Fluid temperature control system

Abstract

To provide systems and methods for heating and cooling fluids for use in health care.SOLUTION: Described herein is a system for heating and / or cooling a fluid that includes a temperature forcing device having a bottom plate and a top plate hingedly coupled to the bottom plate. At least one of the bottom plate and the top plate has a recess or other area for receiving at least one flexible fluid holder (e.g., a polymer bag). The bottom plate and / or top plate also has at least one protrusion and / or recession in its interior wall(s) such that a fluid passageway is defined in the flexible fluid holder when the fluid holder is placed between the top and bottom plates and the plates are closed together. The fluid holder further has a fluid inlet for receiving the fluid to be heated and / or cooled and a fluid outlet for delivering the fluid.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application No. 62 / 888,301, filed on August 16, 2019; U.S. Provisional Application No. 62 / 891,156, filed on August 23, 2019; and U.S. Provisional Application No. 62 / 948,717, filed on December 16, 2019, the entire contents of which are incorporated herein by reference.

[0002] The subject matter described herein relates to systems and methods for heating and cooling fluids, particularly for medical use.

Background Art

[0003] In modern medical systems and treatment methods, treatment fluids such as blood, saline, crystalloid solutions, dialysis fluids, etc. often require temperature adjustment (heating and / or cooling) before being delivered to a patient. Treatment may include adjustment of a patient's body temperature using a temperature management device. Temperature adjustment is often performed by warming a heat transfer fluid using a resistive heater and cooling the same heat transfer fluid using a cooling system as needed. The heat transfer fluid may then be pumped through a heat exchanger where heat energy is transferred to and / or from the treatment fluid and / or the temperature management device.

[0004] Other systems may utilize solid heater / cooling devices to perform both heating and cooling functions via a heat transfer fluid. In these systems, the heat transfer fluid is pumped through a heat exchanger where heat energy is transferred to the treatment fluid.

[0005] One drawback of these methods and systems is that the heat transfer fluid typically operates at a temperature at (or near) normal body temperature (i.e., 98.6°F). This makes it particularly susceptible to bacterial growth, culturing, and proliferation, increasing the risk of patient infection. In such methods and systems, to inhibit growth, high temperatures (e.g., temperatures exceeding 121°C) and / or disinfectants are required, which can cause damage to the machinery.

[0006] Another drawback of existing systems is the accidental mixing of the heat transfer fluid and the treatment fluid, which can cause bacterial contamination of the system and / or an increased risk to the patient. Additionally, existing fluid heating systems may employ a flexible bag that includes fluid passages defined by welded channels in the form of serpentine fluid paths. Existing systems may also warm blood by inserting it through a cartridge into a chamber with a closed, narrow slot. Since such a chamber with a narrow slot is closed, it can be difficult to clean and detect fluid leakage, and sterilization becomes an issue. Further, since existing fluid heating systems may not be easily opened, it is difficult to visualize whether cleaning is necessary. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0007] Described herein is a system for heating and / or cooling a fluid, comprising a temperature forcing device having a bottom plate and an upper plate hinged to the bottom plate. At least one of the bottom plate and the upper plate has a recess or other area for receiving at least one fluid holder. The system also comprises at least one flexible fluid holder. In certain embodiments, the flexible fluid holder comprises a plastic bag containing polyvinyl chloride (PVC) and / or other polymers such as, for example, ethylene vinyl acetate (EVAM), polypropylene, and / or copolyester ether. The fluid holder has a fluid inlet for receiving the fluid to be heated and / or cooled and a fluid outlet for delivering the fluid. The fluid, when heated and / or cooled by the temperature forcing device, may then be delivered to a patient or to another system component for further heating / cooling. In some embodiments, the system component makes physical contact directly with the patient's body to manage the patient's body temperature. For example, in some embodiments, the system component is a blanket, wrap, or mattress containing the fluid. In some embodiments, the fluid is a treatment fluid. For example, in some embodiments, the fluid is a treatment fluid and the system operates without the need for a heat transfer fluid. In some embodiments, the fluid is a heat transfer fluid. In some embodiments, the fluid being heated and / or cooled (e.g., treatment fluid or heat transfer fluid) does not contact the temperature forcing device directly, so that the temperature forcing device has a reduced risk of being a breeding ground for pathogens in a medical environment. In some embodiments, the fluid passage and the remaining fluid can be completely disposed of, thereby reducing the risk of contamination of the temperature forcing device.

[0008] In some embodiments, the top plate and / or the bottom plate include at least one recess and / or at least one protrusion to create a fluid passage between the top plate and the bottom plate when the device is closed. Closing means bringing (e.g., contacting or not contacting) the top plate and the bottom plate closer to each other by a hinge that couples the top plate and the bottom plate. In the closed position, the top plate and the bottom plate may contact each other at edges, protrusions, and / or other locations(s). When the device is closed, a fluid passage is defined within the flexible fluid holder by at least one recess and / or at least one protrusion on the inner wall(s) of the top plate and / or the bottom plate, and the fluid holder is inserted between the plates before the device is closed (e.g., the fluid holder is disposed within or on a recess or other area of the bottom plate or the top plate before closing). In certain embodiments, the passage defines a separate channel between the inlet and the outlet of the fluid holder (e.g., pre-welded). In certain embodiments, the fluid passage is formed only when the device is in the closed state; otherwise, the fluid holder does not have a passage that defines a separate channel between the inlet and the outlet of the fluid holder.

[0009] In some embodiments, the temperature forcing device is capable of both cooling and heating the fluid. In some embodiments, the temperature forcing device includes a solid device (e.g., a Peltier device and / or a thermoelectric cooler). In some embodiments, the temperature forcing device includes a resistive heater. In some embodiments, the temperature forcing device includes a compressor. In some embodiments, the temperature forcing device may include at least one fin disposed on at least one of the bottom plate and / or the top plate.

[0010] In some embodiments, the system includes at least one latch disposed within or on at least one of the bottom plate and the top plate, or within or on a support or housing for at least one of the bottom plate and the top plate.

[0011] In some embodiments, the system has at least one fluid holder attached to the mounting sheet.

[0012] In some embodiments, the system has at least one fluid holder (e.g., a mounting sheet) shaped and sized to be inserted into and removed from the device.

[0013] In some embodiments, the system includes at least one power source electrically coupled to a resistive heater disposed in or on or under at least one of the top plate and the bottom plate. In some embodiments, the system includes at least one power source electrically coupled to a solid device (e.g., a Peltier device, and / or a thermoelectric cooler, e.g., a dry solid device) disposed in or on or under at least one of the top plate and the bottom plate.

[0014] In some embodiments, the system includes at least one pin protruding from the bottom plate and / or the top plate, and when disposed within the temperature forcing device, each of the at least one pin is inserted through a corresponding hole in the fluid holder and / or its mounting sheet to secure the fluid holder and / or its mounting sheet.

[0015] In some embodiments, the system does not include any heat transfer fluid.

[0016] In some embodiments, the temperature forcing device has a maximum operating temperature (e.g., the maximum controlled temperature of the fluid) of from about 40°C to about 60°C, or from about 40°C to about 50°C, or from 40°C to about 45°C. In some embodiments, the temperature forcing device has an operating temperature range (e.g., the controlled temperature range of the fluid) that encompasses a range of from about 1°C to about 60°C, or from about 20°C to about 50°C, or from about 30°C to about 45°C.

[0017] In some embodiments, the system is adapted to (e.g., enables) a maximum flow rate through the temperature forcing device of from about 5 L / min to about 15 L / min, or from about 7 L / min to about 13 L / min, or from about 9 L / min to about 12 L / min.

[0018] In some embodiments, the treatment fluid includes at least one of blood, a crystalloid fluid, and a dialysis fluid.

[0019] In some embodiments, the heat transfer fluid is selected from the group consisting of water, saline, oil, silicone fluid, propylene glycol, and combinations thereof.

[0020] Also described herein is a flexible fluid holder for containing a fluid (e.g., a treatment fluid or a heat transfer fluid), the fluid holder including a fluid inlet that enables the fluid to flow into the fluid holder, a fluid outlet that enables the fluid to flow out of the fluid holder, and at least one fluid passage within the fluid holder that fluidly connects the fluid inlet to the fluid outlet. In certain embodiments, the fluid passage is defined by an upper plate and / or a bottom plate of a solid device into which the fluid holder is inserted, the passage being formed when the upper plate and the bottom plate are closed.

[0021] In some embodiments, the upper plate and / or the bottom plate comprises at least one recess and / or at least one protrusion (e.g., for creating the passage when the upper plate and the bottom plate are closed, e.g., for the upper plate and the bottom plate to be proximate or in contact along an edge when closed).

[0022] In another embodiment, the fluid holder for containing the treatment fluid includes a fluid inlet that allows the treatment fluid to flow into the fluid holder, a fluid outlet that allows the treatment fluid to flow out of the fluid holder, and at least one fluid passage disposed within the fluid holder that fluidly connects the fluid inlet to the fluid outlet. The fluid passage is defined by at least one protrusion and / or at least one recess on the inner wall of the solid device into which the fluid holder is inserted (e.g., the passage is formed when the device is in a closed state).

[0023] Also described herein is a method of regulating the temperature of a fluid, including providing a temperature forcing device having a bottom plate and an upper plate hingedly coupled to the bottom plate. At least one of the bottom plate and the upper plate includes a region (e.g., a recess) disposed therein or thereon for receiving a flexible fluid holder (e.g., a plastic bag) through which a fluid to be heated and / or cooled flows. The upper plate and / or the bottom plate include at least one recess and / or at least one protrusion for creating a fluid passage between the upper plate and the bottom plate when the temperature forcing device is closed, the fluid passage defining a channel between a fluid inlet and a fluid outlet of the flexible fluid holder. The upper plate and / or the bottom plate may include a solid device and / or a resistive heater, and / or a heater heat exchanger from a compression cycle, disposed therein, thereon, or thereunder. The method further includes inserting a fluid holder between the bottom plate and the upper plate, positioning the upper plate near the bottom plate (e.g., thereby forming a channel through which fluid can flow from an inlet to an outlet within the fluid holder, the channel being formed by raised portions, grooves, and / or other textural features of the upper plate and / or the bottom plate), delivering fluid to a fluid inlet disposed in the fluid holder, and supplying power to at least one power source electrically coupled to the temperature forcing device to adjust the temperature of the fluid as the fluid flows from the fluid inlet to the fluid outlet of the flexible fluid holder between the upper plate and the bottom plate of the temperature forcing device. The method may include implementing one or more features of an embodiment of the system described herein.

[0024] Throughout the description, when an apparatus, system or composition is described as having, including or comprising certain components, or when a method is described as having, including or comprising certain steps, it is contemplated that there are also systems or compositions of the invention that consist essentially of or consist of the described components, and methods according to the invention that consist essentially of or consist of the described process steps, in addition thereto.

[0025] It should be understood that the order of steps or the order of performing certain acts is not critical as long as the invention is operable. Further, two or more steps or acts may be performed simultaneously.

[0026] The following description is for the purpose of illustration and description of the present disclosure only and is not intended to limit the invention to the specific embodiments described.

[0027] Any mention of publications in this specification, for example in the background art section, does not admit that the publication is prior art with respect to any of the claims presented herein. The background art section is presented for clarity and is not intended as an explanation of prior art with respect to any claim.

[0028] The present invention provides, for example, the following. (Item 1) A system for heating and / or cooling a fluid, at least one flexible fluid holder, A temperature forcing device including a bottom plate and an upper plate hinged to the bottom plate, at least one of the bottom plate and the upper plate including a recess or other area for receiving the at least one flexible fluid holder (e.g., a plastic bag) disposed therein or thereon, the at least one fluid holder including a fluid inlet for receiving the fluid to be heated and / or cooled and a fluid outlet for delivering the heated and / or cooled fluid from the temperature forcing device. The system. (Item 2) The system according to item 1, wherein the fluid is a therapeutic fluid (e.g., the system operates without the need for a heat transfer fluid). (Item 3) The system according to item 1, wherein the fluid is a heat transfer fluid. (Item 4) The system according to any one of the preceding items, wherein the at least one flexible fluid holder and the temperature forcing device are arranged such that the fluid being heated and / or cooled does not directly contact the temperature forcing device. (Item 5) The system according to any one of the preceding items, including a completely disposable fluid passage. (Item 6) The system according to any one of the preceding items, wherein the upper plate and / or the bottom plate includes at least one recess and / or at least one protrusion for creating a fluid passage between the upper plate and the bottom plate when the temperature forcing device is closed. (Item 7) The system according to item 6, wherein when the temperature forcing device is closed, the fluid passage is defined by the at least one recess and / or the at least one protrusion on the inner wall(s) of the upper plate and / or the bottom plate in the flexible fluid holder, and the flexible fluid holder is inserted between the upper plate and the bottom plate before the temperature forcing device is closed. (Item 8) The system according to item 7, wherein the fluid passage defines a separate channel between the inlet and the outlet of the fluid holder. (Item 9) The system according to any one of items 6 to 8, wherein the fluid passage is formed only when the temperature forcing device is in a closed state, and otherwise, the fluid holder does not have a passage defining a separate channel between the inlet and the outlet of the fluid holder. (Item 10) The system according to any one of the preceding items, wherein the temperature forcing device performs both heating and cooling of the fluid. (Item 11) The system according to any one of the preceding items, wherein the temperature forcing device includes a solid device (e.g., a Peltier device and / or a thermoelectric cooler). (Item 12) The system according to item 11, wherein the solid device is disposed in, on, or under at least one of the upper plate and the bottom plate. (Item 13) The system according to any one of the preceding items, wherein the temperature forcing device includes a resistance heater. (Item 14) The system according to any one of the preceding items, further comprising at least one power source electrically coupled to one or more heating and / or cooling elements (s) of the temperature forcing device. (Item 15) The system according to any one of the preceding items, including at least one fin disposed on at least one of the bottom plate and the upper plate. (Item 16) The system according to any one of the preceding items, including at least one latch for releasably fixing the bottom plate and the upper plate in a closed position. (Item 17) The system according to any one of the preceding items, wherein each of the at least one fluid holder is attached to a mounting sheet. (Item 18) The system according to any one of the preceding items, wherein the at least one fluid holder (e.g., and / or the mounting sheet(s)) is shaped and sized to be inserted into and removed from the temperature forcing device. (Item 19) The system according to any one of the preceding items, comprising at least one pin protruding from the bottom plate, the at least one pin being inserted through at least one hole of one or more of the at least one fluid holder (e.g., and / or the mounting sheet(s)) to maintain the fluid holder removably disposed within the temperature forcing device. (Item 20) The system according to any one of the preceding items, wherein the temperature forcing device has a maximum operating temperature of from about 40°C to about 60°C, or from about 40°C to about 50°C, or from about 40°C to about 45°C. (Item 21) The system according to any one of the preceding items, wherein the temperature forcing device has an operating temperature range encompassing a range of from about 1°C to about 60°C, from about 20°C to about 50°C, or from about 30°C to about 45°C. (Item 22) The system according to any one of the preceding items, wherein the system corresponds to (e.g., enables) a maximum flow rate through the temperature forcing device of from about 5 L / min to about 15 L / min, or from about 7 L / min to about 13 L / min, or from about 9 L / min to about 12 L / min. (Item 23) The system according to item 2, wherein the treatment fluid comprises at least one of blood and dialysate. (Item 24) The system according to item 3, wherein the heat transfer fluid is selected from the group consisting of water, oil, silicone fluid, propylene glycol, and combinations thereof. (Item 25) The system according to any one of the preceding items, further comprising a pump (e.g., a peristaltic pump) for pumping fluid through the temperature forcing device. (Item 26) The system according to any one of the preceding items, further comprising a component sized and shaped to at least partially conform to the body of the patient when physically contacting the patient to manage the patient's body temperature. (Item 27) The system according to item 26, wherein the component is a blanket, wrap, or mattress containing the fluid. (Item 28) A method of adjusting the temperature of a fluid, comprising: providing a temperature forcing device, the temperature forcing device including a bottom plate and an upper plate hinged to the bottom plate, at least one of the bottom plate and the upper plate including a region (e.g., a recess) for receiving a flexible fluid holder (e.g., a plastic bag) through which a fluid for heating and / or cooling flows, disposed therein or thereon, the upper plate and / or the bottom plate including at least one recess and / or at least one protrusion for creating a fluid passage between the upper plate and the bottom plate when the temperature forcing device is closed, the fluid passage defining a channel between a fluid inlet and a fluid outlet of the flexible fluid holder (e.g., the upper plate and / or the bottom plate includes a solid device and / or a resistance heater disposed therein, thereon, or thereunder), the providing; placing the at least one flexible fluid holder in the region of the bottom plate or the upper plate disposed therein or thereon for receiving the at least one flexible fluid holder; placing the upper plate near the bottom plate with the flexible fluid holder disposed between the upper plate and the bottom plate (e.g., when the temperature forcing device is closed); delivering the fluid to the fluid inlet disposed in the at least one fluid holder; When the fluid flows from the fluid inlet to the fluid outlet of the flexible fluid holder between the upper plate and the bottom plate of the temperature forcing device, to adjust the temperature of the fluid, supplying the power of at least one power source electrically coupled to the temperature forcing device The method including the above. (Item 29) The method according to item 28, wherein the fluid is a treatment fluid. (Item 30) The method according to item 28, wherein the fluid is a heat transfer fluid. (Item 31) A flexible fluid holder for containing a fluid, wherein the fluid holder has a fluid inlet that enables the fluid to flow into the fluid holder, and a fluid outlet that enables the fluid to flow out of the fluid holder, and at least one fluid passage disposed within the fluid holder, the at least one fluid passage fluidly connecting the fluid inlet to the fluid outlet, wherein the at least one fluid passage is defined by at least one of the upper plate and the bottom plate of the temperature forcing device into which the fluid holder is inserted (for example, when the device is closed, i.e., when the upper plate and the bottom plate are joined). The flexible fluid holder. (Item 32) The fluid holder according to item 31, wherein the fluid is a treatment fluid. (Item 33) The fluid holder according to item 31, wherein the fluid is a heat transfer fluid. (Item 34) The fluid holder according to item 31, wherein at least one of the upper plate and the bottom plate further comprises at least one of a recess and a protrusion that defines the at least one fluid passage when the temperature forcing device is closed. (Item 35) A flexible fluid holder for containing a fluid, wherein the fluid holder has a fluid inlet that enables the fluid to flow into the fluid holder, a fluid outlet that enables the fluid to flow out of the fluid holder, and at least one fluid passage disposed within the fluid holder that fluidly connects the fluid inlet to the fluid outlet, wherein the at least one fluid passage is defined by at least one protrusion and / or at least one recess in at least one inner wall of a temperature forcing device into which the fluid holder is inserted, the flexible fluid holder. A complete and enabling disclosure of embodiments of the present disclosure, including the best mode, directed to those of ordinary skill in the art, is set forth in this specification with reference to the accompanying figures.

Brief Description of the Drawings

[0029]

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Mode for Carrying Out the Invention

[0030] Embodiments of the present disclosure will now be described in detail, one or more examples of which are shown in the accompanying drawings. The detailed description uses numbers and / or letters to refer to features of the drawings. Similar designations in the drawings and the description are used to refer to similar parts of the embodiments.

[0031] Some embodiments of the present disclosure provide systems and methods for heating and cooling a treatment fluid using a dry solid heating and cooling device that does not use a heat transfer fluid. The solid system of this embodiment is "dry" because it does not use a heat transfer fluid (such as glycol or water) to transfer heat to and from the treatment fluid. However, in other embodiments, the systems and methods of the present disclosure may be used to heat and / or cool a heat transfer fluid. The system may include hinges to facilitate the placement and removal of the bag. The system may also include a plurality of fins to assist in heat transfer. Additionally, the system may include one or more latches to ensure that the solid heating and cooling device remains closed during operation.

[0032] FIG. 1 shows a top view of an exemplary fluid holder 10 including a fluid inlet 12, a fluid outlet 14, a serpentine passage 16, and a mounting plate 18 to which the serpentine passage 16 is welded.

[0033] FIG. 2 shows a perspective view of the exemplary fluid holder of FIG. 1. In both FIGS. 1 and 2, the fluid entering and leaving the fluid holder is a heat transfer fluid rather than a treatment fluid such as blood and / or dialysate. In the exemplary embodiments of FIGS. 1 and 2, other heat exchangers (not shown) may also be included to transfer heat from the heat transfer fluid to the treatment fluid and / or temperature management device, or vice versa.

[0034] Figure 3 shows a perspective view of the solid device 20 according to this embodiment. In the depiction shown in Figure 3, the solid device 20 is in the closed position. The solid device 20 may include a fluid inlet 22 for receiving a treatment fluid (such as blood or dialysis fluid) from a patient and / or a pump, and a fluid outlet 24 for delivering and returning heated and / or cooled fluid to the patient. The fluid inlet 22 and the fluid outlet 24 are each fluidly coupled to a fluid holder 44 (not shown) within the solid device 20 in the embodiment of Figure 3. Thus, when the fluid holder 44 (not shown) is inserted into the solid device 20, each of the fluid inlet 22 and the fluid outlet 24 is inserted into the solid device 20. The fluid inlet 22 and the fluid outlet 24 may each include a cylindrical tube that can be fluidly connected to a tube and / or component of another system via various connection mechanisms (such as nipples, couplings, valves, elbows, unions, tees, male adapters, female adapters, compression fittings, face seal fittings, bird tube fittings, quick disconnect fittings, and other suitable fluid coupling mechanisms). The solid device 20 may include an upper plate 26 and a bottom plate 28, and the upper plate 26 and the bottom plate 28 are hingedly coupled by one or more hinges 30. In some embodiments, one or more hinges 30 are proximate to the fluid inlet 22, and in other embodiments, one or more hinges 30 are proximate to the fluid outlet 24. The one or more hinges 30 enable the upper plate 26 to rotate about the hinge 30 and open, thereby providing a space between the upper plate 26 and the bottom plate 28 and allowing the fluid holder 44 (not shown) to be inserted. In some embodiments, the one or more hinges 30 may be disposed on the opposite side of the fluid inlet 22 and the fluid outlet 24. In some embodiments, the solid device 20 further includes a blood detector, a fluid temperature sensor (such as a resistive, infrared, or fiber optic temperature sensor), a pressure transducer, a patient temperature probe, an air detector (such as an ultrasonic sensor for detecting air in the fluid), and / or a fluid flow detector.

[0035] Referring further to FIG. 3, the solid device 20 may include an upper inlet recess 32A and a bottom inlet recess 32B, which may each include a contour and / or recess disposed in each of the upper plate 26 and the bottom plate 28 to enable the fluid inlet 22 to function as a fluid conduit through the upper inlet recess 32A and the bottom inlet recess 32B while the solid device is in the closed position. Similarly, the solid device 20 may include an upper outlet recess 34A and a bottom outlet recess 34B, which may each include a contour and / or recess disposed in each of the upper plate 26 and the bottom plate 28 to enable the fluid outlet 24 to function as a fluid conduit through the upper outlet recess 34A and the bottom outlet recess 34B while the solid device is in the closed position. The upper inlet recess 32A and the bottom inlet recess 32B may each be disposed near the fluid inlet 22 to allow fluid to enter the solid device, and the upper outlet recess 34A and the bottom outlet recess 34B may each be disposed adjacent to the fluid outlet 24 to allow fluid to exit the solid device. The solid device 20 may also include one or more, a plurality of fins 36 that extend vertically upward from the upper plate 26 and vertically downward from the bottom plate 28. One or more spaces 38 may separate the plurality of fins 36 from each other. Each fin may include a proximal portion 40 near each of the upper plate 26 or the bottom plate 28, as well as a distal portion 42 that extends away from each of the upper plate 26 or the bottom plate 28. In some embodiments, each fin of the plurality of fins 36 may be thinner at the distal portion 42 than at the proximal portion 40. In other words, each proximal portion 40 may be thicker than each distal portion 42. In other embodiments, each fin of the plurality of fins 36 may have a uniform thickness from the proximal end 40 to the distal end 42.

[0036] Referring further to FIG. 3, one or more, a plurality of fins 36 may be aligned in the width direction (shown in FIG. 3), in the longitudinal direction (not shown), or in a hybrid configuration including one or more, a plurality of fins 36 aligned in the width direction, longitudinal direction, diagonal, and / or other configurations. One or more, a plurality of fins 36 may be oriented so that they extend at an angle away from the upper plate 26 and the bottom plate 28 (i.e., the plane defined through the center of each fin intersects the plane defined by the upper plate 26 and / or the bottom plate 28 at an angle other than 90 degrees). The solid device 20 may include a various number of a plurality of fins 36 on each of the upper plate 26 and the bottom plate 28, as well as a various number of fins within each plurality of fins 36. For example, three pluralities of fins 36 each including 10 fins may be disposed on each of the upper plate 26 and the bottom plate 28. In other embodiments, about 2 to about 4 pluralities of fins 36 each including about 8 to about 12 fins may be disposed on each of the upper plate 26 and the bottom plate 28. In other embodiments, about 1 to about 10 pluralities of fins 36 each including about 1 to about 20 fins may be disposed on each of the upper plate 26 and the bottom plate 28. Other embodiments may include other numbers of pluralities of fins 36, as well as other numbers of fins within each plurality of fins 36. In some embodiments, the upper plate 26 and the bottom plate 28 may have the same number and arrangement of pluralities of fins 36, and in other embodiments, the upper plate 26 and the bottom plate 28 may have different numbers of pluralities of fins 36 and / or arrangements of fins. The solid device 20 may include one or more latches 42 to ensure that the upper plate 26 remains coupled to the bottom plate 28 while the solid device 20 is operating. One or more latches 42 may be hingedly coupled to the upper plate 26 and / or the bottom plate 28. Other suitable mechanisms for coupling the upper plate 26 and the bottom plate 28 together and for coupling one or more latches 42 to the upper plate 26 and / or the bottom plate 28 are also possible.

[0037] Referring further to FIG. 3, the solid device 20 may be used for both heating and cooling. Each of the upper plate 26 and the bottom plate 28 may include one or more embedded resistance heaters (not shown) or one or more Peltier heaters / coolers and may be electrically coupled to one or more power supplies (not shown) to provide heating and / or cooling inside the solid device 20. For example, the temperature forcing devices disposed on each of the upper plate 26 and the bottom plate 28 may be configured as Peltier devices (or Peltier heat pumps) such that each of the upper plate 26 and the bottom plate 28 can provide heating and / or cooling inside the solid device depending on the direction of the current flowing through the Peltier device. In a desired use case where each Peltier device and / or other temperature forcing device provides cooling inside the solid device 20, it may be used in connection with one or more, a plurality of fins 36. Further, since the room temperature (usually between 55°F and 85°F) is often lower (+ / - 2 - 3°F) than the normal temperature of about 98.6°F, the one or more, plurality of fins 36 can provide passive cooling inside the solid device 20. The shape of the fins, the material constituting the fins, the number of fins, the groups of fins, the spacing between the fins, and the orientation of the fins may vary to enhance the heat transfer efficiency of the solid device 20. The solid device 20 can provide cooling and / or heating to the treatment fluid without the need for a dedicated heat transfer fluid or moving parts. In some embodiments, the resistive heating elements and the plurality of fins 36 may be disposed both within the upper plate 26 and within the bottom plate 28. In other embodiments, the resistive heating elements and / or the plurality of fins 36 may be disposed in either, but not both, of the upper plate 26 or the bottom plate 28. The plurality of fins 36 may be made of a different material(s) than the material of the upper plate 26 and the bottom plate 28 to enhance heat transfer. The solid device 20 may also include a fan (not shown) for increasing the air flow across the one or more, plurality of fins 36.

[0038] Figure 4 shows a perspective view of the solid device 20 in the open position with the fluid holder 44 disposed therein. In the embodiment of FIG. 4, one or more latches 42 are released and the upper plate 26 rotates about the hinge 30 to an open position, enabling the fluid holder 44 to be disposed within the solid device 20. The fluid holder 44 may include a first portion 46 proximate to the fluid inlet 22 and a second portion 48 proximate to the fluid outlet 24. Between the first portion 46 and the second portion 48, the fluid holder may include a rounded portion 45 on the opposite side of the solid device 20. The fluid holder 44 may include a mounting sheet 60 that helps both to ensure that the fluid holder 44 is disposed in the precisely correct position within the solid device 20 and to ensure a uniform distribution of heat transfer from the solid device 20 to the fluid holder 44. The solid device may include a first pin 50 and a second pin 52 that project upwardly from the upper surface 29 of the bottom plate 28 through an opening in the mounting sheet 60 to ensure that the fluid holder 44 is accurately positioned within the solid device 20.

[0039] FIG. 4 further shows an inlet coupling 53 circumferentially disposed around one end of the fluid inlet 22 and an outlet coupling 55 circumferentially disposed around the fluid outlet 24. Each of the inlet coupling 53 and the outlet coupling 55 forms a transition between the interior of the fluid holder 44 and the fluid inlet 22 and / or the fluid outlet 24. The inlet coupling 53 and the outlet coupling 55 may each include a diameter slightly larger than the fluid inlet 22 and the fluid outlet 24 so that the fluid inlet 22 and the fluid outlet 24 can be firmly inserted into the inlet coupling 53 and the outlet coupling 55 via compression fittings and / or other mechanisms (epoxy, adhesion, sintering, adjustable hose clamps and / or ring clamps). The inlet coupling 53 and the outlet coupling 55 may be composed of a material harder and / or more rigid than the fluid inlet 22 and the fluid outlet 24 (and any associated pipes to which the fluid inlet 22 and the fluid outlet 24 are connected), thereby assisting the inlet coupling 53 and the outlet coupling 55 in supporting the weight of the upper plate 26 (and any compression associated with the latch 42 when the solid device is closed). For example, when the upper plate 26 rests on the bottom plate 28, the recesses 32A, 34A of the upper plate 26 contact and / or interface with the inlet coupling 53 and the outlet coupling 55, thereby allowing the weight and / or downward force of the upper plate to be distributed across the inlet coupling 53 and the outlet coupling 55 (and the first pin 50 and the second pin 52). The height of the first pin 50 and the second pin 52, (and the diameter of the inlet coupling 53 and the outlet coupling 55) may be designed such that when the solid device 20 is in the closed position, the spacing between the upper plate 26 and the bottom plate 28 is optimized from an operational perspective. For example, if the upper plate 26 and the bottom plate 28 are tightened together too tightly, damage may occur to the fluid holder 44 and the flow through the fluid holder 44 may be restricted. If the upper plate 26 and the bottom plate 28 are not sufficiently joined, heat transfer to and from the fluid holder 44 may be impeded.The first pin 50, the second pin 52, the inlet coupling 53, and the outlet coupling 55 also ensure that the mounting sheet 60 and the fluid holder 44 attached thereto are not placed within the solid device 20 in an incorrect orientation.

[0040] Referring further to FIG. 4, the fluid holder 44 may include an inlet tapered portion 57 and an outlet tapered portion 59, each coupling the fluid holder 44 to the inlet coupling 53 and the outlet coupling 55, respectively. Each of the inlet tapered portion 57 and the outlet tapered portion 59 also provides a gradual transition between the inlet coupling 53 and the outlet coupling 55 and the fluid holder 44, allowing the fluid holder 44 to expand as necessary while remaining securely coupled to the inlet coupling 53 and the outlet coupling 55. The inlet tapered portion 57 and the outlet tapered portion 59 serve to increase the surface area around the inlet coupling 53 and the outlet coupling 55 to which the fluid holder 44 can be connected, thereby enabling a stronger attachment. The fluid holder 44 may be attached to the inlet coupling 53 and the outlet coupling 55 (i.e., at the inlet tapered portion 57 and the outlet tapered portion 59) via epoxy, adhesion, adhesive, sintering, fusion, compression fitting, tape, and / or other suitable mechanisms. The connections and / or attachments between the fluid inlet 22 and the fluid outlet 24 and the inlet coupling 53 and the outlet coupling 55, and between the inlet coupling 53 and the outlet coupling 55 and the fluid holder 44, need to be sufficiently robust so that when removed from the steady-state device 20, the fluid holder 44 remains suspended from the fluid inlet 22 and the fluid outlet 24 and does not separate from the fluid inlet 22 and / or the fluid outlet 24, even if the fluid holder 44 is filled with fluid.

[0041] Referring further to FIG. 4, the attachment sheet 60 may include angled and / or tapered corners 54 at its ends proximate the fluid inlet 22 and the fluid outlet 24, which may assist in the insertion and / or removal of the fluid holder 44 within the solid device. The attachment sheet 60 may also include rounded corners 56 at the ends opposite the fluid inlet 22 and the fluid outlet 24. The bottom plate 28 may include a first recess 58 that conforms to the general shape and thickness of the attachment sheet 60 such that the attachment sheet 60 is readily received within the bottom plate 28. During operation (i.e., while the solid device 20 is in the closed position shown in FIG. 3), the treatment fluid flows through the fluid inlet 22 into the fluid holder 44 at the first portion 46, from the rounded portion 45 towards the second portion 48, and out through the fluid outlet 24. Thus, the fluid inlet 22 is fluidly coupled to the fluid outlet 24 via the fluid holder 44.

[0042] Referring further to FIG. 4, each of the first portion 46, the second portion 48, and the rounded portion 45 is formed within the fluid holder 44 via corresponding recesses and protrusions in the upper plate 26. The upper plate 26 includes recesses and protrusions (not shown) that define a fluid passage within the fluid holder 44 for the fluid flowing therebetween when the fluid holder 44 begins to fill with fluid. In other words, the fluid holder 44 itself does not include any fluid passages prior to being inserted into the solid device 20. The passages (i.e., the first portion 46, the second portion 48, and the rounded portion 45) are formed in the fluid holder 44 as a result of the fluid holder 44 bending along and conforming to the protrusions and recesses of the upper plate 26 (bottom plate 28) when the solid device 20 is closed and the treatment fluid is flowing through the fluid holder 44. The recesses and protrusions that define the fluid passage within the fluid holder 44 may be disposed in both the upper plate 26 and / or the bottom plate 28. FIG. 4 also shows a central wall 61 of the passage that functions as a barrier defining the boundary between the first portion 46 and the second portion 48 of the passage. When the solid device 20 is operating, the treatment fluid may flow around the central wall 61 of the passage. The central wall 61 of the passage is formed in the fluid holder 44 as a result of corresponding protrusions (not shown) in the upper plate 26 (the protrusions of the upper plate 26 (and, similarly, the bottom plate 28) are surrounded by recesses in the upper plate 26 that define the fluid passage within the fluid holder 44).

[0043] FIG. 5 shows a perspective view of an empty fluid holder 44 in which a first hole 64 (into which a first pin 50 may be inserted) is disposed and a second hole 62 (into which a second pin 52 may be inserted) is disposed. When compared with FIG. 4 (and FIG. 6), the fluid holder 44 of FIG. 5 is empty, and the fluid holders 44 of FIGS. 4 and 6 are filled. In the embodiment of FIG. 5, the fluid inlet 22 and the fluid outlet 24 are disposed within an inlet coupling 53 and an outlet coupling 55, which are connected to the fluid holder 44 via an inlet taper portion 57 and an outlet taper portion 59. In the embodiment of FIG. 5, the mounting sheet 60 appears to be integral (and monolithic) with the fluid holder 44. Stated another way, in some embodiments, the mounting sheet 60 is a continuous portion of the fluid holder 44 and does not form (or become part of) a fluid passageway that is formed when the fluid holder 44 is used within the solid device 20 (e.g., when the device is closed).

[0044] Referring further to FIG. 5, in other embodiments, the attachment sheet 60 (i.e., the edge of the fluid holder 44 and / or the portion of the fluid holder 44 surrounding the periphery) may have different material properties than the central portion of the fluid holder 44 such that the attachment sheet 60 is less flexible than the central portion of the fluid holder 44, thereby facilitating handling of the fluid holder 44, making it more resistant to damage, and making it easier to insert into the solid device 20. In other embodiments, the interior of the fluid holder 44 may be formed by two materials (e.g., polymers and / or thermoplastic materials, among other possible materials) joined by a seam extending around the fluid holder 44. In this embodiment, the seam extending around the fluid holder 44 includes a first hole 62 and a second hole 64 disposed therethrough, enabling easy handling of the fluid holder 44 and insertion into the solid device 20 as described above. The seam extending around the fluid holder 44 may be formed via any suitable mechanism for attaching two sheets including, but not limited to, adhesion, adhesives, epoxy, sintering, and / or melting. The fluid holder 44, as well as the connections between the fluid holder 44 and the fluid inlet 22 and the fluid outlet 24, may be constructed (and / or composed of suitable materials) such that the fluid holder 44 always remains airtight and sterile during operation, and does not tear, rip, or develop holes during use and / or during insertion into or removal from the solid device 20.

[0045] FIG. 6 is a perspective view of the filled fluid holder 44, with the treatment fluid therein, and the portions around the fluid holder 44 (i.e., the attachment sheet portions) appear to be unfilled with the treatment fluid because the fluid holder 44 cannot expand at those portions by the protrusions in the upper plate 26 and the bottom plate 28. As described above, the fluid passage formed around the passage center wall 61 in the fluid holder 44 is defined by the recesses and protrusions in the upper plate 26 and the bottom plate 28 (in certain embodiments, the recesses and / or protrusions may be present in one or both of the upper plate and the bottom plate). Thus, a bottom perspective view (i.e., similar to the top perspective view of FIG. 6) shows a similar fluid passage defined under the fluid holder 44. The fluid holder 44, together with the inlet coupling 53 and the outlet coupling 55, and the fluid inlet 22 and the fluid outlet 24 disposed therein, may be pre-assembled and / or pre-manufactured such that a new pre-assembled fluid holder 44 can be disposed within the solid device 20 and then discarded each time the solid device 20 is used, thereby eliminating the need to clean and / or disinfect the solid device 20 or the fluid holder 44 (and the attachment sheet 60). If the solid device 20 requires cleaning or sterilization, the interior of the solid device can be easily accessed by disposing the solid device 20 in the open configuration shown in FIGS. 4 (and FIG. 7). The fluid holder 44 may be attached to the attachment sheet 60 using any suitable means including adhesion (e.g., epoxy), compression fittings, and other suitable means. Further, the fluid holder 44 and the attachment sheet 60 may be integrally formed and / or manufactured during the same continuous construction or manufacturing process such that the fluid holder 44 and the attachment sheet 60 form a single integral monolithic structure.

[0046] Figure 7 shows a perspective view of the solid device 20 without the fluid holder installed. The solid device 20 includes an upper plate 26 hinge - connected to a bottom plate 28 via one or more hinges 30. A latch 44 holds the upper plate 26 near the bottom plate 28 when the solid device 20 is in the closed position. As described above, the upper plate 26 and the bottom plate 28 include an upper inlet recess 32A, a bottom inlet recess 32B, an upper outlet recess 34A, and a bottom outlet recess 34B to enable the fluid inlet 22 and the fluid outlet 24 to function as fluid conduits through which fluid enters and exits the solid device 20. The first pin 50 and the second pin 52 project upward from the upper surface 29 of the bottom plate 28 (as also described above).

[0047] Continuing to refer to FIG. 7, the solid device 20 may include a bottom - plate recess 66 and a bottom - plate protrusion 68 disposed within a first recess 58 of the bottom plate 28. The first recess 58 is slightly recessed from the upper surface 29 of the bottom plate 28, taking into account the thickness of the mounting plate 60 and / or the unfilled portion of the fluid holder 44. The bottom - plate recess 66 is further recessed (i.e., from both the upper surface 29 of the bottom plate 28 and the first recess 58), enabling the fluid holder 44 to expand when the fluid holder 44 is inserted into the solid device 20 and filled with the treatment fluid, thereby defining the outer boundary of the fluid passage within the fluid holder 44. The bottom - plate protrusion 68 extends upward from the bottom - plate recess 66, thereby defining the passage - center wall 61 (shown in FIGS. 4 and 6) within the fluid holder 44 when the bag is being used within the solid device 20.

[0048] FIG. 8 shows a side view of the solid device 20 with the upper plate 26 partially open and rotating about one or more hinges 30. FIG. 8 shows the upper inlet recess 32A and the upper outlet recess 34A disposed within the upper plate 26, as well as the latch 42 coupled to the upper plate 26. In the embodiment of FIG. 8, the second recess 80 is slightly recessed from the bottom surface 78 of the upper plate 26 to allow for the thickness of the mounting plate 60 and / or the unfilled portion of the fluid holder 44 (i.e., when the fluid holder 44 is inserted into the solid device 20). The upper plate recess 70 is further recessed (i.e., from both the bottom surface 78 of the upper plate 26 and the second recess 80) to allow for expansion within the fluid holder 44 when the fluid holder 44 is inserted into the solid device 20 and filled with the treatment fluid, thereby defining the outer boundary of the fluid passageway within the fluid holder 44. The upper plate protrusion 72 extends upward from the upper plate recess 70, thereby defining the central passage wall 61 (shown in FIGS. 4 and 6) within the fluid holder 44 when the bag is being used within the solid device 20. FIG. 8 also shows the first pin hole 74 and the second pin hole 76 disposed within the second recess 80 for receiving the first pin 50 and the second pin 52 when the solid device 20 is closed.

[0049] FIG. 9 shows a method 900 for heating and / or cooling a treatment fluid according to an embodiment of the present claim. At step 902, the method may include attaching a fluid inlet tube and a fluid outlet tube (not shown) to the fluid inlet 22 and the fluid outlet 24. Step 902 enables the fluid holder 44 to be fluidly coupled to a patient, a dialysis system, a blood warming system, and / or other equivalent systems. At step 904, method 900 may include inserting the fluid holder 44 into the solid device 20. At step 924, method 900 may include forming (e.g., by closing the device, i.e., by coupling the upper plate and the bottom plate) a fluid passage defined by recesses, contours, and protrusions disposed within the upper plate 26 and the bottom plate 28 within the fluid holder 44. At step 926, method 900 may include initiating a flow of treatment fluid (such as blood or dialysis fluid) through the fluid inlet 22, the fluid holder 44, and the fluid outlet 24. At step 928, method 900 may include initiating heating and / or cooling within the upper plate 26 and the bottom plate 28 via one or more temperature forcing devices disposed therein to adjust the temperature of the treatment fluid flowing through the solid device 20. Method 900 may include other steps and may skip the steps detailed above. Further, the steps may be performed in an order different from that shown in FIG. 9. Additional steps may include stopping the flow of treatment fluid through the solid device 20, interrupting the heating and / or cooling within the solid device 20, opening the solid device 20, removing the fluid holder 44, removing the tube from the fluid holder 44, and discarding the fluid holder 44. Further, method 900 may include several sub-steps at step 904 (inserting the fluid holder 44 into the solid device), as detailed below.

[0050] Referring further to FIG. 9, this method may include several sub-steps to ensure that the fluid holder 44 is correctly installed within the solid device 20. In many cases, some of these sub-steps may not need to be performed. According to method 900, these sub-steps are, at step 906, opening the top plate of the solid device 20; at step 908, aligning the fluid inlet 22 and the fluid outlet 24 with the first recess 32B and the second recess 34B of the bottom plate 28; at step 910, aligning the first hole 62 and the second hole 64 of the fluid holder 44 with the first pin 50 and the second pin 52 of the bottom plate 26; at step 912, rotating the top plate 26 via one or more hinges 30 to partially close it; at step 914, checking that the first recess 32A and the second recess 34A on the top plate 26 are aligned with the fluid inlet 22 and the fluid outlet 24; at step 916, checking that the first pin 50 and the second pin 52 are aligned with the first pin hole 74 and the second pin hole 76 of the top plate 26; at step 918, checking that the fluid holder 44 is aligned with the recesses 58, 80 of the top plate 26 and the bottom plate 28; at step 920, closing the solid device 20; and at step 922, attaching one or more latches 42. Some of the steps shown in FIG. 9 may be optional, may be skipped, and / or may be performed in an order different from that shown in FIG. 9.

[0051] The solid device 20 of the present embodiment eliminates the need for a dedicated heat transfer fluid. The solid device 20 of the present embodiment directly or indirectly heats and cools the treatment fluid, thereby reducing and / or eliminating the risk of infection due to the heat transfer fluid. During operation, the solid device 20 may include a maximum operating temperature of from about 40°C to about 60°C, or from about 40°C to about 50°C, or from about 40°C to about 45°C. During operation, the solid device 20 may correspond to a maximum flow rate of from about 5 L / min (i.e., liters per minute) to about 15 L / min, or from about 7 L / min to about 13 L / min, or from about 9 L / min to about 12 L / min, or from about 10 L / min to about 11 L / min. One cause of nosocomial pathogens in existing patient treatment devices is the heat transfer fluid, which is eliminated in some embodiments of the systems described in this disclosure. Further, the present embodiment enables the use of a fluid holder 44 that does not have a pre-defined fluid passage or channel within it. By enabling the definition of fluid passages in the fluid holder 44 via the recesses, protrusions, and contours 58, 66, 68, 72, 78, 80 of the upper plate 26 and the bottom plate 28, the manufacture of the fluid holder 44 can be much simpler and easier. The hinge 30 connecting the upper plate 26 and the bottom plate 28 facilitates the quick and easy insertion of the fluid holder 44 into and removal from the solid device 20, while at the same time providing convenient access to the interior of the solid device 20 for cleaning and sterilization operations.

[0052] FIG. 10 shows a temperature forcing device of a system for heating and / or cooling a fluid according to an exemplary embodiment. The bar disposed on the upper plate of the temperature forcing device forms a fluid passage in a disposable bag disposed in the device when the device is closed. When the device is open, no fluid passage is defined. In this embodiment, the thermoelectric Peltier heater / cooler components are shown on both the upper and bottom plates of the temperature forcing device.

[0053] Figure 11 shows a view of the temperature forcing device of Figure 10, with the inlet and outlet of the fluid passage formed when the upper and lower plates are closed visible, and arrows indicating the direction of flow into the formed channels.

[0054] Figures 12, 13, and 14 show, respectively, a front view, a side view, and a top view of the temperature forcing device of Figure 10.

[0055] Figure 15 shows a flexible fluid holder (disposable bag) with the fluid passage formed by the temperature forcing device of Figure 10 when the device is closed. Figure 16 shows the bag in its normal state with no fluid passage formed (e.g., when not within the temperature forcing device of Figure 10).

[0056] Figure 17 shows a direct fluid heating and / or cooling system with flow of fluid provided by gravity, according to an exemplary embodiment. The fluid depicted is a treatment fluid. The fluid enters the inlet of a flexible fluid holder (disposable heat exchange bag), the bag is placed between the upper and lower plates of a temperature forcing device (dry heater / cooler), and when those plates are closed together, channels are formed. The fluid is heated and / or cooled by the dry heater / cooler as it flows from the inlet to the outlet of the heat exchange bag and is then delivered to a patient. The fluid does not come into direct contact with the dry heater / cooler.

[0057] Figure 18 shows a direct fluid heating and / or cooling system with pump assist, according to an exemplary embodiment. This system is the same as that shown in Figure 17, except that a pump (here a peristaltic pump) is depicted as assisting the flow of a treatment fluid (e.g., blood or IV solution) through the temperature forcing device. The fluid does not come into direct contact with the dry heater / cooler.

[0058] FIG. 19 shows an adjusted fluid heating and / or cooling system according to an exemplary embodiment. Here, the adjusted fluid from the source is pumped through a reservoir (labeled "Belmont Convective Fluid Disposable") into a disposable heat exchange bag disposed between the upper and lower plates of a temperature forcing device (here, a dry heater / cooler). When heated and / or cooled by the temperature forcing device, the adjusted fluid flows through the outlet of the disposable heat exchange bag into a connecting tube and is used as a temperature-controlled heat exchange fluid in another part of the system. The fluid does not come into direct contact with the dry heater / cooler. Further, the entire fluid flow path including the reservoir, peristaltic pump (if used), connecting tube, and heat exchange bag can be made disposable, further reducing the risk of contamination.

[0059] In some embodiments, the system according to the present disclosure includes a component that physically contacts the patient's body directly to manage the patient's body temperature. In some embodiments, the component is a blanket, wrap, or mattress that contains a fluid. In some embodiments, the component may be worn covering a part of the patient's body. For example, the component may be designed to cover at least about 30%, 40%, or 50% of the surface of the body. The system can stabilize the patient's body temperature at a desired core body temperature. Such a component may take different forms depending on its intended use. For example, the component may be designed for medical use for the purpose of lowering the core body temperature (e.g., for a patient having a disease accompanied by a very high fever), raising the core body temperature (e.g., as a heat treatment or after a heat treatment), or both purposes.

[0060] In some embodiments, the system may further comprise one or more thermometers or other temperature sensors for detecting the temperature of the circulating fluid and / or the patient's body temperature. In some embodiments, the thermometer (or other temperature sensor) measures the temperature of the fluid as it enters a component (e.g., a blanket, wrap, or mattress). In some embodiments, the thermometer (or other temperature sensor) measures the temperature of the fluid as it exits a component (e.g., a blanket, wrap, or mattress).

[0061] These and other features, aspects, and advantages of the present invention will be better understood with reference to the following description and the appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with the description, serve to explain the principles of the embodiments.

[0062] Specific Definitions To facilitate a better understanding of the present disclosure, certain terms are first defined below. Additional definitions of these and other terms are set forth throughout this specification.

[0063] An apparatus, composition, or method described herein as "comprising" one or more named elements or steps is open-ended and means that, while the named element or step is essential, other elements or steps may be added within the scope of the composition or method. To avoid redundancy, any apparatus, composition, or method described as "comprising or comprises" one or more named elements or steps also describes the corresponding, more limited composition or method "consisting essentially of" the same-named element or step, which means that the composition or method includes the named essential element or step and may also include additional elements or steps that do not substantially affect the basic and novel features (s) of the composition or method. It should also be understood that any apparatus, composition, or method described herein as "comprising" or "consisting essentially of" one or more named elements or steps also describes the corresponding, more limited, closed-ended composition or method "consisting of" any other elements or steps not named, excluding the named element or step. In any composition or method disclosed herein, known or disclosed equivalents of any named essential element or step may be used in place of that element or step.

[0064] As used herein, the terms "patient" or "subject" (used interchangeably herein) refer to any organism to which the provided composition is administered, or may be administered, for purposes such as experimentation, diagnosis, prevention, cosmetic, and / or treatment. Typical patients include animals (e.g., mammals such as mice, rats, rabbits, non-human primates, etc., and / or humans). In certain embodiments, the patient is human. In certain embodiments, the patient suffers from, or is susceptible to, one or more disorders or conditions. In certain embodiments, the patient exhibits one or more symptoms of a disorder or condition. In certain embodiments, the patient is diagnosed with one or more disorders or conditions. In certain embodiments, the disorder or condition is a bacterial infection or includes a bacterial infection. In certain embodiments, the patient has received, or has been subjected to, a particular treatment for diagnosing and / or treating a disease, disorder, or condition.

[0065] As used herein, the term "substantially" refers to a qualitative condition indicating the degree or extent of an entire or nearly entire characteristic or property of interest.

[0066] Equivalents Although the present disclosure has been described in conjunction with its detailed description, it should be understood that the foregoing description is intended to be illustrative of examples of the scope of the invention(s), and not limiting. Other aspects, advantages, and modifications are within the scope of the claims.

[0067] This specification discloses the invention, including the best mode, by way of examples, and enables one of ordinary skill in the art to practice this embodiment, including making and using any device or system and performing any incorporated method. The patentable scope of this embodiment is defined by the claims and may include other examples that occur to one of ordinary skill in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements that do not have a substantial difference from the literal language of the claims.

Claims

【Claim 1】 The invention described in this specification.

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