Patent Publication Number: US-2017360593-A1

Title: Holder for a stoma dressing

Description:
The invention relates to a holder for a stoma dressing. 
     A stoma is an artificial opening in the human or animal body and can function to discharge faecal matter or urine or bile or to facilitate the respiration. In the latter case the term “tracheostoma” is used. Where in the present application the term “stoma” is used, however, a stoma is meant which is placed to facilitate the discharge of faecal matter and urine. In such situations, the term “ileostoma” is used to indicate a stoma that is connected to the small intestine, or “colostoma”, to indicate a stoma that is connected to the large intestine, or “urostoma”, to indicate a stoma that functions to discharge urine. 
     Usually the stoma wound is covered by a stoma dressing (also called collecting material or skin flange), possibly provided with an ostomy pouch for collecting the faecal matter. It will be understood that said dressing (or skin flange) must be replaced at regular intervals, on which occasion the stoma wound must be cleaned. 
     Such a stoma dressing is known, for example from International patent publication WO2013/142577. Such a stoma dressing usually comprises two wall surfaces secured together along their circumferential edges to define a collection cavity. One of the wall surfaces is provided with an opening to be placed around the stoma, such that faecal matter can be received in the collection cavity. To that end an adhesive barrier is provided around the opening in the wall surface, so that an adequate, durable and above all moisture-tight connection of the stoma dressing to the skin directly surrounding the stoma wound is ensured. 
     In another type of stoma dressing, a flange is applied around the stoma wound, to which flange a separate ostomy pouch can be connected. The ostomy pouch is in that case replaced more often, whilst the flange is only exchanged after 2-3 days. 
     Generally, however, stoma dressings are intended for single or short use and must be exchanged regularly, therefore. When the stoma dressing is being exchanged, the clean stoma dressing adheres best to the body (to the skin surrounding the stoma wound) if the temperature of the stoma dressing, and in particular of the adhesive barrier, is about the same as the skin temperature. 
     The stoma patient is to that end advised to heat the clean stoma dressing by rubbing it with his hands or temporarily putting the dressing under his armpits or under his waistband. 
     International patent publication no. WO95/011644 A1 discloses a style having a heated tip for use as an auxiliary device in this regard. The user must touch the location of the adhesive barrier of the already applied clean stoma dressing with the heated style so as to heat the adhesive barrier and thus realise the desired adhesive effect. 
     The application method proposed therein is laborious, however, and uncomfortable for the stoma patient, since displacement or incomplete local heating of the adhesive barrier will lead to an incorrect, not very durable and above all not moisture-tight connection of the stoma dressing to the skin surrounding the stoma wound. 
     The object of the invention is to provide a solution to the above-described drawbacks, and in order to achieve that object a holder for a stoma dressing is proposed which comprises an envelope which encloses a space, in which space the stoma dressing can be placed, as well as heating means for heating the stoma dressing. 
     In this way a uniform and complete heating of the stoma dressing prior to the application thereof around the stoma wound is realised, so that the stoma dressing can be correctly applied around the stoma wound in one go without displacement of the dressing, whilst furthermore an adequate, durable and above all moisture-tight connection is obtained. 
     The envelope may in particular be closable, in which case the closable envelope is provided with a zip fastener or one or more press-studs, or with a Velcro closure or a magnetic closure. In addition to the fact that in this way a quick(er) and (more) uniform heating of the stoma dressing to the desired treatment temperature (skin temperature) is realised, the use of a closable envelope for storing and pre-heating stoma dressings is also desirable for hygienic reasons. Being able to close the holder is furthermore desirable for reasons of thermal insulation. 
     With a view to realising a quick and effective heat transfer to the stoma dressing, the heating means are provided in the envelope at the location of this space. In this way there is substantially direct contact between the heating means and the stoma dressing present in the envelope, which reduces the heating time. 
     The heating means comprise one or more heating wires worked into the envelope. In this way a direct and effective heat transfer is ensured, and in addition the entire space in which the stoma dressing is present is heated, thus guaranteeing a uniform heating of the stoma dressing. 
     The latter leads to an adequate, durable and above all moisture-tight connection of the stoma dressing to the skin surrounding the stoma wound. 
     The heating means comprise a power supply, which is connected to the heating wires. The power supply is capable of being switched on and off; preferably it is also rechargeable. 
     In another embodiment, the envelope is provided with a further envelope, in which the power supply can be accommodated. 
     In addition to that, in another embodiment the heating means are provided with heating time setting means for setting a heating time, or with temperature setting means for setting a heating temperature. In this way the holder can be adjusted by the stoma patient in a user-friendly manner, making it possible to set the heating time on the one hand or a maximum heating temperature on the other hand. In another functional embodiment, the duty cycle can be set as a percentage, for example 100%-75%-50%-25% of the output of the power supply, thereby realising a pulsed heating action by the heating means. 
     In all cases the stoma dressing is prevented from being heated too long or to a too high temperature, which might cause damage to the skin upon application of the stoma dressing. 
     In another functional embodiment, the envelope is made of a fabric, so that it is easy to produce. 
    
    
     
       The invention will now be explained in more detail with reference to a drawing in which: 
         FIG. 1  is a first view of an embodiment of a stoma dressing holder according to the invention; 
         FIG. 2  is a second view of an embodiment of a stoma dressing holder according to the invention; 
         FIG. 3  is a detailed view of an embodiment of a stoma dressing holder according to the invention; 
         FIG. 4  is another detailed view of an embodiment of a stoma dressing holder according to the invention. 
     
    
    
     For a better understanding of the invention, corresponding parts shown in the various figures will be referred to by identical numerals in the description of the figures below. 
     In  FIG. 1  a first view of an embodiment of a stoma dressing holder according to the invention is shown. 
     The holder for the stoma dressing is indicated at  10  and forms an envelope which envelopes or encloses a space  15 . The envelope is preferably made up of a first layer of fabric  11  and a second layer of fabric  12 , which are joined at their circumferential edges  13 . The two layers of fabric  11  and  12  are not joined at one circumferential edge portion, so that the space  15  formed by the two layers of fabric  11  and  12  can be accessed. One of the layers of fabric  11  or  12 , in this case layer  12 , may be provided with a flap  14  that can be folded over the open circumferential edge portion, so that the space  15  can (more or less) be closed. 
     In  FIG. 2  another side of the stoma dressing holder according to the invention is shown. The layer of fabric  12  is provided with a further layer of fabric  20  on this side, which layer of fabric  20  is provided on top of the layer of fabric  12 , thus forming a further envelope. Said further envelope can preferably be closed using suitable closure means  22 , in the form of a zip fastener in  FIG. 2 . It is also possible, however, to use other closure means  22 , for example a press-stud or a magnetic closure, or a Velcro-based closure. Said further additional layer of fabric  20  is provided with a see-through window  21 , whose function will be explained hereinafter. 
     Although the holder  10  is described herein as an envelope made up of two first and second layers of fabric  11  and  12 , respectively, which are joined near their circumferential edges  13 , the layers  11  and  12  need not be made of a fabric. The two layers  11  and  12  may also be made of a different kind of material, for example plastic. Furthermore, the layers  11  and  12  may be made of one double-folded strip (of fabric), with one of the joined circumferential edges  13  forming the folded edge. 
     The envelope described with reference to  FIGS. 1 and 2  is intended to receive a stoma dressing. Stoma dressings are provided with an opening that is to be placed around the stoma wound, and with an adhesive barrier for attachment to the skin directly surrounding the stoma wound. Such stoma dressings are usually intended for single or short use and must be exchanged regularly, therefore. It has been found that when the stoma dressing is exchanged, the clean stoma dressing adheres best to the body if the temperature of the stoma dressing, and in particular of the adhesive barrier around the stoma dressing of the collection cavity, is about the same as the temperature of the patient&#39;s skin. 
     The holder  10  according to the invention is for that purpose provided with heating means for heating the clean stoma dressing, which is to that end temporarily placed in the space  15  of the envelope holder  10 . 
     An embodiment of the heating means is shown in  FIG. 3  and  FIG. 4 . The heating means shown therein comprise an electrical heating element  25 , which is provided in one (or both) of the layers  11 - 12  of the envelope holder  10  in the form of an electrical heating wire. 
     For the sake of clarity of the invention, numerals  11   a - 12   a  indicate the outer side of the layers  11  and  12 , respectively, whilst numerals  11   b  and  12   b  represent the inner side of the two layers, which inner sides  11   b - 12   b  face one another in the space  15 . According to the invention, the heating means are provided in the inner layer  11   b  or  12   b  of the layers  11  or  12 . 
     The electrical heating wire  25  is arranged in the form of several envelopes or windings  25 ′ over the entire inner layer area  11   b - 12   b  of the layers  11  and/or  12 . As a result, a maximum area of contact between the inner layers  11   b  and/or  12   b  and the stoma dressing present in the space  15  is realised, so that an optimum heat transfer from the electrical heating wire  25  to the stoma dressing takes place. This results in a uniform but above all quick heating of the stoma dressing, which can thus be evenly but also quickly heated to about the temperature of the patient&#39;s skin. In this way also the adhesive barrier will quickly and homogeneously reach the temperature that corresponds to the temperature of the patient&#39;s skin, resulting in a better adhesion of the stoma dressing to the skin surrounding the stoma wound and thus to an adequate, durable and above all moisture-tight connection. 
     It should be noted that the space  15  formed by the envelope holder  10  can be closed, preferably by means of a flap  14 , as shown in  FIG. 1 . The holder  10  may or may not be provided with additional closure means, analogously to the closure means  22  that close the further envelope  20 . The closure means by which the space  15  of the envelope holder  10  can be closed may consist of a zip fastener or one or more press studs, or of a magnetic closure or, for example, a Velcro closure, in which case Velcro material will be present both on the inner side of the flap  14  and on the portion of the outer side  11   a  (or  12   a ) of the layer  11  (or  12 ) that is brought into contact with the flap  14 . 
     As shown in  FIG. 3 , the electrical heating wire  25  is worked into the envelope, and in particular into the inner side  11   b - 12   b  of the layer  11  and/or  12 , in the form of loops  25 ′. The electrical heating wire  25  is further provided with terminal ends  25   a - 25   b , to which a power supply (power source) can be connected. The power supply may in particular be a power supply that is capable of being switched on and off; more in particular it may be a rechargeable power supply. In a very functional embodiment, the power supply in question is accommodated in the further envelope  20 , in which envelope  20  it is connected to the wire ends  25   a  and  25   b , which to that end project from the layer of fabric  11   b  or  12   b  and extend into the further envelope  20  for being suitably connected to the terminals of the power supply. The heating wire  25  may on the other hand be a wire which is configured as a bundle comprising a large number of conducting wires. 
     On the other hand, the holder can be connected to a 110V/220V power source. 
     The power supply accommodated in the further envelope  20  may be provided with suitable setting means, such as an on-off button that can be operated by being pressed by the user. For this purpose the transparent part  21  of the further envelope  20  is used, behind which the power supply provided with the setting means can be placed, enabling the user (the stoma patient) to suitably switch the power supply on and off through the transparent window. 
     In the case of further functionality, the setting means are provided with time setting means, so that the power supply is activated for a certain, preferably preset heating time upon being switched on and is automatically switched off after said heating time has elapsed. 
     In another, suitable embodiment the heating time is preset in the setting means, which time setting is of a permanent nature. In another, more functional embodiment, the heating time can be set as desired in dependence on the type of stoma dressing and the varying properties of the associated adhesive barrier. It should be emphasised in this regard, however, that with all the different types of stoma dressings the heating times can be set so that the stoma dressing in question will have been brought to the correct temperature corresponding to the patient&#39;s skin temperature once the respective, separately adjusted heating time has lapsed. 
     Furthermore, the temperature can be increased in steps during a certain heating time (a fixed heating time or a heating time to be set by the user), for example by adjusting the output of the power supply in steps of 25%-50%-75%-100% of its maximum output. 
     In another, more complex embodiment, the setting means are provided with a temperature sensor which measures the heating temperature that prevails in the envelope  15  and automatically switches off the power supply when the desired, maximum heating temperature is reached. 
     In all these functional embodiments, the stoma dressing is prevented from being heated too long or to a too high temperature, which may lead to irritation or injury upon application of the stoma dressing to the skin. Nor can the stoma dressing be heated for too short a period of time, as a consequence of which the adhesive barrier would be heated insufficiently for realising an adequate, durable and above all moisture-tight connection to the skin. 
       FIG. 4  shows in more detail an embodiment of the way in which the electrical heating wire  25  is worked into a layer  11  or  12  of an envelope holder according to the invention. 
     In this embodiment, each layer  11  or  12  is made up of an outer side layer  11   a  ( 12   a ) and an inner side layer  11   b  ( 12   b ), respectively. The inner side layers  11   b  ( 12   b ) form the space  15  in which the stoma dressing is accommodated. Between the outer side layer  11   a  ( 12   a ) and the inner side layer  11   b  ( 12   b ), the heating wire  25  is provided in several loops or windings  25 ′, whilst the two layers  11   a - 11   b  ( 12   a - 12   b ) are joined at the locations indicated by numerals  11   c - 12   c . In this way channel-shaped spaces  11   d - 12   d  are formed, in which the electrical heating wire  25  is accommodated. In this embodiment the electrical heating wire  25  is made up of a bundle comprising a large number of conducting wires  250 , which may optionally be enveloped in a sheath  25   a . Said large number of conductor wires  250  may also be provided in the layers  11  ( 12 ) in the form of a bundle (without a sheath  25   a ). 
     It will be understood, however, that also other types of heating wires may be worked into the layers of material  11  or  12 .