AU2011253768A1 - Product or process for modifying skin - Google Patents

Product or process for modifying skin

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Publication number
AU2011253768A1
AU2011253768A1 AU2011253768A AU2011253768A AU2011253768A1 AU 2011253768 A1 AU2011253768 A1 AU 2011253768A1 AU 2011253768 A AU2011253768 A AU 2011253768A AU 2011253768 A AU2011253768 A AU 2011253768A AU 2011253768 A1 AU2011253768 A1 AU 2011253768A1
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Australia
Prior art keywords
skin
cryogenic material
area
method according
spraying
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Granted
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AU2011253768A
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AU2011253768B2 (en
Inventor
John James Steinfort
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GOLD RYTHMN Pty Ltd
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GOLD RYTHMN Pty Ltd
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Priority to AU2010905281A priority patent/AU2010905281A0/en
Application filed by GOLD RYTHMN Pty Ltd filed Critical GOLD RYTHMN Pty Ltd
Priority to AU2011253768A priority patent/AU2011253768B2/en
Publication of AU2011253768A1 publication Critical patent/AU2011253768A1/en
Application granted granted Critical
Publication of AU2011253768B2 publication Critical patent/AU2011253768B2/en
Application status is Active legal-status Critical
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Abstract

A method of tautening skin of an animal by reducing the size of a skin fold or skin area of the animal including the steps of clamping the skin fold to present an area of skin to 5 be treated, applying a cryogenic material to the area of skin for a predetermined time period in order to freeze the area of skin, wherein after application of the cryogenic material the skin surrounding the affected area of skin contracts or tautens and the area of skin has a reduced skin area and/or eliminated skin fold. There is also disclosed a tool for clamping a skin fold of an animal to which a cryogenic material is applied and A 10 hand-held spraying apparatus for spraying a cryogenic material on a skin fold of an animal to in order to tauten the skin.

Description

AUSTRALIA Patents Act 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT ORIGINAL Applicant(s): GOLD RYTHMN PTY LTD Actual Inventor(s): JOHN JAMES STEINFORT and JASON VANDYK Address for Service: PATENT ATTORNEY SERVICES 26 Ellingworth Parade Box Hill Victoria 3128 Australia Title: PRODUCT OR PROCESS FOR MODIFYING SKIN Associated Provisional Applications: No(s): 2010905281 The following statement is a full description of this invention, including the best method of performing it known to me/us:- PRODUCT OR PROCESS FOR MODIFYING SKIN Field of the Invention 5 The present invention relates to a method of tautening skin and/or reducing skin folds, particularly in the tail and breach areas of an animal. The present invention also relates to a tool for clamping the skin of an animal in assisting in the method and to a spraying apparatus used in the method. 10 Background of the Invention Merino sheep are commonly bred in Australia and New Zealand for their high quality wool. A trait of the Merino sheep is their loose skin which can result in the presence of skin wrinkles or skin folds, Figure 1 shows the presence of tail and breech wrinkles 4 15 present at the rear of a sheep 2. Wrinkles or skin folds 4, such as those in the regions of skin bounded by lines 6 and 8 in Figure 2 can create a warm and moist protected environment which, given their close proximity to the sheep's perineum, are susceptible to soilage by the sheep's urine and 20 faeces, thereby forming a suitable breeding ground for female flies to lay their eggs. Once the eggs hatch the larvae infest the sheep's skin causing skin necrosis and lesions which may become infected and ultimately lead to death of the animal if left untreated. This process is known as flystrike or cutaneous myiasis and is particularly prevalent in Australia given the presence of the primary strike fly in association with the hot and 25 humid conditions and the predisposition of merino sheep with wrinkly skin. A technique commonly used to overcome this problem is known as 'mulesing' whereby four areas of skin about the tail and back of hind limbs of a sheep are cut open without anaesthetic in order to remove skin and reduce wrinkles in areas which are susceptible to 30 cutaneous myiasis, This causes considerable pain to the animal, predisposes the area to infection, undergoes a slow healing process, and is a technique which is strongly opposed by animal rights groups. 2 Furthermore, in the process of reducing skin folds, there is a need to securely pinch an area around the skin fold which provides adequate exposure to a cryogenic fluid without hanging the subcutaneous layer as well as deeper layers in the skin of the animal. At present there is no suitable tool apparatus to carry out this procedure. 5 Furthermore, there is also a requirement to provide a dispensing container or spraying apparatus to emit a cryogenic fluid at a particular temperature range, pressure range, flow rate as well as allowing for a mix of gaseous and aqueous fluid to the skin fold to be treated. At present there is no such spraying equipment available to provide these 10 features, Thus it would be advantageous to provide a new apparatus or process for tautening skin and or reducing skin folds which substantially ameliorates one or more of the aforesaid problems. 15 When used in this specification and claims, the terms "comprises" and "comprising" and variations thereof mean that the specified features, steps or integers are included. The terms are not to be interpreted to exclude the presence of other features, steps or components. 20 The above references to and descriptions of prior proposals or products are not intended to be, and are not to be construed as, statements or admissions of common general knowledge in the art in Australia. 25 Disclosure of the Invention According to a first aspect of the invention, there is provided a method of tautening skin of an animal by reducing the size of a skin fold of the animal including the steps of: clamping the skin fold to present an area of skin to be treated; 30 applying a cryogenic material to the area of skin for a predetermined time period in order to freeze the area of skin; 3 wherein after application of the cryogenic material the skin surrounding the affected area of skin contracts or tautens and the area of skin has a reduced or eliminated skin fold, 5 According to a second aspect of the invention, there is provided a tool for clamping a skin fold of an animal to which a cryogenic material is applied, the tool including: a pair of handles connected at a pivot point to enable rotational movement of one handle in said pair with respect to the other handle in said pair; a cylindrical clamp attachable to a first end of each of said handles, said 10 cylindrical clamps being substantially elongate; a hook located at a second end of one of the cylindrical clamps and at least one groove located adjacent a second end of the other of the cylindrical clamps; such that each cylindrical clamp clamps against a respective side of the skin fold and is retained in the clamped position by latching said hook in one of said at least one 15 groove. According to a third aspect of the invention, there is provided a hand-held spraying apparatus for spraying a cryogenic material on a skin fold of an animal to in order to tauten the skin, the apparatus including: 20 a container for storing the cryogenic material; a handle for holding the apparatus; dispensing means having an opening through which the cryogenic material is dispensed and applied to the skin fold; trigger means for releasing the cryogenic material from the container: 25 valve means adapted to enable flow of the cryogenic material from the container to the nozzle upon operation of the trigger; wherein a mixture of gaseous and aqueous cryogenic material is released when applied to the skin fold of the animal. 30 According to an embodiment of the invention there is provided a method of tautening skin comprising freezing the skin. The epidermal and dermal layers of the skin may be frozen, The method may reduce wrinkles or skin folds of the skin. The method may increase the skin tension or tautness. For the purpose of this specification skin wrinkles 4 and skin folds are interchangeable terminologies. These terminologies are used within the sheep industry to describe the result of skin looseness. Freezing the skin may comprise causing intracellular ice or crystal formation in the skin. 5 This may lead to irreversible damage of the skin. Thus the or some of the skin may contract, scab and form a scar. The skin surrounding the treated area may also contract or tau ten. Freezing the skin may cause damage to the collagen layer of the dermis. Scarring may 10 result. This may lead to contraction of the skin. Freezing the skin may comprise achieving a temperature of less than 0 ( zero) degrees Celsius in the skin. More particularly, the temperature achieved in the skin may be less than minus 25 degrees Celsius. Even more particularly, the temperature may be less than 15 minus 50 degrees Celsius. The treated skin may feel solid when the freezing agent is applied. Optimally, the temperature in the skin is between minus 60 degrees Celsius and minus 80 degrees Celsius, Freezing the skin may comprise applying a freezing agent or cryogenic material to the 20 skin of the animal. The freezing agent may be at a temperature less than minus 5 degrees Celsius. More particularly, the temperature of the freezing agent may be less than minus 60 degrees Celsius. Even more particularly, the temperature may be less minus 190 degrees Celsius. 25 The freezing agent may be applied in vivo. The freezing agent may comprise a cryogen. The cryogen may comprise liquid nitrogen or liquid oxygen or a combination of liquid nitrogen and liquid oxygen. However, extreme caution must be applied when using solely oxygen as a cryogen due to its severe oxidising effects. The freezing agent may be applied by spraying on to the skin of the animal and may comprise a mixture of aqueous 30 and gaseous cryogen. 5 The region of skin to be treated may extend along the back of the hind leg and lateral or substantially parallel to the sheep's perineum. This region may be called the breech region. 5 The region of skin to be treated may extend along the lateral aspect of the tail which hangs posterior to the sheep's perineum. This region may be called the tail region. Wrinkles may be reduced in the region of the skin treated. Additionally wrinkles may be reduced in the area of skin surrounding the region of skin treated. The area of 10 surrounding skin in which wrinkles may be reduced may extend up to 100mm beyond the region of skin treated, Suitably, it may extend up to 50mm beyond the region of skin treated. The method may be bloodless. The method may be non-invasive. The method may 15 comprise shielding the skin around the region of skin to which the freezing agent is to be applied. The method may comprise clipping hair which covers the skin prior to applying the freezing agent. The hair may comprise wool. The method may comprise spraying the freezing agent onto the skin through variable 20 lengths of wool. The method may comprise clamping the wrinkle of skin prior to applying the freezing agent. 25 The method may comprise spraying the freezing agent at a rate between 5 and 800 grams per minute, More specifically, the rate may be between 50 and 700 grams per minute. Even more specifically, the rate may be between 140 and 600 grams per min. The method may comprise spraying the freezing agent on to the skin for between 5 and 30 60 seconds, More specifically, the freezing agent may be sprayed on to the skin for between 5 and 30 seconds. 6 The cryogen may be in part liquid and part vapour form as it contacts the skin. The freezing agent may be sprayed continuously on to the skin. The freezing agent may be sprayed longitudinally along the skin fold or skin or both. It 5 may be sprayed along the designated region of skin in a line, in a lengthwise back and forth fashion, or in a crosswise zigzag fashion. The method may comprise allowing the skin to thaw before reapplying the freezing agent. The skin may be allowed to thaw for 15 to 60 sees. Suitably, the skin may be 10 allowed to thaw for between two and three minutes. The freezing agent may be re applied immediately or some time after the initial application, especially if skin solidity is not achieved sufficiently. The freezing agent may be sprayed between 0.5 and 10 cm away from the skin. More 15 particularly, the freezing agent may be sprayed between 2 and 4 cm away from the skin. The skin may be animal skin. More particularly it may be sheep skin. The sheep may be of the Merino type. Suitably, it may be a lamb, weaner, or older sheep. The sheep may generally be between 1 week and 18 months of age when presented for treatment. 20 The method may comprise restraining the sheep prior to application of the freezing agent. The sheep may be restrained on its haunches or in a marking cradle. The sheep may be restrained in a standing position. 25 The method may be used to treat animals en masse. It may be used in conjunction, and without interfering, with normal animal husbandry procedures. In another aspect the invention provides a method of reducing or removing skin, wrinkles or both comprising freezing the skin. The wrinkles may be reduced by tautening of the 30 skin which may occur following freezing. The degree of tautening may depend on the area of skin treated. An increase in the skin area applied with cryogen, may result in an increase of surrounding skin tautening. 7 Sheep with loose skin have increased predisposition to fly strike. These animals generally have more skin wrinkles. Skin wrinkles may be significantly reduced when an appropriate skin area is treated, 5 In an embodiment, the invention provides an apparatus for spraying a freezing agent on to skin, the apparatus comprising, - a bottle for holding the freezing agent, and - dispensing means for dispensing the freezing agent disposed on the bottle, 10 the dispensing means comprising a nozzle having an opening for passage of the freezing agent, the opening or internal diameter being between 1.0mm and 6.0 mm in diameter, This compares with about 2.2mm for medical applications. 15 The nozzle may be interchangeable. The bottle may be double walled. Thus, the bottle may comprise an inner wall and an outer wall with a space therebetween. The walls may be made of steel, in particular mild steel or stainless steel. There may be a substantial vacuum in the space between the 20 walls. The dispensing means may comprise a variable flow valve for adjusting the flow of the freezing agent out through the nozzle, The dispensing means may comprise a draw tube for drawing up freezing agent in the bottle. 25 The apparatus may be adapted to spray the freezing agent at a rate between 5 and 800 grams per minute, More specifically, the rate may be between 50 and 700 grams per minute. Even more specifically, the rate may be between 140 and 600 grams per minute. 30 The apparatus may be adapted to spray an area of skin between 10 and 30 mm in diameter when the opening is between 5 and 70 mm away from the skin. 8 In another aspect the invention provides a nozzle for a spray bottle containing a freezing agent, the nozzle having an opening for passage of the freezing agent, the opening being between 1.0 and 6 mm in diameter or between 3.0mm and 3.5rm. 5 Brief Description of the Drawings By way of example only, embodiments of the invention are described more fully hereinafter with reference to the accompanying drawings, in which: 10 Figure 1 is a rear view of a sheep with skin folds prior to cryogenic treatment; Figure 2 is a rear view of the sheep of Figure 1 and shows area of skin treatment; Figure 3 is a side view showing a sheep undergoing cryogenic skin modification treatment; Figure 4 is a side sectional view of spraying apparatus for spraying a cryogenic 15 fluid onto the skin of an animal; Figure 5 is a perspective view of a tool, in particular forceps, for grabbing and holding a skin fold having a pair of substantially identical cylindrical clamps, such as rods; Figure 6 is a perspective view of a tool similar to the tool shown in Figure 5 with 20 a pair of cylindrical clamps having differing lengths; Figure 7 shows a rear view of a sheep with a pair of the tools shown in Figure 5 applied to skin folds around the edge of the tail of the sheep; Figure 8 is a rear view of a sheep having applied to skin folds in the tail of the sheep a pair of forceps similar to the tool shown in Figure 5 with curved handles; 25 Figure 9 is a rear view of a sheep similar to Figure 8 with clamping tools that have one or more cylindrical clamps with a looped section therein to enable cylindrical clamps of another tool to laterally pass underneath such a cylindrical clamp; Figure 10 is a side sectional view of the layers of skin on an animal before 30 treatment by the present method; Figure 11 is a side sectional view of the outer layers of the skin of the animal with a tool of Figure 5 applied to a skin fold such that the epidermis and dermis is clamped ready for treatment; 9 Figure 12 is a rear view of the sheep of Figure I approximately two weeks post treatment; Figure 13 is a rear view of the sheep of Figure 1 approximately four to six weeks post treatment; and 5 Figure 14 is a side sectional view of the outer layers of the skin of the animal after treatment showing scar tissues and tautening or tightening of the skin in the immediate region of the scar tissue. Detailed Description of Elements of the Drawings 10 The various elements identified by integers in the drawings are listed in the following integer list. Integer List 15 2 lamb 4 skin wrinkle/fold 6 breech region 8 tail region 20 10 marking cradle 12 spray bottle 14 liquid nitrogen and liquid nitrogen vapour 16 trigger 18 hind leg 25 20 tail 21 spraying apparatus 22 container 24 liquid nitrogen 30 inner wall 30 32 outer wall 34 vacuum space 40 nozzle 44 trigger 10 46 draw tube 52 flow valve 62 safety relief valve 5 Detailed Description of the Preferred Embodiments Referring to Figures 1 and 2 there is shown the hind legs 18 and tail 20 of an animal such as a Merino lamb, generally designated 2, with extensive breech and tail skin wrinkles 4. Breech regions and tail regions, shown by outlines referenced 6 and 8 respectively, 10 represent areas of skin to which a cryogen, such as liquid nitrogen, is to be applied during cryogenic treatment, The breech regions 6 extend separately on both sides along the upper hind legs, adjacent to the tail and lateral or parallel to the perineum. Each breech region 6 is approximately 15 150 mm long and 35 mm wide. Due to its close proximity to the perineum, the breech region 6 is prone to being soiled by urine and faeces, leaving wrinkles in the region susceptible to cutaneous myiasis. The area of treatment varies according to the animal's age and animal type (degrees of wrinkliness) 20 The tail regions 8 extend laterally on opposite sides along the upper aspect of the tail 20, posterior to the perineum when the tail 20 hangs down. Each tail region 8 is about 85 mm long and 25 mm wide, and its closeness to the perineum also leaves it susceptible to soilage by the sheep's urine and faeces. This can lead to cutaneous myiasis in the tail regions 8. 25 With reference to Figure 3, wrinkles 4 in and surrounding the breech regions 6 and tail regions 8 may be reduced, thereby reducing incidence of cutaneous myiasis, in the following manner: 30 - Mount the lamb 2, being between 1 and 12 weeks of age, on its haunches securely in a marking cradle 10 with its hips flexed. - Grasp a spray bottle 12 containing liquid nitrogen 14 with one hand and grasp the sheep's tail 8 with the clamping tool 20 in the other hand. The 11 tail 8 grasped using the clamping tool is to be discussed in relation to Figures 5 to 9. - Rotate the clamp handles 20 to expose the other skin sections of the breech area to be treated; 5 - Hold the tip of the nozzle of the spray bottle 3 to 7 cm away from the breech region. - Depress a trigger 16 on the spray bottle in order to spray liquid nitrogen 14 on to the breech region 6. - Spray longitudinally back and forth along the breech region 6 for 10 10 seconds before releasing the trigger. Hold and rotate the clamp handles away from the sheep's body and spray the section of skin that is exposed; - Spray longitudinally back and forth along the breech region 6 for 10 seconds, maintaining the tip of the nozzles 3 to 7 cm away from the skin. 15 Alternatively, the following can be performed: - Mount the lamb 2, being between I and 12 weeks of age, on its haunches securely in a marking cradle 10 with its hips flexed. - Using electric shears or clippers, shear the wool covering the breach and tail edges. 20 - Grasp a liquid nitrogen dispenser unit 12 containing liquid nitrogen 14 with one hand and pinch and clamp the loose breech skin including wrinkles with a skin clamp 20 with the other hand. - Hold the tip of the probe 22 of the spray bottle 3 to 7 cm away from the breech region. 25 - Depress a trigger 16 on the liquid nitrogen dispenser in order to spray liquid nitrogen 14 on to the breech region 6. - Spray longitudinally back and forth along the one aspect of the tented or pinched skin for 10 seconds, defined by the skin clamp before releasing the trigger. 30 - Then slightly rotate the skin clamp outwards to exposure the other aspect of the pinched skin. Repeat the liquid nitrogen spray application where the area of skin application is defined by pinched skin height and skin clamp jaw ventrally. 12 - Repeat skin clamp technique and Liquid Nitrogen spray application to the other breech area. - Clamp section of skin on lateral tail edge. - Spray longitudinally back and forth along the tail region for 10 seconds, 5 maintaining the tip of the probe 3 to 7 cm away from the skin. - Rotate skin clamp and repeat process to other aspect usually ventral of tail edge. - Repeat the same process to the other lateral tail skin edge. - Follow similar process to tail end if tail has been previously docked. 10 The nozzle 40 of the spray bottle 12 (or 21) is specially designed with an opening of between 1.0mm and 6.0 mm in diameter or cylindrical slot for the passage .of liquid nitrogen. Its shape can be cylindrical or oval for the passage of the cryogenic Material This allows high flow rates of around 150 to 250 grams per minute of liquid nitrogen 15 vapour mix to be expelled. Thus with the nozzle held at about 3 to 7 cm from the skin, much of the liquid nitrogen reaches the skin in a combination vapour and liquid form. The liquid Nitrogen quickly evaporates once exposed to air and upon skin contact, thereby limiting spillage and run off from the designated region. 20 In the days following application of the liquid nitrogen an inflammatory response ensues with skin darkening and slight swelling occurring at the application site in the breech and tail regions, but the lamb is still fully mobile and only elicits slight pain response on deep palpation of the treated region within 1- 3 days post application. Over the next couple of weeks as the inflammation abates the skin in the treated region contracts, a scab forms 25 and eventually lifts, forming a generally lineal scar, resulting in tautening of the skin in the larger surrounding area and results in reduction or flattening of the wrinkles in the breech and tail regions, thereby reducing the incidence of cutaneous myiasis in the sheep. 30 Referring to Figure 4 there is shown a spraying apparatus 21 including a container 22 which contains a liquid cryogen 24, in this case liquid nitrogen. The container 22 is insulated essentially from the neck 26 down to the bottom of the container 28 whereby there exists an inner wall 30, and an outer wall 32 with a vacuum space 34 in between the 13 inner wall 30 and the outer wall 32. The container 22 may be made from mild steel or stainless steel and therefore insulates the liquid nitrogen 24 to keep it at a predesignated temperature. The upper reaches or upper section of the container 22 at neck 36 does not have the vacuum space 34 and enables partial evaporation of the liquid nitrogen so that a 5 mixture of gaseous nitrogen and aqueous nitrogen is able to be emitted through tube 38 and nozzle 40. A higher percentage of liquid cryogen compared to gaseous nitrogen is able to be ejected from spraying apparatus 21 compared with existing spraying apparatus used in a medical application where a much greater percentage of gas is emitted. A user can hold the container 22 through handle 42 and operates the container 22 to inject the 10 liquid nitrogen by. using trigger 44 and pushing trigger 44 towards the container 22. The applied pressure of the cryogen exiting nozzle 40, which -dictates the amount of displacement of the valve 52, is proportional to the amount of hand pressure applied to trigger 44. Typically the trigger is pressed inwardly about one-third to a half of the distance to the container 22. It is to be noted that a much higher percentage of liquid 15 nitrogen is delivered to the skin than compared with medical spray containers, which typically- only provide about 20% of the total volume as a liquid. The nozzle and container of the present invention supply at least 40% liquid cryogen of the total volume of cryogen emitted from the nozzle 40, and generally between 50% and 70% liquid cryogen of the total volume of cryogen, 20 Liquid nitrogen is drawn out through the draw tube 46 whereby upon depressing trigger 44, lever or pin 48 forces washers 61, 63 upwardly(or just washer 63 where part 61 designates a portion of the end of the trigger 44 connected to the head through pin 48). These washers 61, 63 are connected to the valve 52 by rod/shaft 51 so that spring 50 25 moves upwardly, under pressure from the valve 52, to open valve 52 which enables the passage of a mixture of gaseous and liquid nitrogen from the draw tube 46, through the tube 38 and the nozzle 40 under pressure from within container 22. A seat 54 together with 0 ring seal 56 ensures that there is no escape of nitrogen from the top of the bottle or container 22 and that it solely goes through the tube 38. Valve 52, sits into a 30 corresponding inverted conical V-shaped element 65 having an aperture therein, through which liquid nitrogen flows which is enabled through the top part or neck 36 of the container 22 not being insulated so that the nitrogen boils faster at this location in order to keep the pressure up within the container 22. Thus the further upward the valve 52 is 14 drawn, with more pressure from the trigger 44, the greater the volume of cryogen that flows out through tube 35 due to the greater volume available in the V-shaped element 65. The thickness of the container wall at neck 36, where there is no vacuum space, is about 9mm. This ensures that when the dispenser unit is tilted forward during the 5 application process, the liquid nitrogen within container contacts the container wall neck 36 and there is sufficient heat transfer from the environment to keep part of the liquid nitrogen boiling with resultant production of the gas phase to ensure a relatively high and continual flow rate. The external diameter of the wall at the neck 36 is about 70 to 80mm, preferably 75 to 77mm and the internal diameter is preferably 60 to 70mm. The 10 external diameter at the lower part of the container 22 where there is vacuum space 34 is preferably about 140 to 150mm. The trigger 44, as well as the nozzle 40 and tube 38, form part of the head 39 of the container 22 which is screwed. onto the top part of the container 22 via threads 58 with a 15 pair of 0 ring seals 59 and 60 positioned to prevent escape of nitrogen vapour. The draw tube 46 is rigidly affixed by screw means to shaft 61 which is threaded and hollow to accommodate the valve 52 and spring 50. Manual as well as automatic relief valves as shown at 62 may be used to relieve pressure from within container 22. 20 The spraying apparatus 21 is suitable for treating sheep or other animals en masse. Draw tube 46 may have a diameter range of between 2.5mm to 5.0mm. The diameter is 3.2mm in the embodiment shown in Figure 4, Draw tube 46 is screwed into the centrally located shaft 61 at the top of the container. The nozzle 40 is interchangeable to provide a variable flow rate of nitrogen, once the valve 52 is drawn up, and typically it has an 25 aperture range of 1.0mm to 6.0mm. Thus the inlet and outlet at respective ends of the internal tube 35, through which the freezing agent is dispensed, is in the range of 1.0mm to 6.0mm in diameter. The operator can adjust the diameter of the nozzle passage, through a knob or lever (not shown) as well as the passage through the valve 52. A relief valve or opening 64 is also located at the bottom of the container. This allows passage of 30 liquid or gaseous nitrogen to the atmosphere. Generally the spraying apparatus 21 has a capacity of about 2 kg of liquid nitrogen in the embodiment shown in Figure 4. It is possible that the size of the container 22 can vary to 15 hold anywhere between 0.5 kg and 5 kgs of liquid nitrogen when used in an en masse application. The double walled container 22, although it is a good insulator, still allows sufficient heat 5 transfer through the walls in order to cause evaporation of some of the liquid nitrogen, which has a boiling point of about minus 196 degrees Celsius. This results in a build up of pressure in the bottle up to a level of about 1 OOkPa, and at which level the safety relief valve 62 is set to relieve any further pressure build up. The operating pressure may range from a few kPa to 100kPa. In a preferred embodiment, the optimal range is between 10 lOkPa and 100kPa. This possible variation of pressure in the container 22 results in variable vapour and liquid output flow rates. The flow rates can then be adjusted as required by adjustment of a flow valve 52 by the operator using a lever or knob (not shown). 15 In a further embodiment, the double walled container 22 may have an outlet in a double sided wall near the base as shown in 64, which allows the vacuum to occur within the container 22. Referring to Figures 5 and 6 there is shown a tool 70, in the form of forceps, which is 20 used to clamp a skin fold or wrinkle of the skin of an animal. The forceps 70 has a pair of handles 71 and 72 which are pivoted and joined at pivot 75. At one end of handle 71 there is located a transverse cylindrical clamp or rod 74 and at one end of handle 72 is located a transverse cylindrical clamp or rod 73 which acts with rod 74 to clamp a skin fold. The diameter of each of rods 73, 74 can be between 1mm and 5mm, preferably 25 2.7mm, Spring 76 enables the forceps or the handles of the forceps 71 and 72 to be apart in a resting state so that their rods 73 and 74 are apart. Upon depressing the handles 71 and 72 together against the forceps spring 76, the rods 73 and 74 are drawn together around the skin fold and by virtue of a hook 82 at end 78 of 30 handle 72 and a series of grooves 84 at end 80 of handle 71, and as is shown in Figure 6, a number of positions can be located to keep the rods 73 and 74 locked or engaged against the base of the skin fold. This is more clearly shown in Figure 11. Thus depending on the thickness of the skin fold and degree of clamping force required, any 16 one of the grooves 84 can be used to receive the hook 78 to clamp the tool 70 in a fixed position. Unclamping is simply a matter of depressing the handles against each other further to release the hook 78 from the respective groove 84. The handles 71 and 72 then return to their natural resting state with the rods 73 and 74 apart. 5 Figure 6 shows a further rod 85 which replaces rod 74 in Figure 5, Rod 85 is generally between 30mm to 50mm long compared with rods 73 and 74 which can be between 60mm and 150mm long, but preferably about 100mm long. The advantage in having a shorter rod is particularly for where clamping is required around the lower pail of the 10 sheep's tail to allow for one or more clamps to be simultaneously applied against skin folds in the tail of the sheep, and the end section of the tail skin is raised forming a raised V for the whole perimeter of the tail. Shown in Figure 7 is a pair of forceps 70 applied to respective sides 90 and 92 of the tail 15 20, One of the rods of each of the forceps 70 lies underneath the tail so that the whole tail is clamped. The operator can then freely use the spraying apparatus 22 to spray liquid nitrogen at the desired location. As an alternative a skin fold on the top part of the tail may be clamped between the rods 73 and 74 and then the operator sprays the designated area. The operator can then spray on the other side of the tail 20 by releasing 20 the clamp firstly and then reapplying the clamp to the underneath surface to produce a skin fold near the edge of the tail 20 and thereafter spray liquid nitrogen to the desired area. Each of the breech sections identified by numeral 6 either side of the perineum can then be similarly grasped between the rods 73 and 74 of forceps 70 to apply a liquid and gaseous nitrogen mixture to the particular skin fold. 25 With reference to Figure 8 (and Figures 5, 6) there is shown an alternative set of forceps 70 applied to breech skin. The handles of the forceps 70 are curved to assist in providing better positioning or gripping of the forceps handles compared to the arrangement of handles shown in Figures 5 and 6. Points 94 and 95 represent the junction of the handles 30 welded to the clamps/rods 73, 74, 85, One of the rods or both of the rods of the forceps may be looped as is shown at 96 and 97 to allow for multiple clamping via a series of forceps so that where two clamps meet, this makes it easier to have one clamp handle going underneath another clamp handle. 17 With regard to Figure 9, as with Figure 8, tail clamps are shown but instead of having a curved set of handles for each set of forceps, they may be bent at a particular angle at the clamp handle attachments points 94 and 95 so that a pair of relatively straight handle 5 sections meets at 94 and 95 with clamp handle attachments. Referring to Figure 10 there is shown a cross section 100 of an animal's skin, subcutaneous tissue and muscle. The skin primarily comprises two layers being the epidermis 102 and dermis 104. The subcutaneous layer 106 is underneath the dermis 104 10 and the muscle 108 is beneath the subcutaneous layer 106. A wool follicle 110 is shown with its root embedded in the dermis 104. Also in the dermis 104 is shown an artery 112, a vein 114 with capillaries 116 located between the artery 112 and vein 114. A nerve ending 118 is also shown. 15 Referring to Figure 11, there is shown a cross section of the animal's skin, subcutaneous tissue and muscle similar to Figure 10. However rods 73 and 74 of forceps 70 (shown end on) has clamped a section of skin or a skin fold 120 ready for treatment via the application of liquid and gaseous nitrogen. The skin fold 120 which has been clamped contains only the epidermis 102 and dermis layer 104. This is so that the complete 20 epidermis layer and dermis layer of the treated skin is fully treated and undergone a freezing process. A third degree cryo burn, which occurs through the action or application of the cryogenic fluid through the complete skin layers is less painful than a first degree burn or a second degree bum. Upon application of the liquid nitrogen through the spraying apparatus 22, the skin right through to the centre of the skin fold 25 120 is frozen at an optimal temperature between minus sixty degrees Celsius and minus eighty degrees Celsius. Pinching isolates the skin from the subcutaneous layer and prevents any harmful destruction of the subcutaneous layer. When frozen, the cells produce large ice crystals particularly at around minus sixty degrees Celsius and thereafter undergo cellular necrosis. This is termed cellular lysis after the ice crystals 30 form and melt from exposure to the liquid and gaseous nitrogen. 18 Figures 1, 2, 12 and 13 are a sequence of rear views of a sheep 2 at various times before and after cryogenic treatment. This single case sequence illustrates the changes in the skin which can occur following cryogenic treatment. 5 Referring to Figure 1, there is shown a sheep 2 prior to cryogenic treatment. The sheep has generally vertically aligned skin folds 4 present at the rear of the sheep. In particular, there is one pair of skin folds 4 on opposite lateral aspects of the tail 20, and three pairs of generally parallel skin folds 4 along the back of the hind legs 18. 10 Figure 2 shows the sheep 2 of Figure I immediately following cryosurgical treatment. Outlined breech regions 6 and tail regions 8 represent areas of skin to which liquid nitrogen was applied, with the application of liquid nitrogen causing these areas of skin to be frozen at the time of treatment. The treatment areas will darken over the first day after treatment and then from that time, up to about seven days after, swelling of the skin 15 will occur. Figure 12 shows the sheep 2 of Figure 1 approximately two weeks post treatment. As shown, the treated areas of skin (i.e. the breech regions 6 and the tail regions 8) have contracted with resultant scabbing or skin crusts with hardened skin formation, appearing 20 superficially like dry areas of skin with matted wool. Contraction of the skin in the breech and tail regions, 6 and 8 respectively, has resulted in flattening of the skin folds 4 within these regions. Additionally, contraction of the skin in the breech and tail regions 6, 8 has resulted in pulling of the surrounding skin towards the treated area, thereby reducing skin folds 4 in the surrounding skin. This process of contraction and scab 25 formation generally takes place over 7 to 42 days after treatment, Referring to Figure 13, the sheep of Figure 1 is shown approximately four to five weeks post treatment. The breech and tail regions of skin, 6 and 8 respectively, have further contracted to forn longitudinal scars which do not grow wool. In addition, folds in the 30 skin surrounding the breech and tail regions 6, 8 have further reduced with smoothness of the skin being evident in the general areas around the breech and lateral aspects of the tail. 19 Referring to Figure 14, there is shown a cross section 100 of the skin of the sheep 4 to 5 weeks after treatment. It is seen that scar tissue 122 remains in the epidermis 102 and dermis 104 while movement of skin towards the scar tissue 122, in the adjacent areas shown by arrows 124, has provided a tightening or tautening of the adjacent skin, and as 5 a consequence of the freezing and tautening, the skin fold is removed or substantially reduced. Example 10 The Australian Wool Innovation commissioned the Commonwealth Scientific and Industrial Research Organisation (CSIRO) to undertake a pilot study to assess the time course and clinical impact of cold-induced skin necrosis and wound healing caused by the application of liquid nitrogen to skin on the breech and tail regions of sheep as a method to modify breech and tail conformation in order to reduce the risk of breech 15 strike. The anticipated advantages of the method over surgical mulesing include the absence of an open skin wound, accurate delivery of liquid nitrogen in a precise 'dosing' of each animal of the treatment modifying breach conformation. Furthermore less pain and 20 discomfort and fewer systemic impacts than mulesing are additional anticipated advantages. Data was provided on the impact of the treatment on clinical signs including rectal temperature, heart rate, lung sounds, demeanour, appetite, freedom of movement, wound appearance and wound healing. 25 The animals studied and tested were six merino sheep aged about six months with a body weight range of 20-28 kilograms and gender being castrated males. Vaccinations occurred on 21 March 2011 and then subsequently the sheep were crutched on 30 March 2011 with cryogenic treatment supplied on 6 April 2011. Breech wrinkle 30 was scored according to the AWI/MLA Visual Sheep Score standard. Assessments were based on clinical observations of treated and control lambs. 20 Standard clinical procedures were employed, rectal temperature was measured by digital thermometer while heart and lung sounds were assessed with the aid of a stethoscope. Clinical examinations were made before offering feed in a communal feed trough. Appetite was assessed by the interest as shown by sheep in approaching and eating the 5 newly offered feed. Ease of movement was assessed from outside the pen when the sheep were disturbed by the approach of a human and as the sheep approached the feed trough, Treated and control sheep shared a single pen so that assessments were made informally based on comparison between treated and control animals. 10 Treatment The lambs were restucted in a cradle and the hind legs held forward by an animal handler standing at the head of the cradle. Skin on the side of the tail and beside the perineum was clamped in forceps, such as tool 70 ,to raise a fold of tissue to which liquid nitrogen 15 was applied. The liquid nitrogen was applied via a modified applicator, such as the spraying apparatus 21. Skin temperature at the sites of application of liquid nitrogen was measured with infrared thermometer. Control lambs were placed in the cradle for measurement of bare areas and for photography of the breech. 20 Results - Breech Scores Odays 3 3 2 2.7 4 3 28days 2 2 1 17 4 3 3 3.3 Wrinkles on the tails of the three treated sheep appeared to be more pronounced when scored at 28 days than at day 1. At this time, the skin folds on the tails that had been treated with liquid nitrogen had not sloughed, which may account for the more 25 pronounced appearance of the wrinkles. The decrease in breech score from day 0 to day 28 in control sheep is likely to reflect the effect of wood growth on accuracy of scoring breeches. 21 With regard to body temperature, there was identified a moderate increase in rectal temperature evident from about six to nine hours after treatment. In relation to the respiration rate, a substantial increase in respiration rate occurred at about six hours after treatment. The results suggest that the rate might still have been elevated at 24 or 48 5 hours afterwards. Regarding hear rate, this was highly variable between the animals and no clear trend was evident. No significant alterations in demeanour throughout the observation period were evident. All animals were considered in general to be bright, alert and responsive. There was also no significant effect on appetite observed. Little effect was evident on the movement of the animals. Treated animals were observed to 10 stand with their tails tucked slightly under and to walk a little stiffly on their hind legs at about 9 hours after treatment on each of days one and two. By day three the sheep had returned to normal. In conclusion it was evident that lambs experienced discomfort in the initial moments 15 after application of liquid nitrogen to the skin. Subsequently there was a moderate increase in body temperature and respiration rate, indicative of a mild stress response to the treatment. In comparison to the known effects of mulesing and intradermal alternatives, the response appeared to be very mild and did not represent a substantial insult to the lambs. There was little impact on appetite and lambs remained bright 20 following the treatment, They showed little restriction on freedom of movement. Mild swelling of the treated sites was noticeable for several days and was followed by hardening of the tissues without marked exudation except for a few hours at skin sites damaged by freezing of the skin to the forceps used as clamps. Subsequently the treated tissue became shrivelled and the overlying skin appeared to be dry and dead without 25 formation of a dark eschar before being shed over a period of several weeks to leave linear scars. 22

Claims (43)

1. A method of tautening skin of an animal by reducing the size of a skin area, such as a skin fold, of the animal including the steps of: 5 clamping the skin fold to present an area of skin to be treated; applying a cryogenic material to the area of skin for a predetermined time period in order to freeze the area of skin; wherein after application of the cryogenic material the skin surrounding the affected area of skin contracts or tautens and the area of skin has a reduced or eliminated 10 skin fold.
2. A method according to claim 1 only the epidermis layer and dermis layer of the skin fold is clamped. 15
3. A method according to claim 1 or claim 2 further including forming intracellular ice or crystals in the area of skin upon application of the cryogenic material
4. A method according to any one of the preceding claims wherein after a period of time following application of the cryogenic material, the skin contracts, form a scab and 20 subsequently a scar.
5. A method according to any one of the preceding claims whereupon application of the cryogenic material, the temperature in the area of skin is less than minus 25 degrees Celsius. 25
6. A method according to claim 5 wherein the temperature in the area of skin is less than minus 50 degrees Celsius.
7. A method according to claim 6 wherein the temperature in the area of skin is 30 between minus 60 degrees Celsius and minus 80 degrees Celsius.
8. A method according to any one of the preceding claims wherein the cryogenic material is at a temperature of less than minus 5 degrees Celsius. 23
9. A method according to claim 8 wherein the cryogenic material is at a temperature of less than minus 60 degrees Celsius. 5
10. A method according to claim 9 wherein the cryogenic material is at a temperature of less than minus 190 degrees Celsius.
11. A method according to any one of the preceding claims wherein the cryogenic material is a mixture of liquid and gas. 10
12. A method according to any one of the preceding claims wherein the cryogenic material is nitrogen.
13. A method according to any one of the preceding claims wherein the cryogenic 15 material is applied to a tail region and/or a breech region of the animal.
14. A method according to any one of the preceding claims wherein the applying step includes spraying the cryogenic material onto the area of skin. 20
15. A method according to claim 14 including spraying the cryogenic material at a rate of 5 grams per minute to 800 grams per minute.
16. A method according to claim 15 including spraying the cryogenic material at a rate of 50 grams per minute to 700 grams per minute. 25
17, A method according to claim 15 including spraying the cryogenic material at a rate of 140 grams per minute to 600 grams per minute.
18. A method according to any one of claims 14 to 17 wherein the cryogenic material 30 is part liquid and part vapour form as it contacts the skin area. 24
19. A method according to any one of claims 14 to 18 further including spraying the cryogenic material onto the skin area wherein the predetermined time period is from 5 seconds to 60 seconds, 5
20. A method according to claim 19 further including spraying the cryogenic material onto the skin area wherein the predetermined time period is from 5 seconds to 30 seconds.
21. A method according to any one of claims 14 to 20 further including spraying the 10 cryogenic material from between 0.5 cm and 10 cm away from the skin area.
22. A method according to claim 21 further including spraying the cryogenic material from between 2 cm and 4 cm away from the skin area. 15
23. A tool for clamping a skin area, such as a skin fold, of an animal to which a cryogenic material is applied, the tool including: a pair of handles connected at a pivot point to enable rotational movement of one handle in said pair with respect to the other handle in said pair; a cylindrical clamp attachable to a first end of each of said handles, said 20 cylindrical clamps being substantially elongate; a hook located at a second end of one of the cylindrical clamps and at least one groove located adjacent a second end of the other of the cylindrical clamps; such that each cylindrical clamp clamps against a respective side of the-skin fold and is retained in the clamped position by latching said hook in one of said at least one 25 groove.
24. A tool according to claim 23 such that in order to release the tool from the skin fold after application of the cryogenic material, the handles at each of the respective second ends are initially biased toward one another to disengage the hook from the at 30 least one groove.
25 25, A tool according to claim 23 or claim 24 further including resilient means connected between each of the handles that provide a resting state of the tool whereby each of first and second ends of the handles are apart. 5
26. A tool according to any one of claims 23 to 25 wherein the cylindrical clamps are substantially identical in length,
27. A tool according to any one of claims 23 to 26 wherein the diameter of each of the cylindrical clamps is between Imm and 5mm. 10
28. A tool according to any one of claims 23 to 27 wherein in order to clamp the tool against or around a skin fold, a user places a rod on respective sides of the skin fold and presses the second ends of each handle toward one another until a suitable one of said at least one groove is selected to retain the hook. 15
29. A tool according to any one of claims 23 to 28 wherein the cylindrical clamps are curved.
30. A tool according to any one of claims 23 to 29 wherein at least one of the 20 cylindrical clamps has a loop formed therein to allow overlap of an adjacent tool.
31. A tool according to any one of claims 23 to 30 being forceps.
32. A hand-held spraying apparatus for spraying a cryogenic material on a skin area 25 of an animal to in order to tauten the skin, the apparatus including: a container for storing the cryogenic material; a handle for holding the apparatus; dispensing means having an opening through which the cryogenic material is dispensed and applied to the skin fold; 30 trigger means for releasing the cryogenic material from the container: valve means adapted to enable flow of the cryogenic material from the container to the nozzle upon operation of the trigger; 26 wherein a mixture of gaseous and aqueous cryogenic material is released when applied to the skin fold of the animal.
33. Spraying apparatus according to claim 32 wherein a portion of the container wall 5 has a vacuum space between an inner wall and an outer wall to keep the cryogenic material within a predetermined temperature range.
34. Spraying apparatus according to claim 32 or claim 33 wherein a portion of the container wall has no vacuum space so as to enable part of the cryogenic material to be in 10 gaseous form to maintain pressure within the container to enable release of the cryogenic material.
35. Spraying apparatus according to claim 34 wherein the pressure within the container is up to 100 kPa. 15
36. Spraying apparatus according to claim 35 wherein the pressure within the container is in the range 10 kPa to 100 kPa.
37. Spraying apparatus according to claim 35 or claim 36 wherein the valve means is 20 adjustable to control the rate of flow of the cryogenic material exiting the apparatus.
38. Spraying apparatus according to any one of claims 32 to 37 wherein the valve means is activated through resilient means upon operation of the trigger. 25
39. Spraying apparatus according to any one of claims 32 to 38 wherein the dispensing means is a nozzle attached at the end of a dispensing tube.
40. Spraying apparatus according to claim 39 further including a hollow shaft mounted in a head portion for housing the resilient means and valve means. 30
41. Spraying apparatus according to claim 40 further including a draw tube connected at one end to the hollow shaft and had another end extending into aqueous cryogenic material. 27
42. Spraying apparatus according to any one of claims 32 to 41 further including safety relief valve means to relieve any build up in pressure within the container above 100 kPa. 5
43. Spraying apparatus according to any one of claims 32 to 42 wherein the cryogenic material is nitrogen. 28
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US9314368B2 (en) 2010-01-25 2016-04-19 Zeltiq Aesthetics, Inc. Home-use applicators for non-invasively removing heat from subcutaneous lipid-rich cells via phase change coolants, and associates devices, systems and methods
US9375345B2 (en) 2006-09-26 2016-06-28 Zeltiq Aesthetics, Inc. Cooling device having a plurality of controllable cooling elements to provide a predetermined cooling profile
US9408745B2 (en) 2007-08-21 2016-08-09 Zeltiq Aesthetics, Inc. Monitoring the cooling of subcutaneous lipid-rich cells, such as the cooling of adipose tissue
US9545523B2 (en) 2013-03-14 2017-01-17 Zeltiq Aesthetics, Inc. Multi-modality treatment systems, methods and apparatus for altering subcutaneous lipid-rich tissue
USD777338S1 (en) 2014-03-20 2017-01-24 Zeltiq Aesthetics, Inc. Cryotherapy applicator for cooling tissue
US9655770B2 (en) 2007-07-13 2017-05-23 Zeltiq Aesthetics, Inc. System for treating lipid-rich regions
US9737434B2 (en) 2008-12-17 2017-08-22 Zeltiq Aestehtics, Inc. Systems and methods with interrupt/resume capabilities for treating subcutaneous lipid-rich cells
US9844460B2 (en) 2013-03-14 2017-12-19 Zeltiq Aesthetics, Inc. Treatment systems with fluid mixing systems and fluid-cooled applicators and methods of using the same
US9861421B2 (en) 2014-01-31 2018-01-09 Zeltiq Aesthetics, Inc. Compositions, treatment systems and methods for improved cooling of lipid-rich tissue
US9861520B2 (en) 2009-04-30 2018-01-09 Zeltiq Aesthetics, Inc. Device, system and method of removing heat from subcutaneous lipid-rich cells
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US5200170A (en) * 1989-07-18 1993-04-06 Mcdow Ronald A Medical process--use of dichlorodifluoromethane (CCl2 F2) and chlorodifluoromethane (CHClF2) as cryogens for treating skin lesions
US6726693B2 (en) * 2000-11-10 2004-04-27 Pearl Technology Holdings, Llc Tissue resurfacing using biocompatible materials
US6375652B1 (en) * 2000-05-04 2002-04-23 Brymill Corporation Cutaneous cryosurgical clamp
US7799018B2 (en) * 2006-01-06 2010-09-21 Olga Goulko Cryogenic applicator for rejuvenating human skin and related method

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US9375345B2 (en) 2006-09-26 2016-06-28 Zeltiq Aesthetics, Inc. Cooling device having a plurality of controllable cooling elements to provide a predetermined cooling profile
US9655770B2 (en) 2007-07-13 2017-05-23 Zeltiq Aesthetics, Inc. System for treating lipid-rich regions
US9408745B2 (en) 2007-08-21 2016-08-09 Zeltiq Aesthetics, Inc. Monitoring the cooling of subcutaneous lipid-rich cells, such as the cooling of adipose tissue
US9737434B2 (en) 2008-12-17 2017-08-22 Zeltiq Aestehtics, Inc. Systems and methods with interrupt/resume capabilities for treating subcutaneous lipid-rich cells
US9861520B2 (en) 2009-04-30 2018-01-09 Zeltiq Aesthetics, Inc. Device, system and method of removing heat from subcutaneous lipid-rich cells
US9844461B2 (en) 2010-01-25 2017-12-19 Zeltiq Aesthetics, Inc. Home-use applicators for non-invasively removing heat from subcutaneous lipid-rich cells via phase change coolants
US9314368B2 (en) 2010-01-25 2016-04-19 Zeltiq Aesthetics, Inc. Home-use applicators for non-invasively removing heat from subcutaneous lipid-rich cells via phase change coolants, and associates devices, systems and methods
US10092346B2 (en) 2010-07-20 2018-10-09 Zeltiq Aesthetics, Inc. Combined modality treatment systems, methods and apparatus for body contouring applications
US9844460B2 (en) 2013-03-14 2017-12-19 Zeltiq Aesthetics, Inc. Treatment systems with fluid mixing systems and fluid-cooled applicators and methods of using the same
US9545523B2 (en) 2013-03-14 2017-01-17 Zeltiq Aesthetics, Inc. Multi-modality treatment systems, methods and apparatus for altering subcutaneous lipid-rich tissue
US9861421B2 (en) 2014-01-31 2018-01-09 Zeltiq Aesthetics, Inc. Compositions, treatment systems and methods for improved cooling of lipid-rich tissue
US10201380B2 (en) 2014-01-31 2019-02-12 Zeltiq Aesthetics, Inc. Treatment systems, methods, and apparatuses for improving the appearance of skin and providing other treatments
USD777338S1 (en) 2014-03-20 2017-01-24 Zeltiq Aesthetics, Inc. Cryotherapy applicator for cooling tissue

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