阅读说明：本技术 具有线性阵列的喷嘴的皮肤病学冷冻喷射装置及其使用方法 (Dermatological cryogenic spray device with linear array of nozzles and method of using same ) 是由 杰西·罗森 埃里克·斯陶贝尔 斯特文·哈林顿 里安·里查德·布特里姆 于 2018-06-27 设计创作，主要内容包括：本发明涉及用于向患者的皮肤输送冷冻剂以用于皮肤处理的改进的系统、装置和方法。一种构造成向患者的皮肤输送冷冻剂的冷冻喷射装置可以包括施加器、供给通道和喷嘴组件。施加器可以包括头部部分,并且供给通道可以延伸穿过头部部分的至少一部分。喷嘴组件可以联接至头部部分,并且喷嘴组件可以流体地联接至供给通道。喷嘴组件可以包括孔口的线性阵列,该孔口的线性阵列构造成引导冷冻剂的平面喷射以在线性冷却处理中对患者的皮肤组织的区域进行冷却。(The present invention relates to improved systems, devices and methods for delivering a cryogen to the skin of a patient for skin treatment. A cryogenic spray device configured to deliver a cryogen to the skin of a patient may include an applicator, a supply channel, and a nozzle assembly. The applicator may include a head portion, and the feed channel may extend through at least a portion of the head portion. The nozzle assembly may be coupled to the head portion, and the nozzle assembly may be fluidly coupled to the supply passage. The nozzle assembly may include a linear array of orifices configured to direct a planar jet of cryogen to cool a region of skin tissue of a patient in a linear cooling process.)

1. A method of cooling an area of skin of a patient, the method comprising:

positioning a cryogenic spray applicator to a location proximate the area of skin tissue of the patient to be treated; and

directing a planar spray of cryogen through a linear array of orifices of the cryogenic spray applicator to cool the region of the skin tissue of the patient in a cooling treatment line to effect treatment of the skin.

2. The method of claim 1, further comprising: a tank containing liquid cryogen and gaseous cryogen is heated with a tank heater so that the tank maintains a desired pressure.

3. The method of any one of claims 1 and 2, wherein directing the planar jet of cryogen through the linear array of orifices comprises: transporting the liquid cryogen from the tank to an applicator via a supply tube, wherein a pressure of the liquid cryogen in the supply tube is substantially equal to the desired pressure in the tank.

4. The method of any of claims 1, 2, and 3, further comprising: moving the cryogenic spray applicator to provide a linear curtain of cooling treatment to the region of the skin tissue of the patient.

5. The method of any of claims 1 to 4, wherein directing the planar jet of cryogen through the linear array of orifices comprises: locally freezing epidermis to alter pigmentation of the region of the skin tissue of the patient.

6. The method of any of claims 1 to 5, wherein directing the planar jet of cryogen through the linear array of orifices comprises: locally disrupting epidermis to produce gradual skin lightening in the region of the skin tissue of the patient.

7. The method of any of claims 1 to 6, wherein the cryogen comprises: a liquid cryogen; a gaseous cryogen; a two-phase fluid; cooled air; or carbon dioxide.

8. The method of claim 7, wherein the liquid cryogen comprises liquid carbon dioxide.

9. The method of any one of claims 1 to 8, wherein the cryogen comprises a plurality of droplets.

10. The method according to any one of claims 1 to 9, wherein the planar jet of liquid cryogen has a temperature at the skin surface of between-4 ℃ and-80 ℃.

11. The method of any one of claims 1 to 10, wherein each orifice comprises a cylindrical opening.

12. The method of any of claims 1-11, wherein the linear array of orifices comprises a single row of orifices or multiple rows of orifices.

13. The method of any of claims 1 to 12, further comprising delivering a gas to form a protection curtain through which the cryogen moves downstream of the orifice.

14. The method of claim 13, wherein the protective curtain prevents entrainment of water or entrainment of ambient air as the cryogen moves downstream of the orifice.

15. The method of any one of claims 13 and 14, wherein the gas is expelled from the orifice before or during directing the planar jet of cryogen from the orifice.

16. The method of any one of claims 13, 14 and 15, wherein the gas comprises at least one of: drying the gas; or an inert gas.

17. The method of any of claims 1 to 16, further comprising: applying a mask to the area of the skin tissue of the patient prior to directing a planar jet of the cryogen from the linear array of apertures.

18. The method of claim 17, wherein the mask comprises a perforated film.

19. The method according to any one of claims 1 to 18, wherein positioning the cryogenic spray applicator to a location proximate the region of the skin tissue of the patient comprises: contacting the area of the skin tissue of the patient with a mechanical spacer to maintain a predetermined distance between the cryogenic spray applicator and the skin tissue.

20. The method of claim 19, wherein the predetermined distance comprises a range from 0.125 inches to 3 inches.

21. The method of any one of claims 19 and 20, wherein the mechanical spacer comprises at least one of: a wheel spacer; and a slider spacer.

22. The method according to any one of claims 1 to 21, wherein positioning the cryogenic spray applicator to a location proximate the area of the skin tissue of the patient to be treated comprises: positioning a non-contact freeze jet applicator proximate to the region of the skin tissue of the patient.

23. The method of any of claims 1 to 22, further comprising: warming the area of the skin tissue of the patient after the cooling treatment.

24. The method of claim 23, wherein the region of the skin tissue of the patient is warmed by delivering warmed air or coolant from the same or different orifices for convective warming.

25. A skin cooling treatment system comprising:

a source of cryogen;

a non-contact cryogenic spray applicator fluidly coupled to the source of cryogen and configured for directing a planar spray of cryogen to an area of skin tissue of a patient to be treated, wherein the non-contact cryogenic spray applicator comprises a linear array of orifices configured to spray the cryogen to cool the area of the skin tissue of the patient in a cooling treatment line.

26. The skin cooling treatment system of claim 25, further comprising a supply tube fluidly coupled to a bottom portion of the coolant source.

27. The skin cooling treatment system according to any one of claims 25 and 26, wherein the coolant source further comprises a heater to maintain the coolant source at a desired pressure range or a desired temperature range.

28. The skin cooling treatment system of claim 27, wherein the desired temperature range includes temperatures above ambient temperature.

29. The skin cooling treatment system of claim 27, wherein the coolant source comprises a liquid coolant and a gaseous coolant.

30. The skin cooling treatment system of any one of claims 25-29, wherein the linear array of apertures comprises a single row of apertures or a plurality of rows of apertures.

31. The skin cooling treatment system of claim 30, wherein the orifices in the linear array of orifices are the same size.

32. The skin cooling treatment system of any one of claims 30 and 31, wherein the orifices in the linear array of orifices are of different sizes.

33. The skin cooling treatment system of any one of claims 30 to 32, wherein the apertures are evenly spaced.

34. The skin cooling treatment system of any one of claims 30-33, wherein the apertures are staggered.

35. The skin cooling treatment system of any one of claims 25-34, wherein each orifice comprises a cylindrical opening.

36. The skin cooling treatment system of any one of claims 25 to 35, wherein the non-contact freeze spray applicator further comprises a nozzle tube and a hood extending at least partially around the linear array of orifices of the nozzle tube, wherein the hood creates a stagnation zone at the distal opening of the orifices.

37. The skin cooling treatment system of claim 36, wherein the nozzle tube comprises a first material, and wherein the cover comprises a second material.

38. The skin cooling treatment system of claim 37, wherein the second material of the cover has a thermal conductivity that is lower than a thermal conductivity of the first material of the nozzle tube.

39. The skin cooling treatment system of any one of claims 36 to 38, wherein the mask has a depth equal to at least twice a diameter of one of the apertures of the linear array of apertures.

40. The skin cooling treatment system of any one of claims 25 to 39, further comprising a temperature control mask or perforated film configured to contact the area of the skin tissue of the patient.

41. The skin cooling treatment system according to any one of claims 25 to 40, wherein the coolant comprises: a liquid cryogen; a gaseous cryogen; a two-phase fluid; cooled air; or carbon dioxide.

42. A cryo-spray device for delivering cryogen to a patient's skin for altering the appearance of pigmentation, the cryo-spray device comprising:

an applicator comprising a head portion;

a feed channel extending at least partially through the head portion; and

a nozzle assembly coupled to the head portion and fluidly coupled to the supply channel, the nozzle assembly including a linear array of orifices configured to eject the cryogen to cool an area of the patient's skin tissue in a linear cooling process to change a pigmentation appearance of the area.

43. The cryogenic spray device of claim 42, wherein the linear array of orifices comprises a single row of orifices or multiple rows of orifices.

44. The cryogenic spray device of any one of claims 42 and 43, wherein each orifice comprises a cylindrical opening.

45. The cryogenic spray device of any of claims 42 to 44, wherein the nozzle assembly comprises a nozzle tube and a shroud extending at least partially around the linear array of orifices, wherein the shroud creates a stagnation zone at the distal opening of the orifices.

46. The cryogenic spray device of claim 45, wherein the nozzle tube comprises a first material and wherein the shroud comprises a second material.

47. The cryogenic spray device of claim 46, wherein the second material of the shroud has a thermal conductivity that is lower than a thermal conductivity of the first material of the nozzle tube.

48. The cryogenic spray device of any of claims 45 to 47, wherein the shroud has a depth equal to at least twice a diameter of one of the orifices of the linear array of orifices.

49. The cryogenic spray device of any of claims 42 to 48, further comprising a filter located within the head portion and upstream of the linear array of orifices.

50. The cryogenic spray device of claim 49, wherein the filter comprises a sintered metal filter.

51. The cryogenic spray device of any of claims 42 to 50, further comprising an array of curtain apertures in the nozzle assembly.

52. The cryogenic spray device of any of claims 42 to 51, further comprising a mechanical spacer coupled to the head portion, wherein the mechanical spacer is configured to maintain at least a minimum or constant distance between the linear array of orifices and the surface of the patient's skin.

53. The cryogenic spray device of claim 52, wherein the mechanical spacer is adjustable to vary the minimum distance.

54. The cryogenic spray device of any of claims 52 and 53, wherein the mechanical spacer comprises a wheel spacer.

55. The cryogenic spray device of claim 54, wherein the wheel spacer comprises a first wheel positioned proximate a first end of the linear array of orifices and a second wheel positioned proximate a second end of the linear array of orifices.

56. The cryogenic spray device of any of claims 52 and 53, wherein the mechanical spacer comprises a slide spacer.

57. The cryogenic spray device of claim 56, wherein the slide spacer comprises a plurality of adjustable legs or limbs.

58. The cryogenic spray device of any one of claims 42 to 57, wherein the applicator further comprises a handle portion configured to be gripped by an operator of the cryogenic spray device.

Technical Field

Cryotherapy is the topical or general use of cold in medical therapy. Cryotherapy may include controlled freezing of biological tissue, which may produce various effects, such as skin tissue. Certain tissue freezing processes and devices, such as conventional cryoprobes, may cause severe freezing of tissue and produce cellular and visible skin damage.

Background

There is a need for dermatological products that can lighten the appearance of skin or otherwise controllably affect skin pigmentation. For example, for cosmetic reasons, it may be desirable to lighten the overall complexion or color of an area of skin to change the overall appearance. Furthermore, for cosmetic reasons, it may also be desirable to lighten specific hyperpigmented areas of the skin, such as freckles, "cafe milk" spots ('spot'), melasma or dark eye circles, which may be caused by a local excess of pigments in the skin. Hyperpigmentation may be caused by a variety of factors such as ultraviolet radiation, aging, stress, trauma, inflammation, and the like. Such factors may lead to overproduction of melanin or melanogenesis in the skin by melanocytes, which may lead to the formation of hyperpigmented regions. Such hyperpigmented areas may be associated with excess melanin within the epidermis and/or the dermal-epidermal junction. However, hyperpigmentation may also be caused by excess melanin deposited in the dermis.

Hypopigmentation of skin tissue has been observed as a side effect in response to temporary cooling or freezing of tissue, such as may occur during conventional cryosurgical procedures. The reduction of pigmentation after cooling or freezing of the skin may be caused by a reduction in melanogenesis, a reduction in melanosome production, destruction of melanocytes, or inhibition of melanosome transfer or modulation of keratinocytes entry into the lower region of the epidermal layer. The resulting hypopigmentation may be persistent or permanent. However, it has also been observed that some of these freezing processes may produce hyperpigmented areas of skin tissue (or darkened skin). The level of increase or decrease in pigmentation may depend on certain aspects of the cooling or freezing conditions, including the temperature of the cooling process and the length of time the tissue is kept in a frozen state.

Improved hypopigmentation processes, devices and systems have been developed to improve the consistency of skin freezing and the consistency of overall hypopigmentation. For example, it has been observed that moderate freezing (e.g., -4 degrees celsius to-30 degrees celsius) over a short time frame (e.g., 30 seconds to 60 seconds) can produce special dermatological effects, such as affecting the expression of skin pigmentation (e.g., hypopigmentation). Cryotherapy may be provided using a variety of techniques including applying a cryogen spray directly to the patient's skin or applying a cooled probe or plate to the patient's skin. Exemplary methods and apparatus are described in the following patent documents: U.S. patent publication No.2011/0313411, entitled "METHOD AND apparatus for evaluating catalyst AND catalyst", filed on 7.8.2009; U.S. patent publication No.2014/0303696, entitled "METHOD AND APPATUS FOR CRYOGENIC TREATimE OF SKINTISSUE", filed 11, 16/2012; U.S. patent publication No.2014/0303697 entitled "METHOD AND APPARATTUS FOR CRYOGENIC TREATimE OF SKIN TISSUE", filed 11, 16/2012; U.S. patent publication No.2015/0223975, entitled "METHOD AND APPATUS FOR AFFECTINGPING PROTATION OF TISSUE", filed on 12.2.2015; U.S. patent publication No.2017/0065323, entitled "MEDICAL SYSTEMS, METHODS, AND DEVICES FOR HYPOPIGMENT COOLINGTREATMENTS," filed on 6/9/2016, the entire contents of each of which are incorporated herein by reference.

While treatment of skin or local lesions to affect pigmentation may be accomplished with cryotherapy, it may be desirable to provide improved methods, systems, and devices for cryotherapy. In particular, improved designs, controls and parameters associated with coolant delivery may be beneficial in order to achieve consistent and reliable skin freezing and desired skin treatment effects. Accordingly, improved dermatological cryogenic spray methods, systems, and devices are desired.

Disclosure of Invention

The present invention relates to improved systems, devices and methods for delivering a cryogen to the skin of a patient for skin treatment. More particularly, the present invention relates to improved dermatological cryogenic spray methods, devices and systems that provide consistency in skin treatment by reliably freezing the skin during treatment while limiting the adverse side effects of skin freezing. Exemplary embodiments include nozzle designs that include a linear array of orifices. Such a linear array of orifices can deliver a linear jet of cryogen or cold gas to the skin surface as the cryogen or cold gas is dispensed through those orifices. Advantageously, such a linear spray application provides a cooling treatment line that facilitates uniform and uniform treatment of a large area of skin. The linear cooling process facilitates the scanned delivery of the cryogen or cold gas to the patient's skin by delivering the cryogen or cold gas uniformly through the linear array of orifices. Treating large areas of skin uniformly and consistently can be particularly beneficial for a variety of skin indications, such as: indications associated with pigmentation or pigmentation, including hypopigmentation or hyperpigmentation; acne; rosacea; psoriasis; chloasma; lentigo; freckle; birthmark, liver spot, senile plaque or coffee milk spot.

One aspect of the present disclosure relates to a method of cooling an area of skin of a patient. The method comprises the following steps: positioning a cryogenic spray applicator to a location proximate to an area of skin tissue of a patient to be treated; and directing a planar spray of cryogen through the linear array of orifices of the cryogenic spray applicator to cool the region of skin tissue of the patient in a cooling treatment line to effect treatment of the skin.

In some embodiments, the method comprises: the tank containing the liquid cryogen and the gaseous cryogen is heated with a tank heater so that the tank maintains a desired pressure. In some embodiments, the cryogen may include: a liquid cryogen; a gaseous cryogen; a two-phase fluid; cooled air; and/or carbon dioxide. In some embodiments, directing a planar jet of cryogen or cold gas through a linear array of orifices comprises: a cryogen, such as a liquid cryogen, is transported from the tank to the applicator via a supply tube. In some embodiments, the pressure of the liquid cryogen in the supply tube is approximately equal to the desired pressure in the tank. In some embodiments, the method comprises: the cryogenic spray applicator is moved to provide a linear curtain of cooling treatment to the area of skin tissue of the patient. In some embodiments, directing a planar jet of liquid cryogen or cold gas through a linear array of orifices comprises: the epidermis is locally frozen to alter the pigmentation of an area of skin tissue of a patient.

In some embodiments, directing a planar spray of cryogen through a linear array of orifices comprises: locally disrupting the epidermis to produce a gradual skin lightening in the region of the skin tissue of the patient, the cryogen may comprise: liquid cryogen, cold gas, or a two-phase fluid comprising liquid cryogen and gas. In some embodiments, the planar spray of cryogen may comprise one or several liquid cryogen droplets, and in some embodiments, the liquid cryogen may be liquid carbon dioxide. In some embodiments, the planar jet of liquid cryogen has a temperature between-4 ℃ and-80 ℃ at the skin surface.

In some embodiments, each aperture may be and/or include a cylindrical opening. In some embodiments, the linear array of orifices may be a single row of orifices or multiple rows of orifices. In some embodiments, the method comprises: the gas is delivered to form a protective curtain through which the liquid cryogen or cold gas moves downstream of the orifice. In some embodiments, the protective curtain prevents entrainment of water or ambient air as the liquid cryogen or cold gas moves downstream of the orifice. In some embodiments, the gas is expelled from the orifice before or during directing a planar jet of liquid cryogen or cold gas from the orifice. In some embodiments, the gas comprises at least one of: drying the gas; or an inert gas.

In some embodiments, positioning the cryogenic spray applicator to a location proximate to the region of skin tissue of the patient comprises: the region of the skin tissue of the patient is contacted with the mechanical spacer to maintain the predetermined distance between the cryogenic spray applicator and the skin tissue. In some embodiments, the predetermined distance comprises a range from 0.125 inches to 3 inches. In some embodiments, the mechanical spacer comprises at least one of: a wheel spacer; and a slider spacer. In some embodiments, positioning the cryogenic spray applicator to a location proximate to a region of skin tissue of a patient to be treated comprises: the non-contact freeze jet applicator is positioned proximate to the region of skin tissue of the patient.

In some embodiments, the method comprises: a mask is applied to a region of skin tissue of a patient prior to directing a planar jet of liquid cryogen or cold gas from a linear array of orifices. In some embodiments, the mask may be a perforated film. In some embodiments, the method comprises: the area of skin tissue of the patient is warmed after the cooling treatment. In some embodiments, a region of skin tissue of a patient is warmed by delivering warmed gas or liquid from the same or different orifices for convective warming.

One aspect of the present disclosure relates to a skin cooling treatment system. The system comprises: a source of cryogen; a non-contact cryogenic spray applicator fluidly coupled to a source of cryogen, the cryogenic spray applicator operable to direct a planar spray of liquid cryogen to a region of skin tissue of a patient to be treated, the non-contact cryogenic spray applicator comprising a linear array of orifices operable to spray liquid cryogen or cold gas to cool the region of skin tissue of the patient in a manner that cools a treatment line.

In some embodiments, the processing system includes a supply tube fluidly coupled to a bottom portion of the cryogen source. In some embodiments, the cryogen source further comprises a heater to maintain the cryogen source at a desired pressure range or a desired temperature range. In some embodiments, the desired temperature range may include temperatures above ambient temperature. In some embodiments, the source of cryogen includes a liquid cryogen and a gaseous cryogen. In some embodiments, the linear array of orifices comprises a single row of orifices or a plurality of rows of orifices. In some embodiments, the orifices in the linear array of orifices are the same size, or are of different sizes. In some embodiments, the apertures are evenly spaced or at least some of the apertures are staggered. In some embodiments, each aperture comprises a cylindrical opening.

In some embodiments, the non-contact cryogenic spray applicator further comprises a nozzle tube and a shroud extending at least partially around the linear array of orifices of the nozzle tube. In some embodiments, the shroud creates a stagnation zone at the distal opening of the orifice. In some embodiments, the nozzle tube may be made of a first material and the cap may be made of a second material. In some embodiments, the second material of the shroud has a thermal conductivity that is lower than a thermal conductivity of the first material of the nozzle tube. In some embodiments, the mask has a depth equal to at least twice a diameter of one of the orifices of the linear array of orifices. In some embodiments, the processing system includes a temperature-controlled mask or perforated film. The temperature control mask or perforated skin may contact an area of skin tissue of the patient.

One aspect of the present disclosure relates to a cryogenic spray device for delivering cryogen to a patient's skin for altering the appearance of pigmentation. The freezing injection device includes: an applicator comprising a head portion; a feed channel extending at least partially through the head portion; and a nozzle assembly coupled to the head portion and fluidly coupled to the supply channel, the nozzle assembly including a linear array of orifices that can spray a cryogen to cool an area of skin tissue of a patient in a linear cooling process to change a pigmentation appearance of the area.

In some embodiments, the linear array of orifices comprises a single row of orifices or a plurality of rows of orifices. In some embodiments, each aperture comprises a cylindrical opening. In some embodiments, the nozzle assembly includes a nozzle tube and a shroud extending at least partially around the linear array of orifices. In some embodiments, the shroud creates a stagnation zone at the distal opening of the orifice. In some embodiments, the nozzle tube may be made of a first material and the cap may be made of a second material. In some embodiments, the second material of the shroud has a thermal conductivity that is lower than a thermal conductivity of the first material of the nozzle tube. In some embodiments, the mask has a depth equal to at least twice a diameter of one of the orifices of the linear array of orifices.

In some embodiments, the cryogenic spray device includes a filter located within the head portion and upstream of the linear array of orifices. In some embodiments, the filter comprises a sintered metal filter. In some embodiments, the cryogenic spray device comprises an array of curtain apertures in a nozzle assembly. In some embodiments, the array of curtain apertures may be configured to deliver a shielding gas to prevent entrainment of water or ambient air as the liquid cryogen or cold gas moves downstream of the orifice.

In some embodiments, the cryogenic spray device includes a mechanical spacer coupled to the head portion. In some embodiments, the mechanical spacer may maintain at least a minimum or constant distance between the linear array of orifices and the surface of the patient's skin. In some embodiments, the mechanical spacer is adjustable to vary the minimum distance. In some embodiments, the mechanical spacer comprises a wheel spacer. In some embodiments, the wheeled spacer includes a first wheel positioned proximate a first end of the linear array of apertures and a second wheel positioned proximate a second end of the linear array of apertures. In some embodiments, the mechanical spacer comprises a slider spacer, and in some embodiments, the slider spacer comprises a plurality of adjustable legs or limbs. In some embodiments, the applicator further comprises a handle portion sized and shaped for gripping by an operator of the cryospray device.

Embodiments of the invention covered by this patent are defined by the appended claims, not this summary. This summary is a high-level overview of various aspects of the invention and introduces some of the concepts that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used alone to determine the scope of the claimed subject matter. The subject matter should be understood by reference to appropriate portions of the entire specification of this patent, any or all of the figures, and each claim.

The invention will be better understood upon reading the following description and upon examination of the accompanying drawings which follow. These drawings are provided as illustrations only and do not limit the invention in any way.

Drawings

FIG. 1 is a schematic diagram of one embodiment of a freeze processing system.

Fig. 2 is a side cross-sectional view of one embodiment of an applicator of the cryogenic treatment system.

FIG. 3 is a close-up side cross-sectional view of aspects of the head portion of the applicator.

Fig. 4 is a close-up front cross-sectional view of a nozzle including an elongated member.

Fig. 5 is a bottom view of one embodiment of a nozzle and an elongate member including a linear array of orifices.

FIG. 6 is a schematic view of an embodiment of a linear array of evenly spaced orifices on an elongate member of a nozzle.

FIG. 7 is a schematic view of an embodiment of a linear array of staggered orifices on an elongate member of a nozzle.

FIG. 8 is a schematic view of an embodiment of applying a cryogen to the skin of a patient.

Fig. 9 is a perspective view of an embodiment of a wheel spacer.

FIG. 10 is a perspective view of one embodiment of a slider spacer.

FIG. 11 is a flow chart illustrating one embodiment of a process for cooling a patient's skin by applying a spray of cryogen.

Detailed Description

Embodiments of the present disclosure relate to systems, methods, and devices for providing cryotherapy skin treatments. In some embodiments, these systems, methods, and devices may include a freeze jet applicator that utilizes a nozzle comprising a linear array of orifices to direct a cryogen or cold gas toward the skin in a planar manner that produces lines of frozen tissue to achieve a desired skin treatment, such as skin lightening or hypopigmentation. The linear array of orifices may be arranged in a single row of orifices or multiple rows of orifices. Such a linear array nozzle design may direct a curtain-like application of a cryogen or cold gas such that the cryogen or cold gas impinges the skin surface, which may facilitate uniform and controlled application of a cooling treatment to a larger treatment area of the patient's skin without undesirable side effects.

The fine-tuned linear array nozzle design of the present invention provides advantages over conventional nozzle designs, which typically include a single opening or a cluster of openings. For example, a single opening has a limited treatment area and it is difficult for a single opening to provide a uniform cooling treatment when spraying over a region. A cluster of openings can provide a larger treatment area, but a cluster of openings can undesirably increase the intensity of the cryogen or cold gas spray against the patient's skin, resulting in an undesirable impact and lack of control of the skin. Conventional nozzle designs may also increase the difficulty of providing reliable and consistent cryogenic spray doses over large areas of skin tissue. In contrast, the nozzle of the present disclosure includes a linear array of orifices to help the coolant or cold gas to be delivered uniformly and uniformly toward a large area of skin in a planar manner that creates a line of skin treatment. This linear coverage facilitates the nozzle scanning over the skin while delivering a controlled and consistent dose of cryogen to the skin.

The nozzle may include features to prevent clogging of some or all of the orifices in the linear array of orifices and/or entrainment of an undesirable amount of moisture in the dispensed cryogen and/or be controlled to prevent clogging of some or all of the orifices in the linear array of orifices and/or entrainment of an undesirable amount of moisture in the dispensed cryogen. These features may include a shroud, which may be part of the nozzle. The shroud may extend completely or partially around the linear array of apertures. In some embodiments, the shroud may reduce the likelihood of ice crystal formation at the orifice and thus block the flow of cryogen through the orifice.

The nozzle may also include one or several orifices from which the shielding gas may be dispensed. In some embodiments, such a shielding gas may form a protective curtain through which a cryogen may be dispensed or within the interior of the protective curtain to prevent entrainment of ambient moisture in the cryogen and to prevent freezing of the nozzle surfaces during or after spraying or cryogen. The shielding gas may be dispensed from the same orifice or applicator that dispenses the cryogen by delivering the shielding gas before or after the cryogen is delivered, or the shielding gas may be delivered from a separate orifice other than the orifice that dispenses the cryogen. In some embodiments, the shielding gas may be nitrogen, carbon dioxide, helium, hydrogen, neon, oxygen, fluorine, argon, methane, refrigerant, and/or air. In some embodiments, the shielding gas may be an inert gas.

Referring now to fig. 1, one embodiment of a freeze processing system 100 is shown. The refrigeration processing system 100 may contain and/or deliver a refrigerant. In some embodiments, the cryogen may comprise a liquefied gas such as liquid helium, liquid hydrogen, liquid neon, liquid oxygen, liquefied fluorine, liquefied argon, liquefied methane, liquefied air, or the like. In some embodiments, the cryogen may comprise a cooled gas or a cold gas, such as, for example, cooled air or chilled air. In some embodiments, the cryogen in the tank may be a mixture of liquid and gas, such as liquid cryogen and gaseous cryogen, or in other words, the cryogen may be partially liquid. The cryogenic process system 100 may include a tank 102, the tank 102 also being referred to herein as a vessel 102, a cryogen source 102, or a canister 102. The tank 102 may have various shapes and sizes, and the tank 102 may be made of various materials. In some embodiments, the tank 102 may include a metal cylinder defining an interior volume, which may contain a cryogen and/or which may contain a pressurized cryogen. In some embodiments, the metal cylinder may be made of aluminum or steel.

In some implementations, the tank 102 may include a heater 104, a thermostat 106, and/or a controller 108. The heater 104 may include any desired heater capable of heating the tank 102 and/or the cryogen contained in the tank 102 to a desired temperature and/or until the cryogen contained in the tank 102 reaches a desired pressure. In some embodiments, the desired pressure may be less than 100psi, less than 500psi, less than 1,000psi, less than 2,000psi, less than 5,000psi, between 0psi and 2,000psi, between 500psi and 1,500psi, about 1,000psi, or any other pressure or intermediate pressure. In some embodiments, the heater 104 may be located at the bottom 110 of the tank 102 or on the bottom 110 of the tank 102 and/or near the bottom 110 of the tank 102. In some embodiments, the location of the heater 104 on and/or in the tank 102 may help to heat the cryogen contained within the tank 102, and in particular to heat the liquid portion of the cryogen contained within the tank.

The thermostat 106 may include one or several features configured to measure the temperature within the tank 102. These features may include, for example, one or several thermocouples, thermistors, thermometers, and the like. The thermostat 106 may be positioned at any desired location on the tank 102, and in some embodiments, the thermostat 106 may be positioned proximate to the heater 104.

The controller 108 may be communicatively coupled with the heater 104 and/or with the thermostat 106. In some implementations, the controller 108 may include one or several features that display one or several properties of the tank 102 and/or the cryogen, such as, for example, the pressure in the tank 102, the amount of cryogen in the tank 102, the temperature of the cryogen or the temperature of the tank 102, etc. The controller 108 may also include one or several features by which set point information may be provided to the controller by a user and/or by which the set point may be changed.

The controller 108 may control the temperature of the cryogen and/or the temperature of the tank 102 via a communicative coupling with the heater 104 and/or with the thermostat 106. In some implementations, for example, the controller may receive one or several signals from the thermostat 106 indicative of the temperature of the cryogen and/or the temperature of the tank 102. The controller may compare the signal to set point information and may determine whether to increase or decrease the temperature of the cryogen and/or the temperature of the tank 102. The temperature of the cryogen and/or the temperature of the tank are controlled by, for example, controlling the energization of the heater 104, such as by controlling the amount of current to the heater 104. In some embodiments, the controller 108, heater 104, and thermostat 106 may heat the tank 102 sufficiently to maintain a constant pressure and/or temperature during dispensing of the cryogen.

The tank 102 may include a switch 112, such as a safety switch. In some embodiments, the safety switch may be communicatively coupled with the controller 108 and/or the heater 104. In some embodiments, operation of the switch 112 may cut off power to the heater 104 to prevent any further heating of the tank 102 and/or the cryogen in the tank 102. In some embodiments, the switch 112 may be separate from the controller 108, and in some embodiments, the switch 112 may be integrated in the controller 108.

The freeze treatment system 100 may include an applicator 114, the applicator 114 also referred to herein as a freeze spray applicator 114, the applicator 114 may include a nozzle 116, the nozzle 116 also referred to herein as a nozzle assembly 116, and the nozzle 116 may include a linear array of orifices. In some embodiments, the freeze jet applicator 114 may be a non-contact freeze jet applicator because the nozzle 116 or other portion of the applicator 114 does not contact the patient's skin to cool the patient's skin, but rather, the coolant is dispensed by the nozzle 116 to the patient's skin to cool the patient's skin.

The applicator 114, and in particular the nozzle 116, can dispense the cryogen from the tank 102 to the skin of the patient. In some embodiments, the applicator 114 may be fluidly connected with the tank 102 via a tube 118, the tube 118 also referred to herein as a hose 118, a supply tube 118, or a connecting tube 118. In some embodiments, the tube 118 may be fluidly connected with the interior volume of the tank via a port or aperture extending through the tank. In some embodiments, the tube 118 may be connected to the tank 102 at or near the bottom 110 of the tank 102. The connection of the tube 118 at or near the bottom 110 of the tank 102 may facilitate the extraction of cryogen, and in particular the extraction of liquid cryogen into the tube 118, and the delivery of cryogen, and in particular the delivery of liquid cryogen to the applicator 114 and the nozzle 116.

The tube 118 may have various shapes and sizes and may be made of various materials. In some embodiments, the tube may be made of a material capable of withstanding the temperature and/or pressure of the cryogen and/or withstanding the cryogen. In some embodiments, the tube 118 may have a diameter, shape, and/or connection such that the pressure of the cryogen at the nozzle 116 and/or at the applicator 114 is the same or approximately the same as the pressure at the tank 102. As used herein, approximately or approximately refers to a value having one or more values associated therewith that deviate by less than 10%, 5%, 2%, or 1%. Thus, when the pressure of the cryogen at the nozzle 116 and/or at the applicator 114 deviates from the pressure of the cryogen in the tank 102 by less than 10%, 5%, 2%, or 1%, the pressure of the cryogen at the nozzle 116 and/or at the applicator 114 is the same or approximately the same as the pressure of the cryogen in the tank.

Fig. 2 is a side cross-sectional view of one embodiment of an applicator 114 including a nozzle 116. The applicator 114 may have various shapes and sizes and may be made of various materials. In some embodiments, the applicator 114 may be a handheld applicator 114, while in other embodiments, the applicator 114 may be part of an automated system or device, such as a robotic system or device, a remote control system or device, or the like.

The applicator 114 may include a handle portion 200 and a head portion 202. The handle portion 200 may include a grip portion 204 connected to the head portion 202. The grip 204 may be sized and shaped to be held in the hand of an operator of the applicator 114. The head portion 202 may be connected to the nozzle 116, and in particular may be coupled to an elongated member 206 of the nozzle 116 via a nozzle base 208, the elongated member 206 also being referred to herein as a nozzle tube 206. In some embodiments, the nozzle base 208 may include a threaded plug, such as, for example, an NPT threaded plug. Nozzle base 208 may be made from a variety of materials including, for example, brass, steel, stainless steel, nickel alloys, and the like.

As shown in fig. 2, the tube 118 may extend along the grip portion 204 and may be coupled to the head portion 202 at a coupler 210. The coupling 210 may include, for example, a hose coupling 212, and the hose coupling 212 may include, for example, a female hose coupling. The hose coupling 212 may be threadably engaged with a head coupling 214, which head coupling 214 may be, for example, a threaded coupling. In some embodiments, and as shown in fig. 2, the head coupler 214 is threadably engaged with features of the head portion 202 of the applicator 114 to couple the head coupler 214 to the head portion 202.

The applicator 114 may include a filter 216. The filter 216 may have various shapes and sizes and may be made of various materials. The filter 216 may be located at multiple locations throughout the applicator 114 and/or the tube 118. In some embodiments, filter 216 may be located between tube 118 and nozzle 116, filter 216 may be located in nozzle 116, such as, for example, in nozzle base 208, filter 216 may be located in coupler 210, such as, for example, in head coupler 214, and so forth.

The filter 216 may be sized to eliminate and/or minimize clogging at the nozzle 116. In some embodiments, filter 216 may be a 1 μ filter, a 10 μ filter, a 25 μ filter, a 50 μ filter, a 100 μ filter, a filter between 10 μ and 100 μ, a filter between 40 μ and 50 μ, a filter of approximately 50 μ, or any other desired filter. In some embodiments, the filter 216 may comprise a ceramic filter, a polymer filter, a sintered metal filter, or any other desired filter type. In some embodiments, the filter 216 may comprise a sintered stainless steel filter or mesh.

The head portion 202 of the applicator 114 may include a valve 218, and the valve 218 may control the flow of coolant to the nozzle 116 and/or the dispensing of coolant from the nozzle 116. In some embodiments, the valve 218 may be controlled by a control feature 220, and the control feature 220 may be, for example, a button. For example, in some embodiments, operation of the control feature 220 may cause opening or closing of the valve 218, and thus may cause initiation or termination of refrigerant dispensing. In some embodiments, the head portion 202 of the applicator 114 may include a filler plug 222. In some embodiments, the fill plug 222 may comprise a dead volume fill plug, and the fill plug 222 may be located in a feed channel 224 of the head portion 202 proximate to the nozzle 116 and particularly proximate to the nozzle base 208. In some embodiments, the feed channel 224 may extend through at least a portion of the head portion 202 of the applicator. In some embodiments, the valve 218 interacts with the fill plug 222 to provide cryogen to the nozzle 116 and/or dispense cryogen from the nozzle 116.

As seen in the close-up side cross-sectional view of fig. 3 and the close-up front cross-sectional view of fig. 4, the elongated member 206 of the nozzle includes an interior volume 400 defined by a wall 402 of the elongated member 206. A plurality of apertures 404, some or all of which apertures 404 may comprise cylindrical holes or cylindrical openings and thus may be cylindrical apertures 404, extend through the wall 402 of the elongate member 206 to fluidly couple the interior volume 400 of the elongate member 206 to the exterior of the elongate member 206. Specifically, the aperture 404 extends from a proximal opening 406 in contact with the interior volume 400 of the elongate member 206 to a distal opening 408. As seen in fig. 4, the channel 500 extending through the nozzle base 208 is fluidly connected with the interior volume 400 of the elongate member 206. The channel 500 may further be fluidly connected with the tube 118 and/or fluidly connected with the valve 218 or the filler plug 222.

In some embodiments, the apertures 404 may each have the same or substantially the same diameter and/or depth, and in some embodiments, some or all of the apertures 404 may have different diameters and/or depths. In some embodiments, the orifice 404 may be sized and shaped such that the expansion of the cryogen through the orifice 404 is nearly adiabatic. For example, in some embodiments, each orifice 404 may have the following diameter: about 0.001 inch, about 0.005 inch, about 0.007 inch, about 0.008 inch, about 0.01 inch, about 0.02 inch, about 0.05 inch, about 0.08 inch, about 0.1 inch, between about 0.001 inch and 0.01 inch, between about 0.005 inch and 0.008 inch, or any other diameter or intermediate diameter. In some embodiments, the apertures may have the following depths: about 0.001 inches, about 0.005 inches, about 0.008 inches, about 0.01 inches, about 0.02 inches, about 0.05 inches, about 0.08 inches, about 0.1 inches, about 0.5 inches, between about 0.001 inches and 0.05 inches, between about 0.005 inches and 0.02 inches, and/or any other depth or intermediate depth.

In some embodiments, and as seen in fig. 5-7, the plurality of orifices 404 may be arranged in a linear array 600 of orifices 404. The array 600 of orifices 404 may include, for example, 3 orifices, 5 orifices, 8 orifices, 10 orifices, 11 orifices, 15 orifices, 20 orifices, 30 orifices, 50 orifices, 100 orifices, between 0 and 50 orifices, between 0 and 25 orifices, between 0 and 11 orifices, or any other or intermediate number of orifices. In some embodiments, the linear array 600 may have the following lengths: about 10 inches, about 5 inches, about 2 inches, about 1 inch, about 0.5 inches, between 0 inches and 10 inches, between 0 inches and 5 inches, between 0 inches and 2 inches, or any other length or intermediate length. In some embodiments, each of the nozzles may be spaced apart by a distance of: about 1 inch, about 0.5 inch, about 0.1 inch, about 0.05 inch, about 0.01 inch, between 0 inch and 1 inch, between 0 inch and 0.5 inch, between 0 inch and 0.2 inch, or any other distance or intermediate distance.

In some embodiments, the plurality of orifices 404 forming the linear array of orifices may be arranged in a single row of orifices as shown in FIG. 5, or in multiple rows 602-A, 602-B, 602-C of orifices 404. In some embodiments, the linear array 600 may include one row of orifices, two rows of orifices, three rows of orifices, 5 rows of orifices, 7 rows of orifices, 10 rows of orifices, 20 rows of orifices, between 1 row and 10 rows of orifices, or any other or intermediate number of rows of orifices. In some embodiments, each of the rows 602-A, 602-B, 602-C of apertures 404 may have the same number of apertures 404, and in some embodiments, some or all of the rows 602-A, 602-B, 602-C of apertures 404 may have a different number of apertures. In embodiments where the linear array 600 includes multiple rows of apertures 404, the apertures 404 in different rows may be aligned as shown in fig. 6, or the apertures may be staggered as shown in fig. 7. In some embodiments, the apertures 404 in different rows of apertures 404 may have the same size or dimension, and in some embodiments, the apertures may have different sizes or dimensions. In some embodiments, some or all of the apertures 404 in the linear array 600 may be equally and/or uniformly spaced, and in some embodiments, some or all of the apertures 404 in the linear array 600 may be unequally spaced and/or staggered.

In some embodiments, some or all of the plurality of orifices 404 may dispense cryogen, and in some embodiments, some or all of the plurality of orifices 404 may dispense shielding gas, such as inert gas. In some embodiments, the inert gas may have a desired water content, such as, for example, less than 10% water by weight, less than 5% water by weight, less than 1% water by weight, less than 0.1% water by weight, less than 0.05% water by weight, less than 0.01% water by weight, less than 0.005% water by weight, less than 0.001% water by weight, or any other or intermediate value. Such a shielding gas may form a protective curtain through which cryogen may be dispensed to prevent entrainment of ambient moisture in the cryogen. In some embodiments, for example, entrainment of ambient moisture in the cryogen adversely affects the temperature of the cryogen and/or the ability to control the temperature of the skin or the temperature of the cryogen at the skin. The entrained moisture may be detrimental to the operation of the applicator 114, as the entrained moisture may block one or several orifices 404 and prevent proper dispensing of the cryogen. In addition, the entrained moisture may cause a "snow" layer to form on the skin due to the accumulation of ice crystals formed from the entrained moisture. This layer of ice can insulate the skin and can prevent the desired treatment from being provided to the skin.

The shielding gas may be dispensed from the same orifice 404 as the orifice 404 from which the cryogen is dispensed by delivering the shielding gas prior to delivering the cryogen, or the shielding gas may be delivered from a separate orifice 404 other than the orifice from which the cryogen is dispensed, such as a curtain orifice 604, the curtain orifice 604 also referred to herein as a curtain orifice 604 or curtain opening 604. As used herein, the curtain orifice 604 refers to the orifice 404 that delivers the shielding gas, and the cryogen orifice 606, also referred to herein as the cryogen orifice 606 or the cryogen opening 606, refers to the orifice 404 that delivers the cryogen. In some embodiments, the plurality of curtain orifices 604 may form an array of curtain orifices 604 and the plurality of cryogen orifices 606 may form an array of cryogen orifices 606.

For example, in some embodiments, one or more of the rows 602-A, 602-B, 602-C of the orifices 404 may be selected to deliver a cryogen, and one or more of the rows 602-A, 602-B, 602-C of the orifices 404 may be selected to deliver a shielding gas. For example, in one embodiment, one or several of the orifices 404 and/or one or several of the rows 602-A, 602-B, 602-C of orifices 404 are selected for delivering shielding gas simultaneously or partially simultaneously with delivering cryogen. In one such embodiment, for example, some or all of the orifices 404 in one or both of rows 602-A and 602-C may be curtain orifices 603, the curtain orifices 603 configured for delivering shielding gas simultaneously or partially simultaneously with delivering cryogen from one or several of the cryogen orifices that may be located in row 604-B. In some embodiments, the curtain orifice 604 may be positioned to form a perimeter around the cryogen orifice 606. In such an embodiment, the orifices 404 in rows 602-A and 602-C are curtain orifices 604, and additionally, the orifices 404 in row 602-B closest to the first end 806 of the nozzle tube 206 and the orifices 404 in row 602-B closest to the second end 808 of the nozzle tube 206 are curtain orifices.

In some embodiments, some or all of the orifices 404 may deliver heated gas. In some embodiments, for example, the cryogen and heated gas may be delivered alternately to cycle the temperature of the patient's skin. In some embodiments, the heated gas may be delivered through a different orifice 404 than the orifice 404 that delivers the cryogen, and in some embodiments, the heated gas may be delivered through the same orifice 404 that delivers the cryogen.

The nozzle 116 may also include a shroud 700, which shroud 700 may shield one or several of the orifices 404. For example, in some embodiments, the cover 700 may be sized and shaped to shield the plurality of apertures 404 from contact with humid air and/or from formation of ice crystals that may block one or several of the apertures 404. In particular, in some embodiments, the shroud 700 may create a stagnation zone at the exterior opening and/or distal opening of the orifice. In some embodiments, the cap 700 may comprise the same material as the material of the nozzle tube 206, and in some embodiments, the cap 700 may comprise a different material than the material of the nozzle tube 706. In some embodiments, for example, the cap may comprise a material having a lower thermal conductivity than the material of the nozzle tube 706, or specifically, in some embodiments, the nozzle tube 706 may comprise a metal, such as, for example, steel, stainless steel, nickel or nickel alloy, aluminum, or brass, and the cap 700 may comprise a polymer.

The shroud 700 may extend completely or partially around the linear array 600 of apertures 404. In some embodiments, the shroud includes a rectangular or oblong aperture 702 extending around the linear array 600 of apertures 404. The aperture 702 may have a width 704, a depth, and a length 706. In some embodiments, the shroud 700 may have a depth of about the following values: i times the diameter of the orifice 404, 2 times the diameter of the orifice 404, 3 times the diameter of the orifice 404, 5 times the diameter of the orifice 404, i 0 times the diameter of the orifice 404, between i and i 0 times the diameter of the orifice 404, between i and 4 times the diameter of the orifice 404, or any other depth or intermediate depth.

FIG. 8 is a schematic view of an embodiment of applying a cryogen to the skin of a patient. As can be seen, the cryogenic spray applicator 114 may be positioned proximate to the portion of the patient's skin 300 to be treated, the skin 300 also referred to herein as skin tissue 300. The applicator 114 may be controlled to direct a planar spray 302 of cryogen, which may be or may include liquid cryogen or cold gas, through a linear array 600 of orifices 404 in the nozzle 116 of the applicator 114, the planar spray 302 also being referred to herein as a linear curtain. In some embodiments, the planar spray includes a cryogen mist, such as a liquid cryogen mist, and in some embodiments, the liquid cryogen may include liquid carbon dioxide. Such a liquid cryogen or cold gas may cool a region 304 of the patient's skin tissue 300 in a manner that cools the treatment line to effect treatment of the skin 300. In some embodiments, the planar jet 302 may have a temperature between-4 ℃ and-80 ℃ at the skin surface.

The applicator 114 may move in the direction indicated by arrow 306 as indicated by arrow 306, which may cause the region 304 to move in the direction indicated by arrow 308 as indicated by arrow 308. This movement of the area 304 over the patient's skin 300 may produce a treated area 310, which treated area 310 may be continuous when the applicator 114 delivers a continuous planar jet 302, or the treated area 310 may be intermittent when the applicator 114 delivers a non-continuous planar jet 302, such as by delivering the planar jet 302 intermittently.

In some embodiments, the mask 312 may be applied to and/or covered over the skin prior to delivery of the cryogen. The mask 312 may include an object, item, or substance. In some embodiments, mask 312 may include a perforated member, a perforated film, a mesh, and/or a temperature-controlled member. In some embodiments, for example, the temperature of the mask 312 may be controlled to control the temperature of all or part of the skin, and in particular, in some embodiments, the mask 312 may be heated to heat the skin and/or cyclically heat the skin. In some embodiments, mask 312 may affect the temperature of skin 300 by isolating and/or shielding skin 300 from some of the cryogen applied to skin 300 by applicator 114 and/or mask 312.

In some embodiments, the applicator 114 may also include a spacer, and in particular a mechanical spacer 800 as shown in fig. 9 and 10. The mechanical spacer 800 may be configured to engage the patient's skin to maintain and/or at least maintain a desired, constant, and/or minimum spacing and/or distance between the nozzle 116 and/or orifices 404 or linear array 600 and the patient's skin. The mechanical spacer 800 may be coupled to the head portion 202 and/or the nozzle 116. The mechanical spacer 800 may have a variety of shapes, sizes, and designs. In some embodiments, the mechanical spacer 800 may maintain a fixed spacing between the patient's skin and the nozzle 116 and/or orifices 404 or linear array 600, and in some embodiments, the mechanical spacer 800 may be adjustable to vary a desired, constant, and/or minimum spacing and/or distance.

The mechanical spacer 800 may include a wheel spacer 802. The wheeled spacer 800 may include one or several wheels 804, the one or several wheels 804 including, for example, 1, 2, 3, 4, 6, 8, 10, or any other or intermediate number of wheels 804. In the embodiment of fig. 8, the wheel spacer 802 includes a first wheel 804-a and a second wheel 8004-B. The first wheel 804-a is positioned proximate to a first end 806 of the nozzle tube 206 and/or a first end 806 of the linear array 600, and the second wheel 804-B is positioned proximate to a second end 808 of the nozzle tube 206 and/or a second end 808 of the linear array 600.

The mechanical spacer 800 may include a slider spacer 900. The slider spacer 900 may include a plurality of legs 902 or prongs 902, the plurality of legs 902 or prongs 902 including, for example, 1, 2, 3, 4, 6, 8, 10, or any other or intermediate number of legs 902. In some embodiments, the leg 902 is adjustable with respect to the linear array 600 of nozzles 116 and/or orifices 404 to vary the distance between the linear array 600 of nozzles 116 and/or orifices 404 and the patient's skin.

Referring now to fig. 11, a flow diagram illustrating one embodiment of a process 1000 for cooling the skin of a patient and/or for applying a cryogen is shown. In some embodiments, the skin may be cooled and/or a cryogen may be applied as part of the freezing process. In some embodiments, such treatment may alter the hyperpigmented appearance and/or pigmentation of the treated skin, and in some embodiments, such treatment may alter the texture, tone, smoothness, or firmness of the treated skin. In some embodiments, such a freezing treatment may be used to treat one or several indications that may affect a large area of skin, such as, for example: indications associated with pigmentation or pigmentation, including hypopigmentation or hyperpigmentation; acne; rosacea; psoriasis, and the like. In some embodiments, such a freezing process may be used to treat blemishes, including pigmentation-related blemishes. Such defects may include: chloasma; lentigo; freckle; birthmark, liver spot, senile plaque or coffee milk spot.

The process may be performed using all or part of the freeze processing system 100. Process 1000 begins at block 1002, where a mask 312 is applied to and/or placed on skin at block 1002. After the mask is applied to the skin, the cryogen source 102 is heated, as indicated by block 1004 of process 1000. In some embodiments, the mask may be applied to the skin prior to directing the planar spray from the linear array 600 of apertures 404. The cryogen source 102 may contain cryogen in both liquid and gaseous forms, for example. In some embodiments, based on information received from the thermostat 106, the tank 102 may be heated by the heater 104 as controlled by the controller 108. In some embodiments, the tank 102 may be heated to a desired temperature and/or until a desired pressure inside the tank 102 is reached. In some embodiments, the tank 102 may be heated such that the tank 102 maintains a desired pressure.

After the tank is heated, coolant, and in particular liquid coolant, is transported from the coolant source 102 to the applicator 114 via the supply tube 118, as indicated in block 1006 of the process 1000. In some embodiments, the cryogen may be transported through the tube 118 via a pressure differential that may be caused, for example, by the opening of the valve 218. In some embodiments, the pressure of the liquid cryogen in the tube 118 may be equal to and/or approximately equal to the pressure of the liquid cryogen in the tank 102.

At block 1008 of process 1000, applicator 114 is positioned proximate to the patient's skin. In some embodiments, positioning the cryogenic spray applicator 114 proximate the skin of the patient, and in particular proximate the area of skin tissue of the patient to be treated, may include: the non-contact freeze jet applicator 114 is positioned adjacent to the area of the patient's skin tissue or the freeze jet applicator 114 including the mechanical spacer 800 is positioned adjacent to the area of the patient's skin tissue. In some embodiments, this may include positioning the applicator at a desired distance from the patient's skin, which may include, for example, adjusting the mechanical spacer 800 such that the applicator 114 is held at the desired distance from the patient's skin by the mechanical spacer 800. In some embodiments, the mechanical spacer 800 may include a wheel spacer 802 and/or a slide spacer 900. In some embodiments, and as part of positioning applicator 114, the patient's skin may be in contact with mechanical spacer 800. In some embodiments, the mechanical spacer may maintain a predetermined distance between the applicator 114 and the skin. In some embodiments, the predetermined distance may be, for example, between 1 inch and 3 inches, and/or between 0.125 inch and 3 inches.

At block 1010, a protection gas is delivered to form a protection curtain. In some embodiments, the generating of the protective curtain may include dispensing a protective gas, which may include an inert gas and/or a dry gas. In some embodiments, the shielding gas may be delivered before, during, and/or after the delivery of the cryogen. The shielding gas may be delivered from the same orifice 404 that delivers the cryogen, or from an orifice 404 that is different from the orifice 404 that delivers the cryogen, such as one or several curtain orifices 604. In some embodiments, the protective curtain may prevent entrainment of water or ambient air as the cryogen moves downstream of the orifice 404 as it is delivered from the orifice 404, which cryogen may include: a liquid cryogen; a gaseous cryogen; a two-phase fluid; cooled air; and/or carbon dioxide and/or cold gas.

At block 1012, the cryogen is dispensed, delivered, and/or expelled from the applicator 114, and in particular, the planar jets 302 of cryogen or cold gas are directed through the linear array 600 of orifices 404 of the cryogenic spray applicator 114. In some embodiments, this may include controlling the applicator 114 to dispense and/or expel the cryogen. In some embodiments, this may include, for example, manipulating the control feature 220 to cause dispensing and/or discharge of the cryogen from the applicator 114. In some embodiments, the cryogen may be dispensed and/or discharged from the nozzle 206, and in particular from a linear array of orifices 600, to form a linear curtain of cryogen downstream of the nozzle 206.

In some embodiments, directing a planar jet of cryogen or cold gas through a linear array of orifices may include locally freezing the epidermis. This local freezing of the epidermis may alter the pigmentation of an area of skin tissue of a patient. In some embodiments, directing a planar jet of cryogen or cold gas through a linear array of orifices may include localized disruption of the epidermis. This local disruption of the epidermis may cause gradual skin lightening in the area of the skin tissue of the patient.

In some implementations, the step of block 1012 may include: the cryogen is transported from the cryogen source 102 to the applicator 114 via the supply tube 118, and in other embodiments this may be a separate step as indicated in fig. 11. In some embodiments, the pressure of the cryogen at the supply line 118 may be approximately equal to the desired pressure in the cryogen source 102.

At block 1014, the cryogenic spray applicator 114 may be moved relative to the skin as indicated, for example, in fig. 8. In some embodiments, the movement of the applicator 114 may provide a linear curtain of cooling treatment to the skin, and in particular, the region 304 of the patient's skin tissue 300. In some embodiments, the applicator 114 may be moved by hand, and in other embodiments, the applicator 114 may be moved by machine.

After the cryogenic spray applicator 114 has been moved, the process 1000 may proceed to block 1016 where all or a portion of the skin is warmed in block 1016. In some embodiments, such warming may be performed via the mask 312, and in some embodiments, such warming may be performed via the applicator 114. In one embodiment, for example, warm gas, coolant, and/or air may be dispensed by the nozzle 116 to the skin to warm the skin, and in particular, to warm the skin in a convective manner. In some embodiments, the warm gas, cryogen, and/or air may be dispensed through the same or different orifices 404 as the protective gas and/or cryogen is dispensed.

In some embodiments, some or all of the steps of process 1000 may be repeated during a single treatment. In some implementations, for example, some or all of the steps of blocks 1010-1016 may be repeated once or several times as part of the process. This may include, for example, repeated directing of the plane jet and/or delivery of a cryogen or cold gas, movement of the applicator, and warming of the skin. In some embodiments, such cyclical warming and cooling of the skin can provide treatment benefits, and the cycle can be performed to maximize such treatment benefits and/or achieve desired treatment benefits.

The subject matter of the present disclosure is described with specificity herein, but the claimed subject matter can be embodied in other ways, can include different elements or steps, and can be used in conjunction with other present or future technologies.

Unless the order of individual steps or arrangement of elements is explicitly described, this description should not be construed as to imply any particular order or arrangement among or between various steps or elements. Different arrangements of the components depicted in the drawings or described above, as well as components and steps not shown or described, are possible. Similarly, some features and subcombinations are of utility and may be employed without reference to other features and subcombinations. Embodiments of the present invention have been described for illustrative, but not restrictive, purposes, and alternative embodiments will become apparent to the reader of this patent. Accordingly, the present invention is not limited to the embodiments described above or depicted in the drawings, and various embodiments and modifications may be made without departing from the scope of the appended claims.