Patent Grant
10987460
The present specification relates generally to dialysis systems and more particularly, to hemofiltration systems with enhanced blood toxin clearance through varying pressure cycles generated within at least a blood circuit of the dialysis systems.
Blood purification systems, which are used for conducting hemodialysis, hemodiafiltration or hemofiltration, involve the extracorporeal circulation of blood through an exchanger having a semi-permeable membrane. Such systems further include a hydraulic system for circulating blood and a hydraulic system for circulating replacement fluid or dialysate including the certain blood electrolytes in concentrations close to those of the blood of a healthy subject.
Hemodialysis (“HD”), using a high flux membrane, removes toxins from the blood using transport mechanisms including diffusion and ultrafiltration (i.e., convective transport). Diffusion removes toxins using a concentration gradient across the semi-permeable membrane. For example, in a hemodialysis circuit, the dialysate solution flows on one side of the dialyzer membrane in one direction while simultaneously blood flows on the other side of the membrane. Ultrafiltration occurs when water (along with small solutes) is driven from the blood to dialysate in the dialyzer because of the hydrostatic pressure gradient between the blood and dialysate compartments (i.e., the transmembrane pressure (“TMP”). However, the small amount of waste removed by ultrafiltration during HD is not enough to provide convective clearance.
During hemofiltration (“HF”), a significant amount of ultrafiltration (more than is required to remove excessive fluid) is coupled with infusion of a replacement fluid to remove solutes. When compared to HD, HF achieves a higher removal of larger, poorly diffusible solutes, such as inulin (MW 5,200).
Hemodiafiltration (“HDF”) is a treatment modality that combines convective and diffusive clearances. Like HD, HDF uses dialysate flowing through a dialyzer to provide a diffusive clearance. In addition, substitution solution is provided directly to the extracorporeal circuit, to provide convective clearance.
Most of the conventionally available blood purification systems are, however, quite bulky in size and difficult to operate. Further, the design of these systems makes them unwieldy and not conducive to the use and installation of disposable components. These conventional blood purification systems require a continuous supply of large amounts of fresh filtered water to create the dialysate fluid.
Another problem with existing dialysis machines is as these machines become smaller and a bit more portable, smaller hemofilters or dialyzer filters must be used that do not clog or clot too quickly so that extended or continuous dialysis can be performed. A common type of dialyzer includes several hundred or more cylindrical hollow fibers through which blood flow is provided. The hundreds of cylindrical hollow fibers are contained in a shell or container in which dialysate fluid is circulated around and past the exterior walls of the hollow fibers. The exterior walls of the hollow fibers or lumens are semi-porous so that impurities in the blood can be moved from the blood and into the dialysate. One problem that occurs in a dialyzer is the clogging or clotting of blood flow within individual hollow fibers. Such clogging of blood flow through the fibers decreases the effectiveness of the dialyzer's filtration and blood cleaning properties. Furthermore, it is understood that proteins and other compounds or substances in the blood may clog the pores of the semi-porous membrane overtime and decrease the effectiveness of the dialyzer filter.
Conventional systems and methods for improving the effectiveness of filtration of the dialyzer have been directed towards enabling a higher trans-membrane pressure (“TMP”) gradient that is consistently positive, even at time scales less than 5 seconds, and does not cycle from negative to positive. For example, U.S. Patent Publication No. 20110139704 discloses a blood dialyzing apparatus that “includes a blood dialyzing filter for dialyzing blood by using a pressure difference between the blood and a dialysis solution, and a supplying means for supplying the blood and the dialysis solution to the blood dialyzing filter to alternately generate a state where a blood pressure is higher than a dialysis solution pressure and a state where the dialysis solution pressure is higher than the blood pressure. The blood dialyzing apparatus dialyzes a large volume of blood in a short period without increasing the size of the blood dialyzing filter and simply controls the volume of the dialyzed blood by adjusting the supply pressures of the blood and the dialysis solution.”
U.S. Patent Publication No. 20110142700 discloses “a dual channel pulsatile pump for use with a completely wearable renal replacement device” such that “the pulsating flow of the exemplary dual channel pulsatile pump 1206 produces higher clearances than a continuous, steady, non-pulsating flow.”
U.S. Patent Publication No. 20090120864 discloses a system that “uses two pulsatile pumps, a first pulsatile pump 301 for the blood circuit 310 and a second pulsatile pump 321 for the dialysate circuit 320. Prior art dialysis machines generate steady flow in both the blood circuit and the dialysate circuit. Some prior art dialysis machines use pulsatile flow in the blood circuit to more closely mimic the flow generated by a healthy heart but use steady flow in the dialysate circuit. In accordance with a novel feature, the dialysis system 300 of the present invention uses pulsatile flow in both circuits 310, 320 and runs the two pulsatile pumps 180 degrees out of phase so that the blood circuit pressure reaches a maximum when the dialysate circuit pressure reaches a minimum and vice versa. This pressure waveform periodically increases the trans-membrane pressure gradient in the dialyzer which adds convective mass transfer forces to drive fluid and waste exchange.”
However, there is a need for a dialysis system that provides enhanced dialyzer clearance with reduced quantities of filtered water to create the dialysate. There is also a need for modulating pressure profiles within blood and/or dialysate circuits to generate desired pressure waveform characteristics for enhanced dialyzer clearance.
The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods, which are meant to be exemplary and illustrative, not limiting in scope. The present application discloses numerous embodiments.
Conventional hemofiltration (“HF”) systems create a high convective force across the dialyzer using a large influx of water. This results in a transfer of larger sized molecules that are difficult or impossible to remove by diffusive transport alone. However, conventional HF systems pump significant amounts of filtered water (e.g., >15 L/treatment) into the blood circuit. This can be prohibitively expensive and raises safety concerns about the purity of the filtered fluid. The system of the present specification provides hemofiltration-like capabilities without requiring a large infusion of water, over and above the fluid required for dialysis itself, by generating and controlling a rapidly cycling pressure profile within the blood circuit. Specifically, the system of the present specification also generates and controls a varying pressure profile within the dialysate circuit to further enhance the dialyzer clearance.
In some embodiments, the present specification discloses a method for providing improved clearance levels of blood toxins in hemodialysis by generating a varying pressure profile in a fluid flow through a dialysis machine, said method including: providing a portable dialysis system including: a manifold, including a plurality of blood and dialysate circuits; at least one tube segment in fluid communication with at least one of said blood and dialysate circuits; and at least one pump for pumping a fluid through said at least one tube segment and at least one of said plurality of blood and dialysate circuits; and operating said at least one pump to apply a force to said at least one tube segment to generate fluid flow through said at least one tube segment, wherein said at least one pump is configured to generate said fluid flow with a pressure profile that varies between a positive pressure and a negative pressure within a predetermined period of time.
Optionally, said at least one pump includes a rotor pump having a plurality of rollers.
Optionally, said rotor pump has a diameter no greater than 4 inches.
Optionally, said rotor pump has a range of 4 to 6 rollers.
Optionally, each of said plurality of rollers includes a plurality of equidistantly spaced cylindrical pins.
Optionally, said plurality of equidistantly spaced cylindrical pins is in a range of 4 to 6.
Optionally, said fluid flow is any one of dialysate flow, blood flow, and infusate flow.
Optionally, a change in pressure amplitude experienced by said fluid flow is at least 100 mmHg and said predetermined period is less than 0.5 seconds.
Optionally, a change in pressure amplitude experienced by said fluid flow is at least 100 mmHg and said predetermined period is less than 0.05 seconds.
Optionally, a change in pressure amplitude experienced by said fluid flow is at least 200 mmHg and said predetermined period of time is less than 0.5 seconds.
Optionally, a change in pressure amplitude experienced by said fluid flow is at least 200 mmHg and said predetermined period of time is less than 0.05 seconds.
Optionally, an amplitude of said pressure profile varies from a positive 100 mmHg, or more, to a negative 25 mmHg, or less, over a period of time of less than 0.5 seconds.
Optionally, an amplitude of said pressure profile varies from a positive 100 mmHg, or more, to a negative 25 mmHg, or less, over a period of time of less than 0.05 seconds.
Optionally, an amplitude of said pressure profile varies from a positive 200 mmHg, or more, to a negative 50 mmHg, or less, over a period of time of less than 0.5 seconds.
Optionally, an amplitude of said pressure profile varies from a positive 300 mmHg, or more, to a negative 100 mmHg, or less, over a period of time of less than 0.5 seconds.
Optionally, a pressure amplitude of said fluid flow changes from positive pressure to negative pressure in less than 1 second and wherein a magnitude of the pressure amplitude change increases as the flow rate increases for the corresponding fluid flow.
Optionally, a pressure amplitude of said fluid flow changes from positive pressure to negative pressure in less than 1 second and a magnitude of the pressure amplitude change decreases as the flow rate decreases for the corresponding fluid flow.
Optionally, a pressure amplitude of said fluid flow cycles between a positive pressure and a negative pressure at least once in less than 0.5 seconds.
Optionally, a pressure amplitude of said fluid flow cycles between a positive pressure and a negative pressure at least twice in less than 0.5 seconds.
Optionally, a pressure amplitude of said fluid flow cycles between a positive pressure and a negative pressure at least three times in less than 0.5 seconds.
Optionally, the method further includes operating said at least one pump to fill said tube segment with said fluid at a first point in time such that said pressure profile reaches a maximum amplitude and operating said at least one pump to expel said fluid from said tube at a second point in time, occurring after said predetermined period of time, such that said pressure profile reaches a minimum amplitude.
The present specification also discloses a method for providing increasing clearance levels of blood toxins including providing a portable dialysis system comprising a manifold comprising a blood circuit, wherein said blood circuit has at least one tube segment; a rotor pump for pumping a blood through said at least one tube segment, wherein said rotor pump has a diameter no greater than 4 inches; and operating said at least one pump to apply a force to said at least one tube segment to generate blood flow through said at least one tube segment, wherein said at least one pump is configured to generate said blood flow with a pressure profile that varies between a positive pressure and a negative pressure within a predetermined period, wherein an amplitude of said pressure profile varies from a positive 100 mmHg, or more, to a negative 25 mmHg, or less, over a period less than 0.5 seconds and wherein an average pressure of said blood flow remains positive over a period of at least 5 seconds.
The present specification also discloses a dialysis system for providing increasing clearance levels of blood toxins including a manifold comprising a blood circuit, wherein said blood circuit has at least one tube segment; a rotor pump in physical communication with said at least one tube segment and configured to pump blood through said at least one tube segment, wherein said rotor pump has a diameter no greater than 4 inches; and a controller configured to operate said at least one pump to apply a force to said at least one tube segment to generate blood flow through said at least one tube segment, wherein said controller is adapted to control the at least one pump to generate said blood flow with a pressure profile that varies between a positive pressure and a negative pressure within a predetermined period.
Optionally, the dialysis system further includes a single fluid reservoir having a fluid capacity no greater than 10 liters. Optionally, the rotor pump has a range of 4 to 6 rollers. Optionally, the blood toxins include compositions having a molecular weight greater than 500 Daltons.
Optionally, the change in pressure amplitude experienced by the blood flow is at least 100 mmHg and said predetermined period is less than 0.5 seconds. The change in pressure amplitude experienced by the blood flow is at least 100 mmHg and said predetermined period is less than 0.05 seconds. The change in pressure amplitude experienced by the blood flow is at least 200 mmHg and said predetermined period is less than 0.5 seconds. The change in pressure amplitude experienced by the blood flow is at least 200 mmHg and said predetermined period is less than 0.05 seconds. The amplitude of the pressure profile varies from a positive 100 mmHg, or more, to a negative 25 mmHg, or less, over a period less than 0.5 seconds. The amplitude of the pressure profile varies from a positive 100 mmHg, or more, to a negative 25 mmHg, or less, over a period less than 0.05 seconds. The amplitude of the pressure profile varies from a positive 200 mmHg, or more, to a negative 50 mmHg, or less, over a period less than 0.5 seconds. The amplitude of the pressure profile varies from a positive 300 mmHg, or more, to a negative 100 mmHg, or less, over a period of less than 0.5 seconds. The pressure amplitude of the blood flow changes from positive pressure to negative pressure in less than 1 second and a magnitude of the pressure amplitude change increases as the blood flow rate increases for the corresponding blood flow. The pressure amplitude of the blood flow changes from positive pressure to negative pressure in less than 1 second and a magnitude of the pressure amplitude change decreases as the blood flow rate decreases for the corresponding blood flow. The pressure amplitude of the blood flow cycles between a positive pressure and a negative pressure at least once in less than 0.5 seconds. The pressure amplitude of the blood flow cycles between a positive pressure and a negative pressure at least twice in less than 0.5 seconds. The pressure amplitude of the blood flow cycles between a positive pressure and a negative pressure at least three times in less than 0.5 seconds. The amplitude of the pressure profile varies from a positive 100 mmHg, or more, to a negative 25 mmHg, or less, over a period less than 0.5 seconds and wherein an average pressure of said blood flow remains positive over a period of at least 5 seconds.
The aforementioned and other embodiments of the present shall be described in greater depth in the drawings and detailed description provided below.
These and other features and advantages of the present specification will be appreciated, as they become better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:
The embodiments of the present specification are directed towards a dialysis system, and more specifically to a hemofiltration system, that is modular and portable, with improved clearance levels of blood toxins. In accordance with an aspect, embodiments of the present specification use at least one roller pump that is designed and operated to generate a varying pressure profile of fluid within at least a portion of the blood circuit of the dialysis system. The enhanced clearance of toxins from blood that occurs in embodiments of the present specification is achieved in part by application of a push/pull effect, particularly on mid-sized toxins or molecules, created by the varying pressure profile of blood (and optionally that of the dialysate) generated by the pumping action and the resulting transmembrane pressure (“TMP”) across the semi-permeable membrane.
The systems and methods of the present specification are directed toward enhancing the clearance of toxins from the blood while providing certain advantages over current systems. Specifically, the dialyzer material used in systems of the present specification does not need to be modified (e.g. changing dialyzer permeability) to improve clearance capabilities. The systems of the present specification do not require redundant components (e.g. dialyzers in sequence) or extra components (e.g. substitution fluid sources or substation circuits) to enhance clearance. In addition, using a single dialyzer in the blood circuit provides HD and HF-like treatment without using a substitution fluid. By generating a negative-positive pressure cycle using existing blood and/or dialysate pumps, the systems and methods of the present specification achieve these advantages without requiring additional components in order to create a high pressure convective trans-membrane force.
In particular, the presently disclosed methods and systems generate a convective force within the blood and/or dialysate circuit, thereby resulting in an ability to remove middle to larger sized toxins, such as β2 microglobulin and those compositions with a molecular weight of greater than 500 Daltons, including compositions with a molecular weight between 500 and 50,000 Daltons, from blood via a dialyzer. This is accomplished without requiring additional water, other than the 6-8 liters of water required for a conventional dialysis treatment, and specifically using less than the 15 liters, and preferably less than 10 liters, of water typically required by prior art systems. Accordingly, the presently disclosed embodiments can be practiced in dialysis systems having a single fluid reservoir with a fluid capacity of no greater than 10 liters (and preferably no greater than 8 or 9 liters), a single dialyzer, and no separate pump for a water ultrafiltrate supply conventionally required to generate the hydrostatic forces necessary for convection.
The present specification is directed towards multiple embodiments. The present disclosure is provided to enable a person having ordinary skill in the art to practice the invention. Language used in this specification should not be interpreted as a general disavowal of any one specific embodiment or used to limit the claims beyond the meaning of the terms used therein. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention. In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated.
As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context clearly dictates otherwise.
It should be noted herein that any feature or component described in association with a specific embodiment may be used and implemented with any other embodiment unless clearly indicated otherwise
As used herein, the terms “roller” and “rotor” are used interchangeably. Further, the terms “rotor pump” and “roller pump” are used interchangeably. Referring to
To a first side of the top unit 101 is a clasp 105 used to detachably affix a dialyzer 103. To a second, opposing side of the top unit 101 is a sorbent cartridge locking base 104 used to detachably affix a sorbent cartridge 107. It should be appreciated that the clasp 105, dialyzer 103, sorbent cartridge locking base 104 and sorbent cartridge 107 can also be positioned on the same side of the top unit 101. In either case, the bottom unit 102 has a sufficiently larger area relative to the top unit 101 such that shelves are formed on either side of the top unit 101 to hold the sorbent cartridge 107, to hold an infusate jar, to capture any spillage, and/or to channel any leaks into a leak detector.
Between the dialyzer 103 and door 110 are anti-coagulant pumps in the form of syringe pumps 190. Optionally, the top unit 101 can include a bottle holder that has a spiked base to receive a bottle, top-down, within the bottle holder housing. Infusion lines are connected to the inlet of the blood pump, outlet of the blood pump, or outlet of the dialyzer (blood side). The infusion lines could also ‘thread’ through air bubble detectors to sense if/when the anti-coagulant is emptied or blocked.
Grouped in this manner, the pairs of membranes form three two-way valves 211, 212 and 213. The two-way valves provide greater flexibility in controlling the configuration of a circuit. When conventional two-way valves are used to occlude portions of a fluid pathway, they are typically configured to enable two different fluid pathways, one for a first valve state and one for the second valve state.
The pump tube segments 201, 202, 203, 204 are bonded into the compact manifold 240. A number of ports are provided in the manifold 240, which connect with tubes external to the manifold 240 to allow the flow of various fluids in and out of the manifold 240. These ports are connected to various tubes in the dialysis system 200 for carrying fluids as follows:
Port A 215—blood to the dialyzer 230,
Port B 216—dialyzer output (used dialysate);
Port C 217—blood from the patient;
Port D 218—saline (from saline/heparin source 260) for rinse back;
Port E 219—fresh dialysate reservoir 255 output (fresh dialysate);
Port F 220—patient return (clean blood);
Port G 221—dialyzer output (blood);
Port H 222—dialyzer input (fresh dialysate);
Port J 223—connects to prime and drain line;
Port K 224—infusate out/input to infusate reservoir 245;
Port L 225—infusate in from infusate reservoir 245;
Port M 226—dialysate flow into dialysate regeneration system 250.
In one implementation, a tube segment 214, formed as a pathway molded into the manifold 240, connects the fluid flow of saline, entering via Port D 218, to the flow entering via Port C 217. It should be appreciated that in alternate embodiments, the tube segment 214 connects a fluid flow of an anticoagulant, such as heparin, entering via Port D 218 to the fluid flow of blood entering via Port C 217. In such alternate embodiments, the bag 260 contains heparin instead of saline fluid. In some embodiments, the combined heparin and blood flow through port 217a, via pump tube segment 201, and into port 217b of the manifold 240. The pressure sensor or transducer 205 formed in the manifold 240, in turn, passes the blood and heparin fluid through Port A 215. Fluid flows out of the manifold 240 at Port A 215 passes through dialyzer 230, which is external to the manifold 240. The dialyzed blood passes back into the manifold 240 through Port G 221 and into a segment 207a, formed as a pathway molded into the manifold 240 that is in physical communication with the pressure sensor 207. Fluid then passes from the segment 207a through Port F 220 and into a patient return line.
Separately, dialysis fluid enters the manifold 240 from a dialysate reservoir 255 via Port E 219. The reservoir 245 has infusate in it, which first enters the manifold 240 via Port L 225, passes through a segment, formed as a pathway molded into the manifold 240, through another port 225a, through the pump tube segment 202 in communication with a pump, and back into the manifold 240 via port 225b. The infusate passes through another segment, formed as a pathway molded into the manifold 240, and out the manifold 240 at Port K 224. The fresh dialysate fluid which entered the manifold via Port E 219, passes through a segment formed as a pathway molded into the manifold 240, through another port 219a, through the pump tube segment 203 in communication with a pump, and back into the manifold 240 via port 219b.
The fresh dialysate fluid passes into a segment, formed as a pathway molded into the manifold 240, which is in physical communication with the pressure sensor 208 at one end and a pair of valves 213 at the other end. The fresh dialysate fluid passes out of the manifold 240 through Port H 222, and into a line that passes into the dialyzer 230.
A line out of the dialyzer 230 passes spent dialysate back into the manifold 240 through Port B 216 and into a segment, formed as a pathway molded into the manifold 240, that is in physical communication with a first pair of valves 211, a second pair of valves 212, and the pressure sensor 206. The used dialysate fluid passes out of the manifold 240 through port 226b, through the pump tube segment 204 in communication with a pump, and back into the manifold via port 226a. A segment in fluid communication with the port 226a is in physical communication with pressure transducer 209 and passes fluid through Port M 226 and to the dialysate regeneration system 250. In various embodiments, the ports are designed for circuit tubing in a range of 0.1″ to 0.4″×0.05″ to 0.3″, more preferably 0.265″×0.180″, or anticoagulant/saline and infusate tubing 0.05″ to 0.3″×0.05″ to 0.3″, more preferably 0.165″×0.110″.
The fresh or regenerated dialysate is output from the dialysate regeneration system 250 to the fresh dialysate reservoir 255 via an ammonia sensor 261. The dialysate regeneration system 250 includes a plurality of cartridges and/or filters containing sorbents for regenerating the spent dialysate. By regenerating the dialysate with sorbent cartridges, the dialysis system 200 uses a small fraction of the amount of dialysate of a conventional single-pass hemodialysis device.
In one implementation, each sorbent cartridge in the dialysate regeneration system 250 is a miniaturized cartridge containing a distinct sorbent. For example, the dialysate regeneration system 250 may employ five sorbent cartridges, wherein each cartridge separately contains activated charcoal, urease, zirconium phosphate, hydrous zirconium oxide and activated carbon. In another embodiment, each cartridge may include a plurality of layers of sorbents described above and there may be a plurality of such separate layered cartridges connected to each other in series or parallel in the dialysate regeneration system. Persons of ordinary skill in the art would appreciate that activated charcoal, urease, zirconium phosphate, hydrous zirconium oxide and activated carbon are not the only chemicals that could be used as sorbents in the present specification. In fact, any number of additional or alternative sorbents, including polymer-based sorbents, could be employed without departing from the scope of the present specification.
In one implementation, the manifold 240 includes a composite plastic manifold, into which the blood and dialysate flow paths are molded. Dialysis system 200 components, such as sensors and pumps, are placed into pressure, thermal, and/or optical communication with the fluid flow contained within the molded manifold 240.
Referring to
The mid-body 304 contains molded in channels on one side. These channels are completed by the front cover layer which is fixedly attached to the mid-body by any number of methods, including ultrasonic welding. This combined front cover-mid-body structure forms the major part of the fluid pathways within the manifold. On the opposite side of the mid-body 304, there are features that form surfaces for valving and pressure sensing, which communicate to the fluid pathways on the front cover side of the manifold. The manifold includes elastomeric components for valving and pressure sensing. These elastomeric components are captured between the back cover layer and mid-body layer through the use of ultrasonic welding and complete the fluid pathways throughout the manifold.
In one implementation, the manifold 300 includes five pressure transducer membranes 302 and three to four membranes 303 for two-way valves. In one implementation, the two covers 301 and 305, and mid-body 304 of the manifold 300 are molded of a polycarbonate material or ABS (acrylonitrile butadiene styrene). The pressure transducer membranes 302 and valve membranes 303 are molded of a common material, such as Santoprene, or more preferably Sarlink, which is a medical grade elastomeric polymer. In one implementation front and back covers 305 and 301 may be molded of optically clear material, at least transparent to certain preselected wavelengths of light, to allow for spectroscopic analysis of the fluid(s) contained within.
Additionally, the manifold preferably includes four pumping components 308. These pumping components 308 are segments of extruded polyvinyl chloride (PVC″) tubing formulated and dimensioned to have properties optimized for pump use, particularly roller pump use. This tubing is bonded to barbed fittings that are integrally molded to the manifold mid-body. One of the four pumping components is for drawing blood from the patient's artery and pumping it through a dialyzer and back to the patient's vein. Two pumping components are for dialysate flow and one is for infusate delivery to the dialysate fluid circuit. A separate syringe pump can be used for pumping anticoagulant/saline into the arterial blood pathway, pre-dialyzer.
In one implementation, the manifold further incorporates tubing ports 310, preferably in the range of 10-14 and more preferably 12 ports (corresponding to Ports A through M of
Referring back to
The manifold 240 contains structures that allow for fluid pressure monitoring across diaphragms through the use of pressure sensors 205, 206, 207, 208 and 209. These pressure sensors may be transducers. Fluid is allowed to flow from channels on the front cover (305 of
The valves and diaphragms can be made from a variety of different materials and by different processes. In one implementation, the elastomeric components are made from silicone. In another embodiment, the elastomeric components are made from a variety of thermoplastic elastomers. Two shot molding may be used to attach the valves and diaphragms to the back cover (301 of
Pumping components in the manifold design have been defined as PVC header tubing. These headers combined with rotary peristaltic pumping system provide the flow of blood, dialysate, and infusate. The circuit tubing material for dialysate, infusate, and anticoagulant/saline is preferably kink resistant, such as the tubing referred to as Colorite, Unichem 8011-02®, a TEKNIPLEX® company. In various embodiments, the tubing dimensions for the dialysate lines are in a range of 0.1″ to 0.4″×0.05″ to 0.3,″ more preferably 0.265″±0.003″ outer diameter (“OD”)×0.180″±0.003″ inner diameter (“ID”), or anticoagulant/saline and infusate tubing 0.1″ to 0.4″×0.05″ to 0.3″, more preferably 0.268″ OD×0.175″ ID.
Referring again to
In accordance with an aspect of the present specification, at least one of the four pulsatile roller pumps, such as the blood pump, is configured, designed and/or operated to generate a desired varying pressure profile of flow within the blood circuit of the dialysis system 200. The desired varying pressure profile is characterized by instantaneous pressure that goes through repeated, rapid cycles of positive and negative pressure at a given rate of flow. While the instantaneous pressure swings from high or positive and low or negative pressure, as further described below, the average or mean pressure remains positive and substantially constant over at least a 5 second period. It is preferred that the average pressure remains positive in order to make sure the flow is both in the appropriate direction, e.g. toward the dialyzer and not back flowing into the manifold, and not excessively turbulent, which may occur if the average pressure over 5 seconds or more is not substantially constant.
Thus, in various embodiments, to generate the desired varying pressure profile the blood pump of the present specification has a combination of following operational and design parameters: a flow rate greater than 200 mL/min, more specifically ranging from 200 mL/min to 500 mL/min; a pump speed ranging from 40 to 200 rotations-per-minute (“RPM”); a pump rotor size of no greater than 4.0 inches diameter; and number of rotors in the rotor pump ranging from 4 to 6.
In an implementation, each of the four rotors includes a set of equidistantly spaced rollers 425, placed horizontally with respect to the rotors, in a range of four to six. The rollers exert pressure on the pump tube segments to help generate the desired varying pressure profile. The positive swing in the varying pressure profile is achieved as the rollers 425 come into contact with the manifold tubing, compressing the tubing and expelling fluid from the tubing. The negative swing in the varying pressure profile is caused as the rollers 425 move away from the tubing, allowing the tubing to expand and refill with fluid. In various embodiments, the frequency and degree of variation in the pressure profile is determined by the size of the rollers, number of rollers, and space between each roller. The diameter of the rollers influences the push/pull effect created by the pressure peaks of the varying pressure profile. For example, a roller having too large of a diameter will not produce the desired pressure peaks. In one implementation, the number of rollers in each rotor ranges from four to six.
While in some embodiments, the desired varying pressure profile is generated only within the blood circuit by the blood pump, it should be appreciated that in various alternate embodiments similar pressure profiles may also be simultaneously generated within the dialysate circuit. In such embodiments, either one or both of the fresh and spent dialysate pumps may also have operational and design parameters similar to those of the blood pump of the present specification. In still further embodiments, along with the blood pump, additionally any one, two or all three of the fresh, spent and infusate pumps are designed and operated to generate the desired varying pressure profile within their corresponding fluid circuits.
Accordingly, in one implementation, a dialysis machine has between 2 and 6 rotors, each positioned such that the rollers which include the edges of each rotor are positioned against a tube segment of a manifold, and is operated to achieve a varying pressure profile for the flow of liquids through the manifold, dialyzer, sorbent cartridge and/or other components of the dialysis system, said liquids including dialysate, blood, and infusate. The varying pressure profile is preferably achieved by operating the pumps to achieve a flow rate greater than 200 mL/min, more specifically ranging from 200 mL/min to 500 mL/min with a pump rotor size of no greater than 4.0 inches diameter and a number of rollers ranging from 4 to 6. The varying pressure profile shall be defined in at least one of the following ways:
Referring now to
The above examples are merely illustrative of the many applications of the system of present invention. Although only a few embodiments of the present invention have been described herein, it should be understood that the present invention might be embodied in many other specific forms without departing from the spirit or scope of the invention. Therefore, the present examples and embodiments are to be considered as illustrative and not restrictive, and the invention may be modified within the scope of the appended claims.
The present specification relies on U.S. Patent Provisional Application No. 62/305,206, filed on Mar. 8, 2016, for priority, which is expressly incorporated herein by reference.
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| 6691047 | Fredericks | Feb 2004 | B1 |
| 6752172 | Lauer | Jun 2004 | B2 |
| 6836201 | Devenyi | Dec 2004 | B1 |
| 6948697 | Herbert | Sep 2005 | B2 |
| 7087026 | Callister | Aug 2006 | B2 |
| 7097148 | DeWall | Aug 2006 | B2 |
| 7270015 | Feller | Sep 2007 | B1 |
| 7387022 | Korniyenko | Jun 2008 | B1 |
| 8040493 | Fulkerson | Oct 2011 | B2 |
| 8105487 | Fulkerson | Jan 2012 | B2 |
| 8114288 | Robinson | Feb 2012 | B2 |
| 8137553 | Fulkerson | Mar 2012 | B2 |
| 8240636 | Smith | Aug 2012 | B2 |
| 8395761 | Fulkerson | Mar 2013 | B2 |
| 8475399 | Fulkerson | Jul 2013 | B2 |
| 8535522 | Fulkerson | Sep 2013 | B2 |
| 8597505 | Fulkerson | Dec 2013 | B2 |
| 8771511 | Robinson | Jul 2014 | B2 |
| 9157786 | Fulkerson | Oct 2015 | B2 |
| 9199022 | Fulkerson | Dec 2015 | B2 |
| 9201036 | Fulkerson | Dec 2015 | B2 |
| 9295772 | Fulkerson | Mar 2016 | B2 |
| 9308307 | Fulkerson | Apr 2016 | B2 |
| 9352282 | Fulkerson | May 2016 | B2 |
| 9354640 | Byler | May 2016 | B2 |
| 9358331 | Fulkerson | Jun 2016 | B2 |
| 9360129 | Smith | Jun 2016 | B2 |
| 9415152 | Robinson | Aug 2016 | B2 |
| 9517296 | Fulkerson | Dec 2016 | B2 |
| 9759710 | Fulkerson | Sep 2017 | B2 |
| 20020151804 | O'Mahony | Oct 2002 | A1 |
| 20020158019 | Collins | Oct 2002 | A1 |
| 20030048185 | Citrenbaum | Mar 2003 | A1 |
| 20030056585 | Furuki | Mar 2003 | A1 |
| 20030220598 | Busby | Nov 2003 | A1 |
| 20040031756 | Suzuki | Feb 2004 | A1 |
| 20050086008 | DiGianfilippo | Apr 2005 | A1 |
| 20050101901 | Gura | May 2005 | A1 |
| 20050131332 | Kelly | Jun 2005 | A1 |
| 20050133439 | Blickhan | Jun 2005 | A1 |
| 20060195064 | Plahey | Aug 2006 | A1 |
| 20060226057 | Robinson | Oct 2006 | A1 |
| 20060289342 | Sugioka | Dec 2006 | A1 |
| 20070112297 | Plahey | May 2007 | A1 |
| 20070179425 | Gura | Aug 2007 | A1 |
| 20070253463 | Perry | Nov 2007 | A1 |
| 20070269340 | Dannenmaier | Nov 2007 | A1 |
| 20080041792 | Crnkovich | Feb 2008 | A1 |
| 20080214979 | Brugger | Sep 2008 | A1 |
| 20080230450 | Burbank | Sep 2008 | A1 |
| 20080258735 | Quackenbush | Oct 2008 | A1 |
| 20080290974 | Adams | Nov 2008 | A1 |
| 20090008306 | Cicchello | Jan 2009 | A1 |
| 20090101549 | Kamen | Apr 2009 | A1 |
| 20090101552 | Fulkerson | Apr 2009 | A1 |
| 20090101577 | Fulkerson | Apr 2009 | A1 |
| 20090127193 | Updyke | May 2009 | A1 |
| 20100129247 | Lauer | May 2010 | A1 |
| 20100140149 | Fulkerson | Jun 2010 | A1 |
| 20100331754 | Fulkerson | Dec 2010 | A1 |
| 20110054378 | Fulkerson | Mar 2011 | A1 |
| 20110071465 | Wang | Mar 2011 | A1 |
| 20110142700 | Gura | Jun 2011 | A1 |
| 20110303598 | Lo | Dec 2011 | A1 |
| 20110315611 | Fulkerson | Dec 2011 | A1 |
| 20120214117 | Broker | Aug 2012 | A1 |
| 20130220907 | Fulkerson | Aug 2013 | A1 |
| 20130280104 | Heide | Oct 2013 | A1 |
| 20140188040 | Busby | Jul 2014 | A1 |
| 20140276537 | Kruse | Sep 2014 | A1 |
| 20150258263 | Hogard | Sep 2015 | A1 |
| 20150314055 | Hogard | Nov 2015 | A1 |
| 20160069732 | Fulkerson | Mar 2016 | A1 |
| 20160109398 | Fulkerson | Apr 2016 | A1 |
| 20160317733 | Fulkerson | Nov 2016 | A1 |
| 20160319954 | Smith | Nov 2016 | A1 |
| 20170007756 | Robinson | Jan 2017 | A1 |
| 20170021085 | Fulkerson | Jan 2017 | A1 |
| 20170021088 | Fulkerson | Jan 2017 | A1 |
| 20170021306 | Fulkerson | Jan 2017 | A1 |
| 20170023953 | Byler | Jan 2017 | A1 |
| 20170232177 | Fulkerson | Aug 2017 | A1 |
| Number | Date | Country |
|---|---|---|
| 101291704 | Oct 2008 | CN |
| 102089020 | Jun 2011 | CN |
| 102427835 | Apr 2012 | CN |
| 2002139165 | May 2002 | JP |
| 20015069412 | Jul 2001 | WO |
| 2009073567 | Jun 2009 | WO |
| 2010042666 | Apr 2010 | WO |
| 2010062698 | Jun 2010 | WO |
| 2010081121 | Jul 2010 | WO |
| 2012108910 | Aug 2012 | WO |
| 2014105267 | Jul 2014 | WO |
| 2014105755 | Jul 2014 | WO |
| 2014161008 | Oct 2014 | WO |
| 2017106356 | Jun 2017 | WO |
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| Number | Date | Country | |
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| 20170258979 A1 | Sep 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62305206 | Mar 2016 | US |
