Medical fluid system with flexible sheeting disposable unit

ES 2 445 950 T3

DESCRIPTION

Medical fluid system with disposable flexible blade unit

BACKGROUND

The examples described below relate generally to the supply of medical fluids. More particularly, the examples disclose systems, methods and apparatus for the control of fluid flow in systems for the treatment of renal failure.

A person's renal system can fail for a variety of reasons. Kidney failure produces various physiological disorders. The balance between water and minerals and the excretion of the daily metabolic load are no longer possible, and the toxic end products of nitrogen metabolism (urea, creatinine, uric acid and others) can accumulate in the blood and tissues.

Kidney failure and reduced kidney function are treated with dialysis. Dialysis removes waste, toxins, and excess water from the body, which would otherwise have been removed by the normal function of the kidneys. Dialysis treatment to replace kidney functions is critical for many people, as their life depends on it.

Hemodialysis and peritoneal dialysis are two types of dialysis therapy commonly used to treat loss of kidney function. A hemodialysis (HD) treatment uses the patient's blood to remove waste, toxins, and excess water from the patient. The patient is connected to a hemodialysis machine and his blood is pumped through the machine. Catheters are inserted into the patient's veins and arteries so that blood can flow to and from the hemodialysis machine. The blood passes through a dialyzer in the machine, which removes waste, toxins, and excess water from the blood. The clean blood is returned to the patient. During a single hemodialysis therapy, a large amount of dialysis fluid, for example about 120 liters, is consumed to dialyze the blood. Hemodialysis treatment lasts several hours and is usually carried out in a treatment center, about three to four times a week.

Another form of treatment for kidney failure involving the blood is hemofiltration (HF), which is an alternative therapy for kidney failure based on convective transport of toxins from the patient's blood. This therapy is carried out by adding replacement or replacement fluid to the extracorporeal circuit during treatment (usually between ten and ninety liters of said fluid). This replacement fluid and the fluid accumulated by the patient between treatments are subjected to ultrafiltration during the HF treatment, providing a convective transport mechanism that is particularly beneficial for removing residual products of medium and large molecules.

Hemodiafiltration (HDF) is another blood treatment modality that combines both convection and diffusion clearances. HDF uses dialysis fluid that flows through a dialyzer, similar to standard hemodialysis, providing diffusion clearance. In addition, a replacement solution is supplied directly to the extracorporeal circuit, producing a purification by convection.

Peritoneal dialysis uses a dialysis solution, also called dialysis fluid, which is infused into a patient's peritoneal cavity through a catheter. The dialysis fluid comes into contact with the peritoneal membrane of the peritoneal cavity. Waste, toxins, and excess water from the patient's bloodstream pass through the peritoneal membrane and enter the dialysis fluid by diffusion and osmosis, that is, an osmotic gradient occurs across the membrane. The used dialysis fluid is then drained from inside the patient, removing toxin residues and excess water from the patient. This cycle repeats.

There are several types of peritoneal dialysis therapy, including continuous ambulatory peritoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”), tidal flow APD and peritoneal dialysis. continuous flow (continuous flow peritoneal dialysis - “CFPD”). CAPD is a manual dialysis treatment. The patient manually connects an implanted catheter to a drain, allowing used dialysis fluid to drain out of the peritoneal cavity. The patient then connects the catheter to a bag of fresh dialysis fluid, infusing the fresh dialysis fluid into the patient through the catheter. The patient disconnects the catheter from the bag of fresh dialysis fluid and allows the dialysis fluid to remain within the peritoneal cavity, where the transfer of waste, toxins, and excess water takes place. After a residence time, the patient repeats the manual dialysis procedure, for example four times a day, each treatment lasting approximately one hour. Manual peritoneal dialysis requires considerable time and effort on the part of the patient, leaving much room for improvement.

Automatic peritoneal dialysis (“APD”) is similar to CAPD in that dialysis treatment includes drain, fill, and dwell cycles. However, APD machines cycle automatically, usually while the patient is sleeping. APD machines free patients from having to manually cycle through treatment and transport supplies throughout the day. APD machines are placed in fluid connection with an implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drain. APD machines

ES 2 445 950 T3 pump fresh dialysis fluid from a source of dialysis fluid, through the catheter, into the patient's peritoneal cavity, allowing it to remain within the cavity to allow transfer of waste, toxins, and excess of water. The source can consist of multiple bags of sterile dialysis solution.

APD machines pump used dialysis fluid from the peritoneal cavity, through the catheter, to the drain. As with the manual process, several drain, fill, and dwell cycles occur during APD. At the end of CAPd and APD, a “last fill” can be performed, which remains in the patient's peritoneal cavity until the next treatment.

Both CAPD and APD are staged systems that send used dialysis fluid to a drain. Tidal flow systems are modified staged systems. With tidal flow, instead of removing all of the fluid from the patient over a long period of time, some of the fluid is removed and then replaced in shorter periods of time.

Continuous flow systems, or CFPDs, can purify or regenerate used dialysis fluid rather than dispose of it. The systems pump fluid into and out of the patient through a closed circuit. Dialysis fluid flows into the peritoneal cavity through one catheter lumen and exits through another catheter lumen. The fluid leaving the patient passes through a reconstitution device that removes residues from the dialysis fluid, for example through a urea removal column that uses urease to enzymatically convert urea to ammonia. The ammonia is then removed from the dialysis fluid by adsorption before reintroducing the dialysis fluid into the peritoneal cavity. Additional sensors are used to monitor ammonia removal. CFPD systems are typically more complicated than staged systems.

In each of the kidney failure treatment systems described above, it is important to control ultrafiltration, which is the process by which water (with electrolytes) moves through a membrane, such as a dialyzer or peritoneal membrane. For example, ultrafiltration in HD is the result of a transmembrane and osmotic pressure difference between blood and dialysis fluid across a dialyzer membrane. For a given osmotic pressure, the higher the transmembrane pressure, the faster the ultrafiltration.

Many of the dialysis systems described above employ a pump cartridge. The pump cartridge typically includes a flexible membrane that is mechanically moved to push and draw the dialysis fluid out and into the cartridge respectively. Known systems include flexible sheets on one side of the cartridge, while others include sheets on both sides of the cartridge. Positive and / or negative pressure can be used to operate the pump cartridges.

Pump cartridges have many design problems. For example, a problem with pump cartridges is leaks. If flexible membranes experience a pit or tear, fluid and air can pass from one side of the membrane to the other. The movement of fluid from the interior of the cartridge to the internal mechanisms of the machine can deteriorate the machine. Movement of air from the machine into the cartridge can compromise the sterility of the fluid paths defined by the cartridge.

Another problem related to cartridge-based pumping occurs when the cartridge is incorrectly loaded into the machine. Proper alignment is important as parts of the flexible membrane have to match corresponding parts of the machine, for example the pump and valve actuators. Improper loading can place the cartridge under undue mechanical stress, potentially leading to cartridge and / or actuator damage. Improper cartridge loading can also degrade or prevent system performance.

Another dilemma, especially in the case of CFPD, is the coordination of multiple fluid supplies. Cartridge-based peritoneal pumping systems that deliver fluids continuously to the patient must withdraw fluid (ultrafilter) from a closed loop of continuous-flow dialysis fluid and add fluid (concentrate) to it. Additional fluids typically require additional specialized pumps, which increase the size and noise level of the cartridge and the dialysis machine. Programming the operation of multiple pumps also represents a challenge for system developers.

Another problem associated with cartridge-based pumping is entrapment of air or other gas in the fluid paths. Air can enter the system through leaky connections, improper preparation, defective tubing, and defective cartridges. The patient's therapy also produces various gases that enter the system. Cartridge-based pumps are designed to pump liquid, not gas. In addition, the withdrawal of fluid from the patient and the delivery of fluid to the patient must be monitored and controlled. In the case of PD-type systems, air and gases upset the volume measurement systems, which assume that there is no air or gas in the fluid paths. Air and gases can also be uncomfortable for the patient and prevent proper waste disposal. In the case of HD-type systems, air in the bloodstream can be harmful to the patient.

Other problematic aspects of cartridge-based dialysis systems are cost, ease of manufacture, durability, and reliability. Accordingly, there is a need for improved cartridges for cartridge-based dialysis systems, which solve the problems described above.

ES 2 445 950 T3

WO 2005/044339 describes a system for performing renal replacement therapy. The system includes a cartridge, a part of which may include three flexible membranes that form a balance chamber, as well as pumps that comprise a pumping chamber defined at least in part by a rigid cartridge.

SUMMARY

The invention provides a renal failure therapy system according to claim 1. Various embodiments, applications and examples are described and illustrated below. These embodiments, applications and examples form part of the invention as long as they fall within the scope of claim 1. The examples described here disclose dialysis systems using a flexible pump cartridge such as: hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF), peritoneal dialysis ((peritoneal dialysis - PD), including modalities of continuous ambulatory peritoneal dialysis (CAPD), automatic peritoneal dialysis (APD), tidal flow APD and continuous flow peritoneal dialysis (“CFPD”). The systems can also be used in any type of continuous renal replacement therapy (CRRT). Examples given below include a diffusion or filter membrane, such as a dialyzer, for example for HD or hDf, a hemofilter, for example for HF or the patient's peritoneum, for example for PD. Furthermore, each of the systems described here can be used in clinical or home installations. For example, the systems can be used in a central HC machine, which is in operation practically around the clock. Alternatively, the systems can be used in a home PD machine, which is normally in operation at night, while the patient is sleeping. A particularly suitable therapy for the embodiments described herein is home hemodialysis (HHD) and in particular high convection home hemodialysis (HCHD).

The examples given below include a dialysate supply (replacement fluid), which may consist of multiple bundled dialysate supply bags that are used in succession. Also, alternatively, each of the systems shown below may be used with an in-line dialysate source, such as one or more concentrate pumps configured to combine one or more concentrates with water to generate the in-line dialysate. Online fonts are typically used in on-site HD systems, for example. Although the systems are described herein for use with a dialysate, the flexible blade cartridges and other devices are also expressly intended for use with other medical fluids, such as saline, lactated Ringer's solution, drugs, and / or blood.

Various flexible sheet cartridges are shown and described here. Flexible Foil Cartridges utilize multiple flexible foils welded, heat sealed, bonded, chemically bonded, folded or otherwise formed together at desired locations to produce fluid flow paths, fluid heating paths, peristaltic pump paths, pump areas volumetric, balancing chambers (adapted flow compensators) and any combination thereof. The different sheets can be formed as separate sheets before being joined together or they can consist of a single sheet that is folded one or more times to produce the different layers. The sheets provide an inexpensive and easily produced alternative to known medical fluid pump cartridges, which typically include a hard plastic component and one or more flexible sheets sealed in the hard plastic component.

However, it is expressly intended to provide a cartridge in which some components use a hard plastic element and others only use flexible foils. For example, it may be advantageous to form the valves and certain pathways using a piece of hard plastic in combination with one or more flexible sheets and to form the pumping part (s), balance chamber (s) and / or passageway. heating fluid using only flexible foils. Some embodiments shown below combine flexible sheet cartridges with tube loops, for example tube loops used in combination with a peristaltic pump roll. It is also expressly intended to provide a cartridge where the flow paths, the heating path, the pumping part and the volume control part are each formed using flexible sheets, but which includes a rigid frame to facilitate handling, loading , etc.

In one embodiment a cartridge is shown where two or three layers of sheets are used, as required, to provide fluid paths, a peristaltic pumping part, a balancing chamber part, sealed together and formed with connectors that connect with one or more supply bags, a drainage bag, and a patient (as used herein, the term patient generally refers to a patient's peritoneum, dialyzer, hemofilter, an extracorporeal circuit and any combination thereof). In one embodiment, a separate fluid heating path is provided having a fluid connection to the flexible blade cartridge through separate tubes.

In another embodiment, the fluid heating path is formed using the same sheets that form other components of the dialysis fluid system, such as volumetric pump parts. The volumetric or diaphragm pumping parts pump a known volume of fluid with each stroke and thus avoid the need for adaptive flow compensators or separate balance chambers.

Any of the flexible sheet cartridges described herein may have one or more pumping parts. For example, flexible reed cartridges can form multiple peristaltic pumping parts in combination with multiple

ES 2 445 950 T3 balancing chambers, which act to produce an at least essentially constant flow of fresh and used dialysate to the patient and drain, respectively. In another example, flexible sheet cartridges can form multiple membrane or volumetric pump parts.

Flexible sheet membranes also incorporate a vent opening, which may advantageously be located just downstream of an integrated or separate fluid heating pathway. This configuration allows air or gas generated by heating to be purged or released to the atmosphere. The purge opening may be located for example at the top of a vertically arranged or positioned cartridge to enable automatic air purging. Another possibility is that the cartridge is mounted horizontally in the machine and acts with a valve, which opens when air is detected. The system could purge / release gas / air to other parts of the disposable equipment (eg solution bag or drain line), not just to atmosphere.

In one embodiment, flexible blade cartridges include connectors that connect tubes leading to fluid bags, the patient, a dialyzer, an extracorporeal circuit, and so on. In one embodiment, the connectors include a body that can be rigid and that is sealed between two of the flexible sheets. One or both of the flexible sheets may have a thermoformed flow path, which is sealed with the other flexible sheet to form a closed flow path leading from the connector body to a desired destination within the flexible sheet cartridge. An outer end of the connector body may include a luer or splint end, configured to be hermetically sealed with a tube extending from the flexible reed cartridge.

In one embodiment, one of the flexible sheets includes an essentially circular thermoformed path leading to inlet and outlet pump paths. A roller or peristaltic pump driver acts with the essentially circular fluid path to form an integrated peristaltic pump portion of the flexible reed cartridge. As indicated above, one or more of these pumping parts can be provided on any individual cartridge. In this case, two embodiments for using a single roller to drive two different peristaltic pump paths are described below. In one example, the flexible reed cartridge is folded over one member, causing two inwardly facing peristaltic pump parts to be operatively coupled to a single peristaltic pump roll. In a second example, the peristaltic pump path is a semi-circle rather than an essentially full circle, with two of the semi-circular flow paths operating with the same peristaltic pump roller to drive two different fluids through two different paths.

Also disclosed herein are multiple embodiments for producing adapted flow compensators or balance chambers using multiple flexible sheets. In one embodiment, three sheets are used to create an upper and a lower balance chamber compartment, that is, one between a top sheet and a center sheet and the other compartment between the center sheet and a bottom sheet. Each compartment may have one or more fluid paths extending to and from said compartment. Pumping fluid into one compartment distributes a similar amount of fluid from the other compartment, and vice versa. In one embodiment, each compartment includes two pathways connected thereto, one pathway being inlet to the compartment and the other an outlet pathway from the compartment. In another embodiment, a single pathway communicates with each of the compartments, causing fluid entering and leaving each compartment to flow through the same individual pathway.

In an alternative embodiment, two flexible sheets are formed with a rigid chamber, for example a spherical plastic chamber, to form a balance chamber. In this case, a compartment is formed between the rigid chamber and a flexible top sheet. The second compartment is formed between the two flexible sheets. A rigid plate or support is supported against the lower flexible sheet, causing the upper flexible sheet to have only one direction of movement when the lower compartment is filled. When the lower compartment is filled, the upper flexible sheet moves upward toward an interior wall of the rigid chamber, dispensing fluid from the upper compartment. Fluid is then introduced into the upper compartment, pushing the upper sheet downward toward the lower sheet, to distribute fluid from the lower compartment.

In another alternative embodiment of the balance chamber, multiple flexible sheets are formed with multiple balance chamber tubes to form the balance chamber. The tubes act as fluid inlets and outlets, which are alternately formed by thermoforming one or both flexible sheets. Again, each balance chamber compartment may include a single inlet / outlet tube or multiple specialized inlet / outlet tubes to produce a single fluid inlet / outlet or independent fluid inlets / outlets.

Balance chambers are generally described herein in cooperation with pumps, such as peristaltic pumps. In an alternative embodiment described below, the balance chamber is disposed within a magnetic field. Thus, the membrane (eg, the inner membrane) of the balance chamber moving back and forth within the chamber is doped or otherwise coupled with a ferromagnetic material. For example, a thin layer of carbon can be sandwiched between the flexible outer layers of a medical grade aerial insert material. The magnetic field is modulated or polarized to move the impregnated membrane. A controller of the dialysis unit sequentially feeds electromagnets located on both sides of the balance chamber, moving the inner magnetic membrane to one side of the chamber and then to the other, dissipating and aspirating fluid with each half stroke. In this way, the balance chamber (or double balance chamber) is driven by itself rather than being driven by a separate pump, eliminating the need for the second pump. As described more

ES 2 445 950 T3 below, balancing chamber systems often use an ultrafiltration (UF) meter, which is typically also passive or not self-acting. The UF meter can also be magnetically actuated as described here. Alternatively, one of the magnetically actuated balance chambers drives the UF meter. As further described below, volumetric pumps can also be modified to be magnetically actuated.

As shown below, an integrated volumetric or membrane pump can be formed using two flexible sheets and an upper and lower chamber defined by the machine in which the cartridge is loaded. The machine is configured to apply a vacuum on each of the independent sheets in order to pull the sheets toward the chamber wall and to supply a positive pressure that pushes the sheet toward the opposite chamber wall, as needed. draw the fluid in or blow it out. A fluid inlet path and a fluid outlet path are in fluid communication with the space between the flexible sheets.

The inlet and outlet ports have valves to allow the aspiration of fluid into the volumetric pump chamber in one step and the expulsion of the fluid from the volumetric pump chamber in a second step. As shown below, to draw fluid into the chamber of the volumetric pump, the positive pressure is removed and negative pressure is applied to the outer surface of one of the flexible sheets to pull it from the other flexible sheet (which is subjected to a negative pressure from the other face of the chamber) towards its source of vacuum, whereby the pumping chamber opens between the sheets creating a vacuum that thus draws fluid into the chamber. A positive pressure is then applied to one of the lamellae, whereby the flexible membranes close and the fluid is expelled through the outlet port of the pump.

Multiple embodiments are discussed here to form an integrated fluid heating pathway. The track may consist of a track thermoformed in a sheet that is attached to a second sheet. In another embodiment three blades are used, an upper and a lower path being formed with a flat central blade. In any of the embodiments described herein, the center sheet includes one or more openings to allow a fluid, for example, to travel from an upper fluid heating path to a lower fluid heating path. Or with respect to the balance chambers, an opening in the central flexible membrane allows a fluid to exit one compartment (upper or lower) to combine with a fluid that leaves the other compartment in a single flow path.

Described herein are various embodiments for selectively forming the seals between two out of three contiguous sheets and for sealing three sheets together. For example, on one or more faces of the center sheet, a settable adhesive pattern may be provided to allow one or more outer sheets to be selectively adhered and sealed therewith. Alternatively, the energy provided by a heating matrix can be varied so that the heat generated by the matrix is ​​adjusted to seal only two of the three sheets to each other or to seal the three sheets to each other.

As described above, any of the flexible reed cartridges can include a rigid component, which for example can include flow paths, valve seats, rigid balance chamber parts, and the like. As shown below, said rigid part can be made to be in communication with a completely flexible part, which forms the remaining components of the cartridge.

As described above, the peristaltic pumping parts may alternatively consist of tubes in fluid connection with a flexible reed cartridge, which may include a heater flow path, one or more balance chamber parts, and flow paths. and associated valve seats.

In one embodiment, a flexible blade cartridge is provided for the dialysis fluid portion of a HD, HF or HDF system, a second cartridge being provided for blood. In one embodiment, the two cartridges are loaded on the same machine. Alternatively, the blood and dialysis fluid portions of a HD, HF, or HDF system may be formed on the same cartridge.

Thus, an advantage of the present invention is that it provides improved dialysis systems.

Another advantage of the present invention is that it provides improved dialysis cartridges.

Another advantage of the present invention is that it provides improved home dialysis therapies.

Another advantage of the present invention is that it incorporates peristaltic pumping parts in a cartridge formed from multiple flexible sheets.

Another advantage of the present invention is that it incorporates membrane or volumetric pumping parts into a cartridge formed from multiple flexible sheets.

Another advantage of the present invention is that it provides multiple methods of forming fluid paths in two or three contiguous flexible membranes.

ES 2 445 950 T3

Another advantage of the present invention is that it incorporates balance chamber parts into a cartridge formed from multiple flexible sheets.

Another advantage of the present invention is that it provides a flexible sheet cartridge at a relatively low cost.

Furthermore, an advantage of the present invention is that it provides methods for selectively sealing two of three contiguous sheets or three of three contiguous sheets, for example.

Additionally, an advantage of the present invention is that it provides a magnetically actuated volumetric balancing or pumping device.

Other features and advantages of the present invention will become apparent from the following detailed description thereof and from the figures.

BRIEF DESCRIPTION OF THE FIGURES

<td>Fig. 1:</td><td>Schematic view of one embodiment of a cartridge-based dialysis system employing a flexible blade cartridge having a peristaltic pumping part, a single balance chamber volumetric control part, and an external heater bag.</td>

<td>Fig. 2:</td><td>Schematic view of one embodiment of a cartridge-based dialysis system employing a flexible blade cartridge with a volumetric or membrane pumping portion and an in-line heating portion.</td>

<td>Fig. 3:</td><td>Schematic view of one embodiment of a cartridge-based dialysis system employing a flexible blade cartridge with dual peristaltic pumping parts, dual balancing chamber parts, and an external heating bag.</td>

<td>Fig. 4:</td><td>perspective sectional view of Detail IV of Fig. 1, which highlights an embodiment of a part of the inlet / outlet connector of the flexible sheet cartridges.</td>

<td>Fig. 5:</td><td>perspective sectional view of Detail V of Fig. 1, which highlights an embodiment of a peristaltic part for the flexible sheet cartridges.</td>

<td>Fig. 6:</td><td>A perspective sectional view of Detail VI of Fig. 1, which highlights an embodiment of a part of the balance chamber for the flexible sheet cartridges.</td>

<td>Fig. 7:</td><td>Sectional elevation view along line VII-VII of Fig. 6 illustrates the balance chamber portion of the flexible blade cartridge in cooperation with a dialysis machine.</td>

<td>Fig. 8:</td><td>Sectional elevation view along line VIII-VIII of Fig. 6 shows upper and lower fluid paths leading to the balance chamber portion of the flexible blade cartridge of Fig. 6.</td>

<td>Fig. 9A-9C:</td><td>Sectional elevation views of Detail IX of Fig. 2, illustrate different valve states of a pump cycle for volumetric pumping that operates using the flexible reed cartridges.</td>

<td>Fig. 10A:</td><td>A perspective sectional view of Detail X of Fig. 2, highlights an embodiment for an in-line heater part of the flexible sheet cartridges.</td>

<td>Fig. 10B:</td><td>Sectional elevation view of an in-line heater portion on two levels, in cooperation with a dialysis fluid heater.</td>

<td>Fig. 11:</td><td>perspective view of Detail XI of Fig. 2 illustrates an embodiment of an in-line air purge part for flexible sheet cartridges.</td>

<td>Fig. 12A:</td><td>Sectional elevation view illustrating an embodiment for configuring a simple peristaltic pump driver to conduct fluid through two different flow paths of the flexible blade cartridges.</td>

<td>Fig. 12B:</td><td>Plan view illustrating another embodiment for configuring a simple peristaltic pump driver to conduct fluid through two different flow paths of the flexible blade cartridges.</td>

<td>Fig. 13:</td><td>perspective sectional view illustrating an embodiment of flexible sheet cartridges where a pressure (or other parameter) sensing area is used in combination with a pressure (or other parameter) sensor.</td>

<td>Fig. 14:</td><td>A perspective sectional view of the flexible sheet cartridges, shows a method and the resulting apparatus for selectively sealing three flexible sheets together.</td>

<td>Fig. 15:</td><td>A perspective view of an example of a flexible sheet cartridge showing a second method and the resulting apparatus for selectively sealing three flexible sheets together.</td>

<td>Fig. 16:</td><td>An elevational view of a portion of a flexible sheet cartridge illustrating a third method of selectively sealing three flexible sheets together.</td>

<td>Fig. 17:</td><td>A perspective view of an embodiment of an overall cartridge that combines flexible path-forming sheets with a rigid cartridge portion.</td>

<td>Fig. 18:</td><td>illustrates an embodiment for configuring a cartridge with a flexible blade part and a rigid part with a corresponding valve actuation, a pump actuation, and a heater.</td>

<td>Fig. 19A and 19B:</td><td>Sectional elevation views showing another embodiment for a balance chamber part using two flexible sheets in combination with a rigid plastic dome component.</td>

<td>Fig. 20A and 20D:</td><td>perspective views at various stages of production of another alternative embodiment of a part of</td>

balance chamber produced by multiple flexible sheets.

ES 2 445 950 T3

Fig. 21A-21G: various views of a system where a flexible blade dialysis fluid cartridge is used in combination with a separate cartridge for the blood side.

Fig. 22A-22D: perspective views of another alternative system where a flexible blade dialysis liquid cartridge is used in combination with a separate cartridge for the blood side.

Fig. 23: perspective view of another alternative medical fluid cartridge to be used with a system where a gravimetric volume control methodology is used.

Fig. 24A and 24B: perspective views of an alternative flexible blade cartridge system where the machine includes pinching elements that form, by compression, pump paths, flow and fluid heating.

Fig. 25A: schematic view of a fluid heating path formed by a compressive pinch and a fluid heater that can cooperate with the compressed fluid heating path.

Fig. 25B: A perspective view of a separate heater bag with a fluid heating path formed by mechanical compression and a separate heater for the heater bag.

Fig. 26A and 26B: show a balance chamber portion of the disposable cartridge formed by mechanical clamping and also illustrate a magnetic field used to actuate the balance chamber.

Fig. 27: illustrates a balance tube or balance piston actuated by a magnetic field.

Fig. 28: illustrates a volumetric pump driven by a magnetic field.

DETAILED DESCRIPTION

The examples described herein are applicable to any medical fluid therapy system (such as dialysis fluid, replacement fluid, and blood) that requires a disposable fluid pump cartridge. The systems are particularly suitable for the monitoring of true failure therapies, such as all forms of hemodialysis (HD), including (HHD), hemofiltration (HF), hemodiafiltration (HDF), peritoneal dialysis (PD, including peritoneal dialysis modalities Continuous Ambulatory Dialysis (CAPD), Automatic Peritoneal Dialysis (APD), Tidal Flow APD, and Continuous Flow Peritoneal Dialysis (“CFPD”). The systems can also be used in any type of continuous renal replacement therapy (CRRT).

Examples shown below include a diffusion or filter membrane, such as a dialyzer, for example for HD or HDF, a hemofilter, for example for HF, or a peritoneum, for example for PD. Some examples show a cartridge with a single patient inlet and outlet, for example for discontinuous type CAPD or APD. In CAPD and APD dialysis fluid is typically supplied to the patient, allowed to remain in the patient for a period, and then pumped from the patient and disposed of to the drain. These cycles are then repeated a number of times. The lines to and from the patient are T-connected to each other and equipped with appropriate valves, for example, so that dialysis fluid can be supplied to the patient and said fluid withdrawn from the patient at different times through the same line and simple connection.

Other systems include a dialysate inlet and a dialysate outlet, for example for a dialyzer or hemofilter used with HD, HDF or HF. These systems can also be modified for use with a single or double catheter, as appropriate. CFPD typically includes a dual lumen catheter and therefore also requires separate inlets and outlets.

In addition, each of the cartridge-based systems described herein can be used in clinical settings or at home. For example, the systems can be used in a central HC machine, which is in operation practically around the clock. Alternatively, the systems can be used in a home PD machine, which is normally in operation at night, while the patient is sleeping. Home hemodialysis (HHD) machines (including high convection home hemodialysis (HCHD)) are also a preferred type of hemodialysis machine to be used with the embodiments described herein.

Examples given below include a supply of dialysate (or replacement fluid), which, for convenience, is shown in the form of multiple fluid bags. Alternatively, a single dialysate supply bag can be used. Also alternatively, each of the systems shown below may be used with an in-line source of dialysate or replacement fluid, such as one or more concentrate pumps configured to combine one or more concentrates with water to form the in-line dialysate. For example, online fonts are typically used on HD systems.

Each of the systems described herein cooperates with a heater, which heats the dialysate or replacement fluid to a desired temperature. The heaters can be in-line heaters located upstream or downstream of the fresh supply pump. Alternatively, the systems can cooperate with a batch type heater and / or with a heater upstream of the pump.

The systems also include a cartridge with an in-line air removal device (eg, hydrophobic purge). Alternatively, a discontinuous type air removal device such as a siphon is used. The air removal device may be located on or near the heating path to capture air that comes out of the solution due to heating.

ES 2 445 950 T3

The flow charts shown here refer primarily to the dialysate or replacement fluid portion of the kidney failure treatment machine. HD, HF and HDF machines also include blood pumping systems. Various examples of blood cartridges are also described below.

HD, HF, and HDF also include dialysate dosing systems, mentioned above, which are also known, so they do not need to be described here. US Patent No. 5,247,434 ('434 Patent), assigned to the assignee of the present application, describes an example of a suitable dosage system.

With reference to the figures, in particular to Fig. 1, an embodiment of a system is illustrated by the system 10 where a flexible sheet cartridge 10a is used. System 100a is advantageous in one respect, as it employs a peristaltic pump 30 in combination with a volumetric balancing device or balance chamber. Peristaltic pumps, such as pump 30, are typically used to pump clean or sterile fluids, such as dialysate or replacement fluid, as the pump material does not come into contact with the fluid and consequently does not contaminate it. The only part of the pump that comes into contact with the dialysate / replacement fluid is the peristaltic pump line or segments, which are sterilized prior to therapy. Furthermore, since peristaltic pumps do not include any moving parts in contact with the replacement fluid / dialysate, the pumps are relatively inexpensive. Peristaltic pumps also do not have the valves, seals and packings used in other types of pumps, making the pump 30, for example, comparatively inexpensive and easy to maintain.

In one embodiment, the volumetric balancing of system 100a uses first and second chambers of essentially equal volumes. Each chamber includes two compartments, one called a pre-dialyzer compartment and the other a post-dialyzer. The pre and post opposing compartments of a single chamber chamber are separated by a flexible diaphragm. Solenoid-actuated valves control the filling and emptying of each compartment. In general, each compartment is completely filled before its contents are downloaded. Furthermore, the pre-filled and unloaded compartments alternately and the post compartments are alternately filled and discharged. Filling of a pre compartment causes a discharge from a corresponding and opposite post compartment, respectively. The filling of a post compartment causes a discharge of a corresponding and opposite pre compartment.

Since the opposing pre and post compartment volumes of the two chambers are equal, the system volumetrically balances the flow of dialysate to and from the dialyzer. An advantage of this volumetrically controlled system is that the flow of dialysate to the dialyzer can be accurately measured over a wide range of flow rates.

System 100a includes multiple supply bags 12a through 12c. Alternatively, the dialysate supply to system 100a is any of the systems described above, such as an in-line supply. System 100a also includes an initial drainage bag 14 in the illustrated embodiment. For example, in PD the patient's peritoneum is filled with the dialysate used at the beginning of therapy. This used dialysate comes from the last fill of the previous night therapy. Therefore, the first step in treating PD is to drain the used dialysate into the drainage bag.

14. Accordingly, the dialysate supply is pumped from supply bags 12a to 12c through cartridge 10a to the patient (as used herein, the term patient refers to a dialyzer, an extracorporeal circuit, a patient's peritoneum, or a combination of them, depending on the therapy in question). These delivery bags then play a dual role as drainage bags during different treatment cycles, for example, once the dialysate has remained within the patient's peritoneum for a set time and is then pumped back into the drainage bag. through the cartridge. For example, dialysate can be initially pumped from a supply bag 12a to the patient through cartridge 10a. After a predetermined residence time, the used dialysate is pumped from the patient through cartridge 10a to bag 12a, which is now a drainage bag. Then, in a next cycle, the system 100a pumps fresh dialysate from the supply bag 12b to the patient, etc.

Supply bags 12a through 12c are in fluid connection with supply connectors 16a through 16c through supply tubes 18a through 18c, respectively. The supply connectors 16a to 16c are hermetically connected to the flexible reed cartridge 10a, as illustrated in greater detail below in relation to Fig. 4. The drain bag 14 is in fluid connection with the drain connector 22 a through drain line 24. Drain connector 22 is hermetically connected to flexible reed cartridge 10a in the same way that supply connectors 16a to 16c are hermetically connected to flexible reed cartridge 10a, as shown in greater detail below in connection with Fig. Four.

Flexible reed cartridge 10a defines or includes flow paths 26a through 26d that allow fluid to flow through lines or tubes 18a through 18c and 24 to establish fluid communication with a peristaltic pump portion 30, which is also defined or included in the flexible reed cartridge 10a. The peristaltic pumping portion 30 is shown in greater detail below in connection with Fig. 5. The peristaltic pump part 30 cooperates with a peristaltic pump driver located on the dialysis machine. Each of the flow paths 26a to 26d defined by the flexible reed cartridge 10a includes or defines a valve contact portion 28a to 28d, respectively. Flow paths

ES 2 445 950 T3

26a to 26d and the respective valve contact portions 28a to 28d are shown in greater detail below in connection with Fig. 4.

In the system 100a, the fluid from one of the supply bags 12a to 12c is pumped through the peristaltic pump portion 30, through a pump outlet port 32, through a path to the heater 34a, through a connector to heater 36a, through an outer tube to heater 38a, and finally to an outer line heater 40, which includes a fluid heating path 42a. In one embodiment, the connectors to and from the heater 36a and 36b are sealed with the flexible reed cartridge 10a in the same manner as the connectors 16a to 16c and 22 shown in detail below in relation to FIG. 4.

External heating bag 40 defines a coiled fluid heating path 42a through which dialysis fluid or fluid travels. As the dialysis fluid or liquid travels through the heating path 42a, a plate, convection, radiation, induction or other heater, alone or in combination, is used to heat the fluid. The heater that heats the fluid flowing through the heating path 42a may be located outside the dialysis machine that houses the flexible blade cartridge 10a or may be integrated therein. As can be seen in Fig. 2, alternatively a fluid heating path is integrated into a flexible foil cartridge 10b. An example of a fluid heating path is shown in more detail below in connection with FIG. 10A. Fig. 10B shows a bilateral fluid heating path cooperating with a fluid heater.

Hot dialysate flows from in-line heater 40, through an outer line or tube from heater 38b, through a connector from heater 36b to cartridge 10a, through a path from heater 34b defined by the cartridge of flexible sheets 10a, and towards the volumetric control part of the cartridge 10a, which is described in more detail below. Paths to and from heating 34a and 34b each define or include a valve contact portion 28e and 28f, respectively. Examples of valve contact parts are shown in greater detail below by the valve contact parts 28a to 28d of Fig. 4.

It should be noted that the valve contact portions 28e and 28f are open when fluid is pumped to the patient, so that the dialysis fluid or liquid can be heated. When fluid is drawn from the patient and pumped to the drain, associated valve actuators close lines 34a and 34b at valve contact portions 28e and 28f. In the drain cycle, a valve actuator cooperates with the valve contact portion 28g defined by or included in the pump outlet port 32 to open the port 32. Thus, the heater and associated ports and lines are avoided during drainage.

The materials used for the supply bags 12a to 12c and the drainage bag 14 can consist of any suitable medical grade material such as polyvinyl chloride (PVC), for example PVC monolayer films, PVC monolayer non-DEHP film, films non-PVC monolayer (different layers being chosen to provide strength, weldability, abrasion resistance and minimal tack with other materials such as rigid cartridge materials), polypropylene / polyethylene blends, polypropylene blend or Kraton, coextruded or laminated, with or without gas barrier, polyester, polyolefin, ULDPE. The materials used for outer lines or tubes 18a to 18c, 24, 38a and 38b can consist of any suitable medical grade pipe material such as PVC, non-DEHP PVC, polybutadiene (PB), ethylene vinyl acetate (EVA), polypropylene (PP), polyethylene (PE), Kraton blend and polyolefin blends. Materials used for outer fluid heater bag 40 including fluid path 42a include PVC, PP / Kraton blend.

The dialysis unit or machine (examples of which are shown below in connection with Figs. 21G and 22A) operating with the flexible membrane cartridge 10a includes apparatus configured to detect air in the dialysate flow path. A very good place to detect air or other gas bubbles in the system is a point in the flow path just downstream of fluid heater 40. Heat from the heater causes air or other gas to escape from solution. Accordingly, in one embodiment an air sensing sensor is arranged to cooperate with the path from heater 34b. Suitable air detectors are disclosed in the patent application prior to the present disclosure.

Cartridge valve actuators 10a with valve contact portions 28h and 28i allow the dialysate to be directed in the desired and alternative manner to an in-line purge 44 or to a volumetric balancing device or balance chamber 50. If air is detected in the system, the valve actuator cooperating with the valve contact part 28i closes, while the valve actuator cooperating with the valve contact part 28h opens, allowing the fluid to reach the purge 44 so that the air eventually contained in the fluid can exit the system 100a. An embodiment of purge 44 is shown in greater detail below in relation to FIG. 11. Once the air is purged from the flexible sheet 10a, the valve actuator cooperating with the valve contact part 28h closes, while the valve actuator operating in combination with the valve contact part 28i opens. , allowing the purged dialysate to flow into balance chamber 50.

In an alternative embodiment, the cartridge 10a is vertically mounted in the machine with the purge 44 located on top of the mounted cartridge so that any air in the path from the heater 34b is automatically expelled through the purge 44. In an alternative embodiment in this case valve actuators and valve seats are not required 28h

ES 2 445 950 T3 and 28i independent. Furthermore, if the valve 44 is oriented upward, separate valve actuators and valve seats 28h and 28i are not required even if the cartridge 10a is mounted horizontally in the machine.

In an alternative embodiment, air from flexible foil cartridge 10a is pumped into heater bag 40 or drain bag 14. For example, air can be allowed to collect at the top of heater bag 40, which in one embodiment is arranged horizontally on a heating plate. If air is detected downstream of the heater bag 40, the appropriate valve seats 28 are switched so that fluid is pumped to the drain until air is no longer detected.

In one embodiment, the balance chamber 50 of the flexible sheet cartridge 10a (and other components described herein) includes three flexible layers or sheets. An embodiment of a balancing chamber 50 is shown below with reference to Figs. 6 to 8, which will be described in greater detail later. In one embodiment, the three layers are sealed in a circular arrangement 52 forming the upper and lower fluid compartments 54a and 54b (which can be seen particularly in Fig. 7). The fluid pumped through the outlet port 32 eventually flows through the inlet ports 56a or 56b of the balance chamber, according to the selective determination by the valve actuators cooperating with the valve contact parts 28j or 28k, respectively. In an embodiment illustrated in relation to FIGS. 6 through 8, the balance chamber inlet 56a is in fluid communication with the upper compartment 54a of the balance chamber 50, while the chamber inlet 56b The balance chamber is in fluid communication with the lower compartment 54b of the balance chamber. As described in greater detail below, fluid flows from compartments 54a and 54b through balance chamber outlet ports 58a and 58b, as determined selectively by valve actuators cooperating with the valve contact parts 28l or 28m, respectively.

Fluid flowing through the balance chamber outlet ports 58a or 58b flows into a pathway to the patient 60a as can be seen in Fig. 1. Figs. 6 and 8 show in one embodiment how the Fluids flowing through the independent outlets 58a and 58b of the balance chamber eventually T-connect to each other in a single pathway to the patient 60a.

The system 100a illustrated in FIG. 1 can be used with APD, tidal flow PD, or CAPD, for example, which typically uses a single connection to the patient for batch-type fill and drain cycles. In this case, the pathway to the patient 60a also serves as a pathway from the patient that communicates with the connector 62a. To perform a drainage cycle, the connector 62a becomes a connector from the patient, the pathway to the patient 60a becomes a pathway from the patient, the outlet ports 58a and 58b to the compartments of the balance become inputs, and the above-described inputs 56a and 56b of the balance chamber compartments become balance chamber outputs. The peristaltic pump cooperating with the peristaltic pump portion 30 of the cartridge 10a works in reverse, drawing the used dialysate from the patient's peritoneum through the balance chamber 50 and associated pathways, and then propelling it afterwards into a bag. drain, a household drain, or other appropriate drain.

However, it is also possible to use the system 100a in a hemodialysis treatment that typically includes a dialyzer with a dialysate inlet and a dialysate outlet (not shown in the figures). System 100a could also be used with a PD system where a dual lumen catheter is used. In this case, a separate path from patient 60b is T-connected with a path to patient 60a. A separate connector is provided from patient 62b, which is in fluid communication with the pathway from patient 60b. The connectors 62a and 62b are attached to the flexible foil cartridge 10a by means of the same apparatus and the same technique shown for example with the connectors 16a to 16c and 22 in Fig. 4. The valve actuators are configured to cooperate with valve contact portions 28n and 28o in order to allow fluid to selectively flow out of the connector to patient 62a or in through the connector from patient 62b, respectively. To pump fluid out of the cartridge 10a to the patient or to the dialyzer, the valve actuator cooperating with the valve contact part 28o is closed, while the valve actuator cooperating with the valve contact part 28n is open. To pump fluid into the cartridge 28a, the valve actuator cooperating with the valve contact portion 28n is closed, while the valve actuator cooperating with the contact portion 28o is open.

Regardless of whether a single connector 62a or a double connector 62a and 62b is provided, the system 100a is configured to pump fluid to and from a dialyzer using a desired sequence of pump strokes to the dialyzer and pump strokes from the dialyzer. For example, a peristaltic pump in cooperation with a peristaltic pump part 30 could act in an impulse pumping direction to stroke the balance chamber 50 ten times, in each case supplying a volume of fluid through the connector 62a. to the dialyzer. The peristaltic pump is then reversed for a period of time so that, for example, twelve strokes occur in the balance chamber 50, in each case drawing a known amount of fluid from the dialyzer through the connector 62b, through the cartridge 10a, to one of the drainage bags. The additional amount of fluid aspiration strokes from the dialyzer corresponds to the amount of ultrafiltration fluid withdrawn from the patient. Alternatively, balance chamber 50 is magnetically actuated as described below in connection with FIGS. 26A and 26B.

ES 2 445 950 T3

It should be noted that system 100a could also be used to carry out hemofiltration. In this case, the patient connector 62a is directly connected to the extracorporeal circuit, so that an injectable grade replacement fluid can be introduced upstream or downstream (or both) of the hemofilter. The hemofilter port is connected to the port from the patient 62b in a dual port configuration, or to the single port 62a, the sequential stroke mode described above being employed in both cases. Hemodiafiltration could be carried out in a similar manner, with the line in connection with the patient connector 62a being connected both directly to the extracorporeal circuit and to an inlet of the dialyzer. Again, the dialyzer outlet on the HDF can be connected to either a patient port 62b or a single port 62a, depending on the configuration of the cartridge 10a used.

Referring to Fig. 2, an alternative flexible sheet cartridge 10b is employed in an alternative system 100b. System 100b includes many components the same as those included in system 100a. For example, system 100b includes supply vessels 12a and 12c and drain vessel 14. As in the previous case, the supply containers 12a to 12c are in fluid connection with the cartridge 10b through the supply connectors 16a to 16c, through the supply lines 18a to 18c, respectively. Furthermore, a drain bag 14 is in fluid connection with the drain connector 22 through the drain line 24. The connectors 16a to 16c and 22 are each connected to the flow paths 26a to 26d, each of the flow paths having a valve contact portion 28a to 28d, respectively. All flow paths 26a to 26d lead to a pump inlet manifold 64a.

One of the main differences between system 100b and system 100a is that system 100b uses volumetric or diaphragm pumps instead of peristaltic pumps. In this case, the inlet manifold path 64a is in fluid communication with the pump inlet paths 66a and 66b, each leading to a volumetric or membrane pump portion 7a and 70b, respectively. Valve actuators cooperating with valve contact portions 28p and 28q allow fluid to be selectively pumped through one of the two volumetric pump portions 70a or 70b, as desired. The volumetric pump parts 70a and 70b cooperate with a pneumatic and / or mechanical pump actuator located within the dialysis machine, as described in greater detail below in connection with Figs. 9A through 9C. Alternatively, the volumetric pump parts are magnetically actuated, as shown below in connection with Fig. 28.

In Fig. 2, pump outlet paths 68a and 68b extend from the outlet side of pump parts 70a and 70b, respectively, and open into a pump outlet manifold path 64b. The fluid exits the pump outlet manifold 64b and then enters an alternate integrated in-line fluid heating path 42b. The inline integrated fluid heating path 42b is shown in more detail in cooperation with a fluid heater with reference to Fig. 10A. All air that exits the dialysis fluid or other medical fluid (including blood) during heating within fluid heating path 42b can be selectively removed from the system through in-line purge 44. Shown below in greater detail detail one embodiment of purge 44 in relation to Fig. 11. Air is pumped to drain or alternatively left in fluid heating path 42b. Cartridge 10b can be mounted on the machine in a vertical position, with purge 44 facing upward to allow air to exit cartridge 10b automatically and without valve actuator or valve seat 28h for said actuator. Furthermore, the purge 44 can be oriented upward when the cartridge 10b is loaded, so that the valve actuator and valve seat 28h can be eliminated even if the cartridge 10b is loaded horizontally.

If no air is detected, through the valve actuators cooperating with contact parts 28i and 28h, the heated dialysate is allowed to be pumped into the patient (dialyzer or hemofilter, etc.) through the patient connector 62a. As described above in connection with system 100a, system 100b may alternatively include a connector from patient 62b (not shown here). In either configuration, system 100b can perform HD (including HHD), HF, or sequential HDF as described above.

In the illustrated configuration of system 100, flexible reed cartridge 10b is configured to perform PD, such as CAPD, tidal flow PD, and APD. In this case, as described above, once the dialysate has remained in the patient's peritoneum for a prescribed time, the patient-facing connector 62a becomes a from-patient connector, receiving the used dialysate from the patient. . In the illustrated embodiment, used fluid is drawn back through fluid heating path 42b by pumps 70a and 70b, which propel used dialysate to a suitable drain bag or drain. In an alternative embodiment (not illustrated), cartridge 10b has a suitable bypass path and corresponding valve contact portions to allow returning used fluid to bypass the fluid heating path 42b.

As shown, a major difference between system 100b and system 100a is the incorporation of fluid heating path 42b within flexible foil cartridge 10b. Here, the corresponding heater is arranged in the same machine housing as the pump actuator and the valve actuators. As described above, the separate in-line heater bag 40 of the system 100a may alternatively cooperate with a heater housed in the same unit as the pump and valve actuators of the system 100a or with a heater arranged separately from the actuator unit of pump and valve. It should be noted that the integrated inline path 42b of the system 100b can be used with the peristaltic pump part 30 and / or the balance chamber 50.

ES 2 445 950 T3 of the system 100a of Fig. 1. In addition, the separate heating bag 40 of the system 100a can also be used with the volumetric pump parts 70a and 70b of Fig. 2.

As described, a major difference between system 100b and system 100a is the use of membrane or volumetric pump parts 70a and 70b instead of the peristaltic type pump used above for system 100a. Volumetric pump actuators cooperating with parts 70a and 70b pump a known quantity or volume of dialysate with each pump stroke. The total volume pumped by the membrane or volumetric pump parts 70a and 70b is determined by counting the number of strokes of the pump. In this case, the advantage is that no separate volumetric control apparatus, such as a balancing chamber 50, is required. Two pump drivers operate in phase opposition with portions 70a and 70b to produce an at least essentially continuous flow of dialysate. towards and from the patient.

All of the materials described above for system 100a are also applicable to similar components of system 100b. In operation, one of the supply valves 28a to 28c opens to allow fresh dialysate to flow from one of the supply bags 12a to 12c to one of the pump parts 70a and 70b, through a respective supply path 26a. , 26b or 26c. The pumped fluid flows through manifold 64a, through inlet port 66a or 66b into pump portion 70a or 70b, respectively. The fluid then flows through respective outlet ports 68a or 68b, through outlet manifold 64b, through heating path 42b when heated, and through fluid connector to patient 62a to patient.

Volumetric pump parts 70a and 70b can pump fluid to or from the patient using different valve sequences. For example, to pump fluid to the patient through part 70a and to draw fluid into pump part 70a, the valve actuator that can cooperate with the valve contact part 28p is open, while the actuator of valve that can cooperate with the valve contact part 28r is closed. The valves are then switched to pump the volume out of portion 70a through heating path 42b to the patient. For operation in reverse, for example to drain the patient, the valve states described above are reversed to draw used fluid into pump part 70a and then pump used fluid from pump part 70a to a suitable drain.

Referring to FIG. 3, a system 100c employing a third flexible sheet cartridge 10c is illustrated. The system 100c is similar to the system 100a of Fig. 1 and includes many components the same as the system, such as the supply bags 12a to 12c, the drain bag 14, the supply connectors 16a to 16c, the drain connector 22 and lines 18a through 18c connecting supply bags with inlet connectors 16a through 16c, respectively. System 100c also includes a line 24 extending from drain connector 22 to drain bag 14. Flexible reed cartridge 10c includes the same valve contact portions 28a through 28h as described above for system 100a. System 100c cooperates with a separate heating bag 40 having a fluid heating path 42a coupled with heating lines 38a and 38b and connectors 36a and 36b. The operation of purge 44 is as described above. Air is pumped into drain bag 14 or alternatively left in heater bag 40.

One of the main differences between system 100c and system 100a is that it uses two independent peristaltic pump drivers that can cooperate with independent peristaltic pumping parts 30a and 30b. The illustrated configuration of the pumping parts is located upstream of the fresh liquid and used liquid inlets of the double balance chambers 50a and 50b. This configuration enables simultaneous bi-directional pumping, as described above.

System 100c provides dual balance chambers 50a and 50b. As can be seen, each balance chamber 50a and 50e cooperates with balance chamber inlets 56a and 56b and balance chamber outlet paths 58a and 58b. Each of these ways includes a respective valve contact portion 28j, 28k, 28l, or 28m, respectively.

At the same time, bidirectional pumping requires a pathway to patient 60a in fluid connection with a connector to patient 62a and a pathway from patient 60b in fluid connection to a connector from patient 62b. The pathway from the patient 60b is in fluid connection with the used liquid pump portion 30b and with the balance chamber inlets 56a leading to the balance chambers 50a and 50b. Accordingly, the balance chamber inlets 56a are used fluid inlets and the used fluid is driven by a pump actuator cooperating with the peristaltic pump part 30b.

On the other hand, the fluid inlet paths 56b are in fluid connection with the pump outlet path 32, exiting the supply pump part 30a. Accordingly, the balance chamber inlets 56b are fresh fluid inlets receiving fresh fluid driven by a pump actuator cooperating with the peristaltic pump portion 30a. However, as shown below, the balance chambers 50a and 50b act as secondary pumps receiving a volume of fresh or used fluid from the fresh supply pumping part 30a or the used supply pumping part 30b, respectively, and they expel a similar amount of used or fresh fluid, respectively.

ES 2 445 950 T3

On the outlet side of the balance chambers 50a and 50b, the pathway to the patient 60a is in fluid connection with the outlet pathways 58b. This general path allows fresh fluid to be delivered from balance chambers 50 (collectively referenced balance chambers 50a and 50b) to a dialyzer, an extracorporeal circuit, or the peritoneum of a patient, depending on the therapy used. The outlet ports 58a are in fluid connection with a drainage path 26d, which empties into the drain bag 14 or into one of the supply bags 12 that acts as a drain bag, as determined by the valve contact parts of the valve. 28d, 28u, 28v and 28w drain. Alternatively, drain 14 is sized to contain the volumes of each of supply bags 12a through 12c, eliminating contact portions 28u through 28w and simplifying drain path 26d.

In operation, the system 100c can supply fluid to the patient and at the same time withdraw fluid from the patient. For this, in a half cycle, for example, the valve actuators cooperating with the seats 28k and 28l of the balance chamber 50a and the valve seats 28j and 28m of the balance chamber 50b are in an open valve position, while the valve actuators cooperating with the valve seats 28j and 28m of the balance chamber 50a and the valve seats 28k and 28l of the balance chamber 50b are in a closed valve position. This configuration allows the pump portion 30a to deliver a volume of fresh solution through the inlet port 56b into the balance chamber 50a, which in turn causes a similar volume of previously supplied used solution to flow out of the chamber. balance 50a through outlet path 58a and drain path 26d to drain 14 or to one of supply bags 12a or 12b, which act as drainage bags. At the same time, the pump part 30b supplies a volume of used solution through the inlet port 56a into the balance chamber 50b, which in turn causes a similar volume of previously supplied fresh solution to flow out of the chamber. balance 50b through outlet 58b and patient line 60a to the patient.

Then, in a second half cycle, the valve seats 28k and 28l of the balance chamber 50a and the valve seats 28j and 28m of the balance chamber 50b are closed, while the valve seats 28j and 28m of the balance chamber are closed. balance 50a and valve seats 28k and 28l of balance chamber 50b are open. This configuration allows pump part 30a to supply a volume of fresh solution through inlet port 56b into balance chamber 50b, which in turn causes a similar previously supplied volume of used solution to flow out of the chamber. balance 50b through outlet path 58a and drain path 26d to the drain or to one of the supply bags 12a or 12b. At the same time, pump portion 30b delivers a volume of used solution through patient line 60b and inlet port 58a into equilibrium chamber 50a, which in turn causes a similar volume of fresh dialysate previously delivered exits the balance chamber 50a through the outlet port 58b and into the patient line 60a, to the patient.

As shown and described, balancing chambers 50a and 50b ensure delivery to and withdrawal from the patient of similar volumes of fresh and used dialysate in each half cycle. System 100c can remove excess fluid or ultrafiltered liquid by various methods. In one embodiment, the two balance chambers 50a and 50b are filled with used fluid. The valve contact portions 28l, 28k, and 28n are then opened and the pump actuator cooperating with the pump portion 30a acts in the reverse direction, drawing fluid from the patient through the line to the patient 62a in the reverse direction. . This action causes the used fluid to be propelled out of the drain path 26d to a drain through the used fluid drawn through the pumping portion 30a. Next, the two fresh liquid compartments of the balance chambers 50 are filled with used fluid and the pump part 30b causes the used fluid to refill the two used liquid compartments of the chambers 50a and 50b with used liquid. This causes a supply of used liquid from the two fresh liquid compartments of the chambers 50 to the patient. In this process there is a loss of net fluid, since this volume came from the patient rather than the source. Alternatively a bypass line (not shown) is provided extending from the patient line 60a to a drain path 26d, so that used fluid is alternately sent to a drain. The valve bypass line increases the efficiency of the UF, but adds additional valves and flow paths. Either way, the valve sequence described above is repeated to the extent required to remove the required amount of ultrafiltration liquid.

The UF embodiments described above are administered intermittently. That is, they occur in a certain sequence with non-UF or balanced races. For example, the control unit that drives the pump and the valve actuators could sequence the system 100c to deliver twelve balanced strokes and then three UF strokes. Before terminating therapy, the cumulative volume of the UF strokes reaches the predicted UF volume, which is the volume of fluid that must be removed to return the patient to dry weight, as this term is known in the art.

In an alternative embodiment, system 100c provides a third peristaltic pump cooperating with a third UF peristaltic pumping part (not illustrated, but configured and valved in the same way, at least essentially, as pumping parts 30a and 30b ) and a third UF balance chamber (not shown, but configured and valved in the same way, at least essentially, as balance chambers 50a and 50b). In one embodiment, the inlet of the UF pump portion is T-connected with the line from the patient 60b or is separately connected with a tube from the patient extending from the patient to the connector from the patient 62b.

ES 2 445 950 T3

The outlet of the UF pump part empties into the two compartments of the UF balance chamber. Valves are provided to allow the UF pump portion to fill a first compartment of the UF balance chamber with used fluid, thus emptying the second compartment of the UF balance chamber of used fluid. The second compartment is then filled, emptying the first compartment of used fluid to complete a complete cycle. In each cycle a known amount of used fluid is removed as UF. Fluid emptied from the UF balance chamber is sent through drain path 26d to drain 14 or to one of the supply bags 12 which acts as a drain bag as described above.

The UF cycle is repeated as necessary until the expected UF withdrawal volume is reached. An important aspect is that this can be done while pumping parts 30a and 30b and balance chambers 50a and 50b deliver / withdraw a set volume of fresh / used fluid to / from the patient. It may be beneficial to have the ability to operate the UF pump portion and the UF balance chamber continuously, for example at a constant or variable speed according to a patient profile during therapy. For this, the valves that control the UF balance chamber are switched more or less frequently. The UF balance chamber can have different dimensions, for example smaller, than the balance chambers 50a and 50b for finer control of the UF.

The third pump cooperating with the UF pumping part can operate at any desired speed with respect to the pumps cooperating with the balanced pumping parts 30a and 30b. Fig. 12A and 12B show embodiments of peristaltic pumps where a single roller drives two flexible reed cartridge pumping parts. Given the above-mentioned need to vary the UF pump speed, the two pumping parts driven by the same roller (and therefore at the same speed) would consist of adjusted flow parts 30a and 30b in one embodiment. In this case, the UF pumping part would cooperate with its own roller.

In another alternative embodiment, the third UF balance chamber is provided, but not a third pumping part. In this case, the used fluid pumping part 30b deactivates the UF balance chamber of the return path (downstream of the used fluid pumping part 30b) in addition to the balance chambers 50a and 50c. That is, the first and second compartments of the UF balance chamber are in fluid connection with the return path 60b downstream of the used fluid pumping part 30b. Again, the valves that control the UF balance chamber are switched more or less frequently to control the UF rate.

It should be noted that separate UF pumping parts and volumetric control devices can also be provided for the systems 100a and 100b of Figs. 1 and 2. For example, a peristaltic pumping part and a balance chamber can be provided. Separate units for system 100a of Fig. 1. A third volumetric UF pump can also be provided for system 100b of Fig. 2. These configurations allow simultaneous balanced and UF strokes. Alternatively, in any of the configurations described above, any of the balance chambers and / or the UF pump portion can be magnetically actuated as shown below in connection with Figs. 26A, 26B and 27.

With reference to Fig. 4, Detail IV of Fig. 1 is shown in perspective. Fig. 4 shows an embodiment for sealing connectors, such as supply connectors 16a to 16c and drain connector 22, between two layers or sheets 74a and 74b (which can be separate sheets or the same folded piece of material) of the cartridge. of flexible sheets 10a. However, it should be noted that the features described in connection with Fig. 4 are applicable to any of the reed cartridges 10 (collectively referenced to the flexible reed cartridges 10a, 10b, 10c, etc.) and also to any type of connector, such as connectors to and from heater 36a and 36b and connectors to and from patient 62a and 62b.

In the illustrated embodiment, connectors 16 (collectively referenced 16a through 16c) and 22 each include a connector body 80, which may be semi-rigid or rigid. Suitable materials for body 80 include semi-rigid or rigid polymers or plastics, such as acrylic and cyclic olefin copolymer (COC). The body 80 includes or defines a sealing apparatus 82, such as a luer connector, a magnetized connector, another type of snap connection, or a threaded seal. In one embodiment, supply lines 18 and drain line 24 (not shown) are removably or permanently sealed around connector 82. The seal may be based on the snap connection alone or may be reinforced by a medically adhesive. suitable, a chemical bond or a weld, such as ultrasonic, heat, or other welding.

In an alternate embodiment, lines 18 (collectively referenced 18a and 18c of Fig. 1) and 24 are hermetically and removably or permanently attached to body 80. A permanent seal may include any of the bonding techniques. described above, such as adhesive, heat energy, etc. In another alternative embodiment (not illustrated), the first layer 74a, the second layer 74b, or both are thermoformed to form a male port extending outward from the leading edge 78a. The supply of drain lines 18 and 24 may then be removably or permanently sealed around or within the thermoformed port via any of the techniques described above.

As illustrated by the rows of Xs (used throughout the application to illustrate a sealed seam), the first layer 74a is longitudinally sealed at seals 72a and 72b with the second layer 74b on both sides of the body.

ES 2 445 950 T3

80. Seals 72a and 72b may also include a seal of layers 74a and 74b to body 80. As can be seen, seals 72a and 72b extend inward from bodies 80 to seal and form supply flow paths 26a. at 26c and the drainage path 26d.

In the illustrated embodiment, the vias 26 are configured by thermoforming a longitudinal arc, at least essentially semicircular, in the first or second layer or sheet 74a and 74b or both. Suitable processes for making such a longitudinal arch include thermoforming and injection molding. In an alternative embodiment, the arch is not preformed. Rather, seals 72a and 72b define relatively flat flow paths 26 (collectively referenced to flow paths 267a through 26d, etc.) and the pumps are sized and configured to drive fluid through layers 74a and 74b into the less essentially flat, thus forming vias 26. Also alternatively, one or more tubes, bars, or other temporary patterns may be placed on sheet 74a or 74b. Sheet 74a or 74b is spread over the tube or pattern and welded to sheet 74b or 74a, respectively. The tube or template is then removed, leaving the tracks 26.

Along the front edge 78a of the flexible sheet cartridge 10a a seal 72c is made. Seal 72c includes a seal between sheet 74a and sheet 74b at certain locations and a circumferential seal between sheets 74a / 74b and body 80 adjacent to connectors 16 and 22. Along side edge 78b of the sheet cartridge flexible 10b a seal 72d is made. Sealing 72 (collectively referring to seals 72a, 72b, 72c, 72d, etc.) may be accomplished by any of the adhesive, chemical bonding, or welding embodiments described herein. In addition, edges 78b can be alternately formed by folding a single piece of material over edge 78b to form first and second sheets 74a and 74b. Also further, edges 78a and 78b can be welded to form a rigid frame that provides structural support for the sheet cartridges 10a, 10b, and 10c. The frame helps to handle and load the cartridge.

In the illustrated embodiment, the bodies 80 of the connectors 16 and 22 are at least essentially cylindrical. In an alternative embodiment, the bodies 80 are flared or conical in shape to provide larger surfaces for sealing the upper and lower layers 74a and 74b. In US Patent Application Serial No. 10 / 155,384, entitled Disposable Medical Fluid Unit Having Rigid Frame, filed May 12, 2002, owned by the assignee of the present application, a conical body configuration 80 is shown.

In the illustrated embodiment, valve contact portions or seals 28a through 28d consist of flat sections or recesses formed or made at appropriate positions along flow paths 26. Flat sections or recesses can be formed during the process of formation of the tracks 26 or they can be performed on the tracks 26 once they are already formed. Flat sections or notches tend to increase the contact area with flat head valve actuators. However, it is also envisaged that the valve contacts, parts or seals 28 do not have a different configuration than the rest of the flow paths 26 and that they are simply areas where the valve actuator is in contact with the flow paths 26. . In this case, the head configuration and the force of the valve actuator are sufficient to close the semicircular or circular flow paths 26 when requested. The valve actuator can be actuated pneumatically, mechanically, hydraulically and / or electrically. For example, in one embodiment a fail-safe actuator is used, which is closed by spring force and opened by vacuum. Alternatively, the valve actuators are pneumatically opened and closed. In addition, valve actuators can be cam actuated, via a camshaft.

With reference to Fig. 5, Detail V of Fig. 1 is shown in perspective. Fig. 5 shows an embodiment of a peristaltic pump part 30 (including pump parts 30a, 30b, etc.). Pump portion 30 includes an at least essentially circular flow path 84, which is formed using upper and lower layers 74a and 74b by any of the means described herein and includes any of the configurations described above for fluid paths 26. Peristaltic pump inlet 86 and peristaltic pump outlet 88 are in fluid communication with peristaltic flow path 84 and with supply paths 26a through 26c and pump outlet path 32, respectively, shown above in connection with FIGS. 1 and 3. In the embodiment shown, inlet 86 and outlet 88 are disposed adjacent and at least essentially parallel to each other to maximize the distance or stroke of the peristaltic pump path 84.

As shown, the peristaltic pump portion 30 cooperates with a peristaltic pump driver 90. The peristaltic pump driver 90 generally includes components known to those skilled in the art, such as a drive shaft 92 and at least one driven roller 94. by drive shaft 92. A difference between the peristaltic configuration of Fig. 5 and that of known peristaltic pumps is that known pumps normally use round tubes looped within a circular channel. That is, the outer circumference of the loop is abutted against the channel. The rollers of the drive shaft are in contact with the inner circumference of the loop and press the tube radially against the channel. On the other hand, in Fig. 5 a channel or pressure plate 126 is located behind the second sheet 74b. In one embodiment, the channel or pressure plate 126 forms part of the dialysis machine and, for example, may form part of a door that closes against the flexible foil cartridge 10a or 10c after it is loaded into the machine. The rollers 94 are located within the machine on the opposite side of the cartridge 10a or 10c.

ES 2 445 950 T3

Rollers 94 rotate in essentially the same plane in which blades 74a and 74b are located and press track 84 in multiple locations against plate 126 to drive fluid from inlet 86 toward outlet 88. In particular, shaft 92 rotates so that rollers 94 create negative and positive pressure gradients to drive fluid from inlet 86 to outlet 88. Thermoformed flow paths are configured to resist, for example not sagging or closing, forces created by vacuum or negative peristaltic pressures. As the arrows in Fig. 5 show, shaft 92 can be driven bi-directionally if required, as described above.

Referring now to FIG. 6, an embodiment of balance chamber 50 (generally referring to balance chambers 50a, 50b, etc.) used in flexible sheet cartridges 10a and 10c is illustrated. Fig. 6 shows Detail VI of Fig. 1 in perspective view. Fig. 7 and 8 are cross-sectional views of Fig. 6 along the lines VII-VII and VIII-VIII, respectively, shown in Fig. 6. As can be seen in Fig. 6 at 8, the balance chamber 50 uses three layers or sheets 74a to 74c of flexible material. Various embodiments for sealing three independent layers together are described herein. The three sheets 74a to 74c can be completely independent or they can be formed by the same piece of material folded twice.

As shown in Fig. 6 and as described above, the balance chamber 50 includes a sealed circle 52 formed by a first seal 78e shown by the circular axis between the first sheet 74a and the second sheet 74b. The chamber formed within the circular seal 72e between the sheets 74a and 74b, forms the upper balance chamber compartment 54a, as can also be seen in Fig. 7. In Fig. 6 A second seal 74f is shown with a dashed line, located below the sheet 74a and around the same sealed circle 52 between the second sheet 74b and the third sheet 74c, which form the lower balance chamber compartment 54b. In one embodiment, the seals 72e and 72f are made at the same time or as the same seal, so that a simple sealing process, for example a welding or chemical bonding process, forms the two seals 72e and 72f simultaneously and comparatively. associates. However, the possibility is also provided of first forming one of the seals 72e and 72f and then forming the second of the two seals 72e and 72f. Seals 72e and 72f can be made by any of the methods described herein. Additional seals (not illustrated) are made along the edges of the three sheets 74a through 74c and at other locations of the cartridge 10a or 10c as described herein.

In the illustrated embodiment, the seal 72e extends to form the balance chamber inlet 56a and the balance chamber outlet 58a. The figures show a sufficient part of the balance chamber outlet 58a, so that the valve or seat contact part 28l shown in Fig. 1 can also be seen in Figs. 6 and 7. The sealing 72f is also seen It extends to form the balance chamber inlet 56b and the balance chamber outlet 58b. The figures show a sufficient part of the balance chamber outlet 58b so that the valve seat 28m is hidden and with a broken line in Fig. 6 and can also be seen in Fig. 8. As can be seen in FIG. 1, the balance chamber outlet paths 58a and 58b are combined into the patient path 60a. Figs. 6 and 8 illustrate an embodiment for allowing fluid to travel between two pairs of flexible sheets or levels. As can be seen, the central flexible sheet 74d defines an opening 96 located directly above the distal end of the balance chamber outlet 58b and in line with the balance chamber outlet 58a and the subsequent pathway to the patient 60a. In this configuration, the fluid exiting the lower balance chamber compartment 54b travels through the balance chamber outlet 58b and upward, through the second sheet 74b through the opening 96, enters the balance chamber outlet 58b and in patient path 60a, which are located and defined by flexible sheets 74a and 74b.

Fig. 8 illustrates a cross section of sealed layers 74a to 74c from a front view, the cartridge being divided through the vias 58a and 58b shown in Fig. 6. As can be seen, in Fig. 8 the seat Valve valve 28m is located laterally offset from valve seat 281, so cooperating valve actuators can open and close ports 58a and 58b independently. That is, a valve actuator can close either of the two valve seats 28l or 28m without also closing the flow path 58b or 58a, respectively. Fig. 8 also shows opening 96 in cross section, which is formed in sheet 74b and allows fluid communication between pathways 58a and 58b, so that flow from upper and lower compartments 54a and 54b can be combined. in patient track 60a. Fig. 8 further shows that tracks 58a and 58b can be lifted by thermoforming or other method to leave a gap between the inner surface of layers 74a and 74c and the outer surfaces of layer 74b.

Referring to FIG. 7, an apparatus and method for operating the balance chamber 50 (generally referring to each of the balance chambers described herein) is illustrated. The balance chamber 50 is shown in operation with a part of the dialysis machine 100a and 100c (cooperating with the cartridges 10a and 10c, respectively). Dialysis machine 100a or 100c includes or defines elements 102a and 102b that form the first and second chambers. For example, one of the elements 102a or 102b is stationary and is configured to house a flexible sheet cartridge, such as cartridge 10a or 10c. The other of the chamber-forming elements 102a or 102b forms part of a door that is closed on the opposite side of the flexible blade cartridge 10a and 10c after it has been loaded into the dialysis machine 100a or 100c.

Chamber-forming elements 102a and 102b each define or include a port 104 in which a tube (not shown) is removably or permanently attached by any of the above methods and embodiments.

ES 2 445 950 T3 described in relation to connectors 16 and 22 of Fig. 4. In one embodiment, once cartridge 10a or 10c is loaded into machine 100a or 100c, a negative pressure is formed in ports 104 or vacuum, sucking the first and third layer or sheet 74a and 74c against the interior cavities of essentially spherical configuration defined by the first and second elements 102a and 102b. Although the elements 102a and 102b shown define at least essentially spherical shapes, other suitable cross-sectional shapes, such as essentially triangular or trapezoidal shapes, can also be used. In addition, although not illustrated, elements 102a and 102b may define air channels that extend radially from ports 104 in various directions to help spread the vacuum over a greater surface area of ​​layers 74a and 74c. Such channels are shown and described in US Patent No. 6,814,547, entitled Medical Fluid Pump and assigned to the assignee of the present application. Once the sheets 74a and 74c are vacuum drawn against the inner surface of the chamber-forming elements 102a and 102b, respectively, the balance chamber 50 is ready for operation. In an alternative embodiment, no negative pressure is applied against sheets 74a and 74c, so ports 104 are not necessary. In this case, the positive pressure of the liquid or dialysate is sufficient to extend, respectively, the blades 74a and 74c against the elements 102a and 102b, respectively, and to drive the central blade 74b between the blades 74a and 74c.

Fig. 7 illustrates an operating state where no fluid has been supplied to the balance chamber 50. Consequently, the central or drive sheet 74b has not been pushed towards the top sheet 74a and the bottom sheet 74c. Section VII-VII through the detail of Fig. 6, for Fig. 7, includes the valve seat 231. As can be seen in Fig. 8, the valve seat 28m is not aligned with the valve seat 28l with respect to the section plane along the line VII-VII of Fig. 6. Consequently, the valve seat 28m is not seen in the view in section of Fig. 7, since in said view the valve seat 28m is located in front of the valve seat 28l. The valve seat 28l shown cooperates with a valve actuator 106, which is part of the machine 100a or 100c. For simplicity, valve actuator 106 is shown as a fully pneumatic actuated valve actuator. Here a positive air pressure is applied to the port of the actuator 106, which pushes a plunger 108 which compresses the valve seat 281 against the second leaflet 74b closing the balance chamber outlet 58a. Actuator 106 includes an O-ring seal 110 that creates a sliding seal between plunger 108 and the inner, eg, cylindrical, housing of valve actuator 106. To open the balance chamber outlet 58a, negative pressure is applied to port 106 which pulls plunger 108 up against stop 112, allowing fluid to open seat 281 and flow out from upper balance chamber compartment 54a. through the balance chamber outlet 58a. Figures 6 to 8 do not show valve seats 28j, 28k, or 28l that are in communication with valve actuators, such as valve actuator 106. These actuators and seats control the inlet of the balance chamber 50a and the inlet and outlet of the balance chamber 50b of Fig. 1.

In operation, to fill the upper balance chamber compartment 54a, the plunger 108 is pressurized and closes the valve seat 28l and the balance chamber outlet 58a. The valve actuator 106 that cooperates with the balance chamber inlet 56a opens, allowing fluid to fill the upper balance chamber compartment 54a. If the fluid has already filled the lower compartment 54b, the fluid entering the compartment 54a pushes the fluid from the lower balance chamber compartment 54b through the balance chamber outlet 58b to its destination. To do this, a valve actuator 106 cooperating with the balance chamber outlet 58b is opened, while a valve actuator 106 cooperating with the inlet 56b closes. Since the volume defined by the compartments 54a and 54b is fixed and since the second sheet 74b is pushed the full stroke against the sheets 74a or 74c in each half stroke, in each half stroke the same volume of fluid exits through the balance chamber outputs 58a and 58b. Accordingly, flexible sheets 74a and 74c are made of a suitably stretchable, elastic, and leak-free material, for example one of the materials listed above for sheets 74 (collectively referring to sheets 74a through 74c). Alternatively, as described below in connection with Figs. 26A and 26B, sheet 74b is magnetic and is magnetically actuated.

Referring to Figs. 9A through 9C, an apparatus and method for the operation of the volumetric pumps 70 is illustrated. The portion of the cartridge 10b shown in Fig. 2 and marked as Detail IX is shown in a front view at cross section in Figs. 9A to 9C, showing volumetric pump 70b. The characteristics described with respect to 70b are applicable to the volumetric pump 70a.

Volumetric pump 70b is shown in cooperation with a dialysis machine 100b using cartridge 10b. Machine 100b includes first and second pump chamber forming elements 114a and 114b, which define the shape of volumetric pump 70b. Cartridge 10b is configured to be loaded into machine 100b, such that a circular flexible membrane portion of cartridge 10b, as seen in Fig. 2, is aligned with the spherical shaped chamber defined by pump chamber forming elements 114a and 114b. In addition, valve seats 28q and 28s are aligned with valve actuators 106 shown in FIGS. 9A through 9C. Valve actuator 106 operates as described above in connection with Fig. 7 and includes a plunger 108 that slides back and forth within the actuator body.

Chamber 70b uses first and second flexible sheets 74a and 74b. The first and second pump chamber forming elements 114a and 114b each include a port 104, described above in connection with Fig. 7. As described below, negative pressure is used to drain the lamellae 74a and 74b. and positive. Alternatively,

ES 2 445 950 T3 one of the blades 74a or 74b can be mechanically actuated. A suitable mechanical / pneumatic hybrid pump is shown and described in US Patent No. 6,819,547, noted above. Although the spherical shape shown in Figs. 9a through 9c is a suitable shape, other shapes could also be defined for the volumetric pump 70, such as a trapezoidal or triangular shape.

Fig. 9A shows an initial state of the volumetric pump 70b. Here a negative pressure is applied to the port 104 of the chamber-forming element 114b, which pulls the second flexible sheet 74b to conform to the inner surface of the second chamber-forming element 114b. At the same time, a positive pressure is applied to the port 104 of the first pump chamber forming member 114a. The positive pressure causes the first flexible sheet 74a to be pushed against the second flexible sheet 74b. In Fig. 9A a positive pressure is applied to the two valve actuators 106, closing the valve seats 28q and 28s. Again, valve actuators 106 can consist of any combination of pneumatic, mechanical, and / or electrical actuation. As is also seen in Fig. 9A, the dialysate or medical fluid (including blood) 116 is pushed under pressure against the valve seat 28q, but its entry into the sealed chamber of the volumetric pump 70b is prevented.

In FIG. 9B, the negative pressure at port 104 of lower pump chamber forming member 114b is maintained, as is the positive pressure applied to valve actuator 106 at valve seat 28s. Negative pressure is applied to valve actuator 106 at valve seat 28q, which pulls plunger 108 against stop 112, allowing fluid 116 to flow through pump inlet path 66b into the chamber chamber. volumetric pump 70b. The force of fluid 116, for example by gravity, may be sufficient to cause the first flexible member 74 to be urged against the inner surface of the upper pump chamber-forming member 114a. Alternatively, negative pressure may be applied to port 104 of element 114a to pull the first flexible sheet 74a against the interior surface of the element. This action produces a vacuum, which draws fluid 116 into the pump chamber. As in the case of the peristaltic pump, the thermoformed flow paths are configured to withstand, for example not to sink, under the negative pressure of the diaphragm pump. In both cases, fluid 116 fills the at least essentially spherical cavity between leaflets 74a and 74b and stops against valve seat 28s, which remains in its closed position.

In Fig. 9C, valve seat 28q is closed, while valve seat 28s is open. Negative pressure is maintained in lower port 104 so that sheet 74b is drawn against element 114b. Here a positive pressure is applied to port 104, closing the first flexible sheet 74a against the second flexible sheet 74b and causing the fluid 116 to be expelled from the at least essentially spherical chamber of the volumetric pump 70b, through the outlet port. pump 68b, to your desired destination. The first and second membranes 74a and 74b are now in the position shown in Fig. 9A, so that the pump 70b can repeat the cycle described above as soon as the valve seat 28s closes. Alternatively, as shown below in connection with Fig. 28, the membranes are magnetic and are magnetically actuated.

The pump fill and eject strokes of pumps 70a and 70b in FIG. 2 can be staggered so that the flow of dialysate or medical fluid (including blood) through cartridge 10b is at least essentially continuous. Since the volume formed by the chamber of elements 114a and 114b is known and since the first flexible sheet 74a repeatedly moves toward the upper and lower surfaces of the chambers, the volume of fluid pumped with each stroke is known and repeatable. Accordingly, no separate volumetric control apparatus is required, such as a balance chamber 50. The total volume of fluid pumped is equal to the volume of each stroke multiplied by the number of strokes. The UF is controlled through one of the methods described above.

In one embodiment, the volumetrically controlled chambers of the balance chamber 50 and the volumetric pumps 70 are formed by respective circular seals. In an alternative embodiment, the respective seals are made with a diameter greater than necessary to achieve the desired volume. In this case, a seal is created between the sheets 74 by the pressure of the door pressed against the machine, or by the pressure of a part of a first machine against a second machine. As shown and described in connection with Figs. 24A and 24B, the machine seal is sized to form the proper diameter sphere to achieve the desired volume. Mechanical pinch sealing reduces alignment constraints. The machine-to-machine sealing can be ensured manually, for example via a lever or lock, clamps, cam pressure connection, etc., or it can be additionally secured or alternatively formed with the aid of pneumatic or electromechanical pressure. FIGS. 25A and 25B described below show embodiments for fluid heating paths formed by mechanical pinching and a heater that can cooperate with said fluid heating path. Fig. 26A, 26B and 28 described below show embodiments of the balance chamber and volumetric pump parts of the flexible reed cartridge, respectively, formed by mechanical pinching and an embodiment for driving the membranes within the balance and pump chambers.

Referring to Figs. 10A and 10B, two different embodiments of an integrated heater path for the flexible sheet cartridges described herein are illustrated. Fig. 10A illustrates Detail X of the flexible sheet cartridge 10b shown in Fig. 2. Fig. 10B shows an alternative three-layer two-sided heater path portion. Fig. 10A shows the heater or heater plates 118, while Fig. 10B shows dual heater plates or heaters 118a and 118b. Heaters or heater plates 118 (collectively referenced to heater 118

ES 2 445 950 T3 of Fig. 10A and heater plates 118a and 118b of Fig. 10B) can carry out any suitable mode of heat transfer, such as electrical resistance, induction, radiant, convection and any combination of these. As FIG. 10A shows, heater 118 is continuously below fluid heating path 42b. In Fig. 10B, heater elements 18a and 118b are located around fluid paths 42c and 42d of the flexible reed cartridge.

In FIG. 10A, the fluid heating path 42b is formed by a first and a second sheet 74a and 74b. A serpentine pathway is formed in the sheet 74a of a semicircular or other suitable cross-sectional configuration by any of the apparatuses and methods described above in connection with Fig. 4. Alternatively, the two sheets 74a and 74b may form semi-circular halves. that together form a complete circle. In this case, heater 118 may be formed or adapted to a semi-circular notched heating path to increase surface contact. A continuous outer seal 72g has been made around the outside of the coil loops or turns of the fluid heating path 42b. Along the interior curve of track 42b, an interior seal has been made for 72h. The 72g and 72h seals have been made by any of the methods described above. Edge seal 72i is also made along edge 78c, as can be seen in FIG. 10A. Alternatively, edge 78c is made through a crease. In operation, the dialysate or fluid flows through line 42b and is heated by thermal energy from heater 118.

In FIG. 10A, the flexible foil cartridge 10b is loaded on top of the heater 118 or is supported vertically against it. In Fig. 10B, the flexible reed cartridge is loaded between two insulating housings 120a and 120b. The heater elements 118a are secured within an insulating heater housing 120a. Likewise, heater elements 118b are attached to insulating heater housing 120b. Housings 120a and 120a can be part of the dialysis machine or a separate heater.

The fluid heating pathways 42b and 42c of FIG. 10B are formed from three sheets 74a, 74b, and 74c. Second sheet 74b serves as a support for vias 42c and 42d thermally formed in sheets 74a through 74c. The sheets 74a and 74c are sealed at the same time or at different times with the center sheet 74b by any of the sealing methods described above. As can be further seen in Fig. 10B, openings 96 are made in the second sheet 74b to allow dialysate to flow from the lower fluid heating path 42d of the third sheet 74c to the upper fluid heating path 42c of the sheet 74c, or vice versa. Therefore, Fig. 10B provides an efficient fluid heating apparatus, which essentially doubles the heating capacity for the same surface area compared to the flexible foil cartridge shown in Fig. 10A. Dual lanes such as lane 42d could also be made with the separate heater bag 40 of Figs. 1 and 3.

Referring to Fig. 11, an embodiment is illustrated for mounting the purge 44 to one of the flexible reed cartridges 10 (collectively referring to the flexible reed cartridges 10a through 10c). In particular, Fig. 11 shows Detail XI of the flexible sheet cartridges 10b of Fig. 11. The flexible sheet cartridge 10b includes a first and a second flexible sheet 74a and 74b. These sheets are sealed around the purge 44, which includes a purge body 46 and a filter 48. In one embodiment, the filter 48 is a hydrophobic membrane or other type of filter that allows air to pass but not fluid or liquid. dialysis through. Purge 44 is attached to lamellae 74a and 74b in more or less the same way as connectors 16 and 22 in Fig. 4. To this end, the seals 72a and 72b are made on either side of the body 46 of the filter 48 and / or on the body 46 itself. The seals 72a and 72b extend forming a fluid path, to which it can contribute a thermoformed shape created in one or both sheets 74a and 74b.

In operation, when air is detected in the hot dialysate, a valve seat 28h opens as shown in Figs. 1 to 3, allowing fluid to reach vent 44 and push air through vent 48 The fluid is then pumped to its desired destination. Alternatively, as described above, the bleed 44 is oriented vertically when the corresponding cartridge is mounted, so that no separate valve seat or actuator is required.

Referring to Fig. 12A, an embodiment for conducting fluid through two flow paths using a single peristaltic pump driver 90 is illustrated. Actuator 90 includes a drive shaft 92 and rollers 94 as described above in in relation to Fig. 5. When the flexible reed cartridge is loaded, for example the dual pump cartridge 10c, it slides in the horizontal or vertical direction on an axis 122 so that a slot 124 of the reeds 74a and 74b slides on an axis 98 of the actuator. peristaltic pump 90. The rollers 94 guide the fluid through the two pumping parts 30a and 30b shown for example in the cartridge 10c of Fig. 3. Cartridge 10c is mounted so that second sheet 74b abuts against channel plates 126a and 126b, which provide a rigid surface against which rollers 94 can compress the flow paths of pumping portions 30a and 30b, so similar to pressure plate 126 of Fig. 5. In the illustrated embodiment, rollers 94 guide fluid so that fluid enters and exits pumping portions 30a and 30b in the same direction. As described above, one use of the configuration of Fig. 12 is to provide a single peristaltic pump driver 90 that drives two pumping portions 30a and 30b, which in turn feed the inlets to the balance chambers 50a. and 50b with fresh or used fluid.

ES 2 445 950 T3

Referring now to FIG. 12B, a second embodiment is illustrated for utilizing a simple peristaltic pump driver 90 to conduct fluid through two pump flow paths. In this case, the peristaltic pumping parts 30a and 30b are configured as semicircles or half circles. Shaft 92 rotates rollers 94 (actuator 90 may have any suitable number of rollers 94) a full 260 degrees, to drive fluid through the two fluid paths of pumping portions 30a and 30b. A suitable channel plate (not shown) such as channel plate 126 of Fig. 5, is mounted behind the flexible blade cartridge 10b to provide a rigid surface against which the rollers 94 can compress the raised tracks 84a and 84b of the pumping portions 30a and 30b. Unlike the double pump embodiment of Fig. 12A, the double pump embodiment of Fig. 12B propels fluid in opposite directions, as can be seen by the inlets 86a / 86b and outlets 88a / 88b arranged in opposite positions. . However, in the two embodiments of Fig. 12A and 12B, the shaft 92 can rotate in either direction, as shown by the arrows in Fig. 12B.

The dialysis machine 100 (collectively referring to each of the machines 100a, 100b, etc.) uses many different sensors, such as pressure sensors, flow sensors, temperature sensors, air bubble detectors, identification detectors of solution to check for example peritonitis, composition and pH, conductivity sensors and ultrasound sensors, for example for the detection of air or blood. These sensors are typically used to detect some parameters of the dialysate or fluid pumped through one of the flexible reed cartridges 10.

Referring now to FIG. 13, an embodiment for the operation of a sensor 130 with any one of the flexible sheet cartridges 10a through 10c is illustrated. Sensor 130 can be any of the sensors described above and includes cables or wires 132 leading to a control unit or controller of dialysis machine 100. Sensor 130 detects a parameter of the dialysate or medical fluid (including blood) flowing through a flow path 128. Cartridge 10 (including any cartridge) is mounted such that a sensing area 134 is aligned with sensor 130. Sensing area 134 is an expanded flow path area defined by seals 72a and 72b, which slows down the fluid flow and can increase detection time and accuracy. Seals 72a and 72b are made by any of the methods and embodiments described above. Sensing area 134 is configured and dimensioned to fit sensor head 130.

Referring to Fig. 14, an embodiment for effecting different seals between three layers 74 of material is illustrated. Sheets 74b and 74c are illustrated in Fig. 14. Sheet 74a (not shown) is sealed to the top of sheet 74b. Between the plates 74b and 74c a flow path 128 is configured. As illustrated, a thermoformed notch or raised portion is made in the sheet 74c, which is then sealed with the sheet 74b by any of the different methods described above in connection with the seals 72a and 72b. Next, a printable adhesive is deposited on the top surface of sheet 74b along lines 72j and 72k. A suitable printable adhesive is cyclohexanone, for example for polyvinyl chloride (PVC) sheets, or a polyester elastomer for other types of sheets. A sheet or layer 74a is then arranged in the desired shape on top of sheet 74b. Radio frequency (RF), ultraviolet (UV) energy, or heat is then applied to adhesive seal lines 72j and 72k to activate the printed adhesive along the applied pattern, sealing sheet 74a with 74b. Thus, the three sheets 72a to 72c can form any desired sealing pattern (the same or different) between sheets 74a and 74b and between sheets 74b and 74c.

Referring to Fig. 15, another method is illustrated for selectively sealing three sheets 74a to 74c of flexible material to form a flexible sheet cartridge. A sealed seam 136 extends along one length of the cartridge 10d, for example in the center of or near the other length of the cartridge. Seam 136 allows the cartridge to be manipulated and folded to make selectable seams on the three different sheets 74a through 74c. This method is applicable to any of the flexible sheet cartridges described above. For illustrative purposes, the flexible reed cartridge 10d of Fig. 15 includes the single peristaltic pump and balance chamber 50 of Fig. 1 and incorporates the fluid heating path 42b of Fig. 2. As shown Above, many features of the flexible reed cartridge only require two reeds 74a and 74b. Other components, such as balance chamber 50, require three blades 74a through 74c. Thus, the possibility is also envisaged to provide a cartridge 10d that includes three sheets or layers 74 in areas that require three sheets, and only two sheets 74a and 74b in other areas of cartridge 10d that only require two sheets. Alternatively, three blades 74a to 74c are used throughout the cartridge 10d. Again, the sheets 74a to 74c can be independent or can be formed by folding a single piece of material one or more times.

The left side of cartridge 10d is used to produce the bilateral three-layer heating flow paths 42c and 42d, described above in connection with FIG. 10B. As illustrated, one of the outward facing flow paths, such as flow path 42d, is formed by first sealing the sheets 74b and 74c together. Next, sheet 74a is sealed with the combination of sheets 74b and 74c. In one embodiment, sheet 74a is sealed with the combination of sheets 74b and 74c with the printable adhesive described above. In another embodiment, energy is applied to the outer face of sheets 74a and 74c sufficiently to chemically bond or melt sheets 74a and 74b together. Also alternatively, sheets 74a through 74c can be secured to simultaneously form fluid heating pathways 42c and 42d. Center sheet 74b defines openings 96, as described above, located between fluid heating pathways 42c and 42d.

ES 2 445 950 T3

The right side of cartridge 10d is used to form balance chamber 50, peristaltic pump 30, pressure sensing area 134, fluid flow paths 26a to 26d, and other flow paths associated with the components listed above. Here, the flexible sheets 74a and 74b are first sealed to each other, after which the sheet 74c is sealed with the sheet 74b, for example to complete the balance chamber 50. Although not illustrated in the figures, additional flow paths may be formed between sheets 74b and 74c, with one or more openings 96 that allow fluid to flow from flow paths or flow apparatus formed by means of sheets 74a and 74b and others formed between sheets 74b and 74c. The sheet 74c can be sealed to the sheet 74b with the printable adhesive or alternatively or additionally by applying energy to the three sheets 74a to 74c.

As illustrated, the pump outlet path 32 extends from the peristaltic pump portion 30 through the seam 136, through paired openings defined in the plates 74a and 74b, into the fluid heating path. lower 42d, through its serpentine path, back through another set of paired openings in lamellae 74a and 74b, into and through upper fluid heating pathway 42c, before extending into balance chamber 50 and exiting into patient connector 62a.

Referring to Fig. 16, another method of sealing three sheets 74a to 74c to each other is illustrated. In Fig. 16, layers 74a to 74c are sealed using die sealing apparatus 136a and 136b using machinery constructed, for example, by KIEFEL Extrusion GmbH, Cornelius-Heyl-Str. 49, 67547 Worms / Germany. Apparatus 136a and 136b apply heat to sheets 74a through 74c with a predefined die pattern. The die pattern includes areas where the three sheets 74a to 74c are sealed to each other and other areas where only two sheets 74a and 74b or 74b and 74c are sealed to each other.

In a conductive die sealing machine, each die apparatus 136a and 136b is controlled to emit a desired amount of heat in direct contact with the outer sheets 74a and 74c. For example, die apparatus 136a can be adjusted to emit more heat than die apparatus 136b. When using this type of conductive heating, if it is desired to seal the central layer 74b with only the foil 74a or 74c, the apparatus 136a or 136b on the side where the foil 74a or foil 74b is not to be sealed it is adjusted to emit less heat in order to avoid sealing between said foil and central foil 74b. The heat from the opposing die apparatus 136a or 136b coming into contact with the sheet 74a or 74c in which a seal is to be formed with the sheet 74b is adjusted to emit a greater amount of heat, sufficient to melt the two sheets. and stamp them with a desired pattern. The temperatures of the hot and cold die apparatus 136a and 136b must be adjusted to create a temperature profile higher than the melt temperature of the core layer 136b on the side to be sealed and lower on the opposite side of the sheet 136b to prevent this side of the core layer from melting. To this end, it may happen that one of the die apparatus is completely deactivated. Accordingly, the die machine can control the heat outputs of each apparatus 136a and 136b independently to heat the different sheets 74a to 74c to the desired temperatures.

In another embodiment, the die sealing machine is of the radio frequency (RF) type. In this case, one of the apparatuses 136a and 136b is positive and the other is negative and they come into direct or indirect contact with the sheets 74a and 74c. RF type sealing is especially suitable for sealing PVC, for example PVC pipes and PVC sheets, although it can be used to seal other types of tube and sheet materials listed here. For example, RF-type sealing can be used in the embodiment of Fig. 15 to seal all three sheets in multiple steps.

Referring to Figs. 17, 18, 19A and 19B, an alternative embodiment is illustrated in which a cartridge 10e includes a flexible portion 138 and a rigid portion 140. The flexible portion 138 includes a first sheet 74a and a second sheet 74b . A peristaltic pump part 30 and an in-line fluid heating path 42b are formed by means of the plates 74a and 74b in the flexible part 138 by any of the methods described above. However, in cartridge 10e, balance chamber 50 is formed using two blades 74a and 74b instead of the three bladed version described above. In this case, the balance chamber 50 is partially formed through a rigid chamber 142 formed in the rigid part 140. As can be seen in Fig. 18, the flexible part 138 is folded under the rigid part 140 or otherwise attached to the bottom of it. When this occurs, the flexible membrane portion of the balance chamber 50 is aligned with the rigid chamber 142 of the rigid portion 140 and then sealed therewith.

Fig. 18 also shows a heater 118, which cooperates with the heating path 42b, and a peristaltic pump actuator 90, which cooperates with the peristaltic pump part 30. Valve actuators, such as actuators 106 described above, are disposed in valve actuator unit 144. Valve actuator unit 144 is located on the side of cartridge 10e opposite heater 118 and actuator 90. In the illustrated embodiment, valve actuator unit 144 may form part of a door that presses valve actuators 106, heater 118, and pump actuator 90 against appropriate positions of cartridge 10e.

Valve seats, like seats 28a through 28d, are provided as part of rigid portion 140 of cartridge 10e. Rigid flow paths, such as flow paths 26a to 26d, 32, 58a, and 58b, communicate with pumping portion 30, balance chamber 50, their associated flow paths, and fluid heating path 42b of the flexible portion 138 through openings, such as openings 96 provided in one or more sheets 74b and 74a with the rigid fluid paths.

ES 2 445 950 T3

With respect to the balance chamber 50, the flow paths 56a and 58a flow from the flexible part of the balance chamber 50 of the flexible part 138 to the rigid ways defined by the rigid part 140. The valve seats 28j to 28m are located in the rigid part 140. In addition, in the rigid part 140 the tracks 56b and 58b leading to the rigid chamber 142 are also provided.

With reference to Figs. 19A and 19B, a balance chamber 50 is illustrated formed by a rigid chamber 142 of the rigid part 140 and two flexible sheets 74a and 74b of the flexible part 138 of the cartridge 10e. Although Figs, 19A and 19B show the balance chamber 50 in connection with the cartridge 10e having a rigid part 140 and a flexible part 138, it is also expressly intended to provide the balance chamber 50 of Figs. 19A and 19B with a flexible reed cartridge that only has a rigid part. That is, the rigid chamber 142 can be provided independently or separately and need not be part of a larger rigid portion 140.

As shown, the sheet 74a rests on a rigid support member 146. The rigid support member 146 may be supplied together with the cartridge 10d or alternatively forms part of the dialysis machine 100d using the cartridge 10d. The support plate 146 causes the lower balance chamber compartment 54b to expand in the cavity formed by the rigid chamber 142 when the lower balance chamber compartment 54d is filled. Valve seats 28k and 28m are figuratively shown in cooperation with rigid chamber 142. Similarly, valve seats 28j and 28l are figuratively shown in cooperation with leaflets 74a and 74b. For illustrative purposes, valve seats are shown with an X when in the closed flow position and without X when in the open or fluid flow position.

In Fig. 19A, valve actuators cooperating with valve seats 28j and 28m cause the seats to close, while valve actuators cooperating with valve seats 28k and 28l cause said seats to open. With this configuration of valve positions, the upper balancing chamber compartment 54a fills with a volume of fluid 116, while the lower balancing chamber compartment 54b ejects a similar volume of fluid to a desired destination. In Fig. 19B, valve actuators cooperating with valve seats 28k and 28l cause these seats to close, while valve actuators cooperating with valve seats 28j and 28m cause said seats to open. In this case, the lower balance chamber compartment 54b is filled with fluid 116, while the upper balance chamber compartment 54a supplies a similar volume of fluid, beyond the valve seat 28m, to a desired destination.

The rigid balance chamber 50 version can simply be provided in a cartridge, for example as shown in Figs. 1 and 17 with cartridges 28a and 28d. Alternatively two or more versions of rigid balance chamber 50 are provided in one cartridge, as described above in connection with cartridge 10c of FIG. 3. Under normal adaptive flow conditions, fresh fluid enters one of the compartments 54a or 54b, supplying used fluid from the other compartment, and vice versa. Alternatively, the rigid balance chamber 50 can be used for UF only, in which case the used fluid is supplied to the two compartments 54a and 54b.

Referring to FIGS. 20A through 20D, an alternate embodiment of balance chamber 50 is illustrated where flexible sheets 74a through 74c are employed. The balance chamber 50 of FIGS. 20A to 20D incorporates tubes 156a and 156b as inlet to the balance chamber and tubes 158a and 158b as outputs from the balance chamber. Tubing 156a, 156b, 158a, and 158b can be made from any suitable medical grade material, such as PVC, non-DEHP PVC, polybutadiene (PB), ethylene vinyl acetate (EVA), polypropylene blend (PP), polyethylene blend (PE), Kraton blend and polyolefin blends. The tubes are sealed in place along the 72l seams. The upper and lower seals 72e and 72f described above in connection with Figs. 6 and 7 are made to form the upper balance chamber compartment 54a and the lower balance chamber compartment 54b. Inlet tube 156a and outlet tube 158a are in fluid communication with upper balance chamber compartment 54a, while inlet tube 156b and outlet tube 158b are in fluid communication with lower balance chamber compartment. 54b.

The inner ends 160 of the balance chamber inlet tubes 156a and 156b and the balance chamber outlet tubes 158a and 158b are configured to align with the circular chambers formed by seals 72a and 72f, in order to allowing the first and third sheets 74a and 74c to separate against respective interior walls of the previous balance chamber elements located within the dialysis machine, such as chamber walls 102a and 102b shown in Fig. 7. Center layer 74b is sealed to the bottom of tubes 156a and 158a so that fluid entering from tube 156a can flow only into upper compartment 54a. Center sheet 74b is sealed around the top of inner ends 160 of tubes 156b and 158b, so that fluid entering sheet and tube type balance chamber 50 through 156b can only enter the tube. bottom compartment 54b of balance chamber 50. Otherwise, center sheet 74b is freely movable back and forth within outer sheets 74a and 74c when balance chamber 50 is in operation.

FIGS. 20C and 20D illustrate sheets 74a to 74c having semicircular curvatures 76. The curvatures may be preformed or preformed at least in part, for example by thermoforming. Alternatively, bends 76 are formed during the sealing process of sheets 74a through 74c around tubes 156 and 158. Bends 76

ES 2 445 950 T3 are oriented outwardly on the outer sheets 74a and 74c. The curvatures 76 of the central sheet 74b alternate direction as necessary. Depending on which side is being welded, seal 72l can weld two sheets 74a / 74b or 74b / 74c or one sheet 74a or 74b to tubes 156a or 156b.

In the illustrated embodiment, the sheet and tube type balance chamber 50 is provided as a separate apparatus that can be placed in fluid connection with another part of the disposable unit or with the dialysis system. To this end, the tubes 156a to 158b may have the necessary length to connect them with the other part of the dialysis liquid circuit. In an alternative embodiment, two or more balance chambers 50 with the configuration of Figs. 20A through 20D are formed by sheets 74a through 74c and two or more tube groups 156a through 158b. Also alternatively, one or more of the balance chambers 50 of Figs, 20A to 20D are provided in a cartridge such as cartridges 10a to 10d, which contain most, if not all, of the dialysate circuit components. except bags, patient connection and associated tubing.

Tubes 156a through 158b may have or include valve seats, such as valve seats 28j through 28l described above, in connection with balance chamber 50 of Fig. 1. Alternatively, automatic tube or clamping pliers are used to pinching a portion of tubes 156a through 158b without the need for any modified valve seat area. The balance chamber 50 of Figs. 20A to 20D can be used in any of the cartridges described herein in which one or more balance chambers are used.

Referring to FIGS. 21A through 21G, an alternative flexible blade cartridge 10e is shown in operation with a hemodialysis machine 100e, which in a preferred embodiment is a home hemodialysis (HHD) machine. Alternatively, cartridge 10e can be used with any of the dialysis therapies described herein. As stated in the previous application, hemodialysis is normally carried out in a clinic or center, where the dialysis fluid is produced online using a source of water and concentrates. In a home setting, a similar in-line dialysate generating unit is typically also used. These units are large and require the dialysis machine to be connected to a water source. In the embodiment illustrated in Fig. 21A to 21G and in the prior application an alternative system is shown which uses a dialysate supplied from one or more supply bags, and which can provide convection scrub in addition to diffusion scrub. Alternatively, the disposable part of blood is combined with the disposable part of the dialysate. A separate blood cartridge 150 is provided in Figs. 21B and 21F.

FIGS. 21A and 21C to 21E illustrate a flexible sheet cartridge 10e. Cartridge 21e differs from the cartridges described above in several respects. One difference is that separate peristaltic pump tubes 148 and 154 are used instead of the flexible reed cartridge pump portion 30 shown and described for example in connection with Figs. 1, 3 and 5. A second difference is that the collection of the different supply and drain bags is done through tubes external to the flexible sheets 74a to 74c of the cartridge 10e. In FIG. 21A, peristaltic pump actuators cooperating with dialysate line 148 and UF line 154 conduct fluid to the inlets of balance chambers 50a and 50b. In HHD therapy, fluid exits the valve outlets of the balance chambers 50a and 50b into a dialyzer or drain as described above. As before, the balance chambers 50 act as intermediate dosing devices that dispense a similar volume of fluid to the drain and dialyzer. Any of the methods described above for controlling ultrafiltration can be used with the flexible foil cartridge 10e. For example, a series of balancing chamber 50 strokes may be specialized UF strokes, in which used fluid is pumped into the two halves of the balancing chambers 50a and 50b. Alternatively, a separate UF balance chamber can be provided.

As seen in Figs. 21A and 21E, fresh dialysate is pumped from one of the supply bags through a respective supply line 18a through 18e, to a manifold 162 and a dialysate pump tube 148, which cooperates with a peristaltic dialysate pump driver. The peristaltic dialysate pump pumps fresh dialysate through inlet connector 16, through integrated in-line fluid heating path 42b, into one of balance chambers 509a or 50b. Any air escaping from the heated solution is vented through vent 44. In one embodiment, cartridge 10e is vertically mounted as shown in Figs. 21A and 21E, so that air automatically rises to the top of cartridge 10e and is released through air purge 44 and purge line 164 (Fig. 21E). This reduces the number of actuators and valve seats as described above in relation to cartridges 10a to 10c. In other words, all the air is purged automatically without the need to stop the normal operation of the machine.

Pumping fresh dialysate into an inlet compartment of one of the balance chambers 50a and 50b causes a similar amount of used fluid already present in the balance chamber to be pumped to the drain through drain line 24. At the same time, the UF pump actuator cooperating with the UF pump line 154 pumps the used fluid from the dialyzer, through the line from the patient 152b, into the inlet compartment of the other of the balance chambers 50a and 50b. This action causes a similar volume of fresh fluid to be pumped through the patient connector 62a and the patient line 152a to the dialyzer.

As can be seen in Fig. 21A, a tube organizer 168 is provided to hold the supply lines 18a through 18e, the drain line 24, the purge line 164, the line to the dialyzer 152a and the line from the dialyzer 152a. Dialyzer 152b

ES 2 445 950 T3 an organized mode, and to allow easy mounting of the cartridge 10e and associated tubes. Fig. 21A also shows darkened areas 188 cooperating with collector 162. Darkened areas 188 indicate portions of the associated tubing that are snapped closed to selectively allow fresh dialysate to be aspirated from a desired supply bag 12 and used to be pumped into a drain bag 14 or one of the supply bags. 12 used as a drainage bag.

Referring to Figs. 21C and 21D, a number of additional features of the flexible sheet cartridge 10e are illustrated. The schematic side view of FIG. 21D illustrates sheets 74a, 74b, and 74c formed from a single sheet of material, which is folded twice to produce all three layers 74 (collectively referring to layers 24a through 24c). This allows the amount of outer edge seams or seams to be reduced and also helps to align the separate layers 74a through 74c. It should be noted that any of the flexible sheet cartridges described herein can be formed using a single folded sheet, two sheets with one fold, or three separate sheets, etc.

Figs. 21C and 21D also show first weld areas 190a in which only the first sheet 74a is welded or otherwise attached to the sheet 74b. They also show areas 190b where the three sheets 74a to 74c are welded or bonded together. FIG. 21C also shows third areas 190c in which only the second layer 74b is welded or otherwise attached to the third sheet 74c. This selective welding enables the cartridge 10e to be produced efficiently. It is not necessary to weld all three layers in areas where only two sheets are required to be welded together. However, all three sheets can be welded or otherwise joined in areas where this is necessary. Two layer 190a and 190c adhesive bonding or bonding is generally required when flow is desired in one layer but not the other. In an alternative embodiment, the three-layer welds 190b (except for the three-layer peripheral welds and the three-layer welds for the inlet and outlet ports) are removed and replaced by the compression seals described below in connection with Figs. 24A, 24B, 25A, 25B, 26A, 26B and 28.

FIG. 21C shows selective welding in areas associated with balance chambers 50a and 50b. Fig. 6 provides more information on how to weld three-foil balance chambers together. The serpentine path 42b is formed from a three-foil weld. This allows fluid heating path 42b to more efficiently extend into the space between sheets 74a and 74b and sheets 74b and 74c.

Figs. 20C and 20D show that fluid travels between different layers or pairs of sheets through openings 96 made at desired locations in central sheet 74b. Fluid enters for example through the single supply connector 16 in a first path between the plates 74b and 74c. An opening 96a allows fluid to travel to a fluid heating path portion 42b located between the plates 74a and 74b, where it is heated a first time. The fluid then moves through an opening 96b to a second fluid heating path portion 42b located between the plates 74b and 74c. All air exiting the heater solution is purged through the top of the cartridge 10e by purge 44. The hot fluid then enters the equilibrium chamber area, which in one embodiment uses all three blades 74a. at 74c. Fresh fluid exits through a balancing chamber compartment located between blades 74b and 74c into the dialyzer through the connector into the patient 62a. Used fluid returns from the dialyzer to cartridge 10e through the connector from patient 62b, to a balance chamber compartment located between blades 74a and 74b. The used fluid is sent to the drain through the drain connector 22 located between the plates 74a and 74b.

Referring to FIGS. 21B and 21F, an embodiment of a blood cartridge 150 used with HD, HHD, and HF is illustrated. Blood cartridge 150 is also vertically mounted as illustrated in one embodiment. Cartridge 150 includes a rigid portion 170 having a rigid housing 172 and a flexible membrane 174, made of any of the materials described above, attached to housing 172. The rigid part 170 is made of a suitable material, such as polyvinyl chloride (PVC) blends, acrylic, ABS, polycarbonate, polyolefin. Housing 172 includes or defines a patient port 176, a patient port 178, a saline port 180, a purge 44, a dialyzer port 182, and a dialyzer port 184. As shown in Figs. . 21B and 21F, some ports, such as ports 178 and 180, port 184, and vent 44 may be formed at different relative locations along housing 172.

FIG. 21B illustrates valve seats 28x to 28z cooperating with the patient line, the patient line, and the saline line, respectively. A peristaltic pump driver cooperates with the blood pump line 166 to pump blood from the patient to the cartridge 150, to the dialyzer, back to the cartridge 150, and then back to the patient. Fluid received from the dialyzer enters an air separation chamber 192 before being returned to the patient. Blood 186 collects at the bottom of an air separation chamber, while air eventually present in the blood rises to the top of air separation chamber 192. Air separation chamber 192 may further include a purge 44, such as a hydrophobic membrane, which allows air to purge from cartridge 150.

The operation of the blood cartridge 150 of FIG. 21F is similar to that described in connection with FIG. 21B. However, in this case the valve seat 21y cooperates with the line to the dialyzer connected at the access to the dialyzer 182. The valve seat 28x controls the fluid entering the cartridge 150 from the patient, as shown in Fig. 21B. The valve seat 21z controls the flow of saline solution to the cartridge. Air separation chamber

ES 2 445 950 T3

192 works as in the previous case, the air at the top of the chamber 192 being able to exit the cartridge 150 through the vent 44. The blood at the bottom of the air separation chamber 192 flows into the patient through the access to the patient 178. FIG. 21F further shows that a flexible sheet 174 is welded or adhered to a rigid portion 172 of housing 170. Flexible sheet 174 allows a valve actuator to exert pressure on valve seats 28x to 28z to open / close a respective fluid flow path. As FIG. 21F also shows, the blood cartridge 150 includes or provides detection areas 194a and 194b for detecting a parameter of the blood, such as blood pressure, venous pressure, or its temperature.

Cartridge 150 illustrates components associated with a cartridge for blood used with HD, HHD, HF, HDF, and any combination thereof as described in the previous application. As can be seen, the blood cartridge can be provided as a separate cartridge 150 installed separately from a dialysis cartridge 10a to 10b. Alternatively, the components of the blood cartridge are integrated with any one of the dialysis cartridges 10 disclosed herein.

Referring to Fig. 21G, a top view of the hemodialysis machine 100e illustrates an embodiment for mounting the cartridge 10e, the various delivery bags 12, and the drainage bag 14. The cartridge 10e can be arranged at an angle relative to the upper part of the machine 100e, in order to create at least one slightly vertical component for mounting the cartridge 10e for the purging purposes described above. Supply bags 12 and drain bag 14 are supported by the top of machine 100e and are brought into fluid connection with cartridge 10e before or after the cartridge is mounted in machine 100e. Machine 100e includes user interface 196, which allows the patient or healthcare personnel to start, control, and monitor therapy. User interface 196 may employ a touch screen overlay operable with a touch screen controller and / or membrane switches as desired.

Referring to Figs. 22A through 22D, another alternative system 100f is illustrated in which an alternative flexible foil cartridge 10f is employed. The 100f system is suitable for performing hemodialysis, for example home hemodialysis. In this case, the system 100f also employs a second blood cartridge, which may be similar or equal to the blood cartridge 150 described above. Fig. 22A illustrates an embodiment for loading cartridges 10f and 150 into machine 100f. Here, the dialysate components are located on one side of the user interface 196, while the blood components are located on the other side of the user interface 196. This configuration makes loading the cartridges relatively easy for you. the user and also enables efficient mounting of the valve and pump actuators and heater located within the machine 100e, thus reducing the overall size of the machine 100f.

In machine 100f, cartridge 10f is positioned vertically, which is advantageous for the air purging purposes described above. Machine 100f includes two peristaltic pump drivers 90, of which one conducts fluid through a dialysate tube, while the other conducts fluid through a UF tube, similar to the arrangement described above for the cartridge. 10e. A separate heating bag 40, described above in connection with Fig. 1, extends to the right from a rigid housing portion 200 of cartridge 100f. As shown in greater detail below, rigid housing portion 200 defines flow paths and associated valve seats. Accordingly, the valve actuators of the machine 100f are located behind the rigid cartridge portion 200 of the cartridge 10f. A plate heater or other type of heater is located behind the heater bag 40. A dual balance chamber flexible membrane component 198 of cartridge 10f is located below rigid portion 200. As described herein, peristaltic pump drivers 90 conduct fresh and used fluid alternately through the inlet compartments of the tubes. balance chambers 50a and 50b. A hinged door 202 allows the cartridge 10f, including its rigid portion 200, the balance chamber component 198 and the heater bag 40, to be easily inserted and removed from the machine 100f.

Referring now to FIG. 22B, a more detailed view of cartridge 10f is illustrated. As described, cartridge 10f includes a rigid portion 200 in fluid connection with a separate heater bag 40 and a balance chamber unit 198. Therefore, the cartridge 10f differs from the cartridge 10e in that the heating and balancing chamber functions are performed through the flexible reed membranes, while the valve actuation is performed using a rigid element 200 in combination with a flexible sheet 202. Valve actuators, eg, spring loaded closed and pneumatically open actuators, cooperate with valve seats 28 to open and close selected flow paths as desired. Cartridge 10f also includes separate peristaltic pump tubes 148 and 154, described above in connection with cartridge 10e. Heating bag 40 includes a coiled heating path (not illustrated) and is in communication with rigid element 200 through lines to the heater and from heater 38a and 38b, respectively. Balance chamber unit 198 is also in communication with rigid valve member 200 through access connectors and tubing as illustrated.

The balance chamber unit 198 is shown in more detail in Figs. 22C and 22D. The balance chamber unit 198 is similar to the flexible sheet balance chamber 50 described above in connection with FIGS. 20A through 20D. Here, unit 198 includes two balance chambers 50a and 50b, which are made of flexible sheets 74a to 74c, fresh fluid tubes 156, and used fluid tubes 158. As can be seen in particular in Fig. 22D, each compartment of the balance chambers 50a and 50b is in communication with a single tube of fresh fluid 156 o

ES 2 445 950 T3 used fluid tube 158. The fresh fluid tube 156 is in communication with a first equilibrium chamber compartment located between the plates 74a and 74b, while the used fluid tube 158 is in fluid communication with a second balance chamber compartment located between sheets 74b and 74c. Balance chambers 50a and 50b each include seals 72e, 72f, and 72l, as described above in connection with Figs. 20A to 20D.

FIG. 22D shows that the blades 74a through 74c have semi-circular curvatures 76, similar to those of the balance chamber 50 of FIGS. 20A through 20D. The curvatures may be preformed or preformed at least in part, for example by thermoforming. Alternatively, bends 76 are formed during the sealing process of sheets 74a through 74c around tubes 156 and 158. Bends 76 face outwardly in outer sheets 74a and 74c. The curvatures 76 of the central sheet 74b alternate direction for each of the balance chambers 50a and 50b. As can be seen, each tube 156 and 158 has a single sheet 74a or 74c welded on one side and two sheets 74a or 74c in combination with the center sheet 74b welded on its other side. In one embodiment, tubes 156 and 158 are first welded to center sheet 74b. Then, the outer sheets 74a and 74c are welded to the center sheet 74 and the exposed portions of the tubes 156 and 158.

In operation, fresh fluid enters and leaves through tube 156. Used fluid enters and leaves through tube 158. That is, there are no separate inlet and outlet tubes for each balance chamber compartment, as in the case of the balance chamber 50 of FIGS. 20A to 20D, which has two fresh fluid tubes 156a and 156b and two used fluid tubes 158a and 158b. Instead, the tube itself acts as an inlet and outlet for fresh or used fluid for its compartment. Valves and flow paths are configured within rigid member 200 to direct flow into or out of balance chambers 50a and 50b, as desired.

Fresh fluid entering the fresh fluid balance chamber compartment between lamellae 74a and 74b through tube 156 causes center lamella 74b to dissipate a similar amount of used fluid from the used fluid compartment between lamella 74b and 74c through the used fluid tube 158. As this occurs in one of the balance chambers 50a and 50b, the used fluid enters the used fluid compartment between the sheets 74b and 74c of the other balance chamber, bending the center sheet 74b to dissipate a similar amount of fluid. fresh from the fresh fluid compartment between the plates 74a and 74b through the fresh fluid tube 156. This sequence is then reversed. In this way an at least semi-continuous flow of fluid is sent to the patient or dialyser and to the drain.

Referring to Fig. 23, another alternative cartridge 10g is illustrated. The 10g cartridge is a simplified version of the 10e cartridge. Cartridge 10g includes supply lines 18a through 18e, drain line 24, dialysate pump tube 148, return pump tube 154, in-line fluid heating path 42b, purge 44, purge 164, a connector to patient 62a, a line to dialyzer 152a, and a line from dialyzer 152b. The main difference between the 10g cartridge and the 10e cartridge is that the balance chambers 50a and 50b used in the 10e cartridge are not used in the 10g cartridge. That is, the volumetric control of fluid is not carried out using adaptive flow compensators or balance chambers 50a and 50b with the flexible sheet cartridge 10g. Instead, another method is used, for example by weight or gravimetric control of the fluid delivered and withdrawn from the patient or with a flow management system (FMS) used with a HomeChoice® dialysis machine sold by the assignee of the present application. The reed cartridge body 10g may include valve seats and flow paths as necessary to direct the flow in a desired manner. Alternatively, flow can be controlled by pinching and unclamping the tubes connected to cartridge 10g, in which case cartridge 10g primarily serves as a fluid heating pathway. The flow paths, valve seats, and fluid heating path 42b may be provided by means of two blades 74a and 74b or three blades 74a to 74c, as described herein, or they may have a rigid component, such as a rigid frame.

Referring to FIGS. 24A and 24B, another alternative system 100h is illustrated using a flexible membrane cartridge 10h. The 100h system is suitable for performing hemodialysis, for example home hemodialysis. The 100h system uses a blood cartridge, such as the 150 cartridge. Fig. 24A shows the 100h system without the 10h cartridge loaded. Fig. 24B shows the 100h system with the 10h cartridge loaded.

Cartridge 10h is further simplified as paired die plates 210a and 210b of machine 100h are brought together around cartridge 10h to form the balance chamber portion, fluid heating paths, and other fluid flow paths. cartridge fluid when installed. That is, the part of the balance chamber, tracks, etc. They must not be preformed in the cartridge 10h before loading. Instead, closing the door 202 against the wall 220 of the machine 100h mechanically forms the fluid-tight pathways. Cartridge 10h is preformed as a sack 212, as can be seen in FIG. 25B, which is formed of three sheets 74a through 74c or two sheets 74a and 74b, as needed to form the desired components. Bag 212 is in fluid connection with line to dialyzer 152a, line from dialyzer 152b, purge line 164, inlet connector 16, supply lines 18a through 18f, and drain line 24, such as can be further seen in Fig. 24b.

Plate 210a is formed on hinged door 202. Adaptive die plate 210b is formed on wall 220 of machine or system 100h. In the illustrated embodiment, die plate 210a includes ribs 214a that

ES 2 445 950 T3 form a heating path corresponding to the ribs 214b that form a heating path of the die plate 210b. Die plate 210a includes ribs 216a that form a balance chamber corresponding to ribs 216b that form a balance chamber of die plate 210b. Die plates 210a and 210b also form or include tube / connector housing grooves 218a and 218b, respectively, which secure tubes 152a, 152b, and 164 in position when door 202 is closed without crimping or closing the tubes. Alternatively or additionally, die plates 210a and 210b form any further flexible sheet apparatus described herein, such as volumetric pumping parts 70, internal flow paths 26 of UF meter parts, valve seats 28, etc.

At least one of the die plates 210a and 210b is integrated upon activation of the component, such as a heater, pump actuator, balance chamber actuator, and / or valve actuator. The heating is carried out by means of the heat of a plate by electrical, radiant and / or ultrasonic resistance. Fig. 25A shows one embodiment of an in-line electrical resistance or plate heater configured to heat a fluid heating path formed by mechanical pinching. Fig. 25B shows a freestanding heater having clamshell sides forming heating pathways, the characteristics of which are also applicable to system 100h. Fig. 26A and 26B show a balance chamber portion of a flexible sheet cartridge formed by clamshell ribs, which can be activated pneumatically, mechanically, hydraulically or, in the case illustrated, electromagnetically. Fig. 28 shows a volumetric pump part of a flexible reed cartridge formed by mechanical clamshell ribs, which can also be activated pneumatically, mechanically, hydraulically or, in the case illustrated, electromagnetically. System 100h can integrate any of these technologies into one or more die plates 210a and 210b.

The illustrated embodiment shows the sack 212 without any interior seams, except those necessary to seal it to the connectors, for example the connector 16, and / or the tubes 152a, 152b and 164. Alternatively, provision is also made to provide internal security seams to reduce damage due to leaks. For example, a seam could be provided to separate the fluid path portion of the bag 212 from the balance chamber portion of the bag. Another seam could also be provided to separate or isolate the balance chamber part 50a from the balance chamber part 50b, etc. The security seams can have any desired shape or pattern, but may advantageously be simpler than the shape or pattern necessary to form the flow component parts as a whole. The security seams can be made between sheets 74a and 74b, 74b and 74c or between the three sheets 74a to 74c.

Alternatively, it is also expressly intended to form the two-sheet seals, for example between sheets 74a and 74b, or 74b and 74c, using the joining or welding methods described above to form the actual flow components having two-sheet seals. In this case, the mechanical clamshell seal is used whenever a seal is required between the three sheets 74a to 74c. Again, here the total amount and the drawing of the welds or joints should have been reduced and simplified, respectively.

Referring to Fig. 25A, the heating portion of the cartridge 10h is shown formed by the mechanical pinching of nerves that form heating pathways 214a and 214b. Cartridge 10h shown in Fig. 25B includes a sac 212, which receives fresh dialysate through the fresh fluid inlet connector 16. Ribs 214a and 214b form an inline fluid heating pathway 42b, which receives fresh fluid. from input connector 16. In-line fluid heating path 42b snakes back and forth as shown above to absorb heat. The hot dialysate exits through the inner line 222, which is also formed by mechanical clamping. The hot fluid travels through pathway 222 to balance chambers 50a and 50b or to a volumetric pump 70, for example.

In the illustrated embodiment, pinch ribs 214a and 214g are also heating elements, for example aluminum plate heating elements. Other elements 224a and 224b are connected to door 202 and machine wall 202, which may also consist of electrical resistance elements. In one embodiment, the thermal actuator is a power source that supplies power, for example 200 watts, to resistor elements 214a, 214b, 224a, and 224b. Alternative types of heat actuators include inductive, radiant, convective, ultrasonic, or a combination of heating types. Pinch ribs 214a and 214b can supply heat, although this is not necessarily necessary.

As illustrated, in one embodiment the heater using any one or more types of heat transfer can heat the dialysate from a temperature of between about five and about thirty ° C to a temperature of about thirty-seven ° C or to body temperature. , and at a flow rate between zero and approximately three hundred ml / min. In one embodiment, a controller (not illustrated) within machine 100h controls a duty cycle or on / off cycle to accommodate different initial dialysate temperatures and different flow rates. The controller may consist of a delegate or subordinate processor cooperating with a supervisory processor and a safety processor. An outlet fluid temperature controller 226 senses the temperature of the dialysate exiting fluid heating path 42b and provides feedback to the controller to increase or decrease duty cycle as necessary to achieve the desired outlet temperature. .

ES 2 445 950 T3

Referring to Fig. 25B, a separate fluid heater 240 is illustrated where mechanical pinching is used to create a fluid heating path (eg, such as path 42a of Figs. 1 and 3) within the separate heater. 240. The independent fluid heater 240 can be used for example in the system 100a of Fig. 1, the system 100c of Fig. 3 and in the cartridge 10f of Figs. 22A and 22B. Heater 240 uses any of the types of heating in any combination as described herein.

A fluid heating bag 230 is connected to heater lines 38a and 38b by any of the methods described herein. Materials for bags 212, 230 include any of those listed for sheets 74a through 74c. The tube materials 38a and 38b include any of the tube materials described herein. As can be seen, the formed heating bag 230 is simpler than the fluid heating path 42a of a separate heater 40 of FIGS. 1 and 3.

In the illustrated embodiment, heater 240 includes a clamshell configuration in which first and second heater boxes 242 and 244 are connected to each other by hinges. When closed, the ribs that form heating pathway 214a and 214b of boxes 242 and 244, respectively, mate and clamp on sac 230. Boxes 242 and 244 also form or include slots 218a and 218b, respectively, which exclude lines 38a and 38b, respectively, allowing boxes 242 and 244 to fit flush with each other without gathering said lines.

The ribs 214a and 214b themselves may be heating elements, as described above in connection with Fig. 25A. In one embodiment, each of the boxes 242 and 244 includes a heating plate 246a and 246b, respectively. The heating plates 246a and 246b heat the fluid within the gathered fluid heating path, for example, in accordance with the temperatures and flow rates described above in connection with FIG. 25A.

Referring to FIGS. 26A and 26B, an alternative apparatus and method for operating a balance chamber 250 is illustrated. One of the major differences shown in FIG. 26A is that the balance chamber 250 is magnetically actuated and not with a separate pump as described above. Center sheet 74b includes outer layers 74d and 74e, between which is disposed a layer of ferromagnetic material 252, such as carbon or iron. Ferromagnetic material 252 is thin enough to allow center sheet 74b to bend back and forth as necessary within a chamber formed by chamber-forming elements 102a and 102b. The outer layers 74d and 74e may consist of any of the materials listed above for sheets 74a through 74c. Alternatively, the ferromagnetic material 252 is impregnated or intermixed, for example in powder or grain form, in a single layer sheet 74b. In any case, the movable central sheet 252 must be compatible with sterile or practically sterile medical fluids.

The balance chamber 250 shown acts with a part of a dialysis machine 100 (for example 100a, 100c, 100e, 100f and 100h) that cooperates with a cartridge 10 (for example in cartridge 10a, 10c, 10e, 10f and 10h, respectively). Dialysis machine 100 includes or defines elements 102a and 102b that form a first and a second chamber. For example, one of the elements 102a or 102b is stationary and is configured to house a flexible sheet cartridge 10 (for example formed in the wall 220 of the machine 100h), while the other of the chamber forming elements 102a or 102b it is part of a door (eg, door 202), which closes on the opposite side of flexible blade cartridge 10 after it has been loaded into dialysis machine 100.

In the illustrated embodiment, electromagnets 254a and 254b are integrated within elements 102a and 102b, respectively, creating around the chamber a magnetic field that can be modulated and polarized to pull the ferromagnetic sheet 74b toward the topsheet 74a or the bottom sheet 74c of cartridge 10. Alternatively, electromagnets 254a and 254b are wound around spherical chamber-forming elements 102a and 102b, respectively, and in any event have sufficient mass to actuate balance chamber 250 as described below.

Electromagnets 254a and 254b are each connected to a controller 248 via wires 256 and 258. In one embodiment, controller 248 is a delegate or slave controller or a cooperating printed circuit board (PCB). with a monitoring processor and a safety processor. In one embodiment, controller 248 also controls valves that cooperate with valve seats 28j to 28m (see Figs. 1 and 3), which are switched in synchronization with the switching of electromagnets 254a and 254b.

To bias electromagnet 254a, controller 248 causes leads 256 and 258 to electromagnet 254a to energize it. To bias electromagnet 254b, controller 248 causes leads 256 and 258 to electromagnet 254b to energize it. When electromagnet 254a is energized, ferromagnetic sheet 74b moves toward the top of the balance chamber. When electromagnet 254b is energized, ferromagnetic sheet 74b moves toward the bottom of the chamber. Thus, the balancing chamber 250 is self-powered or self-powered and provides a pumping function in addition to a dosing function. No separate pump is required.

ES 2 445 950 T3

The magnetically doped core layer 74b is also intended to allow a measurement of its position. By oscillating the energy towards the electromagnetic coils 254a and 254b it is possible to read the current generated by the inertial movement of the layer in the electromagnetic coil when it is switched off. This information is related to or dependent on the velocity of the magnetically doped core layer 74b. Position can be reliably determined by integrating speed information. This information can be used to determine the flow rate entering or leaving the chamber and to determine when the stroke of the chamber has ended.

In the illustrated embodiment, chamber-forming elements 102a and 102b each define or include a port 104 in which a tube (not illustrated) is removably or permanently attached by any of the methods and embodiments described herein. In one embodiment, after the cartridge 10 is loaded into the machine 100, a static negative pressure or vacuum is created in the ports 104, pulling the first and third layer or sheet 74a and 74c against the interior cavities, at least essentially spherical, defined by the first and second elements 102a and 102b. Flexible sheets 74a through 74c are made of a suitably stretchable, elastic, non-magnetic, and leak-free material.

Although elements 102a and 102b define at least essentially spherical shapes, other suitable cross-sectional shapes, such as essentially triangular or trapezoidal shapes, can also be used. In addition, although not shown in the figures, elements 102a and 102b may define air channels that extend radially from ports 104 in various directions to help spread the vacuum over a greater area of ​​layers 74a and 74c. Once the sheets 74a and 74c are drawn by the vacuum against the inner surface of the chamber-forming elements 102a and 102b, respectively, the balance chamber 50 is ready for operation.

In an alternative embodiment, the sheets 74a and 74c are rigid or semi-rigid and are preformed with a chamber shape for example semicircular, making ports 104 and associated negative pressure unnecessary. In another alternative embodiment, the electromagnets 254a and 254b and the ferromagnetic sheet 74b are used with a balance chamber that is reusable, that is, it is not disposable, so that the outer sheets 74a and 74c are not needed. That is, the magnetic drive can be used with any type of balance chamber and is expressly not limited to a cartridge based or flexible sheet cartridge based application as shown herein.

Figure 26A illustrates a state of operation where no fluid has been supplied to balance chamber 250. In the embodiment shown, valve seat 281 is shown in cooperation with a valve actuator 106 that is part of machine 100. In this In this case, positive air pressure is applied to the port of the actuator 106 to push the plunger 108 to compress the valve seat 281 against the second leaflet 74b, closing the balance chamber outlet 58a. Actuator 106 includes an O-ring 110 that creates a sliding seal between plunger 108 in the inner, eg, cylindrical, housing of valve actuator 106. Negative pressure is applied to port 106 to open balance chamber outlet 58a, pulling plunger 108 up against stop 112 to allow fluid to open seat 281 and flow out from upper balance chamber compartment 54a through the balance chamber outlet 58a.

During operation, plunger 108 is pressurized to fill upper balance chamber compartment 54a, closing valve seat 281 and balance chamber outlet 58a. A similar valve and plunger actuator closes the balance chamber inlet 56a. Electromagnet 254a is energized, pulling sheet 74b against topsheet 74a. Next, the valve actuator and plunger cooperating with the balance chamber inlet 56a are opened, the electromagnet 254a is de-energized, and the electromagnet 254b is energized, pulling the sheet 74b completely through the chamber and against the bottom sheet 74c, creating a vacuum and filling the top balance chamber compartment 54a.

To empty the upper balance chamber compartment 54a and fill the lower balance chamber compartment 54b, the valve actuator and plunger cooperating with the balance chamber inlet 56a are closed, the plunger 108 is pulled against the stop 112 opening the valve seat 281 and the balance chamber outlet 58a, electromagnet 254b is de-energized and electromagnet 254a is energized pulling sheet 74b completely through chamber and against topsheet 74a, dissipating fluid from balance chamber compartment 54a through balance chamber outlet 58a and simultaneously creating a vacuum within the balance chamber compartment 54b to fill said chamber. The cycle is then reversed using the second balance chamber inlet 56b and the second balance chamber outlet 58b (see Fig. 1) to dissipate fluid from the balance chamber compartment 54b and at the same time fill the chamber compartment. balance 54a.

Since the volume defined by the compartments 54a and 54b is fixed and in each half stroke the second sheet 74b is pushed all the way against the upper and lower sheets 74a or 74c, in each half stroke the same volume of fluid exits through balance chamber outlets 58a and 58b. In this way, the balance of fresh and used fluid and UF removal can be easily and precisely controlled.

It is also envisaged to impregnate the plungers 108 with a ferromagnetic material and to open and close the valve seats 28 electromagnetically.

ES 2 445 950 T3

Referring to FIG. 26B, FIG. 26A is rotated ninety degrees about one pass through ports 104 to show an embodiment where balance chamber seals are created by mechanical pinch gathering. Each of the chamber-forming elements 102a and 102b defines or includes a balance chamber shirring rib or ring 216a and 216b (described above in connection with Figs. 24A and 24B). In one embodiment, rings 216a and 216b extend around the circumference of balance chamber 50 or 250, except to allow inlet and outlet ports 56 and 58. Rings 216a and 216b are mechanically gathered together to seal the sheets 74a to 74c sufficiently to withstand positive and negative pressures and variations thereof within the chamber. Pinch rings 216a and 216b act with any type of balance chamber operation, for example through a pump or independent electromagnetic operation.

Optionally, an external security annular seal 72m can be provided. The 72m seal is formed by any of the techniques described here. It serves to mitigate the damage caused by the dialysis liquid that may eventually leak from the mechanical seal formed by the mechanical rings 216a and 216b. It also allows for a tolerance in the alignment of the cartridge 10 within the machine 100.

Referring to FIG. 27, an embodiment of a magnetically actuated balance tube 260 is shown. The balance tube is described in connection with FIG. 45 of the prior application. As described in the previous application, balance tube 260 here includes a spacer 262 that functions similarly to flexible membrane 74b of balance chamber 250. In the illustrated embodiment, the spacer 262 consists of a ball or spherical object that moves snugly within a cylindrical housing 264. At both ends of the cylindrical housing 264 are provided two caps 266 and 268. Caps 266 and 268 seal the cylindrical tube 264 by the outer O-rings 270. The spacer or ball 262 is sealed with respect to the caps 266 and 268 with the inner O-rings 272. In an alternative embodiment, caps 266 and 268 are permanently or hermetically sealed with cylindrical tube 264. Ports 274 and 276 are integrally formed with or attached to caps 266 and 268, respectively. Ports 274 and 276 are sealed from the corresponding tubes by any mechanism known to those skilled in the art.

Separator 262 is impregnated with a ferromagnetic material, such as carbon or iron. For example, a carbon core could be covered with a wrap made of a medically safe material. In one embodiment, electromagnets 254a and 254b are integrated within caps 266 and 268, respectively, creating around separator 262 a magnetic field that can be modulated and polarized to pull ferromagnetic separator 262 toward top cap 266 or bottom cap. 268. Electromagnets 254a and 254b are each connected via cables 256 and 258 to a controller 248 described above. Alternatively, electromagnets 254a and 254b are located outside of caps 266 and 268 and wound around caps 266 and 268 and potentially at the end positions of tube 264. In this case, the magnets may be housed within the machine instead. be located within tube 260.

To bias electromagnet 254a, controller 248 causes leads 256 and 258 to electromagnet 254a to energize electromagnet. To bias electromagnet 254b, controller 248 causes leads 256 and 258 leading to electromagnet 254b to energize electromagnet. When electromagnet 254a is energized, ferromagnetic separator 262 is attracted to cap 266. When electromagnet 254b is energized, ferromagnetic separator 262 is attracted to cap 268. Movement of ball 262 ejects and draws fresh / used or used / fresh fluid through port 274 or 276 with each stroke. Thus, the balance tube 260 is self-powered or self-powered and provides a pumping function in addition to a dosing function. No separate pump required. As described above, a magnetically impregnated spacer 262 allows its position within housing 264 to be determined.

In one embodiment, the cylindrical tube 264 is translucent or transparent so that an optical sensor can detect whether the ferromagnetic ball or spacer 262 has properly reached the end of its travel. Alternatively, ultrasonic sensors or other types of sensors can be used. Ferromagnetic ball or spacer 262 is sized to fit snugly but smoothly within cylinder 264. A small amount of mixing can be produced between the fresh fluid and the effluent fluid without essentially affecting the operation of the system. In an alternative embodiment a cylindrical piston type spacer is provided. In any case, the ferromagnetic separator 262 may have additional sealing apparatus, such as brushes or deformable flanges that help improve the sliding or rolling seal, as the case may be.

Balance tube 260 can be made of plastic or other suitable material. In one embodiment, balance tube 260 is a disposable element that may be integrally formed with cartridge 10 or attached to it by tubes. O-rings and accessories may not be required if injection molded caps or mounts are used. Additionally, sensors such as ultrasonic or optical sensors for separator positioning can eliminate the need to seal the end of the tube.

Referring to Fig. 28, an electromagnetically controlled volumetric pump 280 is illustrated. The volumetric pump 280 shown cooperates with a dialysis machine 100, such as machine 100b (Fig. 2), which uses a cartridge 10, such as cartridge 10b. (Fig. 2). Pump 280 may operate in phase opposition to a second electromagnetically controlled volumetric pump 280 in the manner described herein.

ES 2 445 950 T3

Machine 100 includes first and second pump chamber forming elements 114a and 114b, which define the shape of volumetric pump 280. Cartridge 10 is configured to be loaded into machine 100 such that a cartridge portion 10 of circular flexible membrane is aligned with the spherical chamber defined by pump chamber forming elements 114a and 114b. Although the spherical shape shown in Fig. 28 is a suitable shape, other shapes could also be defined for the volumetric pump 280, such as trapezoidal or triangular. Also, valve seats 28q and 28s are aligned with valve actuators 106, as shown. Valve actuators 106 operate as described above in connection with Fig. 7 and include a plunger 108 that slides back and forth within the actuator body.

Pump 280 uses first and second flexible sheets 74a and 74b. The sheets 74a and 74b are each impregnated with a ferromagnetic material 252, such as an inner layer of carbon or iron. Electromagnets 254a and 254b are integrated into pump chamber-forming elements 114a and 114b, respectively, creating a magnetic field around sheets 74a and 74b, both of which can be energized to separate ferromagnetic sheets 74a and 74b toward upper elements and lower 114a and 114b, respectively. Alternatively only one of the electromagnets 254a and 254b is energized, pulling the two blades 74a and 74b towards said electromagnet. Electromagnets 254a and 254b are each connected by wires 256 and 258 to a controller 248 as described above. Alternatively they may be located outside and wound around elements 114a and 114b.

In an initial state (shown in Fig. 28), electromagnet 254b is energized and pulls the first and second flexible sheets 74a and 74b to conform to the inner surface of the lower chamber forming element 114b. Positive pressure is initially applied to both valve actuators 106, closing valve seats 28q and 28s. Again, valve actuators 106 can consist of any combination of pneumatic, mechanical, electrical, and / or electromagnetic actuators. As can be seen in FIG. 28, dialysate or medical fluid (including blood) 116 is pressed against valve seat 28q, but is prevented from entering the sealed chamber of volumetric pump 280.

In a second state, electromagnet 254b continues to be energized, as does the positive pressure applied to valve actuator 106 at valve seat 28s. Negative pressure is applied to valve actuator 106 at valve seat 28q, which pulls on plunger 108 and holds it against stop 112, allowing fluid 116 to flow through pump inlet path 66b and into the the chamber of the volumetric pump 280. The force of fluid 116, for example by gravity, may be sufficient to cause the first flexible member 74a to be urged against the inner surface of the upper pump chamber-forming member 114a. Alternatively or additionally, the electromagnet 254a is energized to pull the first flexible sheet 74a against the inner surface of the upper member 114a. This action creates a vacuum, which draws fluid 116 into the pump chamber.

In a third state, valve seat 28q closes, while valve seat 28s opens. Power to electromagnet 254b is maintained so that sheet 74b continues to be drawn against element 114b. Power to electromagnet 254a is turned off, causing electromagnet 254b to attract upper flexible sheet 74a against lower flexible sheet 74b at element 114b, which in turn causes expulsion of fluid 116 from the at least essentially spherical chamber of the volumetric pump 280 through pump outlet port 68b, to its desired destination. The first and second membranes 74a and 74b are now in the initial state shown in Fig. 28, so that pump 280 is ready to repeat the cycle described above as soon as valve seat 28s closes.

Since the volume formed by the chamber of elements 114a and 114b is known and the flexible sheets repeatedly move to the upper and lower surfaces of the chambers, the volume of fluid pumped with each stroke is known and repeatable. Consequently, no separate volumetric control apparatus, such as a 50 or 250 balance chamber, is required. The total volume of fluid pumped is equal to the volume of each stroke multiplied by the number of strokes. The UF is controlled through one of the methods described above. As described above, a magnetic impregnation of the sheets 74a and 74b allows their position within the chamber-forming elements 114a and 114b to be determined.

Herein, embodiments of different flexible sheet cartridges exhibiting different grades and types of fluid flow components and functionality have been described. The application prior to this application referred to herein includes many different embodiments for hemodialysis, hemofiltration, and hemodiafiltration systems. In particular embodiments are shown in which dual dialyzers are used and a flow restriction between the dialyzers causing both diffusion and convection clearances associated with HHD. The flexible sheet cartridges described herein can be used for each of the systems described in the previous application, including but not limited to: (i) the HCHDF systems based on volumetric pumps of Figs. 1, 4 and 5, which provide diffusion and convection purification; (ii) the volumetric pump-based HF systems of Figs. 6 and 7; the alternative volumetric pump-based HDF system of Fig. 8; (iv) the regeneration systems based on volumetric pumps of Figs. 9 to 11; (v) the peristaltic pump-based HDF and HF systems of Figs. 12 and 13; (vi) the parallel flow system of Fig. 14; the pneumatically controlled system of Fig. fifteen and 16; (vii) the single balance chamber systems of Figs. 17-22; (viii) the tortuous path system of Figs. 24 and 29, the tortuous pathways being formed between the sheets or layers 74a to 74u by any of the above methods

ES 2 445 950 T3 described; (ix) the dual balance chamber systems of Figs. 25 and 26; (x) the weight measurement system of Figs. 30 and 31; the improved convection of the HDF filter of Fig. 32; (xi) the linear tube pump systems of Figs. 38 to 41; and (xii) the fluid heater of Figs. 42 and 43.

It is to be understood that various changes and modifications of the 5 presently preferred embodiments described herein will be apparent to those skilled in the art. These changes and modifications can be made without departing from the scope of the present invention and without reducing its intended advantages, provided that these changes and modifications are covered by the appended claims.