438. In some embodiments, the porous distal end 438 may be made porous by coupling a spring winding around the distal end of the guidewire forming the patency device 412. Among other configurations, the spring winding may be in the form of a fixed coil, a variable coil, a repeating variable coil, and an open-end extension coil. In some embodiments, the spring winding of the porous distal end 438 may be covered by a knob. In some embodiments, the length of the porous distal end 438 may be variable and may be as long as or shorter than the distance between the distal end of a fluid passage formed in a vascular access device connector 404 and the distal end of a seal (not shown), which is formed in the vascular access device connector 404 to seal the orifice of the patency device 412 from fluid paths within the vascular access device connector 404 and within a solid lumen 448. In these embodiments, the diameter of the orifice through the seal may be smaller than the diameter of the porous distal end 438, and the porous distal end 438 may be prevented from entering the orifice formed through the seal.

[0093] In some embodiments, the translation handle 414 may include a series of locking teeth 452 that engage with channel locking teeth 450 formed at the opening to the channel 442. During operation, the translation handle 414 can be gripped by a clinician to disengage the locking teeth 452 formed on the translation handle 414 from those channel locking teeth 450 formed at the opening to the channel 442. This allows the clinician to hold the translation handle 414 at any distance along the lumen 448 of the physical device, such that any portion or length of the patency device 412 extends from and into, for example, the PIVC connected to the vascular access device connector 404.

[0094] In another embodiment, the translation handle 414 may include a spring mechanism (not shown) biased against the wall of an opening leading to a channel 442 when no pressure is applied to the translation handle 414, the channel of which may be quarter-lunar in shape. When a clinician or other HCP applies a clamping force to the translation handle 414 at a location on the translation handle 414, the pressure can compress the biased spring mechanism and release the translation handle 414 to slide along the longitudinal axis of a lumen 448, which may be rigid or semi-rigid. Furthermore, by doing so, the clinician can fix the translation handle 414 at any distance along the solid lumen 448, such that any portion or length of the patency device 412 extends from and into, for example, a PIVC coupled to the patency device connector 404.

[0095] exist Figure 10B In the illustrated embodiment, a collapsible sleeve 410 may be formed around the solid cavity 448. In one embodiment, the collapsible sleeve 410 may be mechanically coupled to the distal side of the translation handle 414. Alternatively, the collapsible sleeve 410 may be coupled to the distal end of the solid cavity 448. In these embodiments, the collapsible sleeve 410 prevents contaminants from entering the channel 442 and contacting the surface of the patency device 412 during operation.

[0096] Furthermore, similar to other embodiments described in this disclosure, the lumen 402 can be fluidly coupled to the blood sample access device 424 via an intravenous device assembly connector 408. In these embodiments, a blood sampling tube (not shown) can be inserted into the blood sample access device 424. In one specific embodiment, when the blood sampling tube is inserted into the blood sample access device 424, a diaphragm formed on the blood sampling tube can be punctured by a needle within the blood sample access device 424. Blood can then be allowed to flow into the blood sampling tube and a blood sample can be received.

[0097] Figure 10C This is a side view of an intravenous device assembly 400 according to some embodiments of the present disclosure, which may be rigid or semi-rigid. Figure 10D This is a side view of an intravenous device assembly 400 according to some embodiments of the present disclosure, which may be rigid or semi-rigid. Figure 10E This is a side view of an intravenous device assembly 400 according to some embodiments of the present disclosure, which may be rigid or semi-rigid. Figure 10F These are side views of an intravenous device assembly 400 according to some embodiments of the present disclosure, which may be rigid or semi-rigid. Each of these views illustrates the assembly as combined with... Figure 10A and 10B Possible shapes of the channels 442 formed by the described rigid or semi-rigid solid cavity 448.

[0098] Figure 10C It shows the presentation as follows Figure 10B The channel 442 is shown in a quarter-moon shape. In some embodiments, the lumen 402 can be centered as shown in... Figure 10A In the fluid path formed in the vascular access device connector 404 shown. In some embodiments, the lumen 402 may be relative to, for example, Figure 10A Fluid path offset formed in the vascular access device connector 404 shown.

[0099] Figure 10C A translation handle 414 formed around a solid cavity 448 is also shown. In this embodiment, the translation handle 414 includes a neck 454 and a crescent-shaped body 456. In this embodiment, the translation handle 414, neck 454, and crescent-shaped body 456 can be formed as a single integral piece. Figure 10C The diagram also shows a channel 418 formed by the crescent-shaped body 456 passing through the translation handle 414. As described in this disclosure, the patency device 412 can pass through this channel 418 such that when the translation handle 414 is translated distally or proximally along the longitudinal axis of the internal cavity 448, the patency device 412 extends from or retracts into the internal cavity 448, respectively. Although Figure 10C The passage 442 is shown to intersect with the translation handle 414 via the crescent-shaped body 456 and neck 454, but this specification contemplates that any extension of the translation handle 414 may be used based on the shape and form of the solid cavity 448, so that the passage 418 can be formed therein and the patency device 412 can pass through the passage 418 as described.

[0100] Figure 10D One or more cavities 402, formed through a solid lumen 448 according to some embodiments, are shown to accommodate one or more fluids passing through the solid lumen 448 or a single fluid passing through the lumen 402. Additionally, in these embodiments, a channel 442 may be formed through the center of the solid lumen 448. In some embodiments, a patency device 412 may pass through this channel 442 such that the patency device 412 enters the lumen 402 at a location offset from the fluid path formed through the vascular access device connector 404. Additionally, in some embodiments, the lumen 402 may be offset from the fluid path formed through the vascular access device connector 404. Figure 10D In this embodiment, the translation handle 414 includes an arm that intersects with a channel 442 formed through the internal cavity 448 of the body. Additionally, the arm includes a channel 418 through which the patency device 412 can pass as described in this disclosure.

[0101] Figure 10EThe solid lumen 448, according to some embodiments, may further include one or more lumens 402. The lumen 402 may contain one or more fluids passing through the solid lumen 448 or a single fluid passing through the lumen 402. The lumen 402 is also shown to deviate from the fluid path formed via the vascular access device connector 404. Figure 10E It is also shown that, according to some embodiments, a channel 442 may be formed through a solid cavity 448. In these embodiments, the channel 442 may include multiple dedicated channel portions through which the patency device 412 may pass, and multiple mating protrusions may be used to maintain the alignment of the patency device 412 as it passes through the channel 442. Figure 10E In the middle, the translation handle 414 includes an arm that intersects with a channel 442 formed through the internal cavity 448 of the solid. Figure 10D In contrast, the arm meanders through channel 442 in a shape similar to that of channel 442. Additionally, the arm includes channel 418 through which the patency device 412 can pass, as described in this disclosure.

[0102] Figure 10F The diagram shows a solid lumen 448 comprising one or more lumens 402. The lumen 402 may contain one or more fluids passing through the solid lumen 448, or a single fluid passing through the lumen 402. The lumen 402 is also shown as deviating from the fluid path formed by the vascular access device connector 404. Figure 10F A channel 442, which may be serpentine, is also shown. In this example, channel 442 may include multiple dedicated channel sections through which the patency device 412 can pass. Figure 10F In the middle, the translation handle 414 includes an arm that intersects with a channel 442 formed through the internal cavity 448 of the solid. Figure 10D Instead, the arm meanders through channel 442 in a shape similar to that of channel 442. Additionally, as described in this disclosure, the arm includes channel 418 through which the patency device 412 can pass.

[0103] exist Figures 10C to 10F In each of these, the translation handle 414 can be wrapped around the outer surface of the solid cavity 448 and engaged with... Figure 10A and Figure 10B The solid lumen 448 and the patency device 412 are connected. In some embodiments, the translation handle 414 may be made of a flexible and resilient material that returns to its original shape when the clinician does not apply a pinching force to the translation handle 414 to translate the translation handle 414 toward the distal end of the intravenous device assembly 400.

[0104] Figure 11This is a perspective view of a vascular access device connector 504 assembly according to some embodiments of the present disclosure. In some embodiments, the vascular access device connector 504 may be as follows: Figure 1 The combination shown is a vascular access device connector 104 and a funnel-shaped connector 106.

[0105] As described in this disclosure, the patency device 512 can pass through the vascular access device connector 504 for a distance. Figure 11 In the illustrated embodiment, the patency device 512 may extend to the distal end of the vascular access device connector 504. Alternatively, the distal end of the patency device 512 may be a multi-port distal end.

[0106] The vascular access device connector 504 may further include a connector channel 540. The connector channel 540 can connect, in a funnel shape, an output from one or more lumens fluidly connected to the vascular access device connector 504 to a fluid channel 550. The connector channel 540 can connect from the... Figure 1 The described cavity receives fluid.

[0107] The vascular access device connector 504 may further include a seal 520. The seal 520 prevents fluid from flowing out of the connector channel 540 and fluid channel 550 from the point where the patency device 512 intersects with the vascular access device connector 504. The seal prevents these fluids from entering, for example, the connection point. Figure 1 In the aforementioned foldable sleeve.

[0108] The vascular access device connector 504 may further include a plurality of connector clamping arms 555. In this particular example of the vascular access device connector 504, the connector clamping arms 555 may be used to mechanically secure the vascular access device connector 504 to a vascular access device, thereby fluidly connecting the fluid channel 550 to a fluid path formed in the connected vascular access device. Although Figure 11 One specific type of vascular access device connector 504 is shown, but this disclosure contemplates the use of any type of connector, such as a blunt cannula snap-fit ​​connector (e.g., vascular access device connector 504), a threaded male Luer connector, a sliding Luer connector, a threaded male Luer connector with a detachably connected blunt cannula snap-fit ​​connector, etc.

[0109] The intravenous device assembly described in this disclosure provides an integrated extension kit in the form of the intravenous device assembly of the present invention, which has optimized fluid resistance and includes a patency-improving guidewire device with relatively minimal vascular trauma to the patient. The intravenous device assembly currently described includes a patency device that can be operated with one hand. The intravenous device assembly described in this disclosure can be more compact than other extension kits that can combine patency testing procedures with blood sampling procedures by using a blood sampling access device to improve workflow and reduce steps and procedures in patency testing and blood sampling. Due to the form and components used in this intravenous device assembly, the amount of waste and the amount of waste generated can be reduced.

[0110] All examples and conditional language referenced in this disclosure are intended for educational purposes to aid the reader in understanding this disclosure and the ideas made by the inventors for further development of the art, and should be construed as not being limited to the examples and conditions listed. 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, characterized in that, The intravenous device assembly includes: An inner lumen forming a fluid channel within the intravenous device assembly is fluidly connected to a vascular access device connector via a funnel-shaped connector, and the inner lumen is fluidly connected to an intravenous device assembly connector at the proximal end of the inner lumen. A foldable sleeve, which is coaxially formed around a portion of the inner cavity and mechanically connected to the funnel-shaped connector; A patency device, wherein at least a portion of the patency device is formed within the collapsible sleeve along a portion of the lumen, wherein a first end of the patency device is mechanically coupled to the funnel-shaped connector and a second end of the patency device extends into the vascular access device connector; Translation handle, the translation handle moving the patency device distal to the vascular access device connector; and A fixed grip portion is formed around the inner cavity to maintain the position of the translation handle.

2. The intravenous device assembly according to claim 1, characterized in that, The patency device passes through a channel formed in the translation handle, and through the funnel-shaped connector and into the vascular access device connector.

3. The intravenous device assembly according to claim 1, characterized in that, The lumen is offset from the fluid axis of the vascular access device connector.

4. The intravenous device assembly according to claim 1, characterized in that, The intravenous device assembly also includes a catheter connected to the vascular access device connector.

5. The intravenous device assembly according to claim 1, characterized in that, The intravenous device assembly also includes a blood sample access device mechanically connected to the intravenous device assembly connector to receive blood samples via the intravenous device assembly.

6. The intravenous device assembly according to claim 1, characterized in that, The patency device includes a guidewire with a multi-hole distal end.

7. The intravenous device assembly according to claim 1, characterized in that, The patency device is mechanically coupled to the translation handle, and the patency device exits the intravenous device assembly as the translation handle is translated toward the distal end of the intravenous device assembly.

8. The intravenous device assembly according to claim 1, characterized in that, The collapsible sleeve also includes a helical spring that forms a space between the inner cavities and biases the translation handle toward the proximal end of the intravenous device assembly.

9. An intravenous device assembly, characterized in that, The intravenous device assembly includes: An inner lumen forming a fluid channel within the intravenous device assembly is fluidly connected to a vascular access device connector via a funnel-shaped connector, and the inner lumen is fluidly connected to an intravenous device assembly connector at the proximal end of the inner lumen. A patency device formed along the length of the inner cavity, wherein a first end of the patency device is mechanically connected to the funnel-shaped connector; A translation handle that translates the patency device out of the distal end of the vascular access device connector, wherein the patency device passes through a channel formed in the translation handle and passes downward into the vascular access device connector; and A fixed grip portion is formed around the inner cavity to maintain the position of the translation handle.

10. The intravenous device assembly according to claim 9, characterized in that, The lumen is offset from the fluid axis of the vascular access device connector.

11. The intravenous device assembly according to claim 9, characterized in that, The intravenous device assembly also includes: The catheter, which is connected to the vascular access device connector; and A blood sample access device mechanically connected to the intravenous device assembly connector to receive blood samples through the intravenous device assembly.

12. The intravenous device assembly according to claim 9, characterized in that, The patency device includes a guidewire connected to a porous distal end formed at the end of the patency device.

13. An intravenous device assembly, characterized in that, The intravenous device assembly includes: An inner lumen forming a fluid channel within the intravenous device assembly is fluidly connected to a vascular access device connector via a funnel-shaped connector, and the inner lumen is fluidly connected to an intravenous device assembly connector at the proximal end of the inner lumen. A patency device, which is formed along the length of the lumen and enters the vascular access device connector; A translation handle that moves the patency device distal to the vascular access device connector, wherein a first end of the patency device is mechanically connected to the translation handle; and A fixed grip portion is formed around the inner cavity to maintain the position of the translation handle. The lumen is offset from the fluid axis of the vascular access device connector.

14. The intravenous device assembly according to claim 13, characterized in that, The intravenous device assembly also includes a catheter connected to the vascular access device connector.

15. The intravenous device assembly according to claim 13, characterized in that, The patency device contains a guidewire with a porous second end.

16. The intravenous device assembly according to claim 13, characterized in that, The intravenous device assembly also includes a collapsible sleeve that is coaxially formed around a portion of the lumen and mechanically coupled to the funnel-shaped connector.

17. The intravenous device assembly according to claim 16, characterized in that, The collapsible sleeve also includes a helical spring that creates space between the inner cavities and biases the translation handle toward the proximal end of the intravenous device assembly.

Images