Process for Delivering Slush for Injection

Abstract

A process and related assemblies for delivering slush through a tube towards a patient. Obtaining an elongated container partially filled with slush with a port end that has a first port and a second port. Placing the first port in fluid communication with tubing for delivery of slush towards the patient. Placing the second port in fluid communication with a source of gas which may be air. Subjecting the elongated container to automated repetitive movements so that the slush in the partially filled elongated container moves against interior surfaces within the elongated container. Ideally, two different forms of repetitive motion are used to impose complex movement upon the slush within the elongated container. Applying a pressure gradient to cause slush to flow out of the first port towards the patient. The elongated container may be made from a slush bottle with a reversibly engaged cap with the two ports.

Claims

1. A process for delivering slush through a tube towards a proximal tip of a slush output connector, the process comprising: obtaining an elongated container partially filled with slush and with a port end that has a first port and a second port; placing the first port in fluid communication with slush output connector; placing the second port in fluid communication with a source of gas; subjecting the elongated container to at least one form of repetitive movement so that the slush in the partially filled elongated container moves against interior surfaces within the elongated container; and creating a pressure gradient to cause slush to flow out of the first port towards the proximal tip of a slush output connector.

2. The process of claim 1 wherein the elongated container is a capped bottle comprising a slush bottle and an engaged cap at a capped end of the slush bottle, the cap having the first port and the second port.

3. The process of delivering slush of claim 2 wherein the cap further comprises: a slush output connector integrated with the first port, to create a flow path for slush from the interior of the elongated container, through the first port and through the slush output connector; and a vent tube integrated with the second port, to create a vent path for gas from an exterior of the elongated container, through the vent tube and through the second port to the interior of the elongated container.

4. The process of delivering slush of claim 2 wherein the cap with the first port and the second port were part of the elongated container before the elongated container was delivered to a slush making machine that converted liquid saline within the elongated container to slush.

5. The process of delivering slush of claim 2 wherein the cap with the first port and the second port was placed on a container body after the container body was retrieved from a slush making machine that converted liquid saline within a capped container body to slush.

6. The process for delivering slush through the tube of claim 1 wherein a first plug is removed from the first port before attaching a slush output connector to the first port, to create a flow path for slush from the interior of the elongated container, through the first port and through the slush output connector.

7. The process of delivering slush of claim 1 wherein a second plug is removed from the second port before attaching a vent tube to the second port, to create a vent path for gas from an exterior of the elongated container, through the vent tube and through the second port to the interior of the elongated container.

8. The process of delivering slush of claim 1 wherein the source of gas is ambient air.

9. The process of delivering slush of claim 8 wherein the source of gas is ambient air that passes through a filter as the ambient air moves towards the interior of the elongated container.

10. The process of delivering slush of claim 1 wherein the source of gas is a gas other than air.

11. The process of delivering slush of claim 1 wherein the source of gas is pressurized and forces slush out the first port.

12. The process of delivering slush of claim 1 wherein the pressure gradient is caused by use of pressurized gas in fluid communication with the second port.

13. The process of delivering slush of claim 1 wherein the pressure gradient is caused by connecting the first port to a closed channel connected to an inlet of a pump such that pump suction draws slush out of a first path.

14. The process of delivering slush of claim 1 wherein the pressure gradient is caused by a combination of: connecting the first port to a closed channel connected to an inlet of a pump such that pump suction draws slush out of a first path; and use of pressurized gas in fluid communication with the second port.

15. The process for delivery of slush of claim 1 wherein at least one form of repetitive movement continues without interruption until the elongated container is no longer providing slush.

16. The process for delivery of slush of claim 1 wherein the at least one form of repetitive movement is two forms of repetitive movement which include a first form of repetitive movement with a first cycle length and a second form of repetitive movement with a second cycle length that is different from the first cycle length and neither cycle length is an even multiple of the other cycle length.

17. The process for delivery of slush of claim 16 wherein one of the two forms of repetitive movements is tilting of a longitudinal centerline of the elongated container between a bottom of the elongated container and the port end.

18. The process for delivery of slush of claim 16 wherein one of the two forms of repetitive movements rocking of the elongated container around a rocking axis different from a longitudinal centerline of the elongated container between a bottom of the elongated container and the port end.

19. The process for delivery of slush of claim 1 wherein the slush is slowed from melting by chilling ambient air that is in contact with an exterior of the elongated container.

20. The process for delivery of slush of claim 1 wherein the slush is slowed from melting by placing cooling plates in contact with an exterior of the elongated container.

21. The process for delivery of slush of claim 20 wherein the cooling plates contain material that undergoes a phase change to absorb heat at a temperature useful for maintaining the slush as a slush slurry without causing additional freezing within the slush slurry.

22. The process of delivering slush of claim 1 wherein the elongated container has a removable cap with the first port and the second port, and the removable cap was placed on a container body before the elongated container was delivered to a slush making machine that converted liquid saline within the elongated container to slush.

23. The process of delivering slush of claim 1 wherein the elongated container has a removable cap with the first port and the second port, and the removable cap was placed on a container body after the elongated container was retrieved from a slush making machine that converted liquid saline within the elongated container to slush.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0083] The disclosure can be better understood with reference to the following figures. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the disclosure. Moreover, in the figures, like reference numerals designate corresponding parts throughout the different views.

[0084] FIG. 1 shows a side view of prior art slush container 100 with slush bottle 110 with cap 104.

[0085] FIG. 2 and FIG. 3 show a top perspective view of cap 204 that can fit onto a slush bottle such as shown as slush bottle 110 in FIG. 1.

[0086] FIG. 4 shows a bottom perspective view of the cap plug 250.

[0087] FIG. 5 shows a side view of a cross section of an exploded view of sealed slush container 200.

[0088] FIG. 6 shows a cross section of the sealed slush container 200.

[0089] FIG. 7 shows a slush bottle 240 with an attached slush cap 204 after removal of the two cap plugs 250 and replacement with a slush output connector 300 and a vent tube 350.

[0090] FIG. 8 shows the slush container 200 inserted into a slush mixing device 400. The slush mixing device 400 secures the slush feed container 1200 with the slush cap 204 and the slush output connector 300 located lower than the end of the slush bottle 240 that is remote from the slush cap 204.

[0091] FIG. 9 shows a slush feed container 1200 and a portion of a slush mixing device 400.

[0092] FIG. 10 shows a simplified cross section of the slush feed container 1200 at a 15 degrees downward tilt.

[0093] FIG. 11 shows a slush feed container 1200 and a portion of a slush mixing device 400.

[0094] FIG. 12 shows a simplified cross section of the slush feed container 1200 at a 30 degrees downward tilt.

[0095] FIG. 13 shows a simplified cross section of the slush feed container 1200 at a 30 degrees downward tilt as in FIG. 12 as the quantity of slush 188 is almost gone.

[0096] FIG. 14 shows a simplified cross section of the slush feed container 1200 at a 15 degrees downward tilt as the quantity of slush 188 is almost gone.

[0097] FIG. 15 and FIG. 16 show a slush mixing device 400 that has active rocking imposed by rocking shaft 440 upon the cradled slush feed container 1200.

[0098] FIG. 17 shows a slush feed container 1200 in a slush mixing device 400.

[0099] FIG. 18 illustrates another form of temperature maintenance for the slush feed container 1200.

[0100] FIG. 19 is like FIG. 18 with an insulating encapsulation for the slush feed container 1200 but FIG. 19 adds one or more cooling plates 470.

[0101] FIG. 20 contains a flowchart of process 1000 for delivery of well-mixed, atraumatic sterile slush through a tube towards a patient.

DETAILED DESCRIPTION

[0102] The presently disclosed subject matter is described with specificity to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. Rather, the inventors have contemplated that the claimed subject matter might also be embodied in other ways, to include different steps or elements similar to the ones described in this document, in conjunction with other present or future technologies. Moreover, although the term step may be used herein to connote different aspects of methods employed, the term should not be interpreted as implying any particular order among or between various steps herein disclosed unless and except when the order of individual steps is explicitly described.

[0103] FIG. 2 and FIG. 3 show a top perspective view of cap 204 that can fit onto a slush bottle such as shown as slush bottle 110 in FIG. 1. Cap 204 has a pair of ports 220 and 224 which each provide a passageway through the cap so that liquid or gases (such as air) may pass through the cap 204 while the lid remains attached to a slush bottle.

[0104] FIG. 2 shows the cap 204 without the cap plugs 250. FIG. 3 shows the cap plugs 250 in the ports 220 and 224 to seal the ports 220 and 224. The ports 220 and 224 may start sealed and remained sealed until the slush bottle 240 with liquid to be made into sterile slush is initially sealed by the cap 204. After the slush bottle has been processed so that the slush bottle and cap 204 now encapsulate surgical slush for use in a surgical procedure, the cap plugs 250 may be removed so that slush may be provided through one of the ports 220 or 224 while using the other port as a vent to allow gas to flow into the volume defined by the slush bottle and the interior side of the cap 204 as slush leaves that volume.

[0105] FIG. 4 shows a bottom perspective view of the cap plug 250. The cap plug 250 has a stopper 252 that forms an interference fit with the interior walls of the ports 220 or 224. The stopper 252 has a tapered portion 246 that forms the interference fit and a cylindrical portion 248 that seals the inlet to the port to prevent ice from forming in the port inlet. The stopper 252 could be made of polypropylene or another suitable material. The exterior walls of the port 220 or 224 fit within annular port cavity 254. The annular port cavity could employ a Luer fitting thread or another thread type which would interact with corresponding threads on the ports. A knurled perimeter 256 facilitates a gloved end user in twisting the engaged cap plug 250 in order to remove the cap plug 250 from the port 220 or 224 when the end user wishes to obtain surgical slush for a medical procedure.

[0106] FIG. 5 shows a side view of a cross section of an exploded view of sealed slush container 200. Sealed slush container 200 has cap 204, cap plugs 250, and slush bottle 240. This simplified drawing does not show the threads within cap 204 that would engage with corresponding threads on the upper portion of slush bottle 240.

[0107] FIG. 6 shows a cross section of the sealed slush container 200. Shown in this view are cap 204, slush bottle 240 and cap plugs 250 covering ports 220 and 224 (see FIG. 5). Slush container 200 has a liquid 180 such as sterile saline which may include additives and air 184 as the preferred processes for making sterile slush with atraumatic particles requires some air in the sealed slush container to allow for sloshing of the slush slurry to help dislodge slush from the interior 210 of the sealed slush container 200.

[0108] A careful observer will note that the distal ends of the stoppers 252 of the two cap plugs 250 extend at least to the interior wall 208 of the cap 204. The stoppers 252 may be sized relative to the interiors of the ports 220 and 224 to actually extend beyond the interior wall 208 of the cap 204 and into the interior 210 of the sealed slush container 200 so as to preclude the formation of ice within the ports 220 and 224. The sealed slush container 200 is ready to be sent to a slush making device such as described within U.S. Pat. No. 9,549,843 for the Production of Well-Mixed Surgical Slush.

[0109] After the liquid within the sealed slush container 200 has been turned into a mixture of ice and liquid with a desired ratio of solid to liquid material and with desirable atraumatic spheroids of ice of substantially uniform size, it is time to use the slush. As previously noted, this slush will have a substantially uniform consistency. Desirable surgical slush will feel soft to the touch without any hard, crystalline formations. The slush is likely to be 30 to 50% solid in order to make the material relatively easy to pump to the treatment site.

[0110] FIG. 7 shows a slush bottle 240 with an attached slush cap 204 after removal of the two cap plugs 250 and replacement with a slush output connector 300 and a vent tube 350. To avoid confusion with the slush container 200 with the two cap plugs 250, this container with the slush output connector 300 and the vent tube 350 will be called the slush feed container 1200.

[0111] The slush output connector 300 can be a standard fitting to allow a long flexible tube to be connected similar to the tubing used for an IV connection. In some applications, the tubing may be run through a peristaltic or similar pump.

[0112] The vent tube 350 may include a filter if the vent tube will be used in a non-sterile environment. The vent tube 350 may include a fitting to allow a long tube (possibly flexible) to be attached to the vent tube 350 so that the end of the connected tubing is high enough that slush does not spill out of the end of that tubing during agitation of the slush feed container 1200. If a check valve is used with the vent tube 350 then the height of the end of the tubing is not important.

[0113] Another alternative is to connect the vent tube 350 to a pressurized source of air or another gas.

[0114] FIG. 8 shows the 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 the slush output connector 300 located lower than the end of the slush bottle 240 that is remote from the slush cap 204. The slush mixing device 400 may limit the movement of an inserted slush feed container 1200 relative to the slush mixing device 400 with one or more supports 404 and the front plate 408 although those of skill in the art will understand that many other options exist for limiting or partially limiting the movement of a substantially cylindrical item relative to a machine that oscillates the item.

[0115] When the slush feed container 1200 is placed and retained within the slush mixing device 400, the slush output connector 300 can be connected to a slush feed pump (not shown) using conventional tubing and connectors. The slush feed pump can be any known pump used for precise delivery of viscous liquids or slurries such as a peristaltic pump (also called a roller pump). Peristaltic pumps are used in a number of medical applications such as to provide controlled delivery of fluids to an IV connection as the material being pumped stays within sterile tubing and never comes in contact with the pump. An overview of peristaltic pumps can be found at - - - ://en.wikipedia.org/wiki/Peristaltic_pump and is incorporated herein by reference.

[0116] Slush mixing device 400 has a tilt shaft 420 that allows the longitudinal centerline 280 of the slush feed container 1200 to be tilted towards horizontal and titled to a cap-down orientation to cause waves of slush within the partially filled slush feed container 1200 to move back and forth to keep the slush from clumping or adhering to the walls of the slush feed container 1200. The motor drive to provide a range of tilt angles is not shown in this explanatory drawing as such matters are conventional to those of skill in the art.

[0117] The slush mixing device 400 may have a second operative shaft to provide a rocking of the slush feed container 1200. Rocking shaft 440 may be connected to an appropriate drive to rotate the cradle and the engaged slush feed container 1200 clockwise and counterclockwise around an axis running through the rocking shaft 440 and parallel to the longitudinal centerline 280. Having a second form of oscillation allows for more complex movement of the waves of slush within the slush feed container 1200. While not required, it may be advantageous to select the cycle of stimulus for the tilt shaft 420 to not be an even fraction or even multiple of the cycle of rotation for the rocking shaft 440 so that the combination of positions from the effects of the tilt shaft 420 and the rocking shaft 440 do not repeat on a frequent basis.

[0118] FIG. 9 shows a slush feed container 1200 and a portion of a slush mixing device 400. The current position of the rotating tilt shaft 420 places the longitudinal centerline of the slush feed container 1200 at about 15 degrees downward with respect to horizontal.

[0119] FIG. 10 shows a simplified cross section of the slush feed container 1200 at this 15-degree downward tilt. The simplified drawing does not show all the details for the slush output connector 300 or the vent tube 350. The liquid 180 has been converted into slush 188 which is a mixture of small particles of ice and liquid with higher mean salinity than the liquid 180 before the creation of slush 188. Air 184 or another gas fills the remainder of the interior of the slush feed container 1200. The slush 188 is more viscous than liquid 180 but still flows downward and sloshes within the interior of the slush feed container 1200.

[0120] One of skill in the art will appreciate the vent tube 350 may have a check valve to allow gas in but not allow slush 188 out. The vent tube 350 may be connected to a pressurized source of gas such as sterile air or a gas that will be non-reactive with the slush 188.

[0121] FIG. 11 shows a slush feed container 1200 and a portion of a slush mixing device 400. The current position of the rotating tilt shaft 420 places the longitudinal centerline of the slush feed container 1200 at about 30 degrees downward with respect to horizontal.

[0122] FIG. 12 shows a simplified cross section of the slush feed container 1200 at this 30-degree downward tilt.

[0123] FIG. 13 shows a simplified cross section of the slush feed container 1200 at a 30 degrees downward tilt as in FIG. 12 as the quantity of slush 188 is almost gone. The process would stop removing slush 188 from a slush feed container 1200 before the slush 188 stops covering the inlet to the slush output connector 300. Many pumps have counters so it will be possible to know that after a certain amount of pump operation that the slush feed container 1200 is sufficiently depleted that it is time to switch to another slush feed container 1200. Even with the variation in actual flow volume that may occur with a peristaltic pump, the degree of variability will not interfere with being able to reliably remove the slush feed container 1200 before pulling air into the outlet line.

[0124] FIG. 14 shows a simplified cross section of the slush feed container 1200 at a 15 degrees downward tilt as the quantity of slush 188 is almost gone. Note that even with relatively little slush 188 remaining, the inlet to slush output connector 300 is covered.

[0125] Rocking.

[0126] FIG. 15 and FIG. 16 show a slush mixing device 400 that has active rocking imposed by rocking shaft 440 upon the cradled slush feed container 1200. Optionally, the supports 404 and the gap 412 in front plate 408 may be sized relative to the shape of slush feed container 1200 so that rocking of the slush feed container 1200 causes the slush feed container to continue rolling as the rocking shaft 440 reverses direction. The slush feed container 1200 can rotate far enough to hit the supports 404 which are now stopped or moving in the opposite direction. Ports 220 may make contact with the walls of the gap 412 in front plate 408 but this is not required.

[0127] The range of rocking does not need to be symmetric relative to having the gap 412 of the front plate 408 at 12 o'clock. The rocking may be in the range 15 or 20 degrees to each side.

[0128] Temperature Maintenance of the Slush Feed Container.

[0129] FIG. 17 shows a slush feed container 1200 in a slush mixing device 400. The slush mixing device 400 may have a housing 450 which creates a finite volume of air that can be cooled using refrigeration techniques that would chill the interior of the housing 450 and the slush mixing device 400 to maintain the slush 188 with an ice/liquid mix ratio that is desired within the slush feed container 1200. As noted above, the salinity of the remaining liquid increases as the amount of ice in the slush 188 increases. This means that the temperature to freeze additional ice continues to move downward as the amount of ice increases and thus the salinity of the remaining liquid increases. Thus, careful control of the temperature will control the equilibrium ratio of ice to liquid. One of skill in the art will appreciate that the simplified drawing in FIG. 17 does not include the openings in the housing 450 that would be required for one or more tubes to pass slush out of the housing 450 from slush output connector 300.

[0130] FIG. 18 illustrates another form of temperature maintenance for the slush feed container 1200. The slush mixing device 400 still has front plate 408. The front plate 408, lower body 468, rear wall 464, and clam shell top 460 can substantially encapsulate the slush feed container 1200 with insulating materials to limit the flow of heat to the slush feed container. Use of just insulation to limit melting will mean that the ratio of ice to liquid will change as the slush feed container 1200 slowly warms. Thus, an insulation-only solution would be selected for applications where the slush is used relatively rapidly.

[0131] FIG. 19 is like FIG. 18 with an insulating encapsulation for the slush feed container 1200 but FIG. 19 adds one or more cooling plates 470. The cooling plates 470 may be shaped to approximate the outer diameter of the slush feed container 1200. The cooling plates may be made of a material with a high thermal mass and be cooled to a temperature at or below the temperature range for the slush 188. The cooling plates 470 may 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 cooling plates 470 may be replaced with other cooling plates 470 periodically to provide extended temperature maintenance of the slush 188 within the slush feed container 1200.

[0132] The cooling plates 470 may be made for aluminum. The cooling plates may be prechilled to around 10 degrees Celsius to compensate for thermal losses and to cool the internal supports in order to keep the slush 188 within a range of 4 to 5 degrees Celsius. A slush with a different target maintenance temperature may merit use of cooling plates 470 with a different initial temperature.

[0133] Process of Use.

[0134] FIG. 20 contains a flowchart of process 1000 for delivery of well-mixed, atraumatic sterile slush through a tube towards a patient.

[0135] Step 1004Obtain an elongated container partially filled with atraumatic sterile slush with a first port and a second port. The process is can use any elongated container with the relevant ports on one end. The elongated container may have a top end with ports that cannot be reversibly removed from the rest of the elongated container. The elongated container may be a slush bottle and cap as shown in the figures for this disclosure. The cap with the set of two ports may have been placed on the slush bottle before the liquid within the slush bottle was converted into slush or the cap may have replaced an initial cap that was used during the production of slush. Alternatively, the slush may have been made in a first container and then transferred to the slush bottle to partially fill the slush bottle before the cap with the set of two ports was engaged with the slush bottle.

[0136] Step 1008Optionally the two ports may have been sealed with cap plugs that prevent movement of material through the ports and block liquid from entering from the interior of the slush bottle to the port so as to preclude the formation of ice within the ports.

[0137] Step 1012Connect a slush output connector to one of the two ports. The slush output will ultimately be placed in fluid communication with the delivery site within the patient.

[0138] Step 1016Connect a vent tube to the other one of the two ports. The vent tube will be used to provide a pathway for gas to enter the elongated container. The output port and the vent port may be specialized ports that are only used for one purpose or the two ports may be interchangeable.

[0139] Step 1020Place the elongated container into a slush mixing device. Those of skill in the art will appreciate that the elongated container may be placed into the slush mixing device before or after the connections are made to the ports and the connections to the ports may be made in any order.

[0140] Step 1024Optional Step-Work to maintain the frozen state of the slush. Depending on the length of time that this elongated container of slush will be in use, it may be helpful to retard the melting of the slush inside the capped bottle that would naturally occur when the ambient air temperature of the room is above the melting temperature for the slush. As noted elsewhere in this disclosure this effort could employ: [0141] chilling air in a housing that encloses the elongated container and the slush mixing device; [0142] using insulation around the elongated container to slow the heat transfer from ambient air to the slush within the elongated container; [0143] using cooling plates that are put in contact or proximity with at least portions of the elongated container to absorb heat. This may use chilled plates of high thermal mass and may use some material that undergoes a phase change at an appropriate temperature to maintain the slush but not further freeze the ice/liquid mixture that forms the slush. For a lengthy use of a single elongated container, the cooling plates may be swapped out to provide additional cooling capacity; or [0144] using two or more of these options.

[0145] Step 1028Use the slush mixing device to impose complex movement upon the elongated container that is partially filled with slush. This complex movement will cause movement of the slush with the elongated container to help maintain the well-mixed, atraumatic sterile slush in a state appropriate for delivery through a tube. The complex movement may include a cycle of tilting of the longitudinal centerline of the elongated container between the bottle bottom and the cap. The tilting will cause movement of slush along an axis from the bottle bottom to the cap. The complex movement may include rocking of the elongated container around 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 will need to be maintained below horizontal so that slush is available to the port even as the supply of slush within the elongated container is near the end.

[0146] Step 1032Move slush out the slush outlet connector towards the patient. Those of skill in the art will recognize the use of the slush mixing device to impose complex movement upon the elongated container is most likely initiated before moving slush out of the slush outlet connector but the movement of slush out of the slush outlet connector could occur first as long as the complex movement is initiated shortly thereafter.

[0147] Those of skill in the art will appreciate that delivery of material to a patient can be achieved simply by positioning the reservoir of material well above the patient so that gravity is the sole driver. Those of skill in the art will appreciate that for a material like slush to be forced through tubing to reach a delivery site within a patient, that a pressure gradient is useful.

[0148] The pressure gradient could be achieved by using a pressurized gas source that ingresses the elongated container through the vent tube and the connected port. The pressurized gas would push out slush through the port connected to the slush output connector and the subsequent flow path to the delivery site within the patient. The pressurized gas may be air but may be another gas.

[0149] Alternatively, the pressure gradient could be achieved by using one or more pumps on the path between the slush output connector or the delivery site within the patient. When using pumps, 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 flow path for air entering into the elongated container. Nothing precludes using pressurized gas in combination with one or more pumps to provide the pressure gradient to move slush to the delivery site within the patient.

[0150] Material Choices.

[0151] Slush bottle 240 and cap 204 or a different elongated container may be made of highly hydrophobic materials with smooth surface finishes that work well for the teachings of the present disclosure. Thus, material choices made with or coated with Teflon material work well in the context of this disclosure. Coatings will work well but may not be ideal choices for the slush containers that are intended to go through multiple sterilization and use cycles as any scratches or removal of coating may cause slush to adhere to the underlying material. Thus, elongated containers made of a hydrophobic material are preferred over slush containers with coated interiors.

[0152] The term Teflon materials is actually an imprecise statement. E.I. DuPont De Nemours and Company Corporation (DuPont) owns a series of registered trademarks for various uses of material containing polymers of fluorinated hydrocarbons. There are actually several different materials that fall within this category of materials covered by the Teflon mark. The materials that fall within the category of materials covered by the Teflon mark may also be provided by other sources of goods. Thus, a focus on the chemical names rather than the trademarked product names is appropriate. Those of skill in the art will appreciate that the production of medical components often uses a medical grade supply that is created under more stringent process controls and has fewer impurities. Medical grade resin may be used here to make the elongated containers.

[0153] Polytetrafluoroethylene (PTFE) is the most commonly provided material 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. Prominent in the perfluoroether materials is perfluoroalkoxy alkanes (PFA). - - - ://www.guarniflon.com/index.php/en/materials/pfa.html. There are other materials in this group that have different ratios of PTFE and methylvinylether (MVE). One such material is known as MFA. - - - ://www.guarniflon.com/index.php/en/materials/mfa.html.

[0154] PFA like PTFE is known for resistance to chemicals (chemically inert), being hydrophobic, and having extremely low coefficients of friction. One way that PFA is superior to PTFE is that PFA polymer may be melt processed which is useful when seeking to create slush containers by injection molding. Another drawback of PTFE is that it is less dimensionally stable than PFA. Dimensional stability rather than a tendency to creep is useful when a slush container is being used through multiple sterilization cycles so that a slush container lid continues to fit all the different slush containers that just underwent sterilization.

[0155] Another material in the Teflon family that may be injection molded is FEP (fluorinated ethylene propylene) which is a copolymer of hexafluoropropylene and tetrafluoroethylene. FEP differs from the PTFE (polytetrafluoroethylene) resins 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 this disclosure. PFA is preferred over FEP as PFA is harder and more dimensionally stable than FEP.

[0156] While PFA and FEP are preferred materials, acceptable results may be obtained with PET (sometimes called PETE) or with 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/.

[0157] As such elongated containers made with PFA, FEP, or other suitable materials are hydrophobic and have extremely low surface friction, ice crystals tend not to form or stick to the walls of the slush container. The coefficient of friction (both static and dynamic) 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 have ice crystals adhere to the walls of the elongated container promotes mixing when used in connection with an oscillating agitation.

[0158] Having a situation where ice does not form on the container wall, and mixing to keep ice from building up close to the wall more than near the longitudinal centerline of the elongated container, allows use of a slush making machine with ambient air that is chilled well below the freezing temperature range for the saline. Reducing the ambient air temperature increases the rate of cooling of the container contents which is desirable when done without the adverse consequences of creating unacceptable ice deposits on or near the walls of the slush bottle 240 or cap 204.

[0159] The material choice for the elongated container may allow sterilization of the container per standard hospital protocols. Those of skill in the art recognize that there are a number of different protocols and some may be contraindicated for certain materials. Examples of common sterilization protocols include using EtO (ethylene oxide), autoclave, and low temperature plasma. Other methods are known to those of skill in the art.

[0160] Alternatives and Variations

[0161] Tilt Angle Ranges

[0162] A range of tilt angles of 15 to 30 degrees was used for the figures in this specification. The minimum tilt angle may be different than 15 degrees of declination. Those of skill in the art will recognize that having a minimum tilt angle less than 15 degrees may impact the fraction of slush that is not used with each slush feed container 1200.

[0163] For example, a minimum tilt angle of 15 degrees with a particular level of agitation of the slush feed container may lead to leaving about 150 ml of slush 188 in a slush feed container 1200 that was initially filled with one liter of sterile saline. Likewise, the use of a minimum tilt angle less than 15 degrees may require a reduction in the intensity of the tilt angle changes and rocking so that wave troughs do not introduce air into the inlet of the slush output connector 300. Conversely, air detection or air mitigation mechanisms between the slush feed container 1200 and the patient may allow for a minimum tilt angle of less than 15 degrees as undesirable results from air entering the inlet are not a problem.

[0164] Likewise, the maximum tilt angle of 30 degrees may be modified to be less than 30 degrees or more than 30 degrees. Those of skill in the art will appreciate that the tilt shaft 420 does not have be separated from the slush feed container 1200 by the front plate 408. The tilt shaft 420 could be located under the slush feed container 1200 perhaps midway along the length of the slush feed container 1200.

[0165] More than Saline.

[0166] While the discussion above focused on surgical slush made from sterile saline, the teachings of the present disclosure could be applied to the creation of surgical slush that is made of a mixture of medical saline or sterile water and clinically appropriate materials. The clinically appropriate materials may include sugars, vitamins, enzymes, or other bioactive agents. Glycerol may be added to the slush. The operation of the slush freezer to make the slush and the slush cradle to maintain the slush 188 may need to be adopted for a particular use such as altering the temperature settings of the expected amount of time to create the slush, but these adjustments can be made by those of skill in the art.

[0167] The present disclosure does not require standard 0.9% saline to be a base material for use in creating the slush for injection.

[0168] Non-Circular Cross Section.

[0169] While the cross section of the slush bottle 240 has been indicated as substantially cylindrical, other shapes are possible for the slush bottle or the elongated container generally, including an oval or an extremely rounded tri-lobe or square shape. The shape should avoid the use of sharp corners which might retain slush. Use of shapes other than circular may require adjustments to the rate of cooling or the agitation levels in order to compensate for any tendency of slush to form in the highly rounded corners. Thus the present disclosure encompasses implantations with a cross section of the elongated container taken perpendicular to a longitudinal centerline of the elongated container from bottom to port end where the cross section is not a circle.

[0170] Single Use Slush Containers.

[0171] While the disclosure teaches the use of slush bottles and lids that may undergo sterilization and reuse, the teachings of this disclosure do not require re-use. Single-use slush containers may be used, particularly for one piece elongated containers with an integrated top with ports. The single-use slush containers may come prefilled with an appropriate volume of liquid such as sterile saline.

[0172] The single-use containers may come initially with a simple cap 104 (FIG. 1) which is replaced with a cap 204 having a pair of ports 220 and 224 for use in creating a slush feed container 1200. The single-use containers may be an elongated container with integrated ports wherein the elongated container is already partially filled with the liquid to become slush or the elongated container may be partially filled with liquid through one or more ports after receipt.

[0173] Speed of Agitation.

[0174] The speeds of tilting and rocking will be selected to ensure adequate mixing of the slush 188 while avoiding wave movements that are sufficient to capture large bubbles after waves make contact with an interior wall of the elongated container.

[0175] Ports May be Specialized.

[0176] This disclosure showed two interchangeable ports 220. Interchangeable ports are not a requirement of this disclosure and it may be desirable to have one port that is intended for use with the slush output connector 300 and a different port that is intended for use with the vent tube 350. For example, the internal diameter of the interior of the port used for the vent tube 350 may be smaller than the internal diameter of the interior of the port used with the slush output connector 300 or the two ports may use different fitting connectors.

[0177] Instrumentation and Controls.

[0178] Bubble detectors may be placed between the slush feed container 1200 and the pump to at minimum provide an alarm if a discernable bubble is present in the line. A clinician may stop the delivery of slush when an alarm is given by using the controls for the device for delivery of slush to the patient. Bubble detectors may be linked with the control system to stop the pump pending intervention by the clinician to indicate that the problem has been cleared.

[0179] A pressure sensor may be placed to detect pressures in the outlet from the pump to the device delivering slush to the patient. This pressure sensor would respond in the event that a blockage was limiting the delivery of slush but the peristaltic pump or other pump was continuing to operate.

[0180] Alternatives to Use of a Pump.

[0181] An alternative to the use of a pump connected to the slush output connector 300 is to apply pneumatic pressure to the interior of the slush feed container 1200 through the vent tube 350. Applying pneumatic pressure to the interior of the slush feed container 1200 would force slush 188 out of the slush output connector 300 without reliance on a pump. Pneumatic feed systems are commonly used in delivery of paint, gasoline, and wine.

[0182] Thus, the term delivery mechanism should be interpreted broadly enough to include pumps operating on slurry material coming from the slush feed container 1200 but also systems to apply controlled amounts of pneumatic pressure to the interior of the slush feed container 1200.

[0183] Those of skill in the art will recognize that the application of force to impose a pressure gradient across the elongated container to force slush out of a port towards the patient may be applied intermittently as the delivery of slush to the patient may not be continuous. Alternatively, the application of force may be constant but a control used by the medical professional may close a flow path to the patient near the point of delivery for the slush.

[0184] Cap with Integrated Components.

[0185] This disclosure describes a cap 204 with two ports 220 and 224 that are subsequently connected to a slush output connector 300 and to a vent tube 350 as shown in FIG. 7. This works well with a process that partially fills a slush bottle with saline and then places a cap 204 with the ports sealed with port plugs 250 into a slush making machine before bringing the slush feed container 1200 now partially filled with slush for use. Not having the slush output connector 300 and the vent tube 350 protruding during the agitation in the slush making machine such as described in U.S. Pat. No. 9,549,843 for the Production of Well-Mixed Surgical Slush is sensible.

[0186] One of skill in the art will appreciate that if the slush making machine was provided a partially filled slush bottle sealed with a simple cap 104 (FIG. 1) that a slush delivery cap with integrated slush output connector 300 and integrated vent tube 350 preconnected to channels through the delivery cap could provide a viable route to a status equivalent to FIG. 7. This would be an alternative route to an elongated container with a fluid communication path from a proximal tip of the slush output 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 a elongated container would be suitable for use in the slush mixing device of FIG. 8 and in the rest of the process.

[0187] Periodic Cessation of Repetitive Movements.

[0188] This disclosure teaches the use of one or more types of repetitive movements in order to agitate the slush through varying types of movement within the partially filled elongated container. The repetitive motion may be maintained without interruption from soon after the elongated container is placed in the slush mixing device until the elongated container is no longer able to provide slush or the need for slush has ended. One of skill in the art will appreciate that the repetitive movement may be stopped for a short period of time without adverse impact. The cessation of movement could be one type of movement or all movement. The cessation of movement could be a routine part of the cycle of movement. For example, the movement may proceed for 45 seconds and then cease for 15 seconds before repeating the cycle.

[0189] One of skill in the art will recognize that some of the alternative implementations set forth above are not universally mutually exclusive and that in some cases additional implementations can be created that employ aspects of two or more of the variations described above. Likewise, the present disclosure is not limited to the specific examples or particular embodiments provided to promote understanding of the various teachings of the present disclosure.

[0190] Where methods and/or events described above indicate certain events and/or procedures occurring in a certain order, the ordering of certain events and/or procedures may be modified. Additionally, certain events and/or procedures may be performed concurrently in parallel processes, when possible, as well as performed sequentially as described above.

[0191] The legal limitations of the scope of the claimed invention are set forth in the claims that follow and extend to cover their legal equivalents. Those unfamiliar with the legal tests for equivalency should consult a person registered to practice before the patent authority which granted this patent such as the United States Patent and Trademark Office or its counterpart.