CROSS-REFERENCE TO RELATED APPLICATIONS

[001] This application claims the benefit of the filing date of U.S. provisional application No. 62/173,678, filed June 10, 2015. The content of this earlier-filed provisional application is hereby incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

[002] This invention relates to skin care systems and more particularly to a dermal roller that is encased to minimize damage when the dermal roller is not in use (e.g., during storage, sterilization, disinfection, or the like).

BACKGROUND OF THE INVENTION

[003] The health and beauty industry continually strives to provide products and therapies that reduce or conceal imperfections in human skin. Examples of such perceived imperfections include wrinkles, sagging skin, scars (e.g., scars caused by acne), stretch marks, and others. One such therapy is collagen induction therapy (CIT), which is an aesthetic medical procedure in which a subject's skin is repeatedly punctured with tiny needles (sometimes referred to as microneedles) in order to induce endogenous production of cutaneous collagen. With increased production of cutaneous collagen, the appearance of imperfections in the subject's skin is reduced or, in some cases, eliminated.

[004] One device commonly used for CIT is a rolling device referred to as a "microroller" or "dermaroller."

SUMMARY OF THE INVENTION

[005] It is important to the functionality of a dermal treatment device that the

microneedles of the device are not damaged (e.g., bent, blunted, or otherwise damaged). However, there are a number of activities such as storage of the device, transportation of the device, and sterilization of the device during which it can potentially become damaged even if one is being careful. Aspects of the skin care systems described herein include features that address this problem (among other problems) by minimizing or even preventing damage to the microneedles over a wide range of activities, including but not limited to storage of the device, transportation of the device, and sterilization of the device.

[006] The present invention features skin care systems that include: (a) a dermal treatment device comprising a handle having a mounting element disposed at one end and a substantially cylindrical roller rotatably mounted in the mounting element, the roller having a surface with a plurality of needles protruding radially therefrom; and (b) a container configured to surround at least a portion of the dermal treatment device, wherein the container comprises (i) a plurality of walls forming an inner chamber, a first wall of the plurality comprising a first through hole for receiving a portion of the handle of the device and a second wall of the plurality comprising a second through hole for permitting passage of a fluid into and out of the inner chamber and (ii) a support member extending into the inner chamber from one of the walls and configured to engage the mounting element of the dermal treatment device such that the cylindrical roller is held in the inner chamber with the needles being spaced apart from the walls.

[007] The second wall can include a plurality of through holes for permitting passage of a fluid into and out of the inner chamber, and each hole in the plurality can have substantially the same shape and diameter. For example, the through holes can be circular and have a diameter in the range of about 1.5-8.0 mm (e.g., 2-7.5 mm; 3-6 mm; or 4-5 mm). By "about" we mean ± 10%. Thus, a through hole having a diameter of about 1.5 mm has a diameter from 1.35-1.65 mm. The distance separating the periphery of one through hole from another can be in the range of about 0.6-3.0 mm, and the density of the holes in the plurality of through holes can be 5-113 holes per square inch. In other embodiments, the second wall comprises a plurality of through holes, at least one of which varies independently from the others in shape and diameter.

[008] The system can further comprise a sterilization chamber configured to receive the container with the dermal treatment device disposed therein.

[009] The container can be formed by a first container portion attached to a second container portion. For example, the first and second container portions can be attached to one another with a latching mechanism. The first and second container portions can be connected by a hinge. Each container portion can include a support member of the one or more support members. [010] One or more of the handle, the mounting element, the roller, and the container can be made of a plastic material or a metal.

[Oil] In another aspect, the invention features a kit that includes a system as described herein and instructions for use. The kit can further include a sterilization chamber configured to receive the container with the dermal treatment device disposed therein and/or a sterilization solution. The kit, in any embodiment, can also include a preparation (e.g., a cream or gel) that reduces the sensation in the skin (e.g., a preparation of lidocaine or other topical anesthetic) and/or that moisturizes or otherwise treats, nourishes, cleans, or protects the skin.

[012] Various aspects of the system described herein may have one or more of the following advantages. The microroller case that forms a part of the present system protects the delicate needles of the microroller from being bent, blunted, or otherwise damaged during storage and transport and particularly when the needles are exposed to any sort of cleaning, disinfecting, or sterilizing solution; the microroller case allows for cleaning, disinfecting, and sterilization without having to remove the microroller from the case. The needles of the microroller therefore remain protected throughout the sterilization process. Other features and advantages of the invention may be apparent from the following description, the drawings, and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[013] FIG. 1 illustrates a skin care system including a microroller and a microroller case.

[014] FIG. 2 illustrates the skin care system of FIG. 1 with the microroller secured in the microroller case.

[015] FIG. 3 is a cross-sectional view of the microroller in the microroller case.

[016] FIG. 4 illustrates the microroller in the microroller case prior to immersion in a contained sterilization or disinfection fluid.

[017] FIG. 5 shows the microroller in the microroller case immersed in the sterilization or disinfection fluid.

[018] FIG. 6 shows the microroller in the microroller case after removal from the sterilization or disinfection fluid. [019] FIG. 7 is a perspective view of an embodiment of the microroller case having alternatively shaped through holes.

[020] FIG. 8 is a side view of an embodiment of the microroller case with multiple through holes of varying shape.

DETAILED DESCRIPTION

1 Skin Care System

[021] Referring to FIG. 1, a skin care system 100 includes a microroller 102 and a microroller case 104. Very generally, the microroller case 104 is configured to receive a portion of the microroller 102 in such a way that the portion of the microroller 102 is protected from unintended contact that may damage to the microroller 102 and in particular the needles 114 protruding therefrom. This allows the microroller 102 to be easily cleaned (e.g., sterilized) without requiring removal of the microroller from the microroller case 104 protecting it.

1.1 Microroller

[022] The microroller 102 is a skin care device for performing collage induction therapy (CIT) on a subject's skin. In some embodiments, the microroller 102 includes a handle 108 including a mounting element 110 in which a substantially cylindrical roller 112 is rotatably mounted. In some embodiments, the mounting element 110 includes an axle (not shown) that extends through a hole in the cylindrical roller 112. The cylindrical roller 112 is free to rotate about the axle.

[023] A number of tiny needles 114 (sometimes referred to as microneedles) extend from an outer surface of the cylindrical roller 112 in a radially outward direction. In some embodiments, the tiny needles 114 are arranged in rows on the outer surface of the cylindrical roller 112. In other embodiments, the tiny needles 114 may be arranged in patterns other than a row pattern, including patterns that are regular or irregular and in which the microneedles are placed equidistant from one another or at non-equal distances from one another. Although the invention is not so limited, the microneedles may protrude or extend from the surface of the cylindrical roller by about 0.1-2.5 mm (e.g., by about 0.5, 1.0, 1.5, or 2.0 mm). [024] To use the microroller 102, a subject or a technician grasps the handle 108 of the microroller 102 with their hand, positions the cylindrical roller 112 on an area of skin to be treated, and moves their hand in a back and forth motion such that the cylindrical roller 112 rolls back and forth over the area of skin to be treated. Accordingly, the handle can be dimensioned for use by a human hand and can include features that improve hand control (or "grip"), such as grooves, indentations, and curves proportioned for or corresponding to the thumb and fingers or fingertips. One or more of the regions of the handle intended to be gripped can include a textured surface. As the cylindrical roller 112 rolls back and forth over the area of skin, the tiny needles 114 repeatedly puncture the subject's skin.

Endogenous production of cutaneous collagen is induced at and around the puncture sites. 1.2 Microroller Case

[025] The microroller case 104 is configured to receive and secure a portion of the microroller 102 including the mounting element 110 and the cylindrical roller 112. As is noted above, while secured in the microroller case 104, the delicate, tiny needles 114 of the cylindrical roller 112 are protected from unintended contact with any item or surface that may damage them. Furthermore, the microroller case 104 enables one to partially or fully submerge the microroller 102 in a liquid (e.g., a sterilizing fluid) without risking damage to the microroller 102.

[026] In some embodiments, the microroller case 104 includes a first half 116a and a second half 116b. A first end 118 of the first half 116a and a first end 120 of the second half 116b are coupled to one another using, for example, a hinge (not shown).

[027] The first half 116a includes a first body 122, a first support member 132, a second support member 134, a first handle receiving portion 140, and one or more latching protrusions 142.

[028] The first body 122 defines a first hollow interior space 124 in the first half 116a of the microroller case 104 and includes a first opening 129 through which a portion of the microroller 102 can be inserted into the first hollow interior space 124. The first body 122 also includes a number of holes 130 extending therethrough. We may refer to such holes as "through holes." In some embodiments, one or more and up to all of the holes 130 has/have a circular shape. The shape and diameter of the holes 130 can vary independently from one another and the diameter can be in a range of about 1.5-8.0 mm. In some examples, the holes 130 are spaced apart from one another by a distance in a range of about 0.6 mm and 3.0 mm. In some embodiments, there are approximately 5-113 holes per square inch in the body 122.

[029] In some embodiments, both the first support member 132 and the second support member 134 are formed as a rib extending into the first hollow interior space 124 from the first body 122. In some embodiments, both the first support member 132 and the second support member 134 have a shape that conforms to a shape of a portion of the mounting element 110 of the microroller 102. For example, each of the support members 132, 134 may have a shape conforming to a respective end portion 111 of the mounting element 110. Alternatively, the support members 132, 134 may have a shape conforming to the axle (not shown) of the mounting element 110. In all cases, the support members 132, 134 are sized and shaped such that, when the portion of the microroller 102 is received in the first half 116a of the microroller case 104, the cylindrical roller 112 and the tiny needles 114 are held in a position with the tiny needles 114 spaced apart from the first body 122.

[030] In some embodiments, the first handle receiving portion 140 extends from a second end 144 of the first half 116a of the microroller 102 and has a substantially semi-cylindrical shape. The first handle receiving portion 140 is configured to receive a portion (e.g., half of) the handle 108 of the microroller 102.

[031] In some embodiments, the one or more latching protrusions 142 are disposed at the second end 144 of the first half 116 of the microroller 102 and are configured to interact with one or more latching recesses (described below) on the second half 116b of the microroller case 104 to latch the two halves 116a, 116b together.

[032] The second half 116b of the microroller case 104 includes a second body 126, a third support member 136, a fourth support member 138, a second handle receiving portion 146, and one or more latching recesses 148. The second body 126 defines a second hollow interior space 128 in the second half 116b of the microroller case 104 and includes a second opening 131 through which a portion of the microroller 102 can be inserted into the second hollow interior space 128. The second body 126 also includes a number of holes 130 extending therethrough. As with the first body, each of the holes 130 of the second body 126 can be circular in shape with a diameter independently selected within a range of about 1.5-8.0 mm. The holes 130 can be spaced apart from one another by a distance in the range of about 0.6 mm and 3.0 mm, and there can be approximately 5-113 holes per square inch in the second body 126.

[033] In some embodiments, both the third support member 136 and the fourth support member 138 are formed as a rib extending into the second hollow interior space 128 from the second body 126. In some embodiments, both the third support member 136 and the fourth support member 138 have a shape which conforms to a shape of a portion of the mounting element 110 of the microroller 102. For example, each of the support members 136, 138 may have a shape conforming to a respective end portion 111 of the mounting element 110. Alternatively, the support members 136, 138 may have a shape conforming to the axle (not shown) of the mounting element 110. In all cases, the support members 136, 138 are sized and shaped such that, when the portion of the microroller 102 is received in the second half 116b of the microroller case 104, the cylindrical roller and the tiny needles 114 are held in a position with the tiny needles 114 spaced apart from the second body 126.

[034] In some examples, the second handle receiving portion 146 extends from a second end 150 of the second half 116b of the microroller 102 and has a substantially semi- cylindrical shape. The second handle receiving portion 146 is configured to receive a portion (e.g., half of) the handle 108 of the microroller 102.

[035] In some embodiments, the one or more latching recesses 148 are disposed at the second end 150 of the second half 116b and are configured to interact with the one or more latching protrusions 142 (described above) on the first half 116a of the microroller case 104 to latch the two halves 116a, 116b together.

2 Placement of Microroller into the Microroller Case

[036] In some examples, to secure the microroller 102 in the microroller case 104, a first portion of the mounting element 110 of the microroller 102 is first inserted into the hollow interior space 128 of the second half 116b of the microroller case 104 such that it rests on the support members 136, 138 of the second half 116b. With the first portion of the mounting element 110 resting in the support members 136, 138 of the second half 116b, a first portion of the handle 108 of the microroller 102 rests in the second handle receiving portion 146.

[037] The first half 116a of the microroller case 104 is then rotated about the hinge until a second portion of the mounting element 110 of the microroller 102 enters the hollow interior space 124 of the first half 116b of the microroller case 104 until the second portion of the mounting element 110 engages the support members 132, 134 of the first half 116a. With the second portion of the mounting element 110 engaged with the support members 132, 134 of the first half 116a, a second portion of the handle 108 of the microroller 102 rests in the first handle receiving portion 140.

[038] Finally, when the first half 116a reaches the end of its rotational range of motion, the latching protrusions 142 of the first half 116a engage the latching recesses 148 of the second half 116b, latching the two halves 116a, 116b into a closed position with a portion of the microroller 102, including the cylindrical roller 112, the mounting element 110, and a portion of the handle 108 held inside.

[039] Note that, while in the above example the portion of the microroller 102 is first inserted into the second half 116b and the first half 116a is then rotated to close the microroller case 104 around the portion of the microroller 102, in other examples, the order can be reversed. That is, in other examples the portion of the microroller 102 is first inserted into the first half 116a and the second half 116b is then rotated to close the microroller case 104 around the portion of the microroller 102. Indeed, in some examples, the first half 116a and the second half 116b of the microroller case 104 are substantially mirror symmetrical {i.e., they are mirror images of one another) with the exception of the latching features.

[040] Referring to FIG. 2, the microroller case 104 is shown in its closed position with a portion of the microroller 102 including the mounting element 110, the cylindrical roller 112, and its tiny needles 114 secured inside. In FIG. 2, the hinge 252 connecting the first half 116a of the microroller case 104 to the second half 116b of the microroller case 104 is visible. In the closed position, the support members 132, 134, 136, 138 of the first and second halves 116a, 116b securely hold the mounting element 110 and the cylindrical roller 112 in place within the microroller case 104.

[041] Referring to FIG. 3, a cross-sectional view of the microroller case 104 in its closed position with a portion of microroller 102 held inside shows that the tiny needles 114 of the cylindrical roller 112 are maintained at a safe distance from the bodies 122, 126 of the first and second halves 116a, 116b. The distance between the bodies 122, 126 and the tiny needles 114 ensures that the delicate, tiny needles 114 are not damaged (e.g., bent or blunted) by inadvertent contact with an object.

3 Sterilization Procedure

[042] Over the course of a microroller treatment, any potion of the microroller 102 may come into contact with and become contaminated by the subject's blood, skin, or other non- sterile matter. For this reason, it is it is desirable to sanitize the microroller 102. Referring to FIG. 4, to sanitize the microroller 102, the microroller 102 is first placed into the protective microroller case 104 (as is described above).

[043] Referring to FIG. 5, the microroller case 104 with the portion of the microroller 102 secured therein is immersed in a tub 554 of sterilization fluid 556. Upon being immersed in the sanitation fluid, sanitation fluid flows through the holes 130 in the bodies 122, 126 of the microroller case 104, filling the interior space (i.e., the first hollow interior space 124 of the first half 116a and the second hollow interior space 128 of the second half 116b) of the microroller case 104 and bathing the cylindrical roller 112, the tiny needles 114, and the mounting element 110 of the microroller 102. Note that, due to the microroller 102 being secured in the microroller case 104 while in the tub 554 of sterilization fluid, damage to the tiny needles 114 due to inadvertent contact with, for example, the sides of the tub 554 is prevented.

[044] Referring to FIG. 6, after a sufficient period of time has passed, the microroller 102 is considered to be sterile. At that time, the microroller case 104 with the portion of the microroller 102 secured therein is removed from the tub 554 of sterilization fluid 556, at which time any sterilization fluid 556 present in the interior space of the microroller case 104 drains out of the interior space through the holes 130. The microroller case 104 with the portion of the sterilized microroller 102 secured therein can then be safely stored and or transported.

[045] Referring to FIG. 7, in one embodiment, the microroller case 704 includes holes 730 with a rectangular, "slit-like" shape.

[046] Referring to FIG. 8, in one embodiment, the microroller case 804 includes a first type of hole 830a with an elongated "slit-like" shape and a second type of hole 830b with a circular shape. 4 Alternatives

[047] In several of the aspects described above, the holes in the microroller case are described as having a circular shape or a slit-like or irregular shape. However, other shapes can be chosen based on characteristics such as drain rate and fill rate. Suitable shapes include triangular, square, rectangular, polygonal, or curvilinear, which can be selected based on any number of design criteria (e.g., drain rate, fill rate, aesthetic appearance, and so on). A variety of sizes and shapes can also be included, if desired, in a given system.

Although it may not provide the same level of protection to the microneedles, the case can include a single large hole or a limited number of large holes that allow for rapid filling and draining of sterilization fluid. In some embodiments, the single large hole may be formed by omitting an entire wall of the body of microroller case or a portion thereof, and alternatives for the wall shape are described further below.

[048] In the aspects described above, the microroller case is described as having a substantially cylindrical shape (including two semi-cylindrical "clam shell" shaped halves). However, in other examples, the microroller case can have any number of shapes. For example, the microroller case may have a cubic, more spherical, or irregular shape (e.g., such as a sculpted shape). Thus, one or more of the walls of the container may or may not be congruent or even roughly congruent with the encased roller. For example, the walls may be cloche-shaped with the open bottom of the cloche providing for contact with a surface (e.g., the bottom of a sterilization tub) while maintaining the long axis of the dermal treatment device perpendicular to the surface upon which the bottom of the cloche rests. In this embodiment, the open bottom of the cloche-shaped container can stabilize the dermal treatment device in an upright position such that the handle is not fully submerged in the sterilization tub. As in other embodiments described and illustrated herein, the cloche- shaped container can include first and second container portions that are attached to one another with a latching mechanism (e.g., a hinge), and at least one of the container portions can include a support member that supports the mounting element.

[049] In the aspects described above, the support members are described as ribs that are spaced apart from the bodies of the halves of the microroller case. However, the support members may be integrally formed as grooves or cut-outs in the bodies of the halves of the microroller case.

[050] Any sufficient type of latching mechanism (e.g., snap latches, hook latches, and so on) can be used to hold the microroller case in its closed position.

[051] In some embodiments, the halves of the microroller case are not coupled by a hinge, but are instead two separate members. In such cases, the microroller case may include additional latching mechanisms such that the two halves can be held together.

[052] In general, the sterilization fluid can be a gas or a liquid. In some examples, the sterilization fluid can be any one of ethylene oxide, nitrogen dioxide, ozone, chlorine bleach, glutaraldehyde and formaldehyde, phthalaldehyde, hydrogen peroxide, paracetic acid, an alcohol, or any other suitable sterilization fluid. In some examples, rather than using a sterilization fluid, radiation (e.g., non-ionizing radiation such as UV light) or heat can be used as a sterilant.

[053] In some embodiments, the tub included in the skin care systems for containing sterilization fluid can include an indentation (e.g., a notch or groove) on an upper surface that is configured to accommodate a portion of the handle of the dermal treatment device such that the handle is not completely submerged in the sterilizing fluid. The tub can also include a lining (e.g., an inner mesh basket) having a handle that remains above the level of the sterilizing fluid and can be used to lift the dermal treatment device, via the liner, out of the sterilization fluid. The size of the tub itself can also vary such that it is large enough for the entire dermal treatment device, including the entirety of the handle, to be submerged or small enough for only the encased roller-portion of the device and the portion of the handle most proximal to the roller to become submerged; the distal portion of the handle, which is gripped by the user, can then remain above the surface of the sterilizing or storage fluid.

[054] In some embodiments, the microroller case is made of a plastic material, which may be opaque or transparent. In other embodiments, the microroller case is made of a metallic material, such as stainless steel.

[055] It is to be understood that the foregoing description is intended to illustrate and not to limit the scope of the invention, which is defined by the scope of the appended claims. Other embodiments are within the scope of the following claims.