Abstract:
A method and an apparatus for determining hyperhidrosis zones of a patient. A flexible sheet carrying a moisture-indicating substance is provided. The moisture indicating substance indicates hyperhidrosis zones, when the moisture-indicating substance is placed against the skin of a patient.

Description:
FIELD  
       [0001]     The present application relates to a flexible sheet to be applied to the skin of a patient to determine hyperhidrosis zones.  
       BACKGROUND  
       [0002]     One treatment of hyperhidrosis that has proven to be effective is botox injections into zones of hyperhidrosis, which correspond to the locations of sweat glands. The location of sweat glands is either determined by a direct observation of the skin by a doctor, or by applying an iodine-starch paste by hand to the target skin. The blackened areas of the iodine-starch past indicate the location of sweat glands. The iodine-starch procedure is messy, stains clothing and, unfortunately, must be repeated at each subsequent appointment.  
       SUMMARY  
       [0003]     There is provided an apparatus for determining hyperhidrosis zones of a patient, includes a flexible sheet carrying a moisture-indicating substance. The moisture indicating substance indicates hyperhidrosis zones when the moisture-indicating substance is placed against the skin of a patient. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0004]     These and other features will become more apparent from the following description in which reference is made to the appended drawings. The drawings are for the purpose of illustration only and are not intended to be in any way limiting, wherein:  
         [0005]      FIG. 1  is a perspective view of an embodiment of a sweat gland activity delineator consisting of one flexible sheet.  
         [0006]      FIG. 2  is a perspective view of another embodiment of a sweat gland activity delineator.  
         [0007]      FIG. 3  is a perspective view of the sweat gland activity delineator of  FIG. 1  with a cover sheet.  
         [0008]      FIG. 4  is a top-down view of an embodiment of a sweat gland activity delineator consisting of two flexible sheets.  
         [0009]      FIG. 5  is an exploded view of an embodiment of the sweat gland activity delineator of  FIG. 4 .  
         [0010]      FIG. 6  is an exploded view of a further embodiment of a sweat gland activity delineator consisting of two flexible sheets.  
         [0011]      FIG. 7  is a top-down view of the sweat gland activity delineator of  FIG. 6 .  
         [0012]      FIG. 8  is a perspective view of the sweat gland activity delineator of  FIG. 5  with a cover sheet.  
         [0013]      FIG. 9  is a perspective view of the sweat gland activity delineator of  FIG. 5  with a cover sheet, contained in an air-tight and moisture-free pouch.  
         [0014]      FIG. 10  is a view of the sweat gland activity delineator of  FIG. 5  in use on a human limb.  
         [0015]      FIG. 11  is a view of a human arm after the sweat gland activity delineator of  FIG. 5  has been applied, used, and removed.  
         [0016]      FIG. 12  is a view of the sweat gland activity delineator of  FIG. 6  in use on a human limb.  
         [0017]      FIG. 13  is a close-up view of several of the aligned perforations from the sweat gland activity delineator of  FIG. 6 . 
     
    
     DETAILED DESCRIPTION  
       [0018]     Structure and Relationship of Parts:  
         [0019]      FIG. 1  shows a first embodiment of a sweat gland activity delineator  10 , which is a flexible sheet  12  consisting of a first side  14  and a second side  15 . First side  14  carries a moisture-indicating substance  18 , such that moisture-indicating substance  18  indicates hyperhidrosis zones when placed against the skin of a patient. An adhesive layer  20 , adapted to adhere to the skin of a patient, is positioned on first side  14 . Adhesive layer  20  is preferably a hypoallergenic adhesive. A margin  22  denotes an area adjacent to side lengths  24  where no moisture indicating substance  18  is placed. In addition, there is a flap  26  having an area adjacent to one or more side lengths  24  of flexible sheet  12  which contains no adhesive layer  20  or moisture indicating substance  18 . This allows for easy removal of sweat gland activity delineator  10  from the skin of the patient without contacting moisture indicating substance  18 . It will be understood that margin  22  and flap  26  may be modified or removed, depending on the application. As an example, flap  26  of sweat gland activity delineator  10  may contain an area that extends one-inch perpendicularly inward from one of the side lengths  24 , while margin  22  has an area extending 0.5 inches perpendicularly inward from the parts of side lengths  24  that are not directly adjacent to flap  26 . In the embodiment shown, the word “HOLD” is written on flap  26  to instruct the user to hold flap  26 . Alternatively, other words or phrases, or nothing at all may be written on flap  26 . Moisture-indicating substance  18  is preferably a starch-iodine mixture, but may be other suitable substances. Adequate results have been obtained with moisture-indicating substance  18  being a mixture of dry iodine powder and dry starch powder. Moisture-indicating substance  18  is carried by or directly adhered to adhesive layer  20 . Second side  15  may be smooth, with no adhesive layer  20  or moisture-indicating substance  18 .  
         [0020]      FIG. 2  shows a second embodiment of a sweat gland activity delineator  10  consisting of a flexible sheet  12 . This embodiment contains all the same parts described above for the first embodiment with the addition that flexible sheet  12  contains a series of perforations  28 . Perforations  28  allow access to the skin through flexible sheet  12  by a marking instrument  30 , such as a pen, as is shown in relation to a further embodiment with respect to  FIG. 12 . Referring to  FIG. 2 , the word “HOLD” is written twice on flap  26  to demonstrate an alternative set of words that could be used to instruct the user to hold flap  26 .  
         [0021]      FIG. 3  shows the first embodiment of sweat gland activity delineator  10  wherein first side  14  of flexible sheet  12  is covered by a removable cover sheet  32 . Removable cover sheet  32  protects moisture-indicating substance  18  from undesired contact with moisture. It is important that moisture-indicating substance  18  be kept dry in order to work properly. Removable cover sheet  32  contains a cover sheet flap  34 . Cover sheet flap  34  has an area adjacent to one end  35  of removable cover sheet  32 . End  35  is positioned so that cover sheet flap  34  covers flap  26 . Removable cover sheet  32  attaches to flexible sheet  12  by adhering to adhesive layer  20 . Because flap  26  contains no adhesive and therefore does not adhere to flap  26 , cover sheet flap  34  can be easily gripped. Referring to  FIG. 3 , the phrase “PEEL OFF” is written on cover sheet flap  34  to instruct the user to remove removable cover sheet  32 . This appears on the side of removable cover sheet  32  that is not adhered to flexible sheet  12 . Alternatively, other words or phrases, or nothing at all may be written on cover sheet flap  34 . Removable cover sheet  32  may also contain arrows  37  that instruct the user to peel off removable cover sheet  32  in the direction indicated. The second embodiment of sweat gland activity delineator  10  operates by the same principles and contains the same parts as described above for the first embodiment. Preferably, sweat gland activity delineator  10  comes packaged in an air-tight, moisture-free pouch before use.  
         [0022]      FIG. 5  shows a third embodiment of sweat gland activity delineator  10  consisting of a first flexible sheet  36  and a second flexible sheet  38 . First flexible sheet  36  has a first side  40  and a second side  42 , and second flexible sheet  38  has a first side  44  and a second side  46 . First flexible sheet  36  and second flexible sheet  38  are permeable. First flexible sheet  36  contains a first part  45  of a two part moisture-indicating substance, and second flexible sheet  38  carries a second part  50  of the two part moisture-indicating substance. The two part moisture-indicating substance operates such that when the first part and the second part are brought together in the presence of moisture from the skin of a patient, they act to indicate hyperhidrosis zones. First part  45  consists of one of iodine or starch, and second part  50  consists of the other of iodine or starch. Alternatively, other suitable substances may be used as the two part moisture-indicating substance. Second flexible sheet  38  may be composed of fabric  52  that has had a solution of one of iodine and starch applied and then dried. In the embodiment shown in  FIG. 5 , fabric  52  has been pre-soaked with a solution of iodine and left to dry.  
         [0023]     Referring to  FIG. 5 , first side  44  of second flexible sheet  38  is positioned up against first side  40  of first flexible sheet  36 . In use, second side  46  of second flexible sheet  38  faces the skin of the patient. Positioned on first side  40  of first flexible sheet  36  is an adhesive layer  58 , designed to adhere to the skin of a patient, and also to second flexible sheet  38 . Adhesive layer  58  is composed of a hypoallergenic adhesive. First part  45  is carried by adhesive layer  58  by adhering first part  45  to an inner portion  62  of adhesive layer  58 . An outer portion  63  adheres to both the skin of the patient and second flexible sheet  38 . Outer portion  63  is free of first part  45  and second part  50 , with a margin  65  separating outer portion  63  from inner portion  62 .  FIG. 4  shows first flexible sheet  36  and second flexible sheet  38  in contact with each other.  
         [0024]     Referring to  FIG. 5 , a removable impermeable sheet  64  separates first part  45  and second part  50  of the two-part moisture-indicating substance. First part  45  is carried on first flexible sheet  36  and second part  50  is carried on second flexible sheet  38 . Removable impermeable sheet  64 , such as a thin piece of stiff fabric, prevents first part  45  and second part  50  of the two-part moisture-indicating substance from coming into contact before sweat gland activity delineator  10  is used. Removable impermeable sheet  64  is loosely held between first flexible sheet  36  and second flexible sheet  38  before use, and is not adhered to adhesive layer  58 .  
         [0025]     As shown in  FIG. 8 , second side  46  of second flexible sheet  38  is covered by a removable cover sheet  66 . Removable cover sheet  66  adheres to outer portion  63  of first flexible sheet  36 , and contacts both first flexible sheet  36  and second flexible sheet  38  before its removal. Removable cover sheet  66  protects first part  45  and second part  50  of the two-part moisture-indicating substance from undesired contact with moisture before use. First flexible sheet  36  has a flap  68 , which aids in handling sweat gland activity delineator  10 . Flap  68  contains no first part  45  or second part  50  of the two-part moisture indicating substance and adhesive layer  58 . Removable cover sheet  66  has a cover flap  69 , which is positioned over flap  68  of first flexible sheet  36 . Flap  68  allows removable cover sheet  66  to be peeled off easily before use, by gripping cover flap  69  with fingers. Flap  68  also allows sweat gland activity delineator  10  to be peeled off of the skin of the patient easily after use. In the embodiment shown in  FIG. 5 , flap  68  contains an area that extends one-inch perpendicularly outwards from an end  71  of first flexible sheet  36 . In addition, outer portion  63  contains an area that extends 0.5 inches perpendicularly outwards from one or more side lengths  73  of first flexible sheet  36 . Second flexible sheet  38  may also have a flap  67 , without either of first part  45  or second part  50  of the two-part moisture-indicating substance. Flap  67  covers a portion  61  of flap  68 . Also shown in the embodiment of  FIG. 5 , inner portion  62  contains powderized starch adhered to adhesive layer  58 .  
         [0026]     The word “HOLD” may be written on flap  68 , as shown in  FIGS. 4 and 5 . This is written to instruct the user to hold first flexible sheet  36  by flap  68 . Alternatively, other words or phrases may be written on flap  68 . The words “PEEL-OFF” may be written on cover flap  69 , as shown in  FIG. 8 . This is written to instruct the user to peel-off removable cover sheet  66  by flap  68 . Alternatively, other words or phrases may be written on cover flap  69 . In addition, arrows  60  appear on removable cover sheet  66 , to instruct the user to peel in the direction indicated. Referring to  FIG. 9 , sweat gland activity delineator  10  with attached removable cover sheet  66  comes contained in a sealed moisture-free pouch  70 .  
         [0027]      FIG. 6  shows a fourth embodiment of sweat gland activity delineator  10  consisting of a first flexible sheet  36  and a second flexible sheet  38 . This embodiment contains all the same parts described above for the third embodiment with the addition that both first flexible sheet  36  and second flexible sheet  38  contain a series of aligned perforations  54 . Aligned perforations  54  allow access to the skin through first flexible sheet  36  and second flexible sheet  38  by a marking instrument  30 , such as a pen, as is described in relation to a further embodiment with respect to  FIG. 12 .  FIG. 7  shows first flexible sheet  36  and second flexible sheet  38  of the fourth embodiment of a sweat gland activity delineator  10  in contact with each other.  
         [0028]      FIG. 10  shows the third embodiment of sweat gland activity delineator  10  in use on a skin surface  72  of a human patient. The first embodiment of sweat gland activity delineator  10 , operates by the same principles. Removable impermeable sheet  64  and removable cover sheet  66  have both been removed.  
         [0029]      FIG. 11  shows skin surface  72  from  FIG. 10 , after the third embodiment of sweat gland activity delineator  10  has been removed. The presence of sweat on skin surface  72  has moistened the dehydrated iodine and starch particles from sweat gland activity delineator  10 , and formed a dark blue complex. This complex has stained skin surface  72  dark blue over a zone of hyperhidrosis  74 . Zone of hyperhidrosis  74  is delineated by outline  76 . Outline  76  consists of markings made with marking instrument  30 .  
         [0030]      FIG. 12  shows the fourth embodiment of sweat gland activity delineator  10  in use on a skin surface  72  of a human patient. The second embodiment of sweat gland activity delineator  10  operates by the same principles. Removable impermeable sheet  64  and removable cover sheet  66  have both been removed. A zone of hyperhidrosis  74  is delineated by outline  76 , consisting of markings made with marking instrument  30 , made through aligned perforations  54 .  
         [0031]      FIG. 13  shows the hole spacing of aligned perforations  54  of the fourth embodiment of a sweat gland activity delineator  10 . Each perforation  54  shown has a diameter A of 3 millimetres. Individual perforations are separated by a distance B of 7 millimetres. The values for diameter A and distance B may differ from those described above, as long as both are consistent for any given sweat gland activity delineator  10 . The hole spacing described above for aligned perforations  54  are the same for series of perforations  28  of flexible sheet  12  from the second embodiment.  
       OPERATION OF THE FIRST EMBODIMENT  
       [0032]     The first embodiment of sweat gland activity delineator  10  is removed from the sealed, moisture-free package it comes contained within, similar to pouch  70  shown in  FIG. 9 . Referring to  FIG. 3 , cover sheet flap  34  is gripped with fingers, and removable cover sheet  32  is peeled off of first side  14  of flexible sheet  12 . Immediately, first side  14  of flexible sheet  12  is applied directly to skin surface  72  over a suspected zone of hyperhidrosis  74 , as shown in  FIG. 10  for the third embodiment of sweat gland activity delineator  10 . Light pressure is applied, which ensures good contact between skin surface  72  and sweat gland activity delineator  10 . The presence of sweat on skin surface  72  moistens the dehydrated iodine and starch particles, forming a dark blue complex. This complex stains skin surface  72  and flexible sheet  12  dark blue over zone of hyperhidrosis  74 . Sweat gland activity delineator  10  is held in contact with skin surface  72  for a sufficient amount of time. Gripping flap  26  with fingers, flexible sheet  12  is peeled off of skin surface  72  and disposed. Referring to  FIG. 11 , outline  76  is then drawn directly around zone of hyperhidrosis  74 , as indicated by dark staining present on skin surface  72 . Outline  76  is made using marking instrument  30 . After outline  76  is drawn, skin surface  72  is cleaned with moist gauze to remove any stain present as a result of the moisture-indicating substance  18 . Botox may then be applied to zone of hyperhidrosis  74 , in order to treat hyperhidrosis. If desired, a map may be made of zones of hyperhidrosis  74  for future treatments.  
       OPERATION OF THE SECOND EMBODIMENT  
       [0033]     The second embodiment of sweat gland activity delineator  10  is removed from the sealed, moisture-free package it comes contained within, similar to pouch  70  shown in  FIG. 9 . Referring to  FIG. 3 , cover sheet flap  34  is gripped with fingers, and removable cover sheet  32  is peeled off of first side  14  of flexible sheet  12 . Immediately, first side  14  of flexible sheet  12  is applied directly to skin surface  72  over a suspected zone of hyperhidrosis  74 , as shown in  FIG. 12  for the fourth embodiment of sweat gland activity delineator  10 . Light pressure is applied, which ensures good contact between skin surface  72  and sweat gland activity delineator  10 . The presence of sweat on skin surface  72  moistens the dehydrated iodine and starch particles, forming a dark blue complex. This complex stains skin surface  72  and flexible sheet  12  dark blue over zone of hyperhidrosis  74 . Sweat gland activity delineator  10  is held in contact with skin surface  72  for a sufficient amount of time. An outline  76  of zone of hyperhidrosis  74  is then made using marking instrument  30 , through series of perforations  28 . Gripping flap  26  with fingers, flexible sheet  12  is peeled off of skin surface  72  and disposed. After flexible sheet  12  is removed, skin surface  72  is cleaned with moist gauze to remove any stain present as a result of the moisture-indicating substance  18 . Botox may then be applied to zone of hyperhidrosis  74 , in order to treat hyperhidrosis. If desired, a map may be made of zones of hyperhidrosis  74  for future treatments.  
       OPERATION OF THE THIRD EMBODIMENT  
       [0034]     Referring to  FIG. 9 , the third embodiment of sweat gland activity delineator  10  is removed from sealed moisture-free pouch  70  it comes contained within. Gripping cover flap  69  with fingers, removable cover sheet  66  is peeled off of first flexible sheet  36 . Immediately, sweat gland delineator  10  is applied directly to skin surface  72 , as shown in  FIG. 12 , with second side  46  of second flexible sheet  38  below first flexible sheet  36  (as shown in  FIG. 5 ) contacting skin surface  72  over a suspected zone of hyperhidrosis  74 . Removable impermeable sheet  64 , shown in  FIG. 5 , is carefully removed, and light pressure is applied, which ensures good contact between skin surface  72  and sweat gland delineator  10 . Referring still to  FIG. 12 , the presence of moisture on skin surface  72  moistens second part  50  of the two-part moisture-indicating substance, and permeates second part  50  into contact with first part  45 , contained on first flexible sheet  36 , forming a dark blue complex. This complex stains skin surface  72 , first flexible sheet  36 , and second flexible sheet  38  dark blue over zone of hyperhidrosis  74 . Sweat gland activity delineator  10  is held in contact with skin surface  72  for a sufficient amount of time. Gripping flap  68  with fingers, sweat gland delineator  10  is peeled off of skin surface  72  and disposed of. Outline  76  is drawn directly around zone of hyperhidrosis  74 , as indicated by dark blue staining present on skin surface  72 , using marking instrument  30 . After outline  76  has been drawn, skin surface  72  is cleaned with moist gauze to remove any stain present as a result of the two-part moisture-indicating substance. Botox may then be applied to zone of hyperhidrosis  74 , in order to treat zone of hyperhidrosis  74 .  
       OPERATION OF THE FOURTH EMBODIMENT  
       [0035]     Referring to  FIG. 9 , the fourth embodiment of sweat gland activity delineator  10  is removed from sealed moisture-free pouch  70  it comes contained within. Gripping cover flap  69  with fingers, removable cover sheet  66  is peeled off of first flexible sheet  36 . Immediately, sweat gland delineator  10  is applied directly to skin surface  72 , as shown in  FIG. 12 , with second side  46  of second flexible sheet  38  below first flexible sheet  36  (as shown in  FIG. 7 ) contacting skin surface  72  over a suspected zone of hyperhidrosis  74 . Removable impermeable sheet  64 , shown in  FIG. 6 , is carefully removed, and light pressure is applied, which ensures good contact between skin surface  72  and sweat gland delineator  10 . Referring still to  FIG. 12 , the presence of moisture on skin surface  72  moistens second part  50  of the two-part moisture-indicating substance, and permeates second part  50  into contact with first part  45 , contained on first flexible sheet  36 , forming a dark blue complex. This complex stains skin surface  72 , first flexible sheet  36 , and second flexible sheet  38  dark blue over zone of hyperhidrosis  74 . Sweat gland activity delineator  10  is held in contact with skin surface  72  for a sufficient amount of time. Outline  76  of zone of hyperhidrosis  74  is then made using marking instrument  30 , through aligned perforations  54 . Gripping flap  68  with fingers, sweat gland delineator  10  is peeled off of skin surface  72  and disposed of. After outline  76  has been drawn, skin surface  72  is cleaned with moist gauze to remove any stain present as a result of the two-part moisture-indicating substance. Botox may then be applied to zone of hyperhidrosis  74 , in order to treat zone of hyperhidrosis  74 .  
       ADVANTAGES  
       [0036]     The teachings of the present invention provide an approach which speeds up the location of hyperhidrosis zones and makes the process less messy. It also provides an accurate “map” that can be used to provide a guide for use in locating hyperhidrosis zones on subsequent visits. This guide can also be used with methods used to treat the symptoms of hyperhidrosis, such as botox injection, by outlining the areas which require treatment.  
         [0037]     In this patent document, the word “comprising” is used in its non-limiting sense to mean that items following the word are included, but items not specifically mentioned are not excluded. A reference to an element by the indefinite article “a” does not exclude the possibility that more than one of the element is present, unless the context clearly requires that there be one and only one of the elements.  
         [0038]     It will be apparent to one skilled in the art that modifications may be made to the illustrated embodiment without departing from the spirit and scope defined in the Claims.