Abstract:
An applicator for treating skin, includes a housing, in which a device for perforating an area of skin is arranged, wherein the device for perforating the skin can be brought into contact with the area of skin through an opening in the housing. At least one device for disinfecting is additionally arranged in the housing, and the device for disinfecting acts upon the area of skin through the same opening. With the applicator, a particularly secure and simple handling can be achieved.

Description:
This application is a 35 U.S.C. §371 National Stage Application of PCT/EP2010/051089, filed on Jan. 29, 2010, which claims the benefit of priority to Application Serial No. DE 10 2009 002 019.5, filed on Mar. 31, 2009 in Germany, the disclosures of which are incorporated herein by reference in their entirety. 
     BACKGROUND 
     The disclosure relates to an applicator for treating skin. 
     Such an applicator is known from DE 10 2004 032 892 A1. The known applicator has a needle plate, which can be actuated by means of a lifting device and with which the skin, in the area where an active-substance patch is later to be applied for example, is multiply perforated in order to form passages for the active substances stored in the active-substance patch. With active-substance patches of this kind, the active substances can pass through the skin and into the body as long as the passages are open. The self-healing process of the body means that the passages close again independently, for example after a few hours. The needles that are used in this context are in particular so-called micro-needles which, with the correct dimensions, cause almost no pain during perforation. 
     Micro-needles that are made of porous silicon or of biodegradable polymer and that can remain in the skin are also known from the prior art. The material, suitably produced, is automatically slowly decomposed by the intracellular liquid of the body such that, with micro-needles of this kind, the passages allow the active substance to pass through for about 2 to 3 days. 
     A problem when using certain known applicators is that the use of active-substance patches, for example, requires preparation and/or disinfection of the skin at the area to be perforated, so as to avoid infections of the perforated area of skin. The area of skin to be perforated is usually disinfected manually, for example using a swab soaked with disinfectant, and errors can arise both as regards the position of the subsequently perforated area of skin and also as regards the correct amount of disinfectant. Moreover, a high degree of spatial precision is also needed when applying the active-substance patch, so as to ensure that the active substances of the active-substance patch can penetrate as completely as possible into the skin. 
     SUMMARY 
     The object of the disclosure is therefore to develop an applicator for treating skin in such a way that handling is made easier, for example when using active-substance patches, and at the same time at least the risk of infections is reduced. This object is achieved in an applicator having the features set forth herein. The disclosure is based on the concept that the steps of disinfecting and perforating the area of skin are carried out in succession using one and the same applicator, without this requiring the applicator to be placed several times onto the area of skin that is to be treated. In this way, a very high degree of positioning accuracy is achieved as regards the different treatments of the area of skin. This means that an applicator according to the disclosure, in addition to having the device for perforating the area of skin, also has at least a device for disinfecting the area of skin, which disinfecting device acts on the area of skin to be treated by way of the same opening in the housing. This ensures that, in the required manner, the area of skin to be perforated is prepared optimally for the subsequent perforation, both as regards the site of the disinfection and also as regards the amount of disinfectant and the execution of the disinfection, as a result of which subsequent infections can be avoided. 
     Advantageous developments of the applicator according to the disclosure for treating skin are set forth in the dependent claims. All combinations of at least two of the features disclosed in the description, in the claims and/or in the figures fall within the scope of the disclosure. 
     In a preferred embodiment of the applicator, a control device is provided, which controls the perforating device and the disinfecting device independently in accordance with at least one stored program sequence, and means are provided which, in accordance with the program sequence, bring the perforating device and the disinfecting device into operative contact with the area of skin through the opening of the housing. In this way, the treatment steps can proceed completely automatically, thereby permitting a particularly simple and error-free operation of the applicator. 
     In another embodiment of the disclosure, a device for applying an active-substance patch to the previously disinfected and perforated area of skin is additionally provided, and the device for applying an active-substance patch can likewise be controlled automatically by the control device. By means of this embodiment, active-substance patches can be applied to the previously disinfected and perforated area of skin automatically and with precise positioning, such that handling errors are avoided in this respect too. 
     The design of the disinfecting device can be made relatively simple by having a carrier which is treated by means of a disinfectant and which is movable with surface contact across the area of skin to be disinfected. 
     In terms of its design, provision is advantageously made that the carrier is band-shaped, that the carrier, on the outer face thereof coming into contact with the area of skin, has an absorbent material, and that a reservoir for the disinfectant is provided, via which reservoir the outer face can be wetted with disinfectant. In this way, the disinfecting device has a long useful life and works particularly reliably. 
     When manually applying an active-substance patch, it is particularly advantageous, for the purpose of positionally accurate placement of the active-substance patch, if a marking device is provided which peripherally surrounds the disinfecting device or the perforating device and can be brought into surface contact with the area of skin in order to visually identify the extent of the area of skin. 
     In order to perforate the area of skin, provision is additionally made that the perforating device has a perforating punch with a multiplicity of micro-needles arranged alongside one another. A perforating punch of this kind has a compact structure, permits reliable perforation of the area of skin and has a long useful life. 
     Alternatively, and in order to obtain passages in the area of skin that close again only after quite a long time, provision is also made, in one development, that the perforating device has a multiplicity of micro-needles which are arranged on a carrier, and that the micro-needles are designed as self-disintegrating micro-needles, which are detachable from the carrier. The micro-needles can in this case be made, for example, of porous silicon or biodegradable polymer. 
     In order to bring at least the disinfecting device and the perforating device into the area of the opening of the housing, provision is made, in a structurally advantageous embodiment, that a support device is arranged in the housing, and that the perforating device and the disinfecting device can be pivoted into the area of the opening by means of the support device. 
     It is also particularly advantageous if at least the perforating device and the disinfecting device are arranged exchangeably on the support device. This means that these devices can be easily replaced at the end of their useful life or in order to refill disinfectant, with the result that the applicator has a particularly long operating life and can be used again and again. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further advantages, features and details of the disclosure will become clear from the following description of preferred illustrative embodiments and from the drawings, in which: 
         FIG. 1  shows, in a simplified longitudinal section, an applicator for treating skin, 
         FIG. 2  shows, in a longitudinal section, a partial area of the applicator according to  FIG. 1  during disinfection of an area of skin, 
         FIG. 3  shows, in a longitudinal section, a partial area of the applicator according to  FIG. 1  during perforation of the area of skin disinfected in  FIG. 2 , 
         FIG. 4  shows, in a longitudinal section, a partial area of the applicator according to  FIG. 3  after perforation of the area of skin, and 
         FIG. 5  shows, in section, the previously disinfected and perforated area of skin after application of an active-substance patch. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  depicts an applicator  10  for treating an area of skin  1 , in particular an area of skin  1  of a human. An active-substance patch  3  containing medical active substances  2  is intended to be applied to the area of skin  1  and release its active substances  2  into the human body through passages or perforations  4  formed in the area of skin  1  ( FIG. 5 ). The applicator  10  here serves at least to prepare the area of skin  1 , such that the active-substance patch  3  can be applied to the area of skin  1  in exactly the right position. 
     The applicator  10  has a housing  11  with a first area  12 , of which the cross section is in particular rectangular or square and on the side of which a second area  14  designed as a handle  13  is integrally formed, such that, in cross section, the housing  11  has an approximately L-shaped configuration. The housing  11  has, on the side thereof coming into surface contact with the area of skin  1 , an opening  16 , which can be closed by means of a removable protective cover  17 . An anatomically shaped molding  18  is arranged on the outer face of the handle  13 , either as a separate structural part or integrally with the housing  11 . By means of the molding  18 , the applicator  10  can be held in one hand by an operator, who can also be the person to be treated. On the outer face of the housing  11 , an actuating switch  19  is also arranged, which is electrically connected to a control device  20  arranged in the interior of the housing  11  of the applicator  10 . 
     In the interior of the housing  11 , the applicator  10  has, for example, a support device  21 . The support device  21  comprises a shaft  24 , which is mounted rotatably in two bearings  22 ,  23  and which is rotatable via a toothed wheel  25  and via a servomotor  26  that can be controlled by the control device  20 . Support arms  27 , arranged in particular at uniform angular intervals, are connected to and rotate with the shaft  24 , and functional units  30 ,  40  are arranged at the outer ends of the support arms  27 , in each case in a holder  28 . 
     The functional units  30 ,  40 , designed as devices for respectively disinfecting and perforating the area of skin  1 , each have their own respective housing  31 ,  32  which, on the upper face thereof, has an adapter  33 ,  34  that engages with a correspondingly shaped mating piece  35  of a lifting mechanism  36 . By means of the lifting mechanism  36 , the corresponding functional unit  30 ,  40  controlled by the control device  20  can be removed from the holder  28  and moved into the area of the opening  16  of the housing  11  and back again. The functional units  30 ,  40  each serve for a particular treatment of the area of skin  1 . Thus, the first functional unit  30  is used to disinfect the area of skin  1 , while the second functional unit  40  is used to perforate the area of skin  1 . 
     As can best be seen from  FIG. 2 , the first functional unit  30  has, within its housing  31 , a plurality of rotatably mounted rollers  37 , at least one of which rollers  37  can be driven by means of a drive mechanism (not shown). A band-shaped carrier  38  for a disinfectant stretches around the rollers  37 . The carrier  38 , at least on the outer face thereof coming into contact with the area of skin  1 , is made of absorbent material, for example fleece, padding or the like. On the face of the carrier  38  lying opposite the opening  16 , the carrier  38  is operatively connected to a reservoir  39  for the disinfectant. The disinfectant is a standard disinfectant used for disinfecting skin, for example ethanol. The face of the carrier  38  directed toward the reservoir  39  is wetted or saturated with the disinfectant from said reservoir  39 . 
     As can be seen from  FIG. 3 , the second functional unit  40  has a perforating punch  43  for the area of skin  1 , which perforating punch  43  is provided with a multiplicity of micro-needles  42  arranged alongside one another. The perforating punch  43  is axially movable, in the direction of the double arrow  44 , within its housing  32  open on the side directed toward the opening  16 . When used on the area of skin  1 , this means that the perforating punch  43  moves substantially perpendicularly with respect to the area of skin  1 . The perforating punch  43  has a shaft  45 , which is enclosed by a compression spring  46 . By means of the force of the compression spring  46 , the perforating punch  43 , with its perforating micro-needles  42 , is pressed with a defined force (for example because the compression spring  46  is suitably pretensioned) against the area of skin  1  in order to perforate it. As an alternative to this, it is also possible that the movement of the perforating punch  43  for carrying out the perforation is executed either via the lifting mechanism  36  or via another suitable mechanism, particularly one arranged integrally in the functional unit  40 . If appropriate, additional sensors, for example optical sensors, can also be provided, which ensure that the area of skin  1  has been perforated in the right way. 
     Moreover, provision can additionally be made that, inside the housing  11  in the area of the opening  16 , the perforating punch  43  is surrounded about its circumference by a marking device  47 . The marking device  47  has a marking frame  48 , of which the front face  49  directed toward the opening  16  is treated with a skin-compatible dye which, upon contact with the area of skin  1 , transfers itself onto the area of skin  1 . The movement of the marking frame  48  is preferably coupled to the perforating punch  43 . 
     Alternatively, instead of using a marking device  47 , it is also possible to dye the disinfectant such that, when the area of skin  1  is being disinfected by means of the carrier  38 , the disinfectant is transferred onto the area of skin  1  and identifies the disinfected area of skin  1  by a color. 
     The mode of operation of the applicator  10  is explained as follows. In a first step, the operator manually places the applicator  10  with the opening  16  thereof onto the area of skin  1  that is to be perforated. As soon as this is done, the operator presses the actuating switch  19 . This causes the start-up of an automatically running program in the control device  20 . A first program step of said program provides that the first functional unit  30  serving to disinfect the area of skin  1  is triggered. By means of the lifting mechanism  36 , this functional unit  30  is brought into surface contact with the area of skin  1  according to  FIG. 2 , after which the carrier  38  saturated with disinfectant is set in motion by means of the at least one driven roller  37 , and this has the effect of disinfecting the entire surface of the area of skin  1  by means of the carrier  38  sliding across the area of skin  1 . Then, in a second program step, the second functional unit  40  with the perforating punch  43  and with the marking device  47  is triggered by the control device  20 . According to  FIG. 3 , these cause perforation of the area of skin  1 , such that the perforations  4  are formed within the previously disinfected area of skin  1 . At the same time, the perforated area is identified in color by means of the marking device  47  and is therefore then visually discernible to the operator. As soon as this is done, the operator can remove the applicator  10  from the area of skin  1  ( FIG. 4 ) and, in a final step, apply the active-substance patch  3  in the exact position onto the area of skin  1  previously identified by the dye ( FIG. 5 ). The active substances  2  can now pass from the active-substance patch  3  into the body through the perforations  4 . 
     It will further be noted that the abovementioned steps (without the application of the active-substance patch  3 ) of disinfecting and perforating can be repeated at the same site in order to achieve more intense treatment. Alternatively, however, the treatment can also be repeated on, for example, directly contiguous areas of skin  1 , in order to treat a larger skin surface. 
     Moreover, in the illustrative embodiment described above, the active-substance patch  3  is applied manually to the area of skin  1  by the operator. Such a procedure is expedient if the applicator  10  is intended to be used for different active-substance patches  3 . However, in a modification of the illustrative embodiment described above, it is also possible to design the applicator  10  in such a way that one or more additional functional units are arranged in the applicator  10  analogously to the functional units  30  and  40 . These additional functional units are then, like the functional units  30 ,  40 , also arranged exchangeably or replaceably on the support device  21 . In each of these additional functional units, for example, a defined number of active-substance patches (of different formats) can be stored which, after activation via the control device  20 , are applied fully automatically to the previously disinfected and perforated area of skin  1 . In this case, of course, it is possible to do without a marking device  47 . In an applicator  10  that has been modified in this way, all the steps are therefore triggered fully automatically after activation of the actuating switch  19  (or of modified operating elements via which, for example, different patch formats or treatment courses can be selected). Moreover, the applicator  10  can also be modified such that, instead of the functional unit  40  with the micro-needles  42  and the perforating punch  43 , use is made of a functional unit that has micro-needles made of porous silicon or of biodegradable polymer. After penetrating the skin, these micro-needles are detached from a carrier by means of a suitable device and thereafter remain in the skin until the intercellular liquid slowly breaks them up. 
     Of course, the mechanical set-up of the applicator  10  can deviate greatly from the described illustrative embodiment. In particular, the functional units  30 ,  40  for disinfecting and perforating can be designed and controlled in other ways.