Patent Grant
12161787
The present invention relates to the preparation of dialysis fluid for hemodialysis and related therapies and substitution fluid for use in online therapies, such as hemodiafiltration and hemofiltration. In particular, the present invention relates to a method for heat sanitization of a liquid used in one of the above processes.
It is known to use heat to destroy microorganisms. During a thermal destruction process, the rate of destruction of microorganisms is logarithmic, as is the rate of growth of the microorganisms. Thus bacteria subjected to heat are killed at a rate that is proportional to the number of organisms present. The process is dependent both on the temperature of exposure and the time required at this temperature to accomplish to desired rate of destruction.
Thermal calculations thus involve the need for knowledge of the concentration of organisms to be destroyed, the acceptable concentration of organisms that can remain behind (spoilage organisms, for example, but not pathogens), the thermal resistance of the target organisms (the most heat tolerant ones), and the time-temperature relationship required for destruction of the target organisms.
Disinfection of many water based systems in medical devices is frequently achieved by elevating the temperature for a stipulated period of time, thereby using heat to destroy the microorganism in the water. In dialysis it is common for a combination of 80 degrees Celsius (° C.) to be maintained for 30 minutes.
There are several well-established time-temperature relationships for moist heat disinfection which are regarded as equally acceptable. For moist heat disinfection a particular time at a particular temperature can be expected to have a predictable lethal effect against a standardised population of organisms. It is therefore possible to define a standard exposure which will yield a disinfected product in a correctly operated Washer Disinfector (WD). Actual exposures can then be related to these standard exposure conditions.
Definition of such disinfection processes may be achieved by means of the A0 method which uses a knowledge of the lethality of the particular process at different temperatures to assess the overall lethality of the cycle and express this as the equivalent exposure time at a specified temperature.
The A value is a measure of the heat resistance of a microorganism.
A is defined as the equivalent time in seconds at 80° C. to give a disinfection effect.
The z value indicates the temperature sensitivity of the reaction. It is defined as the change in temperature required to change the A value by a factor of 10.
When the z value is 10° C., the term A0 is used.
The A0 value of moist heat disinfection process is the equivalent time in seconds at a temperature of 80° C. delivered by that process to the product with reference to microorganisms possessing a z value of 10° C.
Where:
A0 is the A value when z is 10° C.;
t is the chosen time interval, in seconds;
and T is the temperature in the load in ° C.
In calculating A0 values a temperature threshold for the integration is set at 65° C. since for temperatures below 65° C. the z and D value of thermophillic organisms may change dramatically and below 55° C. there are a number or organisms which will actively replicate.
In dialysis current practice, raising the temperature to 80° C. for 30 minutes gives a benchmark value A0 equal to 1800.
The present invention aims to provide an efficient method of heat sanitization of a haemodialysis water circuit.
According to the first aspect of the present invention, there is provided a method of sanitizing liquid for use in a medical device, comprising the steps of sensing the temperature of a volume of liquid with a sensor; heating the volume of liquid from an initial temperature to exceed a threshold temperature; maintaining the volume of liquid above the threshold temperature; determining a time-temperature value for the volume of liquid periodically once the threshold temperature has been exceeded; calculating a cumulative time-temperature value; and providing an output signal once the cumulative time-temperature value has reached a level indicative of a sanitizing dose.
Calculation of the time-temperature value for the volume of liquid based on the cumulative effect of heating the water provides a more accurate model of the sanitization process by ensuring a fixed dose of heat sanitization is applied to the volume of liquid. Furthermore, it maximises the benefits of high temperatures (in particular those above 80° C.) thereby reducing the time for which components are exposed to elevated temperatures. Natural variation in the control loop and water recirculation will cause natural temperature oscillations. Those time periods below 80° C. but above the minimum temperature range are integrated into the dose and those above are not leveraged according to the power law relationship.
The cumulative time-temperature value may be calculated by a processor. Alternatively, the cumulative time-temperature value may be calculated from a lookup table.
The method may comprise the further step of setting a target cumulative time-temperature value and providing the output signal once the target cumulative time-temperature value is reached.
The output signal may be in the form of an audible or visual alarm. This informs the user or operator that the sanitization process is complete.
The output signal may automatically cause termination of the liquid heating. This prevents the heat sanitization cycle from running for longer than is necessary.
The method may comprises the further step of maintaining the volume of liquid below an upper temperature. This may be to prevent boiling of the sanitizing liquid, or prevent unnecessary thermal stress on the components of the heat sanitization device.
The method may comprise the further step of setting the threshold temperature. The method may comprise the further step of setting an overall heating time. This allows the process to be tailored according to the environmental conditions (for example room temperature, liquid input temperature) the situational conditions, (for example emergency procedure, routine procedure, clinic timetables) and the patient's needs. Thus the time and/or temperature may be selected without compromising the dose of heat sanitization applied to the volume of liquid.
The threshold temperature may be between 55° C. and 65° C.
The upper temperature may be between 70° C. and 99° C.
Multiple temperature sensors may be used to provide the temperature of the volume of liquid.
In one embodiment, the cumulative time-temperature value may be calculated according to
Where:
A0 is the A value when z is 10° C.;
t is the chosen time interval, in seconds;
and T is the temperature in the load in ° C.
This allows the destruction of organisms at 65° C. to 80° C. to be included in the calculation of the cumulative time-temperature value.
The A0 value may be equal to 1800.
According to a second aspect of the present invention, there is provided a liquid sanitizer comprising a tank containing a volume of liquid; a sensor arranged to sense the temperature of the volume of liquid; a heater arranged to heat the volume of liquid from an initial temperature to exceed a threshold temperature, and maintain the volume of liquid above the threshold temperature; and a processor, wherein the processor is configured to determine a time-temperature value for the volume of liquid periodically once the threshold temperature has been exceeded and calculate a cumulative time-temperature value so as to provide an output signal once a cumulative time-temperature value indicative of a sanitizing dose is reached.
The processor may be programmable to alter at least one of the threshold temperature and the cumulative time-temperature value.
According to a third aspect of the present invention, there is provided a dialyser incorporating the liquid sanitizer according to the second aspect of the present invention.
An embodiment of the present invention will now be described, by way of example only, with reference to the accompanying figures, in which:
Referring to
The machine 10 has a blood pumping portion indicated generally at 9 for pumping patient blood to and from a dialyser (not shown for clarity) in a known manner. The main body 12 has a platen 21 behind which is an engine portion (not shown for clarity). The platen 21 is configured to receive the dummy cartridge 16 within a recessed portion 25.
The engine portion includes a pneumatic pump for providing pressure and vacuum to operate the machine and a controller to control retention of the dummy cartridge 16 within the machine 10 and fluid flow on the dummy cartridge 16 as will be discussed in further detail below.
The door 14 has an outer side including a user interface 2. The door 14 includes an actuator in the form of an airbag (not shown), operable by the engine portion to provide a closure load to close the dummy cartridge 16 onto the platen 21 and to ensure that a continuous seal fully engages the dummy cartridge 16.
The dummy cartridge 16 will now be described in further detail. The dummy cartridge 16 has a chassis defining a door side and a platen side. In use the platen side of the cartridge 16 engages the platen 21 on the main body 12 of the machine 10, and the door side engages an interface plate (not shown) on the door 14 of the machine 10.
The dummy cartridge 16 is formed from an acrylic such as SG-10 which is moulded in two parts (a platen side and a patient side) before being bonded together to form the chassis. Both the platen side and door side are covered in a clear flexible membrane formed from, for example, DEHP-free PVC which is operable by pneumatic pressure applied to the membrane by the pneumatic compressor in the main body via the platen 21. In this way a series of flow paths 17 are formed in the cartridge for carrying sanitizing water.
In use, the engine portion of the machine 10 applies either a positive or negative pressure to the membrane via the platen 21 in order to selectively open and close valves and pumps to pump sanitizing fluid through the dummy cartridge 16, which is described in detail below.
The machine 10 has liquid sanitizer generally designated as 200. The arrows on
With reference to
The liquid sanitizer 200 has a tank 202, a heater 210 and a processor 230. The tank 202 contains, in use, a volume of water 203.
The tank 202 has an inlet 204 and a drain 206. The inlet 204 is connectable to a water source (not shown) and the drain 206 is connectable to a waste pipe (also not shown). The tank 202 also has a feed pipe 220 connectable to the dummy cartridge 16 via the platen 21 and a return pipe 224, also connectable to the dummy cartridge 16 via the platen 21. Referring back to
The heater 210 has a heating element 212 arranged to heat the volume of water 203 contained within the tank 202, in this case by immersion in the volume of water 203 in the tank 202. The heater 210 is electronically connected to processor 230 by heater connector 211.
Temperature sensors are arranged on the sanitizing water circuit. A driver temperature sensor 222 is arranged on the feed pipe 220 adjacent the water tank 202. A return temperature sensor 226 is arranged on the return pipe 224 adjacent the water tank 202. A check temperature sensor 228 is arranged on the return pipe adjacent, but offset from, the return temperature sensor 226. All three temperature sensors are electronically connected to the processor 230 via sensor connectors. Driver temperature sensor 222 is electronically connected to processor 230 by sensor connector 223. Return temperature sensor 226 is electronically connected to processor 230 by sensor connector 227. Check temperature sensor 228 is electronically connected to processor 230 by sensor connector 229.
The electronic connectors 211, 223, 228, 229 may be wired or wireless. The processor 203 may be remote to both the tank 202 and heater 210.
The processor 230 thereby controls both the heating of the water and receives the temperature values for the sanitizing water circuit.
In use, the tank 202 of liquid sanitizer 200 is filled with the desired quantity of water via inlet 204. This would typically be 500 ml, which is the amount sufficient to flush out the water circuit of a kidney dialyser.
The liquid sanitizer is then turned on. The processor 230 activates the heater 210 to heat the volume of water via the heating element 221 and the pump draws the water around the sanitizing water circuit. The temperature of the water exiting the tank 202 via feed pipe 220 is periodically sensed by drive temperature sensor 222, and the temperature data is periodically sent to processor 230 via sensor connector 223. The temperature of the water returning to the tank 202 via return pipe 224 is periodically sensed by return temperature sensor 226, and the temperature data is periodically sent to processor 230 via sensor connector 227. The processor 230 therefore periodically receives sensed temperature data to provide a feedback loop to moderate the heating of the volume of water 203 to maintain the temperature of the volume of water 203 above a threshold temperature.
When the processor 230 receives data from the sensor 220 that the volume of water 203 has exceeded the threshold temperature, the processor 230 periodically samples the temperature of the volume of water via the return temperature sensor 226, which theoretically represents the lowest possible temperature of the water on the sanitizing water circuit.
The value is checked by periodically sampling the temperature of the volume of water via the check temperature sensor 228.
The sampling is performed periodically at, for example, 1 second intervals. The sampling intervals may be varied as appropriate.
Each sampled temperature represents a time-temperature value, which can be calculated by the processor 230, or alternatively generated by a look-up table.
The processor 230 calculates a cumulative time-temperature value for the volume of liquid 20 by summing the sampled time-temperature values. This is compared to a target total time-temperature value indicative of a sanitizing dose.
Once the calculated cumulative time-temperature value and the target cumulative time-temperature value are equal, the processor 230 sends an output signal to indicate that a sanitizing dose has been reached. The output signal is received by the heater and automatically switches off the heater 210.
In an alternate embodiment, the processor 230 may switch off the water heater 210 in advance of a sanitizing dose being reached, by calculating that there is sufficient thermal energy contained within the water circuit that the water temperature will remain above the threshold temperature for long enough to ensure a sanitizing dose is reached. In that case, periodic sampling would be continued, such that the processor 230 is able to send the output signal to indicate that a sanitizing dose had indeed been reached.
The output signal is received by the LCD display unit, which displays the text “COMPLETE” in reference to the completed sanitizing dose. In alternate embodiments, the LCD display unit includes an audible alarm. The audible alarm can be configured to bleep repeatedly until the sanitizer is turned off.
With reference to
The water already contained within the tank is at room temperature 301 (18° C.) initially. As cool fresh water is added from a tap to ensure the correct quantity of water is provided in the tank (wherein the cool fresh water is typically 8° C.), the overall temperature of the liquid will drop slightly 302.
The water temperature then rises substantially linearly towards the target temperature of 80° C. 305, which is reached at about 60 seconds. There is a slight oscillation 304 of about one and a half wavelengths where the water temperature exceeds and passes below 80° C. (to approximately 85° C. and 75° C. respectively) as the water heater finds the correct balance to maintain a constant water temperature of 80° C. After approximately 30 minutes at 80° C. the water heater is switched off 307 and the water temperature steadily decreases to room temperature (18° C.) 301.
With reference to
Similar notable points on the temperature profile are given similar reference numerals as that for
The initial drop in temperature 402 from room temperature 401 (18° C.) and subsequent heating of the water occurs following a similar time-temperature profile to that shown in
However, when the temperature of the water exceeds the threshold temperature. 65° C. 403, the liquid sanitizer begins to record a time-temperature value.
Furthermore, when the target temperature 80° C. 405 is reached, the water temperature is continually raised 406 such that a greater time-temperature value contribution can be achieved with each sample.
The heater is switched off 407 after less than 8 minutes as there is sufficient thermal energy within the water to ensure that a complete sanitizing dose is achieved before the temperature of the water falls below the threshold temperature of 65° C. 403.
The overall cycle time for the sanitizing dose is slightly more than 8 minutes. This compares to the overall cycle time for a sanitizing dose according to the temperature profile of
An exemplary Lookup Table may include the following values for 1 second sampled increments:
Thus it can be seen that for each 1° C. increase in water temperatures above 80° C., the time-temperature contribution is significantly increased. Three seconds at 85° C. is equivalent to over 10 seconds at 80° C.
In
In chart 510, the 10, one second samples are taken after approximately 50 seconds. During the 10 seconds, the water temperature increases from 64 to 67° C. This is shown by the line graph corresponding to the water temperature Y-axis on the left hand side of the chart. The time temperature contribution at these temperatures is represented by the bars, corresponding to the time temperature Y-axis on the right hand side of the chart.
No contribution is made when the water temperature is 64° C. A relatively small contribution to the time temperature value is made when the water temperature is 65 to 67° C. This corresponds to the flat region of the main graph. Summing the values for the bars indicates that the total contribution of the 10, one second intervals is 0.296. Although these contributions are small, they are counted and do contribute to shorten the time required for sanitisation. In the prior art, no credit is given for this heating phase.
In chart 520, the 10, one second samples are taken after approximately 140 seconds. During the 10 seconds, the water temperature increases from 79 to 82° C. This is shown by the line graph corresponding to the water temperature Y-axis on the left hand side of the chart. The time temperature contribution at these temperatures is represented by the bars, corresponding to the time temperature Y-axis on the right hand side of the chart. Note the difference in scale of the time temperature Y-axis of chart 520 to chart 510.
Increasing contributions to the time temperature value are made as the water temperature increases from 79 to 82° C. This corresponds to the steadily increasing region of the main graph. Summing the values for the bars indicates that the total contribution of the 10, one second intervals is 12.056.
In chart 530, the 10, one second samples are taken after approximately 420 seconds. During the 10 seconds, the water temperature increases from 83 to 86° C. This is shown by the line graph corresponding to the water temperature Y-axis on the left hand side of the chart. The time temperature contribution at these temperatures is represented by the bars, corresponding to the time temperature Y-axis on the right hand side of the chart. Note the difference in scale of the time temperature Y-axis of chart 530 to charts 510 and 520.
Greatly increasing contributions to the time temperature value are made as the water temperature increases from 83 to 86° C. This corresponds to the steep region of the main graph. Summing the values for the bars indicates that the total contribution of the 10, one second intervals is 30.282. Counting the actual contribution to sanitisation for the periods above 80° C. rather than treating these as the same as 80° C. considerably shortens the required time.
The charts are exemplary in nature only, and different time, temperature and associated time-temperature values are possible, and indeed envisaged.
One second intervals have been chosen as a reasonable sampling rate. The sampling interval could be longer or shorter. A longer sampling interval would preferably be associated with a steady temperature profile, whilst a shorter temperature cycle would preferably be associated with greater processing power.
In alternate embodiments of the liquid sanitizer, the processor may be programmable. Therefore the threshold temperature may be set manually. For example the threshold temperature may be set to a temperature between 55° C. and 65° C. The overall heating time may be set manually. For example, the heating time may be set to 8, 9 or 10 minutes. In this case the processor 230 calculates the necessary temperature profile over the heating time to ensure the volume of water receives a sanitizing dose.
| Number | Date | Country | Kind |
|---|---|---|---|
| 1409796 | Jun 2014 | GB | national |
The present application is a continuation of U.S. application Ser. No. 16/752,507, filed 24 Jan. 2020, which is a continuation of U.S. application Ser. No. 15/315,114, filed 30 Nov. 2016 (Now U.S. Pat. No. 10,543,305), which is a submission under 35 USC § 371 of international application no. PCT/GB2015/051610, filed 2 Jun. 2015 and published in the English language with publication number WO 2015/185920 A1 on 10 Dec. 2015, which claims the benefit of the filing date of GB 1409796.8, filed 2 Jun. 2014; each of the aforementioned applications is expressly incorporated herein by reference in its entirety.
| Number | Name | Date | Kind |
|---|---|---|---|
| 2696173 | Thormod et al. | Dec 1954 | A |
| 3338171 | Conklin et al. | Aug 1967 | A |
| 3468261 | Schmierer et al. | Sep 1969 | A |
| 3605566 | Vetter et al. | Sep 1971 | A |
| 3606592 | Madurski et al. | Sep 1971 | A |
| 3753493 | Mellor | Aug 1973 | A |
| 3774762 | Lichtenstein | Nov 1973 | A |
| 3807906 | Breit | Apr 1974 | A |
| 3921622 | Cole | Nov 1975 | A |
| 3972320 | Kalman | Aug 1976 | A |
| 4070725 | Austin et al. | Jan 1978 | A |
| 4142845 | Lepp et al. | Mar 1979 | A |
| 4161264 | Malmgren et al. | Jul 1979 | A |
| 4205686 | Harris et al. | Jun 1980 | A |
| 4353990 | Manske et al. | Oct 1982 | A |
| 4366061 | Papanek et al. | Dec 1982 | A |
| 4368261 | Klose et al. | Jan 1983 | A |
| 4370983 | Lichtenstein | Feb 1983 | A |
| 4430048 | Fritsch | Feb 1984 | A |
| 4494912 | Pauliukonis | Jan 1985 | A |
| D277991 | Becker | Mar 1985 | S |
| 4534755 | Calvert et al. | Aug 1985 | A |
| 4534756 | Nelson | Aug 1985 | A |
| 4546669 | Fischer et al. | Oct 1985 | A |
| 4564342 | Weber et al. | Jan 1986 | A |
| 4599165 | Chevallet | Jul 1986 | A |
| 4648869 | Bobo, Jr. | Mar 1987 | A |
| 4666598 | Heath et al. | May 1987 | A |
| 4710163 | Butterfield | Dec 1987 | A |
| 4771792 | Seale | Sep 1988 | A |
| 4828543 | Weiss et al. | May 1989 | A |
| 4897184 | Shouldice et al. | Jan 1990 | A |
| D308249 | Buckley | May 1990 | S |
| 4969991 | Valadez | Nov 1990 | A |
| 5000664 | Lawless et al. | Mar 1991 | A |
| 5012197 | Seiffert et al. | Apr 1991 | A |
| 5032265 | Jha et al. | Jul 1991 | A |
| 5055198 | Shettigar | Oct 1991 | A |
| 5095910 | Powers | Mar 1992 | A |
| 5103211 | Daoud et al. | Apr 1992 | A |
| 5126831 | Nakagawara | Jun 1992 | A |
| 5232434 | Inagaki et al. | Aug 1993 | A |
| 5252213 | Ahmad et al. | Oct 1993 | A |
| D341890 | Sievert et al. | Nov 1993 | S |
| D344339 | Yoshikawa et al. | Feb 1994 | S |
| 5304349 | Polaschegg | Apr 1994 | A |
| D347896 | Dickinson et al. | Jun 1994 | S |
| D351470 | Scherer et al. | Oct 1994 | S |
| 5385540 | Abbott et al. | Jan 1995 | A |
| 5421823 | Kamen et al. | Jun 1995 | A |
| 5458468 | Ye et al. | Oct 1995 | A |
| 5476368 | Rabenau et al. | Dec 1995 | A |
| 5476792 | Ezrielev et al. | Dec 1995 | A |
| D370979 | Pascale et al. | Jun 1996 | S |
| 5558347 | Nicholson | Sep 1996 | A |
| 5586872 | Skobelev et al. | Dec 1996 | A |
| 5586873 | Novak et al. | Dec 1996 | A |
| 5591344 | Kenley et al. | Jan 1997 | A |
| 5643201 | Peabody et al. | Jul 1997 | A |
| 5650071 | Brugger et al. | Jul 1997 | A |
| 5653456 | Mough | Aug 1997 | A |
| 5658456 | Kenley et al. | Aug 1997 | A |
| 5665307 | Kirschner et al. | Sep 1997 | A |
| 5727550 | Montecalvo | Mar 1998 | A |
| D395085 | Kenley et al. | Jun 1998 | S |
| 5788851 | Kenley et al. | Aug 1998 | A |
| 5807322 | Lindsey et al. | Sep 1998 | A |
| 5882300 | Malinouskas et al. | Mar 1999 | A |
| 5948247 | Gillerfalk et al. | Sep 1999 | A |
| 5957670 | Duncan et al. | Sep 1999 | A |
| 5995910 | Discenzo | Nov 1999 | A |
| 6077443 | Goldau | Jun 2000 | A |
| 6126831 | Goldau et al. | Oct 2000 | A |
| 6132378 | Marino | Oct 2000 | A |
| 6143181 | Falkvall et al. | Nov 2000 | A |
| 6153102 | Kenley et al. | Nov 2000 | A |
| 6216029 | Paltieli | Apr 2001 | B1 |
| 6218329 | Singh et al. | Apr 2001 | B1 |
| 6251279 | Peterson et al. | Jun 2001 | B1 |
| 6261065 | Nayak et al. | Jul 2001 | B1 |
| 6303036 | Collins et al. | Oct 2001 | B1 |
| 6382923 | Gray | May 2002 | B1 |
| 6514462 | Simons | Feb 2003 | B1 |
| 6517239 | Roth | Feb 2003 | B1 |
| 6558347 | Jhuboo et al. | May 2003 | B1 |
| 6582206 | Schluecker | Jun 2003 | B2 |
| 6626832 | Paltieli et al. | Sep 2003 | B1 |
| 6626878 | Leisner et al. | Sep 2003 | B1 |
| 6645176 | Christenson et al. | Nov 2003 | B1 |
| 6663829 | Kjellstrand | Dec 2003 | B1 |
| 6733476 | Christenson et al. | May 2004 | B2 |
| 6743204 | Christenson et al. | Jun 2004 | B2 |
| 6801646 | Pena et al. | Oct 2004 | B1 |
| 6814547 | Childers et al. | Nov 2004 | B2 |
| 6967002 | Edgson et al. | Nov 2005 | B1 |
| 7040142 | Burbank | May 2006 | B2 |
| 7107837 | Lauman et al. | Sep 2006 | B2 |
| 7153286 | Busby et al. | Dec 2006 | B2 |
| 7220358 | Schacht et al. | May 2007 | B2 |
| 7284964 | McDowell et al. | Oct 2007 | B2 |
| 7383721 | Parsons et al. | Jun 2008 | B2 |
| 7434312 | Christenson et al. | Oct 2008 | B2 |
| 7494590 | Felding et al. | Feb 2009 | B2 |
| 7604398 | Akers et al. | Oct 2009 | B1 |
| 7648627 | Beden et al. | Jan 2010 | B2 |
| 7857976 | Bissler et al. | Dec 2010 | B2 |
| 7874999 | Busby | Jan 2011 | B2 |
| 7896197 | Furey et al. | Mar 2011 | B2 |
| D641882 | Hickey et al. | Jul 2011 | S |
| 8114043 | Muller | Feb 2012 | B2 |
| 8132388 | Nagy et al. | Mar 2012 | B2 |
| 8137184 | Ajiro et al. | Mar 2012 | B2 |
| 8137300 | Han et al. | Mar 2012 | B2 |
| 8167431 | DeCusatis et al. | May 2012 | B2 |
| 8187184 | Muller et al. | May 2012 | B2 |
| 8192388 | Hogard | Jun 2012 | B2 |
| 8197431 | Bennison | Jun 2012 | B2 |
| 8221320 | Bouton | Jul 2012 | B2 |
| 8348850 | Frinak et al. | Jan 2013 | B2 |
| 8360977 | Marttila et al. | Jan 2013 | B2 |
| 8529490 | Wariar et al. | Sep 2013 | B2 |
| 8535522 | Fulkerson et al. | Sep 2013 | B2 |
| 8535525 | Heyes et al. | Sep 2013 | B2 |
| D693469 | Chung et al. | Nov 2013 | S |
| 8597505 | Fulkerson et al. | Dec 2013 | B2 |
| D702842 | Hyde et al. | Apr 2014 | S |
| 8685244 | Heyes et al. | Apr 2014 | B2 |
| 8696571 | Marttila et al. | Apr 2014 | B2 |
| 8708908 | Bouton | Apr 2014 | B2 |
| 8708946 | Han et al. | Apr 2014 | B2 |
| D705432 | Lura et al. | May 2014 | S |
| 8798908 | Bourdeaut | Aug 2014 | B2 |
| 8801646 | Han et al. | Aug 2014 | B2 |
| D714454 | Amemiya et al. | Sep 2014 | S |
| D714946 | Lura et al. | Oct 2014 | S |
| 8926544 | Hogard | Jan 2015 | B2 |
| D724740 | Collins et al. | Mar 2015 | S |
| 8974394 | Frinak et al. | Mar 2015 | B2 |
| 9011334 | Bouton | Apr 2015 | B2 |
| D735868 | Mareguddi et al. | Aug 2015 | S |
| 9220825 | Buckberry | Dec 2015 | B2 |
| D781410 | Ritter et al. | Mar 2017 | S |
| 9744285 | Heyes et al. | Aug 2017 | B2 |
| 9833553 | Higgitt et al. | Dec 2017 | B2 |
| 10314962 | Buckberry | Jun 2019 | B2 |
| 10456516 | Heyes et al. | Oct 2019 | B2 |
| D867597 | Bauer et al. | Nov 2019 | S |
| 10543305 | Buckberry et al. | Jan 2020 | B2 |
| D879967 | Verguldi et al. | Mar 2020 | S |
| D907211 | Spurling | Jan 2021 | S |
| 10881775 | Wallace | Jan 2021 | B2 |
| 10960120 | Wallace et al. | Mar 2021 | B2 |
| D924410 | Mendoza et al. | Jul 2021 | S |
| D938046 | Gupta et al. | Dec 2021 | S |
| 11365728 | Westenbrink | Jun 2022 | B2 |
| 11571499 | Milad et al. | Feb 2023 | B2 |
| 11583618 | Buckberry et al. | Feb 2023 | B2 |
| 20030217962 | Childers et al. | Nov 2003 | A1 |
| 20040195157 | Mullins et al. | Oct 2004 | A1 |
| 20040206703 | Bosetto et al. | Oct 2004 | A1 |
| 20040215129 | Edgson et al. | Oct 2004 | A1 |
| 20040223857 | Kline et al. | Nov 2004 | A1 |
| 20050020961 | Burbank et al. | Jan 2005 | A1 |
| 20050205476 | Chevallet et al. | Sep 2005 | A1 |
| 20050209547 | Burbank et al. | Sep 2005 | A1 |
| 20050234384 | Westberg et al. | Oct 2005 | A1 |
| 20060121623 | He et al. | Jun 2006 | A1 |
| 20070083193 | Werneth et al. | Apr 2007 | A1 |
| 20080006089 | Adnan et al. | Jan 2008 | A1 |
| 20080200865 | Bedingfield | Aug 2008 | A1 |
| 20080283096 | Scheringer et al. | Nov 2008 | A1 |
| 20090007642 | Busby et al. | Jan 2009 | A1 |
| 20090009290 | Kneip et al. | Jan 2009 | A1 |
| 20090012450 | Shah et al. | Jan 2009 | A1 |
| 20090012452 | Slepicka et al. | Jan 2009 | A1 |
| 20090012457 | Childers et al. | Jan 2009 | A1 |
| 20090101550 | Muller et al. | Apr 2009 | A1 |
| 20090211975 | Brugger et al. | Aug 2009 | A1 |
| 20090230043 | Heyes et al. | Sep 2009 | A1 |
| 20100043694 | Patel | Feb 2010 | A1 |
| 20100045471 | Meyers | Feb 2010 | A1 |
| 20100089807 | Heyes et al. | Apr 2010 | A1 |
| 20100139254 | Sebestyen et al. | Jun 2010 | A1 |
| 20100263687 | Braun et al. | Oct 2010 | A1 |
| 20110009797 | Kelly et al. | Jan 2011 | A1 |
| 20110034850 | Jonsson | Feb 2011 | A1 |
| 20110132838 | Curtis et al. | Jun 2011 | A1 |
| 20110168614 | Pouchoulin et al. | Jul 2011 | A1 |
| 20120164022 | Muginstein et al. | Jun 2012 | A1 |
| 20120269907 | Coates | Oct 2012 | A1 |
| 20120276549 | Cunningham et al. | Nov 2012 | A1 |
| 20120292237 | Heyes et al. | Nov 2012 | A1 |
| 20120308431 | Kotsos et al. | Dec 2012 | A1 |
| 20130037465 | Heyes et al. | Feb 2013 | A1 |
| 20130056419 | Curtis | Mar 2013 | A1 |
| 20130153495 | Kelly et al. | Jun 2013 | A1 |
| 20130199998 | Kelly et al. | Aug 2013 | A1 |
| 20130274642 | Soykan et al. | Oct 2013 | A1 |
| 20140224736 | Heide et al. | Aug 2014 | A1 |
| 20140251885 | Heyes | Sep 2014 | A1 |
| 20140271106 | Alessandro et al. | Sep 2014 | A1 |
| 20140299544 | Wilt et al. | Oct 2014 | A1 |
| 20150027951 | Wallace et al. | Jan 2015 | A1 |
| 20150076053 | Higgitt et al. | Mar 2015 | A1 |
| 20150112119 | Buckberry | Apr 2015 | A1 |
| 20150129481 | Higgitt et al. | May 2015 | A1 |
| 20150238673 | Gerber et al. | Aug 2015 | A1 |
| 20150258263 | Hogard et al. | Sep 2015 | A1 |
| 20150352269 | Gerber et al. | Dec 2015 | A1 |
| 20150359954 | Gerber et al. | Dec 2015 | A1 |
| 20160045656 | Buckberry | Feb 2016 | A1 |
| 20160051743 | Buckberry | Feb 2016 | A1 |
| 20160058933 | Ballantyne et al. | Mar 2016 | A1 |
| 20160076535 | Clifton et al. | Mar 2016 | A1 |
| 20160077644 | Ritter et al. | Mar 2016 | A1 |
| 20170056576 | Doyle et al. | Mar 2017 | A1 |
| 20170167983 | Klomp et al. | Jun 2017 | A1 |
| 20170252498 | Heyes et al. | Sep 2017 | A1 |
| 20170296730 | Soto et al. | Oct 2017 | A1 |
| 20180133391 | Heyes et al. | May 2018 | A1 |
| 20180154059 | Heyes et al. | Jun 2018 | A1 |
| 20180193545 | Crnkovich et al. | Jul 2018 | A1 |
| 20180344915 | Wallace | Dec 2018 | A1 |
| 20190001042 | Buckberry | Jan 2019 | A1 |
| 20190015577 | Garrido et al. | Jan 2019 | A1 |
| 20190024654 | May et al. | Jan 2019 | A1 |
| 20190358381 | Westenbrink | Nov 2019 | A1 |
| 20190374698 | Buckberry et al. | Dec 2019 | A1 |
| 20190376504 | Westenbrink | Dec 2019 | A1 |
| 20190385434 | Yuds et al. | Dec 2019 | A1 |
| 20200030515 | Merchant et al. | Jan 2020 | A1 |
| 20200075159 | Bardorz et al. | Mar 2020 | A1 |
| 20200268958 | Heyes et al. | Aug 2020 | A1 |
| 20200276372 | Milad et al. | Sep 2020 | A1 |
| 20200330671 | Buckberry et al. | Oct 2020 | A1 |
| 20210110920 | Heyes et al. | Apr 2021 | A1 |
| 20220001087 | Heyes et al. | Jan 2022 | A1 |
| 20220160943 | Buckberry et al. | May 2022 | A9 |
| 20220241480 | Fincham | Aug 2022 | A1 |
| 20220241573 | Fincham | Aug 2022 | A1 |
| Number | Date | Country |
|---|---|---|
| 81430 | Aug 1997 | CA |
| 10024447 | Nov 2001 | DE |
| EU0043757640001 | Oct 2017 | EM |
| EU0043757640002 | Oct 2017 | EM |
| EU0079551250002 | Jun 2020 | EM |
| 0165751 | Dec 1985 | EP |
| 0754468 | Jan 1997 | EP |
| 2219703 | Aug 2010 | EP |
| 2955512 | Dec 2015 | EP |
| 2310136 | Dec 1976 | FR |
| 90079551250001 | May 2020 | GB |
| 90079551250002 | May 2020 | GB |
| H04266740 | Sep 1992 | JP |
| H06261872 | Sep 1994 | JP |
| H07174659 | Jul 1995 | JP |
| 2000130334 | May 2000 | JP |
| 1645323 | Nov 2020 | JP |
| WO-8101800 | Jul 1981 | WO |
| WO-9100113 | Jan 1991 | WO |
| WO-9116542 | Oct 1991 | WO |
| WO-9506205 | Mar 1995 | WO |
| WO-9525893 | Sep 1995 | WO |
| WO-9625214 | Aug 1996 | WO |
| WO-9710013 | Mar 1997 | WO |
| WO-9728368 | Aug 1997 | WO |
| WO-9929356 | Jun 1999 | WO |
| WO-0006217 | Feb 2000 | WO |
| WO-0057935 | Oct 2000 | WO |
| WO-02066833 | Aug 2002 | WO |
| WO-02081917 | Oct 2002 | WO |
| WO-03101510 | Dec 2003 | WO |
| WO-2005044339 | May 2005 | WO |
| WO-2005080794 | Sep 2005 | WO |
| WO-2006120415 | Nov 2006 | WO |
| WO-2006120417 | Nov 2006 | WO |
| WO-2008100671 | Aug 2008 | WO |
| WO-2008106191 | Sep 2008 | WO |
| WO-2008135245 | Nov 2008 | WO |
| WO-2009006489 | Jan 2009 | WO |
| WO-2009024333 | Feb 2009 | WO |
| WO-2009038834 | Mar 2009 | WO |
| WO-2009061608 | May 2009 | WO |
| WO-2009127624 | Oct 2009 | WO |
| WO-2010089130 | Aug 2010 | WO |
| WO-2010146343 | Dec 2010 | WO |
| WO-2011027118 | Mar 2011 | WO |
| WO-2011068885 | Jun 2011 | WO |
| WO-2011105697 | Sep 2011 | WO |
| WO-2011105698 | Sep 2011 | WO |
| WO-2013052680 | Apr 2013 | WO |
| WO-2013057109 | Apr 2013 | WO |
| WO-2013110906 | Aug 2013 | WO |
| WO-2013110919 | Aug 2013 | WO |
| WO-2013114063 | Aug 2013 | WO |
| WO-2013121162 | Aug 2013 | WO |
| WO-2013121163 | Aug 2013 | WO |
| WO-2014072195 | May 2014 | WO |
| WO-2014082855 | Jun 2014 | WO |
| WO-2014155121 | Oct 2014 | WO |
| WO-2015007596 | Jan 2015 | WO |
| WO-2015022537 | Feb 2015 | WO |
| WO-2016016870 | Feb 2016 | WO |
| WO-2017137723 | Aug 2017 | WO |
| WO-2018115816 | Jun 2018 | WO |
| Entry |
|---|
| Ergo-Express Motorized Dialysis Cart, Aug. 14, 2017, youtube.com [online], [site visited Jan. 9, 2022], Available from internet, URL: [https://www.youtube.com/watch?v=j4rAXthOmbY] (Year: 2017), 1 page. |
| He et al., “A Fluorescent Sensor with High Selectivity and Sensitivity for Potassium in Water,” Journal of the American Chemical Society 2003 125 (6), 1468-1469. |
| Home Dialysis Tescon Aqua Tech, Aug. 1, 2020, youtube.com [online], [site visited Jan. 9, 2022], Available from internet, URL: [https://www.youtube.com/watch?v=WLLPZoS_mz] (Year: 2020), 1 page. |
| Kivi, Air Embolism, Healthline, Aug. 20, 2012, p. 1-5. |
| LHO2028 Portable Hemodialysis Machine, date unknown, aliexpress.com [online], [site visited Jan. 4, 2022], Available from internet: [https://www.aliexpress.com/item/1005003324875329.html?randl_currency=USD&_randl_shipto=US&src=google&afffcid=1003bab3b8db4e93b9ba88522a14cfc1-1641319351626-05232-UneMJZVf&aff_fsk=UneMJZVf&aff_platform=aaf&sk=UneMJZVf&aff_trace_key=] (Year: 2022), 9 pages. |
| Medical Hemodialysis Machine, date unknown, aliexpress.com [online], [site visited Jan. 4, 2022], Available from internet: [https://www.aliexpress.com/item/1005003445721549.html?_randl_currency=USD&_randl_shipto=US&src=google&aff_fcid=a524f3f9cd9b4976b6b47962f3439d62-1641319166409-02691-UneMJZVf&aff_fsk=UneMJZVf&aff_platform=aaf&sk=UneMJZVf&aff_trace_key=a524f3f9cd9b4976b6b47962f3439d62-1641319166409-02691-UneMJZVf&terminal_id=d0c2cca4b7664d 128cb4801 a9ef03ff2] (Year: 2022), 12 pages. |
| Millenium HX Portable Dialysis Water System, Jul. 2, 2014, youtube.com [online], [site visited Jan. 10, 2022], Available from internet, URL: [https://www.youtube.com/watch?v=IGEbPi2CDsw] (Year: 2014), 1 page. |
| Portable home dialysis device, Nov. 2, 2017, med-technews.com [online], [site visited Jan. 4, 2022], Available from internet: [https://www.med-technews.com/news/portable-home-dialysis-device-to-launch-next-year/] (Year: 2017), 2 pages. |
| Number | Date | Country | |
|---|---|---|---|
| 20230201433 A1 | Jun 2023 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16752507 | Jan 2020 | US |
| Child | 18111529 | US | |
| Parent | 15315114 | US | |
| Child | 16752507 | US |
