Fluid connector device and blood collection system

Abstract

The utility model relates to a fluid connector device and a blood collection system. The fluid connector device may have passages for regulating movement of a fluid passing therethrough, including a flow restricting device having first and second passages, the flow restricting device may regulate fluid flow in a first direction through the device, and may regulate fluid flow in a second direction through the device, the fluid flow restricting device may include a first connector having an interior surface defining an inner lumen, a second connector coupled to an end of the first connector, and a channel switching device contained within the lumen of the first connector and the second connector.

Description

Technical Field

[0001] The present disclosure relates generally to blood drawing and administration of parenteral fluids to a patient, and more particularly to fluid connector devices and blood collection systems. Background Art

[0002] Catheters are commonly used for various infusion therapies. For example, catheters can be used to infuse fluids, such as saline solutions, various medications, and total parenteral nutrition, into a patient. Catheters can also be used to draw blood from a patient.

[0003] One common type of catheter is an over-the-needle peripheral intravenous ("IV") catheter (PIVC). As the name implies, an over-the-needle catheter can be mounted over an introducer needle having a sharp distal tip. The catheter assembly can include a catheter hub, from which the catheter extends distally, and through which the introducer needle extends. The catheter and introducer needle can 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 upward away from the patient's skin. The catheter and introducer needle are typically inserted through the skin at a shallow angle into the patient's vasculature.

[0004] To verify the correct placement of the introducer needle and / or catheter in the blood vessel, the clinician typically confirms the presence of "flashback" of blood in the flashback chamber of the catheter assembly. Once the placement of the needle is confirmed, the clinician can temporarily occlude the flow in the vasculature and remove the needle, leaving the catheter in place for future blood draws or fluid infusions.

[0005] In order to draw blood from a patient or collect a blood sample, a blood collection container may be used. The blood collection container may include a syringe. Alternatively, the blood collection container may include a test tube with a rubber stopper at one end. In some cases, the test tube has all or part of the air removed from the test tube so that the pressure inside the test tube is lower than ambient pressure. Such blood collection containers are often referred to as internal vacuum devices or vacuum tubes. Often used as internal vacuum devices or vacuum tubes. The blood collection container may also be a 10-150 mm, ... Blood collection tube.

[0006] The blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is higher than the pressure in the blood collection container, which pushes blood into the blood collection container, thereby filling the blood collection container with blood. The vacuum within the blood collection container decreases as the blood collection container fills until the pressure in the blood collection container equals the pressure in the vein and the flow of blood stops.

[0007] Unfortunately, when blood is drawn into the blood collection container, the red blood cells are under high shear stress and are susceptible to hemolysis due to the high initial pressure differential between the vein and the blood collection container. Hemolysis may result in the rejection and discarding of the blood sample. The high initial pressure differential may also result in collapse of the catheter tip, collapse of the vein, or other complications that prevent or limit blood from filling the blood collection container.

[0008] The description provided in the background section should not be admitted to be prior art merely because it is mentioned in or related to the background section.The background section may include information describing one or more aspects of the subject technology. Utility Model Content

[0009] The present disclosure provides devices and accessories for reducing hemolysis, which may include features for limiting and regulating fluid flow therethrough. In some cases, the present disclosure provides a multi-purpose connector with a switchable flow channel device (based on the application) that is uniform and supports effective flushing of the connector.

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

[0011] In some embodiments, the present disclosure further provides a flow restriction device configured to guide fluid extracted from the patient to move through the first passage and guide fluid infused toward the patient to move through any one of the first passage and the second passage.

[0012] The switchable flow channel device includes two paths or flow lines, one for infusion and the other for blood extraction from a patient. The channel switch can be switched or rotated for a specific procedure to align with the Luer piece in the infusion or blood extraction procedure. In addition, the axis about which the channel switch device rotates is asymmetric, or offset from the center of the device. This asymmetric axis of rotation provides different advantages for each mode. The channel diameter for the blood extraction mode is smaller to reduce hemolysis during blood extraction, and the channel diameter for the infusion mode is larger to reduce clogging during fluid infusion.

[0013] Embodiments of the present disclosure provide a fluid connector device, which includes a first connector, a second connector combined with the first connector to form an internal chamber, and a switchable flow channel device having a distal end and a proximal end contained in the internal chamber. In some embodiments, the switchable flow channel device includes two flow channels, which are fluidically connected to the first connector and the second connector to allow fluid to flow through the switchable flow channel device in opposite directions. In some embodiments, the switchable flow channel device has two modes of use, namely an infusion mode and a blood extraction mode. In some embodiments, the switchable flow channel device is manually rotated to switch between the infusion mode and the blood extraction mode. In some embodiments, the fluid flowing from the first connector to the second connector is an intravenous injection (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 includes a plurality of O-rings located on the proximal end and the distal end of the switchable flow channel device.

[0014] In some embodiments, the fluid connector device 1 further includes an alignment post extending from the first connector and the second connector, the alignment post providing an axis around which the switchable flow channel device can rotate. In some embodiments, the alignment post is not aligned with the center of the fluid connector device. In some embodiments, the axis (on which the switchable flow channel rotates) is asymmetric or offset from the center of the fluid connector device. In some embodiments, the flow channel for the blood extraction mode is smaller in diameter than the flow channel for the infusion mode.

[0015] An embodiment of the present disclosure provides a blood collection system, which includes a blood collection device and a fluid connector device fluidly connected to the blood collection device, the fluid connector device including a first connector, a second connector combined with the first connector to form an internal chamber, and a switchable flow channel having a distal end and a proximal end located in the internal chamber.

[0016] It should be understood that from the following detailed description, those skilled in the art will easily understand other configurations of the subject technology, wherein the various configurations of the subject technology are shown and described by way of illustration. As will be appreciated, the subject technology can have other and different configurations and its several details can be modified in various other aspects, all without departing from the scope of the subject technology. Therefore, the drawings and detailed description are considered to be illustrative rather than restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The following drawings are included to illustrate certain aspects of the embodiments and should not be considered as exclusive embodiments. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure.

[0018] Figure 1A A vascular access device including a peripheral intravenous catheter (PIVC) assembly including a fluid connector device is shown according to some embodiments of the present disclosure.

[0019] Figure 1B Some embodiments of the present disclosure are shown Figure 1A A perspective exploded view of the components of a fluid connector device.

[0020] Figure 2A FIG. 1 shows an infusion mode according to some embodiments of the present disclosure. Figure 1A A perspective view of a fluid connector device.

[0021] Figure 2B Some embodiments of the present disclosure are shown Figure 2A A cross-sectional view of a fluid connector device.

[0022] Figure 3A FIG. 1 shows a rotation from an infusion mode toward a blood extraction mode according to some embodiments of the present disclosure. Figure 2A A perspective view of a fluid connector device.

[0023] Figure 3B A perspective view of a fluid connector device in a blood withdrawal mode is shown according to some embodiments of the present disclosure.

[0024] Figure 3C Some embodiments of the present disclosure are shown Figure 3A A cross-sectional view of a fluid connector device. DETAILED DESCRIPTION

[0025] The detailed description set forth below describes various configurations of the subject technology, and is not intended to represent the only configuration that can practice the subject technology. The specific implementation includes specific details for the purpose of providing a thorough understanding of the subject technology. Therefore, dimensions can be provided as non-limiting examples with respect to certain aspects. However, it is clear to those skilled in the art that the subject technology can be implemented without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid blurring the concept of the subject technology.

[0026] It should be understood that the present disclosure includes examples of subject technology and does not limit the scope of the appended claims. The following will illustrate various aspects of the subject technology according to specific but non-limiting examples. The various embodiments described in this disclosure can be implemented in different ways and variations and according to the intended application and implementation.

[0027] Compared with the traditional method of blood extraction using venipuncture, blood extraction via vascular access devices has received increasing attention due to the minimization of needle insertion and the improvement of surgical efficiency. Currently, there are some challenges in using peripheral intravenous catheters (PIVC) for blood extraction, one of the most critical challenges is blood quality related to hemolysis. In particular, for the PIVC products currently available on the market, together with standard connectors (such as short extension kits and needleless connectors) and blood collection devices (such as vacuum blood collection tubes), the shear stress applied to blood cells is often on the verge of hemolysis.

[0028] Various embodiments of the present disclosure are intended to provide a system for addressing hemolysis in PIVC blood draws with a hemolysis reducing accessory (also referred to herein as a fluid connector device) that is pre-attached to the PIVC and acts as a flow restrictor to reduce the risk of hemolysis. The hemolysis reducing accessory is advantageously compatible with PIVC placement and does not require any changes to existing operations. The hemolysis reducing 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 disposable infusion items.

[0029] Various embodiments of the present disclosure focus on effective flow restriction utilizing an additional hemolysis reducing accessory (also referred to herein as a fluid connector device) that adjusts the total flow rate of the entire fluid path as blood cells pass through. The fluid connector device can be assembled with the PIVC, or can be packaged together with the PIVC. Therefore, there are no additional operations during catheter placement because the device has a ventilation lumen that enables blood to flow back. The clinician can connect a blood collection device to the port of the accessory, and can then draw blood to the desired volume. After the blood is drawn, the clinician can disconnect the fluid connector device and discard it together with the blood collection device. Therefore, the fluid connector device can be used for a single blood draw or can remain in series throughout the indwelling period.

[0030] According to various embodiments of the present disclosure, a fluid connector device may include a distal connector configured to be coupled to a catheter assembly. The distal connector may have a proximal end including a first connection portion and a distal end including a second connection portion. The first connection portion may have an internal surface defining a lumen passing therethrough, and the second connection portion may have an internal surface defining a lumen passing therethrough. The distal connector may be in the form of a male Luer connector or another suitable connector, which may be coupled to a female Luer portion of a needleless connector, which may be coupled to a catheter fluidly via an extension tubing.

[0031] In some embodiments, the fluid connector device may further include a proximal connector coupled to the proximal end of the distal connector. The proximal connector may be configured to be coupled to a fluid collection device (e.g., a blood collection device). For example, the proximal connector may be integrated with the blood collection device, or may be integrally formed with the blood collection device as a single unit. As another example, the proximal connector may be in the form of a female Luer connector or another suitable connector that can be coupled to the male Luer portion of the blood collection device. The proximal connector may have a proximal end, a distal end, and an interior surface that defines a lumen extending therethrough for coupling to the male Luer portion of the blood collection device.

[0032] According to various embodiments of the present disclosure, the fluid connector device may further include an insert (channel switching member), which is installed in the lumen of the first connecting part and between the proximal connector and the distal connector. As shown in the figure, the insert may have an outer surface, a proximal end and a distal end. The insert may further include a plurality of flow channels extending longitudinally from the proximal end of the insert to the distal end, for selectively connecting the lumen of the first connecting part of the distal connector to the lumen of the proximal connector fluidically. In some embodiments, the plurality of channels may include a first or blood extraction channel and a second or infusion channel. In some embodiments, the plurality of channels may include three or four channels for selective infusion or extraction.

[0033] In some embodiments, the blood extraction channel can be in the form of a microchannel fluid passage through which a fluid (e.g., blood) flows from a distal connector to a proximal connector for collection in a fluid collection device. The diameter of the blood extraction channel in the form of a microchannel can be in the range of 0.015 inches to 0.15 inches, in some cases 0.02 inches to 0.1 inches, in other cases 0.04 inches to 0.08 inches, and in other cases about 0.06 inches, along which a fluid (e.g., blood) can flow from a distal connector to a proximal connector for collection in a fluid collection device. Thus, during blood collection or extraction from a patient, blood can flow into a blood collection device via a microchannel defined in a blood flow channel having a minimum diameter. The fluid connector devices of various embodiments described herein are superior to currently available blood collection systems. For example, during blood extraction with a currently available blood extraction device, blood cells may be subjected to wall shear stress as they flow from the distal end to the proximal end of a blood collection system. As described above, wall shear stress on blood cells is considered to be the main source of mechanical damage to blood cells, resulting in hemolysis of blood cells. Microchannels defined in a blood extraction channel with a minimum diameter can help increase the flow resistance within the vascular access system to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood. For example, the minimum diameter of the blood extraction channel can increase the resistance to blood flow and thus reduce the blood flow rate within the flow connector device. Since the reduced blood flow rate causes the shear stress experienced by the red blood cells in the blood to be reduced, the risk of hemolysis during blood collection can be advantageously reduced.

[0034] In the case where the medical fluid is blood drawn or collected from a patient, the medical fluid may be a blood sample and the fluid collection device may be a blood collection device. In some embodiments, the blood collection device may be a Luer Lock Access Device (LLAD).

[0035] Figure 1AA vascular access device including a peripheral intravenous catheter (PIVC) assembly according to some embodiments of the present disclosure is shown, and the assembly includes a fluid connector device. The fluid connector device can be configured to reduce the possibility of hemolysis during blood collection using the vascular access device. In some embodiments, the vascular access device can include a catheter assembly (e.g., PIVC). In some embodiments, the fluid connector device can include a distal end, which can include a body or a distal connector configured to be connected to the catheter assembly. The distal connector can include a male Luer connector or another suitable connector. In some embodiments, the catheter assembly can include a catheter hub, which can include a distal end, a proximal end, and a lumen extending through the distal end and the proximal end. The catheter assembly can further include a catheter, which can be fixed in the catheter hub and can extend distally from the distal end of the catheter hub. In some embodiments, the catheter can be a peripheral intravenous catheter (PIVC).

[0036] Figure 1A A collection system 10 according to some aspects of the present disclosure is shown. The collection system 10 is designed to collect fluid (e.g., blood) from a patient. Therefore, the collection system 10 can be referred to as a blood collection system. The collection system 10 can take the form of a vascular access device having a PIVC component. As shown, the collection system 10 includes a catheter assembly 20. In some embodiments, the catheter assembly 20 can include or correspond to any suitable catheter assembly. In some embodiments, the catheter assembly 20 can be integrated with and include an extension tube that can extend from and be integrated with a side port of a catheter hub. A non-limiting example of an integrated catheter assembly is the BD NEXIVA TM A closed IV catheter system, which is available from Becton Dickinson & Company. In some embodiments, the proximal end of the extension tube can be coupled to an adapter, such as, for example, a Y-adapter or a single-port Luer adapter.

[0037] In addition, the collection system 10 may include a connector 30 connected to the catheter assembly 20. In order to collect fluid (such as blood) from the patient, the collection system 10 further includes a collector 40. When the collected fluid is blood from the patient, the collector 40 may be referred to as a blood collector.

[0038] In addition, according to some aspects of the present disclosure, the collection system 10 includes a fluid connector device 100. The fluid connector device 100 can be configured to reduce the possibility of hemolysis during blood collection using the collection system 10. In some embodiments, the fluid connector device 100 can include a distal end, which can include a body or distal connector that is configured to be coupled to the catheter assembly 20 via a connector 30. The connector 30 can include a male Luer connector 103 or another suitable connector.

[0039] In certain embodiments, the distal connector of fluid connector device 100 can be configured to be coupled to the Y-shaped adapter of catheter assembly 20 without using connector 30. In certain embodiments, catheter assembly 20 can be non-integrated and can not include extension tube. In these and other embodiments, fluid connector device 100 can be configured to be coupled to the proximal end of catheter hub or another appropriate part of catheter assembly. In certain embodiments, catheter assembly 20 can be coupled to removable extension tube. In certain embodiments, fluid connector device 100 can be directly coupled to catheter adapter, thereby eliminating extension tube and providing compact catheter system.

[0040] According to some aspects of the present disclosure, Figure 1B Shows Figure 1A Exploded view of a fluid connector device 100 shown in FIG. The fluid connector device 100 may include a female Luer 101 on a proximal end, a switchable flow channel (channel switching device) 102, and a male Luer 103 on a distal end. The channel switching device may be varied based on the application of the fluid connector device and have a uniform channel, which supports effective flushing and reduces the risk of hemolysis.

[0041] The channel switching device 102 can have multiple operation modes. Figure 2B and Figure 3C , the channel switch can contain two paths or flow lines. In some embodiments, one flow line can be used for drug infusion (as shown by arrow A) and the other flow line can be used for blood extraction (as shown by arrow B). The channel switch can be switched or rotated to align with the Luer piece for a specific procedure, whether it is an infusion or blood extraction procedure. Figure 3C As shown, the axis X on which the channel switch device rotates is asymmetric, eccentric, or spaced from the center of the device 102. In some embodiments, the axis of rotation is centered on the alignment posts 105 on the female Luer 101 and male Luer 103. The alignment posts 105 provide an axis about which the channel switch device can rotate. Figure 3CAs shown, the alignment post 105 is not located at the center of the fluid connector device. In other embodiments, the alignment post can be located on the channel switching device. In some embodiments, the alignment post can extend through the fluid connector device. This asymmetric rotation axis X provides different advantages for each mode. The channel diameter for the blood extraction mode is smaller to reduce hemolysis during blood extraction, and the channel diameter for the infusion mode is larger to prevent or limit clogging events during fluid infusion.

[0042] The default aligned channel is the infusion line. Whenever a blood extraction procedure is required, the channel switch can be rotated and aligned with the blood extraction channel. In the drug infusion mode (arrow A), the infusion flow path is connected to the male Luer piece 103 and the female Luer piece 101. The diameter of the infusion flow path is higher than the diameter of the blood extraction flow path. In the blood extraction mode (arrow B), the blood extraction flow path is connected to the male Luer piece 103 and the female Luer piece 101. The diameter of the blood extraction flow path can be optimized for high-quality blood extraction.

[0043] In some embodiments, the channel switching device 102 may be marked to help the user switch channels to perform the correct procedure. Figure 3A-3B As shown, the channel switching device 102 may be labeled "infusion" to indicate that the drug infusion flow channel (arrow A) is open, or the channel switching device 102 may be labeled "blood extraction" to indicate that the blood extraction flow channel (arrow B) is open. In operation, medical personnel or other users can simply rotate the Figure 3A The insert (switching channel) shown in FIG. Figure 2A and Figure 2B The infusion mode shown switches to Figure 3B and Figure 3C Blood draw pattern shown.

[0044] To prevent leakage in the flow channel, the channel switching device 102 may include a plurality of rings 104 mounted to the channel switching device on the proximal and distal ends of the channel switching device. In some embodiments, the rings 104 are O-rings.

[0045] The fluid connector device further includes a tactile response configured to provide tactile feedback to a user of the fluid connector device when the O-ring on the channel switch device 102 is aligned in the fluid connector device 100. When the O-ring 104 is rotated into position, whether in the infusion mode or the blood withdrawal mode, the device will provide a tactile response to indicate to the user that the channel switch device is in place and ready for operation.

[0046] The fluid connector devices and associated blood collection systems of the various embodiments described herein provide additional advantages over currently existing blood collection systems. For example, the additional fluid connector devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood draws. Furthermore, the fluid connector devices described herein are compatible with PIVC placement and allow for seamless blood draws upon insertion. In some embodiments, for multiple blood draws, the fluid connector device has the potential to remain in series throughout the PIVC indwelling period. Furthermore, because the fluid connector device is an additional device, it can be easily incorporated without requiring any changes to the existing PIVC, thereby having minimal impact on clinical setup and operation.

[0047] The optimized fluid pathway (also referred to herein as a first fluid pathway or flow path or microchannel) can be configured to provide a restricted flow rate for reducing hemolysis and can have features including but not limited to tubular fluid pathways, cannulas, lumens, continuous non-linear channels, grooves, fluid channels, etc.

[0048] The length of the fluid pathway can be selected based on one or more of the following factors: the specifications of a particular catheter, the configuration of a particular catheter assembly, or the clinical setting. In some embodiments, the optimized fluid pathway can include a length L from the female Luer adapter 101 to the male Luer adapter 103. In some embodiments, the optimized fluid pathway can include an inner diameter D.

[0049] The flow of fluid in a tubular fluid path can be analyzed using the Poiseuille equation:

[0050]

[0051] where ΔP is the change in pressure gradient across the length of the fluid path, D and L are the inner diameter and length of the fluid path, respectively, and Since μ is the viscosity of the fluid and not part of the extended tube geometry, the geometry factor G f Defined as R f (Fluid resistance) is in

[0052] In some embodiments, the optimized fluid path may have multiple segments with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), then the geometric factor is:

[0053]

[0054] In some embodiments, the optimized fluid passage may have a cross-section with a non-circular or complex inner diameter profile. The geometric factor can be determined by measuring the flow rate (Q) of a fluid of known viscosity (μ) at a given pressure (ΔP):

[0055]

[0056] G of optimized fluid path can be selected f value to reduce the maximum shear stress of each catheter size to be equal to or less than BD 21G UltraTouch TM The maximum shear stress of a push-button blood collection kit, which was previously considered the gold standard for blood draws. In some embodiments, the G of the optimized fluid path can be selected. f value to reduce the maximum shear stress of each catheter size to be equal to or less than BD 25G UltraTouch TM Maximum shear stress of a push-button blood collection kit.

[0057] In some embodiments, and by way of non-limiting example, the optimized fluid passageway may have a diameter of approximately 0.014 inches. In another non-limiting example, the cross-sectional area of ​​the optimized fluid passageway is approximately 0.000152 square inches.

[0058] In some embodiments, the infusion channel can define a channel having a larger diameter than the blood extraction channel, through which a fluid (e.g., an infusion or intravenous (IV) fluid) flows from the proximal connector to the distal connector for delivering the infusion fluid to the catheter via the extension tubing. In some embodiments, the diameter of the second or infusion channel can be larger than the diameter of the microchannel of the blood extraction channel. For example, in some embodiments, the diameter of the second or infusion channel can be approximately 4 or 5 times the diameter of the microchannel of the blood extraction channel. The above configuration of the infusion channel having a larger diameter than the diameter of the blood extraction channel as compared to the smaller (minimized) diameter of the blood extraction channel can be advantageous in further allowing an unrestricted and increased amount of infusion fluid to flow to the patient. 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 having blood cells flows.

[0059] The fluid connector devices and associated blood collection systems of the various embodiments described herein provide additional advantages over currently existing blood collection systems. For example, the additional fluid connector devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood draws. Furthermore, the fluid connector devices described herein are compatible with PIVC placement and allow for seamless blood draws upon insertion. Furthermore, for multiple blood draws, the fluid connector devices have the potential to remain in series throughout the PIVC indwelling period. Furthermore, because the fluid connector device is an additional device, it can be easily incorporated without requiring any changes to the existing PIVC, thereby having minimal impact on clinical setup and operation.

[0060] In some embodiments, the catheter assembly can include or correspond to any suitable catheter assembly. In some embodiments, the catheter assembly can be integrated and include an extension tube that can extend from and be integrated with the side port 59 of the catheter hub. A non-limiting example of an integrated catheter assembly is the BD NEXIVA TM A closed IV catheter system, which can be obtained from Becton Dickinson & Company. In some embodiments, the proximal end of the extension tube can be coupled to an adapter, such as a Y-shaped adapter or a single-port Luer adapter. In some embodiments, the distal connector of the fluid connector device can be configured to be coupled to a Y-shaped adapter.

[0061] In certain embodiments, catheter assembly can be non-integrated and can not include extension tube.In these and other embodiments, fluid connector device can be configured to be connected to the proximal end of catheter hub or another appropriate part of catheter assembly.In certain embodiments, catheter assembly can be connected to removable extension tube.In certain embodiments, fluid connector device can be directly connected to catheter adapter, thereby eliminate extension tube and provide compact catheter system.

[0062] In some embodiments, the male Luer 103 and the female Luer 101 can be joined together by ultrasonic welding. In a fully assembled flow connector device, the channel switching device is contained in the male Luer and the female Luer.

[0063] The present disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Multiple modifications to these aspects are very clear to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0064] Description of this subject technology

[0065] Item 1: A fluid connector device comprising: a first connector; a second connector that is combined with the first connector to form an internal chamber; and a switchable flow channel device having a distal end and a proximal end contained within the internal chamber.

[0066] Clause 2: A fluid connector device according to clause 1, wherein the switchable flow channel device includes two flow channels, which are fluidly connected to the first connector and the second connector to allow fluid to flow through the switchable flow channel device in opposite directions.

[0067] Clause 3: The fluid connector device of clause 1, wherein the switchable flow channel device has two usage modes, namely, an infusion mode and a blood extraction mode.

[0068] Clause 4: The fluid connector device of clause 3, wherein the switchable flow channel device is manually rotated to switch between an infusion mode and a blood extraction mode.

[0069] Clause 5: The fluid connector device of clause 1, wherein the fluid flowing from the first connector to the second connector is intravenous (IV) fluid.

[0070] Clause 6: The fluid connector device of clause 1, wherein the fluid flowing from the second connector to the first connector is blood.

[0071] Clause 7: The fluid connector device of clause 1, wherein the switchable flow channel device comprises a plurality of O-rings at the proximal end and the distal end of the switchable flow channel device.

[0072] Clause 8: The fluid connector device of clause 1, further comprising an alignment post extending from the first connector and the second connector, the alignment post providing an axis about which the switchable flow channel device can rotate.

[0073] Clause 9: The fluid connector device of clause 8, wherein the alignment post is not aligned with a center of the fluid connector device.

[0074] Clause 10: The fluid connector device of clause 8, wherein the axis (about which the switchable flow channel rotates) is asymmetric, or offset from the center of the fluid connector device.

[0075] Clause 11. The fluid connector device of Clause 3, wherein a diameter of the flow channel for the blood withdrawal mode is smaller than a diameter of the flow channel for the infusion mode.

[0076] Item 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 combined with the first connector to form an internal chamber; and a switchable flow channel having a distal end and a proximal end located in the internal chamber.

[0077] Unless otherwise specified, reference to an element in the singular is not intended to mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter genders (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the disclosure.

[0078] 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, the various alternative configurations and operations described herein may be considered to be at least equivalent.

[0079] As used herein, the phrase "at least one" preceding a list of items (with the term "or" separating any items) modifies the list as a whole rather than each individual member of the list. The phrase "at least one" does not require selection of at least one of the items; rather, the phrase allows for a meaning that includes at least one of any one item, and / or at least one of any combination of items, and / or at least one of each item. For example, the phrase "at least one of A, B, or C" may mean: only A, only B, or only C; or any combination of A, B, and C.

[0080] Phrases such as "aspects" do not mean that such aspects are essential to the subject technology, or that such aspects apply to all configurations of the subject technology. The disclosure associated with an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. Phrases such as "an aspect" may refer to one or more aspects, and vice versa. Phrases such as "embodiments" do not mean that such embodiments are essential to the subject technology, or that such embodiments apply to all configurations of the subject technology. The disclosure associated with an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "an embodiment" may refer to one or more embodiments, and vice versa. Phrases such as "constructions" do not mean that such constructions are essential to the subject technology, or that such constructions apply to all configurations of the subject technology. The disclosure associated with a construction may apply to all configurations or one or more constructions. A construction may provide one or more examples. Phrases such constructions may refer to one or more constructions, and vice versa.

[0081] In one aspect, unless otherwise indicated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications in this specification, including those set forth in the claims that follow, are approximate and not exact. In one aspect, they are intended to have a reasonable range consistent with the functions to which they are related and with the customary practices in the art to which they belong.

[0082] It should be understood that the specific order or hierarchy of steps or operations in the disclosed process is an illustration of an exemplary method. Based on implementation preferences or scenarios, it should be understood that the specific order or hierarchy of steps, operations or processes can be rearranged. Some steps, operations or processes can be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations or processes can be performed automatically without user intervention.

[0083] All structural and functional equivalents of the elements of the various aspects described throughout the present disclosure are known or will be known to those of ordinary skill in the art, and are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, regardless of whether such disclosure is explicitly recited in the claims, the content disclosed herein is not intended to be committed to the public. No claim element can be interpreted according to the provisions of 35 U.S.C. § 112 (f) unless the element is explicitly stated using the phrase "means for..." In addition, for the scope of the terms "including", "having", etc. used, such terms are intended to refer to inclusiveness in a manner similar to the term "including", as explained when "including" is used as a transitional word in the claims.

[0084] The title, background technology, utility model content, description of the drawings and abstract of the present disclosure are incorporated into the present disclosure and are provided as illustrative examples of the present disclosure, rather than restrictive descriptions. Submitting this application is based on such an understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the specific implementation, it can be seen that the description provides illustrative examples, and in order to simplify the present disclosure, various features are combined together in various embodiments. The claims below are therefore incorporated into the detailed description, and each claim is independently a subject matter claimed separately.

[0085] The claims are not intended to be limited to the aspects described herein but are to be accorded the full scope consistent with the language of the claims and including all legal equivalents. Nevertheless, all claims are not intended to include subject matter that fails to satisfy the requirements of 35 U.S.C. §101, 102, or 103 and should not be interpreted in such a manner.

Claims

1. A fluid connector device, characterized in that: It includes: a first connector; a second connector that combines with the first connector to form an internal chamber; as well as A switchable flow channel device has a distal end and a proximal end and is contained within the interior chamber.

2. The fluid connector device according to claim 1, characterized in that: The switchable flow channel arrangement includes two flow channels fluidly connected to a first connector and a second connector to allow fluid to flow through the switchable flow channel arrangement in opposite directions.

3. The fluid connector device according to claim 1, characterized in that: The switchable flow channel device has two usage modes, namely, an infusion mode and a blood extraction mode.

4. The fluid connector device according to claim 3, characterized in that: The switchable flow channel device is manually rotated to switch between an infusion mode and a blood withdrawal mode.

5. The fluid connector device according to claim 1, characterized in that: The fluid flowing from the first connector to the second connector is an intravenous fluid.

6. The fluid connector device according to claim 1, characterized in that: The fluid flowing from the second connector to the first connector is blood.

7. The fluid connector device according to claim 1, characterized in that: The switchable flow channel device includes a plurality of O-rings at a proximal end and a distal end of the switchable flow channel device.

8. The fluid connector device according to claim 1, characterized in that: It further includes an alignment post extending from the first connector and the second connector, the alignment post providing an axis about which the switchable flow channel device can rotate.

9. The fluid connector device according to claim 8, characterized in that: The alignment post is not aligned with the center of the fluid connector device.

10. The fluid connector device according to claim 8, characterized in that: The axis about which the switchable flow channel rotates is asymmetric, or offset from the center of the fluid connector device.

11. The fluid connector device according to claim 3, characterized in that: The flow channel for the blood withdrawal mode is smaller in diameter than the flow channel for the infusion mode.

12. A blood collection system, characterized in that: It includes: Blood collection devices; as well as A fluid connector device fluidly coupled to a 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 has a distal end and a proximal end and is located in the interior chamber.

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