Patent Grant
10117985
This disclosure relates to determining a volume of medical fluid pumped into or out of a medical fluid cassette.
Dialysis is a treatment used to support a patient with insufficient renal function. The two principal dialysis methods are hemodialysis and peritoneal dialysis. During hemodialysis (“HD”), the patient's blood is passed through a dialyzer of a dialysis machine while also passing a dialysis solution or dialysate through the dialyzer. A semi-permeable membrane in the dialyzer separates the blood from the dialysate within the dialyzer and allows diffusion and osmosis exchanges to take place between the dialysate and the blood stream. These exchanges across the membrane result in the removal of waste products, including solutes like urea and creatinine, from the blood. These exchanges also regulate the levels of other substances, such as sodium and water, in the blood. In this way, the dialysis machine acts as an artificial kidney for cleansing the blood.
During peritoneal dialysis (“PD”), the patient's peritoneal cavity is periodically infused with dialysate. The membranous lining of the patient's peritoneum acts as a natural semi-permeable membrane that allows diffusion and osmosis exchanges to take place between the solution and the blood stream. These exchanges across the patient's peritoneum result in the removal of waste products, including solutes like urea and creatinine, from the blood, and regulate the levels of other substances, such as sodium and water, in the blood.
Many PD machines are designed to automatically infuse, dwell, and drain dialysate to and from the patient's peritoneal cavity. The treatment typically lasts for several hours, often beginning with an initial drain cycle to empty the peritoneal cavity of used or spent dialysate. The sequence then proceeds through the succession of fill, dwell, and drain phases that follow one after the other. Each phase is called a cycle.
In one aspect, a method includes (a) pumping medical fluid out of or drawing medical fluid into a chamber of a medical fluid cassette, (b) calculating a theoretical volume of fluid pumped out of or drawn into the chamber, and (c) multiplying the theoretical volume of fluid pumped out of or drawn into the chamber by a correction factor to determine a corrected volume of fluid pumped out of or drawn into the chamber.
In another aspect, a medical fluid pumping system includes a medical fluid cassette including a flexible membrane that at least partially defines a pump chamber and a medical fluid pumping machine defining a compartment configured to receive the medical fluid cassette. The medical fluid pumping machine includes a piston that is aligned with the pump chamber of the medical fluid cassette when the medical fluid cassette is disposed within the compartment. The piston is operable to pump medical fluid out of or draw medical fluid into the pump chamber of the medical fluid cassette. The medical fluid pumping machine also includes a control unit that is operable to calculate a theoretical volume of fluid pumped out of or drawn into the pump chamber and that is operable to multiply the theoretical volume of fluid pumped out of or drawn into the pump chamber by a correction factor to determine a corrected volume of fluid pumped out of or drawn into the pump chamber.
Implementations can include one or more of the following features.
In some implementations, the method further includes multiplying the theoretical volume by the correction factor to determine an adjustment volume.
In certain implementations, the adjustment volume is added to the theoretical volume to determine the corrected volume.
In some implementations, the medical fluid cassette includes a flexible membrane that at least partially defines the chamber.
In certain implementations, the medical fluid cassette includes a rigid base that cooperates with the flexible membrane to at least partially form the chamber.
In some implementations, the medical fluid cassette includes a fastening member attached to the flexible membrane. The fastening member defines a recess configured to receive a piston head of a medical fluid pumping machine, and the fastening member has an engagement surface that engages an engagement surface of the piston head when the piston head is disposed in the recess such that, when the piston head is disposed in the recess and is moved linearly away from the base of the cassette, the engagement surface of the piston head is engaged with the engagement surface of the fastening member and pulls the fastening member and the flexible membrane to which the fastening member is attached away from the base to increase a volume of the fluid pump chamber.
In certain implementations, pumping the medical fluid out of the chamber includes driving the membrane of the medical fluid cassette to decrease a volume of the chamber, and drawing the medical fluid into the chamber includes driving the membrane of the medical fluid cassette to increase the volume of the chamber.
In some implementations, the method further includes driving a fastening member that is attached to the membrane. The fastening member is configured to mechanically couple to a piston.
In certain implementations, the membrane is driven by a piston.
In some implementations, the piston includes a piston head attached to a piston shaft.
In certain implementations, the piston head is substantially dome-shaped or mushroom head shaped.
In some implementations, at least a portion of the piston head has an outer diameter that is less than a maximum inner diameter of a recessed region of the rigid base that cooperates with the membrane to form the chamber.
In certain implementations, the method includes pumping medical fluid out of the chamber of the medical fluid cassette by driving a piston against a membrane of the medical fluid cassette to decrease a volume of the chamber, calculating the theoretical volume of fluid pumped out of the chamber, and multiplying the theoretical volume of fluid pumped out of the chamber by the correction factor to determine the corrected volume of fluid pumped out of the chamber.
In some implementations, the method includes drawing medical fluid into the chamber of the medical fluid cassette by retracting a piston to pull a membrane of the medical fluid cassette to increase a volume of the chamber, calculating the theoretical volume of fluid drawn into the chamber, and multiplying the theoretical volume of fluid drawn into the chamber by the correction factor to determine the corrected volume of fluid drawn into the chamber.
In certain implementations, the method includes repeating steps (a)-(c) (listed in the first paragraph of this section) multiple times during the course of a dialysis treatment and summing the determined corrected volumes to determine a total corrected volume of fluid pumped out of or drawn into the chamber over the course of the dialysis treatment.
In some implementations, the dialysis treatment includes pumping dialysate out of the pump chamber and into a peritoneal cavity of a patient multiple times and drawing dialysate out of the peritoneal cavity of the patient and into the pump chamber multiple times, and the method includes carrying out steps (a)-(c) each time the dialysate is pumped out of the pump chamber and into the peritoneal cavity of the patient and each time the dialysate is drawn out of the peritoneal cavity of the patient and into the pump chamber to determine a total volume of dialysate delivered to the peritoneal cavity of the patient and a total volume of dialysate removed from the peritoneal cavity of the patient during the treatment.
In certain implementations, calculating the theoretical volume of fluid pumped out of or drawn into the chamber includes determining a linear displacement of a piston.
In some implementations, determining the linear displacement of the piston includes determining a number of turns of a stepper motor operatively connected to the piston.
In certain implementations, the method further includes measuring a pressure of medical fluid within the medical fluid cassette or within a fluid line connected to the medical fluid cassette.
In some implementations, the method further includes isolating the pump chamber prior to measuring the pressure.
In certain implementations, isolating the pump chamber includes closing valves adjacent first and second ports of the pump chamber.
In some implementations, the pressure is measured a period of time (e.g., 0.5 seconds) after isolating the pump chamber.
In certain implementations, the pump chamber is isolated and the pressure is measured after drawing medical fluid into the pump chamber.
In some implementations, the pump chamber is isolated and the pressure is measured after pumping medical fluid out of the pump chamber.
In certain implementations, the method further includes selecting the correction factor based on the measured pressure.
In some implementations, the coefficient factor varies as a function of measured pressure for measured pressures between a first pressure value and a second pressure value, and the first pressure value is less than the second pressure value.
In certain implementations, when the measured pressure is between the first and second pressure values, the coefficient factor is determined using the following equation:
((measured pressure−30)*2/5)/10.
In some implementations, when the measured pressure is between the first and second pressure values, the coefficient factor is determined using the following equation:
(15−(measured pressure+40)*15/80)/10.
In certain implementations, the coefficient factor is a first constant for all measured pressures that are less than or equal to the first pressure value and the coefficient factor is a second constant for all measured pressures that are greater than or equal to the second pressure value.
In some implementations, the first constant is 0 and the second constant is 0.02.
In certain implementations, the first pressure value is 30 mbar and the second pressure value is 80 mbar.
In some implementations, the first constant is 0.015 and the second constant is 0.
In certain implementations, the first pressure value is −40 mbar and the second pressure value is 40 mbar.
In some implementations, the coefficient factor has a first value if the measured pressure is less than or equal to a first pressure value and the coefficient factor has a second value if the measured pressure is greater than or equal to a second pressure value.
In certain implementations, the coefficient factor has a third value if the measured pressure is greater than the first pressure value and less than the second pressure value.
In some implementations, the coefficient factor has the first value for all measured pressures less than or equal to the first pressure value, and the first value is a constant.
In certain implementations, the coefficient factor has the second value for all measured pressures greater than or equal to the second pressure value, and the second value is a constant.
In some implementations, the first pressure value is 30 mbar.
In certain implementations, the second pressure value is 80 mbar.
In some implementations, the first pressure value is −40 mbar.
In certain implementations, the second pressure value is 40 mbar.
Implementations can include one or more of the following advantages.
Methods described herein can be used to accurately determine the volume of medical fluid pumped out of or drawn into a chamber of a medical fluid cassette. Some such methods, for example, account for a portion of the membrane of the medical fluid cassette that overlies the chamber and bulges outward and inward as pressure within the chamber increases and decreases, respectively. Bulging of the membrane changes the volume of the chamber (as compared to theoretical volume calculations that assume no such bulging of the membrane takes place) and can thus result in inaccuracies of fluid volumes that are determined using a calculation that assumes no such bulging of the membrane occurs. By accounting for bulging of the membrane (e.g., by multiplying a theoretical fluid volume calculation that assumes no bulging of the membrane by a correction factor to determine an adjustment volume and then adding the adjustment volume to the theoretical volume), the volume of fluid pumped out of or drawn into the chamber can be more accurately determined.
In some implementations, the correction factor by which the theoretical fluid volume calculation is multiplied is selected based on the pressure of the medical fluid in the cassette (e.g., the chamber of the cassette). It has been found that the degree to which the cassette membrane overlying the chamber bulges changes as the pressure of the medical fluid within the chamber changes. Therefore, selecting the correction factor based on the pressure of the medical fluid within the chamber can increase the accuracy with which the volume of medical pumped out of or drawn into the chamber is determined.
In certain implementations, the correction factors used during the drain phase of a treatment (i.e., the phase during which medical fluid is drawn out of the patient and into the chamber of the medical fluid cassette and then pumped from the chamber to a drain or drain bag) differ from the correction factors used during the fill phase of the treatment (i.e., the phase during which medical fluid is drawn into the chamber of the medical fluid cassette from a medical fluid source and then pumped from the chamber to the patient). It has been found that the tendency of the cassette membrane to bulge and the degree to which the cassette membrane bulges differs from the drain phase to the fill phase. By using different coefficient factors for these phases, the accuracy with which the volume of medical fluid pumped out of and drawn into the chamber of the medical fluid cassette throughout the treatment can be increased.
In some implementations, the correction factor by which the theoretical volume is multiplied to determine the corrected volume (e.g., to determine an adjustment volume that is used to calculate the corrected volume) is a constant for those pump strokes where the measured pressure is below a minimum pressure limit or above a maximum pressure limit but varies for those pump strokes where the measured pressure falls between the minimum and maximum pressures. It has been found that the degree to which the cassette membrane deforms varies little across relative low and relatively high pressure ranges but varies more significantly across an intermediate pressure range. Thus, using constant correction factors for those pump strokes where the measured pressure falls below a minimum pressure or above a maximum pressure can simplify the determination of the corrected volume without significantly affecting the accuracy of the corrected volume. Using a correction factor that varies based on pressure for those pump strokes where the measured pressure falls between the minimum and maximum pressures helps to ensure the accuracy of the corrected volume.
In certain implementations, a piston is used to drive the membrane of the cassette to pump medical fluid out of the chamber and to draw medical fluid into the chamber. The use of a mechanically operated piston pump as compared to a hydraulic pump can be advantageous because mechanically operated piston pumps tend to be less complex and less expensive than hydraulic pumps. As discussed above, using methods described herein can also increase the accuracy with which the volume of medical fluid pumped out of and drawn into the chamber of the cassette is determined. Thus, certain systems described herein can be less complex and less expensive than systems using hydraulic pumps while achieving comparable volumetric pumping accuracy.
Other aspects, features, and advantages will be apparent from the description and drawings, and from the claims.
Referring to
Dialysate bags 122 are suspended from fingers on the sides of the cart 104, and a heater bag 124 is positioned in the heater tray 116. The dialysate bags 122 and the heater bag 124 are connected to the cassette 112 via dialysate bag lines 126 and a heater bag line 128, respectively. The dialysate bag lines 126 can be used to pass dialysate from dialysate bags 122 to the cassette 112 during use, and the heater bag line 128 can be used to pass dialysate back and forth between the cassette 112 and the heater bag 124 during use. In addition, a patient line 130 and a drain line 132 are connected to the cassette 112. The patient line 130 can be connected to a patient's abdomen via a catheter and can be used to pass dialysate back and forth between the cassette 112 and the patient during use. The drain line 132 can be connected to a drain or drain receptacle and can be used to pass dialysate from the cassette 112 to the drain or drain receptacle during use.
The PD system 100 also includes encoders (e.g., optical encoders) that measure the rotational movement of the lead screws. The axial positions of the pistons 133A, 133B can be determined based on the rotational movement of the lead screws, as determined by the encoders. Thus, the measurements of the encoders can be used to very accurately position the piston heads 134A, 134B of the pistons 133A, 133B.
As discussed below, when the cassette 112 (shown in
As shown in
Still referring to
Still referring to
The door 108 of the PD cycler 102, as shown in
A control unit (e.g., microprocessor) 139 (shown in
As an alternative to programming the control unit 139 to mathematically determine or calculate the volume of fluid in the pump chamber, in certain implementations, the control unit simply accesses a look-up table that provides the theoretical volume based on the known positions of the pistons 133A, 133B. When the pump chamber 138A, 138B has been isolated in the manner discussed above and the pressure sensor 151A, 151B detects the reference pressure (e.g., 300 mbar), which is indicative of liquid (rather than air) being pressurized within the pump chamber 138A, 138B, the control unit 139 determines the position of the piston 133A, 133B that corresponds to that pressure. It is that position of the piston 133A, 133B that is used when consulting the look-up table to determine the theoretical volume of fluid in the pump chamber 138A 138B.
In order to populate the look-up table with relevant data, the volume of fluid in the pump chamber 138A, 138B can be mathematically determined (based on the known geometries of the piston head 134A, 134B and the recessed region of the base that forms the pump chamber 138A, 138B) for various different positions of the pistons 133A, 133B. Once the look-up table is populated in this manner, the control unit 139 need only determine the position of the piston 133A, 133B to figure out the theoretical volume of dialysate in the pump chamber 138A, 138B in a single step, rather than having to perform numerous mathematical computations during each piston stroke.
As an alternative to populating the look-up table with theoretical volumes that are mathematically determined, the look-up table can be populated with theoretical volumes that are empirically determined. For example, prior to treatment, the PD system can be set up to pump liquid from the pump chamber 138A, 138B to a drain bag sitting on a weight scale that is level with the PC cycler 102. The control unit 139 monitors the piston position for various different piston strokes and monitors the weight of the drain bag after each piston stroke. The fluid volume pumped to the drain bag as a result of each piston stroke is then determined based on the known weight of fluid that was pumped to the bag. This process is repeated numerous times for each starting position of the piston to increase the accuracy of the approximated fluid volume. In this way, the known starting position of the piston can be matched with the determined corresponding fluid volume in the look-up table.
The control unit is also programmed to adjust the determined theoretical volumes of fluid based on pressure signals received from the pressure sensors 151A, 151B. Specifically, the control unit 139 is programmed to multiply the determined theoretical volumes of fluid by a correction factor, which is selected as a function of the pressure measured by one of the pressure sensors 151A, 151B, to determine an adjustment volume. The pressure used to determine the correction factor is the pressure in the isolated pump chamber 138A, 138B at the end of the inward piston stoke during drain and at the end of the outward piston stroke during fill. After determining the adjustment volume, the control unit 139 adds the adjustment volume to the determined theoretical volume to determine a corrected volume. The corrected volume accounts for bulging outward of annular portions 149A, 149B of a membrane 140 of the cassette 112, which may occur when the patient is positioned above the PD cycler 102 and the pistons 133A, 133B are being retracted to draw liquid into the pump chamber 138A, 138B from the patient. The corrected volume also accounts for bulging inward of the annular portions 149A, 149B of the membrane 140 of the cassette 112, which may occur when the patient is positioned below the PD cycler 102 and the pistons 133A, 133B are being advanced to force liquid from the pump chamber 138A, 138B into the patient. By accounting for bulging of the membrane, the PD system 100 can provide greater volumetric pumping accuracy, as will be discussed below.
The annular flanges 164A, 164B of the dome-shaped members 161A, 161B, as shown in
As shown in
Referring to
Still referring to
The rigidity of the base 156 helps to hold the cassette 112 in place within the cassette compartment 114 of the PD cycler 102 and to prevent the base 156 from flexing and deforming in response to forces applied to the projections 154A, 154B by the dome-shaped members 161A, 161B and in response to forces applied to the planar surface of the base 156 by the inflatable members 142. The dome-shaped members 161A, 161B are also sufficiently rigid that they do not deform as a result of usual pressures that occur in the pump chambers 138A, 138B during the fluid pumping process. Thus, the deformation or bulging of the annular portions 149A, 149B of the membrane 140 can be assumed to be the only factor other than the movement of the pistons 133A, 133B that affects the volume of the pump chambers 138A, 138B during the pumping process.
The base 156 and the dome-shaped members 161A, 161B of the cassette 112 can be formed of any of various relatively rigid materials. In some implementations, these components of the cassette 112 are formed of one or more polymers, such as polypropylene, polyvinyl chloride, polycarbonate, polysulfone, and other medical grade plastic materials. In certain implementations, these components can be formed of one or more metals or alloys, such as stainless steel. These components of can alternatively be formed of various different combinations of the above-noted polymers and metals. These components of the cassette 112 can be formed using any of various different techniques, including machining, molding, and casting techniques.
As noted above, the membrane 140 is attached to the periphery of the base 156 and to the annular flanges 164A, 164B of the dome-shaped members 161A, 161B. The portion of the membrane 140 overlying the remaining portions of the base 156 are typically not attached to the base 156. Rather, these portions of the membrane 140 sit loosely atop the raised ridges 165A, 165B, and 167 extending from the planar surface of the base 156. Any of various attachment techniques, such as adhesive bonding and thermal bonding, can be used to attach the membrane 140 to the periphery of the base 156 and to the dome-shaped members 161A, 161B. The thickness and material(s) of the membrane 140 are selected so that the membrane 140 has sufficient flexibility to flex toward the base 156 in response to the force applied to the membrane 140 by the inflatable members 142. In certain implementations, the membrane 140 is about 0.100 micron to about 0.150 micron in thickness. However, various other thicknesses may be sufficient depending on the type of material used to form the membrane 140.
Any of various different materials that permit the membrane 140 to deflect in response to movement of the inflatable members 142 without tearing can be used to form the membrane 140. In some implementations, the membrane 140 includes a three-layer laminate. In certain implementations, for example, inner and outer layers of the laminate are formed of a compound that is made up of 60 percent Septon® 8004 thermoplastic rubber (i.e., hydrogenated styrenic block copolymer) and 40 percent ethylene, and a middle layer is formed of a compound that is made up of 25 percent Tuftec® H1062 (SEBS: hydrogenated styrenic thermoplastic elastomer), 40 percent Engage® 8003 polyolefin elastomer (ethylene octene copolymer), and 35 percent Septon® 8004 thermoplastic rubber (i.e., hydrogenated styrenic block copolymer). The membrane can alternatively include more or fewer layers and/or can be formed of different materials.
As shown in
After positioning the cassette 112 as desired on the cassette interface 110, the door 108 is closed and the inflatable pad within the door 108 is inflated to compress the cassette 112 between the inflatable pad and the cassette interface 110. This compression of the cassette 112 holds the projections 154A, 154B of the cassette 112 in the recesses 152A, 152B of the door 108 and presses the membrane 140 tightly against the raised ridges 167 extending from the planar surface of the rigid base 156 to form the enclosed fluid pathways 158 and dome regions 146 (shown in
The pistons 133A, 133B are then coupled to the dome-shaped members 161A, 161B of the cassette 112 and the cassette 112 and the various lines connected thereto are primed in the manner described below. After priming is complete, the patient line 130 is connected to the patient's peritoneal cavity via a catheter and treatment is carried out. Typically, the treatment begins by draining spent dialysate that was left in the patient's peritoneal cavity from the previous treatment. Fresh dialysate is then delivered to the patient's peritoneal cavity where it is allowed to dwell for a desired period of time and is then drained. This fill-dwell-drain process is typically repeated several times before the treatment is concluded.
Referring to
As the piston 133A continues to advance, the dome-shaped member 161A contacts the inner surface of the portion of the rigid base 156 that forms the recessed region 162A, as shown in
Referring to
After mechanically coupling the piston head 134A of the PD cycler 102 to the dome-shaped member 161A of the cassette 112, a “learning” process is carried out to ensure that the control unit 139 knows the position of the piston 133A in relation to the pump chamber 138A of the cassette 112 and can be reciprocated in a manner to draw a desired amount of fluid into and pump a desired amount of fluid out of the pump chamber 138A of the cassette 112. Initially, the pistons 133A, 133B are moved to a home position which is sensed by a conventional optical sensor. The stepper motor encoder value is then set to zero. Next the pistons 133A, 133B are advanced until they contact the rigid base of the cassette 112. The control unit 139 can detect when the pistons 133A, contact the rigid base of the cassette 112 because the encoder value of the stepper motor encoder, which is connected to the control unit 139, will no longer change. The pistons 133A, 133B are then retracted slightly by moving the stepper motors a certain number of counts (e.g., 1900 counts). These are the “OUT” positions of the pistons 133A, 133B. Then, the pistons 133A, 133B are further retracted by rotating the stepper motors a desired number of additional counts (e.g., 5000 counts). These are the “IN” positions of the pistons 133A, 133B. To draw fluid into the pump chambers 138A, 138B and pump fluid out of the pump chambers 138A, 138B during priming and treatment, the pistons 133A, 133B are reciprocated between the “IN” and “OUT” positions.
After carrying out the above-noted “learning” process, the cassette 112 and the various lines connected thereto are primed. To prime the cassette 112 and the various lines, the pistons 133A and the inflatable members 142 are operated to pump dialysate from the heater bag 124 to the drain and from each of the dialysate bags 122 to the drain to force any air trapped in the heater bag line 128 and the dialysate bag lines 126 to the drain. Dialysate is also passed (e.g., by gravity) from the heater bag 124 to the patient line 130 to force any air trapped in the patient line out of a hydrophobic filter positioned at the distal end of the patient line 130.
After priming is complete, the patient line 130 is connected to the peritoneal cavity of the patient and the PD cycler 102 is operated to drain any spent dialysate that was left in the patient's peritoneal cavity from a previous treatment. To drain the spent dialysate from the patient's peritoneal cavity, the inflatable members 142 of the PD cycler 102 are configured to create an open fluid flow path between the patient line 130 and the port 187A (shown in
As shown in
To ensure that the desired volume of dialysate is drawn from the patient during treatment, the theoretical volume of dialysate that is drawn into the pump chamber 138A from the peritoneal cavity of the patient is first calculated by the control unit 139 and stored in memory of the control unit 139. The theoretical volume of dialysate drawn into the pump chamber 138A is determined using the following equation:
Vdialysate=Vtotal−Vair, (1)
where
Vdialysate is the volume of dialysate in the pump chamber;
Vtotal is the total pump chamber volume, and
Vair is the volume of air in the pump chamber.
The total pump chamber volume (Vtotal) can be determined based on the position of the piston 133A. Specifically, since the volume of the pump chamber (prior to the cassette membrane being deformed by the piston 133A) is known based on the dimensions of the cassette and the volume of the piston head 134A is known based on the dimensions of the piston head 134A, the total volume of the pump chamber (i.e., the total volume of the pump chamber when the piston 133A is in the retracted position or “IN” position) can be determined by subtracting the volume of the portion of the piston head 134A that projects into the pump chamber in the “IN” position from the pump chamber volume when the membrane 140 is undeformed. The volume of the portion of the piston head 134A that penetrates into the volume of the pump chamber in the “IN” position can be determined based on the linear position of the piston 133A relative to the cassette 112.
As an alternative to performing the above-noted calculations to determine the total pump chamber volume (Vtotal), it is possible to determine this volume empirically. For example, the cassette 112 can be positioned in the cassette compartment 114 of the PD cycler 102 and the piston 133A can be retracted a certain distance to draw dialysate into the pump chamber 138A. The piston 133A is then advanced to pump the dialysate from the pump chamber 138A to a collection bag sitting on a weight scale that is level with the PD cycler 102. The volume of dialysate pumped to the collection bag can then be determined based on the weight of the dialysate. In addition, the distance by which the piston 133A was retracted is known. Thus, the retracted position of the piston 133A and the total volume of fluid contained in the pump chamber 138A that corresponds to that retracted piston position are known and can be stored in a look-up table accessible by the control unit of the PD cycler 102. This process can be repeated many times to arrive at an accurate correlation between the retracted piston position and the total volume of the pump chamber 138A when the piston 133A is in that retracted position.
After determining the retracted position of the piston 133A and the total pump chamber volume (Vtotal), the volume of air in the pump chamber (Vair) is determined using the following equation:
Vair=((Vol25 mbar−Vol300 mbar)*slope+intercept)/1000 (2)
where
Vol25 mbar is the volume of the pump chamber when the pump chamber 138A is isolated and the pressure sensor 151A detects a pressure of 25 mbar;
Vol300 mbar is the volume of the pump chamber when the pump chamber 138A is isolated and the pressure sensor 151A detects a pressure of 300 mbar;
slope=(7*1000000)/1704; and
intercept=−slope*200.
The respective volumes of the pump chamber 138A when the pressure sensor 151A detects pressures of 25 mbar and 300 mbar can be determined based on the position of the piston 133A when those pressures are detected. As discussed above, due to the known geometries of the piston head 134A and the pump chamber 138A (when the membrane 140 is undeformed), the control unit 139, which receives data from the pressure sensor 151A and from the stepper motor encoder, can use the known position of the piston 133A when the pressure sensor 151A detects pressures of 25 mbar and 300 mbar to mathematically determine the volumes of the pump chamber 138A at those pressures. Alternatively, the control unit 139 can access a look-up table that contains various piston positions and corresponding pump chamber volumes. The look-up table could be populated by first mathematically calculating the pump chamber volume associated with each piston position or by empirically determining the pump chamber volume associated with each piston position in the manner described above.
After determining the total volume (Vtotal) of the pump chamber 138A (assuming no bulging of the cassette membrane 140) and the volume of air in the pump chamber 138 (Vair), the volume of dialysate in the pump chamber 138 (Vdialysate) determined using equation 1 above (i.e., by subtracting the volume of air in the pump chamber 138A from the total volume of the pump chamber 138A).
The volume of dialysate determined to be in the pump chamber 138 (Vdialysate) using equation 1 above will differ from the actual volume of dialysate in the pump chamber 138A if the annular portion 149A of the cassette membrane 140 bulges outward as a result of high positive pressure within the pump chamber 138A when the piston 133A is retracted. The tendency of the annular portion 149A of the membrane 140 to bulge outward during retraction of the piston 133A is closely correlated with the pressure within the pump chamber 138A or the sensing chamber 163A adjacent the pump chamber 138A when the piston 133A is in the retracted position (i.e., at the end of the inward stroke). For example, when the patient is positioned above the PD cycler 102 during the drain cycle, gravity assists the pumping operation to facilitate the transfer of spent dialysate from the patient to the pump chamber 138A. As a result, increased positive pressure is generated within the pump chamber 138A. It is this increase in pressure that causes the annular portion 149A of the cassette membrane 140 to bulge outward.
At the end of each inward stroke of the piston 133A during the drain phase of the cycle, the pump chamber 138A is isolated by inflating the inflatable member 142 that is positioned adjacent the pressure sensing chamber 163A of the cassette 112 (i.e., near the top of the pump chamber 138A) and by inflating the inflatable member 142 that is adjacent the inlet/outlet port positioned near the bottom of the pump chamber 138A. After the pump chamber 138A has been isolated in this manner for a certain period of time (e.g., 0.5 seconds), a signal indicating the pressure within the sensing chamber 163A, which is approximately equal to the pressure within the pump chamber 138A, is transmitted from the pressure sensor 151A to the control unit 139. Using the rules and equations below, the control unit 139 determines an appropriate correction factor (K) to be used based on the measured pressure:
If P≤30 mbar, then K=0;
If P≥80 mbar, then K=0.02; and
If 30 mbar<P<80 mbar, then K=((P−30)*2/5)/1000,
After determining the appropriate correction factor (K), the control unit 139 uses that correction factor (K) to determine an adjustment volume (Vadjustment), as follows:
Vadjustment=Vdialysate*K, (3)
The control unit 139 then uses the calculated adjustment volume (Vadjustment) to adjust the volume of dialysate previously determined to be in the pump chamber 138 (Vdialysate) to determine a corrected volume of dialysate in the pump chamber 138 (Vcorrected), as follows:
Vcorrected=Vdialysate+Vadjustment. (4)
Referring to
During the patient drain phase of the treatment, the pistons 133A, 133B are typically alternately operated such that the piston 133A is retracted to draw spent dialysate solution into the pump chamber 138A from the patient while the piston 133B is advanced to pump spent dialysate solution from the pump chamber 138B to the drain and vice versa. The control unit 139 determines an appropriate correction factor based on pressure signals received from the pressure sensor 151B and uses that correction factor to calculate a corrected volume of spent dialysate drawn into the pump chamber 138B from the patient in the same manner as discussed above with respect to the pump chamber 138A. The control unit determines a corrected volume of fluid drawn into the pump chambers 138A, 138B from the patient for each stroke of the pistons 133A, 133B.
The corrected volume (Vcorrected) for each inward piston stroke during the drain phase is stored in memory of the control unit 139. This allows the total corrected volume during the patient drain phase (i.e., the sum of corrected fluid volumes calculated for each piston stroke during the patient drain phase) to be monitored. When the total corrected volume of fluid drained from the patient during the patient drain phase reaches the total desired volume of fluid to be drained during the drain phase, the cycler 102 transitions from the patient drain phase to a patient fill phase.
To begin the patient fill phase, the inflatable members 142 are configured to create a clear fluid flow path between the pump chamber 138A and the heater bag line 128, and then the piston 133A is retracted, as shown in
The warm dialysate is then delivered to the peritoneal cavity of the patient via the patient line 130 by configuring the inflatable members 142 to create a clear fluid flow path between the pump chamber 138A and the patient line 130 and advancing the piston 133A, as shown in
Under certain conditions, the negative pressure generated within the pump chamber 138A as the piston 133A is advanced causes the annular portion 149A of the membrane 140 to bulge inwardly toward the rigid base 156 of the cassette 112, as shown in
To ensure that a desired volume of dialysate is delivered to the patient during the patient fill phase, the volume of dialysate that is pumped out of the pump chamber 138A is calculated by the control unit 139 for each stroke of the piston 133A. Because the starting volume of the fluid pump chamber 138A (assuming no bulging of the cassette membrane 140) and the volume of the dome-shaped member 161A are known, the linear distance traveled by the dome-shaped member 161A, which is equal to the linear distance traveled by the piston 133A, can be used to determine the volume of dialysate pumped out of the fluid pump chamber 138A. To allow this linear distance to be determined, signals indicating the number of revolutions or steps of the motor used to drive the piston 133A during use are transmitted to the control unit 139. The linear distance traveled by the piston 133A (and thus the linear distance traveled by the dome-shaped member 161A) can be determined based on the number of revolutions or steps of the motor used to drive the piston 133A. Thus, the theoretical volume of solution pumped out of the fluid pump chamber 138A can be determined based on the number of revolutions or steps of the motor (i.e., the position of the piston 133A). Equations (1) and (2) above can be used for determining the theoretical volume.
As discussed above, this theoretical volume of fluid pumped out of the pump chamber 138A will differ from the actual volume of fluid pumped out of the pump chamber 138A if the annular portion 149A of the cassette membrane 140 bulges inward as a result of excessive negative pressure generated within the pump chamber 138A when the piston 133A is advanced. It has been found that the tendency of the annular portion 149A of the membrane 140 to bulge inward during advancement of the piston 133A is closely correlated with the pressure within the pump chamber 138A and the sensing chamber 151A adjacent the pump chamber 138A. For example, when the patient is positioned below the PD cycler 102 during the fill cycle, gravity assists the pumping operation to facilitate the transfer of fresh dialysate from the pump chamber 138A to the patient. As a result, increased negative pressure is generated within the pump chamber 138A. It is this increase in negative pressure that causes the annular portion 149A of the cassette membrane 140 to bulge inward.
At the end of each outward stroke of the piston 133A (i.e., when the piston 133A is in the “OUT” position) during the fill phase of the cycle, the pump chamber 138A is isolated by inflating the inflatable member 142 that is positioned adjacent the pressure sensing chamber 163A of the cassette 112 (i.e., near the top of the pump chamber 138A) and by inflating the inflatable member 142 that is adjacent the inlet/outlet port positioned near the bottom of the pump chamber 138A. After the pump chamber 138A has been isolated in this manner for a certain period of time (e.g., 0.5 seconds), a signal indicating the pressure within the sensing chamber 163A, which is approximately equal to the pressure within the pump chamber 138A, is transmitted from the pressure sensor 151A to the control unit 139. Using the rules and equations below, the control unit 139 determines an appropriate correction factor (K) to be used based on the measured pressure:
If P≤−40 mbar, then K=0.015;
If P≥40 mbar, then K=0; and
If −40 mbar<P<40 mbar, then K=(15−(P+40)*15/80)/1000,
where P is the pressure reading of the pressure sensor 151A and K is the correction factor.
After determining the appropriate correction factor, the control unit 139 multiplies the previously determined theoretical fluid volume by the correction factor to determine an adjustment volume (see Equation (3) above) and then adds the adjustment volume to the previously determined theoretical fluid volume to arrive at the corrected volume (see Equation (4) above). The corrected fluid volume for each piston stroke is stored in memory of the control unit 139. This allows the total corrected volume during the patient fill cycle (i.e., the sum of corrected fluid volumes calculated for each piston stroke during the patient fill cycle) to be monitored.
During the patient fill phase of the treatment, the pistons 133A, 133B are typically alternately operated such that the piston 133A is retracted to draw warm dialysate into the pump chamber 138A from the heater bag 124 while the piston 133B is advanced to pump warm dialysate from the pump chamber 138B to the patient and vice versa. The control unit 139 determines an appropriate correction factor based on pressure signals received from the pressure sensor 151B and uses that correction factor to calculate a corrected volume of warm dialysate pumped out of the pump chamber 138B to the patient in the same manner as discussed above with respect to the pump chamber 138A. The control unit 139 determines a corrected volume of fluid pumped out of the pump chambers 138A, 138B to the patient for each stroke of the pistons 133A, 133B. When the total corrected volume of fluid pumped to the patient reaches the total desired volume of fluid to be pumped to the patient, the cycler 102 transitions from the patient fill phase to a dwell phase during which the dialysate is allowed to sit within the peritoneal cavity of the patient for a long period of time.
During the dwell period, toxins cross the peritoneum of the patient into the dialysate from the patient's blood. As the dialysate dwells within the patient, the PD cycler 102 prepares fresh dialysate for delivery to the patient in a subsequent cycle. In particular, the PD cycler 102 pumps fresh dialysate from one of the four full dialysate bags 122 into the heater bag 124 for heating. To do this, the pump of the PD cycler 102 is activated to cause the pistons 133A, 133B to reciprocate and certain inflatable members 142 of the PD cycler 102 are inflated to cause the dialysate to be drawn into the fluid pump chambers 138A, 138B of the cassette 112 from the selected dialysate bag 122 via its associated line 126. The dialysate is then pumped from the fluid pump chambers 138A, 138B to the heater bag 124 via the heater bag line 128.
After the dialysate has dwelled within the patient for the desired period of time, the spent dialysate is pumped from the patient to the drain in the manner described above. The heated dialysate is then pumped from the heater bag 124 to the patient where it dwells for a desired period of time. These steps are repeated with the dialysate from two of the three remaining dialysate bags 122. The dialysate from the last dialysate bag 122 is typically delivered to the patient and left in the patient until the subsequent PD treatment.
After completion of the PD treatment, the pistons 133A, 133B are retracted in a manner to disconnect the piston heads 134A, 134B from the dome-shaped members 161A, 161B of the cassette. The door 108 of the PD cycler is then opened and the cassette 112 is removed from the cassette compartment 114 and discarded.
While the control unit 139 of the PD cycler 102 has been described as being programmed to determine an adjustment volume based on a pressured measured by one of the pressure sensors 151A, 151B and to add that adjustment volume to the previously determined theoretical volume to determine the corrected volume, in certain implementations, the control unit simply accesses a look-up table that provides the corrected volume based on the position of the piston 133A, 133B (at the pressure that indicates the initial pressurization of the liquid) and the pressure in the isolated chamber at the end of the piston stroke (i.e., at the end of the inward stroke during drain and at the end of the outward stroke during fill). The look-up table can be populated with mathematically derived data and/or empirical data. In some implementations, the theoretical volume is determined mathematically in the manner described above and the correction factor is determined empirically in the manner described above. In certain implementations, both the theoretical volume and the correction factor are determined empirically using the methods discussed above.
While the PD system 100 has been described as including certain types of pressure transducers for measuring fluid pressure within the sensing chambers of the cassette, other types of pressure sensors can alternatively or additionally be used. In some implementations, for example, a Wheatstone bridge is used to determine the fluid pressure within the pump chamber 138A, 138B.
While the correction factor (K) has been described as varying across intermediate pressure ranges, in some implementations, the correction factor (K) can be a constant across each of the pressure ranges (i.e., the low pressure range, the intermediate pressure range, and the high pressure range). For example, a correction factor (K) of 0.01 can be used when the pressure (P) is between 30 mbar and 80 mbar during the drain phase, and a correction factor (K) of 0.0075 can be used when the pressure (P) is between −40 mbar and 40 mbar during the fill phase.
While the dialysate has been described as being pumped into the heater bag 124 from a single dialysate bag 122, dialysate can alternatively be pumped into the heater bag 124 from multiple dialysate bags 122. Such a technique may be advantageous, for example, where the dialysates in the bags 122 have different concentrations (e.g., different dextrose concentrations) and a desired concentration for treatment is intermediate to the concentrations of the dialysate in two or more of the bags 122.
While the piston heads 134A, 134B have been described as including spring-loaded latch mechanisms with sliding latches 145A, 145B that can be move radially inward and outward to allow those piston heads 134A, 134B to be mechanically connected to the dome-shaped members 161A, 161B of the cassette 112, piston heads of simpler construction that include no such sliding latches can alternatively be used in some cases. In some implementations, for example, each of the piston heads is a unitary structure that includes a peripheral flange that can be engaged with an annular projection of a dome-shaped member of a cassette in order to mechanically connect the piston head to the cassette and enable a fluid pumping process of the type described above to be carried out. In such implementations, the rear surface of the flange can be arranged at an angle of about 45 degrees to about 75 degrees (e.g., about 60 degrees) relative to the longitudinal axis of the piston to facilitate insertion of the piston head into the dome-shaped member. The peripheral flange of the piston head and/or the flange of the dome-shaped member can elastically deform as the piston head is advanced into the dome-shaped member. Examples of this type of piston head and dome-shaped member as well as other suitable types of piston heads and dome-shaped members are described in U.S. Patent Application Publication No. 2012/0271226, which is incorporated by reference herein.
While the piston heads and dome-shaped members of the cassette have been described above as being mechanically coupled to one another, other coupling techniques can be used. In some implementations, for example, the cassette includes a membrane that overlies the entire area of the pump chambers and that is driven by dome-shaped piston heads that generally conform to the recessed regions of the rigid base of the cassette. One example of such a system is illustrated in
During treatment, the piston heads 234A, 234B are reciprocated in much the same way as the piston heads 134A, 134B described above to draw fluid into and pump fluid out of pump chambers 238A, 238B of the cassette 212. As the piston heads 234A, 234B are retracted, the vacuum applied to the membrane 240 via the annular openings 236A, 236B helps to ensure that the portions of the membrane 240 overlying the pump chambers 238A, 238B retract at the same speed as the piston heads 234A, 234B. Because the outer diameter of those portions of the piston heads 234A, 234B that are in contact with the membrane 240 throughout most of the piston stroke are smaller than the maximum inner diameter of the recessed regions 162A, 162B of the rigid base 156 of the cassette 212, the membrane 240 will include annular portions that surround each of the piston heads 234A, 234B and overlie the pump chambers 238A, 238B. In much the same way as discussed above, these annular portions will tend to bulge outward and inward under certain conditions as fluid is pumped out of and drawn into the pump chambers 238A, 238B by advancing and retracting the piston heads 234A, 234B, respectively. For example, when the patient is positioned above the PD cycler 202 during the drain cycle, gravity assists the pumping operation to facilitate the transfer of spent dialysate from the patient to the pump chamber 238A. As a result, increased positive pressure is generated within the pump chamber 238A, causing the annular portion of the cassette membrane 240 to bulge outward. Similarly, when the patient is positioned below the PD cycler 202 during the fill cycle, gravity assists the pumping operation to facilitate the transfer of fresh dialysate from the pump chamber 238A to the patient. As a result, increased negative pressure is generated within the pump chamber 238A, causing the annular portion of the cassette membrane 240 to bulge inward. The volume of fluid that is pumped out of and drawn into the pump chambers 238A, 238B can be determined with greater accuracy by using the volume correction methods described herein, which account for the bulging of the annular portions of the membrane 240. Correction factors can be selected and applied in the manner discussed above to carry out such methods.
While the cassette interface 110 of the PD cycler 102 has been described as including locating pins 148 that help to ensure that the dome-shaped members of the cassette are aligned with the pistons 133A, 133B when the cassette is positioned in the cassette compartment 114, other structures or techniques can be used to ensure this alignment. In some implementations, for example, the cassette is placed against the door of the PD cycler with the hollow projections of the cassette disposed in recesses of the PD cycler's door, and the cassette is held in this position by retainer clips attached to the door. Upon closing the door, the pistons of the PD cycler align with the dome-shaped members of the cassette.
While the door 108 of each of the PD cyclers above has been described as including an inflatable pad that, when inflated, can press the cassette against the cassette interface, the inflatable pad can alternatively be positioned behind the cassette interface such that the cassette interface can be moved toward the door 108 to compress the cassette therebetween. Similarly, as an alternative to an inflatable pad, any of various mechanisms that can be operated to move a surface of the door 108 toward the cassette interface or vice versa can be used.
While the door 108 of the PD cyclers described above are shown as being positioned on a front face of the PD cyclers, the doors can alternatively be positioned at various other locations on the PD cyclers. For example, the doors could be positioned on a top face of the PD cycler such that the cassette is slid into the cassette compartment in a substantially horizontal orientation instead of a substantially vertical orientation. In some implementations, the door and the cassette interface of the PD cycler are positioned at an angle of about 10 to about 35 degrees to vertical when the PD cycler is rested on a horizontal surface. It has been found that this configuration makes it easier for the user to load the cassette into the cassette compartment.
While the cassettes discussed above have two pump chambers, the cassettes can alternatively have more or fewer than two pump chambers.
While each of the pump chambers of the cassettes described above has been described as including multiple ports, in certain implementations, the pump chambers include a single port that is used as both an inlet and an outlet. In such implementations, the inflatable valve members of the PD cycler that act on the valve portions of the cassettes would be activated and deactivated in a different sequence to allow fluid to be drawn into the pump chamber from a desired location and then to be forced out of the pump chamber to a desired location.
While certain PD cyclers above have been described as including a touch screen and associated buttons, the PD cyclers can alternatively or additionally include other types of screens and user data entry systems. In certain implementations, for example, the cycler includes a display screen with buttons (e.g., feather touch buttons) arranged on the console adjacent the display screen. Certain buttons can be arranged to be aligned with operational options displayed on the screen during use such that the user can select a desired operational option by pressing the button aligned with that operational option. Additional buttons in the form of arrow buttons can also be provided to allow the user to navigate through the various display screens and/or the various items displayed on a particular screen. Other buttons can be in the form of a numerical keypad to allow the user to input numerical values in order, for example, to input operational parameters. A select or enter button can also be provided to allow the user to select an operational option to which the user navigated by using the arrow keys and/or to allow the user to enter values that the user inputted using the numerical keypad.
While PD systems have been described, the methods described herein for determining a corrected volume of medical fluid pumped into and out of a chamber of a medical fluid cassette can be used in any of various other types of medical fluid pumping systems that use cassettes or cartridges. Other examples of medical fluid pumping systems with which the methods described herein can be used include hemodialysis systems, blood perfusion systems, and intravenous infusion systems.
Similarly, while many of the systems above have been described as being used to pump dialysate, other types of dialysis fluids can be pumped through the cassettes. As an example, in the case of cassettes used with hemodialysis machines, blood can be pumped through the cassettes. In addition, priming solutions, such as saline, can similarly be pumped through cassettes using the various different systems and techniques described above. Similarly, as an alternative to dialysis fluids, any of various other types of medical fluids can be pumped through the above-described cassettes depending on the type of medical fluid pumping machines with which the cassettes are used.
Other embodiments are within the scope of the following claims.
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