pourable slush feed supply

Abstract

A process and associated assembly for delivering slush to a patient through a tube includes obtaining an elongated container partially filled with slush, the elongated container having a port end with a first port and a second port. The first port is fluidly connected to a tube for flush delivery to the patient. The second port is fluidly connected to a gas source, which may be air. The elongated container is subjected to an automated, repetitive motion to move the slush within the partially filled elongated container against an interior surface within the elongated container. Ideally, two different forms of repetitive motion are used to impart a complex movement to the slush within the elongated container. A pressure gradient is applied to force the slush out of the first port toward the patient. The elongated container may be made from a slush bottle having a reversibly engaging cap with two ports.

Description

[Technical Field]

[0001] The present disclosure relates generally to the controlled delivery of sterile therapeutic media, such as sterile surgical slush, for use in surgery or other therapeutic uses. The patient receiving the treatment may be a human or non-human animal. [Background technology]

[0002] Production of sterile slush. Sterile saline slush has long been used in various surgical applications to slow the metabolic rate of organs and tissues, thereby protecting them from irreversible tissue damage during cardiac, neuro-organ transplant, vascular, urological, and other complex surgeries. For these applications, it is important that the slush be as smooth and spherical as possible to ensure an atraumatic slush without sharp crystalline edges that could puncture or damage tissue. The slush should have a substantially uniform consistency to maintain optimal thermodynamic cooling performance. Surgical slush is a mixture of ice crystals formed during saline cooling and some liquid saline that remains in liquid form.

[0003] The desired surgical slush has a substantially uniform consistency. The desired surgical slush will be soft to the touch without any hard crystalline structure. Therefore, ice crystals produced for use in shaved ice are unacceptable, and this type of consistency should be avoided by controlling the slush production process.

[0004] U.S. Patent No. 6,269,999, entitled "The Production of Well-Mixed Surgical Slush," addresses a process for producing a surgical slush from a base of sterile saline that may have additional therapeutic agents, the contents of which are incorporated herein by reference in their entirety.

[0005] Ideally, sterile surgical slush is produced in a controlled manner so that the slush slurry has the desired mechanical properties, allowing it to be introduced into the surgical site without causing mechanical trauma to the tissue. Patent Document 1 teaches a method in which the contents of the slush container are kept stirred and mixed, thereby distributing the slush substantially evenly throughout the slush container and preventing the formation of large slush ice structures. Atraumatic slush, desirable for use in surgical procedures, can be produced by this process.

[0006] A more detailed look at slush formation. As energy is removed from the liquid, the temperature continues to decrease until it reaches the point where crystal formation begins. Crystallization can be divided into two parts: nucleation and crystal growth. Nucleation occurs when molecules begin to arrange into a defined crystalline structure. Crystal growth occurs on the nuclei formed during nucleation.

[0007] During nucleation, an interface forms at the boundary between the solid and liquid phases of water. The creation of this interface is actually an exothermic process, meaning that heat and pressure are released. To form stable nuclei, the fluid temperature must be sufficiently below the melting point of the fluid (supercooled) to absorb the energy release during nucleation without raising the temperature above the melting point. The amount of supercooling required to initiate nucleation depends on whether a nucleating agent is present in the fluid.

[0008] Nucleating agents are things like impurities, undissolved solids, and irregularities on container walls. Without nucleating agents, a fluid would undergo homogeneous nucleation, requiring significant supercooling due to the large amount of energy required to form crystalline surface boundaries where none existed before. In the presence of nucleating agents, a fluid can undergo heterogeneous nucleation, forming stable nuclei at the sites of the nucleating agents just below the melting point.

[0009] The crystal growth part of freezing is also an exothermic process. The freezing process continues as long as the heat generated by crystal growth is removed. If the fluid is supercooled sufficiently before nucleation occurs, initial crystal growth can be very rapid. For example, a bottle of water supercooled to -20°C before nucleation can turn about 25% of the fluid into ice in about 2 or 3 seconds when something happens to initiate freezing. The trigger to initiate freezing can be the addition of an impurity. Another possible trigger to initiate freezing is crashing the bottle onto a table, causing a pressure wave to propagate through the liquid.

[0010] Because the latent heat of freezing is about 334.9 J / g (about 80 cal / gm) and the specific heat of water is about 4.2 J per gram per degree Celsius (about 1 calorie), only 25% of the fluid will undergo a phase change. This means that the freezing process generates enough heat to raise the temperature of 1 gram of water by 80°C, but because water is only 20°C below its melting point, freezing can only occur in 20 / 80 = 25% of the fluid. In this example, the liquid temperature rises rapidly from -20°C to 0°C. After this initial freezing, crystal growth continues more slowly, limited by how quickly heat can be removed from the water.

[0011] If pure water is thoroughly mixed during the phase change process, its temperature remains at its melting point. When the heat that tends to lower the temperature below the melting point is removed, energy is available for crystal growth, but the crystals can only grow until the heat generated by their growth returns the temperature to the melting point. This balancing act between heat removal and crystal growth continues until all the liquid is frozen, at which point the temperature of the ice begins to decrease. When a temperature change occurs within a fluid, localized frozen areas can form, producing solid ice, while other portions of the fluid remain completely liquid. This occurs most frequently at the walls of a container where heat is removed, or at the surface of a body of water, such as a pond, that is exposed to subzero temperatures.

[0012] Sterile saline slush can be made from a fluid solution containing sodium chloride (NaCl) in water, typically 0.9% sodium chloride by weight. The sodium chloride helps suppress the fluid's initial freezing point to approximately −3.3°C. However, because sodium chloride molecules are not incorporated into the water crystal structure, the concentration of sodium chloride in the liquid water increases as the proportion of water ice increases. This increasing concentration of sodium chloride pushed ahead of the advancing ice causes a further depression of the freezing point of the remaining fluid. As long as the sodium chloride molecules remain mobile and are not trapped by the surrounding water crystal structure, the sodium chloride concentration in the remaining liquid will continue to increase, thus depressing the freezing point to approximately −21.1°C, the temperature at which salt begins to crystallize from solution.

[0013] Slush is essentially a collection of ice crystals surrounded by liquid. The microscopic structure and size of the ice crystals significantly affect the macroscopic feel and appearance of the slush. Soft slush is composed of many small crystals, while slush with fewer but larger crystals will have a more grainy texture or small ice fragments. While controlled crystal growth occurs, maintaining an increasing sodium chloride concentration uniform throughout the container tends to promote the formation of many small ice crystals rather than fewer, larger ones. Maintaining a uniform solution temperature is also important. Failure to maintain a substantially uniform temperature distribution will result in localized cold spots that can cause bridges between crystal clusters. However, because localized cold spots result in relatively rapid freezing, these bridges can grow over a wider area and are not easily broken.

[0014] One of the most difficult areas to prevent large crystal formation is the container wall. Because the wall temperature is well below the freezing point, heat transfer occurs at the surface, so any ice crystals in contact with the wall have immediate access to the cooling necessary for rapid growth. However, if contact between the ice crystal and the wall is brief, the rapid growth expansion into the crystal lattice is weak and may be destroyed when returned to the warmer bulk fluid. The problem of rapid crystal formation at the wall is exacerbated if the crystal forms on an already existing surface, since the crystal requires less energy to form a new interface between the liquid and solid phases.

[0015] This heterogeneous nucleation at the wall can also be accelerated if there are pits or cracks on the wall surface. Ice crystals form faster if the contact angle between the wall and the fluid droplet decreases, in that there is more contact with the cooled wall.

[0016] Appropriate selection of the container geometry and complex mixing motion promotes proper slush formation, which reduces the contact time between the crystals and the container walls and maintains a uniform sodium chloride concentration and temperature throughout the container. Achieving the desired mixture while the saline solution is still liquid is relatively easy, as the fluid's mobility facilitates its movement throughout the container. However, once a portion of the saline solution becomes slush, proper mixing becomes increasingly difficult because the slush viscosity constantly changes as the crystal concentration increases.

[0017] Regarding Patent Document 1 (U.S. Patent No. 9,549,843). US Patent Publication No. 2009 / 0129998 teaches a method for making atraumatic slush. Figure 1 shows a side view of a prior art slush container 100 with a slush bottle 110 having a cap 104. Mechanical agitation as the slush is being produced allows small crystal structures to form at nucleation sites, but the size growth of the crystal structures is inhibited because mechanical agitation prevents larger crystal growth. When these small crystals are suspended in the bulk fluid, they form a slurry or slush. Mechanical agitation also helps maintain a more consistent bulk fluid temperature, reducing the growth of large crystals that would otherwise occur at fluid boundaries (such as either the fluid / air boundary or the container wall) where heat is typically transferred from the fluid.

[0018] The carriage moves to subject the contents of the slush container to a series of accelerations, moving the contents relative to the container walls and lid. This complex movement (other than remaining stationary or purely uniform rotation about the container's longitudinal centerline) helps keep the slush well-mixed within the closed slush container. The slush container can be oriented with its longitudinal centerline near horizontal. Relative movement of the top of the container relative to the bottom of the container promotes movement of voids within the container from one end of the container to the other, preventing the slush from remaining attached to the container's interior walls. By applying agitation cycles that rotate the slush container, the starting position of the container from one agitation cycle to the next exposes different portions of the slush container's interior to the voids, and the movement of the voids in and out helps remove ice crystals from the interior walls.

[0019] By keeping the contents of the slush container agitated and mixed, the slush is distributed substantially evenly throughout the slush container, preventing the formation of large slush ice structures. Atraumatic slush, desirable for use in surgical procedures, can be produced by this process.

[0020] The complex movement of the slush saline mixture in the air gap can be generated by a variety of different types of stimuli. An example provided in this disclosure includes an asymmetric rotational inversion about the longitudinal axis, where a rotation of less than one revolution is followed by an inversion of less than one revolution. Another type of stimuli involves rotating the slush container about its longitudinal axis multiple times without changing direction. Stimuli include periodically dropping one or both ends of the slush container and lifting the slush container. Lifting and dropping can be achieved using humps or troughs on the rotating carriage containing the slush container. Other forms of stimuli, such as lifting and dropping one or both ends of the slush container, are disclosed.

[0021] Commercially available devices using the teachings of the '661 patent have gained wide acceptance for use in hospitals for the production of atraumatic slashes. Cryotherapy or cryolipolysis Cryotherapy is the application of low temperature in medical therapy. Cryotherapy can be used to destroy abnormal or diseased tissue. A common use is to treat skin conditions such as the destruction of warts.

[0022] Cryolipolysis does not target abnormal or diseased tissue. Cryolipolysis is the use of low temperatures to induce cell death ("apoptosis") in adipose tissue. Adipose tissue is more easily damaged by cooling than some other tissue types (such as skin).

[0023] An early form of cryolipolysis was achieved percutaneously, a process sometimes referred to as CoolSculpting®. Cryolipolysis has been explored by direct percutaneous injection of chilled materials into targeted adipose tissue. See, for example, U.S. Patent No. 6,269,994, for "Injectable Slurries and Methods of Manufacturing and Using the Same," which is incorporated by reference in its entirety.

[0024] The process of creating and delivering surgical slash to target tissue for cryolipolysis is in its infancy, and there is room for improvement in the process of maintaining the surgical slash in a usable format and in providing the slash for controlled transdermal delivery.

[0025] vocabulary. unit. Note that the following description refers to various "units" to focus on specific functions. In this context, a unit refers to the resources necessary to perform a given set of functions. This may include a combination of an electromechanical device, such as a microphone or camera, and the processing power to control the device and then process the data acquired by the device. In some examples, the functionality from some individually described units may be performed using physical components shared by some of the units described below.

[0026] Or (or). Unless expressly stated otherwise, the word "or" should be interpreted as an inclusive or rather than an exclusive or. Thus, the default meaning of or should be the same as the more intractable and / or.

[0027] set. Unless expressly stated otherwise, the term "set" should be construed as a group of one or more items.

[0028] Gne and Gnes. To avoid the awkward use of he / she and his / her, or the potentially confusing singular use of they and their, this application uses the gender-neutral pronoun gne and the possessive gnes.

[0029] Essentially. Often, when describing an industrial process, it is useful to note that given parameters are substantially met. Examples may be substantially parallel, substantially perpendicular, substantially uniform, and substantially flat. In this context, substantially X means that for the purposes of the industrial process, it is X. For example, something that is parallel for all practical purposes is substantially parallel, even if it is not absolutely parallel. Similarly, a mixed air stream with a substantially uniform temperature may have temperature deviations that are not significant to the industrial process.

[0030] As recognized in CEEquipment Co. v. United States, 13 USPQ2d 1363, 1368 (Cl.Ct.1989), the term "substantially" in a claim creates some definitional leeway and, therefore, can preclude avoidance of infringement by minor variations that do not affect the results sought to be achieved.

[0031] Proximal and distal. For items that may be oriented in different directions, it is useful to have proximal and distal reference points. For purposes of this application, the proximal end of slush feed container 1200, the proximal end of slush outlet connector 300, is proximal tip 904, which may be a location relative to other components in the slush delivery system. Similarly, the proximal end of vent tube 350 would be proximal tip 954, which may be tethered to other components in the slush delivery system or simply an opening to the atmosphere. Distal end 920 of slush feed container 1200 is the closed bottom of slush bottle 240. In this set of extremes, the proximal and distal sides of the components between proximal tips (904 and 954) and distal end 920 are distinct.

[0032] The numbers are minimum values. The numbers of items set forth in the following disclosure and claims should be construed as the minimum number for the associated items unless a specific number excluding a greater number is expressly stated. Thus, the phrase "two ports" refers to two or more ports, and the phrase "one pump" refers to one or more pumps.

[0033] material. The channels through the ports and other passages are adapted to allow the passage of substances, including gases, liquids, and solids. Non-limiting examples of substances include gases, including air, solids, such as slush, ice crystals, and liquids, such as liquid saline.

[0034] Wall around the circle. A cylinder has a perimeter. Some people think of the wall around the circumference as a single wall. Others think of the walled perimeter around a circle as a series of infinitely short walls that join together to encircle the circle. This application and the following claims allow for the term wall to include structures that encircle the circumference. [Prior art documents] [Patent documents]

[0035] [Patent Document 1] U.S. Patent No. 9,549,843 [Patent Document 2] US Patent Application Publication No. 2017 / 0274011 Summary of the Invention

[0036] Aspects of the teachings contained within this disclosure are addressed in the claims filed with this application upon filing, and rather than adding a redundant restatement of the claim content, these claims should be considered incorporated by reference into this Summary.

[0037] This Summary is intended to provide an introduction to the concepts disclosed herein, rather than an exhaustive listing of the many teachings and variations on those teachings provided in the expanded description within this disclosure. Accordingly, the contents of this Summary should not be used to limit the scope of the claims that follow.

[0038] The inventive concepts are illustrated in a series of examples, with some examples illustrating more than one inventive concept. Individual inventive concepts can be implemented without implementing all the details provided in a particular example. Those skilled in the art will recognize that the inventive concepts illustrated in the various examples can be combined with each other to address specific applications, so it is not necessary to provide examples of all possible combinations of the inventive concepts provided below.

[0039] An aspect of the teachings of the present disclosure is an assembly for use in providing a slush for injection to a patient, comprising: a slush bottle having an interior defined by a bottle bottom at a distal end of the slush bottle and at least one set of bottle sidewalls connecting the bottle bottom to an open end of the slush bottle at a proximal end of the slush bottle; a cap adapted to reversibly engage the proximal end of the slush bottle to cover the open end and form a capped bottle; a set of two ports, each port providing one open channel from the proximal end of the cap to the distal end of the cap such that a substance can traverse the cap when the cap is engaged with the proximal end of the slush bottle; The assembly may be summarized as comprising:

[0040] Additional aspects of the teachings of the present disclosure include: a slush outlet connector coupled to an outlet port, the outlet port being one of a set of two ports, the slush outlet connector having a delivery channel for delivering slush from the interior of the capped bottle through the one of the set of two ports and the slush outlet connector to a tube carrying the slush toward an entry point in a patient; a vent tube connected to a vent port that is one port of the set of two ports but is not the port connected to the slash outlet connector, the vent tube having a vent channel that allows gas to flow through the vent tube and the vent port, thereby allowing gas to enter the capped bottle; can be summarized as adding

[0041] An additional aspect of the teachings of the present disclosure can be summarized as adding a slush mixing device to the assembly, which supports the capped bottle and tilts the capped bottle so that the longitudinal centerline of the capped bottle from the bottle bottom to the cap moves toward the horizontal, followed by movement of the cap of the capped bottle to a second position where the cap is lower than the bottle bottom, thereby moving the water line between the slush and the gas-filled space within the capped bottle. The slush mixing device may force a second type of vibration of the capped bottle, thereby forcing a complex movement of the slush within the capped bottle. The second type of vibration may rock the capped bottle clockwise and counterclockwise about a rocking axis running parallel to the longitudinal centerline, and the rocking of the capped bottle may increase the tilt of the capped bottle to agitate the slush contained within the capped bottle. The slush mixing device may rock the capped bottle using a rocking cycle of a first duration, and the slush mixing device may tilt the capped bottle using a tilting cycle of a second duration different from the first duration.

[0042] The two forms of vibration may be applied without stopping until the capped slush bottle is no longer needed to provide slush or is no longer capable of providing slush.

[0043] Alternatively, aspects of the teachings of the present disclosure may be summarized as a process for delivering a slush to a patient through a tube, the process comprising: obtaining an elongated container, which may be a capped slush bottle, having a port end with a first port and a second port, the container being partially filled with slush; fluidly connecting the first port to a tube for delivering the slush toward the patient; placing the second port in fluid communication with a gas source; moving the slush within the partially filled slush bottle against an interior surface within the elongated container by subjecting the elongated container to two automated forms of repetitive motion; generating a pressure gradient causing the slush to flow out of the first port toward the patient.

[0044] The port end may have a slash outlet connector associated with the first port to form a flow path for slash from the interior of the elongated container through the first port and through the slash outlet connector. The slash outlet connector may be a separate component that couples to the first port or may be integrated with the first port as part of the port end.

[0045] The port end may have a vent tube associated with the second port to provide a vent flow path for gas from the exterior of the elongated container through the vent tube and into the interior of the elongated container through the second port. The vent tube may be a separate piece that connects to the second port or may be integral with the second port as part of the port end of the elongated container.

[0046] The port end of the two-port elongated container may be a cap used while the slush bottle is in the slush-making machine, or it may be a delivery cap added to the slush bottle after the slush is made.

[0047] The slush may be forced out of the elongated container by using pressurized gas applied to a vent tube associated with the second port, or pump suction applied to a slush outlet connector associated with the first port, or a combination of both forms of force.

[0048] Efforts can be made to slow the melting of the slush within the elongated container, including cooling the ambient air around the elongated container, insulating the elongated container from the ambient air, or using a cold plate to absorb heat from outside the elongated container.

[0049] Aspects of the teachings of the present disclosure may be summarized as an assembly for use in providing a slush for injection into a patient. The assembly includes: an elongated container having an interior defined by a container bottom at a distal end of the elongated container, a port end of the elongated container opposite the container bottom, and at least one set of container sidewalls connecting the container bottom to the port end at a proximal end of the elongated container; two sets of ports, each port providing an open channel from a proximal side of the port end of the elongated container to a distal side of the port end of the elongated container such that material can traverse the port end of the elongated container; and a slash outlet connector coupled to an outlet port, the outlet port being one of the set of two ports, the slash outlet connector having a delivery channel for delivering slush from the interior of the elongated container through the one of the set of two ports and the slash outlet connector to a tube carrying the slush toward an entry point in the patient; a vent tube connected to a vent port that is one of the set of two ports but is not the port connected to the slash outlet connector, the vent tube having a vent channel that allows gas to flow through the vent tube and the vent port, thereby allowing gas to enter the elongated container; A slush mixing device that supports the elongated container and tilts the elongated container so that the longitudinal centerline of the elongated container from the container bottom to the port end of the elongated container moves toward the horizontal, followed by movement of the port end of the elongated container to a second position where it is lower than the container bottom of the elongated container, thereby moving the water line between the slush and the gas-filled space within the elongated container.

[0050] Those skilled in the art will recognize that some of the alternative implementations described above are not universally mutually exclusive, and in some cases, additional implementations may be created that employ aspects of two or more of the variations described above. Similarly, the present disclosure is not limited to specific examples or specific embodiments provided to facilitate understanding of the various teachings of the present disclosure. Furthermore, the following claims encompass the scope of variations, modifications, and substitutions of the components described herein, as would be known to one skilled in the art.

[0051] Other systems, methods, features, and advantages of the disclosed teachings will be immediately apparent, or will become apparent, to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within and protected by the accompanying claims. [Brief explanation of the drawings]

[0052] The present disclosure may be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numerals refer to corresponding parts throughout the different views. [Figure 1] A side view of a prior art slush container 100 is shown, comprising a slush bottle 110 with a cap 104. [Figure 2] A top perspective view of a cap 204 that can fit onto a slush bottle, such as shown as slush bottle 110 in FIG. 1, is shown. [Figure 3] A top perspective view of a cap 204 that can fit onto a slush bottle, such as shown as slush bottle 110 in FIG. 1, is shown. [Figure 4] A perspective view of the bottom of the cap plug 250 is shown. [Figure 5] 1 shows an exploded cross-sectional side view of a sealed slush container 200. FIG. [Figure 6] A cross-sectional view of a sealed slush container 200 is shown. [Figure 7] A slush bottle 240 with an attached slush cap 204 is shown after removal of two cap plugs 250 and replacement with a slush outlet connector 300 and vent tube 350. [Figure 8] The slush container 200 is shown inserted into the slush mixing device 400. The slush mixing device 400 secures the slush feed container 1200 with the slush cap 204 and slush outlet connector 300 positioned below the end of the slush bottle 240 remote from the slush cap 204. [Figure 9] A slush feed container 1200 and a portion of the slush mixing device 400 are shown. [Figure 10] A simplified cross-sectional view of a slush feed container 1200 with a 15 degree downward tilt is shown. [Figure 11] A slush feed container 1200 and a portion of the slush mixing device 400 are shown. [Figure 12] A simplified cross-sectional view of a slush feed container 1200 with a 30 degree downward tilt is shown. [Figure 13] A simplified cross-sectional view of a 30 degree downward tilted slush feed container 1200 as in FIG. 12 is shown when the amount of slush 188 is nearly depleted. [Figure 14] A simplified cross-sectional view of a slush feed container 1200 with a 15 degree downward tilt is shown when the amount of slush 188 is almost gone. [Figure 15] A slush mixer 400 is shown with active rocking forced by a rocking shaft 440 on a cradled slush feed container 1200 . [Figure 16] A slush mixer 400 is shown with active rocking forced by a rocking shaft 440 on a cradled slush feed container 1200 . [Figure 17] A slush feed container 1200 is shown in the slush mixing device 400. [Figure 18] 12 illustrates another form of temperature maintenance for the slush feed container 1200. [Figure 19] 18 with an insulating capsule for the slush feed container 1200, but adds one or more cold plates 470. [Figure 20] 10 includes a flowchart of a process 1000 for delivering a well-mixed, atraumatic, sterile slush to a patient through a tube. DETAILED DESCRIPTION OF THE INVENTION

[0053] The subject matter of the present disclosure is described with specificity to satisfy statutory requirements. However, the description itself is not intended to limit the scope of the patent. Rather, the inventors contemplate that the claimed subject matter may be embodied in other ways, including various steps or elements similar to those described herein, in conjunction with other current or future technologies. Furthermore, while the term "step" may connote various aspects of the method used herein, this term should not be construed as implying any particular order between the various steps disclosed herein unless and until the order of individual steps is explicitly described.

[0054] 2 and 3 show perspective views of the top of a cap 204 that can fit onto a slush bottle, such as slush bottle 110 shown in FIG. 1. Cap 204 has a pair of ports 220 and 224 that each provide a passageway through the cap, allowing liquid or gas (such as air) to pass through cap 204 even when the lid remains attached to the slush bottle.

[0055] Figure 2 shows cap 204 without cap plug 250. Figure 3 shows cap plug 250 within ports 220 and 224 to seal ports 220 and 224. Ports 220 and 224 begin to seal and may remain sealed until slush bottle 240 containing the liquid to be made into sterile slush is first sealed by cap 204. After the slush bottle is processed and the slush bottle and cap 204 seal the surgical slush for use in a surgical procedure, cap plug 250 is removed so that slush can be provided through one of ports 220 or 224 while the other port is used as a vent to allow gas to flow into the volume defined by the interior side of slush bottle and cap 204 as the slush exits.

[0056] FIG. 4 shows a perspective view of the bottom of the cap plug 250. The cap plug 250 has a stopper 252 that forms an interference fit with the inner wall of the port 220 or 224. The stopper 252 has a tapered portion 246 that forms the interference fit and a cylindrical portion 248 that seals the entrance to the port and prevents ice from forming at the port entrance. The stopper 252 may be made of polypropylene or another suitable material. The outer wall of the port 220 or 224 fits into an annular port cavity 254. The annular port cavity may use a luer fitting thread or another thread type that interacts with corresponding threads on the port. The knurled periphery 256 facilitates a gloved end user's ability to twist the engaged cap plug 250 to remove it from the port 220 or 224 when the end user is attempting to obtain a surgical slash for a medical procedure.

[0057] 5 shows an exploded cross-sectional side view of a sealed slush container 200. The sealed slush container 200 has a cap 204, a cap plug 250, and a slush bottle 240. This simplified view does not show the threads in the cap 204 that may mate with corresponding threads on the top of the slush bottle 240.

[0058] 6 shows a cross-sectional view of sealed slush container 200. Shown in this view are cap 204, slush bottle 240, and cap plug 250 covering ports 220 and 224 (see FIG. 5). Because the desired process for making sterile slush with atraumatic particles requires some gas in the sealed slush container to allow sloshing of the slush slurry and aid in removing the slush from interior 210 of sealed slush container 200, slush container 200 has liquid 180, such as sterile saline, which may include additives, and gas 184.

[0059] A careful observer will notice that the distal ends of the stoppers 252 of the two cap plugs 250 extend at least to the inner wall 208 of the cap 204. The stoppers 252 may be sized relative to the interior of the ports 220 and 224 so as to extend beyond the inner wall 208 of the cap 204 and actually into the interior 210 of the sealed slush container 200 to prevent ice formation within the ports 220 and 224. The sealed slush container 200 is adapted to be fed into a slush-making device such as that described in U.S. Patent No. 9,549,843 for the Production of Well-Mixed Surgical Slush.

[0060] After the liquid in the sealed slush container 200 has become an ice / liquid mixture with the desired ratio of solid to liquid material and the desired atraumatic spheroids of ice of substantially uniform size, it is time to use the slush. As previously mentioned, this slush will have a substantially uniform consistency. The desired surgical slush will be soft to the touch, without any hard crystalline structure. The slush may be 30-50% solidified to allow for relatively easy delivery of the material to the treatment site.

[0061] 7 shows a slush bottle 240 with an attached slush cap 204 after removal of two cap plugs 250 and replacement with a slush outlet connector 300 and vent tube 350. To avoid confusion with the slush container 200 with two cap plugs 250, this container with a slush outlet connector 300 and vent tube 350 will be referred to as a slush-feed container 1200.

[0062] The slash outlet connector 300 may be a standard accessory that allows for the connection of long lengths of flexible tubing, similar to the tubing used for IV connection. In some applications, the tubing may be passed through a peristaltic or similar pump.

[0063] Vent tube 350 may include a filter if the vent tube is used in a non-sterile environment. Vent tube 350 may include a fitting that allows a long length of tubing (possibly flexible) to be attached to vent tube 350 so that the end of the connected tubing is high enough that slush does not spill out the end of the tube during agitation of slush feed container 1200. If a check valve is used with vent tube 350, the height of the end of the tube is not critical.

[0064] Another alternative may be to connect the vent tube 350 to a pressurized source of air or another gas. 8 shows a slush feed container 1200 inserted into a slush mixing device 400. The slush mixing device 400 secures the slush feed container 1200 with the slush cap 204 and slush outlet connector 300 positioned below the end of the slush bottle 240 remote from the slush cap 204. The slush mixing device 400 may limit the movement of the inserted slush feed container 1200 relative to the slush mixing device 400 by one or more supports 404 and a front plate 408, although one skilled in the art will appreciate that many other options exist for limiting or partially limiting the movement of a substantially cylindrical item relative to a machine that vibrates the item.

[0065] When the slush feed container 1200 is placed and held within the slush mixing device 400, the slush outlet connector 300 may be connected to a slush feed pump (not shown) using conventional tubing and connectors. The slush feed pump may be any well-known pump, such as a peristaltic pump (also called a roller pump), used to precisely deliver viscous liquids or slurries. Peristaltic pumps are used in numerous medical applications, such as to provide controlled delivery of fluids to IV connections, while the pumped material remains within sterile tubing and does not come into contact with the pump. An overview of peristaltic pumps can be found at: ---: / / en.wikipedia.org / wiki / Peristaltic_pump, incorporated herein by reference.

[0066] Slush mixing device 400 has a tilt shaft 420 that allows the longitudinal centerline 280 of slush feed container 1200 to be tilted toward horizontal and in a cap-down orientation to move waves of slush back and forth within partially filled slush feed container 1200 so that the slush does not clump or remain attached to the walls of slush feed container 1200. A motor drive to provide the range of tilt angles is not shown in the figures for purposes of this illustration, as such matters are standard to those skilled in the art.

[0067] The slush mixing device 400 may have a second moving shaft for providing oscillation of the slush feed container 1200. The oscillation shaft 440 may be coupled to a suitable drive for rotating the cradle and engaged slush feed container 1200 clockwise and counterclockwise about an axis passing through the oscillation shaft 440 and parallel to the longitudinal centerline 280. Having a second form of oscillation results in a more complex movement of the slush waves within the slush feed container 1200. Although not required, it may be advantageous to select a cycle of excitation to the tilt shaft 420 that is not an even fraction or even multiple of the cycle of rotation relative to the oscillation shaft 440, thereby preventing frequent repetition of position combinations due to the effects of the tilt shaft 420 and oscillation shaft 440.

[0068] 9 shows a portion of the slush feed container 1200 and the slush mixing device 400. The current position of the rotating inclined shaft 420 positions the longitudinal centerline of the slush feed container 1200 approximately 15 degrees below horizontal.

[0069] FIG. 10 shows a simplified cross-sectional view of this 15-degree downwardly inclined slush feed container 1200. The simplified view does not show all the details of the slush outlet connector 300 or vent tube 350. Liquid 180 is converted to slush 188, which is a mixture of small particles of ice and a liquid with a higher average salinity than liquid 180, prior to the creation of slush 188. Air 184 or another gas fills the rest of the interior of slush feed container 1200. Slush 188, although more viscous than liquid 180, still flows downward and sloshes within slush feed container 1200.

[0070] Those skilled in the art will recognize that the vent tube 350 may have a check valve to allow gas in but not the outflow of slush 188. The vent tube 350 may be connected to a pressurized source of gas, such as sterile air or a gas that is non-reactive with slush 188.

[0071] 11 shows a portion of the slush feed container 1200 and the slush mixing device 400. The current position of the rotating inclined shaft 420 positions the longitudinal centerline of the slush feed container 1200 approximately 30 degrees downward from the horizontal.

[0072] FIG. 12 shows a simplified cross-sectional view of this 30 degree downward tilt slush feed container 1200. 13 shows a simplified cross-sectional view of a 30-degree downward tilted slush feed container 1200, as in FIG. 12, when the amount of slush 188 is almost gone. The process will stop removing slush 188 from slush feed container 1200 before slush 188 no longer covers the entrance to slush outlet connector 300. Many pumps have counters so that it is possible to know when it is time to switch to another slush feed container 1200 after a certain amount of pumping that fully depletes the slush feed container 1200. While there may be differences in the actual flow rate that can be generated by a peristaltic pump, that amount of variation will not interfere with ensuring that slush feed container 1200 can be removed before drawing air into the outlet line.

[0073] 14 shows a simplified cross-sectional view of a 15 degree downward tilted slush feed container 1200 when the amount of slush 188 is nearly gone. Note that even with relatively little slush remaining, the entrance to the slush outlet connector 300 is covered.

[0074] Rocking. 15 and 16 show a slush mixing apparatus 400 with active rocking forced by a rocking shaft 440 on a cradled slush feed container 1200. Optionally, gap 412 in support 404 and front plate 408 can be sized relative to the shape of slush feed container 1200 so that rocking of slush feed container 1200 causes the slush feed container to continue rotating when rocking shaft 440 reverses direction. Slush feed container 1200 can rotate a sufficient distance to impact a support 404 that is currently being held back or moving in the opposite direction. Port 220 may contact the wall of gap 412 in front plate 408, but is not required.

[0075] The range of rocking does not have to be symmetrical with the gap 412 at the 12 o'clock position of the front plate 408. The rocking can range from 15 to 20 degrees on each side. Maintains temperature of slush feed container.

[0076] FIG. 17 shows the slush feed container 1200 in the slush mixer 400. The slush mixer 400 may have a housing 450 that generates a finite amount of air that can be cooled using refrigeration technology to cool the interior of the housing 450 and the slush mixer 400, maintaining the slush 188 with the desired ice / liquid mixture ratio in the slush feed container 1200. As discussed above, as the amount of ice in the slush 188 increases, the salinity of the remaining liquid increases. This means that the temperature at which additional ice freezes continues to move downward as the salinity of the remaining liquid increases with increasing amounts of ice. Therefore, careful control of temperature will control the equilibrium ratio of ice to liquid. Those skilled in the art will understand that the simplified diagram of FIG. 17 does not include openings in the housing 450 that may be required for one or more tubes to pass the slush from the slush outlet connector 300 out of the housing 450.

[0077] 18 shows another form of temperature maintenance for slush feed container 1200. Slush mixing apparatus 400 still has front plate 408. Front plate 408, lower body 468, rear wall 464, and clamshell top 460 can substantially enclose slush feed container 1200 with insulating material to limit heat flow into the slush feed container. Limiting melting by using only insulation means that the ratio of ice to liquid will change as slush feed container 1200 gradually warms. Therefore, an insulation-only solution may be selected for applications where the slush will be used relatively quickly.

[0078] FIG. 19 is similar to FIG. 18 with an insulated enclosure for the slush feed container 1200, but adds one or more cold plates 470. The cold plates 470 can be formed to approximate the outer diameter of the slush feed container 1200. The cold plates can be made from a material with high thermal mass and can be cooled to a temperature at or below the temperature range for the slush 188. The cold plates 470 can be filled with a material that undergoes a phase change at a temperature selected to maintain the temperature of the slush 188 without inducing unwanted additional freezing of the slush 188. The cold plates 470 can be periodically replaced with other cold plates 470 to provide extended temperature maintenance of the slush 188 within the slush feed container 1200.

[0079] The cooling plate 470 may be made for aluminum. The cooling plate may be pre-cooled to approximately -10°C to compensate for heat loss and to cool the internal support to maintain the slush 188 within the range of -4°C to -5°C. Slushes with different target maintenance temperatures may merit the use of a cooling plate 470 with a different internal temperature.

[0080] The process of use. FIG. 20 includes a flowchart of a process 1000 for delivering a well-mixed, atraumatic, sterile slush to a patient through a tube.

[0081] Step 1004—Partially filling an elongated container with atraumatic sterile slush, resulting in a container having a first port and a second port. This process may use any elongated container with an associated port at one end. The elongated container may have a top end with a port that is not reversibly removable from the remainder of the elongated container. The elongated container may be a slush bottle and cap as shown in the drawings of this disclosure. The cap with the two ports may be placed on the slush bottle before the liquid in the slush bottle is converted to slush, or the cap may replace an original cap used during the production of the slush. Alternatively, the slush may be created in a first container and then transferred to the slush bottle, partially filling the slush bottle before the cap with the two ports engages the slush bottle.

[0082] Step 1008—Optionally, the two ports may be sealed with cap plugs that prevent the transfer of material through the ports and block liquid from entering the ports from the interior of the slush bottle, preventing ice formation within the ports.

[0083] Step 1012—Connect the slash outlet connector to one of two ports. The slash outlet is ultimately in fluid communication with the delivery site to the patient. Step 1016—Connect a vent tube to the other of the two ports. The vent tube will be used to provide a passageway for gas to enter the elongated container. The outlet port and vent port may be dedicated ports used for only one purpose, or the two ports may be interchangeable.

[0084] Step 1020—Place the elongated container in the slush mixer. Those skilled in the art will appreciate that the elongated container may be placed in the slush mixer before or after it is connected to the ports, and that the connections to the ports may be made in any order.

[0085] Step 1024 - optional step - activates to keep the slush frozen. Depending on how long this elongated container of slush will be used, this may help slow the melting of the slush in the capped bottle, which can occur naturally when the ambient room temperature is above the melting temperature of the slush. As noted elsewhere in this disclosure, this effect is cooling the air within a housing surrounding the elongated container and the slush mixing device; - Using insulation around the long container to slow the heat transfer from the outside air to the slush inside the long container; absorbing heat using a cold plate placed in contact with or in close proximity to at least a portion of the elongated container; This may use a cooled plate of high thermal mass, and may use some material that undergoes a phase change at the appropriate temperature to maintain the slush but not further freeze the ice / liquid mixture that forms the slush. In long-term use of a single elongated container, the cold plate may be swapped out to provide additional cooling capacity, or You may use more than one of these options.

[0086] Step 1028—Using a slush mixing device, a complex motion is forced on the elongated container partially filled with slush. This complex motion will cause the slush to move with the elongated container, helping to maintain a well-mixed, atraumatic, sterile slush suitable for delivery through the tube. The complex motion may include a cycle of tilting the longitudinal centerline of the elongated container between the bottle bottom and the cap. The tilting causes the slush to move along an axis from the bottle bottom to the cap. The complex motion may include rocking the elongated container about a rocking axis different from the longitudinal centerline of the elongated container. To maintain a steady supply of slush, the port with the slush outlet connector needs to be kept below horizontal so that slush is available to the port even when the supply of slush in the elongated container nears the end.

[0087] Step 1032 - Moving the slush out of the slush outlet connector towards the patient. Those skilled in the art will recognize that use of the slush mixing device to force a complex motion into the elongated container is most often initiated before moving the slush out of the slush outlet connector, although moving the slush out of the slush outlet connector may occur first, as long as the complex motion is initiated shortly thereafter.

[0088] Those skilled in the art will appreciate that delivery of a substance to a patient can be achieved simply by positioning a container of the substance high above the patient so that gravity is the only driving force. Those skilled in the art will appreciate that a pressure gradient is useful for forcing a substance, such as slush, through a tube to a delivery site within the patient.

[0089] The pressure gradient can be achieved by using a source of pressurized gas that enters the elongated container through a vent tube and a connector port. The pressurized gas can force the slush through a port connected to the slush outlet connector and a subsequent flow path to a delivery site within the patient. The pressurized gas can be air or another gas.

[0090] Alternatively, a pressure gradient may be achieved by using one or more pumps on the path between the slush outlet connector or the delivery site within the patient. When using a pump, the vent tube may allow ambient air to pass through the vent tube and into the elongated container. Optionally, a filter may be used on this path for air to enter the elongated container. Nothing excludes the use of pressurized gas in combination with one or more pumps to provide a pressure gradient to move the slush to the delivery site within the patient.

[0091] Material selection. Slush bottle 240 and cap 204, or other elongated container, may be made from a highly hydrophobic material with a smooth surface finish that works well for the teachings of this disclosure. Thus, material choices made from or coated with Teflon® material work well in the context of this disclosure. While coatings work well, they may not be an ideal choice for slush containers intended to undergo multiple sterilization and use cycles, as any scratching or removal of the coating can result in the slush adhering to latent materials. Thus, elongated containers made from hydrophobic materials are preferable to slush containers with coated interiors.

[0092] The term Teflon material is, in fact, an imprecise expression. EI DuPont De Nemours and Company ("DuPont") owns a series of registered trademarks for various uses of materials including polymers of fluorinated hydrocarbons. There are actually several different materials that exist within this category of materials covered by the Teflon mark. Materials that exist within the category of materials covered by the Teflon mark may also be provided by other commercial sources. Therefore, it is appropriate to focus on chemical names rather than trademarked product names. Those skilled in the art will appreciate that the production of medical components often uses medical-grade supplies that are produced under stricter process controls and have fewer impurities. Medical-grade resins may be used to fabricate the elongated containers herein.

[0093] Polytetrafluoroethylene (PTFE) is the material most commonly offered under the Teflon trademark and is often mistakenly associated by the public as synonymous with Teflon® material. Other materials sold under the Teflon name are a class of perfluoroethers. Notable among the perfluoroether materials are the perfluoroalkoxyalkanes (PFAs). ----: / / www.guarniflon.com / index.php / en / materials / pfa.html. Other materials in this group exist with various ratios of PTFE to methyl vinyl ether (MVE). One such material is known as MFA. -----: / / www.guarniflon.com / index.php / en / materials / mfa.html.

[0094] Like PTFE, PFA is known for its chemical resistance (chemically harmless), hydrophobicity, and extremely low coefficient of friction. One advantage PFA has over PTFE is that the PFA polymer can be melt-processed, which is useful when attempting to create slush containers by injection molding. Another drawback of PTFE is that it is less dimensionally stable than PFA. When slush containers are used over multiple sterilization cycles, dimensional stability outweighs any tendency to creep, so that slush container lids continue to fit across a variety of freshly sterilized slush containers.

[0095] Another material in the Teflon family that can be injection molded is FEP (fluorinated ethylene propylene), a copolymer of hexafluoropropylene and tetrafluoroethylene. FEP differs from PTFE (polytetrafluoroethylene) resin in that it is melt processable using conventional injection molding and screw extrusion techniques (see ----: / / en.wikipedia.org / wiki / Fluorinated_ethylene_propylene). This material has been tested and found to be viable for use in slush containers used in accordance with the teachings of the present disclosure. PFA is more desirable than FEP because it is harder and more dimensionally stable.

[0096] Although PFA and FEP are desirable materials, acceptable results can be obtained with PET (sometimes referred to as PETE) or the related material PETG (PETG (Polyethylene Terephthalate Glycol Modified)). The differences between PET and PETG are summarized at: -----: / / www.plasticingenuity.com / packaging / differences-between-petg-and-apet / .

[0097] Such elongated containers made of PFA, FEP, or other suitable materials are hydrophobic and have extremely low surface friction, so ice crystals tend not to form or adhere to the walls of the slush container. The coefficients of friction (both static and kinetic) for various products known as Teflon, including PTFE, FEP, and FPA, are extremely low relative to other solid materials. The use of elongated containers made from materials that tend not to allow ice crystals to adhere to the walls of the elongated container facilitates mixing when used in conjunction with vibratory agitation.

[0098] By having conditions that prevent ice from forming on the container walls and mixing to prevent ice accumulation closer to the walls than near the longitudinal centerline of the elongated container, it becomes possible to use the slush machine with ambient air that is cooled sufficiently below the freezing temperature range of saline. Reducing the ambient temperature increases the rate at which the container contents cool, which is desirable when done without the adverse effect of creating unacceptable ice buildup on or near the walls of the slush bottle 240 or cap 204.

[0099] Standard long container material selection Something like that hospital of Sterilization of the containers per protocol may be possible. Those skilled in the art will recognize that many different protocols exist, and some may be contraindicated for certain materials. Examples of common sterilization protocols include the use of EtO (ethylene oxide), autoclaves, and low-temperature plasma. Other methods are known to those skilled in the art.

[0100] Alternatives and Variations Tilt Angle Range A range of tilt angles from 15 to 30 degrees has been used in the drawings herein. The minimum tilt angle may be different than the 15 degree tilt angle. One skilled in the art will recognize that having a minimum tilt angle less than 15 degrees may impact the percentage of unused slush in each slush feed container 1200.

[0101] For example, a minimum tilt angle of 15 degrees that agitates the slush feed container at a particular level may result in approximately 150 ml of slush 188 remaining in a slush feed container 1200 that was initially filled with 1 liter of sterile saline. Similarly, use of a minimum tilt angle less than 15 degrees may require a change in tilt angle and a reduction in the intensity of the agitation so that the wave troughs do not introduce air into the inlet of the slush outlet connector 300. Conversely, an air detection or air movement mechanism between the slush feed container 1200 and the patient may tolerate a minimum tilt angle less than 15 degrees, since the undesirable consequences of air entering the inlet are not an issue.

[0102] Similarly, the maximum tilt angle of 30 degrees may be modified to be less than or greater than 30 degrees. Those skilled in the art will appreciate that tilt shaft 420 need not be separated from slush feed container 1200 by front plate 408. Tilt shaft 420 may be positioned below slush feed container 1200, perhaps midway along the length of slush feed container 1200.

[0103] More than normal saline. While the above discussion focused on surgical slush made from sterile saline, the teachings of the present disclosure may be applied to the production of surgical slush made from a mixture of medical saline or sterile water and clinically appropriate substances. Clinically appropriate substances include sugars, vitamins, enzymes, or other bioactive agents. Glycerol may be added to the slush. The operation of the slush freezer to create the slush and slush cradle and maintain the slush 188 may need to be adapted for a particular use, such as changing the temperature settings for the expected amount of time to generate the slush, but these adjustments can be made by one skilled in the art.

[0104] The present disclosure does not require standard 0.9% saline as a base material for use in creating the injectable slush. Non-circular cross section.

[0105] While the cross-section of the slush bottle 240 has been shown as substantially cylindrical, other shapes are possible for the slush bottle, or elongated containers in general, including oval, or highly rounded trilobes or squares. The shape should avoid the use of sharp corners that may retain slush. The use of shapes other than circular requires adjusting the cooling rate or agitation level to compensate for any tendency to form slush in highly rounded corners. Thus, the present disclosure encompasses implants having a cross-section of an elongated container taken perpendicular to the longitudinal centerline of the elongated container from the base to the port end, where the cross-section is not circular.

[0106] Single-use slush container. While the present disclosure teaches the use of slush bottles and lids that are amenable to sterilization and reuse, the teachings of the present disclosure do not require reuse. Single-use slush containers may be used, particularly for one-piece elongated containers having an integrated top with a port. Single-use slush containers may be pre-filled with an appropriate amount of liquid, such as sterile saline.

[0107] The single-use container may initially include a simple cap 104 (FIG. 1) that is replaced with a cap 204 having a pair of ports 220 and 224 for use in creating the slush feed container 1200. The single-use container may be an elongated container with integrated ports, the elongated container already partially filled with the liquid that will become the slush, or the elongated container may be partially filled with the liquid through one or more ports after receipt.

[0108] Stirring speed. The tilt and rocking speeds are selected to ensure adequate mixing of the slush 188 while avoiding sufficient wave movement to trap large air bubbles after the waves contact the interior walls of the elongated container.

[0109] Ports may be specialized. This disclosure has shown two interchangeable ports 220. Interchangeable ports are not a requirement of this disclosure, and it may be desirable to have one port intended for use with slash outlet connector 300 and a different port intended for use with vent tube 350. For example, the interior inner diameter of the port used for vent tube 350 may be smaller than the interior inner diameter of the port used with slash outlet connector 300, or the two ports may use different mating connectors.

[0110] Measurement and control. An air bubble detector may be placed between the slush feed container 1200 and the pump to at least sound an alarm if a discernible air bubble is present in the line. When an alarm is given by using the controls for the device for delivering slush to the patient, the clinician may stop the delivery of slush. The air bubble detector may be linked to the control system to stop the pump pending intervention by the clinician, indicating that the problem has been resolved.

[0111] A pressure sensor may be positioned to detect pressure at the outlet from the pump to the device that delivers the slush to the patient, and responds if an occlusion limits the delivery of the slush but the peristaltic or other pump continues to operate.

[0112] Alternatives to using a pump. An alternative to using a pump connected to the slush outlet connector 300 is to apply air pressure to the interior of the slush feed container 1200 through the vent tube 350. Applying air pressure to the interior of the slush feed container 1200 forces the slush 188 out of the slush outlet connector 300 without relying on a pump. Pneumatic delivery systems are commonly used to deliver paint, gasoline, and wine.

[0113] Therefore, the term "delivery mechanism" should be interpreted broadly enough to include not only a pump that operates on the slurry material coming from the slush feed container 1200, but also a system that applies a controlled amount of air pressure inside the slush feed container 1200.

[0114] Those skilled in the art will recognize that the application of a force that exerts a pressure gradient on the elongated container to force the slush out the port and toward the patient may be applied intermittently, as the delivery of the slush to the patient may not be continuous. Alternatively, the application of force may be constant, but controls used by the medical professional may close off the flow path for the slush to the patient near the delivery point.

[0115] A cap with integrated components. This disclosure describes a cap 204 with two ports 220 and 224 that are subsequently connected to a slush outlet connector 300 and a vent tube 350 as shown in Figure 7. This works well in a process where a slush bottle is partially filled with saline, the cap 204 with the ports sealed with port plugs 250 is then placed in a slush maker, and the slush delivery container 1200 is then partially filled with slush for use. It is advisable not to allow the slush outlet connector 300 and vent tube 350 to protrude during mixing in a slush maker such as that described in U.S. Patent No. 9,549,843 for "Production of Well-Mixed Surgical Slush."

[0116] Those skilled in the art will appreciate that if a slush-making machine is provided with a partially filled slush bottle sealed with a simple cap 104 (FIG. 1), a slush delivery cap pre-connected to a channel through a delivery cap having an integrated slush outlet connector 300 and an integrated vent tube 350 may provide a viable route to a situation equivalent to that of FIG. 7. This is an alternative route to an elongated container with a fluid communication path from the proximal tip of the slush outlet connector to the interior of the elongated container and a fluid communication path from the proximal tip of the vent tube to the interior of the elongated container. Such an elongated container would be suitable for use in the slush mixing apparatus of FIG. 8 and the remainder of the process.

[0117] Periodic cessation of repetitive movements. The present disclosure teaches the use of one or more types of repetitive motions to agitate slush through various types of movements within a partially filled elongated container. The repetitive motion may be maintained without interruption from immediately after the elongated container is placed into the slush mixing device until the elongated container can no longer provide slush or the need for slush has passed. Those skilled in the art will understand that the repetitive motion may be stopped for a short period of time without adverse effects. The halt in motion may be for one type of motion or all motions. The halt in motion may be a routine part of a motion cycle. For example, the motion may proceed for 45 seconds and then pause for 15 seconds before repeating the cycle.

[0118] Those skilled in the art will recognize that some of the alternative implementations described above are not universally mutually exclusive, and in some cases, additional implementations may be created that employ aspects of two or more of the variations described above.Similarly, the present disclosure is not limited to specific examples or specific embodiments provided to facilitate understanding of the various teachings of the present disclosure.

[0119] Where the methods and / or events described above indicate certain events and / or actions occurring in a particular order, the order of the certain events and / or actions may be changed. Furthermore, certain events and / or actions may be performed simultaneously in parallel processes, where possible, or may be performed sequentially as described above.

[0120] The legal limitations on the scope of the claimed invention are set forth in the following claims, which are extended to encompass their legal equivalents. Those unfamiliar with the legal tests for equivalence should consult with a person registered to practice before the patent authority that granted this patent, such as the U.S. Patent and Trademark Office or its equivalent.

Claims

1. 1. An assembly for use in providing a slush for injection into a patient, comprising: a slush bottle having an interior defined by a bottle bottom at a distal end of the slush bottle and at least one set of bottle sidewalls connecting the bottle bottom to an open end of the slush bottle at a proximal end of the slush bottle; a cap adapted to reversibly engage the proximal end of the slush bottle to cover the open end to form a capped bottle; a set of two ports, each port providing an open channel from a proximal side of the cap to a distal side of the cap such that a substance can traverse the cap when the cap is engaged with the proximal end of the slush bottle; a slush outlet connector coupled to an outlet port of one of the two sets of ports, the slush outlet connector having a delivery channel for delivering slush from the interior of the capped bottle through the one of the two sets of ports and the slush outlet connector to a tube carrying the slush toward an entry point for the patient; a vent tube connected to a vent port that is one of the two ports but is not the port connected to the slash outlet connector, the vent tube having a vent channel that allows gas to flow through the vent tube and the vent port, thereby allowing gas to enter the capped bottle; a slush mixing device that supports the capped bottle and tilts the capped bottle so that a longitudinal centerline of the capped bottle from the bottle bottom to the cap moves toward a horizontal position, followed by movement of the cap of the capped bottle to a second position where the cap is lower than the bottle bottom of the capped bottle, thereby moving a water line between the slush and the gas-filled space within the capped bottle; 1. An assembly used to provide a slash, comprising:

2. 2. The assembly for use in providing slush according to claim 1, wherein the vent tube is open to the atmosphere so that outside air passes through the vent tube and enters the capped bottle.

3. 3. The assembly for use in providing slush as claimed in claim 2, wherein the vent tube includes a filter so that outside air passes through the filter before entering the capped bottle.

4. 2. The assembly for use in providing slush described in claim 1, wherein the vent tube has a check valve to prevent substances from the interior of the capped bottle from migrating from the interior of the capped bottle out the proximal end of the vent tube.

5. 10. The assembly for use in providing a slush according to claim 1, wherein the vent tube is connected to a source of pressurized gas.

6. each port of the set of two ports on the cap is connectable to the slash outlet connector but not to the vent tube; 2. The assembly for use in providing a slash according to claim 1, wherein each port of the set of two ports on the cap is connectable to the vent tube but not to the slash outlet connector.

7. 10. The assembly for use in providing slush as claimed in claim 1, wherein the tube conveying the slush towards the entry point in the patient is connected to a slush delivery pump.

8. 2. The assembly for use in providing slush described in claim 1, wherein the slush mixing device stops moving toward the horizontal when the longitudinal centerline of the capped bottle from the bottle bottom to the cap is at an angle of 15 degrees or more from the horizontal, with the cap remaining lower than the bottle bottom.

9. 9. The assembly for use in providing slush described in claim 8, wherein the slush mixing device rotates the longitudinal centerline of the capped bottle from the bottle bottom to the cap from a state in which the cap is approximately 15 degrees below the bottle bottom to a state in which the cap is approximately 30 degrees below the bottle bottom.

10. 2. The assembly for use in providing slush described in claim 1, wherein the slush mixing device rocks the capped bottle clockwise and counterclockwise about a rocking axis running parallel to the longitudinal centerline, and the rocking of the capped bottle increases the tilt of the capped bottle to agitate the slush contained within the capped bottle.

11. 10. The assembly for use in providing slush described in claim 1, wherein the slush mixing device shakes the capped bottle using a shake cycle of a first duration and the slush mixing device tilts the capped bottle using a tilt cycle of a second duration different from the first duration.

12. 10. The assembly for use in providing slush as defined in claim 1, wherein the slush mixing device agitates the capped bottle using a rocking cycle having a range of motion of about 40 degrees.

13. The slush mixer includes an inclined shaft and a swinging shaft perpendicular to the inclined shaft; the tilting shaft is configured to generate a first type of vibration that tilts the longitudinal centerline of the capped bottle; the swing shaft is configured to generate a second type of vibration of the capped bottle that is perpendicular to the first type of vibration; 2. The assembly for use in providing slush described in claim 1, wherein the tilting shaft and the oscillating shaft are configured to be driven to force a complex movement of the slush within the capped bottle by a combination of the first form of vibration and the second form of vibration.

14. 10. The assembly for use in providing slush described in claim 1, wherein the slush mixing device and the capped bottle are within a housing such that air adjacent to and surrounding at least a portion of the capped bottle is cooled below the ambient air temperature outside the housing.

15. 10. The assembly for use in providing slush described in claim 1, wherein the capped bottle is substantially surrounded by an insulating material to limit the transfer of heat from air adjacent the capped bottle to the slush within the capped bottle.

16. 10. The assembly for use in providing slushies of claim 1, wherein the capped bottle is at least partially surrounded by at least one cold plate that removes heat from the capped bottle.

17. 17. The assembly for use in providing slush of claim 16, wherein at least one cold plate comprises a material that undergoes a phase change while in contact with the capped bottle containing the slush.

18. 10. The assembly for use in providing slush of claim 1, wherein the slush bottle and the cap are both made from a hydrophobic material.

19. 10. The assembly for use in providing slush of claim 1, wherein the slush bottle and the cap are both made from materials suitable for multiple cycles of sterilization using at least one standard hospital protocol selected from the group consisting of the use of EtO, autoclave, and low-temperature plasma.

20. 10. The assembly for use in providing slush as claimed in claim 1, wherein a cross section of the slush bottle perpendicular to a longitudinal centerline of the capped bottle from the bottle base to the cap is oval.

21. 10. The assembly for use in providing the slash of claim 1, further comprising a plurality of cap plugs for covering both proximal ends of the two sets of ports to prevent material from moving across the cap until such movement is desired.

22. 22. The assembly for use in providing a slash according to claim 21, wherein at least one cap plug engages one port of the set of two ports using a threaded connection.

23. 22. The assembly for use in providing a slash according to claim 21, wherein at least one cap plug engages one port of the set of two ports using a stopper that forms an interference fit.

24. 22. The assembly for use in providing slush described in claim 21, wherein the plurality of cap plugs prevent liquid from migrating from the distal side of the cap into each open channel from the proximal side of the cap to the distal side of the cap, thereby preventing ice formation in the set of two ports.

25. 1. An assembly for use in providing a slush for injection into a patient, comprising: an elongated container having an interior defined by a container bottom at a distal end of the elongated container, a port end opposite the container bottom, and at least one set of container sidewalls connecting the container bottom to the port end at the proximal end of the elongated container; a set of two ports, each port providing an open channel from a proximal side of the port end of the elongated container to a distal side of the port end of the elongated container so that a substance can traverse the port end of the elongated container; a slash outlet connector coupled to an outlet port, the outlet port being one of the two ports, the slash outlet connector having a delivery channel for delivering slush from the interior of the elongated container through the one of the two ports and the slash outlet connector to a tube carrying the slush toward an entry point in the patient; a vent tube connected to a vent port that is one of the two ports but is not the port connected to the slash outlet connector, the vent tube having a vent channel that allows gas to flow through the vent tube and the vent port, thereby allowing gas to enter the elongated container; and a slush mixing device that supports the elongated container and tilts the elongated container such that a longitudinal centerline of the elongated container from the container bottom to the port end of the elongated container moves toward a horizontal position, followed by movement of the port end of the elongated container to a second position where the port end of the elongated container is lower than the container bottom of the elongated container, thereby moving a water line between the slush and the gas-filled space within the elongated container; The assembly to use when providing a slash.

26. 26. The assembly for use in providing slush described in claim 25, wherein the slush mixing device stops the movement toward the horizontal when the longitudinal centerline of the elongated container from the container bottom to the port end is 15 degrees or more from horizontal with the port end remaining lower than the container bottom.

27. 26. The assembly for use in providing slush described in claim 25, wherein the slush mixing device rotates the longitudinal centerline of the elongated container from the container bottom to the port end from a state in which the port end is approximately 15 degrees below the container bottom to a state in which the port end is approximately 30 degrees below the container bottom.

28. 26. An assembly for use in providing slush as described in claim 25, wherein the slush mixing device rocks the elongated container clockwise and counterclockwise about a rocking axis running parallel to the longitudinal centerline, and the rocking of the elongated container increases the inclination of the elongated container to agitate the slush contained within the elongated container.

29. 26. The assembly for use in providing a slush of claim 25, wherein the slush mixer agitates the elongated container using a rocking cycle having a range of motion of about 40 degrees.

30. The slush mixer includes an inclined shaft and a swinging shaft perpendicular to the inclined shaft; the tilting shaft is configured to generate a first form of vibration that tilts the longitudinal centerline of the elongated container; the swing shaft is configured to generate a second type of vibration of the elongated container that is perpendicular to the first type of vibration; 26. An assembly for use in providing slush as described in claim 25, wherein the inclined shaft and the oscillating shaft are configured to be driven to force a complex movement of the slush within the elongated container by a combination of the first form of vibration and the second form of vibration.

31. 26. An assembly for use in providing slush as described in claim 25, wherein the slush mixing device and the elongated container are within a housing such that air adjacent to and surrounding at least a portion of the elongated container is cooled to below the ambient temperature outside the housing.

32. 26. An assembly for use in providing slush as described in claim 25, wherein the elongated container is substantially surrounded by insulating material to limit the transfer of heat from air adjacent the elongated container to the slush within the elongated container.

33. 26. An assembly for use in providing slush as claimed in claim 25, wherein the elongated container is at least partially surrounded by at least one cold plate that removes heat from the elongated container.

34. 34. The assembly for use in providing slush of claim 33, wherein at least one cold plate comprises a material that undergoes a phase change while in contact with the elongated container containing the slush.

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