Fluid access devices and fluid access system

Abstract

The fluid access device includes a machine-side hydraulic circuit and a patient-side hydraulic circuit, and can be configured between a connected state and at least one disconnected state. In the connected state, fluid flows between the machine-side hydraulic circuit and the patient-side hydraulic circuit. In the disconnected state, fluid does not flow between the machine-side hydraulic circuit and the patient-side hydraulic circuit. In some disconnected states, fluid is recirculated through at least one of the machine-side hydraulic circuit or the patient-side hydraulic circuit.

Description

Prior Technology

[0001] Needle-based fluid access devices (e.g., grafts / fistulas) require specialized skills, and cannulation is painful and unsuitable for needle-phobic individuals. Grafts / fistulas may fail over time, causing other health complications and are prone to displacement and bleeding. An alternative is a permanent central venous catheter (CVC); however, these require excessive expertise and strict adherence to aseptic techniques. CVC connection requires numerous manual tasks, leading to human error and an increased risk of infection. The inadequacies of these access methods are exacerbated when used for treatments requiring multiple and / or frequent connections throughout the day. Therefore, there is an urgent need for a specially designed fluid interface for use between a catheter and a machine to achieve safe and reliable connection / disconnection and manage blood flow in a safe and convenient manner. Simple Explanation of the Diagram

[0002] When considered in conjunction with the accompanying drawings and appendices, the aforementioned state of the claimed object and its many accompanying advantages will become more readily apparent by referring to the following [implementation], wherein:

[0003] Figure 1 shows a perspective view of a hemodialysis system connected to a fluid access device of the present invention.

[0004] Figure 2A shows a perspective view of one of the fluid access devices of the present invention.

[0005] Figure 2B shows a partial exploded perspective view of the fluid access device in Figure 2A.

[0006] Figure 3 shows a schematic top view of a portion of one of the fluid access devices of the present invention.

[0007] Figure 4A shows a first perspective view of one of the fluid access devices of the present invention.

[0008] Figure 4B shows a second perspective view of one of the fluid access devices in Figure 4A.

[0009] Figure 4C shows a third perspective view of one of the fluid access devices of Figure 4A in a disconnected state.

[0010] Figure 4D shows a fourth perspective view of one part of the fluid access device in Figure 4A.

[0011] Figure 5A shows a perspective view of a base of a fluid access device according to the present invention in a first state.

[0012] Figure 5B shows a perspective view of the base of one of the fluid access devices in Figure 5A in a second state.

[0013] Figure 6A shows a schematic top view of a portion of one of the fluid access devices of the present invention in a connected state.

[0014] Figure 6B shows a schematic top view of a portion of the fluid access device of Figure 6A in a short-term disconnected state.

[0015] Figure 6C shows a schematic top view of a portion of the fluid access device of Figure 6A in a long-term disconnected state.

[0016] Figures 7A to 7H illustrate a representative method for decoupling a machine-side hydraulic circuit of one fluid access device of the present invention from a patient-side hydraulic circuit.

[0017] Figure 8 illustrates one step in a representative method of coupling the machine-side hydraulic circuit of the fluid access device of Figures 7A to 7H to one of its patient-side hydraulic circuits.

[0018] Figures 9A to 12 show perspective views and schematic diagrams of another fluid access device according to the present invention.

[0019] Figure 13A shows a schematic cross-sectional view of a fluid access device in a disconnected state according to the present invention.

[0020] Figure 13B shows a schematic cross-sectional view of one of the fluid access devices of Figure 13A in a connected state.

[0021] Figure 14A shows a schematic top view of a fluid access device in a disconnected state according to the present invention.

[0022] Figure 14B shows a schematic top view of one of the fluid access devices of Figure 14A in a connected state.

[0023] Figure 15A shows a schematic top view of a fluid access device in a disconnected state according to the present invention.

[0024] Figure 15B shows a schematic top view of one of the fluid access devices of Figure 15A in a connected state.

[0025] Figure 16 shows a schematic top view of a manifold of a fluid access device according to one of the present invention.

[0026] Figure 17 shows a schematic top view of a recirculation bridge of a fluid access device according to the present invention.

[0027] Figure 18 shows a schematic top view of another recirculation bridge of a fluid access device according to one of the present invention.

[0028] Figure 19A shows a top view of a fluid access device having an electronic module according to the present invention.

[0029] Figure 19B shows a schematic cross-sectional view of one of the electronic modules according to the present invention.

[0030] Figure 19C shows a schematic cross-sectional view of another electronic module according to the present invention.

[0031] Figure 20 shows a schematic top view of one of the fluid connection schemes between a fluid access device and a patient blood access device.

[0032] Figure 21 shows a schematic top view of a blood sampling device, one of the fluid access devices according to the present invention.

[0033] Figures 22A to 22C show schematic diagrams of a disengagement mechanism of a fluid access device according to the present invention.

[0034] Figures 23A and 23B show schematic diagrams of another disengagement mechanism of a fluid access device according to the present invention.

[0035] Figures 24A to 24F show schematic diagrams of another disengagement mechanism of a fluid access device according to one of the present invention.

[0036] Figures 25A and 25B show schematic diagrams of an in-cavity valve in a fluid access device according to the present invention.

[0037] Figures 26A to 26C show schematic diagrams of another in-cavity valve of a fluid access device according to one of the present invention.

[0038] Figures 27A and 27B show schematic diagrams of another in-cavity valve of a fluid access device according to one of the present invention.

[0039] Figures 28A and 28B show schematic diagrams of another in-cavity valve of a fluid access device according to one of the present invention.

[0040] Figures 29A to 29C show representative cross-sections of the fluid access lines of a fluid access device according to one of the present invention.

[0041] Figures 30A and 30B show additional representative cross-sections of the fluid access line of a fluid access device according to one of the present invention.

[0042] Figures 31A to 31C show schematic cross-sectional views of a representative leak detection and blocking system of a fluid access device according to the present invention.

[0043] Figure 32 shows a schematic cross-sectional view of another representative leak detection and blocking system of a fluid access device according to the present invention.

[0044] Figures 33A and 33B show schematic cross-sectional views of a representative pathogen detection system of a fluid access device according to one of the present invention.

[0045] Figure 34 illustrates a method using any blood retrieval device according to the present invention.

[0046] Figure 35 illustrates another method using any blood retrieval device according to the present invention. Implementation

[0047] Cross-reference to related applications This application claims the rights of U.S. Provisional Patent Application No. 63 / 282,912, filed November 24, 2021, and U.S. Provisional Patent Application No. 63 / 165,099, filed March 23, 2021, pursuant to 35 USC § 119, the full disclosure of which is hereby incorporated by reference.

[0048] This invention provides a fluid access device for medical device applications and a method of using the same. Although generally described in the background description of a blood access device for hemodialysis applications for the purpose of facilitating understanding, the disclosed device is not limited to dialysis applications or blood access devices, and can be used in many other medical fluid access applications, such as blood cell separation, blood transfusion, continuous sensing of patient condition, and other procedures.

[0049] Compared to known devices and methods, the fluid access device of the present invention reduces the number of human contact points required to connect a patient's fluids to a machine by using best practices of automation, and reduces the risk of infection and improves the patient's experience by integrating many functions to achieve fast, hygienic and repeatable fluid connections.

[0050] Figure 1 illustrates a fluid access device 100 according to one embodiment of the present invention, coupled to a hemodialysis system 102 configured to dialyze the blood of a patient. The hemodialysis system 102 may be a single-pass dialysis system, a recirculation dialysis system, or other system designed for removing urea and uremic toxins from the bloodstream of a patient. Therefore, the hemodialysis system 102 is fluidly coupled to a fluid access line 104 that supplies the patient's blood to a dialysis unit of the hemodialysis system 102 and returns filtered (dialyzed) blood to the patient. In the illustrated embodiment, the patient-side fluid access line 104 and the machine-side fluid access line 106 are multi-lumen catheters having at least two lumens. However, in some embodiments, the fluid access device 100 is connected to a plurality of single-line fluid access lines. In the illustrated embodiment, the fluid access line 104 is fluidly coupled to the hemodialysis system 102 via an optional disconnection mechanism 108 that disconnects the fluid access line 104 from the hemodialysis system 102 upon experiencing at least a critical tension. Representative disconnection mechanisms are described below with respect to Figures 22A to 24B. In some embodiments, the fluid access line 104 includes one or more connectors disposed on the machine side of one of the fluid access devices 100. These connectors may be configured to be aligned with the blood lumen of the fluid access line 104 or disposed on an auxiliary fluid line to enable fluid connection to a third-party tubing assembly.

[0051] In other embodiments, the disengagement mechanism 108 is positioned along one of the fluid access lines (e.g., along the patient-side fluid access line 104 near a catheter location entering the patient's body). In some embodiments, the disengagement device includes a fragile element that disconnects the connection along one of the fluid access lines, for example, in response to a tension or compressive force exceeding a certain threshold.

[0052] Fluid access device 100 is an assembly arranged in a straight line with fluid access line 104, operable to selectively connect and disconnect a patient-side fluid access line 104 with a machine-side fluid access line 106. Specifically, fluid access device 100 establishes a selective and reversible fluid connection between the patient-side fluid access line 104 and the machine-side fluid access line 106. Broadly speaking, fluid access device 100 includes a patient-side hydraulic circuit 110 and a machine-side hydraulic circuit 112, described in detail below. In any of the embodiments described herein, the fluid access device may (but does not need to) include all or part of the fluid access line, for example, a disposable segment thereof.

[0053] To provide greater mobility and quality of life for a patient, the fluid access device 100 can be configured between a connected state and at least one disconnected state. In the connected state, a fluid connection is maintained between the machine-side hydraulic circuit and the patient-side hydraulic circuit, allowing fluid to flow freely between the patient-side fluid access line 104 and the machine-side fluid access line 106. For example, during dialysis, undialyzed blood flows from the patient-side hydraulic circuit to the machine-side hydraulic circuit (to a hemodialysis system), and dialyzed blood flows from the machine-side hydraulic circuit to the patient-side hydraulic circuit. In the disconnected state, no fluid connection exists between the machine-side hydraulic circuit and the patient-side hydraulic circuit. Potential disconnected states include at least a short-term disconnected state and a long-term disconnected state. For example, a short-term disconnected state is suitable when a patient needs to be quickly disconnected from the hemodialysis system 102 and plans to reconnect to the hemodialysis system 102 within a relatively short timeframe (e.g., 1 to 2 hours). As described below, in a short-term disconnection state, fluid can be recirculated back and forth through the patient side of the fluid access device 100; depending on the situation, fluid is recirculated through the machine side of the fluid access device 100. Advantageously, allowing the patient's blood to be recirculated through one or both of the hydraulic circuits reduces the risk of thrombosis and improves patient autonomy (by eliminating the need for a clinician to sterilize and lock the device). The short-term disconnection state is also advantageous because it does not require a complete "rinseback" of the patient's blood within the machine tubing. Because blood rinsing involves saline, it adds fluid to the patient, which is contrary to the purpose of dialysis.

[0054] A long-term disconnect state is suitable for situations where a patient needs to be disconnected from the hemodialysis system 102 for an extended period (e.g., between dialysis sessions). In the long-term disconnect state, both the patient side and the machine side of the fluid access device 100 are sealed, and no fluid is recirculated on the machine side (e.g., after backflushing the blood with saline). In some embodiments, fluid is recirculated on the patient side to reduce thrombus formation and fibrosis. In some embodiments, one of the fluid access devices is preset to a no-power / error state to prevent fluid flow.

[0055] Figures 2A and 2B show high-resolution perspective views of a fluid access device 200 having the features of the fluid access device 100 of Figure 1 according to the present invention. Specifically, the fluid access device 200 includes a machine-side hydraulic circuit 202 and a patient-side hydraulic circuit 204 respectively connected to a machine-side fluid access line 206 and a patient-side fluid access line 208. The machine-side hydraulic circuit 202 and the patient-side hydraulic circuit 204 are housed in a plurality of housings 210a to 210c formed of a medical-grade polymer (e.g., polypropylene) or other rigid and reusable material. The machine-side fluid access line 206 includes a conductive power line integrated therein, which is configured to draw AC or DC power from a connected machine (e.g., a hemodialysis system) to power the fluid access device 200.

[0056] The following description, with reference to Figures 29A to 30B, depicts representative cross-sections of the machine-side fluid access line 206 and the patient-side fluid access line 208. To facilitate use with multiple patients, in some embodiments, the machine-side hydraulic circuit 202 is at least partially disposable. In some embodiments, the machine-side fluid access line 206 also includes one or more communication lines for supporting data communication and / or power transmission between the machine and the patient-side hydraulic circuits 202, 204, as described below.

[0057] Figure 2A shows the fluid access device 200 in a connected state, while Figure 2B shows the fluid access device 200 in a disconnected state. As is evident from comparing Figures 2A and 2B, the machine-side hydraulic circuit 202 can be reversibly connected to the patient-side hydraulic circuit 204 at a fluid interface 212. The machine-side hydraulic circuit 202 includes a first disconnect mechanism 214 (such as a button or latch) and / or the patient-side hydraulic circuit 204 includes a second disconnect mechanism 216, which operate to initiate a method of disconnecting the machine-side hydraulic circuit 202 from the patient-side hydraulic circuit 204 (described below). Thus, according to a particular method of the invention, a user initiates a disconnect sequence by pressing one or both of the disconnect mechanisms. In some embodiments, the disconnect mechanisms are presented on a user interface (e.g., a screen) disposed on the fluid access device 200 and / or on a user interface disposed on a mobile device (e.g., a smartphone) programmed with an application controlling the fluid access device 200.

[0058] In some embodiments, disconnection mechanisms 214, 216 include an indicator, such as an LED and / or an audible audible sound. The indicator communicates to the user one or more of the following states: when the fluid access device 200 is changing state (e.g., a flashing red light); when it is safe to disconnect the machine-side hydraulic circuit 202 from the patient-side hydraulic circuit 204 (e.g., a flashing green light); when fluid is traveling through the fluid access device 200 (e.g., a continuous green light); or an error condition (e.g., a continuous red light, haptic feedback, and the like). These states and signals are representative and not limiting.

[0059] In some embodiments, an application 218 is provided for the fluid access device 200 to facilitate a user's operation and understanding of the execution of the device 200 and to communicate with a clinician and / or device manufacturer. The application 218 includes a plurality of modules implemented as software logic (e.g., executable software code), firmware logic, hardware logic, or various combinations thereof configured to be stored in the fluid access device or mobile device 220 (e.g., a smartphone and / or a smartwatch) and configured to be executed by a processor of the fluid access device 200 and / or mobile device 220.

[0060] In some embodiments, application 218 includes a monitoring module that receives a signal from an onboard control circuit of fluid access device 200 indicating a state of fluid access device 200 (e.g., connected, short-term disconnect, long-term disconnect, system in dialysis) and displays a message corresponding to the received signal. In some embodiments, the monitoring module enables bidirectional communication with fluid access device 200. For example, a user inputs a command (e.g., start disconnect sequence, start connection sequence, etc.) on an interface of mobile device 220, and application 218 sends a signal to fluid access device 200 based on the input (e.g., execute disconnect sequence). In some embodiments, application 218 includes a sensing module that uses mobile device 220 to sense one or more biometric parameters (e.g., blood pressure) and then transmits a signal to fluid access device 200 based on the sensed parameters, which causes fluid access device 200 to execute a sequence (e.g., start disconnect sequence). In some embodiments, application 218 displays a dashboard containing information related to the operation of device 200, including, for example, device status (connected / disconnected), one or more parameters sensed by the device (e.g., blood pressure, flow rate), and any relevant alerts (e.g., pathogen detection alerts). In other embodiments, application 218 provides an interface to initiate communication with a clinician and / or device manufacturer. The foregoing functionality is representative and not limiting.

[0061] Figure 3 illustrates the components of a representative fluid access device 300. As described above, the fluid access device 300 generally comprises a machine-side hydraulic circuit 302 and a patient-side hydraulic circuit 304, which are selectively fluid-coupled to each other at a fluid interface 306 and respectively housed in protective housings 308a and 308b.

[0062] The machine-side hydraulic circuit 302 is mounted on a base 310 (e.g., a rigid frame, platform, enclosure, or the like) for secure connection to one of the patient-side hydraulic circuits 304. The base 310 provides a stable common platform to which the hydraulic circuits are attached in the connected state and to which specific components (such as sensors, pumps, and locking mechanisms) are housed. However, some embodiments do not include a base, and in these embodiments, the hydraulic circuits contain all subsystems and are directly coupled and locked to each other in the connected state. A machine-side input lumen 312 and a machine-side output lumen 314 are lumens configured to be parallel to the fluid connected to the previously described machine-side fluid access lines. In use, fluid enters and exits the machine-side hydraulic circuit 302 via the machine-side input lumen 312 and the machine-side output lumen 314, respectively. An optional machine-side recirculation lumen 316 bridges the machine-side input lumen 312 and the machine-side output lumen 314. The machine-side hydraulic circuit 302 can be selectively secured to the base 310 via a lock 318 (e.g., an electromechanical, magnetic, or pneumatic locking latch or the like). In embodiments without a base, the lock(s) may be directly mounted on the hydraulic circuit, allowing the hydraulic circuits to be directly locked to each other. While electromechanical locks, valves, and other features are generally described herein, the fluid access device of the present invention is not limited to electromechanical features. In any embodiment, one or more discrete features (e.g., locks and valves) may be magnetic or pneumatic, i.e., operated under the prime power of a pressurized air source or vacuum source coupled to the fluid access device. For example, some embodiments include direct pneumatic devices (actuated by vacuum or positive pressure) configured to lock the hydraulic circuits together (directly or via the base) and / or for advancing / retracting needles, sleeves, or other fluid elements. Representative examples of such devices and components for supplying air to the fluid access device are described below.

[0063] To achieve selective control of the machine-side hydraulic circuit 302, a plurality of valves 320a to 320c are disposed in the machine-side hydraulic circuit 302. Specifically, the first valve 320a, the second valve 320b, and the third valve 320c are each configured to selectively open and close the machine-side input cavity 312 (downstream of the machine-side recirculation cavity 316), the machine-side recirculation cavity 316, and the machine-side output cavity 314 (upstream of the machine-side recirculation cavity 316), respectively. Representative and non-limiting valves include push / pull plunger valves, pinch / squeeze valves, and any of the in-cavity valves described below with respect to Figures 25A to 28B, actuated via an electromechanical valve actuator (e.g., a pin) disposed in the base 310. Any valve described herein may be an electromechanical valve, a pneumatic valve, a chemical valve, or other valve type. In some embodiments, one or more valves of the fluid access device are in-lumen valves of any type described herein, which advantageously reduce the size of the fluid access device and can prevent leakage in the event of damage to the external portion of the conduit and / or the fluid access device.

[0064] The machine-side hydraulic circuit 302 includes a selected solution hydraulic circuit (e.g., for lock solutions such as heparin, saline solution, sodium citrate, or the like) that is fluidly integrated with the machine-side input lumen 312 and the machine-side output lumen 314. In any embodiment described herein, the solution hydraulic circuit may be integrated via a manifold and one or more passive valves as described below with respect to FIG16. The solution hydraulic circuit includes, for example, a solution supply lumen 322 and a waste lumen 324, which may be configured to remove liquids and / or gases from the hydraulic circuit(s) and direct the waste to a drain or a separate waste reservoir, as discussed below. Advantageously, the solution hydraulic circuit enables, for example, selective flushing, priming, and sterilization of the machine-side hydraulic circuit 302 and the patient-side hydraulic circuit 304 before disconnecting the machine-side hydraulic circuit 302 from the patient-side hydraulic circuit 304. Some embodiments of the solution hydraulic circuit include a first circuit or fluid line for a locating solution (e.g., heparin and sodium citrate), a second circuit for a second solution (such as brine), and an optional third circuit for waste. These fluid lines may be fluidly parallel to each other, and in some embodiments, may be fluidly connected to a manifold located between a machine-side input lumen 312 and a machine-side output lumen 314.

[0065] In any of the embodiments herein, a waste reservoir may be fluid-coupled to receive waste, including saline, locomotor solution, biofluid, or other fluids. In some embodiments, the waste reservoir is integrated into a fluid access line coupled to a fluid access device (e.g., a disposable tubing assembly). In other embodiments, the waste reservoir is housed within a hemodialysis system. In other embodiments, the waste reservoir is housed together with a control unit between the fluid access device and the hemodialysis system, or is an external fluid supply module configured to provide the fluid(e) to the fluid access device 300 and / or receive the fluid(e) from the fluid access device 300.

[0066] Similar to the machine-side hydraulic circuit 302, the patient-side hydraulic circuit 304 is selectively secured to the base 310 by a lock 326. A patient-side input lumen 328 and a patient-side output lumen 330 are configured to be parallel to the fluid connected to the previously described patient-side fluid access lines. In use, fluid enters and exits the patient-side hydraulic circuit 304 via the patient-side input lumen 328 and the patient-side output lumen 330, respectively. A patient-side recirculation lumen 332 bridges the patient-side input lumen 328 and the patient-side output lumen 330.

[0067] Multiple pumps move fluid (e.g., blood) between the hemodialysis system and the patient. In the representative embodiment shown, a first pump 334a is positioned in line with the patient-side output lumen 330, and a second pump 334b ​​is positioned in line with the patient-side input lumen 328. Both pumps 334a to 334b ​​are powered by the onboard control circuitry described below. Although positioned in the patient-side hydraulic circuit 304 in FIG. 3, in other embodiments, one or more pumps are positioned in the machine-side hydraulic circuit 302.

[0068] The patient-side hydraulic circuit 304 includes a plurality of valves 336a to 336c. Specifically, the first valve 336a, the second valve 336b, and the third valve 336c are each configured to selectively open and close the patient-side inlet lumen 328 (downstream of the patient-side recirculation lumen 332), the patient-side recirculation lumen 332, and the patient-side outlet lumen 330 (upstream of the patient-side recirculation lumen 332), respectively. As described above, representative valves include electromechanical and pneumatic valves, including the lumen valves described below. The patient-side hydraulic circuit 304 can be selectively secured to the base 310 via a lock 326.

[0069] The valves (and other components) described herein are actuated by a control circuit 338 disposed in the fluid access device 300 (e.g., in the base 310). A data / power interface 340 (e.g., a USB interface or similar) electrically connected to the control circuit 338 is configured to draw power and / or data from a hemodialysis system and to provide such power and data to the components of the fluid access device 300.

[0070] Control circuitry 338 is operatively connected (e.g., electrically connected) to a power supply provided by a power source (e.g., a battery) located on fluid access device 300 via a data / power interface 340 connected to the hemodialysis system. Control circuitry 338 includes a processor (e.g., a general-purpose processing unit, graphics processing unit, or application-specific integrated circuit), a data storage device (a tangible machine-readable storage medium), and a plurality of modules implemented as software logic (e.g., executable software code), firmware logic, hardware logic, or various combinations thereof. In some embodiments, control circuitry 338 includes a transceiver that transmits signals from any of the modules discussed below to a mobile device and receives signals transmitted from the mobile device via a connected machine (hemodialysis system). The data storage device of control circuitry 338 is a tangible machine-readable storage medium that includes a mechanism for storing information in a non-transitory form accessible by a machine (e.g., the processor of control circuitry 338). For example, a machine-readable storage medium includes recordable / non-recordable media (e.g., read-only memory (ROM), random access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, etc.).

[0071] In some embodiments, the control circuit 338 includes a communication interface having circuitry configured to communicate with a hemodialysis system, a mobile device (e.g., a smartphone), and / or other network elements via the Internet, cellular network, RF network, personal area network (PAN), local area network, wide area network, or other networks. In any embodiment, the control circuit 338 may include communication components that enable communication between the machine-side hydraulic circuit 302 and the patient-side hydraulic circuit 304, for example, enabling the machine-side hydraulic circuit 302 to receive electronic data from the patient-side hydraulic circuit 304 and vice versa. Therefore, the communication interface can be configured to communicate using wireless protocols (e.g., WIFI®, WIMAX®, BLUETOOTH®, ZIGBEE®, cellular, infrared, near-field, etc.) and / or wired protocols (General Purpose Serial Bus or other serial communications (such as RS-216, RJ-45, etc.), parallel communication buses, etc.). In some embodiments, the communication interface includes a circuitry configured to initiate a discovery protocol that allows the control circuitry 338 and other network components to identify each other and exchange control information. In one embodiment, the communication interface has a circuitry configured to initiate a discovery protocol and negotiate one or more pre-shared keys.

[0072] Any fluid access device and / or fluid access line of the present invention may have one or more selectable access sites for drug delivery and / or fluid sampling. In some embodiments, such access sites are diaphragms, valves, or ports that may be disposed through a wall of any of the machine-side inlet lumen 312, machine-side outlet lumen 314, machine-side recirculation lumen 316, patient-side inlet lumen 328, patient-side outlet lumen 330, or patient-side recirculation lumen 332.

[0073] Figures 4A to 4D illustrate a representative fluid access device 400 that includes the features of the fluid access device 300 of Figure 3. Thus, the fluid access device 400 includes a machine-side hydraulic circuit 402 and a patient-side hydraulic circuit 404 that can be selectively fluid-coupled at a fluid interface 406.

[0074] The machine-side hydraulic circuit 402 and the patient-side hydraulic circuit 404 are mounted on a base 408 (e.g., a rigid frame, platform, or the like) for secure connection to one of the patient-side hydraulic circuits 404. To facilitate disengagement from the base 408, the machine-side hydraulic circuit 402 includes a second disconnect mechanism 410 (e.g., a button or latch). Similarly, the patient-side hydraulic circuit 404 includes a first disconnect mechanism 412. Depending on the situation, one or both of the machine-side hydraulic circuit 402 and the patient-side hydraulic circuit 404 may be selectively secured to the base 408 by one or more magnets 414, latches, or the like, which helps guide a user to properly couple the hydraulic circuits.

[0075] A machine-side input cavity 416 and a machine-side output cavity 418 are configured to be parallel to the fluid in the machine-side fluid access line described previously. In use, fluid enters and exits the machine-side hydraulic circuit 402 via the machine-side input cavity 416 and the machine-side output cavity 418, respectively. A machine-side recirculation cavity 420 bridges the machine-side input cavity 416 and the machine-side output cavity 418 (see Figure 4D).

[0076] To achieve selective control of the machine-side hydraulic circuit 402, a plurality of valves 422a to 422c are disposed in the machine-side hydraulic circuit 402. Specifically, the first valve 422a, the second valve 422b, and the third valve 422c are each configured to selectively open and close the machine-side input cavity 416 (downstream of the machine-side recirculation cavity 420), the machine-side recirculation cavity 420, and the machine-side output cavity 418 (upstream of the machine-side recirculation cavity 420), respectively. Representative and non-limiting valves include push / pull piston valves actuated via an electromechanical or pneumatic valve actuator (e.g., a pin) disposed in the base 408, and any of the in-cavity valves described below with respect to Figures 25A to 28B. Each of the valves disclosed herein may be biased toward a closed state (e.g., by a spring or other biasing mechanism) and / or by one of its valve actuators, such that when the fluid access device 400 is unpowered, the valve closes and prevents fluid flow.

[0077] The patient-side hydraulic circuit 404 includes a patient-side input cavity 424, a patient-side output cavity 426, and a patient-side recirculation cavity 428 bridging the two cavities. A first valve 430a, a second valve 430b, and a third valve 430c are each configured to selectively open and close the patient-side input cavity 424 (downstream of the patient-side recirculation cavity) and the patient-side output cavity 426 (upstream of the patient-side recirculation cavity), respectively.

[0078] The fluid interface 406 includes a plurality of retractable sleeves 432a to 432b (or retractable needles, diaphragms, and receivers, or similar, as described below with respect to Figures 13A to 17) that extend and retract in response to a signal received by the self-control circuitry (e.g., a connect / disconnect signal). Sleeve 432a selectively couples a machine-side output lumen 418 to a patient-side input lumen 424, and sleeve 432b selectively couples a machine-side input lumen 416 to a patient-side output lumen 426. After or substantially simultaneously with the retraction of sleeves 432a to 432b, a closing mechanism such as gates 434a to 434b automatically closes the fluid path (i.e., the distal end of the fluid path at the fluid interface 406) to prevent contamination and / or to waterproof the device. In any embodiment, the closing mechanism may be considered part of the fluid interface. In some embodiments, the gates 434a to 434b are actuated by one or more actuators based on the receipt of a connection / disconnection signal from a control circuit. In some embodiments, the gates 434a to 434b are biased toward a closed position (i.e., a position that closes a fluid passage) by one or more biasing mechanisms (such as a spring).

[0079] Figures 5A and 5B illustrate a representative base 500 adapted for use with any of the fluid access devices described herein. As previously described, some fluid access devices of the present invention do not include a separate base. For example, in some embodiments, a base structure is integrally formed with one of the machine-side or patient-side hydraulic circuits. Figure 5A shows a base 500 in a first state with some elements retracted, while Figure 5B shows a base 500 in a second state with some elements extended. The base 500 includes a housing 502 formed in one or more portions of a polymer (e.g., polypropylene), a metal (e.g., aluminum), or a similar rigid material, which protects and stabilizes the internal components.

[0080] One or more retaining mechanisms 504a, 504b (e.g., latches, magnets, or the like) selectively couple the machine-side and patient-side hydraulic circuits to the base 500. In some embodiments, the retaining mechanism includes a magnet disposed in the housing 502 and in the hydraulic circuit. Advantageously, the retaining mechanism stabilizes the fluid connection between the hydraulic circuits and prevents accidental disconnection between the hydraulic circuits.

[0081] One or more sensors 506a, mounted on housing 502 and communicatively coupled to control circuitry, detect the presence (or absence) of the hydraulic circuit. Therefore, sensor 506a provides a connection / disconnection signal to control circuitry. Based on the connection / disconnection signal, control circuitry determines whether the fluid access device is in a connected or disconnected state.

[0082] In some embodiments, the base 500 includes additional sensors such as the following: Ÿ Sensors for continuous monitoring of blood channels, including heart rate, temperature, hemoglobin and other blood properties, and uremic toxins (such as urea and uric acid). A sensor used to monitor blood pressure directly or in combination with biometric data from a mobile device coupled to a base station 500. Sensors used to monitor the presence of air Ÿ Sensors used to detect leaks in the system

[0083] Any or all of the aforementioned sensed parameters can be transmitted to a machine (e.g., a hemodialysis system) and / or a mobile device to help inform patients and clinicians about treatment progress and / or to ensure system safety if an out-of-range or abnormal condition is detected.

[0084] In some embodiments, the control circuitry actuates one or more valves, dampers, pumps, locks, sterilization modules, or other features based on a connection / disconnection signal. Suitable sensors 506a include optical sensors, capacitive or resistive touch sensors, pressure switches, and the like.

[0085] A data / power interface 508 is an interface between the machine-side hydraulic circuit (which houses the fluid access device and the data / power interface connected to the hemodialysis system) and the control circuit housed in the base 500. That is, the data / power interface 508 transmits power and data from the machine-side hydraulic circuit to the base 500 and the patient-side hydraulic circuit.

[0086] A plurality of valve actuators 510a to 510f are electrically connected to a control circuit and selectively cycle the valves in the hydraulic circuit between open and closed states. In the illustrated embodiment, actuators 510a to 510f are pin-based actuators that retract (as shown in FIG. 5A) and extend (as shown in FIG. 5B) to cycle the valves in the hydraulic circuit between open and closed states. Thus, a first plurality of valve actuators 510a, 510c, 510d are mounted on the machine side of one base 500, and a second plurality of valve actuators 510b, 510e, 510f are mounted on the patient side of one base 500.

[0087] Similar to valve actuator 510a, a plurality of closing mechanism actuators 512a actuate a closing mechanism (e.g., a stop) toward an open and / or closed position. In the illustrated embodiment, the closing mechanism actuator 512a is a pin-based actuator that retracts (as shown in FIG. 5A) and extends (as shown in FIG. 5B) to circulate the stop in the hydraulic circuit. For example, the closing mechanism actuator may be electromechanical or pneumatic.

[0088] The base 500 includes a sterilization module 514a operated to sterilize, for example, the hydraulic circuit of the fluid access device prior to disconnection and / or reconnection of the machine-side and patient-side hydraulic circuits. In the illustrated embodiment, the sterilization module 514a includes a plurality of ultraviolet LEDs positioned to sterilize the fluid interface and hydraulic circuits by irradiating them with ultraviolet light. In some embodiments, such as fluid access devices without a separate base, the sterilization module is embedded in one or both of the machine-side and patient-side hydraulic circuits.

[0089] Pump plungers 516a and 516b oscillate up and down against an elastic diaphragm on the patient-side inlet and outlet lumens to pump fluid through them. In some embodiments, the pump plungers are located on the machine side and / or alternatively on the patient side. Other suitable pumps include linear peristaltic pumps and impeller pumps that drive an impeller in the lumen via electromagnetic coupling.

[0090] Figures 6A to 6C illustrate a representative fluid access device 600 in one of three different operating states: a connected state (Figure 6A), a short-term disconnected state (Figure 6B), and a long-term disconnected state (Figure 6C). Fluid access device 600 includes all the features of fluid access device 300 of Figure 3. Therefore, similar terms used with respect to Figures 6A to 6C refer to similar features described above with respect to Figure 3. However, the operating states described below are not limited to fluid access device 600. In fact, the operating state represents the fluid flow configuration that any fluid access device of the present invention can be configured to achieve.

[0091] In the connection configuration shown in Figure 6A, the machine-side hydraulic circuit 602 is adjacent to the patient-side hydraulic circuit 604 at the fluid interface 608. The machine-side hydraulic circuit 602 is fluidly connected to the patient-side hydraulic circuit 604 at the fluid interface 608 via retractable sleeves 606a and 606b, thus forming two parallel and fluid-separated fluid paths. The first fluid path includes a machine-side input lumen 610 and a patient-side output lumen 612, and supplies fluid 614 (e.g., dialysis blood) from the hemodialysis system to the patient. Therefore, the control circuit sets valves 616a and 616d to an open position.

[0092] The second fluid path includes a patient-side inlet lumen 618 and a machine-side outlet lumen 620, and supplies fluid (e.g., the patient's blood) to the hemodialysis system. To allow fluid to travel from the patient to the machine, the control circuit sets valves 616b and 616f to an open position.

[0093] To maintain fluid separation between parallel fluid paths, the control circuit sets valves 616c and 616e to a closed position, so that neither the machine-side recirculation lumen 624 nor the patient-side recirculation lumen 626 is bridged to the parallel fluid paths.

[0094] The valve configuration shown in Figure 6A is a connected valve configuration. In some embodiments, the valve is actuated into a connected valve configuration based on a connection / disconnection signal received from a sensor (as shown in Figure 5A) and / or from one or more disconnection mechanisms.

[0095] Figure 6B illustrates a fluid access device 600 in a short-term disconnection state, for example, suitable for a patient to be disconnected from the hemodialysis system for a relatively short period of time (e.g., 1 to 2 hours). However, it should be understood that the following disconnection state is not limited to applications where the disconnection period is less than two hours.

[0096] As shown, the machine-side hydraulic circuit 602 is fluidly disconnected and physically separated from the patient-side hydraulic circuit 604. This disconnection sequence may include a closing mechanism and the substantial simultaneous retraction of one of the machine-side and patient-side lumens. Additionally, fluid is recirculated through at least one of the machine-side hydraulic circuit 602 or the patient-side hydraulic circuit 604. Specifically, blood is recirculated on the machine side through the hemodialysis system and through the machine-side hydraulic circuit 602. On the patient side, the patient's blood is drawn through the patient-side hydraulic circuit 604 and then pumped back to the patient to prevent thrombosis. Advantageously, this configuration allows the hemodialysis system to continue operating in the event of partial interruption and allows the patient to quickly resume treatment after reconnection to the hemodialysis system.

[0097] To achieve disconnection, locking solution can be supplied (e.g., overflow, filling, or flushing) to both the machine-side hydraulic circuit 602 and the patient-side hydraulic circuit 604 via the solution hydraulic circuit 628. Then, retractable sleeves 606a and 606b retract, thereby disconnecting the fluid in both hydraulic circuits. To prevent contamination of the sleeves and to waterproof the device, closing mechanisms (e.g., doorstops) 630a and 630b seal their respective sleeves, for example, simultaneously with the sleeve retraction. Furthermore, to achieve physical separation of the machine-side hydraulic circuit 602, a retaining mechanism 632 detaches from the housing of the machine-side hydraulic circuit 602. In some embodiments, a certain volume of locking solution is retained via the retractable sleeve after retraction / disconnection.

[0098] To achieve recirculation in the machine-side hydraulic circuit 602, the control circuit (e.g., before the machine-side hydraulic circuit 602 is disconnected from the base) sets valves 616a and 616b to a closed position and valve 616c to an open position. This allows fluid to be recirculated from the machine-side input lumen 610 to the machine-side output lumen 620 via the machine-side recirculation lumen 624, powered by the hemodialysis system pump.

[0099] To achieve recirculation in the patient-side hydraulic circuit 604, the control circuit sets valves 616d and 616f to a closed position and valve 616e to an open position. Additionally, one or more pump interfaces 634a and 634b are opened. This allows fluid to recirculate from the patient-side input cavity 618 to the patient-side output cavity 612 via the patient-side recirculation cavity 626 under the power of the pump interfaces 634a and 634b.

[0100] The valve configuration shown in Figure 6B is a disconnected valve configuration. In some embodiments, the valve is actuated to the disconnected valve configuration based on a connection / disconnect signal received by the self-control circuit, a connection / disconnect signal received by a sensor (as shown in Figure 5A), and / or a connection / disconnect signal received by one or more disconnect mechanisms.

[0101] Figure 6C illustrates a fluid access device 600 in a long-term disconnected state, for example, suitable for a patient being disconnected from the hemodialysis system for a relatively long period of time (e.g., between dialysis treatments). However, it should be understood that the following disconnected state is not limited to applications where the disconnection period is relatively long.

[0102] The long-term disconnection state in Figure 6C is the same as the short-term disconnection state in Figure 6B, except as follows: First, fluid is not recirculated through the machine-side hydraulic circuit 602; in fact, the machine-side hydraulic circuit 602 is backflushed (i.e., blood is returned to the patient) and, as appropriate, sterilized by a port or valve through one or more sidewalls of the fluid path provided by the solution hydraulic circuit 628 and / or by an acidic mixture, hot water, ozone, ultraviolet light, sodium citrate, or saline solution provided by a sterilization module mounted on the base. Second, in some embodiments, the patient's fluid (e.g., blood) is not recirculated through the patient-side hydraulic circuit 604. Therefore, the control circuit closes pump interfaces 634a, 634b, drains the patient's fluid from the patient-side hydraulic circuit 604 by providing sterile octane solution to the patient-side hydraulic circuit 604 via the solution hydraulic circuit 628 (before disconnection), and seals the patient-side output lumen 612 and the patient-side input lumen 618 with a line lock or similar device. However, in some embodiments, the patient's fluid is recirculated through the patient-side hydraulic circuit 604. In these embodiments, the control circuit shuts off pump interfaces 634a, 634b, but the patient's fluid is circulated through the patient-side hydraulic circuit 604 by one or more pumps (e.g., pump plungers (such as 516a, 516b shown in Figures 5A-5B), peristaltic pumps, or the like). Pump plungers 516a, 516b represent suitable positive displacement pumps, including but not limited to diaphragm and membrane pumps. Alternative embodiments may include alternative positive displacement pumps.

[0103] In some embodiments, the long-term disconnected state shown in FIG6C is a preset state to prevent fluid flow when the patient-side hydraulic circuit is separated from the machine-side hydraulic circuit.

[0104] Figures 7A to 7H illustrate a representative method of decoupling a machine-side hydraulic circuit of a fluid access device 700 from a patient-side hydraulic circuit. The fluid access device 700 includes all the features of the fluid access device previously described, and the previously introduced terms used below should have the same meaning as described above.

[0105] Specifically, the illustrated method demonstrates a representative approach for transitioning a fluid access device 700 from a connected state to a short-term disconnected state.

[0106] In one of the first steps shown in Figure 7A, a user initiates the disconnection of the machine-side hydraulic circuit from the patient-side hydraulic circuit by pressing one or more disconnect mechanisms disposed on a housing of the machine-side hydraulic circuit and / or the patient-side hydraulic circuit. In some embodiments, the user presses the disconnect mechanism(s) in a different sequence to initiate a transition to a short-term disconnection state, compared to a long-term disconnection state. Pressing the disconnect mechanism(s) sends a connection / disconnection signal to the control circuitry.

[0107] In one of the second steps shown in Figure 7B, a solution hydraulic circuit of the fluid access device 700 provides a sterile LOCK solution to both the machine-side hydraulic circuit and the patient-side hydraulic circuit (which are fluidly connected via a retractable sleeve). In one embodiment, the solution hydraulic circuit flushes the fluid interface between the machine-side and patient-side hydraulic circuits, as well as portions of both circuits.

[0108] In the third step shown in Figure 7C, the control circuit of the fluid access device 700 closes the valve, which is arranged in a straight line with the machine-side input cavity, the machine-side output cavity, the patient-side input cavity, and the patient-side output cavity. This action isolates the fluid interface between the machine-side hydraulic circuit and the patient-side hydraulic circuit.

[0109] Additionally, open the valve positioned in a straight line with both the machine-side recirculation lumen and the patient-side recirculation lumen. This action bridges the fluid in the machine-side input lumen to the machine-side output lumen via the machine-side recirculation lumen, and bridges the patient-side input lumen to the patient-side output lumen via the patient-side recirculation lumen.

[0110] In the fourth step shown in Figure 7D, the sleeve retracts at the fluid interface, thereby completing the fluid isolation between the machine-side hydraulic circuit and the patient-side hydraulic circuit.

[0111] Additionally, one or more inline pumps located on the patient-side hydraulic circuit are activated, causing fluid to recirculate within them. The fluid also recirculates through the machine-side hydraulic circuit under the prime mover power of the hemodialysis system pumps.

[0112] In one of the fifth steps shown in Figure 7E, a sterilization module is used to sterilize and / or disinfect the fluid interface. In one embodiment, the fluid interface is sterilized by irradiating it with ultraviolet light from one or more UV light-emitting diodes mounted on a base.

[0113] In one of the sixth steps shown in Figure 7F, a closing mechanism (such as a stop) closes at the fluid interface, thereby sealing the distal ends (i.e., the ends at the fluid interface) of the machine-side inlet lumen, the machine-side outlet lumen, the patient-side inlet lumen, and the patient-side outlet lumen.

[0114] In one of the seventh steps shown in Figure 7G, a retaining mechanism disengages from the machine-side hydraulic circuit and / or the patient-side hydraulic circuit, thereby achieving physical separation of the two hydraulic circuits.

[0115] In the eighth step shown in Figure 7H, the machine-side hydraulic circuit and the patient-side hydraulic circuit are physically separated. After separation, the patient-side fluid continues to be recirculated under the power of the tubing pump, and the machine-side fluid continues to be recirculated under the power of the hemodialysis system pump.

[0116] In one embodiment, a method for changing the fluid access device from a disconnected state to a connected state is performed in reverse order of Figures 7A to 7H. Specifically, the machine-side hydraulic circuit is physically connected to the patient-side hydraulic circuit, and then locked together using a retaining mechanism. Next, the closing mechanism retracts, exposing the distal end of the lumen at the fluid interface. The fluid interface is then sterilized using a sterilization module. Next, a sleeve extends, thereby connecting the machine-side hydraulic circuit to the patient-side hydraulic circuit. Next, a valve positioned in a straight line with the machine-side input lumen, machine-side output lumen, patient-side input lumen, and patient-side output lumen is opened by a control circuit. Additionally, a valve positioned in a straight line with the machine-side recirculation lumen and patient-side recirculation lumen is closed. As shown in Figure 8, the solution hydraulic circuit draws the lux solution from the lumen into the solution waste lumen, and the fluid flows freely between the machine-side and patient-side hydraulic circuits.

[0117] The fluid access device of the present invention is not limited to the specific configuration described above. Figures 9A to 33B illustrate variations and optional features, any one or more of which can be incorporated into any fluid access device of the present invention.

[0118] Figures 9A to 12 illustrate an alternative embodiment of a fluid access device according to the present invention. The alternative fluid access device of Figures 9A to 12 includes the same features as the previously described embodiments, but has a different pump and valve configuration. Specifically, each of the patient-side and machine-side hydraulic circuits includes a single valve block instead of several discrete valves. The valve block selectively acts on each lumen according to the connection / disconnection states discussed above.

[0119] Figures 13A and 13B illustrate one of the alternative connection structures that can be used in any fluid access device incorporating the present invention.

[0120] As shown, a fluid access device 1300 includes a patient-side hydraulic circuit 1302 and a machine-side hydraulic circuit 1304 as described above. Unlike previous embodiments that utilize a latch-type coupling to physically connect the patient-side and machine-side hydraulic circuits, the fluid access device 1300 utilizes a lead screw mechanism. Specifically, the machine-side hydraulic circuit 1304 includes a lead screw 1306 that can be rotated by an electric motor, a pneumatic motor, or manually. In the illustrated embodiment, the lead screw 1306 is rotatably driven by a pneumatic motor (e.g., a turbine coupled to a pneumatic supply line). The patient-side hydraulic circuit 1302 includes a threaded portion 1308 sized and positioned to receive the lead screw 1306 when the patient-side hydraulic circuit 1302 and the machine-side hydraulic circuit 1304 are coupled together.

[0121] Fluid access device 1300 includes another variation of any fluid access device that can be used in this invention. That is, it uses needles and diaphragms instead of tubing to fluidly couple the patient-side hydraulic circuit 1302 and the machine-side hydraulic circuit 1304 (otherwise, a similar hydraulic connection is assumed and not shown again for simplicity). Specifically, the machine-side hydraulic circuit 1304 includes needles 1310, 1312, while the patient-side hydraulic circuit 1302 includes self-healing diaphragms 1314, 1316. When the fluid access device is in an open state, a retractable closing mechanism (e.g., gates 1318, 1320) is biased to the closed state shown in FIG. 13A to protect needles 1310, 1312.

[0122] In use, to connect the patient-side hydraulic circuit 1302 and the machine-side hydraulic circuit 1304, the threads of the lead screw 1306 engage with the threaded portion 1308. The lead screw 1306 is rotated by a motor, causing the machine-side hydraulic circuit 1304 to advance towards the patient-side hydraulic circuit 1302. Needles 1310 and 1312, driven by the lead screw 1306, penetrate diaphragms 1314 and 1316 until the patient-side hydraulic circuit 1302 and the machine-side hydraulic circuit 1304 are fluidly connected.

[0123] Advantageously, as the lead screw 1306 advances the hydraulic circuits toward each other, the gates 1318 and 1320 open simultaneously and automatically. The opposite occurs when the two hydraulic circuits are disconnected; that is, the gates close automatically to prevent contamination and to waterproof the device. Automatic gate opening / closing reduces the need for human intervention to disinfect and secure the device. In any embodiment, the advancement of the two hydraulic circuits also establishes an electrical and / or pneumatic connection between them.

[0124] Figures 14A and 14B illustrate a fluid access device 1400 comprising an electrical connection scheme that can be used with any fluid access device of the present invention to transmit power and / or electrical signals between two hydraulic circuits.

[0125] The patient-side hydraulic circuit 1402 and the machine-side hydraulic circuit 1404 respectively include electrical contacts 1406 and 1408. Electrical contact 1408 is electrically coupled to a power supply for a control circuit, a hemodialysis system, or the like. Electrical contact 1406 is operatively coupled to at least one electrical load (such as a motor 1410, which, in the illustrated embodiment, opens and closes a stop gate 1412). In other embodiments, the electrical load operates a sensor, a communication device, a lead screw, a latch, and / or any other electrical device on the patient-side hydraulic circuit.

[0126] In the disconnected state shown in Figure 14A, when the patient-side hydraulic circuit 1402 and the machine-side hydraulic circuit 1404 are in a disconnected state, the electrical contacts 1406 and 1408 are also disconnected. However, when the hydraulic circuits are physically connected, the electrical contacts 1406 and 1408 are electrically coupled so that the power supply can supply power to the electrical load in the patient-side hydraulic circuit.

[0127] Figures 15A and 15B illustrate another fluid access device 1500 having a multi-needle and diaphragm fluid connection scheme that can be used in any fluid access device of the present invention, for example as an alternative to a cannula or single-needle fluid coupling arrangement to increase fluid flow rate. Specifically, the machine-side hydraulic circuit 1502 includes a first plurality of needles 1504 and a second plurality of needles 1506 fluidly connected to respective fluid access lines 1512, 1514. Needles 1504 and 1506 may be connected to machine-side input lumens and machine-side output lumens, respectively, or vice versa. In some embodiments, needles 1504, 1506 may be located on patient-side hydraulic circuit 1508 instead of machine-side hydraulic circuit 1502. Advantageously, providing a plurality of needles (e.g., two, three, or four needles) for each input and output increases flow rate and reduces damage to the self-healing diaphragm.

[0128] The fluid access device 1500 includes another feature that can be used with any fluid access device of the present invention. The machine-side hydraulic circuit 1502 includes an actuator (in this embodiment, a pin 1510) that, when the machine-side hydraulic circuit 1502 is coupled to the patient-side hydraulic circuit 1508, actuates in-cavity valves 1516, 1518 in the patient-side hydraulic circuit 1508. These in-cavity valves can be preset to close or block the patient-side inlet and outlet cavities until a closed position is physically opened by the pin 1510 (e.g., via a linkage assembly) (shown in FIG. 15A). When the machine-side hydraulic circuit 1502 is coupled to the patient-side hydraulic circuit, the pin 1510 causes the valves 1516, 1518 to retract so that they do not block the corresponding cavities. Advantageously, this feature automates the transition from a disconnected state to a connected state and prevents accidental fluid loss (e.g., bleeding) from a patient in the event of unintentional disconnection of the hydraulic circuit. The following describes a representative in-cavity valve.

[0129] Figure 16 illustrates a fluid access device 1600 that includes a manifold 1602 that can be used with any fluid access device of the present invention, for example, as part of a solution hydraulic circuit as described above. The fluid access device of the present invention can interact with several fluids, including blood, locomotor solutions (e.g., heparin and sodium citrate), cleaning solutions (e.g., saline), initiation infusion / backflush / flushing fluids (again, saline), and waste fluids. Manifold 1602 provides a novel structure for managing these fluids. In any embodiment, a separate and optional fluid supply module 1601 can be configured to supply one or more of the aforementioned fluids to the fluid access device 1600 and / or receive one or more of the aforementioned fluids from the fluid access device 1600.

[0130] Generally, manifold 1602 is fluid-coupled between machine-side inlet lumen 1604 and machine-side outlet lumen 1606, and includes a passive valve (e.g., a check valve) that regulates the fluid flow to / from machine-side inlet lumen 1604 and machine-side outlet lumen 1606 under different pressure conditions.

[0131] One of the manifolds 1602, a first conduit 1608, is fluid-coupled between a machine-side inlet lumen 1604, a machine-side outlet lumen 1606, and a first solution conduit 1626 (e.g., a brine conduit). The first solution conduit 1626 supplies a first solution (e.g., brine) to the first conduit 1608, and check valves 1610 and 1612 allow the first fluid to flow unidirectionally from the first conduit 1608 to the machine-side inlet lumen 1604 and the machine-side outlet lumen 1606 respectively, at a first pressure limit (e.g., twice the normal operating pressure of the machine-side inlet lumen 1604 and the machine-side outlet lumen 1606).

[0132] One of the manifolds 1602, a second manifold conduit 1614, is fluid-coupled between a machine-side inlet lumen 1604, a machine-side outlet lumen 1606, and a second solution conduit 1628. The second solution conduit 1628 supplies a second solution (e.g., locol solution, such as heparin) to the second manifold conduit 1614, and check valves 1616 and 1618 allow the second fluid to flow unidirectionally from the second manifold conduit 1614 to the machine-side inlet lumen 1604 and the machine-side outlet lumen 1606, respectively, at a second pressure limit that may be the same as or different from a first pressure limit (e.g., twice the normal operating pressure of the machine-side inlet lumen 1604 and the machine-side outlet lumen 1606).

[0133] A third manifold 1624 of manifold 1602 is fluid-coupled between machine-side inlet lumen 1604, machine-side outlet lumen 1606, and a third solution conduit 1630. Check valves 1620 and 1622 allow a third fluid (e.g., waste) to flow unidirectionally from machine-side inlet lumen 1604 and machine-side outlet lumen 1606 to the third manifold 1624 and the third solution conduit 1630 at a third pressure limit that may be the same as or different from the first and / or second pressure limits (e.g., 1.5 times the normal operating pressure of machine-side inlet lumen 1604 and machine-side outlet lumen 1606).

[0134] Therefore, manifold 1602 enables selective passage of some fluids (e.g., locomotor solution and / or saline) into the fluid conduit carrying the patient's blood, and allows selective drainage of waste fluid. Although the illustrated device includes three conduits, this number is representative and not limiting. Other embodiments are prudently considered to include a different number, such as two, four, or five conduits, each of which may be equipped with valves to supply fluid to or receive fluid from machine-side inlet lumen 1604 and machine-side outlet lumen 1606. Furthermore, the flow direction of each conduit may vary between embodiments. In addition, in some embodiments, the lumens (conduits) may be controlled by an active valve and / or contain a two-way valve.

[0135] As described above, some fluid access devices of the present invention include a permanent recirculation lumen between the patient-side inlet and outlet lumens and / or between the machine-side inlet and outlet lumens. While these embodiments are advantageous, the recirculation lumen is a optional feature. Any embodiment of the fluid access device of the present invention may not include such a permanent recirculation lumen or any recirculation lumen. In fact, the present invention is explicitly and prudently considered to alternatively provide any embodiment described herein without one or more recirculation lumens. These embodiments still provide significant benefits to patients by reducing human contact points, lowering the risk of infection, and facilitating the monitoring of patient fluids.

[0136] Figure 17 provides an alternative solution for bridging the input and output lumens in any fluid access device of the present invention (especially a fluid access device without a permanent recirculation lumen).

[0137] As shown, the fluid access device 1700 includes needles 1702 and 1704 corresponding to a machine-side inlet lumen and a machine-side outlet lumen, respectively. A recirculation bridge 1706 (essentially a removable cap forming a channel therein) fluidly connects the needles 1702 and 1704 via a U-shaped fluid path. Specifically, a housing 1708 of the recirculation bridge 1706 forms a U-shaped channel therein. The U-shaped recirculation bridge 1706 includes self-healing diaphragms 1710 and 1712 at each end. In use, the needles 1702 and 1704 are inserted into the diaphragms 1710 and 1712, respectively, and thereafter, a patient's blood can be recirculated from the machine-side outlet lumen to the machine-side inlet lumen to prevent clotting on the machine side, or alternatively, recirculated from the patient-side outlet lumen to the patient-side inlet lumen under the power of a pump as described herein.

[0138] Figure 18 illustrates a representative fluid access device 1800 with a recirculation bridge 1802, which can be used with any fluid access device of the present invention, and particularly for any patient-side or machine-side hydraulic circuit. For example, a system may include any fluid access device of the present invention, except for a segment of a fluid access line including the recirculation bridge 1802. In some embodiments, the recirculation bridge 1802 fluidly bridges the patient-side inlet lumen and patient-side outlet lumen between a fluid access device 1808 and a skin access site 1810. Advantageously, this allows the fluid access device 1808 to be disconnected from a hemodialysis system and locked with LORD solution while still allowing circulation of the patient's blood. Therefore, the recirculation bridge 1802 may be part of a fluid access device or may be provided separately from a fluid access device, for example, as part of a fluid access system.

[0139] In this embodiment, the recirculation bridge 1802 allows blood to pass from the patient-side output lumen to the patient-side input lumen via artificial palpation (this pumping of blood) through a flexible diaphragm 1812 or a septum. Therefore, one or more check valves are positioned at several interfaces between the input / output lumen and the recirculation bridge 1802 to ensure unidirectional flow. In the illustrated embodiment, a check valve 1814 is positioned upstream of the flexible diaphragm 1812, and an optional check valve 1816 is positioned downstream of the flexible diaphragm 1812. In other embodiments, check valve 1816 is included, but check valve 1814 is not.

[0140] The fluid access device of this invention provides an advantageous platform for monitoring the health of a patient and / or sampling biological fluids from the patient. For example, in practice, the fluid access device may be positioned relatively close to the patient's heart. This, in turn, enables the sensing of parameters of the patient's blood and other biological fluids at high resolution.

[0141] Figures 19A to 19C illustrate a representative electronic module 1900 that can be integrated as a selectable feature of any fluid access device or any recirculation bridge of the present invention to achieve accurate sensing of fluid flow to a patient. In the illustrated embodiment, the electronic module 1900 is configured to be integrated with a recirculation bridge that fluidly connects a patient-side output lumen 1904 and a patient-side input lumen 1906 of a patient-side fluid access device. In some embodiments, the electronic module 1900 is integrated with a different portion of a fluid access line or fluid access device on either the machine side or the patient side.

[0142] Electronic module 1900 is reversibly coupled to one of the recirculation bridge interfaces, allowing different electronic modules to be connected for different purposes. Cross-sectional views of representative electronic modules are provided in Figures 19B and 19C.

[0143] Figure 19B shows a cross-sectional view of a representative electronic module 1900. As shown, the electronic module 1900 is positioned around a blood channel 1908 of the recirculation bridge. Specifically, the electronic module 1900 is formed in a U-shape or C-shape to receive a patient fluid channel (blood channel 1908 in this embodiment) therein. A thin film 1910 is disposed in a wall of the blood channel 1908 and forms a portion of the recirculation bridge (specifically, a mating interface 1912 thereon). The mating interface may, if applicable, include a locking mechanism on which a locking mechanism of the electronic module 1900 is selectively engaged, such as a latch, magnet, or the like.

[0144] Electronic module 1900 is configured to contact a mating interface such that a piston 1914 presses against a diaphragm 1910, which is then driven by a motor 1916 via a linkage 1918. An onboard battery 1920 may be, for example, a rechargeable lithium-ion battery. Electronic module 1900 includes one or more optional sensors, such as a pressure sensor 1922 (which monitors blood pressure in blood channel 1908 through diaphragm 1910) and an optical sensor 1924 (which monitors blood flow in blood channel 1908). In any embodiment, one or more of sensors 1922, 1924 may be configured to detect at least one of the following: a pathogen in blood channel, a temperature of blood in blood channel, a color of blood in blood channel, a blood pressure in blood channel, or a clarity of blood in blood channel. Due to their close proximity to the patient, these sensors are well-positioned to detect infection or infection symptoms at high resolution.

[0145] Figure 19C shows a cross-sectional view of another representative electronic module 1900 configured to interface with a recirculation bridge. The electronic module 1900 includes a needle configured to sample blood from a blood channel 1908 through a membrane 1910 and a testing device configured to test the blood for one or more relevant parameters (such as urea concentration).

[0146] The aforementioned electronic modules are representative rather than limiting.

[0147] Figure 20 shows a representative configuration in which any fluid access device of the present invention can be connected to a patient.

[0148] In the illustrated embodiment, the patient has an implanted blood access device 2002, such as a central venous catheter, a fistula, a bypass graft, or the like. A fluid access device 2004 (which has any of the fluid access device configurations described herein) is coupled to the access device 2002 by a fluid access line 2006 comprising a patient-side inlet lumen and a patient-side outlet lumen as described above. Thus, the fluid access line 2006 may be any of the cross-sectional profiles shown herein (such as the cross-sectional profiles described with respect to Figures 29A to 29C) of a multi-lumen catheter.

[0149] A fluid access line 2006 is inserted into a patient's blood access device 2002, preferably at a position sufficiently close to the patient's heart such that a proximal end of the fluid access line 2006 (i.e., the end closest to the heart) extends into an undiluted blood region of the blood access device 2002, i.e., through any region containing blood diluted with saline and / or locomotor solution. The fluid access line 2006 includes a fluid coupling element 2008 (e.g., a Luer lock) for reversible coupling with the patient's blood access device 2002.

[0150] Figure 21 illustrates a representative blood sampling device 2100, which can be incorporated as one of the optional features of any fluid access device of the present invention and enables the sampling of blood from a patient's bloodstream. As discussed above, the fluid access device of the present invention is an ideal platform for sampling and analyzing a patient's biological fluids at high resolution due to its proximity to the patient.

[0151] The blood sampling device 2100 is integrated with any fluid access device described herein and includes a capillary 2102 extending from one inlet / outlet point 2104 of the fluid access device 2101 (which can be configured to couple to a syringe or other device via a Luer lock or similar coupler) into the lumen of a patient's catheter 2106 (or fistula or similar). The capillary 2102 is long enough that one of its inlets 2108 extends sufficiently close to a location close to the patient's heart to allow sampling of undiluted blood, i.e., from an area of ​​undiluted blood that has not been diluted with saline and / or locol solution. In some embodiments, the capillary 2102 is coated with a pharmacological substance (e.g., heparin) or a polymer coating to prevent coagulation / fouling. Where appropriate, a centering device 2110 (e.g., an annular support, a convex ring, a strut, or the like) supports the inlet 2108 at a central location within the lumen of the patient's catheter 2106. In these embodiments, the centering device 2110 may be attached to the capillary 2102.

[0152] The inlet / outlet point 2104 includes a selected UV radiation source 2112 configured to sterilize the capillary 2102. In some embodiments, the UV radiation source 2112 includes a UV light source (e.g., an LED) optically attached to a light guide (e.g., an optical fiber filament or light guide tube). The light guide extends along the capillary 2102 and irradiates the capillary 2102 and the surrounding catheter lumen with UV light. In some embodiments, the light guide extends within the capillary 2102. In some embodiments, the light guide is configured to extend at least to the locomotor injection area of ​​the patient's catheter 2106.

[0153] Figures 22A to 22C illustrate a representative disconnection mechanism 2200 that can be integrated into any fluid access line of the present invention, such as between a fluid access device and a hemodialysis system. The disconnection mechanism 2200 is configured to disconnect the patient from the hemodialysis system when the fluid access line 2202 experiences a tension exceeding a predetermined threshold (e.g., 100 N). To prevent injury to the patient (e.g., bleeding), the disconnection mechanism 2200 is also configured to close and completely block the patient-side fluid access line in the event of a disconnection.

[0154] Therefore, the disengagement mechanism 2200 includes a machine-side connector 2204 and a patient-side connector 2206. The machine-side connector 2204 includes a male portion that remains open when the two sides are fluidly coupled together, corresponding to a female portion of the patient-side connector 2206. The female portion of the patient-side connector 2206 (e.g., by a spring, shape memory material, or the like) is biased to a closed position on the patient side of the fluid-tight fluid access line 2202. In some embodiments, the machine-side connector 2204 and the patient-side connector 2206 are held together by a sacrificial coupler configured to fail or release at a predetermined tension threshold.

[0155] In use, the machine-side connector 2204 and the patient-side connector 2206 are fluidly coupled together, for example, between the fluid access device and the hemodialysis system. When the fluid access line 2202 experiences tension exceeding one of a predetermined threshold, the machine-side connector 2204 begins to separate from the patient-side connector 2206. See Figure 22B. When the machine-side connector 2204 and the patient-side connector 2206 are completely separated (Figure 22C), the patient-side connector 2206 automatically closes and seals the fluid access line 2202, thereby preventing blood loss.

[0156] Figures 23A and 23B illustrate another representative disconnection mechanism 2300 that can be integrated into any fluid access line of the present invention, such as between a fluid access device and a hemodialysis system. The disconnection mechanism 2300 is configured to disconnect the patient from the hemodialysis system when the fluid access line 2202 experiences a tension exceeding a predetermined threshold (e.g., 100 N). To prevent injury to the patient (e.g., bleeding), the disconnection mechanism 2300 is also configured to close the patient-side fluid access line in a disconnection event.

[0157] The disengagement mechanism 2300 includes an annular housing 2302 that receives a machine-side fluid access line 2304 and a patient-side fluid access line. A weakened region 2308 (e.g., a thin portion of the annular housing 2302) is formed at a central location around a circumference of the annular housing 2302. A valve 2310 is flexibly attached to the annular housing 2302 by a hinge 2312 (e.g., a movable hinge) disposed on the patient side of the weakened region 2308. The valve 2310 is held in an open position (shown in FIG. 23A) by a coupling member (such as a magnet 2314) disposed on the machine side of the weakened region 2308.

[0158] During operation, valve 2310 is held in the open position by magnet 2314, allowing fluid to travel through the machine-side fluid access line 2304 and the patient-side fluid access line. See Figure 23A. However, when disengagement mechanism 2300 experiences tension exceeding a predetermined threshold, annular housing 2302 fails at the disengagement mechanism 2300 position. This causes valve 2310 to release from magnet 2314 and immediately return to the closed position, sealing the patient-side fluid access line to prevent patient bleeding. See Figure 23B.

[0159] Figures 24A and 24B illustrate another representative disconnection mechanism that can be integrated into any fluid access line of the present invention, such as between a fluid access device and a hemodialysis system. The disconnection mechanism is configured to disconnect the patient from the hemodialysis system when the fluid access line 2202 experiences a tension exceeding a predetermined threshold (e.g., 100 N). To prevent harm to the patient (e.g., bleeding), the disconnection mechanism is also configured to close the patient-side fluid access line in a disconnection event.

[0160] A detachment mechanism is formed in the wall of a fluid access line 2402. Specifically, a patient-side lumen wall 2404 is connected to a machine-side lumen wall 2406 by a first weakened region 2408 and a second weakened region 2410 (in series). A first reservoir holding a first chemical component 2412 and a second reservoir holding a second chemical component 2414 are both formed within the lumen wall and separated by the first weakened region 2408. The second reservoir contains an elastic membrane 2416 that expands into the lumen of the fluid access line 2402 when pressurized. The first chemical component 2412 and the second chemical component 2414 are selected such that they react when combined with each other by increasing their equal volume.

[0161] Referring to Figure 24B, in use, the patient-side lumen wall 2404 and the machine-side lumen wall 2406 are connected by a first weakened region 2408 and a second weakened region 2410. In this state, fluid travels freely through the fluid access line 2402. However, when the disengagement mechanism experiences tension exceeding a predetermined threshold, the first weakened region 2408 fails, causing the first chemical component 2412 and the second chemical component 2414 to mix and react, thereby increasing the pressure within the second reservoir. This pressure increase causes the elastic membrane 2416 to expand into the lumen of the fluid access line 2402, thereby completely blocking the lumen and preventing fluid flow. If the tension increases beyond a second predetermined threshold (higher than the first tension threshold), the second weakened region 2410 fails, causing the patient-side lumen wall 2404 to completely separate from the machine-side lumen wall 2406. In this state, the first and second reservoirs remain intact and connected to the patient-side lumen wall 2404, such that the elastic membrane 2416 blocks the fluid access line 2402 and prevents fluid loss from the patient.

[0162] Figures 25A and 25B illustrate a representative in-lumen valve 2500, which, for example, is also applicable to any fluid access device of the present invention, other than or as an alternative to any electromechanical valve described herein. The in-lumen valve 2500 is also suitable for use with any disengagement mechanism of the present invention to prevent fluid loss from a patient. Therefore, the in-lumen valve 2500 is suitable for emergency, single-use, or reusable applications.

[0163] An in-lumen valve 2500 is disposed within the lumen of a fluid access line or a fluid access device and is modulated between a blocked position (FIG. 25B) and a flowing position (FIG. 25A). In the blocked position, the in-lumen valve 2500 is configured to selectively block the lumen by inflating an elastic balloon 2502 (which presses against an inner surface of the lumen wall 2504). The balloon 2502 is pneumatically coupled to a pressure regulating device 2508 via a pneumatic conduit 2506. In some embodiments, the pressure regulating device 2508 is a reversible valve. In other embodiments, the pressure regulating device 2508 is configured for single-use purposes, for example, to pneumatically connect the pneumatic conduit 2506 to a fragile bladder at atmospheric pressure upon rupture. In other embodiments, the pressure regulating device 2508 is a fragile bladder containing one of two or more chemicals that expand upon mixing. The chemicals are individually maintained in fragile capsules unless the pressure regulating device 2508 ruptures, in which case the chemicals mix, expand, and are pressurized through the pneumatic conduit 2506.

[0164] In some embodiments, the balloon 2502 is maintained in a collapsed state under negative pressure. See Figure 25A. In these embodiments, the balloon 2502 inflates and blocks the lumen when subjected to atmospheric or higher pressure (e.g., when the pressure regulating device 2508 is a valve open to atmospheric pressure or when the pressure regulating device 2508 mixes two expanding chemicals). In some embodiments, the pressure regulating device 2508 is coupled to the lumen wall 2504 such that when the lumen wall 2504 is cut off or broken, the balloon 2502 inflates to the blocked position.

[0165] Figures 26A to 26C show another representative in-lumen valve 2600, for example, used as a disengagement mechanism in any fluid access device of the present invention to prevent fluid loss from a patient.

[0166] An in-line valve 2600 is disposed within the lumen of a fluid access line or a fluid access device and is modulated between a blocked position (FIG. 26C) and a flowing position (FIG. 26A). In the blocked position, the in-line valve 2600 is configured to selectively block the lumen by expanding a resilient expandable sleeve 2602 (which presses against an inner surface of the lumen wall 2604). The expandable sleeve 2602 is disposed within or along an in-line tube 2606 and contains a reactive substance 2608 that expands upon exposure to a liquid (e.g., sodium polyacrylate).

[0167] A weakened wall segment 2610 is selected to promote the failure of the lumen wall 2604 near the expandable sleeve 2602. During use, when the lumen wall 2604 experiences tension exceeding a predetermined threshold, the weakened wall segment 2610 fractures, causing the lumen wall 2604 to separate into a patient-side portion and a machine-side portion. See Figure 26B. After the lumen wall 2604 fractures, the inner tube 2606 experiences tension, causing the orifice to open in the expandable sleeve 2602, allowing blood / fluid to enter the sleeve while non-reactive substance 2608 escapes. Therefore, the reactive substance 2608 reacts with the fluid and expands within the elastic expandable sleeve 2602, thereby blocking the lumen. See Figure 26C.

[0168] Figures 27A and 27B illustrate another representative in-line valve 2700 that can be utilized in any fluid access device of the present invention and is modulated between a blocked position (Figure 27A) and a flow position (Figure 27B). The in-line valve 2700 comprises an expandable valve (e.g., an umbrella-shaped element 2702 or a similar shape) housed within a sheath having a resilient sleeve 2704. The umbrella-shaped element 2702 is formed of a shape memory alloy, spring steel, or the like, which is biased toward the blocked position in some embodiments or toward the flow position in others. The umbrella-shaped element 2702 is modulated between the blocked position (Figure 27A) and the flow position (Figure 27B) by a guide line 2706, which pulls the umbrella-shaped element 2702 into the sheath in the flow position. To move the valve 2700 in the lumen to the blocked position, the umbrella 2702 is allowed to expand within the resilient sleeve 2704 and / or be pushed to the blocked position by the guide line 2706 using the potential energy stored within the umbrella 2702.

[0169] Figures 28A and 28B illustrate another representative in-line valve 2800 that can be utilized in any fluid access device of the present invention and is modulated between a blocked position (Figure 28B) and a flow position (Figure 28A). The in-line valve 2800 includes an expandable valve (e.g., an umbrella-shaped element 2802) formed of a spring steel, shape memory alloy, or similar material. In some embodiments, the umbrella-shaped element 2802 is biased toward the blocked position; however, in other embodiments, the umbrella-shaped element 2802 is biased toward the flow position.

[0170] The umbrella-shaped structure 2802 has a first end 2804 and a second end 2806. One of the first end 2804 or the second end 2806 is fixed relative to a guide wire 2808, while the other of the first end 2804 or the second end 2806 is movable along the guide wire 2808. To move the valve 2800 in the lumen to the blocked position shown in FIG. 28B, the guide wire 2808 is pulled, thereby bringing the second end 2806 closer to the first end 2804 and causing the diameter of the umbrella-shaped structure 2802 to increase. To move the valve 2800 in the lumen to the flow position, the second end 2806 is pushed away from the first end 2804 by the guide wire 2808 and / or by the potential energy stored in the umbrella-shaped structure 2802.

[0171] Figures 29A and 29C show representative cross-sections of a fluid access line 2900 and, specifically, representative configurations of valves within the lumen of the fluid access line 2900. Any of the fluid access line 2900 can be used in conjunction with any fluid access device of the present invention.

[0172] In Figure 29A, fluid access line 2900 has a double D-shaped extrusion with an in-lumen valve 2902, which has any of the in-lumen valve configurations described herein and selectively expands to block both a first lumen 2904 and a second lumen 2906.

[0173] In Figure 29B, the fluid access line 2900 has valves 2908 and 2902, each located in one of the D-shaped lumens 2904 and 2906 and configured to selectively block them.

[0174] In Figure 29C, the fluid access line 2900 includes in-cavity valves 2908 and 2902, each disposed within one of the circular cavities 2904 and 2906 and configured to selectively block them.

[0175] Figures 30A and 30B show representative cross-sections of a fluid access line 3000 that may include any in-cavity valve of the present invention and may be used in conjunction with any fluid access device of the present invention.

[0176] As shown in Figure 30A, the fluid access line 3000 includes a plurality of parallel lumens, including lumens for: arterial blood (A); lux solution (LS); venous blood (V); pneumatic supply (Pn); saline (NaCl); waste (W); and optional material / power conductors 3002, 3004. The arterial lumen, venous lumen, and saline lumen have a larger diameter than the other lumens to accommodate higher fluid flow rates. The order of any of the aforementioned lumens may vary in different embodiments.

[0177] As shown in Figure 30B, the fluid access line 3000 includes the same lumen, but is arranged such that the loc solution lumen, the pneumatic supply lumen, the waste lumen, and the data / electrical conductors 3002 and 3004 are grouped together between the saline lumen and the blood lumen.

[0178] The aforementioned layout is representative rather than restrictive.

[0179] Figures 31A to 31C illustrate a representative leak detection and blocking system 3100 configured to block a lumen after detecting fluid outside the lumen and integrated as an optional feature in any fluid access device and / or fluid access line of the present invention. Detection of fluid outside the fluid access device indicates the intrusion of external fluid (and therefore, a risk of infection), and also indicates that a fluid line may have ruptured (presenting a risk of bleeding in the patient). The leak detection system described herein mitigates these risks.

[0180] The system includes a perforation or aperture 3102 formed in a fluid access line 3104, the perforation or aperture 3102 being in fluid communication with an annular elastic ring 3106 disposed within the fluid access line 3104. The elastic ring 3106 contains a reactive substance 3108 that expands upon exposure to a liquid (e.g., sodium polyacrylate). If a leak occurs outside the fluid access line 3104, the leaking fluid 3110 communicates with the reactive substance 3108 through the perforation or aperture 3102. See Figure 31B. Subsequently, the reactive substance 3108 expands, causing the elastic ring 3106 to expand and block the lumen, thereby stopping the flow of fluid within the fluid access line 3104. See Figure 31C.

[0181] Figure 32 illustrates another representative leak detection and containment system 3200 that can be integrated as one of the optional features in any fluid access device and / or fluid access line of the present invention. The fluid access device or fluid access line 3202 has conductive paths 3204 printed on its inner / outer surface. When liquid is present, it short-circuits the conductive paths 3204, which can be detected by a control circuit to trigger an action / alarm, such as causing one or more in-line valves (or any other valves) to close. In some embodiments, the conductive paths 3204 are formed of a conductive material (such as indium tin oxide) and deposited via a sputtering or screen printing process.

[0182] Figures 33A and 33B illustrate a representative pathogen detection system 3300 that can be integrated as an optional feature into any fluid access device and / or fluid access line of the present invention, configured to detect the presence of at least one pathogen in a lumen and display a visual indicator of the presence of the pathogen.

[0183] Figure 33A illustrates a representative pathogen detection system 3300 suitable for a fluid access line 3302. For example, the fluid access line 3302 may be fluidly connected to both ends of the pathogen detection system 3300. The pathogen detection system 3300 includes a pathogen-sensitive material 3304 fluidly connected to the lumen of the fluid access line 3302. The pathogen-sensitive material 3304 is visible through an observation window 3306 of a housing 3308, allowing an observer to see the pathogen present within the fluid access line 3302. Where appropriate, the pathogen detection system 3300 includes a color sensor 3310 that senses when the pathogen-sensitive material 3304 changes color and causes illumination of a user interface (such as a light source 3312 (e.g., an LED)).

[0184] In Figure 33B, the pathogen detection system 3300 includes a pathogen sensor 3314 operatively connected to one of the light sources 3312. When the pathogen sensor 3314 detects a pathogen in the fluid access line 3302, it causes the user interface (e.g., the light source 3312) to illuminate or otherwise indicate the presence of the pathogen.

[0185] Figure 34 illustrates a representative method of operating a fluid access device. The following steps are performed in the order presented, unless otherwise stated. Any of the following steps may be performed by acting directly on the fluid access device or by causing the fluid access device to perform such steps, such as through a software or firmware application as described above.

[0186] In step 3402, a machine-side hydraulic circuit and a patient-side hydraulic circuit are provided in a fluid access device. In some embodiments, the machine-side hydraulic circuit includes a machine-side input cavity and a machine-side output cavity, and the patient-side hydraulic circuit includes a patient-side input cavity and a patient-side output cavity.

[0187] Next, in an embodiment having one or more closing mechanisms (e.g., one or more gates) located at a fluid interface between the machine-side hydraulic circuit and the patient-side hydraulic circuit, selection step 3404 is performed. In step 3404, the closing mechanism(s) is retracted or causes the fluid access device to retract the closing mechanism(s).

[0188] In step 3406, the machine-side inlet lumen and the patient-side outlet lumen are fluidly coupled (e.g., by coupling two cannulas or by inserting one or more needles through a corresponding diaphragm), and the machine-side outlet lumen is fluidly coupled to the patient-side inlet lumen. Where appropriate, the lumen may be sterilized prior to fluid coupling, for example, by using UV light radiation.

[0189] Next, step 3408 is performed on a fluid access device having a plurality of valves disposed in a hydraulic circuit (i.e., selectively blocking the valves of such hydraulic circuits). Step 3408 includes opening the plurality of valves in the machine-side hydraulic circuit and the patient-side hydraulic circuit, such that the machine-side input lumen, the machine-side output lumen, the patient-side input lumen, and the patient-side output lumen are not blocked.

[0190] Step 3410 includes allowing the biofluid to flow from the patient-side output lumen to the machine-side input lumen, and allowing the biofluid to flow from the machine-side output lumen to the patient-side input lumen. In some embodiments, step 3410 includes allowing undialyzed blood to flow from the patient-side output lumen to the machine-side input lumen, and allowing dialyzed blood to flow from the machine-side output lumen to the patient-side input lumen.

[0191] Figure 35 provides an additional representative method of operating a fluid access device. The following steps are performed in the order presented, unless otherwise stated. Any of the following steps may be performed by acting directly on the fluid access device or by causing the fluid access device to perform such steps, such as through a software or firmware application as described above.

[0192] In step 3502, a machine-side hydraulic circuit and a patient-side hydraulic circuit are provided in a fluid access device. In some embodiments, the machine-side hydraulic circuit includes a machine-side input lumen and a machine-side output lumen, and the patient-side hydraulic circuit includes a patient-side input lumen and a patient-side output lumen.

[0193] Step 3504 includes closing multiple valves in the machine-side hydraulic circuit and the patient-side hydraulic circuit, thereby blocking the machine-side input lumen, the machine-side output lumen, the patient-side input lumen, and the patient-side output lumen.

[0194] In step 3506, the fluid flow in the machine-side inlet lumen and the patient-side outlet lumen is disconnected (e.g., by decoupling the two cannulas or by withdrawing one or more needles from a corresponding diaphragm), and the fluid flow in the machine-side outlet lumen is disconnected from the patient-side inlet lumen. Where appropriate, the lumen may be sterilized, for example, by UV light radiation, before disconnection.

[0195] Next, in an embodiment having one or more closing mechanisms (e.g., one or more gates) located at a fluid interface between the machine-side hydraulic circuit and the patient-side hydraulic circuit, selection step 3508 is performed. In step 3508, the closing mechanism(s) is closed at the fluid interface, sealing or waterproofing at least one of the machine-side or patient-side hydraulic circuits, as appropriate.

[0196] The selection step 3510 can be performed in a fluid access device, for example, having one or more recirculation lumens between a patient-side lumen and / or a machine-side lumen. In these embodiments, the fluid access device (e.g., via a patient-side recirculation lumen) recirculates a biological fluid (such as blood) from a patient-side output lumen to a patient-side input lumen, and / or causes the fluid access device to recirculate a biological fluid from a machine-side output lumen to a machine-side input lumen.

[0197] This invention may also refer to quantities and numbers. Unless specifically stated otherwise, such quantities and numbers should not be considered limiting, but rather indicate possible quantities or numbers associated with this application. Also in this regard, this application may use the term "plural" to refer to a quantity or number. In this respect, the term "plural" means any number more than one, for example, two, three, four, five, etc. The terms "about," "approximately," "close to," etc., mean a value plus or minus 5%. For the purposes of this invention, for example, the phrase "at least one of A, B, and C" means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B, and C), and when more than three elements are listed, all further possible permutations are included.

[0198] The embodiments disclosed herein can utilize circuit systems to implement the techniques and methodologies described herein, operatively connecting two or more components, generating information, determining operational status, controlling an electrical appliance, device, or method, and / or the like. Any type of circuit system can be used. In one embodiment, the circuit system particularly includes one or more computing devices, such as a processor (e.g., a microprocessor), a central processing unit (CPU), a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or the like or any combination thereof, and may include discrete digital or analog circuit elements or electronic devices or combinations thereof.

[0199] In one embodiment, the circuit system includes one or more ASICs having a plurality of predefined logic components. In one embodiment, the circuit system includes one or more FPGAs having a plurality of programmable logic components. In one embodiment, the circuit system includes hardware circuit implementations (e.g., implementations in analog circuit systems, implementations in digital circuit systems, and combinations thereof). In one embodiment, the circuit system includes a combination of circuitry and computer program products (such as those having software or firmware instructions stored on one or more computer-readable memories) that operate together to cause a device to perform one or more methodologies or techniques described herein. In one embodiment, the circuit system includes circuitry requiring software, firmware, and the like for operation, such as (for example) a microprocessor or a portion thereof. In one embodiment, the circuit system includes one or more processors or portions thereof and accompanying software, firmware, hardware, and the like. In one embodiment, the circuit system includes a baseband integrated circuit, an application processor integrated circuit, or a similar integrated circuit, selected from a server, a cellular network device, other network device, or other computing device. In one embodiment, the circuit system includes one or more remote positioning components. In one embodiment, the remote positioning components are operatively connected via wireless communication. In one embodiment, the remote positioning components are operatively connected via one or more receivers, transmitters, transceivers, or the like.

[0200] One embodiment includes one or more data storage devices, such as those storing instructions or data. Non-limiting examples of the one or more data storage devices include volatile memory (e.g., random access memory (RAM), dynamic random access memory (DRAM), or the like), non-volatile memory (e.g., read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), optical disc read-only memory (CD-ROM), or the like), persistent memory, or the like. Further non-limiting examples of the one or more data storage devices include erasable programmable read-only memory (EPROM), flash memory, or the like. The one or more data storage devices may be connected to, for example, one or more computing devices via one or more instruction, data, or power buses.

[0201] In one embodiment, the circuit system includes one or more computer-readable media drivers, interface sockets, universal serial bus (USB) ports, memory card slots, or the like, and one or more input / output components, such as (for example) a graphical user interface, a display, a keyboard, a keypad, a trackball, a joystick, a touchscreen, a mouse, a switch, a dial pad, or the like, and any other peripheral devices. In one embodiment, the circuit system includes one or more user input / output components operatively connected to at least one computing device to control (electrically, electromechanically, software-implemented, firmware-implemented, or other controls, or combinations thereof) one or more embodiments.

[0202] In one embodiment, the circuit system includes a computer-readable media drive or memory slot configured to receive a signal-carrying medium (e.g., computer-readable memory media, computer-readable recording media, or the like). In one embodiment, a program for causing a system to perform any of the disclosed methods may be stored on, for example, a computer-readable recording medium (CRMM), a signal-carrying medium, or the like. Non-limiting examples of signal-carrying media include: a recordable medium, such as any form of flash memory, magnetic tape, floppy disk, a hard disk drive, an optical disc (CD), a digital video disc (DVD), a Blu-ray disc, a digital magnetic tape, a computer memory, or the like; and a transmission medium, such as a digital and / or analog communication medium (e.g., a fiber optic cable, a waveguide, a wired communication link, a wireless communication link (e.g., a transmitter, a receiver, a transceiver, transmission logic, reception logic, etc.)). Further non-limiting examples of signal transmission media include, but are not limited to, DVD-ROM, DVD-RAM, DVD+RW, DVD-RW, DVD-R, DVD+R, CD-ROM, Super Audio CD, CD-R, CD+R, CD+RW, CD-RW, video disc, Super Video disc, flash memory, magnetic tape, magneto-optical disc, mini disk, non-volatile memory card, EEPROM, optical disc, optical storage, RAM, ROM, system memory, web server, or the like.

[0203] The [implementations] described above in conjunction with the accompanying drawings (where the same element symbols refer to the same elements) are intended to be described as one of various embodiments of the invention and are not intended to represent only embodiments. The embodiments described herein are provided as examples or illustrations only and should not be construed as superior or advantageous to other embodiments. The illustrative examples provided herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Similarly, any step described herein may be interchanged with other steps or combinations of steps to achieve the same or substantially similar results. Generally, the embodiments disclosed herein are non-limiting, and the inventors have prudently considered that other embodiments within the scope of the invention may include the structure and functionality of more than one specific embodiment shown in the figures and described in the specification.

[0204] In the foregoing description, specific details are set forth to provide a thorough understanding of one of the exemplary embodiments of the invention. However, those skilled in the art will understand that the embodiments disclosed herein can be practiced without showing all the specific details. In some examples, well-known procedures have not been described in detail to avoid unnecessarily obscuring the various aspects of the invention. Furthermore, it will be understood that additional embodiments of the invention may employ any combination of the features described herein.

[0205] This application may include references to directions, such as "vertical," "horizontal," "front," "back," "left," "right," "top," and "bottom." These references, and other similar references in this application, are intended to aid in the description and understanding of particular embodiments (such as when embodiments are positioned for use) and are not intended to limit the invention to such directions or locations.

[0206] 100: Fluid access device 102: Hemodialysis System 104: Fluid access line / Patient-side fluid access line 106: Machine-side fluid access lines 108: Departure from the organization 110: Hydraulic circuit on the affected side 112: Machine-side hydraulic circuit 202: Machine-side hydraulic circuit 204: Hydraulic circuit on the affected side 206: Machine-side fluid access lines 208: Patient-side fluid access line 210a to 210c: Outer casing 212: Fluid Interface 214: First disconnection mechanism 216: Second disconnection mechanism 218: Application 220: Mobile Device 300: Fluid access device 302: Machine-side hydraulic circuit 304: Hydraulic circuit on the affected side 306: Fluid Interface 308a: Protective casing 308b: Protective casing 310: Base 312: Machine-side input cavity 314: Machine-side output cavity 316: Machine-side recirculation lumen 318: Lock 320a: First valve 320b: Second valve 320c: Third valve 322: Solution supply lumen 324: Waste Material Pipeline 326: Lock 328: Aspiration lumen on the affected side 330: Outflow lumen on the affected side 332: Recirculation lumen on the affected side 334a: First pump 334b: Second pump 336a: First valve 336b: Second valve 336c: Third valve 338: Control Circuit 340: Data / Power Interface 400: Fluid access device 402: Machine-side hydraulic circuit 404: Hydraulic circuit on the affected side 406: Fluid Interface 408: Base 410: Second disconnection mechanism 412: First disconnection mechanism 414: Magnet 416: Machine-side input cavity 418: Machine-side output cavity 420: Machine-side recirculation lumen 422a: First valve 422b: Second valve 422c: Third valve 424: Aspiration lumen on the affected side 426: Outflow lumen on the affected side 428: Recirculation lumen on the affected side 430a: First valve 430b: Second valve 430c: Third valve 432a: Retractable sleeve 432b: Retractable sleeve 434a: Door blocking 434b: Door Block 500: Base 502: Outer casing 504a: Holding mechanism 504b: Maintaining mechanism 506a: Sensor 508: Data / Power Interface 510a to 510f: Valve actuators 512a: Closing Mechanism Actuator 514a: Disinfection Module 516a: Pump plunger 516b: Pump plunger 600: Fluid access device 602: Machine-side hydraulic circuit 604: Hydraulic circuit on the affected side 606a: Retractable sleeve 606b: Retractable sleeve 608: Fluid Interface 610: Machine-side input cavity 612: Outflow lumen on the affected side 614: Fluid 616a: Valve 616b: Valve 616c: Valve 616d: Valve 616e: Valve 616f: Valve 618: Aspiration lumen on the affected side 620: Machine-side output cavity 624: Machine-side recirculation lumen 626: Recirculation lumen on the affected side 628: Solution hydraulic circuit 630a: Closing Mechanism 630b: Closing Mechanism 632: Maintaining the organization 634a: Pump Interface 634b: Pump Interface 700: Fluid Access Device 1300: Fluid Access Device 1302: Hydraulic circuit on the affected side 1304: Machine-side hydraulic circuit 1306: Lead screw 1308: Threaded portion 1310: Needle 1312: Needle 1314: Self-healing diaphragm 1316: Self-healing diaphragm 1318: Blocking the door 1320: Blocking the door 1400: Fluid access device 1402: Hydraulic circuit on the affected side 1404: Machine-side hydraulic circuit 1406: Electrical contacts 1408: Electrical Contacts 1410: Motor 1412: Blocking the door 1500: Fluid access device 1502: Machine-side hydraulic circuit 1504: Needle 1506: Needle 1508: Hydraulic circuit on the affected side 1510: Sales 1512: Fluid access pipeline 1514: Fluid access pipeline 1516: Intra-tubular valve 1518: Intra-tubular valve 1600: Fluid access device 1601: Fluid Supply Module 1604: Machine-side input cavity 1606: Machine-side output cavity 1608: First manifold pipe 1610: Check valve 1612: Check valve 1614: Second manifold pipe 1616: Check valve 1618: Check valve 1620: Check valve 1622: Check valve 1624: Third manifold pipe 1626: First solution pipeline 1628: Second solution pipeline 1630: Third solution pipeline 1700: Fluid access device 1702: Needle 1704: Needle 1706: Recirculation Bridge 1708: Outer shell 1710: Self-healing diaphragm 1712: Self-healing diaphragm 1800: Fluid access device 1802: Recirculation Bridge 1808: Fluid Access Device 1810: Skin entry / exit points 1812: Flexible film 1814: Check valve 1816: Check valve 1900: Electronic Module 1904: Outflow lumen on the affected side 1906: Aspiration lumen on the affected side 1908: Blood Channel 1910:Film 1912: Dating Interface 1914: Piston 1916: Motor 1918: Linkage 1920: Onboard Battery 1922: Pressure Sensor 1924: Optical Sensor 2002: Blood Storage Device 2004: Fluid Access Device 2006: Fluid Access Piping 2008: Fluid Coupling Components 2100: Blood Sampling Device 2101: Fluid access device 2102: Capillary 2104: In / Output Location 2106: Catheter for Patients 2108: Pipe Inlet 2110: Centering device 2112: UV radiation source 2200: Departure from the organization 2202: Fluid access pipeline 2204: Machine-side connector 2206: Patient-side connector 2300: Departure from the organization 2302: Ring-shaped shell 2304: Machine-side fluid access lines 2308: Weakened Area 2310: Valve 2312: Hinges 2314: Magnet 2402: Fluid access pipeline 2404: Lumen wall on the affected side 2406: Machine side tube wall 2408: First weakened region 2410: Second weakened region 2412: First chemical component 2414: Second chemical component 2416: Elastic film 2500: Intra-pipe valve 2502: Elastic Balloon 2504: Tube wall 2506: Pneumatic Pipeline 2508: Pressure regulating device 2600: Intra-pipe valve 2602: Flexible expandable sleeve 2604: Tube wall 2606: Tube inside the lumen 2608: Reactive substances 2610: Weakened wall section 2700: Intra-tubular valve 2702: Umbrella-shaped object 2704: Flexible Enclosure 2706: Guide wire 2800: Intra-pipe valve 2802: Umbrella-shaped object 2804: First End 2806: Second End 2808: Guide wire 2900: Fluid Access Line 2902: Intra-tubular valve 2904: First lumen 2906: Second lumen 2908: Intra-tubular valve 3000: Fluid Access Line 3002: Data / Power Wires 3004: Data / Power Conductors 3100: Leak Detection and Containment System 3102: Perforation / Hole 3104: Fluid access lines 3106: Annular elastic ring 3108: Reactive substances 3110: Leaked fluid 3200: Leak Detection and Containment System 3202: Fluid access pipeline 3204: Conductive path 3300: Pathogen Detection System 3302: Fluid access pipeline 3304: Pathogen-Sensitive Materials 3306: Observation Window 3310: Color Sensor 3312: Light source 3314: Pathogen Sensor 3402: Steps 3404: Steps 3406: Steps 3408: Steps 3410: Steps 3502: Steps 3504: Steps 3506: Steps 3508: Steps 3510: Steps

Claims

1. A fluid access device configurable between a connected state and a disconnected state, comprising: A first housing enclosing a machine-side hydraulic circuit, the first housing including a distal end and a proximal end; the machine-side hydraulic circuit including a machine-side input lumen extending from the proximal end to the distal end of the first housing within the first housing and a machine-side output lumen extending from the proximal end to the distal end of the first housing within the first housing, and a machine-side recirculation lumen enclosing the first housing and connecting the machine-side input lumen to the machine-side output lumen; a second housing enclosing a patient-side hydraulic circuit, the second housing including a distal end and a proximal end; The patient-side hydraulic circuit includes a patient-side input lumen extending from the proximal end to the distal end of the second housing within the second housing, and a patient-side output lumen extending from the proximal end to the distal end of the second housing within the second housing, and a patient-side recirculation lumen surrounding the second housing and connecting the patient-side input lumen to the patient-side output lumen; and one or more locks or retaining mechanisms that secure the first housing to the second housing to create a fluid interface between the distal end of the first housing and the distal end of the second housing, wherein the one or more locks or retaining mechanisms are disengaged to separate the first housing from the second housing, wherein in the connected state of the fluid access device, the machine-side input lumen and the machine-side output lumen are adjacent to the patient-side output lumen and the patient-side input lumen at the fluid interface, and the machine-side input lumen is fluidly coupled to the patient-side output lumen, and the machine-side output lumen is fluidly coupled to the patient-side input lumen. In the disconnected state of the fluid access device, the machine-side input lumen is not fluidly coupled to the patient-side output lumen, and the machine-side output lumen is not fluidly coupled to the patient-side input lumen.

2. The fluid access device of claim 1, further comprising a closing mechanism configured to block fluid coupling between at least one of the machine-side input lumen and the patient-side output lumen or the machine-side output lumen and the patient-side input lumen, wherein in the connected state, the closing mechanism does not block fluid coupling between the machine-side input lumen and the patient-side output lumen or the machine-side output lumen and the patient-side input lumen.

3. The fluid access device of claim 2, wherein the closing mechanism is configured to seal at least one of the distal ends of a machine-side input lumen, a machine-side output lumen, a patient-side input lumen, or a patient-side output lumen when the fluid access device transitions from the connected state to the disconnected state.

4. The fluid access device of claim 2, wherein the fluid access device is configured to retract the closing mechanism from at least one of a distal end of a machine-side input lumen, a distal end of a machine-side output lumen, a distal end of a patient-side input lumen, or a distal end of a patient-side output lumen when the fluid access device transitions from the disconnected state to the connected state.

5. The fluid access device as claimed in claim 4, wherein the fluid access device is configured to electrically couple the machine-side hydraulic circuit to the patient-side hydraulic circuit when the fluid access device transitions from the disconnected state to the connected state.

6. The fluid access device of claim 2, wherein the patient-side hydraulic circuit further includes a sensor configured to detect at least one of the following: a pathogen, a temperature of a biological fluid, a color of the biological fluid, a pressure of the biological fluid, or a clarity of the biological fluid.

7. The fluid access device of claim 6, wherein the sensor is disposed along the recirculation lumen on the affected side.

8. The fluid access device of claim 6, wherein the sensor is housed in an electronic module reversibly coupled to an interface with a recirculation lumen on the affected side.

9. The fluid access device of claim 1, wherein the patient-side recirculation lumen is a removable recirculation lumen that fluidly connects the patient-side input lumen to one of the patient-side output lumen.

10. The fluid access device of claim 1, wherein the patient-side hydraulic circuit includes a pump configured to pump fluid from the patient-side output cavity to the patient-side input cavity via the patient-side recirculation cavity.

11. The fluid access device as claimed in claim 10, wherein the pump is configured to draw power from the machine-side hydraulic circuit.

12. The fluid access device of claim 1, wherein each of the machine-side recirculation lumen and the patient-side recirculation lumen includes a valve operable to be configured to block the machine-side recirculation lumen and the patient-side recirculation lumen, respectively.

13. The fluid access device of claim 1, wherein the patient-side hydraulic circuit includes a first plurality of valves, each of the first plurality of valves being configured to selectively open the patient-side input lumen and selectively open the patient-side output lumen.

14. The fluid access device of claim 13, wherein the first plurality of valves are simultaneously actuated by a control circuit disposed in the fluid access device between a connected state valve configuration and a disconnected state valve configuration, wherein in the connected state valve configuration, the first plurality of valves do not obstruct the patient-side input lumen and the patient-side output lumen, wherein in the disconnected state valve configuration, the first plurality of valves obstruct the patient-side input lumen and the patient-side output lumen.

15. The fluid access device of claim 14, wherein the patient-side hydraulic circuit includes a pump configured to pump fluid from the patient-side output cavity to the patient-side input cavity via the patient-side recirculation cavity when the first plurality of valves are in the open state valve configuration.

16. The fluid access device of claim 14, wherein the machine-side hydraulic circuit includes a second plurality of valves, each of the second plurality of valves being configured to selectively open the machine-side input lumen and selectively open the machine-side output lumen.

17. The fluid access device of claim 16, wherein the second plurality of valves are simultaneously actuated by the control circuit between a connected state valve configuration and a disconnected state valve configuration, wherein in the connected state valve configuration, the second plurality of valves do not obstruct the machine-side input lumen and the machine-side output lumen, and wherein in the disconnected state valve configuration, the second plurality of valves obstruct the machine-side input lumen and the machine-side output lumen.

18. The fluid access device of claim 1, further comprising an electronic module including a patient fluid channel connected to the patient-side hydraulic circuit, and a sensor disposed along the patient fluid channel, wherein the sensor is configured to detect at least one of: a pathogen in the patient fluid channel, a temperature of a biological fluid in the patient fluid channel, a color of the biological fluid in the patient fluid channel, or a clarity of the biological fluid in the patient fluid channel.

19. The fluid access device of claim 18, wherein the electronic module is disposed along the patient-side recirculation lumen bridging the patient-side input lumen and the patient-side output lumen.

20. The fluid access device of claim 18, wherein the electronic module is reversibly coupled to a docking interface of one of the patient-side hydraulic circuits.

21. The fluid access device of claim 1, wherein the machine-side hydraulic circuit includes a manifold that fluidly couples the machine-side input lumen and the machine-side output lumen to at least one fluid conduit, wherein a plurality of valves regulate fluid flow between the manifold and the machine-side input lumen and the machine-side output lumen.

22. The fluid access device of claim 21, wherein the at least one fluid conduit comprises at least one of a loc solution conduit, a brine solution conduit, or a waste liquid conduit.

23. The fluid access device of claim 1, further comprising a base, wherein the one or more retaining mechanisms include a first retaining mechanism for locking the first housing to the base and a second retaining mechanism for locking the second housing to the base.

24. A fluid access system comprising the fluid access device as claimed in claim 21 and a fluid supply module configured to supply at least one fluid to the manifold of the machine-side hydraulic circuit and / or receive at least one fluid from the manifold of the machine-side hydraulic circuit.

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