Patent Publication Number: US-2021171371-A1

Title: Sterile and/or purified fluid and/or solution delivery system

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 15/555,612, filed Sep. 5, 2017 which is a 371 of PCT/US2016/022287, filed Mar. 14, 2016, which claims the benefit of U.S. Provisional Patent Application Ser. Nos. 62/132,618, filed Mar. 13, 2015, and 62/132,589, filed Mar. 13, 2015, the entirety of each of which is hereby incorporated by reference for all purposes. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to systems and methods for the production of a sterilized and/or purified fluid and/or solution and, more particularly, to a system for on-demand delivery of sterile and/or purified fluids and/or solutions. 
     BACKGROUND 
     The use of systems in the medical field is known. A system may be used to dispense purified water, sterilized water, a sodium chloride solution, or any other fluid that may be needed during a medical procedure (e.g., surgery). Conventional systems rely on one or more containers (generally bags) for the supply of sterile fluid. The storage and transport of the bags, however, can be cumbersome. Additionally, certain medical procedures often require a greater volume of sterile fluid than what can be provided via the bags. 
     SUMMARY 
     The present disclosure relates to systems and methods for the production of a sterilized and/or purified fluid and/or solution and, more particularly, to a system for on-demand delivery of sterile and/or purified fluids and/or solutions. 
     One aspect of the present disclosure can include a system for on-demand deliver of sterile and/or purified fluids and/or solutions. The system can comprise a housing and at least one fluid reservoir associated with the housing. The at least one fluid reservoir can be configured to hold a fluid. A sterilization and/or purification mechanism can be in fluid communication with the at least one fluid reservoir. The sterilization and/or purification mechanism can be configured to sterilize and purify the fluid held by the at least one fluid reservoir. A solution production mechanism can be in fluid communication with the sterilization and/or purification mechanism. The solution production mechanism can be configured to optionally mix a solute with the sterilized and/or purified fluid to produce a solution. A dispensing mechanism can be in fluid communication with the sterilization and/or purification mechanism and configured to dispense the fluid and/or the solution. A controller can be associated with one or more of the housing, the at least one fluid reservoir, the sterilization and/or purification mechanism, the solution production mechanism and the dispensing mechanism. The controller can be configured to modulate at least one operating characteristic of the system. The system can be configured to deliver the sterile and/or purified fluid and/or solution immediately after a request for fluid and/or solution is made by an operator. 
     Another aspect of the present disclosure can include a method for providing a sterile and/or purified fluid and/or solution. The method can include the following steps: (a) flowing fluid through at least one filter of a system to remove impurities from the fluid; (b) deionizing the fluid; (c) reducing microorganisms (e.g., bacteria) and/or endotoxins (e.g., bacterial endotoxins) in the fluid (e.g., as compared to an initial or baseline level of the microorganisms and/or endotoxins); (d) optionally creating a solution by mixing the fluid with a solute after steps (a)-(c); and (d) requesting that the fluid and/or solution be dispensed from the system such that fluid and/or solution is dispensed immediately after the request is made. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing and other features and advantages of the present disclosure will become apparent to those skilled in the art to which the present disclosure relates upon reading the following description with reference to the accompanying drawings, in which: 
         FIG. 1  is a perspective view showing a sterile and/or purified fluid and/or solution delivery system constructed in accordance with one aspect of the present disclosure; 
         FIG. 2  is a schematic illustration of the system in  FIG. 1 ; 
         FIG. 3  is a schematic illustration of a sterilization mechanism comprising the system in  FIG. 1 ; 
         FIG. 4  is a perspective view of the system in  FIG. 1  showing a multi-bore solute cartridge carrier; 
         FIG. 5  is a perspective view of the system in  FIG. 1  with portions of its housing removed; 
         FIG. 6  is a rear perspective view of the in  FIG. 5 ; 
         FIG. 7  is an image of a dispensing mechanism comprising the system in  FIG. 1 ; and 
         FIG. 8  is a process flow diagram illustrating a method for providing a sterile and/or purified fluid according to another aspect of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Definitions 
     Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which the present disclosure pertains. 
     In the context of the present disclosure, the singular forms “a,” “an” and “the” can include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” as used herein, can specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. 
     As used herein, the term “and/or” can include any and all combinations of one or more of the associated listed items. 
     As used herein, phrases such as “between X and Y” and “between about X and Y” can be interpreted to include X and Y. 
     As used herein, phrases such as “between about X and Y” can mean “between about X and about Y.” 
     As used herein, phrases such as “from about X to Y” can mean “from about X to about Y.” 
     It will be understood that when an element is referred to as being “on,” “attached” to, “connected” to, “coupled” with, “contacting,” etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly on,” “directly attached” to, “directly connected” to, “directly coupled” with or “directly contacting” another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature. 
     Spatially relative terms, such as “under,” “below,” “lower,” “over,” “upper” and the like, may be used herein for ease of description to describe one element or feature&#39;s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms can encompass different orientations of the apparatus in use or operation in addition to the orientation depicted in the figures. For example, if the apparatus in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. 
     It will be understood that, although the terms “first,” “second,” etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise. 
     Overview 
     The present disclosure relates to systems and methods for the production of a sterilized and/or purified fluid and/or solution and, more particularly, to a system for on-demand delivery of sterile and/or purified fluids and/or solutions. The present disclosure provides a convenient and economical way of dispensing a sterile and/or purified fluid and/or solution. Drawbacks associated with conventional sterile fluid delivery systems (e.g., reverse osmosis-based systems), include fluid supply limitations, and the need to store fluid bags associated with such systems. Additionally, reverse osmosis-based systems are only capable of supplying on-demand sterile fluid at extremely low flow rates. Advantageously, the systems and methods of the present disclosure are able to provide on-demand sterile and/or purified fluid and/or solution at a flow rate greater than such conventional systems. Other advantages of the present disclosure are discussed below. In particular, it has been found that certain configurations of the present disclosure have been unexpectedly found to produce sterile and/or purified water that conforms to United States Pharmocopeial standards for water for injection and has less than 0.5 mg/L of total organic carbon, less than 1.3 μs/c, @ 25° C., less than 0.25 EU/mL endotoxins, and less that 10 CFU/100 mL microbial count. 
     Systems 
     One aspect of the present disclosure can include a system  10  ( FIGS. 1-2 ) for on-demand delivery of a sterile and/or purified fluid and/or solution. As shown in  FIG. 2 , the system  10  can comprise a housing  12  and at least one fluid reservoir  40  associated with the housing  12 . The at least one fluid reservoir  40  can be configured to hold a fluid. Alternatively, the reservoir  40  can be omitted, and the system  10  can be permanently attached to an external fluid source (e.g., a faucet). A sterilization and/or purification mechanism  50  can be in fluid communication with the at least one fluid reservoir  40 . The sterilization and/or purification mechanism  50  can be configured to sterilize and purify the fluid held by the at least one fluid reservoir  40 . A solution production mechanism  70  can be in fluid communication with the sterilization and/or purification mechanism  50 . The solution production mechanism  70  can be configured to optionally mix a solute with the sterilized and/or purified fluid to produce a solution. A dispensing mechanism  90  can be in fluid communication with the sterilization and/or purification mechanism  50  and configured to dispense the fluid and/or the solution. A controller  14  can be associated with one or more of the housing  12 , the at least one fluid reservoir  40 , the sterilization and/or purification mechanism  50 , the solution production mechanism  70  and the dispensing mechanism  90  via electronic signals  13 . The controller  14  can be configured to modulate at least one operating characteristic of the system  10 . 
     The system  10  can be configured to deliver the sterile and/or purified fluid and/or solution immediately after a request for fluid and/or solution is made by an operator. As used herein, the terms “on-demand” and “instantaneously” can mean that, after an initial start-up time period (e.g., five minutes or less), the systems and methods of the present disclosure can supply sterile and/or purified fluids and/or solutions within about ten seconds after a request for the sterile and/or purified fluid and/or solution has been made. 
     In one aspect, the housing  12  can be configured to enclose certain components of the system  10 , such as the fluid reservoir  40 , the sterilization and/or purification mechanism  50 , and the solution production mechanism  70 . The housing  12  can include a plurality of walls that define an interior storage space for certain components of the system  10 . One or more of the walls can be opaque or transparent. In one aspect, the walls of the housing  12  can be arranged to have a cuboid configuration that occupies approximately 0.5 cubic meters of space. It will be appreciated that the housing  12  can be arranged to have any other suitable shape that allows the housing  12  to enclose components of the system  10 . The housing  12  can be made of one or a combination of materials, such as metals (e.g. stainless steel) or non-metals (e.g. hardened plastics). The housing  12  can be provided with wheels  16  to facilitate transportation of the system  10 . The housing  12  can be provided with one or more doors for accessing components of the system  10 . In one aspect, a door  18  can be configured to gain access to components of the solution production mechanism  70 , such as a multi-bore solute cartridge carrier  72  (discussed below). An additional door (not shown) can be configured to gain access to filtration components. 
     A connection port  20  can be provided on the housing  12 . The connection port  20  can be configured to connect the dispensing mechanism  90  to the housing  12 . An intake port  21  can also be provided on the housing  12 . The intake port  21  can be configured to allow the system  10  to be filled with a fluid, such as water. The housing  12  can be provided with an electrical connection (not shown) for providing power to the system  10  (e.g., no more than 20 amperes at 115 volts alternating current or 10 amperes at 220 volts single phase). The system  10  can also include a frame  22  ( FIGS. 5-6 ) to which the housing  12  is mounted. The frame  22  can be manufactured out of a single material or a combination of materials, such as metals, plastics, or a combination thereof. 
     A user interface/control module  23  can be associated with the housing  12 . The user interface/control module  23  can be in electrical communication with the controller  14 . The user interface/control module  23  may include various electrical components (e.g. micro processor, memory) configured to control certain operational characteristics of the system  10 , such as fluid flow rate, fluid temperature, and/or solute concentration. The user interface/control module  23  may be provided with software programs. In one aspect, the user interface/control module  23  can comprise a touch screen that enables an operator to interact with the software program(s) and control operational characteristics of the system  10 . 
     The fluid reservoir  40  can be directly or indirectly attached to the frame  22 . The fluid reservoir  40  can be configured to hold a fluid (e.g., non-sterile water) prior to sterilization and/or purification by the system  10 . In one aspect, the fluid reservoir  40  is capable of holding at least 15 L of fluid. It will be appreciated that other sized fluid reservoirs may be used. The fluid reservoir  40  is fluidly coupled to the intake port  21  by a first fluid conduit  24   a . In general, the first fluid conduit  24   a  can be a tube having a substantially circular cross-section. The first fluid conduit  24   a  can have a rigid, semi-rigid, or flexible configuration, and be made of one material or a combination of materials. A second fluid conduit  24   b  can fluidly couple the fluid reservoir  40  to a water pump  42 , which is attached to the frame  22 . In one aspect, the water pump  42  is a ⅛ horsepower diaphragm-type pump. It will be appreciated that any other suitable pump may be used. 
     The sterilization and/or purification mechanism  50  can be directly or indirectly attached to the frame  22  and fluidly coupled to the water pump  42  by a third fluid conduit  24   c  ( FIG. 3 ). The sterilization and/or purification mechanism  50  can include any number of components and arrangements configured to remove impurities from, and sterilize, the fluid contained in the fluid reservoir  40 . The sterilization and/or purification mechanism  50  can include at least one filter  51 , at least one mixed bed resin tank  58 , at least one continuous electrodeionization module  60 , and at least one ultra-violet module  62 . In one example, the sterilization and/or purification mechanism  50  can include three filters  52 ,  54 ,  56 , one mixed bed resin tank  58 , one continuous electrodeionization module  60 , and two ultra-violet modules  62 ,  64 . 
     In some instances, the filters  51  comprising the sterilization and/or purification mechanism  50  can include a pre-filter  52  designed to remove impurities larger than about 5 μm, a carbon filter  54  designed to remove impurities larger than about 1 μm, and a fines filter  56  designed to remove impurities larger than about 1 μm. The mixed bed resin tank  58  can include anion and cation resins configured to remove poisonous and heavy metals from the fluid. The continuous electrodeionization module  60  can be configured to substantially deionize the fluid. The ultra-violet modules  62 ,  64  can be configured to emit energy at about 254 nm to disinfect the fluid and destroy ozone in the fluid. The ultra-violet modules  62 ,  64  can further be configured to emit energy at about 185 nm to destroy and decompose organic molecules in the fluid. 
     It will be appreciated that the components comprising the sterilization and/or purification mechanism  50  can be configured to achieve various purification and sterilization goals. For example, the number of filters can be increased or decreased. Additionally, the selectivity of the filters can be changed to remove impurities larger than 5 μm or smaller than 1 μm. In another example, the number of ultra-violet modules can be increased or decreased, as can the emitted wavelength of each lamp. As a further example, a capacitive deionization module can be substituted for the continuous electrodeionization module  60 . 
     The solution production mechanism  70  can be configured to mix the sterilized and/or purified fluid produced by the sterilization and/or purification mechanism  50  with a solute to create a sterilized and/or purified solution. The solution production mechanism  70  can be directly or indirectly attached to the frame  22 . The solution production mechanism  70  can be fluidly coupled to the sterilization and/or purification mechanism  50  by a fourth fluid conduit  24   d . In one aspect, the solution production mechanism  70  can include a multi-bore solute cartridge carrier  72 , at least one mix tank  74 , and at least one solution reservoir tank  76 . One example of the multi-bore solute cartridge carrier  72  is disclosed in U.S. Prov. Patent Appln. Ser. No. 62/132,589, filed Mar. 13, 2015 (hereinafter, “the &#39;589 application”). The mix tank  74  can be configured to ensure that the sterilized and/or purified solution is adequately mixed to form a desired solution. For example, the mix tank  74  can include agitators that agitate the sterilized and/or purified fluid to ensure the solute is completely dissolved therein. 
     The solution reservoir tank  76  can be configured to hold the resultant sterilized and/or purified solution until it is requested by an operator. It will be appreciated that the solution production mechanism  70  can be modified to alter various performance characteristics of the system  10 . For example, the size of the solution reservoir tank  76  may be increased or decreased to allow the system  10  to hold a greater or lesser amount of purified and sterilized solution that is ready for on-demand use. 
     A solution bypass line  80  can be provided in parallel flow with the solution production mechanism  70 . The solution bypass line  80  can include a bypass line filter that is fluidly  82  coupled to the sterilization and/or purification mechanism  50  by a sixth fluid conduit  24   f . In one aspect, the bypass line filter  82  is designed to remove impurities larger than 0.1 μm. 
     A temperature regulating mechanism  84  configured to heat and/or cool the fluid can be directly or indirectly attached to the frame  22 . The temperature regulating mechanism  84  can be fluidly coupled to the solution production mechanism  70  and the solution bypass line  80  by a seventh fluid conduit  24   g . A final filter  78  can be disposed between the solution production mechanism  70  and the temperature regulating mechanism  84 . The final filter  78  can be fluidly coupled to the solution production mechanism  70  and the temperature regulating mechanism by a fifth fluid conduit  24   e , and the seventh fluid conduit  24   g , respectively. In one aspect, the first final filter  78  is designed to remove impurities larger than about 0.1 μm. 
     The temperature regulating mechanism  84  can additionally be configured to direct fluid that flows through the solution production mechanism  70  along a first fluid route  25   a  and/or to direct fluid that passes through the solution bypass line  80  along a second fluid route  25   b . In one aspect, the temperature regulating mechanism  84  can include resistive heaters to heat the fluid and/or a compressed gas refrigeration cycle to cool the fluid to regulate the fluid temperature to about 45° C. such that the fluid is close to body temperature once the fluid reaches the patient. It will be appreciated that any other suitable heating and cooling mechanism may be used, and that the temperature regulating mechanism  84  can be configured to regulate the temperature of the fluid to any desired temperature. An eighth fluid conduit  24   h  can fluidly couple the temperature regulating mechanism  84  to the connection port  20 . The eighth fluid conduit  24   h  can be configured to maintain the separate first and second fluid routes  25   a ,  25   b.    
     Referring to  FIG. 7 , the system  10  can include a dispensing mechanism  90  adapted for connection with the connection port  20 . In one aspect, the dispensing mechanism  90  can include a tubular portion  92 , a male connection member  94  disposed at a first end of the tubular portion  92 , and a dispensing member  96  disposed at a second end of the tubular portion  92  opposite the first end. The male connection member  94  can include a first fluid path  25   c  and a second fluid path  25   d , and can be configured to be inserted into the connection port  20 . When the male connection member  94  is inserted into the connection port  20 , the first and second fluid paths  25   c ,  25   d  of the male connection member  94  can be fluidly coupled to the first and second fluid routes  25   a ,  25   b , respectively, of the eighth fluid conduit  24   h.    
     The tubular portion  92  of the male connection member  94  can include a flexible hose configured to separately maintain the first and second fluid paths  25   c ,  25   d . The tubular portion  92  can include a first tubeset filter  98  and a second tubeset filter  99  respectively disposed in the first fluid path  25   c  and the second fluid path  25   d . In one aspect, the first and second tubeset filters  98 ,  99  can be designed to remove impurities larger than about 0.05 μm. It will be appreciated that any other suitable filter can be used. 
     The dispensing member  96  can include an ergonomic handle  100 . A first end of the handle  100  can be configured for connection with the second end of the tubular portion  92 . A second end of the handle  100  opposite the first end can be configured to dispense the purified and sterilized fluid and/or solution to a desired area. In one aspect, the handle  100  can be configured to combine the first and second fluid paths  25   c ,  25   d  into a single fluid path that flows out of the second end of the handle  100 . It will be appreciated that the handle can be configured to keep the first and second fluid paths  25   c ,  25   d  separate. 
     The handle  100  can comprise at least one dispensing button  102   a - c . In one aspect, the handle  100  can include a first dispensing button  102   a  associated with the first fluid path  25   c , and a second dispensing button  102   b  associated with the second fluid path  25   d . It will be appreciated that the handle  100  may be provided with a fewer or greater number of buttons to customize the level of fluid control afforded to an operator of the system  10 . 
     Methods 
     Another aspect of the present disclosure can include a method  300  ( FIG. 8 ) for providing a sterile and/or purified fluid and/or solution. First, an operator can fill the fluid reservoir  40  with a desired fluid, such as water. In one example, the operator can fill the fluid reservoir  40  by attaching a filling hose to the intake port  21 . It will be appreciated that other methods can be used to fill the fluid reservoir  40 . For example, the housing  12  can be provided with an access port that allows access to the fluid reservoir  40 . Alternatively, an operator can transfer water directly from a fluid carrying vessel to the fluid reservoir  40  via the access port. 
     Next, the operator can connect the system  10  with a power source via the electrical connection provided on the housing  12 . The operator can also ensure the dispensing mechanism  90  is connected with the connection port  20 . The operator can then interface with the system  10  via the user interface/control module  23  to set desired parameters relating to the fluid and/or solution that is to be dispensed. In one example, the user interface/control module  23  can enable the operator to control the temperature and flow rate of the dispensed fluid and/or solution. It will be appreciated that the user interface/control module  23  can be customized to control other operational characteristics of the system  10 , such as the concentration of the dispensed fluid and/or solution. The user interface/control module  23  can also be configured to provide information relating to the condition of various characteristics of the system  10 , such as the amount of fluid remaining in the fluid reservoir  40 . 
     Once the parameter(s) of the fluid and/or solution to be dispensed is/are programmed, the water pump  42  is operated to pump water from the fluid reservoir  40  to the sterilization mechanism  50  via the second and third fluid conduits  24   b ,  24   c . At Steps  301 - 304 , the water is purified and sterilized as it passes through the sterilization mechanism  50 . For example, purification and sterilization of the water can be achieved by passing the water through the pre-filter  52 , the carbon filter  54 , the mixed bed resin tank  58 , the fines filter  56 , the first ultraviolet module  62 , the continuous electrodeionization module  60  and the second ultraviolet module  64 . 
     Next, the water can be directed into one of two separate fluid paths. A first fluid path carries the water to the solution production mechanism  70 . A second fluid path carries the water to the bypass line  80 . If the water is directed to the solution production mechanism  70  (Step  306 ), the multiple-bore solute cartridge carrier  72  mixes the sterilized and/or purified water with a solute to create a sterilized and/or purified solution as discussed in the &#39;589 application. The solution can then pass into the mix tank  74 , where the solution can be further agitated. The solution can next pass into the solution reservoir tank  76  where the solution remains until the operator makes a request for its delivery. 
     The operator can request that the solution be dispensed by depressing the first button  102   a  on the handle  100 . When the first button  102   a  is depressed, the solution can flow through the final filter  78  into the temperature regulating mechanism  84 . At Step  308 , the temperature regulating mechanism  84  can heat or cool the fluid and/or solution as desired. The fluid and/or solution can then flow from temperature regulating mechanism  84  through the connection port  20 , via the dispensing mechanism  90  while passing through the first tubeset filter  98  (Step  310 ). The solution can be dispensed at a rate of at least 1 L/min (e.g., about 1-2 L/minute, about 2-3 L/minute, about 3-4 L/minute, about 4-5 L/minute, about 5-6 L/minute, about 6-7 L/minute, about 7-8 L/minute, about 8-9 L/minute, about 9-10 L/minute, or greater than 10 L/minute, such as 10-20 L/minute, 20-30 L/minute, 30-40 L/minute, or more), which advantageously allows the operator to thoroughly and quickly irrigate a worksite (e.g., cleaning tissue during surgery in an operating room). In one example, the solution can be dispensed at a rate of 10 L/minute. 
     The operator can additionally or alternatively request that a sterilized and/or purified fluid (e.g., free of solute) be dispensed by depressing the second button  102   b  on the handle  100 . When the second button  102   b  is depressed, the fluid can be directed along the second fluid path through the bypass line  80 . The fluid can then flow through the second final filter  82  and the connection port  20  via the dispensing mechanism  90  while passing through the second tubeset filter  99  (Step  310 ). The fluid can be dispensed at a rate of at least 1 L/minute (e.g., 10 L/minute), which advantageously allows the operator to thoroughly and quickly irrigate a worksite (e.g., cleaning tissue during surgery). It will be appreciated that the system  10  can be configured to dispense a sterilized and/or purified solution or fluid at a rate of less than 1 L/minute (e.g. about 1-0.9 L/minute, about 0.9-0.8 L/minute, about 0.8-0.7 L/minute, about 0.7-0.6 L/minute, about 0.6-0.5 L/minute, about 0.5-0.4 L/minute, about 0.4-0.3 L/minute, about 0.3-0.2 L/minute, about 0.2-0.1 L/minute, or 0.1 L/minute or less). For instance, the system  10  can be configured to dispense a sterilized and/or purified solution or fluid at a rate of 0.8 L/minute. 
     From the above description of the present disclosure, those skilled in the art will perceive improvements, changes and modifications. For example, the system  10  can be configured to deliver pulsatile flow. Additionally, the system can include a sensing mechanism (not shown) in electrical communication with the controller  14  and/or the user interface/control module  23 . The sensing mechanism can sense characteristics of the fluid and or solution, such as flow rate, pH level, pressure, salinity, etc. All patents and patent applications identified herein are hereby incorporated by reference for all purposes. Such improvements, changes, and modifications are within the skill of the art and are intended to be covered by the appended claims.