Disposable Cartridge and Pump Orbital Mechanism

Abstract

Disclosed are exemplary embodiments of a dialysis machine having a frame, a cartridge cassette, one or more alignment and locking features, and an actuation mechanism. The frame is fixedly coupled to the dialysis machine, and the cassette is slidably coupled to the frame. The cassette can have one or more track structures, each having a rotor and one or more rollers. The one or more alignment and locking features extend from the frame and are configured to be inserted into one or more alignment features of the disposable cartridge, which function to secure or release the disposable cartridge. The actuation mechanism is configured to slide the cassette relative to the one or more track structures.

Description

[Technical field]

[0001] The present invention relates to an artificial kidney system for use in providing dialysis. In some embodiments, the present disclosure is directed to a hemodialysis system having an actuatable platform to allow for easy placement of a disposable cartridge. [Background technology]

[0002] Hemodialysis is a medical procedure used to achieve extracorporeal removal of waste products, including creatine, urea, and free water, from a patient's blood, involving diffusion of solutes across a semi-permeable membrane. Failure to adequately remove these waste products can lead to renal failure.

[0003] During hemodialysis, the patient's blood is removed through an arterial line, treated by a dialysis machine, and returned to the body through a venous line. The dialysis machine includes a dialyzer, which contains a number of hollow fibers that form a semi-permeable membrane through which the blood is transported. In addition, the dialysis machine utilizes a dialysate liquid that contains the appropriate amount of electrolytes and other vital components (such as glucose) and is pumped through the dialyzer.

[0004] Typically, the dialysis solution is prepared by mixing water with the appropriate proportions of acid and bicarbonate concentrates. Preferably, the acid and bicarbonate concentrates are separated until final mixing immediately prior to use in the dialyzer, since the calcium and magnesium in the acid concentrate will precipitate when in contact with the high bicarbonate levels in the bicarbonate concentrate. The dialysis solution may also contain appropriate levels of sodium, potassium, chloride, and glucose.

[0005] The dialysis process across the membrane is accomplished by a combination of diffusion and convection. Diffusion involves the migration of molecules by random motion from areas of high concentration to areas of low concentration, while convection typically involves the movement of solutes in response to differences in hydrostatic pressure. The fibers that form the semipermeable membrane separate the plasma from the dialysate, allowing waste products including urea, potassium, and phosphate to permeate into the dialysate while providing a larger surface area for diffusion to occur, preventing the transport of larger molecules such as blood cells, polypeptides, and certain proteins into the dialysate.

[0006] Typically, the dialysate flows in the extracorporeal circuit in a countercurrent direction to the blood flow. The countercurrent flow maintains a concentration gradient across the semi-permeable membrane to improve the efficiency of dialysis. In some cases, hemodialysis can provide fluid removal, also referred to as ultrafiltration. Ultrafiltration is generally accomplished by lowering the hydrostatic pressure in the dialysate compartment of the dialyzer, thus allowing water containing dissolved solutes, including electrolytes and other osmotic substances, to move from the plasma across the membrane to the dialysate. In more rare circumstances, the fluid in the dialysate flow path portion of the dialyzer is higher than the blood flow portion, causing fluid to move from the dialysate flow path to the blood flow path. This is generally referred to as reverse ultrafiltration. Because ultrafiltration and reverse ultrafiltration can increase risks to the patient, ultrafiltration and reverse ultrafiltration are typically performed only while supervised by highly trained medical personnel.

[0007] Unfortunately, hemodialysis suffers from a number of drawbacks. An arteriovenous fistula is the most commonly recognized access point. To create an arteriovenous fistula, a physician splices an artery and a vein together. Because this process bypasses the patient's capillaries, blood flows rapidly. For each dialysis session, the arteriovenous fistula must be punctured with a large needle to deliver blood into the dialyzer, from which it must then be returned. Typically, the procedure is performed three times a week, for three to four hours per treatment. To a lesser extent, patients perform hemodialysis at home. Home hemodialysis is typically performed six days a week, for two hours. Home hemodialysis is typically considered less stressful and more simple than that performed with a catheter. However, home hemodialysis requires more frequent treatments.

[0008] Home hemodialysis still suffers from additional drawbacks. The home hemodialysis systems are large, complex, intimidating, and difficult to operate. The equipment requires significant training. Home hemodialysis systems are currently too large to be portable, thereby discouraging hemodialysis patients from traveling. Home hemodialysis systems are expensive and require a high initial financial investment, especially compared to in-center hemodialysis, where patients are not required to pay for the machines. The home hemodialysis systems do not adequately provide for reuse of consumables, making home hemodialysis less economically viable for medical supply providers. Because of the drawbacks stated above, very few patients are motivated to go through the rigors of home hemodialysis.

[0009] Thus, there is a significant need for a hemodialysis system that is portable, lightweight, easy to use, and patient friendly, thus enabling in-home use. Summary of the Invention [Means for solving the problem]

[0010] Disclosed herein are examples of dialysis systems. In one embodiment, the dialysis system includes a disposable cartridge with a housing and first, second, and third sets of tubing lines mounted on the housing. Each set of tubing lines has a U-shaped section designed to reside in a recessed track of a dialysis machine. The housing can have two or more alignment features designed to receive alignment locking features from the dialysis system. The alignment locking features are designed to pull the housing of the cartridge into the cavity of the dialysis machine. This action secures the housing to the frame of the dialysis machine.

[0011] The two or more alignment features can be slots, holes, cylindrical features that reside on the dialysis machine. The alignment locking feature can be a pin with actuatable side fingers designed to extend outward to grip on the housing of the disposable cartridge when the pin is pulled away from the housing. The actuatable side fingers of the pin are also designed to fold inward when the pin is pushed forward toward the housing.

[0012] In some embodiments, the dialysis system also includes an actuation mechanism and a cassette having a recessed track for receiving the first, second, and third sets of tubing lines. The cassette can be slidably mounted to the cartridge cavity or the frame of the dialysis machine. When actuated, the actuation mechanism is designed to slide the cassette and engage or disengage the tubing lines. In some embodiments, when set to a locked state, the actuation mechanism is designed to slide the cassette inward and push the set of tubing lines against the rollers.

[0013] The actuation mechanism is also designed to slide the cassette outward and relieve pressure on the set of tubing lines when set in the open state, hi some embodiments, the actuation mechanism is designed to push the pin forward and retract the side fingers when set in the locked state.

[0014] When set in the open state, the actuation mechanism is designed to pull the pin rearward and expand the side fingers. In some embodiments, the actuation mechanism includes a lever coupled to the first shaft, a first cam coupled to the first shaft, a number of links coupled to the first cam, and a sliding element coupled to the number of links and the cassette. The number of links are arranged such that the cassette slides inward or outward when the lever is actuated.

[0015] The actuation mechanism further includes a gear assembly coupled to the first shaft, a second shaft coupled to the gear assembly, a second cam coupled to the second shaft, and a pull plate coupled to the second cam and a pin (e.g., a matching locking feature). The pull plate and pin are actuated in parallel forward or backward when the lever is actuated.

[0016] The dialysis machine can include a frame fixedly coupled to the dialysis machine and a cassette slidably coupled to the frame. The cassette can include one or more track structures, each having a rotor and one or more rollers. The dialysis machine also includes one or more matching locking features extending from the frame and the actuation mechanism. The one or more matching locking features are designed to be inserted into one or more matching features of a disposable cartridge. Once inserted, the matching locking features can secure or release the disposable cartridge.

[0017] The actuation mechanism is fabricated to slide the cassette against one or more track structures, actuating one or more matching locking features, and either securing or releasing the disposable cartridge. The actuation mechanism can include a linkage assembly designed and engineered to translate the cassette, actuating one or more matching locking features, and locking or releasing the disposable cartridge while the frame remains stationary. The linkage assembly is designed to slide the cassette inwardly and press the set of tubing lines against the rollers and the inner wall of the recessed track when the linkage assembly is set to a closed state. The linkage assembly is also designed to slide the cassette outwardly and release pressure on the set of tubing lines when the linkage assembly is set to an open state.

[0018] The linkage assembly is designed (and fabricated) to push the pin forward and retract the side fingers when set to the locked state. The linkage assembly is also designed to pull the pin rearward and expand the side fingers when set to the open state. The linkage assembly can also include a lever coupled to the first shaft, a first cam coupled to the first shaft, a plurality of links coupled to the first cam, and a sliding element coupled to the plurality of links and the cassette. The plurality of links can be arranged such that the cassette slides inward or outward when the lever is actuated.

[0019] In some embodiments, the linking assembly further includes a gear assembly coupled to the first shaft, a second shaft coupled to the gear assembly, a second cam coupled to the second shaft, and a pull plate coupled to the second cam and pin, the pull plate and pin being actuated forward or backward in parallel when the lever is actuated. The dialysis machine also includes a disposable cartridge having a housing that may have one or more alignment features designed to receive one or more alignment locking features from the frame of the dialysis machine. The dialysis machine also includes a first, second, and third set of tubing lines coupled onto the housing. Each set of tubing lines may have a U-shaped section designed to reside in one or more track structures of the cassette.

[0020] In some embodiments, the actuation mechanism can be a set of one or more motors configured to translate the cassette relative to the frame and advance or retract the pull pins to release or capture the disposable cartridge. The set of one or more motors can be coupled to a controller configured to control the actuation of the cassette and the multiple pull pins.

[0021] The features and advantages described herein are not all-inclusive, and in particular many additional features and advantages will become apparent to those skilled in the art in light of the drawings, specification, and claims. It should also be noted that the language used within this specification has been selected primarily for readability and instructional purposes, and may not have been selected to bound or delimit the disclosed subject matter. The present invention provides, for example, the following items. (Item 1) 1. A dialysis system comprising: 1. A disposable cartridge, the disposable cartridge comprising: a housing having two or more matching features; first, second, and third sets of tubing lines mounted on the housing, each set of tubing lines comprising a U-shaped section configured to reside within a recessed track of a dialysis machine; Equipped with the two or more alignment features are configured to receive alignment locking features from the dialysis machine, the alignment locking features being configured to draw the housing into a cartridge cavity of the dialysis machine and secure the housing. A dialysis system comprising: (Item 2) 2. The dialysis system of claim 1, wherein each of the two or more alignment features comprises a slot or a hole. (Item 3) 2. The dialysis system of claim 1, wherein the alignment locking feature comprises a pin having an actuatable side finger. (Item 4) 4. The dialysis system of claim 3, wherein the actuatable side fingers of the pin are configured to extend outwardly to grip onto the housing of the disposable cartridge when the pin pull rod is pulled away from the housing. (Item 5) Item 4. The dialysis system of item 3, wherein the actuatable side fingers of the pin are configured to fold inwardly when the pull rod of the pin is pushed forward toward the housing. (Item 6) An actuation mechanism; a cassette having the recessed tracks for receiving the first, second, and third sets of tubing lines, the cassette being slidably mounted in a cartridge cavity of the dialysis machine, the actuation mechanism being configured to slide the cassette when actuated; 4. The dialysis system of item 3, further comprising: (Item 7) 7. The dialysis system of claim 6, wherein the actuation mechanism is configured to slide the cassette inward and push the set of tubing lines against rollers when the actuation mechanism is set in a locked state. (Item 8) 7. The dialysis system of claim 6, wherein the actuation mechanism, when set to an open state, is configured to slide the cassette outward and relieve pressure on the set of tubing lines. (Item 9) 7. The dialysis system of claim 6, wherein the actuation mechanism is configured to push the pin forward and retract the side fingers when set in a locked state. (Item 10) 7. The dialysis system of claim 6, wherein the actuation mechanism, when set in an open state, is configured to retract the pin rearward and expand the side fingers. (Item 11) The actuation mechanism includes: a lever coupled to the first shaft; a first cam coupled to the first shaft; A plurality of connectors coupled to the first cam; a sliding element coupled to the plurality of connectors and the cassette, the plurality of connectors being arranged such that the cassette slides inwardly or outwardly when the lever is actuated; 7. The dialysis system according to item 6, comprising: (Item 12) The actuation mechanism further comprises: a gear assembly coupled to the first shaft; a second shaft coupled to the gear assembly; and a second cam coupled to the second shaft; a pull plate coupled to the second cam and the pin, the pull plate and the pin being actuated in parallel forward or backward when the lever is actuated; Item 12. The dialysis system according to item 11, comprising: (Item 13) A dialysis machine comprising: a frame fixedly coupled to the dialysis machine; a cassette slidably coupled to the frame, the cassette comprising one or more track structures, each of the one or more track structures comprising a rotor and one or more rollers; one or more matching locking features extending from the frame, the one or more matching locking features configured to be inserted into one or more matching features of a disposable cartridge to secure or release the disposable cartridge; an actuation mechanism configured to slide the cassette relative to the one or more track structures and actuate the one or more matching locking features to either secure or release the disposable cartridge; A dialysis machine comprising: (Item 14) Item 14. The dialysis machine of item 13, wherein the actuation mechanism comprises a linkage assembly configured to translate the cassette while the frame remains stationary, actuate the one or more matching locking features, and lock or release the disposable cartridge. (Item 15) Item 15. The dialysis machine of item 14, wherein the coupling assembly is configured, when set in a locked state, to slide the cassette inwardly and push the set of tubing lines against the pump motor. (Item 16) Item 15. The dialysis machine of item 14, wherein the connection assembly, when set in an open state, is configured to slide the cassette outwardly and relieve pressure on the set of tubing lines. (Item 17) Item 15. The dialysis machine of item 14, wherein the coupling assembly is configured to push the pin forward and retract the side fingers when set in a locked state. (Item 18) Item 15. The dialysis machine of item 14, wherein the coupling assembly is configured to retract the pin rearward and expand the side fingers when set in an open state. (Item 19) The connection assembly includes: a lever coupled to the first shaft; a first cam coupled to the first shaft; A plurality of connectors coupled to the first cam; a sliding element coupled to the plurality of connectors and the cassette, the plurality of connectors being arranged such that the cassette slides inwardly or outwardly when the lever is actuated; Item 15. The dialysis machine according to item 14, comprising: (Item 20) The connection assembly further comprises: a gear assembly coupled to the first shaft; a second shaft coupled to the gear assembly; and a second cam coupled to the second shaft; a pull plate coupled to the second cam and the pin, the pull plate and the pin being actuated in parallel forward or backward when the lever is actuated; 20. The dialysis machine according to item 19, comprising: (Item 21) 1. A disposable cartridge, the disposable cartridge comprising: a housing having one or more alignment features configured to receive the one or more alignment locking features from a frame of the dialysis machine; first, second, and third sets of tubing lines mounted on the housing, each set of tubing lines comprising a U-shaped section configured to reside in one or more track structures of the cassette; A disposable cartridge comprising: Item 14. The dialysis machine according to item 13, further comprising: (Item 22) The actuation mechanism includes: a first set of one or more motors configured to slide the cassette relative to the one or more track structures; a second set of one or more motors configured to actuate the one or more matching locking features to either secure or release the disposable cartridge; Item 14. The dialysis machine according to item 13, comprising: [Brief description of the drawings]

[0022] The foregoing summary, as well as the following detailed description, will be better understood when read in conjunction with the accompanying drawings, which are incorporated in and form a part of this specification, illustrate several embodiments and, together with the description, serve to further explain the principles involved and to enable those skilled in the art to make and use the disclosed technology.

[0023] [Figure 1A] FIG. 1A is a side view of a disposable cartridge according to some embodiments of the present disclosure.

[0024] [Figure 1B] FIG. 1B is a perspective view of the disposable cartridge of FIG. 1A according to some embodiments of the present disclosure.

[0025] [Figure 1C] FIG. 1C is a perspective view of one of the sensors according to some embodiments of the present disclosure.

[0026] [Figure 1D] FIG. 1D is a perspective view of the sensor of FIG. 1C on a dialysis machine according to some embodiments of the present disclosure.

[0027] [Figure 1E] FIG. 1E is a side view of a disposable cartridge according to some embodiments of the present disclosure.

[0028] [Figure 2A] 2A and 2B are side views of a pump raceway structure according to some embodiments of the present disclosure. [Figure 2B] 2A and 2B are side views of a pump raceway structure according to some embodiments of the present disclosure.

[0029] [Figure 3A]3A, 3B, 3C, 3D, 3E, 3F, and 3G are perspective front and rear views of the pump raceway structure of FIG. 2A according to some embodiments of the present disclosure. [Figure 3B] 3A, 3B, 3C, 3D, 3E, 3F, and 3G are perspective front and rear views of the pump raceway structure of FIG. 2A according to some embodiments of the present disclosure. [Figure 3C] 3A, 3B, 3C, 3D, 3E, 3F, and 3G are perspective front and rear views of the pump raceway structure of FIG. 2A according to some embodiments of the present disclosure. [Figure 3D] 3A, 3B, 3C, 3D, 3E, 3F, and 3G are perspective front and rear views of the pump raceway structure of FIG. 2A according to some embodiments of the present disclosure. [Figure 3E] 3A, 3B, 3C, 3D, 3E, 3F, and 3G are perspective front and rear views of the pump raceway structure of FIG. 2A according to some embodiments of the present disclosure. [Figure 3F] 3A, 3B, 3C, 3D, 3E, 3F, and 3G are perspective front and rear views of the pump raceway structure of FIG. 2A according to some embodiments of the present disclosure. [Figure 3G] 3A, 3B, 3C, 3D, 3E, 3F, and 3G are perspective front and rear views of the pump raceway structure of FIG. 2A according to some embodiments of the present disclosure.

[0030] [Figure 4A] FIG. 4A is a perspective view of a dialysis machine from the back according to some embodiments of the present disclosure.

[0031] [Figure 4B] FIG. 4B is a perspective view of the dialysis machine shown in FIG. 4A without the pimple plate according to some embodiments of the present disclosure.

[0032] [Figure 4C] FIG. 4C is an enlarged view of the cross section of the dialysis machine shown in FIG. 4B.

[0033] [Figure 4D] 4D and 4E are perspective views of the dialysis machine shown in FIG. 4A from the front, according to some embodiments of the present disclosure. [Figure 4E] 4D and 4E are perspective views of the dialysis machine shown in FIG. 4A from the front, according to some embodiments of the present disclosure.

[0034] [Figure 5A] 5A and 5B are perspective views of an actuation mechanism according to some embodiments of the present disclosure. [Figure 5B] 5A and 5B are perspective views of an actuation mechanism according to some embodiments of the present disclosure.

[0035] [Figure 6A] FIG. 6A is a perspective view of an alignment lock pin according to some embodiments of the present disclosure.

[0036] [Figure 6B] FIG. 6B is a side view of the alignment lock pin shown in FIG. 6A.

[0037] [Figure 6C] FIG. 6C is a side cutaway view of the alignment lock pin shown in FIG. 6A according to some embodiments of the present disclosure.

[0038] The figures and the following description illustrate certain embodiments by way of example only. Those skilled in the art will immediately recognize from the following description that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles described herein. Reference will now be made in detail to several embodiments, examples of which are illustrated in the accompanying figures. It should be noted that where practical, like or similar reference numerals may be used in the figures to indicate like or similar functionality. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] Detailed Description (Disposable cartridges) The disposable cartridge is one of the most important parts of the dialysis system, since it contains the fluid pathways that are in direct contact with the patient's blood. For this reason, the pathways need to be clean and free of foreign matter. The disposable needs to be tightly coupled to the machine so that sensors and actuators can interface with the disposable in a reliable manner. Finally, the disposable is one of the major contributors to the cost of the treatment, and therefore needs to be inexpensive.

[0040] 1A and 1B illustrate a disposable cartridge 100 according to some embodiments of the present disclosure. FIG. 1A is a top view of the disposable cartridge 100, and FIG. 1B is a perspective view of the disposable cartridge 100, both of which will be discussed in parallel. The disposable cartridge 100 can include a housing 105, a tubing support structure 125, floating suspension structures 160 and 165, and tubing lines 110a, 110b, and 110c. The housing 105 can be made from an inexpensive and recyclable material such as plastic. The housing 105 can include multiple alignment features (not shown) configured to aid in the alignment of the housing 105 onto the body of the dialysis machine. The housing 105 can also include multiple alignment features 117 to aid in the alignment of the tubing support structure 125 onto the housing 105. The tubing support structure 125 can have a number of built-in couplings 130a-130f configured to receive the openings of the tubing lines 110a, 110b, and 110c and hold them tightly in place while allowing fluid to pass therethrough.

[0041] The tubing lines 110 (i.e., 110a, 110b, 110c) can have a predetermined path having an overall shape, such as, but not limited to, a U-shape. The path of the tubing lines 110 can have other shapes, such as, for example, a semicircle.

[0042] The disposable cartridge 100 can have one or more tubing lines (i.e., 110a, 110b, 110c) that can carry blood from a patient's artery, blood to a patient's vein, dialysate to a dialyzer, or dialysate from a dialyzer. For example, the disposable cartridge 100 can have two tubing lines 110a and 110b. In another embodiment, the disposable cartridge 100 can have four tubing lines. As shown, the disposable cartridge 100 has three tubing lines that are coupled onto the tubing support structure 125 by couplings 130a-130f. Each tubing line is secured and held in place by two couplings. The tubing lines 110 can be made of medical grade PVC or other flexible materials such as rubber.

[0043] In some embodiments, coupling 130a can receive blood from an arterial blood line, and coupling 130f can be directly or indirectly coupled to a venous blood line. The fluid paths can also be reversed. For example, coupling 130f can receive blood from an arterial blood line, and coupling 130a can be directly or indirectly coupled to a venous blood line. In some embodiments, instead of blood, dialysate can be pumped into one or more of tubing lines 110a, 110b, and 110c. Dialysate can also be pumped into heating bag 140 instead of the patient's blood. If dialysate is used in one of these paths, one skilled in the art will understand that adding additional tubing lines in sequence will properly run dialysate and blood from one of the other paths to the dialyzer (not shown).

[0044] In some embodiments, the disposable cartridge 100 can include one or more additional tubing lines (not shown) connecting the coupling pairs 130b-130c and 130d-130e. The disposable cartridge 100 can also include additional tubing lines (not shown) connecting the outlet 135 at the coupling 130f directly or indirectly to the inlet of the heater bag 140 (not shown). Alternatively, the outlet 137 at the coupling 130a can be coupled to the inlet of the heater bag 140 using an additional tubing line (not shown). Although not shown, there can be one or more intermediate components (e.g., valves, couplings, pumps, dialyzers, tubing lines) between the outlet 135 and the inlet of the heating bag 140. For example, there can be a tubing line extending from the outlet 130f to the opposite side of the main surface 145 of the housing 105 and back into the inlet 147 of the heating bag 140. Major surface 145 is the surface of housing 105 that faces tubing line 110 in direction 150 (see FIG. 1B).

[0045] 1B, the disposable cartridge 100 can optionally include a heating bag 140 that can be hingedly mounted to a major surface 145 of the housing 105 (hinges not shown). This allows the heating bag 140 the ability to lie flat against the major surface 145 and to rock perpendicular to the major surface (parallel to direction 150), as illustrated in FIG. 1B. The heating bag 140 can be secured to the major surface 145 in two or more locations, which can also be fittings formed on the major surface 145. The heating bag 140 includes an inlet fitting 147 and an outlet fitting 148, both of which can also function as anchors to support and anchor the heating bag 140 on the major surface 145.

[0046] The heating bag 140 can include an internal channel with a pattern 152. The internal channel is designed to provide a large surface area across which blood can flow and be easily heated by the large surface area of ​​the channel. When the disposable cartridge 100 is disposed on the dialysis machine, the cartridge 100 is inserted on the dialysis machine in a direction 150 that is normal to the main surface 145. As the disposable cartridge 100 is disposed, the heating bag 140 is inserted into a slot on the dialysis machine. The slot can include one or more heating elements that provide heat to the heating bag 140, which can have an outer layer made of a thermally conductive material (e.g., aluminum, copper). The pattern 152 can have a continuous "S" pattern as shown. Alternatively, the pattern 152 can have a circular, zigzag, or spiral pattern.

[0047] In some embodiments, the heating bag 140 can include its own heating element disposed on an outer surface of the heating bag 140. However, because the cartridge 100 is a disposable cartridge, the heating element can be disposed on the dialysis machine, and the heating bag 140 can be made from an inexpensive material, such as polyvinyl chloride (PVC) or other medical grade plastic.

[0048] The couplings 147 and 148 can be pivotable couplings such that the heating bag 140 can be folded generally parallel to the major surface 145 during shipping or packaging. Alternatively, the heating bag 140 can be secured and coupled to the couplings 147 and 148 during the installation process of the disposable cartridge 100.

[0049] 1A, the tubing support structure 125 can include two spring members 160 and 165. The spring member 160 can be pivotally attached to a pivot point 162, and the spring member 165 can be pivotally attached to a pivot point 167. Each spring member can be made of plastic, metal, or other suitable material. In some embodiments, the spring members 160 and 165 are made of the same material as the tubing support structure 125, which can be molded, machined, or 3D printed with high precision using medical grade (FDA approved) plastic. In other words, the tubing support structure 125 and the spring members 160 and 165 can be a single integrated unit. The spring members 160 and 165 can be designed to have a natural spring constant (e.g., k constant) such that the tubing support structure 125 is constantly urged toward a direction 170 that is parallel to the main surface 145 of the housing 105.

[0050] Spring members 160 and 165 are each designed to have certain geometric features 169 (e.g., bends, kinks) to impart a spring-like force in direction 170. By varying geometric features 169, spring members 160 and 165 can be designed to impart a predetermined amount of force on tubing structure 125 toward direction 170.

[0051] In some embodiments, the tubing support structure 125 is mounted to the housing 105 at two locations, namely attachment points 162 and 167. This allows the tubing support structure 125 to float within the housing 105. This unique design gives the tubing support structure 125 some room to move along the X-axis 172 while limiting movement in the z-axis (perpendicular to the major surface 145). In some embodiments, the locations of the attachment points 162 and 167 and the k constants of the spring members 160 and 165 are configured such that the tubing support structure can move at least the width 177 of the tubing line 110a. In this way, during installation of the disposable cartridge 100, the tubing line 110 can be easily moved, if necessary, to be properly seated within the pump track (not shown), which will be discussed below.

[0052] In some embodiments, attachment points 162 and 167 can be pivotable points. In other words, spring member 160 can be pivotally attached to attachment point 162. Similarly, spring member 165 can be pivotally attached to attachment point 167. Spring members 162 and 167 can be shaped such that movement is only allowed along the x-axis, and movement along the z-axis (outside or into the plane of the paper) is prevented. This can be done by making the spring members thicker along the z-axis. Movement along the y-axis can be limited by attachment points 162 and 167 and / or by the sidewalls of housing 105.

[0053] FIG 1C illustrates a sensor 158, according to some embodiments of the present disclosure. FIG 1D illustrates how a tubing line can be mounted on a frame or body of the dialysis machine and engaged with the sensor 158. The sensor 158 can be mounted on a portion of the dialysis machine such that when the disposable cartridge 100 is placed, one of the tubing lines will automatically be guided into the slot 165 of the sensor 160 (see FIG 1D).

[0054] A sensor 158 is configured to sense pressure through a tubing line, which may be guided and retained on the housing 105 using one or more alignment features (not shown). The disclosed dialysis machine (not shown) may include one or more sensors disposed therein.

[0055] The sensor can include a channel (e.g., slot) 165, which can be a V-shaped or U-shaped channel. In some embodiments, the channel 165 has a V-shape near the bottom. At the bottom, the channel 165 includes a sensor 160 configured to detect an expansion pressure exerted by the outer surface of the tubing line as pressure inside the tubing line pushes outward. For example, when the tubing line is inserted into the sensor 158, the tubing line will exert a force on the sensor 160 at the bottom of the channel 165. This initial force can also indicate that the tubing is properly installed in the sensor. In some embodiments, after the disposable cartridge 100 is disposed, if the initial force is detected or does not have a predetermined range, an alarm can be activated to indicate an error in the disposable cartridge 100 disposal. Once the disposable cartridge 100 and tubing lines are properly disposed in the dialysis machine, the control system (not shown) of the dialysis machine can initiate a warming cycle to heat and relax the tubing lines.

[0056] The control system can also bring the pressure inside the tubing to atmospheric pressure. In addition, the control system can adjust the sensor offset reading to read the ambient pressure. From that point on, the control system can monitor the sensor to determine if there is a tubing blockage or too high pressure by translating the force of the tubing on the sensor into pressure inside the tubing. If a blockage is detected, the control system can activate an alarm to alert the user.

[0057] FIG. 1E illustrates a cartridge 180 according to some embodiments of the present disclosure. The cartridge 180 can be a disposable cartridge. In some embodiments, the tubing lines 110a, 110b, 110c of the cartridge 180 can be coupled to couplings 130a to 130f (130a-f) that are no longer mounted on a movable tubing support structure similar to the structure 125 of FIG. 1A. In this embodiment, a section 182 of the overall tubing structure (e.g., a pump track section) is allowed to move about a plane that is parallel to the main surface 145. This is due to the flexible nature of the section 182 of the tubing structure. In addition, in the section 182, no part of the tubing structure is directly affixed to the housing 105. This allows the section 182 to have an inherent flexibility that allows it to move and flex as it is disposed and engaged with a pump track cassette (e.g., assembly 200 of FIG. 2A).

[0058] In some embodiments, the cartridge 180 includes a plurality of matching engagement openings (e.g., matching features) 185a to 185e (185a-e). The matching openings (e.g., holes, slots) 185a-e are each configured to receive a pull pin (not shown) that is designed to be inserted beyond the plane of the main surface 145 and pull the housing 105 into the body of the dialysis machine. In this manner, the cartridge 180 can be securely affixed to the dialysis machine. Although five specific matching openings 185a-e are shown, the cartridge 180 can have any number of matching openings (e.g., two, three).

[0059] In some embodiments, the housing 105 can include a plurality of support structures 183 disposed within the section 182. Each support structure 183 can be made to hold a tubing line loosely or tightly. In some embodiments, the support structures 183 are made to hold the tubing lines loosely such that during placement of the cartridge 100, the tubing lines 110a, 110b, and 110c can be wiggled into position if any misalignments are present. The cartridge 180 can also include one or more features of the cartridge 100, as described with respect to FIGS. 1A and 1B. (Pump Raceway Assembly)

[0060] 2A and 2B are side views of a pump track assembly 200 located on a reusable dialysis machine according to some embodiments of the present disclosure. FIG. 2A illustrates the pump track assembly 200 with the lever 205 in an engaged (up) position. The pump track assembly 200 can include a frame 210, a cassette 215, and the lever 205. The frame 210 can be fixedly secured to the frame of the dialysis machine such that the frame 210 remains stationary during operation of the pump track assembly 200. The frame 210 can include one or more rotational actuators (e.g., motors) located behind the cassette 215. In some embodiments, the frame 210 can have three rotational actuators. Each rotational actuator can be rigidly attached to the frame 210.

[0061] The cassette 215 can be coupled to the frame 210 via a linkage assembly (not shown), which will be discussed in further detail below. The linkage assembly allows the cassette 215 to be translatable in one direction relative to the frame 210. Translation of the cassette 215 can be actuated by a lever 205, which is coupled to the linkage assembly. The cassette 215 can have one or more track structures 220. Each track structure 220 includes a recessed track 225, a rotor 230, and at least two rollers 235. In some embodiments, the cassette 215 has three track structures, each configured to receive a corresponding tubing line of the disposable cartridge 100. The recessed track 225 can have a shape that corresponds to the shape of a predetermined path of a tubing line (e.g., tubing line 110) of the disposable cartridge 100. For example, the tubing line 110a of the disposable cartridge 100 has a U-shaped path, so the recessed track 225 can also have the same U-shaped track. The recessed track 225 is recessed below the surface 217 of the cassette 215. The depth of the recess can be at least the thickness of the tubing line 110a. In this manner, the tubing line can be snugly seated within the recessed track.

[0062] As mentioned above, FIG. 2A shows the cassette 215 in an open position for disposition of the disposable cartridge 100 and its tubing lines. Once the disposable cartridge 100 is disposed, the tubing lines 110 will be positioned to the side of the recessed track 225. Because the tubing lines 110 can also move along the x-axis (due to the floating tubing support structure), the tubing lines 110 can be easily guided into the recessed track 225 between the spaces 219. The combination of the floating tubing lines 110 and the translatable cassette 215 makes disposition of the disposable cartridge 100 much easier. This design also allows the disposable cartridge 100 to be disposed using only one hand, since the tubing 110 has some play, and in addition, a large space 219 is available when the cassette 215 is in the disengaged position (lever 205 is in the upper position as shown).

[0063] Each of rotors 230a-c includes at least two rollers. For example, rotor 230a includes rollers 235a and 235b. Rollers 235a and 235b can be positioned on opposite sides of rotor 230. Each of rotors 230 can be coupled to a shaft (not shown), which can be coupled to a rotary actuator (not shown) via one or more gears. In some embodiments, rotors 230 can also be directly coupled to the shaft of the rotary actuator (not shown).

[0064] 2B illustrates the pump track assembly 200 in a closed position with the lever 205 in an engaged (down) position. When the lever 205 is down, the coupler assembly (not shown) is actuated such that the cassette 215 is translated toward the rotor 230 and rollers 23 while the frame 210 remains stationary. The rotor 230 includes a central shaft (not shown) at the center of the rotor 230. When the cassette 215 is in the closed position (as shown), the center of the rotor 230 corresponds to the center of the concave track 225. Thus, as the rotor 230 rotates, the rollers 235 that are closest to the curved portion of the concave track are at a fixed distance away from the curved portion. This allows the rollers 235 to reduce (e.g., compress) the tubing line (not shown) while pushing the fluid forward as the rotor 230 rotates and the rollers 235 extend along the curved portion ## of the concave track 225, stopping the flow of fluid at the reduced area. The rollers 235 are positioned on the rotor 230 such that at least one roller 235 impacts on the tubing line 110 and stops the flow of fluid.

[0065] The cassette 215 can include a slot 240 configured to receive a pin 245 fixedly secured to the frame 210. The slot 240 allows the cassette 215 to translate back and forth along the axial length of the slot 240. When the lever 205 is actuated from an open (up) position to a locked (bottom, as shown in FIG. 2A ) position, the cassette 215 is moved to a closed position by one of the connectors (not shown) on the opposite side (hidden from view) of the cassette 215. As shown, the lever 205 can have a relatively long handle 250 to provide a mechanical advantage for the user. This allows the user to easily operate the lever.

[0066] Cassette 215 can be slidably mounted to frame 210 at locations 255a and 255b. At each location 255a or 255b, the cassette is fixedly mounted to a linkage assembly (not shown) using a nut or bolt. At the same time, however, the nut / bolt is slidably coupled to a slot (not shown) on frame 210 (see FIG. 3A). This allows cassette 215 to be translatable relative to frame 210.

[0067] 3A, 3C, 3E, and 3F are rear perspective views of pump assembly 200 in various operating positions according to some embodiments of the present disclosure.

[0068] FIG. 3A illustrates the cassette 215 in an open position. FIG. 3C illustrates the cassette 215 in a semi-closed position where the level has been actuated halfway. FIG. 3E illustrates the cassette 215 in a fully closed position, but unlocked. FIG. 3F illustrates the cassette 215 in a fully closed and locked position where certain connector elements are lined up, thereby making it more difficult for the linkage assembly to accidentally disengage. Additionally, the linkage assembly 300 is designed such that the linkage assembly is locked when the lever 205 is in a downward position (toward the ground). This eliminates the possibility of accidental disengagement of the linkage assembly (that the roller 235 would disengage) since gravity would not contribute to the disengagement, but rather would help to keep the lever 205 in a downward position, thereby keeping the linkage assembly and cassette 215 in a locked position.

[0069] Figures 3B, 3D, and 3G are front perspective views of pump assembly 200 in various actuated positions, according to some embodiments of the present disclosure. Figure 3B illustrates cassette 215 in an open position. See also Figure 3A, which is in the same position, but from the rear side. Figure 3D illustrates cassette 215 in a semi-closed position, actuated to the middle level. Figure 3C shows the same position from the front side. Figure 3G illustrates cassette 215 in a fully closed position and locked. Figure 3F shows the exact same position from the front side.

[0070] 3A and 3B, pump assembly 200 includes frame 210 and rotary actuators 305a, 305b, and 305c. Each rotary actuator can be actuated at a different time and / or rate of rotation such that the positions of the rollers on each rotor can differ (see FIG. 3B). For example, rollers 235a, 235c, and 235e are all in different positions relative to cassette 215 or its respective recessed tracks.

[0071] As previously mentioned, linkage assembly 300 can be actuated using lever 205. Linkage assembly 300 includes arms 310a and 310b, pivot brackets 315a and 315b, mini links 320a and 320b, a center link 325, and an actuation arm 330 coupled to lever 205.

[0072] 3C, when lever 205 is pulled downward from the upper position (FIGS. 3A-3C), lever 205 urges distal end 340 of actuation arm 330 in a distal direction, as shown in FIG. 3C. This action also urges central link 325 in a distal direction, causing pivot brackets 315a and 315b to pivot in a distal direction. At the same time, cassette 215 is urged in a distal direction because cassette 215 is fixedly coupled to arms 310a and 310b at locations 255a and 255b.

[0073] As lever 205 is pulled further downward, mini-connectors 320a and 320b begin to align with each other and with central connector 325 (see FIG. 3E). FIG. 3F shows mini-connectors 320a and 320b with central connector 325 fully aligned with each other. Once actuation arm 330 is perpendicular to central connector 325, the link assembly is locked. It can be unlocked, however, the force required to unlock may be slightly greater than the force required to move the link assembly from the open position to the locked position.

[0074] 3E, linkage assembly 300 can be slidably coupled to frame 210 at locations 355a, 355b, and 355c via slots 350a, 350b, and 350c on frame 210. By coupling a slidable nut assembly at each slot 350a, 350b, and 350c, center connector and actuation arm 330 can be slidably attached to frame 210 as shown. In some embodiments, linkage assembly 300 can be actuated using a motor, such as a stepper motor.

[0075] FIG. 4A is a perspective view of various internal components of a reusable dialysis machine 400 according to some embodiments of the present disclosure. The reusable dialysis machine 400 can incorporate one or more features described above with respect to FIGS. 1A-1D, 2A, 2B, and 3A-3G. In other words, the dialysis machine 400 can be configured to use the cartridges 100 and / or 180. FIG. 4 shows the rear side internal components of the dialysis machine 400, including a pimple plate 405, a plurality of guide posts 410, a capture and locking pin 415 (e.g., a locking pin), a pin mounting area 420, a pull plate cam 425, a camshaft 430, a gearbox 432, a lever cam 440, a coupling member 445, and a chassis 447.

[0076] When the lever 205 is in the upper position as shown in FIG. 4, the pimple plate 405 is in the forward-most position. In other words, the pimple plate 405 is closer to (towards) the cassette 215 at the front of the dialysis machine 400. In the forward-most position, the pimple plate 405 pushes the pin 415 (e.g., the matching locking feature) forward and maximally protrudes out from the front side of the dialysis machine 400. The pin 415 is pushed forward with its rear end attached to the pin mounting area 420 that is affixed to the pimple plate 405. As the pimple plate 405 moves forward or backward, the pin 415 also moves forward and backward due to the pin 415 being attached to the pin mounting area 420. During the movement of the pimple plate 405, it can be guided by one or more guide posts 410 that help the pimple plate 405 move in a linear and smooth manner. As will be explained further below, the pins 415 are designed to grip the cartridge 100 and pull it toward the rear of the dialysis machine 400 (e.g., into the cassette 215) as the pimple plate 405 moves from a forward-most position to a rear-most position toward the rear of the dialysis machine 400 (away from the cartridge 100).

[0077] A lever 205 is used to actuate the pimple plate 405 from a forward-most position and a rearward-most position. When the lever 205 is in an up position, as shown in FIG. 4, a mid-coupler assembly (which couples the lever 205 to the pimple plate 405) is configured to move the pimple plate 405 to a forward-most position. When the lever 205 is in a bottom position (see FIG. 10), the mid-coupler assembly is configured to move the pimple plate 405 to a rearward-most position (not shown). The mid-coupler assembly can include a pull plate cam 425, a camshaft 430, a transmission 432, a lever cam 440, and a coupling member 445 between the lever 205 and the transmission 432.

[0078] Figure 4B is a perspective view of the reusable dialysis machine 400 shown in Figure 4A with the pimple plate 405 hidden from view and the internal components of the transmission 432 exposed. Figure 4C is an enlarged view of section 449 of Figure 4B with the chassis 447 hidden from view. Figure 4D is a front perspective view of the internal components of the dialysis machine 400. These views will be discussed in parallel.

[0079] Lever 205 is coupled to pimple plate 405 via lever cam 440, shaft 441, bevel gears 437a, 437b, camshaft 430, and pull plate cam 425. Motion of lever cam 440 is guided in part by slot 442, which is slidably mounted to post 443 in chassis 447. Linkage member 445 is also pivotally coupled to post 443. When lever 205 is actuated, shaft 441 and lever cam 440 rotate together because shaft 441 is fixedly attached to lever cam 440.

[0080] Referring to FIG. 4C, a linking member 445 is pivotally attached to a pivot linkage 451 and a drive linkage 452 at a drive pin 453. The drive linkage 452 is pivotally coupled to a slide member 454 (e.g., a slide element) that is slidably mounted on a track 455. When the lever 205 is actuated, the cam lever 440 will rotate and push the linking member 445 either upwards or downwards. As shown, the linking member 445 is in a downward position (lever 205 is upwards). When the lever 205 is pulled downwards, the lever cam 440 will rotate and drive the linking member 445 upwards, which will push the pivot linkage 451 and the drive linkage 452 upwards and straighten them (not shown). This action also causes the slide member 454 to slide on the track 455 towards the right of FIG. 4C. Please note that cassette 200 is...

[0081] Both the track 455 and the pivot post 457 are mounted directly to a front plate 456, which may support a number of other structures, such as the chassis 447. The cassette 215 is slidably attached to the front plate 456 such that the cassette 215 may translate along the track 455. The front plate 456 includes a window 458 that allows the cassette 215 to be directly coupled to the slide member 454. As the lever 205 is actuated, the cassette 215 is translated along the track 455. When the lever 205 is in the upper (open) position, the cassette 215 is translated towards the lever 205. In other words (with reference to FIG. 4C ), the cassette 215 moves towards the pivot post 457 in the opposite direction of the arrow 459. When the lever 205 is in the lower (locked or closed) position, the cassette 215 is translated away from the pivot post 457 in the direction of the arrow 459. Once the cassette 215 is moved to the locked position, i.e., when the sliding member 454 is all the way to the right in FIG. 4C in the direction of arrow 459, the tubing lines 110a, b, c are compressed against the rollers (e.g., 235a-f) of each rotor (e.g., 230a, b, c).

[0082] Referring to FIG. 4D, lever 205, shaft 441, and umbrella gear 437a are coupled to one another. When lever 205 is actuated, shaft 441 and umbrella gear 437a will also rotate. This in turn rotates umbrella gear 437b (see FIG. 4B), shaft 430, and pull plate cam 425. Pimple plate 405 is coupled to pull plate cam 425 such that as pull plate cam 425 rotates, pimple plate 405 will move up and down. This in turn pushes pins 415 forward (towards cartridge 100, not shown) or retracts them (away from cartridge 100).

[0083] When the pimple plate 405 is in its forward-most position, the pins 415 are also in their forward-most position. In this position, a side arm or side finger (not shown) of each pin 415 is retracted into the cylindrical body of the pin 415. The side fingers are pushed outwardly from the cylindrical body of the pin 415 only when the pimple plate 405 is in its rearmost position. The side fingers are configured to expand outwardly to capture and retract the cartridge 100 (not shown). Further discussion of the pins 415 and side fingers is provided below with respect to FIG. 6.

[0084] FIG. 4E is a perspective view of the dialysis machine 400 showing various internal components as viewed from the front side of the machine. In FIG. 4E, the dialysis machine 400 is shown without a cartridge installed. The dialysis machine 400 can include three sets of tubing lines 110a, 110b, and 110c. Each tubing line can have one or more flow and bubble sensors 470, a bubble trap sensor 472, and an occlusion (e.g., strain) sensor 474. The dialysis machine 400 can also include one or more pinch valves 477, and a blood leak sensor 480. Once a disposable cartridge (e.g., 100, 800) is installed, the tubing lines of the cartridge will mate with and reside within the slots of each sensor (e.g., 470, 472, 474, 480).

[0085] As mentioned above, the cassette 215 is slidably mounted to the front plate 456. This allows the cassette 215 to move back and forth in the direction of the arrow 482. The rotors 230a, 230b, and 230c are configured to remain stationary relative to the front plate 456 while the cassette 215 moves back and forth. To dispose the disposable cartridge (e.g., cartridges 100, 180), the lever 205 is moved to an open position (as shown in FIG. 4E). With the lever 205 in this position, the cassette 215 is pulled forward toward the level 205, which widens the gap 484. This allows the tubing lines 110a, 110b, 110c to easily reside in the gap 484 once the disposable cartridge is dropped into the receiving cavity of the dialysis machine 400. In other words, the disposable cartridge is dropped onto the surface of the front plate 456 until it is stopped by the protrusion of the lead-in 415 (see item 640 in FIG. 6B).

[0086] After the disposable cartridge is dropped into the receiving cavity 490 of the dialysis machine 400, the lever 405 can be closed. This closing movement of the lever 205 moves the cassette 215 towards the rotor 230 and the constricted gap 484, which causes one of the rollers to reduce in cross section on the outer surface of one of the tubing lines. At the same time, the cassette 215 moves towards the rotor 230, the pull pin 415 is retracted and the side fingers (see item 615 in FIG. 6) expand and grip on the outer surface of the disposable cartridge. As the lever 205 moves into the final locking position (see FIG. 5B), the pin 415 fully retracts the disposable cartridge, pulling it inward and securing it with the side fingers. This also causes the various tubing lines to reside in the slots of the sensors 470, 472, 474, and 480.

[0087] FIG. 5A is a perspective view of a linkage assembly (e.g., actuation mechanism) 500 as partially shown and described in FIGS. 4A-D, according to some embodiments of the present disclosure. FIG. 5A is an isolated view of linkage assembly 500 with other components hidden from view to more clearly present the various components of the assembly. As previously described, assembly 500 includes lever 205, shaft 441, lever cam 440, bevel gears 437a and 437b, coupling member 445, pivot link 451, drive link 452, front plate 456, shaft 430, and pull plate cam 425. FIG. 5B is a close-up view of linkage assembly 500 with lever 205 in a lowered (locked) position. As shown, in the locked position, pivot coupler 451 and drive coupler 452 are parallel to one another with a distal end 505 of drive coupler 452 in its rightmost position (in the direction of arrow 510). Drive coupler 452 is oriented and coupled to slide member 454, which is directly coupled to cassette 215. As drive coupler 452 moves, slide member 454 and cassette 215 are also moved.

[0088] In addition, when lever 205 is in the locked position, cam 425 is rotated as shown. Cam 425 includes guide slots 515 designed to drive pimple plate 405 into its rearmost position. This action also draws pins 415 rearward, expanding and spreading the side fingers of each pin.

[0089] In some embodiments, the actuation mechanism can be a collection of motors (e.g., actuators) configured to translate the cassette (e.g., 215) relative to the frame of the dialysis machine. For example, linear motors can be provided to replace the pivot link 451 and the drive link 452. In this example, two linear motors can be provided, one at the top and one at the bottom of the cassette. The linear motors can be controlled by a control system that can operate the linear motors on demand.

[0090] The actuation mechanism can also include one or more motors for actuating the pull pins 415. For example, each pull pin 415 can be coupled to a motor (e.g., a stepper motor or a linear motor), which can be coupled to a controller (e.g., a control system). The controller can be the same controller that controls the motor configured to translate the cassette. In this embodiment, one or more motors coupled to one or more pull pins can replace the pimple plate 405. In some embodiments, the controller can actuate each pull pin (in response to a command from a user) to release or secure the disposable cartridge.

[0091] 6A is a perspective view of a pull pin 415 according to some embodiments of the present disclosure. The pull pin 415 includes a pin body 605, a pull rod 610, fingers 615a, 615b, a front mounting bracket 620, a rear mounting bracket 625, a stop pin 630, and a stop window 635. The pull pin 415 is mounted to a front plate 456 (not shown) by the front mounting bracket 620 (which includes a number of screws). The pull pin 415 also includes a pull rod 610 that is coupled to the fingers 615a, 615b via a pin linkage assembly (not shown) located inside the pin body 605. When the pull rod 610 is pulled back by the pin pull plate 405, the pin linkage assembly causes the fingers 615a, 615b to protrude outwardly from the pin body 605. This allows the retraction portion 415 to retract and secure a disposable cartridge (e.g., cartridges 100, 180) as it is inserted into the dialysis machine 400. When the pull rod 610 is pushed upward (towards the tip of the pin body 605), the pin interlocking assembly causes the fingers 615a, 615b to fold inwardly so that they do not cause any interference with the body of the cartridge 100. This allows the disposable cartridge to be removed from the dialysis machine 400.

[0092] When the disposable cartridge is deployed, it seats on the protrusions 640 and is secured by the bottom protrusions 645 of each finger (615a, 615b). Thus, the disposable cartridge is secured in place when the pimple plate 405 is retracted until the fingers 615a, 615b are retracted.

[0093] 6C is a cutaway view of pin 415 to show the pin linkage assembly interaction with fingers 615a, 615b. As shown, pull rod 610 is coupled to links 650a, 650b at a distal end 647 of pull rod 610 by stop pin 630. Pull rod 610 is slidable within a lumen of pin body 605. A second (proximal) end (not shown) of pull rod 610 is attached to pimple plate 405. Thus, when plate 405 is retracted (lever 205 is moved to a locked position), pull rod 610 is pulled downward toward base 650 of pin 415. This motion in turn also pulls links 650a and 650b downward, straightening them (making them parallel to one another). At the same time, the finger elements 615a, 615b are pushed outward, causing them to grip and secure on the outer surface of the disposable cartridge. When the plate 405 is advanced toward the disposable cartridge (the lever 205 is moved to the open position), the pull rod 610 is pushed upward toward the tip of the pin 415. As the pull rod 610 is pushed upward, the links 650a and 650b spread outward away from each other at the non-pivot end. This causes the tips of the fingers 615a, 615b to retract inward. In some embodiments, the fingers 615a, 615b retract completely into the inner body of the pin 415. In this way, the fingers 615a, 615b do not impede removal of the disposable cartridge.

[0094] 1D and 6C in parallel, the length of the pin 415 is selected such that the tip of the pin 415 will extend through and beyond the aligned openings (e.g., 185a, 185b) of the disposable cartridge 180. In addition, when the lever 205 is in the open position, the tips of the side fingers (e.g., 615a, 615b) of the pin 415 will also clear the aligned openings. In this way, when the lever 205 is moved to the closed position, the side fingers 615a, 615b will have sufficient clearance above the outermost surface of the cartridge 180 to grip and pull back the retainer of the disposable cartridge. (Additional embodiments)

[0095] In some embodiments, a disposable cartridge for a dialysis machine is disclosed. The disposable cartridge includes a housing and a tubing support structure having one or more tubing lines, the tubing support structure is coupled to the housing such that it can move only along a single axis parallel to a major surface of the housing, and the one or more tubing lines are parallel to the major surface of the housing. The tubing support structure can include one or more spring members coupled to the housing. The one or more spring members allow the tubing support structure to move along the single axis.

[0096] In some embodiments, the one or more spring members are constructed such that the movement of the tubing support structure is limited on at least one axis. The one or more spring members can be plastic elements having a flat geometry. The disposable cartridge can also include a heating bag having an inlet configured to receive fluid from one of the one or more tubing lines. The heating bag includes one or more channels extending into and out of the heating bag, which can be attached perpendicular to a main surface of the housing.

[0097] The housing can include a tubing support structure and a number of alignment structures for supporting and aligning one or more tubing lines.

[0098] In some embodiments, a pump track structure of a dialysis machine is also disclosed. The pump track structure can include a frame fixedly coupled to the dialysis machine, a cassette having one or more track structures, and a linkage assembly configured to translate the cassette while the frame remains stationary. The one or more track structures can each include a rotor and one or more rollers. The linkage assembly can be slidably coupled to the cassette at one or more points and pivotally coupled to the frame at one or more points.

[0099] The linkage assembly may include a first arm slidably coupled to the frame and fixedly coupled to the cassette, a first pivotable bracket pivotally coupled to the frame and to the first arm, a first small arm pivotally coupled to the first pivotable bracket, and a central linkage pivotally coupled to the first small arm and the second small arm. The second small arm is pivotally coupled to the second pivotable bracket, which is pivotally coupled to the frame. The second arm is slidably coupled to the frame and fixedly coupled to the cassette. The central linkage is slidably attached to the frame and the actuation linkage, which is coupled to the lever.

[0100] The controller can be a combination of hardware components (e.g., processor, memory) and software components having instructions and logic for controlling the various components of the dialysis system, as described above. For example, the controller can have instructions and logic for controlling the operation of the actuation mechanisms for actuating the cassettes (e.g., 215) and pins (e.g., 415), as described above.

[0101] In closing, it should be understood that a hemodialysis system is disclosed with respect to the exemplary embodiments of the invention as shown and described herein. It should be understood that the principles of the invention may be practiced in several configurations other than those shown and described, and therefore the invention is not limited in any way by the exemplary embodiments, but is generally directed to hemodialysis systems, and may take many forms to do so without departing from the spirit and scope of the invention. It will also be understood by those skilled in the art that the invention is not limited to the specific geometries and materials of construction disclosed, but instead may involve other functionally equivalent structures or materials now known or later developed without departing from the spirit and scope of the invention. Furthermore, it is intended that the various features of each of the embodiments described above may be combined in any logical manner and still fall within the scope of the invention.

[0102] The grouping of alternative embodiments, elements, or steps of the invention shall not be construed as limiting. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in or deleted from a group for convenience and / or patentability reasons. When any such inclusion or deletion occurs, the specification shall be considered as containing the group as amended.

[0103] Unless otherwise indicated, all numerical values ​​expressing properties, items, quantities, parameters, characteristics, terms, etc. used in the specification and claims should be understood as being modified in all instances by the term "about". As used herein, the term "about" means that the property, item, quantity, parameter, characteristic, or term so qualified contains a range of ±10 percent above and below the value of the stated property, item, quantity, parameter, characteristic, or term. Thus, unless otherwise indicated, the numerical parameters set forth in this specification and the appended claims are approximations that may vary. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical indication should be construed at least in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and values ​​setting forth the broad scope of the invention are approximations, the numerical ranges and values ​​set forth in the specific examples are reported as precisely as possible. However, any numerical range or value inherently contains certain errors that necessarily result from the standard deviation found in their respective testing measurements. The recitation of numerical ranges of values ​​herein is merely intended to serve as a shorthand method of referring individually to each separate numerical range falling within the range, and unless otherwise stated herein, each individual value of a numerical range is incorporated herein as if it were individually recited herein.

[0104] The terms "a," "an," "the," and similar referents used within the context of the description of the present invention (particularly in the context of the claims below) should be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. All of the methods described herein can be performed in any suitable order, unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "etc.") provided herein is intended only to more clearly illuminate the invention and does not impose limitations on the scope of the invention as otherwise claimed. No language in this specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0105] Specific embodiments disclosed herein may be further limited in the claims using the phrases "consisting of" or "consisting essentially of." When used in the claims, whether as filed in an amendment or as added, the transitional term "consisting of" excludes any element, step, or ingredient not recited in the claim. The transitional term "consisting essentially of" limits the scope of the claim to those materials or steps recited and which do not materially affect the basic and novel characteristics. The embodiments of the invention so claimed are essentially or explicitly described and enabled herein.

[0106] It should be understood that the logical code, programs, modules, processes, methods, and order in which the individual elements of each method are implemented are purely illustrative. Depending on the implementation, they may be implemented in any order or in parallel, unless otherwise indicated in this disclosure. Furthermore, the logical code is not related to or limited to any particular programming language, and may comprise one or more modules executing on one or more processors in a distributed, non-distributed, or multi-processing environment.

[0107] While several particular forms of the invention have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and invention of the invention. Accordingly, it is not intended that the invention be limited, except as by the following claims.

Claims

1. 1. A dialysis system comprising: The dialysis system includes a dialysis machine and a disposable cartridge; The dialysis machine comprises: a cassette having a recessed track; Matching locking features Equipped with The disposable cartridge comprises: a housing having two or more alignment features; a first set of tubing lines, a second set of tubing lines, and a third set of tubing lines mounted on the housing, each set of tubing lines comprising a U-shaped section configured to reside in the recessed track of the cassette; Equipped with the two or more alignment features are configured to receive the alignment and locking features from the dialysis machine, the alignment and locking features configured to draw the housing into a cartridge cavity of the dialysis machine and to secure the housing; the recessed track is shaped to accommodate the first set of tubing lines, the second set of tubing lines, and the third set of tubing lines; the cassette further comprises one or more track structures; The dialysis system, wherein the dialysis machine further comprises an actuation mechanism configured to slide the cassette relative to the one or more track structures and actuate the alignment and locking features to either secure the disposable cartridge or release the disposable cartridge.

2. The dialysis system of claim 1 , wherein each of the two or more alignment features comprises a slot or a hole.

3. The dialysis system of claim 1 , wherein the alignment locking feature comprises a pin having actuatable side fingers.

4. 4. The dialysis system of claim 3, wherein the actuatable side fingers of the pin are configured to extend outwardly to grip on the housing of the disposable cartridge when the pin's pull rod is pulled away from the housing.

5. 4. The dialysis system of claim 3, wherein the actuatable side fingers of the pin are configured to fold inwardly when a pull rod of the pin is pushed forward toward the housing.

6. The dialysis system further comprises an actuation mechanism, 4. The dialysis system of claim 3, wherein the cassette is slidably mounted in the cartridge cavity of the dialysis machine, and the actuation mechanism is configured to slide the cassette when actuated.

7. 7. The dialysis system of claim 6, wherein the actuation mechanism is configured to slide the cassette inwardly and push the set of tubing lines against rollers when the actuation mechanism is set in a locked state.

8. 7. The dialysis system of claim 6, wherein the actuation mechanism is configured to relieve pressure on the set of tubing lines by sliding the cassette outward when the actuation mechanism is set to an open state.

9. 7. The dialysis system of claim 6, wherein the actuation mechanism is configured to push the pin forward and retract the side fingers when the actuation mechanism is set in a locked state.

10. 7. The dialysis system of claim 6, wherein the actuation mechanism is configured to retract the pin rearward and expand the side fingers when the actuation mechanism is set in an open state.

11. The actuation mechanism includes: a lever coupled to the first shaft; a first cam coupled to the first shaft; a plurality of links coupled to the first cam; a sliding element coupled to the plurality of connectors and the cassette, the plurality of connectors being arranged such that, when the lever is actuated, the cassette is caused to slide inwardly or outwardly; The dialysis system of claim 6 .

12. The actuation mechanism includes: a gear assembly coupled to the first shaft; a second shaft coupled to the gear assembly; a second cam coupled to the second shaft; a pull plate coupled to the second cam and the pin, the pull plate and the pin being actuated in parallel forward or backward directions when the lever is actuated; The dialysis system of claim 11 further comprising:

13. A dialysis machine comprising: a frame fixedly coupled to the dialysis machine; a cassette slidably coupled to the frame, the cassette comprising one or more track structures, each of the one or more track structures comprising a rotor and one or more rollers; one or more matching locking features extending from the frame, the one or more matching locking features configured to be inserted into one or more matching features of a disposable cartridge and to either secure the disposable cartridge or release the disposable cartridge; an actuation mechanism configured to slide the cassette relative to the one or more track structures and actuate the one or more matching locking features to either secure the disposable cartridge or release the disposable cartridge; A dialysis machine comprising:

14. 14. The dialysis machine of claim 13, wherein the actuation mechanism comprises a linkage assembly configured to translate the cassette while the frame is fixedly secured to the dialysis machine and to actuate the one or more matching locking features to lock or release the disposable cartridge.

15. 15. The dialysis machine of claim 14, wherein the coupling assembly is configured to slide the cassette toward the rotor and push a set of tubing lines of the disposable cartridge against a pump motor when the coupling assembly is set in a locked state.

16. 15. The dialysis machine of claim 14, wherein the connection assembly is configured to relieve pressure on a set of tubing lines of the disposable cartridge by sliding the cassette away from the rotor when the connection assembly is set in an open state.

17. The one or more matching locking features include a pin having actuable lateral finger-like projections; 15. The dialysis machine of claim 14, wherein the connection assembly is configured to push the pin away from the frame and retract the actuatable side fingers when the connection assembly is set in a locked state.

18. The one or more matching locking features include a pin having actuable lateral finger-like projections; 15. The dialysis machine of claim 14, wherein the coupling assembly is configured to pull the pin toward the frame and expand the actuatable side fingers when the coupling assembly is set in an open state.

19. The connection assembly includes: a lever coupled to the first shaft; a first cam coupled to the first shaft; a plurality of links coupled to the first cam; a sliding element coupled to the plurality of connectors and the cassette, the plurality of connectors being arranged such that, when the lever is actuated, the cassette is slid toward or away from the rotor; The dialysis machine of claim 14 comprising:

20. The one or more matching locking features include a pin having actuable lateral finger-like projections; The connection assembly includes: a gear assembly coupled to the first shaft; a second shaft coupled to the gear assembly; a second cam coupled to the second shaft; a pull plate coupled to the second cam and the pin, the pull plate and the pin being actuated in tandem away from or toward the frame when the lever is actuated; 20. The dialysis machine of claim 19, further comprising:

21. The dialysis machine further comprising a disposable cartridge, The disposable cartridge comprises: a housing having one or more alignment features configured to receive the one or more alignment locking features from the frame of the dialysis machine; a first set of tubing lines, a second set of tubing lines, and a third set of tubing lines mounted on the housing, each set of tubing lines comprising a U-shaped section configured to reside within one or more track structures of the cassette; The dialysis machine of claim 13 comprising:

22. The actuation mechanism includes: a first set of one or more motors configured to slide the cassette relative to the one or more track structures; a second set of one or more motors configured to actuate the one or more matching locking features to either secure the disposable cartridge or release the disposable cartridge; The dialysis machine of claim 13 comprising:

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