Dialysis system having supply container autoconnection.

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PATENT TITLE No. 348969

Holders): BAXTER INTERNATIONAL INC .; BAXTER HEALTHCARE SA

Address: One Baxter Parkway, Deerfield, Illinois, 60015-4633, USA

Name: DIALYSIS SYSTEM THAT HAS SELF-CONNECTION OF SUPPLY VESSEL.

Classification: CIP: A61M1 / 28.

CPC: A61M1 / 288 ............

Inventor (s): ROBERT CHILDERS; KURT HOLMQU1ST; PETER HOPPING

REQUEST

Number: International Presentation Date:

MX / a / 2013/008452 July 1, 2008.

Divisional Patent Number: 311740

PRIORITY

Country: Date: Number:

US July 5, 2007 11 / 773,750

Validity: Twenty years

Expiration Date: July 1, 2028

Issue Date: July 5, 2017 ......

The reference patent is granted based on articles 1^or, 2nd section V, 6th section III, and 59 of the Industrial Property Law.

In accordance with Article 23 of the Industrial Property Law, this patent is valid for twenty years. Non-derogable from the date of filing the international application and will be subject to the payment of the fee to keep the rights in force.

Whoever signs this title does so based on the provisions of articles 6 ° fractions lll and 7 ° bis 2 of the Industrial Property Law (Official Gazette of the Federation (DOF) 08/27/1991, amended on 02 / 08/1994, 10/25/1996, 12/26/1997, 05/17/1999, 01/26/2004, 06/16/2005, 01/25/2006, 05/06/2009, 06/01 / 2010, 06/18/2010, 06/28/2010, 01/27/2012 and 04/09/2012); items 1^or, 3^or Section V subsection a), 4th and 12th sections I and III of the Regulations of the Mexican Institute of Industrial Property (DOF 12/14/1999, amended on 07/01/2002, 07/15/2004 07/28/2004 and 9/7/2007); Articles 1, 3, 4, 5 section V subsection a), 16 sections I and III and 30 def Organic Statute of the Mexican Institute of Industrial Property (DOF 12/27/1999, amended on 10/10/2002, 07/29/2004, 08/04/2004 and 09/13/2007) 1st, 3rd and 5th subsection a) of the Agreement that delegates powers to the Deputy General Directors, Coordinator, Divisloffitfes Directors, Heads of the (Regional Offices, Divisional Deputy Directors, Departmental Coordinators and other subordinates of the Mexican Institute of Industrial Property, (DOF 12/15/1999, amended on 02/04/2000, 29 / 07/2004, 04/08/2004 and 13/09/2007)

This document is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 of its Regulations, and 1 fraction lll, 2 fraction V, 26 BIS and 26 TÉR of the Agreement establishing the guidelines for the use of the Payment and Electronic Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.

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DIVISIONAL PATENT DIRECTOR NAHANNY CANAL REYES

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Arenal No 550 Floor t Town Santa María Tepepan, Xochimilco. 16020

Mexico City (55) 53340700 www.gob.mx/impi ira

MX / 2017/53220

INSTITUTO MLXICANI; ίζ ** · * ^ ·. £, OF THE HRUNEUAD kSMr'W 'industrial -

DIALYSIS SYSTEM THAT HAS AUTO-CONNECTION OF

SUPPLY CONTAINER

BACKGROUND

The examples discussed below generally refer to a supply of medical fluid. More particularly, the examples describe systems, methods and apparatus for automatic peritoneal dialysis (APD).

Due to various causes, a person's kidney system can fail. Kidney deficiency produces several physiological disorders. The balance of water, minerals and the excretion of the daily metabolic load is no longer possible and the toxic end products of nitrogen metabolism (urea, creatinine, uric acid, and others) can accumulate in the blood and tissue.

Kidney failure and reduced kidney function have been treated with dialysis. Dialysis removes waste, toxins, and excess water from the body that the normally functioning kidneys would otherwise remove. Dialysis treatment for the replacement of kidney function is critical for many people because the treatment saves lives.

One type of kidney failure therapy is peritoneal dialysis, which infuses a dialysis solution, also called dialysate, into a patient's peritoneal cavity through a catheter. The dialysate contacts the peritoneal membrane of the cavity

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INDUSTRIAL peripherals !. Water, toxins, and excess water pass from the patient's bloodstream, through the peritoneal membrane, and into the dialysate due to infusion and osmosis, that is, an osmotic gradient occurs, across the membrane. Spent dialysate is drained from the patient, removing waste, toxins, and excess water from the patient. The cycle repeats.

There are several types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis (CAPD), automatic peritoneal dialysis (APD), tidal flow dialysate, and continuous flow peritoneal dialysis (CFPD). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to a drain, which allows spent dialysate fluid to drain from the peritoneal cavity. The patient then connects the catheter to a bag of fresh dialysate, which infuses the fresh dialysate through the catheter and into the patient. The patient disconnects the catheter in the fresh dialysate bag and allows the dialysate to remain within the peritoneal cavity, where the transfer of waste, toxins, and excess water takes place. After a period of residence, the patient repeats the manual dialysis procedure, for example, four times a day, each treatment lasting approximately 1 hour. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, leaving ample room for improvement.

Automatic peritoneal dialysis (APD) is similar to CAPD in that dialysis treatment includes drainage cycles,

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I ND'JSI rial filled, and permanence. However, APD machines cycle automatically, typically while the patient is sleeping. APD machines free patients from having to manually go through treatment cycles and stop to transport supplies during the day. APD machines are fluidly connected to an implanted catheter, to a fresh dialysate source or bag, and to a fluid drain. APD machines pump fresh dialysate from a dialysate source, through the catheter, into the patient's peritoneal cavity, allowing the dialysate to remain within the cavity and for the transfer of waste, toxins, and water to take place. in excess. The source can be multiple bags of sterile dialysate solution.

APD machines pump spent dialysate from the peritoneal cavity, through the catheter, without drainage. As with the manual procedure, it occurs in several drain, fill, and dwell cycles during dialysis. A last fill occurs at the end of APD, which remains in the patient's peritoneal cavity until the next treatment.

Both CAPD and APD are batch or intermittent type systems that send dialysis fluid down a drain. Tidal flow systems are modified group systems. With tidal flow, instead of removing all of the fluid from the patient over a longer period of time, a portion of the fluid is removed and replaced after smaller increments of time.

Some flow-through systems, or CFPDs, clean or

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H · PE industrial pronegap regenerates spent dialysate instead of discarding it. Others use a large volume of fresh dialysate. The systems pump fluid in and out of the patient, through a circuit. In a regeneration system, dialysate flows into the peritoneal cavity through one catheter lumen and out of another catheter lumen. The fluid leaving the patient passes through a reconstitution device that removes waste from the dialysate, for example, through a urea removal column that uses urease to enzymatically convert urea to ammonia. The ammonia is then removed from the dialysate by absorption before the dialysate is reintroduced into the peritoneal cavity. Additional sensors are used to monitor ammonia removal. Regeneration CFPD systems are typically more complicated than group systems.

For PD systems, home hemodialysis / hemofiltration, and intensive care unit procedures using peritoneal dialysate or bagged hemodialysis, the hemofiltration replacement solution can use a double chamber bag. For example, bicarbonate-based solutions were developed for certain of the above applications. Bicarbonate is unstable in the presence of magnesium and calcium reports a precipitate after a period of time. The bicarbonate-based solutions are therefore provided in a double-lot chamber. Before use, a seal is broken between the two chambers and the two concentrate solutions are mixed and

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IMPI ΐΜ-πτυτο Mexican

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used before a calcium or magnesium precipitate can form. Unfortunately, a single concentrate solution dispensed to a patient because the two concentrated solutions do not mix can create a physiologically unsafe condition for the patient.

The posterior system addresses several disadvantages with the aforementioned medical fluid treatments.

BRIEF DESCRIPTION OF THE INVENTION

The present description describes an improved automatic peritoneal dialysis (APD) system, however, many of the teachings here are applicable to other medical fluid treatments, especially other renal failure therapy treatments, such as hemodialysis (HD), hemofiltration ( HF), hemodiafiltration (HDF) and continuous renal replacement therapy (CRRT).

The system offers improved treatment and ease of use features. The system is mobile in a mode so that the patient can, for example, initiate therapy in the family room and move the system to a room on the same floor. The system handles the use of supplies, which are transported with the device and instrument when the patient moves the instrument. The system also employs a bag handling system, which tilt the supply bags so that gravity

<img file="MX348969B_D0004.tif" />

cause fluid to flow from them, leaving air behind during normal setup and operating sequence. The gravity-induced air separation in the supply bags allows the system to pump at high flow rates because there is little concern that air will not be properly removed while pumping fluid.

The system provides a cart that has a swivel support plate or turntable that supports the instrument and allows it to rotate for convenient operation, making at least the vast majority of system features easily accessible. This can allow the patient to correct most alarms when they get out of bed. The turntable can optionally have brake positions every ninety degrees or so on.

The system includes an improved setup procedure that utilizes a patient line that has dual lumens. During patient line preparation, fluid flows down one lumen away from a discard cassette and back to the other lumen into the cassette forming a closed loop feedback indicating when preparation is complete. This feedback is operable even with patient line expressions. U.S. Patent Application No. 2004/001 931 2 A1, Figure 2, provided by the possible representative of the present description, shows a tip protector for a double lumen patient line that is compatible with this preparation technique. The dual lumen line also eliminates the bulk of the

INSTITUTO MEXICANi DE LA MOHEDAL) INDUSTRIAL spent effluent fluid that returns (recirculates) when the drain instrument cycles are filled. Additionally, the dual lumen line adapts the perception of Intraperitoneal Pressure (IPP) to optimize patient filling and drainage volumes as described in US Patent 6,497,676, assigned by the eventual attorney-in-fact of the present disclosure, the complete contents which are expressly incorporated herein by reference. Additionally, the dual lumen patient line allows the same disposable appliance to be used for small and large patients due to the near zero recirculation volume.

The system also provides a self-connecting mechanism that connects supply bag connectors to cassette supply line connectors. In one embodiment, the system provides up to four supply bags, which can be connected to a self-connecting mechanism connector. Each bag of solution can be the same or different. The self-connecting mechanism is advantageously capable of using the same solution bag (eg, made having existing barbs and barb septa with existing equipment and procedures). The tip protectors that protect the supply and bag pigtail connectors are modified to be compatible with self-connection mechanisms.

As discussed in detail below, the system of the present disclosure is readily adapted for high volume therapy. In one implementation, the system uses multiple of₈ ΙΜΡΙλ ^

INSTITUTO MEXICANO b 'LA I POPI “I&gt; AO (ΝΟύν.νίΛΙ four to one, which allow any or more of the four supply bag inputs to the se cna cassette ο I é ^ lYou keep up to four bags for treatment. The four-to-one multiples work in conjunction with the self-connection and self-identification systems described here. Up to four four-to-one multiples, each being capable of connecting to four, for example, with the same solution, of the supply bags can accommodate a therapy volume of, for example, up to ninety-six liters.

Each of the manifold lines in the four-to-one manifold is placed on the self-connecting mechanism for connection to the supply lines connected to the disposable cassette. The single supply line of the disposable cassette can now connect up to four solution bags. A resonance system recognizes the four-to-one connector and the type of junction made at the end of the multiple (line one) of the four-to-one multiple.

The auto-connect system also includes an automatic clamping system, which allows the user to avoid having to clamp and release the solution lines during connection procedure or when an alarm condition occurs.

The resonance system or solution identification system that verifies volume, expiration date, composition, and configuration (for example, single bag solution, multi-chamber bag solution, or multi-bag solution that requires mixing) before the bags are connected. The solution identification system verifies that the composition and volume of the solutions are r ^ ngigigrites with the therapy prescription before connection. The solution identification system also: (i) automatically draws the solution in the correct sequence when the correct solution bags are loaded; (ii) informs the user if the wrong solution bags are loaded; and (iii) alerts the user if a solution bag connector is deformed, potentially causing an improper connection.

The disposable device (coffee, bags and lines) of the system is relatively simple and easy to use and requires few product codes because all geographic regions can use the same disposable device for pediatric and adult patients, and with volumes of therapy. up to ninety-six liters. Disposal apparatus lines are connected to organizers (e.g., cassette supply lines - connected to a first organizer and patient and drain lines connected to a second organizer), which prevents the lines from tangling and facilitates loading of the tubes. lines in the auto-connection system.

The disposable apparatus allows mixing as described in US Patent No. 5,925.01 1, assigned by the eventual attorney of the present description, the full contents of which are expressly incorporated herein by reference, or for the provision of solutions. individual part, or dodle part solutions contained in an individual bag. If a loose or brittle seal needs to be broken before use, the system can verify₁₀ IMPI ^

Mexican INSTITUTE

Di- LA PROi lLDAD INCUSTRIAL that broke before the solution is delivered to the patient. Capacitive sensors located on the bag handling shelves are used to verify that the seal has been broken and that the same solution is present in both chambers (ends) of the solution bag.

In an alternative embodiment, the sensor is an inductive sensor, which can (i) detect whether an emitter chamber bag was properly loaded on one of the bag handling shelves and (ii) detect whether a brittle seal between two bags of chambers are broken so that the concentrated solutions can be properly mixed for delivery to the patient. The inductive sensing apparatus and method are not limited to renal applications and can be used to confirm placement, mixing, etc. for any medical fluid system using dual or multiple chamber bag solutions.

The system further provides a non-invasive temperature measurement feature or technique. The heat perception technique uses a non-invasive infrared temperature sensor and electromagnet. The electromagnet controls the orientation of the temperature sensor. The disposable cassette has lamination with a black or opaque area. A first orientation of the infrared sensor is trained in the black or opaque area and consequently measures the lamination temperature. The second orientation of the infrared sensor is trained on a lamination area that is not black or opaque and thus can be seen through the lamination on the

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fluid behind the lamination. This second infrared sensor reading measures a combination of film and fluid temperature. Algorithms for calculating fluid temperature from the two infrared temperature readings are discussed here.

The HomeChoice® APD system marketed by the attorney-in-fact within the present disclosure uses a method described in US Patent No. 4,826,482 (the '482 Patent), to determine the volume of fluid pumped to the patient or drain. This method essentially looks back after a pump stroke to see how much fluid was pumped into the patient. While this system has been highly successful, there are several reasons to know the volume of the pumped fluid during the pump stroke or in real time. The reasons are discussed in detail below but generally include: (i) being able to fill / drain a patient to a volume that is not equal to a full number of pump strokes; (I) be able to know immediately when a patient is drained or emptied or virtually emptied to reduce pain at the end of the drain; (iv) provide the necessary accuracy for mixing solutions; and (v) help eliminate the need to provide an alternate fluid source, so that a partially filled pump chamber can be differentiated from a pump chamber containing air and fluid.

Real-time system and method in one mode verifies pressure drop in a pressurized tank in fluid communication ¹²

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DI U rKCHHlA · -, o7_ * Sr «3 with the cassette pump chamber discard. The systemjsnaino ^ íwns' * volume of air or gas (V_gas) in the chamber of hnmkn nntnr Hp open the _ valve to the tank. Then after the valve to the tank is opened the system takes pressure readings at desired intervals and performs a calculation after each reading. The initial pressure (P1) in the tank is known. If the pressure at any given point in time is taken as ΡΓ then a relationship can be expressed in an equation form as follows:

(Ρ1 / ΡΓ-1)

This ratio is multiplied by an addition of the volume of gas

V_gas θ a known volume of the tank V_sothan to form a volume in real time) of the pumped fluid V_Fj_or¡_d0 = (P1 / P1 '-1) Vtank⁺ Vgas) · P1 is initially equal to ΡΓ, which thus makes the initial real-time volume of the pumped fluid equal to zero. As P1 'becomes increasingly smaller than P1 with time, (Ρ1 / ΡΓ-1) becomes increasingly larger with time as does Vfi ui do ·

Realtime volumes are useful for many purposes as described above. An algorithm for using real-time volumes to determine characteristics such as: (i) whether a fill pump stroke occurred is described below; (ii) if a line occlusion occurred; (iii) if a leak occurred; and (iv) whether multiple concentrates were properly mixed, for example.

The cassette in one embodiment has a lamination welded to the

MEXICAN INSTITUTE

Dt LA TROFITTY v * · *. ™ * '* »^ industrial molded plastic part as described in US Patent Nos. 5,401,342, 5,540,808, 5,782,575 7 bUUl2LH. In an alternative embodiment, the plastic part molded into a lamination is enclosed within a lamination welded but not welded to the lamination. The lamination in one embodiment is welded to itself and to the tubing attached to the cassette, allowing the interior of the lamination that includes the molded plastic part to be isolated from the environment. This cassette assembly provides flexibility in material selection for molded plastic, lamination, and tubing because lamination to the molded plastic seal was eliminated. The lamination material therefore needs to be compatible with the rigid cassette material from a welding or bonding point of view.

A disposable cassette having three pump chambers is also shown and described later. The three-chamber cassette provides a number of advantages, such as allowing continuous flow into and out of the pump even when running standard therapy, for example in a group. With two pump chambers, fluid measurement is performed in an attempt to make the patient flow essentially continuous. For example, fluid measurements can be made in one pump chamber, while the other pump chamber is halfway through its pump stroke and vice versa. However, fresh supply and drain flow rates are trading because it will flow more fluid at certain times than at others. The three-pump cassette¹⁴ IΜ p I ί ^ 5

INSTITUTO MúiüC. '. Nr; · also allows continuous flow to a patient inc mix two solutions online. __. ____________

The system also includes an improved manifold cassette / membrane system or assembly. Assembly to a system includes a bottom plate having pump actuation areas with actuation ports to allow a positive or negative portion to be applied within the pump actuation areas toward the membrane gasket to correspondingly position a positive or negative pressure on a juxtaposed flexible lamination of the discard cassette. Similarly, the interface plate includes valve actuation areas with actuation ports to allow positive or negative pressure to be applied within the valve actuation areas to the membrane gasket to correspondingly position the positive or negative pressure. negative on the juxtaposed flexible lamination of the discard cassette. In addition to the actuation ports, the cassette interface includes an exhaust port to evacuate air between the membrane gasket and the cassette lamination adjacent to each pump and each valve.

The packing includes knockouts that seal around the side walls of the valve actuation ports or pump chambers. Knockouts include a thin sleeve or portion that extends over the valve or pump actuation ports. The positive or negative pressure applied across the actuation ports similarly therefore¹⁵ IMPl * 5S ^

INSTITUTO MUiCANí »applies to the sheath portion of the blind holes of iS ^ ií ^^ j'ibrSs ^^ gdl positive or negative pressure applied to the sheath portion consequently causes a bending of the sheath portion and correspondingly a pressure of the cassette lamination.

The membrane also provides a through hole for each vent port on the interface plate. Through holes seal around the protruding evacuation ports sidewalls and allow negative pressure applied through the evacuation ports to suck the cassette lamination against the sheath portions of the membrane gasket forming pump areas or valve. In this way, for a given pump or valve area, the membrane gasket and the cassette lamination flex back and forth together.

If a hole develops in the membrane packing or cassette lamination, the vacuum level through the evacuation port on the leak decreases, indicating the leak. Thus, the evacuation ports also serve as multi-location leak detectors on the cassette, providing superior leak detection with the ability to indicate where the leak occurred from the cassette lamination or membrane packing. This leak detection ability is present prior to initiation of therapy as well as during therapy.

The system also says that membrane packing and cassette lamination incur a leak. If the fluid is not drawn

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between membrane packing and lamination, the leak is in membrane packing. If fluid is drawn between the membrane gasket and the lamination, the leak is in the cassette lamination. This can be a valuable tool, for example when diagnosing a machine that appears to be malfunctioning.

The cassette infeed, in one embodiment, also integrates the pneumatic manifold with the cassette interface so that the air traveling from the rear side of the cassette pump chambers is discarded into the volumetric reference chambers (one for each pump chamber). , used for air and volumetric accuracy calculation) of multiple tire do not have to travel too much. The enclosed space also tends to make the air temperature in the passages, reference chambers, and pump chambers the same. This is useful for a pneumatic pumping technique that assumes a constant temperature between the air in the volumetric reference chambers and the medical fluid or dialysate pumped through the disposable cassette. The dialysate is located on another side of the cassette roll from the air in communication with the pneumatic source and the volumetric reference chamber. The fluid temperature needs to be approximately that of the human body, for example approximately 37 ° C. The air in the reference chamber should therefore be approximately 37 ° C.

The system in one embodiment provides a heater at the cassette interface, which heats the interface plate, the chambers

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DE La MOMEI * I&gt; C ^ jL · industrial * r¡ of volumetric reference and the pneumatic passages at an individual temperature to stabilize the entire pneumatic circuit at a desired temperature. The heated interface plate also allows reference chambers to be brought to temperature more quickly, especially on cold days. Quick warm-up also saves a substantial amount of time during system calibration. The interface plate in one embodiment is made entirely of metal, which can be heated. Alternatively, a cassette interface portion of the manifold, to which pneumatic control valves that control pressure are attached to the fluid valves, is plastic. The reference chambers are metallic and are provided in a module with a heating element, such as a rugged heating element. The module is attached to the plastic interface. The interface includes pump chamber walls that have a metallic or thermally conductive section. This transfers heat to the pump chamber interface wall, which heats the air there.

Therefore it is an advantage of the present disclosure to provide an improved medical fluid system, such as for APD, HD, HF, HDF and CRRT.

It is another advantage of the present disclosure to provide a medical fluid system that has a swivel base, which makes the features of the device easily accessible.

Furthermore, it is an advantage of the present disclosure to provide a medical fluid system that is relatively mobile. ¹⁸ IMPI

INSTITUTE MV.IéANO * οΕΐΛΝ · .ο. · Ί · - · Μ.

and that transports the supply bags while se'W ^ eAre system.

It is a further advantage of the present disclosure to provide a medical fluid system that positions the fluid supply bags while tending to trap air in the bags.

Another advantage of the present disclosure is to provide a non-invasive temperature sensing apparatus and method.

It is even a further advantage of the present disclosure to provide a disposable coffee where at least one of: (i) the cassette includes three pump chambers; and (ii) the molded plastic part of the cassette is provided within a bag made of flexible lamination sealed together with the tubing already attached to the molded plastic part.

It is yet another advantage of the present disclosure to provide a method and apparatus for real time measurement of the volume of pumped fluid.

Furthermore, it is an advantage of the present disclosure to provide a fluid management system (FMS), which has improved temperature control for a fluid volume measurement system using the ideal gas law.

Yet another advantage of the present disclosure is to provide improved leak detection in a pneumatically actuated pumping system.

Furthermore, it is an advantage of the present disclosure to provide an improved manifold membrane cassette / package.

¹⁹ IMPI »INSTITUTO MEXICAN

OF THE RROPIEDAI

Even a further advantage of the present ISRW'P'b i ó ñ * -is to provide a solution self-connection mechanism and a self-identification mechanism to ensure that an appropriate solution in a Appropriate volume for a particular supply bag will be delivered to a patient.

Still a further advantage of the present disclosure is to provide an improved preparation technique utilizing a dual lumen patient line and an apparatus and method for automatically connecting the dual lumen patient line to a dual port transfer apparatus.

Furthermore, an advantage of the present disclosure is to provide an apparatus and method for automatically detecting whether a bag of therapy solution was loaded.

A related advantage is to use the above bag detection apparatus and method to automatically detect whether a multi-chamber solution bag was properly opened so that the solution within is properly mixed for delivery to the patient.

A further related advantage is that the above bag detection apparatus and method is non-invasive, which maintains the sterility of concentrates and preserves bags and other solution disposables.

Additional features and advantages are described herein and will be apparent from the following detailed description and figures.

BRIEF DESCRIPTION OF THE FIGURES

IMPI

MEXICAN INSTITUTE.

Dk LA PROFIEL'Ab INDUSTRIAL

Figure 1 illustrates an embodiment of a dialysis system cart with a machine stand, rotating stand.

Figure 2 illustrates the cart of Figure 1, where the dialysis machine was rotated to have the solution bags facing the front of the cart.

Figure 3 illustrates a system using the cart in Figure

1, where the dialysis machine was rotated to have the machine controls facing the front of the cart.

Figures 4-9 illustrate an embodiment for a delivery bag loading procedure for a bag handling system of a dialysis system of the present disclosure.

Figure 10 is a perspective view of one embodiment of a disposable apparatus of the system of the present disclosure.

Figure 11 is a perspective view of one embodiment of a four-to-one manifold useful with the disposable apparatus of Figure 10.

Figure 12 is a perspective view of an embodiment of an instrument of the system of the present disclosure, including a self-connecting mechanism operable with the disposable apparatus of Figure 10.

Figures 13A to 131 are perspective views illustrating one embodiment of the supply line self-connection sequence utilizing the self-connection mechanism of Figure ₂₁ WICKED ¹ MEXICAN INSTITUTE

BE THE PROPERTY

INDUSTRIAL ί

12.

Figure 14 is a perspective view of one embodiment of a self-identification mechanism operable with the self-connection mechanism of Figure 12.

Figures 15A to 15C illustrate one embodiment of a patient line auto-connect sequence using the auto-connect mechanism of Figure 12.

Figure 16 is a perspective view of one embodiment for a disposable pump cassette having a rigid portion supported in a sealed pump lamination bag.

Figures 17A and 17B are front and rear views, respectively, of an embodiment of a disposable pump cassette having three pump chambers.

Figure 17C shows one possible valve arrangement for the three-chamber pump cassette of Figures 17A and 17B to achieve the pumping rates shown in connection with Figures 18A through 18C.

Figures 18A through 18C are schematic views showing pumping sequences using the three-pump chamber cassette of Figures 17A and 17B.

Figure 19 is a perspective view of one embodiment of a pneumatic pumping system of the present disclosure, including a manifold cassette interface, a membrane package, and a disposable cassette.

Figure 20 is a perspective view of an interface of ²² IΜPI mmn n, mexícan. , »,, .....,,,,.^Dt the remaining cassette of manifold and membrane packing of the pneumatic system of Figure 19. ........—- Figure 21 is a perspective view of an interface plate of the cassette interface of the pneumatic pumping system of Figure 1 9.

Figure 22 is a perspective view of a membrane gasket of the pneumatic pumping system of Figure 19.

Figure 23 is a perspective view of the reverse side of the interface plate of Figure 21, which metal and may include a heating band for heating the reference chambers formed on the interface plate.

Figure 24 is a perspective view of a reverse side of an alternative manifold, including a plastic interface and a control valve connection portion and a heated reference chamber module connected to the plastic portion.

Figures 25A and 25B are front and rear perspective views of the plastic interface and control valve connection portion of the assembly of Figures 24.

Figures 26A and 26B are front and rear perspective views of the heated reference camera module of the assembly of Figure 24.

Figure 27 is a schematic view of one embodiment of a pneumatic system for operating a real-time method of determining the volume of fluid moved.

Figures 28A through 28F illustrate one embodiment of a real-time method for determining the volume of fluid moved df^DUSTWAL

Figure 29 is a real-time 4th fluid volume chart calculated through the method of Figures 28A and 28F.

Figure 30 is a schematic flow chart illustrating an example of pneumatically actuated pumps undergoing a fresh fluid base fill, utilizing the real-time method discussed in connection with Figures 28A through 28F, and wherein the The dialysis system uses mixed lines of dextrose and bicarbonate concentrates.

Figure 31 is a schematic flow chart illustrating an example of pneumatically actuated pumps undergoing fluent phase fill (drain fluid from patient), using the real-time method discussed in connection with Figures 28A through 28F.

Figure 32 is a schematic view of one embodiment for a non-invasive temperature sensing system and method having a temperature sensor in a first position.

Figure 33 is a schematic view of one embodiment for a non-invasive temperature sensing system and method having a temperature sensor in a second position.

Figure 34 is a graph comparing the results of the temperature sensing system of Figures 32 and 33 against those of an invasive temperature sensor.

Figure 35 is a schematic illustration of one embodiment of an inducer solution container charging system in a

IMPI unmixed state of perception.

Figure 36 is a schematic illustration of the embodiment of the system of Figure 35 in a mixed perception state.

Figures 37A to 37D are schematic views of one embodiment of an inductive sensing system employing multiple emitters and receiving the system capable of orientation detector supply container loading.

DETAILED DESCRIPTION

Mobile Cart System

Referring now to the drawings and in particular Figures 1 to 3, there is illustrated a dialysis system, such as the automatic peritoneal dialysis (APD) system 10. It should be appreciated that the system 10 can be used with other types of devices. renal failure therapy systems, such as any of those previously maintained.

Figure 1 illustrates that the system 10 includes a movable cart 12, which allows the system to be easily moved, for example, from a family room to a bedroom and vice versa. Cart 12 includes a turntable type bracket 14, which provides ample access to controls 22 and bag handling system 30 of instrument 20 at all times. The bag handling system 30 organizes the loading of supply bags at the start of therapy 25 as shown here in detail. The turntable holder 14 in

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One mode is equipped with retainers that prevent the system from rotating during operation. A cutout or hole in the center turntable bracket 14 allows a power cable to pass through the shelves 16 of the calrro 12. The turntable bracket can also have a total rotation limit, for example 360 ​​degrees or the like. , to prevent damage to the power cable due to over-rotation.

For example, instrument 20 can be rotated to face the patient to provide easy access to the bag handling shelves of bag handling system 30. Instrument 20 can then be rotated to provide optimal access to controls 22, display 24, self-connecting mechanism 26 and cassette loading mechanism 28 during the setup procedure as seen in Figure 3. Also, the instrument 20 can be rotated so that the screen 24 and controls 22 face the patient's bed when the patient is asleep. Here, if an alarm sounds, the patient can potentially access controls 22, drain line, supply bag lines, etc., without leaving the bed.

Mobile cart 12 includes shelves or drawers 26, which support auxiliary supplies needed for dialysis therapy. To move the system 10, the patient needs to disconnect a power cord. The movable cart 12 accommodates the drainage bag, for example, on the lower shelf 16. The separate drainage cart allows the cart 12 to move without first having to load the drainage bag.²⁶ pi

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bag of a drain. If a drain line runs to'-dreTr ^? ^^ from home instead of a bag, the drain line pi übyUluiiie.Hlw · --- will have to be removed from the drain and placed on carriage 12 when moving the system 10. A handle 18 makes it easy to move the system 10 and in one embodiment it can rotate upward for movement of the carriage 12 and down and out of the path when not necessary.

Bag Management System

Referring now to Figures 4 through 9, one embodiment is illustrated for the bag handling system 30 of the dialysis system 10. As illustrated, the bag handling system 30 is connected to or made integral with the instrument. or circulator 20. The bag handling system 30 as illustrated is configured for four, for example, six liter supply bags 40a to 40d (collectively referred to herein as supply bags 40 or generally individually as supply bag 40). System 30 is alternately configured to hold more or less six liter bags 40. Figures 4-9 also show that circulator 20 includes a hinged display 24, which can be operated with separate controls 22 and / or a touch screen cover.

Figure 4 shows the bag handling system 30 with each of the shelves 32, 34, 36 and 38 turned downward and with no supply bags 40 loaded. Figure shows bag handling system 30 with lower shelf 22 folded down and shelves “« τπντοmexicano · &lt;

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34, 36 and 38 rotated up and out of the way to provide access to the lower shelf 32. In one embodiment, the shelves are configured in a waterfall or telescope shape so that the third shelf 36 can be bent or rotated toward the shelf. upper 38, second shelf 34 can be bent or rotated towards third shelf 36 and lower shelf 32 can be bent or rotated towards second shelf 34. The shelf hinges may have releasably locking devices (eg, tabs and docking retainers) that releasably hold the shelves in place when folded or rotated upward. Alternatively or additionally, the shelves can be releasably secured to each other, for example, the third shelf 36 locks the upper shelf 38, the second shelf 34 locks the third shelf 36, and so on. For example, the locking tabs or retainers 42 and 44, respectively, are provided on the sides or brackets of the shelves so that the locking mechanisms 42 and 44 do not interfere with the bags 40 when loaded.

Figure 6 shows a bag handling system 30 with the lower shelf 32 folded down, a first supply bag 40a loaded on a lower shelf 32, and the shelves 34, 36 and 38 hinged up and out of the way. Figure 7 shows a bag handling system 30 with the lower shelf 32 and the second shelf 34 folded down, the first supply bag 40a loaded on the lower shelf 32, a second supply bag 40b loaded on the second 34, and shelves 36 and 38

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hinged up and out of the way.

Figure 8 shows bag handling system 30 with bottom shelf 32, second shelf 34 and third shelf 36 folded down, first supply bag 40a loaded on bottom shelf 32, second supply bag 40b loaded on the second shelf 34, a third supply bag 40c loaded on the third shelf 36, and the shelf 38 hinged up and out of the way. Figure 9 shows bag handling system 30, bottom shelf 32, second shelf 34, third shelf 36, and top resource 38 all folded down, first supply bag 40a loaded on bottom shelf 32, second supply bag 40b loaded on second shelf 34, third supply bag 40c loaded on third shelf 36, and fourth supply bag 40d loaded on top shelf38.

Each tray in bag handling system 30 folds up providing easy access to the lower shelf. When used on the trolley 12 above, the system 30 minimizes the height to which patients have to lift the solution bags. The shelves hold the solution bags 40 in elevation over a heater, which can be positioned at the bottom of the instrument 12 for example, and orient the bag so that the bag exit port resides under the rest of the bag. The setup causes the dialysis fluid to flow from the bags until they are emptied, leaving any air trapped in the empty bags. This shelf configuration, bag placement, and orientation can²⁹ • NOUSTUial '^ “ÍrL« improve the volumetric pumping speed and accuracy of fluid supply oolsms— when fluid is pumped direct nTGHit - from supply bags, for example, through an in-line heater, and into the patient as air does not flow down, for example, from a bag 40 into the pump chamber of cassette 28.

One or more of or all of the shelves 32 to 38 may employ a sensor operable with a sensing system stored in memory. The sensor and associated system perform multiple functions. One function is to determine whether a double chamber or multi-chamber bag was opened to allow two or more concentrates to mix to form a dialysis fluid that can be pumped into the patient. Sensing a properly open bag may be a prerequisite for pumps and / or valves or that obstruct operation. The sensors can also detect which shelves 32 to 38 have pockets and which ones don't and that way if you have or can connect enough fluid. A suitable sensor and associated system is found in copending Patent Application Serial No. 1 1 / 773,505, filed on July 5, 2007, entitled, Apparatus and 20 Method to Verify a Seal between Multiple Chambers ”, assigned to the eventual attorney-in-fact of this description, the full contents of which are hereby incorporated by reference and transferred . An alternative inductive sensing apparatus and method is discussed below starting at Figure 35.

Disposable Device

Referring now to Figures 10 and 11, one embodiment of disposable apparatus or kit 50 is illustrated for system 10. Figure 10 illustrates that disposable apparatus 50 includes a disposable cassette 28 and supply bag 40 as discussed above. The bags 40 in one embodiment each include a solution line or pigtail 46a through 46d (collectively referred to as pigtails 46 or generally individually as pigtail 46), which are connected to a first supply line apparatus 48a. Solution lines or pigtails 46 in one embodiment terminate in female connectors 56 protected by tip protector 66a. The connectors 56 in one embodiment are female connectors protected by a pierceable cover. Disposable apparatus 50 may include a second supply line apparatus 48b for high volume therapy as discussed below. The first and second supply line devices each include multiple lines that terminate in a connector 58 protected by a tip protector 66b. The connectors 58 may be male barb connectors that fit through the protective covers of the female connectors 56 of the bag lines 46.

The disposable apparatus 50 also includes a patient line 52 and drainage line 54. The patient line 52 may be a dual lumen line where a line terminates in a pierceable sealed female connector 56 protected by a protective shield.

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Pigtails 46 in one embodiment terminate at female connectors 56 protected by tip protector 66a. The connectors 56 / tip protectors 66a are held together in a single organizer in one embodiment. Patient line 52 can be a single lumen patient line (group dialysis) or a dual lumen patient line (for group or continuous dialysis) as desired. The first apparatus of supply line 48a, patient line 52, and drain line 54 are each connected to cassette 28.

Figure 10 further illustrates an embodiment for a high volume disposable apparatus (e.g., eight bags), which are provided by t-joining a second supply line apparatus 48b outside of the first supply line apparatus 48a ( cassette 28) and provide an organizer to hold four barb connectors 58 at the end of each supply line 48a or 48b. The tines and organizers can be integrated into a single molded tine group that contains the tines and features to hold and hold the group during operational setup. Each barb connector 58 of each supply line can be fluidly and sealingly connected to a female connector 56 at the end of each bag pigtail.

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Figure 11 illustrates a second embodiment for producing a high volume disposable apparatus 50. Here the first tube apparatus from a supply 48a is converted to a high volume apparatus through a manifold of four to one 60. The manifold of four a one 60 in an embodiment at one end has the same organizer supporting four lines 48c terminating in barbed connectors 58 / tip protectors 66b as described above for supply lines 48a and 48b. The manifold 60 therefore by itself can connect up to four supply bags 40. A connector 56 / tip protector 66a of an individual input line 64 of the four-to-one manifold 60 is then inserted into the auto-connect mechanism. (shown later) in place of the connector 56 / tip protector 66a at the pigtail end 46 of an individual supply bag 40. A self-loading system

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Self-connection

Referring now to Figure 12, an instrument 20 in one embodiment includes puncture clamps or puncture valves 68a through 68b (collectively referred to herein as valves 68 or generally individually as valve 68), one valve 68 for each pigtail 46a to 46d from supply bags 40a to 40d, respectively (or multiplex line 64 from multiples four to one 60). Clamps 68a through 68d are positioned to support and obstruct 15 manifolds 46a through 46d, respectively, when (i) connectors 56 at the end of each pigtail 46 are attached to a stationary connector bracket 70 and (ii) protectors Tips 66a protecting each connector 56 are initially attached to a tip shield removal transport 72 of the self-connecting mechanism. The tip shield removal transport 20 72 is also configured to remove the tip connector 58 from the tip shields 66b as shown below. Clamps or puncture valves 68 are open, for example, sequentially, to allow fluid to be sequentially withdrawn from supply bags 40.

Clamps 68 in one mode automatically close if

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There is a need to reload the cassette 28 from WHAT the supply bags 40 were connected to. The stationary bracket 70 holds the stationary supply bag pigtail connectors 56 during the self-connection procedure.

Figure 12 also illustrates a movable connection transport 74, which supports the barb connectors 58 / tip protectors 66b arranged at the end of the supply lines 48a connected to the cassette 28. The individual supports of the stationary support 70 and the Moving transports 72 and 74 are aligned in the Z direction as shown by the coordinate system in Figure 12.

The mobile transport 72 moves in the + X and -X directions to remove the tip protectors 66a from the connectors 56 and the tip protectors 66b from the barb connectors 58. The mobile transport 72 also moves in the + Y directions e -Y to pull the removed tip protectors 66a and 66b out of the way for line connection and possibly to reload the tip protectors. Mobile transport 72 in one embodiment utilizes an XY scaffold system, which includes a pair of guide screws each driven by a motor, such as a stepping motor. For example, the movable transport 72 can be threaded and receive a ballscrew supported at two ends by brackets and driven by a stepper motor to move the transport 72 back and forth in a precise manner in the + X and - directions. X. That X-direction Assembly in turn can be threaded, for example, into a bracket,

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The movable transport 74 moves in the + X and -X directions to push the barb connectors 58 of the cassette supply lines 48a into sealed communication with the pierceable sealed female connectors 56 of the bag collects 46. Here, the movable transport 74 can be threaded and receive a ball screw supported at two ends by the brackets driven by a stepping motor to move the transport 74 back and forth a precise way in the + X and -X directions. .

System 10 is a controlled computer and for example may include master processing and memory operating with legacy controllers including legacy memory and processing. The processor and master memory can operate with a safety controller that has safety memory and processing. In one mode, processing and master memory operate with a delegated motion controller that has processing and memory (for example, programmable or through an application-specific integrated circuit (ASIC)), which drive the stepper motors and they receive inputs, for example positioning inputs from position sensors.

Referring now to Figures 13A through 13J, a self-connecting sequence is illustrated for the sealing engagement of

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INDUSTRIAL correctors 56 from the pigtails 46 of the supply bags 40 to the barb connectors 58 of the supply lines of apparatus 48a (alternatively supply line apparatus 48b and 48c as discussed above) of cassette 28. In Figure 13A , an organizer supporting four spike connectors 58 / spike protectors 66b of the cassette supply line apparatus 48a connected to the cassette 28 is loaded into the movable transport group holder 74. Alternatively, a group of four integrated prongs with connectors 58 / tip protectors 66b is loaded into the group holder of the movable transport 74. In this step, the cassette 28 is also loaded into the instrument 20 (see Figures 2 and 3).

In Figure 13B, the connectors 56 / tip protectors 66a located at the end of the four supply bag pigtails 46 are loaded onto individual supports of the stationary support 70 and the mobile transport 72. In particular, the connectors 56 are loaded On individual supports of the stationary support 70 and the tip protectors 66a are loaded mobile transports 72. Thus in Figure 13B, tip protectors 66a and 66b are set to automatically remove from connectors 56.

After the barb connectors 58 / tip protectors 66b and the connectors 56 / tip protectors 66a have been loaded into the auto-connect mechanism, a cover or port (not illustrated), insulating support 70, transport 72 and 74, 58 barb connectors / 66b tip protectors and female connectors

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56 / environmental tip protectors 66a. The system

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o air injects particularly high efficiency air (“ultra-low penetration HEPA (ULPA)) into the sealed compartment to reduce bioburden in the region prior to removal of tip protector from connectors 56 and 58. Pneumatic control of HEPA or ULPA air can be located in the aforementioned motion controller or in a separate pneumatic controller that operates with the master controller.

The resonance system determines which supply bags have been loaded (quantity, size, type of solution, expiration date, lot code, etc.) and alerts the user if a problem arises with any of the above identifiers. For example, the volume of solution may be insufficient to perform the selected therapy. Alternatively, a connector may become distorted or damaged so it will not connect properly.

In Figure 13C, the movable transport 72 is moved in the -X direction (in accordance with the coordinate system of Figure 12) to remove the preloaded tip protectors 66a from the supply bag connectors 56.

In Figure 13D, the movable transport 72 is further moved in the -X direction (according to the coordinate system of Figure 12) to lock the tip protectors 66b to protect the barb connectors 58.

In Figure 13E, the movable transport 72 moves in the

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In Figure 13F, movable transport 72 is moved in the + Y direction (according to the coordinate system of Figure 12) to get out of the way of supply bag connectors 56 and barb connectors 58.

In Figure 13G, the movable transport 74 is moving in the + X direction (according to the coordinate system of Figure

12) towards the stationary bracket 70 to push the barb connectors 58 into the pierceable sealed supply bag connectors 56 and to make the supply bag 40 sealed to the cassette connections 28. After the barb connector connections were made 58 to the supply bag connectors 56, a resonance system described later verifies that the connections were made properly and that no leaks are present.

Figure 13H (a) shows a removal modality where a connected supply of apparatus lines 48a and solution lines or pigtails 46 and associated empty supply bag 40 and cassette 28 are removed from transport 74 and holder 70, respectively, together. In Figure 131, movable transport 72 is then moved in the -Y direction (Figure 12) to allow spent tip protectors 66a and 66b to recover.

Figure 13H (b) shows another removal modality where ³⁹ fMPTáSs ^ mobile transport 74 moves in direction -X aíS% to connectors 56 and 58, after which 113TT3μ u rt or mή^w'। 72 ^r। it moves in the -Y direction (according to the coordinate system of Figure 12) and then back and forth in the + and -X directions. to reattach tip protectors 66a and 66b to connectors 56 and 58, respectively, allowing apparatus supply lines 48a, pigtails 46 and associated supply bags 40 and cassette 28 to be removed from transports 72 and 74 and bracket 70, respectively. This latter method of removal is preferable if it is common for the supply bags to not be completely empty when the bags have to be removed.

Self-identification

Figure 14 illustrates one modality for a self-identification system. The system includes a color capture device (CCD) camera 80, which utilizes a charge coupled device image sensor and an integrated circuit containing an array of coupled, bonded, or light sensitive capacitors. Other cameras that create a three-dimensional image of a connection area shown in Figure 14 can alternatively be used. The self-identification system uses the image from camera 80 to determine characteristics of solution bags 40 and to verify that the correct undamaged connectors 56 and 58 are loaded into the mechanism.

The self-identification system performs solution identification through a character recognition routine (located for example in the motion controller or a separate video controller operable with the central processing unit or master controller) that reads the printed codes on pigtail connectors 56 connected to supply bags 80. The codes provide (i) type of solution, for example, glucose or bicarbonate concentrate or premixed dialysate, (ii) bag volume, for example, six liters, and (ii) number of bags per connector 56, for example , single bag, or multiple bags across the four-to-one manifold 60. The image of each connector 56 is compared to stored images of the variety of acceptable geometries for connector 56. A deformed connector, or a connector that was improperly loaded, or that does not match the therapy prescription will fall outside of a variety of acceptable geometries and cause the system 10 to signal an alarm and cause other appropriate action, for example, closing the clamps. 68 or do not allow them to open until the alarm clears. The resonance system also verifies that the connected joints fall within an acceptable variety of geometries for a good joint connection. If leaks and small junction droplets form, the tiny droplet resonance system and triggers an alarm. Primer

In one embodiment, a dual lumen patient line 52 is used (Figure 10). One lumen is connected to a patient drain port cfe through a BTS waste cassette pump chamber 28. The other lumen is connected to a patient fill port through a different pump chamber from the waste cassette 28. During priming of the patient line, the two lumens of the patient line are connected. Circulator 20 causes one of the cassette diaphragm pumps 28 to pump or push fresh fluid out of the patient fill port on the waste cassette 28, down into a patient line lumen 52, until it reaches the end from the patient line. The fresh fluid is then pumped back into the other lumen of patient line 52, into cassette 28 through the patient drain port and onto another diaphragm pump in cassette 28, which removes air that the fluid pushes through. from the patient line 52. When the fluid fills the second pump chamber, the patient line is fully prepared.

Patient Login / Disconnect

The prepared dual lumen patient line (fill volume 52a and drain lumen 52b connected) and transfer set 82 (with fill line 84 and drain line 86 connected) are loaded into a patient line in an auto device. -connection 90 illustrated in Figures 15A to 15E. Device 90 may be separate from or integrated into instrument 20. Instrument 20 or carriage 12 in one embodiment provides an area and

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INSTITUTO MtXICANu DE LA MOHEDAL · INDUSTRIAL device to store device 90. Device 90 can be powered or configured for manual / automatic operation. Device 90 includes a stationary portion 92 and a portion 94 rotatable and translatable with respect to stationary portion 92.

As seen in Figure 15E, device 90 includes a cover 91 and base 93 that mate (eg, hinged or separately) to encompass connectors 56 (pierceable membrane) and 58 (barb) of lumens 52a and 52b and lines 84 and 86 when loaded in portions 94 and 96. Cover 91 and base 93 can be metal plastic as desired. Figure 15E also illustrates that device 90 includes one or more motors 95 having an output shaft 97 operably connected to portion 94 to rotate and / or translate portion 94 relative to portion 92. For example, the output shaft 97 Output 97 of motor 95 can drive a ball screw which in turn is threadedly connected to portion 94, which allows motor 95 to translate the portion. In the illustrated embodiment, output shaft 97 of motor 95 is coupled to portion 94 in a way so that motor 95 can rotate portion 94. A lever 99 is connected to motor sub-assembly 95 and movable portion. 94, so that the patient or caregiver can translate portion 94 back and forth relative to parked portion 92 via lever 99. Device 90 is alternative and fully automatic (eg, AC or battery powered) or fully manual.

Device 90 also includes apparatus for maintaining an aseptic environment when lumens 52a and 52b and lines 84-y ^ e are separated. For example, device 90 may employ ürTa * 1n? -O ultraviolet (UV) radiator described in US Patent Nos. 4,412,834 and 4,503,333, assigned by the possible attorney-in-fact of the present application, the full contents of which are incorporated herein by reference. Device 90 may also introduce HEPA or ULPA filtered air into the volume around the connector prior to connection.

Referring further to Figures 15A through 15D, once dual lumen patient line 52 and transfer apparatus 82 are loaded into device 90, the patient line shown here as having fill lumen 52a (ending in a female connector 56 as described above) and drainage lumen 52b (terminating in a barb connector 58 as described above) are routed and connected to patient transfer apparatus 82. Transfer apparatus 82 includes a fill line 84 (terminating in a barb connector 58) and a drain line 86 (terminating in a female connector 56).

In Figure 15A, fill lumen 52a is connected through the setup sequence to drain lumen 52b. Fill line 84 and drain line 86 or transfer apparatus 82 are also connected. The mated connectors 56 and 58 of each pair are loaded into the device 90, so that the return lumen 52b and the fill line 84 (both having barb connectors 58) are loaded into the stationary portion 92 the device 90 and the lumen. of

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female 56) are loaded onto the rotatable portion 94 of the devicejyg._Q „CL—— In one embodiment the portions 92 and 94 are structured so that the portion 92 can only accept barb connectors 58 and the portion 94 can only accept female connectors 56. The cover of the device 90 is closed and the aseptic apparatus is started or energized.

In Figures 15B, portion 94 through, for example, electrically driven stepper motor 95 coupled to a ballscrew (not illustrated), or solenoid (not illustrated), pulls lumens 52a and 52b and lines 84 and 86, respectively. Portion 90 includes a transport that supports lumen 52a and line 86 connectors 56, which are separated from barbed connectors 58. The translatable portion 94 and the motor can be fully housed within the device 90 and sealed from the outside environment.

In the illustrated embodiment, the porter operates manually through the lever 99 that the patient holds and translates the translation portion 94 that transports the lumen 52a and line 86 connectors 56 to / away from the barb connectors 58. In the modality Illustrated, the most delegated arrow of lever 99 is sealed to device 90, so that the handle portion of lever 99 remains outside of device 90 and is configured for the patient to grip and move comfortably. The shaft of the lever 99 connects to the motor 95, which in turn is coupled to the portion 94 that supports the connectors 56 of the lumen 52a and line 86.

In Figures 15B, the aseptic apparatus of device 90

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In Figure 15C, the motor 95 rotates the rotating portion 94 that supports the female connectors 56 hundred and eighty degrees relative to the stationary barb portion 92, so that now the return lumen 52b from the patient line of the dual lumen 52 is align with drain line 86 of transfer set 82. Also now, fill lumen 52a of dual lumen patient line 52 is aligned with fill line 84 of transfer set 82. The aseptic apparatus of device 90 continues to be energized to prevent the connector tips 56 and 38 from becoming contaminated.

In Figure 15D, the translatable portion 94 (manual electrical) pushes the fill lumen 52a of the dual lumen patient line 52 toward the fill line 84 of the transfer set 82, which connects the barb connector 58 to the female connector. 56. Simultaneously, the return lumen 52b of the patient line of the dual lumen 52 is sealed and operably connected with the drain line 86 of the transfer set 82. The system 10 can now perform an initial patient drain to remove the last spent bag fill from the previous procedure and ready the patient for a first fill of the present therapy.

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In a patient disconnect sequence -; - ha-e-line do .. connected incoming flow 52a and 84 are loaded on one side 96 or 98 of device 90. Connected outgoing flow lines 52b and 86 are loaded on the other device side 90. In a next step, device 90 (manually or automatically) disconnects cassette inflow line 52a from transfer set inflow line 84 and cassette outflow line 52b from group outflow line. transfer 86.

Then, the rotating portion 94 that supports and the female connectors 56 rotates 180 degrees relative to the stationary barb portion 92, so that the return lumen 52b of the dual lumen 52 patient line is now aligned with the fill lumen. 52a of the dual lumen patient line 52, and the drain line 86 of the transfer set 82 is now aligned with the fill line 84 of the transfer set 82.

In a next step, device 90 (manually or automatically) connects cassette inflow line 52a to cassette outflow line 52b and transfer apparatus inflow line 84 to apparatus outflow line. transfer 86. Device 90 provides an aseptic environment for the above four steps. The patient can then remove the connected dual lumen line 52 and transfer set 82 from device 90 and is free of the dialysis instrument.

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It should be appreciated that device 90 is not limited to the just described dual lumen patient line 52 / transfer set 82 on / off application or even APD. For example, a single patient line 84 having a barb connector 58 protected by a female cap 56 may instead be loaded onto the side 98 of device 90, while a supply bag pigtail 46 having a female pierceable connector 56 and a cap 6 load on side 96 of device 90. The female cap 56 is then removed from the male end patient line 84, while simultaneously removing a cap from the female end supply pigtail 46 from its cap (by pulling the swivel portion 94 away from the barb portion 92). . Then, the rotatable portion 94 rotates relative to the spike portion 92. After that, the female portion 94 slides into the barb portion 92, which mates the barb connector 58 of the patient line 84 with the female connector 56 of the supply bag pigtail 46, thereby connects a supply bag 40 to the patient, for example for CAPD. A similar connection can be made by connecting the patient to the pump cassette 28.

Drain and Fill Patient

During patient drainage, system 10 removes effluent from the patient through return lumen 52b of dual-lumen patient line 52. When drainage is complete and system 10 advances a fill cycle, system 10 delivers fresh fluid to the patient through fill lumen 52a of dual lumen patient line 52. Here, the only effluent recirculating back to the patient is the small volume of effluent in the fill line 84 of the transfer apparatus 82 and the patient's catheter. Even this volume does not need to be recirculated to the patient if a dual lumen catheter and transfer set is used. In addition, if a dual lumen catheter and dual lumen transfer set are used with system 10, system 10 can perform multiple pass continuous flow peritoneal dialysis ("CFPD) therapy." Multiple pass CFPD therapy can employ individual fill, with a long recirculating flow dwell, or CFPD therapy can be tidal in nature and recirculate flow for at least one of the dwell periods.

Cassette enhancements

Referring now to Figure 16, cassette 100 illustrates one embodiment of a cassette and method of being the same, wherein a rigid plastic portion 110 of the cassette is encapsulated within cassette lamination 102. However, lamination 102 It is not welded to the sides of the rigid portion 110, the lamination 102 in turn welds itself. The plastic portion 110 is in a rigid embodiment and made of acrylonitriIo-butadiene styrene (ABS), acrylic, polyolefin, polycarbonate, polyethylene, or polypropylene. Lamination 102 in one embodiment is flexible, for example, to

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Lamination 102 is folded to produce a first side 104a, a second side 104b, a folded top 106, and edge 108a to 108c as illustrated. The folded sheet 102 is slid over the rigid portion 110 as shown in Figure 16. Next, the lateral edges 108a of the sides 104a and 104b are welded together and around the supply lines 48, patient lines 52 or line of drain 54. Alternatively, edges 108a of sides 104a and 104b are welded together and around ports that extend from rigid portion 110 (not seen in Figure 16) to which supply lines 48, patient lines 52, or line drain 54 fit tightly. The lower edges 108b of the sides 104a and 104b are welded together. The side edges 108c of the sides 104a and 104b are welded together. Flexible lamination 102 thus forms a sealed bag around rigid portion 110. Sides 104a and 104b are alternately spaced sheets welded together along the long sides. -

Rigid portion 110 includes or forms pump chambers 112. As will be shown later, an alternative cassette includes three pump chambers. The rigid portion 110 in the illustrated embodiment also includes a plurality of valve chambers 114. The pump chambers 112 and valve chambers 114 each include ridges 116 defining the respective pump or valve chamber, extending outward from a base wall 118 of rigid portion 110. The opposite side of the rigid portion includes ridges 116 extending in the other direction from base wall 118 and defining flow paths (not observed) communicating with pump chambers 112 and valve chambers 114.

In operation, side 104a of lamination 102 needs to be sealed to lips des16 of the pump and valve chambers for pneumatic movement and fluid control. A dialysis instrument that operates with bag cassette 100, having lamination 102 sealed to itself around rigid portion 110 (and to tubes as discussed above) but not directly to raised ridges 116, applies positive pressure to through surface 104a relative to rigid portion 110. Positive pressure seals surface 104a to raised lips 116 temporarily during operation so that pumps 112 and valves 114 can function properly. Positive pressure is also provided on the reverse surface 104b of the₅₁ WICKED

MEXICAN INSTITUTE

Of LA RROPIEUAÜ INDUSTRIAL lamination 102 to compress surface 104b to raised ridges 116 in flow paths (not observed). Positive pressure can also be provided pneumatically, for example, through an inflatable bladder, and / or mechanically, for example, through spring deflection, solenoid actuation, and / or closing a door behind which it is charged. cassette 100.

Figure 16 also shows that base wall 118 may include instrument loading and locating holes 120, which allow locating guide 122 to snap into place after lamination 102 is welded to itself and tubing 48, 52, and 54. In one embodiment, the lamination 102 is welded through a heat sealing process, using a die. That same die can also punch alignment holes 124 through lamination 102 to facilitate installation of load / locator guide 122.

Cassette 100 includes integrated valve ports 114. System 10 of Figures 1-3 and instrument 20 of Figure 12 show line clamps 68 external to the cassette, which obstruct associated tubing. Puncture valves 68 allow system 10 to access each of the supply lines independently but also eliminate the need for the manual clamps that are typically present on cassette supply lines 48. The machine 20, not the user, clogs the supply lines 48 when necessary, such as when bag connections are made, and they are opened to perform the

5²

Mexican INSTITUTE

DI LA COIN C ** 2SS ^ C therapy. Supply lines 48 also ηθοβειΙ'ΪΉ ^^ ΡβΓΛΠΒδΒ * ^ after many alarm / fault conditions τΐ'ΐ.ί Ii n Ih rg ί n fn II a

Puncture valves 68 also aid in fluid withdrawal from solution lines 46. For example, puncture valve 68 only to the top shelf 38 can be opened, allowing bag 40b to partially drain, for example, more than 50%, before opening valve 68 to supply bag 40c on the second shelf. top 36 allowing bag 40c to partially drain, for example more than 50%, before opening valve 68 to supply bag 40b on third top shelf 34, allowing bag 40b to partially drain, for example, more than 50%, prior to opening valve 68 to supply bag 40a on bottom shelf 32. Fluid will flow with gravity into the pumps and air will tend to float backward from each bag 40. Using this sequence, all supply bags 40 they can be emptied without sucking any area in the solution lines 46. If all the supply lines 48 are opened at the same time, the lower bags 40a and 40b will swell due to the weight of fluid from the upper supply bags 40c and 40b.

It should be appreciated that the flexible bag cassette 100 may include valve chambers 114 or not include valve chambers 114 if rather puncture clamps described above 68 are used. Furthermore, it should be appreciated that the apparatus and methods described in connection with the system 10 and instrument 20 are not limited to use with puncture clamps 68 and rather can be used with cameras ⁵³ IΜ ΡI of valve 114 discussed above. In addition to 11 é * famn system 10 it can operate with a combination of valve chambers 114 and puncture clamps 68, for example, using cassette-based valve chambers 114 during treatment and puncture clamps 68 during setup and condition conditions. alarm.

Referring now to Figures 17A, 17B, cassette 130 illustrates one embodiment of a disposable three-pump chamber that pumps and valve positions the cassette. Figures 18A through 18C illustrate three methods for operating the three pump chambers to achieve the desired outputs.

Cassette 130 in the illustrated embodiment includes many of the same structures or types of structures as cassette 100, such as rigid portion 110 having a base wall 118 with flanges 116 extending from base wall 118 to form pump chambers. 112a to 112c (collectively referred to as cameras 112 or generally individually as cameras 112). Flanges 116 also define valve chambers 114 as previously described. Alternatively, cassette 130 with all three valve chambers 112 operates with puncture clamps 68 and does not use or provide valve chambers 114.

Figure 17B illustrates the rear side of cassette 130. Here, ridges 116 extending from base wall 118 define a flow path 132. Flow path 132 includes connector sections 134a and 134b and cushioned sections 136a through 1 36f extending between connector sections 134a and 134b connector sections 134a and 134b and the damped sections

136a to 136f of flow path 132 allow conversation between pump rooms 112, so that the flow patterns discussed later in connection with Figures 18A through 18C can be achieved as will be shown in more detail later in connection with Figure 17C .

Cassette 130 includes flexible lamination 104a and 104b as discussed above. Lamination 104a and 104b may be separate laminates welded or attached to the sides of rigid portion 110 and flanges 116 of pump chambers 112 and valve chambers 114. Alternatively, the lamination 104a and 104b is provided through a single sheet 102 shown above, which includes a folded edge 106 and welded or bonded edges 108a to 108c as described and shown in connection with Figure 16.

Figure 17C illustrates one possible valve arrangement for the three-pump cassette 130 of Figures 17A and 17B. Figure 17C illustrates the ports extending out of the bottom of cassette 130, which is a preferable arrangement for air handling because any air in the cassette will tend to rise to the top of the cassette, leaving only! fluid to exit the bottom cassette. The boxes marked A are areas of the cassette 130 that interact with air sensors located within the instrument 20. The boxes marked T are areas of the cassette 130 that interact with the sensors.

I jM PI

INSTITUTO MEXICANi de temperature Iocaeí ^ q instrument 20. The box marked C is a cassette area 130 that interacts with a conductivity sensor located inside the instrument 20.

As illustrated, cassette 130 includes six delivery ports, a dedicated patient port, a patient to / from port, a drain port, and an additional port for mixing, additional delivery, or sending or receiving of fluid from a heater. intermittent. Cassette 130 includes three pump chambers 112a through 112c described above. Valves 114 in

Figures 17A and 17B differ through valves V1 to V28. The following valve states are simply examples showing different flow regimes that can be achieved through cassette 1 30.

Filling the patient with a premixed solution for example can occur by allowing a fresh mixed solution in cassette 130 through valve V16, which flows through the heater through valve V1 into pump chamber 112c. At the same time, the pump chamber 112b pushes the same fluid to the patient through the open valves V10, V15, V27 and the port valve to / from the patient. In this regimen, the port to the patient and the valve are not necessary. At the same time, the pump chamber 112c can perform a volume measurement determination as discussed later. In an alternative modality, a dedicated patient port and₅₆ IMPI ^ g

MEXICAN INSTITUTE

OF THE PROPERTY ®P

INDUSTRIAL valve are used as a second outlet to the patient.

Drainage of fluent from the patient for example can occur by allowing fluent from cassette 130 through the valve and port to / from the patient, to flow through valves V26 and V12 in pump room 112a. At the same time, the pump chamber 112b pushes the effluent to drain through the open valves V4 and the drain valve. In this regimen, the dedicated patient port and valve are not required. At the same time, the pump room 112a can also perform a volume measurement determination as discussed later. In an alternative embodiment, the temperature sensor access valve V15 can be opened simultaneously to allow the temperature of the effluent inlet chamber 112a to be sensed.

In a concentrate mix regime, chamber 112c can be filled with concentrate supply 1 through valves V17 and V7. Chamber 112b can be filled with concentrate supply 2 through valves V20 and V9. Chamber 112a, which here acts as an accumulator as described later in Figure 18C, draws the mixed concentrates through valves V5 and V16 to a mixer, for example. In an alternative embodiment, a separate mixer is not used, the length of the patient line is sufficient to mix the concentrates, and chamber 112a alternately draws through valves V5, V28, V27 and the valve to / from the patient collectively towards the patient.

<img file="MX348969B_D0017.tif" />

_S7 IMPI j! msriTUTo mexicam. ··

OF THE NOHtDAL ·

INDUSTRIAL

In a second stroke as described later in Figure 18C, chambers 112c and 112b empty half of their respective concentrates through valves V1 and V3, respectively, and V5 collectively into chambers 112a. At the same time, the chambers 112c and 112b of the other half of their respective concentrates through the valves V1 and V3, respectively and the valve V16 collectively to a mixer. In an alternative embodiment, a separate mixer is not used, the length of the patient line is sufficient to mix the concentrates, and the chambers 112c and 112b of the other half of their respective concentrates alternately through valves V1 and V3, respectively and the valves V28, V27 and the valve to / from the patient collectively the patient.

In a multi-pass flow regime, chamber 112c is filled with a fresh solution, eg, premixed from supply one through valves V17 and B7. At the same time, chamber 112b empties fresh to the patient through valves V3, V28 and the valve to the patient to the patient. At the same time, chamber 112a is filled with effluent from the patient through the valve to / from the patient, and valves V26 and V12. Here, the fluid can be recirculated because there is no net loss of fluid or It ration (UF) to take place.

In a UF to drain multi-way flow for example, chamber 112c empties fresh to the patient through valves V1, V28 and the valve into the patient to the patient. The same

IMPI Mexican institute • e la cold industrial time chamber 112b is filled with patient effluent through the valve to / from the patient, and valves V26 and V10. At the same time, the chamber 112a empties the effluent to drain through the valve V6 and the drain valve. In an alternate FU into the bag for multiple bag passage mode, chamber 112a alternately empties effluent into an empty supply bag, eg, supply 3 through valves V11, V24, and V25.

In a second state of the UF bag in multi-bag pass mode, chamber 112c is filled with a fresh, eg, premixed solution from supply 1 through valves V17 and V7. At the same time, chamber 112b empties fresh to the patient through valves V3, V28 and the valve into the patient to the patient. At the same time, chamber 112a is filled with effluent from the patient through the valve to / from the patient, and valves V26 and V1 2.

A test can be done to see if a double or multiple chamber bag has opened properly. Here one of the pump chambers empties the fluid to drain, which causes the fluid to flow past the conductivity sensor (C), which checks to see if the measured conductivity is indicative of a properly mixed solution, in which case the therapy, and an improperly mixed case where an alarm is generated.

Figure 18A illustrates a pumping sequence for pump chambers 112 where a chamber fill stroke (black segments) is slightly shorter in duration than a ⁵⁹chamber emptying stroke (diagonal segments), which are separated by relatively short fluid measurement periods (dotted segments). A method of measuring fluid (amount of fluid pumped) is discussed in detail later. Also discussed later is a way to eliminate fluid metering periods (dotted segments) that occur after chamber emptying strokes (diagonal segments).

In another embodiment, a pneumatic actuator applies negative and positive pressure to lamination 104a to pump fluid into or out of one of the pump chambers 112. A pump controller, eg, microprocessor and computer program memory, controls pneumatic actuators to apply positive, negative, or zero pressure to the appropriate chamber 112 at the appropriate time. The processor cycles through a program that at any time chooses the processor what state each pump driver should be in. The processor controls each actuator based on that cycle.

The three-pump cassette 130 provides continuous flow to the patient during filling, while also continuously drawing fluid from the supply bag through an in-line heater for example. As seen in Figure 18A, at any given time at least one pump chamber 112a to 112c supplies fluid to the patient or to an accumulator (a purpose for an accumulator is described later in connection with Figure 18C). At any given time at least one pump chamber

<img file="MX348969B_D0018.tif" />

112a to · 112c fills the patient with heated dialysate.

IMPI / NSTITUTC MEXICANO DE LA PROMEt ΑΓ * INDUfflUAl

As seen in Figure 18A, at time T1, pump chamber 112a is at rest for a calculation measured from a previous emptying stroke, pump chamber 112b is draining fluid to the patient, pump chamber 112c is at rest. is filling with fluid. At time T2, pump chamber 112a is filling with fluid, pump chamber 112b is still flushing fluid to the patient, pump chamber 112c is at rest for a measurement calculation from a previous fill stroke. At time T3, pump chamber 112a is still filling, pump chamber

112b starts a fill stroke, pump chamber 112c is emptying. At time T4, pump chamber 112a is emptying, pump chamber 112b is filling, pump chamber 112c is initiating a rest period for metering calculation. At time T5, pump chamber 112a is still emptying, pump chamber 112b is beginning to empty, pump chamber 112c is filling. At time T6, pump chamber 112a is filling, pump chamber 112b is emptying, pump chamber 112c is filling. At time T7, pump chamber 112a is still filling, pump chamber 112b is initiating a rest period for metering calculation, pump chamber 112c is emptying. At time T8, pump chamber 112a initiates an emptying stroke, pump chamber 112b is filling, pump chamber 112c is emptying. At time T9, pump chamber 112a is emptying, pump chamber 112b is emptying.

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INJT IT! ITO MtXICAN '' lien c ^ S ^ iMe pump 112c is starting a fill stroke ._______, -.

While the above sequence was described in connection with fresh fluid filling pump chambers 112a to 112c or flushing chambers 112 to the patient, the same sequence can be used in connection with spent fluid filling pump chambers 112a to 112c or empty chambers 112 to drain. In any case, the filling and emptying of the pump chambers 112 is continuous when the operation of the three-chambers 112 is superimposed.

Figure 18B shows a sequence similar to that of Figure 18A. Here, however, the overlap of the fill strokes and the dump strokes is the same. Figure 18B illustrates that the relative durations of the fill and empty strokes can be modified to suit a particular pump chamber and drive configuration. Figures 18A and 18B also show that each time a dump run is to begin, another dump run is already in progress and will stay in progress long enough for the start of the dump run to be delayed for a short period. time, for example, to discharge a small amount of air from the chamber approximately at the beginning without interrupting the continuity of the fluid drain. For example, at time T in Figure 18B, pump chamber 112a is assumed to begin by flushing fresh fluid to the patient or spent fluid to drain. The beginning of the career of ot THE PROPERTY,. . . ,,, inoustriai. . , pumping out may be delayed for a short time

<img file="MX348969B_D0019.tif" />

e time to discharge for example, without interrupting the flow δϋΐιΐιτητσ ^ - because the pump chamber 112c still has some of its emptying stroke remaining.

Figure 18C illustrates a sequence in which fluid is mixed, for example, from two sources to make a stable dialysate for the patient. This can be done for PD or HD, either online or from bags or containers. Here, the pump rooms 112a and 112b are synchronized. Pump chambers 112a 10 and 112b receive fresh fluid that has already been mixed in one embodiment.

Alternatively, pump chamber 112a pumps one fluid, while pump chamber 112b pumps a second fluid, each into the same line where two fluids are appropriately mixed. Pump chamber 112c is an accumulator that receives mixed fluid from pump chambers 112a and 112b. Pump chamber 112c vents to the patient.

The system operating the sequence of Figure 18C is valve regulated or the flow paths of the system are structured so that half of the mixed fluid leaving the pump chambers 112a and 112b during the emptying stroke flows to the patient, while the other half flows into the accumulator or fill pump chamber 112c. When pump chambers 112a and 112b are filled, accumulator or pump chamber 112c delivers its volume of mixed fluid to the patient. Since all fluid flowing to and from accumulator 112c has been represented in the periods of

<img file="MX348969B_D0020.tif" />

measurement of pump chambers 112a and 112b, separate measurement periods are not needed for pump accumulator 112c. Here, the flow to the patient is continuous. Filling from concentrate sources is intermittent. A similar routine can be used to remove fluent from the patient. Accumulator 112c always attempts to fill patient effluent with this routine. When pumps 112a or 112b fill, the pumps pull some fluid from accumulator 112c as well as from the patient. A routine such as one in Figure 18A or Figure 18B can also be used in turn to push the effluent so that the flow from the patient is continuous and smoother.

Cassette Interface Enhancements

Referring now to Figures 19 through 22, pneumatic system 150 illustrates one embodiment of a disposable cassette pump interface of the present disclosure. System 150 includes a disposable cassette 140. Disposable cassette 140 is similar to cassettes 100 and 130 described above and includes many of the same components, which are numbered the same. Cassette 140 includes a rigid housing or portion 110. Flexible sheets 104a and 104b (not seen in Figure 19) are welded or attached to rigid portion 110. Alternatively, sheets 104a and 104b are formed from the individual folded sheet 102 discussed above in connection with cassette 100. The cassette 140 is shown from the reverse side to that shown in Figure 16 for cassette 100. Here, the ⁶⁴pump 112a and 112b bulge out, showinxi '&amp; reverse of pump chambers 112 as c-muoct¹^ in Figure 16. Cassette 140 may alternatively include third pump chamber 112c discussed above in connection with cassette 130.

Cassette 140 includes base wall 118 as previously described. The ridges 116 extend outward from the base wall 118 to form a plurality of flow paths 132. The valve chambers 114 and surfaces of the pump chambers 112 that interact with the cassette lamination are provided on the opposite side of the cassette 140 instead of the side shown in Figure 19. Cassette 140 further includes a plurality of valve ports 126, which fluidly communicate with flow paths 132 and are sealingly connected to tubing, such as supply tubing 48, patient line 52, and drain line 54 shown. above for example in connection with Figure 16.

The pneumatic system 150 includes a membrane gasket 145, shown in detail in connection with Figures 20 and 22. The membrane gasket 145 fits and seals in a plurality of locations to a cassette manifold 180, shown with detail in connection with Figures 20 and 21. In particular, cassette manifold 180 includes an interface plate 185, to which membrane packing 145 is attached and sealed.

Referring now to Figures 20 and 22, "IMPIOS

IWTHVFM MEXICAN Jí

LA FR / PIEDAD VS- jBr in detail the membrane packing 145. The packing «^xltfe^TOmiCTñl5í ^ n ^ 145 is made of a suitable Go-n + pri-miÍr · y-hermetic material, such as Silicon rubber, Ethylenepropylene Diene Monomer (EPDM) rubber, Viton or other elastomers that they have a good fatigue life. In one embodiment, the membrane gasket 145 is made of compression molded Silicon rubber. Membrane packing 145 includes a side 146, which interconnects with, and actually moves with, lamination 104 of cassette 140. Membrane gasket 145 includes an opposite side 154, which interfaces with and seals at various locations to interface plate 185.

The cassette side 146 of the membrane packing 145 includes raised pump lips 148a and 148b, which in one embodiment engage with and press the seal against the raised lips 116 shown for example in Figures 16 and 17A as forming the shape of the pump chambers 112. A pneumatic bladder, for example, contained in the instrument door 20, can be inflated when the door is closed to press a packed plate (not shown) against the cassette 145 which, in turn, compresses the lamination 104a of the cassette 145 against the raised ridges 148a and 148b, such that such ridges 148a and 148b form an "o" -shaped ring-type seal around the raised ridges 116 of the pump chambers 112 of the disposable cassette 140. This seal is described in US Patent Application No. 2004/019313 A1, entitled, Systems, Methods and Apparatus for Therapies Based on

IMPIAS ⁰⁰ INSTITUTO MEXICANO JA

OF INDUSTRIAL PROPERTY

Pumping Cassette, and US Patent 6,261,065, entitled, Systems and Methods for the Control of Pumps Employing Electric Field Sensing, both are incorporated herein by reference and assigned to the eventual proxy of the present disclosure.

The cassette-facing surface 146 of membrane package 145 further includes raised lips 152 that form a closed path that thus seals around raised ridges 116 of valve chambers 114 of disposable cassette 140. Figure 15 shows ten valve chambers 114, which are generally aligned with and shaped like the ten enclosed ridges 152 of the cassette surface 146 of the membrane packing 145. Again, in one embodiment, the enclosed flanges 152 engage and seal against the flanges 116 of the valve chamber 114 of the disposable cassette 140.

Figure 22 illustrates the opposing surface 164 of the membrane gasket 165, which is oriented and interacts with the interface plate.

185 cassette manifold 180. A raised edge 156 runs along the outside of surface 154, so that the package maintains its shape. An inner plain 158 also extends outside of surface 154. The removal of material between the plain 158 and raised edge 156 allows the two structures to move independently when the instrument door is closed and the cassette 140 is pressed between the door. instrument

12ví p I is industrialized and the membrane gasket 145, which interface 185. The raised edge 156 optionally seals over its raised edge 202 of the interface plate 185, which helps the membrane gasket 145 to seal to the interface plate and prevent water or particles from entering.

Plain 158 defines a pair of blank pump cavities 160a and 160b. The blind pump cavities do not extend in the full direction through the thickness of the membrane gasket 145. Instead, the pump cavities 160a and 160b each include side walls 162, which extend most of the direction to Through the thickness of the membrane gasket 145 a thin wall 168 is left. As described in detail below, a thin wall 168 moves with lamination 104 of cassette 140 residing within pump chambers 112a and 112b of the cassette.

In a similar fashion, the plain 158 defines a plurality of blind valve cavities 164. The blind valve cavities 164 similarly do not extend in the entire direction through the plain 158 of membrane gasket 145. Instead , the blind valve cavities include side walls 166 that extend in the majority of the direction through plain 158 but terminate at blind wall 168. The blind wall 168 of the blind valve cavities 164 in turn is operated with the lamination cassette 104a in the valve chambers 114.

The membrane gasket 145 defines ports or openings 170 that extend in the full direction through the plain 158 of the ⁶⁸ IM PI membrane packing 145. Therefore, the aba ^ fc ^ '^ s observed on both surfaces 154 of Fig-nrn ?? and 146 of Figure 20. As further seen in Figure 20, raised pump lips 148a and 148b and raised valve lips 152 on surface 146 of membrane gasket 145 enclose or encompass pneumatic ports 170. As discussed in detail below, the pneumatic ports 170 allow a rated negative pressure through the membrane packing 145 to push the surface 168 of the blind pump cavities 160a and 160b and the surfaces 168 of the valve cavities 164 together with the lamination 104a of cassette 140. The configuration causes the wall 168 of lamination 104a to operate on an individual membrane for each of the individual pump chambers 112 and valve chambers 114 of the disposable cassette.

The membrane packing 145 also includes dead spaces 172, only it does not extend in the entire direction across the plain 158. Consequently, dead spaces 172 are only seen on the bulky surface 154 of Figure 22. Dead spaces 172 remove material from the membrane gasket where it is not needed and, therefore, allow the membrane gasket 145 to be made more economical.

Figures 20 and 21 illustrate the bottom plate 185. The bottom plate 185 can be made of metal, such as aluminum, or plastic. Various configurations for interface board 185 and cassette interface 180 are discussed later in connection with "IMPI

MEXICAN INSTITUTE 'DE LA ERUPlEi&gt; Λί.' Figures 23 through 30. Interface plate 185 includes 4-side 186, top wall 188, and a closed edge a4 »-SO ^ ~ &amp; 0" oxtiond-c - from top wall 188 As discussed above, lip 202 friction fits within rim 156 of membrane gasket 145 to help maintain a sealing environment between the two structures.

The pump chamber cavities 190a and 190b are defined in or provided by the membrane plate 185. The pump cavities 190a and 190b cooperate with the pump chambers 112a and 112b respectively of the disposable cassette 140. In particular, the Pumps 190a and 190b include pneumatic actuation ports 198. When negative air pressure is supplied through ports 198, the negative pressure pulls the combination of blind wall 168 and lamination 104a associated with the pump chamber toward wall or cavity 190a or 190b. This expands the volume between the sheet 104a and the pump chamber 112 of the rigid portion 110 of the cassette 140 which causes a negative pressure to build up within the cassette, which in turn causes a volume of fluid to be pulled (fresh or spent ) in pump chamber 112. Similarly, when positive pressure is applied through opening 198, the positive pressure pushes the combination of blind wall 168 and cassette lamination 104a into pump cavity 1 90 / pump chamber interface 112, which pushes the wall. 168 and lamination 104a towards or into pump chamber 112 or rigid portion 110, which in turn repels or pushes fluid from the respective pump chamber

IMPI

112 towards the patient or drain.

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

Pump cavities 190a and 190b each include a wall 192. Wall 192 fits tightly and tightly within wall 162 of a respective blank wall 160a or 160b of membrane packing 145. The sealing interface between the walls 192 or interface plate 185 and walls 162 or pump walls 160a and 160b further enhance the sealed and separate operation of the various pumps and valves within system 150.

Interface plate 185 also includes a plurality of raised valve seats 194. In particular, one valve seat 194 is provided for each blind valve cavity 164 of membrane packing 145. Each valve seat 194 and blind valve cavity 164 corresponds to one of the valve chambers 114 of the disposable cassette 140. Valve seats 194 include raised sidewalls 196 that extend outward from top surface 188 of interface plate 185. Valve cavities 164 of membrane packing 145 fit tightly around valve seats 194, so that the walls 166 of the valve walls 164 seal against the walls 196 of the valve seats 194.

The valve actuation ports 198 are defined at least substantially in the center of the seats 194. In one embodiment, the top surface is of the valve seats 194 sloping downward towards the actuation ports 198. This allows the surface to blind coupling 168 and lamination

<img file="MX348969B_D0021.tif" />

cassette 104a is pushed away from valve chambers 114 of cassette 140 to open a respective valve to allow fluid to flow through.

As seen in Figure 16, each valve chamber 114 includes a relatively centrally located, relatively centrally protruding volcano-type port. When cassette 140 is used with system 150 the volcano ports align with one of the actuation ports 198. When positive pressure is applied through one of the actuation ports 198, the positive pressure pushes the recovery blind wall 168 and the cassette lamination 104a into the respective valve seat 194 and the valve chamber 114 of the cassette 140, to cover or close the volcano port, which closes the respective valve chamber 114.

As best seen in Figure 21, interface plate 185 includes a plurality of packing seal ports 200. One packing seal port 200 is provided for each pump cavity 190a and 190b and for each valve seat 194. It should be appreciated from the observation of Figures 21 and 22 that the seal ports 200 mate with the opening 170 of the membrane gasket 145. The seal ports 200 may extend in part or all direction through the openings 170. In one embodiment, the openings 170 fit around the ports 200 to create a sealed fit between the ports and the walls they define. the openings 170.

The sealing membrane packing 145 on the surfaces

<img file="MX348969B_D0022.tif" />

IMPIAS

ΟΕ THE PROPERTY

INDUSTRIAL S verticals 196 of the protruding valve seats 194, walls 192 in the pump cavities 190a and 190b and the —— vacuum puTTlUb 200 provide multiple seals for the pump areas and valve areas of the cassette interface. That is, in addition to the membrane packing side seals, there are additional compression seals between the interface plate 185 and the membrane packing 145 as well as between the packing 145 and the cassette lamination 104a.

In one embodiment the face of the membrane packing 145 at the thin flex sections facing the lamination 104a on the pump and the valve chamber of the cassette 140 is textured. The surface of that same side of the membrane packing 145 in the thinner sections that compress and seal against the cassette channels of the pump chambers, valve chambers, and flow path separators of the cassette 140 are not textured and have a finished fine, smooth surface to create a good seal between cassette lamination 104a and packing lips 148a, 148b and 152.

The texturing of the thin sections of the membrane gasket 145 provides flow channels for air from the vacuum ports to migrate across the face of each of the valve and pump chambers of the cassette 140. The texturing also tends to prevent it from membrane gasket 145 and cassette lamination 104a stick together when it is time to remove the cassette from the system. Introducing a positive pressure is also contemplated

<img file="MX348969B_D0023.tif" />

through ports 200 at the end of therapy to eject cassette 140 from interface plate 185. Alternatively, positive pressure can be applied through valve actuation ports 198 (used to close valve chambers cassette 114) from cassette 140 when it is time to remove the cassette. This drive inflates membrane packing 145 over pump chambers 112 and valve chambers 114 and pushes cassette 140 away from interface plate 185.

During operation, negative pressure is applied through ports 200 and openings 170 to pull cassette sheet 104a tightly against blank wall 168 of membrane gasket 156 for a given pump chamber or valve chamber. This negative pressure is applied throughout the treatment, regardless of whether negative pressure or negative pressure is applied through actuation ports 198 of pump cavities 190a and 19b and valve seats 194.

As discussed above, the operation of applying positive and negative pressure to cassette 140 is computer controlled. The processor that contracts such a drive is also capable of receiving and processing inputs, such as pressure sensor inputs. For example, a pressure sensor can be adjusted and applied to sense pressure within a connector that engages each of the valve seal ports 200.

By using the pressure sensor, the processor in combination win / miAi with a computer program can perform an integrity test that has precision not previously available. Given the apparatus described above, if a hole develops in membrane packing 145 or cassette lamination 104a, the vacuum level in the manifold sensed by the sensor begins to degrade. Sensor output to processor or logic implementer is indicative of negative pressure degradation. The processor and computer program detect a decreasing signal and output that a leak is present. The output can drive any of: (i) close therapy, (ii) sound an alarm, (ii) display a visual message, and (iv) aurally describe that a leak is present to the patient or caregiver.

The processor also accepts one or more signals from any of one or more humidity sensors, such as a conductivity sensor. One or more sensors are placed in the instrument under cassette 140, for example, in a grooved cavity under cassette 140. The output of the conductivity sensor is logically combined with the output of the pressure sensor.

Logically combined signals from pressure and conductivity sensors result in the following diagnostic capabilities. If a leak is detected, for example negative pressure degradation is detected, but no moisture is detected, the leak is logically determined to do from the membrane packing 145. That is, the cassette 140 does not leak fluid to the conductivity. If the leak is detected and the⁷⁵ IMPI

INSTITUTO MEXICANO fluid, the leak is logically determined to be ^ éráo '^ Rj ^ aaJS? ^? * ^ 140. ________________________

To the extent that it is feasible to use multiple pressure sensors with individual pump walls 190a and 190b and valve seats 194 or to multiplex one or more pressure sensors, the diagnostic capabilities of the system 150 can be extended to be able to accurately determine no. only which component is leaking, but which area from which component is leaking. For example, the tubing running to ports 200 can be divided between the pump tubing and the valve tubing. A first pressure sensor can be multiplexed between the tubing leading to the different pumps to accurately signal a leak in the first or second pump. The conductivity sensor then tells the system if it is a cassette pump leak or a packing pump leak. A second pressure sensor can be multiplexed to observe leaks in the different valves. Valve one through valve five for example can check to maintain pressure, while valve six shows a leak, meaning the lick or cassette portion or the packing in operation with valve six is ​​leaking. The conductivity sensor tells the system if the cassette lamination or gasket at valve position six is ​​leaking.

Another advantage of the cassette interface of the present disclosure is illustrated by Figures 23, 24, 25A and 25B, 26A and 26B. System 10 in one mode uses a measurement method ot LA P »OFleo_{TO THE)} industrial fluid based on Boyle's law taught in US 4,826,482 (the '482 patent), the full contents of which are incorporated herein by reference and transferred. The method operates on the premise that air is injected into (or evacuated from) pump actuation port 198 which is at the same temperature as the fluid flowing through cassette 140, and at the same temperature of the air within reference chambers 210a and 210b, which are heated to body temperature or about 37 ° C. If there is a temperature difference between dialysate and operating air temperatures, volumetric accuracy is compromised.

It is difficult to quickly and accurately measure air temperature when the components that are mounted to the mounting sensor are not at the same temperature as the air being measured. Also at the present time, a minimum two-hour warm-up time is required before performing a volumetric calibration on the APD HomeChoice® Pro System, which requires that the interface board 185, reference chambers 210a and 210b, chambers of pump 212 into pump cassette 110 and the fluid being pumped is heated to about 37 ° C.

Figures 19 and 20 illustrate pneumatic solenoid valves 202 that mount directly to plate 182. Figure 23 illustrates that volumetric reference chambers 210a and 210b, which maintain a known volume of air, are located on the reverse side 204 of interface board 185 in one mode. The Purposes and Operation of Volumetric Reference Chambers

HEARD LA MOHíDa * industrial X ^ W ^ iJK

210a and 210b are discussed in the '482 Patent and in detail below in connection with Figures 27, 28A through 28F * and ~ 29, which describe an improvement in the method of the' 482 Patent. Now it is sufficient to understand that chambers 210a and 210b are used to calculate a volume of fluid pumped through the cassette. The advantage here is that the valves 202 and the volumetric reference chambers 210a and 210b are positioned in proximity to each other and to the pneumatic paths for the membrane packing 145.

For reference, side 204 of interface plate 185 in Figure 23 shows actuation ports 198 and packing seal ports 200 as previously described in connection with Figures 20 and 21. In the illustrated embodiment, the chambers Reference 210a and 210b are blind cavities formed in the lower plate 185 with precision to have a fixed and known volume. In one embodiment, a controlled volume (heavy amount) of a highly conductive material such as copper mesh is placed in volumetric reference chambers 210a and 210b, which tends to counteract a cooling effect created when high pressure air flows. back from the pump chambers to the low pressure reference chambers 210a and 210b. The air within the pressure reference chamber 210a and 210b rapidly equilibrates to the temperature of the copper mesh and the walls of the reference chambers.

In Figure 23, the bottom plate 185 is formed of a thermally conductive material, such as metal, for example, ⁷⁸ yjMJLj aluminum, copper, steel or stainless steel. In the present system VÍS— 'thermally conductive interface plate

<img file="MX348969B_D0024.tif" />

For example, by inductively producing a current that flows within interface plate 185, which causes the plate to heat up due to its bulk resistance. Alternatively, a rugged heater is conductively coupled to plate 185, for example, through heating strip 208.

Although not illustrated, a temperature sensing device, such as a thermistor or thermocouple, is attached to the connector, for example, near reference chambers 210a and 210b. The temperature sensor sends a signal back to the processor or logic implementer, which controls a power supply that supplies power to the resistive heater or the current provided by the device, so that the temperature of the interface board 185 remains stable at a desired temperature. In one embodiment, interface plate 185 is heated to approximately 36 ° or 37 ° C.

Referring now to Figures 24, 25A, 25A, and 26B, system 210 illustrates an alternative heated cassette interface mode that connects to a remotely located valve connector, such as that used in the APD HomeChoice® system. Pro. System 210 includes alternate interface plate 215 and a separate heated reference camera module 220. Figure 24 illustrates module 220 attached to alternate interface plate 215. Figures 25A and 25B illustrate the alternate interface plate

215 from the front and from the back, respectively. The Fig^Nur and 26B illustrate the reference camera module 220 from and behind, respectively.

The alternate interface plate 215 in one embodiment is made of plastic, such as injection molded ABS, Derlin®, Noryl®, carbon fiber, or any other suitable plastic. A front surface 212 of plate 215 provides the cassette integer, which is formed broadly the same as the cassette interface of interface plate 185. Interface plate 215 includes a plurality of valve seats 214, each including one high plateau 216. Plains 216 form an inwardly angled or tapered insert 218, which defines an actuation port 222. In the illustrated embodiment, the packing seal ports 200 are not illustrated. However, it should be appreciated that the gasket seal ports 200 can be added and that the membrane gasket 145 shown above can be used with the alternate interface plate 215.

The alternate interface plate 215 includes alternate pump cavities 230a and 230b, each including a plurality of drive posts 232 and a conductive metal, eg, aluminum or copper, interface 234. Interfaces 234 are shown in rear view of plate 215 in Figure 25B as extending through an opening 236 in the rear of pump cavities 230a and 230b. The conductive interfaces 234 contact the heated reference chambers of the

IMPI heated reference 220, so that the heat from the heated reference beds in turn heats the fl uu UftTrms interjases - »-

2. 3. 4. The heated conductive interfaces 234 in turn heat the air present between the pump cavities 230a and 230b and the attached membrane gasket.

Figures 24 and 25B show pneumatic fittings 238, which in one embodiment connect to a remotely located valve connector and molded plastic interface plate 215. Because fittings 238 direct positive and negative air flowing to the 10 seats valve 214 (Figure 25A) or 194 (Figure 21) and to the valve cavities 164 of the membrane packing 145, the temperature of this air is not relevant to the accuracy of volumetric pumping. That is, only the air flowing into the pump chambers 112 of the cassette 140 needs to be heated. Accordingly, the module 220 can be made in a relatively small package, which fits in the lower 215.

Figures 26A and 26B illustrate the heated volumetric reference chamber module 220. As seen in Figure 26A, the volumetric reference chambers 240a and 240b fit into a housing 242 having a side wall 244, a mounting plate 246 and a cover 248. The side wall 244, mounting plate 246 and cover 248 may be made of metal or a thermally conductive plastic. The volumetric reference chambers 240a and 240b may be integrally formed as part 25 of the mounting plate 246 or be separate items attached to the

<img file="MX348969B_D0025.tif" />

mounting plate. Heating cables 250 run to a cartridge style heating element, such as those made by Watlow Electric Manufacturing Company (St. Louis, Missouri), Chromalox Corporation (Pittsburgh, Pennsylvania), or Tempco Electric Heater Corporation (Wood Dale, Illinois). ) and fit into, for example, a round mounting opening. The heating cables 250 can also run resistant heating elements that for example can entangle a coil or otherwise contact the volumetric reference chambers 240a and 240b to heat the volumetric reference chambers conductively, conductively, or via radiant energy. Again, a temperature sensor is incorporated into the heated module 220, to provide feedback to a heating controller, which maintains the volumetric reference chambers at a stable and desired temperature, such as 36 ° or 37 ° C, or alternatively at equilibrium or average operating temperature that the corresponding disposable cassette reaches when it pumps the dialysis fluid.

Volumetric reference chambers 240a and 240b each include a conductive interface 252, which mates with conductive interfaces 234 of pump cavities 230a and 230b shown in Figures 25A and 25B. Conductive interfaces 252 are made of thermally conductive material, such as copper or aluminum. Thus, it should be appreciated that the heat from the heating elements is transferred to the heating chambers.₈₂ IMPI

INSTITUTO MtXICAN de la noritMu JET,. . ,. ,,. . ,. industrial reference, which are also conductive aluminum or copper in a mode urn. The heat is conducted to the conductive inferiase Zb2 ', U IUS¹conductive interfaces 234 and actuation air, which is pumped back and forth from reference chambers 240a and 240b through valves 254, through actuation ports 232 of pump cavities 230a and 230b of the interface plate 215 to membrane and gasket.

Although not shown, a suitable customer material may be dispersed around conductive reference chambers 240a and 240b and housing 242 of module 220. The insulating material may be insulating fiberglass or wool, for example. The insulating material can also be applied to the tubing running from the fittings 254 to the remotely located valve connector and back to the pump ports 232 over the relatively short tubing path to further minimize heat loss to the atmosphere. The proximity of the pneumatic components also allows for the heated configuration, which allows the components to be maintained at a desired stable temperature. These features reduce errors related to temperature and measurement of the volume of fluid pumped when using the method of the '4 82 patent and the improved method discussed later. The remotely located valve connector can also be heated to further improve volumetric accuracy. The embodiments shown in Figures 24 to 26 are more complex than the embodiments of Figures 19 to 23; however, the latter modalities move the valves into the cassette interface and allow the valves to be nested within a second compartment.

Real Time Volume Measurement

Referring now to Figure 27, the system 250 illustrates one embodiment for pneumatic control of the dialysis system 10 described herein. The top of the system 250 represents the components described above in connection with Figures 19-24, 25A, 25B, 26A, and 26B. LP, LS, LH, LF, LD, RP, RS, RH, RF, RD represent the valve cavities of the membrane packing and the valve chambers of the disposable cassette. Although ten valves are described here and in Figures 19 to 24, 25A, 25B, 26A and 26B, more or fewer valves can be provided based on many factors, such as supply bag capacity, whether or not mixing is supported, and whether use online warm-up per group.

The valve and pneumatic lines for the packing seal ports 200 are not shown in Figure 27. As previously described, the ports 200 can be pressurized together so that one or a pair of valves in combination with a connector that runs to each one of the ports 200 can control all the packing seal ports 200.

The left and right pump chambers represent the connector pump cavities and the 112 pump chambers of the connector.

<img file="MX348969B_D0026.tif" />

HEARD THE INDUSTRIAL raontOAp cassette thrown away. VSL and VSR are the volumetric reference chambers discussed earlier. As illustrated, the X-VSL pressure transducer checks the pressure in the VSL reference chamber. The X-VSR pressure transducer checks the pressure in the VSR reference chamber.

Valves CO through C4 and D1 through D5 are three-way valves 238 shown in Figures 24 and 25B. Valves A0 and B4 are pump control valves 254 shown in Figure 26A. The rest of the A, C and D valves are located anywhere on the instrument 20.

System 250 also includes a plurality of initiative positive pressure tanks, NEG T (negative pressure, communicates with VSL and VSR chambers), POS T (positive pressure, communicates with VSL and VSR chambers), NEG PL (pressure negative, communicates with left pump chamber), NEG PR (negative pressure, communicates with right pump chamber), POS PL (positive pressure, communicates with left pump chamber), and POS PR (positive pressure , communicates with the right pump chamber). Separate pressure transducers X-NEG T, X-POS T, X-NEG PL, X-NEG PR, X-POS PL, X-POS PR verify the pressure in the respective pressure tanks.

Separate pressure and vacuum reservoirs NEG PL, NEG PR, POS PL, and POS PR allow a pressure drop (vacuum) to be measured while pushing fluid out of (pulling into) pumping chambers 112 as described in detail subsequently.

ss IMPI ^ iN.'TiTVr &lt;&gt; mexiCan.

ΠΕ THE 'PIETY

For reference, the piston bellows are shown, which can be located in the instrument door 20, push it or seat against the interface plate and an occluder bellows that can release all lines (closed due to failure). Both the bellows and the occluder are pneumatically actuated in one mode.

System 250 also includes a processor or logic implementer that operates on computer memory that has program code configured to perform the real-time method described later. The system 250 can operate with the heated connectors discussed later, which make the constant temperature assumption a more correct assumption.

Referring now to Figures 28A through 28F, an improved method for measuring the volume of fluid pumped through the pneumatic drive is illustrated. Figures 28A to 28D illustrate by way of example how the volume of fluid moved after it has moved is calculated. The valves shown favored were closed, while the unshaded valves are open. The actions shown in Figures 28A and 28B occur during relatively short rest measurement periods just prior to a pump output stroke shown above in connection with Figures 18A through 18C. The actions shown in Figures 28C and 28D occur during the short rest measurement periods just after the pump output strokes of Figures 18A through 18C.

The chamber is filled with fluid in Figures 28A and 28B. In the

Figure 28A, the valve (or valves) between the pump chamber chamber (e.g. chamber ^ cámara¹ I¹¹ _i Ha)?^ctá _ (are) open. The valve (or valves) between the POS T chamber and the associated volumetric reference chamber (eg VSL) is (are) closed. This allows the pump chamber to be pressurized to POS T pressure, for example 0.49 kg / cm²gauges. A vent valve (eg, A1 in Figure 27) is open so that the pressure in the volumetric reference chamber (eg, VSL) is zero. The volumetric reference chamber (eg VSL) has a known volume of 16.5 ml in an illustrated mode.

In Figure 28B, the valve state changes so that the valve (or valves) between the POS chamber T and the pump chamber (eg, the left pump chamber) is (are) closed. The valve (or valves) between the POS T chamber and the associated volumetric reference chamber (eg VSL) is (are) open. The vent valve (eg A1) is closed. This allows the pump chamber to pressurize the volumetric reference chamber (e.g. VSL) to 0.169 kg / cm² gauges, causing the pump pressure to drop 0.49 kg / cm² at 0.169 kg / cm²gauges.

The processor is configured to calculate the volume of air or gas V g_ace behind the fluid pump chamber when full as follows:

V gas, full ⁼ (P ref, final P reí, initial) / (P pres !, initial P presl, final) V _reF,

IMPI

MEXICAN INSTITUTE

Q ^ 7 LE LA O ^k í IL '*. L

O / '/ \ DU21HaL where -, ..........,

P ref, final is a final pressure in the volumetric reference chamber (e.g. VSL) after the medical fluid pump is allowed to pressurize the volumetric reference chamber (e.g. VSL), 0.169 kg / cm² gauges in the example;

P re f&gt; ín icia I is the initial pressure in the reference chamber before the medical fluid pump is allowed to pressurize the volumetric reference chamber (e.g. VSL), 0 kg / cm² gauges in the example;

P pump, initi is an initial pressure in the pressure chamber before the medical fluid pump is allowed to pressurize the volumetric reference chamber (eg, VSL), here 0.49 kg / cm² gauges. P_preyes, final is a final pressure in the pressure chamber after the medical fluid pump is allowed to pressurize the volumetric reference chamber (e.g. VSL), here 0.169 kg / cm² manometric; Y

V _Γβί is the volume of the reference chamber, here 16.5 milliliters.

In that way V _gas, n_eno = (0.169 - 0) / (0.49 - 0.1 69) * 16.5 milliliters = 8.6 milliliters.

The valve chambers 114 of the disposable cassette are then switched so that positive pressure from one of the POS PL and POS PR pump stroke tanks (illustrated in Figures 28E and 28F) pushes fluid from the pump chamber towards the patient. or drainage. The pump outlet stroke is carried out in combination

<img file="MX348969B_D0027.tif" />

₈₈ IMPL ^

MEXICAN INSTITUTE Λ

OE LA η · Π B Γ 'AD INMISTWAL with the real-time fluid volume measurement shown below in connection with Figures 28E and 28F. This is described later with the real-time pressure drop method.

Then, as shown in Figure 28C, the chamber is already emptied. The valve (or valves) between the X-POS T chamber and the pump chamber (for example, the left pump chamber) is (are) open. The valve (or valves) between the X-POS T chamber and the associated volumetric reference chamber (eg, VSL) is (are) closed. This allows the pump chamber to be pressurized to the pressure of X-POS T, for example 0.49 kg / cm² gauges. A vent valve (eg, A1 in Figure 27) is open so that the pressure in the volumetric reference chamber (eg, VSL) is zero. The volumetric reference chamber (for example, VSL) has the known volume of 16.5 milliliters.

In Figure 28D, the valve state changes so that the valve (or valves) between the X-POS T chamber and the pump chamber (eg, the left pump chamber) is (are) closed. The valve (or valves) between the X-POS T chamber and the associated volumetric reference chamber (eg VSL) is (are) open. The vent valve (eg A1) is closed. This allows the pump chamber to pressurize the volumetric reference chamber (e.g. VSL) to 0.29 kg / cm² gauges, causing the pump pressure to drop from 0.49 kg / cm² gauges up to 0.29 kg / cm² gauges.

<img file="MX348969B_D0028.tif" />

iMPJ.

¹

The processor is configured to perform the same as shown earlier this time calculate the volume

V g_ace behind the fluid pump chamber when empty:

v gas. empty = (0.29 - 0) / (0.49 - 0.29) * 16.5 milliliters = 24.75 milliliters.

The pump volume between the measurement periods of Figures 28B and 28C is then: fluid moved V f |_Uld0 = empty chamber air volume V _gas. _Empty_volume of full chamber air V gas. baby, that's 24.75 milliliters - 8.6 milliliters = 16.15 milliliters.

Referring now to Figures 28E and 28F, apparatus for performing a real-time calculation of pumped fluid is illustrated. Here, the pressure drop in the pressure tank that drives the pump chamber during the pump outlet stroke (POS PL and POS PR) is verified in real time. The processor calculates the pumped volume in real time according to the equation: V fj_orDo you ⁼ (P POS P, initial / P POS P, t ”1) (V POS P + V gas, full), ⁱⁿ where

P pos p, initial is an initial pressure of the pressure tank POS PL and POS PR before the pump outlet stroke;

P pos p, t is a pressure of the second pressure chamber at a time t during the pump outlet stroke;

V pos p is a known volume of the second pressure chamber; Y

V gas, Hay is the calculated volume of gas in the pump chamber when full made earlier in connection with Figures 28A and 28B.

<img file="MX348969B_D0029.tif" />

IMPIí

MEXICAN INSTITUTE

The steps of Figures 28E and 28F are made between the anterior and posterior JLC, that is, between the steps of the orjl Finenesses. and 28C. In Figure 28E, at the start of the pump outlet stroke, the valve (or valves) between the POS T chamber and the pump chamber (eg, the left pump chamber) is (are) closed. The valve (or valves) between the POS T chamber and the associated volumetric reference chamber (eg VSL) is (are) closed. The vent valve (eg A1 in Figure 27) is also closed. The volume of air in the pump chamber V_gas, n_ina is known to be 8.6 milliliters as discussed earlier in connection with Figure 28B. The volume of the fixed volume tank POS PL or POS PR is known, for example 500 milliliters. The initial pressure P pos p, initial is known, for example, 0.10 kg / cm² gauges.

The valve (or valves) between the POS PL or POS PR chamber is (are) open starting the pump outlet stroke. At this point the pressure begins to drop. The processor is configured to master pressure readings (P_{P0S P},_t) of the X-POS PL or X-POS PR pressure transducer, for example every twenty milliseconds. The processor also calculates the real-time amount of fluid pumped by using the above equation and measuring

P _POsp, t- Figure 28F shows an end of the pump outlet stroke and a corresponding end of the pressure drop.

Figure 29 shows a table of how the fall (P _{P0S P t}) and the resulting fluid volume (milliliters) calculated according to the above equation, will be seen after the exit stroke of

IMPI 3? ^ Instit! ira m_t.xi_SPOUT i't LA r ''? FRI I&gt; Λ D

Í¡^s DU5TRIAL only a few pump points are shown. For ease of data illustration. The pressure starts at the moment the pump outlet stroke begins. Here, P_POsp, t = P pos p, initial, so that its relation is one, which causes the first term in the equation and the resulting volume of pumped fluid to be zero.

In the second pump stroke time in Figure 29, P pos _Pit fell to 1.13 kg / cm² (absolute), which makes the first term in the above equation equal to 0.0062, which when multiplied by the combined volume of the POS PL or POS PR tank (500 milliliters) and the initial volume of air in the pump chamber (8.6 milliliters) generates an absolute pumped volume of (0.0062) * 508.6 = 3.16 milliliters.

At the third pump stroke time in Figure 29, P _POs _Plt has dropped to 1.12 kg / cm² gauge, which makes the first term in the above equation equal to 0.0125, which when multiplied by the combined volume of the POS PL or POS PR tank (500 milliliters) and the initial volume of air in the pump chamber (8.6 milliliters) generates an absolute volume pumped of (0.0125) * 508.6 = 6.35 milliliters.

At the fourth pump stroke time in Figure 29, P _{P0S P}, t fell to 1.11 kg / cm² gauge, which makes the first term in the above equation equal to 0.0189, which when multiplied by the combined volume of the POS PL or POS PR tank (500 milliliters) and the initial volume of air in the pump chamber (8.6 milliliters) ⁹² IMPI generates an absolute volume pumped of (0.0189 ^^ ¾ ^ ¼ milliliters. - At the fifth pump stroke time in Figure 29, P _{POS P}, t fell to 1.11 kg / cm² gauge, which makes the first term in the above equation equal to 0.0253, which when multiplied by the combined volume of the POS PL or POS PR tank (500 milliliters) and the initial volume of air in the pump chamber (8.6 milliliters) generates an absolute volume pumped of (0.0253) * 508.6 = 12.87 milliliters.

At the sixth and last pump stroke time in Figure 29, which is also illustrated in Figure 28F, P _POs pt fell to 1.10 kg / cm² manometric (0.07 kg / cm² gauge), which makes the first term in the above equation equal to 0.0318, which when multiplied by the combined volume of the POS PL or POS PR tank (500 milliliters) and the initial volume of air in the pump chamber (8 6 milliliters) generates an absolute pumped volume of (0.031 8) * 508.6 = 16.19 milliliters.

The final absolute fluid volume moved or pumped through the real-time algorithm, 16.19 milliliters, is virtually the same as the fluid volume calculated through the pre and post algorithm of Figures 28A through 28D, 16.15 milliliters (.25% of difference). However, the real-time method allows the mean pump stroke volumes to be known. As described above and shown below, there are many uses for intermediate volumes including but not limited to

<img file="MX348969B_D0030.tif" />

a line occlusion; (i¡¡) if a leak occurred; v (iv) whether multiple concentrates were properly mixed, for example.

As discussed above, real-time fluid volume calculation can be used in combination with pre and post fluid volume calculation. However, it should be appreciated that the real-time fluid volume calculation does not have to be used in combination with the pre and post fluid volume calculation. That is, after the determination of V gas, filled θΠ Figure 28B, the system can perform the real-time calculation shown in Figures 28E, 28F and 29, without doing the pressurization and the calculation of the chamber thereafter. post-race reference. Therefore it is expressly contemplated not to use pressurization and post-stroke reference chamber calculation, which would negate the need for the post-stroke fluid measurement periods shown for example in connection with Figures 18A and 18B for full strokes. and empty. The post-stroke fluid metering period can be eliminated for systems that have any number of pump chambers, eg, one, two, or three pump chambers.

Figures 28A through 28F and 29 show a pump outlet stroke and associated fluid volume measurement. It should be appreciated that the above methodology also applies a fill or pump inlet stroke. Here, the same pump chamber (left to right) and reference chamber (VSL or VSR) are used. The

IMPIAS »··

MEXICAN INSTITUTE

DE LA MOHEDAL · X / * main difference is that the pressure né'tij ^ Wa is used to select the cassette lamination, extray in iTer ”flU'Itl ΰ — CTe σπ ~ supply or a patient towards the pump chamber . Thus, when looking at Figure 27, the negative pressure tank NEG PL or NEG PR replaces the positive pressure tanks Pos PL or Pos PR in Figures 28E and 28F. Negative pressure will be used for example in the fresh fluid and drain fluid filling phases shown later in connection with Figures 30 and 31 discussed later. The POS T tank remains as shown in Figures 28E and 28F as used for post-fact fluid measurement (28A to 28D) and not for real-time fluid measurement.

Referring now to Figure 30, the above real-time method is used in connection with a filling method 300 to fill both pump chambers (left and right) in a dialysis system employing a line mix of dextrose concentrates and bicarbonate to form a biocompatible dialysate for the patient, which is physiologically advantageous for the patient. For ease of illustration, it is assumed that the left pump chamber, VSL reference chamber, and NEG PL negative pump tank control dextrose pumping. The right pump chamber, VSR reference chamber and NEG PR negative pump tank control bicarbonate pumping. POS T is used for both pump chambers.

In step 302a and 302b, the system 250 of Figure 27 fills the

9₅

DF THE PROPERTY left pump chamber with dextrose and right chamber ^ He SiS® ¥ e2B with bicarbonate. Here, it is assumed that. .......... «nj airp or gas in the pump chamber before filling was determined by the method of Figures 28A and 28B.

In step 304a and 304b, the real-time calculation of dextrose and bicarbonate is made using the method described above in connection with Figures 28A through 28F. One purpose of doing the calculation in real time is to determine the flow rate. That is, the processor can also be configured to calculate the difference between the instantaneous volume and a previously calculated volume to determine a real-time flow rate that knows the time between measurements. For example in Figure 29, the volume deltas are: 3.16 milliliters, 3.24 milliliters, 3.28 milliliters, and

3.32 milliliters. Assuming the time between pressure readings or the sample time to be the same between each sample, the deltas above show the fluid flow rate during the pump outlet stroke to be gradually increasing (instantaneous rate: volume delta /Sample time). This can be normal due to the configuration of the pneumatic pumping system or a particular pump stroke anomaly.

Real-time flow rate information can be used for many purposes. One use is for heater control. The co-pending patent application entitled Dialysis Fluid Heating Systems, filed July 5, 2007, Patent Application Serial No. 1 1 / 773,903, describes an algorithm

<img file="MX348969B_D0031.tif" />

A fluid heating control device that uses flow rate feedback to control power to the fluid heating element. The flow rate information determined in connection with the real-time volume calculation in step 304a and 304b is one way of providing the flow rate feedback to the referenced heating control algorithm.

At step 306a and 306b, dextrose and bicarbonate volume measurements are made using the anterior and posterior pump stroke method of Figures 28A through 28D. In step 308a and 308b, the final real-time volume is compared to the final before and after volume. If the difference between the two is outside a particular amount (eg, 1 milliliter), method 300 assumes that air is present in the associated pump chamber. Real-time fluid flow measurement essentially measures pump chamber lamination motion. The back of the volumetric calculator in fact only equals and real time measurement when there is no air present inside the pump chamber. If the actual and subsequent factual measurements differ, air can be assumed to be present. If air is present, method 300 attempts to remove the air, which may take a couple of attempts. Method 300 tracks the number of attempts through a counter and eventually raises an alarm if air continues to be present.

A first step in the air purge subroutine is to determine ⁹⁷ IMPTgfe ^ iNsTm / το Mw.cjo if a counter is greater than a maximum amount ^ Wj ^ nl®) ® ^ air removal N than method 300 has ^ er before determining that an alarm should be set as observed in connection with step 310a and 310b. If the counter is greater than N (the test can alternatively be if the counter equals N), and the assigned number of air removal procedures was exceeded, method 300 resets the counter in step 312a and 312b, and sets an alarm in step 314a and 314b, for example, an air in system alarm, which can be at least an audio alarm, visual alarm, audiovisual alarm, signal sent to a nurse, operator, pager or control center. User can clear alarm and resume therapy. The procedure that begins in step 302a and 302b is then repeated. The alarm may or may not reappear.

If the counter is less than or equal to N (the test can alternatively be if the counter is less than N), and the assigned number of air removal procedures is not exceeded, method 300 increases the count by one in step 316a. and 316b and causes instrument 20 to perform an air purge procedure in step 310a and 318b, which for example may involve opening the drain line valve and belching air out of a pump chamber port and into the drain line. The procedure begins at step 302a and 302b then is repeated.

Returning to the real-time volume against the pre and post volume comparison of step 308a and 308b, if the difference,,,,,. , Γ * THE PIOPI'OAG between the two is within a particular scale (eg'ewpl «,

<img file="MX348969B_D0032.tif" />

milli liters), method 300 then determines if-al, 4la-nado was — L-filled completely in step 320a and 320b. For example, if the defined volume between the cassette pump chambers 112 and the interface plate pump cavities when they collided is 16.5 milliliters, method 300 can observe to see if the total delivered volume meets or exceeds some amount close to of the defined volume, for example, 15 milliliters. To perform this step, method 300 can observe the total volume in real time, the volume before and after, or both.

If not enough fluid is drawn into the pump chamber, for example, the volume is less than 15 milliliters and the number of attempts exceeded a maximum number of attempts (step 322a or 3 22b), method 300 checks for kink. line or other fluid flow obstruction and attempts to untangle the line or otherwise remove the occlusion. Doing it again may take a couple of tries. Method 300 tracks the number of occlusion removal attempts in steps 324a and 324b. If no kink or occlusion is present, the fluid source can be determined to be empty.

A first step of the occlusion removal subroutine is to increment a count at step 324a and 324b. A next step is to determine if the count is greater than a maximum number of occlusion removal attempts N that the method 300 wishes to make before determining that an alarm should be placed. If an accountant

IMPI ^yy ΐΝίΤίτυιυ mugCaNv

DE the nor&gt; t (jA »&gt; (NDUil KLM is greater than N (the test can alternatively be if the counter equals N), and the assigned number of occlusion removal procedures was exceeded, method 300 sets a continuous alarm the operator needs to correct before therapy can continue.

If the counter is less than or equal to N (the test can alternatively be if the counter is less than N), and the assigned number of occlusion removal procedures is not extended, method 300 causes instrument 20 to perform a procedure occlusion removal "in step 326a and 326b, which for example may involve pulling the fluid back into its source or bag in step 326a and 326b in an attempt to untangle the line or bag port. A push is a push from a pump chamber of fluid back into the fountain solution bag that does not allow the pump chamber to fill with fluid. The push will fail if the fluid cannot flow back to the source indicating that the source line is kinked, or clogged. A real-time pressure drop, or lack thereof, can be used to verify thrust flow, or lack thereof.

If the push is not successful as determined in relation to step 328a and 328b, the system 300 determines that the source is occluded in step 330a and 330b. If the push is successful as determined in relation to step 32 8a and 32 8b, the source is determined to empty at step 332a and 332b. Once the occluded source or empty source is detected, the System 300 can cause it to go into audible or visual alarm. System 300 can cause

<img file="MX348969B_D0033.tif" />

¹⁰⁰

INSTITUTE MtXtCANí that the filling automatically summarizes one or two, set a non-recoverable alarm that requires the intervention of the user. The counter at step 322a and 322b keeps track of the number of times the push attempt is made.

In passage 334a and 334b, the left and right pump chambers empty their respective concentrates into a line that connects to the patient, which is long enough for the concentrates to mix sufficiently before dialysate is delivered to the patient. In steps 336a and 336b, method 300 determines to use the real-time fluid volume method of Figures 28A through 28F if the total delivered dextrose volume reached the delivered target dextrose pump stroke volume and if the delivered dextrose pump stroke volume Total bicarbonate delivered reached target bicarbonate delivered pump stroke volume, respectively.

If the delivered target dextrose volume was not met in step 336a, fluid delivery continues and method 330 determines if the real-time volume difference (dextrose-bicarbonate) is greater than 1/2 milliliters in step 338a. If not, the left pump chamber continues its dextrose depletion in step 334a, causing real-time evacuation of step 336a to be done again. If the real-time volume difference (dextrose-bicarbonate) is greater than 1/2 milliliters in step 338a, the left patient valve (LP in Figure 27) closes momentarily to prevent the left pump chamber from proceeding too far. away from the volume Ha c right pump stroke supplied in step 340a. Once the volume delivered by the left and right pump chambers is within 1/2 milliliters, the left pump chamber will resume its dextrose flush in step 334a, causing the real-time evaluation to be done again. from step 336a. Left pump fluid delivery will stop when the left pump chamber empties, so that the target pump stroke volume is delivered.

If the delivered target bicarbonate volume was not met in step 336b, method 330 determines if a real-time volume difference (bicarbonate-dextrose) is greater than 1/2 milliliters in step 338b. If not, the right pump chamber continues to empty the bicarbonate again in step 334b, causing the real-time evaluation of step 336b to be done again. If the real-time volume difference (bicarbonate dextrose) is greater than 1/2 milliliters in step 338b, the right patient valve (RP in Figure 27) is closed momentarily to prevent the right pump chamber from proceeding too far from the left pump stroke volume in step 340b. Once the pump delivered by the left and right pump chambers is within 1/2 milliliters, the right pump chamber resumes its bicarbonate flush in step 334b, causing the real-time evaluation of the step to be done again. 336b. The supply delivery of the right pump is¹⁰² IMPI ^ will stop when the right pump chamber * empties, ul ^ sga delivers the target pump stroke volume.

Once the dextrose and bicarbonate target pump dump volumes are met in steps 336a and 336b, respectively, the processor measures the total volumes delivered using the before and after sequence of Figures 28A through 28B so that the dextrose and bicarbonate in steps 342a and 342b, respectively. In step 344, the processor determines whether a cumulative measured bicarbonate-dextrose volume is less than the threshold difference, eg, 1 milliliter. The processor also determines if a cumulative measured bicarbonate-dextrose volume is less than a threshold, for example, 1 milliliter. In essence, the processor determines whether the cumulative delivered volumes of dextrose and bicarbonate are within 1 milliliter.

If the cumulative delivered volumes when compared are outside the threshold scale, the processor adjusts the volume of the next pump stroke by calculating a correction factor in step 346. For example, if the normal target pump stroke volume is 15 milliliters, the System 300 will actually deliver a volume of 15 minus the correction factor for dextrose. If the cumulative dextrose delivered volume exceeds the cumulative bicarbonate delivered volume by 1.2 milliliters, the correction factor is 1.2 milliliters and the next target stroke volume for dextrose is 15-1.2 milliliters = 13.8 milliliters.

103

IMPI

INSTITUTO MEXICANO Di la munti AL&gt;

<img file="MX348969B_D0034.tif" />

INDUSTUAL

The correction factor · is similar when the bicarbonate supplied is greater than the dextrose supplied by 1 milliliter or more. The correction factor is zero when the cumulative dextrose delivered is less than the cumulative bicarbonate delivered.

After step 346, or if the cumulative pump dump volumes when compared are within the threshold scale, the processor determines whether the sum of the cumulative bicarbonate and dextrose pump dump volumes is within a range (for example, 1 milliliter) of a total bicarbonate and dextrose fill volume prescribed or programmed in step 348. If the measured total is within the prescribed total scale, the fill phase is completed in step 350.

If the measured total is out of the range of the prescribed total, the processor determines if the cumulative measured volume is less than the prescribed pump dump volume by more than the next programmed group of pump strokes, for example, 30 milliliters, in the step 352. If so, another group of pump strokes is delivered and step 352 is reached again. Steps 354 and 356 calculate the target fill volume for the next group of pump strokes. Step 356 calculates each target volume by 15 milliliters minus the correction factors calculated in step 346. Step 354 calculates the fill volume to be 1/2 of the remaining volume (cumulative measured fill, dextrose and bicarbonate). If the remaining volume is 20 milliliters, and the correction factor for dextrose is 1.2 milliliters, the following¹⁰⁴ τι / ητ target running volumes for the last

INDUSTRIAL pump are calculated to be, for example:

(20 milliliters plus 1.2 milliliters) / 2-1 2 = 9.4 milliliters for dextrose (20 milliliters plus 1.2 milliliters) / 2-0 = 10.6 milliliters for bicarbonate

The target group of pump stroke volumes adds up to 20 milliliters while correcting for the cumulative volume of dextrose so that the cumulative volume of dextrose equals the cumulative volume of bicarbonate.

Referring now to Figure 31, the above real-time method is illustrated in connection with a drain method 400 for filling one of the pump chambers (left or right) with effluent fluid from the patient. For ease of illustration, the left pump chamber, VSL reference chamber, and NEGP-L negative pump tank are used in this example. The right pump chamber, VSR reference chamber, and NEGP-R negative pumping tank will perform the same method simultaneously, but asynchronously so that the right pumping chamber fills with effluent when the left pump system empties and vice versa.

Drain method 400 determines if the drain is flowing properly and if air is present. In step 402, the left pump chamber is filled with effluent. In step 404, the processor determines the effluent volume in real time and the flow for filling and the manner described above. In step 406, if the flow rate is greater than a minimum flow rate threshold¹⁰⁵ IMPI iMSTinno muicanu / normal, for example, 50 m ¡Iiliters / minute, method r the real-time volume calculation of Hpnarin Has effluent Pereda a minimum pump stroke volume threshold, for example, 12 milliliters, in step 408. If not, the left pump chamber continues to fill with effluent from step 402, forming a circulating loop until the real-time effluent fill volume calculation exceeds the threshold at step 408.

When the effluent fill real-time volume calculation exceeds the threshold in step 408, the effluent fill volume measurement using the pre and post pump stroke method of Figures 28A through 28D is performed in step 410. If the volume of real-time fluid moved is greater than the pre and post stroke method of Figures 28A to 28D, air can be drawn into the pump chamber when the chamber is filled with fluid. The 28A to 28D pre and post pump stroke method will not be able to distinguish a pump chamber containing 13 milliliters of fluid and 2 milliliters of air from a pump chamber containing only 13 milliliters of fluid because air It will compress no matter which side of the flex lamination it resides on, resulting in some volume calculation. However, flexible lamination will move more when it accepts 13 milliliters of fluid and 2 milliliters of air than it would if it had only accepted 13 milliliters. The HomeChoice® System marketed by the eventual attorney of the present description attempts to complete the filling of the pump chamber by using an alternate source if the

106

INSTITUTO MIXICAN fz * ΓΧ LA «· ΝΕΟΛΟ„ ^^ 1 (NBUSTtlAL ~ -pump chamber fill volume is greater than 3 short milliliters of full volume. If the HomeChoice® System cannot fill the pump chamber completely, the assumes air is present The contents of the pump chamber are then pumped to the drain to remove the air The HomeChoice® system remedy therefore wastes time and fluid. The detection of pump air and the discharge rate that occurs after step 410 is discussed later while deleting step 438.

Returning to step 406, if the flow rate calculated through the real-time calculation is less than the normal minimum flow rate threshold, for example, 50 milliliters / minute, method 400 determines whether the flow rate in time actual is greater than an intermediate or low flow rate threshold, eg, 30 milliliters / minute, in step 412. If the real-time flow rate is greater than the intermediate threshold, method 400 determines whether a time T1 in which the flow rate is between the intermediate and high end thresholds (for example, between 30 and 50 ml / minute ) is less than a preset time, for example, 5:00 minutes in step 414. If flow rate remained between the intermediate and high end thresholds for more than the preset time, method 400 assumes that the patient line may be partially occluded and will attempt to clean the line that is pushing fresh dialysate into the patient. If the push is unsuccessful an alarm will be set (step 476). If the push is successful (determined through

107 of the volume when using the stroke method of

<img file="MX348969B_D0035.tif" />

later of Figures 28A through 28D in step 416) the method advances to fill (step 300) or set a low drain volume alarm (step 482). This routine is discussed in more detail later.

If the flow rate remained between the mid and high end thresholds for less than the preset time, method 400 determines if the effluent fill real-time volume calculation exceeds a threshold, for example, 12 milliliters, in step 418 . If not, the timer T1 starts at 0 seconds starting in step 420 and the left pump chamber continues to fill with effluent in step 402, which forms a circuit that circulates until (i) T1 reaches the preset time. (eg, 5 minutes) in step 414 or (ii) the real-time volume calculation of the effluent fill exceeds the threshold (eg, 12 milliliters) in step 418.

When the effluent fill real-time volume calculation exceeds the threshold in step 418, the effluent fill volume measurement using the pre and post pump stroke method of Figures 28A through 28D is performed in step 410. The pump air detection and discharge rate that occur after step 410 are discussed later in step 438.

Returning to step 412, if the flow rate calculated through the real-time calculation is less than the intermediate threshold, by&gt; &lt;* IMPI ^

MEXICAN INSTITUTE. FROM ERONITY example, 30 milliliters / minute, method 400 determines dT^0l¿Wn d nseSE? real-time flow is greater than a threshold riu ^ miiui j? fi, jj ^ gin low-end flow, for example, 12 milliliters / minute, in step 422. If the real-time flow rate is greater than the low-end threshold, method 400 determines whether a time T2 in the which the flow rate is between the low end and intermediate thresholds (eg, between 12 and 30 milliliters / minute) is less than a second preset time, eg, 3:00 minutes in step 424. In the illustrated embodiment T2 is less than T1, which means that method 400 does not wait as long at the lower flow rate before running the occlusion routine at step 416 because an occlusion is more likely at the flow rate. lower.

If the flow rate remained between the low end and the intermediate thresholds for more than the preset second time, method 400 assumes that the patient line may be partially occluded and attempts to clear the line by pushing the fresh dialysate into the patient. If the push is unsuccessful, an alarm is set at step 476. If the push is successful (determined by measuring the pump fill volume using the pre and post pump stroke method of Figures 28A through 28B in step 416), the pump advances to fill (step 300) or places a low drain volume alarm (step 482). This routine was discussed in detail later.

If the flow rate remained between the low end and the intermediate thresholds for less than the second preset time

INDUSTRY!

T2, method 400 determines whether the effluent fill-time volume calculation exceeds a threshold, eg, 12 mllItttTOs, in step 426. If not, the timer T2 starting at 0 seconds is started in step 428 and the left pump chamber 5 continues to fill with effluent in step 402, which forms a circuit that runs until (i) T2 reaches the time preset (eg, 3 minutes) in step 424 or (ii) the effluent fill real-time volume calculation exceeds the threshold (eg, 12 milliliters) in step 426.

When the effluent fill real-time volume calculation exceeds the threshold in step 426, the effluent fill volume measurement using the pre and post pump stroke method of Figures 28A through 28D is performed in step 410. The pump air detection and discharge rate that occur after step 410 are discussed later in step 438.

Returning to step 422, if the flow rate calculated through the real-time calculation is less than the threshold with no extreme low flow, for example, 12 milliliters / minute, method 400 starts a third timer T3 if the timer fails. started at step 430. If the real-time flow rate is less than the low end threshold, method 400 determines whether a time T3 in which the flow rate is less than the extreme low threshold is less than a third preset time, for example , 1:00 minutes in step 432. At 25 the illustrated mode T3 is less than T2, which means that the ¹¹⁰ ίΝΤΠΤυΤΟ MEXICANO method 400 does not expect so much in the flow index^AND^®^pJ ^? O before running the occlusion routine in step 41 6 because an occlusion or an empty patient is more likely in the lower flow rate.

If the lower index remained below the extreme low threshold for less than the second preset time T3, the method 400 determines whether the real-time volume calculation of the fountain fill exceeds a threshold, for example, 12 milliliters, in step 434 If not, and timer T3 is not equal to 0 seconds, method 400 causes the left pump chamber to reduce suction pressure in step 436 (for example, by changing NEGP-L from -0.10 kg / cm² gauges down to minus -0.08 kg / cm² gauges as indicated in the pneumatic system 250 of Figure 27).

At step 436 the patient is probably close to emptying or is completely drained. To reduce nonconformity in removing the remaining effluent from the patient, method 400 lowers the suction pressure in step 436. The left pump chamber continues to fill with effluent in step 402, forming a circuit that circulates until (i) T3 reaches the preset time (for example, 1 minute) in step 432 or (i) the volume calculation in time Actual effluent fill exceeds threshold (eg, 12 milliliters) in step 434.

When the effluent fill real-time volume calculation exceeds the threshold in any of steps 408, 418, 426, or

434, the measurement of the effluent fill volume used by the

<img file="MX348969B_D0036.tif" />

Post-pre-pump stroke method of Figures 28A through 28D is performed in step 410 and a pump air detection check is performed. Here, method 400 calculates the difference between the real-time calculation of effluent removed from the patient through the method of Figures 28A to 28F and the volume calculated using the pre and post pump stroke method of Figures 28A to 28D. . If the volume difference is less than a threshold difference (for example, 1 milliliter) in step 438, the system assumes that little or no air is present and that normal pumping can continue because any air that may be present will not pass through the pump.

If the finish difference in step 438 is greater than the threshold, the method 400 starts a fourth timer T4 in step 440 if the timer has not yet been started. If the difference stayed out of range for more than a fourth preset time (eg, 3 minutes) as determined in step 442, method 400 sets an air on the system alarm in step 444. If (i) the difference did not stay off the scale for more than the fourth preset time as determined in step 442 or (ii) the difference between the real time and the pre / post volumes is less than the threshold, the 400 method causes the left pump chamber to drain the effluent to the drain in step 44 6. However, if T4 is greater than 3 minutes, the system assumes that the pump chamber ingested air from the patient for 3 minutes and sets an alarm on the step 444.

₁₁₂ IMPI

INSTITUTE MEX1CAN,

FROM THE INDUSTRIAL FOPIEDaü • Step 448 creates a circuit in which the left pump chamber continues to drain to the drain while the drain flow is greater than a threshold value, for example, 80 milliliters / minute. When the drain flow falls below the threshold, method 400 determines whether the real-time volume calculation of effluent sent to the drain exceeds a threshold volume, eg, 12 milliliters, in step 450. If not, method 400 determines if the drain flow fell below an extreme low threshold, for example, 12 milliliters / minute, in step 452.

If the drain flow did not fall below the extreme low threshold in step 452, a longer timer T5 is started if it was not already started in step 454. A circuit is created as long as the real-time volume is less than the threshold, for example, 12 milliliters, and the drain flow remains below the extreme low threshold, for example, 12 milliliters / minute and below the upper threshold, for example. , 80 milliliters / minute until timer T5 reaches a fifth (higher) preset time (for example, 3 minutes) in step 456, where time method 400 sends an alarm (audio, visual or audiovisual) to check the drain line for an occlusion in step 458..

If the drain flow fell below the extreme low threshold in step 452, a shorter timer T6 is started if it was not already started in step 460. Another circuit is created as long as the real-time volume is less than the threshold, for example, 12 milliliters, and the drain flow remains below the extreme low threshold, for example, 12 _1I3 IMPI

INSTITUTE MLXíO.Níj

D fe LA P KO Η E i 'AD miIiIiters / minute, until the timer T6 reaches dWW ^ to preset time (shorter) (for example, 30 seconds) ~ FTT ~ etprastr 462, where the time method 400 sends the alarm to check the drain line for an occlusion in step 458.

When the drain flow falls below the threshold in step 448 and the real-time volume calculation of effluent sent to the drain exceeds a threshold volume, for example, 12 milliliters, in step 450, the method 400 calculates the volume of total effluent sent to drain via the pre and post method of Figures 28A through 28D as observed in step 464, before which the left pump chamber begins another effluent fill in step 402.

When any of the T1, T2, or T3 timers expire at steps 414, 424, or 432, respectively, it is possible that the patient line has an occlusion, which for example could be due to fibrin blockage or a partially twisted line. In step 416, method 400 calculates the total effluent withdrawn from the patient during the current pump stroke using the pre or post method of Figures 28A through 28D. In step 466, the left pump chamber empties the effluent to the drain. In step 468, the total effluent volume sent to the drain via the pre-post method of Figures 28A through 28D is calculated, after which the left pump chamber draws a bolus of fresh fluid from a supply bag into the step 470.

The left pump chamber pushes the fresh bolus into the patient through the patient line to verify that the ₁₁₄ IMPI ^

MEXICAN INSTITUTE

DE LA MORULA! - The industrial poisoning can be performed and to remove any fibrin blockage or to untangle the patient line if it is partially occluded between an examination at step 472. If the push procedure is unsuccessful, for example, fluid cannot reach the patient or the real-time flow rate is below a threshold, as determined in step 474, method 400 in step 476 sets an alarm occluded patient line through any of the ways discussed above. If the procedure is successful, for example, fluid reaches the patient and / or the real-time flow rate is above a threshold, as determined in step 474, method 400 assumes that the patient is empty in step 478 .

After the patient is determined to be empty in step 478, a total volume of effluent withdrawn from the patient is calculated and compared to a minimum drain volume in step 480. If the total effluent volume is less than a minimum volume, set a low drain alarm in step 482 via any of the techniques described above. If the total effluent volume reaches or exceeds the minimum volume, the system 10 employing method 400 advances to the fill phase 300 described above in connection with Figure 30. The minimum volume can be a percentage of the programmed fill volume when drains to empty. When draining to a target volume, for example with a tidal therapy, the minimum volume is the target volume. Method 400 also checks the cumulative volume of the

<img file="MX348969B_D0037.tif" />

115

IMPI

INSTITU ID MEXICAN

EU LA MOHEDAL)

INÜUSTK1AI effluent drained after step 410. This cumulative volume is reported as the volume drained when the tidal drain ends while under normal flow condition. Otherwise, the cumulative drain volume from step 480 is reported as the volume drained.

Temperature sensor

Referring now to Figures 32 and 33, system 500 illustrates one possible fluid temperature measurement apparatus and method for system 10. Temperature measurement system 500 is advantageous in that it is non-invasive. System 500 measures the temperature of fluid flowing through a portion of disposable apparatus 50. For example, system 500 may measure the temperature of fluid flowing through disposable cassette 28, 100, 130, 140, for example, upstream, downstream, or directly in a fluid heating path of a cassette used with the warming up online. Or, the fluid can be sensed as it flows through one of the fluid lines, such as directly up and / or down the fluid heater. Also alternatively, the fluid may be perceived while receiving within a bag or container, such as a heater bag used with group heating.

In the illustrated embodiment, the system 500 includes a housing 502, which is part of the instrument 20 of system 10. For example, the housing 502 can be integrated into the interface board.

IMPI

INSTITtm.) MEXICAN.

HEARING THE FIGURES^üus:r ^^L

<img file="MX348969B_D0038.tif" />

116

185 described above in connection with

When cassette 28, 100, 1 30, 140 is loaded into T Ιή'δΤΓΙΙΠΙδηΤσ 2Ότ a portion of the cassette is pressed against housing 502. Housing 502 may be plastic or metal and must be at least substantially opaque, for example, to infrared wavelengths. With cassette 28,100,130,140 compressed against housing 102 and instrument or machine door 20 closed on the other side of cassette 28,100,130,140, ​​little ambient light reaches the cassette portion 28, 100, 130, 140 that interacts with the system

500.

The lamination 102 of the cassette 28, 100, 130, 140 includes a transparent portion 504, for example, for infrared wavelengths and a non-transparent or opaque portion 506. The portions 504 and 506 are positioned adjacent to the housing 502. The portion opaque 506 is formed for example through an ink (eg inkjet), printing or painting (eg spray paint) process. Alternatively, the opaque portion 506 is formed through an opaque patch adhered to the disposable article. The size of the opaque portion 506 can range from about 6.4 millimeters by 6.4 millimeters to about 2.54 centimeters by 2.54 centimeters or the same size on one diameter if circular. Transparent portion 504 may be clear lamination 102 and may have an infrared target area at least as large as that of opaque portion 506. The size of the target area depends on the infrared sensor selected

<img file="MX348969B_D0039.tif" />

IMPIO wyriTon.xuii'ANu 'arearoQ / Dtieti

117 and the distance the sensor is mounted away from the For example, a MIKRON M50 IIJU Infrared sensor for this first application has a target diameter of 1.27 millimeters when pressed against the target. The target diameter increases to 3.18 cm when the sensor is moved 15.25 cm from the target.

The temperature measurement system 500 includes an arm 508, which supports a temperature sensor 510. The arm 508 is capable of rotating back and forth at a pivot point 512, so that the temperature sensor 510 selectively points to the transparent portion 504 or opaque portion 506. Temperature sensor 510 in one embodiment is an Infrared temperature sensor. Suitable Infrared temperature sensors 510 are provided by PerkinElmer (Walthen, Massachusetts), Dexter Research (Dexter, MI), Electro Optical Components (Santa Rosa, CA).

In the illustrated embodiment, the handle 502 includes electromagnets 514. When energized the electromagnets will push and / or pull on the metal portion of the magnetized pivot arm 516. Reversing the polarity will cause the polarity orientation to change. Arm 508 includes a magnetic portion, eg, steel, 516, that pulls toward one of electromagnets 514 when that electromagnet is energized. The electromagnets control the orientation of the infrared temperature sensor so that the infrared temperature sensor 510 can selectively point (i) at the opaque portion 506 to take a

<img file="MX348969B_D0040.tif" />

¹¹⁸ IMPI

1NSTTTVTO MUiCan.

first temperature reading, temp_Wall, as observed in Figure 32 or (ii) in clear portion 504 to take a second temperature reading, temp_{wall and} fi_uid0, which is a combination (A * temp_paired ⁺ B * temp_F|_LJ¡_d0) of lamination 102 and the fluid within lamination 102 as seen in Figure 33.

A and B are constant depending on film or tube thickness and composition and are determined experimentally.

Because temp_paired was measured and known, the fluid temperature temp_F|_Uid0 can be calculated using temp_Wall measure and temp_panetwork and fluid measured according to the equation:

temp_F।_or¡_do = ltemp._{Dared vf}|_OR¡_d0 measure- (A) * (temp_nared measure)]

B

A processor and memory in the temperature controller or in a central processing unit stores constants A and B and performs the above calculation. The Temperature Sensing System 500 should provide non-invasive near real-time monitoring of fluid temperature.

Sensor 510 rotates back and forth and different temperature measurements are taken for example every second. Alternatively, two independent Infrared temperature sensors are used, one for infrared energy transmitting portion 504 and the other for infrared energy non-transmitting portion 506. In addition, alternatively, a dual or quad infrared sensor package is used, such as a Perkinselmer® TPS 2534 dual element thermopile or single element thermopile.

WICKED

INSTITUTO MEXICANO f,,,, ___Λ _,. . ,, t&gt; E LA PROÍ'IEDZ.UV quadruple TPS-4339. The redundant temperature measurement foot box element system. Multiple complexity of calibration.

A motor or solenoid can be used in place of electromagnets. Also alternatively, arm 508 may be spring biased to a pivot position and pneumatically retracted to the second pivot position.

Referring now to Figure 34, data illustrating the accuracy of fluid sensing system 500 is shown. The system 500 in Figure 34 appears to provide non-invasive temperature readings that are close to accuracy and response time and an invasive temperature sensor.The correlation between the readings from a resistance temperature detector (RTD) sensor immersed in the fluid the calculated readings of the Infrared Sensing System 500 is good specifically considering that the fluid temperature arose just over 20 ° C to over 50 ° C during a course 10 minute time frame where temperature readings were taken. In the example, a constant A was set at 0.877985 and the constant B was set at 0.1 09635. The curve-fit line was found to be T_Calc⁼1 047 * T_Rt_D-0.0303.

Multiple Chamber Bag Open Sensor

Referring now to Figures 35 and 36, the inductive sensing system 5 30 illustrates one modality for detecting: (i) if

IMPI a single cable supply bag 40 (generally referred to as the supply bags 40a or 4Qb_.de discussed above) or a multi-chamber supply bag 540 resides on one particular of shelves 32, 34, 36 and 38; and (ii) if the supply bag is a multi-chamber supply bag 540, if an associated brittle seal 542 was broken allowing two or more separate chamber concentrates 544a and 544b 546a and 546b, respectively, to be mixed.

The multi-chamber supply bag inductive sensing system 530 measures current, for which a fully opened container is an indicator of electrical conductivity or electrical impedance. The measured current indicates whether the brittle seal 542 between chambers 546a and 546b of multi-chamber bag 540 has been broken so that previously separated solutions can be mixed prior to delivery to a patient.

The different concentrates 544a and 544b within the separate chambers 546a and 546b of the multi-chamber bag 540 have different ion concentrations. The different ionic nature of different concentrates 544a and 544b provides an opportunity to correlate a measured current in a mixed solution to a conductivity or impedance of the solution. The 530 system can therefore compare the determined conductivity or impedance to an expected conductivity or impedance to confirm whether the concentrates were properly mixed. The 530 system is non-invasive, which is advantageous when it comes to sterile __χχ_: ι__ ._ι _____ ζ, ~ .. ____JWTIIAI&gt; 2 'Ί # * medical fluids, such as dialysis fluids. It should be appreciated that ^ the · ^ system 530 can operate with non-stere eδ 11 or iré— injectable fluids.

System 530 includes a first spool 532 and a second spool 534, which are located at different positions within the limits of the tray or shelf (for example, one of shelves 32 to 38) where the multi-chamber bag is placed. or container 540 for treatment. For example, coils 532 and 534 are installed in the top door of or under the tray or shelf (eg, one of shelves 32 or 38) or laminated within the tray or shelf. If installed on top of the tray, the 532 and 534 coils can be covered with a protective liner or layer. Coils 532 and 534 for example can be formed from a single stranded cable or a multi-stranded cable, such as LITZ cable. In the illustrated embodiment, coils 532 and 534 are round or flat coils.

One of the coils 532 and 534 performs a transmitter function while the other of the coils performs a receiver function. The coils may be dedicated to one of the functions, for example, coil 532 transmits and coil 534 receives as shown in Figures 36 and 37. Alternatively, coils 532 and 534 alternate between transmitter and receiver functions.

A signal generator (voltage or current) 536 stimulates the transmitter coil 532 with a signal that varies with time, such as sine wave, square wave, sawtooth wave or other.

122

ΪΝΠΤΠΙΤΟ MEXICAN

Say LA HtUAtmL · variable wave over time. Generator 536 for example ^ can s? T ~ (i) a logic level oscillator, (i) a combi Π and CT 0 'Π 7Ϊ tí' 'BS C11 and U ΰ Γ “and filter or (iii) a waveform generator circuit. A suitable voltage scale includes 4 to 20 volts. Transmitter coil 532 induces small currents in the dialysate, while receiver coil 534 senses those currents. The intensity of the currents that the coil to the receiver 534 perceives depends on the type of solution and the degree of electrical coupling between the bags and the coils 532 and 534. For example, if the shape of the supply bag or the container is that its footprint is not projected onto the top of a receiver coil, the receiver coil will not pick up any current. If the shape of the supply bag or container is such that its footprint does not project onto the top of the transmitter coil, the transmitter coil will not induce any current or a relatively small current in the solution.

Figure 35 shows that the closed seal 542 causes the container 540 to engage less effectively with the flat areas of the chambers 546a and 546b that lie flat on the tray or shelf. Accordingly, a sensor or measurement device 538 will measure less current from the receiver coil 534. This current level in Figure 35 is shown to reside on an unmixed scale. The current measuring device 538 in one mode is a millimeter or an ammeter.

Figure 36 shows that open seal 542 mates securely.

123 the same shape effectively with the flat areas of the a and 546b, since the complete bag or the content ahül á 'and ύϋΰΊΤηίΑΙϊΜΤδ⁵on the tray or shelf. Consequently, the sensor or measurement device 538 measures more current from the receiver coil 534.

This current level in Figure 36 is shown to reside on a mixed scale.

Figures 37A through 37D illustrate an inducer system 560 that can determine if bag 540 is positioned and oriented correctly on tray or shelf 32, 34, 36 or 38. Bag 540 shown from the top in Figures 37A through 37D shows brittle seal 542 separating chambers 546a and 546b. System 560 includes four coils 532a, 532b, 534a, and 534b. Each coil can be used for transmission or reception. The arrows represent some of the possible couplings between the coils.

Figure 37A illustrates a suitable loading of bag 540, wherein a port or pigtail 548 of bag 540 aligns with and rests in opening 35 of tray or shelf 32, 34, 36 or 38. Here, seal 542 separates coils 532a and 532b of coils 534a and 534b, respectively. Seal 542 does not separate coil 532a from coil 534a or coil 534a from coil 534b. The proper load placement or orientation of Figure 37A therefore results in a signature inductive coupling pattern of (i) coil 532a to coil 532b-high coupling, (ii) coil 534a to coil 534b-high coupling, (! ii) coil 532a to coil 534a-uncoupled, and (iv) coil 532b to coil 534b-uncoupled.

<img file="MX348969B_D0041.tif" />

¹²⁴ IMPI

MU1CANO INSTITUTE

The improperly charged bag 540 from the Ia ^. ^ 2 ^ 3 other side results in a different inductive coupling pattern of _ (i) high coupling, (ii) high coupling, (ii) high coupling, and (iv) high coupling because the four coupling coils are located on one side of the brittle seal 542. The improperly loaded bag 540 of Figure 37C even results in a different inductive coupling pattern of (i) low coupling, (ii) low coupling, (iii) high coupling, and (iv) high coupling due to seal position 542 relative to the coils illustrated in Figure 37C. The improperly loaded bag 540 of Figure 37D results in the same inductive coupling pattern of Figure 37C, primarily, (i) low coupling, (ii) low coupling, (iii) high coupling, and (iv) high coupling due to the position of the seal 542 relative to the coils illustrated in Figure 37D.

A system controller takes the four measurements before the seal 542 is broken and classifies the coupling signature into an appropriately bag loaded state or an improperly loaded state. The electronics of the system 10 in one embodiment includes a multiplexer that sequences through each transmitter / receiver pairs (i) through (iv) upon receiving a signal from a load cell that detects that a bag was loaded or upon receiving a user input that a bag or bags were loaded. An individual signal source 536 can be multiplexed to a desired coil that functions as the transmitter for the particular pair being used.

INSTITUTE M EX1CAN j 1 7 C DE LA PROPERTY

INDUSTRIAL perceives, for example, coil 532a for pair (i), coil 53.4a for pair (ii), coil 532a for pair (ii), and coil 534a for pair (iv) shown above. The multiplexer also sequences through a plurality of electrical switching states to electrically connect the appropriate coils of each pair (i) through (iv) to source 536 and sensor 538 at the appropriate time.

It is also possible, after determining that bag 540 was loaded properly, that the controller can verify from the inductive coupling signature that the composition of the stock solutions 544a and 544b in compartments 546a and 546b is correct according to a expected conductivity for each solution. The pairs tested (iii) and (iv) for the correct bag position in Figure 37A reveal the conductivity for concentrates 544a and 544b from compartments 546a and 546b, respectively. If a conductivity is outside of an expected range, an error can be generated. The controller can also verify the integrity of the 542 seal. Before allowing treatment to begin, the system 560 also checks the seal 542 that was opened allowing concentrates 544a and 544b to mix. Once the solution is mixed, the conductivity of the mixed dialysate can also be checked.

Correct bag placement is helpful for systems that use gravity for any of the treatment operations. Verification of each of the individual solutions makes it possible to determine whether the concentrations are adequate for the intended treatment. Verification of

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IMPI

INSTITUTO MEXICANO M LA MtOF! E&gt; AD industrial

<img file="MX348969B_D0042.tif" />

the integrity of the seal allows the instrument 12 to assess that the solutions were not mixed before starting the treatment. Premature mixing of solutions considerably shortens the shelf life of the product. Such a measurement ensures that no degradation of the solution occurred.

The aforementioned controller can operate directly or indirectly with a central processing unit, which in turn operates with a video controller and graphical user interface (GUI). If all of the above checks have been verified, the system 10 causes the GUI to present an acceptable bag loading message or similar and allows therapy to continue. If one of the bags 540 is loaded incorrectly, the system 10 causes a GUI to display a check bag load or similar message and perhaps even identify the bag, eg check second bag load from above. If the 540 bags are loaded correctly but the 560 system detects abnormal conductivity, the system 10 causes the GUI to display a check solution for loaded bags or similar message and perhaps even identify the bag, for example check solution on the second bag from above ”. If the bag open load and concentration are verified but the user attempts to start therapy without opening one or all of the bags 54, the system 10 causes the GUI to display an open bag seal before treatment message or the like and such. Once you even identify the bag, for example, open the top bag seal before treatment.

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MEXICAN INSTITUTE

USE THE TROUBLE

INDlbTlÚAL

Figures 4 through 9 illustrate a bag handling system 30, which holds multiple supply bags in a single guide for fluid flow and air handling purposes. It should be appreciated that the inductive sensing systems 530 and 560 may operate in the bag angle of the system 30, alternatively with the bags 540 loaded at least substantially horizontally or further alternatively with the bags 540 loaded at least substantially vertically. In the inclined system 30, the coils can be laminated to a top and bottom surface of each tray or they can be integrated into the tray. With a vertical manager, the coils can be connected to one or more vertical bars that run vertically to one of the bags and press the respective coils against each bag. The signals from the coils are provided through the vertical support bars. Bag handling systems can supply additional information such as weight information through a load cell.

It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present topic and without diminishing its intended benefits. Such changes and modifications are therefore intended to be covered by the appended claims.