Abstract:
A medical garment or patch, at least a portion of which is formed from a flexible, air-impervious film. The garment or patch is configured to be directly applied to a region of an individual&#39;s skin surface when the garment or patch is donned by an individual. The garment may be used to apply a medical device to the body.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention relates to devices comprising a flexible film for application to a body surface.  
       BACKGROUND OF THE INVENTION  
       [0002]     Medical devices are often applied to a subject&#39;s skin in order to measure or record a parameter of the skin or to apply a stimulus to the skin. Such devices include, for example, thermometers, stethoscopes, electrodes, microphones, and so on. If the device is to be applied to the skin for a short period of time (e.g. a stethoscope), it may be applied manually by the care giver. If the device is to be applied to the skin for a prolonged period of time (e.g. ECG electrodes), the device is usually affixed to the skin. Such means of fixation include, for example, use of straps, embedding the device in a garment worn by the subject, or by means of a vacuum.  
         [0003]     In many cases, functioning of a device applied to a subject&#39;s skin requires firm contact between the device and the skin. In practice, however, the presence of skin defects, such as hair, pimples or wrinkles, prevent firm application of the device to the skin. The problem is especially significant when a device is to be applied to the skin by vacuum. The presence of skin defects, often prevents the formation of an airtight seal between the device and the skin.  
       SUMMARY OF THE INVENTION  
       [0004]     The present invention provides a thin flexible film that is applied to a subject&#39;s skin. The film is formed into a patch or garment, the shape of which matches the skin surface to which it is to be applied. The film is provided with means for firmly applying it to the shape of the skin surface. Such means include elastic straps and/or a nipple for connection to a negative pressure source so as to generate a vacuum between the film and the skin surface.  
         [0005]     Due to the firm attachment of the film to the skin surface, the film forms a smooth surface juxtaposed to the skin surface. After firm application of the film to the skin surface, a medical device, such as a microphone is applied to the film. The absence of geometrical defects in the film surface allows the device to be applied firmly to the film surface. In particular, a better airtight seal may be formed between the device and the film than is normally possible when the device is applied directly to the skin surface. If the device is a microphone, the film is preferably acoustically transparent in the frequency range of interest. In this case, an airtight seal between the microphone and the film, has been found to allow an acoustic signal to be recorded from the skin surface having a higher signal to noise ratio than is obtainable when the microphone is applied directly to the skin.  
         [0006]     Thus, in its first aspect, the invention provides a medical garment or patch, at least a portion of which is formed from a flexible, air-impervious film, the garment or patch being configured to be directly applied to a region of an individual&#39;s skin surface when the garment or patch is donned by an an individual.  
         [0007]     In its second aspect, the invention provides a system for applying a flexible film to a body surface comprising: 
    (a) A garment or patch at least a portion of which is formed from an air impervious flexible film and having a nipple for connection to a source of negative pressure to remove air between the film and the body surface when the film is applied to the body surface; and     (b) a source of negative pressure.    
 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]     In order to understand the invention and to see how it may be carried out in practice, a preferred embodiment will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:  
         [0011]      FIG. 1  shows a medical garment in accordance with one embodiment of the invention;  
         [0012]      FIG. 2  shows the garment of  FIG. 1  after having been donned by an individual;  
         [0013]      FIG. 3  shows a portion of the garment of  FIG. 1  after removal of air from between the film and skin surface;  
         [0014]      FIG. 4  shows application of a medical device to a portion of the garment of  FIG. 1 ;  
         [0015]      FIG. 5  shows a medical garment in accordance with another embodiment of the invention; and  
         [0016]      FIG. 6  shows the garment of  FIG. 5  after having been donned by an individual. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0017]      FIG. 1  shows a film  5  for application to a body surface in accordance with one embodiment of the invention. In the embodiment of  FIG. 1 , the film is incorporated into a vest  10  to be worn over a subject&#39;s trunk. The vest  10  is shown in a front view in  FIG. 1   a  and in a rear view  FIG. 1   b . This is by way of example only, and the film may be configured to be applied to any skin region of the subject. The vest includes a zipper  12  that is opened to allow the subject don the vest, and is then closed so as to create a tight fit of the vest over the subject&#39;s trunk.  
         [0018]     The film  5  in this embodiment is formed from an air impervious material such as polyurethane or latex. The film  5  forms the portion of the vest that is to be applied to a subject&#39;s back ( FIG. 1   b ). The front of the vest is formed from an inelastic material  6  that may be for example a non-woven cellulose based material. A nipple  16  extends from the film  5  that is configured to be attached to a source of negative pressure. The inset  1   b  shows a portion of the vest  10  and the nipple  16 . At the bottom exposed edge of the film  5  is a sealing surface  14  that forms an airtight seal with the skin when firmly pressed against the skin. A similar sealing surface may also be present on the upper exposed edge of the film  5  around the neck region. The inset  FIG. 1   a  shows a portion of the vest  10  and a portion of a sealing surface  14  at an edge of the film. The sealing surface  14  may be formed as a lip extending from the edge as shown in the insert  1   a . Alternatively, the sealing surface may be formed from a biocompatible gel applied between the edge of the film  5  and the subject&#39;s skin. As yet another alternative, the sealing surface may be formed by an adhesive layer applied along the edge of the film. As explained below, the nipple  16  is used to evacuate a chamber formed by the skin surface, the film  5  and the sealing surface  14 .  
         [0019]      FIG. 2  shows the vest  10  of  FIG. 1  after having been donned by a subject  20 . The vest  10  is donned with the film  5  over the subject&#39;s back in direct contact with the subject&#39;s skin. The nipple  16  has been connected to a vacuum pump  22  by means of a vacuum hose  24 .  
         [0020]     The sealing surface or surfaces  14  are then pressed against the skin, so as to create an airtight seal with the skin at the edges of the vest. The vacuum pump  22  is then activated in order to remove air trapped in the space bounded by the film  5 , the sealing lips  14  and the subject&#39;s skin. This causes the film  5  to be firmly applied to the subject&#39;s skin.  
         [0021]      FIG. 3  shows the film  5  after having been affixed to a subject&#39;s skin  30  after applying a negative pressure via the nipple  16  to remove air trapped between the film  5  and the skin  30 . A valve  32  located in the nipple  16  may be closed so that the hose  24  may be disconnected from the nipple  16  without loss of vacuum in the space between the film  5  and the skin  30 .  
         [0022]      FIG. 4  shows application of a vacuum dome  40  to the film  5 , after removal of air from the space between the film  5  and the skin  30 . The dome  40  is formed from an air impervious material. A sealing ring  32  forms an airtight seal between the dome  40  and the film  5 . A nipple  36  allows the interior  38  of the dome  40  to be evacuated by means of a vacuum pump (not shown). The dome  40  may be used to affix a medical device to the film  5  such as a microphone  42 . Application of the dome and device  40  to the film  5  is more hygienic than applying the dome  40  and device  42  directly to the skin surface.  
         [0023]      FIG. 5  shows a film  5  for application to a body surface in accordance with another embodiment of the invention. In the embodiment of  FIG. 5 , the film is incorporated into a vest  48  to be worn over a subject&#39;s trunk. The vest  48  is shown in a front view in  FIG. 5   a  and in a rear view  FIG. 5   b . The embodiment of  FIG. 5  is provided with a plurality of elastic straps  44 . Each strap  44  has a left portion  45  and a separate right portion  46 . The left portion  45  and the right portion  46  are joined together by means of a buckle  47  that allows the length of the straps  44  to be selected. The straps  44  are opened to allow the subject don the vest, and are then closed so as to create a tight fit of the vest over the subject&#39;s trunk.  
         [0024]     The film  5  is formed from an air impervious material such as polyurethane or latex. The film  5  forms the portion of the vest that is to be applied to a subject&#39;s back ( FIG. 5   b ). The front of the vest is formed from an inelastic material  6  that may be for example a non-woven cellulose based material.  
         [0025]      FIG. 6  shows the vest  48  after having been donned by a subject  21 . The vest  48  is donned with the film  5  over the subject&#39;s back in direct contact with the skin. After donning, the lengths of the elastic straps  44  are determined so that the vest  48  fits snugly on the subject and the film  5  is applied firmly to the subject&#39;s skin. A medical device may then be applied to the film  5  as described above for the embodiment of  FIG. 1 .