This disclosure relates to peritoneal dialysis therapy validation.
Peritoneal dialysis is a treatment for kidney failure that involves filling a patient's peritoneal cavity with a dialysis solution that aids in removing waste products from the body and later draining that solution. The filling and draining is handled by a device known as a cycler, such as the Newton™ IQ and the forthcoming Liberty™ Cycler from Fresenius Medical Care N.A. and the HomeChoice™ from Baxter Healthcare. Four types of peritoneal dialysis are discussed in this disclosure: continuous cycling peritoneal dialysis, intermittent peritoneal dialysis, PD plus, and tidal peritoneal dialysis.
Continuous cycling peritoneal dialysis (CCPD) is a continuous therapy. CCPD is the most common cycling therapy prescribed. With CCPD, the patient has dialysis solution in peritoneum at all times but the exchanges are done only at night by the cycler. Several exchanges are done during sleep. The last thing that the cycler will do is fill for the day. When reconnecting to the cycler, the dialysate that has been dwelling in the patient during the day first has to be drained.
Intermittent peritoneal dialysis (IPD), as its name suggests, is an interrupted or intermittent therapy. With IPD, the patient will receive exchanges every night from the cycler while sleeping, but will not have any dialysis solution in peritoneum during the day.
PD plus therapy (PD+) is a continuous therapy in which one or more exchanges are received during the day from the cycler, in addition to the nighttime exchanges. These daytime exchanges are called pause exchanges. With PD plus therapy, the patient carries dialysis solution in peritoneum during the day. This allows for continuous waste product and fluid removal.
Tidal peritoneal dialysis (Tidal) differs from other dialysis therapies in the way that dialysis solution is delivered during the nighttime. With Tidal the patient is filled with a prescribed amount of solution, then only a portion is drained and refilled with each exchange. Depending on the prescription, the treatment may end with a fill or a drain.
In general, in one aspect, parameter values are set in a peritoneal dialysis device by receiving from a user a selection of a therapy type, a value for an input parameter is received from the user, and a value is set for a number of fills parameter or a dwell time parameter based on the value received from the user.
Implementation may include one or more of the following features. Setting a value for the number of fills or dwell time parameter includes calculating a value for the number of fills or dwell time, and assigning the calculated value to the parameter. Setting a value for the number of fills or dwell time parameter includes calculating an updated value for the number of fills or dwell time, determining that the updated value does not meet a criterion, and assigning a value to a third parameter. Calculating an updated value for the number of fills or dwell time based on the value assigned to the third parameter, and assigning the updated value to the number of fills or dwell time parameter. The criterion is that the updated value is within a pre-set range. The criterion is that the updated value has a specified relationship to a fourth parameter. Communicating the value set for the number of fills or dwell time parameter to the user, and communicating to the user a relationship between the value received from the user and the value set for the number of fills or dwell time parameter.
In general, in one aspect, parameter values are set in a peritoneal dialysis device by receiving from a user a selection of a therapy type, receiving from a user values for a plurality of parameters, calculating a value for a plurality of additional parameters based on the values received from the user, the plurality of additional parameters comprising a number of fills parameter or a dwell time parameter, determining that values for one or more of the plurality of parameters or one or more of the additional parameters do not meet one or more criteria, and updating one or more of the values received from the user so that all of the values for the plurality of parameters and the additional parameters meet all the criteria.
In general, in one aspect, parameter values are set in a peritoneal dialysis device by displaying on a graphical interface a plurality of parameters and any values currently assigned to the parameters, in response to a user selecting one of the displayed parameters, allowing the user to input a value to be assigned to the parameter, calculating updated values for one or more parameters based on the value input by the user and assigning the updated values to the corresponding parameters, determining whether values assigned to one or more of the parameters meet one or more criteria, and, if the values do not meet the criteria, calculating one or more also updated values for other parameter values that will cause a value that does not meet a criterion to meet the criterion and assigning the also updated values to the corresponding parameters.
In general, in one aspect, parameter values are set in a peritoneal dialysis device by receiving an instruction from a user to change a value of a parameter to a new value, determining whether the new value is greater than a maximum value for the parameter, if the new value is greater than the maximum value, rejecting the new value, if the new value is less than the maximum value, determining whether the new value is less than a minimum value for the parameter, and if the new value is less than the minimum value, rejecting the new value.
Implementations may include, calculating an updated value for a second parameter based on the new value if the new value is greater than the minimum value, calculating a total fill volume, determining whether the total fill volume is greater than a total treatment volume, if the total fill volume is greater than the total treatment volume, rejecting the new value, and if the total fill volume is less than the total treatment volume, changing the value of the parameter to the new value.
In general, in some aspects, a peritoneal dialysis device displays on a graphical interface a plurality of parameters and any values currently assigned to the parameters, and in response to a user selecting one of the displayed parameters, allows the user to input a value to be assigned to one of the parameters. The device calculates updated values for one or more additional parameters based on the value input by the user and assigns the updated values to the corresponding parameters, determines whether values assigned to one or more of the additional parameters meet one or more criteria, and if the values do not meet the criteria, calculates one or more further updated values for other parameter values that will cause a value that does not meet a criterion to meet the criterion and assign the further updated values to the corresponding parameters
Implementations may include one or more of the following features. The device displays the updated values on the graphical interface. The device determines that values assigned to one or more of the additional parameters do not meet one or more criteria, and informs the user that the input value is rejected. The device performs peritoneal dialysis fills and drains based on the values assigned to the parameters. The device determines that the value input by the user does not meet one or more criteria, and informs the user that the input value is rejected. The graphical interface is part of the peritoneal dialysis device. The graphical interface includes a touch-sensitive display screen.
Other features and advantages of the invention will be apparent from the description and the claims.
In current dialysis machines, the therapies are not customized to the specific dialysis type, e.g., CCPD, IPD, PD+, or Tidal. The user creates a therapy scenario himself based on values he chooses for such parameters as the total volume of solution to use, how much to use per fill, or how many pauses to have. Setting large numbers of parameters and keeping track of their interdependencies can be overwhelming. Some of this difficulty can be overcome by providing a user interface that enables a user to select from one of the pre-defined therapy types and then customize it to his prescription, with the system updating dependent and interdependent values as the user changes the ones under his control.
The following description relates to a prototype of the Liberty™ Cycler shown in more detail in U.S. patent application Ser. No. 11/515,359 filed Aug. 31, 2006, entitled “Improved Cassette System for Peritoneal Dialysis Machine,” which is incorporated here by reference in its entirety. Such a cycler is shown in
The cycler 10 is controlled by a computer 30, as shown in
In some examples, as shown in
When the user chooses the type of therapy, a screen,
When a user changes the value of any one parameter, the other parameters that are affected by it can be seen instantly. All the parameter values on the screen are updated “on the fly.” A comprehensive algorithm can be used to calculate the values as discussed below. This algorithm can be executed in software programmed in the cycler's memory. Validations can be used to make sure that none of the values are out of range and that all the dependencies are satisfied. For example, when the fill volume 122c is changed, the number of fills 124a and the dwell time 124b update automatically according to the calculations. Validation makes sure that, for example, the last fill volume 122d is <=150% of fill volume 122c in treatments that have a fill volume setting. When fill volume 122c is decreased to a value that violates this condition, last fill volume 122d also decreases automatically to ensure that it is always <=150% of fill volume 122c. In the user interface, when the value of a parameter goes out of range, it can be locked so that the user cannot exceed the limits. For example, the minimum value for total volume 122a may be 50 ml. If a user tries to decrease it below 50 ml, then the value locks at 50 ml and allows the user only to increase it and not decrease it. In another example, a check is made to ensure that there is enough sleep time 122b for the treatment. If the total sleep time 122b is not long enough, then the total therapy volume 122a is locked and cannot be increased unless the total therapy time is increased. This may include locking other settings that would increase total volume 122a, for example, fill volume 122c. Alternatively, if a user decreases the total sleep time 122b, the system could automatically reduce the fill volume 122c and total volume 122a to accommodate the new sleep time.
This “on the fly” updating gives the user a clear idea of how each parameter value reflects on the others. The user may not be aware of the dependencies but he can still be confident that he is not entering any bad values.
In some examples, parameters for CCPD, IPD, and PD+ are calculated using the process 200 shown in
Next, in step 214, the remaining volume is divided by the fill volume 216, and the quotient is added to the number of pauses (if any) to determine the number of fills 217. In step 218, the fill volume 216 is divided by the fill rate and drain rate, read from a stored setting 220, to compute the fill time and drain time respectively. If there are no pauses (222), then the pause fill time and drain time are set (224) to zero, otherwise they are computed (226) by dividing the pause volume 212 by the fill rate and drain rate accordingly. Process 200 continues in
If there is no last fill (230) (i.e., the treatment is IPD), the number of dwells is the number of fills minus the number of pauses (232), the number if drains is one more than the number of fills (234), the last fill Boolean is zero (false) (236), and the last fill and first drain times are zero (238, 240). If there is a last fill (230) (i.e., the treatment is CCPD or PD+), the previously calculated number of fills 217 is incremented (242), the number of dwells is set to one less than the number of fills minus the number of pauses (244), the number of drains is set to equal the number or fills (246), the “last fill” Boolean is one (true) (248), and the last fill and first drain times are equal to the last fill volume divided by the fill rate and drain rate, respectively (250, 252).
The time needed for each of the fills and drains is subtracted (256) from the total sleep time 254, to find the total dwell time, which is divided (258) by the number of dwells to find and output the dwell time 260.
A similar process 300, as shown in
The remaining calculations are the same as in process 200, with the exception of the calculation 256b of total dwell time (
Example parameter calculations for each of the therapy types are described below.
An example tidal treatment is shown in
In addition to calculating the number of fills and the dwell time, the system is able to evaluate the validity of each of the input parameters whenever one of them is changed, as mentioned above. A validation table 500 in
In the example shown, the last fill volume 508 depends on the fill volume 506 according to rule 11 in table 500, that is, last fill volume 508 must be less than 150% of fill volume 506. Similarly, the pause volume 510 must be less than 150% of fill volume 506 according to rule 12. Pause volume is also validated against the number of pauses 512, as pause volume can only have non-zero values when the number of pauses 512 is also non-zero. The number of pauses 512 in turn is validated against the number of fills 520, as its maximum value is one less than the number of fills 520 according to rule 10. The total volume 504 must be less than the total fill volume 524 per rule 13. The total fill volume 524 is not used in the process 200, but is used to validate the total volume input. It is calculated from the fill volume 506, last fill volume 508, pause volume 510, and number of pauses 512 and fills 520 according to rules 13a, b, and c, depending on whether last fill or pauses are enabled (i.e., last fill volume>0 or number of pauses>0). The dwell time 514 depends on the fill time 516 and number of dwells 522 according to rule 2. Each of the parameters in
Applying these tables 500 and 550 to the example tidal therapy calculation above, the total sleep time, total volume, last fill volume, pause volume, and number of fills are all within the fixed numeric ranges of rules 1, 5, 7, 8, and 9. The dwell time is greater than the fill time per rule 2. As for the tidal-specific parameters, the first fill volume, tidal fill volume, tidal drain volume, and number of pauses are all within the ranges of tidal rules 1-4. (The number of pauses also meets the general rule 10 in table 500 as it is zero.) The total volume meets tidal rule 5-a, having a last fill but no pauses, as the total fill volume is 3×900+1000+500=3300 ml, and this is less than the total volume of 5000 ml.
In some examples, a process shown in
If the new value is between the minimum and maximum values, then the process 600 calculates 612 all the other parameters based on that new value, using the process 200 (
Other implementations are within the scope of the following claims and other claims to which the applicant may be entitled.