WO2025015051A2

WO2025015051A2 - Enhanced device to treat topical lesions and methods of treatment thereof

Info

Publication number: WO2025015051A2
Application number: PCT/US2024/037391
Authority: WO
Inventors: R. Sam Niedbala; Philip Michael Formica; Lincoln C. Young
Original assignee: Cryoconcepts LP
Current assignee: Cryoconcepts LP
Priority date: 2023-07-10
Filing date: 2024-07-10
Publication date: 2025-01-16
Anticipated expiration: 2026-01-10
Also published as: WO2025015051A3

Abstract

The invention relates to a cryosurgical device and method that simplify the application of and accurately position foam or other material saturated or infused with cryogen on to the surface of the skin to treat topical lesions. The invention further relates to a one-handed application design that allows operators to precisely freeze targeted areas of the body while holding the skin lesion in position for treatment and minimizing the potential to damage the surrounding healthy skin. After treatment of the area, the frozen tissue will necrose and slough off after a period of time leaving the healthy surrounding tissue undamaged by the extreme cold.

Description

ENHANCED DEVICE TO TREAT TOPICAL LESIONS AND METHODS OF TREATMENT THEREOF

CROSS REFERENCE TO RELATED APPLICATION

[001] This application claims the benefit of U.S. Provisional Application No. 63/512,785 filed on July 10, 2023; the disclosure of which is incorporated herein by reference.

TECHNICAL FIELD

[002] The invention relates to devices for and methods of treating the skin using extreme cold to remove unwanted lesions.

BACKGROUND OF THE INVENTION

[003] As the largest organ of the body, the skin has a number of functions; however, thermoregulation is one of the most important. The skin is composed of three major layers including the epidermis, the dermis, and subcutaneous tissue. The layers of the skin act, in part, to insulate the body against heat and water loss.

[004] Normally, tissue exists at a homeostatic or constant temperature. The human core temperature ranges from 97.7-99.5°F, with the surface temperature being several degrees cooler. When extreme cold is applied to the skin, any heat loss is offset for a time by the heat transfer from the surrounding tissue. When cryogen is applied for a sufficient period of time and temperature that exceeds the capacity for the tissue to return to homeostatic temperature, the tissue is frozen and a cryosurgical effect is achieved. Namely, the cryosurgical effect is the destruction of tissue using extreme cold. The precise temperature when cryosurgical destruction is achieved is debated in the literature, but, generally, it can be achieved at temperatures below -20°C, with temperatures below -50°C being most effective.

[005] Numerous types of benign lesions may be treated with cryosurgery and the peer reviewed literature is replete with many examples.

[006] Warts are often discussed as the primary lesion treated using cryosurgery. Warts may be thickened and difficult to adequately freeze. Skin tags, in contrast, are soft and usually pedunculated. They can range in size from 2-6 mm and may or may not be pigmented. Skin tags pose no malignant threat, increase in number with age, and often appear where clothing rubs the skin. Being benign, they may simply be left alone; however, they are often removed for cosmetic reasons or because of irritation. The occurrence of skin tags in the general population is much higher than for warts, up to 50%, and a number of homeopathic treatments are available on the internet. However, when one reads the online reviews of these products and their poor performance, it is evident that they are not controlled or effective.

[007] A sponsored study of the U.S. market showed that, for those with skin tags, 34% will have them treated by a physician while 29% cut or snip them at home. A surprising 10% reported already using over- the-counter cryosurgical wart removers to treat their skin tags at home, while another 10% used herbal remedies and other approaches. The largest single category of those surveyed, 42%, reported never having treated skin tags. The typical procedure for existing commercial kits for treatment of skin tags using cryosurgery involves using two hands: one to hold the skin tag with forceps and the other hand to apply an applicator saturated with liquified cryogen gas. The operator must hold both hands in position for 40 seconds until the target tissue is frozen. This procedure is cumbersome and tedious.

[008] Freezing lesions using extreme cold is commonplace in physicians' offices as well as with over- the-counter consumer use. There is a need for making the process easy to execute given each use environment.

SUMMARY OF THE INVENTION

[009] The invention relates to a cryosurgical device for the treatment of a skin lesion that allows for targeted, more precise application of cryogen to a specific skin lesion while preventing damage to the healthy skin tissue surrounding the skin lesion. The invention may include a container of cryogen which dispenses gas onto an applicator material, thus infusing the applicator with the cryogen. The cryogen- infused applicator material is then positioned and applied to a targeted skin lesion. The positioning of the invention in relation to the targeted lesion may be accomplished using one hand by the patient or other operator (e.g., a health care professional). When assembling the components of the cryosurgical device, the actuator with the applicator inserted is placed into a holder that positions the applicator in line with a section of the holder that acts as a skin lesion positioner and/or immobilizer. This skin lesion positioner may be in the shape of a "V". The "V" shape guides the skin lesion into position to allow easier and more precise application of the cryogen-infused applicator. The use of the "V" design results in the correct positioning of the skin lesion over a very wide range of skin lesion sizes. The design and procedure controls not only the positioning of the target skin lesion, but also minimizes damage to the healthy skin near the targeted skin lesion.

[0010] The invention further relates to a method for treatment of skin lesions using a cryosurgical skin lesion treatment device. The method involves positioning the targeted skin lesion in the skin lesion positioner of the cryosurgical skin lesion treatment device. Pressure is then applied to an actuator which causes a cryogen-infused applicator to contact the targeted skin lesion.

[0011] In any of the embodiments of the invention, the cryogen-infused applicator may be applied in a perpendicular direction to the targeted skin lesion or in a direction parallel to the skin surface where the targeted skin lesion resides.

[0012] The invention also relates to a kit comprising, consisting essentially of, or consisting of the cryosurgical device and, optionally, the container of cryogen disclosed herein.

BRIEF DESCRIPTION OF THE FIGURES

[0013] FIG. 1A shows a disassembled view of an exemplary skin lesion treatment device 100 in accordance with the invention.

[0014] FIG. IB shows the insertion of an applicator 102 into an actuator 101 of an exemplary skin lesion treatment device in accordance with the invention.

[0015] FIG. 1C shows a container 105 of an exemplary skin lesion treatment device in an upright position in accordance with the invention.

[0016] FIG. ID shows the attachment of an actuator 101, with an applicator 102 inserted, to a container 105 of an exemplary skin lesion treatment device in accordance with the invention.

[0017] FIG. IE shows an actuator 101, with an applicator 102 inserted, of an exemplary skin lesion treatment device in accordance with the invention.

[0018] FIG. IF shows the attachment of an actuator 101 with an applicator 102 inserted to a holder 103 of an exemplary skin lesion treatment device in accordance with the invention.

[0019] FIG. 1G shows the application of an exemplary skin lesion treatment device 100 to a skin lesion 109 in accordance with the invention.

[0020] FIG. 1H shows the removal of an applicator 102 from an actuator 101 of an exemplary skin lesion treatment device in accordance with the invention.

[0021] FIG. 2A shows an actuator 101 with an applicator 102 detached from a holder 103 of an exemplary skin lesion treatment device in accordance with the invention.

[0022] FIG. 2B shows an actuator 101, with an applicator 102 inserted, attached to a holder 103 of an exemplary skin lesion treatment device 100 in accordance with the invention.

[0023] FIG. 3A shows a preassembled exemplary skin lesion treatment device 110 detached from a container 105 in accordance with the invention. [0024] FIG. 3B shows a preassembled exemplary skin lesion treatment device 110 attached to a container 105 in accordance with the invention.

[0025] FIG. 4 shows an exemplary skin lesion treatment device 400 that applies treatment to a skin lesion in a perpendicular direction in accordance with the invention.

[0026] FIG. 5 shows an exemplary skin lesion treatment device 500 that applies treatment to a skin lesion in a direction parallel to the skin surface in accordance with the invention.

[0027] FIG. 6A shows a simulated skin lesion dyed with thermochromic dye.

[0028] FIG. 6B shows an exemplary skin lesion treatment device positioned to target a simulated skin lesion.

[0029] FIG. 6C shows a simulated skin lesion after treatment with an exemplary skin lesion device.

DETAILED DESCRIPTION OF THE INVENTION

[0030] The invention relates to a skin lesion treatment device utilizing cryogen to treat skin lesions by way of freezing. The invention allows for a user to position the skin lesion treatment device and apply cryogen to the skin lesion using only one hand. The invention allows for easier cryosurgical treatment of skin lesions. The application of cryogen to a targeted skin lesion utilizing the invention results in the targeted skin lesion sloughing off the patient. The preferred end result of using the invention is the complete removal of the targeted skin lesion.

[0031] FIG. 1A-1H show the assembly and use of an exemplary embodiment of the invention to treat skin lesions. FIG. 1A shows a disassembled view of the components of an exemplary embodiment of the invention 100: an actuator 101, an applicator 102, a holder 103, a skin lesion positioner 104, a container 105, an applicator insert 106, a container attachment 107, and a safety shield 108. In an exemplary embodiment of the invention, the applicator 102 is attached to the actuator 101 by firmly twisting the applicator 102 into the applicator insert 106 located on the bottom of the actuator 101 as shown in FIG. IB. In some embodiments of the invention, the applicator is any material that can incorporate and retain the cryogen until application, including, but not limited to, foam, cotton, other absorbent materials, or combinations thereof.

[0032] The container 105 is positioned upright throughout the insertion into the safety shield 108 as shown in FIG. 1C. In the embodiments of the invention, the container is filled with cryogen gas. In some embodiments of the invention, the cryogen gas is selected from the group consisting of dimethyl ether, propane, butane, R410A refrigerant (difluoromethane and pentafluoroethane), R404A refrigerant (pentafluoroethane, 1,1,1-trifluoroethane, and 1,1,2,2-tetrafluoroethane), R152A refrigerant (1,1- difluoroethane), carbon dioxide, nitrous oxide, and liquid nitrogen. In some embodiments of the invention, the container is filled with a composition of multiple cryogen gases. In some embodiments of the invention, the composition of cryogen gases is made of one or more of the following: dimethyl ether, propane, butane, R410A, R404A, R152A, carbon dioxide, nitrous oxide, and/or liquid nitrogen. In some embodiments of the invention, the cryogen gas is liquefied. In some embodiments of the invention, the cryogen gas is an aerosol.

[0033] The end of the applicator 102 that is not inserted into the bottom of the actuator 101 is inserted into the safety shield 108 of the container 105 as shown in FIG. ID. The actuator 101 is pressed down onto the top of the container 105 and attached via the container attachment 107 while the applicator 102 is positioned in the safety shield 108 as shown in FIG. ID. In some embodiments of the invention, the actuator 101 is pushed down onto the container 105 for a period of 3-5 seconds. The applicator 102 and the actuator 101 are then removed from the safety shield 108 and top of the container 105, respectively, as shown in FIG. IE. After removal, the holder 103 is attached to the actuator 101 as shown in FIG. IF. In some embodiments of the invention, there is a wait time period of about 15 seconds between removal of the applicator 102 and the actuator 101 and attachment of the holder 103 to the actuator 101. The end of the holder 103 not attached to the actuator 101 contains the skin lesion positioner 104.

[0034] The holder 103 is positioned behind a skin lesion 109. In some embodiments of the invention, the skin lesion is a skin tag. In some embodiments of the invention, the skin lesion is a wart. In some embodiments of the invention, the skin lesion is another topical lesion other than a skin tag or wart. The holder 103 slides forward until the skin lesion 109 is located in the skin lesion positioner 104. In some embodiments of the invention, the skin lesion positioner 104 is V-shaped. The V-shape allows for the proper positioning of the skin lesion over a wide range of lesion sizes while minimizing damage to the healthy skin near the target skin lesion. The skin lesion positioner, however, may also be configured in any shape that positions and/or immobilizes the skin lesion. In some embodiments of the invention, pressure is applied to the actuator 101 which allows for the applicator 102 to make contact with the skin lesion 109 positioned and immobilized in the skin lesion positioner 104 as shown in FIG. 1G. In some embodiments of the invention, the applicator 102 is in contact with the skin lesion for 40 seconds or less. In some embodiments of the invention, the applicator 102 is removed from the actuator 101 and discarded after use as shown in FIG. 1H. [0035] The invention can be used to treat skin lesions located anywhere on the dermis. In some embodiments of the invention, the applicator 102 is applied to treat a skin lesion located on the neck. In some embodiments of the invention, the applicator 102 is applied to treat a skin lesion located on the chest. In some embodiments of the invention, the applicator 102 is applied to treat a skin lesion located on the hands. In some embodiments of the invention, the applicator 102 is applied to treat a skin lesion located on the arms. In some embodiments of the invention, the applicator 102 is applied to treat a skin lesion located on or around the groin. In some embodiments of the invention, the applicator 102 is applied to treat a skin lesion located on or around the breasts. In some embodiments of the invention, the applicator 102 is applied to treat a skin lesion located on or around the knees or feet.

[0036] In some embodiments of the invention, the applicator 102 may be removably coupled with the actuator 101 using any means known in the art. For example, referring to FIG. IB, applicator 102 may have an attachment piece, which may be removably coupled with actuator 101. Conversely, the actuator 101 may have an attachment piece, which may be removably coupled with applicator 102. Alternatively, applicator 102 can be configured to be removably coupled with actuator 101 via a connector. The connector can be any type of connector or fitting configured to facilitate connection and disconnection between applicator 102 and actuator 101. For example, the connector can be a fitting that includes threading to allow applicator 102 to be threaded onto the connector. In some embodiments of the invention, applicator 102 is configured to be removably coupled from the actuator 101 (and other elements of the cryosurgical device 100) such that the system can be easier to package, transport, and use. Applicator 102 can be stored or disposed of separately from the other elements of the cryosurgical device 100. In an exemplary embodiment of the invention, applicator 102 can be disposed of quickly and easily after a procedure is performed.

[0037] In some embodiments of the invention, the holder 103 may be removably coupled with the actuator 101 using any means known in the art. For example, referring to FIG. IF, holder 103 may have an attachment piece, which may be removably coupled with actuator 101. Conversely, actuator 101 may have an attachment piece, which may be removably coupled with holder 103. Alternatively, holder 103 can be configured to be removably coupled with actuator 101 via a connector. The connector can be any type of connector or fitting configured to facilitate connection and disconnection between holder 103 and actuator 101. For example, the connector can be a fitting that includes threading to allow holder 103 to be threaded onto the connector. In some embodiments of the invention, holder 103 is configured to be removably coupled from the actuator 101 (and other elements of the cryosurgical device 100) such that the system can be easier to package, transport, and use. Holder 103 can be stored or disposed of separately from the other elements of the cryosurgical device 100. In an exemplary embodiment of the invention, holder 103 can be disposed of quickly and easily after a procedure is performed.

[0038] In some embodiments of the invention, the container 105 may be removably coupled with the actuator 101 using any means known in the art. For example, referring to FIG. ID, container 105 may have an attachment piece, which may be removably coupled with actuator 101. Conversely, actuator 101 may have an attachment piece, which may be removably coupled with container 105. Alternatively, container 105 can be configured to be removably coupled with actuator 101 via a connector. The connector can be any type of connector or fitting configured to facilitate connection and disconnection between container 105 and actuator 101. For example, the connector can be a fitting that includes threading to allow container 105 to be threaded onto the connector. In some embodiments of the invention, container 105 is configured to be removably coupled from the actuator 101 (and other elements of the cryosurgical device 100) such that the system can be easier to package, transport, and use. Container 105 can be stored or disposed of separately from the other elements of the cryosurgical device 100. In an exemplary embodiment of the invention, container 105 can be disposed of quickly and easily after a procedure is performed.

[0039] FIG. 2A-2B show an exemplary embodiment of the invention comprising the actuator 101, the applicator 102, the holder 103, and the skin lesion positioner 104. FIG. 2A indicates the assembly of an exemplary embodiment of the invention after exposure to the cryogen, in which the actuator 101 with applicator 102 inserted and soaked in cryogen is inserted into the holder 103. The assembled device 100 is then situated so that a skin lesion may be positioned and immobilized within the skin lesion positioner 104 as shown in FIG. 2B. In some embodiments of the invention, downward pressure is applied to the actuator 101 to allow the cryogen-infused applicator 102 to contact the skin lesion. In some embodiments of the invention, the applicator is in contact with the skin lesion for about 40 seconds.

[0040] FIG. 3A-3B show an exemplary embodiment of the invention comprising a pre-assembled skin lesion treatment device 110 and a container 105. The pre-assembled skin lesion treatment device 110 is detached from the container 105 as shown in FIG. 3A. The pre-assembled device 110 is attached to the top of the container 105 as shown in FIG. 3B. The cryogen from the container 105 is then applied to the applicator of the pre-assembled device to be used to treat skin lesions.

[0041] In some embodiments of the invention, a smaller, more-portable design may be used for the treatment of skin lesions. This smaller design is shown in FIG. 4. This embodiment of the invention comprises an applicator insert 401, a skin lesion positioner 402, and a finger receptacle 403. In this embodiment of the invention, a small applicator (not shown) is saturated with cryogen and inserted into the applicator insert 401. In some embodiments of the invention, the applicator is made of any material that can incorporate and retain the cryogen until application, including, but not limited to, foam, cotton, other absorbent materials, or combinations thereof. The device 400 is situated so that the targeted skin lesion is positioned and immobilized in the skin lesion positioner 402. In some embodiments of the invention, the skin lesion positioner 402 is V-shaped. The V-shape allows for the proper positioning and immobilization of the skin lesion over a wide range of lesion sizes while minimizing damage to the healthy skin near the target skin lesion. The skin lesion positioner, however, may also be configured in any shape that positions and/or immobilizes the skin lesion. The applicator located within the applicator insert 401 is then applied in a perpendicular direction to the targeted skin lesion by applying downward pressure to the finger receptacle 403 located on the top of the device 400. This embodiment of the invention allows for application of cryogen to the targeted skin lesion without touching the surrounding healthy tissue. It also allows for a user to position and immobilize the targeted skin lesion and apply the cryogen to the targeted skin lesion with one hand.

[0042] In some embodiments of the invention, the applicator 501 is designed to be applied parallel to the surface of the skin on which the targeted skin lesion resides. This parallel application device 500 is shown in FIG. 5. This embodiment of the invention comprises an applicator insert 504, applicator 501, a skin lesion guide 502, and two finger tabs 503. In this embodiment of the invention, an applicator 501 containing cryogen is inserted into the applicator insert 504. In some embodiments of the invention, the applicator is made of any material that can incorporate and retain the cryogen until application, including, but not limited to, foam, cotton, other absorbent materials, or combinations thereof. The device 500 is situated so that the targeted skin lesion aligns with the skin lesion guide 502The applicator 501 located within the applicator insert 504 is then applied in a direction parallel to the skin surface to the targeted skin lesion by compressing the two finger tabs 503 together until contact is made between the applicator and targeted skin lesion. The targeted skin lesion is squeezed between the applicator 501 and the skin lesion guide 502 to maintain contact with the targeted skin lesion throughout treatment. The applicator 501 is contained by the device in the applicator insert 504 in a way that prevents the freezing of the surrounding healthy skin. The parallel application device also allows for a user to position and immobilize the targeted skin lesion and apply the cryogen to the targeted skin lesion with one hand. In some embodiments of the invention, a skin lesion positioner is located on the bottom of the applicator insert 504. When applicator 501 is inserted into the device 500, the skin lesion positioner is located underneath the applicator 501. The skin lesion positioner positions and/or immobilizes the targeted skin lesion as the two finger tabs 503 are compressed together to allow the applicator 501 to contact the targeted skin lesion. In some embodiments of the invention, the skin lesion positioner is V-shaped. The V-shape allows for the proper positioning and immobilization of the skin lesion over a wide range of lesion sizes while minimizing damage to the healthy skin surrounding the target skin lesion. The skin lesion positioner, however, may also be configured in any shape that positions and/or immobilizes the skin lesion.

[0043] The invention further provides a kit comprising, consisting of, or consisting essentially of the cryosurgical device disclosed herein; and instructions for administration of the cryosurgical device. As used herein, the term "instructions" when used in the context of a kit includes a publication, a recording, a diagram, or any other medium of expression which can be used to communicate the usefulness of the kit for its designated use. The instructions can, for example, be affixed to or included within a container for the kit. The actuator, cryogen applicator, holder comprising a skin lesion positioner, and/or the container filled with cryogen may be sealed as separate articles (i.e., fully or partially disassembled) or may be combined into one or more articles of manufacture (i.e., fully or partially assembled). The actuator, cryogen applicator, holder comprising a skin lesion positioner, and/or the container filled with cryogen may also be packaged as separate articles of manufacture. For example, the actuator, cryogen applicator, and holder comprising a skin lesion positioner may be packaged as a first article of manufacture, and the container filled with cryogen may be packaged as a second article of manufacture. Individual components of the cryosurgical device may be packaged as their own articles of manufacture as well. Furthermore, more than one of any component of the cryosurgical device and optional container containing the cryogen may be packaged in a single article of manufacture. For example, one article of manufacture may contain two or more cryogen applicators for more than one treatment application.

[0044] The term "container" as used herein refers to any receptacle or applicator means capable of holding, storing, and/or applying the cryogen disclosed herein. Such a container may be in any container configuration known to a person skilled in the art, such as, but not limited to, a canister. The containers may be made of any material suitable for the materials contained therein and additionally suitable for short- and/or long-term storage under any kind of temperature. Such materials include, by way of example, inorganic materials, such as Type I glass (including amber colored glass), ceramics, metals (e.g., steel, aluminum, tin), etc., and organic materials such as inert polymers including polyolefins (e.g., high density polyethylene), fluorinated polyolefins, and the like. Suitable containers include those that maintain the sterility and integrity of their contents, for example, by providing a barrier to moisture.

[0045] Exemplary Embodiments of the Invention

[0046] El. A cryosurgical device for the treatment of a skin lesion comprising: a cryogen applicator; and a holder comprising a skin lesion positioner located at one end of the holder, wherein the cryogen applicator is saturated with cryogen, and wherein the cryogen applicator is attached to an end of the holder opposite the skin lesion positioner.

[0047] E2. The cryosurgical device of El, wherein the cryosurgical device further comprises an actuator, wherein the cryogen applicator is inserted into the bottom of the actuator, and wherein the actuator with the inserted cryogen applicator is attached to an end of the holder opposite the skin lesion positioner.

[0048] E3. The cryosurgical device of E2, wherein the cryosurgical device is optionally attached to a top of a container filled with cryogen.

[0049] E4. The cryosurgical device of E3, wherein the container is filled with a cryogen gas which is liquified.

[0050] E5. The cryosurgical device of E4, wherein the cryogen gas is selected from the group consisting of dimethyl ether, propane, butane, R410A refrigerant, R404A refrigerant, R152A refrigerant, carbon dioxide, nitrous oxide, and liquid nitrogen.

[0051] E6. The cryosurgical device of E4, wherein the cryogen gas is a composition of one or more of dimethyl ether, propane, butane, R410A refrigerant, R404A refrigerant, R152A refrigerant, carbon dioxide, nitrous oxide, and/or liquid nitrogen.

[0052] E7. The cryosurgical device of any one of E3-E6, wherein the cryogen applicator is contacted with the cryogen in the container.

[0053] E8. The cryosurgical device of any one of E1-E7, wherein the skin lesion is a skin tag, a wart, or other topical skin lesion.

[0054] E9. The cryosurgical device of any one of E1-E8, wherein the cryogen applicator is made of foam, cotton, other absorbent materials, or combinations thereof.

[0055] E10. The cryosurgical device of any one of E1-E9, wherein the skin lesion positioner is configured in any shape that positions and/or immobilizes the skin lesion. [0056] Ell. The cryosurgical device of E10, wherein the shape is a V-shape.

[0057] E12. The cryosurgical device of any one of El-Ell, wherein the skin lesion positioner is positioned perpendicular to the skin lesion.

[0058] E13. The cryosurgical device of any one of El-Ell, wherein the cryosurgical device is positioned parallel to the skin.

[0059] E14. The cryosurgical device of any one of E1-E13, wherein the skin lesion positioner immobilizes the skin lesion.

[0060] E15. A method for treating skin lesions, the method comprising: providing the cryosurgical device of any one E1-E14; contacting the cryogen applicator of the cryosurgical device with cryogen to form a cryogen- infused applicator; positioning and/or immobilizing a targeted skin lesion on a patient in the skin lesion positioner of the cryosurgical device; applying pressure to the cryosurgical device with the inserted cryogen-infused applicator; contacting the targeted skin lesion with the cryogen-infused applicator; and removing the cryogen-infused applicator from the targeted skin lesion after a period of time.

[0061] E16. The method of E15, wherein the cryosurgical device is optionally attached to a top of a container filled with cryogen.

[0062] E17. The method of E16, wherein the cryogen applicator is contacted with the cryogen in the container.

[0063] E18. The method of any of E15-E17, wherein the targeted skin lesion sloughs off the patient.

[0064] E19. The method of any of E15-E18, wherein the period of time is greater than 1 second.

[0065] E20. The method of any one of E15-E19, wherein the targeted skin lesion is located on the dermis of the patient.

[0066] E21. The method of E20, wherein the targeted skin lesion is located on the neck, chest, hands, arms, groin, breasts, knees, and/or feet of the patient.

[0067] E22. The method of any one of E15-E21, wherein the skin lesion positioner is positioned perpendicular to the targeted skin lesion.

[0068] E23. The method of any one of E15-E21, wherein the cryosurgical device is positioned parallel to the skin. [0069] E24. The method of any one of E15-E23, wherein the pressure on the cryosurgical device is applied in a direction toward the skin lesion positioner.

[0070] E25. The method of any one of E15-E24, wherein the targeted skin lesion is compressed between the applicator and the skin lesion positioner.

[0071] E26. The method of any one of E15-E25, wherein the patient or other operator uses one hand to position and/or immobilize the targeted skin lesion in the skin lesion positioner of the cryosurgical device and to apply the pressure to the cryosurgical device to contact the targeted skin lesion with the cryogen- infused applicator.

[0072] E27. The method of E26, wherein the other operator is a health-care professional or a general consumer.

[0073] E28. The method of any one of E15-E27, wherein the targeted skin lesion is a skin tag, a wart, or other topical skin lesion.

[0074] E29. The method of any one of E15-E28, wherein the cryogen applicator is made of foam, cotton, other absorbent material, or combinations thereof.

[0075] E30. The method of any one of E16-E29, wherein the container is filled with a cryogen gas which is liquified.

[0076] E31. The method of E30, wherein the cryogen gas is selected from the group consisting of dimethyl ether, propane, butane, R410A refrigerant, R404A refrigerant, R152A refrigerant, carbon dioxide, nitrous oxide, and liquid nitrogen.

[0077] E32. The method of E30, wherein the cryogen gas is a composition of one or more of dimethyl ether, propane, butane, R410A refrigerant, R404A refrigerant, R152A refrigerant, carbon dioxide, nitrous oxide, and/or liquid nitrogen.

[0078] E33. The method of any one of E15-E32, wherein the skin lesion positioner is configured in any shape that positions and/or immobilizes the skin lesion.

[0079] E34. The method of E33, wherein the shape is a V-shape.

[0080] E35. A kit comprising the cryosurgical device of any one of E1-E14.

[0081] E36. The kit of E35, wherein the cryosurgical device is partially or fully preassembled.

[0082] E37. The kit of E35, wherein the cryosurgical device is disassembled.

EXAMPLES

[0083] Simulated Skin Tag Treatment [0084] FIG. 6A-6C demonstrate the invention's ability to treat a skin tag. In this example, the applicator was applied perpendicularly to treat the targeted skin lesion. A model skin tag was painted with a thermochromic dye as shown in FIG. 6A. The mock skin tag was then positioned and immobilized in a skin lesion positioner of an exemplary embodiment of the invention, for example, the embodiment of the invention depicted in FIG. 2A-2B or FIG. 4, as shown in FIG. 6B. The model skin tag changed color from light blue to dark blue when touched by the cryogen-infused foam applicator as shown in FIG. 6C. FIG. 6C also shows treatment of the mock skin tag with no collateral freezing or damage to the area around the mock skin tag, indicating no freezing or damage to the skin that surrounds the targeted skin tag.

Claims

The claimed invention is:

1. A cryosurgical device for the treatment of a skin lesion comprising: a cryogen applicator; and a holder comprising a skin lesion positioner located at one end of the holder, wherein the cryogen applicator is saturated with cryogen, and wherein the cryogen applicator is attached to an end of the holder opposite the skin lesion positioner.

2. The cryosurgical device of claim 1, wherein the cryosurgical device further comprises an actuator, wherein the cryogen applicator is inserted into the bottom of the actuator, and wherein the actuator with the inserted cryogen applicator is attached to an end of the holder opposite the skin lesion positioner.

3. The cryosurgical device of claim 2, wherein the cryosurgical device is optionally attached to a top of a container filled with cryogen.

4. The cryosurgical device of claim 3, wherein the cryogen applicator is contacted with the cryogen in the container.

5. The cryosurgical device of claim 3, wherein the container is filled with a cryogen gas which is liquified.

6. The cryosurgical device of claim 5, wherein the cryogen gas is selected from the group consisting of dimethyl ether, propane, butane, R152A refrigerant, R410A refrigerant, R404A refrigerant, carbon dioxide, nitrous oxide, and liquid nitrogen.

7. The cryosurgical device of claim 5, wherein the cryogen gas is a composition of one or more of dimethyl ether, propane, butane, R152A refrigerant, R410A refrigerant, R404A refrigerant, carbon dioxide, nitrous oxide, and/or liquid nitrogen.

8. The cryosurgical device of any one of claims 1-7, wherein the skin lesion is a skin tag, a wart, or other topical skin lesion.

9. The cryosurgical device of any one of claims 1-7, wherein the cryogen applicator is made of foam, cotton, other absorbent material, or combinations thereof.

10. The cryosurgical device of any one of claims 1-7, wherein the skin lesion positioner is configured in any shape that positions and/or immobilizes the skin lesion.

11. The cryosurgical device of claim 10, wherein the shape is a V-shape.

12. The cryosurgical device of any one of claims 1-7, wherein the skin lesion positioner is positioned perpendicular to the skin lesion.

13. The cryosurgical device of any one of claims 1-7, wherein the cryosurgical device is positioned parallel to the skin.

14. The cryosurgical device of any one of claims 1-7, wherein the skin lesion positioner immobilizes the skin lesion.

15. A method for treating skin lesions, the method comprising: providing the cryosurgical device of claim 1; contacting the cryogen applicator of the cryosurgical device with cryogen to form a cryogen- infused applicator; positioning and/or immobilizing a targeted skin lesion on a patient in the skin lesion positioner of the cryosurgical device; applying pressure to the cryosurgical device with the inserted cryogen-infused applicator; contacting the targeted skin lesion with the cryogen-infused applicator; and removing the cryogen-infused applicator from the targeted skin lesion after a period of time.

16. The method of claim 15, wherein the cryosurgical device is optionally attached to a container filled with cryogen.

17. The method of claim 16, wherein the cryogen applicator is contacted with the cryogen in the container.

18. The method of any one of claims 15-17, wherein the period of time is greater than 1 second.

19. The method of any one of claims 15-17, wherein the targeted skin lesion is located on the dermis of the patient.

20. The method of claim 19, wherein the targeted skin lesion is located on the neck, chest, hands, arms, groin, breasts, knees, and/or feet of the patient.

21. The method of any one of claims 15-17, wherein the skin lesion positioner is positioned perpendicular to the targeted skin lesion.

22. The method of claim 21, wherein the pressure on the cryosurgical device is applied in a direction toward the skin lesion positioner.

23. The method of claim 22, wherein the targeted skin lesion is compressed between the applicator and the skin lesion positioner.

24. The method of any one of claims 15-17, wherein the cryosurgical device is positioned parallel to the skin.

25. The method of claim 24, wherein the pressure on the cryosurgical device is applied in a direction toward the skin lesion positioner.

26. The method of claim 25, wherein the targeted skin lesion is compressed between the applicator and the skin lesion positioner.

1. The method of any one of claims 15-17, wherein the patient or other operator uses one hand to position and/or immobilize the targeted skin lesion in the skin lesion positioner of the cryosurgical device and to apply the pressure to the cryosurgical device to contact the targeted skin lesion with the cryogen- infused applicator.

28. The method of claim 27 , wherein the other operator is a health-care professional or a general consumer.

29. The method of any one of claims 15-17, wherein the targeted skin lesion is a skin tag, a wart, or other topical skin lesion.

30. The method of any one of claims 15-17, wherein the cryogen applicator is made of foam, cotton, other absorbent materials, or combinations thereof.

31. The method of claim 16 or claim 17, wherein the container is filled with a cryogen gas which is liquified.

32. The method of claim 31, wherein the cryogen gas is selected from the group consisting of dimethyl ether, propane, butane, R152A refrigerant, R410A refrigerant, R404A refrigerant, carbon dioxide, nitrous oxide, and liquid nitrogen.

33. The method of claim 31, wherein the cryogen gas is a composition of one or more of dimethyl ether, propane, butane, R152A refrigerant, R410A refrigerant, R404A refrigerant, carbon dioxide, nitrous oxide, and/or liquid nitrogen.

34. The method of any one of claims 15-17, wherein the skin lesion positioner is configured in any shape that positions and/or immobilizes the skin lesion.

35. The method of claim 34, wherein the shape is a V-shape.

36. A kit comprising the cryosurgical device of any one of claims 1-7, and, optionally, a container filled with cryogen.

37. The kit of claim 36, wherein the cryosurgical device and optional container are partially or fully preassembled.

38. The kit of claim 36, wherein the cryosurgical device and optional container are disassembled.