AUTOMATIC PERITONEAL DIALYSIS CYCLER AND METHODS OF USE.

专利摘要:
automatic peritoneal dialysis cyclist and methods of use. automatic peritoneal dialysis cyclist (apd) systems and methods are disclosed. the apd cycler may include a heating tray with load cells configured to measure the weight of fluid contained in a heating bag and / or a drainage bag. the load cells can be fixed with a pin between the activated and deactivated configurations. the apd cycler may include a pressure-based volume measurement system that can be used to confirm measurements made by the load cells. in some embodiments, the apd cyclist may have algorithms to track an estimated patient volume to avoid overfilling the patient.
公开号:BR112012015669A2
申请号:R112012015669-1
申请日:2010-12-20
公开日:2021-04-13
发明作者:Li Pan
申请人:Vr Medical Technology Co., Ltd.；
IPC主号:

专利说明:

"Invention patent descriptive report for:" AUTOMATIC PERITONEAL DIALYSIS THERMOCYCLER AND METHODS OF USE ". Cross Reference To Related Applications This application claims the benefit under 35 USC S $ 119 (e) of US Provisional Patent Application No. 61 / 284,745, filed on December 24, 2009, entitled AUTOMATED PERITONEAL DIALYSIS CYCLER EMPLOYING REDUNDANT FLUID MEASUREMENT SYSTEMS, all of which are hereby incorporated by reference, and made part of this descriptive report for all that is described.
Incorporation by Reference The following references are hereby incorporated by reference here in their entirety and constitute a part of this specification for everything they describe: American Patent Publication No. 2006/0195064; American Patent Publication No. 2007/01172297; American Patent No. 4,560,470; American Patent No. 4,585,436; American Patent No. 4,826,482; American Patent No. 4,976,162; American Patent No. 4,421,823; American Patent No.
S: S24 022; American Patent No. 5,338,293; American Patent NO.
S5.350.357; American Patent No. 95,421,823; American Patent No.
. two
5,474,683; American Patent No. 5,722,947; and chapters 12 and 14 of Aseptic Pharmaceutical Manufacturing 1717 (ISSN: 0-935184-77-5). The devices, structures, compositions, methods and procedures described in these references are provided as background and may be used in addition to or instead of those disclosed in various sections of this application. Field of the Invention The present disclosure relates in general to the systems and method for carrying out a dialysis treatment, and more specifically to the systems and methods for carrying out an automatic peritoneal dialysis treatment. Background Although the systems and methods for performing: dialysis treatment exist, there remains a need for automated peritoneal dialysis systems and better methods. Summary of the Invention Some exemplary embodiments are summarized below. In some embodiments, a dialysis system may have a pressure-based volume measurement system. The dialysis system can include a containment chamber and a reference chamber, and one or more pumps configured to control the pressure inside the containment and pressure chamber.
: 3 reference chamber. The dialysis system can have a controller configured to define the containment chamber up to a first pressure and to define the reference chamber up to a second pressure. The controller can open a connection between the containment chamber and the reference chamber so that the pressures are allowed to substantially equalize. The equalized pressure can then be measured in one or both of the containment chamber and the reference chamber.
One or both of the first and second pressures can be negative pressure. In some embodiments, the second pressure in the containment chamber may be a higher negative pressure than the first pressure in the containment chamber. In some embodiments, the ratio of the pressure in the reference chamber to the pressure in the containment chamber can be greater than about 2 to 1, 4 to 1 or 10 to 1. In some embodiments, positive pressures can be used in one or both of the containment chamber and the reference chamber. The reference chamber can have a higher pressure than the containment chamber. In some embodiments, the first pressure applied to the containment chamber is a negative pressure of at least about - 0.1 psig and / or less than or equal to - 1.0 psig or - 0.5 psig. In some modalities, a negative pressure from
-: 4 at least about - 5.0 psig and / or less than or equal to about - 9.0 psig. In some embodiments, the containment chamber or the reference chamber can be adjusted substantially to atmospheric pressure.
Ss The controller can be configured to calculate the volume of gas inside the containment chamber based at least in part on the measured equalized pressure. The controller can be configured to determine a volume of a fluid quantity in at least one of a heating bag and a drain bag based at least in part on the calculated volume of gas inside the containment chamber.
One or more pressure sensors can be configured to measure pressure in the containment chamber and the reference chamber. The system can also include temperature sensors in some modes, and the controller can be configured to determine the volume of gas inside the containment chamber, at least in part, in a measured change in temperature in one or both of the containment chamber and the reference chamber.
The system can have a weighted scale configured to measure the weight of an amount of fluid in at least one of a heating bag and a drainage bag. The pressure-based volume measurement system can be used to confirm measurements made using the weighing scale (which may include, for example, one or more load cells). The controller can be configured to compare the weight scale measurement with the calculated volume of fluid quantity in at least one of the heating bag and the drain bag, and the controller can display an alarm if the calculated volume is different from the measurement weigh on the weight scale in more than a limit quantity.
The controller can use the weight measured by the weight scale to determine a volume of fluid and compare that volume with the volume measured by the pressure-based volume.
The volume of the containment chamber can be determined by applying a first pressure to the containment chamber using one or more pumps, applying a second pressure to the reference chamber using one or more pumps, opening a path between the containment chamber and the reference chamber, allowing the pressures of the containment chamber and the reference chamber to substantially equalize, by measuring an equalized pressure in at least one of the containment chamber and the reference chamber, and calculating, using one or more computing devices , the first volume of gas inside the containment chamber 6 based at least in part on the measured equalized pressure.
A volume of a quantity of fluid in at least one of the heating bag and the drainage bag can be determined based, at least in part, on the first calculated volume of gas inside the containment chamber.
The weight of an amount of fluid in at least one heating bag and the drain bag can be measured using a weight scale, and that weight can be compared to the calculated volume of the fluid quantity in at least one of the heating bag and the drain bag. An alarm can be displayed if the calculated volume differs from the weight scale measurement by more than a threshold quantity. The weight can be used to calculate a volume of fluid to be compared with the volume of fluid that was calculated from the equalized pressure.
A load cell can be used to measure the weight applied to a dialysis tray. The load cell can be switched between an enabled configuration and a disabled configuration. When the system is moved, or is not in use, the load cell can be set to the disabled setting, so that movement, or vibrations, etc. do not damage the load cell. The load cell can include a main body á: TF and a sensor configured to generate a signal representative of the force applied to the main body.
A tray can be attached to the main body.
An insulating member (such as a screw) can be movable between an enabled position and a disabled position.
When the insulating member is in the enabled position, the weight applied to the tray is transferred to the main body to generate a signal using the sensor that is representative of the weight applied to the tray.
When the insulating member is in the disabled position, the weight applied to the tray is transferred through the insulating member in such a way that the weight is not applied to the main body.
The load cell can have a support bar, and The insulating member can be configured to engage the support bar when in the disabled position, so that the weight of the tray is transferred through the insulating member to the support bar.
The system may have several load cells that can be configured to operate in parallel, so that measurements of the plurality of cells are combined to produce a value representative of the weight applied to the tray.
In some modalities, the dialysis system can be configured to reduce the pressure applied when draining the
. 8 fluid (for example, from a patient), when drainage is almost complete. A dialysis system can have a sealed containment chamber, a drainage container positioned within the containment chamber, and a patient tube in fluid communication with the drainage container. The patient tube can be configured to attach to a patient catheter. A controller can be configured to apply negative pressure to the containment chamber, using one of the most pumps, so that fluid is drawn through the patient's tube into the drain pan. The flow can be monitored, and the controller can reduce the negative pressure in the containment chamber in response to a measured reduction in fluid flow within the drain pan.
The controller can be configured to gradually reduce the negative pressure inside the containment chamber, as the flow of fluid into the drainage bag reduces. The controller can be configured to maintain the negative pressure in the containment chamber at a substantially constant level until the flow rate drops below a first threshold rate, and the controller can be configured to reduce the negative pressure in response to the rate of flow that falls below the first threshold level. The controller can be configured to stop draining the
: 9 fluid into the drainage bag, in response to the flow rate that falls below a second threshold level.
In some embodiments, the system can be configured to control an estimated patient volume (for example, the amount of fluid present in the patient's peritoneum), to avoid overfilling.
The system can drain fluid from a patient, identify an indicator that drainage is complete, and measure the volume of fluid in the drainage bag.
The system can calculate a minimum drainage volume, such as a predetermined percentage of the expected drainage volume.
The expected drainage volume can be the volume of infusion from the previous filling stage plus an estimated residual patient volume.
In some cases, the expected drainage volume may also include an expected ultrafiltration volume.
The system can determine, using one or more computing devices, whether the measured volume of liquid is less than the minimum drainage volume.
The system can issue an alarm if the measured volume of liquid is less than the minimum drain volume.
The system can continue dialysis treatment if the measured volume of liquid is not less than the minimum drainage volume.
The system can update the patient's residual volume x 10 estimated to be the difference between the expected drainage volume and the measured volume.
A connector can allow a sealed container (for example, a pouch) to be opened without introducing contamination.
The connector can include a port configured to attach a container to contain fluid, the port having a septum configured to seal the container, a connector tube configured to attach a pipe element, and a tip attached to the tube connector.
The tip can pierce the septum of the pouch port when the tube connector advances towards the port, such that a fluid connection is formed from the container through the port, through a fluid path at the tip, through the tube connector, and into the tube element.
A sealing member can be attached to a first end on the colt and be attached to a second end to the pipe connector.
The sealing member can provide a seal between the pouch door and the tube connector, such that the tip can advance to pierce the septum without exposing the tip or septum to the external environment.
The sealing member can be a bellows member.
One or more chias limbs can be configured to guide the tip towards the septum as the tip advances.
r 11 In some embodiments, one or more protective cover pieces can be included and can be configured to keep the tube connector at a distance from the port where the tip does not pierce the septum. The one or more protective cover pieces can be removable to allow the tip to proceed to pierce the septum.
BRIEF DESCRIPTION OF THE DRAWINGS Certain modalities of the inventions will now be discussed in detail with reference to the following figures.
These values are provided for illustrative purposes only, and inventions are not limited to the object illustrated in the figures.
Figure 1 is a perspective view of an exemplary embodiment of an APD thermal cycler.
Figure 2 is another perspective view of the APD thermal cycler in Figure 1 with the heater / weight scale in an open position.
Figure 3 is another perspective view of the APDO thermal heater in figure | with the compression valve access door in an open position.
Figure 4 is a perspective view of an exemplary embodiment of a disposable set for use with the APD thermal cycler in Figure 1.
. 12 Figure 9S is a perspective view of an exemplary embodiment of a disposable set for use with the APD thermal cycler without a heating bag or drainage bag attached to it.
Figures 6A-E illustrate an exemplary modality of a connector for fixing the heating bag to a pipe element.
Figure 7 is another perspective view of the APD thermal cycler in figure 1 with the disposable assembly in figure 4 loaded thereon.
Figure 8 is a close-up perspective view of the APD thermal cycler of Figure 1 with the compression valve access door removed to show the piping elements aligned with the corresponding compression valves.
Figure 9 is a cross-sectional view of the compression valves and piping in Figure 8.
Figures 10A-C illustrate a heating tray assembly including load cells that are articulated between enabled and disabled configurations.
Figure 11 shows schematically how the heating pan can transfer multiple different values of charges into the multiple load cells.
Figure 12 shows schematically an exemplary modality of a pressure-based volume-based measurement system that can be used by the APD thermal cycler of Figure 1.
Figure 13 is a flowchart showing an exemplary embodiment of a method of determining a volume of fluid using the pressure-based measurement system of Figure 12.
Figure 14 is a flowchart showing an exemplary embodiment of a method of applying automatic peritoneal dialysis treatment to a patient.
Figure 15 is a flowchart showing an example of a method of manipulating a drainage stage in an automatic peritoneal dialysis treatment.
DETAILED DESCRIPTION OF EXEMPLIFYING MODALITIES The following detailed description is now directed at certain “specific disclosure modalities. In this description, reference is made to the drawings, in which equal parts are designated with equal reference numbers as throughout the description and the drawings.
Figure 1 is a perspective view of a modality — an example of an Automatic Psritoneal Dialysis (APD) 10 system, commonly referred to here as an APD 10 thermal cycler 10. The APD 10 thermal cycler may include a support 5. A cover 2, such as a heating / weight scale cover, it can be attached to the support 5 (for example, using one or more hinges), so that the heating / weight scale cover 2 can open and close like a door.
In figure 1, the heating cap / with weight scale 2 is shown in the closed position.
An access region, such as a compression valve access door 52, can be connected to support 5 (for example, using one or more hinges) so that the compression valve access door 52 can open and close.
The pressure valve port 52 is shown in the closed configuration in Figure 1. A lock, such as a latch 54, can be used to hold the pressure valve 52 access door in the closed position.
A lock, such as a latch (not shown in Figure 1), can also be used to hold the heating / weight cap 2 in the closed position.
The heating cap / with weight scale 2 and / or the compression valve access door 52 can be kept closed using locks such as pins, or a pressure or friction fitting structure, or in any other suitable form.
The APD thermal cycler 10 may include a user exit, such as a screen 12, and a user entry, such as
:: 15 as control buttons 15, which can be fitted and / or fully contained within the support profile 5, to prevent the screen 12 and buttons 15 from being damaged, for example, during the movement of the APD thermal cycler 10. A screen 12 can be configured to provide information to the user and to request information from the user, as described here.
The buttons 15 can be configured to receive user input, as described here.
In some embodiments, the 12th screen can be a touch screen, thereby reducing the number of buttons 15, or allowing buttons 15 to be omitted.
Figure 2 is a perspective view of the APD 10 thermal cycler with the heating cap / with weight scale 2 in the open position.
A heater tray assembly 70 can be positioned in a recess formed in support 5 so that it is protected from unintended forces that can cause errors in weight measurements taken using heater tray 72. In some embodiments, the heater tray assembly 10 it can be removable from the recess, for example, to provide access to the components of the weight scale.
The heater tray assembly 70 can be substantially surrounded below and on the sides by walls 71 and the top of the heater tray assembly 70 can be opened, so that the components of an assembly
= 16 disposable 30 can be placed there, as shown in Figure 5. The support 9 can include a support flap 3 that extends upwards to receive the flap of the lid 4 formed on the underside of the heating cover / with a weight scale 2 The flap of the lid 4 can be coupled with the flap of the support 3 to form a containment chamber 6 in between, and these components can be configured to form a seal, for example, so that due to the negative pressure it can be kept inside the containment chamber 6, as described herein. The support 5 can have a channel 74 which leads away from the heater tray assembly 70, and the support flap 3 can extend substantially around the channel
74. Grooves 7 and 8 can be formed on the support flap 3. Many alternatives are possible. For example, the heating cap / with weight scale 2 can be configured to seal directly with the walls 71 of the heating tray assembly 70. Figure 3 is a perspective view of the APD thermal heater with the compression valve access port 52 in the open position. For example, the user can disengage latch 54 to open the compression valve access door, 52, thereby exposing the compression valve actuators 60. In the mode shown in Ekigura 3, O and 17 APD 10 thermal cycler can be configured to receiving a disposable set 30. Figure 4 is a perspective view of an exemplary embodiment of a disposable set 30 that includes a filling container, such as a heating bag 20, and a drainage container, such as a drainage bag 22 The heating bag 20 can be filled with fluid to be heated before being introduced into the patient, and the drainage bag 22 can be used to receive drained fluids from the patient.
The disposable assembly 30 may include multiple supply lines 31 and 32 for introducing fluid into the heating bag, although in some embodiments a single supply line may be used.
A patient tube 34 can direct the fluid from the heating bag 20 to the patient and then, from the patient to the drain bag 22, A drain tube 36 can be used to remove fluid from the drain bag 22. Connections branches, such as Y-fittings 33, 35 and 37, and tubing elements 28, 29, sS6 and 39, can be positioned as shown in Figure 4 to connect the disposable 30 components together to provide an adequate flow path into the fluid through the system.
In some modalities, all or parts of the elements of
DO 18
Piping 27, 28, 29, 36, and 39 and / or portions of supply tubes 31 and 31, patient tube 34 and drain tube 36 can be flexible, so that the compression valve actuators 60 can compress the elements of
<piping 27, 28, 29, 38, 39 to close the fluid passages to direct the flow of Eluid through the system, as described herein.
Connectors (not shown) can be included at the ends of the supply tube lines 31 and 32, at the end of the patient tube
34, and / or at the end of the drain tube 36. Various suitable connectors can be used to connect these tubes to a fluid source, 9 the patient's catheter, or a waste receptacle, as appropriate.
A sterile connector 40 can be used to provide access to the heating pouch 20, as shown in greater detail in figures 68 to 6D,
A low recirculation volume set can be created by providing long piping lines 28 and 29 (for example, in some cases at least about 25 cm or 50 cm or more in length), thus moving the connection * 35 closer from the patient connector to patient tube 34. The freshly prepared dialysis solution flows down tube 28 and spent dialysis and ultratiltration are fluids drained through tube 29. Tube 34, in which both the
D—. 19 freshly prepared dialysis solution as the spent dialysis fluids pass, can be shortened (for example, to less than or equal to about 10 hundred, 5 hundred, 1 om, or less) so that the volume of recirculation it could be low or generally negligible. (Note: A 4 mm ID tube contains 1 mL of fluid for every 8 cm in length). In some embodiments, lines 28 and 29 could remain as shown, and patient tube 34 is replaced by a double extrusion D that ends at the patient connection which limits the volume of recirculation to the volume within the catheter itself.
Figure 5 is a perspective view of an exemplary modality of a disposable set 230 that does not include the heating pouch 20 or the drain pouch
22. In some embodiments, the heating pouch 20 and / or the drain pouch 22 may be reusable, while the tubing and other components shown in figure 5 may be disposable. In some embodiments, the entire heating bag 20 and / or the drainage bag 22 may be disposable in the same way. The disposable set 30 can be a low cost unit. In some embodiments, the disposable set 30 may include several Y connections (for example, four) 35, 33 and 37; multiple lengths of tubing (for example, nine); and multiple connectors (for
: 20 example, six), which may have tip protectors, Many alternatives are possible. For example, a 4-way connection can be used instead of a Y-connection, thereby reducing the number of connections and pipe lengths (for example, one connection less and one pipe length less than that shown in the figure. 5).
Figures 6a-re illustrate an exemplary embodiment of connector 40 that is configured to provide a fluid connection between heating pouch 20 and 140 tubing 38. In some embodiments, connector 40 can be attached to heating pouch 20 and / or the pipe 38 when the disposable set is manufactured.
Figure 6a is a perspective view of connector 40 with protective covers 41 and 42 in place. A heater pouch port 21 can be attached to heater pouch 20 and a tube connector 43 can be attached to tubing 38. When engaged, protective caps 41 and 42 can substantially secure and restrict tube connector 43 from moving in in relation to the port of the adductor bag 21. Figure 6b is a cross-sectional view of connector 40 with protective covers 41, 42 engaged. Protective covers 41, 42 may include flaps that lean against & heater pouch door 21 and against tube connector 43 to prevent them from advancing towards each other. A port adapter 18 may be connected to the inner surface of the heating pouch 20 via heat welding, ultrasonic welding, RF welding, solvent welding, adhesive welding, or other suitable method.
The adapter port 18 can be attached to the inner surface of the heating pouch 20 instead of the outer surface of the heating pouch 20 to reduce the likelihood that the adapter port can be dislodged during transport and handling.
The port portion of the heating pouch 21 can be attached to the adapter port 18 using an adhesive or other suitable method.
In some embodiments, the heater bag adapter 21 and adapter port 18 can be integrally formed as a single piece.
The heater pocket 21 may have a septum 19 that prevents fluid from being transferred between the heater pocket 20 and the tube 38. Does figure 6Cc show the connector 40 with the protective cover 142 removed, exposing the flexible bellows member 40 that connects the heater bag 21 to the tube connector 43, The bellows member 40 can be connected at one end to the heater bag 21 and at a second end to the tube connector 43, using a sticker or any other suitable form.
Figure 68d shows the connector 40 with both protective covers 41 and 42
DO 22 removed.
Figure 6e is a cross-sectional view of connector 40 with protective caps 41 and 42 removed.
With the protective caps 41 and 42 removed, the tube connector 43 can be pushed towards the door of the heating bag Ss 21, thus closing the bellows member 45. The bellows member 45 can be made of a flexible material, elastomeric and / or elastic, such as silicone.
The tube connector 43 may have a tip 47 connected to it.
As the connector of the tube 43 moves towards the port of the pouch 21, the tip 47 can penetrate the septum 19, thereby aseptically initiating a fluid connection between the tube 38 and the interior of the heating pouch 20. In some embodiments , the tube connector 43 and the tip 47 can retract after the septum 19 is penetrated, but a fluid connection can continue to exist between the heating bag 20 and the tube 38 because the fluid can pass through the hole in the formed septum 19 through the tip 47. In some embodiments, the tube connector 43 and the tip 47 can be retained in the forward position (not shown) with the tip tip 47 projecting through the septum 19, thus allowing fluid to flow through the septum 19 through the fluid path formed inside the tip 4 /. At the door of the heating pouch 21, it may include guide walls 49 which generally surround the tip end 47, and at the
The 23 guide walls can direct the tip 47 through the septum 19 to reduce the risk that the tip 47 could unintentionally pierce the bellows member 45 or another wall in the heating pouch 20, or that the heating pouch door 21 could dislodge, thus generating a liquid leak.
In this way, the connector 40 can provide a barrier that seals the interior of the heating bag 20 until the tip 47 advances to pierce the septum 19, for example, when the user is ready to start a dialysis procedure.
In some embodiments, the heating bag 20 can be filled with fluid for administration to a patient, and the septum 19 can provide a barrier to keep the fluid within the heating bag 20 until the septum 19 is punctured.
The connector can also prevent bacteria or other contaminants from entering the heating bag 20, or other components of the disposable assembly 30. The connector 40 can allow the seal of the heating bag 20 to be broken without introducing any bacteria or other contaminants, thus maintaining the sterile environment within the disposable assembly 30. For example, the user can advance tip 47 to pierce septum 19 without touching tip 47, and bellows member 45 can work to seal the interior of connector 40 in the forward and retracted position discussed above.
The connector 40 can be designed so that it is in permanent contact with the heating bag 20 and the tube 38, and is not intended to be disconnected from it during normal use.
For example, the bellows member 45 can adhere to the heater pocket 21 and the tube connector 43, which can adhere to the heater bag 20 and the tube 38, respectively.
Thus, in some embodiments, connector 40 does not allow disconnection of tube 38 from the heating pouch 20. Instead, connector 40 remains connected to it during 9 use, and can be changed from a closed state to an open state by advancing. the tip 47 through the septum 19 without opening the connector 40 or otherwise exposing the interior of the connector 40 to the surrounding environment.
In addition, connector 40 can be configured to remain open after it was initially opened (for example, advanced to pierce septum 19), and not to reseal or close if the connector is subsequently placed in the stowed position.
Thus, connector 40 can be designed to not be able to perform repeated transitions between open and closed configurations.
Several alternative connectors can be used to connect tube 38 to the heating pouch 20. For example, in
In some embodiments, the heating pouch 20 may have a male or female luer connector attached to it and can be configured to selectively attach to a corresponding male or female luer attached to tube 38. This embodiment can be advantageous if the heating pouch is intended to be reused, and if the tubing is intended to be disposable, because the male luer can be disengaged from the female luer to allow the heating pouch to be disconnected from the tube
238. In some embodiments, the tube 36 can be attached directly to the adapter port 18 of the heating pouch 20 without a septum or other barrier to seal the heating pouch
20. This configuration can be used, for example, if the heating bag is not pre-loaded, so that it is kept empty inside the ADPF 10 thermal cycler and is subsequently filled with fluid through the supply tubes 31, 32. In some cases, the user can mix two or more fluids (for example, having different concentrations of dextroseil, to form a mixture (for example, having an intermittent concentration of dextrose), which can allow better control of ultrafiltration. pre-filled can be used, thus reducing the cost of therapy. In some embodiments, supply tubes 31 and 32 can be omitted, for example, if the pre-filled heating pouch 26 is large enough to contain the total volume of treatment fluid (for example, for use in a pediatric or small mass patient, or using a large volume heating bag).
Now with reference to figure 6c, the tube 39 can be directly connected to an adapter port 17, which can be connected to the interior of the drainage bag 22 in a similar way to that described together with the adapter port above 18. Thus, in some modalities , no septum or other barrier is provided between the tube 39 and the drain bag 22. In some embodiments, a connector similar to connector 40 can be used to seal the drain bag 22 until use. In addition, the detachable connectors (for example, male and female luer connectors) can be used so that the drainage bag 22 is removable from the tube 39.
The disposable set 30 can be sterilized. For example, the heating bag 20 can be pre-filled and then sterilized with steam. The pre-heis warming pouch 20 can be rerouted as 09 wet side of disposable set 30. The dry side of disposable set 30 can include lines 31, 32, 34, 36; piping 27, 28, 29, 38, 39; multi-pipe connections, such as Y connections 33, 35, 37; empty drainage bag 22; and end connections
- 27 (not shown). The dry side of the disposable assembly 30 can be assembled and sterilized, such as by using ethylene oxide gas, gamma radiation, or electron beam sterilization. The wet side and the dry side of the disposable S set can only come out of their respective sterilizers in a sterile barrier “isolation” environment and can be aseptically joined by connector 40. Some suitable sterile barrier “isolation” environments and other details related to sterilization are described in chapters 12 and 14 of Aseptic Pharmaceutical Manufacturing 17 (ISBN: 0-935184-77-5). Many alternatives are possible. For example, the wet side and the dry side of the disposable set 30 can be joined in a clean room environment while an electron beam sterilizes the connection. 30 can be mounted as the dry side and can be sterilized after assembly using any of the appropriate sterilization techniques described herein.
In some embodiments, bags 20 and 22 may have doors located on the side. The location of the side door can allow the thermal cycler to be designed in such a way that its overall dimensions are compact (for example,
D & 28 example, to better fit into a storage box suspended on an airplane). Figure 7 is a perspective view of the APD 10 thermal cycler with the disposable assembly 30 positioned thereon.
The heating element 20 can be positioned, for example, at the bottom of the heating tray assembly, close to one or more heating elements (not shown), so that the fluid introduced in the heating bag 20 can be heated before administration to the patient.
The drainage bag 22 can also be placed inside the containment chamber 6 along the heating bag 20, as shown.
Y 33 connections can fit in grooves 7 and 8, and can be configured to form a substantially vacuum seal when the heater / weight scale 2 cover is closed.
For example, Y-fittings 33 may include O-rings that are larger in size than grooves 7 and &, such that the O-rings are compressed when inserted into grooves 7 and 8 to form the seal.
The connector 40 and the portions of the tubing elements 38 and 39 can be positioned in channel 74. The disposable assembly 30 can be positioned in such a way that compression valves 60 are located directly under the flexible portions of the tubing, so that the valves compression hoses 60 can elastically deform portions of the tubing to prevent
There is fluid flow through it, to thereby direct the flow or fluid through the system.
The APD 10 thermal cycler can be configured to hold the flexible parts of tubing in position over the corresponding compression valves 60 during use.
In some embodiments, the underside of the compression valve access port 52 may have grooves or slits (not shown) configured to receive the tubing therein, to position the pieces of tubing above the compression valves 60, when on the access port compression valve 52 is closed.
A series of clamps (not shown) can be included to position the pieces of tubing above the corresponding compression valves 60. Figure 8 is a partial perspective view of the APD 10 thermal cycler with the compression valve 52 access port omitted from the View.
The supply tubes 31 and 32 are positioned above the compression valves 60d and 60e, respectively, in such a way that the compression valves 60d and 60e can control the flow of fluid through the supply tubes 31 and 32, such as when a volume of fresh fluid is transferred into the heating bag 20. The tubing element 28, which interconnects the patient tube 34 to the heating bag 20 can be positioned above the compression valves 60c and o. 30 60g, such that the compression valves 60c and 60g can control the flow of fluid through the tubing element 28, such as when the newly prepared heated fluid is transferred from the heating bag 20 to the patient tube 34 for administration to the patient.
The tubing element 27, which interconnects the patient tube 34 to the drainage bag 22, is positioned above the compression valves 60b and 60f, such that the compression valves 60b and 60f can control the flow of fluid through the element line 27, such as when fluid is drained from the patient through patient line 34 to drain bag 22. Drain line 36 can be positioned over compression valve 60a, so that compression valve 60a can control The fluid flow through the drain tube 36, just as when the fluid that was drained from the patient is transported from the drain bag 22 out through the drain tube 36. In the illustrated embodiment, the tubing elements 27 and 28 that connect to the patient's tube 34 may have multiple compression valves (for example, two) 60b and 608 om 600 and 60g associated with it, so that if a compression valve (for example, 60c) fails or malfunctions , O Another compression valve (eg 60g) can still close the tubing, thereby reducing
- 31 the likelihood that a malfunction of the valve could adversely affect the patient (eg,
overfilling or excessive drainage). Figure 9 is a partial cross-sectional view taken through the compression valve 60c and 60g, which are used to control the flow of fluid through the pipe element 28. The other compression valves 60 can be similar to the compression valves 60c and 60g in construction and operation.
Compression valves 60 can be spring-closed / vacuum-opened compression valves, which are tilted towards a closed position (as shown in figure 9) by a spring 64, and can be retracted to an open position by negative pressure .
This configuration can reduce the amount of noise produced by the compression valves, compared to a system in which the valves are inclined open by one or more inclination members, (for example, springs) and forced into a closed position by pressure (pressure negative or positive). In some embodiments, a rigid plate 61 may have holes for receiving the plungers of the compression valve 60, so that only the plunger tips are visible to the user above plate 61. A flexible spring diaphragm 62 can create a seal between the plate 61 and driver support 68. Retainers, such as 32 as nuts 66, can attach diaphragm 62 to the plungers 60, creating a seal around the guide rods € 5, which can be integrally formed with the plungers 60. The mojias 64 can tilt the clamping valve plungers 60 towards the closed position, for example, by pressing against the underside of the retaining nuts 66. Actuator supports 68 can be configured to have negative pressure selectively applied to them, for example, by a bomb (not shown). When sufficient negative pressure is applied to a sufficient support for driver 68, the tilt force of spring 64 can be overcome and a portion of flexible spring diaphragm 62 can be pulled into driver support 68, thereby compressing spring 64 and retracting the plunger of the compression valve 60 downwards to the open position in which the fluid is allowed to flow through the corresponding tube.
In some embodiments, the compression valves 60 can be configured so that, when in the closed position, they can form PVC pipes that have an internal diameter of about 4 mm and an external diameter of about 6 mm when the due fluid has a temperature of around 10 ºC is present in the piping. The compression valves 60 can be configured in such a way that negative pressure of about -7 psig is able to retract
= 33 the compression valve plungers 60 to the open position. For example, the internal diameter of the driver brackets can be at least about 0.62 inch and / or less than or equal to about 0.75 inch, although values outside these ranges can also be used. By using a stronger spring 64, the compression valve 60 can be tilted more strongly towards the closed position and may be able to occlude the stronger tubing. However, if a stronger spring is used, the amount of negative pressure that is used to retract the plunger 60 also increases. If a weaker spring 64 is used than that shown in the illustrated embodiment, less negative pressure would be required to retract the plunger 60, but the compression valve 60 would also have less force to occlude the tubing in the closed position. For example, the springs can be selected so that the compression valves 60 can retract under a negative pressure of at least about -7.0 psig and / or less than or equal to about -10.0 psig.
Both the 60c and 60g compression valves can isolate the patient so that fluid replenishment from the supply tube 31 is not inadvertently administered to the patient during the refueling phase, even in the event of a single valve failure.
The 34 compression. Likewise, both compression valves 60b and 60f (not shown in Figure 9) can isolate the patient when the fluid is being transferred to the drain tube from the temporary drain bag, even in the event of a failure of a single compression valve.
Figure 10 is a perspective view of an exemplary embodiment of a heater tray set 70. Heater tray 72 may have walls 71 that substantially surround the sides and bottom of heater tray 72, and a switch 73 that provides a path for Channel / 74 when tray 72 is inserted in the APD 10 thermal cycler, as shown in figure 3. The lower part of heating tray 72 can tilt towards the side with switch 73 so that when balls 20 and 22 are placed in the heating tray 72, the fluid is driven to flow towards the side with the switch 73. The heating tray 72 can be supported by multiple 7/5 load cells (for example, three or more), which can be located in the corners of a triangle, in such a way that two of the load cells are located on the bottom side of the sloped bottom of the heating tray 72, since more weight could in general be applied to the bottom side, load cell types 75 can be used. For example, a single cell of
. 35 load 75 can be used, but in general it would be exposed to more extremes under load conditions than the set of three load cells 75 shown in the illustrated embodiment. Other numbers of load cells 75 can be used, such as at least 2 load cells, 4 load cells or 5 load cells, or more. The load cells can operate in parallel in such a way that the measurements taken from each of the load cells are combined to provide a measurement of the torus.
40 One or more load cells 75 can be articulated between a disabled configuration, where the load cell 75 is not configured to measure the weight applied to tray 72, and an enabled configuration where the load cell 75 is capable of measuring the weight applied to tray 1/2.
Thus, when the APD 10 thermal cycler is not in use, the load cells 75 can be adjusted to the disabled configuration to prevent the load cells 75 from being damaged, for example, because they are relatively extremely stressed which can be applied accidentally. during transport of the AFD 10 thermal heater. When in use, the user can transition the load cells 75 to the enabled configuration.
Figure 10B is a close cross-sectional view through the center of the load cell 75 at the o end. 36 at the top of the heating tray 72. The load cell 75 may include a support bar 76 located, for example, on the bottom side of the load cell 75. The load cell may have a main body 80 that can be movable with respect to the support bar 76, so that when the force is applied to the load cell 75, the movement of the main body 80 can apply force to a sensor, such as a tension meter (not shown), which generates data corresponding to the force applied to the load cell 75. The support bar 76 can be fixed directly to the support 5 of the APD 10 thermal cycler by means of connectors, such as screws 77. The screws 77 can have sealing members, such as O-rings or elastomeric washers (not shown), which create a seal between the screw heads 77 and the bracket 5 to prevent air from escaping into the containment chamber when it is evacuated to generate negative pressure as described herein.
A connector, such as screw 78, can pass through a hole 83 in the heating tray 72 and can engage a threaded hole 82 formed in the load cell 75, thereby securing the heating tray 72 in the load cell 75. The loading cell load 75 can be attached to tray 72 in any other suitable way, such as using an adhesive or snap fit.
Orifice 83 can be threaded to attach to tray 37 in the load cell 78, or orifice 83 can be threaded and tray 72 can be attached to the load cell 75 by the screw head 78 which leans against the pitch of the recess 81 formed at the base of the heating pan 72.
A connector, such as an isolation screw 79, can be used to configure the load cell to enable or disable configurations. In some embodiments, the head of the isolation screw 79 may fit under the head of the screw 78. The recess 81 may be large enough to receive the insulation screw 79 in addition to the screw 78, and a channel 86 that is wide enough to receive the seotation screw head: can be formed below the recess R1 so that the isolation screw 79 can be tightened and loosened (forward and retracted) to articulate the load cell between the enabled and disabled configurations. In figure 10B, the isolation screw 79 is configured to the enabled position. To set the isolation screw to the enabled position, the isolation screw can be turned in the direction of loosening (for example, counterclockwise). The isolation screw head 79 can rest against the underside of the screw head 78, thus preventing the user from unintentionally loosening the isolation screw 79 to the point where
two! 38 it could disengage from the load cell 75. The stop screw 79 is thus retracted to a position in which it does not engage the support bar 76. Thus, when a force is applied to the heating tray 72, the stop screw isolation 79 does not prevent force from being applied to the sensor to generate a reading of the weight applied to the tray
72. Figure 10C is a cross-sectional view close to the load cell 75 with the isolation screw 79, in the disabled position. The insulation screw 79 can be tightened (for example, rotated clockwise) so that the insulation screw 79 advances until it engages the support bar 76. The hole 85 can be threaded or threadless. In some embodiments, hole 85 is not required to be threaded. For example, the insulation screw 79 can advance through a threaded hole 84 formed in the load cell 75 until the insulation screw is engaged with both the support bar 76 and the main body portion 80 of the load cell 75 to prevent movement between them and to isolate the sensor from the force applied to the load cell 75. When the force is applied to the heating tray 72, it is transferred through the isolation screw 79 into the support bar 76 instead from to the sensor. In some embodiments, an O-ring 39 can be positioned between the head of the isolation screw 79 and the inner surface of the channel 86. In some embodiments, the isolation screw 79 can cause the O-ring to be pressed firmly against a Internal surface of channel 86 to seal the inside of the heating tray 72 from the area below the heating tray
72. Thus, if liquid is spilled on the heating tray 72, it will not leak down into the load cells 75. Screw 78 may have an O-ring or other seal, or because it is not intended to be moved during the use (as is the isolation screw 79), the threads of the screw 78 can form a seal with the hole 83. The user can insert a tool (for example, a hexagon wrench) through the recess 81 and into the channel 86 to engage the head of the isolation screw 79 to effect the transition of the exemption screw 79 between the enabled and disabled positions. In some embodiments, during the manufacturing process, the left end of the support bar 76 is initially formed connected to the left end of the main body 80 and is separated from the main body 80 after the threaded hole 84 so that the isolation screw 79 has been punched and struck. Thus, the threads formed in the hole 84 in the support bar 76 can coincide with the
- 40 isolation screw 79, without placing any load on load cell 75. Many alternatives are possible.
For example, in some embodiments, orifice 85 at the base of channel 86 can be threaded to secure the heating tray 72 to the insulation screw 79. Thus, when the insulation screw 79 is in the disabled position, the force applied to the tray 72 is transferred by means of the isolation screw 79 and to the support bar 76 instead of to the sensor.
In 10, in some embodiments, the insulation screw 79 can engage threads of the support bar 76 to fix the insulation screw 79 in the support bar 76, When in the disabled position, thus preventing the insulation screw 79 (or the tray 72 which is attached to the insulation bolt 79) moves in relation to the support bar 76. In some embodiments, the insulation bolt 79 is not necessary to engage the support bar 76, but is advanced to a point where the insulation bolt 79 abuts against the support bar 76, or against the support 5, or other rigid stationary portion of the APD 10 thermocieler, so that force on tray 72 does not move tray 72 towards load cell 75, because the force is transferred through the isolation screw 79 to the support bar 76, The support 5, or other rigid stationary portion of the 41 thermocouple APD 10. Thus, in some embodiments, the hole 85 is threaded, but it is not necessary that the hole 84 through cell load 75 is threaded.
In addition, in some embodiments, the isolation screw 79 can be displaced from the load cell 75. For example, the isolation screw 79 can pass through a threaded hole in the base of the tray 72 that is not associated with the load cell. 75 (for example, positioned adjacent to the load cell). The isolation screw 79 can advance until 40, against the support, 5 below the tray 72. Thus, when a force is applied to the tray 72, the force will be transported through the isolation screw 79 to &
support 5, and not for the load cell 75. Figure 11 shows schematically how the heating tray 72 can transfer multiple (for example, three) different load values in three load cells 75 that, support the tray 72, to the bag heater 20 and temporary drainage bag 22. The weight of the heating tray 72 and the bags 20, 22 it contains are represented by the 20th) "phab W in figure 11º The loads that are transmitted to the load cells 75 are represented by Li, L2 and L3 The dimensions 231 and Y, represent the distance that theThe center of gravity of the weight W is far from the central lines, which work, pass through the three load cells.
A, sum of
. 42 loads and weights are equal to zero and the sum of the moments around each of the central lines through the load cells is equal to zero.
This generates 3 equations with 3 algorithms. $$ P = W-Lebtobe O Equation 1 DM mixed x = W * Y, -LiY2 = O Equation 2 SM eso y = WiXItlsNo = Loxo = D Equation 3 These three equations can be solved for L: ,, L, and L3 . Equation 2 can be solved directly for L1. E: = (11 / Y2) * W Equation 4 This expression of L, can then be substituted in Equation 11 for "Li, so that" Tb "can be) expressed in terms of W and L; yielding the following: do = WW "(Y, / Y2) -Ls Equation 5 This expression for Ls» can then be replaced by La in Equation 3 resulting in W * X, + L3 * tX> - WrX + W * Ho * (Va / Y2) T + LatNo = O.
The resolution for L; produces the following: L3 = W * (X2-X1) / (24X2) - W / 2 * (Y1 / Y2) Equation 6 The expression for L3 in Equation 6 can be replaced by L3 in Equation 5 resulting in the following: L2 = W * (X2 + X1) / (2 * X2) + W / 2 * (Y1 / X2) Equation 7 The geometry of the containment chamber 6 and the solution pockets 20, 22 can prevent the entire weight of the pockets and 43 heaters and drainage 20, 22 is placed over a single single load cell.
Each load cell 75 can have a capacity of at least about 5 kg and / or less than or equal to about 20 kg, although other values outside these ranges can also be used.
In some embodiments, load cells 75 can individually have a nominal capacity of about 10 kg with a safe overload of about 15 kg and be suitable for use in this application.
In some instances, a maximum volume of fluid that could be contained within the containment chamber may occur after the initial drainage stage at the beginning of therapy.
For example, the patient may have an initial drainage volume of twice their prescribed filling volumes (for example, 3000 mL), resulting in an initial drainage of 6000 mL, and a full 6-liter heating bag may be present in the ADP 10 thermal cycler, in the same way.
This load of 12 liters (about 12 kg) of load could be distributed across three load cells by equations 4, 6 and 7 based on the location of the combined center of gravity of the heating tray 72, the heating pouch 20 and the pouch temporary drainage 22. In some embodiments, the APD thermal cycler can use load cells 75 to measure the amount of fluid contained in the heating bag 20 and / or the drainage bag at 44
22. Thus, as the heating bag 20 is filled with freshly prepared dialysis solution, the load cells 75 can measure the amount of liquid in the heating bag 20 and the system can stop filling the heating bag 20 when the desired volume of fluid is contained in that. The load cells 75 can also measure the weight of the fluid as it is transferred from the heating bag 20 to the patient, and the patient's filling stage can end when the desired volume of fluid is transferred to the patient. Similarly, load cells 75 can measure the weight of the spent dialysate and the associated ultrafiltration fluid that comes from the patient into the drainage bag 22, and when the drainage stage is complete, the system can measure the amount of fluid drained from the patient. Thus, the amount of ultrariltration can be measured. Then, the fluid can be drained from the drainage bag 22 to exit through the ADP 10 Cermocycler. In this way, the drainage bag 22 can be an intermediate drainage bag 22, since the fluid is first drained into the drainage bag. intermediate 22 to be measured, and is then drained from the system after measurement. Likewise, the heating pouch 20 can serve not only for the purpose of providing a reservoir for heating the fluid, but can also serve as a filling pouch o. 45 intermediate to measure fresh fluid before being administered to the patient.
In some embodiments, the APD 10 thermal cycler can use a backup volume to monitor the volumes of fluid that are administered to the patient and / or drained from the patient. The backup volume monitor can be used to confirm measurements made by load cells 75. In some embodiments, the backup volume monitor can use negative pressure (subatmospheric) and make calculations based on the ideal gas law. In some embodiments, the accuracy of the backup volume monitor has a lower level of accuracy compared to the primary monitoring system (for example, 75 load cells) and the backup volume monitor can be used to verify that the system primary monitoring systems (eg load cells 75) are functioning properly.
Figure 12 is a schematic representation of an exemplary embodiment of an implementation of the pressure-based volume measurement system that can be used by the APD 10 thermal cycler. As described here, the containment chamber 6 can be sealed so that a negative pressure can be maintained on that. The containment chamber can have a total volume of Ven. The heating bag 20 and the drain bag bag 22 can be positioned o 46 inside the containment chamber 6. The heating bag 20 can contain a volume of Vaporizer fluid, & the drainage bag 22 can contain a volume of fluid. The volume of air inside the containment chamber 6 Vcont ar is equal to Vcont - Vaquecedor - Varenagenn A reference chamber 90 can have a Vret volume and can also be sealed to maintain the negative pressure in it. The reference chamber 90 can be connected to the containment chamber 6 by a path
92. A valve 94 can be positioned in path 94 such that the path can be selectively opened and closed. A vacuum pump 96 can be connected to the reference chamber 90 via a path 98. A valve 99 can selectively open and close the path 98. Negative pressure can be applied to the containment chamber 6 by opening valves 94 and 99 and operating at vacuum pump 96 until the desired negative pressure is reached. Then, the valve 94 can be closed by sealing the negative pressure inside the containment chamber 6. The negative pressure can be applied in the reference chamber 90, by closing the valve 94 and opening the valve 99 and operating the vacuum pump 96 until that the desired negative pressure is achieved. Thereafter, the valve 99 can be closed to seal the negative pressure within the reference chamber 90, Thus, the containment chamber 6 and the reference chamber 90 and 90 may independently have one or more pressure sensors to measure the pressure contained therein.
Several suitable pressure sensors can be used.
For example, the Freescale differential pressure sensors from Motorola MPX2053 and MPX2010 or Fujikura XFDM differential pressure sensors can be used by measuring the pressure of the containment chamber 6 and the reference chamber 90 during pressure measurements.
Many alternatives are possible.
For example, a separate path can connect the vacuum pump 96 to the containment chamber 6 and a valve can selectively open and close that separate path.
In this embodiment, the negative pressure can be applied to the containment chamber 6 without opening to the reference chamber 90. In some embodiments, the reference chamber 90 and the containment chamber 6 may have independent vacuum pumps.
Although much of the description here describes the negative pressure (sub-thermostatic) being applied to the containment chamber 6 and the reference chamber 90, in some embodiments, pump 96 can be used to apply positive pressure to the containment chamber 6 and / or the chamber reference number 90. Figure 13 is a flowchart showing an exemplary embodiment of a method 1300 for determining the volume of the fluid contained in the heating bag 20 or drainage bag 22. In block 1302, a first pressure Pioonk & applied in the containment chamber .
In some embodiments, the Prieoae pressure may be at least about -0.1 psig € / or less than or equal to about -1i, 0 psig.
An example of a suitable pressure is about 0.5 psig.
Other values outside these ranges can also be used.
Although several examples provided here are described using a pressure of -0.5 psig in the containment chamber 6, pressures can be used.
In some cases, the Picont pressure can be adjusted up to about 0.0 psig, for example, by venting the pressure containment chamber outside the APD 10 thermal cycler. In some embodiments, a positive or negative pressure is used for Pic, from to test that the containment chamber 6 is properly sealed.
For example, if Picont were intentionally defined as atmospheric pressure, the system would not be able to detect leaks from the containment chamber.
Thus, in some embodiments, the containment chamber 6 is maintained as a non-atmospheric pressure (for example, a negative pressure such as -0.1 psig or more), during use.
In block 1304, a second Pier pressure is applied to reference chamber 90. The Pires pressure can be at least about -5.0 psig and / Cu Less than or equal to about - 9.0 psig, and can be about -7.0 psig, although other
> 49 pressures outside these ranges can be used, IN some modalities, the saucer pressure is set to a more negative pressure than Pick. For example, Pires can be adjusted to a negative pressure value that is 5 times or 10 times or 20 times greater (in the negative direction) than Picont. Other multipliers can be used. In block 1306, valve 94 is opened and, in block 1308, the pressures in the containment chamber 6 and in the reference chamber 90 are equal through path 92. In block 1310, the substantially equalized pressure is measure. & equal pressure can be registered in some modalities. For example, the APD 10 thermal cycler may include a controller that comprises a computer-readable storage medium (non-transitory storage medium). The equalized pressure can be recorded on the computer-readable medium. In some cases, the equalized pressure is stored for later reference, and in some cases, the equalized pressure can be stored for just as long as it is necessary to do the other calculations, as described here.
In block 1312, the volume of air inside the containment chamber is calculated based on the equalized pressure, When the bress Stop & adjusted to a more negative pressure than Picontr in general, after certain and 50 equalization, the equalized pressure will be generally lower as the volume of air Vcont increases, because a larger volume of air inside the containment chamber 6 will have more air available to move into the reference chamber 90 to compensate for the greater negative pressure therein.
In some cases, the computer-readable medium may contain a lookup table that includes values of air volume due to the equalized pressure values. [e] controller can use the lookup table to identify the Veont ar value that corresponds to the measured equalized pressure.
In some embodiments, the controller may understand a formula or algorithm for calculating Vecont ar from the measured equalized pressure.
The search table and / or formula can be generated from or confirmed with previously measured values.
An example formula that can be used is as follows:
Veont ar = ((Poret-Pires) / (PacontP2acont)) * Vres
The measurement can be carried out substantially isothermally with the air temperatures kept at a constant value.
Thus, the APD 10 thermal cycler may have a temperature and heating sensor and / or cooling elements to control the temperature inside the APD 10 thermal cycler. In some embodiments, the temperature sensor
-. s1 temperature e The heating element used to heat fluid inside the heating bag 20 can be used, although other dedicated sensors and heating elements without cooling elements can be used.
It is observed that it is not necessary for the temperature to remain substantially constant throughout the entire process, until the temperature is substantially the same in block 1310 (when equalized pressure is measured) as it is in blocks 1302 and 1304, when the pressures of the containment chamber 6 and the reference chamber 90 are defined.
In some embodiments, a threshold level of temperature difference is considered acceptable, such as, for example, about 2 C, 1 C, 0.5 * C or less.
Other acceptable temperature differences in thresholds can be used as well.
In some cases, the process can be carried out quickly (substantially adiabatically), so that essentially no thermal energy is transferred from the gases being used.
Thus, in some embodiments, the calculations can be based on Boyle's law where the temperature is substantially constant.
In some embodiments, the temperature is not controlled and is not considered to be constant.
On the contrary, temperature measurements can be taken (for example, using one or more temperature sensors 52 configured to measure the temperature in the containment chamber 6 and / or the reference chamber 90) and considered when making the Vcont calculation ar- An example formula that can be used is as follows: mu = P, Ate) / (efe) Tres Tier I / Ticm - Pacom In block 1314, the volume of fluid in the heating bag 20 or in the drainage bag 22 can be determined from the calculated volume of air inside the containment chamber 6 Vecont arr Using the equation Vcont air = Veont - Vaquisor = Varenagen: IF Vaqueceor is known, then Varenagen can be determined, and if Varenagen is known, then Vaquentor can be determined .
Assill, in some modalities, during the operation of the APM Merchant APD, the volume of fluid inside the heating bag 20 and the volume of fluid inside the drainage bag 22 are not changed between the sequential pressure measurements made using the monitoring system pressure-based volume control.
In some embodiments, the Vreg volume of the reference chamber 90 may be at least about 0.25 liter and / or less than or equal to about 5.0 liters.
Some examples of Vret can be about 0.5 liter, 1.0 liter, 2.0 liters or 3.0 liters.
Other values outside these ranges Can be used, In some embodiments, a volume of 53 Low volume teher can be used to keep the size of the APD 10 thermal cycler relatively compact in size so that it can be easily transported (for example, by adjusting it in an overhead airplane compartment to facilitate travel by the user). The maximum volume of the heating bag 20 and the drainage bag 22 can be the same size or different sizes, each of which is at least about 2 liters and / or less than OR equal to about 10 liters, and can be of about 6 liters, although values outside these ranges can also be used. For example, if the heating pouch 20 is not configured to be refilled (for example, supply tubes 31 and 32 omitted), then the maximum volume of the heating pouch 20 may be greater than 10 liters. The volume of the containment chamber 6 can be at least about 5 liters and / or less than or equal to about 20 liters, and can be around 16 liters in some cases, although other values outside these ranges may be used.
Table 1. contains the calculations made using modalities with the reference chambers 90 of volumes of 0.5 liter, 1.0 liter, 2.0 Jitros and 3.0 liters, in which the reference chamber was evacuated to -7 , 0 psiyg. The containment chamber 6 having a volume of 16 liters was used and the measurements were carried out with both the heating bag 54 and the drainage bag having 3 liters of fluid in it, resulting in a Vcont air value of liters, and also with the heating bag 20 empty with 3 liters of fluid in the drainage bag, resulting in a 13 liter S vote, The containment chamber 6 was evacuated to about -0.5 psig. The two pressures were allowed to balance, as described here, and the pressure changes are shown in Table 1. Using a reference volume of 3 liters, with the difference in equalized pressure for an empty heating pouch 20 versus a heating pouch 20 containing 4 , 0 liters of Eluido is 1.5 psi - 1.2198 psi = 0.2812 psi. This indicates that an inaccuracy in the pressure reading of 0.001 psi now corresponds to a fluid measurement error of about 10 grams, or about 10 mL. The volumes and pressures can be adjusted to provide a system that is more or less sensitive to error and / or that exposes the APD 10 thermal heater to more or less negative pressure. Delta Delta Var P2ref | Plref | PlCOon | P2Con | Vref
TETE 6.1905 | -0.3095 | 10.00 - ”- - 0.500 oo 0.809 | 7,000 [0.500 [0.809 o Ss o o 5 compsepen pc pc po [1 and 55 1.090 | 7,000 | 0.500 | 1,090
LFFEET 5.4167 | -1.0833 | 10.00 - ”- - - 2,000 oo 1,583 | 7,000 | 0.500 | 1,583 o o o o 3 5,0000 | -1.5000 | 10.00 - - - -. 3,000 or 2,000 | 7, 000 | 0.500 | 2,000 o o o o o 6,2593 | -0.2407 | 13.00 - - - - 0.500 oo 0.740 | 7,000 | 0.500 | 0.740 o 7 o o 7 6.0357 | -0.4643 | 13.00 - io - - 1,000 oo 0.964 | 7,000 | 0.500 | 0.964 o -s o o Ss 5.6333 | -0.8667 | 13.00 - - 7 - 2,000 oo d, 366 |) 7,000 | 0.500 | 1,366 o 7 o o 7 S, 2813 | -1.2188 | 13.00 -. - - - 3,000 oo 1,718 | 7,000 | 0.500 | 1,718 o 8 o o 8 Table 1: Boyle's Law with —7 psig Vacuum Applied to the Reference Chamber
In some embodiments, the negative pressure inside the containment chamber does not exceed a maximum negative value of about -2.0 psig.
Thus, the containment chamber 6 does not need to be constructed to withstand high negative pressures greater than -2.0 psig, thereby reducing the size, weight and cost of manufacture for the APD 10 thermal cycler, and allowing the APD thermal cycler 10 is used as an ADP gravity / vacuum thermocycler 10, where the containment chamber 10 has O-rings and / or seals that may not be able to reliably withstand extreme negative pressures, for example, as described herein.
Other configurations of APD thermal cyclers can be used.
In some modalities, the reference chamber
90 can be exposed to high levels of negative pressure
(for example, -7.0 psig), and the reference chamber 90 can be constructed to withstand the high negative pressure more easily than can the containment chamber 6 because the reference chamber is a simpler structure (for example, not having a hinged cover to allow the user to access the interior, and / or without having flexible tubes and pins that come out of the chamber with the O-rings and seals). Applying a relatively low negative pressure to the containment chamber can also result in less noise during the operation of the thermal cycler
APD 10, compared to a system that applies a higher negative pressure to it.
Table 2 contains the calculations made using the reference chambers 90 for volumes of 0.5 liter, 1.0 liter, 2.0 liters and 3.0 liters, in which the reference chamber 90 was Wentilated to atmospheric pressure instead to be taken to negative pressure.
A containment chamber 6 with a volume of 16 liters was used and the measurements were made both with the heating bag 20 and with the drainage bag having 3 liters of fluid in it, resulting in a value of Vcont burning 10 liters, and also with the bag heats 20 empty with 3 liters of fluid in the drain bag, resulting in a Vcont air of 13 liters.
The containment chamber 6 was evacuated to about -1.5 psig.
The two pressures were allowed to balance and the pressure changes are shown in table 2. Using a reference volume of 3 liters, the difference in equalized pressure for an empty heating bag 20 versus a heating bag 20 containing 3.0 liters of fluid is 0.34652 - 0.2913 weight = N, 0649 psi. fetus indicates that an inaccuracy in the pressure reading of 0.001 psi now corresponds to a fluid measurement error of about 50 grams (or about 50 mb) which in some cases may be unacceptable to the dialysis community.
However, this modality does not expose the APD thermocylator to negative pressures of more than 1.5 psig.
Delta Delta VarCo | P2ref | Pirer | PICon | P2Con | Vref TErT FS - 0.0714 10.00 - 0.000 -. - 0.500 1.4286 oo 1.428 o 1.500 | 1,428 o 6 o 6 - 0,1364 10,00 - 0,000 - - 1,000 1,3636 oo 1,363 o 1,500 | 1,363 o 6 o 6 - 0,2500 10,00 - ”0,000 - - 2,000 1,2500 oo 1,250 o 1,500 | 1,250 o o o o - ”0.3462 10.00 - 0.000 - - 3.000 1.1538 oo 1.153 o 4.500 | 1.153 o 8 o 8 - 0.0556 | 13.00 - 0.000 - - 0.500 1.4444 oo 1.444 o 1.500 | 1,444 o 4 o 4 ”0,1071 13,00 - 0,000 - - 1,000 4,392 oo 1,392 o 1,500 | 1,392 th 3rd Er TEA
* 59 pemp pe pp | * [* | - 0.2813 | 13.00 | 1,218 | 0.000 | 1,500 | 1,218 | 3,000
STE FEEF Table 2: Boyle's Law with -1.5 psig of vacuum in the Containment Chamber Table 3 contains calculations made using the reference chambers 90 volumes of 0.5 liter, 1.0 liter, 2.0 liter and 3.0 liter, in which the reference chamber 90 was vented to atmospheric pressure instead of being brought up to a negative pressure. The containment chamber 6, which had a volume of 16 liters, was used and the measurements were performed both with the heating bag 20 and with the drainage bag having 3 liters of fluid in it, tasuitando in a 10 liters Vcont air tank, and also with the heating bag 20 empty with 3 liters of fluid in the drainage bag, resulting in a Vcont burns 13 liters. The containment chamber 6 was evacuated to about - 7.0 psig. The two pressures were allowed to balance and the pressure changes are shown in Table 3. Using a reference volume of 3 liters, the difference is the equalized pressure for an empty heating bag 20 versus a heating bag 20 containing 3.0 liters of fluid 1.6154 psi -
1.3125 0.3029 psi = psi. This indicates that an inaccuracy in the pressure reading of 0.001 psi now corresponds to an error
“The measuring fluid of about 10 grams (about 10 mL). Delta Delta VairC | P2ref | Plref | PlICon | P2Con | Vref
TEETTEE 0.3333 10.00 - 0.000 - - 0.500 6, 6667 oo 6.666 o 7,000 | 6.666 o 7 o 7 - 0.6364 10.00 - 0.000 - - 1.000 6.3636 oo 6.363 o 7.000 | 6.363 o 6 o 6 - 1.1667 10.00 - 0.000 ”- 2,000 5.8333 oo 5.833 o 7,000 | 5.833 o 3 o Ss - 1.6154 10.00 io 0.000 - - 3.000 5.3846 00 5.384 o 7.000 | 5,384 o 6 o 6 - 0,2593 13,00 e 0,000 - - 0,500 6,7407 oo 6,740 o 7,000] 6,740 o 7 o 7 - 0,5000 13,00 - 0,000 - - 1,000 6, 5000 oo 6,500 o 7,000 | 6,500 o o o o
EA o 61 6.0667 6.066 7,000 | 6.066
IEF - 1.3125 13.00 - 0.000 - - 3.000 5.6875 oo 5.687 o 7.000 | 5,687 oo 5 Table 3: Boyle's Law with -7 psig Vacuum in the containment chamber Although many of the modalities described here demonstrate the use of negative pressure applied to the Ss containment 6 chamber and / or the reference chamber 90, in some modalities , positive pressure can be used. In some embodiments, the negative pressure applied to the containment chamber 6 can be used not only to determine the volume of fluid being transferred, but also to pull the liquid into the containment chamber 6, such as draining fluids from a patient, as described herein. In some cases, the use of negative pressure, as opposed to positive pressure, can reduce the occurrence of problems during treatment, such as air being pushed into bags 20 and 22 by positive pressure or "unintentional excessive filling due to force applied to bags 20 and 22 by positive pressure Figure 14 is a flowchart that schematically illustrates an exemplary modality of an o 62 method 1400 of treating a patient, for example, by performing automatic peritoneal dialysis (APD). 1402, an APD 10 thermal heater is configured The heating pouch 20 is the temporary drain pouch S 22 can be placed inside the heating tray 72, and the Disposable set 30 can be Loaded, for example, as described here, The system can perform the preparation of the tube and integrity test of the disposable set 30 and any other appropriate preliminary configuration procedures. In some cases, a filled heating pouch 20 is placed on the heating tray 72 in order to reduce therapy costs and to minimize the time before therapy can begin. However, a partially filled pouch, or even an empty pouch, can be placed in the warming pouch when two or more solutions are mixed (for example, introduced through supply tubes 31 and 32) to form a solution that has, for example, an intermediate concentration of dextrose.
In block 1404, the system can determine the initial volume of air in the containment chamber. The containment chamber can be adjusted to a first pressure (for example, about -0.5 psig). The reference chamber can be adjusted for a second pressure (for example, about -7
- 63 psig). The nressions can be equalized and the initial volume of air in the containment chamber can be calculated as described here (for example, using Boyle's Law). d45to can be used to determine the initial fluid volume, if any, in the heating bag 20.
In some embodiments, the equalized pressure in the containment chamber 6 is at a negative pressure (for example, about -1.5 psig) after equalization. The negative pressure can be used to pull the liquid into the drainage bag 20 for the initial drain in block 1406. Compression valves 60b and 60f are opened and the fluid is drained through the patient's tube coil 34 after the open compression valve 60b, after the open compression valve 601, through the line 27, through the seal connector 23º Y, through the pipe 39 and inside the temporary drainage bag 22. In some embodiments, the negative pressure in the containment chamber 6 can be adjusted before or during the drainage to regulate the fluid drainage.
The load cells 75, under the heating tray Ve, can measure the change in the weight of the temporary drainage bag 20 and provide continuous feedback to the controller of the APD 10 thermal cycler. The controller can calculate the flow rate of fluid into the drainage bag
22. The flow rate can typically initially be between about 125 and 250 mMG / min, or it can be less than or equal to about 200 mL / min, for example, and can generally start to slow down according to the peritoneum of the patient empties the fluid.
In block 1408, controller S can recognize when the flow has decreased below a threshold value, or some other indicator that drainage of the patient's peritoneum is almost complete, and in response the controller can reduce the negative pressure inside the containment chamber 6 to the end of the drain when the flow decreases and approaches the “no flow” state. The negative pressure can be released gradually as the rod becomes slower OR it can be released relatively quickly.
In some embodiments, the negative pressure can be reduced to a value of at least about -0.5 and / or less than or equal to -1.2 when the flow rate decreases below a “low flow” rate. The pressure can be adjusted to values outside these ranges when “low flow” is reached.
Reducing pressure at the end of drainage can reduce the level of pain or discomfort experienced by the patient when negative pressure is applied to the patient's peritoneum, when little or no fluid is left to drain.
The negative pressure can be kept substantially constant until the fluid naturally becomes slower, at that time the negative t 65 pressure can be reduced to further delay the flow until the lowest pressure is applied at the end of the drain, depending on the flow for.
This differs from the reduction in suction pressure that occurs naturally with gravity-based drainage as the level of liquid in the temporary drainage bag gradually rises as it increases, gradually reducing the drainage suction throughout the drainage phase.
A “slow flow” threshold can be set to trigger negative pressure reduction.
A “slow flow” event can be triggered (causing a reduction in pressure), if the flow rate remains below the “slow flow” rate for a predetermined period or, such as at least about 1 minute and / or less than or equal to about 10 minutes, or at least about 3 minutes and / or less than or equal to about 10 minutes, the IlLusion threshold ”can be configured to trigger the drain stage stop ( for example, closing the compression valves 60b and 60f.
A “no flow” event can be triggered (causing a drainage stage to end), if the flow remains below the “slow flow” rate for a predetermined time, such as at least about 1 minute and / or less than or equal to about 10 minutes, or at least about 3 minutes and / or less than t 66 or equal to about 6 minutes.
In some modalities, the “slow flow” and “no flow” thresholds are adjustable.
For example, the standard “slow elution” flow rate threshold for an adult patient with a 2000 ml fill volume could be 2% the fill volume or 40 ml / min and the standard flow threshold for “no flow ”could be 0.5% of the fill volume of 2000 ml or 10 ml / min. These values could be reduced to 32 ml / min and 8 mb / min, 20 ml / min and S ml / min, or 16 mi / min and 4 mL / min, if the patient drainageu slower than normal.
The same is true for non-adult patients, where, for example, the standard “slow flow” flow threshold for an adolescent patient with a filling volume of 1000 mB can be 2% of the filling volume or 20 mL / min and the standard flow threshold for “no flow” could be 0.9% of the filling volume of 1000 mt or 5 ml / min.
These values could be reduced to 16 ml / min and 4 ml / min, 12 ml / min and 3 ml / min, or 8 ml / min and 2 ml / min if the patient drained or slower than normal.
In some embodiments, the "slow flow" threshold may be at least about 5 ml / min and / or less than or equal to about 50 ml / min.
Values outside these ranges can be used.
In some modalities, the “no flow” rate can be at least about
Vc 67 1 ml / min and / or less than or equal to about 15 ml / min.
Values outside these ranges can be used. When the drain phase ends, the compression valves 60a and 60f can close and the volume of fluid drained, as measured by the load cells, can be recorded. In block 1410, the volume of fluid in the drainage bag 22 can be determined using the pressure-based system. The vacuum in the containment chamber 6 can be adjusted to a first value (for example, decreased to -0.5 psig crown) and the vacuum in the reference chamber 90 (3 liter size) can be set up to a second value ( for example, increased to about -7 psig). After the two pressures are recorded, the two chambers can be connected and the internal pressure can be equalized. The new pressure readings can be recorded and used together with the previous pressure readings and the air volume from the pre-dry containment chamber previously calculated to calculate the volume of fluid that was drawn into the containment chamber 6 during the drainage. If the volume of fluid as measured by the load cells differs by more than a threshold amount or percentage (for example, 10%) from that calculated using the pressure-based system, an alarm will be issued. Thus, if the volume measurement by the system based
(68 in pressure is between 90% and 110% of the value that was reported by the load cell system, therapy can continue.
If not, an alarm can be issued, Other percentages of error tolerance can be used, such as, for example, any suitable value that is at least about 3% & s / or less than o4 equal to about in
15%. If no alarm is given, the volume of air in the containment chamber after draining can be recorded and the fluid can be administered to the patient from the heating bag in block 1412. In some embodiments, the temperature is measured to determine whether the fluid it is of a temperature suitable for administration to the patient, and the temperature of the fluid can be adjusted, if necessary.
The vacuum in the containment chamber 6 can be adjusted to about -0.1 psig or to any other suitable pressure, or it can be vented to the surrounding pressure.
The compression valves 60g and 60C can be opened and the fluid can flow out of the heating bag 20, through the tube 38, through a sealing connection Y 33, through the tube 28, through the connection 35, and in everything patient 34. Since gravity drives the fluid as it flows, air does not enter the patient’s tube. For example, air can simply remain in the heating bag 20. In some embodiments, a small positive pressure may be applied in order to to facilitate the flow of fluid out of the heating bag 20, or a small negative pressure (for example, -0.1 psig) can be used to prevent air from entering the patient.
The load cells / 5 can measure the change in the weight of the heating bag 20 and provide continuous feedback to the controller. Fluid flow will typically be between about 125 and 250 mL / min and will not generally slow down unless patient tube 34 is restricted. 60g and & 0C compression valves can close when the delivered volume reaches the programmed filling volume. The volume administered, as measured by the load cells, can be recorded on a computer-readable medium.
In block l41d, the volume of rhyme in the heating bag, and thus the volume of fluid administered to the patient, can be determined. The vacuum in the containment chamber 6 will be set to a first value (for example, increased to about -0.5 psig) and the vacuum in the reference chamber 90 can be adjusted to a second value (for example, about - 7 psig). After the two pressures are recorded, the two chambers are connected and the internal pressure can be substantially equalized. The new reading (s) of the
7The pressure is recorded and used together with the previous pressure readings and the volume of air from the post-drainage / pre-filled containment chamber to calculate the volume of fluid that was administered to the patient, if The volume of fluid as measured by the cells of load differs by more than a threshold value (for example, 10%) from that calculated using the pressure-based system, an alarm will be sent. The calculated post-fill air volume of the containment chamber 6 can be recorded.
The fluid can be left in the patient's peritoneum for ONE time known as the stop period. In block 1436, during the downtime period, the vacuum in the containment chamber 6 can be adjusted to about -0.1 psig, or to any other suitable pressure (for example, at least about -0.05 and / or less than or equal to about 0.2), or vented to atmospheric pressure, and the compression valve 60a can be opened. Gravity can cause the temporary drainage bag 22 to empty through line 39, through the sealing Y connection 33, and to and through drainage line 36. Load cells 75 can measure the change in the weight of the temporary drainage 22 and provide Continuous feedback to the controller. Fluid flow will typically be between about 125 and about 250 mL / min and will generally not be
+ * 71 slower unless interim drain bag 22 is empty.
The G60a compression valve can close when flow rates stop and transfer is complete if the displaced volume is within a threshold value (per erxenphto, 100 mL) of the patient's previously drained volume.
The volume that was transferred from the drainage bag 22, as measured by the load cells, can be recorded.
In block 1418, the volume of fluid drained from the drainage bag 22 is determined using the pressure system.
The pressure in the containment chamber 6 can be adjusted to a first value (for example, about -0.5 psig) and the pressure in the reference chamber can be adjusted to a second value (for example, about -7 psid) i.
After the two pressures are recorded, the two chambers can be connected and the internal pressure can be left to substantially equalize.
The new pressure readings can be recorded and used together with the previous pressure readings and the air volume of the post-filled containment chamber previously calculated to calculate the volume of fluid that was transferred out of the drainage bag 22, If it is volume of the fluid as measured by the load cells is different by more than a threshold value (for example, 10%) from that calculated using the Law of
'72
Boyle, an alarm will be sent.
The volume of air transferred after the calculated drainage from the containment chamber 6 can be recorded.
In case the heating bag needs to be refilled before the next filling, the fluid can be transferred to the heating bag in block 1420. The containment chamber can be evacuated up to about -1.5 psid, or to any other suitable value.
The compression valves 60d or 60e are opened as appropriate and the flow rates of the supply or the last bag through tubes 31 or 3º, through connection Y 37, through tube 27, through sealing Y connection 33, through from tube 38 and into the heating bag 20. The load cells 75 measure the change in the weight of the heating bag 20 and provide continuous feedback to the controller. The fluid flow rate will typically be initially between about 125 mL / min and 250 ml / min, or can be less than or equal to about 200 ml / min.
The flow may start to decrease at speed if the reservoir (for example, supply bag) runs out of fluid.
In some embodiments, gravity can be used to transfer the fluid to the heating bag 20. The pressure in the containment chamber 6 can be allowed to decrease (for example, up to a value that is at least about -0.5 psig and / or less than or equal
+: 7s at about -1.2 psig, or even any other suitable value) at the end of the supply phase if the flow substantially decreases.
When the supply phase ends, the Ss compression valve 60d or 60e can close and the fluid volume is replenished, as measured by the load cells, is recorded.
In block 1422, the system can determine the volume of fluid in the heating bag 20 using the pressure system.
The pressure in the containment chamber 6 can be adjusted to a first value (for example, about -0.5 psig) and the pressure in the reference chamber 90 can be adjusted to a second value (for example, about -7 psio) ). After the two pressures are recorded, the two chambers can be connected and the internal pressure can be left to substantially equalize.
The new pressure reading (s) can be recorded and used together with the previous pressure readings and the pre-refueling chamber air volume previously calculated to calculate the volume of fluid that has been withdrawn for the containment chamber 6. If the fluid volume as measured by the load cells differs by more than a threshold value (for example, about 10%) from that calculated using the pressure-based system, a
74 alarm can be sent.
The system can then return to block 1406 and repeat the cycle, if necessary.
Many variations for the 1400 method are possible.
For example, blocks 1420 and 1422 can be omitted if the heating bag 20 contains enough fluid for the next patient's filling stage.
In addition, block 1408 may be an optional feature, not present in all modalities.
The order of certain events described can be changed.
For example, the heating bag 20 could be refilled in blocks 1420 and 1422 before the drainage bag 22 is drained in blocks 1416 and 1418 if space allows.
Treatment can begin with a drainage stage, as described above, in order to drain the fluid that was left in the patient after the final filling step of the previous treatment session.
The treatment session may have a filling stage (near the end of treatment) that is not drained, so that fluid (eg, high density dextrose solution) is left in the patient during the time between treatments (for example, example, which can be performed daily). In some cases, the treatment session may have a filling stage before the first drainage stage, for example, if the patient does not receive an undrained filling stage in a previous treatment.
In some cases, the
: 75 treatment session can start with a drainage stage even if there is no undrained filling stage in a previous treatment (which can result in a low volume initial drainage), thus ensuring that the patient was emptied before the first filling for reduce the risk of filling a patient too much. Other variations are possible.
In some embodiments, the load cells and / or the pressure-based measurement system are able to determine when the temporary drainage bag 22 and the heating bag 22 contain fluid. If the fluid does not flow from the bags when they contain fluid as expected, an alarm can be sent. If the flow rate drops or stops unexpectedly, an alarm can be sent.
The APD 10 thermal cycler may include a controller configured to control the APD process. The controller can control compression valves 60, vacuum pump 96, valves 94 and 99, heating elements, alarms, etc. If the fluid flow slows down or stops during a drain, an alarm, such as an audible alarm that sounds continuously at a low level, can be sent over a period of time (for example, at least about 1 second and / or less than or equal to 10 seconds, or any other suitable time), so that the patient can roll or otherwise change position.
The system can automatically resume draining for an additional time (for example, at least about 1 minute and / or less than about 10 minutes) during which time the condition that caused the alarm can be handled by the user.
If the flow of fluid remains lens or stopped after the 5-minute delay, a continuous audible alarm of a higher level can be sent for an appropriate time (for example, at least about 1 second and / or less than or equal to about 10 seconds, or any other suitable time), so that the patient can roll or otherwise change position.
The system will automatically return the drain for a longer time (for example, skin less than about 1 minute and / or less than about 10 minutes) during which time the condition that caused the alarm can be handled by the user.
If the fluid flow remains slow or stopped after a 6-minute delay, a continuously audible alarm of the highest level can be sent, and can continue until the STOP button is pressed to silence the alarm.
The system can automatically resume draining after the STOP button is pushed and can continue without sending an additional alarm for a period of time (for example, at least about 1 minute and / or less than about 10 minutes).
: 7 minutes), during which time the condition that caused the alarm can be treated. Many variations are possible. A beep alarm can be used. In some cases, a continuous alarm, instead of an audible alarm, is used, as it can be detected by devices used by hearing impaired individuals to alert them when their phones are ringing or the doorbell is emitting. sound. In some cases, the beep alarms could be ignored by these devices, such as closing doors, car explosion, etc. In some modes, alarms can emit sounds for 3 seconds, and the system can delay 5 minutes between alarms, although other times can be used, as described above.
In some embodiments, the audible alarm can be suppressed by plugging a suppression device into the port of the parallel output device. The suppression device can signal to a parent or caregiver (for example, via a text message or pager or e-mail or other notification). The suppression device can also signal a light signaling device, a bed shaker or a vibrating pager in case the patient is hearing impaired. The suppression device could be incorporated into the thermal cycler itself and
: 76. on or off via the operator interface, or it can be an external device.
The APD 10 thermal cycler can emit an alarm when less fluid than expected is drained from the patient into the Ss drain bag 22, possibly indicating a bend OR other obstruction in the tube (for example, if the patient rolls over the tube while sleeping) ). In some embodiments, the system will not emit the alarm if it is close to the expected total amount of fluid that has been drained.
The amount of fluid that failed to drain can be recorded and the volume of fluid to be administered in later filling stages can be reduced to reduce the risk of overfilling the patient.
For example, if multiple drainage stages end prematurely without complete drainage of the patient's peritoneum and if total filling volumes are administered to the patient, the residual fluid left by each incomplete drainage can be added, resulting in overfilling and discomfort and potential injury. for the patient.
This may be the case with a system that sets the patient volume to zero for each cycle.
Thus, in some modalities, the ADP 10 thermal cycler can track the fluid volume in the patient through multiple fillings and drainage cycles and does not define the
Í 79 patient volume as being zero, unless the measured drained volume has exceeded the expected drainage volume (for example, the volume administered in the last filling stage, plus the patient's expected ultrafiltration (UF), plus the residual volume left previous cycles). In some modalities, the system can also adjust the patient's volume to zero after the initial drainage, regardless of the measured drainage volume. In some modalities, an expected drainage volume can be
10. calculated using the filling information from the previous treatment session and the patient's volume is automatically adjusted to zero after the initial drainage. In some modalities, the user can feed an expected UF value that indicates how much extra fluid is expected to be removed from the patient's body at each drainage stage (in excess of the fluid infused from the filling stage). The system can be configured to determine whether to send an alarm when a drain stops before the expected amount of fluid is drained. In some embodiments, the system can send an alarm if less than a threshold amount of fluid has been successfully drained, but if the amount of fluid drained is generally considered close to the full drain value.
: 80 expected, no alarms are sent and treatment continues.
The threshold quantity can be calculated as a percentage (for example, at least about 75% and / or less than or equal to about 99%, or about 85%) of the total patient volume expected at the start of drainage ( for example, the volume of fluid delivered in the previous filling stage plus any residual fluid remaining from previous cycles), or the total expected drainage volume (for example, the volume of fluid delivered in the previous filling stage plus any residual fluid remaining in previous cycles plus the expected UF volume). Table 4d contains a comparison between the two systems when consecutive incomplete drains occur d5 during therapy.
In the first example shown, The system is configured to continue The treatment, instead of sending an “incomplete drain” alarm if about 85% of the previously filled fluid has been drained, regardless of whether the residual fluid remains in the patient from previous cycles .
In the second example shown, the system is configured to continue treatment in order to issue an "incomplete drain" alarm if about 85% of the patient's current expected volume is drained successfully.
: 81 Phase According to Example By Effective For Drainage | 2000 2000 2000 200 (
FNBNINIRA Ee Filling | Start the Lo Finals End 450 750 495 495 Err 750 2 3
: 82 Filling | Start 2250 580 580 Fer EO End 3000 5950 3880 38BU0 (1:
LED Table 4 (values in milliliters) As shown in Table d, in the first example, the patient can be overfilled by about 10% after incomplete drainage, by about 35% after two incomplete drains, and for about 60 % after three incomplete drains, and about 85% after four incomplete drains. In the second example, the patient is overfilled by about 10% after incomplete drainage, by about 27% after two incomplete drains, by about 29% after three incomplete drains, and again by about 29% after four incomplete drains . In the second example, the system
: 83 tracks the expected patient volume and limits the magnitude of any potential overfills.
Figure 15 is a flowchart that illustrates an exemplary modality of a 1500 method for handling an S drainage stage.
If the system receives ONE due indicator the drainage can be completed (for example, the flow stops or falls below a “slow flow” or “no flow” level threshold), the system can perform method 1500. In block 1502, the amount of fluid drained from the patient is measured. The measurement can be made by load cells 75, another weight scale and / or by the pressure-based system described here.
In block 1504, 6 minimum drainage volume can be calculated.
For example, the minimum drainage volume can be the expected drainage volume (for example, the volume of fluid administered in the previous fill stage plus any residual fluid remaining from previous cycles plus the expected UF volume) multiplied by a minimum drainage percentage (for example, about 85%). In block 1506, the system can determine whether the measured drainage volume is less than the minimum threshold drainage volume. if the measured drainage volume is less than the minimum threshold drainage volume, process 1500 can proceed to block 1508 and issue an “incomplete drain” alarm.
: 84 The alarm can be designed to wake the patient so that the patient can change position to unlock the drain tube or take another appropriate action.
If the measured drainage volume is not less than the minimum threshold drainage volume, process 1500 proceeds to Pploco 1510 and updates the expected patient volume.
If the measured volume of fluid drained exceeds the amount of drainage expected, the estimated volume of the patient can be adjusted to zero.
If the measured drained drainage fluid is less than the expected drainage volume, the system can add the difference to the estimated patient volume, which can be used for future calculations.
The overfill limit can be calculated from the prescribed filling volume, the percentage of minimum and expected drainage per UF cycle as follows: Filling Limit = (Prescribed Filling Volume + UF per Cycle) / Minimum Drain% In the modality shown in the second example in Table 1, the filling limit is calculated to be (3000 + 300) / 0.85 = 3882 mL.
On the other hand, the% of minimum drainage can be calculated from a selected filling limit, the prescribed filling volume and the UF per cielo as follows:
: 85
Minimum Drainage% = (Prescribed Filling Volume
+ UF Per Cycle) / Fill Limit In the embodiment shown in the second example of table 1, the minimum drainage percentage is calculated as (3000 + 300) / 3882 = 0.85 = 85%. If the user wants to limit the amount of potential excessive excess to a different number (for example, 3500 mL), the appropriate drainage percentage can be calculated (for example, (3000 + 300) / 3500 = 0.94 = 94%) . The user can enter the desired filling limit, expected UF and the filling volume per cycle, and the system can select a suitable minimum drainage percentage.
If the user selects a low maximum fill limit, then the system will be more sensitive to incomplete drains (for example, giving off an alarm only if a small amount of fluid is not drained), and if the user selects a relatively high maximum fill limit. high, then the system only sounds an alarm if a relatively large amount of fluid is not drained.
In some embodiments, ignoring a minimum drain volume alarm can cause the system to supply less fluid in later filling stages, thus additionally “preventing overfilling of the patient.
In some modalities, an additional cycle may
Õ 86 be added to the treatment session to compensate for the fluid activity that is reduced from the filling stages. The new filling volume can be determined by dividing the remaining therapy volume, excluding the last filling volume, by the number of cycles remaining (including 9 newly added cycles). If necessary, multiple additional cycles can be added, for example, if the patient volume predicted at the end of the stop could still exceed a desired volume after an additional cycle is added. This method of reducing the last filling volumes can result in the use of the entire volume of therapy available, while avoiding filling the patient up to a volume that is greater than a desired limit.
In some modalities, the system can record the uitrafiltration values for each therapy and calculate an average UF for the patient. If the expected programmed UF varies by more than a threshold amount (for example, about 50%) from this average value the system can notify the user that the expected UF entered may be inappropriate. The system can display the average UF value for the patient and ask the patient to confirm the original Value or enter a new expected UF value. If a patient uses different Dextrose solutions, UF can be recorded and an average can be calculated for multiple different concentrations of dextrose (for example, 2 or 3 OR More). The UF target for a therapy can then be programmable for each of the different concentrations of Dextrose.
In some embodiments, the system can use the average UF value if no expected UF value is provided by the user.
The APD 10 thermal cycler can operate at 100-250V AC of 50/60 Hz.
A universal voltage power supply can be used.
In some cases, the heating elements can be powered by a dedicated power source.
A single heating element can be used, or multiple title elements (for example, 2 or 3 or more) can be used.
When the system is switched on, the heating elements can be configured in series.
A comparator circuit can check the voltage drop across a circuit to determine whether the input power was 90-132 volts or 180-275 volts or some other value.
If the input power is 180-275VAC, the heaters can continue to operate in series.
If the power is 90-132VAC, the heaters can be switched to operate in parallel.
The system can retain the heater configuration after momentary power failures.
': 88 The system can use pulse width modulation (PWM) techniques to further refine the power output from the heating elements. For example, a 400 watt heater could be turned on for 50 ms and turned off for 50 ms to produce a useful power of 200 watts. This technique could also be used instead of the series / parallel configuration of the heating elements to allow the system to operate over the range of 400-250V RC 50/60 Hz.
2-0 The heating elements can be added from the heating tray to at least two layers of electrical insulators, instead of one layer of insulation, so that a “pin hole” in one layer would not compromise efficiency isolation and compromise patient safety.
10114] Some aspects of the systems and methods described here can be implemented using, for example, computer software, hardware, firmware or any combination of software, hardware and firmware. Computer software may include computer executable code stored on a computer readable medium (for example, a non-transitory computer readable medium) which, when executed, causes one or more computing devices to perform the functions described herein.
. 7 89 modalities, executable computer code is executed by one or more general purpose computers. It will be realized, in light of the present disclosure, that any feature or function that can be implemented using software to run on one or more general purpose computers can also be implemented using a different combination of hardware, software and / or EFirmware. For example, such a feature can be implemented completely in hardware using a combination of integrated circuits. Alternatively or additionally, such a feature or function can be implemented completely or partially using one or more specialized computers designed to perform the particular functions described here, in instead of general-purpose computers.
Multiple distributed computing devices can be substituted for any computing device described here. In such distributed modalities, the functions of a computing device are distributed (for example, over a network) such that some functions are performed on each of the distributed computing devices.
Some characteristics of the present disclosure can be described with reference to the equations, algorithms and / or
. It is 90 flowcharts.
These methods can be implemented using computer program instructions executable on one or more computing devices, using one or more computer processors.
These methods can also be implemented as computer software, either separately from or as a component of an appliance or system, In this sense, each equation, algorithm, or block or step of a flowchart, and their combinations, can be implemented by hardware, firmware - and / or software, including instructions for computer programs embedded in the computer-readable medium.
As will be appreciated, any such computer program instructions may be loaded onto one or more computers, including, without limitation, a general purpose computer or special purpose computer, or other programmable processing apparatus to produce such a machine. that computer program instructions that exceed computations (nots) or other programmable processing device (s) implement (s) the functions specified in the equations, algorithms and / or flowcharts.
It will also be understood that each algorithm and / or block equation in the flowchart illustrations, and combinations thereof, can be implemented by special purpose hardware-based computer systems, which perform the specified functions or ç 91 steps, or by combinations of hardware for special purposes and logical means of program code readable by computer. Any characteristics of the modalities shown and / or described in the figures that were not expressly described in the present text, such as distances, proportions of components, etc., are also intended to be formed. part of this disclosure.
In addition, although these inventions have been disclosed in the context of various modalities, characteristics, aspects and examples, it will be understood by those skilled in the art that the present inventions go beyond the modalities specifically described for other alternative modalities and / or uses of the obvious inventions and modifications and their equivalents.
Therefore, it should be understood that various characteristics and aspects of the disclosed modalities can be combined with, or by one another in order to carry out different modes of the described inventions.
The present disclosure describes several characteristics, none of which is solely responsible for the benefits described herein.
It will be understood that several features described herein can be combined, modified or omitted, as could be evident to a person normally skilled in the art.
"92
Combinations and sub-combinations other than those specifically described here will be evident to a person normally skilled in the art, and are intended to form a part of this disclosure.
Various methods are disclosed here together with several flowchart blocks.
It will be understood. that, in many cases, certain steps can be combined in such a way that multiple steps shown in the flowcharts can be performed as a single step.
In addition, certain steps can be divided into additional substeps to be performed separately.
In many cases, the order of the steps can be rearranged and certain steps can be omitted entirely.
In addition, the methods described here are to be understood as being open, in such a way that the additional steps to those presented and described in this document can also be performed.
Thus, it is intended that the scope of the present inventions described herein should not be limited by the particular modalities disclosed herein.

权利要求:
Claims (1)
[1]
1. Dialysis system characterized by the fact that it comprises: an infusion system configured to infuse a volume of infusion of dialysis solution to a patient; a drainage system configured to drain fluid from the patient into a drainage container; a controller configured to: identify an indicator that drainage may be complete; determining a drainage volume of the fluid within the drainage container; determine a minimum drainage volume, where the minimum drainage quantity is a percentage of the expected drainage volume, where the expected drainage volume comprises the infusion volume and an estimated residual volume of the patient; and determine if the drainage volume is less than the minimum drainage volume.
2. Dialysis system, according to claim 1, characterized by the fact that the controller is configured to send an alarm if the drainage volume is less than the minimum drainage volume.
3. Dialysis system, according to claim 1, characterized by the fact that the controller is configured to continue the dialysis treatment, if the drainage volume is not less than the minimum drainage volume. 4, Dialysis system, according to claim 3, characterized by the fact that the controller is configured to update the estimated residual volume of the patient as the difference between the expected drainage volume and the drainage volume.
5. Dialysis system, according to claim 4, characterized by the fact that the controller is configured to perform a subsequent infusion step and a subsequent drainage step and to use the updated residual volume of the updated patient to calculate a drainage volume updated minimum for the subsequent drainage stage.
6. Dialysis system, according to claim 3, characterized by the fact that the controller is configured to reduce the volume of a subsequent infusion phase, if the measured volume is less than the expected drainage volume.
7. Dialysis system, according to claim 6, characterized by the fact that the controller is configured to: add an additional infusion cycle to a treatment session schedule; determine an amount of infusion fluid that remains to be infused during dialysis treatment, and determine an adjusted infusion volume by dividing the amount of infusion fluid remaining by a number of programmed infusion cycles.
8. Dialysis system, according to claim 1, characterized by the fact that the expected drainage volume also comprises an expected ultrafiltration volume.
9. Dialysis system, according to claim 1, characterized by the fact that: the infusion system is configured to infuse a second volume of infusion of the dialysis solution to the patient; the drainage system is configured to drain patient fluids into the drainage container a second time, and the controller is configured to: determine a second drainage volume of the liquid drained into the drainage container a second time;
determine a second minimum drainage volume greater than the minimum drainage quantity, where the second minimum drainage volume is the predetermined percentage of an expected second drainage volume, where the expected second drainage volume comprises the second volume infusion and a second estimated residual volume of the patient, in which the second estimated residual volume of the patient is based, at least in part, on the difference between the expected drainage volume and the drainage volume; and determine whether the second drainage volume is less than the second minimum drainage volume.
10. Dialysis system, according to claim 1, characterized by the fact that the predetermined percentage is determined using a formula comprising A = (B + C) / (D), where: A comprises the percentage predetermined; B comprises the volume of infusion; Cc comprises an estimate per ultrafiltration cycle; and D comprises a fill limit.
11. Method for analyzing drainage in a dialysis system, the method characterized by the fact that it comprises: storing a value of a volume of dialysis solution delivered in an infusion filling phase; measuring a fluid drain volume from a drain container after a drain phase; calculate a minimum drainage volume, where the minimum drainage volume is a predetermined percentage of an expected drainage volume, where the expected drainage volume comprises the infusion volume and an estimated residual volume of the patient, and determine using one or more computing devices, if the drainage volume is less than the minimum drainage volume.
12. Method, according to claim 11, characterized by the fact that it also comprises the sending of an alarm, if the drainage volume of the liquid is less than the minimum drainage volume.
13. Method, according to claim 11, characterized by the fact that it also comprises updating the estimated residual volume of the patient as the difference between the expected drainage volume and the drainage volume.
Method according to claim 13, characterized in that it further comprises: storing a value of a subsequent infusion volume for a subsequent filling phase; measure a subsequent drainage volume of the liquid in the drainage vessel after a subsequent drainage phase, and calculate an updated minimum drainage volume using the patient's updated estimated residual volume.
15. Method according to claim 11, characterized in that it further comprises determining a reduced volume for a subsequent infusion phase, if the drainage volume is less than the expected drainage volume.
16. Method, according to claim 15, characterized by the fact that it further comprises: adding an additional infusion cycle to a treatment session schedule; determine an amount of infusion fluid remaining to be infused during dialysis treatment, and calculate an adjusted unfusion volume by dividing the amount of infusion fluid remaining by a number of programmed infusion cycles.
17. Method according to claim 11, characterized by the fact that the expected drainage volume further comprises an expected ultrafiltration volume.
18. Method, according to claim 11, characterized by the fact that it further comprises: storing a value of a second infusion volume for a second filling stage; measure a second volume of fluid drainage in the drainage container, after a second drainage phase, and calculate a second minimum drainage volume greater than the minimum drainage quantity, where the second minimum drainage volume is the pre- determined second expected drainage volume, where the second expected drainage volume comprises the second estimated volume of infusion and a second estimated residual volume of the patient, where the second estimated residual volume of the patient is based, at least in part, on the difference between the expected drainage volume and the drainage volume; and determining whether the second drainage volume is less than the second minimum drainage volume.
19. Method according to claim 11, characterized by the fact that the predetermined percentage is determined using a formula comprising A = (B + C) / (D), in which: A comprises the predetermined percentage determined; B comprises the volume of infusion;
Cc comprises an estimate per ultrafiltration cycle; and D comprises a fill limit.
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Apply —a first 1302 pressure to the container chamber FIG. 13 Apply a second pressure 1304 to the container chamber 4—— 1300 Open The path between the container chamber and the 1306 reference chamber Allow the pressures in the container chamber and reference chamber 1308 to generally equalize 1310 Measure equalized pressure the volume of air 1312 inside the container chamber - based - on the general equalized pressure Determine the volume of 1214 fluid in the bag heater or bag drain based on the volume of air in the container chamber
. 18/19 1402 Adjusting the APD cyclist: | Determine the volume of air | FIG. 14 1404 initial in the chamber | container 1406 Draining patient fluid into the drainage bag 1400 1408 Reduce the vacuum to slowly drain the flow rate Determine the volume of 1410 fluid in the drainage ball Distribute the fluid to the patient ne Determine the volume of 1414 fluid transferred - from the bag heated 1416 Drain the fluid from the drain bag Determine the volume of 1418 drain fluid from the drain bag Reset the fluid in the heated bag 12 Determine the volume of 1422 fluid in the heated bag
Measure the amount of 1502 fluid drained FIG. 15 Calculate the volume of 1504 minimum drainage + - 1500 gm axency Is the measured post-alarm less than minimum : yes Shovel: The drained volume Adjust the measured volume is greater than: 1510 the drained volume AND RIDED os Ceperado E gin | Patient to zero No 1512 Adjust the estimated volume 1514: of the patient
. Summary of the Invention Patent for: “AUTOMATIC PERITONEAL DIALYSIS CYCLIZER AND METHODS OF USE”. Automatic peritoneal dialysis (APD) cyclist systems and methods are disclosed.
The APD cyclist may include a heating tray with load cells configured to measure the weight of fluid contained in a heating bag and / or a drainage bag.
The load cells can be fixed with a pin between the activated and deactivated configurations.
The APD cyclist may include a pressure-based volume measurement system that can be used to confirm measurements made by the load cells.
In some embodiments, the APD cyclist may have algorithms to track an estimated patient volume to avoid overfilling the patient.

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US20210128809A1|2019-11-05|2021-05-06|Fresenius Medical Care Holdings, Inc.|Measuring fluid flow associated with a dialysis machine|

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WO2021242762A1|2020-05-27|2021-12-02|Baxter International Inc.|Peritoneal dialysis using pressurized chamber|

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WO2022031504A1|2020-08-03|2022-02-10|Baxter International Inc.|Peritoneal dialysis cycler using micropump|

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US11135360B1|2020-12-07|2021-10-05|Icu Medical, Inc.|Concurrent infusion with common line auto flush|

法律状态:
2021-04-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-08-03| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-10-13| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 20/12/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |

优先权:

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申请号 | 申请日 | 专利标题

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US28474509P| true| 2009-12-24|2009-12-24|

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US61/284,745|2009-12-24|

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PCT/US2010/061378|WO2011079083A2|2009-12-24|2010-12-20|Automated peritoneal dialysis cycler and methods of use|

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