Cold slurry syringe

Information

  • Patent Grant
  • 11241541
  • Patent Number
    11,241,541
  • Date Filed
    Monday, November 25, 2019
    4 years ago
  • Date Issued
    Tuesday, February 8, 2022
    2 years ago
Abstract
A cold slurry syringe with enhanced features is provided for delivering a cold slurry into the human body. The syringe includes a syringe body for holding a volume of cold slurry, a plunger that slides within the syringe body for ejecting the cold slurry, and a tapered syringe head for delivering an even flow of cold slurry. An agitator can be added to keep the cold slurry from agglomerating and clogging the syringe. Insulation added around the syringe can keep the cold slurry from melting too quickly. A ball screw drive can be added to provide a smooth and consistent application of pressure as the cold slurry is delivered. The cold slurry flow can be enhanced by adding a streamline flow feature that reduces the occurrence of eddies or swirls inside the syringe. This feature can also help maintain the composition and consistency of the cold slurry.
Description
BACKGROUND

A syringe is a pump consisting of a plunger that fits tightly in a cylindrical tube. The plunger can be pulled and pushed along inside the tube allowing the syringe to take in and expel a liquid through an orifice at the open end of the tube. The open end can be fitted with a hypodermic needle, a nozzle or tubing.


SUMMARY

The internal deposition of cold slurry has many potential clinical benefits. The present invention relates to the delivery of cold slurry to internal tissues and organs as a therapy for a variety of health conditions. For example, cold slurry is delivered at or near adipose tissue, colonic tissue, or abdominal tissue. The cooling effect of the cold slurry on those tissues or others stimulates thermogenesis in brown adipose tissue and increases general metabolic activity. As such, cold slurry therapy is useful to treat obesity, to reduce adipose tissue, and to treat metabolic conditions associated therewith. In another example, cold slurry is delivered at or near internal tissue injured by trauma or disease. The cooling effect of the cold slurry on the injured tissue reduces inflammation which, in turn, reduces pain and promotes healing.


The application of cold slurry is also useful to treat a number of muscular and neurological disorders as well as to treat pain. For example, the cooling effect of cold slurry delivered at or near a nerve reduces the neuronal activity, thereby reducing spasms or pain. The cooling effect of cold slurry on tissue is also used to reduce or remove tissue, for example, to treat fibroadenomas or scar tissue.


One approach to delivering cold slurry is to inject the cold slurry under a patient's skin using a syringe 10 shown in FIG. 1. The syringe 10 includes a syringe body 15 having a first end 20 and a second end 25. The syringe body 15 defines a cavity 30 for holding cold slurry 35. Extending from the first end 20, there is an outlet 40 defining a passageway that is in fluid communication with the cavity 30. The outlet serves as a port for discharging the cold slurry 35 from the cavity 30 or a cool fluid that transitions to a slurry. Extending from the outlet 40 there is hollow needle 45 for piercing through the patient's skin and providing a conduit from delivering the cold slurry 35 at or near a tissue the targeted for the cold slurry treatment.


The syringe 10 further includes a plunger 50 that slides within the cavity 30 between the first end 20 and the second end 25. At one end, facing the first end 20 of the syringe body 15, the plunger 50 includes a stopper 55 for pushing the cold slurry 35. A stem 60 extends from the stopper 55 towards the second end 25 and terminates at a flange 70. In use, to deliver the cold slurry 35 to a target tissue, a clinician pierces the patient's skin with the needle 45 and advances the needle 45 to a location at or near the target tissue. The clinician then pressed down on the syringe flange 70, which in turn delivers the cold slurry 35 from the cavity 30 through the outlet 40 and out the needle 45 to the target tissue.


The cold slurry is preferably kept at a proper treatment temperature. Depending on the tissue being treated, cold slurry temperature ranges from about 10° C. to about −50° C. Cold slurry melts quickly, so temperature must be maintained, especially when multiple injections are used.


A cold slurry syringe according to the invention has enhanced features for delivering a cold slurry into the human body. A syringe of the invention includes a syringe body for holding a volume of cold slurry (or a cool fluid that transitions to a cold slurry), a plunger that slides within the syringe body for ejecting the cold slurry, and a tapered syringe head for delivering an even flow of cold slurry. The taper prevents, or assists in preventing, clogging or phase change of the material in the syringe. An agitator can be added to keep the cold slurry from agglomerating and clogging the cold slurry syringe. The agitator can have many forms such as vibration, rotation, and use of augers. Insulation added around the cold slurry syringe can keep the cold slurry from melting too quickly. A ball screw drive, or other mechanism for controlling content pressure and/or flow from the device, can be added to provide a smooth and consistent application of pressure as the cold slurry is delivered. The cold slurry flow can be enhanced by adding a streamline flow feature that reduces the occurrence of eddies or swirls inside the syringe. This feature helps maintain the composition and consistency of the cold slurry.


One aspect of the invention is a device comprising a syringe body having a first end, a second end, and a longitudinal axis extending through the first and second ends. The syringe body further includes an interior lumen defined by an interior wall of the syringe body. The interior lumen is configured to receive and contain a volume of cold slurry. In some examples, the cold slurry can be made inside the syringe. In such examples, the interior lumen receives a cool fluid where it is cooled down to become a cold slurry. The device further has a plunger that is slideably movable within the interior lumen between the first and second ends along the longitudinal axis. The plunger includes a stopper and a stem extending from the stopper.


The device further has a syringe head extending from the first end of the syringe body along the longitudinal axis. The syringe head includes an inlet defining a first passageway in fluid communication with the interior lumen of the syringe body. The first passageway has a first diameter that is about the same as a diameter of the interior lumen. The syringe head further includes an outlet spaced a predetermined distance from the inlet along the longitudinal axis. The outlet defines a second passageway in fluid communication with the outside to serve as an exit for delivering cold slurry. The second passageway has a second diameter smaller than the first diameter. Extending between the inlet and outlet there is a reducer. The reducer defines a third passageway in fluid communication with the first and second passageways. The third passageway has a third diameter tapering from the first diameter to the second diameter.





BRIEF DESCRIPTION OF DRAWINGS


FIG. 1 shows a syringe for delivering cold slurry.



FIG. 2A is a cross section view of an example cold slurry syringe.



FIG. 2B is a cross section view of an example syringe head.



FIG. 2C is a cross section view of an example syringe head with projections.



FIG. 3A is a cross section view of an example cold slurry syringe with an agitator.



FIGS. 3B and 3C are views of the agitator circulating cold slurry within the cold slurry syringe.



FIG. 3D is a view of another example cold slurry syringe with an agitator.



FIGS. 4A and 4B are views of different motor configurations for rotating the agitator.



FIGS. 5A and 5B are views of example cold slurry syringes each with a ball screw drive for moving a plunger within a syringe body and delivering cold slurry.



FIG. 6A is a view of a cold slurry syringe having insulation for limiting heat from transferring from the environment surrounding the cold slurry syringe to the cold slurry.



FIG. 6B is a cross section view of the cold slurry syringe with insulation of FIG. 6A.



FIG. 7A is a view of an example of a streamline flow feature.



FIG. 7B is a view of devices for generating and delivering cold slurry that incorporate the streamline flow feature.





DETAILED DESCRIPTION

The present invention provides a cold slurry syringe with enhanced features for delivering cold slurry into the human body. A cold slurry syringe of the invention includes a syringe body for holding a volume of cold slurry, a plunger that slides within the syringe body for ejecting the cold slurry, and a tapered syringe head for delivering an even flow of cold slurry. An agitator can be added to the cold slurry syringe to keep the cold slurry from agglomerating and clogging the cold slurry syringe. A ball screw drive, or other mechanism for controlling flow of pressure, can be added to the cold slurry syringe to provide a smooth and consistent application of pressure as the cold slurry is delivered. Insulation added around the cold slurry syringe can keep the cold slurry from melting too quickly. The flow of cold slurry can be enhanced by adding a streamline flow feature to the cold slurry syringe that can reduce eddies or swirls from occurring inside the cold slurry syringe. Examples of the aforementioned enhancements and others are now described in greater detail below.



FIG. 2 shows an example cold slurry syringe 100. The cold slurry syringe 100 includes a syringe body 110 having a first end 112, a second end 114, and a longitudinal axis LA extending through the first end 112 and the second end 114. The cold slurry syringe 100 also includes an interior lumen 130 defined by the interior wall of the syringe body 110 to receive and contain cold slurry.


The cold slurry syringe 100 further includes a plunger 120 at least partially disposed within the interior lumen 130. The plunger 120 is configured to move in and out of the syringe body 110 between the first end 112 and the second end 114. The plunger 120 includes a stopper 122, a plunger head 124, and a stem 126 extending between the stopper 122 and the plunger head 124 along the longitudinal axis LA. The stopper 122 and the plunger head 124 are spaced apart at a predetermined distance.


The syringe body 110 can be made of any type of biocompatible pharmacologically inert material suitable for use in containing and supplying fluids to be provided within a human body. Exemplary materials for the syringe body 110 include plastic, such as polyethylene or polypropylene, and glass. The cold slurry syringe 100 can be any size that is suitable to hold one or more aliquots of cold slurry for delivery to the target tissue. The volume capacity of the cold slurry syringe 100 is typically between 1 ml and 60 ml, although capacity outside of those volumes is also contemplated.


The cold slurry syringe 100 further includes a syringe head 155 extending from the first end 112 of the syringe body 110 along the longitudinal axis LA. The syringe head 155 has an inlet 160 and an outlet 165 spaced a predetermined distance from the inlet 160 along the longitudinal axis LA. The inlet 160 defines a first passageway 170 in fluid communication with the interior lumen 130. The interior lumen 130 has a diameter D and the first passageway 170 has a first diameter D1 that is about the same as the interior lumen diameter D. The outlet 165 defines a second passageway 175 in fluid communication with the outside environment and serves as an exit for delivering the cold slurry. The second passageway 175 has a second diameter D2 that is smaller than the first diameter D1.


Extending between the inlet 160 and outlet 165, there is a reducer 180 defining a third passageway 185 in fluid communication with the first passageway 170 and the second passageway 175. The third passageway 185 has a third diameter that tapers from the first diameter D1 to the second diameter D2. This arrangement of passageways provides a smooth transition that allows the cold slurry to flow evenly from the interior lumen 130 through the inlet 160 and out the outlet 165. Reducing turbulence in the cold slurry flow can reduce the possibility that ice particles making up the cold slurry will aggregate and clog the cold slurry syringe 100.


The configuration and geometry of the syringe head 155 can be changed to alter the flow characteristics of the cold slurry. For example, FIG. 2B shows an example of the syringe head in which the inlet 160 and the outlet 165 have walls that are generally parallel with the longitudinal axis LA. In this example, the first diameter D1 extends over a distance d1 such that the cold slurry travels this distance through the first passageway 170 before the cold slurry flow is narrowed by the reducer 180 and increases in speed. Similarly, the second diameter D2 extends over a distance d2 such that the cold slurry travels this distance through the second passageway 175 before it exits the cold slurry syringe 100. In another example, an angle made between the longitudinal axis LA and an interior wall of the third passageway 185 (denoted in the figure as A) can be between 0 and 90 degrees. Preferably the angle is between about 10 and about 80 degrees and more preferably between about 20 and 70 degrees.


The syringe head 155 can include features for improving the flow of cold slurry. For example in FIG. 2C, the syringe head 155 includes projections 190 extending from an interior wall of the third passageway 185 toward the longitudinal axis LA. Ice particles making up the cold slurry can aggregate together and form ice clumps that can clog the cold slurry syringe 100 and impede cold slurry delivery. As the cold slurry flows through the syringe head 155, the projections 190 break up the ice clumps and, thereby, reduce the likelihood of clogging the cold slurry syringe. It is also contemplated that other areas of the cold slurry syringe can be lined with projections to improve the flow of cold slurry. For example, the first passageway 170 can include at least one projection 190 extending inwardly to agitate the cold slurry.


The cold slurry syringe 100 also includes at least one needle 140 (not shown) extending from the outlet 165. The needle can have a thickness between 7 gauge and 34 gauge; and can have a length between ¼″ and 10″, such as about ¼″, ½″, 1″, 2″, 3″, 4″, 5″, 6″, 7″, 8″, 9″, or 10″. Preferably, the needle is a hypodermic needle. Exemplary needle materials include, but are not limited to, stainless steel and carbon steel, with or without nickel plating.


In a convenient example, the outlet 165 is configured to receive and engage the needle. For example, the outlet 165 of the second passageway 175 can have threads to receive the needle, or the outlet 165 and the needle can be Luer lock connectors that twist together to make a Luer lock connection. In another example, the outlet 165 is a slip tip onto which the needle is connected. A cold slurry syringe with a slip tip outlet can be connected to tubing or other flexible conduit. In this case, cold slurry is delivered through the tubing.


In order for cold slurry to pass through the needle without clogging, the largest cross-section of the ice particles must be smaller than the internal diameter of the needle and second diameter D2 of the second passageway 175. More particularly, the second diameter D2 is at least 5% larger than a largest cross-section of the ice particles. For example, the largest cross section can be less than about 95% of the internal diameter, less than about 85% of the internal diameter, less than about 75% of the internal diameter, less than about 65% of the internal diameter, less than about 55%, and preferably about 50% of the internal diameter. Exemplary ice particle sizes for various internal diameters, as disclosed in International Patent Application No. PCT/US2015/047292, are provided below in Table 1. It is to be understood that these particles sizes are only meant to be exemplary and not for limitation.

















Needle
Nominal Internal
Recommended Largest



Gauge
Diameter
Cross-Section of Ice Particles






















 7
3.81
mm
1.905
mm



 8
3.429
mm
1.7145
mm



 9
2.997
mm
1.4985
mm



10
2.692
mm
1.346
mm



11
2.388
mm
1.194
mm



12
2.159
mm
1.0795
mm



13
1.803
mm
0.9015
mm



14
1.6
mm
0.8
mm



15
1.372
mm
0.686
mm



16
1.194
mm
0.597
mm



17
1.067
mm
0.5335
mm



18
0.838
mm
0.419
mm



19
0.686
mm
0.343
mm



20
0.603
mm
0.3015
mm



21
0.514
mm
0.257
mm



22
0.413
mm
0.2065
mm



22s
0.152
mm
0.076
mm



23
0.337
mm
0.1685
mm



24
0.311
mm
0.1555
mm



25
0.26
mm
0.13
mm



26
0.26
mm
0.13
mm



26s
0.127
mm
0.0635
mm



27
0.21
mm
0.105
mm



28
0.184
mm
0.092
mm



29
0.184
mm
0.092
mm



30
0.159
mm
0.0795
mm



31
0.133
mm
0.0665
mm



32
0.108
mm
0.054
mm



33
0.108
mm
0.054
mm



34
0.0826
mm
0.0413
mm










Returning back to the cold slurry syringe 100, the plunger 120, including the stopper 122 and the stem 126, can be any type of biocompatible, pharmacologically inert material suitable for coming in contact with sterile substances to be provided within a human body. Exemplary materials for the plunger 120 include plastic, such as polyethylene or polypropylene, and glass. With respect to the stopper 122, a portion or all of the stopper 122 can be a rubber material, such that a seal is formed between the sides of the stopper 122 and the interior wall of the syringe body 110. The rubber material can be any rubber suitable for coming in contact with sterile substances to be provided to the human body, such as natural rubber latex or a synthetic rubber.


To keep ice particles making up the cold slurry from aggregating, as the cold slurry is contained within a cold slurry syringe awaiting delivery, the cold slurry can be agitated. FIG. 3A shows an example cold slurry syringe 200 with an agitator 250 for stirring the cold slurry syringe and retarding the formation of ice clumps, which can clog the cold slurry syringe 200. The agitator 250 is housed within an interior lumen 230 between a plunger 220 and a first end 212 of a syringe body 210. The agitator 250 includes a hub 255 and a plurality of fins 260 radiating from the hub 255 towards the wall of the interior lumen 230.


As shown, the fins 260 extend out from the hub 255 along a plane that intersects longitudinal axis LA at an angle forming a spiral (or helical) pattern. Alternatively, the fins can extend out from the hub along a plane wherein one dimension of the plane is defined by the longitudinal axis. The agitator 250 can be made out of any material that is suitable for contact with sterile compositions to be delivered to the human body, including those exemplary materials previously provided with respect to the syringe body 110, plunger 120, and needle of FIGS. 2A-2C.


The agitator 250 includes a shaft 275 extending from the hub 255 and through a central bore 280 of the plunger 220. Rotating the shaft 275 turns the agitator 250, which in turn causes cold slurry to flow within the interior lumen 230 in multiple directions, as shown in FIGS. 3B and 3C. As shown, the shaft 275 terminates at a plunger head 224. In this example, the agitator 250 is turned manually by turning the plunger head 224 by hand or with a crank.


In another example, rotation of the agitator 250 is aided by the use of a motor 285. The motor 285 can be drivingly coupled to the cold slurry syringe 200 in any number of ways. For example, the motor 285 is directly coupled to the shaft 275, as shown in FIG. 4A, with the shaft 275 acting as a gear. In another example shown in FIG. 4B, the motor 285 is coupled to the plunger head 224 and the shaft 275 is fixed to the plunger head 224. In this case, the plunger head 224 acts a gear, which when driven by the motor (not shown), spins the agitator 250.


The agitator 250 can have a number of different configurations. For example, FIG. 3D shows an agitator 282 with a hub 284 shaped like a frustum of a cone. A base 286 of the hub 284 (i.e., wider end) faces the first end 212 of the syringe body 210. The hub 284 and fins 288 define a mixing profile. As shown, the mixing profile of the agitator 282 increases in the direction toward an outlet 265. Advantageously, this arrangement facilitates breaking up of ice clumps and improves the flow of cold slurry.


Referring back to FIG. 2A, to deliver cold slurry using the cold slurry syringe 100, for example, a clinician presses down on the plunger head 124, which in turn forces the plunger 120 downward towards the first end 112 of the syringe body 110. The force of the descending plunger 120 on the cold slurry, in conjunction with the increase in pressure of the cold slurry, forces the cold slurry out the syringe body and delivers the cold slurry. In this example, a linear motion is used to deliver the cold slurry. Other examples of the invention, convert a rotary motion to a linear motion for driving the plunger and delivering the cold slurry.



FIG. 5A shows the user end of an example syringe 300 in which a rotary motion is converted into a linear motion for delivering cold slurry. The syringe 300 includes a syringe body 305 having a first end (not shown) and an opposing second end 310. Extending away from the syringe body 305 from the second end 310 is a fixed screw 315 with threads 317.


The syringe 300 further includes a plunger 320 partially disposed within an interior lumen 307 containing a volume of cold slurry. The plunger 320 has a through bore 322 for receiving the screw 315 allowing the plunger 320 to rotate about the screw 315. The plunger 320 further includes a stopper 325 at one end and a plunger head 330 at an opposing end. A stem 335 extends between the stopper 325 and the plunger head 330 separating the two by a distance. The stem 335 further includes a nut 340 for engaging the screw threads 317. Rotating the plunger head 330 in a first direction moves the stopper 325 from the second end 310 to the first end. This in turn, pushes the cold slurry out of the interior lumen 307 and delivers the cold slurry to a target tissue. Rotating the plunger head 330 in a second direction moves the stopper 325 from the first end to the second end 310. This motion can be used to draw cold slurry into the interior lumen 307 from, for example, a cold slurry generator (an example of which is described in U.S. Provisional Application 62/416,484, which is incorporated herein in its entirety).



FIG. 5B shows the user end of another example cold slurry syringe 350 in which a rotary motion is converted into a linear motion for delivering cold slurry. The cold slurry syringe 350 includes a syringe body 355 having a first end (not shown) and an opposing second end 360. A nut 390 is fixed to the second end 360 of the syringe body 355.


The cold slurry syringe 350 further includes a plunger 370 partially disposed within an interior lumen 357 containing a volume of cold slurry. The plunger 370 includes a stopper 375 at one end and a plunger head 380 at an opposing end. A screw 385 extends between the stopper 375 and the plunger head 380 separating the two by a distance. The screw 385 further includes threads 387 for engaging the nut 390, which is fixed to the second end 360 of the syringe body 355. Rotating the plunger head 380 in a first direction moves the stopper 375 from the second end 360 to the first end. This in turn, pushes the cold slurry out of the interior lumen 357 and delivers the cold slurry to a target tissue. Rotating the plunger head 380 in a second direction moves the stopper 375 from the first end to the second end 360. This motion can be used to draw cold slurry into the interior lumen 357 from, for example, a cold slurry generator (an example of which is described in U.S. Provisional Application 62/416,484, which is incorporated herein in its entirety). Some examples of the cold slurry syringe 350 have a motor drivingly coupled to the plunger head 380, for example, by way of gears, belt and pulley or rack and pinion. The motor drives the head in the first direction to inject the cold slurry and drives the head on the second direction to withdraw the cold slurry. The motor, in turn, can be operable coupled to an electronic controller. Advantageously, with such a controller cold slurry can be injected or withdraw in an automated, autonomous or regulated fashion. The motor can be electrical DC or AC motor. Example motors include rotational and vibrational motors.


As shown in FIGS. 5A and 5B, the screw 315/385 can be a ball screw and the nut 340/390 can a ball nut that make up a ball screw drive. The ball nut is packaged as an assembly with recirculating ball bearings that roll in matching forms in the interface between the ball screw and the ball nut. With rolling elements, the ball screw drive has a very low coefficient of friction (on the order of u=0.01 to u=0.005), and is suitable for use with high precision and can apply/withstand high thrust loads. (In comparison, a conventional slide screw having similar a lead angle has a coefficient of friction on the order of u=0.1 and requires three times the driving torque.) A benefit to using the ball screw drive in the cold slurry syringe 300/350 is that it allows for a smooth and consistent application of pressure as cold slurry is ejected. The ability to withstand high thrust loads allows for the cold slurry to maintain a smooth, consistent force directed downwards and out of the cold slurry syringe 300/350, counteracting any opposing force to the system.


Another example of the cold slurry syringe includes a hydraulic piston for controlling the rate at which the cold slurry syringe is pressed and the cold slurry is ejected. The hydraulic piston is coupled to the plunger in order to maintain a constant and consistent pressure on the plunger throughout the closed system while plunging and delivering the cold slurry. In this mechanism, the hydraulic piston is mounted on top of the plunger, which with mechanical force, acts on a small cross-sectional area, displacing an incompressible fluid and displacing an equal volume of slurry at a constant rate from the syringe body. This process is performed in order to control possible changes in phase, temperature, and/or pressure on the slurry.


In general, to limit heat from transferring from the environment surrounding the cold slurry syringe to the cold slurry and melting the cold slurry, the cold slurry syringe can be surrounded in insulation. In one embodiment according to the present invention shown in FIG. 6A, an insulation 400 surrounds the syringe body 110 and maintains a temperature of the cold slurry within the interior lumen 130. As best seen in the cross section of FIG. 6B (with the plunger 120 omitted for clarity), the insulation 400 is concentric with an outer surface 111 of the syringe body 110.


As shown in FIG. 6A, the insulation 400 extends past the first end 112 of the syringe body 110 towards the outlet 165 at its bottom 405. The insulation 400 extends past the second end 114 of the syringe body 110 towards the plunger head 124 at its top 410. As such, the insulation 400 substantially encompasses the cold slurry syringe 100. Alternatively, the insulation 400 can surround the syringe body 110 with the bottom 405 ending at or near the first end 112 and the top 410 ending at or near the second end 114.


In a convenient example, the insulation 400 is an insulation sleeve for receiving the cold slurry syringe 100. The insulation sleeve can have an open end through which the cold slurry syringe 100 is loaded. A removable cap can further be provided at the open end to allow for insertion and subsequent enclosure of the cold slurry syringe 100 within the insulation sleeve. In another example, the insulation sleeve is of a clamshell design with two halves.


The insulation 400 can be made out of fiberglass insulation, foam insulation, gel insulation, and aerogel insulation, just to name a few examples. The insulation 400 can also be rigid insulation so that when pressure is exerted on the cold slurry syringe (e.g., when delivering cold slurry), the syringe body does not expand or change shape. Similar to the components of the cold slurry syringe, the insulation 400 can also be made out of any material that is biocompatible and pharmacologically inert.


A streamline flow feature can be used to maintain velocity, pressure, and other properties of cold slurry flow from when the cold slurry is generated to when the cold slurry is injected. FIG. 7A shows an example of the streamline flow feature 500 having a core structure 505 that extends between a first end 510 and a second end 515. The core structure 505 defines a passageway 520 through which cold slurry flows.


The passageway 520 extends along a longitudinal axis LA between the first end 510 and the second end 515 with a plane of the passageway 520 intersecting the longitudinal axis LA at an angle forming a spiral (or helical) pattern. Because of this arrangement, cold slurry can flow throw through the streamline flow feature 500 without turbulence, in parallel layers with no disruption between the layers, and with no cross-currents perpendicular to the flow direction. The streamline flow feature 500 can also reduce the occurrence of eddies or swirls.


Cold slurry moves through the streamline flow feature 500 as a laminar flow allowing ice particles to move parallel to the passageway surface. This can help maintain cold slurry composition (e.g. ice content) from when the cold slurry is generated to when the cold slurry is injected in a patient. It can further help reduce agglomeration and/or inconsistency in cold slurry composition. FIG. 7B shows the streamline flow feature used in devices for generating and delivering cold slurry, including a cold slurry generator 525 (of which only an internal component is shown), a cold slurry syringe 530, tubing 535 for transferring cold slurry from the cold slurry generator 525 to the cold slurry syringe 530, and a needle 540 for piercing the patient's skin and delivering cold slurry to a target tissue.


The cold slurry syringes 100, 200, 300, 350, and 530 described above can be used to deliver a wide variety of cold slurries. For example, the cold slurry can have a temperature of about 10° C., 7° C., 5° C., 4° C., 3° C., 2° C., 1° C., 0° C., −1° C., −2° C., −3° C., −4° C., −5° C., −10° C., −15° C., −20° C., −30° C., −40° C., and −50° C. The cold slurry can contain between about 0.1% and about 75% ice by weight, between about 0.1% and 1% ice by weight, between about 1% and 10% ice by weight, between about 10% and about 20% ice by weight, between about 20% and about 30% ice by weight, between about 30% and about 40% ice by weight, between about 40% and about 50% ice by weight, between about 50% and about 60% ice by weight, between about 60% and about 70% ice by weight, and greater than about 50% ice by weight. (The proportions of ice by volume are slightly higher due to the densities of solid and liquid water.) The cold slurry can include ice particles having a largest cross-sectional dimension that is less than about 2 mm, about 1.75 mm, about 1.5 mm, about 1.25 mm, about 1 mm, about 0.9 mm, about 0.8 mm, about 0.7 mm, about 0.6 mm, about 0.5 mm, about 0.4 mm, about 0.3 mm, about 0.2 mm, or about 0.1 mm. Other exemplary cold slurry compositions, slurry temperatures, and cross-sectional dimensions of ice particles are provided in PCT/US2015/047292, which is incorporated herein in its entirety. It is to be understood that an advantage of the cold slurry in accordance with the present invention is that the composition of the cold slurry is suitable to delivery to tissues within the body, such that the slurry can be delivered to a tissue within the body of a patient and remain within the body (e.g. no removal of the slurry is necessary after cooling has been effected).


EQUIVALENTS

While the present invention has been described in conjunction with certain preferred embodiments, one of ordinary skill, after reading the foregoing specification, will be able to effect various changes, substitutions of equivalents, and other alterations to the apparatuses and methods set forth herein.

Claims
  • 1. A device for delivering cold slurry, the device comprising: a syringe body comprising: a first end and a second end;an interior lumen defined by an interior wall of the syringe body, the interior lumen configured to receive and contain a volume of cold slurry;a longitudinal axis extending through the interior lumen;a plunger slideably movable within the interior lumen along the longitudinal axis, the plunger comprising a stopper and a stem extending from the stopper; anda syringe head extending from the first end of the syringe body, the longitudinal axis extending through the syringe head, the syringe head comprising: an inlet defining a first passageway in fluid communication with the interior lumen of the syringe body, the first passageway having a first diameter about the same as a diameter of the interior lumen;an outlet spaced a predetermined distance from the inlet along the longitudinal axis, the outlet defining a second passageway in fluid communication with outside to serve as an exit for delivering the volume of cold slurry, the second passageway having a second diameter smaller than the first diameter; anda reducer extending between the inlet and outlet, the reducer defining a third passageway in fluid communication with the first and second passageways, the third passageway having a third diameter tapering from the first diameter to the second diameter;wherein, the cold slurry comprises ice particles, and wherein the second diameter is at least 5% larger than a largest cross-section of the ice particles.
  • 2. The device of claim 1, wherein the first passageway includes at least one projection extending inwardly towards to the longitudinal axis to agitate the cold slurry as the cold slurry is being delivered from the device.
  • 3. The device of claim 1, wherein the third passageway includes at least one projection extending inwardly towards to the longitudinal axis to agitate the cold slurry as the cold slurry is being delivered from the device.
  • 4. The device of claim 1, wherein the second passageway includes threads for receiving a needle.
  • 5. The device of claim 1, wherein second passageway is a slip tip for receiving tubing.
  • 6. The device of claim 1 further comprising an agitator for stirring the cold slurry within the interior lumen, the agitator housed within the interior lumen and interposed between the plunger and the first end of the syringe body.
  • 7. The device of claim 6, wherein the agitator comprises: a hub; anda plurality of fins radiating from the hub towards the interior wall of the syringe body.
  • 8. The device of claim 7, wherein the plurality of fins are arranged in a spiral pattern around the hub.
  • 9. The device of claim 7, wherein the hub is shaped as a frustum of a cone with a base facing the first end of the syringe body.
  • 10. The device of claim 6, wherein the plunger includes a central bore; and wherein the agitator includes a shaft extending through the central bore of the plunger, the shaft for rotating the agitator and stirring the cold slurry within the interior lumen.
  • 11. The device of claim 10, wherein the agitator includes a motor coupled to the shaft for stirring the cold slurry within the interior lumen, mechanically.
  • 12. The device of claim 10, wherein the agitator includes a plunger head coupled to the shaft for stirring the cold slurry within the interior lumen, manually.
  • 13. The device of claim 1 further comprising an insulation surrounding the syringe body to maintain a temperature of the cold slurry within the interior lumen.
  • 14. The device of claim 13, wherein the insulation is any one of fiberglass insulation, foam insulation, gel insulation, and aerogel insulation.
  • 15. The device of claim 13, wherein the insulation is an insulating sleeve for receiving the syringe body.
  • 16. The device of claim 1 further comprising a ball screw fixed to and extending away from the second end of the syringe body; wherein the plunger includes a through bore for rotating the plunger about the ball screw;wherein the plunger further includes a plunger head at an end opposite the stopper;wherein the stem includes a ball nut located between the plunger head and the stopper; andwherein the ball nut threadedly engages the ball screw such that turning the plunger head moves the stopper between the first end to the second end of the syringe body.
  • 17. The device of claim 1, wherein the stem is a ball screw with a plunger head at an end opposite the stopper, and the device further comprising a ball nut fixed to the second end of the syringe body; and wherein the ball nut threadedly engages the ball screw such that turning the plunger head moves the stopper between the first end to the second end of the syringe body.
  • 18. The device of claim 1 wherein the interior lumen is a streamline flow feature comprising a core structure and a passageway defined by the core structure; wherein a plane of the passageway intersects the longitudinal axis at an angle.
  • 19. The device of claim 1, wherein the interior lumen receives a volume of cool fluid that changes to the volume of cold slurry.
CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S. patent application Ser. No. 15/682,234, filed Aug. 21, 2017, for which a patent was issued on Dec. 10, 2019, having U.S. Pat. No. 10,500,342, the contents of which are incorporated by reference herein.

US Referenced Citations (211)
Number Name Date Kind
3373906 Hart et al. Mar 1968 A
3767085 Cannon Oct 1973 A
3893834 Armstrong Jul 1975 A
4363329 Raitto Dec 1982 A
4619678 Rubin Oct 1986 A
4966601 Draenert Oct 1990 A
4983045 Taniguchi Jan 1991 A
4986079 Koseki et al. Jan 1991 A
5143063 Fellner Sep 1992 A
5304128 Haber et al. Apr 1994 A
5445523 Fischer et al. Aug 1995 A
5507790 Weiss Apr 1996 A
5769879 Richards et al. Jun 1998 A
6032675 Rubinsky Mar 2000 A
6041787 Rubinsky Mar 2000 A
6067803 Wolsey et al. May 2000 A
6244052 Kasza Jun 2001 B1
6300130 Toner et al. Oct 2001 B1
6324863 Henry Dec 2001 B1
6334328 Brill Jan 2002 B1
6403376 Toner et al. Jun 2002 B1
6413444 Kasza Jul 2002 B1
6430957 Inada et al. Aug 2002 B1
6458109 Henley et al. Oct 2002 B1
6475212 Dobak, III et al. Nov 2002 B2
6547811 Becker et al. Apr 2003 B1
6575930 Trombley, III et al. Jun 2003 B1
6673607 Toner et al. Jan 2004 B2
6849072 Lee et al. Feb 2005 B2
6962601 Becker et al. Nov 2005 B2
7118591 Frank et al. Oct 2006 B2
7276051 Henley et al. Oct 2007 B1
7367341 Anderson et al. May 2008 B2
7389653 Kasza et al. Jun 2008 B2
7422601 Becker et al. Sep 2008 B2
7507234 Utley et al. Mar 2009 B2
7588547 Deem et al. Sep 2009 B2
7603868 Sveinsson Oct 2009 B2
7681411 DiLorenzo Mar 2010 B2
7713266 Elkins et al. May 2010 B2
7854754 Ting et al. Dec 2010 B2
8117854 Lampe et al. Feb 2012 B2
8192474 Levinson Jun 2012 B2
8275442 Allison Sep 2012 B2
8285390 Levinson et al. Oct 2012 B2
8298216 Burger et al. Oct 2012 B2
8308681 Slocum et al. Nov 2012 B2
8337539 Ting et al. Dec 2012 B2
8505315 Kasza et al. Aug 2013 B2
8523927 Levinson et al. Sep 2013 B2
8535275 Salzman Sep 2013 B2
8603073 Allison Dec 2013 B2
8608696 DiMeo et al. Dec 2013 B1
8676338 Levinson Mar 2014 B2
8702774 Baker et al. Apr 2014 B2
8808241 DiMeo et al. Aug 2014 B2
8840608 Anderson et al. Sep 2014 B2
8936577 Lee Jan 2015 B2
8974451 Smith Mar 2015 B2
9016925 Faccioli Apr 2015 B2
9044212 LePivert Jun 2015 B2
9078634 Gonzales et al. Jul 2015 B2
9132031 Levinson et al. Sep 2015 B2
9314368 Allison et al. Apr 2016 B2
9345526 Elkins et al. May 2016 B2
9375345 Levinson et al. Jun 2016 B2
9398930 Leung et al. Jul 2016 B2
9408745 Levinson et al. Aug 2016 B2
9522031 Anderson et al. Dec 2016 B2
9545523 Nanda Jan 2017 B2
9585687 Tenenbaum et al. Mar 2017 B2
9649220 Anderson et al. May 2017 B2
9655770 Levinson et al. May 2017 B2
9656056 Boyden et al. May 2017 B2
9980765 Avram et al. May 2018 B2
10174985 Arnitz et al. Jan 2019 B2
10406021 Wu et al. Sep 2019 B2
10500342 Velis Dec 2019 B2
20010005338 Muhlbauer et al. Jun 2001 A1
20020107199 Walker Aug 2002 A1
20030012079 Coffeen et al. Jan 2003 A1
20030032996 Hallman Feb 2003 A1
20030074903 Upadhye et al. Apr 2003 A1
20030171715 Hommann et al. Sep 2003 A1
20030220674 Anderson et al. Nov 2003 A1
20040073280 Dae et al. Apr 2004 A1
20040092883 Casey et al. May 2004 A1
20040199115 Rosenman Oct 2004 A1
20040220559 Kramer et al. Nov 2004 A1
20050203598 Becker et al. Sep 2005 A1
20050251120 Anderson et al. Nov 2005 A1
20060036302 Kasza et al. Feb 2006 A1
20060161232 Kasza et al. Jul 2006 A1
20060190066 Worthen Aug 2006 A1
20070010861 Anderson et al. Jan 2007 A1
20070056313 Kasza et al. Mar 2007 A1
20070106247 Burnett et al. May 2007 A1
20070198071 Ting et al. Aug 2007 A1
20070255362 Levinson et al. Nov 2007 A1
20070270925 Levinson Nov 2007 A1
20080045880 Kjeken et al. Feb 2008 A1
20080077201 Levinson et al. Mar 2008 A1
20080077202 Levinson Mar 2008 A1
20080077211 Levinson et al. Mar 2008 A1
20080161772 Nayak et al. Jul 2008 A1
20080195114 Murphy Aug 2008 A1
20080236186 Kasza et al. Oct 2008 A1
20080287839 Rosen et al. Nov 2008 A1
20080300540 Lewis Dec 2008 A1
20090012497 Uber, III et al. Jan 2009 A1
20090018623 Levinson et al. Jan 2009 A1
20090018624 Levinson et al. Jan 2009 A1
20090018625 Levinson et al. Jan 2009 A1
20090018626 Levinson et al. Jan 2009 A1
20090018627 Levinson et al. Jan 2009 A1
20090030366 Hochman Jan 2009 A1
20090071829 O'Banion et al. Mar 2009 A1
20090118722 Ebbers et al. May 2009 A1
20090125087 Becker et al. May 2009 A1
20090149929 Levinson et al. Jun 2009 A1
20090255276 Kasza et al. Oct 2009 A1
20090270814 Masi et al. Oct 2009 A1
20100036295 Altshuler et al. Feb 2010 A1
20100081971 Allison Apr 2010 A1
20100152824 Allison Jun 2010 A1
20100152880 Boyden et al. Jun 2010 A1
20100249753 Gaisser et al. Sep 2010 A1
20100274184 Chun Oct 2010 A1
20100280582 Baker et al. Nov 2010 A1
20100308257 Lampe et al. Dec 2010 A1
20100312202 Henley et al. Dec 2010 A1
20110066216 Ting et al. Mar 2011 A1
20110190751 Ingle et al. Aug 2011 A1
20110238050 Allison et al. Sep 2011 A1
20110238051 Levinson et al. Sep 2011 A1
20110300079 Martens et al. Dec 2011 A1
20120000217 Gudnason Jan 2012 A1
20120022518 Levinson Jan 2012 A1
20120055187 Raines et al. Mar 2012 A1
20120101478 Stroumpoulis Apr 2012 A1
20120203312 Batzer et al. Aug 2012 A1
20120239123 Weber et al. Sep 2012 A1
20120289761 Boyden et al. Nov 2012 A1
20130066309 Levinson Mar 2013 A1
20130079684 Rosen et al. Mar 2013 A1
20130116758 Levinson et al. May 2013 A1
20130116759 Levinson et al. May 2013 A1
20130158440 Allison Jun 2013 A1
20130158636 Ting et al. Jun 2013 A1
20130190744 Avram et al. Jul 2013 A1
20130245731 Allison Sep 2013 A1
20130253496 Anderson et al. Sep 2013 A1
20130319080 Sezaki et al. Dec 2013 A1
20140005760 Levinson et al. Jan 2014 A1
20140067025 Levinson et al. Mar 2014 A1
20140091113 Brewster et al. Apr 2014 A1
20140200511 Boyden et al. Jul 2014 A1
20140257443 Baker et al. Sep 2014 A1
20140277219 Nanda Sep 2014 A1
20140277302 Weber et al. Sep 2014 A1
20140303608 Taghizadeh Oct 2014 A1
20140303696 Anderson et al. Oct 2014 A1
20140303697 Anderson et al. Oct 2014 A1
20140316393 Levinson Oct 2014 A1
20140358079 Fischell et al. Dec 2014 A1
20140378937 Anderson et al. Dec 2014 A1
20150080769 Lotsch Mar 2015 A1
20150090769 Lotsch Mar 2015 A1
20150112195 Berger et al. Apr 2015 A1
20150141916 Albrecht et al. May 2015 A1
20150216816 O'Neil et al. Aug 2015 A1
20150297246 Patel et al. Oct 2015 A1
20150320938 King et al. Nov 2015 A1
20150328077 Levinson Nov 2015 A1
20150328405 Metzner Nov 2015 A1
20150342780 Levinson et al. Dec 2015 A1
20150343156 Fischell et al. Dec 2015 A1
20160051401 Yee et al. Feb 2016 A1
20160058956 Cohn et al. Mar 2016 A1
20160081974 Lee et al. Mar 2016 A1
20160089550 DeBenedictis et al. Mar 2016 A1
20160112195 Jochheim et al. Apr 2016 A1
20160128767 Azamian et al. May 2016 A1
20160175141 Wu et al. Jun 2016 A1
20160184568 Harris et al. Jun 2016 A1
20160242661 Fischell et al. Aug 2016 A1
20160317621 Bright Nov 2016 A1
20160354137 Fischell et al. Dec 2016 A1
20160354237 Gonzales et al. Dec 2016 A1
20170035603 Kammer et al. Feb 2017 A1
20170051353 Eng Feb 2017 A1
20170105869 Frangineas, Jr. Apr 2017 A1
20170136237 Eckhouse et al. May 2017 A1
20170143538 Lee et al. May 2017 A1
20170164965 Chang et al. Jun 2017 A1
20170202613 Pellegrino et al. Jul 2017 A1
20170246032 Gonzales et al. Aug 2017 A1
20170274011 Garibyan Sep 2017 A1
20170274078 Garibyan et al. Sep 2017 A1
20170325992 DeBenedictis et al. Nov 2017 A1
20180008500 Anderson et al. Jan 2018 A1
20180116868 Velis May 2018 A1
20180140514 Velis et al. May 2018 A1
20180289537 Velis Oct 2018 A1
20180289538 Velis Oct 2018 A1
20180311079 Garibyan et al. Nov 2018 A1
20190053939 Garibyan et al. Feb 2019 A1
20190054242 Velis Feb 2019 A1
20200046552 Velis et al. Feb 2020 A1
20200113627 Alas et al. Apr 2020 A1
20200114041 Alas et al. Apr 2020 A1
Foreign Referenced Citations (21)
Number Date Country
102307545 Jan 2012 CN
103110473 May 2013 CN
105640706 Jun 2016 CN
0418979 Mar 1991 EP
0 445 951 Sep 1991 EP
2 421 545 Sep 2013 ES
2 338 428 Dec 1999 GB
2008-529663 Aug 2008 JP
2006086479 Aug 2006 WO
2009086399 Jul 2009 WO
2009089090 Jul 2009 WO
2013113970 Aug 2013 WO
2016033380 Mar 2016 WO
2016033384 Mar 2016 WO
2016054165 Apr 2016 WO
2016090175 Jun 2016 WO
WO 2017147367 Mar 2017 WO
2017147367 Aug 2017 WO
WO 2017147367 Aug 2017 WO
2017196548 Nov 2017 WO
2018187573 Oct 2018 WO
Non-Patent Literature Citations (29)
Entry
Ash, 2003, Chronic peritoneal dialysis catheters: overview of design, placement, and removal procedures, Int Nephrol Dialysis 16(4):323-34.
Brink, 2008, Abdominoplasty with direct resection of deep fat, Plast Reconstructive Surg 123(5):1597-1603.
Ding, 2008, The association between non-subcutaneous adiposity and calcified coronary plaque: A substudy of the multi-ethnic study of atherosclerosis, Am J Clin Nutr 88(3):645-650.
Esposito, 2016, Do you know this syndrom? Type 2 benign symmetric lipomatos (Launois-Bensaude), Brazilian Annals of Dermatology 91:841.
Fox, 2007, Abdominal visceral and subcutaneous adipose tissue compartments—association with metabolic risk factors in the Framingham heart study, Circulation 116:39-48.
Garaulet, 2006, Relationship between fat cell size and number and fatty acid composition in adipose tissue from different fat depots in overweight/obese humans, Int J Obes 30(6):899-905.
Gentile, 2016, Lipodystrophy in Insulin-Treated Subjects and Other Injection-Site Skin Reactions: Are we Sure Everything is Clear?, Diabetes Therapy 7.
Gradinger, 2005, Abdominoplasty, Chapter 83, pp. 2935-3026, in The art of aesthetic surgery: principles & techniques, Nahai, Ed., Quality Med Pub, St. Louis Mo. (92 pages).
International Search Report and Written Opinion dated May 15, 2018, for PCT/US17/59947, filed Nov. 3, 2017 (8 pages).
International Search Report and Written Opinion dated Apr. 12, 2011, for PCT/US11/24766, filed Feb. 14, 2011 (11 pages).
Kanamori, 2015, A case of an 8-year-old boy who was strongly suspected of suffering from familial angiolipomatosis, J Pediatric Surg 3.
Kosseifi, 2010, Dercum's Disease: An Unusual Presentation, Pain Medicine 11:1432.
Laven, 2006, A pilot study of ice-slurry application for inducing laparoscopic renal hypothermia, BJU Int 99:166-70.
Laverson, 2006, Improving abdominoplasty results: reconstruction of the linea alba sulcus by direct excision, Aesthetic Surg J 26:682-6.
Lv, 2017, A review of the postoperative lymphatic leakage, Oncotarget 8:69069.
Popescu, 2014, Proteus Syndrome: a difficult diagnosis and management plan, J Med and Life 7:1.
Stevens, 2014, Does cryolipolysis lead to skin tightening? A first report of cryodermadstringo, Aesth Surg J 34(6): NP32-NP34.
Yamamoto, 2010, Adipose depots possess unique developmental gene signatures, Obesity 18(5):872-78.
Extended European Search Report dated Aug. 28, 2020 in European Application No. 17868153.2.
Written Opinion dated Jul. 1, 2020 in Singapore Application No. 11201903946S.
International Preliminary Report on Patentability dated Aug. 21, 2012, for International application No. PCT/US2011/024766, filed Feb. 14, 2011 (8 pages).
Office Action dated Mar. 1, 2021 in Chinese Application No. 2017800786800, with English translation.
Int Search Report & Written Opinion dated Aug. 29, 2018 for PCT/US2018/026273 (15 pages).
Int Search Report & Written Opinion dated Dec. 11, 2019 for International Application No. PCT/US2019/054828.
Int Search Report & Written Opinion dated Dec. 23, 2019, for PCT/US19/54834, filed Oct. 4, 2019 (10 pages).
Int Search Report & Written Opinion dated Feb. 11, 2020, for PCT/US19/55633, filed Oct. 10, 2019 (12 pages).
Int Search Report & Written Opinion dated Jan. 2, 2020, for PCT/US19/55605, filed Oct. 10, 2019 (9 pages).
Int Search Report & Written Opinion dated Jun. 11, 2018, for PCT/US2018/026260, filed Apr. 5, 2018 (6 pages).
Int Search Report & Written Opinion dated May 7, 2018, for PCT/US18/20387, filed Mar. 1, 2018 (7 pages).
Related Publications (1)
Number Date Country
20200086054 A1 Mar 2020 US
Continuations (1)
Number Date Country
Parent 15682234 Aug 2017 US
Child 16694346 US