Switching flow path stay-on Hemoshield connector

Abstract

Disclosed is a fluid connector device for a blood collection system, comprising a fluid connector device that can include passages for regulating fluid movement through the fluid connector device, a flow restriction device having a first passage and a second passage that can regulate fluid flow in a first direction through the device and can regulate fluid flow in a second direction through the device, a first connector having an interior surface defining an internal lumen, a second connector coupled to an end of the first connector, and a flow path switching device received within the lumens of the first connector and the second connector.

Description

[Technical Field]

[0001] The present disclosure relates generally to blood collection and parenteral fluid administration to patients, and more particularly to systems and methods for inhibiting hemolysis in PIVC blood collection. [Background technology]

[0002] Catheters are commonly used for various intravenous therapies. Catheters can be used to infuse fluids into a patient, such as saline, various medications, and total parenteral nutrition. Catheters can also be used to withdraw blood from a patient.

[0003] A common type of catheter is the over-the-needle peripheral intravenous ("IV") catheter ("PIVC"). As the name suggests, an over-the-needle catheter may be fitted over an introducer needle with a sharp distal tip. The catheter assembly may include a catheter hub, a catheter extending distally from the catheter hub, and an introducer needle extending through the catheter. The catheter and introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle pointing up and away from the patient's skin. The catheter and introducer needle are generally inserted through the skin at a shallow angle into the patient's vasculature.

[0004] Clinicians typically confirm proper placement of the introducer needle and / or catheter within the vessel by checking for a "flashback" of blood within the catheter assembly's flashback chamber. Once needle placement is confirmed, the clinician can temporarily occlude flow through the vasculature and withdraw the needle, leaving the catheter in place for future blood draws or infusions.

[0005] A blood collection container can be used to collect a blood draw or blood specimen from a patient. The blood collection container can comprise a syringe. Alternatively, the blood collection container may comprise a test tube with a rubber stopper at one end. In some instances, the test tube has all or a portion of the air removed from it so that the pressure inside the tube is less than ambient pressure. Such blood collection containers are often referred to as internal vacuum or evacuated tubes. These are commonly used as internal vacuum or evacuated tubes. The blood collection container may be a VACUTAINER® blood collection tube available from Becton Dickinson & Company.

[0006] The blood collection container can be connected to the catheter. When the blood collection container is connected to the catheter, the pressure in the vein becomes greater than the pressure in the blood collection container, forcing blood into the blood collection container, thereby filling it. As the blood collection container fills, the vacuum in the blood collection container decreases and blood flow stops until the pressure in the blood collection container equals the pressure in the vein.

[0007] Unfortunately, when blood is drawn into the blood collection container, the large initial pressure difference between the vein and the blood collection container places red blood cells under high shear stress, making them susceptible to hemolysis. Hemolysis can result in the blood sample being discarded and wasted. The large initial pressure difference can also cause collapse of the catheter tip, collapse of the vein, or other complications that prevent or restrict blood from filling the blood collection container.

[0008] A statement presented in the Background Art section should not be assumed to be prior art merely because it is mentioned in or related to the Background Art section. The Background Art section may contain information that describes one or more aspects of the present technology. Summary of the Invention [Means for solving the problem]

[0009] The present disclosure provides devices and accessories that inhibit hemolysis, which can have features for restricting and regulating fluid flow therethrough. The present disclosure provides, in some instances, multi-purpose connectors with switchable flow channel devices that support uniform and effective flushing of the connector (based on application).

[0010] In some examples, the present disclosure provides flow restricting devices that can regulate fluid flow moving in one or more directions through the device, such as a first fluid flow moving in a direction away from the patient and a second fluid flow moving in a direction toward the patient.

[0011] In some embodiments, the present disclosure also provides a flow restriction device configured to direct fluid collected from a patient to travel through a first passageway and to direct fluid infused toward the patient to travel through either the first passageway or the second passageway.

[0012] The switchable flow channel device houses two pathways or flow paths, one for infusion and the other for withdrawal of blood from the patient. This flow path switch can be switched or rotated to align with the luer for a particular procedure, either for infusion or blood withdrawal. Furthermore, the axis around which the flow path switch device rotates is asymmetric, or off-center from the device. This asymmetric axis of rotation provides distinct advantages for each mode. The flow path used for the blood withdrawal mode has a smaller diameter to reduce hemolysis during blood withdrawal, while the flow path used for the infusion mode has a larger diameter to reduce the occurrence of occlusions during fluid infusion.

[0013] Embodiments of the present disclosure provide a fluid connector device comprising: a first connector; a second connector mating with the first connector to form an internal chamber; and a switchable flow channel device housed within the internal chamber, the switchable flow channel device having a distal end and a proximal end. In some embodiments, the switchable flow channel device comprises two flow channels fluidly connected to the first connector and the second connector, allowing fluid to flow in opposite directions through the switchable flow channel device. In some embodiments, the switchable flow channel device has two modes of use: an infusion mode and a blood draw mode. In some embodiments, the switchable flow channel device is manually rotated to switch between the infusion mode and the blood draw mode. In some embodiments, the fluid flowing from the first connector to the second connector is intravenous (IV) fluid. In some embodiments, the fluid flowing from the second connector to the first connector is blood. In some embodiments, the switchable flow channel device comprises a plurality of O-rings at the proximal and distal ends of the switchable flow channel device.

[0014] In some embodiments, the fluid connector device 1 further comprises alignment posts extending from the first connector and the second connector and forming an axis about which the switchable flow channel device can rotate. In some embodiments, the alignment posts are not aligned with the center of the fluid connector device. In some embodiments, the axis about which the switchable flow channel rotates is asymmetric or off-center from the fluid connector device. In some embodiments, the flow channel used in the blood withdrawal mode has a smaller diameter than the flow channel used in the infusion mode.

[0015] An embodiment of the present disclosure provides a blood collection system comprising a blood collection device and a fluid connector device fluidly connected to the blood collection device, the fluid connector device comprising a first connector, a second connector that combines with the first connector to form an internal chamber, and a switchable flow channel within the internal chamber, the switchable flow channel having a distal end and a proximal end.

[0016] An embodiment of the present disclosure provides a method of using a fluid connector device, comprising rotating a switchable flow channel device within the fluid connector device to switch between two use modes, the fluid connector device comprising a first connector and a second connector that combines with the first connector to form an internal chamber, the switchable flow channel device comprising two flow channels fluidly connected to the first connector and the second connector, allowing fluid to flow in opposing directions through the switchable flow channel device.

[0017] In some embodiments, the two modes of use are an infusion mode and a blood draw mode. In some embodiments, the fluid flowing from the first connector to the second connector is an intravenous (IV) fluid. In some embodiments, the fluid flowing from the second connector to the first connector is blood. In some embodiments, the switchable flow channel device comprises a plurality of O-rings at each of a proximal end and a distal end of the switchable flow channel device. In some embodiments, the infusion mode is a default mode of the fluid connector device. In some embodiments, an axis about which the switchable flow channel device rotates is spaced from a center of the fluid connector device. In some embodiments, the flow channel used for the blood draw mode has a smaller diameter than the flow channel used for the infusion mode. In some embodiments, when the O-ring is rotated and aligned into position within the fluid connector device in either the infusion mode or the blood draw mode, the device generates a tactile response that indicates to a user that the switchable flow channel device is ready for surgery.

[0018] It should be understood that other configurations of the present technology will be readily apparent to those skilled in the art from the following detailed description, wherein various configurations of the present technology are shown and described for purposes of illustration. The present technology is capable of other different configurations, as will be recognized, and its several details are capable of modification in various other respects, all without departing from the scope of the present technology. Accordingly, the drawings and detailed description should be regarded as illustrative in nature, and not as restrictive.

[0019] The following figures are included to illustrate certain aspects of the embodiments and should not be considered as exclusive examples. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in form and function that will occur to those skilled in the art having the benefit of this disclosure. [Brief explanation of the drawings]

[0020] [Figure 1A] 1 is a diagram of a vascular access device comprising a peripheral intravenous catheter (PIVC) assembly with a fluid connector device according to some embodiments of the present disclosure. [Figure 1B] FIG. 1B is an exploded perspective view of components of the fluid connector device of FIG. 1A according to some embodiments of the present disclosure. [Figure 2A] FIG. 1B is a perspective view of the fluid connector device of FIG. 1A in an infusion mode, according to some embodiments of the present disclosure. [Figure 2B] 2B is a cross-sectional view of the fluid connector device of FIG. 2A according to some embodiments of the present disclosure. [Figure 3] Figure 3(a) is a perspective view of the fluid connector device of Figure 2A rotated from an infusion mode to a blood withdrawal mode according to some embodiments of the present disclosure, and Figure 3(b) is a perspective view of the fluid connector device in a blood withdrawal mode according to some embodiments of the present disclosure. [Figure 3C] FIG. 4 is a cross-sectional view of the fluid connector device of FIG. 3(a) according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0021] The detailed description set forth below describes various configurations of the present technology and is not intended to represent the only configurations in which the technology may be practiced. The detailed description includes specific details to provide a thorough understanding of the technology. Thus, dimensions for particular embodiments may be provided as non-limiting examples. However, it will be apparent to those skilled in the art that the technology may be practiced without such specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the technology.

[0022] It should be understood that the present disclosure includes examples of the present technology and does not limit the scope of the appended claims. Various aspects of the present technology will now be disclosed according to certain non-limiting examples. The various embodiments described in this disclosure can be implemented in a variety of ways and variations, and according to a desired application or implementation.

[0023] Blood collection via vascular access devices has been gaining increasing attention due to its ability to minimize needlestick injuries and improve operational efficiency compared to traditional venipuncture blood collection. Current blood collection methods using peripheral intravenous catheters (PIVCs) present several challenges, one of the most important of which is blood quality, which is related to hemolysis. In particular, PIVC products currently on the market with standard connections (e.g., short extension sets and needleless connectors) and blood collection devices (e.g., blood collection tubes) tend to exert shear stress on blood cells, leading to near-hemolysis.

[0024] Various embodiments of the present disclosure provide systems and methods for addressing hemolysis in PIVC blood collection using a hemolysis prevention accessory (also referred to herein as a fluid connector device) that is pre-attached to the PIVC and functions as a flow restrictor to reduce the risk of hemolysis. The hemolysis prevention accessory is advantageous because it fits into the placement of the PIVC and does not require any changes to existing operations. The hemolysis prevention accessories of various embodiments described herein are potentially applicable to a wide variety of PIVC products and are compatible with existing blood collection devices and IV disposables.

[0025] Various embodiments of the present disclosure focus on effective flow restriction using an add-on hemolysis control accessory (also referred to herein as a fluid connector device) that regulates the overall flow rate of the entire fluid pathway through which blood cells pass. The fluid connector device can be assembled with or packaged with the PIVC. Therefore, there is no additional manipulation during catheter placement because the device has a vented lumen that allows for blood backflow. The clinician can connect a blood collection device to the accessory port and then draw blood up to the desired volume. After blood collection, the clinician can remove and discard the fluid connector device and blood collection device together. Therefore, the fluid connector device can be used for a single blood draw or remain in-line throughout the entire placement.

[0026] According to various embodiments of the present disclosure, a fluid connector device can include a distal connector configured to couple to a catheter assembly. The distal connector can include a proximal end with a first connecting portion and a distal end with a second connecting portion. The first connecting portion can include an inner surface defining a lumen therethrough, and the second connecting portion can include an inner surface defining a lumen therethrough. The distal connector can be in the form of a male luer connector or another suitable connector and can be coupled to a female luer portion of a needleless connector, which can be fluidly coupled to a catheter via extension tubing.

[0027] In some embodiments, the fluid connector device can further include a proximal connector coupled to the proximal end of the distal connector. The proximal connector can be configured to couple to a fluid collection device (e.g., a blood collection device). The proximal connector can be, for example, integral with the blood collection device or formed integrally with the blood collection device as a single unit. The proximal connector can, as another example, be in the form of a female luer connector or another suitable connector that can couple with a male luer portion of the blood collection device. The proximal connector can include a proximal end, a distal end, and an interior surface defining a lumen extending therethrough that couples with the male luer portion of the blood collection device.

[0028] According to various embodiments of the present disclosure, the fluid connector device can further include an insert (flow path switch) mounted within the lumen of the first connection portion and interposed between the proximal connector and the distal connector. The insert can have an outer surface, a proximal end, and a distal end, as shown. The insert can further include a plurality of flow channels extending longitudinally from the proximal end to the distal end of the insert and selectively fluidly connecting the lumen of the first connection portion of the distal connector with the lumen of the proximal connector. In some embodiments, the plurality of flow paths can include a first flow path, i.e., a blood withdrawal flow path, and a second flow path, i.e., an infusion flow path. In some embodiments, the plurality of flow paths can include three or four flow paths for selective infusion or withdrawal.

[0029] In some embodiments, the blood collection flow path can be in the form of a microchannel fluid passageway through which fluid (e.g., blood) flows from the distal connector to the proximal connector for collection in the fluid collection device. A blood collection flow path in the form of a microchannel through which fluid (e.g., blood) can flow from the distal connector to the proximal connector for collection in the fluid collection device can have a diameter ranging from 0.015 inches to 0.15 inches, in some instances from 0.02 inches to 0.1 inches, in other instances from 0.04 inches to 0.08 inches, and in other instances about 0.06 inches. Thus, during blood collection or withdrawal from a patient, blood can flow into the blood collection device through a microchannel defined in the blood flow channel having the smallest diameter. The fluid connector devices of various embodiments described herein offer advantages over existing blood collection systems. For example, during blood collection using existing blood collection devices, blood cells may experience wall shear stress as they flow from the distal end to the proximal end of the blood collection system. As previously discussed, wall shear stress on blood cells is believed to be a major cause of mechanical damage to blood cells, leading to hemolysis. Microchannels with minimal diameters defined within the blood collection channel can facilitate increased flow resistance within the vascular access system, dispersing pressure differentials and reducing the shear stress experienced by red blood cells. For example, a minimized diameter within the blood collection channel can increase resistance to blood flow, thereby reducing the blood flow rate within the flow connector device. A reduced blood flow rate is advantageous in that it reduces the shear stress experienced by red blood cells, potentially reducing the risk of hemolysis during blood collection.

[0030] When the medical fluid is blood drawn or collected from a patient, the medical fluid may be a blood specimen and the fluid collection device may be a blood collection device, hi some embodiments, the blood collection device may be a luer lock access device (LLAD).

[0031] FIG. 1A illustrates a vascular access device comprising a peripheral intravenous catheter (PIVC) assembly including a fluid connector device according to some embodiments of the present disclosure. The fluid connector device can be configured to reduce the likelihood of hemolysis during blood collection using the vascular access device. In some embodiments, the vascular access device can comprise a catheter assembly (e.g., a PIVC). In some embodiments, the fluid connector device can comprise a distal end and can comprise a body or distal connector configured to couple to the catheter assembly. The distal connector can include a male luer connector or another suitable connector. In some embodiments, the catheter assembly can comprise a catheter hub and can include a distal end, a proximal end, and a lumen extending through the distal and proximal ends. The catheter assembly can further comprise a catheter that can be secured within the catheter hub and extend distally from the distal end of the catheter hub. In some embodiments, the catheter can be a peripheral intravenous catheter (PIVC).

[0032] FIG. 1A illustrates a collection system 10 according to some embodiments of the present disclosure. The collection system 10 is designed to collect fluid (e.g., blood) from a patient. The collection system 10 may therefore be referred to as a blood collection system. The collection system 10 may take the form of a vascular access device including a PIVC assembly. The collection system 10, as illustrated, includes a catheter assembly 20. In some embodiments, the catheter assembly 20 may include or correspond to any suitable catheter assembly. In some embodiments, the catheter assembly 20 may be integrated with an extension tube that extends from a side port of the catheter hub and may be integrated with the side port. A non-limiting example of an integrated catheter assembly is the BD NEXIVA™ Closed IV Catheter system available from Becton Dickinson and Company. In some embodiments, the proximal end of the extension tube may be coupled to an adapter, such as a Y adapter or a single-port Luer adapter.

[0033] The collection system 10 may also include a connector 30 that connects to the catheter assembly 20. The collection system 10 further includes a collector 40 for collecting fluid (e.g., blood) from the patient. The collector 40 may be referred to as a blood collector when the collected fluid is blood from the patient.

[0034] Collection system 10, according to some aspects of the present disclosure, further comprises a fluid connector device 100. Fluid connector device 100 can be configured to reduce the likelihood of hemolysis during blood collection using collection system 10. In some embodiments, fluid connector device 100 comprises a distal end, which can comprise a body or distal connector configured to couple to catheter assembly 20 via connector 30. Connector 30 can include a male Luer 103 connector or another suitable connector.

[0035] In some embodiments, the distal connector of the fluid connector device 100 may be configured to couple to a Y-adapter of the catheter assembly 20 without the use of connector 30. In some embodiments, the catheter assembly 20 may not be integrated and may not include an extension tube. In these and other embodiments, the fluid connector device 100 may be configured to couple to the proximal end of a catheter hub or another suitable portion of the catheter assembly. In some embodiments, the catheter assembly 20 may be coupled to a removable extension tube. In some embodiments, the fluid connector device 100 may be coupled directly to a catheter adapter, eliminating the need for an extension tube and providing a compact catheter system.

[0036] 1B illustrates an exploded view of the fluid connector device 100 shown in FIG. 1A, according to some embodiments of the present disclosure. The fluid connector device 100 can include a female luer 101 at the proximal end, a switchable flow channel (flow path switch device) 102, and a male luer 103 at the distal end. The flow path switch device may be modified depending on the application of the fluid connector device, providing a uniform flow path and supporting effective flushing to reduce the risk of hemolysis.

[0037] The flow switch device 102 can have multiple modes of operation. Referring to FIGS. 2B and 3C, the flow switch can accommodate two pathways or flow paths. In some embodiments, one flow path can be used for infusion of medication (indicated by arrow A) and the other flow path is for blood withdrawal (indicated by arrow B). The flow switch can be switched or rotated to align the luers for a particular procedure, whether it is an infusion or blood withdrawal procedure. The axis X about which the flow switch device rotates is asymmetric, off-center, or spaced apart from the center of the device 102, as shown in FIG. 3C. In some embodiments, the axis of rotation is centered on alignment posts 105 on both the female luer 101 and the male luer 103. The alignment posts 105 form the axis about which the flow switch device can rotate. The alignment posts 105 are not at the center of the fluid connector device, as shown in FIG. 3C. In other embodiments, alignment posts may be present on the flow switch device. In some embodiments, the alignment posts may extend through the fluid connector device. This asymmetric axis of rotation X provides different advantages for each mode: the fluid channels used in the blood draw mode are smaller in diameter to reduce hemolysis during blood draw, and the fluid channels used in the infusion mode are larger in diameter to prevent or limit the occurrence of occlusions when infusing fluids.

[0038] The initially aligned flow path is the infusion path. Whenever a blood draw procedure is required, the flow path switch can be rotated to align with the blood draw path. In drug infusion mode (arrow A), the infusion flow path is connected to the male luer 103 and the female luer 101. The diameter of this infusion flow path is larger than the blood draw flow path. In blood draw mode (arrow B), the blood draw flow path is connected to the male luer 103 and the female luer 101. The diameter of this blood draw flow path can be optimized for high quality blood draw.

[0039] In some embodiments, the fluid path switch device 102 may be labeled to assist a user in switching fluid paths for the appropriate procedure. As shown in FIGS. 3A-3B, the fluid path switch device 102 may be labeled "Infusion" to indicate that the drug infusion flow channel (arrow A) is open, or may be labeled "Blood Draw" to indicate that the blood draw flow channel (arrow B) is open. During surgery, a medical professional or other user can switch the fluid connector device 100 from the infusion mode shown in FIGS. 2A and 2B to the blood draw mode shown in FIGS. 3B and 3C by simply rotating the insert shown in FIG. 3A (switching fluid paths).

[0040] The flow path switch device 102 can include a plurality of rings 104 attached to the proximal and distal ends of the flow path switch device to prevent leakage of the flow channels. In some embodiments, the rings 104 are O-rings.

[0041] The fluid connector device further has a tactile response configured to provide tactile feedback to a user of the fluid connector device when the O-ring on the fluid connector device 102 is aligned within the fluid connector device 100. When the O-ring 104 is rotated into position in either the infusion mode or the blood draw mode, the device generates a tactile response that indicates to the user that the fluid connector device is in place and ready for surgery.

[0042] The fluid connector devices and associated blood collection systems of various embodiments described herein further provide additional advantages over currently existing blood collection systems. For example, the retrofit fluid connector devices described herein enable the integration of hemolysis control features for PIVC blood collection. The fluid connector devices described herein further conform to the placement of the PIVC, allowing for seamless blood collection upon insertion. In some embodiments, the fluid connector devices have the potential to remain in-line throughout PIVC placement for multiple blood collections. Furthermore, because the fluid connector devices are retrofittable, they can be easily integrated into existing PIVCs without modification, minimizing impact to clinical practice and surgery.

[0043] The optimized fluid passage, also referred to herein as a first fluid passage, flow path, or microchannel, can be configured to provide flow restriction that inhibits hemolysis and can have features including, but not limited to, a tubular fluid passage, a cannula, a lumen, a continuous nonlinear flow path, a groove, a fluid flow path, etc.

[0044] The fluid pathway can have a length selected based on one or more of a particular catheter gauge, a particular catheter assembly configuration, or a clinical setting. In some embodiments, the optimized fluid pathway can have a length L from the female luer adapter 101 to the male luer adapter 103. In some embodiments, the optimized fluid pathway can have an inner diameter D.

[0045] Fluid flow through a tubular fluid passage can be analyzed using Poiseuille's equation.

number

number

number

number

[0046] In some embodiments, the optimized fluid pathway can include multiple sections having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), where the geometric factor is:

number

number

[0047] Optimized fluid path G f The value of G may be selected to reduce the maximum shear stress per catheter gauge to less than or equal to the maximum shear stress of the BD21G VACUTAINER® UltraTouch™ push-button blood collection set, previously considered the gold standard for blood collection. In some embodiments, the optimized fluid path G fThe value of may be selected to reduce the maximum shear stress per catheter gauge to be equal to or less than the maximum shear stress of the BD25G VACUTAINER® UltraTouch™ push button blood collection set.

[0048] In some embodiments, the optimized fluid passageway can have a diameter of, by way of non-limiting example, about 0.356 mm (0.014 inches). The cross-sectional area of ​​the optimized fluid passageway, by way of another non-limiting example, is about 0.098064 square mm (0.000152 square inches).

[0049] In some embodiments, the infusion flow path can define a flow path having a larger diameter than the blood draw flow path, through which fluid (e.g., infusion or intravenous (IV) fluid) flows from the proximal connector to the distal connector, delivering the infusion fluid to the catheter through the extension tubing. In some embodiments, the second flow path, i.e., the infusion flow path, can have a larger diameter than the diameter of the microchannels of the blood draw flow path. For example, in some embodiments, the second flow path, i.e., the infusion flow path, can have a diameter approximately four or five times the size of the diameter of the microchannels of the blood draw flow path. The aforementioned configuration, in which the diameter of the infusion flow path is larger than the diameter of the blood draw flow path, can be advantageous in that it further allows for a greater amount of infusion fluid to flow unrestrictedly to the patient compared to the smaller (minimized) diameter of the blood draw flow path. Thus, the infusion fluid can flow in a second unrestricted (less flow resistance) direction (from proximal to distal) opposite to the first direction (from distal to proximal) in which the blood sample with blood cells flows.

[0050] The fluid connector devices and associated blood collection systems of various embodiments described herein further provide additional advantages over existing blood collection systems. For example, the retrofit fluid connector devices described herein enable the integration of hemolysis control features for PIVC blood collection. The fluid connector devices described herein further conform to the placement of the PIVC, allowing for seamless blood collection upon insertion. The fluid connector devices further have the potential to remain in-line throughout PIVC placement for multiple blood collections. Furthermore, because the fluid connector devices are retrofittable, they can be easily integrated into existing PIVCs without modification, minimizing impact to clinical practice and surgery.

[0051] In some embodiments, the catheter assembly may include or correspond to any suitable catheter assembly. In some embodiments, the catheter assembly may be integrated and include an extension tube extending from the side port 59 of the catheter hub and may be integrated with the side port 59. A non-limiting example of an integrated catheter assembly is the BD NEXIVA™ Closed IV Catheter System, available from Becton Dickinson and Company. In some embodiments, the proximal end of the extension tube may be coupled to an adapter, such as a Y adapter or a single-port Luer adapter. In some embodiments, the distal connector of the fluid connector device may be configured to couple to a Y adapter.

[0052] In some embodiments, the catheter assembly may not be integrated and may not include an extension tube. In these and other embodiments, the fluid connector device may be configured to couple to the proximal end of the catheter hub or another suitable portion of the catheter assembly. In some embodiments, the catheter assembly may be coupled to a removable extension tube. In some embodiments, the fluid connector device may be coupled directly to the catheter adapter, eliminating the need for an extension tube and enabling a compact catheter system.

[0053] In some embodiments, the male luer 103 and the female luer 101 may be joined together by ultrasonic welding. In a fully assembled flow connector device, the flow path switch device is housed within the male and female luers.

[0054] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure presents various examples of the technology, and the technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects.

[0055] Examples of this technology as clauses Clause 1 A fluid connector device comprising: a first connector; a second connector that mates with the first connector to form an internal chamber; and a switchable flow channel device having a distal end and a proximal end that is housed within the internal chamber.

[0056] Clause 2 10. The fluidic connector device of claim 1, wherein the switchable flow channel device comprises two flow channels fluidly connected to a first connector and a second connector, allowing fluids to flow in opposing directions through the switchable flow channel device.

[0057] Clause 3 1. A fluid connector device according to claim 1, wherein the switchable flow channel device has two modes of use: an infusion mode and a blood withdrawal mode.

[0058] Clause 4 The switchable flow channel device is manually rotated to switch between infusion mode and blood withdrawal mode.

[0059] Clause 5 10. The fluid connector device of claim 1, wherein the fluid flowing from the first connector to the second connector is an intravenous (IV) fluid.

[0060] Clause 6 The fluid connector device of clause 1, wherein the fluid flowing from the second connector to the first connector is blood.

[0061] Clause 7 10. The fluid connector device of clause 1, wherein the switchable flow channel device comprises a plurality of O-rings at a proximal end and a distal end of the switchable flow channel device.

[0062] Article 8 10. The fluid connector device of clause 1, further comprising an alignment post extending from the first connector and the second connector and forming an axis about which the switchable flow channel device can rotate.

[0063] Article 9 Clause 8. A fluid connector device in which the alignment post is not aligned to the center of the fluid connector device.

[0064] Article 10 9. The fluidic connector device of clause 8, wherein the axis about which the switchable flow channel rotates is asymmetric or off-center from the fluidic connector device.

[0065] Article 11 Section 3. Fluidic Connector Device, where the flow channel used for blood draw mode is smaller in diameter than the flow channel used for infusion mode.

[0066] Article 12 A blood collection system comprising a blood collection device and a fluid connector device fluidly connected to the blood collection device, the fluid connector device comprising a first connector, a second connector that combines with the first connector to form an internal chamber, and a switchable flow channel within the internal chamber, the switchable flow channel having a distal end and a proximal end.

[0067] Article 13 A method of using a fluid connector device, the method including the step of rotating a switchable flow channel device within the fluid connector device to switch between two use modes, the fluid connector device having a first connector and a second connector that combines with the first connector to form an internal chamber, the switchable flow channel device having two flow channels fluidly connected to the first connector and the second connector, allowing fluid to flow in opposing directions through the switchable flow channel device.

[0068] Article 14 14. The method of clause 13, wherein the two modes of use are an infusion mode and a blood collection mode.

[0069] Article 15 14. The method of clause 13, wherein the fluid flowing from the first connector to the second connector is an intravenous (IV) fluid.

[0070] Article 16 14. The method of clause 13, wherein the fluid flowing from the second connector to the first connector is blood.

[0071] Article 17 14. The method of clause 13, wherein the switchable flow channel device comprises a plurality of O-rings at each of a proximal end and a distal end of the switchable flow channel device.

[0072] Article 18 15. The method of clause 14, wherein the infusion mode is a default mode of the fluid connector device.

[0073] Article 19 14. The method of clause 13, wherein an axis about which the switchable flow channel device rotates is spaced from a center of the fluidic connector device.

[0074] Article 20 14. The method of clause 13, wherein the flow channel used for the blood draw mode has a smaller diameter than the flow channel used for the infusion mode.

[0075] Article 21 18. The method of clause 17, wherein when the O-ring is rotated and aligned into position within the fluid connector device in either an infusion mode or a blood draw mode, the device generates a tactile response indicating to the user that the switchable flow channel device is ready for surgery.

[0076] Reference to an element in the singular is intended to mean "one or more" rather than "one and only one" unless specifically so stated. The term "some" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and are not intended to limit the invention.

[0077] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0078] As used herein, the phrase "at least one" preceding a list of items, with the term "or" separating any of the items, modifies the list as a whole, not each member of the list. The phrase "at least one" does not require the selection of at least one item; rather, the phrase can mean including at least one of any one of the items, at least one of any combination of the items, and / or at least one of each of the items. Illustratively, the phrase "at least one of A, B, or C" can refer to A only, B only, or C only, or any combination of A, B, and C.

[0079] The use of a phrase such as "aspect" does not imply that such aspect is essential to the technology or that such aspect applies to all configurations of the technology. The disclosure of one aspect may apply to all configurations, or to one or more configurations. One aspect may provide one or more examples. A phrase such as "aspect" may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such embodiment is essential to the technology or that such embodiment applies to all configurations of the technology. The disclosure of one embodiment may apply to all embodiments, or to one or more examples. One embodiment may provide one or more examples. Such an embodiment phrase may refer to one or more embodiments, and vice versa. The use of a phrase such as "configuration" does not imply that such embodiment is essential to the technology or that such embodiment applies to all configurations of the technology. The disclosure of one configuration may apply to all configurations, or to one or more configurations. One configuration may provide one or more examples. The phrase "such a configuration" may refer to one or more configurations, and vice versa.

[0080] In one aspect, unless otherwise specified, all measurements, values, ratings, locations, dimensions, sizes, and other specifications set forth in this specification, including those in the following claims, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and that which is customary in the art to which they pertain.

[0081] It is understood that the specific order or hierarchy of steps or operations in the disclosed processes or methods represents example approaches. It is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged based on implementation preferences or scenarios. Some of the steps, operations, or processes may be performed simultaneously. Certain operations may or may not be performed, depending on implementation preferences or scenarios. Some or all of the steps, operations, or processes may be performed automatically without user intervention. The accompanying method claims present the various steps, operations, or process elements in an example order, and are not intended to be limited to the specific order or hierarchy presented.

[0082] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known, or that later become known, to those of ordinary skill in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Furthermore, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is expressly recited in the claims. No claimed element is to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for." Furthermore, to the extent the terms "comprise," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprises" is construed when "comprises" is used as a transitional term in the claims.

[0083] The "Title," "Background," "Summary," "Brief Description of the Drawings," and "Abstract" of this disclosure are hereby incorporated into this disclosure and are presented as illustrative examples of the disclosure, not as a limiting description. They are presented with the understanding that they will not be used to limit the scope or meaning of the claims. Additionally, in the "Summary," it will be understood that the description presents exemplary illustrations, and that various features, in various embodiments, have been grouped together to streamline the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the "Summary," with each claim standing on its own as separately claimed subject matter.

[0084] The claims are not intended to be limited to the embodiments described herein, but are intended to be accorded full scope consistent with the claim language and encompass all legal equivalents. Nevertheless, none of the claims are intended, and should not be interpreted, to encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. a first connector; a second connector that mates with the first connector to form an interior chamber; a switchable flow channel device housed within the internal chamber, the switchable flow channel device having a distal end and a proximal end; A fluid connector device comprising:

2. 2. The fluid connector device of claim 1, wherein the switchable flow channel device comprises two flow channels fluidly connected to the first connector and the second connector, allowing fluid to flow in opposite directions through the switchable flow channel device.

3. 10. The fluid connector device of claim 1, wherein the switchable flow channel device has two modes of use: an infusion mode and a blood withdrawal mode.

4. 4. The fluid connector device of claim 3, wherein the switchable flow channel device is manually rotated to switch between the infusion mode and the blood withdrawal mode.

5. 10. The fluid connector device of claim 1, wherein the fluid flowing from the first connector to the second connector is an intravenous (IV) fluid.

6. 10. The fluid connector device of claim 1, wherein the fluid flowing from the second connector to the first connector is blood.

7. 10. The fluid connector device of claim 1, wherein the switchable flow channel device comprises a plurality of O-rings at the proximal and distal ends of the switchable flow channel device.

8. 10. The fluid connector device of claim 1, further comprising alignment posts extending from said first connector and said second connector and forming an axis about which said switchable flow channel device can rotate.

9. The fluid connector device of claim 8 , wherein the alignment post is not aligned with the center of the fluid connector device.

10. 9. The fluid connector device of claim 8, wherein the axis about which the switchable flow channel rotates is asymmetric or off-center from the fluid connector device.

11. 4. The fluid connector device of claim 3, wherein the flow channel used in the blood draw mode is smaller in diameter than the flow channel used in the infusion mode.

12. a blood collection device; a fluid connector device fluidly connected to the blood collection device; 1. A blood collection system comprising: a first connector; a second connector that mates with the first connector to form an interior chamber; a switchable flow channel within the interior chamber, the switchable flow channel having a distal end and a proximal end; A blood collection system comprising:

13. 1. A method of using a fluid connector device, said method comprising: rotating a switchable flow channel device within said fluid connector device to switch between two modes of use. wherein the fluid connector device comprises: a first connector; a second connector that mates with the first connector to form an internal chamber; and wherein the switchable flow channel device comprises two flow channels fluidly connected to the first connector and the second connector, allowing fluid to flow in opposite directions through the switchable flow channel device.

14. 14. The method of claim 13, wherein the two modes of use are an infusion mode and a blood draw mode.

15. 14. The method of claim 13, wherein the fluid flowing from the first connector to the second connector is an intravenous (IV) fluid.

16. The method of claim 13 , wherein the fluid flowing from the second connector to the first connector is blood.

17. The method of claim 13 , wherein the switchable flow channel device comprises a plurality of O-rings at each of a proximal end and a distal end of the switchable flow channel device.

18. The method of claim 14, wherein the infusion mode is a default mode of the fluid connector device.

19. The method of claim 13 , wherein the axis about which the switchable flow channel device rotates is spaced from the center of the fluid connector device.

20. 14. The method of claim 13, wherein the flow channel used in the blood withdrawal mode has a smaller diameter than the flow channel used in the infusion mode.

21. 18. The method of claim 17, wherein when the O-ring is rotated and aligned into a predetermined position within the fluid connector device in either the infusion mode or the blood draw mode, the device generates a tactile response that indicates to a user that the switchable flow channel device is ready for surgery.

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