Dialysis system with external conduit surface cleaning

Abstract

A peritoneal dialysis ("PD") system includes a housing, a PD fluid pump contained by the housing, and a reusable line in fluid communication with the PD fluid pump. The reusable line is configured to be pulled into the housing. The PD system further includes an outer conduit surface cleaning unit positioned and arranged to at least one of: (i) remove debris from at least a portion of an exterior of the reusable conduit as the reusable conduit is pulled into the housing, or (ii) applying a disinfectant to at least the portion of the exterior of the reusable line when the reusable line is pulled into the housing.

Description

Technical Field

[0001] The present disclosure relates generally to medical fluid therapy, and in particular to dialysis fluid therapy requiring pumping of patient injectable fluids. Background Art

[0002] For a variety of reasons, a person's kidney system may fail. Kidney failure produces a variety of physiological disturbances. It is no longer able to balance water and minerals or excrete the daily metabolic load. Toxic end products of metabolism (such as urea, creatinine, uric acid, and other substances) may accumulate in the patient's blood and tissues.

[0003] Dialysis is used to treat decreased kidney function, especially kidney failure. Dialysis removes waste products, toxins, and excess water from the body that would normally be removed by the kidneys. Dialysis treatment to replace kidney function is vital for many people because it is life-saving.

[0004] One type of renal failure therapy is hemodialysis ("HD"), which typically uses diffusion to remove waste products from a patient's blood. A diffusion gradient is created across a semipermeable dialyzer between the blood and an electrolyte solution called dialysate or dialysis fluid to induce diffusion.

[0005] Hemofiltration ("HF") is an alternative renal replacement therapy that relies on the convective transport of toxins from the patient's blood. HF is achieved by adding replacement or substitution fluid to the extracorporeal circuit during treatment. During HF treatment, the replacement fluid and the patient's accumulated fluid between treatments are ultrafiltered, providing a convective transport mechanism that is particularly beneficial for the removal of middle and large molecules.

[0006] Hemodiafiltration ("HDF") is a treatment modality that combines convective and diffusive clearance. HDF uses a dialysis fluid flowing through a dialyzer (similar to standard hemodialysis) to provide diffusive clearance. In addition, a replacement solution is provided directly to the extracorporeal circuit, thereby providing convective clearance.

[0007] Most HD, HF, and HDF treatments are performed at centers. Today there is a trend toward home hemodialysis ("HHD"), in part because HHD can be performed daily, which provides efficacy benefits compared to hemodialysis treatments in centers, which are typically performed every two or three weeks. Studies have shown that more frequent treatments remove more toxins and wastes and reduce interdialytic fluid overload compared to patients who receive less frequent but potentially longer treatments. Patients who receive more frequent treatments do not experience as many down cycles (fluctuations in fluids and toxins) as patients in centers, who have accumulated toxins for two or three days before treatment. In some areas, the nearest dialysis center may be many miles away from the patient's home, resulting in home treatment time taking up a large part of the day. Treatment at a center near the patient's home may also take up a large part of the patient's day. HHD can be performed at night or during the day while the patient is relaxing, working, or otherwise productive.

[0008] Another type of renal failure therapy is peritoneal dialysis ("PD"), which infuses a dialysis solution (also called dialysis fluid) into the patient's peritoneal compartment via a catheter. The dialysis fluid contacts the peritoneum within the patient's peritoneal compartment. Waste products, toxins, and excess water flow from the patient's blood through the capillaries in the peritoneum and enter the dialysis fluid due to diffusion and osmosis, i.e., an osmotic gradient occurs across the peritoneum. The osmotic agent in the PD dialysis fluid provides the osmotic gradient. Used or spent dialysis fluid is drained from the patient, thereby removing waste products, toxins, and excess water from the patient. This cycle is repeated, for example, multiple times.

[0009] There are many types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal flow dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to a drain to allow used or spent dialysis fluid to drain from the peritoneal chamber. The patient then switches the fluid connection so that the patient's catheter is connected to a bag of fresh dialysis fluid to inject fresh dialysis fluid through the catheter and into the patient's body. The patient disconnects the catheter from the bag of fresh dialysis fluid and allows the dialysis fluid to reside in the peritoneal chamber, where the transfer of waste, toxins, and excess water occurs. After the residence period, the patient repeats the manual dialysis procedure, for example four times a day. Manual peritoneal dialysis requires a large amount of time and effort from the patient, which leaves much room for improvement.

[0010] Automated peritoneal dialysis ("APD") is similar to CAPD in that dialysis treatment includes drain, fill, and dwell cycles. However, automated PD machines typically perform these cycles automatically while the patient sleeps. PD machines eliminate the need for patients to manually perform treatment cycles or deliver supplies during the day. The PD machine is fluidly connected to an implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drain. The PD machine pumps fresh dialysis fluid from a source of dialysis fluid through the catheter and into the patient's peritoneal compartment. The PD machine also allows the dialysis fluid to dwell within the peritoneal compartment and allows for the transfer of waste, toxins, and excess water. The source can include multiple liters of dialysis fluid, which include several bags of solution.

[0011] The PD machine pumps the spent or exhausted dialysate from the patient's peritoneal cavity through a catheter to a drain. As with the manual process, several drain, fill, and dwell cycles occur during dialysis. A "final fill" may occur at the end of APD treatment. The final fill fluid may remain in the patient's peritoneal compartment until the next treatment begins, or may be manually emptied at some point during the day.

[0012] In any of the above modes, automated machines and even manual CAPDs are typically operated with a disposable kit that is discarded after a single use. Depending on the complexity of the disposable kit, the cost of using one kit per day may become significantly large. Moreover, daily disposable items require space for storage, which may be troublesome for homeowners and businesses. In addition, daily disposable replacement requires daily setup time and effort by the patient or caregiver at home or in the clinic.

[0013] For each of the above reasons, it is desirable to provide an APD machine that reduces disposable waste and does so in a sterile manner. Summary of the invention

[0014] The present disclosure describes an automated peritoneal dialysis ("PD") system that provides improved reusability. The system includes a PD machine or cycler. The PD machine is capable of delivering fresh, heated PD fluid to a patient at, for example, 14 kPa (2.0 psig) or higher. The PD machine is capable of removing used PD fluid or effluent from a patient at, for example, between -5 kPa (-0.73 psig) and -15 kPa (-2.2 psig), such as -9 kPa (-1.3 psig) or higher. Fresh PD fluid can be delivered to a patient via a double-lumen patient line and first heated to body fluid temperature, such as 37°C. The heated PD fluid is then pumped through the fresh PD fluid lumen of the double-lumen patient line to a disposable filter kit, which is connected to the patient's transfer kit, which in turn is connected to an indwelling catheter in the patient's peritoneal cavity. The disposable filter kit is in fluid communication with the fresh and used PD fluid lumens of the double-lumen patient line. A disposable filter kit is provided in one embodiment as a last chance filter for a PD machine that can be heat sterilized between treatments.

[0015] The system may include one or more PD fluid containers or bags that supply fresh PD fluid to the PD machine or cycler. The PD machine or cycler may include internal lines with two-way or three-way valves and at least one PD fluid pump for pumping fresh PD fluid from the one or more PD fluid containers or bags to the patient and for removing used PD fluid from the patient to a house drain or drain container. One or more flexible PD fluid lines lead from the internal lines of the PD machine or cycler to the one or more PD fluid containers or bags. The above-mentioned flexible double-lumen patient line leads from the PD machine or cycler to the patient. The flexible drain line leads from the internal lines of the PD machine or cycler to the house drain or drain container. In one embodiment, the system disinfects all internal lines, PD fluid lines, and double-lumen patient lines after treatment for reuse in the next treatment. Disinfection may involve heat disinfection using remaining fresh PD fluid.

[0016] In one embodiment, the PD system retracts a reusable dual lumen patient line into the housing of the PD machine during disinfection. To this end, the PD machine may include an internal hose reel that pulls the dual lumen patient line into the housing. Maintaining the dual lumen patient line within the housing during disinfection is advantageous because the patient line is held in a coiled arrangement so that there is less surface area to lose heat. In addition, the coiled patient line is retained within the housing, which acts as a thermal insulator relative to ambient temperature and ambient air fluctuations. In short, retracting the patient line into the housing during thermal disinfection improves its efficiency.

[0017] A problem associated with retracting a dual lumen patient line into a housing is that debris collected by the patient line may be pulled into the housing. The debris may contaminate internal components of the PD machine and may migrate to the interior of the patient tubing. The PD machine and associated systems and methods of the present disclosure address the debris collection problem by providing an external tubing surface cleaning unit that removes debris from the tubing and applies disinfectant to the tubing as it is pulled into the housing of the PD machine.

[0018] In one embodiment, the external conduit surface cleaning unit comprises a collar having an inner diameter whose shape matches the shape of the outer diameter of the double lumen patient line. The double lumen patient line may have a circular or substantially circular outer diameter, in which case the collar comprises a matching circular inner diameter. Alternatively, the double lumen patient line may have an oblong or elliptical outer diameter, in which case the collar comprises a matching oblong or elliptical inner diameter. The inner diameter of the collar may be slightly larger than the outer diameter of the double lumen patient line.

[0019] The foam scrubber is arranged along the inner diameter of the collar so that when the patient line is pulled through the external pipe surface cleaning unit of the present disclosure, the foam scrubber extends around all 360 degrees of the double-lumen patient line and contacts all 360 degrees of the double-lumen patient line. The foam scrubber thus has a cylindrical or tubular portion that is held (e.g., mechanically press-fitted and / or adhered) within the collar. The foam scrubber also includes a disinfectant application extension extending from the cylindrical or tubular portion into the disinfectant reservoir. The disinfectant reservoir holds a disinfectant, such as an environmentally friendly disinfectant, such as citric acid or povidone-iodine solution. The disinfectant application extension of the foam scrubber allows the disinfectant to flow or migrate from the disinfectant reservoir to the foam scrubber cylindrical or tubular portion, wherein when the double-lumen patient line is pulled through the external pipe surface cleaning unit, the disinfectant can then be transferred to the outer surface of the double-lumen patient line. The foam scrubber accordingly wipes the outer surface of the patient line and applies disinfectant thereto.

[0020] The foam scrubber may be made, for example, of polyurethane flexible foam or silicone foam, for example having a Shore hardness ranging from Shore A50 to Shore A60, which has good absorption properties when impregnated with a disinfectant such as povidone-iodine solution or citric acid. In one embodiment, the collar and reservoir are made of plastic, such as polyvinyl chloride ("PVC") or non-PVC materials, such as polyethylene ("PE"), polyurethane ("PU"), polycarbonate ("PC"), and / or polyetheretherketone ("PEEK").

[0021] The reservoir includes a sealing diaphragm or other type of openable sealing closure that receives a syringe or other type of disinfectant dispensing device. The patient or caregiver periodically fills the syringe or other disinfectant dispensing device with a disinfectant (e.g., citric acid or povidone-iodine solution). The patient then inserts the distal end of the disinfectant dispensing device through the openable sealing closure and dispenses the disinfectant from the disinfectant dispensing device into the reservoir to fill the reservoir with the disinfectant. Once the filling of the reservoir is completed, the user or caregiver removes the disinfectant dispensing device from the reservoir, after which the openable sealing closure is self-sealingly closed or sealed closed by the patient or caregiver, for example, by applying a threaded cap.

[0022] Knowing when to refill the disinfectant reservoir can be accomplished in a variety of ways. In one embodiment, the disinfectant level is visible to the user, wherein at least a portion of the reservoir is made of a transparent or non-opaque material, so that the patient or caregiver can visually discern when the disinfectant is added to the reservoir. Alternatively or additionally, the PD machine is provided with one or more low level sensors. The low level sensor is positioned and arranged adjacent to the reservoir so as to be able to detect when the level of the disinfectant drops below the refill level, thereby indicating that the reservoir needs to be refilled. The sensor sends a signal indicating the low disinfectant level to the control unit of the PD machine, at which point the control unit can cause the user interface of the PD machine to provide an audio, visual, or audio-visual message to the patient or caregiver indicating that the disinfectant reservoir needs to be refilled. The one or more low level sensors can be, for example, a Hall effect sensor, a magnetic sensor, an inductive sensor, a capacitive sensor, or an optical sensor.

[0023] Alternatively or additionally, the control unit may collaborate with the patient or caregiver to know when to refill the reservoir with disinfectant. In one embodiment, the patient presses or enters a refill confirmation button or input into the control unit when refilling the disinfectant reservoir. At this point, the control unit knows that the reservoir is full. The control unit is also programmed to know how much disinfectant is used for each retraction of the dual lumen patient line, that is, how many times a disinfection sequence patient line retraction can be performed after the disinfectant reservoir is refilled. When the control unit determines that the current retraction is at or near the refill limit, the control unit causes the user interface of the PD machine to provide an audio, visual, or audio-visual message to the patient or caregiver indicating that the disinfectant reservoir needs to be refilled.

[0024] The external pipeline surface cleaning unit of the present disclosure can be implemented in a variety of different ways. In the first way, the cleaning unit is mainly provided as an integrated and mostly durable or reusable unit. The collar and reservoir are permanent unless damaged and need to be replaced, while the foam scrubber can be a semi-permanent component that is replaced periodically. Provide the patient with a reusable syringe or other disinfectant dispensing device and a supply of periodically replaced disinfectants (such as citric acid or povidone-iodine solution). The external pipeline surface cleaning unit is located in the housing of the PD machine so that it is largely hidden from the patient or caregiver. The diaphragm or other type of sealable closure that can be opened provided at the reservoir is visible and accessible from the outside of the housing so that the patient or caregiver can access the reservoir to refill the disinfectant.

[0025] In the second way, the external pipe cleaning unit is provided as a removable and replaceable unit. Here, the collar, the reservoir and the foam scrubber can be semi-permanent parts, wherein the external pipe cleaning unit is removed and replaced as a whole when needed (for example, when the foam scrubber needs to be replaced). A diaphragm or other type of seal closure that can be opened can be set at the reservoir again, so that the patient or caregiver can introduce new disinfectant when needed. Provide the patient with a reusable syringe or other disinfectant dispensing device and a supply of disinfectants (such as citric acid or povidone iodine solution) that are periodically replaced. In an alternative embodiment, a seal closure that can be opened is not provided, and the external pipe cleaning unit is replaced instead when the reservoir is exhausted of disinfectant. In any embodiment, the reservoir of the removable and replaceable unit can be provided with a tab or other feature, the size and shape of which is set to snap fit into a matching aperture formed in the housing of the PD machine. A portion of the collar can also be used to snap fit into a matching aperture formed in the housing of the PD machine. Providing a plurality of snap-fit ​​engagements helps the external tubing cleaning unit remain stable while a reusable line (eg, a reusable dual lumen patient line) is pulled through the cleaning unit while being wiped and disinfected via contact with the foam scrubber.

[0026] In accordance with the disclosure set forth herein and without limiting the present disclosure in any way, in a first aspect of the present disclosure, which may be combined with any other aspect or portion thereof, a peritoneal dialysis ("PD") system comprises: a housing; a PD fluid pump, the PD fluid pump being accommodated by the housing; a reusable PD fluid line, the reusable PD fluid line being in fluid communication with the PD fluid pump, the reusable PD fluid line being positioned and arranged to be pulled into the housing; and an external tubing surface cleaning unit, the external tubing surface cleaning unit being constructed and positioned to perform at least one of the following operations: (i) removing debris from at least a portion of an exterior of the reusable PD fluid line as the reusable PD fluid line is pulled into the housing, or (ii) applying a disinfectant to at least the portion of an exterior of the reusable PD fluid line as the reusable PD fluid line is pulled into the housing.

[0027] In a second aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the reusable PD fluid line is a reusable patient line.

[0028] In a third aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the reusable patient line is a reusable double lumen patient line.

[0029] In a fourth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the PD system includes a hose reel within the housing, the hose reel configured to pull the reusable PD fluid line into the housing.

[0030] In a fifth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PD system comprises a control unit configured to execute a disinfection sequence in which the interior of the reusable PD fluid line is disinfected, and wherein, before executing the disinfection sequence, the reusable PD fluid line is pulled into the housing.

[0031] In a sixth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the external pipe surface cleaning unit comprises a scrubber sized and shaped to extend around and contact the reusable PD fluid line to remove debris from at least the portion of the exterior of the reusable PD fluid line as the reusable PD fluid line is pulled into the housing.

[0032] In a seventh aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the scrubber is a foam or fiber scrubber shaped to apply disinfectant to at least the portion of the exterior of the reusable PD fluid line as the reusable PD fluid line is drawn into the housing.

[0033] In an eighth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the foam or fiber scrubber comprises a cylindrical portion sized and shaped to extend around the reusable PD fluid line and apply disinfectant to the reusable PD fluid line, and a disinfectant application extension extending from the cylindrical portion into a disinfectant reservoir, wherein the disinfectant application extension allows disinfectant to flow from the disinfectant reservoir to the cylindrical portion.

[0034] In a ninth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the cylindrical portion of the foam or fiber scrubber is supported by a collar and the disinfectant reservoir extends from the collar.

[0035] In a tenth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the external pipe surface cleaning unit comprises a disinfectant reservoir configured to hold a disinfectant for application to at least the portion of the exterior of the reusable PD fluid line when the reusable PD fluid line is drawn into the housing.

[0036] In an eleventh aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the disinfectant reservoir comprises an openable sealed closure configured to allow introduction of disinfectant into the reservoir.

[0037] In a twelfth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PD system comprises a disinfectant dispensing device, wherein the openable sealing closure is configured to receive an end of the disinfectant dispensing device such that the disinfectant dispensing device can introduce disinfectant into the reservoir.

[0038] In a thirteenth aspect of the disclosure which may be combined with any other aspect or a portion thereof, the PD system comprises a source of disinfectant and a tube leading from the source of disinfectant to the reservoir.

[0039] In a fourteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the external pipeline surface cleaning unit is located within the housing.

[0040] In a fifteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the housing provides an opening that allows access to an openable sealed closure of the external duct surface cleaning unit for refilling with disinfectant.

[0041] In a sixteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the external pipe surface cleaning unit is attachable to and detachable from the housing.

[0042] In a seventeenth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the housing defines at least one mating aperture, and wherein the external pipe surface cleaning unit comprises at least one feature portion, the size and shape of the at least one feature portion being set to snap fit within the at least one mating aperture.

[0043] In an eighteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the exterior pipeline surface cleaning unit comprises a disinfectant reservoir, and wherein the system comprises at least one sensor positioned and arranged to detect a level of disinfectant within the disinfectant reservoir.

[0044] In a nineteenth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PD system comprises a control unit and a user interface, the at least one sensor outputting to the control unit, and wherein the control unit is configured to cause the user interface to prompt for disinfectant refilling when the output from the at least one sensor indicates a low disinfectant level within the disinfectant reservoir.

[0045] In a twentieth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the PD system comprises at least one ultraviolet ("UV") lamp positioned and arranged to disinfect the exterior of the reusable PD fluid line as the reusable PD fluid line is pulled into the housing.

[0046] In a twenty-first aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PD system comprises a source of disinfectant and a tube leading from the source of disinfectant into the external pipe surface cleaning unit so as to be able to apply disinfectant to at least the portion of the exterior of the reusable PD fluid line when the reusable PD fluid line is pulled into the housing.

[0047] In a twenty-second aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, a peritoneal dialysis ("PD") system comprises: a PD machine comprising a housing; a reusable PD fluid line positioned and arranged to be pulled into the housing; and an external tubing surface cleaning unit constructed and positioned to perform at least one of the following operations: (i) remove debris from at least a portion of an exterior of the reusable PD fluid line as the reusable PD fluid line is pulled into the housing, or (ii) apply a disinfectant to at least the portion of an exterior of the reusable PD fluid line as the reusable PD fluid line is pulled into the housing.

[0048] In a twenty-third aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, a peritoneal dialysis ("PD") method comprises: enabling a reusable PD fluid line to be retracted into a PD fluid machine; and while the reusable PD fluid line is retracted into the housing, performing at least one of: (i) removing debris from at least a portion of an exterior of the reusable PD fluid line, or (ii) applying a disinfectant to at least the portion of the exterior of the reusable PD fluid line.

[0049] In a twenty-fourth aspect of the present disclosure, which may be combined with any other aspect or a part thereof, Figures 1 to 9 Any one or more of the features, functions and alternatives described in any one or more of the above may be combined with Figures 1 to 9 any combination of any features, functions and alternatives described in any other manner.

[0050] In view of the above aspects and the present disclosure set forth herein, it is an advantage of the present disclosure to provide a dialysis system and method that reduces disposable waste in a sterile manner.

[0051] Another advantage of the present disclosure is to provide dialysis systems and methods that help prevent debris and other matter from entering the dialysis machine.

[0052] Another advantage of the present disclosure is to provide a PD system that is easily reloaded with disinfectant.

[0053] Yet another advantage of the present disclosure is to provide a dialysis system and method that helps reduce maintenance and replacement of reusable tubing.

[0054] Yet another advantage of the present disclosure is to provide a PD system and method that increases the safety associated with reusable tubes.

[0055] Additional features and advantages are described in and will be apparent from the following detailed description and accompanying drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to one of ordinary skill in the art with reference to the drawings and description. In addition, any particular embodiment need not have all of the improvements or advantages listed herein, and it is expressly contemplated that individual advantageous embodiments are individually claimed. In particular, the systems disclosed herein may have any one or more or all of the drip-proof structures and methods, PD fluid container emptying structures and methods, and pre-drain patient connection check structures and methods described herein. In addition, it should be noted that the language used in the specification is selected primarily for readability and instructional purposes, and not to limit the scope of the subject matter of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Figure 1 is a fluid flow diagram of one embodiment of a medical fluid system (eg, a PD fluid system) configured for treatment.

[0057] Figure 2 is a fluid flow diagram of one embodiment of a medical fluid system (eg, a PD fluid system) configured for sterilization.

[0058] Figure 3 is a perspective view showing one embodiment of a housing and a retractable and reusable PD fluid patient line of a PD machine of the present disclosure.

[0059] Figure 4 is a front view of one embodiment of an external pipe surface cleaning unit of the present disclosure.

[0060] Figure 5 is a side view showing one embodiment of an external tubing surface cleaning unit of the present disclosure installed within a PD machine with a reusable line (eg, a reusable patient line) partially retracted within the PD machine.

[0061] Figure 6 is a side view showing one embodiment of an external tubing surface cleaning unit of the present disclosure installed within a PD machine with a reusable line (eg, a reusable patient line) fully retracted within the PD machine.

[0062] Figure 7 is a front perspective view of an attachable, detachable and replaceable external duct surface cleaning unit of the present disclosure.

[0063] Figure 8 is a rear perspective view of the attachable, detachable and replaceable external duct surface cleaning unit of the present disclosure.

[0064] Fig. 9 is a front perspective view of the attachable, detachable and replaceable external duct surface cleaning unit of the present disclosure adjacent to a PD machine for operation. DETAILED DESCRIPTION

[0065] System Overview

[0066] Reference is now made to the drawings, and in particular to the Figure 1 , the medical system with external tubing surface disinfection of the present disclosure is shown via a peritoneal dialysis ("PD") system 10. The system 10 includes a PD machine or cycler 20 and a control unit 100 having one or more processors 102, one or more memories 104, a video controller 106, and a user interface 108. Alternatively or additionally, the user interface 108 can be a remote user interface, for example, via a tablet or smartphone. The control unit 100 can also include a transceiver and a wired or wireless connection to a network (not shown) (e.g., the Internet) for sending treatment data to a doctor's or clinician's server interconnected with a doctor's or clinician's computer and receiving prescription instructions / changes from a doctor's or clinician's server interconnected with a doctor's or clinician's computer. In one embodiment, the control unit 100 controls all of the electric fluid flow and heating components of the system 10 and receives outputs from all of the sensors of the system 10. The system 10 in the illustrated embodiment includes durable and reusable components that contact fresh and used PD fluids, which require the PD machine or cycler 20 to be disinfected between treatments, such as by thermal disinfection.

[0067] Figure 1The system 10 in FIG. 1 includes an inline resistive heater 56, reusable supply lines or tubes 52a1 to 52a4 and 52b, an air trap 60 operating with corresponding upper and lower level sensors 62a and 62b, an air trap valve 54d, an exhaust valve 54e positioned along an exhaust line 52e, a reusable line or tube 52c, a PD fluid pump 70, temperature sensors 58a and 58b, pressure sensors 78a, 78b1, 78b2, and 78b3. 8c, reusable patient tubing or lines 52f and 52g with corresponding valves 54f and 54g, reusable dual lumen patient line 28, spring-actuated hose reel 80 for retracting patient line 28, reusable drain tubing or line 52i extending to drain line connector 34 and having drain line valve 54i, and reusable recirculation tubing or lines 52r1 and 52r2 operating with corresponding sterilization valves 54r1 and 54r2. A third recirculation or sterilization tubing or line 52r3 extends between sterilization or PD fluid line connectors 30a and 30b for use during sterilization. A fourth recirculation or sterilization tubing or line 52r4 extends between sterilization connectors 30c and 30d for use during sterilization.

[0068] The system 10 also includes PD fluid containers or bags 38a-38c (e.g., holding the same or different PD fluid formulations) connected to the distal ends 24e of the reusable PD fluid lines 24a-24c, respectively. The system 10d also includes a fourth PD fluid container or bag 38d connected to the distal end 24e of the reusable PD fluid line 24d. The fourth PD fluid container or bag 38d can hold the same or a different type of PD fluid (e.g., icodextrin) as provided in the PD fluid containers or bags 38a-38c. The reusable PD fluid lines 24a-24d, in one embodiment, extend through an aperture (not shown) defined or provided by the housing 22 of the cycler 20.

[0069] The system 10 in the illustrated embodiment includes four sterile or PD fluid line connectors 30a to 30d for connection to the distal ends 24e of the reusable PD fluid lines 24a to 24d, respectively, during sterilization. The system 10 also provides a patient line connector 32 that includes an internal lumen, such as a U-shaped lumen, that directs fresh or used dialysis fluid from one PD fluid lumen of the connected distal ends 28e of the reusable dual lumen patient line 28 to the other PD fluid lumen for sterilization. Reusable supply conduits or lines 52a1 to 52a4 are in communication with the reusable supply lines 24a to 24d, respectively. The reusable supply conduits or lines 52a1 to 52a3 operate with valves 54a to 54c, respectively, to allow PD fluid from the desired PD fluid container or bag 38a to 38c to be drawn into the cycler 20. In the example shown, three-way valve 94a allows the control unit 100 to select between (i) 2.27% (or other) glucose dialysis fluid from container or bag 38b or 38c and (ii) icodextrin from container or bag 38d. In the embodiment shown, icodextrin from container or bag 38d is connected to the normally closed port of three-way valve 94a.

[0070] In one embodiment, system 10 is configured such that drain line 52i is fluidly connected downstream of PD fluid pump 70 during a patient fill. In this way, if drain valve 54i fails or somehow leaks during a patient fill of patient P, fresh PD fluid is pushed down disposable drain line 36 rather than spent PD fluid potentially being pulled into pump 70. Disposable drain line 36 is removed in one embodiment for sterilization, wherein drain line connector 34 is capped via cap 34c to form a closed sterilization loop. PD fluid pump 70 may be an inherently accurate pump, such as a piston pump, or a less accurate pump, such as a gear pump that operates in cooperation with a flow meter (not shown) to control fresh and spent PD fluid flow rates and volumes.

[0071] The system 10 may also include a leak detection disc 82 located at the bottom of the housing 22 of the cycler 20 and a corresponding leak detection sensor 84 that outputs to the control unit 100. In the example shown, the system 10 is provided with an additional pressure sensor 78c located upstream of the PD fluid pump 70, which allows the suction pressure of the pump 70 to be measured to help the control unit 100 more accurately determine the pump volume. The additional pressure sensor 78c in the embodiment shown is located along the exhaust line 52e, which may be filled with air or a mixture of air and PD fluid, but should still be at the same negative pressure as the PD fluid located in the PD fluid line 52c.

[0072] Figure 1The system 10 in the example of FIG. 1 includes redundant pressure sensors 78b1 and 78b2, the output of one of the redundant pressure sensors 78b1 and 78b2 is used for pump control, as discussed herein, while the output of the other pressure sensor is a safety or watchdog output to ensure that the control pressure sensor reads accurately. The pressure sensors 78b1 and 78b2 are located along the line including the third recirculation valve 54r3. The system 10 may also employ a Figure 1 The X marks one or more cross-pieces that can (i) reduce the total amount and volume of internal reusable tubing, (ii) reduce the number of valves required, and (iii) allow for minimization of the portion of the fluid circuit that is shared by fresh and used PD fluids.

[0073] exist Figure 1 The system 10 in the example of also includes an acid source, such as a citric acid container or bag 66. The citric acid container or bag 66 is in selective fluid communication with the second three-way valve 94b via a citric acid valve 54m located along the citric acid line 52m. In one embodiment, the citric acid line 52m is connected to the normally closed port of the second three-way valve 94b to provide a redundant valve between the disinfectant container or bag 66 and the PD fluid circuit during treatment. The redundant valve ensures that no citric acid reaches the treatment fluid line during treatment. Instead, the citric acid is used during disinfection.

[0074] In one embodiment, the control unit 100 uses feedback from any one or more of the pressure sensors 78a-78c to enable the PD machine 20 to deliver fresh, heated PD fluid to the patient at a pressure of, for example, 14 kPa (2.0 psig) or higher. The pressure feedback is used to enable the PD machine 20 to remove spent PD fluid or effluent from the patient at a pressure of, for example, between -5 kPa (-0.73 psig) and -15 kPa (-2.2 psig), such as -9 kPa (-1.3 psig) or higher (more negative). The pressure feedback can be used in a proportional, integral, derivative ("PID") pressure routine for pumping fresh and spent PD fluid at a desired positive or negative pressure.

[0075] The inline resistive heater 56 under the control of the control unit 100 is capable of heating the fresh PD fluid to body temperature, e.g., 37° C., for delivery to the patient P at a desired flow rate. In an embodiment, the control unit 100 uses feedback from the temperature sensor 58 a in a PID temperature routine for pumping fresh PD fluid to the patient P at a desired temperature. The control and operation of the inline resistive heater 56 for thermal disinfection is discussed in detail below.

[0076] Figure 1Also shown is that the system 10 includes and uses a disposable filter kit 40 that is in fluid communication with the fresh and used PD fluid lumens of the dual lumen patient line 28. The disposable filter kit 40 includes a disposable connector 42 connected to the distal end 28e of the reusable patient line 28. The disposable filter kit 40 also includes a connector 44 that is connected to the patient's transfer kit. The disposable filter kit 40 also includes a sterilizing grade filter membrane 46 that further filters the fresh PD fluid. The disposable filter kit 40 is provided in one embodiment as a last chance filter for the PD machine 20, which is heat sterilized between treatments. Any pathogens that may remain after sterilization (although unlikely) are filtered out of the PD fluid via the sterilizing grade filter membrane 46 of the disposable filter kit 40.

[0077] Figure 1 The arrangement of the system 10 for treatment is shown, wherein PD fluid containers or bags 38a to 38d are connected via reusable flexible PD fluid lines 24a to 24d, respectively. The dual lumen patient line 28 is connected to the patient P via a disposable filter kit 40. The disposable drain line 36 is connected to the drain line connector 34. Figure 1 In the embodiment of the present invention, the PD machine or cycler 20 of the system 10 is configured to perform a plurality of patient drain, patient fill, patient dwell and priming procedures as part of a treatment or in preparation for performing a treatment.

[0078] Figure 2 The system 10 is shown in a sterilization mode. The PD fluid containers or bags 38a-38d are removed and the flexible PD fluid lines 24a-24d are inserted in a sealed manner into sterilization or PD fluid line connectors 30a-30d, respectively. The reusable dual lumen patient line 28 is disconnected from the disposable filter kit 40 (which is discarded) and the distal end 28e of the dual lumen patient line 28 is sealingly inserted into the patient line connector 32. The disposable drain line 36 is removed from the drain line connector 34 and discarded. The drain line connector 34 is capped via the cap 34c to form a closed sterilization circuit 90. Figure 2 The PD machine or cycler 20 of the system 10 in is configured to perform a sterilization sequence, such as a thermal sterilization sequence, in which fresh PD fluid is heated to a sterilization temperature, such as 75° C. or higher, via an inline heater 56. The PD fluid pump 70 circulates the heated PD fluid closed sterilization circuit 90 for an amount of time required to properly sterilize the fluid components and lines of the sterilization circuit.

[0079] External pipe surface disinfection

[0080] Figure 1 and Figure 2A hose reel 80 is shown for retracting the dual-lumen patient line 28 into the housing 22 of the PD machine 20 when needed. In one embodiment, the PD system 10 retracts the reusable patient line 28 into the housing 22 during disinfection (e.g., after treatment, when the patient P is disconnected from the filter kit 40 and the filter kit is removed from the end of the patient line 28). In one embodiment, the internal hose reel 80 is spring-actuated to automatically pull the dual-lumen patient line 28 into the housing 22 after treatment and before disinfection begins. Maintaining the dual-lumen patient line 28 in the housing 22 during disinfection is advantageous because the patient line 22 is held in a coiled arrangement so that there is less surface area to lose heat. In addition, the coiled patient line 28 is held in the housing 22, which acts as a thermal insulator relative to ambient temperature and ambient air fluctuations. In short, retracting the patient line 28 into the housing 22 during thermal disinfection improves its efficiency.

[0081] Figure 3 A problem associated with retracting the dual lumen patient line 28 into the housing 22 of the PD machine 20 of the system 10 is that debris collected by the patient line may be pulled into the housing. The debris may contaminate the internal components of the PD machine 20 (see Figure 1 and Figure 2 ), and may migrate to the interior of the patient conduit 28. Figure 3 Also shown is a syringe or other disinfectant dispensing device 140 for refilling the disinfectant. Figures 4 to 9 As shown, the PD machine 20 and associated systems 10 and methods of the present disclosure address the debris collection problem by providing an external tubing surface cleaning unit 110 that removes debris from and applies disinfectant to reusable tubing (such as a dual lumen patient line 28) as the tubing is pulled into the housing 22 of the PD machine 20 via a spring-actuated hose reel 80.

[0082] Figures 4 to 8The external pipe surface cleaning unit 110 in one embodiment is shown to include a collar 112. The collar 112 in the illustrated embodiment is formed by a first (e.g., upper) half 114 and a second (e.g., lower) half 116. The first half 114 and the second half 116 form an inner diameter 112d, the shape of which matches the shape of the outer diameter 28d of the dual lumen patient line 28. The dual lumen patient line 28 may have a circular or substantially circular outer diameter, wherein the halves 114, 116 of the collar 112 form a matching circular inner diameter 112d. Alternatively, the dual lumen patient line 28 may have an oblong or elliptical outer diameter 28d, wherein the halves 114, 116 of the collar 112 form a matching oblong or elliptical inner diameter 112d. The inner diameter 112d of the collar 112 may be slightly larger than the outer diameter 28d of the dual lumen patient line 28.

[0083] Figures 4 to 8 Also shown is a foam scrubber 120 disposed along the inner diameter of the halves 114, 116 of the collar 112, such that when the patient line is pulled through the external pipe surface cleaning unit 110 of the present disclosure, the foam scrubber 120 extends around and contacts the entire 360 ​​degrees of the dual lumen patient line 28. The foam scrubber 120 in the illustrated embodiment has a cylindrical or tubular portion 122 that is retained (e.g., mechanically press-fitted and / or adhered) within the halves 114, 116 of the collar 112. The foam scrubber 120 also includes a disinfectant application extension 124 that extends from the cylindrical or tubular portion 122 into the disinfectant reservoir 130.

[0084] The disinfectant reservoir 130 in the illustrated embodiment includes flat sides 132a to 132d and a rounded top 134. In the illustrated embodiment, the bottom of the disinfectant reservoir 130 is formed by the first or upper half 114 of the collar 112. The disinfectant reservoir 130 holds a disinfectant, such as an environmentally friendly disinfectant, for example, citric acid or povidone-iodine solution. The disinfectant application extension 124 of the foam scrubber 120 allows the disinfectant to flow or migrate from the disinfectant reservoir 130 to the foam scrubber cylindrical or tubular portion 122, where the disinfectant can then be transferred to the outer surface 28d of the double lumen patient line 28 when the double lumen patient line 28 is pulled through the external conduit surface cleaning unit 110. The foam scrubber 120 thus wipes the outer surface or diameter 28d of the patient line 28 and applies disinfectant thereto.

[0085] The foam scrubber 120 may be made, for example, of a polyurethane flexible foam or silicone foam, for example, having a Shore hardness ranging from Shore A50 to Shore A60, which has good absorption characteristics when impregnated with a disinfectant such as a povidone-iodine solution or citric acid. In one embodiment, the collar 112 and the disinfectant reservoir 130 are made (e.g., molded) of one or more plastics such as polyvinyl chloride ("PVC") or non-PVC materials such as polyethylene ("PE"), polyurethane ("PU"), polycarbonate ("PC"), and / or polyetheretherketone ("PEEK").

[0086] Figures 5 to 7 In one embodiment, the flat side 132a of the reservoir 130 includes a sealing septum or other type of openable sealing closure 136 that receives a tip 142 ( Figure 5 , Figure 6 ). The patient or caregiver periodically fills a syringe or other disinfectant dispensing device 140 with a disinfectant (e.g., citric acid or povidone-iodine solution). The patient then inserts the distal tip 142 of the disinfectant dispensing device 140 through the openable sealing closure 136 and dispenses the disinfectant from the disinfectant dispensing device 140 into the disinfectant reservoir 130 to fill the reservoir with the disinfectant (e.g., citric acid or povidone-iodine solution). Once the filling of the reservoir 130 is complete, the user or caregiver removes the disinfectant dispensing device 140 from the reservoir 130, after which the openable sealing closure 136 is sealed closed by itself or by the patient or caregiver, for example, applying a threaded cap.

[0087] Knowing when to refill the disinfectant reservoir 130 can be accomplished in a variety of ways. In one embodiment, the disinfectant level is visible to the user, where at least one side 132a to 132d of the reservoir 130 is made of a transparent or non-opaque material so that the patient or caregiver can visually discern when disinfectant is added to the reservoir. Alternatively or additionally, the PD machine 20 is provided with one or more low level sensors 88 that output to the control unit 100. Figure 5 and Figure 6The low level sensor 88 is shown positioned and arranged adjacent to the disinfectant reservoir 130 so as to be able to detect when the level of the disinfectant drops below the refill level, thereby indicating that the reservoir needs to be refilled. The one or more level sensors 88 send a corresponding signal indicating the low disinfectant level to the control unit 100, at which time the control unit 100 causes the user interface 108 to provide an audio, visual or audio-visual message to the patient or caregiver indicating that the disinfectant reservoir needs to be refilled. The user interface 108 may also provide a refill confirmation button or selector that the patient or caregiver needs to press after refilling the disinfectant, for example, in order to perform the next treatment. The one or more low level sensors 88 may be, for example, a Hall effect sensor, a magnetic sensor, an inductive sensor, a capacitive sensor, or an optical sensor.

[0088] Alternatively or additionally, the control unit 100 may collaborate with the patient or caregiver to know when to refill the reservoir 130 with disinfectant. In one embodiment, the patient presses or enters a refill confirmation button or input into the user interface 108 of the control unit 100 when refilling the disinfectant reservoir 130. At this point, the control unit 100 knows that the reservoir 130 is full. The control unit 100 is also programmed to know how much disinfectant to use for each retraction of the dual lumen patient line 28, i.e., how many disinfection sequence patient line retractions can be performed after refilling the disinfectant reservoir 130. When the control unit 100 determines that the current retraction is at or near the refill limit, the control unit 28 causes the user interface 10 to provide an audio, visual, or audio-visual message to the patient or caregiver indicating that the disinfectant reservoir needs to be refilled.

[0089] Figure 5 and Figure 6 It is also shown that in one embodiment, in addition to the disinfection provided by the liquid disinfectant, one or more ultraviolet ("UV") lamps 92 are provided to disinfect the exterior of the dual lumen patient line 28. In one embodiment, the control unit 100 automatically energizes the UV lamps 92 when a sensor (not shown) (such as a proximity sensor, an optical sensor, or a magnetic sensor) senses the rotation of the hose reel 80 and indicates it to the control unit. Here, the UV lamps 92 are automatically energized while the reusable patient line 28 is retracted into the housing 22 of the PD machine 20. The UV lamps kill pathogens located on the exterior of the reusable patient line 28. Thus, the scrubber 120 of the cleaning unit 110 can be maintained for wiping the exterior of the reusable patient line 28 while the liquid disinfectant is removed from the cleaning unit and UV lamp disinfection is relied upon instead.

[0090] The external pipeline surface cleaning unit 110 of the present disclosure can be implemented in a variety of different ways. Figure 3 , Figure 5 and Figure 6In the first shown form, the cleaning unit 110 is provided primarily as an integrated and largely durable or reusable unit. The collar 112 and reservoir are permanent unless damaged and need replacement, while the foam scrubber 120 may be a semi-permanent component that is replaced periodically. The patient is provided with a reusable syringe or other disinfectant dispensing device 140 and a disinfectant supply (not shown), such as a bag or jug ​​of citric acid or povidone-iodine solution, which is replaced periodically.

[0091] like Figure 3 , Figure 5 and Figure 6 As shown, the external pipe surface cleaning unit 110 in the integrated embodiment is located within the housing 22 of the PD machine 20 so that it is largely hidden from the patient or caregiver. The cleaning unit 110 can be, for example, bolted and / or snap-fitted to the interior of the housing 22. Figure 5 and Figure 6 As shown, the housing 22 provides an opening 22o so that a septum or other type of openable sealing closure 136 disposed at a side 132a of the reservoir 132 is visible and accessible from outside the housing 22 so that a patient or caregiver can access the reservoir for disinfectant refilling.

[0092] like Figures 7 to 9 As shown, in the second mode, the external pipe cleaning unit 110 is provided as an attachable, detachable and replaceable unit. Here, the collar 112, the disinfectant reservoir 130 and the foam scrubber 120 can be semi-permanent components, wherein the external pipe cleaning unit 110 is removed and replaced as a whole when needed (for example, when the foam scrubber 120 needs to be replaced). A diaphragm or other type of seal closure 136 that can be opened can be provided again at the side 132a of the disinfectant reservoir 130, so that the patient or caregiver can introduce new disinfectant when needed. The patient can be provided with a reusable syringe or other disinfectant dispensing device 140 and a supply source of disinfectant (not shown), such as citric acid or povidone iodine solution, which is periodically replaced. In an alternative embodiment, when the disinfectant reservoir 130 runs out of disinfectant, the seal closure 136 that can be opened is not provided, but the external pipe cleaning unit 110 is replaced.

[0093] like Figure 8 As shown, any type of removable and replaceable cleaning unit 110 may include a tab or other feature 138 disposed at the reservoir 130 (e.g., at the flat side 132d of the reservoir). The tab or other feature 138 is sized and shaped to snap fit into a mating aperture (not shown) formed in the housing 22 of the PD machine. Figure 8It is also shown that portions 114p, 116p of the halves 114, 116 of the collar 112 may also be used to snap fit into mating apertures (not shown) formed in the housing 22 of the PD machine 20. Providing a plurality of snap fit engagements (e.g., via the tabs or other features 138 and the collar portions 114p, 116p) helps the external tubing cleaning unit 110 remain stable as a reusable line (e.g., a reusable dual lumen patient line 28) is pulled through the cleaning unit 110 while being wiped and disinfected via contact with the foam scrubber 120.

[0094] Alternative Embodiments

[0095] In various alternative embodiments, while the system 10 is described above as automatically pulling the reusable patient line 28 through the external tube cleaning unit 110 via a spring-actuated hose reel 80, a spring-actuated hose reel 80 may not be required. Instead, a manually operated hose reel, such as via a rotating handle located outside the housing 22, may instead be provided. Here, the reusable patient line 28 is manually pulled through the external tube cleaning unit 110. The control unit 100 may cause the user interface 108 to prompt the patient or caregiver to manually retract the reusable patient line 28 into the housing 22 after treatment and prior to sterilization.

[0096] Further alternatively, while the housing 22 of the PD machine 20 is shown as providing an opening 22o so that a user can access the openable sealed closure 136 of the reservoir 130 for disinfectant refilling, the reservoir 130 is alternatively refilled from a disinfectant source located within the housing 22 (e.g., a citric acid container or bag 66 (also used during disinfection), as shown in FIG. Figure 1 and Figure 2 Here, a tube (not shown), such as a flexible plastic tube, may extend from the disinfectant container or bag 66 to the top of the reservoir 130. The disinfectant container or bag 66 may be located vertically above the reservoir 130 so that the disinfectant gravity flows into the reservoir 130. The head pressure of the disinfectant container or bag 66 may also drive the disinfectant into the reservoir 130. A sensor (such as any of the types described herein for the low level sensor 88) may be provided as a low level sensor at the disinfectant container or bag 66, which outputs to the control unit 100. The control unit 100 thus knows when the disinfectant in the container or bag 66 is low, and causes the user interface 108 to audibly, visually, or audiovisually prompt the patient or caregiver to install a new disinfectant container or bag 66.

[0097] In another alternative embodiment, the reservoir 130 is not filled with disinfectant, but a tube (not shown) from the container or bag 66 extends into the reservoir 130 and terminates just above the scrubber 120 so that the disinfectant can be dispensed onto the scrubber 120, for example, just before the reusable patient line 28 is retracted through the scrubber. Here, a valve (not shown) can be provided along the tube. The control unit 100 opens the valve, for example, after treatment and before the patient line is retracted, wherein the valve remains open only for a period of time sufficient for the tubular portion 122 of the scrubber 120 to become completely wetted or saturated with the disinfectant. The control unit 100 can also open the valve during the retraction of the reusable patient line 28 through the scrubber 120, if determined to be necessary.

[0098] In yet another alternative embodiment, the valve just described is replaced by a clamp. In one embodiment, the clamp is usually spring-biased closed. A lever is provided that actuates a spring (compression or extension spring) to allow the tube extending from the disinfectant container or bag 66 or bag to open so that the disinfectant is dispensed onto the scrubber. The lever is actuated via a button disposed at the housing 22 of the PD machine 20. When the user releases the button, the spring pushes the button back to its normal unactuated position and causes the clamp to occlude the tube extending from the disinfectant container or bag 66, thereby cutting off the flow of disinfectant. In one embodiment, the control unit 100 is programmed so that the user interface 108 audibly, visually, or audiovisually prompts the patient or caregiver to press a button before and / or during the retraction of the reusable patient line 28.

[0099] In yet another alternative embodiment, the external pipe cleaning unit 110 is located outside the housing 22 of the PD machine 20, where it is easy to load the disinfectant into the reservoir 130. The tubular portion 122 of the foam scrubber is provided in two halves 120, each of which is connected to a first half 114 and a second half 116 of the collar 112. The collar and the scrubber halves are typically spring biased to not contact the reusable patient line 28. One or more buttons are provided to allow the patient or caregiver to force the halves of the foam scrubber 120 against the spring bias and contact the reusable patient line 28 when it is retracted into the housing 22. When the patient releases the one or more buttons, the one or more springs are released to bias the halves of the foam scrubber 120 away from the reusable patient line 28. In one embodiment, the control unit 100 is programmed to cause the user interface 108 to audibly, visually, or audiovisually prompt the patient or caregiver to press or otherwise actuate the one or more buttons before and / or during the retraction of the reusable patient line 28.

[0100] In another alternative embodiment, the external pipe cleaning unit 110 is set to a separate handheld unit, which is again configured to be easy to load with disinfectant. Here, the handheld pipe cleaning unit 110 can be set to a clamshell, wherein the reservoir 130 reservoir 130 is set to a hinged half, each half is filled with disinfectant. The foam scrubber 120 is also arranged in half, each half for the half of the reservoir 130. In the case where each half of the scrubber 120 is attached to a half of the reservoir 130, the reservoir is provided with a hole or perforation for allowing the liquid disinfectant to be fully wetted or saturated with the foam scrubber material. In one embodiment, when the patient or caregiver starts the spring-actuated retraction of the patient's pipeline via the hose reel 80, the control unit 100 causes the user interface 108 to audibly, visually or audiovisually prompt the patient or caregiver to place the handheld external pipe cleaning unit 110 around the patient's pipeline 28 that can be reused, directly adjacent to the housing 22.

[0101] It should be understood that various other changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Therefore, these changes and modifications are intended to be covered by the appended claims. For example, although the system 10 is described as cleaning and disinfecting the outer surface of the dual-lumen patient line 28, the system 10 can clean and disinfect the outer surface of any tube retracted into the housing 22 of the PD machine 20. For example, if any one or more of the reusable PD fluid lines 24a to 24d are pulled into the housing 22, the system 10 can clean and disinfect the outer surface of the one or more PD fluid lines. If the drain line 36 is alternatively made to be reusable and pulled into the housing 22, the system 10 can clean and disinfect the outer surface of the drain line 36. Moreover, although the scrubber 120 is described as a foam scrubber, the scrubber 120 can alternatively be made of a fabric or fiber material that allows a disinfectant to flow through the scrubber.

Claims

1. A peritoneal dialysis ("PD") system comprising: case; a PD fluid pump, the PD fluid pump being accommodated by the housing; a reusable PD fluid line in fluid communication with the PD fluid pump, the reusable PD fluid line being positioned and arranged to be pulled into the housing; as well as an external tubing surface cleaning unit constructed and positioned to at least one of: (i) remove debris from at least a portion of an exterior of the reusable PD fluid line as the reusable PD fluid line is drawn into the housing, or (ii) apply a disinfectant to at least the portion of an exterior of the reusable PD fluid line as the reusable PD fluid line is drawn into the housing.

2. The PD system according to claim 1, wherein: The reusable PD fluid line is a reusable patient line.

3. The PD system according to claim 2, wherein: The reusable patient line is a reusable double lumen patient line.

4. The PD system of claim 1, comprising a hose reel within the housing, the hose reel configured to pull the reusable PD fluid line into the housing.

5. The PD system of claim 1, comprising a control unit configured to execute a disinfection sequence in which the interior of the reusable PD fluid line is disinfected, and wherein, Prior to performing the sterilization sequence, the reusable PD fluid line is pulled into the housing.

6. The PD system according to claim 1, wherein: The external pipe surface cleaning unit includes a scrubber sized and shaped to extend around and contact the reusable PD fluid line to remove debris from at least the portion of the exterior of the reusable PD fluid line as the reusable PD fluid line is drawn into the housing.

7. The PD system according to claim 6, wherein: The scrubber is a foam or fiber scrubber shaped to apply disinfectant to at least the portion of the exterior of the reusable PD fluid line as the reusable PD fluid line is drawn into the housing.

8. The PD system according to claim 7, wherein: The foam or fiber scrubber includes a cylindrical portion sized and shaped to extend around the reusable PD fluid line and apply disinfectant to the reusable PD fluid line, and a disinfectant application extension extending from the cylindrical portion into a disinfectant reservoir, wherein the disinfectant application extension allows disinfectant to flow from the disinfectant reservoir to the cylindrical portion.

9. The PD system according to claim 8, wherein: The cylindrical portion of the foam or fiber scrubber is supported by a collar from which the disinfectant reservoir extends.

10. The PD system according to claim 1 or 8, wherein: The external pipe surface cleaning unit includes a disinfectant reservoir configured to hold a disinfectant for application to at least the portion of the exterior of the reusable PD fluid line when the reusable PD fluid line is drawn into the housing.

11. The PD system according to claim 10, wherein: The disinfectant reservoir includes an openable sealed closure configured to allow introduction of disinfectant into the reservoir.

12. The PD system according to claim 10, comprising a disinfectant dispensing device, wherein: The openable sealing closure is configured to receive a distal end of the disinfectant dispensing device such that the disinfectant dispensing device can introduce disinfectant into the reservoir.

13. The PD system of claim 10, comprising a source of disinfectant and a tube leading from the source of disinfectant to the reservoir.

14. The PD system according to claim 1 or 13, wherein: The external pipe surface cleaning unit is located within the housing.

15. The PD system according to claim 14, wherein: The housing provides an opening that allows access to the openable sealed closure of the external duct surface cleaning unit for refilling with disinfectant.

16. The PD system according to claim 1, wherein: The external pipe surface cleaning unit is attachable to and detachable from the housing.

17. The PD system according to claim 16, wherein: The housing defines at least one mating aperture, and wherein the external pipeline surface cleaning unit includes at least one feature sized and shaped to snap fit within the at least one mating aperture.

18. The PD system according to claim 1, wherein: The exterior pipe surface cleaning unit comprises a disinfectant reservoir, and wherein the system comprises at least one sensor positioned and arranged to detect a level of disinfectant within the disinfectant reservoir.

19. The PD system according to claim 18, comprising a control unit and a user interface, the at least one sensor outputting to the control unit, and wherein, The control unit is configured to cause the user interface to prompt for disinfectant refill when the output from the at least one sensor indicates a low disinfectant level within the disinfectant reservoir.

20. The PD system of claim 1, comprising at least one ultraviolet ("UV") lamp positioned and arranged to disinfect the exterior of the reusable PD fluid line as the reusable PD fluid line is pulled into the housing.

21. The PD system of claim 1 , comprising a source of disinfectant and a tube leading from the source of disinfectant into the external pipe surface cleaning unit so as to enable disinfectant to be applied to at least the portion of the exterior of the reusable PD fluid line when the reusable PD fluid line is drawn into the housing.

22. A peritoneal dialysis ("PD") system comprising: A PD machine, the PD machine comprising a housing; a reusable PD fluid line positioned and arranged to be pulled into the housing; as well as an external tubing surface cleaning unit constructed and positioned to at least one of: (i) remove debris from at least a portion of an exterior of the reusable PD fluid line as the reusable PD fluid line is drawn into the housing, or (ii) apply a disinfectant to at least the portion of an exterior of the reusable PD fluid line as the reusable PD fluid line is drawn into the housing.

23. A peritoneal dialysis ("PD") method comprising: Enables the reusable PD fluid line to be retracted into the PD fluid machine; as well as While the reusable PD fluid line is retracted into the housing, at least one of: (i) removing debris from at least a portion of an exterior of the reusable PD fluid line, or (ii) applying a disinfectant to at least the portion of an exterior of the reusable PD fluid line.

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