Peritoneal dialysis disinfection equipment

Abstract

A peritoneal dialysis ("PD") disinfection device includes a top portion, a bottom portion, a printed circuit board ("PCB") secured between the top portion and the bottom portion, a plurality of ultraviolet light emitting diodes ("UV-LEDs") secured to the PCB, and a power source operable to power the plurality of UV-LEDs, the top portion being made of a material configured to pass light through the material. At least one of the top, bottom, and PCB includes features that enable the patient to position and orient the PD disinfection device such that UV light from the plurality of UV-LEDs is directed toward a connection end of a patient's catheter or a catheter / patient exit site.

Description

Technical Field

[0001] The present disclosure relates generally to medical fluid therapy, and particularly to dialysis fluid therapy. Background Art

[0002] Due to various reasons, a person's renal system may fail. Renal failure produces several physiological disturbances. When renal failure occurs, it is no longer possible to balance water and minerals or to secrete the daily metabolic load. Toxic end products of metabolism such as urea, creatinine, uric acid, etc. may accumulate in the patient's blood or tissues.

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

[0004] One type of kidney failure therapy is hemodialysis ("HD"), which typically uses diffusion to remove waste products from a patient's blood. A diffusion gradient occurs 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 convective transport of toxins from the patient's blood. HF is achieved by adding a replacement fluid or substitution fluid to an extracorporeal circuit during treatment. The replacement fluid and the patient's accumulated fluid between treatments are ultrafiltered during the course of HF treatment, providing a convective transport mechanism that is particularly beneficial in removing intermediate and large molecules.

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

[0007] Most HD, HF and HDF treatments occur at centers. Today there is a trend toward home hemodialysis ("HHD"), in part because HHD can be performed every day, providing treatment benefits that are superior to center hemodialysis treatments that are usually 2 or 3 weeks in duration. Studies have shown that more frequent treatments remove more toxins and wastes, and cause less fluid overload between dialysis sessions, compared to patients who receive less frequent but potentially longer treatments. Patients who receive more frequent treatments do not experience as many down cycles (fluid and toxin swings) as center patients who have accumulated toxins for two or three days before treatment. In some areas, the nearest dialysis center may be miles from the patient's home, resulting in door-to-door treatment time consuming most of the day. Treatment at a center near the patient's home may also consume most of the patient's day. HHD can occur at night or during the day when the patient is relaxing, working or otherwise productive.

[0008] Another type of kidney 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 peritoneal membrane 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 membrane. The osmotic agent in the PD fluid provides the osmotic gradient. The used or spent dialysis fluid is drained from the patient, removing waste products, toxins, and excess water from the patient. This cycle is repeated, for example, multiple times.

[0009] There are various 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 compartment. The patient then switches the fluid connection so that the patient's catheter is connected to a bag of fresh dialysis fluid to infuse fresh dialysis fluid into the patient through the catheter. The patient disconnects the catheter from the bag of fresh dialysis fluid and allows the dialysis fluid to reside in the peritoneal compartment, where transfer of waste, toxins, and excess water occurs. After the residence time, the patient repeats the manual dialysis procedure, for example four times a day. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, leaving ample room for improvement.

[0010] APD is similar to CAPD in that dialysis treatment includes drain, fill and stay cycles. However, PD machines usually perform cycles automatically when the patient is asleep. PD machines save the patient from having to manually perform treatment cycles and from having to transport supplies during the day. The PD machine is fluidically connected to an implanted catheter, a source or bag of fresh dialysis fluid, and a fluid discharge port. The PD machine pumps fresh dialysis fluid from a dialysis fluid source through a catheter and into the patient's peritoneal compartment. The PD machine also allows the dialysis fluid to stay in the chamber and allows for the transfer of waste, toxins, and excess water. The source may include multiple liters of dialysis fluid, including several solution bags.

[0011] The PD machine pumps used or spent dialysate from the patient's peritoneal cavity through a catheter and 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 a PD 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] Peritonitis is a risk of any type of PD therapy, including APD and CAPD. Peritonitis is an inflammation of the patient's peritoneal cavity. Peritonitis is usually due to bacterial or fungal infection, which may be caused by lack of aseptic handling and connections involved in the PD therapy setting. Peritonitis can become very painful, and therefore it is desirable to prevent peritonitis.

[0013] Therefore, any improved methods to prevent peritonitis and improve the overall aseptic quality of PD treatment are needed. Summary of the invention

[0014] The present disclosure describes a peritoneal dialysis ("PD") disinfection device that is manually adjustable to disinfect both the connection end of a patient's catheter or transfer kit and the catheter / patient exit site. In one embodiment, the PD disinfection device directs ultraviolet ("UV") light outwardly so that the patient can orient the device so that the outwardly directed UV light irradiates the patient's catheter or transfer kit connection end or the catheter / patient exit site, whichever is desired. The PD disinfection device can be provided with instructions that inform the patient to orient the device toward (i) the patient's catheter or transfer kit connection end and disinfect it before connecting to the patient's line for treatment, and (ii) the catheter / patient exit site and disinfect it after treatment.

[0015] In one embodiment, the PD disinfection device is made of three main components, namely, a see-through or transparent top (made of a material configured to allow light (e.g., ultraviolet light) to pass through the material), a printed circuit board ("PCB"), and a bottom, which in one embodiment is opaque. The top and bottom include mating features so that the top and bottom fit together around the printed circuit board. The mating features of the top and bottom can be configured to snap together, or be provided with openings and threaded holes to receive one or more screws or bolts to secure the top and bottom. The PD disinfection device can weigh about 48 grams and have an expected shelf life of at least five years.

[0016] The see-through or transparent top may have a refractive index of 1.5, wherein both the top and bottom may be made of plastic. In one embodiment, the top and bottom are made of biocompatible materials to allow for sterile handling of the device by the patient during and around PD treatment, and wherein the materials are compatible for use with disinfectants and related wipes, sodium chloride, ammonium chloride, 60601-1 ethanol, and isopropyl alcohol.

[0017] In one embodiment, the UV lamp is a UV light emitting diode ("LED") and is connected (e.g., soldered) to the PCB. In one embodiment, seven UV-LEDs are provided, each of which can be operated at 15mA, at 5VDC, and have a 130 degree viewing angle. Therefore, at the maximum value, each UV-LED will require 20mA of current. Each UV-LED can also be configured to emit UV light with a wavelength in the range of 265nm to 285nm, which is very suitable for avoiding or destroying pathogens. The disinfection device instructions can also notify the patient to keep the disinfection device at a distance of ten to twelve centimeters from the area to be disinfected (e.g., the connection end of the patient's catheter or transfer kit and the catheter / patient exit site). The UV light can be blue or purple so that the patient can easily identify when the UV light is correctly focused on the area to be disinfected.

[0018] The PD disinfection device also includes a universal serial bus ("USB") connector for connecting to a mating USB connector of a power cord to provide power to the disinfection device. In one embodiment, the USB connector is soldered to the PCB, with electrical traces extending along the PCB from the USB connector to a rechargeable (e.g., 5 VDC) power source or battery (button cell), which is also soldered to the PCB. The rechargeable power source or battery can have a capacity of 150 mAh, which ideally can run for 7.5 hours on a single charge. A light emitting diode ("LED") can be soldered to the PCB and electrically connected to the rechargeable power source or battery. The LED can operate, for example, on a 0.6 VDC light and be configured to light up green when the power source or battery is fully charged and light up red when the power source or battery is low (e.g., below twenty-five percent).

[0019] In one embodiment, the PD disinfection device includes a switch, such as a hold-on-off slide type switch, which can also be soldered to the PCB. When the switch is off, no power is supplied from the battery to the UV-LED. When the patient moves the switch to the on position, the power supply powers the UV-LED, which projects UV light for disinfecting the catheter / patient exit site or the connection end of the patient's catheter or transfer kit. In one embodiment, the rechargeable power supply or battery can be recharged regardless of the position of the on-off switch.

[0020] The PD disinfection device may also include a timer, such as a NE555 timer circuit IC (2), configured to automatically cut off power to the UV-LED after a certain period of time (e.g., thirty minutes or more) as a safety feature to avoid excessive exposure to UV light, particularly at the catheter / patient exit site.

[0021] Additional electrical traces are applied to the PCB to electrically connect (i) an on-off switch between the rechargeable power source or battery and the timer circuit, and (ii) a timer circuit between the rechargeable power source or battery and, for example, each of seven UV-LEDs. Thus, the on-off switch or timer circuit is positioned to cut off power to the UV-LEDs. One or more electrical traces are applied to the PCB to electrically connect the red / green power level LEDs and the rechargeable power source or battery. In an embodiment, both sides of the PCB are used to maximize PCB space efficiency. For example, the UV-LEDs, red / green power level LEDs, and the timer circuit can be disposed on the top surface of the PCB, while the USB connector, the rechargeable power source or battery, and the on-off switch are disposed on the bottom surface of the PCB.

[0022] It is contemplated that the PD disinfection device is mounted in a variety of different operating modes. In a first embodiment, each of the see-through or transparent top, PCB, and bottom is hinged via a hinge to allow the opposite end of the PD disinfection device to be opened and placed around the patient's catheter or transfer kit. Once the PD disinfection device is placed around the patient's catheter or transfer kit, the patient closes the PD disinfection device at the opposite end by closing the hinge. The patient hingedly closes the PD disinfection device around the patient's catheter so that the UV light is directed to the catheter / patient exit site or the connection end of the patient's catheter or transfer kit. A snap fit can be formed at the opposite end to keep the PD disinfection device closed around the patient's catheter or transfer kit until it is desired to remove the disinfection device.

[0023] In a second embodiment, the see-through or transparent top, the PCB and the bottom of the device are each provided with slots, wherein the slots are aligned when the disinfection device is assembled. Here, the patient inserts the PD disinfection device over the patient's catheter via the slots so that the UV light is directed to the catheter / patient exit site or to the connection end of the patient's catheter or transfer kit. One or more snap features may be provided with slots at one or more of the see-through or transparent top and / or bottom so that the patient's catheter is prevented from sliding out of the device via the slots during use.

[0024] In a third embodiment, which may alternatively or additionally be provided with a slot, the PD disinfection device (e.g., the bottom of the PD disinfection device) is provided with or formed with an annular member defining an opening through which a chain or pendant worn by the patient is inserted. Here, the PD disinfection device is suspended from a chain or pendant worn around the patient's neck so that the PD disinfection device is located near the catheter / patient outlet to emit UV light onto the catheter / patient outlet.

[0025] In a fourth embodiment, which may be alternatively or additionally provided with a slot and / or annular member, a flexible mechanical link, such as a chain link, is provided. One end of the flexible mechanical link is configured to be connected to a belt or trousers loop of the patient. The other end of the flexible mechanical link is configured to be connected to a mating feature provided on the PD disinfection device (e.g., on the bottom of the PD disinfection device). The flexible mechanical link is configured to be hinged (e.g., anywhere between 0 degrees and 360 degrees) to a desired and maintained position so that UV light from the PD disinfection device is emitted to a desired area, such as a catheter / patient outlet.

[0026] According to the disclosure set forth herein, and without limiting the disclosure in any way, in a first aspect that may be combined with any other aspect or portion thereof, a peritoneal dialysis ("PD") disinfection device includes: a top, a bottom, a printed circuit board ("PCB") secured between the top and the bottom, a plurality of ultraviolet light emitting diodes ("UV-LEDs") secured to the PCB, and a power source operable to power the plurality of UV-LEDs, wherein the top is made of a material configured to allow light to pass through the material. At least one of the top, the bottom, or the PCB includes at least one feature that enables a patient to position and orient the PD disinfection device so that UV light from the plurality of UV-LEDs is directed toward a connection end of a catheter of the patient or toward a catheter / patient exit site.

[0027] In a second aspect of the disclosure which may be combined with any other aspect or portion thereof, the top portion is made of a transparent material.

[0028] In a third aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the top and bottom include mating features for securing the top to the bottom, the mating features including features for bolting the top and bottom together or snap-fitting the top and bottom together.

[0029] In a fourth aspect of the present disclosure which may be combined with any other aspect or part thereof, the bottom portion is opaque.

[0030] In a fifth aspect of the disclosure which may be combined with any other aspect or portion thereof, the power source comprises a rechargeable battery.

[0031] In a sixth aspect of the present disclosure which may be combined with any other aspect or part thereof, the PD disinfection device further comprises a connector for electrically connecting to a power cord. The power supply is configured to be charged via the power cord.

[0032] In a seventh aspect of the present disclosure, which may be combined with any other aspect or part thereof, the connector is at least one of: (i) the connector is a Universal Serial Bus ("USB") connector; or (ii) the connector is fixed to a PCB.

[0033] In an eighth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the PD disinfection device further comprises a switch positioned and arranged to enable power to be selectively supplied from the power source to the plurality of UV-LEDs.

[0034] In a ninth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the switch is at least one of: (i) sized to extend through an opening defined by a top or bottom, or (ii) fixed to a PCB.

[0035] In a tenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the PD disinfection device further comprises a timer circuit configured to remove power from the plurality of UV-LEDs after a certain period of time.

[0036] In an eleventh aspect of the present disclosure which may be combined with any other aspect or part thereof, at least one of the following is provided: (i) the certain period of time is thirty minutes or longer, or (ii) the timer circuit is fixed to the PCB.

[0037] In a twelfth aspect of the present disclosure which may be combined with any other aspect or portion thereof, at least one feature comprises a combined slot formed in the top, PCB and bottom.

[0038] In a thirteenth aspect of the present disclosure which may be combined with any other aspect or portion thereof, at least one feature comprises a ring member defining an opening through which a chain or pendant worn by the patient is inserted.

[0039] In a fourteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, at least one feature comprises a flexible mechanical linkage configured to connect to one of the top or bottom portion and a belt or pants loop of the patient.

[0040] In a fifteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, a PD disinfection device comprises: a top, a bottom, a printed circuit board ("PCB") fixed between the top and the bottom, a plurality of ultraviolet light emitting diodes ("UV-LEDs") fixed to the PCB, and a combined slot formed in the top, the PCB, and the bottom, wherein the top is made of a material configured to allow light to pass through the material, the combined slot enabling a patient to position and orient the PD disinfection device around the patient's catheter so that UV light from the plurality of UV-LEDs is directed toward the connection end of the patient's catheter or toward the catheter / patient exit site.

[0041] In a sixteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the combination slot includes at least one snap feature configured to prevent a catheter of a patient from slipping out of the combination slot during use.

[0042] In a seventeenth aspect of the present disclosure which may be combined with any other aspect or portion thereof, the PD disinfection device further comprises a ring member defining an opening through which a chain or pendant worn by the patient is inserted.

[0043] In an eighteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the annular member is provided with or formed with the bottom portion.

[0044] In a nineteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the PD disinfection device further comprises a flexible mechanical linkage configured to connect to one of the top or bottom portion and a waistband or pants loop of the patient.

[0045] In the twentieth aspect of the present disclosure, which may be combined with any other aspect or part thereof, Figures 1 to 8 Any features, functions and alternatives described in any one or more of the figures may be combined with Figures 1 to 8 Any features, functions and alternatives described in any other figures in the and / or any combination of aspects listed herein.

[0046] It is therefore an advantage of the present disclosure to provide an improved PD disinfection device.

[0047] Another advantage of the present disclosure is to provide a PD sterilization device capable of sterilizing a catheter / patient exit site.

[0048] Another advantage of the present disclosure is to provide a PD sterilization device that is adjustable so as to be able to sterilize the catheter / patient exit site in addition to sterilizing the connection end of the patient's catheter or transfer set.

[0049] Yet another advantage of the present disclosure is to provide a PD sterilization device that is patient-safe and safe for PD therapy.

[0050] Yet another advantage of the present disclosure is to provide a cost-effective PD disinfection device.

[0051] Yet another advantage of the present disclosure is to provide a PD disinfection device that is lightweight and easy for a patient to manipulate.

[0052] 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 in view of the accompanying drawings and description. Moreover, it is not necessary for any particular embodiment to have all of the advantages listed herein, and it is expressly contemplated that each advantageous embodiment is individually claimed. Furthermore, it should be noted that the language used in this specification is selected primarily for readability and instructional purposes, and does not limit the scope of the subject matter of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 is a perspective view of one embodiment of an assembled peritoneal dialysis ("PD") sterilization apparatus of the present disclosure.

[0054] Figure 2 is a first exploded view of one embodiment of a PD disinfection device of the present disclosure.

[0055] Figure 3 is a second exploded view of one embodiment of the PD disinfection device of the present disclosure.

[0056] Figure 4 is a top view of one embodiment of a PD disinfection device of the present disclosure, illustrating one way to recharge the device.

[0057] Figure 5 is a side view of one embodiment of a PD sterilization device of the present disclosure oriented to sterilize the connection end of a patient's catheter or transfer set.

[0058] Figure 6is a side view of one embodiment of a PD disinfection device of the present disclosure oriented to disinfect a catheter / patient exit site.

[0059] Figure 7 Various views of an alternative embodiment of the PD sterilizing device of the present disclosure are shown, the PD sterilizing device being worn around the patient's neck.

[0060] Figure 8 A side view of another alternative embodiment of the PD disinfection device of the present disclosure is shown, attached to a belt worn by a patient. DETAILED DESCRIPTION

[0061] System Overview

[0062] Referring now to the drawings, in particular Figure 1-Figure 3 , a peritoneal dialysis ("PD") disinfection device 10 is shown. The PD disinfection device 10 is manually adjustable to provide a catheter / patient exit site 12 ( Figures 6 to 8 ) and the connecting end of the patient's catheter or transfer kit 14 ( Figures 5 to 7 ) for disinfection. In one embodiment, the PD disinfection device 10 directs ultraviolet ("UV") light outwardly so that the patient can orient the device so that the outwardly directed UV light irradiates the patient's catheter or transfer kit 14 connection end or the catheter / patient exit site 12, whichever is desired. The PD disinfection device 10 may be provided with instructions that inform the patient to orient the device 10 (i) toward the patient's catheter or transfer kit 14 connection end and disinfect it before connecting to the patient line for treatment, and (ii) toward the catheter / patient exit site 12 and disinfect it after treatment.

[0063] In one embodiment, the PD disinfection device 10 is made of three main components, namely, a see-through or transparent top 20 (made of a material configured to allow light (e.g., ultraviolet light) to pass through the material), a printed circuit board ("PCB") 30, and a bottom 60, which is opaque in one embodiment. The top 20 and the bottom 60 include mating (e.g., molded) features 22, 62 so that the top 20 and the bottom 60 fit together around the printed circuit board. The mating features 22, 62 of the top 20 and the bottom 60 can be configured to snap together, or be provided with openings and threaded holes to receive one or more screws or bolts 50 to secure the top 20 and the bottom 60. The PD disinfection device 10 can weigh about 48 grams and have an expected shelf life of at least 5 years.

[0064] The see-through or transparent top 20 may have a refractive index of 1.5, wherein both the top and bottom 60 may be made of one or more plastics, such as acrylonitrile butadiene styrene ("ABS"), polyvinyl chloride ("PVC"), or non-PVC materials such as polyethylene ("PE"), polyurethane ("PU"), polycarbonate ("PC"), ABS combined with PC, and / or polyetheretherketone ("PEEK"). The bottom 60 may alternatively or additionally be made of a metal, such as stainless steel, steel, and / or aluminum. The top 20 and bottom 60 are made of a biocompatible material in one embodiment. In some cases, the material is compatible with disinfectants and related wipes, sodium chloride, ammonium chloride, 60601-1 ethanol, and isopropyl alcohol uses to allow patients to handle the disinfected device 10 during and around PD treatment.

[0065] In one embodiment, the UV lamp is a UV light emitting diode ("LED") 32 and is connected (e.g., soldered) to the PCB 30. In one embodiment, seven UV-LEDs 32 are provided, each of which can be operated at a rated current of 15 mA, at 5 VDC, and have a 130 degree viewing angle. Therefore, at a maximum value, each UV-LED 32 requires a current of 20 mA. Each UV-LED 32 can also be configured to emit UV light with a wavelength in the range of 265 nm and 285 nm, which is very suitable for avoiding or destroying pathogens. The PD disinfection device 10 instructions can further inform the patient to keep the disinfection device at a distance of ten to twelve centimeters from the area to be disinfected (e.g., the connection end of the patient's catheter or transfer kit 14 or the catheter / patient exit site 12). The UV light can be blue or purple so that the patient can easily identify when the UV light is correctly focused on the area to be disinfected.

[0066] Figure 2 and Figure 4 The PD disinfection device 10 is shown also including a Universal Serial Bus (“USB”) connector 34 for connecting to a mating USB connector 72 of a power cord 70 for powering the disinfection device 10 . Figure 2The bottom 60 is shown defining a hole or opening 61 for enabling a USB connector 72 to enter the device 10 and connect to the USB connector 34. The USB connector 34 is soldered to the PCB 30 in one embodiment, wherein electrical traces (e.g., copper traces) (not shown) extend along the PCB 30 from the USB connector 34 to a rechargeable (e.g., 5 VDC) power source or battery 36 (e.g., a button cell) that is replaceably insertable into a power source holder (not shown) that is also soldered to the PCB 30. The rechargeable power source or battery 36 can have a capacity of 150 mAh, which can ideally run for 7.5 hours on a single charge. An LED 38 can be soldered to the PCB 30 and electrically connected to the rechargeable power source or battery 36. The LED 38 can, for example, operate on a 0.6 VDC light and be configured to illuminate green when the power source or battery 36 is fully charged and illuminate red when the power source or battery 36 is low, for example, below 25 percent.

[0067] In one embodiment, the PD disinfection device 10 includes a switch 40, such as a hold-on-off slide-type switch, which may also be soldered to the PCB 30 and extends through the opening provided by the bottom 60. When the switch 40 is off, no power is supplied from the power source or battery 36 to the UV-LED 32. When the patient moves the switch 40 to the on position, the power source or battery 36 powers the UV-LED 32, which projects UV light for disinfecting the catheter / patient exit site 12 or the connection end of the patient's catheter or transfer kit 14. In one embodiment, the rechargeable power source or battery 36 can be recharged regardless of the position of the on-off switch 40.

[0068] The PD disinfection device 10 may also include a timer 42, such as a NE555 timer circuit IC (2), which is configured to automatically cut off power to the UV-LED 32 after a certain period of time (e.g., thirty minutes) as a safety feature to avoid excessive exposure to UV light, particularly at the catheter / patient exit site 12.

[0069] Additional electrical traces (not shown) are applied to the PCB 30 to electrically connect (i) the on-off switch 40 between the rechargeable power source or battery 36 and the timer circuit 42, and (ii) the timer circuit 42 between the rechargeable power source or battery 36 and, for example, each of the seven UV-LEDs 32. Thus, the on-off switch 40 or timer circuit 42 is positioned to cut off power to the UV-LEDs 32. One or more electrical traces (not shown) are applied to the PCB 30 to electrically connect the green / red power level LEDs 38 and the rechargeable power source or battery 36. In one embodiment, both sides of the PCB 30 are used to maximize PCB space efficiency. For example, the UV-LEDs 32, the green / red power level LEDs 38, and the timer circuit 42 can be disposed on (e.g., soldered to) the top surface of the PCB 30, while the USB connector 34, the rechargeable power source or battery 36, and the on-off switch 40 are disposed on (e.g., soldered to) the bottom surface of the PCB 30.

[0070] In some embodiments, the switch 40 and the timer circuit 42 can be positioned in series with the UV-LEDs 32 electrically connected in parallel with each other. Therefore, when the switch 40 is closed and the timer circuit 42 has not timed out, each UV-LED 32 is powered at the same time. In addition, in some cases, the USB connector 34 is electrically connected between the positive terminal and the negative terminal of the power supply or battery 36 for recharging the power supply or battery when the power cord 70 is inserted into the USB connector 34. The voltmeter can be located between the positive terminal and the negative terminal of the power supply or battery 36 for detecting the power storage level of the power supply or battery. The voltmeter has two switches, one for lighting the green / red LED 38 green when the power supply or battery 36 is fully charged, and the other for lighting the green / red LED 38 red when the power supply or battery is low, for example, less than 25 percent.

[0071] It is contemplated that the PD disinfection device 10 may be mounted in a number of different operating modes. Figure 1 A first embodiment is shown in which each of the see-through or transparent top 20, PCB 30, and bottom 60 is hinged via hinges 28, 68 to allow the opposite end of the PD disinfection device 10 to be opened and placed around the patient's catheter or transfer kit 14. Once the PD disinfection device 10 is placed around the patient's catheter or transfer kit 14, the patient closes the PD disinfection device at the opposite end by closing the hinges 28, 68. The patient hingedly closes the PD disinfection device 10 around the patient's catheter 14 so that the UV light is directed to the catheter / patient exit site 12 or the connection end of the patient's catheter or transfer kit 14. A snap fit can be formed at the opposite end to keep the PD disinfection device 10 closed around the patient's catheter or transfer kit 14 until it is desired to remove the disinfection device.

[0072] Figures 2 to 6A second embodiment is shown in which the see-through or transparent top 20, PCB 30 and bottom 60 of the device are each provided with slots 24, 44, 64, wherein the slots 24, 44, 64 are aligned when the PD disinfection device 10 is assembled. Here, the patient inserts the PD disinfection device 10 over the patient's catheter 14 via the combined slots 24, 44, 64 so that the UV light is directed toward the catheter / patient exit site 12 or the connection end of the patient's catheter or transfer kit 14. Figure 4 It is best shown that one or more snap features 26 may be provided at the slot 24 via one or more of the see-through or transparent top 20 and / or bottom 60 so that the patient's conduit 14 is prevented from sliding out of the device via the combined slots 24, 44, 64 during use.

[0073] Figure 7 A third embodiment is shown, which may alternatively or additionally be provided with slots 24, 44, 64. Here, the PD disinfection device 10 (e.g., the bottom 60 of the PD disinfection device) is provided or formed with a ring member 66 that defines an opening through which a chain or pendant 74 worn by the patient is inserted. The PD disinfection device 10 is suspended from the chain or pendant 74 worn around the patient's neck so that the PD disinfection device is located near the catheter / patient exit site 12 for emitting UV light thereon. The combined slots 24, 44, 64 of the device 10 may be inserted additionally and simultaneously over the patient's catheter or transfer kit 14.

[0074] Figure 8 A fourth embodiment is shown, which may be provided alternatively or additionally with slots 24, slots 44, slots 64 and / or ring members 66, wherein a flexible mechanical link 80, such as a chain link, is provided. A first end 82 of the flexible mechanical link 80 is configured to be connected to a waistband 76 or trouser loop of the patient. The other, second end 84 of the flexible mechanical link 80 is configured to be connected to a mating feature (not shown) provided on the PD disinfection device 10 (e.g., on the top 20 or bottom 60 of the PD disinfection device). The flexible mechanical link 80 is configured to be articulated (e.g., anywhere between 0 and 360 degrees) to a desired and maintained position so that UV light from the PD disinfection device 10 is emitted onto a desired area, such as onto the catheter / patient outlet 12.

[0075] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims

1. A peritoneal dialysis ("PD") disinfection device, comprising: a top made of a material configured to allow light to pass through the material; a bottom; a printed circuit board ("PCB") fixed between the top and the bottom; a plurality of ultraviolet light-emitting diodes ("UV-LEDs") fixed to the PCB; and a power supply operable to supply power to the plurality of UV-LEDs, wherein at least one of the top, the bottom, or the PCB includes at least one feature that enables a patient to position and orient the PD disinfection device such that UV light from the plurality of UV-LEDs is directed toward a connection end of a catheter of the patient or a catheter / patient exit site.

2. The PD disinfection device according to claim 1, wherein the top is made of a transparent material.

3. The PD disinfection device according to claim 1, wherein the top and the bottom include mating features for fixing the top to the bottom, the mating features including features for bolting or snap-fitting the top and the bottom together.

4. The PD disinfection device according to claim 1, wherein the bottom is opaque.

5. The PD disinfection device according to claim 1, wherein the power supply includes a rechargeable battery.

6. The PD disinfection device according to claim 1, the PD disinfection device includes a connector for electrically connecting to a power cord, and wherein the power supply is configured to be charged via the power cord.

7. The PD disinfection device according to claim 6, wherein at least one of the following is provided: (i) the connector is a universal serial bus ("USB") connector; or (ii) the connector is fixed to the PCB.

8. The PD disinfection device according to claim 1, the PD disinfection device includes a switch positioned and arranged such that power can be selectively supplied from the power supply to the plurality of UV-LEDs.

9. The PD disinfection device according to claim 8, wherein at least one of the following is provided: (i) the switch is sized to extend through an opening defined by the top or the bottom; or (ii) the switch is fixed to the PCB.

10. The PD disinfection device according to claim 1, the PD disinfection device includes a timer circuit configured to remove power from the plurality of UV-LEDs after a certain period of time.

11. The PD disinfection device according to claim 10, wherein at least one of the following is provided: (i) the certain period of time is thirty minutes or longer; or (ii) the timer circuit is fixed to the PCB.

12. The PD disinfection device according to claim 1, wherein the at least one feature includes a combination slot formed in the top, the PCB, and the bottom.

13. The PD disinfection device according to claim 1, wherein, the at least one feature portion includes an annular member that defines an opening through which a chain or pendant worn by a patient is inserted.

14. The PD disinfection device according to claim 1, wherein, the at least one feature portion includes a flexible mechanical linkage configured to connect to one of the top or bottom and a waistband or pant loop of the patient.

15. A peritoneal dialysis ("PD") disinfection device, comprising: a top made of a material configured to allow light to pass through the material; a bottom; a printed circuit board ("PCB") fixed between the top and the bottom; a plurality of ultraviolet light emitting diodes ("UV-LEDs") fixed to the PCB; and a combined slot formed in a combination of the top, the PCB, and the bottom, the combined slot enabling a patient to position and orient the PD disinfection device around the patient's catheter such that UV light from the plurality of UV-LEDs is directed towards a connection end of the patient's catheter or a catheter / patient exit site.

16. The PD disinfection device according to claim 15, wherein, the combined slot includes at least one snap feature configured to prevent the patient's catheter from slipping out of the combined slot during use.

17. The PD disinfection device according to claim 15, the PD disinfection device further includes an annular member that defines an opening through which a chain or pendant worn by a patient is inserted.

18. The PD disinfection device according to claim 17, wherein, the annular member is provided with or formed with the bottom.

19. The PD disinfection device according to claim 15, the PD disinfection device further includes a flexible mechanical linkage configured to connect to one of the top or the bottom and a waistband or pant loop of the patient.

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