CUTTING GUIDE FOR OSTOMY APPLIANCES

Abstract: A method for making a customised ostomy appliance including an adhesive wafer comprising the steps: measuring the outer periphery of the stoma of the patient, recording the information relating to the measurements of the stoma area, transforming the recorded information into electronic form, utilising the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to the ostomy appliance, in which method the information is utilised for printing a cutting guide pattern on a material for adhering to the adhesive wafer offers a simple and efficient method of customising ostomy appliances.

Description: TITLE Cutting Guide for Ostomy Appliances Field of the invention The present invention relates to a method for making a customised ostomy devices of the type including a waste collection pouch adapted to be adhesively affixed to the skin surrounding the stoma and more particularly to cutting guides for ostomy devices customised to the stomal periphery of the user and a method for fabricating such cutting guides. Description of the related Art In connection with surgery for a number of diseases in the gastro-intestinal tract a consequence is, in many cases, that the colon, the ileum or the urethra has been exposed surgically and the patient is left with an abdominal stoma and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma. Also in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening. Ostomy appliances are well known. Such appliances may be two-piece or one-piece appliances. In both types of appliances, a body side member is attached to the wearer's abdomen, and optionally a receiving member or bag is attached to the body side ostomy member for receiving exudates from the ostomy in case of a two-piece appliance. The body side member comprises an adhesive wafer for securing the device to the wearer's abdomen, said wafer having a hole for accomodating the ostomy and conveying the material discharged through the artificial orifice or opening into the collection bag. Wafers and ostomy devices are manufactured in a variety of different standard shapes, sizes and configurations to meet the many different needs of the users. Although these standard products meet the needs of the average user, they do not ideally meet the needs of any particular individual. In most cases, the user must adapt the product prior to use to suit his or her anatomy or lifestyle. Typical modifications which can be performed include cutting of the stoma receiving opening in the wafer, trimming the outside of the wafer, addition of convex inserts, application of paste and filters and folding or trimming the pouch. However, even these modifications may not result in an ideal product for the particular individual. Users may have difficulty in performing the modifications, as well. This may be due to poor dexterity, poor eyesight or diminished mental capacity. Some desired modifications may be very difficult or impossible without special equipment. Some users may see making such modifications as taking too much time or for other reasons to be an undesirable task. Thus, because of difficulties or simple reluctance on the part of the user, the modifications to the products are done poorly and as a result, product performance may suffer. European patent publication No. EP 800 804 discloses the fabrication of customised ostomy devices according to which the ostomy devices are produced having attributes selected according to measurement information obtained from the respective patient. This solution, however, involves substantial logistic problems with respect to producing, storing and distributing the customised products. It is the general object of this invention to eliminate the above problems by fabricating ostomy devices which are customised so as to be uniquely suited to the needs and preferences of each individual user. This object may be achieved in a variety of different ways, using technologies of different sophistication and cost. BRIEF DESCRIPTION OF THE INVENTION The present invention relates to a method for making a customised ostomy appliance including an adhesive wafer comprising the steps: measuring the outer contour/periphery of the stoma of the patient, recording the information relating to the measurements of the stoma area, transforming the recorded information into electronic form, utilising the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to the ostomy appliance. Further, the invention relates to a method for making a customised ostomy appliance including an adhesive wafer and a collection bag comprising the steps: measuring the outer contour of the stoma of the patient, recording the information relating to the measurements of the stoma area, transforming the recorded information into electronic form, utilising the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to the ostomy appliance. Furthermore, the invention relates to a release liner having a customised printed cutting guide pattern corresponding to the outer contour of the stoma of a patient. Still further, the invention relates to a label having an adhesive for adhering to the release liner of an ostomy appliance, said label comprising a customised printed cutting guide pattern corresponding to the stomal area of a patient. Yet further, the invention relates to a customised ostomy appliance including an adhesive wafer having a stoma receiving opening, attachment means for attaching an ostomy collection bag and a customised printed pattern indicating a cutting line for adapting the appliance to the specific ostomate. Furthermore, the invention relates to a customised ostomy appliance including an adhesive wafer having a stoma receiving opening and an ostomy collection bag and a customised printed pattern indicating the a cutting line for adapting the appliance to the specific ostomate. DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a method for making a customised ostomy appliance including an adhesive wafer comprising the steps: measuring the outer contour of the stoma of the patient, recording the information relating to the measurements of the stoma area, transforming the recorded information into electronic form, utilising the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to the ostomy appliance, wherein the information is utilised for printing a cutting guide pattern on a material for adhering to the adhesive wafer. The method offers a simple and efficient method of customising ostomy appliances without involving substantial logistic problems with respect to producing, storing and distributing the customised products. The information is preferably stored in electronic form together with information identifying the patient in a manner known per se and then be used for controlling the printing of a customised cutting guide or pattern for the patient. The printing may be carried out in-line by printing directly on the material on finished ostomy appliance as a last step or in an earlier separate step. In use, the printed cutting guide is placed on the adhesive wafer or the release liner and the hole of the wafer is adapted to the periphery of the stoma of the specific patient. Such cutting may be performed by the patient or by the person being in charge of delivering the ostomy appliances to the patient, typically a nurse or other assistant persons, e.g. in the patient's home, in a clinic or in a hospital. It is also foreseen that the cutting may be performed by a manufacturer or distributor who is then able to deliver customised products directly to the users by mail. Another embodiment of the invention relates to a method for making a customised ostomy appliance including an adhesive wafer and a collection bag comprising the steps: measuring the outer contour of the stoma of the patient, recording the information relating to the measurements of the stoma area, transforming the recorded information into electronic form, utilising the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to the ostomy appliance, wherein the information is utilised for printing a cutting guide pattern on a material for adhering to the adhesive wafer. In one embodiment of the invention the pattern is printed on a release liner for placing on the adhesive wafer which enables simple production of series of customised ostomy appliances. In another preferred embodiment the pattern is printed on a material having an adhesive backing for placing on the release liner which enables a customising of the ostomy appliance just before delivery which is cost saving with respect to transportation and storing of customised ostomy appliances. The pattern typically delivered in the form of a number of adhesive labels enabling an easy and simple customisation of a standard product. In a further aspect, the invention relates to a release liner having a customised printed cutting guide pattern corresponding to the stomal area of a patient. The pattern defining the cutting line may obtained by recording the information relating to the measurements of the stoma area of the patient, transforming the recorded information into electronic form, optionally storing the data and utilising the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to the release liner utilising the information for printing the cutting guide pattern on a material for covering to the adhesive wafer. In a still further and preferred aspect the invention relates to a label having an adhesive for adhering to the release liner of an ostomy appliance having a stoma receiving opening, said label comprising a customised printed cutting guide pattern corresponding to the stomal area of a patient. The customised pattern defining the cutting line may be obtained by recording the information relating to the measurements of the stoma area of the patient, transforming the recorded information into electronic form, optionally storing the data and utilising the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to an adhesive label utilising the information for printing the pattern on a material having an adhesive backing. The invention furthermore relates to a customised ostomy appliance including an adhesive wafer having a stoma receiving opening, attachment means for attaching an ostomy collection bag and a customised printed pattern indicating the cutting line for adapting the appliance to the specific ostomate. The customised pattern defining the cutting line is defined after measuring the outer contourof the stoma of the patient, recording the information relating to the measurements of the stoma area, transforming the recorded information into electronic form, optionally storing the data and utilising the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to the ostomy appliance wherein it has been utilised for printing the pattern on a material for covering the adhesive wafer. In a still further embodiment, the invention relates to a customised ostomy appliance including an adhesive wafer having a stoma receiving opening and an ostomy collection bag and a customised printed pattern indicating the cutting line for adapting the appliance to the specific ostomate. The cutting line is defined by measuring the outer contour of the stoma of the patient, recording the information relating to the measurements of the stoma area, transforming the recorded information into electronic form, optionally storing the data and utilising the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to the ostomy appliance wherein it has been utilised for printing the pattern on a material for covering the adhesive wafer. The adhesive wafer of an ostomy appliance may be made from any appropriate skin friendly material known per se for the purpose and may also comprise a top film known per se. The skin-friendly adhesive may be any skin-friendly adhesive known per se, e.g. an adhesive comprising hydrocolloids or other moisture absorbing constituents for prolonging the time of use. The adhesive may suitably be of the type disclosed in those disclosed in GB patent specifications Nos. 1 280 631 and 1 ,586,182, in EP published applications Nos. 0 097 846, 0 264 299, 0 272 149 and 0 415 183, , in WO publication No. 88/06894, and in US patent specification No. 3,419,006, 3,972,328, 4,538,603 and 4,867,748. Especially preferred are the adhesives disclosed in US patents Nos. 4,367,732, 5,051 ,259 and 5,714,225. The attachment means for attaching an ostomy collection bag may be a system known per se comprising matching coupling rings or matching flanges and adhesive surfaces. A release liner may for instance be siliconized paper. It does not need to have the same contour as the dressing, e.g. a number of dressings may be attached to a larger sheet of protective cover. The protective cover is not present during the use of the dressing of the invention and is therefore not an essential part of the invention. A label may be prepared from any appropriate material which may be provided with a suitable adhesive for adhering the label to the release liner and hold it in place when cutting along the cutting guide as long as the materials are compatible and the adhesive has no adverse effect on the ostomy appliance. The printing of the cutting line may carried out using any suitable manner known per se for printing on the material in question. A collection bag may be any suitable conventional collection bag known per se.

Claims: CLAIMS 1. A method for making a customised ostomy appliance including an adhesive wafer comprising the steps: measuring outer contour of the stoma of the patient, recording the information relating to the measurements of the stoma area, trans- forming the recorded information into electronic form, utilising the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to the ostomy appliance, characterised in that the information is utilised for printing a cutting guide pattern on a material for adhering to the adhesive wafer. 2. A method for making a customised ostomy appliance including an adhesive wafer and a collection bag comprising the steps: measuring the outer periphery of the stoma of the patient, recording the information relating to the measurements of the stoma area, transforming the recorded information into electronic form, utilising the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to the ostomy applianace, characterised in that the information is utilised for printing a cutting guide pattern on a material for adhering to the adhesive wafer. 3. A method as claimed in claim 1 or 2, characterised in that the pattern is printed on a release liner for placing on the adhesive wafer. 4. A method as claimed in claim 1 or 2, characterised in that the pattern is printed on a material having an adhesive backing for placing on the release liner. 5. A release liner having a customised printed cutting guide pattern corresponding to the stomal area of a patient obtained by recording the information relating to the measurements of the stoma area of the patient. 6. A label having an adhesive backing for adhering to the release liner of an ostomy appliance having a stoma receiving opening, said label comprising a customised printed cutting guide pattern indicating the a cutting line for adapting the opening to the specific ostomate. 7. A customised ostomy appliance including an adhesive wafer having a stoma receiving opening, attachment means for attaching an ostomy collection bag and a customised printed pattern indicating a cutting line for adapting the opening to the specific ostomate. 8. A customised ostomy appliance including an adhesive wafer having a stόma receiving opening and an ostomy collection bag and a customised printed pattern indicating a cutting line for adapting the receiving opening to the specific ostomate.

Inventors: OTTO JENS LANDKILDE, OTTO, JENS, LANDKILDE
Applicants: COLOPLAST AS, OTTO JENS LANDKILDE, COLOPLAST A/S, OTTO, JENS, LANDKILDE
Application year: 1999
Main classification: A61F5
IPC codes: A61F5