WO2011123018A1 - Procédé de fabrication de plaquettes de fixation au corps pour dispositifs de stomie - Google Patents

Procédé de fabrication de plaquettes de fixation au corps pour dispositifs de stomie Download PDF

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Publication number
WO2011123018A1
WO2011123018A1 PCT/SE2011/050302 SE2011050302W WO2011123018A1 WO 2011123018 A1 WO2011123018 A1 WO 2011123018A1 SE 2011050302 W SE2011050302 W SE 2011050302W WO 2011123018 A1 WO2011123018 A1 WO 2011123018A1
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WO
WIPO (PCT)
Prior art keywords
cutting
body attachment
stoma
cutting geometry
geometry
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Application number
PCT/SE2011/050302
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English (en)
Inventor
Päranders WÄRJA
Original Assignee
Mölnlycke Health Care Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mölnlycke Health Care Ab filed Critical Mölnlycke Health Care Ab
Publication of WO2011123018A1 publication Critical patent/WO2011123018A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices

Definitions

  • the present invention relates to a method of manufacturing body attachment wafers for ostomy devices, a cutting device, a server, and a computer program prod- uct for use in the manufacturing of such body attachment wafers.
  • Ostomy devices typically include a body attachment wafer, which is to be attached to the skin of the user, and a stoma bag, which is attached to the body attachment wafer.
  • the body attachment wafer comprises a polymeric material layer and an adhesive layer and has an opening for the stoma. It is important that the opening is well adapted to the shape of the stoma, in order to prevent skin rash and leakage. Therefore, the opening is often adapted to the individual shape of the stoma by means of cutting with a pair of scissors.
  • Some body attachment wafers have markings printed on the surface thereof to make the cutting easier. The patient using the ostomy device is often assisted by a nurse in cutting the opening, even though some patients may cut the body attachment wafer opening themselves.
  • EP 1 832 256 discloses an adhesive wafer for an ostomy pouch, which includes a release sheet with printed guidelines for enabling a user to cut the wafer to a desired aperture size.
  • the adaption of the stoma opening of the body attachment wafer by cutting it to the suitable shape is a tedious task that often requires assistance from a nurse or the like, and it is difficult to obtain an accurate adaption of the opening. Therefore, it would be desirable to provide a method for manufacture of body attachment wafers, which are adapted to the individual shape of the stoma of each user, which method is less labour-intensive. Summary of the invention
  • the present invention relates to a method of manufacturing body attachment wa- fers for ostomy devices as defines in the appended claims.
  • the method comprises the steps of obtaining an image of the individual stoma of a patient; translating the image of the stoma into a first cutting geometry and providing said first cutting geometry with an identification code, and storing said first cutting geometry along with the identification code in a computer memory; providing a body attachment wafer blank; retrieving the first cutting geometry using the identification code; and cutting an opening for the stoma in the body attachment wafer blank according to said first cutting geometry; and repeating steps of providing a body attachment wafer blank; retrieving the first cutting geometry using the identification code; and cutting an opening for the stoma in the body attachment wafer blank according to said first cutting geometry, until a desired number of body attachment wafers have been obtained.
  • a method for efficiently manufacturing body attachment wafers, which are adapted to the individual shape of the stoma of each user, which is effective and economic.
  • the steps of providing a body attachment wafer blank; retrieving the first cutting geometry using the identification code; and cutting an opening for the stoma in the body attachment wafer blank according to said first cutting geometry, and repeating these steps until a desired number of body attachment wafers have been obtained, may be repeated on demand at a later point in time.
  • the method may fur- ther include marking of the body attachment wafer with the identification code.
  • the body attachment wafer blank used in the method is preferably a plastic film or hydrocolloid, having an adhesive coating on one side.
  • the adhesive coating preferably comprises a silicone gel adhesive.
  • the method may additionally comprise a further step, for retrieving a previously stored second cutting geometry for the outer contour of the body attachment wafer and a step for cutting said outer contour of the body attachment wafer. This step can be performed prior to, or after, or simultaneous with the step for cutting an opening for the stoma.
  • the body attachment wafer blank may be larger than the final outline of the body attachment wafer, preferably a continuous web, or may be pre-cut, such that it has the final outline of the body attachment wafer.
  • the method may further include adjusting the position of the cutting tool in relation to the position of the body attachment wafer blank so as to ensure that the open- ing for the stoma is cut out at the desired spot on the body attachment wafer.
  • the cutting is advantageously performed by laser cutting or water jet cutting, where laser cutting is the most preferred.
  • the present invention also relates to a device for use in manufacturing body attachment wafers, comprising cutting means, and comprising a processing unit wherein the processing unit being arranged to perform the steps of:
  • Another aspect of the invention is a server comprising a processing unit wherein the processing unit is arranged to perform the steps of:
  • the invention also relates to a computer program product for use in manufacturing body attachment wafers for ostomy devices, which comprises computer read- able code means, which when run in at least one processing unit causes the processing unit to perform the steps of: a) receiving an image of an individual stoma of a patient; b) translating the image of the stoma into a first cutting geometry; and c) enabling the first cutting geometry to be provided to a cutting device for cutting an opening for the stoma in a body attachment wafer blank according to the first cutting geometry.
  • the computer program product may further comprise computer readable code means, which when run in the at least one processing unit causes the at least one processing unit to further perform the steps of: d) providing the first cutting geometry with an identification code; e) storing said first cutting geometry along with the identification code in a memory unit; f) retrieving said first cutting geometry using the identification code from the memory unit; g) cutting an opening for the stoma in a body attachment wafer blank according to said first cutting geometry; and h) repeating steps f)-g) until a desired number of body attachment wafers have been obtained.
  • the code means of the computer program product is preferably stored on a readable storage medium.
  • Figure 1 shows a schematic view of a cutting equipment assembly that may be used in an example of the method for manufacturing customised body attachment wafers for ostomy devices.
  • Figure 2 is a top view of a body attachment wafer corresponding to the one to the left in Figure 1 .
  • Figure 3 shows a device for use in manufacturing body attachment wafers for ostomy devices, comprising a processing unit.
  • body attachment wafers can be provided, which are customised to the individual shape of the stoma of the user.
  • baseplates can be manufactured without labour intensive manual cutting and the stoma opening can be very accurately customised to the shape of the individual stoma.
  • the method of the invention includes the steps of
  • the body attachment wafer can be manufactured from a blank, which need not have such a pre-cut stoma opening, since the individual cutting geometry is retrieved from a computer memory and the opening can be cut di- rectly in the blank.
  • any number of baseplates can be obtained, repeating the cutting steps as desired.
  • the individual stoma opening cutting ge- ometry can be retrieved again and an additional number of customised baseplates can be manufactured.
  • Steps 3)-6) may advantageously be repeated on demand at a later point in time.
  • individually adapted baseplates may effectively be manufactured at any desired point in time, using the same cutting geometry, which was stored in the computer memory, thus avoiding the effort of preparation of a cutting geometry at this later point in time.
  • Cutting can be performed by means of any suitable cutting technique, which allows automatic cutting in accordance with a cutting geometry that has been retrieved from a computer memory.
  • the cutting is performed by laser cutting or water jet cutting, since they do not involve compression of the material to be cut, and the resulting cut is thus very smooth and clean.
  • a laser cut product can obtain a larger surface area in the cut, and will thus have an improved swelling performance as compared to a body attachment wafer cut with a pair of scissors.
  • the body attachment wafer material is a plastic film
  • laser cutting allows the body at- tachment wafer to include an adhesive coating of e.g. silicone gel adhesive that has a higher thickness, than is possible with compressing cutting techniques.
  • the image depicts the contour of the individual stoma, and is e.g. a negative reproduction of the stoma.
  • the stoma shape disclosed by the image is then trans- lated into a cutting geometry by means of suitable translation equipment, such as CAD.
  • the cutting geometry is provided with an identification code so that it can be retrieved on demand as desirable, and is stored together with the identification code in a computer memory.
  • the image may e.g. be a photograph, a sketch, or a digital reproduction of the shape of the stoma, or a body attachment wafer in which a hole has been cut by hand.
  • a casting or 3D-scanned image of the stoma may also be used as basis for the image.
  • the translation of the image into a cutting geometry may include an operation in which the image is transformed into a digital representation, such as scanning. In case the image is originally a digital reproduction of the shape of the stoma, such transformation is not needed.
  • the method may further include a step for receiving an image of the individual stoma of the patient, especially in case the manufacturer of the baseplates does not obtain the stoma image in direct connection to manufacturing equipment, or when the image is obtained by another party, e.g. the user himself or medical staff.
  • the image may preferably include a size indicating means, so as to ensure that the stoma opening is cut in correct size.
  • a body attachment wafer blank for cutting an opening for the stoma according to the individual cutting geometry.
  • the opening for the stoma is cut out in the central area of the body attachment wafer blank.
  • the blank is typically a sheet of plastic film or hydrocolloid having an adhesive coating on at least one side.
  • the adhesive layer is preferably a silicone gel adhesive, since such adhesive is very skin friendly.
  • a release sheet which may be made of paper, plastic film, foam layer or the like, may be arranged on the adhesive layer, so as to function as a protective layer, which facilitates handling of the body attachment wafer blank.
  • Suitable materials for body attachment wafer blanks may be a thin flexible plastic film, for example a thin polyurethane plastic film as described in WO 2006/075950.
  • the thin plastic film may have a thickness of less than 100 ⁇ , preferably 10-50 ⁇ .
  • the blank may also be provided with a carrier layer, particularly in case the plastic film is very thin.
  • the function of the carrier layer is to support the plastic film and to provide steadiness, so as to facilitate handling of the blank. Therefore, the carrier layer typically has a higher stiffness than the plastic film, and may be made of paper, which advantageously is polyethylene-coated, or a plastic film, foam layer or the like.
  • a second cutting geometry for the outer contour of the body attachment wafer may also be stored in the computer memory.
  • the method may then also include a step 4a) for retrieving such a previously stored second cutting geometry for the outer contour of the body attachment wafer and a step 5a) for cutting said outer contour of the body attachment wafer, wherein step 5a) can be performed prior to, or after, or simultaneous with step 5.
  • step 5a) can be performed prior to, or after, or simultaneous with step 5.
  • the entire body attachment wafer can be cut out from a continuous web of body attachment wafer blank material in one single operation.
  • the body attachment wafer blank is larger than the final outline of the body attachment wafer.
  • the cutting geometry for the outer contour need typically not be adapted to the individual user of the body attachment wafer, but can be a standard outer contour geometry.
  • the computer memory may contain several different standard outer geometries, each of which could be retrieved as desired, depending on the demands of the individual user.
  • Cutting the outer contour by laser instead of previously used techniques, such as punching or die cutting, provides for an effective manufacturing, with no time required for change to a different cutting geometry and no need for space requiring storage of several different cutting tools.
  • body attachment wafer blank as a continuous web
  • a moving conveyor member may contribute to efficient handling of the finished body attachment wafers.
  • the body attachment wafer blank may be pre-cut in a separate cutting equipment assembly, such that it already has the final outline of the body attachment wafer.
  • This provides for a flexible manufacture of various kinds of body attachment wafers, because previously manufactured body attachment wafers having no stoma opening or a standard stoma opening can be individually adapted to the stoma shape of a particular user.
  • the pre-cut body attachment wafers are advantageously supplied to a conveyor belt, by means of which they are carried through the cutting area.
  • an opening in the carrier layer is first cut out by kiss cut by rotary die cutting (RDC) or laser cutting, while leaving the plastic film unaffected, and the cut out portion of the carrier layer is peeled off, so that an area of the plastic film is exposed, in which area the customised opening for the stoma is then to be cut.
  • RDC rotary die cutting
  • a portion of the carrier layer remains at the outer edge of the body attachment wafer and functions as a stiffening frame around the area in which the hole is cut.
  • the body attachment wafer blank is oriented in the cutting equipment so that the carrier layer is directed towards the cutting tool, typically upwards.
  • the carrier layer is kiss cut by RDC the blank is supported by a support member, such as a working table or a conveyor belt.
  • the release sheet is preferably removed before the opening in the carrier layer is kiss cut by RDC, because the adhesive layer and the release sheet may be too soft, i.e. not be rigid enough to provide sufficient support to the plastic film and carrier layer during the rotary die cutting. Therefore, there is a risk that the cut will not be sufficiently accurate, and pinholes may be created in the plastic film.
  • the method preferably includes a step of marking of the body attachment wafer with the identification code.
  • the marking may be printed or stamped directly on the body attachment wafer, or on a frame, which may be made of a paper or foamed polymeric material.
  • the marking may also be made by laser.
  • the step for cutting the stoma opening may include adjustment of the position of the cutting tool in relation to the position of the body attachment wafer blank so as to ensure that the opening for the stoma is cut out at the desired spot on the body attachment wafer.
  • the final body attachment wafer Prior or subsequent to the cutting of the customised hole the final body attachment wafer is provided with a protective release sheet on the adhesive side, if needed. Thereafter, the body attachment wafers are packed for shipping. If desired, a stoma bag adapted to the needs of the user may be attached to the body attachment wafer before packaging.
  • Figure 1 shows a schematic view of a cutting equipment assembly that can be used in the method for manufacturing body attachment wafers.
  • a cutting device 2 e.g. a laser cutting device is arranged above a support member 12, which may be stationary or moveable.
  • a body attachment wafer blank 3 is carried by the support member 12, and is cut by the cutting device 2.
  • the body attachment wafer blank include a plastic film 4, having an adhesive coating 5 and a release sheet 6 on one side.
  • the body attachment wafer blank is arranged on the support member so that the carrier layer is on top.
  • a body attachment wafer 1 1 is manu- factured by cutting an opening 8 in the carrier layer, leaving the plastic film unaffected.
  • the edge shape of the opening is cut in accordance with a cutting geometry that has been retrieved from a computer memory.
  • a customised stoma opening 10 is cut through all layers of the body attachment wafer blank, in accordance with an individual cutting geometry retrieved from the computer memory.
  • the outer contour of the body attachment wafer is also cut, in accordance with a selected cutting geometry that has been retrieved from a computer memory.
  • the portion of the carrier layer that remains between the cuts, i.e. between the opening in the carrier layer and outer edge of the body attachment wafer forms a frame 9 around the exposed plastic film in which the customised opening 10 is cut.
  • Figure 2 shows the body attachment wafer 1 1 of Figure 1 from above. As can be seen in Fig. 2 the frame 9 encircles the exposed plastic film, and the customised opening 10 is cut out in the plastic film.
  • Figure 3 shows a device 20 for use in manufacturing body attachment wafers for ostomy devices according to the embodiments of the method described above.
  • the device 20 may be a data server or data processing device.
  • the device 20 may comprise an input unit 21 , a processing unit 22, a memory unit 23 and an output unit 24.
  • the device 20 may also comprise or be connected to a cutting device 25.
  • the input unit 21 , the processing unit 22, the memory unit 23 and the output unit 24 may be provided as one physical unit, or alternatively as a plurality of logically interconnected units.
  • the processing unit 22 may comprise processing means or logic for performing the functionality of the device 20 according to the method as described in the previous embodiments. This functionality may be implemented partly by means of a software or computer program.
  • the processing unit 22 may also comprise storage means or memory units for storing such a computer program 23A or processing means and a computer processor, such as a microprocessor, for executing the computer program 23A.
  • the storage means may be a readable storage medium. Alternatively, the storage means may be comprised in the memory unit 23 which is separated from, but connected to the processing unit 22.
  • the input unit 21 , the processing unit 22, the memory unit 23 and/or the output unit 24 performs a certain function or operation it is to be understood that the input unit 21 , the processing unit 22, the memory unit 23 and/or the output unit 24 may use the processing means or logic to execute a certain part 23A1 -23AN of the program 23A which is stored in the storage means.
  • the input unit 21 may be arranged to receive an image of an individual stoma of a patient.
  • the input unit 21 may be arranged to communicate with other electronic devices, such as, for example, another data server or data processing device, a digital camera or a scanning device, etc.
  • the input unit 21 may comprise a wired or wireless network access connection to a communication network (e.g. a local area network, the internet, etc.) through which it may receive the image, or a USB/memory card connection such that the image may be received from a USB-memory stick or memory card.
  • the input unit 21 may also be arranged to retrieve the image from the other electronic devices with which it is arranged to communicate with or be connected to.
  • the processing unit 22 may be arranged to translate the image of the individual stoma of a patient received by the input unit 21 into a first cutting geometry of a body attachment wafer for ostomy devices.
  • the processing unit 22 may also be arranged to enable the first cutting geometry to be provided to a cutting device for cutting an opening for the stoma in a body attachment wafer blank according to the first cutting geometry. According to a first alternative, this may be performed by directly outputting the first cutting geometry through the output unit 24 to a cutting device 25.
  • the output unit 24 may be arranged to communicate with the cutting device 25 using, for example, a wired direct connection to the cutting device 25 (e.g. data buss connection) or a wired/wireless network access connection to a communication network over which the cutting device 25 is also arranged to communicate.
  • the processing unit 22 may be arranged to provide the first cutting geometry with an identification code and store the first cutting geometry along with the identification code in the memory unit 23.
  • the first cutting geometry may thus be retrieved by the processing unit 22 from the memory unit 23 by using the identification code, and be provided to the cutting device 25 for cutting an opening for the stoma in a body attachment wafer blank according to the first cutting geometry. The latter may be repeated until a desired number of body attachment wafers have been obtained.
  • the processing unit 22 may be arranged to store the first cutting geometry along with the identification code in an external memory unit.
  • the processing unit 22 may be connected to or arranged to communicate with the external memory unit using the output unit 24.
  • the first cutting geometry may thus be retrieved by the cutting device 25 from the memory unit 23 provided that the cutting device 25 comprises the identification code and that the cutting device 25 is arranged to communicate with the external memory unit.
  • the first cutting geometry may be provided to the cutting device 25 for cutting an opening for the stoma in a body attachment wafer blank according to the first cutting geometry. The latter may be repeated until a desired number of body attachment wafers have been obtained.
  • a user may, for example, prepare an image of the stoma himself, or be assisted by a nurse or the like.
  • the image is then forwarded to the body attachment wafer manufacturer, where a manufacturing order is created, which is designated an identification code, and/or order number.
  • the image is translated into a cutting geometry and a desired number of body attachment wafer blanks are produced, which are packed and sent to the user.
  • the user needs more body attachment wafers, he can easily send an order to the manufacturer, and additional body attachment wafers can efficiently be produced.
  • the user may send a test image to the manufacturer, who may produce a small number body attachment wafers to low cost, which can be tried out by the user.
  • the customised opening in the body attachment wafer does not fit the user sufficiently well, he can send another image to the manufacturer, and body attachment wafers can be used which have a better fit.
  • the present invention could further allow the user to put an order for body attachment wafer manufacture via the internet, for example by sending a digital photograph of the stoma to the manufacturer, who can manufacture the body attachment wafers based on the photograph and other information given by the user. In a later stage, the user may easily order further body attachment wafers by putting an order which refers to the previous order.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente invention a pour objet un procédé de fabrication de plaquettes de fixation au corps pour dispositifs de stomie comprenant les étapes consistant : à obtenir une image de la stomie individuelle d'un patient ; à traduire l'image de la stomie en une première géométrie de coupe et à attribuer à ladite première géométrie de coupe un code d'identification, et à stocker ladite première géométrie de coupe ainsi que le code d'identification dans la mémoire d'un ordinateur ; à prévoir une ébauche de plaquette de fixation au corps ; à récupérer la première géométrie de coupe à l'aide du code d'identification ; et à couper et à ouvrir pour la stomie dans l'ébauche de plaquette de fixation au corps selon ladite première géométrie de coupe ; et à répéter les étapes consistant à prévoir une ébauche de plaquette de fixation au corps ; à récupérer la première géométrie de coupe à l'aide du code d'identification ; et à couper et à ouvrir pour la stomie dans l'ébauche de plaquette de fixation au corps selon ladite première géométrie de coupe jusqu'à ce que l'on ait obtenu un nombre désiré de plaquettes de fixation au corps ; et un dispositif comprenant des moyens de coupe, un serveur et un produit de programme informatique destinés à être utilisés dans le procédé.
PCT/SE2011/050302 2010-03-29 2011-03-18 Procédé de fabrication de plaquettes de fixation au corps pour dispositifs de stomie WO2011123018A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US31841910P 2010-03-29 2010-03-29
SE1050296 2010-03-29
SE1050296-1 2010-03-29
US61/318,419 2010-03-29

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WO2019120431A1 (fr) * 2017-12-22 2019-06-27 Coloplast A/S Outils et procédés pour découper des trous dans un appareil de stomie
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US11737907B2 (en) 2019-01-31 2023-08-29 Coloplast A/S Moisture detecting base plate for an ostomy appliance and a system for determining moisture propagation in a base plate and/or a sensor assembly part
US11786392B2 (en) 2017-12-22 2023-10-17 Coloplast A/S Data collection schemes for an ostomy appliance and related methods
US11819443B2 (en) 2017-12-22 2023-11-21 Coloplast A/S Moisture detecting base plate for a medical appliance and a system for determining moisture propagation in a base plate and/or a sensor assembly part
US11865029B2 (en) 2017-12-22 2024-01-09 Coloplast A/S Monitor device of a medical system having a connector for coupling to both a base plate and an accessory device
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US11918506B2 (en) 2017-12-22 2024-03-05 Coloplast A/S Medical appliance with selective sensor points and related methods
US11931285B2 (en) 2018-02-20 2024-03-19 Coloplast A/S Sensor assembly part and a base plate for a medical appliance and a device for connecting to a base plate and/or a sensor assembly part
WO2024098101A1 (fr) * 2022-11-09 2024-05-16 Tan Jason Jit Sun Procédé et système de barrière cutanée personnalisée pour stomie
US11986418B2 (en) 2017-12-22 2024-05-21 Coloplast A/S Medical system and monitor device with angular leakage detection
US11998474B2 (en) 2018-03-15 2024-06-04 Coloplast A/S Apparatus and methods for navigating ostomy appliance user to changing room
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