Patent Grant
11110215
The invention relates to a degasser manifold and a vent manifold for use with a degasser in a dialysis system. The degasser manifold and vent manifold include a plurality of fluid passageways that convey dialysate or gases into and out of the degasser. The degasser manifold and vent manifold can also include components such as valves and sensors for control over the degassing of dialysate.
In dialysis systems including sorbent based systems, certain amounts of gas such as carbon dioxide can be created by the breakdown of urea into ammonia and carbon dioxide by urease. The resulting gas can go into solution in a fluid such as a dialysate and/or form gas bubbles. The bicarbonate buffer system can also contribute to the creation of excess carbon dioxide in dialysis fluid. Removal of carbon dioxide and other dissolved and undissolved gases in a dialysis system can be important in order to maintain a required pH, certain fluid conditions such as bicarbonate or ion concentration, and avoid the creation of gas bubbles. Known systems generally use tubing or fluid lines to direct dialysate into and out of the degasser and to remove gases from the degasser. The tubing creates a risk of leaking, kinking, and occlusions. Using excess tubing also increases costs and space required for the system.
Hence, there is a need for systems that can direct fluid from a dialysate flow path into and out of a degasser without the use of complicated and unreliable tubing or fluid lines. The need extends to the removal of gases from the degasser. There is a need for systems that can accurately control the amount of gas removed by the degasser, and in particular carbon dioxide, without the use of tubing. To decrease costs and improve manufacturability, there is a need for systems that use manifolds, rather than fluid lines, to control fluid and gas movement into and out of the degasser.
The first aspect of the invention is drawn to a degasser manifold. In any embodiment, the degasser manifold can comprise a plurality of passageways fluidly connectable to one or more inlets and one or more outlets in a dialysis system; the one or more inlets comprising a first inlet fluidly connectable to a first fluid line, the first fluid line fluidly connectable to a dialysate flow path, and a second inlet fluidly connectable to a second fluid line; the second fluid line fluidly connectable to an outlet of a degasser; the one or more outlets comprising a first outlet fluidly connectable to an inlet of the degasser and a second outlet fluidly connectable to a third fluid line, the third fluid line fluidly connectable to the dialysate flow path downstream of the first fluid line.
In any embodiment, the degasser manifold can comprise a pressure sensor in a fluid passageway between the first inlet and the first outlet.
In any embodiment, the first inlet and first outlet can define a first fluid passageway.
In any embodiment, the degasser manifold can comprise a second fluid passageway from the second inlet to the first fluid passageway.
In any embodiment, the degasser manifold can comprise a second fluid passageway from the first fluid passageway to the second outlet.
In any embodiment, the second fluid line can comprise a first fluid pump.
In any embodiment, the degasser manifold can comprise a controller; the controller controlling the first fluid pump and a dialysate pump to control a ratio of fluid passing to the first outlet and second outlet.
In any embodiment, the controller can control the ratio of fluid passing to the first outlet and second outlet based on a fluid pressure measured by the pressure sensor in the fluid passageway and a gas pressure in the degasser.
In any embodiment, the controller can control the ratio of fluid passing to the first outlet and second outlet by controlling a ratio of pump rates of the first fluid pump and the dialysate pump.
Any of the features disclosed as being part of the first aspect of the invention can be included in the first aspect of the invention, either alone or in combination.
The second aspect of the invention is drawn to a method. In any embodiment, the method can comprise a) pumping a dialysate from a dialysate flow path into a first inlet of a degasser manifold; b) pumping a portion of the dialysate through a fluid passageway of the degasser manifold to a first outlet of the degasser manifold; wherein the first outlet of the degasser manifold is fluidly connected to an inlet of a degasser; c) pumping a portion of the dialysate through a fluid passageway of the degasser manifold to a second outlet of the degasser manifold; wherein the second outlet of the degasser manifold is fluidly connected to the dialysate flow path; and d) pumping fluid from an outlet of the degasser into a second inlet of the degasser manifold; wherein the second inlet of the degasser manifold is fluidly connected to the fluid passageway.
In any embodiment, the method can comprise the step of the step of measuring a fluid pressure with a pressure sensor in the fluid passageway.
In any embodiment, the method can comprise the step of controlling a ratio of fluid pumped to first outlet of the degasser manifold to fluid pumped to the second outlet of the degasser manifold based on the fluid pressure.
In any embodiment, the step of controlling a ratio of fluid pumped to first outlet of the degasser manifold to fluid pumped to the second outlet of the degasser manifold can comprise controlling a ratio of pump rates of first pump positioned between an outlet of the degasser and the second inlet and a second pump positioned downstream of the second outlet.
In any embodiment, the method can comprise the step of pumping gas from a gas outlet of the degasser to a first inlet of a vent manifold with a vacuum pump and from the first inlet of the vent manifold to a first outlet of the vent manifold.
In any embodiment, the method can comprise the step of selectively operating a valve positioned between the first inlet of the vent manifold and the first outlet of the vent manifold to control a gas pressure in the degasser.
In any embodiment, the step of selectively operating the valve can be performed by a controller.
Any of the features disclosed as being part of the second aspect of the invention can be included in the second aspect of the invention, either alone or in combination.
The third aspect of the invention is drawn to a system. In any embodiment, the system can comprise the degasser manifold of the first aspect of the invention; and a vent manifold; the vent manifold comprising a plurality of passageways fluidly connectable to one or more inlets and one or more outlets in a dialysis system; the one or more inlets comprising a first inlet fluidly connectable to a first fluid line and a first passageway, the first fluid line fluidly connectable to a gas outlet of the degasser; at least a first valve fluidly connecting the first inlet to a first outlet; the first outlet fluidly connected to a vacuum pump.
In any embodiment, the vent manifold can comprise a second valve; the second valve fluidly connecting a second inlet of the vent manifold to the first inlet; the second inlet connected to a filter.
In any embodiment, the vent manifold can comprise a second valve; the second valve fluidly connecting the first inlet to a second outlet; the second outlet fluidly connected to the dialysate flow path.
In any embodiment, the system can comprise a controller; the controller controlling the first valve to maintain a desired pressure in the degasser.
Any of the features disclosed as being part of the third aspect of the invention can be included in the third aspect of the invention, either alone or in combination.
Unless defined otherwise, all technical and scientific terms used herein generally have the same meaning as commonly understood by one of ordinary skill in the relevant art.
The articles “a” and “an” are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.
The term “comprising” includes, but is not limited to, whatever follows the word “comprising.” Thus, use of the term indicates that the listed elements are required or mandatory but that other.
The term “consisting of” includes and is limited to whatever follows the phrase “consisting of.” Thus, the phrase indicates that the limited elements are required or mandatory and that no other elements may be present.
The term “consisting essentially of” includes whatever follows the term “consisting essentially of” and additional elements, structures, acts or features that do not affect the basic operation of the apparatus, structure or method described.
The terms “control,” “controlling,” or “controls” can refer to the ability of one component to direct the actions of a second component.
A “controller,” “controller,” “processor,” or “microprocessor” is a device which monitors and affects the operational conditions of a given system. The operational conditions are typically referred to as output variables of the system wherein the output variables can be affected by adjusting certain input variables.
A “degasser” is a component for removing dissolved and undissolved gasses from fluids. The term “degasser” can encompass a degassing vessel, and a fluid pump and a vacuum pump connected to the degassing vessel and working in concert to create a vacuum in the fluid flowing through the degassing vessel and to evacuate gas from the degassing vessel.
A “degasser manifold” can refer to a component containing one or more fluid passageways and optionally one or more components such as valves and sensors. The degasser manifold can be used as part of a dialysis system for conveying fluid, gas, or a combination thereof, to and from a degasser.
The term “dialysate” describes a fluid into or out of which solutes from a fluid to be dialyzed diffuse through a membrane. A dialysate typically contains electrolytes close in concentration to the physiological concentration of electrolytes found in blood.
The term “dialysate flow loop,” “dialysate flow path” or “dialysate conduit flow path” refers to any portion of a fluid pathway that conveys a dialysate and is configured to form at least part of a fluid circuit for hemodialysis, hemofiltration, ultrafiltration, hemodiafiltration or ultrafiltration. Optionally, the fluid pathway can contain priming fluid during a priming step or cleaning fluid during a cleaning step.
A “dialysate pump” can be a pump configured to move fluid, gas, or a combination thereof through a dialysate flow path.
“Dialysis” can be a type of filtration, or a process of selective diffusion through a membrane. Dialysis removes solutes of a specific range of molecular weights via diffusion through a membrane from a fluid to be dialyzed into a dialysate. During dialysis, a fluid to be dialyzed is passed over a filter membrane, while dialysate is passed over the other side of that membrane. Dissolved solutes are transported across the filter membrane by diffusion between the fluids. The dialysate is used to remove solutes from the fluid to be dialyzed. The dialysate can also provide enrichment to the other fluid.
The term “dialysis system” can refer to a set of components configured to carry out dialysis therapy of any type including peritoneal dialysis, hemodialysis, hemofiltration, hemodiafiltration, or ultrafiltration.
The term “downstream” refers to a position of a first component in a flow path relative to a second component wherein fluid, gas, or combinations thereof, will pass by the second component prior to the first component during normal operation. The first component can be said to be “downstream” of the second component, while the second component is “upstream” of the first component.
A “filter” can refer to a component having openings or pores through which fluid, gas or a combination thereof, can pass, but that prevents particles larger than the pores or openings from passing through the filter.
The term “fluidly connectable” refers to the ability of providing for the passage of fluid, gas, or combination thereof, from one point to another point. The ability of providing such passage can be any connection, fastening, or forming between two points to permit the flow of fluid, gas, or combinations thereof. The two points can be within or between any one or more of compartments, modules, systems, components, and rechargers, all of any type.
The term “fluidly connected” refers to a particular state such that the passage of fluid, gas, or combination thereof, is provided from one point to another point. The connection state can also include an unconnected state, such that the two points are disconnected from each other to discontinue flow. It will be further understood that the two “fluidly connectable” points, as defined above, can from a “fluidly connected” state. The two points can be within or between any one or more of compartments, modules, systems, components, and rechargers, all of any type.
A “fluid line” can refer to a tubing or conduit through which a fluid, gas, or combination thereof can pass. The fluid line can also contain air during different modes of operation such as cleaning or purging of a line.
The term “fluid pressure” refers to a force exerted by a fluid on the walls of a container or conduit.
A “fluid pump” can refer to a pump used to move fluid, gas, or combination thereof throughout a system.
The term “gas outlet” refers to a portion of a component through which gas can be pulled out of the component in a fluid line, conduit, or fluid passageway of any type. In one non-limiting embodiment, the component can be a degasser or degas vessel.
The term “gas pressure” refers to a force exerted by a gas. The gas pressure can also refer to the pressure exerted by the gas on the walls of a container or conduit.
The term “inlet” can refer to a portion of a component through which fluid, gas, or combination thereof can be drawn into the component. In one non-limiting example, the component can be a manifold.
To “maintain a desired pressure” or “maintaining a desired pressure” refers to operating a system in such a way that the fluid or gas pressure in a component or conduit remains within a specified range.
The term “measuring” or “to measure” can refer to determining any parameter or variable. The parameter or variable can relate to any state or value of a system, component, fluid, gas, or mixtures of one or more gases or fluid.
The term “outlet” refers to a portion of a component through which fluid, gas, or a combination thereof can be pulled out of the component in a fluid line, conduit, or fluid passageway of any type. In one non-limiting embodiment, the component can be a manifold.
The term “passageway” refers to a fluid path through which fluid, gas, or combinations thereof can flow from one location to another location, where the passageway has walls to restrain the fluid or air within the passageway and the walls at least in-part surround the fluid or gas and connect the two locations.
The term “plurality” can refer to two or more of any type of object. In one embodiment, the term can be used to describe the existence of two or more components, systems, passageways, or fluid paths.
The terms “pumping” or to “pump” refer to moving a fluid, gas, or combinations thereof through a flow path with a pump.
“Pump rate” refers to a volume of a fluid, gas, or combinations thereof moved by a pump per unit time.
The term “pressure sensor” refers to a device for measuring the pressure of a gas, a fluid, or a combination thereof in a vessel, container, or fluid line.
The term “ratio of fluid” refers to relative amounts of fluid moving in differing flow paths.
The term “ratio of pump rates” refers to the relative amounts of fluid, gas, or combinations thereof moved by different pumps in a given amount of time.
The term “selectively operating” a valve refers to opening or closing the valve to create a specified fluid flow path.
The term “upstream” refers to a position of a first component in a flow path relative to a second component, wherein fluid, gas, or a combination thereof, will pass by the first component prior to the second component during normal operation. The first component can be said to be “upstream” of the second component, while the second component is “downstream” of the first component.
A “vacuum pump” is a pump used to create negative pressure in a component.
A “valve” is a device capable of directing the flow of fluid, gas, or combination thereof, by opening, closing or obstructing one or more pathways to allow the fluid, gas, or combination thereof to travel in a path. One or more valves configured to accomplish a desired flow can be configured into a “valve assembly.”
A “vent manifold” refers to a component containing one or more fluid passageways and optionally one or more components such as valves and sensors. The vent manifold can be connected to a gas outlet of a degasser in a dialysate flow path.
Degassing Vessel
The first, second and third aspects of the invention relate to a degasser and related systems and methods for removing gas, and specifically carbon dioxide, generated from the breakdown of urea in the sorbent cartridge. A degassing module in accordance with the first, second and third aspects of the invention is shown in
As the dialysate enters the degassing module, the dialysate can pass a degas restrictor 13 of
The degassing vessel 11 of the first, second and third aspects of the invention can be operated at a pressure lower than atmospheric pressure due to the presence of vacuum pump 14. By maintaining the degassing vessel 11 at a pressure less than atmospheric pressure, carbon dioxide present in the fluid can be more easily removed than in the absence of the described system of pumps of the first, second and third aspects of the invention. The vent valve 10 can allow gas to leave directly into the atmosphere through filter 29, as represented by arrow 30. The filter 29 is a particle filter that serves to remove particulate matter from air flowing through filter 29. The gases may travel through gas removal line 23, to the gas removal pump assembly 15 and into the atmosphere as represented by arrow 24.
Vent valve 10 can be a three way valve, as shown in
Lower level sensor 17 and upper level sensor 16 can sense the fluid level in the degassing vessel 11. The fluid level in the degassing vessel 11 can be a function of the vacuum created by fluid pump 12 and vacuum pump 14 working independently or in concert. The pump rate of the fluid pump 12 and vacuum pump 14 can be adjusted as necessary to maintain the correct fluid level in the degassing vessel 11. The lower level sensor 17 and upper level sensor 16 can be in electronic communication with a controller (not shown). The pump rates of the fluid pump 12 and vacuum pump 14 can be automatically adjusted by the controller to maintain the proper level of fluid in the degassing vessel 11. If the fluid level in the degassing vessel 11 is near or above the maximum fluid level 26, the pump rates of the fluid pump 12 can be increased, and/or vacuum pump 14 can be reduced. If the fluid level in the degassing vessel 11 is near or below the minimum fluid level 22, the pump rates of the fluid pump 12 can be reduced and/or vacuum pump 14 can be increased.
In certain embodiments, only one sensor is necessary to detect the fluid level in the degassing vessel 11. For example, an ultrasonic sensor or mechanical float can be used to determine the fluid level in the degassing vessel 11. Any other type of fluid level sensor known in the art is contemplated by the first, second and third aspects of the invention.
Carbon dioxide sensor 28 can determine the amount of carbon dioxide present in the dialysate flow path after dialysate has passed through the degasser. The pump rates of fluid pump 12 and vacuum pump 14 can be adjusted as discussed below in response to signals received from the carbon dioxide sensor 28 in order to remove more or less carbon dioxide from the dialysate, and therefore deliver more or less carbon dioxide to the main dialysate flow path. The pumps can be adjusted automatically if the level of carbon dioxide detected in the dialysate by carbon dioxide sensor 28 is higher or lower than a pre-set value. Alternatively, the pumps can be adjusted manually in response to output from the carbon dioxide sensor 28. The system can control the degasser to maintain a carbon dioxide level in fluid exiting the degasser between any of 50 and 200 mmHg partial pressure, 50 and 120 mmHg partial pressure, 50 and 80 mmHg partial pressure, 70 and 100 mmHg partial pressure, 80 and 120 mmHg partial pressure, 50 and 200 mmHg partial pressure, or 100 and 200 mmHg partial pressure. The carbon dioxide sensor 28 can be placed anywhere in the dialysate flow path, but preferably between the outlet of the degassing flow path and the inlet of the dialyzer (not shown). One of skill in the art will understand that the carbon dioxide sensor 28 can be any components capable of measuring the carbon dioxide in a fluid, directly or indirectly.
Carbon dioxide sensors and sensors are known in the art. Examples include non-dispersive infrared (NDIR) detectors that detect carbon dioxide concentration in a gas and which are commercially available from a number of manufacturers, for example Gas Sensing Solutions, Glasgow Scotland; colormetric optical detectors that detect carbon dioxide in a liquid by means of a substrate that produce color change when the concentration of carbon dioxide in the liquid changes (PreSens Precision Sensing GmbH, Regensburg Germany); and sensors that utilize Severinghaus electrodes, such as the InPro CO2 sensor from Mettler Toledo, Leicester England.
The pumps of the degassing module can be of any type known in the art. In certain embodiments, fluid pump 12 and vacuum pump 14 can be the same type of pump. Alternatively, fluid pump 12 and vacuum pump 14 may be different types of pumps. In certain embodiments, the fluid pump 12 and vacuum pump 14 can be a gear pump. Alternatively, fluid pump 12 and vacuum pump 14 can be a peristaltic pump, a diaphragm pump or an impeller pump. Fluid pump 12 can also have a sensor 31 attached to the fluid pump 12 to monitor performance of the fluid pump 12 and detect wear. The fluid pump 12 must be selected for operating with the pump inlet at a low absolute pressure necessary to efficiently remove carbon dioxide.
Flow of fluid through the degassing module can be variable. Control over the flow can be provided by fluid pump 12. Under certain operating conditions the flow rate provided by fluid pump 12 can be less than the flow rate through the main dialysate loop. Fluid pump 12 can be operated so that flow through the degassing module is significantly greater than flow through the main dialysate loop. Fluid pump 12 can be operated to move fluid through the degassing flow loop at a rate of 2-3 times that of the dialysate flow path. Alternatively, the fluid pump 12 can be operated to move fluid through the degassing flow loop at a rate between 1-6 times that of the dialysate flow path, 1-2 times that of the dialysate flow path, 3-4 times that of the dialysate flow path, 4-5 times that of the dialysate flow path or 5-6 times that of the dialysate flow path. The flow through the degassing module can be controlled automatically by a controller in communication with the fluid pump 12 depending on the amount of carbon dioxide that is to be removed.
The invention can utilize the vacuum pump 14 to remove gas from the degassing vessel 11 to the atmosphere when the degassing vessel 11 is operated under vacuum. Known degassing systems pump fluid into a vessel at ambient pressure where bubbles are allowed to escape. However, providing a second pump or any one of the specific pump configurations described in the first, second and third aspects of the invention to keep a degassing vessel 11 under vacuum can unexpectedly result in higher amount of gases such as carbon dioxide being removed.
The passage from the degassing vessel 11 to vent valve 10 can be covered by a hydrophobic membrane (not shown). A hydrophobic membrane will prevent fluid from escaping the degassing vessel 11 through mechanical vent valve 20. This, in turn, protects the vacuum pump 14 from being damaged by liquid and prevents undesired loss of liquid from the system while still enabling gas to be removed. The hydrophobic membrane can be positioned in any appropriate location to guard against inadvertent fluid flow to the vacuum pump 14, and thereby prevent fluid damage. One example of a hydrophobic membrane is Polytetrafluoroethylene, or PTFE. However, the hydrophobic membrane can be made of any material.
During draining of the dialysis system of the first, second and third aspects of the invention, air can be drawn into the system in order to drain out the fluid in the fluid pathways of the system. Air can be added to the system through vent valve 10 as shown in
As shown in
In certain embodiments, both a nucleation chamber and a degas sprayer can be used. Such an arrangement can further help gas to be released from solution to collect at the top of the degassing vessel 11. However, in certain embodiments, only one of a degas sprayer or nucleation chamber can be used.
As shown in
As can be seen in
The outlet CO2 concentration can be dependent on the inlet CO2 concentration, the fluid pressures within the degassing flow loop, and the rates of flow through dialysate flow path and the degassing flow loop. The dialysate flow path and the degassing flow loop can operate in parallel or in series.
The controller can set initial pump rates for both the vacuum pump and fluid pump based on the initial carbon dioxide concentration in the dialysate. For example, if the initial carbon dioxide concentration in the dialysate is 415 mmHg partial pressure, the fluid pump and vacuum pump may be set to maintain an absolute pressure in the degas vessel of 100 mmHg. As shown in
In certain embodiments, the degasser can be located in a fluid flow path in a position directly after the sorbent cartridge. The position of the degasser, however, is not limited to any one position. Alternatively, the degassing module may be located in other positions between the sorbent cartridge and the dialyzer.
To make use of the dialysis system of the first, second and third aspects of the invention easier, the valves and pumps may be operated by a programmable controller or computer system that can be programmed to regulate flow through the pumps and valves and into and out of the reservoirs. A rotometer or turbine with optical sensor, photocell, magnetic sensor, or other flow sensing apparatus may detect the flow of fluid through any two points in the degassing system. For example, an optical fluid flow device can be provided for measuring flow wherein the device includes an optical fluid pressure measuring device having sensors positioned in any one of the flow paths between the reservoirs, in the connectors, or in the valves or valve assemblies. The optical fluid sensors described above can be connected to an interferometer associated with an opto-electronic demodulator which has an output signal representing the differential pressure between the two sensed areas. In certain embodiments, a flow sensing apparatus can have a flow-responsive element projecting into a fluid flow path, and a position sensor associated with the element which detects a change in position of the flow-responsive element in response to the fluid flow. The flow-responsive element can be made of a wide variety of materials having the desired properties known to those of ordinary skill in the art.
The reader is directed to
Referring to
The released gas can exit the degassing vessel 68 at outlet connector 33 and pass through vent line 63 to vent control valve 40 through outflow line 42 to outflow valve 41. During degassing, outflow valve 41 directs the flow path to gas removal pump assembly 15 through gas removal line 64. Vacuum pump 14 pulls the gas from the low pressure environment of degassing vessel 68 and pumps the gas out through degassing outlet line 43. Degassing outlet line 43 can optionally be connected to drain line 46. Connecting degassing outlet line 43 to drain line 46 muffles the noise of the vacuum pump 14 and directs any condensed water vapor to reservoir 60 through drain line 46 and connector 59. The removed gas flows out of reservoir 60 through vent 58.
Level sensor 61 can measure the liquid level 26 in degassing vessel 68. Level sensor 61 can be an ultrasonic sensor. Level sensor 61 can be an array of reed switches that detect the height of a magnetic float. Level sensor 61 can include a linear array of hall-effect sensors. The rate of vacuum pump 14 can be increased to increase the liquid level 26 when level sensor 61 detects that the liquid level 26 is below a predetermined level. The rate of vacuum pump 14 can be reduced when the level sensor 61 detects that the liquid level 26 is above a predetermined level. The vacuum pump 14 can act as a check valve preventing air or liquid from returning to the degasser through degassing outlet line 43, but can allow gas outflow from the degasser through degassing outlet line 43 including when the gas removal pump is de-energized or turned off Air can be rapidly evacuated from the dialysate flow path 55 through outlet connector 33, vent line 63, vent control valve 40, degassing outflow valve 41 and gas removal pump assembly 15 and degassing outlet line 43 during priming operations when the liquid entering the dialysate flow path 55 causes the pressure to increase, forcing the air in the gas space 21 of degassing vessel 68 through outlet connector 33 when the pressure in gas space 21 is greater than atmospheric pressure.
Vent control valve 40 can be switched to filter 29 and air can be drawn into the degassing vessel 68 as depicted by arrow 45 when liquid is being drained from the recirculating dialysate flow path 55 through drain valve 47 through drain line 46 and connector 59 to reservoir 60. Filter 29 can have a pore size that excludes microbes and particulate to prevent contamination of the system when air is drawn in.
During flushing, cleaning and disinfection of the dialysis system, degassing vessel 68 can be completely filled with liquid and liquid can be passed out through outlet connector 33 through vent line 63, vent control valve 40, and degassing outflow valve 41 to recirculation line 44. This flow path enables cleaning and disinfection solutions, including the non-limiting examples of hot water, heated citric acid solution, and bleach to be recirculate through the outlet connector 33, vent line 63, and vent control valve 40. In this manner microbiological contamination and biofilms can be minimize in the degassing vessel 68 and also in the flow path used to bring air into the system when liquid is being drained from the system.
The flow restrictor 67 can have a fixed restriction, or can comprise a pressure regulator that changes the amount of flow restriction as the pumping rate of fluid pump 12 changes, such that a predetermined pressure is maintained in the dialysate exiting the restrictor across a range of operating rates of fluid pump 12. The amount of restriction caused by flow restrictor 67 can be controlled to achieve a predetermined pressure in the fluid passing through the degasser.
Pressure sensor 62 can measure the fluid pressure in the degassing system. Pressure sensor 62 can be located on the degassing vessel 11 and can measure the pressure in the liquid or the gas. Pressure sensor 62 can be located at any point in the degasser between the flow restrictor 67 and fluid pump 12. The pressure measurement obtained from pressure sensor 62 can be used to adjust the restriction of flow restrictor 67 to obtain a predetermined pressure in the degassing system. The rate of fluid pump 12 can be controlled to achieve a predetermined fluid pressure in the degassing system. The rate of fluid pump 12 can be increased to reduce the fluid pressure in the degasser if the fluid pressure measured by pressure sensor 62 is above the predetermined pressure. The rate of fluid pump 12 can be decreased to increase the fluid pressure in the degasser if the fluid pressure measured by pressure sensor 62 is below the predetermined fluid pressure.
In
Fluid can be sprayed into the spray chamber 210 of the degassing vessel 206. Gas can be removed from the fluid through a gas outlet fluidly connected to gas outlet line 217. A gage pressure sensor 216 in the gas outlet can measure the pressure inside the degassing vessel 206. Gas bubble nucleation can occur as the fluid is sprayed into the spray chamber 210. Before the gas bubbles can exit the degassing vessel 206, the gas bubbles rise through the liquid and are captured and collected in a headspace of the degassing vessel 206. Bubble capture can be ensured when the downward velocity of the liquid in the degassing vessel 206 is less than the rise velocity of the bubbles through the liquid. The degas sprayer 207 atomizes the fluid and creates a high surface area to volume ratio between the liquid droplets and gas in the degas vessel headspace. In certain embodiments, vacuum pump 218 is used to lower the pressure in the degassing vessel 206, and is fluidly connected to gas outlet line 217 by valve 219 and vacuum line 220 and can be controlled by a controller to maintain a desired pressure within the degassing vessel 206. In a preferred embodiment, the vacuum pump 218 is continuously run at a high rate, and the controller can pulse width modulate valve 219 to control the pressure in the degassing vessel 206 to a desired target. The removed gases are expelled through gas line 221, which can be vented to the air, or alternatively, connected to a waste reservoir.
Degassed fluid can exit the degassing vessel 206 through a liquid outlet 212 in a base 211 of the degassing vessel 206, fluidly connected to fluid line 204. The liquid outlet 212 is located at a lower elevation in the degassing vessel 206 than the gas outlet at gas outlet line 217. Fluid can be pumped by fluid pump 213, through fluid line 205, and back to dialysate line 201 at junction 227. The fluid pump 213 provides the force necessary to move fluid from the low pressure degassing vessel 206 to the higher pressure in dialysate line 201. The fluid lines 204, 205, and 201, with degassing vessel 206, form a degassing flow path that is parallel to a main dialysate flow path. Fluid can be pumped from the degassing flow path at junction 232 into the main dialysate flow path through fluid line 203 by dialysate pump 214 into dialysate line 202. The flow rate of fluid through the main dialysate flow path can be controlled by dialysate pump 214, and optionally one or more additional dialysate pumps. As such, the flow rate of fluid through the degassing flow loop can be controlled independently of the flow rate of fluid in the main dialysate flow path. By operating fluid pump 213 at a higher pump rate than dialysate pump 214, fluid can be recirculated through the degassing vessel 206 multiple times prior to returning to the main dialysate flow path, allowing additional control over the amount of gas removed. The rate of liquid recirculation through the degassing vessel 206 can help to ensure sufficient exposure to the headspace of the degassing vessel 206 so that dissolved gases in the liquid come into equilibrium with the gas partial pressures in the degassing vessel 206. In certain embodiments, the flow rate of fluid through the degassing flow loop can be set to about two times the dialysate flow rate. The fluid pump 213 and dialysate pump 214 can be controlled by a controller (not shown) to operate at the desired ratio.
A vent valve 223 fluidly connected to the gas outlet line 217 can be controlled to allow air into the degassing vessel 206 when the degassing vessel 206 is drained. Filter 224 prevents contamination of the degassing vessel 206, and can have a pore size that excludes microbes and particulate matter to prevent contamination of the system when air is drawn in through vent valve 223. During flushing, cleaning and disinfection of the dialysis system, degassing vessel 206 can be completely filled with liquid and liquid can be passed out through gas outlet line 217 through valve 225 and fluid line 226, to dialysate line 202 at junction 228. The flow path enables cleaning and disinfection solutions, including the non-limiting examples of hot water, heated citric acid solution, and bleach to be recirculate through all of the lines of the degassing system. In this manner, microbiological contamination and biofilms can be minimized in the degassing vessel 206 and also in the flow path used to bring air into the system when liquid is being drained from the system. A temperature sensor (not shown) can be included to monitor the temperature during disinfection, and to measure the temperature of dialysate prior to reaching a heater (not shown) in the dialysate flow path. An ambient pressure sensor 222 can measure the atmospheric pressure outside of the degassing system, and is used in control of gas removal from the fluid.
During treatment, the degassing system should control carbon dioxide removal to maintain a carbon dioxide level within a desired range. In certain embodiments, the desired range can be between 40 mmHg-150 mmHg pCO2. The concentration of the dissolved gases in the dialysate exiting the degassing vessel 206 are proportional to the absolute partial pressures of the gas in the top portion 208, and as such, the environmental pressure as measured by ambient pressure sensor 222 can be used to control the gas pressure within the degassing vessel 206. Ambient pressure sensor 222 measures the absolute pressure of the environment outside of the degassing vessel 206. Gage pressure sensor 216 measures a gage pressure referenced to the ambient pressure sensor 222. The pressure as measured by ambient pressure sensor 222 plus the gage pressure measured by gage pressure sensor 216 provides the absolute pressure in the top portion 208 of the degassing vessel 206. Alternatively, the gage pressure sensor 216 can be replaced by an absolute pressure sensor, and the ambient pressure sensor 222 is not required. The dialysate flow rate also controls the amount of gas removed. In certain embodiments, the dialysate flow rate through the degassing flow loop can be between 100 mL/min to 800 mL/min. In certain embodiments, the dialysate flow path can include a heater (not shown) to heat the dialysate to a desired temperature prior to reaching the dialyzer. The degassing flow loop can be positioned either upstream or downstream of the heater. The degassing system should be able to operate over the entire possible range of dialysate temperatures. When positioned downstream of the heater, the dialysate temperature in the degassing flow loop should be between about 35° C. to about 39.5° C. When positioned upstream of the heater, the possible temperature range of dialysate in the dialysate flow path can be larger, including from between about 10° C. to about 45° C.
The amount of gas removed by the degassing system is a function of the absolute headspace pressure in the degassing vessel 206, as well as the degassing flow loop flow rate. In some embodiments, the headspace pressure of the degassing vessel 206, an estimated degasser inlet carbon dioxide concentration is used, as described. In a preferred embodiment, the size and flow rate through the degassing flow loop and degas sprayer 207 is sufficient to ensure that dissolved gases in the liquid exiting the degassing vessel 206 through fluid line 204 are in approximate equilibrium with the gas partial pressure in the top portion 208, or headspace, of the degassing vessel 206. When the dissolved gases in the liquid are in approximate equilibrium with the gas partial pressure in the top portion 208 of the degassing vessel 206, the carbon dioxide pressure can be controlled by controlling the absolute headspace pressure. As such, the carbon dioxide pressure can be controlled across a very wide range of inlet carbon dioxide pressures. The headspace pressure can be controlled to a predetermined target, irrespective of the estimated carbon dioxide concentration in the liquid entering the degassing vessel through dialysate line 201. In certain embodiments, the vacuum pump 218 is operated by the controller at a fixed rate. The absolute headspace pressure in the degassing vessel 206 is equal to the degassing vessel pressure as measured by gage pressure sensor 216 plus the atmospheric pressure as measured by absolute ambient pressure sensor 222. Valves 219 and 223 can be selectively operated by the controller to allow the vacuum pump 218 to remove air from the degassing vessel 206 or to allow air to flow into degassing vessel 206, thereby controlling the headspace pressure to the headspace pressure set point. In certain embodiments, the estimated degasser inlet carbon dioxide concentration can vary as a profile during a dialysis session, and as such, the headspace pressure set point can also vary during treatment. The degassing flow loop flow rate can be controlled by using a fixed pressure change to achieve a desired flow rate. The pressure change can be measured by the difference between the incoming fluid pressure as measured by pressure sensor 215 and the pressure within the degassing vessel 206 measured by gage pressure sensor 216. Using the fixed pressure change, a pressure change set point can be set, and the fluid pressure at pressure sensor 215 varied by changing the fluid pump 213 rate until the pressure change set point is reached. In certain embodiments, the relationship between the pressure change and the flow rate can be empirically determined. Alternatively, the relationship can be calculated using an algorithm. The degassing flow loop flow rate should be set at a rate sufficient to ensure the dialysate comes into approximate equilibrium with the gas pressures in the degassing vessel 206, but low enough to avoid over degassing, erratic level behavior, or excess foam generation. In certain embodiments, the degassing flow loop flow rate can be set between 750 and 800 mL/min. Over degassing with a degassing flow loop flow rate of ˜800 mL/min and a dialysate flow rate of about 100 mL/min has not been observed. If the pump rate of fluid pump 213 deviates from the normal relationship with the pressure change, an obstruction in the inlet of the degassing vessel 206 or an error in the control over the pressure change may be indicated.
If an error is indicated, the system can generate an alert informing the user of the error and/or stop treatment. In certain embodiments, a protective system can be used. The protective system can receive the dialysate flow rate from a flow sensor (not shown) in the dialysate flow path and determine the change in pressure set point to operate the degassing flow loop flow rate at a set ratio to the dialysate flow path flow rate. The protective system can determine an expected operating rate (RPM) of the fluid pump 213 corresponding to the pressure change set point, and calculate a running average operating rate for fluid pump 213. The protective system can generate an alert if the running average of RPM for fluid pump 213 is outside of a predetermined range of the expected value. In certain embodiments, the predetermined range can be ±10% of the expected value. The protective system can also monitor the pressure in the headspace of the degassing vessel 206. The protective system can measure the ambient pressure with ambient pressure sensor 222 and the pressure inside the degassing vessel 206 with gage pressure sensor 216 to calculate the absolute pressure within the degassing vessel 206 and can calculate a running average of the absolute pressure. The running average of absolute pressure can be compared to a predetermined limit, and an alert generated if the absolute pressure is outside of the predetermined limit.
Gases can be removed from the degassing vessel 301 through gas outlet 308, which can be fluidly connected to a vacuum pump (not shown) by one or more valves. In a preferred embodiment, the gas outlet 308 is positioned at a top portion of the degassing vessel 301 between the spray chamber 302 and the float chamber 303. Placing the gas outlet 308 between the spray chamber 302 and float chamber 303 allows symmetrical gas removal from both chambers while preserving the filling, draining, and disinfection capabilities of the degassing vessel 301. Holes 309 can be included for securing a circuit board including the linear array of Hall effect sensors to detect the level of the float (not shown) and therefore the liquid level in the degassing vessel 301.
As illustrated in
The spray chamber 302 can be any length and diameter sufficient to effectively capture bubbles in the fluid sprayed into the spray chamber 302. In certain embodiments, the spray chamber 302 can have a diameter of about 75 mm and a height of about 10 cm, which gives a balance of degassing capacity and foam control without excessive size or fluid volume. In other embodiments, the diameter can be between about 50 mm to about 100 mm, including between 50 mm and 75 mm, between 50 mm and 60 mm, between 60 mm and 100 mm, or between 75 mm and 100 mm. The height of the spray chamber 302 can be between about 60 mm and about 200 mm, including between 60 mm and 100 mm, between 60 mm and 75 mm, between 70 mm and 100 mm, between 90 mm and 125 mm, between 100 mm and 150 mm, between 125 mm and 200 mm or between 150 mm and 200 mm. A larger length and diameter of the spray chamber 302 can further reduce foaming by creating a better transition zone when fluid is sprayed into the spray chamber 302. A larger diameter spray chamber 302 also increases the surface area of the fluid and causes the sprayed liquid to have a greater contact time with the headspace, allowing more efficient gas removal.
In certain embodiments, the degas sprayer 305 can be constructed to create an even cone shaped spray, rather than a more coarse “fountain like” spray, which can further reduce foaming in the spray chamber 302. Importantly, by placing the degas sprayer at a top of the degassing vessel 301 rather than at a base of the degassing vessel 301, the sprayer can reduce foaming by acting as a cap to control the foam. A finer spray cone, rather than a fountain type spray, can also increase atomization of the fluid and accelerate gas removal, increasing the efficiency of the degasser.
As described, a cone-like spray from the degas sprayer reduces foaming in the degassing vessel.
The degassing system should be able to control the carbon dioxide concentration in the dialysate flow path at the dialyzer inlet to a specified range, which in certain embodiments can be between 40 mmHg-150 mmHg pCO2. The expected range of CO2 concentrations at the inlet to the degassing flow loop can vary from between 85 to 650 mmHg pCO2. To predict the expected degasser inlet CO2 concentration, 10,000 simulated treatments were conducted.
As illustrated in
Fluid entering the degassing system will also contain dissolved nitrogen and oxygen gases. Table 2 summarizes the results of simulated treatments to determine the expected concentration ranges of oxygen and nitrogen when exiting the degasser as a function of the blood flow rate QB, the dialysate flow rate QD, the type of blood access, the dialyzer used, the initial patient nitrogen and oxygen blood concentrations CBin and the degasser inlet concentrations for both nitrogen and oxygen CDin. The simulations provided the dialysance D, as well as the degasser outlet concentration for oxygen and nitrogen CDout. The data in Table 2 was obtained assuming that the concentration of nitrogen in the patient's blood was approximately equal to atmospheric nitrogen concentration, or 600 mmHg. A low blood oxygen concentration was assumed to be 30 mmHg, while a high blood oxygen concentration was assumed to be 100 mmHg. The dialysance of oxygen and nitrogen was approximated by the KoA for urea. Table 3 summarizes the findings for possible ranges of each gas in the dialysate based on high or low values for each gas.
Table 3 summarizes the findings for possible ranges of each gas in the dialysate based on high or low values for each gas. As described, the possible ranges for carbon dioxide, nitrogen, and oxygen concentrations in the dialysate are used to control the degasser by setting a headspace pressure set point and degassing loop flow rate.
In certain embodiments, portions of the degasser flow path can be contained within a degasser manifold 601, as illustrated in
A controller (not shown) can control the pump rates of the fluid pump 613 and the dialysate pump (not shown) as described herein to control the fluid pressure entering the degasser 602. By varying the ratio of pump rates of the fluid pump 613 and dialysate pump, the ratio of fluid passing to the first outlet 605 and second outlet 611 of the degasser manifold 601 is controlled. Pressure sensor 615 can be located inside or outside of the degasser manifold 601 and can provide the fluid pressure of the fluid entering the degasser 602. As described, by using a fixed pressure change between the pressure as measured by pressure sensor 615 and the pressure within the degasser 602, a pressure change set point can be set, and the fluid pressure at pressure sensor 615 varied by changing the fluid pump 613 pump rate, thereby controlling the ratio of fluid passing to the first outlet 605 and second outlet 611 until the pressure change set point is reached.
A vent valve 711 fluidly connectable to the fluid passageway 706 can be selectively operated to allow air into the degasser 702 through inlet 712 of the vent manifold 701 when the degasser 702 is drained. Filter 713 connected to inlet 712 prevents contamination of the degasser 702, as described. During flushing, cleaning and disinfection of the dialysis system, the degasser 702 can be completely filled with liquid and liquid can be passed out of the degasser 702 through fluid passageway 706 through valve 714 to outlet 715 and fluid line 716, to a dialysate line.
As described, a controller (not shown) can control valve 707 to maintain a desired pressure within the degasser 702. In a preferred embodiment, the vacuum pump 709 is continuously run at a high rate, and the controller can pulse width modulate valve 707 to control the pressure in the degasser 702 to a desired target. A pressure sensor (not shown) can be included in the degasser 702 for control over the gas pressure. Alternatively, the pressure sensor can be included within the vent manifold 701. The removed gases are expelled through gas line 710, which can be vented to the air, or alternatively, connected to a waste reservoir.
One of skill in the art will understand that the described degassing systems can use either or both of the degasser manifold 601 illustrated in
The degasser manifold 601 and vent manifold 701 can be made of any biocompatible materials and can be in any shape suitable for being placed in the dialysate flow path. The manifolds can be produced using a standard injection molding, or by any other known methods. The sensors and the valves or other internal structures can be fixed or attached to the degasser manifold 601 and vent manifold 701 using techniques suitable to a person of skill in the art. In certain embodiments, the sensors and the valves can be welded to the main body of the degasser manifold 601 and vent manifold 701.
It will be apparent to one skilled in the art that various combinations and/or modifications and variations can be made in the dialysis system depending upon the specific needs for operation. Moreover, features illustrated or described as being part of an aspect of the invention can be included in the aspect of the invention, either alone or in combination.
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62/634,777 filed Feb. 23, 2018, the entire disclosure of which is incorporated by reference herein.
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| 0743071 | Nov 1996 | EP |
| 1124599 | May 2000 | EP |
| 1175238 | Nov 2000 | EP |
| 711182 | Jun 2003 | EP |
| 2308526 | Oct 2003 | EP |
| 1364666 | Nov 2003 | EP |
| 1523347 | Jan 2004 | EP |
| 1523350 | Jan 2004 | EP |
| 0906768 | Feb 2004 | EP |
| 1691863 | Apr 2005 | EP |
| 2116269 | Feb 2008 | EP |
| 1450879 | Oct 2008 | EP |
| 1514562 | Apr 2009 | EP |
| 2219703 | May 2009 | EP |
| 1592494 | Jun 2009 | EP |
| 1490129 | Sep 2009 | EP |
| 2100553 | Sep 2009 | EP |
| 2398529 | Nov 2010 | EP |
| 2575827 | Dec 2010 | EP |
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| 2388030 | Nov 2011 | EP |
| 2576453 | Dec 2011 | EP |
| 2701580 | Nov 2012 | EP |
| 2701595 | Nov 2012 | EP |
| 1545652 | Jan 2013 | EP |
| 1345856 | Mar 2013 | EP |
| 2344220 | Apr 2013 | EP |
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| 9532010 | Nov 1995 | WO |
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| 9937342 | Jul 1999 | WO |
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| 0057935 | Oct 2000 | WO |
| WO2000057935 | Oct 2000 | WO |
| 200066197 | Nov 2000 | WO |
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| 2001085295 | Sep 2001 | WO |
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| 2002043859 | Jun 2002 | WO |
| 2003043677 | May 2003 | WO |
| 2003043680 | May 2003 | WO |
| 2003051422 | Jun 2003 | WO |
| 2004008826 | Jan 2004 | WO |
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| 2004030716 | Apr 2004 | WO |
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| 2009024566 | Feb 2009 | WO |
| 2009026603 | Mar 2009 | WO |
| 2009061608 | May 2009 | WO |
| 2009064984 | May 2009 | WO |
| 2009067071 | May 2009 | WO |
| 2009071103 | Jun 2009 | WO |
| WO 2009073567 | Jun 2009 | WO |
| 2009094184 | Jul 2009 | WO |
| 2009132839 | Nov 2009 | WO |
| 2009157877 | Dec 2009 | WO |
| 2009157878 | Dec 2009 | WO |
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| 2010042666 | Apr 2010 | WO |
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| 2010052705 | May 2010 | WO |
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| 2010096659 | Oct 2010 | WO |
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| 2010102190 | Nov 2010 | WO |
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| WO 2011112317 | Sep 2011 | WO |
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| Number | Date | Country | |
|---|---|---|---|
| 20190262523 A1 | Aug 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62634777 | Feb 2018 | US |
