All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
This disclosure generally relates to dialysis systems. More specifically, this disclosure relates to systems and methods for creating dialysate in real-time during dialysis treatment.
There are, at present, hundreds of thousands of patients in the United States with end-stage renal disease. Most of those require dialysis to survive. Many patients receive dialysis treatment at a dialysis center, which can place a demanding, restrictive and tiring schedule on a patient. Patients who receive in-center dialysis typically must travel to the center at least three times a week and sit in a chair for 3 to 4 hours each time while toxins and excess fluids are filtered from their blood. After the treatment, the patient must wait for the needle site to stop bleeding and blood pressure to return to normal, which requires even more time taken away from other, more fulfilling activities in their daily lives. Moreover, in-center patients must follow an uncompromising schedule as a typical center treats three to five shifts of patients in the course of a day. As a result, many people who dialyze three times a week complain of feeling exhausted for at least a few hours after a session.
Many dialysis systems on the market require significant input and attention from technicians prior to, during, and after the dialysis therapy. Before therapy, the technicians are often required to manually install patient blood tubing sets onto the dialysis system, connect the tubing sets to the patient, and to the dialyzer, and manually prime the tubing sets to remove air from the tubing set before therapy. During therapy, the technicians are typically required to monitor venous pressure and fluid levels, and administer boluses of saline and/or heparin to the patient. After therapy, the technicians are often required to return blood in the tubing set to the patient and drain the dialysis system. The inefficiencies of most dialysis systems and the need for significant technician involvement in the process make it even more difficult for patients to receive dialysis therapy away from large treatment centers.
Given the demanding nature of in-center dialysis, many patients have turned to home dialysis as an option. Home dialysis provides the patient with scheduling flexibility as it permits the patient to choose treatment times to fit other activities, such as going to work or caring for a family member. Unfortunately, current dialysis systems are generally unsuitable for use in a patient's home. One reason for this is that current systems are too large and bulky to fit within a typical home. Current dialysis systems are also energy-inefficient in that they use large amounts of energy to heat large amounts of water for proper use. Although some home dialysis systems are available, they generally are difficult to set up and use. As a result, most dialysis treatments for chronic patients are performed at dialysis centers.
Hemodialysis is also performed in the acute hospital setting, either for current dialysis patients who have been hospitalized, or for patients suffering from acute kidney injury. In these care settings, typically a hospital room, water of sufficient purity to create dialysate is not readily available. Therefore, hemodialysis machines in the acute setting rely on large quantities of pre-mixed dialysate, which are typically provided in large bags and are cumbersome for staff to handle. Alternatively, hemodialysis machines may be connected to a portable RO (reverse osmosis) machine, or other similar water purification device. This introduces another independent piece of equipment that must be managed, transported and disinfected.
Dialysis machines are used in a variety of settings, including hospital rooms, dedicated clinics and patient homes. In some settings, minimal mobility requirements are needed, such as in the home or the clinic setting. In other settings, such as hospital rooms, mobility could be very important. The machine may need to be transported across long distances, hallways, or even exterior surfaces going from one building to another. Additionally, within a hospital room, space is at a premium, and high maneuverability e.g., ability to spin about its own axis, is desirable. However, mobility solutions that are optimized for one setting may not work well in other settings for size, footprint or cost reasons. Therefore, there is a need for a modular approach where a single dialysis machine could have an option of mobility solutions, and preferably where the installation of that modular mobility solution is minimally burdensome.
Preconfigured dialysis machines are those which have onboard water purification hardware, such as a reverse osmosis system. These systems often have a number of water filters, such as sediment, carbon and ultrafilters that purify the water that is later used to create dialysate. The quality of the incoming water has a significant impact on the life of many of these filters. Factors such as sediment content, chlorine/chloramine concentration, hardness, pH, alkalinity and temperature can shorten the lifespan of filters and/or impact the quality of the water after it is filtered. Due to highly varied nature of the incoming water, different options for treating the water would be desired. It could be conceivable to produce single a water treatment system that could handle a wide range of input variables, although doing so may be prohibitive from a size, weight, cost or maintenance standpoint. Therefore, there is a need for a modular approach for water prefiltration, and preferably one where maintenance such as changing filters is minimally burdensome.
Mobility for dialysis machines has been historically provided with casters. Typically these casters can be locked to brake the machine and prevent motion when it is not desired. If all four casters are allowed to rotate about their axis, the machine has high maneuverability in tight spaces. However, when transporting across long distances, the machine may have a tendency to rotate about its axis and be difficult to control. The need to allow the casters to swing through its arc also necessitates the need to create volume voids, or wheel wells, which limits the ability to minimize the size of the machine. Fixing at least one of the casters to not rotate can remedy the control issue, at the cost of close quarters maneuverability. Some casters have a ‘directional lock’ feature which allows them to be switched from freely rotating to fixed.
Water treatment carts have been known in the art, to provide portable water purification for dialysis machines. These tend to be very bulky and difficult to maneuver. The dialysis machines that they serve typically do not have their own onboard water filtration, so the water treatment carts typically perform all water filtration functions. For preconfigured dialysis machines that require a water connection, only supplemental water treatment is necessary, which may enable smaller form factors.
A dialysis system is provided comprising a dialysis console configured to provide dialysis therapy to a patient, and a modular platform configured to interface with the dialysis console, the modular platform including a fluid and/or power connection to the dialysis console, the modular platform further being configured to receive one or more modular components configured to add filtration and/or fluidic capabilities to the dialysis console.
In some embodiments, the dialysis console is configured to mount atop the modular platform.
In some examples, the modular platform further comprises a plurality of wheels.
In one embodiment, the modular platform includes one or more slots configured to receive the one or more modular components.
In some examples, the modular platform includes an electrical connection configured to mate with a corresponding electrical connection of the one or more modular components.
In some embodiments, the electrical connection is internal to the wheeled platform.
In one example, the electrical connection is on an exterior of the modular platform or dialysis console.
In some examples, the one or more modular components are configured to be electrically and fluidly coupled within the one or more slots by inserting the one or more modular components into the slots and rotating the one or more modular components by a preset angle. In one embodiment, the preset angle comprises up to 90 degrees. In other embodiments, the preset angle comprises up to 45 degrees. In some examples, the preset angle comprises 1-360 degrees.
In some embodiments, the one or more modular components include an exterior handle.
In some examples, the one or more modular components include a first filtration component and a second filtration component.
In one embodiment, the first filtration component comprises a filter and the second filtration component comprises a pump.
In another embodiment, the first filtration component comprises a first filter and the second filtration component comprises a second filter. In some examples, the filter, first filter, or second filter comprises a sediment filter, a carbon filter, a reverse osmosis filter, or an ultrafilter.
In some examples, the one or more modular components include a manifold configured to direct incoming water into a plurality of streams.
In some embodiments, the modular platform comprises a fluid inlet line configured to be coupled to a source of tap water and a fluid outlet line configured to be coupled to a fluid inlet line of the dialysis console.
In one embodiment, the dialysis console further comprises a fluid outlet line configured to be coupled to a drain.
In some examples, the dialysis console further comprises a fluid outlet line configured to be coupled to a drain-in line of the modular platform.
A method is provided, comprising receiving a flow of fluid from a fluid source into a modular platform that is separate from but fluidly coupled to a dialysis system, purifying the fluid with filters in the modular platform, and pumping the fluid from the modular platform to the dialysis system with a pump in the modular platform.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
This disclosure describes systems, devices, and methods related to dialysis therapy, including a dialysis system that is simple to use and includes automated features that eliminate or reduce the need for technician involvement during dialysis therapy. In some embodiments, the dialysis system can be a home dialysis system. Embodiments of the dialysis system can include various features that automate and improve the performance, efficiency, and safety of dialysis therapy.
In some embodiments, a dialysis system is described that can provide acute and chronic dialysis therapy to users. The system can include a water purification system configured to prepare water for use in dialysis therapy in real-time using available water sources, and a dialysis delivery system configured to prepare the dialysate for dialysis therapy. The dialysis system can include a disposable cartridge and tubing set for connecting to the user during dialysis therapy to retrieve and deliver blood from the user.
Dialysis system 100 can also include a cartridge 120 which can be removably coupled to the housing 106 of the system. The cartridge can include a patient tubing set attached to an organizer. The cartridge and tubing set, which can be sterile, disposable, one-time use components, are configured to connect to the dialysis system prior to therapy. This connection correctly aligns corresponding components between the cartridge, tubing set, and dialysis system prior to dialysis therapy. For example, the tubing set is automatically associated with one or more pumps (e.g., peristaltic pumps), clamps and sensors for drawing and pumping the user's blood through the tubing set when the cartridge is coupled to the dialysis system. The tubing set can also be associated with a saline source of the dialysis system for automated priming and air removal prior to therapy. In some embodiments, the cartridge and tubing set can be connected to a dialyzer 126 of the dialysis system. In other embodiments, the cartridge and tubing set can include a built-in dialyzer that is pre-attached to the tubing set. A user or patient can interact with the dialysis system via a user interface 113 including a display.
In
In one embodiment, referring to
As shown, the wheeled platform 401 can include a plurality of wheels 403 configured to provide additional maneuverability and/or mobility to the dialysis system when the wheeled platform is engaged with the system. It should be understood that while the dialysis system itself may have two or more wheels 404 for portability, these wheels typically involve shortcomings as described above that really limit the maneuverability of the system. The entire dialysis system, including the built-in wheels 404, are configured to fit within, connect to, or mate with the wheeled platform. In some embodiments, the dialysis system has wheels of its own, which do not need to be removed in order to mount it to the wheeled platform. In some embodiments, the wheels of the wheeled platform are larger and more robust than the wheels of the dialysis machine. For example, the wheel diameter of the dialysis machine may be 4 inches or less, and the wheel diameter of the wheeled platform may be 5 inches or more. The increase in size will allow the wheeled platform to more easily traverse obstacles such as thresholds or uneven surfaces. The wheeled platform may also have a wider wheelbase than the dialysis machine, in order to provide improved stability.
The dialysis machine can be securely and rigidly fastened to the platform by either its wheels, some other mounting feature designed for this purpose. In some embodiments, the wheeled platform 401 can be connected to the dialysis machine with a threaded connection, a quick release connection, magnets, or the like. The wheeled platform 401 in some embodiments has shrouds 405 which can be configured to attach to, mate to, and or connect with the wheels 404 of the dialysis system. In some embodiments, the shrouds 405 may effectively hide the wheels 404 of the dialysis machine visually, to promote a seamless look. Additionally, any service activities that would need to be performed on the dialysis machine that involve removing panels from the dialysis machine can be performed while the machine is mounted to the wheeled platform 401. Therefore, the wheeled platform can be specifically contoured to the dialysis system so as to not prevent those panels from being removed. Alternatively, the wheeled platform itself can have removable panels that allow for removal of all panels of the dialysis system.
As will be described in more detail below, referring to
In some embodiments, the enhancement module 407 can comprise water treatment equipment (e.g., water filters, ultrafilters, carbon filters, etc.), pumping equipment (e.g., additional pumps), dialysis/dialysate equipment (e.g., dialyzers, additional dialyzers, drip chambers, air removal systems, priming fluid, etc.), waste management equipment (e.g., waste containers for used dialysate or blood waste), filtering equipment, etc., or some combination thereof, and can include both fluidic and electrical connections to both the dialysis machine and wall (power and water). The electrical connections between the wheeled platform and the dialysis system may further comprise one or both of data transfer and/or power transfer. Additionally, the enhancement module 407 can include a user interface 409 which can optionally include a display. In some embodiments, the display can provide information to the user regarding the functionality of the enhancement module components.
In one specific embodiment, as shown in
In other embodiments, the wheeled platform does not include a removable enhancement module as described above, but is instead configured to directly receive specific modular components for enhancing the functionality of the dialysis system. Referring to
In some embodiments, the modular components are optional. In some cases where the water treatment functionality built-in to the dialysis machine is adequate, the machine may still benefit from improved mobility afforded by the separate wheeled platform. In these cases, the volume within the wheeled platform may be empty, and can instead be used for storage. For example, the storage area within the wheeled platform could be accessed by a sliding drawer or hinged door, for example.
In another embodiment, referring to
Referring to
Referring to
The modules could be simple flow through filters, or they could have electronic components (pumps, valves, sensors). For example, one module could be a chemical reservoir with a low flow feed pump that injects fluid into the water to treat it. By plugging the connector in, it could also help to identify what type of module is being inserted.
The pressure drop across the filters 706 can be measured by pressure gauges PG1 and PG2. In some embodiments, the pressure gauges can be integrated into the modular components. In other embodiments, the pressure gauges can be permanently located within the dialysis system or the wheeled platform. The pressure measurements can be used by microprocessors or controllers of the system to determine the pressure drop across the filters. If the pressure drop is excessive, a proportional valve VI may be opened, which bypasses the filters within the fluidic module, and sends the incoming water directly to the dialysis machine, which has its own filters, VI can be a proportional valve, where the degree to which it is opened (and thus the amount of water sent to the filters vs. sent directly to the dialysis machine) may be varied depending on the pressure drop in the filters. In one example, the pump 704 may be set to a pressure control mode, where a target pressure at PG2 is desired. If no water is demanded from the fluidic module by the dialysis machine, for example, if the dialysis machine is powered off, then PG2 will reach a nominal pressure and the pump will shut off. Valve V2 is another bypass valve, which is configured to be normally open, such that when it is not powered, it is opened. In this manner, if the fluidic module is not supplied power, the incoming water may directly flow to the dialysis machine and not be obstructed by the powered down pump. A check valve may be included which allows the system to hold pressure in a no flow condition. Optionally, backflow prevention such as a series of check valves or reduced pressure zone assembly may be provided upstream of all functions. A tank 708 can be used to control dP/dT and can also handle pressure spikes within the system.
The dialysis machine and the fluidic module of the wheeled platform to which the dialysis machine is mounted can both include an electrical connection. In one embodiment, referring to
The dialysis system and wheeled platform can further include various fluidic connections to an outside fluid source (such as a tap water source). Referring to
In another example, referring to
This disclosure also provides novel filtration cartridges that can be used in any of the systems and embodiments described above, including within the wheeled platform or as modular filtration components.
The front of the modular filter component in
A manifold connection system can be utilized to connect the front of the filter cartridges to the overarching fluidic system. The entryway to the manifold system can contain a steep incline step at the connection site. Several of these incline steps coupled with the handle at the other end of the filter allows for a smooth 90-degree locking and unlocking feature of the cartridge filter (inside the manifold).
The housing size of the modular filter component can accommodate various filter media/core types to add flexibility within the water filtration system. A balancing of equations, with the life and size of various filters media cores, is required to find a common volume which encompasses all water specification requirements. In some embodiments, a single large filter housing can be used to separate and house two different types of media cores by utilizing the large space and the housing construction.
In one example, the multi-media core can be arranged in the common concentric separation shown in
In another embodiment, a second type of multi-media core can be provided within the housing which comprises a two-section media/core that utilizes the housing of the filter to separate the cores. This configuration is shown in
The multi-media core within the filter housing can accommodate various modules required for the water filtration system. For the purposes of the illustrations presented in
These large filter housings can accommodate various types of filter cores (both single and multi-media cores) and internal components. By controlling the water flow path using the filter housing, other types of modules can be incorporated within the housing core mimicking tubing within a flow path. Additional modules can be put into a section of the filter housing to accommodate various water filtration system needs. These modules can include (but not limited to) a fluid pump to control flow rate without the water filtration system, injection system to control water pH, and even electronics. Referring to
To accommodate any given electronics within the filtration system, one of two different types of connections may be used. The first option would be a blind connection with the proper structural lead-in, which can be accommodated because the forced orientation of the handle which enables a default 90-degree turn. The predetermined orientation of the filter cartridge along with 90-degree turn/locking mechanism allows for enough control to create a blind connection. A second option would be to have an end connector on the handle area of the filter cartridge. A female or male connection point can be put onto the cartridge (rear) cap area to connect the electronic connections. One example of the end connectors is shown in the embodiment of
For example, referring to
While this specification contains many specifics, these should not be construed as limitations on the scope of an invention that is claimed or of what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Only a few examples and implementations are disclosed. Variations, modifications and enhancements to the described examples and implementations and other implementations may be made based on what is disclosed.
As for additional details pertinent to the present invention, materials and manufacturing techniques may be employed as within the level of those with skill in the relevant art. The same may hold true with respect to method-based aspects of the invention in terms of additional acts commonly or logically employed. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Likewise, reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “and,” “said,” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The breadth of the present invention is not to be limited by the subject specification, but rather only by the plain meaning of the claim terms employed.
This application claims the benefit of priority of U.S. Provisional Application No. 63/298,916, filed Jan. 12, 2022, herein incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2023/060575 | 1/12/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63298916 | Jan 2022 | US |