Patent ID: 12214113

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The present invention, in some embodiments thereof, relates to a pump system and a connector and, more particularly, but not exclusively, to a pump system and/or a connector of a dialysis system.

An aspect of some embodiments relates to disinfecting the internal lumen of a connector. In some embodiments, a disinfecting material is released at least partly into the internal lumen, for example to allow sterilization of the lumen. In some embodiments, some of the disinfecting material contacts a head of the connector, and/or a leading edge of the connector and/or a face of the connector and/or some of the external surfaces of the connector. In some embodiments, the disinfecting material contacts at least 10%, for example 20%, 30, 40% or intermediate percentages of the parts of the external surface of the connector that are within 5 cm linear distances from the tip of the connector. In some embodiments, the disinfecting material contacts the connector for a desired time period that is sufficient to disinfect the connector surfaces. In some embodiments, the desired time period is in a range of 10-200 seconds, for example 10-60 seconds, 30-120 seconds, or 50-200 seconds or intermediate or greater time periods.

In some embodiments of the invention, such disinfection of the internal lumen is for a distance of, for example, 1 cm, 2 cm, 3 cm or intermediate, smaller or greater distances. This may allow any inadvertent contact between the connector and unsterile surfaces (which might transfer pathogens) to be compensated for by such disinfection.

In some embodiments, the disinfecting material is released from a disinfecting compartment, facing the connector internal lumen. Optionally, the disinfecting material is released from an at least one disinfecting compartment surrounding the connector. In some embodiments, penetration of the connector at least partially into the sealed disinfecting compartment forces the disinfecting material into the internal lumen of the connector. In some embodiments, the disinfecting material is pushed from a distant chamber into the connector lumen, optionally by a pump. In some embodiments, penetration of the connector at least partially into the sealed disinfecting compartment forces the disinfecting material into the internal lumen of the connector. In some embodiments, the disinfecting material contacts the connector during a connection process. Optionally, the pump removes or flushes the disinfection fluid from the internal lumen of the connector after a desired time period.

In some embodiments, the disinfecting material disinfects the connector during a connection process. In some embodiments, the disinfecting material disinfects the connector after the connection process is complete.

An aspect of some embodiments of the invention relates to disinfecting a connector by releasing disinfecting fluid from a collapsible compartment. In some embodiments, the disinfecting fluid is released from the collapsible compartment during a connection process. In some embodiments, the collapsible compartment compression releases disinfecting material into the internal lumen of the connector. In some embodiments, the collapsible compartment wipes some of the external surface of the connector and the connector head with disinfecting material. In some embodiments, the collapsible compartment is a sponge. In some embodiments the collapsible compartment is within a tube part to which the connector is connected. Optionally, the collapsible compartment is collapsed by manually.

In some embodiments, the sponge is placed inside a disinfection chamber. In some embodiments, the connector head or the connector face compresses the sponge. Alternatively, the connector head or the connector face penetrates through a central channel within the sponge. In some embodiments, the sponge is compressed by the external surface of the connector. In some embodiments, penetration of the connector into the disinfecting chamber compresses the sponge in at least 20% of its volume, for example 20%, 30%, 40%, 50% or any intermediate or larger percentage.

An aspect of some embodiments of the invention relates to disinfecting a connector, optionally a connector of a dialysis system for a desired time period. In some embodiments the desired time period is the sufficient time period that allows efficient disinfection of the connector. In some embodiments, the desired time period is in a range of 10-200 seconds, for example 20-100 seconds, 30-120 seconds or 100-150 seconds.

In some embodiments, a human-detectable indication is provided when the desired time period is over. Optionally, the indication is provided before flushing or draining of a disinfection material from the connector. In some embodiments, an indication is provided when flushing or draining is complete. Optionally, an indication is provided before pumping dialysate into the connector. In some embodiments, the dialysis system is activated when the time is up, for example, draining the disinfect or starting the dialysis system. Optionally, the disinfecting process is an automatic process that does not involve indication provision.

An aspect of some embodiments of the invention relates to a two-part pump, optionally of a dialysis system. In some embodiments, the two-part pump comprises a detachable rotor assembly and separate motor assembly. In some embodiments, the rotor assembly is detached from the motor assembly after a dialysis treatment session is over (e.g., is disposed of). In some embodiments, the detachable rotor assembly is connected to the motor assembly by at least one connection member that allow, for example, reversible connection and/or easy attachment and/or detachment of the two parts.

In some embodiments, the detachable rotor assembly comprises a rotor, for example a peristaltic pump rotor with at least one blade. In some embodiments, the detachable rotor assembly comprises a flexible membrane, placed in contact with the pump rotor blade and with a rigid wall on the opposite side to the rotor blade. In some embodiments, the rotor is placed within rotor housing. In some embodiments, the flexible membrane is pre-connected to a rigid wall of the rotor housing, for example to form a partly-rigid pump tube. Alternatively, the flexible membrane is in the form a flexible pump tube, for example a compressible tube that is sized and shaped to be compressed by a peristaltic pump rotor. In some embodiments, at least one connector, optionally a disinfecting connector, is connected to an end of the pump tube. In some embodiments, at least one part of the detachable rotor assembly, for example the pump tube, and/or the rotor and/or the connector is replaceable between treatment sessions. In some embodiments, the detachable rotor assembly comprises a rotor, a rotor housing and a channel within the rotor housing sized for placing an external pump tube.

In some embodiments, the motor assembly comprises a motor, for example an electric motor and a motor driven shaft. Additionally, the motor assembly optionally comprises an electric power supply, for example a battery connected to the motor. In some embodiments, the motor assembly comprising a control circuitry, for example to control the rotation direction and/or the rotation speed and/or the rotation time of the motor. In some embodiments, the motor assembly comprises a user interface, which optionally includes at least one button and/or at least one display for example, for providing indications for a user of the pump.

In some embodiments of the invention, the rotor can be separated from the rotor assembly, for example, with one movement. Optionally, this allows release of fluid trapped in the pump.

In some embodiments, the rotor assembly is configured for fast connection to the motor assembly. Optionally, the motor assembly includes one or more alignment elements for aligning the two assemblies. Optionally or alternatively, the motor assembly includes a cover which covers the rotor assembly. In some embodiments, closing the cover serves to complete the connection of the pump to other part(s) of the dialysis system.

In some embodiments, the tubing is provided integral with the rotor assembly. In some embodiments, the dialysate and/or waste compartment are provided integral and pre-connected to the rotor assembly, for example in a single sterile package. Optionally, the user is not required to thread the tubing into the peristaltic pump, as such tubing is already installed in the pump or can be connected to connectors of the pump.

An aspect of some embodiments of the invention relates to pushing disinfecting material by a pump into the lumen of a connector, optionally for sterilizing the connector lumen. In some embodiments, the pump for example, a peristaltic pump, moves the disinfecting fluid from one connector to a different connector. Optionally, the pump moves the disinfecting fluid into a waste storage compartment or other outlet. In some embodiments, a same pump is used for pumping dialysate into a catheter connector. In some embodiments, a same pump is used for disinfecting a connector, draining the disinfecting material and pumping dialysate into a catheter connector, optionally with different pumping directions.

An aspect of some embodiments of the invention relates to avoiding user steps during the assembly of a dialysis system. In some embodiments, a disinfected fluid path between a tube and at least one connector, optionally a connector of a dialysis system is generated by a single mechanical step. In some embodiments, the mechanical step comprises pushing a lever, a handle or closing a door. In some embodiments, closing the door pushes a connector of the tube, for example a pump tube towards a second connector. In some embodiments, closing the door connects the pump tube connector and the second connector. In some embodiments, closing the door and/or forming a connection in other ways, disinfects the connector and/or the fluid path between the tube and the connector

In some embodiments, the door applies force on an actuator that is mechanically coupled to the tube connector. In some embodiments, the force applied on the actuator causes the actuator to move the tube connector closer to the second connector. In some embodiments, the actuator moves the tube connector in an axial direction. Optionally or alternatively, the actuator rotates the tube connector.

An aspect of some embodiments of the invention relates to an easy to use dialysis system. In some embodiments, the system spares the user from fine motor activities and/or delicate force applications. For example, a user may not be required to align connectors, close them exactly and/or ensure correct disinfection processes. Optionally or alternatively, merging steps reduces a memory load of the user and/or opportunity to make mistakes. In some embodiments, the system ensures the completion of critical steps, for example disinfection and/or closure of a flow path. In some embodiments, the system provides at least one indication to a user before, during and/or after the operation of the system, so a user is aware what to do next and/or what is about to happen. Alternatively, the system performs all the steps of the dialysis procedure automatically without any indication.

In some embodiments, the system generates a sterilized flow path between a dialysate storage compartment and a patient catheter in a single step. In some embodiments, the system automatically disinfects the flow path and pushes dialysate into the patient catheter. In some embodiments, the system provides an indication to a user when the flow path is disinfected. In some embodiments, the system provides an indication to a user when a dialysis treatment session is over.

In some embodiments of the invention, user acts do not require tools (e.g., to attach or detach a rotor or connectors).

An aspect of some embodiments of the invention relates to a disinfecting material placed within a tube of a dialysis system. In some embodiments, the disinfecting material is placed in a distance of up to 25 centimeters (cm) from the tube ending for example, 20, 15, 10, 5, 2, 1 cm from the tube ending. In some embodiments, the disinfecting material is placed within a disinfecting chamber. In some embodiments, the disinfecting chamber is a compressible disinfecting chamber. In some embodiments, the disinfecting chamber comprises at least two spaced apart storage compartments of the disinfecting material, optionally compressible storage compartments

In some embodiments, penetration of a connector into the disinfecting chamber compresses the disinfecting chamber in at least 10% of its volume, and optionally releases the disinfecting material. In some embodiments, penetration of a connector into the disinfecting chamber pierces the disinfecting chamber and releases the disinfecting material. In some embodiments, penetration of a connector into the disinfecting chamber ruptures at least one wall or a surface of the disinfecting chamber and causes release of the disinfecting material. In some embodiments, manual compression or deformation of the chamber is provided, optionally by deforming a surrounding fluid flow tube.

An aspect of some embodiments of the invention relates to a quick release mechanism of a pump rotor of a dialysis system. In some embodiments, a pump rotor is connected to a drive shaft of a motor by a quick release connector. In some embodiments, application of force on the connector releases the pump rotor from a drive shaft or a motor interface of the pump motor. In some embodiments, application of force on the connector deforms a part of the connector and/or rotor and prevents reusing of the connector and/or rotor.

In some embodiments, the connector is an interference-type locking connector, for example a snap-click connector. Optionally, the snap-click connector is reusable, and allows reattachment of the rotor to the drive shaft and/or to the motor interface. In some embodiments, the connector is sized and shaped to be operable with a single hand of a user. In some embodiments, releasing of the rotor allows for example, to drain residual fluid from a pump tube contacting the at least partly the rotor. In some embodiments, the connector is disposable and optionally replaced after one or more dialysis treatment sessions.

A potential advantage automatically connecting and sterilizing dialysis equipment, for example peritoneal dialysis equipment, is in fulfilling a need for reducing infection.

An aspect of some embodiments of the invention relates to changing fluid flow direction. In some embodiments, pump rotation direction is changed manually. Optionally or alternatively, the pump rotation direction does not change but the tube is moved relative to rotor to change the flow direction. In some embodiments, pump direction is changed automatically, for example, based on time or based on lack of further flow.

The term “patient” refers hereinafter to a human or animal which is the subject of a treatment.

The term ‘dialysate’ refers hereinafter to fluid being transferred into the patient, as used in some embodiments of the invention.

The term “proximal” or “proximal end” refers hereinafter to the portion of a component furthest outside a patient, if the component is at least partially outside the patient, or to the portion of the component closest to the outside of the patient, if the component is wholly within the patient.

The term “distal” or “distal end” refers hereinafter to the portion of a component furthest inside a patient, if the component is at least partially inside the patient, or to the portion of the component closest to the inside of the patient, if the component is wholly outside the patient.

The term ‘external catheter tube’ refers hereinafter to a tube having a outlet, for example, a single outlet, at its distal end and at least one outlet at its proximal end, as used in some embodiments of the invention.

The term ‘patient catheter’ refers hereinafter to a catheter for transferring fluid into or out of the patient, as used in some embodiments of the invention.

The term ‘peristaltic manner’ refers hereinafter, for example, to moving fluid in a peristaltic manner, such as applied by a peristaltic pump. An example of peristaltic motion is found in the digestive tract, in which contractions and relaxations of a tube create a wavelike movement that pushes the contents of the tube forward.

The term “Sterilization”—refers hereinafter, for example, to the removal of all microorganisms and other pathogens from an object or surface by treating it with chemicals or subjecting it to high heat or radiation.

The term “Disinfection”—refers hereinafter, for example, to the use of a disinfectant (e.g., fluid) to destroy, inactivate or remove microorganisms that are likely to cause infection, spoilage or other undesirable effects in an inanimate object. Disinfection does not normally involve sterilization. However, in some embodiments of the invention disinfection is of a high enough quality to provide sterilization.

Reference is now made toFIG.1, which schematically presents an embodiment of the automatic connector device100. This figure presents a front view of the device in its open configuration. The device comprises pump tube101, with its proximal end connecting to external catheter tube102through first connector20, and its distal end connecting to patient catheter103through second connector21. The device further comprises an actuator (not shown) which enables the transition of first connector20and second connector21from an open configuration to a closed configuration and vice versa. An open configuration is when pump tube101is not in fluid connection with either external catheter tube102or patient catheter103, while a closed configuration is when pump tube101is in fluid communication with external catheter tube102and patient catheter103. The actuator can be any element which reversibly transitions first connector20and second connector21from the closed to the open configuration, and can be, for non-limiting example, a housing which can press the connecting pieces of at least one connector together, a mechanical spring, an electrical signal actuating a connection mechanism, a magnetic signal actuating a connection mechanism, and any combination thereof. Arrows200illustrate the direction in which first connector20and second connector21move during transition from an open configuration to a closed configuration.

FIG.1Aschematically presents an embodiment of the present invention where the external catheter tube102is preconnected to the pump tube101and to the second connector21, and pump interface40. In such embodiments, the pump interface comprises a motor-driven shaft41(motor not shown) and at least one peristaltic blade45. The device further comprises an actuator. In some embodiments, the actuator can be any element which reversibly transitions second connector21from the closed to the open configuration, and can be, for non-limiting example, a housing which can press the connecting pieces of at least one connector together, for example a mechanical spring, an electrical signal actuating a connection mechanism, a magnetic signal actuating a connection mechanism, and any combination thereof.

FIG.1Bschematically presents an embodiment of the present invention of pump interface40. In such embodiments, the pump interface comprises a motor-driven shaft41(motor not shown) and at least one peristaltic blade45.

FIGS.1C and1Dschematically presents an embodiment of the present invention of external catheter tube102is preconnected to the pump tube101and to the second connector21, and pump interface40. In such embodiments, the pump interface comprises a motor-driven shaft41(motor not shown) and at least one peristaltic blade45and an open configuration of a second connector21distal end connecting to patient catheter103through connector21. An open configuration is when pump tube101is not in fluid connection with either external catheter tube102or patient catheter103. The actuator can be any element which reversibly transitions second connector21from the closed to the open configuration, and can be, for non-limiting example, a housing which can press the connecting pieces of at least one connector together, a mechanical spring, an electrical signal actuating a connection mechanism, a magnetic signal actuating a connection mechanism, and any combination thereof

FIG.1Eschematically presents an embodiment of the present invention of external catheter tube102is preconnected to the pump tube101and to the second connector21, and pump interface40. In such embodiments, the pump interface comprises a motor-driven shaft41(motor not shown) and at least one peristaltic blade45pump and a closed configuration of a second connector21distal end connecting to patient catheter103through connector21. Closed configuration is when pump tube101is in fluid communication with external catheter tube102and patient catheter103. The device further comprises an actuator (not shown) which enables the transition of second connector21from an open configuration to a closed configuration and vice versa. In some embodiments, a closed configuration is when pump tube101is in fluid communication with external catheter tube102and patient catheter103. The actuator can be any element which reversibly transitions second connector21from the closed to the open configuration, and can be, for non-limiting example, a housing which can press the connecting pieces of at least one connector together, a mechanical spring, an electrical signal actuating a connection mechanism, a magnetic signal actuating a connection mechanism, and any combination thereof.

FIG.1Fschematically presents an embodiment of the present invention of external catheter tube102is preconnected to the pump tube101and to the second connector21, and pump interface40. In such embodiments, the pump interface comprises a motor-driven shaft41(motor not shown) and at least one peristaltic blade45pump and a closed configuration of a second connector21distal end connecting to patient catheter103through connector21. Closed configuration is when pump tube101is in fluid communication with external catheter tube102and patient catheter103. The device further comprises an actuator (not shown) which enables the transition of second connector21from an open configuration to a closed configuration and vice versa. A closed configuration is when pump tube101is in fluid communication with external catheter tube102and patient catheter103. The actuator can be any element which reversibly transitions second connector21from the closed to the open configuration, and can be, for non-limiting example, a housing which can press the connecting pieces of at least one connector together, a mechanical spring, an electrical signal actuating a connection mechanism, a magnetic signal actuating a connection mechanism, and any combination thereof. In some embodiments, the durable dialysis machine300comprising of at least a pump motor, power unit user interface, control units, memory, sensors, communication units and valves. (not shown). In some embodiments, part300of the device and some of its subcomponents are reusable and are optionally replaced infrequently, if at all, while in some embodiments other parts are disposable and are optionally intended to be replaced each time the device is used. In some embodiments, the pump motor is reusable. In some embodiments, the pump motor interfaces with the pump interface40, since it does not come in contact with the dialysis fluids or other fluids used during a procedure, the pump motor should not require sterilization.

In some embodiments, the durable dialysis machine is provides a housing which can press the connecting pieces of at least one connector together

In some embodiments of the present invention, the patient catheter is a peritoneal catheter and the automatic connecting device is used for peritoneal dialysis.

In some embodiments of the present invention, such as the embodiment shown inFIGS.1and2, the automatic connecting device further comprises pump interface40. In such embodiments, the pump interface comprises a motor-driven shaft41(motor not shown) and at least one peristaltic blade45(3 are shown) which pass along pump tube101, generating a peristaltic fluid movement.

In some embodiments, other types of pump interfaces are used. For non-limiting example, the pump interface can induce the peristaltic fluid movement by periodic compression of pump tube101. Other methods of inducing peristaltic movement of fluid, as known in the art, can also be used. In some embodiments, the pump interface comprises a separate unit; it is not part of the automatic connecting device.

It should be noted that some parts of the device are reusable and are replaced infrequently, if at all, while other parts are disposable and are intended to be replaced each time the device is used. In some embodiments, for example, patient catheter103is reusable, as it is semi-permanently attached to the patient, as is pump tube101. In some embodiments, these are sterilized before each use. In addition, the pump interface is reusable, although, since it does not come in contact with the dialysis fluids or other fluids used during a procedure, the pump interface should not require sterilization.

In some embodiments, the tubes such as the patient catheter pump tube, external catheter tube, and connectors are described herein as being sterilized. However, either sterilization or disinfection can be optionally use on the tubes before dialysis or another procedure is carried out.

In some embodiments, first connector20and second connector21are disposable, as is external catheter tube102. These are typically packaged in a sterile container, so should need minimal sterilization prior to use.

In some embodiments, the proximal end of first connector20is permanently attached to external catheter tube102, such that the proximal end of first connector20and external catheter tube102forms a single unit. In such embodiments, the distal end of first connector20can be permanently attached to pump tube101, or the distal end of first connector20can be reversibly attachable to pump tube101. In the latter case, where the distal end of first connector20is attachable to pump tube101, optionally, the distal end of first connector20will be prepackaged along with the unit comprising proximal end of first connector20and external catheter tube102. In some embodiments, the distal end of first connector20can be packaged separately from the unit comprising proximal end of first connector20and external catheter tube102.

Exemplary Dialysis System

Reference is now made toFIG.1Gdepicting components of a dialysis system with a detachable rotor assembly that does not include integral dialysate and/or waste compartments, according to some embodiments of the invention.

According to some exemplary embodiments, a dialysis system500comprises a detachable component502, for example a detachable rotor assembly and a base component503, for example a motor assembly. Optionally, the base component is a durable component. Optionally, the detachable component is a disposable component. In some embodiments, detachable component502comprises a rotor504, optionally a peristaltic pump rotor in contact with a pump tube506. In some embodiments, the pump tube506is comprised of an elastic material which contracts in at least 30%. Optionally, the pump tube is an integral part of the detachable component housing510. In some embodiments, the pump tube506is partly comprised from the inner surface of the housing510and partly from an elastic material facing and partly in contact with the rotor504.

According to some exemplary embodiments, the detachable component further comprises a disinfecting connector508, and optionally an additional disinfecting connector511, both connected to pump tube506. Optionally, disinfecting connectors508and/or511are cylindrical connectors. In some embodiments, at least one of the disinfecting connectors508and511comprise a disinfecting chamber, for example disinfecting chamber512filled with a disinfecting material509. In some embodiments, the disinfecting chamber is bounded by a proximal barrier, for example a proximal barrier516and a distal barrier, for example distal barrier514. A proximal barrier is a barrier that is closer to a pump tube connected to the disinfecting connector. A distal barrier is a barrier that is placed away or in a large distance from the pump tube connected to the disinfecting connector. In some embodiments, the proximal barrier is located between the disinfecting chamber and the pump tube506. In some embodiments, the distal barrier is located between the disinfecting chamber and a sealing disc, for example sealing disc540.

According to some exemplary embodiments, the barriers, for example proximal barrier516and distal barrier514are barrier foils, optionally with predetermined failure areas that allow, for example defining a tearing propagation path formed in response to penetration of a connector through said barrier. In some embodiments, the barriers, for example proximal barrier516and distal barrier514are pressure seals. In some embodiments, the pressure seals are shaped and sized to resist a radial pressure, but not an axial pressure larger than 0.05 bar. In some embodiments, the barriers, for example proximal barrier516and distal barrier514are made from a non-fluid gel material or from a high-viscosity fluid with a centipoise value larger than 1.4

According to some exemplary embodiments, the disinfecting material509comprises a disinfecting fluid or a non-fluid gel material or a high-viscosity disinfecting fluid with a centipoise value larger than 1.4. In some embodiments, the high-viscosity disinfecting fluid acts as a foil. Optionally, the disinfecting material509is approved for usage within the body and/or in a dialysis treatment.

According to some exemplary embodiments, one of the disinfecting connectors, for example disinfecting connector508is connected to a patient catheter connector518. In some embodiments, the patient catheter connector is further connected to a patient catheter520. In some embodiments, an actuator534pushes disinfecting connector508towards patient catheter518, for example by applying an axial force on disinfecting connector508directed to patient catheter connector518. In some embodiments, when an actuator, for example actuator534or actuator532are pushed down, for example when a lid of the detachable component or base component is closed it applies an axial force towards a patient catheter connector or a Y-connector, respectively. In some embodiments, the axial force applied by the actuator ensures a connection between the disinfecting connector and a second connector. Alternatively, the disinfecting connector and the second connector both comprise a compatible screw thread, that allows for example a secured connection between the two.

According to some exemplary embodiments, disinfecting connector511is connected to a second connector, for example Y connector522. In some embodiments, Y connector is connected to a dialysate compartment524and to a waste compartment526. Alternatively, the dialysate compartment and the waste compartment are connected to two separate disinfecting connectors. In some embodiments, the waste and/or the dialysate compartments are connected directly to pump tube506, for example when they are connected under sterilizing conditions in a factory. In some embodiments, Y connector further comprises a valve, for example a flap valve configured for directing the fluid path into the tube pump either from the dialysate compartment or from the waste compartment. In some embodiments, the waste compartment and/or the dialysate compartment comprise a non-elastic bag. In some embodiments, a lock530is placed in the fluid path between the dialysate compartment524and the Y connector522. In some embodiments, when the530is intact or closed, it prevents the flow of the dialysate from the dialysate compartment towards the pump tube506. In some embodiments, breaking or unlocking the lock530by application of force allows, for example the flow of dialysate towards the pump tube506.

According to some exemplary embodiments, base component503, optionally a durable component comprises a motor513, for example an electric rotor functionally connected to rotor504via drive shaft550. In some embodiments, motor513is under the control of control circuitry540, optionally controlling rotation speed, rotation duration and/or rotation direction of motor513. In some embodiments, base component503further comprises a memory527connected to the control circuitry540. In some embodiments, the memory527stores log files of the dialysis system and/or the motor and/or parameter values received from sensors542and/or communication circuitry525and/or user interface523. In some embodiments, base component503comprises power supply544, for example a rechargeable battery or a replaceable battery which supplies electrical power to control circuitry540and/or motor513. In some embodiments, power supply544is connected to an external power source. In some embodiments, user interface comprises an activation button for activation of the motor and/or dialysis system.

Reference is now made toFIG.1H, depicting a dialysis system that includes a detachable assembly with integral dialysate and/or waste storage compartments, according to some embodiments of the invention.

According to some exemplary embodiments, the detachable assembly, for example detachable assembly550of dialysis system560comprises integral dialysate and/or waste storage compartments connected through a connector to pump tube506. In some embodiments, detachable assembly550comprises a single disinfecting connector508for connecting and disinfecting a catheter connector to pump tube506. In some embodiments, a user of system560connects only a catheter connector to the disinfecting connector508of detachable assembly550.

Exemplary Automatic Connector Device

Reference is now made toFIG.2, schematically presenting various views of the automatic connector device ofFIG.1in the open configuration.FIG.2Apresents a 3D perspective view showing external catheter tube102, pump tube101, patient catheter103, first connector20and second connector21in an open configuration. As shown, from the proximal end, external catheter tube102is connected to a proximal part of first connector20. The distal part of first connector20is connected to pump tube101, which is connected to the proximal part of second connector21. The distal part of second connector21is connected to patient catheter103.FIG.2Billustrates an enlarged view of circled area A inFIG.2AandFIG.2Cillustrates an enlarged view of circled area B inFIG.2A, schematically illustrating non-limiting examples of first connectors20and second connector21. In these exemplary embodiments, inFIG.2B, first connector20is shown with a screw-on connection and, inFIG.2C, second connector21is shown with a clip-on connection. First connector20and second connector21can have any reversible connection known in the art. Non-limiting examples include a screw-on connection, a clip-on connection, a press-fit connection, a magnetic connection, an electrical connection and any combination thereof.

In some embodiments of the present invention, in proximity to at least one of first connector20and second connector21is found at least one sterilizing fluid dispenser (seeFIGS.8-13hereinbelow) which defines a confined volume in at least one of pump tube101, external catheter tube102and patient catheter103. This sterilizing fluid dispenser can be filled with disinfecting material, and, upon removal or rupture of at least part of the sterilizing fluid dispenser, the disinfecting material can spill into at least one of pump tube101, external catheter tube102and patient catheter103, thus automatically and without manual intervention disinfect the tube or tubes into which the disinfectant enters. Removal can be by a member of a group consisting of pulling, stretching, tearing, fracturing, puncture and any combination thereof. Removal can be induced by the actuator, by at least one connector subparts and any combination thereof.

Reference is now made toFIG.3, illustrating a front view of the automatic connector device100in a closed configuration, in which like-components have been given the same reference numbers.

Reference is now made toFIG.4, schematically illustrating various views of the automatic connector device illustrated inFIG.3.FIG.4Apresents a 3D perspective view showing external catheter tube102, pump tube101, patient catheter103and first connector20and second connector21in a closed configuration. As shown, from the proximal end, external catheter tube102is connected to a proximal part of first connector20. The distal part of first connector20is connected to pump tube101, which is connected to the proximal part of second connector21. The distal part of second connector21is connected to patient catheter103.FIG.4Billustrates an enlarged view of circled area A inFIG.4AandFIG.4Cillustrates an enlarged view of circled area B inFIG.4A, schematically illustrating non-limiting examples of first connector20and second connector21. In these exemplary embodiments, first connector20is shown with a screw-on connection inFIG.4Band second connector21is shown with a clip-on connection inFIG.4C.

Reference is now made toFIGS.5Aand B, illustrating a front view and a perspective view, respectively, of first connector20with an actuator80, in a closed configuration. The actuator80is designed to push the proximal connecting parts of first connector20, on pump tube101, and connect them with the distal connecting parts of first connector20, on external catheter tube102. In some embodiments, the pushing movement of the actuator80induces fastening of the clip-on connection of the connector, and can be done in a mechanical manner, electrical manner or magnetic manner. In some embodiments, the actuator80can be mechanically pushed by a housing where closing the housing which, pushes the actuator. In some embodiments, the actuator comprises a spring which pushes apart the proximal and distal parts of the first connector20, thereby restoring it to an open configuration once the pressure, electrical signal, magnetic signal and any combination thereof has been removed.

Reference is now made toFIG.6, schematically illustrating the first connector20exemplified inFIG.5, but in an open configuration, and where like components have been given the same reference identifiers.FIGS.6Aand B illustrate, respectively, a front view and a perspective view of an open configuration of first connector20, optionally connecting between pump tube101and external catheter tube102. Arrow201shows the direction the connector parts move during transition to the open configuration. In some embodiments, operation of the actuator to induce transition to an open configuration can relieve a pressure holding the connector in a closed configuration, for example release a spring which presses the parts of the connector apart, terminate an electrical or magnetic force holding the parts together, activate an electrical or magnetic force to separate the parts, and any combination thereof. In some embodiments, the actuator operates in a mechanical, electrical or magnetic manner.

Reference is now made toFIG.7, schematically presenting a second example of a connector93with an actuator91, which operates in a screw-on manner via screw92.FIGS.7A, B and C illustrate a front, top and perspective view respectively, and arrow202illustrates the direction screw92advances once the actuator91has been activated.

In some embodiments of the device, it comprises at least one sterilizing-fluid dispenser. In some variants of these embodiments, the sterilizing-fluid dispenser is contained in at least one of the connectors20,21and is automatically opened during the process of transition of the connector from the opened configuration to the closed configuration. Exemplary embodiments of sterilizing-fluid dispensers are given hereinbelow.

Reference is now made toFIG.8A-D, schematically presenting an embodiment of first connector20and second connector21comprising a dispenser for automatically dispensing a sterilizing fluid upon transforming the connector from its open configuration to its closed configuration. InFIG.8A-D, the connectors are shown in their open configuration. InFIG.8A, connector21is shown attached to patient catheter103and pump tube101, while inFIG.8B, connector20is shown attached to pump tube101and external catheter tube102. The dashed areas B and A are shown enlarged in, respectively,FIGS.8C and8D. As shown inFIGS.8C and8D, each of the connectors21and20comprises a sterilizing-fluid dispenser210. In the embodiment shown, the sterilizing-fluid dispenser210is, for both first connector20and second connector21, in the portion of the connector attached to the pump tube101, in other words, the sterilizing-fluid dispenser210is in the distal portion of first connector20and in the proximal portion of second connector21. In other embodiments, the sterilizing-fluid dispenser210can be in the proximal portion of first connector20and in the distal portion of second connector21.

Reference is now made toFIG.9A-D, schematically presenting the embodiment ofFIG.8in its closed position. InFIG.9A, connector21is shown attached to patient catheter103and pump tube101, while inFIG.9B, connector20is shown attached to pump tube101and external catheter tube102. The dashed areas B and A are shown enlarged in, respectively,FIGS.9C and9D. As shown inFIGS.9C and9D, each of the connectors21and20comprises a sterilizing-fluid dispenser210. In the embodiment shown, the sterilizing-fluid dispenser210is, for both first connector20and second connector21, in the portion of the connector attached to the pump tube101, in other words, the sterilizing-fluid dispenser210is in the distal portion of first connector20and in the proximal portion of second connector21. Comparison ofFIG.8CtoFIG.9CandFIG.8DtoFIG.9Dshows that the process of transitioning the connectors from the open configuration to the closed configuration has shortened the sterilizing-fluid dispenser210, thereby optionally enabling dispensing of the sterilizing fluid.

FIG.10A-Dschematically illustrates an embodiment of a mechanism by which the sterilizing-fluid dispenser210ofFIGS.8and9can be opened during the connectors' transition from an open configuration to a closed configuration so as to allow the fluid contained therein to be dispensed and thereby to sterilize at least a portion of the tubing comprising the patient catheter103, pump tube101and external catheter tube102. In this embodiment, the sterilizing-fluid dispenser210comprises a frame212, shown face-on inFIG.10Aand in a perspective view inFIG.10B, and sterilizing fluid capsules214, shown in perspective view inFIG.10C. In the embodiment illustrated inFIG.10, there are three sterilizing fluid capsules214; other variants of these embodiments can have more or fewer sterilizing fluid capsules214. The frame comprises three bendable legs2122.FIG.10Dshows the assembled sterilizing-fluid dispenser210of this embodiment before it is opened, i.e., before the connector in which is contained is transitioned to the closed state. The horizontally-striped arrows inFIG.10Dillustrate the direction of the compressive force exerted on the sterilizing fluid container210during transition to the closed state, while the vertically-striped arrows show the direction of motion of the joins in the bendable legs2122.

FIG.11A-Dschematically illustrates the mechanism ofFIG.11after it is opened, i.e., after the connector in which is contained is transitioned to the closed state.FIG.11Ashows a face-on view of the frame212of the sterilizing-fluid dispenser210, whileFIG.11Bshows a perspective view of the frame212, andFIG.11Cshows a perspective view of the sterilizing fluid capsules214. After transition of the connector to the closed state, the bendable legs2122are in a bent state (FIG.11A-B), so that the sides2124of the frame have been brought close together. The pressure this placed on the sterilizing fluid capsules214has ruptured a rupture zone2141in the sterilizing fluid capsules214, thereby enabling dispensing of the sterilizing fluid.FIG.11Dshows the assembled sterilizing-fluid dispenser210of this embodiment after it is opened, i.e., after the connector in which is contained is transitioned to the closed state and after the sterilizing fluid is dispensable, thereby sterilizing at least a portion of the tubing comprising the patient catheter103, pump tube101and external catheter tube102.

FIG.12A-Gshows a second exemplary embodiment of a sterilizing-fluid dispenser210. In this second embodiment, the sterilizing-fluid dispenser210comprises a single sterilizing fluid capsule214, shown face-on inFIG.12A, side-on inFIG.12B, and in perspective view inFIG.10C.FIGS.12D and12Fshow, in the closed state, a sterilizing-fluid dispenser210contained within a second connector21, whileFIGS.12E and12Gshow a sterilizing-fluid dispenser210contained within a first connector20.FIGS.12D and12Eshow, in the closed state, a perspective view of sterilizing-fluid dispensers210contained within, respectively, second connector21and first connector20, whileFIGS.12F and12Gshow a cross-sectional view of sterilizing-fluid dispensers210contained within, respectively, second connector21and first connector21.

In the embodiment ofFIG.12, the sterilizing fluid capsule214is pierced by a punching mechanism216during transition from an open configuration to a closed configuration, thereby releasing the sterilizing fluid and sterilizing at least a portion of the tubing comprising the patient catheter103, pump tube101and external catheter tube102.

FIG.13A-Gshows a third exemplary embodiment of a sterilizing-fluid dispenser210. In this third embodiment, the sterilizing-fluid dispenser210comprises a single sterilizing fluid capsule214, shown face-on inFIG.13A, side-on inFIG.13B, and in perspective view inFIG.10C.FIGS.13D and13Fshow, in the closed state, a sterilizing-fluid dispenser210contained within a second connector21, whileFIGS.13E and13Gshow a sterilizing-fluid dispenser210contained within a first connector20.FIGS.13D and13Eshow, in the closed state, a perspective view of sterilizing-fluid dispensers210contained within, respectively, second connector21and first connector20, whileFIGS.13F and13Gshow a cross-sectional view of sterilizing-fluid dispensers210contained within, respectively, second connector21and first connector21.

In the embodiment ofFIG.13, the sterilizing fluid capsule214is pierced in a piercing region218by a punching mechanism216during transition from an open configuration to a closed configuration, thereby releasing the sterilizing fluid and sterilizing at least a portion of the tubing comprising the patient catheter103, pump tube101and external catheter tube102. The piercing region218can be configured to be easier to pierce than the surrounding material. The piercing region218can be thinner than the surrounding material, of a weaker material than the surrounding material, recessed in order to ensure accuracy of strike by the punching mechanism216and any combination thereof.

This third embodiment is further characterized by comprising at least one soft wiper blade2142which can wipe a portion of the interior surface of the catheter, thereby more efficiently spreading the sterilizing fluid across the surface.

Exemplary User Interface

In some embodiments of the present invention, an automatic connection device can also comprise an analog or digital user interface which enables a user (such as a doctor, nurse or medical technician) or a patient to control various parameters of the device, such as, in a non-limiting example, start fluid flow, stop fluid flow, alter fluid flow speed, alter motor operating power level, switch fluid origin, switch fluid flow direction, alter peristaltic blade movement, initiate disinfection and any combination thereof. In some embodiments, the analog or digital user interface described herein, for example user interface523shown inFIG.1Gcontrols the operation of the pump504, for example the rotation speed, rotation time and/or rotation direction. In some embodiments, the user interface circuitry delivers a human detectable indication, for example a light and/or a sound indication, for example when patient catheter connector518is connected to connector508and/or when patient catheter connector518is sterilized.

In some embodiments of the present invention, the device can also comprise a computer readable medium. This digital storage means enables monitoring and storage of information relating to the device's performance such as, for non-limiting example, number of dialysis events, data on administration of at least one drug, volume of fluid passed through the device, temperature of at least one fluid, pH of at least one fluid, at least one marker found in at least one fluid and any combination thereof. In some embodiments, the computer readable medium, for example memory527shown inFIG.1Gstores log files of the device, log files of the pump component502or system500.

The user interface of the device can also be configured to accept and store personal information and medically related information about the patient, such as, for non-limiting example, age, height, weight, blood pressure, body temperature and any combination thereof. In some embodiments, the information is stored on memory527.

Some embodiments of the present invention can include a communication means, such as, for non-limiting example, Bluetooth wireless communication, thereby enabling transmission of the above mentioned information to at least one second device, which can be, for non-limiting example, a personal computer, a mobile phone, a tablet, a laptop, a remote server, a cloud-like server, a smart TV and any combination thereof. A second device can be in the possession of the patient; medical personnel such as a family doctor, a nephrology doctor, or an endocrinology doctor; a second device could be located at a medical facility, and any combination thereof. In some embodiments, the communication means, for example communication circuitry525shown inFIG.1G, transmits information stored on memory527to a remote computer and/or to a handheld device.

In some embodiments of the present invention, the above mentioned second device can be in operable communication with the device of the present invention and thus control parameters of the device such as, for non-limiting example, starting fluid flow, stopping fluid flow, controlling fluid flow speed, controlling motor operating power level, switching fluid origin, switching fluid flow direction, altering peristaltic blade movement, initiating disinfection and any combination thereof. Thus, for example, the device can be operated and controlled by a patient's smartphone application, which later on will receive information regarding the treatment from the device and further transmit this information to medical personnel giving care to that patient. In some embodiments, the medical personnel can transmit data or control parameters, as described above, to the patient's smartphone or directly to the device, thereby updating stored information on the device or the smartphone, or altering control parameters on the device. In some embodiments, a remote computer and/or a handheld device communicates with pump component502or with user interface523using communication circuitry525.

It should be noted that any combination of the above embodiments of the device also comprises an embodiment of the device.

Exemplary General Disinfection Process

Reference is now made toFIG.13Fdepicting a general disinfection process of a connector, according to some embodiments of the invention.

According to some exemplary embodiments, a connector, for example a catheter connector and/or a Y connector are connected to a disinfecting connector at1302. Optionally, the connector and the disinfecting connector are part of a dialysis system, for example a dialysis system for peritoneal dialysis (PD). In some embodiments, the connector, for example a catheter connector is connected to the disinfecting connector by a straight movement or by a rotation or revolving movement. In some embodiments, the disinfecting connector is pushed against the connector by an actuator, for example actuator534shown inFIG.1G. Optionally, the connector is rotated during at least part of the connection process. In some embodiments, the connector penetrates through a sealing layer placed at the distal end of the disinfecting connector and through at least one barrier of a disinfecting chamber containing disinfecting fluid. In some embodiments, the disinfecting fluid is approved to be used inside the body. Alternatively or additionally, the disinfecting fluid is approved to be used in a dialysis treatment.

According to some exemplary embodiments, the disinfecting fluid is released from the disinfecting chamber at1304. In some embodiments, the disinfecting fluid enters the internal lumen of the connector in a sufficient amount to allow, for example sterilization of the lumen. In some embodiments, the released disinfecting fluid is in contact with the external surface of the connector, the connector opening external surface and/or the internal surface of the connector to allow, for example sterilization of the external surface. In some embodiments, the disinfecting fluid penetrates to a distance of at least 0.5 centimeters (cm) into the internal lumen of the connector, for example 2, 3, 4, 5 cm and any intermediate or larger number. In some embodiments, the disinfecting fluid contacts the connector head and/or the connector leading edge and/or the connector face and/or the external surfaces of the connector, for example to allow their disinfection.

According to some exemplary embodiments, the disinfecting fluid disinfects the connector at1306. In some embodiments, the disinfecting fluid remains within the internal lumen of the connector for a pre-determined time period, for example to allow sterilization of the connector. In some embodiments, the disinfection time period is determined based on the type and/or the composition of the disinfecting fluid. In some embodiments, the disinfecting time period is at least 10 seconds, for example 20, 30, 40, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 seconds or any intermediate or larger time period. In some embodiments, the disinfecting time period is in a range of 10-200 seconds, for example 20-110 seconds, 30-120 seconds or 50-200 seconds.

According to some exemplary embodiments, an indication is delivered when the disinfection time period is over at1308. In some embodiments, the indication is a human detectable indication, for example a sound and/or a light indication. Alternatively or additionally, the indication is based on a chemical reaction that causes a color change of a component in the disinfecting connector or in the connector after a desired time period.

According to some exemplary embodiments, after the disinfecting period is over, the disinfecting fluid is flushed or drained at1310. In some embodiments, the disinfecting fluid is removed from the connector by activation of a pump. Alternatively, the disinfecting fluid is removed by gravitation force, for example when a waste compartment is lowered below the height of the catheter connector.

Exemplary Catheter Disinfection by Releasing Disinfecting Fluid from a Disinfecting Chamber

Reference is now made toFIG.14Adepicting a detailed disinfection process of a connector, according to some embodiments of the invention.

According to some exemplary embodiments, a connector end penetrates into a sealing disc of a disinfecting connector at1400. In some embodiments, the sealing disc is placed at the distal end of the disinfecting connector. In some embodiments, the sealing ring is elastic and is configured to expand and to contract.

According to some exemplary embodiments, after the connector penetrates through the sealing disc, the penetration site is sealed at1402. In some embodiments, the penetration site is sealed by a tightly attachment of the sealing disk to the external surface of the connector.

According to some exemplary embodiments, the connector penetrates into the disinfecting chamber at1404. In some embodiments, the width or diameter of the disinfecting chamber is at least 1.5 times larger, for example 1.5, 2, 2.5, 3 times larger or any intermediate or larger number, than the width or the diameter of the penetrating connector lumen opening. In some embodiments, the connector penetrates through a barrier, for example a foil barrier or a pressure seal barrier. In some embodiments, the barrier is positioned between the penetrating connector and the disinfecting chamber. Optionally, the connector penetrates into the disinfecting chamber by applying axial force on the barrier. In some embodiments, the barrier is a non-fluid gel barrier.

According to some exemplary embodiments, a disinfecting material for example a disinfecting fluid is pushed into the internal lumen of the penetrating connector at1408. In some embodiments, penetration of the connector into the disinfecting chamber decreases the pressure within the chamber and forces the disinfecting fluid into the internal lumen of the connector. Additionally, the disinfecting material disinfects the external surfaces of the connector and the external surface of the connector opening.

According to some exemplary embodiments, the penetrating connector penetrates into the disinfecting connector lumen at1410, for example to create a flow path between the penetrating connector and the disinfecting connector. In some embodiments, the penetrating connector penetrates through a barrier, for example a foil barrier or a pressure seal barrier positioned between the disinfecting chamber and the disinfecting connector lumen. Optionally, the barrier seals the disinfecting chamber after the penetration of the connector, to provide at least two sealing layers between the internal lumen of the connector and the outside environment. In some embodiments, when the barrier seals the disinfecting chamber it allows for some of the disinfecting fluid to remain in contact with the outer surface of the penetrating connector. In some embodiments, pump is activated and applies an axial force against the barrier to create an opening in the barrier.

According to some exemplary embodiments, penetration into the disinfecting connector lumen drains at least some of the disinfecting fluid from the internal lumen of the penetrating connector into the disinfecting connector lumen at1411. In some embodiments, draining is caused by reducing the pressure of the disinfecting fluid placed inside the penetrating connector lumen. Optionally, the disinfecting connector lumen has a lower pressure compared to the pressure of the penetrating connector lumen, which forces the disinfecting fluid to enter the disinfecting connector lumen once the flow path is created.

Reference is now made toFIGS.14B-14Ddepicting connector disinfection by a disinfecting chamber, according to some embodiments of the invention. According to some exemplary embodiments, a disinfecting connector1412comprises a disinfecting chamber1416containing disinfecting material, for example disinfecting fluid1412at the distal end of the disinfecting connector1412. In some embodiments, the disinfecting chamber is defined by the inner surface of the disinfecting connector1412and by at least two barriers, a proximal barrier1418between the disinfecting chamber1416and the internal lumen1424of the disinfecting connector1412, and a distal barrier1420.

In some embodiments, a connector1414, for example a catheter connector penetrates through sealing layer1419, for example a sealing disc and through the distal barrier1420and into the disinfecting chamber1416. In some embodiments, the connector1414penetrates into the disinfecting chamber1416by moving in direction1415or by revolving in axial direction1415. In some embodiments, the penetration of the connector1414into the disinfecting chamber1416pushes the disinfecting fluid in direction1415against the proximal barrier1418. In some embodiments, the disinfecting fluid1412is pushed back from the proximal barrier1418in direction1417, which is an opposite direction to direction1415and into the internal lumen of the connector1414. In some embodiments, the disinfecting fluid disinfects the external surface of connector1414, the internal lumen1413and the external surface of opening1421, for example the opening leading edge.

In some embodiments, for example as shown inFIG.14D, the connector is further pushed in direction1415and applies axial force against proximal barrier1418. In some embodiments, the axial force is sufficient to open proximal barrier1418and to allow, for example penetration of connector1414into the lumen1424of the disinfecting connector1412. In some embodiments, penetration through the proximal barrier1418creates a flow path between the connector1414and the disinfecting connector1412.

In some embodiments, the proximal barrier1418is shaped and sized to resist an axial pressure of up to 0.5 bar.

Reference is now made toFIGS.14E-14Fdepicting catheter disinfection within a disinfecting chamber having breakable internal storage compartment for disinfecting material, according to some embodiments of the invention.

According to some exemplary embodiments, a disinfecting connector1430comprises a disinfecting chamber1432enclosed between a proximal barrier1434and a distal barrier1433. In some embodiments, the disinfecting chamber1432comprises internal storage compartments1431for storing disinfecting material, for example disinfecting fluid1422. In some embodiments, the internal storage compartment1431have inclined walls facing the lumen of the disinfecting chamber1432and optionally create a circular opening1421which has a diameter that is smaller than the maximal diameter of connector1414. In some embodiments, the inclined walls, for example wall1454are positioned in angle smaller than 90° degrees relative to the internal surface1452of the disinfecting chamber1432. In some embodiments, the angle1450between the internal surface1452and the wall1454is at least 5° degrees.

According to some exemplary embodiments, for example as shown inFIG.14F, connector1414penetrates through a sealing barrier, for example sealing barrier1441and distal barrier1433into the disinfecting chamber1432. In some embodiments, the leading edge of opening1421makes contact with the inclined walls of the storage compartments1431.

According to some exemplary embodiments, for example as shown inFIG.14G, while moving in direction1415connector1414applies axial force on the storage compartment1431which causes them to open. In some embodiments, when storage compartments are open, the disinfecting fluid1422is released into the disinfecting chamber1432and into the internal lumen1413of the connector1414.

According to some exemplary embodiments, for example as shown inFIG.14H, the connector penetrates through the proximal barrier1434into the lumen1436of the disinfecting connector1430. Optionally, penetration through the proximal barrier1434creates a fluid path between the connector1414and the disinfecting connector1430.

Exemplary Disinfecting Connector with a Disinfecting Chamber

Reference is now made toFIGS.15A-15Ddepicting a disinfecting connector according to some embodiments of the invention.

According to some exemplary embodiments, a disinfecting connector1504comprises a distal end1506and a proximal end1508. In some embodiments, the disinfecting connector1504comprises a disinfecting chamber1516within the internal lumen of the disinfecting connector1504. In some embodiments, the disinfecting chamber1516is defined by at least two barriers, for example a distal barrier1512and a proximal barrier1514. Additionally, the disinfecting connector comprises a sealing component, for example sealing ring1510distally to the distal barrier1510. In some embodiments, the sealing component is shaped and sized to prevent any leakage of fluid from the disinfecting connector lumen to the outside. In some embodiments, the disinfecting chamber comprises a disinfecting fluid1505. In some embodiments, the disinfecting fluid1505is approved for usage within the body and/or approved to be used in a dialysis treatment.

According to some exemplary embodiments, for example as shown inFIG.15B, a distal end1503of a connector1502penetrates through the sealing ring1510by moving in direction1415into the disinfecting connector1504. Alternatively, the connector1502rotates in a clockwise direction1501or in a counterclockwise direction1507into the disinfecting connector1504. In some embodiments, once the connector1502penetrates through the sealing ring1510, the sealing ring is tightly attached around the external surface of the connector1502, for example to prevent any leakage of fluid from the disinfecting connector lumen to the outside.

According to some exemplary embodiments, for example as shown inFIG.15Cconnector1502penetrates through the distal barrier1512and into the disinfecting chamber1516. In some embodiments, as described inFIGS.14B and14Cthe connector pushes the disinfecting fluid1505against the proximal barrier and into the internal lumen of connector1502. In some embodiments, the movement of the connector1502stops for example to allow disinfection for a desired time period.

According to some exemplary embodiments, for example as shown inFIG.15Dafter the desired disinfection time is over, the connector penetrates through the proximal barrier1514. In some embodiments, penetration through the proximal barrier1514, allows for example removal of at least part of the disinfecting fluid from the internal lumen of the connector. Optionally, the disinfecting fluid is removed back into the disinfecting connector. In some embodiments, the disinfecting fluid is pushed into a waste storage compartment.

Reference is now made toFIGS.15E-15Hdepicting a disinfecting connector with an internal disinfection chamber, according to some embodiments of the invention.

According to some exemplary embodiments, a disinfecting connector1530comprises at least one disinfecting chamber1533, positioned within a lumen1532of the disinfecting connector. In some embodiments, the disinfecting chamber1533comprises an inclined wall1535and contains disinfecting material1505. In some embodiments, the incline of the inclined wall is in an angle of at least 5° degrees with the internal walls of the connector lumen1532. In some embodiments, the disinfecting chamber1533is configured to be ruptured by an axial force.

According to some exemplary embodiments, for example as shown inFIGS.15G and15H, the distal end1503of connector1502penetrates into the connector lumen1532. In some embodiments, the distal end1503penetrates into the connector lumen1532either in a straight movement or in a rotating movement. Optionally, the distal end1503penetrates into the connector lumen1532in a movement which is partially straight movement and partially a rotation movement.

In some embodiments, for example as shown inFIG.15Gthe distal end1503of connector1502contacts the inclined wall1535of the disinfecting chamber1533. In some embodiments, the contact between the inclined wall and the distal end1503seals the entry site of the connector. In some embodiments, when the connector1502moves forward, it ruptures the wall of the disinfecting chamber1533which is perpendicular to the internal surface of the connector lumen. In some embodiments, rupturing the perpendicular wall releases the disinfecting material1505from the disinfecting chamber1533and into the connector lumen1532. In some embodiments, once the disinfecting material1505is released into the connector lumen1532, the disinfecting material is forced into the lumen of connector1502. In some embodiments, the disinfecting material disinfects the connector head and/or the connector leading edge and/or the connector face and some of the connector external surfaces which are in contact with the disinfecting material.

In some embodiments, the distal end1503of connector1502penetrates through a proximal barrier1538placed between the connector lumen1532and a tube connected to the disinfecting connector. Optionally, once the disinfecting chamber1533is ruptured, the movement of the connector1502stops, for example to allow disinfection of the internal lumen of both connector1502and the disinfecting connector1530and/or the connector1502head and/or some of connector1502external surfaces for a desired time period. In some embodiments, once the disinfection time is over, the distal end1503continue to move and penetrate through the proximal barrier1538, for example as shown inFIG.15H.

Exemplary Disinfecting Connector with a Disinfecting Sponge

Reference is now made toFIGS.16A-16Ddepicting a disinfecting connector comprising a disinfecting sponge, according to some embodiments of the invention.

According to some exemplary embodiments, a disinfecting connector1604comprises a disinfecting sponge1620, at least partly saturated with a disinfecting material. In some embodiments, the disinfecting sponge1620is placed within a disinfecting chamber1616positioned at the distal end of the disinfecting connector1604. In some embodiments, the sponge fills the entire volume of the disinfecting chamber. In some embodiments, the sponge1620comprises a central axial channel1619, optionally a tubular channel or an inclined channel. In some embodiments, the diameter of channel1619is larger than the diameter of connector1602opening. In some embodiments, the diameter of channel1619is smaller than the diameter of connector1602. In some embodiments, the disinfecting chamber comprises a sealing barrier, for example a sealing disc1610and a proximal barrier1614, for example a pressure seal barrier or a foil barrier positioned between the disinfecting chamber1616and a disinfecting connector tube1615.

According to some exemplary embodiments, a connector1602, for example a catheter connector penetrates through the sealing disc1610and into the disinfecting chamber1616, by rotating clockwise in clockwise direction1501or by rotating in a counterclockwise direction1507or by moving straight in direction1415. In some embodiments, when the connector1602enters into the disinfecting chamber1616, the distal end1603of the connector1602pushes and contracts the disinfecting sponge1620size in at least 20%, for example 20%, 25%, 30%, 35%, 40%, 45%, 50% or any intermediate or larger number. In some embodiments, contraction of the disinfecting sponge1620releases the disinfecting fluid into the internal lumen of the connector1602in a sufficient amount, to allow for example disinfection or sterilization of the lumen. Optionally, contraction of the disinfecting sponge1620squeezes the disinfecting fluid into the internal lumen of the connector1602. Additionally, the sponge material with the disinfecting material is in direct contact with the outer surface of connector1602and with the leading edge of the connector opening, for example to allow disinfection or sterilization.

According to some exemplary embodiments, for example as shown inFIGS.16C and16D, the distal end1603of the connector1602is inserted into channel1619. Additionally, the external surface of connector1602contracts the disinfecting sponge1620against the proximal barrier1614, for example to squeeze out or to release the disinfecting fluid from the disinfecting sponge1620. In some embodiments, during the penetration of connector1602through the channel1619, the sponge1620wipes and disinfects the external surfaces of connector1602.

Exemplary Disinfecting Connector for Disinfecting a Y-Connector

Reference is now made toFIGS.16E-16depicting a disinfecting connector for sterilization of a Y-connector, according to some embodiments of the invention.

According to some exemplary embodiments, disinfecting connector1630comprising a seal, for example a sealing disc1634at the distal end of the disinfecting connector facing the Y-connector1632. In some embodiments, Y-connector penetrates through the sealing disc1634, which optionally seals the entry site by tightly contacting the external surface of the Y-connector. In some embodiments, the Y-connector penetrates into the disinfecting connector1630in a rotational movement. In some embodiments, the Y-connector rotates in direction1501or in direction1507.

According to some exemplary embodiments, for example as shown inFIG.16Gthe Y-connector penetrates through a distal barrier1636, into a disinfecting chamber1635sealed between the distal barrier1636and a proximal barrier1638. In some embodiments, distal barrier and/or proximal barrier are foil barriers or pressure seals. In some embodiments, penetration into the disinfecting chamber releases disinfecting material that disinfects and optionally sterilizes at least partly the leading edge of the Y-connector opening, and/or the internal lumen of the Y-connector and/or the external surface of the Y-connector.

According to some exemplary embodiments, for example as shown inFIG.16H, the Y-connector penetrates through the proximal foil1638to create a flow path to the pump tube. In some embodiments, the flow path connects a dialysate storage compartment and/or a waste storage compartment to the pump tube.

Exemplary Disinfecting Connector Including a Gel of Disinfecting Material

Reference is now made toFIGS.16I-16Kdepicting a disinfecting connector with a disinfecting material in the form of a gel, according to some embodiments of the invention.

According to some exemplary embodiments, the disinfecting connector comprises disinfecting material in the form of a non-fluid gel placed at the disinfecting chamber of the connector. In some embodiments, connector1652penetrates into disinfecting gel1654of disinfecting connector1650. In some embodiments, during the penetration through the disinfecting gel, the gel disinfects the leading edge of the connector1652and the external surface of the connector. Additionally, disinfecting gel enters at least partly into the lumen of connector1652in an amount sufficient to disinfect and optionally sterilize the lumen.

In some embodiments, connector1652penetrates into disinfecting gel1654by rotating in a clockwise direction or in a counterclockwise direction.

In some embodiments, the disinfecting material comprises any wide range disinfecting material that can be formed as a high-viscosity gel, for example polydin gel.

Exemplary Disinfecting Connector Including Gel Barriers

Reference is now made toFIGS.16L-16N, depicting a disinfecting connector with gel barriers, according to some embodiments of the invention.

According to some exemplary embodiments, a disinfecting connector, for example disinfecting connector1660comprises a distal barrier and/or a proximal made of gel, for example high-viscosity gel with a centipoise value larger than 1.4, optionally an inert gel. In some embodiments, the gel barriers seal a disinfecting chamber, for example disinfecting chamber1662. In some embodiments, the width of a distal gel barrier1666and proximal gel barrier1668made from gel is at least 1 mm, for example 1, 2, 3, 4, 5 mm or any intermediate or larger width.

According to some exemplary embodiments, for example as shown inFIGS.16M and16N, a connector1652penetrates through the distal gel barrier1666into the disinfecting chamber1662. In some embodiments, distal gel barrier1666seals the penetration site of connector1652. Alternatively, a seal is positioned distally to the distal gel barrier1666, for example to seal the penetration site of connector1652into the disinfecting connector1660before passing through the distal gel barrier1666.

In some embodiments, when connector1652enters the disinfecting chamber, a disinfecting material placed within the chamber is released into the lumen of connector1660, as described in other embodiments of the invention. Optionally, the disinfecting material disinfects the leading edge of the lumen opening, and the outer surfaces of connector1660. In some embodiments, after a desired time period, the connector1660penetrates through proximal gel barrier1668, for example to create a flow path between the lumen of connector1660and a lumen of a tube connected to the disinfecting connector1660.

Exemplary Disinfecting Connector Connected to a Pump

Reference is now made toFIGS.17A-17Ddepicting a disinfecting connector connected to a pump, according to some embodiments of the invention.

According to some exemplary embodiments, a disinfecting connector1706comprises a disinfecting disc1708. In some embodiments, the disinfecting disc contains a disinfecting material, for example a disinfecting material that is approved to be used inside the body, and/or approved to be used in a dialysis treatment. In some embodiments, the disinfecting connector is connected via a tube1710to a pump1702, for example a peristaltic pump. In some embodiments, pump1702comprises a pump rotor1704and a pump base1703. In some embodiments, rotation of pump rotor1704within pump base pushes fluid within tube1710in a peristaltic movement to and/or from disinfecting connector1706.

According to some exemplary embodiments, connector1716, for example a catheter connector or catheter connector tube is placed within fins1714. In some embodiments, fins1714are placed distally to the disinfecting connector1706and are sized and shaped to fix the position of the connector1716, when the disinfecting connector1706is pushed towards him, for example by actuators shown inFIGS.1G and1H. In some embodiments, the fins1714prevents the axial movement of connector1716, for example when connector1716is in contact with disinfecting connector1706.

In some embodiments, the distal end1717of connector1716is in contact with the disinfecting plate1708, when the connector1716is fixed within the disinfecting connector1706. In some embodiments, the disinfecting plate1708is made from a sponge material capable of contraction of at least 20% relative to its original size in a relaxed state, for example 20%, 25%, 30%, 35%, 40%, 45%, 50% or any intermediate or larger number. In some embodiments, the distal end1717contracts the disinfecting plate, for example to release disinfection fluid into the internal lumen of the connector1716. Alternatively, for example as shown inFIG.17C, the disinfecting fluid1720is stored within pump tube1710.

According to some exemplary embodiments, for example as shown inFIG.17D, catheter connector1716is connected to connector1706, and Y-connector1712is connected to connector1711, before disinfection initiates. In some embodiments, rotor1704is rotated in one direction and pushes the disinfecting fluid1720into an interface between connector1706and catheter connector1716. Optionally, the disinfecting fluid1720is pushed into the lumen of catheter connector1716, for example to sterilize the interface between the lumen of catheter connector1716and connector1706. In some embodiments, the disinfecting fluid remains within the lumen of connector1706and/or within the interface between connector1706and catheter connector1716for a desired disinfection time period. In some embodiments, the desired disinfection time period is at least 10 seconds, for example 15, 20, 30, 40 seconds or any intermediate or longer time period. In some embodiments, the desired disinfection time period is in a range of 10-200 seconds, for example 20-50 seconds, 30-120 seconds or 60-200 seconds.

According to some exemplary, for example as shown inFIG.17E, after disinfection is complete the rotor is rotated to the opposite direction and pushes disinfecting fluid1720into the lumen of Y-connector1712and/or into the interface between Y-connector1712and connector1711. In some embodiments, the disinfecting fluid remains within the lumen of Y-connector1712and/or within the interface between the Y-connector1712and connector1711for a desired disinfection time period. In some embodiments, the desired disinfection time period is at least 10 seconds, for example 15, 20, 30, 40 seconds or any intermediate or longer time period. In some embodiments, the desired disinfection time period is in a range of 10-200 seconds, for example 20-50 seconds, 30-120 seconds or 60-200 seconds. In some embodiments, after disinfection of the Y-connector is complete, the rotor is further rotated to drain the disinfecting fluid1720out from pump tube1710and into a waste compartment, optionally connected to Y-connector1712via a tube.

Exemplary Means for Releasing a Rotor

Reference is now made toFIGS.18A-18Cdepicting a pump rotor secured to a motor driven shaft via a compressible component, according to some embodiments of the invention.

According to some exemplary embodiments, pump1802comprises a rotor1806connected via a motor driven shaft1808to a rotor of the pump. In some embodiments, the rotor1806comprises a central opening1809, optionally a circular opening sized to fit around the motor driven shaft1808. In some embodiments, a circular connection member1803is placed into the upper side of central opening1809, for example to prevent the detachment of the rotor1806from the motor driven shaft1808. In some embodiments, removal of circular connection member1803allows, for example to remove the rotor from the motor driven shaft. In some embodiments, removal of the rotor allows, for example to drain residual fluid from pump tube sections.

In some embodiments, the motor driven shaft1808comprises an inner circular groove1810circulating an inner central opening. In some embodiments, the size, shape and/or width of the groove1810fit the size of at least 2 movable bulges1808extending through at least two windows on the lower circumference of connection member1803, as shown inFIG.18A. Optionally, the two bulges1808extend through windows on the opposite sides of the circumference of connection member1803. In some embodiments, the two bulges1808are mechanically connected to at least two movable members1804extending from the upper circumference of connection member1803at opposite directions.

In some embodiments, in a relaxed state, the two movable members1804are in a fully extended position, where the distance between the two movable members1804is maximal. In some embodiments, pressing the two movable members1804simultaneously shortens the distance between the two bulges1808and moves them closer to each other. In some embodiments, pressing the two movable members1804moves the two bulges1808out from the groove1810and allow, for example to remove the connection member1803from central opening1809of rotor1806. In some embodiments, removal of the connection member1803from the rotor1806, allows for example detachment of the rotor1806from the motor driven shaft1808of the pump1802and draining of residual fluid left in the pump tube.

Reference is now made toFIGS.18D-18Hdepicting a pump rotor secured to a motor driven shaft via a cap placed on top of the pump rotor, according to some embodiments of the invention.

According to some exemplary embodiments, pump1821comprises rotor1822connected via a motor driven shaft1828to a pump motor. In some embodiments, the rotor1822comprises a central opening1823, optionally a circular opening, sized to fit around the motor driven shaft1828. In some embodiments, a cap1826is placed within the upper side of central opening1823, for example to prevent unwanted detachment of the rotor1822from the motor driven shaft1808.

In some embodiments, cap1826comprises at least one snap-click member sized and shaped to fit an indentation surrounding the motor driven shaft. In some embodiments, application of force on the upper side of the cap1826towards the motor driven shaft pushes the snap-click member away from the indentation and allows, for example to release the cap1826and the rotor1822. In some embodiments, as described herein by releasing the rotor from the motor driven shaft the residual fluid left inside the pump tube can be drained.

According to some exemplary embodiments, cap1820comprises a curved hinge1839or section at the bottom of cap1820, fitted and sized to be trapped underneath indentation1841of motor interface1822, for example to secure rotor1822to motor driven shaft1828. In some embodiments, for example as shown inFIG.18H, to release rotor1822from motor driven shaft1828, a force is applied in direction1842on cap1820. In some embodiments, when force is applied in direction1842, the cap1820is pushed towards the motor driven shaft while hinge1839moves away from indentation1841in direction1843. In some embodiments, the movement of hinge1839from indentation1841, allows for example to release cap1820and to release rotor1822.

According to some exemplary embodiments, cap1820is an interference locking or connection member, for example a snap-click connection member.

Reference is now made toFIGS.18I-18Ldepicting an elastic clip placed on the rotor, for example to release the rotor, according to some embodiments of the invention.

According to some exemplary embodiments, an elastic clip1850is placed on top of rotor1822. In some embodiments, the elastic clip1850comprises a compressible section1849and an elastic section1851positioned around motor interface1829, optionally underneath a circular ring1853that extends from the circumference of motor interface1829. In some embodiments, for example as shown inFIG.18J, compressing section1849, moves elastic section1851away from the motor interface1829. In some embodiments, moving elastic section away from the motor interface1829releases the rotor1829and the attached clip1850from the motor interface1829, for example as shown inFIG.18K. In some embodiments, when rotor1829is released motor interface1829and bottom interface1852are released from the motor driven shaft1828.

In some embodiments, motor driven shaft comprises a pin1849. In some embodiments, the pin1849rotates simultaneously with motor driven shaft1828. In some embodiments, the pin1849pushes at least one blade or the rotor.

In some embodiments, for example as shown inFIG.18J, each rotor blade, for example rotor blade1859comprises a wheel1859at the distal end of the rotor blade facing a pump tube1863. In some embodiments, during the rotation of rotor blade1859, wheel1859rotates and compresses pump tube1863. In some embodiments, the rotor blade comprises a layer of a material, configured to allow sliding on the pump tube1863. In some embodiments, the layer is designed to be worn-out after a desired number of rotor rotations or after a desired time period.

Exemplary Dialysis System Activation Process

Reference is now made toFIG.19depicting an activation process of a dialysis system, for example a PD system, according to some embodiments of the invention.

According to some exemplary embodiments, a catheter connector is opened at1901. In some embodiments, the catheter connector is opened by removing a cap covering the catheter connector lumen.

According to some exemplary embodiments, a catheter connector is connected to the dialysis system, for example dialysis system500shown inFIG.1Gat1902. In some embodiments, the catheter connector is connected to a disinfecting connector of the dialysis system. In some embodiments, the connector of the dialysis system, for example the disinfecting connector is pushed against the catheter connector by an actuator, for example to ensure the connection to the catheter connector. Alternatively, the catheter connector is connected to the dialysis system connector by interlocking a screw thread of the catheter connector with a compatible screw thread on the dialysis system connector. In some embodiments, a Y-connector, for example connector522is connected in a similar way to the system via a second disinfecting connector.

According to some exemplary embodiments, during the connection of the catheter connector, the cap of the catheter connector is opened at1903. In some embodiments, a puncturing mechanism punctures the cap during the connection process.

According to some exemplary embodiments, the catheter connector and/or the Y-connector are sterilized at1904. In some embodiments, the catheter connector and/or the Y-connector are sterilized by a disinfecting material stored in the disinfecting connector. In some embodiments, the catheter connector and/or the Y-connector are sterilized during the connection process, and/or after the connection process is over.

According to some exemplary embodiments, the disinfecting material is drained from the catheter connector at1906. In some embodiments, the disinfecting material is drained by activation of a pump, for example a peristaltic pump that pushes the disinfecting material out from the catheter connector, optionally to a waste compartment. In some embodiments, air is drained from the disinfecting connector through a valve.

According to some exemplary embodiments, the pump pushes dialysate into the catheter connector at1908. In some embodiments, the dialysate is pushed from a dialysate compartment, through the Y-connector and into the catheter connector.

According to some exemplary embodiments, the catheter connector is disconnected at1910. In some embodiments, the catheter connector is disconnected when a desired amount of dialysate is pushed into the catheter connector.

According to some exemplary embodiments, the catheter connector opening is sealed at1912. In some embodiments, the catheter connector opening is sealed by a cap, optionally a sterilizing cap. In some embodiments, the sterilizing cap comprises a disinfecting material, optionally placed within a sponge.

Exemplary Dialysis System Activation Process by a User

Reference is now made toFIG.20depicting an activation process of a dialysis system, for example a PD dialysis system by a user, according to some embodiments of the invention.

According to some exemplary embodiments, a pump motor is provided to a user at2002. In some embodiments, the pump motor is part of a durable component of the system, for example base component503of system500shown inFIG.1G. In some embodiments, the durable component comprises a power supply, for example power supply544and an interface, for example user interface523connected to a control circuitry540.

According to some exemplary embodiments, the user opens a cap sealing a catheter connector at2004.

According to some exemplary embodiments, the user takes a kit of disposable elements at2006. In some embodiments, the disposable elements comprise detachable component502shown inFIG.1G. In some embodiments, the kit comprises a pump rotor, a pump tube and at least one disinfecting connector. In some embodiments, the kit comprises a Y-connector, for example Y-connector522optionally connected to disinfecting connector511. In some embodiments, the kit comprises at least one actuator, for example actuator532, configured to push the at least one disinfecting connector in an axial force against the catheter connector and/or against the Y-connector.

According to some exemplary embodiments, the user attaches the kit, for example, the detachable component to the durable component by at least one connection member, for example at least one pin in one component that fits into an opening on the other component at2008.

According to some exemplary embodiments, the user connects external connectors, to disinfecting connectors of the system at2010. In some embodiments, the user connects a catheter connector and a Y-connector to the system. Alternatively, the user connects only a catheter connector to the system.

According to some exemplary embodiments, the user receives an activation indication at2012. In some embodiments, the user receives a human detectable indication by the interface, indicating that the sterilization process is complete and/or that the system is ready for activation.

According to some exemplary embodiments, the user presses an activation button at2014. In some embodiments, the user presses the activation button after receiving the activation indication at2012. In some embodiments, after pressing the activation button the dialysis system initiates a dialysis treatment session.

According to some exemplary embodiments, once the treatment session is complete the user receives an end of treatment indication, for example a human detectable indication at2016.

According to some exemplary embodiments, the user presses a deactivation button at2018. In some embodiments, pressing the deactivation button stops the rotation of the rotor and/or stops the activation of the pump motor.

According to some exemplary embodiments, the user disconnects the external connectors from the system at2020. In some embodiments, the user disconnects both a catheter connector and a Y-connector from the system. Alternatively, the user disconnects only a catheter connector from the system. In some embodiments, following the disconnection of the connector, the user seals the catheter connector opening by a cap, optionally a disinfecting cap.

According to some exemplary embodiments, the user disconnects and throws away the kit of disposable elements at2022. In some embodiments, some components of the kit are reused, for example the rotor.

Exemplary Detachable Assembly Components

Reference is now made toFIGS.21A-21Ddepicting a detachable assembly of a peristaltic pump, according to some embodiments of the invention.

According to some exemplary embodiments, a peristaltic pump, for example a peristaltic pump for a dialysis system comprises a detachable assembly2100. In some embodiments, the detachable assembly comprises a rotor2112, which rotates within a rotor housing2101. Additionally, the detachable assembly comprises at least a partially elastic tube, for example pump tube2114positioned within the rotor housing2101. In some embodiments, at least one blade of the rotor2112presses pump tube2114against the wall of the rotor housing2101. In some embodiments, when rotor2112rotates, the rotor blade presses a different section of pump tube2114. In some embodiments, the weight of the detachable assembly is at least 20 grams, for example 20, 30, 40, 100 grams or any intermediate or larger weight.

According to some exemplary embodiments, the detachable assembly2100comprises at least one disinfecting connector, for example disinfecting connectors2116and2108connected to both ends of pump tube2114. In some embodiments, the disinfecting connector2116is shaped and sized to connect a catheter connector, for example catheter connector2102. In some embodiments, the disinfecting connector2108is shaped and sized to connect a Y-connector, for example Y-connector2104.

According to some exemplary embodiments, the detachable assembly2100comprises a connecting member, for example connecting member22106configured to fix the position of Y-connector2104. Additionally or alternatively, the detachable assembly comprises a connecting member, for example fins2118configured to fix the position of catheter connector2102. In some embodiments, the disinfecting connectors2108and2116are connected to actuators2110and2118, respectively. In some embodiments, for example as shown inFIG.21B, when the upper part of each actuator is pressed down the actuators move the disinfecting connector in an axial movement towards the external connector. In some embodiments, the connecting member of each external connector restricts the axial movement of the external connector in response to the force applied by the actuator, which forces the connection between the disinfecting connector of the detachable assembly and the external connector, for example as shown inFIG.21C.

Exemplary Pump Tube Embedded within Rotor Housing

Reference is now made toFIG.21Ddepicting a pump tube that is at least partially embedded within a rotor housing of a peristaltic pump, according to some embodiments of the invention.

According to some exemplary embodiments, a pump tube, for example pump tube2002comprises an elastic section2206facing the blades of a peristaltic pump rotor, for example rotor2002, and a non elastic rigid section2204. In some embodiments, the rigid section2204is made from the rotor housing wall. In some embodiments, when the rotor rotates, at least one of the rotor blades makes contact with the pump tube and compresses the elastic section, and not the rigid section2204. In some embodiments. In sections of the tube that are not in contact with the rotor blades, the elastic section2206is in a relaxed state and together with the rigid section2204form a tubular structure.

Exemplary Motor Assembly

Reference is now made toFIGS.22A and22B, depicting a motor assembly of a peristaltic pump, according to some embodiments of the invention.

According to some exemplary embodiments, motor assembly2200comprises an electric motor, for example motor2206, connected to a motor driven shaft, for example drive shaft2208. In some embodiments, drive shaft2208is cylindrical or has a rectangular shape, for example to form a rectangular drive shaft. In some embodiments, motor2206and drive shaft are placed within motor assembly housing2202. In some embodiments, the motor assembly further comprises an electric supply, for example battery2210. In some embodiments, a control circuitry2212is connected to battery2210and/or to motor2206. In some embodiments, control circuitry2212comprises a timing circuitry for timing the operation of motor2206and or a disinfection process of a connector connected to the pump tube or a flow path between the connector and the pump tube. In some embodiments, the motor assembly2200weight is at least 300 grams, for example 300, 400, 500 grams or any intermediate or larger weight.

In some embodiments, housing2202comprises a door2204which includes a opening2214and optionally a display2222on the outer surface of the door2204. In some embodiments, opening2214is a window covered with a transparent material. In some embodiments, housing2202comprises an opening2218sized to allow, for example the insertion of a single tube, for example a catheter tube. Additionally, the housing2202comprises an opening2220, sized to allow, for example the insertion of two tubes. In some embodiments, the housing2202comprising at least one connecting member, for example pin2216that fits a connection member on a detachable assembly of the pump, for example to allow connection between the motor assembly and the detachable assembly.

Exemplary Peristaltic Pump System

Reference is now made toFIGS.23A-23E, depicting the assembly of a peristaltic pump system, according to some embodiments of the invention.

According to some exemplary embodiments, for example as shown inFIGS.23A and23B, a detachable assembly2100as connected to motor assembly2200by matching at least one connection member, for example pin2216of motor assembly2200with an opening, for example opening2302of the detachable assembly. In some embodiments, the detachable assembly comprises at least two openings, for example opening2302and2303, to allow a stable connection of the detachable assembly to the motor assembly during the rotation of the motor. In some embodiments, the at least two openings are placed in a distance between each other in locations surrounding the rotor, for example to stabilize the detachable assembly during rotor rotation. In some embodiments, for example as shown inFIG.23C, once the detachable assembly2100is connected to motor assembly2200, the external connectors, for example catheter connector2102and/or Y-connector2104are connected to the detachable assembly. In some embodiments, each of the external connectors faces a disinfecting connector.

According to some exemplary embodiments, for example as shown inFIG.23D, when door2204is closed, door regions2205press the upper face of actuators2118and2110. In some embodiments, door regions2205are made from a durable material, or that door regions2205are thicker than other regions of door2204, for example to allow application of force on the actuators without cracking or damaging door2204. In some embodiments, pressing the upper face of actuators2118and2110and causes them to move the disinfecting connectors towards the external connectors, for example as previously discussed inFIGS.21A-C. In some embodiments, for example as shown inFIG.23E, in an assembled conformation, the peristaltic pump motor is connected to the rotor and the external connectors are connected to the pump tube, optionally within a closed casing. In some embodiments, display2222provides indications to a user of the peristaltic pump of a user undergoing a dialysis treatment.

While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and the above detailed description. It should be understood, however, that it is not intended to limit the invention to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

It is expected that during the life of a patent maturing from this application many relevant disinfecting connectors will be developed; the scope of the term disinfecting connector is intended to include all such new technologies a priori.

As used herein with reference to quantity or value, the term “about” means “within ±10% of”.

The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

The term “consisting of” means “including and limited to”.

The term “consisting essentially of” means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range/ranging/ranges between” a first indicate number and a second indicate number and “range/ranging/ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.