Peritoneal dialysis patient connection systems using ultraviolet light emitting diodes for sterilisation

The present disclosure relates generally to medical device connectors, and more specifically to sterile patient connection systems for peritoneal dialysis.

Due to a variety of causes, the human renal system can become dysfunctional. Renal failure results in several physiological abnormalities. The balance of excretion of water, minerals, and daily metabolic loads is no longer possible, and toxic end products of nitrogen metabolism (urea, creatinine, uric acid, and others) can accumulate in blood and tissues.

The renal system and impaired renal function are being treated by dialysis. Dialysis removes waste products, toxins, and excess fluid from the body that would otherwise have been removed by the functioning kidneys. Treatment is critical to many because dialysis treatment, which is a substitute for renal function, saves lives.

One type of renal system therapy is peritoneal dialysis, which uses a dialysis solution, also called dialysate, which is injected intraperitoneally into the patient's abdominal cavity via a catheter. The dialysate contacts the peritoneum of the abdominal cavity. Waste products, toxins, and excess water pass through the patient's bloodstream, through the peritoneum, and into dialysate by diffusion and penetration. That is, an osmotic gradient occurs across the membrane. The waste dialysate is drained from the patient and removes waste products, toxins, and excess water from the patient. This cycle is repeated.

There are various types of peritoneal dialysis therapy, including continuous portable peritoneal dialysis (CAPD), automatic peritoneal dialysis (APD), tidal current dialysis, and continuous flow peritoneal dialysis (CFPD).

CAPD's technology for removing impurities from the blood of patients with renal failure generally causes the dialysis patient to carry a surgically implanted catheter that is (intermittently) connected to the peritoneal dialysis transport set. For CAPD treatment, the transport set is in turn connected to a bag of peritoneal dialysis solution, which is transferred intraperitoneally through the transport set (CAPD infusion phase). In the case of CAPD, the patient is not "fastened" to the mechanical device and is able to walk independently during dialysis across the peritoneum (CAPD retention phase). After the retention phase, the peritoneal dialysis solution is drained from the abdominal cavity (CAPD draining phase). This can be done by regurgitating the solution into the feed bag. Preferably, the back is not released during the staying phase. After the drain phase, the bag with the waste peritoneal dialysis solution can be removed from the transport set and discarded.

Automatic peritoneal dialysis (APD) is similar to CAPD in that dialysis treatment involves drainage, filling, and retention cycles. However, APD mechanical devices or "circulatory devices" typically cycle automatically while the patient is sleeping. The APD mechanism frees the patient from the need to manually perform the treatment cycle and to carry the daytime supply device. The APD mechanical device fluidly connects to a bag of implanted catheter, source, or unused dialysate and a fluid drainage tube. The APD mechanism delivers unused dialysate from the dialysate source through the catheter into the patient's abdominal cavity, causing the dialysate to stay in the cavity, resulting in the transport of waste products, toxins, and excess water. .. The source can be multiple sterile dialysate solution bags.

The APD mechanism delivers waste dialysate from the abdominal cavity through a catheter to a drainage duct. Similar to the manual process, some drainage, filling, and retention cycles occur during dialysis. The "final filling" occurs at the end of CAPD and APD and remains in the patient's abdominal cavity until the next treatment.

Both CAPD and APD are batch systems that deliver waste dialysis fluid to the drain. The tidal current system is an improved batch system. The tidal current removes and replaces a portion of the fluid after a slight time increment, instead of removing all of the fluid from the patient over an extended period of time.

A continuous flow or CFPD system purifies or regenerates waste dialysate without discarding. The system pumps fluid in and out of the patient through a loop. The dialysate flows into the abdominal cavity through one catheter cavity and out of the other catheter cavity. The fluid flowing out of the patient passes through a reconstitution device that removes waste products from the dialysate, for example, through a urea removal column that employs urease and enzymatically converts urea to ammonia. Ammonia is then removed from the dialysate by absorption prior to reintroduction of the dialysate into the abdominal cavity. Additional sensors are employed to monitor the removal of ammonia. CFPD systems are typically more complex than batch systems.

<p> All of the above systems require the patient to connect the patient's indwelling catheter to the PD feeder via a transport set. The connection with the patient must remain sterile, otherwise the patient may suffer from a disease called peritonitis. Also, since patients usually perform these tasks at home and / or alone, connection with the patient should be easy for the patient. Therefore, there is a need for an improved peritoneal dialysis patient connection system.</p>

<p> The present disclosure includes systems and methods for connecting supply connectors to patients for medical systems that require connectivity. Such connections often need to be made in a sterile environment to prevent contaminants from reaching the patient from the feed connector or connection process. In peritoneal dialysis, for example, a catheter is implanted in the patient's abdominal cavity. The catheter terminates on the outside of the body with the port. The port is connected to what is called a patient transport set. The patient transport set, in turn, is connected to a supply line, extending from a supply bag (typically with manual peritoneal dialysis (CAPD)) or a disposable cassette, for example.</p><p> The present disclosure provides a luminescent applicator that surrounds the connections described above so that it can be performed in a sterile environment. The applicator includes a housing that is hinged to allow installation of a connection mechanism that holds the connector within the optical applicator. The inner surface of the housing has an ultraviolet (UV) light reflector, such as an etched aluminum coating, which can maximize the exposure of ultraviolet light applied to the contents in the applicator. The connector is light transmissive and allows light from the applicator to reach the connector held by the connector.</p><p> A conventional UV optical element uses a xenon lamp. However, xenon lamps require relatively high operating voltages, such as about several hundred volts, to generate sufficient light energy. In the present disclosure, the optical applicator includes a series of ultraviolet light emitting diodes (LEDs) that substitute for xenon lamps. UV-LEDs do not require the same high voltage, making optical applicators lighter and smaller.</p><p> The UV-LEDs can be arrayed around the inner surface of the optical applicator and at least substantially cylindrical. As mentioned above, the cylindrical housing of the optical applicator is hinged so that, in one embodiment, the patient auxiliary connection device is loaded into the applicator. The optical applicator also includes a circuit that connects to a power source, which is a connector for the patient set that the UV-LEDs collectively supply or disconnect the appropriate amount of power over a period of time. It is possible to operate to apply power to each of the UV-LEDs at the same time so as to effectively sterilize. The power source can be a battery source that allows cordless operation, or an AC source, such as from a wall unit or PD circulation device.</p><p> In an alternative embodiment, the power source is the irradiation time, for example, full power to half of the UV-LED for a period of time and then full power to the other half of the UV-LED for the same time. Throughout, the UV-LEDs are switched to power in sequence. The electric power can be divided into 3 or 4 in order, and is not limited to 2 divisions. As a further alternative, the power supply is operated to alternate between simultaneous and sequential power supply, as many times as desired, over a total period of time.</p><p> In one implementation, each UV-LED emits 1 milliwatt of UV energy at a peak wavelength of 280 nanometers. 0.2 joules / cm²When total energy is required, 50 UV-LEDs are placed in an array on the inner surface of the optical applicator housing and are required over the uptime, as detailed below. Can provide total energy. The UV-LED can illuminate the laterally located inner surface of the system, eg, the outer surface of the bulkhead that initially covers the female (eg, feed) connector prior to its breakage. UV-LEDs also illuminate the complex surface of spikes in spike connectors.</p><p> The optical applicator, in one embodiment, comprises a photocell that measures the total energy of ultraviolet light applied in each sterilization procedure. The total energy is a given overall desired exposure level, eg, about 200 millijoules (mJ) / cm.²When it reaches, the photocell activates the transducer connected to the photocell and blocks the ultraviolet light element. The overall exposure time depends on the microbiological load being sterilized. Alternatively, the amount of energy required to bring about the appropriate sterilization level is determined by microbiological evaluation prior to connection, giving the total time of exposure required. The optical applicator is then excited for a predetermined time of exposure. In both methods, the energy exposure level guarantees maximum antibacterial effect against spikes and female connectors.<u style="single">The present invention provides, for example,:</u><u style="single">(Item 1)</u><u style="single">An optical applicator for connecting peritoneal dialysis conduits</u><u style="single">A housing with an inner surface and</u><u style="single">A plurality of ultraviolet (UV) light emitting diodes (LEDs) located on the inner surface of the housing.</u><u style="single">With a circuit connected to the UV-LED so that power is supplied and at the same time the UV-LED can be excited.</u><u style="single">Equipped with an optical applicator.</u><u style="single">(Item 2)</u><u style="single">The optical applicator according to item 1, wherein the inner surface of the housing includes a UV reflective surface.</u><u style="single">(Item 3)</u><u style="single">The optical applicator according to item 1, wherein the housing is operable and retractable to receive a peritoneal dialysis tube connector.</u><u style="single">(Item 4)</u><u style="single">The optical applicator according to item 1, wherein the inner surface of the housing is at least substantially cylindrical, and the UV-LEDs are circumferentially spaced around the inner surface.</u><u style="single">(Item 5)</u><u style="single">The optical applicator according to item 1, wherein the UV-LEDs are separated in an array around the inner surface of the housing.</u><u style="single">(Item 6)</u><u style="single">The above UV-LEDs combined at least 0.2 joules / cm in less than 1 minute</u>^{<u style="single">2</u>}<u style="single">The optical applicator according to item 1, which provides radiant energy of.</u><u style="single">(Item 7)</u><u style="single">At least one of the above UV-LEDs is selected from the group consisting of (i) having a peak wavelength of about 280 nanometers and (ii) having a power output of about 1 milliwatt. The optical applicator according to item 1, which has one feature.</u><u style="single">(Item 8)</u><u style="single">The optical applicator according to item 1, wherein the housing is at least one of (i) an inner diameter of 15 mm or less and (ii) a length of 50 mm or less.</u><u style="single">(Item 9)</u><u style="single">The optical applicator according to item 1, wherein the UV-LEDs, in combination, provide sufficient energy to provide a sufficient bactericidal effect on the peritoneal dialysis conduit connection in less than 1 minute.</u><u style="single">(Item 10)</u><u style="single">Peritoneal dialysis patient assistive device</u><u style="single">A main body configured to receive a first connector for fluid communication with the patient's indwelling catheter and a second connector for fluid communication with the dialysate supply unit, the first connector and the second connector. Further configured to fit the connector of the body,</u><u style="single">With a plurality of ultraviolet (UV) light emitting diodes (LEDs) positioned relative to the body so that radiant energy is directed towards the mating portion of the first connector and the second connector.</u><u style="single">The device.</u><u style="single">(Item 11)</u><u style="single">The peritoneal dialysis patient assisting device according to item 10, further comprising a housing containing the main body and having an inner surface, and a UV-LED located on the inner surface.</u><u style="single">(Item 12)</u><u style="single">Item 11. The housing comprises at least one of (i) a device that opens and closes the housing and allows it to receive the body, and (ii) an inner surface that reflects UV light. Peritoneal dialysis patient assistive device.</u><u style="single">(Item 13)</u><u style="single">Item 10. The invention comprises a circuit connected to the UV-LED so that it can be powered and excited (i) simultaneously, (ii) in order, or (iii) simultaneously and sequentially. Peritoneal dialysis patient assistive device.</u><u style="single">(Item 14)</u><u style="single">The peritoneal dialysis patient assisting device according to item 10, wherein the main body is made of a UV light transmitting material.</u><u style="single">(Item 15)</u><u style="single">The peritoneal dialysis patient assisting device according to item 10, wherein the main body is configured to translate the first connector and the second connector to fit and disengage the connectors.</u><u style="single">(Item 16)</u><u style="single">A peritoneal dialysis system</u><u style="single">Circulator and</u><u style="single">A disposable cassette that can operate with the circulator,</u><u style="single">A supply bag connected to the disposable cassette</u><u style="single">A supply line extending from the disposable cassette and terminating with a supply connector,</u><u style="single"> A body configured to connect the supply connector to a patient connector that communicates fluidly with the patient's indwelling catheter.</u><u style="single">Multiple ultraviolet (UV) light-emitting diodes (LEDs) that can be placed around the body and are positioned to direct energy towards at least one of the supply connector and the patient connector. With housing including</u><u style="single">The system.</u><u style="single">(Item 17)</u><u style="single">The supply connector is at least selected from the group consisting of (i) a female connector, (ii) having a punctureable partition wall, and (iii) being at least partially opaque to UV light. The peritoneal dialysis system according to item 16, which has one feature.</u><u style="single">(Item 18)</u><u style="single">The peritoneal dialysis system according to item 16, wherein the at least one UV-LED is powered via (i) a battery or (ii) AC power.</u><u style="single">(Item 19)</u><u style="single">16. The peritoneal dialysis system of item 16, wherein the transport set includes a transport set that connects the patient connector to the indwelling catheter.</u><u style="single">(Item 20)</u><u style="single">16. The peritoneal dialysis system of item 16, wherein the housing is hinged or halved to fit around the connection body.</u></p>

<figref num="1">FIG. 1 shows an embodiment of the patient assistance system of the present disclosure.</figref><figref num="2">FIG. 2 is an end view of an ultraviolet (UV) light emitting diode (LED) applicator for the system of FIG. 1, showing a connector for reference, and in one embodiment hinged an applicator. Illustrate.</figref><figref num="3">FIG. 3 is an end view of FIG. 2, with the applicator closed around the connector so that the UV-LEDs on the applicator are positioned to emit light onto the connector from many different angles. Shown.</figref><figref num="4">FIG. 4 is a side sectional view of a cross section along lines IV-IV of FIG.</figref>

The devices and methods discussed herein are illustrated in combination with a peritoneal dialysis system such as continuous portable peritoneal dialysis (CAPD) or automatic peritoneal dialysis (APD). However, it should be understood that the teachings associated with the accompanying drawings are applicable to many types of medical fluid systems. In CAPD and APD, the patient connects the supply bag directly (CAPD) or with a pump circulation device and a supply line extending to an operable disposable cassette (APD). It is important that such connections are made in a sterile condition. It is also desirable to have a system that is convenient for sick or elderly patients.

The patient connects the supply line to the patient line, which in turn can be part of the PD transport set and, in turn, to a catheter that is placed within the patient's peritoneum. The patient then needs to connect the patient line to the drain bag and have the waste dialysate removed from the patient's peritoneum. Each patient may need to connect multiple supply lines, each extending from a separate supply bag to the patient line. Between each supply bag, the patient needs to be connected to the drain bag. Here, it is important that the patient be able to disengage the old supply line, correct the drain line, and then connect the new supply line in an easy and sterile environment.

Next, with reference to the drawings, in particular FIG. 1, System 10 illustrates an embodiment of the patient assistance system of the present disclosure. Figure 1 shows System 10 graphically and overall, highlighting the overall physical and operational relationships between the components. System 10 includes an ultraviolet (UV) light applicator 20. The optical applicator 20 includes a housing 22 that can be formed from plastic or other suitable medical grade material. As detailed below, the housing 22 is, in one embodiment, hinged to fit around the connection / disconnect device 50. A plurality of ultraviolet (UV) light emitting diodes (LEDs) 30 are installed on the inner surface 24 of the housing 22 of the optical applicator 20. The UV-LED30s are positioned to direct energy inward through the body 52 of the connect / disconnect device 50, respectively, to direct germicidal light to the connection and disconnection of the patient connector 80 to and from the supply or port connector 90. Be done. Therefore, the body 52 of the connect / disconnect device 50 is made of a UV transmissive material.

The disconnect / reconnect device 50 has a different configuration and can still operate within the system 10 with the UV-LED applicator 20. However, one of the preferred disconnect / reconnect devices is disclosed in the Co-pending US Patent Application No. 11 / 773,623 (Application No. 623) Peritoneal Dialysis Patient Connection System filed July 5, 2007. (Granted to the ultimate assignee of this application, the entire contents of which are incorporated herein by reference).

The patient connector 80 is hermetically connected to a patient tube 82 that is part of the patient's transport set and is fluidly connectable to the patient's indwelling catheter. The supply or port connector 90, in turn, is connected to a supply line 92, which can extend directly to the supply bag or into a disposable cassette, as described above. The port connector 90 includes a punctureable partition wall 94. The patient or spike connector 80 includes or defines a spike 84 that punctures or breaks the bulkhead 94 of the port connector 90 when the connector is fitted. The patient connector 80 is effectively shown as a male and the port connector 90 is effectively shown as a female, but vice versa is possible as an alternative. The connectors 80 and 90, in one embodiment, are at least partially shielded from UV light.

The connect / disconnect device 50 connects and disconnects connectors 80 and 90 without physical contact and potentially contamination. The germicidal light from the UV-LED30 is generally emitted onto the connectors 80 and 90 immediately before mating the connector and immediately after disengaging the connector, as illustrated and described in detail herein.

The UV applicator 20 is then illustrated in more detail with reference to FIGS. 2-4. FIG. 2 shows that the housing 22 of the UV applicator 20 includes, in one embodiment, at least substantially cylindrical shapes, halves 26 and 28 separated by a hinge 32. Hinge 32 allows the half bodies 26 and 28 to be fitted around the connect / disconnect device 50, which holds the connectors 80 and 90 shown in Figures 2 and 3 for reference.

Figure 3 shows halves 26 and 28, closed around connectors 80 and 90. The UV-LED30 is positioned to radiate energy over the connection or disconnection of connectors 80 and 90. The at least substantially cylindrical housing 22 collects light from each of the UV-LEDs 30 towards the centerline extending through the applicator 20 and thus towards the connector. FIG. 4 is a view of the inner surface 24 of the half body 28 of the housing 22 of the optical applicator 20 along lines IV-IV shown in FIG.

Figure 4 shows that each half body 26 and 28 contains a 5x5 array of UV-LED30s. The trace wire 34, in one embodiment, on the inner surface 24 of the halves 26 and 28 so that the UV-LED30 provides the entire amount of energy to sterilize the connecting and disconnecting parts of the connectors 80 and 90. Formed to power each UV-LED30 at the same time. As shown in FIG. 4, the trace wire 34 terminates at power supply terminals V + and V-. In one embodiment, a single pair of power supply terminals V + and V- are provided for both UV-LED30 halves 26 and 28. The UV-LED30 can be powered from a direct current (DC) source, such as a built-in replaceable or rechargeable battery, or, for example, through a wall outlet or by an alternating current source from a circulation device or infrastructure. Is.

In an alternative embodiment, the software and circuits switch power and provide full power to the UV-LED30 half body 26 for the entire irradiation period, eg, for a period of time, and then for the same period of time, the UV-LED30. It is configured to supply power to the UV-LED 30 in order, such as supplying full power to the other half body 28. Full power can, as an alternative, be switched in half, trisection, quadrant, or otherwise sequentially, if desired. As a further alternative, the software and circuits are configured to operate the power supply and, if desired, alternate between simultaneous and continuous power supply of the UV-LED30 over a total period of time.

In one embodiment, each LED30 operates at 0.6 volts at 20mA, resulting in a power requirement of 120 milliwatts / LED30. Therefore, a total of 50 LEDs 30 would require an overall power requirement of 6 watts. This is well below the approximately 43 watts required by xenon lamp applicators.

The inner surface 24 of the halves 26 and 28, in one embodiment, comprises a UV light reflector, eg, an etched aluminum coating, which maximizes the exposure of UV light that the UV-LED30 imparts on connectors 80 and 90. To. Alternatively, the material of the housing 22 consists of a suitable medical grade material, such as a relatively inexpensive plastic, such as methacrylic resin (yellow).

One of the suitable UV-LED30s is provided by Seoul Semiconductor Co., Ltd (148-29 Gasan-dong Geumcheon-gu Seoul, Korea (model number S8D28D)). In one embodiment, each UV-LED30 has a peak wavelength of about 280 nanometers. Each UV-LED30 has a power output of approximately 1 milliwatt. If the given proper sterilization of connectors 80 and 90 requires a total energy of about 0.2 joules, for example, 50 UV-LED30s will provide the energy required over a suitable time, as described above. Rating is sufficient.

The 5x5 array of UV-LED30s in FIG. 4 is repeated on the hinged half body 26 to provide a total of 50 UV-LED30s. In one embodiment, the 50 UV-LED30s, in one implementation, are uniform over the half bodies 26 and 28 of the housing 22, having, for example, an inner diameter of 10 mm and a length of 40 mm, which is approximately the size of the spike 84 of the connector 80. Spread to. The housing 22 may, as an alternative, be larger, eg, large enough to enclose the connection / disconnect device of application '623. Application No. '623 discloses a hinge joining system in which the half body of the connect / disconnect device is hinged to a housing that holds a motor and other devices for automatic connection and disconnection of connectors. Connected to the lid. In combination with the connection / disconnect device of Application No. '623, the halves 26 and 28 are unlikely to be hinged to each other, but instead, in turn, are hinged to each other in the lid and housing described above. Will be installed in. Therefore, the applicator 20 does not need to be hinged by itself. Each separate half can have its own power supplies V + and V- and can provide the total power required. It should also be appreciated that in any configuration (hinge joint or separate), the inner surface 24 of the halves 26 and 28 is removable for cleaning.

Combined radiation from 50 UV-LEDs 30 is (1 milliwatt x 50 UV-LEDs) / (10mmxπx40mm) = 4 milliwatts / cm²Provides light intensity or brightness (Lux) equal to.

UV effective energy L^uxeff says that if the xenon wavelength is 254 nanometers (nm) and the 280 nm LED is known to have 90% sterilization efficiency for 254 nm light (xenon or LED), then L^uxeff = 4 milliwatts / cm²x0.9 = 3.6 milliwatts / cm. Considering the UV effectiveness for 50 UV-LEDs of 3.6 millijoules, 0.2 joules / cm²The time required for the total energy output of is radiation time = 200 millijoules / cm.²/3.6 milliwatt / cm²= 56 seconds.

Another method of assessing exposure time uses a xenon wavelength of 254 nm as a reference. That is, 200 mJ / cm²Xenon light is sufficient for proper sterilization. Therefore, 200mJ / cm²254 nm UV-LED light is also considered sufficient sterilization. The sterilization efficiency of a 280 nm UV-LED is 0.9x254 nm regardless of whether UV-LED or xenon light is used. Therefore, when 280nm UV-LED light is used, 200mJ / cm²/0.9=222mJ/cm²Is required to be applied to the connector, eg, the spike connector 80. As discussed, spike 84 of connector 80 can be 10mmx4mm, surface area S = 10mmxπx40mm = (4xπ) cm²Bring. The 50 280nm LEDs provide an output of 50mW = 50mJ / sec. Therefore, the applicator 20 is 50mW / S = 50 / (4xπ) mJ / cm.²/ Seconds can be delivered. If it is known that 222mJ is needed, 50 280nm LEDs will illuminate 222x (4xπ) / 50 in 55.8 seconds.

56 seconds of irradiation is an acceptable amount of time for the patient when connecting or disconnecting connectors 80 and 90. The relatively small size UV-LED30 and its associated relatively low power requirements make the applicator 20 a small and lightweight package. In addition, the time for irradiation should reduce the increase in LED power output. For example, LED output has increased 5 to 10 times over the last five years.

It will be appreciated that various changes and modifications to the currently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the subject and without diminishing its intended benefits. Therefore, changes and amendments are intended to be covered by the appended claims.