TOPICAL COOLING DEVICE

Abstract

A topical cooling device for cooling and desensitizing the surface of the skin of a patient is provided that includes a thermally insulating container having at least one side wall, an open end and a closed end, and internal cavity. A thermally transmitting member is included for closing the open end of said container. A refrigerant medium is provided within the cavity of the container and in contact said thermally transmitting member for cooling the surface of the skin of a patient in contact with the thermally transmitting member. The refrigerant medium can be hypertonic aqueous sodium chloride solution. The thermally transmitting member can be flexible bladder that is received within the container where the refrigerant medium is thermally insulated by the container. A lid can be attached to the open end of the container to close the device until ready for use.

Claims

1. A topical cooling device for cooling a target area on a surface of the skin of a patient, comprising: a thermally insulated container having at least one side wall, an open end, a closed end, and internal cavity; a thermally transmitting member closing said open first end of said container, said thermally transmitting member having a skin contact area accessible through said open end; and a refrigerant medium within said cavity of said container and in contact said thermally transmitting member for cooling said thermally transmitting member and the surface of the skin of a patient in contact with said thermally transmitting member, said refrigerant medium contained within said container,

2. The cooling device of claim 1, wherein said refrigerant medium comprises an aqueous salt solution.

3. The cooling device of claim 1, further comprising a thermally insulating lid closing said open end of said container and said thermally transmitting member.

4. The cooling device of claim 3, wherein said lid includes at least one thermally insulating layer.

5. The cooling device of claim 4, wherein said lid includes a heat reflecting surface on an inner surface of said lid.

6. The cooling device of claim 1, wherein said container includes an inner wail and an outer wall forming a gap between said inner wall and outer wall, and where said gap contains a thermally insulating medium.

7. The cooling device of claim 6, wherein said thermally insulating medium comprises air or an inert thermally insulating gas.

8. The cooling device of claim 6, wherein said thermally insulating medium comprises polymer foam.

9. The cooling device of claim 6, wherein said inner wall has an inner surface with a heating reflecting surface and said outer wall has an inner surface with a heat reflecting surface.

10. The cooling device of claim 1, wherein said thermally transmitting member comprises a sealed bladder enclosing said refrigerant medium, and where said bladder is received in said cavity of said container, and said skin contact area is formed on said bladder and projects from said open end of said container.

11. The cooling device of claim 10, further comprising a thermally conducting metal core received in a cavity of said bladder and spaced inwardly from a side wall, a bottom wall and skin contact area of said bladder, and where said thermally conducting core is surrounded by said refrigerant medium.

12. The cooling device of claim 11, wherein said thermally conducting core comprises a metal core having a substantially cylindrical shape complementing a shape of said container.

13. The cooling device of claim 10, wherein said bladder is movable within said container between a retracted position where said bladder is received completely within said container and an extended position where said skin contact area projects from said open end of said container.

14. The cooling device of claim 11, wherein said thermally conducting core is spaced inwardly from said contact area of said bladder.

15. The cooling device of claim 1, wherein said thermally transmitting member comprises a closure coupled to said open end of said container and has a substantially convex outer surface projecting from said open end of said container, and where said thermally transmitting member has surface area sufficient to contact the skin of a patient or provide a desensitizing, cooling and/or numbing effect to the skin to inhibit pain or discomfort to the patient during injection by a needle or cannula.

16. The topical cooling device of claim 1, wherein said thermally transmitting member comprises a closure closing said open first end of said container.

17. The topical cooling device of claim 16, wherein said thermally transmitting member is coupled to said side wall of said container retaining said refrigerant medium in said container.

18. A topical cooling device for cooling the surface of the skin of a patient, comprising a container having a side wall, a bottom wall, and an open end; a flexible bladder received in an internal cavity of said container and having a skin contact portion projecting from said open end of said container, said flexible bladder having an internal cavity containing a refrigerant medium; and a removable lid coupled to said open end of said container.

19. The topical cooling device of claim 18, wherein said bladder is received within said container and thermally insulated by said container.

20. The topical cooling device of claim 19, wherein said bladder includes a contact portion projecting from said open end of said container.

21. A method of cooling a target area of the skin and introducing a medical device into the skin, the method comprising contacting the skin contact surface of the bladder of the topical cooling device of claim 1 with the target area on the skin for sufficient time to desensitize the target area, and introducing the medical device into the target area of the skin.

22. The method of claim 21, wherein the medical device comprises a catheter, needle, or cannula for delivering or removing a fluid to the patient.

23. The method of claim 21, wherein the medical device comprises a delivery device, and said method further comprises introducing a substance to the patient by the delivery device.

24. The method of claim 21, wherein the medical device comprises selected from the group consisting of a pen needle, infusion pump, syringe, patch pump, lancet, and catheter.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The above benefits and other advantages of the various embodiments of the present invention will be more apparent from the following detailed description of exemplary embodiments of the present invention and from the accompanying figures, in which:

[0023] FIG. 1 is a side view of a container and lid in one embodiment;

[0024] FIG. 2 is a side view of FIG. 1 showing the lid separated from the container;

[0025] FIG. 3 is a cross-sectional view of the container of FIG. 1;

[0026] FIG. 4 is a cross-sectional view of the container in another embodiment;

[0027] FIG. 5 is a cross-sectional view of the container and lid in a further embodiment showing the insulating space between an inner and outer wall of the container;

[0028] FIG. 6 is a cross-sectional view of the container in another embodiment;

[0029] FIG. 7 is a cross-sectional view of the container in a further embodiment;

[0030] FIG. 8 is cross-sectional view of the container in another embodiment;

[0031] FIG. 9 is a cross-sectional view of the container in a further embodiment; and

[0032] FIG. 10 is a cross-sectional view of the container of FIG. 9 showing the bladder in the extended position.

[0033] Throughout the drawings, like reference numbers will be understood to refer to like parts, components, and structures.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0034] Reference to embodiments of the present invention are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. The embodiments described herein exemplify, but do not limit, the present invention by referring to the drawings. The exemplary embodiments are presented in separate descriptions, although the individual features and construction of these embodiments can be combined in any number of ways to meet the therapeutic needs of the user. The embodiments and/or elements can be combined with one another to form various additional embodiments not specifically disclosed, as long as the embodiments do not contradict one another.

[0035] It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of of being modified, practiced or carried out in various ways. It will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of including, comprising, or having and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms connected, coupled, and mounted, and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms connected and coupled and variations thereof are not limited to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting.

[0036] A cooling device is provided for cooling the surface of the skin of a patient to provide a temporary desensitizing or numbing effect to the skin immediately or shortly before the insertion of a needle, cannula or other medical device into the skin. The cooing device can be used alone or in combination with a delivery device such as a kit, package, or assembly.

[0037] The cooling device is primarily intended for use with a medical device, such as a delivery device, where a needle or cannula of the delivery device penetrates the skin for delivery of a substance, such as a pharmaceutical, or for withdrawing a fluid from the patient. Examples of a delivery device can include a pen needle, infusion pump, syringe, patch pump, lancet, catheter, or other injection or delivery device. The cooling device is also suitable for use in intravenous drug delivery devices and phlebotomy applications. The medical device can also be a catheter, central line ports, sub-surface ports that can be accessed for drug delivery, such as in chemotherapy applications. The delivery device in one embodiment is a pen needle commonly used delivery of insulin where it is necessary for the patient to introduce the needle into the skin to a controlled depth for the insulin delivery.

[0038] The cooling device contains a refrigerant medium or cooling medium that is re-usable for multiple uses. In one embodiment, the cooling device includes a refrigerant medium where the device can be placed in a freezer to freeze the refrigerant medium until ready for use. As used herein, a freezer refers to a device or apparatus that cools below 20 C. and is able to cool the refrigerant medium below the freezing point of the refrigerant medium. The cooling device is able to keep the refrigerant medium in a frozen, cold, or chilled state for several hours to provide a useful life to the device. The cooling device in one embodiment is able to maintain the cold temperature for 6 to 8 hours during normal use. The refrigerant medium can be cooled to a temperature of a standard freezer to a temperature at or below 20 C. The cooling device is sufficiently insulated to maintain the temperature of the refrigerant medium at or below about 5 C. and preferably at or below about 2 C. for 6-8 hours when stored at room temperature.

[0039] In one embodiment, the cooling device has a sufficiently small size that the device is able to fit within the pocket of the user or can be retained within the package or container that stores the pen needle and supplies until ready for use. The cooling device in one embodiment can have a substantially cylindrical shape with a length of about 2-3 inches and a width or diameter of about 0.5 to 1 inch although other sizes and dimensions can be used as needed.

[0040] Referring to the drawings, the cooling device 10 includes a container 12 having a side wall 14, an open end 16, and a closed bottom end formed by a bottom wall 18. In the embodiment shown, the container 12 has a substantially cylindrical shape although other shapes can be used. The container 12 is made of a thermally insulating material that is able to withstand repeated freezing and thawing cycles and retain the refrigerant medium in a cooled or frozen state. In one embodiment, the container is made from a plastic material with a sufficient thickness and strength to retain the refrigerant medium in a frozen or cooled state for an extended period of time. The container 12 can be made of polymer foam and can include a heat reflective surface or coating 15 on an inner surface of the container. In the embodiment shown in FIG. 3, the heat reflective surface 15 is formed on the bottom wall 18 and the side wall 14. The outer surface of the container can also include a heat reflective coating 17 to inhibit heat conduction and reflect thermal radiation into or out of the container and the refrigerant medium.

[0041] In the embodiment shown in FIGS. 1-3, the cooling device 10 includes a thermally transmitting member functioning as a closure to enclose a cooling composition referred to as a refrigerant medium 22 within the container 12. In the embodiment shown, the thermally transmitting member closing the container is an inner container such as a flexible bladder 20 that contains and encloses the refrigerant medium 22. The bladder 20 forms an enclosure for the refrigerant medium 22 and is positioned within the cavity of the container 12 as shown in FIG. 2. The bladder 20 can be made of a flexible polymer that can conform to the inner configuration of the container 12. The bladder 20 is made of a polymer material that is able to withstand the freezing and thawing of the refrigerant medium and retain the refrigerant medium without leakage during the normal use of the device. In one embodiment, an air gap 24 is provided between the bladder 28 and the bottom wall 18 of the container to allow for expansion of the refrigerant medium during freezing. In other embodiments, an air gap or space can be provided in the bottom portion of the bladder 20 to allow for the expansion of the bladder 20 and the refrigerant medium 22 during freezing as shown in FIG. 2.

[0042] The bladder 20 in one embodiment is flexible to conform to the inner surfaces of the container and to conform to the contour of the skin of the patient when contacted with and pressed against the skin of the patient. In one embodiment, the bladder 20 can be adhesively attached to the walls 14 of the container 12. The bladder 20 has a thickness to contain the refrigerant medium while allowing sufficient heat transmission through the bladder to cool the skin of the patient. The bladder 20 forms a closed, self-contained unit for the refrigerant medium 22 to reduce the risk of leakage. The bladder is typically a flexible polymeric material. The bladder 20 can be fixed in the cavity of the container or can be removable from the container.

[0043] The container in the embodiment shown has a substantially cylindrical side wall with an open end complementing the inner dimension of the side wall. The bladder 20 occupies a substantial portion of the inner cavity of the container 12 to maximize the volume of the refrigerant medium 22 relative to the dimensions of the container. The side wall 14 covers and encloses a substantial portion of the bladder 20 to thermally insulate the bladder 20 during handling of the device.

[0044] II

[0045] In the embodiment shown, the bladder 20 has an end contact portion 26 forming a skin contact area for contacting the skin of the patient during use. The contact portion 26 of the bladder 20 has a domed shape as shown in FIG. 2 to provide a skin contact area for contacting the surface of the skin during use. In the embodiment shown, the contact portion 26 projects outwardly from the open end 16 of the container 12 for ease of contacting the skin. In other embodiments, the contact portion 26 of the bladder 20 can be substantially flush with the open top end 16 of the container 12. The contact portion 26 of the bladder 20 is sufficiently flexible to conform to the surface of the skin when pressed against the skin. In the embodiment shown, the bladder 20 has a substantially uniform wall thickness. In other embodiments, the contact portion can be thinner or thicker than sides and bottom of the bladder to control the heat transfer and cooling effect through the contact portion.

[0046] A lid 30 is provided to fit onto the open top end 16 of the container 12 to close the container and cover the end contact portion 26 of the bladder 20. The lid 30 in the embodiment shown has a side wall 32 forming an open end 34 shown in FIG. 2 with a shape and dimension complementing the shape and dimension of the side wall 14 of the container 12. An end wall 36 is formed with the side wall 32 as a one piece assembly. The lid 30 can be provided with a thermally reflective inner surface or coating 31 to reduce heat transmission through the lid 30. In further embodiments, a reflective surface or coating 33 can be provided on an outer surface of the lid.

[0047] In the embodiment shown, the lid 30 fits over the outer surface of container 12 and is coupled to the container by a friction fit or interference fit. In the embodiment shown, the lid 30 when coupled to the container 12 is spaced a slight distance from the end contact portion 26 of the bladder 20 to inhibit heat transmission through the lid 30 to the bladder 20 and refrigerant medium 22 contained within the bladder 20.

[0048] The container 12 and lid 30 are generally made of a thermally insulating material and constructed to maintain the refrigerant medium in a frozen or cooled state for an extended period of time and preferably up to about 6-8 hours when stored at room temperature. In the embodiment of FIGS. 1-3, the container 12 and lid 30 are made of a thermally insulating plastic material and have a thickness constructed to provide the desired insulating properties to maintain the refrigerant medium at a temperature to provide the cooling and desensitizing of the skin of the patient. The side wall 14 of the container 12 has sufficient thermal insulating properties so that handling of the container 12 by the patient reduces heat transmission from the hand of the patient and the outside environment through the side wall to retain the cooling temperature within the container and the refrigerant medium.

[0049] The refrigerant medium 22 within the container 12 can be a suitable composition that can be frozen by placing in a standard freezer to provide the cooling and desensitizing effect when placed in contact with the skin. In one embodiment, the refrigerant medium can be an aqueous hypertonic solution, such as an aqueous sodium chloride solution that can be placed in a freezer and frozen until ready for use. The refrigerant medium can be an aqueous solution that can include other salts to reduce or lower the freezing point of water. The refrigerant medium can be reused by refreezing the device.

[0050] The refrigerant medium can alternatively be other solutions or compositions that are able to maintain a frozen state for an extended period of time. Examples of suitable refrigerant medium or cooling medium can be a liquid or gel containing one or more compounds that is able to lower the freezing point of water. The refrigerant medium can be an aqueous mixture that can include hydroxyethylcellulose, sodium acrylate, vinyl coated silica gel, and the like. In other embodiments, the refrigerant medium can be an aqueous solution containing calcium chloride, magnesium chloride, sodium formate, potassium formate, sodium acetate, potassium acetate, propylene glycol, ethyl alcohol, propyl alcohol, sorbitol, glycerol, and mixtures thereof.

[0051] In another embodiment shown in FIG. 4, the container 40 can be made with an inner wall 42 and an outer wall 44 defining a gap 46 between the inner wall 42 and outer wall 44. The inner surfaces 48 of the inner wall 42 and the inner surface 50 of the outer wall 44 can be provided with a heat reflecting surface, finish, film, or coating 51 to reduce the heat convection through the container walls. The gap 46 between the inner wall 42 and the outer wall 44 can be filled with polymer foam or other insulation material. In the embodiment shown in FIG. 4, the gap 46 can be filled with air or inert gas to inhibit heat transmission through the side wall and bottom of the container. In a further embodiment, the gap 46 can be a vacuum or pressure below atmospheric pressure to inhibit the transfer of heat through the wall and bottom of the container. The container 40 includes a bladder 20 and air gap 24 as in the previous embodiment that is received in the cavity of the container 40 to retain a refrigerant medium 22 and provide the contact end portion 26 to cooling skin of the patient.

[0052] A lid 52 of the container 40 is also constructed with an inner wall 54 and an outer wall 56 to define a gap 58 between the inner wall 54 and outer wall 56. As with the container 40, the gap 58 between the inner wall and outer wall can be filled with an insulating gas or air or can be provided with a vacuum or reduced pressure. The inner surfaces 60 of the inner wall 54 and the inner surface 62 of outer wall 56 can be provided with a thermally reflective finish or reflective coating 63.

[0053] In the embodiment of FIG. 5, the gap 46 of the container 40 and the gap 58 of the lid 52 are filled with an insulating material 64, such as a foam material. The container of FIG. 5 is substantially the same as in FIG. 3 and need not be described in further detail. The bladder 20 is also substantially the same as in the previous embodiment.

[0054] In a further embodiment shown in FIG. 6, the container 12 and the bladder 20 enclose a solid core 66 within the bladder 20 to provide a greater thermal mass for retaining the refrigerant medium at the desired temperature for an extended period of time. In the embodiment shown, the core 66 has a substantially cylindrical shape complementing the shape and dimension of the bladder 20 and the container 12. The core 66 can be made of a metal such as stainless steel, aluminum or other suitable metal. The metal core 66 can be a solid material that is not reactive with the refrigerant medium.

[0055] In one embodiment, the metal core 66 includes a corrosion resistant coating. The core 66 can be contained within the bladder 20 and surrounded by the refrigerant medium 22. Typically the core 66 is completely surrounded by the refrigerant medium 22. The core in one embodiment is spaced from the skin contact portion 26 or skin contact surface.

[0056] FIG. 7 shows an embodiment where the container 40 include a gap 41 or space between the inner wall 42 and the outer wall 44 providing an insulating effect. The solid core 66 is contained within the bladder 20 as in the previous embodiment.

[0057] The core 66 can have a longitudinal length extending between the open end and the bottom end of the container 12. In one embodiment, the core 66 can have a length to extend past the open end of the container as shown in FIG. 6 and FIG. 7 into the domed shaped end portion of the bladder. Typically the core is spaced from the contact area 26 so that the contact area 26 can bend and conform to the surface of the skin of the patient. The position of the core can be fixed within the bladder by a suitable attachment mechanism. In other embodiments, the core can free floating within the bladder. In other embodiments, the solid core 66 can have a length less than a length of the container to be positioned completely within the container below the open end. In further embodiments, the core can have a hollow cavity 67 as shown in FIG. 7 and enclose a refrigerant medium that is the same as or different from the refrigerant medium surrounding the core.

[0058] FIG. 8 shows another embodiment where the container 70 includes a side wall 72, a bottom wall 74, and an open top end 76. A skin contact member 78 forming a closure is attached to the container side wall 72 to enclose the cavity within the container. The refrigerant medium 80 is provided within the cavity and retained by the skin contact member 78. The container 70 can be made of a thermally insulating material as in the previous embodiments. The closure member 78 seals the container to retain the refrigerant medium 80. In one embodiment, the closure member 78 is made of a flexible polymer that is in direct contact with the refrigerant medium 80 and is able to cool the skin of the patient on contact with the skin of the patient. The flexible polymer is able to conform to the container of the skin when pressed against a target site. In other embodiments, the closure member 78 can be a rigid material such as plastic or metal.

[0059] In the embodiments shown, the refrigerant medium is contained within the bladder in a fixed position relative to the container with at least an end portion projecting from the open end of the container. In other embodiments, the bladder and refrigerant medium can be stored completely within the container and advanced to a position where the bladder containing the refrigerant medium can contact the surface of the skin of the patient.

[0060] An advancing and retracting mechanism 90 can be provided to move the bladder 92 toward the open end 94 of the container 96 and retract the bladder after use. The advancing mechanism can be, for example, a threaded mechanism that moves a plunger-like member and is able to retract the bladder back into the container. In one embodiment shown in FIGS. 9 and 10, the mechanism 90 can be manually operated plunger 98 coupled to a piston 100 that can be manipulated by sliding the plunger 98 toward the open end of the container to advance the bladder to a position where the bladder 20 extends from the open end of the container as shown in FIG. 10. The skin contact surface of the bladder is exposed to contact the skin of the patient to provide the cooling effect. After use, the bladder can be retracted into the container 96 as shown in FIG. 9 and covered by a lid 102. The bladder is typically retracted into the container a distance where the bladder does not contact the lid 102 to reduce the heat transfer from the refrigerant medium through the lid. Other mechanisms can be provided that are able to move the bladder to an operating position.

[0061] The device is used for the insertion of a medical device into a patient by piercing the skin of the patient and introducing the medical device subcutaneously, intravenously, intradermally, or intramuscularly. The device is particularly suitable in a method for the injection of a medication, such as insulin, into a target area of the skin. The skin contact area of the bladder is pressed against the skin in the target area of the skin for a time sufficient to cooling the skin and numb or desensitize the target area. A medical device, such as a needle or cannula then pierces the skin in the target area and the medication is introduced to the patient or fluid drawn from the patient.

[0062] The foregoing embodiments and advantages are merely exemplary and are not to be construed as limiting the scope of the present invention. The description of an exemplary embodiment of the present invention is intended to be illustrative, and not to limit the scope of the present invention. Various modifications, alternatives, and variations will be apparent to those of ordinary skill in the art, and are intended to fall within the scope of the invention. It is particularly noted that the features of different embodiments and claims may be combined with each other as long as they do not contradict each other. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the appended claims and their equivalents.