WO2011070373A1 - Procédé de modification d'un élément adhésif et procédé de fabrication d'un appareil de stomie - Google Patents

Procédé de modification d'un élément adhésif et procédé de fabrication d'un appareil de stomie Download PDF

Info

Publication number
WO2011070373A1
WO2011070373A1 PCT/GB2010/052071 GB2010052071W WO2011070373A1 WO 2011070373 A1 WO2011070373 A1 WO 2011070373A1 GB 2010052071 W GB2010052071 W GB 2010052071W WO 2011070373 A1 WO2011070373 A1 WO 2011070373A1
Authority
WO
WIPO (PCT)
Prior art keywords
cover member
removable cover
flange
opening
incision
Prior art date
Application number
PCT/GB2010/052071
Other languages
English (en)
Inventor
Neil Wiltshire
Peter Argent
Original Assignee
Salts Healthcare Limited
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 Salts Healthcare Limited filed Critical Salts Healthcare Limited
Priority to EP10793289A priority Critical patent/EP2509545A1/fr
Publication of WO2011070373A1 publication Critical patent/WO2011070373A1/fr

Links

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
    • A61F5/448—Means for attaching bag to seal ring
    • 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
    • A61F5/4404—Details or parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B26—HAND CUTTING TOOLS; CUTTING; SEVERING
    • B26D—CUTTING; DETAILS COMMON TO MACHINES FOR PERFORATING, PUNCHING, CUTTING-OUT, STAMPING-OUT OR SEVERING
    • B26D3/00—Cutting work characterised by the nature of the cut made; Apparatus therefor
    • B26D3/08—Making a superficial cut in the surface of the work without removal of material, e.g. scoring, incising
    • B26D3/085—On sheet material

Definitions

  • This invention relates to a method of modifying an adhesive member. More particularly, but not exclusively, this invention relates to a method of modifying a body-side flange or pouch flange for an ostomy appliance, and to a method of manufacturing an ostomy appliance.
  • a stoma is a surgically constructed tube of a user's digestive tract that protrudes through a user's skin and allows for waste to be collected therefrom. It is known to provide a user with an ostomy appliance including a pouch which has an opening to receive the stoma.
  • a flange portion of the pouch is provided with an adhesive member (e.g. a hydrocolloid wafer, covered by a removable cover member) for adhering the pouch either directly to a user's skin surrounding the stoma (known as a one-piece appliance) or for adhering the pouch to a body-side flange, which itself is adhered to the user's skin around their stoma (known as a two-piece appliance).
  • Each flange has an opening therethrough (for receipt of the stoma) which is, conventionally, created by a rotary die cutting process. The rotary die cuts through the hydrocolloid layer and the removable cover member (in that order) to create the opening.
  • waste from the user's digestive tract is expelled through the stoma and is collected in the pouch.
  • the user then either replaces the pouch or drains the collected waste from the pouch (if the pouch provides for such draining - usually by the provision of a resealable aperture at a lower part of the pouch).
  • ostomy pouches One common problem with known ostomy pouches is that if a good seal around the stoma is not provided leaks can occur which can cause damage to the skin around the user's stoma . This can result in irritation and great discomfort to the user.
  • a device having an opening (to receive the stoma) surrounded by a peripheral wall , and a flange part connected to the peripheral wall, the flange part extending substantially perpendicularly (e.g. radially) away from the opening.
  • the peripheral wall of the device is elastically deformable, so as to provide, in use, a fluid-tight seal between the peripheral wall and the user's stoma, thus preventing leakage etc..
  • the device is typically manufactured in a variety of sizes - e.g. a range of opening diameters - and the user can select the size which will match, as closely as possible, the external diameter of their stoma.
  • the device is typically manufactured using a moulding process, for example injection moulding techniques which are well known in the art, and the material used is, typically, polyurethane (e.g. that known as AlphathaneTM), although any other suitable material could be util ised .
  • injection moulding is beneficial, because the thickness (and thus the force required to stretch the opening) of the peripheral wall can be controlled to a tight tolerance. This is important, because a decreased elasticity could render the device harder for a user to position around their stoma and could possibly give rise to discomfort if the fit between the device and the stoma is too tight.
  • the device is positioned by the user over their stoma.
  • the user then removes the removable cover member from the pouch flange or body-side flange (as the case may be for one- and two-piece appliances) and positions the pouch flange or body-side flange on top of the device.
  • the user applies pressure so as to adhere the pouch flange or body-side flange to the device and to their skin.
  • the user then adheres the pouch flange to the body-side flange.
  • One problem with this configuration is that it is time-consuming for the user to install, which is an issue if the user requires a number of installations per day.
  • due to the adhesive nature of the flanges it can often be the case that the flange becomes adhered to a wall part of the device which can increase the difficulty of installation.
  • a method of modifying an adhesive member said adhesive member having an adhesive surface which is covered by a removable cover member, characterised in that the method includes the step of making an incision in the removable cover member using a laser, said incision defining a portion of the removable cover member which can be removed separately from the remainder of the removable cover member.
  • the laser may be directed onto a surface of the removable cover member and may make an incision only in the removable cover member.
  • the incision may originate at a periphery of the removable cover member.
  • the incision may extend inwardly towards a central region of the removable cover member.
  • the method may include the further step of removing a portion of the removable cover member so as to expose a portion of the adhesive surface thereof.
  • the adhesive member may be a body-side flange or pouch flange for an ostomy appliance, the flange including an opening for receiving a user's stoma.
  • a portion of the removable cover member adjacent the opening in the body- side flange or pouch flange may be removed.
  • the incision may extend inwardly towards the opening.
  • the incision may extend around the opening in the flange.
  • the incision around the opening may be substantially circular.
  • the removed portion of the removable cover member may be substantially annular.
  • an ostomy appliance including:- a pouch for receipt of waste; a pouch flange connected to the pouch, the pouch flange having an opening communicating with an interior of the pouch, wherein a surface of the pouch flange which in use faces a user includes an adhesive for adhering the pouch flange to either a user's skin or a body-side flange, the adhesive surface being is covered by a removable cover member; and
  • a device for surrounding a user's stoma having an opening, surrounded by a peripheral wall, to receive the stoma, and a flange part connected to the peripheral wall, which flange part extends substantially perpendicularly away from the opening;
  • the method includes the steps of:- making an incision in the removable cover member using a laser, said incision extending substantially around the opening and defining a portion of the removable cover member which can be removed separately from the remainder of the removable cover member;
  • the laser may be directed onto a surface of the removable cover member and may make an incision only in the removable cover member.
  • the incision may originate at a periphery of the removable cover member.
  • the incision may extend inwardly towards the opening, and then may extend around the opening.
  • the incision may extend radially inwardly towards the opening.
  • the incision around the opening maybe substantially circular.
  • the removed portion of the removable cover member may be substantially annular.
  • Figure 1 is a side cross-sectional view of a device for surrounding a user's stoma;
  • Figure 2 is a plan view of the device of figure 1 ;
  • Figure 3 is a side cross-sectional view of an ostomy appliance in accordance with the second aspect of the invention.
  • Figure 4 is a plan view of a pouch flange with a removable cover member connected thereto.
  • the device 10 for use with an ostomy appliance.
  • the device 10 has an opening 12, surrounded by a substantially cylindrical peripheral wall 1 3 which in this example is less than or equal to 0.2mm in thickness. In use, and discussed in more detail below, the opening 12 receives a stoma (not shown).
  • the device 10 also includes an annular flange part 14 which is connected to and extends substantially perpendicularly away from one end of the peripheral wall 13. The flange part 14 extends substantially radially away from an axis 16 of the opening.
  • the flange part 14 and the peripheral wall 1 3 are connected by a curved portion 1 5 which extends away from the axis 1 6 of the open ing 1 2 as it extends from the peripheral wall 13 to the flange part 14.
  • the curved portion 15 between the peripheral wall 13 and the flange part 14 assists a user in centring the opening 12 over their stoma.
  • the peripheral wall 1 3 tapers towards the axis 1 6 of the opening 12 as it extends away from the flange part 14. This aids in providing an interference, fluid-tight, seal between the peripheral wall 13 and the user's stoma.
  • the internal diameter of the opening 12 should be selected such that it is 3mm to 6mm smaller than the external diameter of the user's stoma, as this provides for an adequate interference, fluid-tight, seal. It has been found that the following dimensions are appropriate for use:-
  • the taper is at an angle of 6° , but is must be appreciated that other angles of taper could be utilised.
  • the tapering of the peripheral wall 13 provides for compact storage of one or more like devices 10, as they can be stacked one on top of each other, with the peripheral wall 13 of one device 10 received in the opening 12 of an adjacent device 10.
  • the device 10 is manufactured as a one-piece component using a moulding process, for example injection moulding. It should be appreciated, however, that any other appropriate forming process can be used.
  • the device 10 is manufactured from a polyurethane material (e.g. that known as AlphathaneTM) and is, as a result, elastically deformable. This material property is essential for the device 10, as it ensures a fluid-tight fit with a user's stoma. It should be appreciate that other materials could be used so long as they provide for adequate elastic deformation of the opening 12.
  • a polyurethane material e.g. that known as AlphathaneTM
  • AlphathaneTM polyurethane material
  • FIG. 4 shows a pouch flange 30 which has been modified using the method according to the first aspect of the invention.
  • the flange 30 has an opening 38 for receiving a user's stoma and has an adhesive surface (provided by a hydrocolloid layer 31 ) which is covered by a removable cover member 32.
  • the opening 38 can be increased in size, depending on the size of the stoma which it is intended to receive.
  • An incision 35, 36 has been made in the removable cover member 32 using a laser.
  • the laser is directed onto the exterior surface of the removable cover member 32 to make the incision 35, 36.
  • the laser originates the incision 35 at a periphery of the removable cover member 32 and from there the laser is moved radially inwardly towards the opening 38 such that the incision 35 also extends radially inwardly towards the opening 38.
  • the laser Once the laser reaches a predetermined distance from the opening 38 (slightly further away from the axis of the opening 38 than the radius of the flange part 14 of the device 10), the laser changes direction and moves in a circular path so as to make a circular incision 36 around the opening 38.
  • the incisions 36 therefore defines an annular portion 32a of the removable cover member 32 which can be removed separately from the remainder of the removable cover member 32. It should be appreciated that two or more lasers could be used to make the incisions 35, 36.
  • FIG 3 shows cross-sectional view of an ostomy appliance 20 which has been manufactured in accordance with the second aspect of the invention.
  • the ostomy appliance 20 has a pouch 21 , to receive waste, and a body-side flange 31 connected to the pouch 21 .
  • the flange 31 is identical to the flange 31 discussed above, albeit that the opening 38 has been increased in size.
  • the appliance 20 includes a device 10 (as described and shown in figures 1 and 2), the flange part 14 of which is adhered to an exposed adhesive surface 33 of the flange 31 .
  • the annular portion 32a of the removable cover member 32 is removed thus exposing an annular adhesive surface 33 of the flange 31 .
  • the peripheral wall 13 is then inserted through the opening 38 until the flange part 14 abuts the exposed annular adhesive surface 33 of the flange 31 .
  • Pressure is then applied at that interface to ensure that the parts adhere satisfactorily to each other.
  • the appliance 20 is then ready for a user to install, and this is achieved in the normal way, as is well known in the art.
  • the flange 31 (whether or not connected to a pouch) may be provided with or without a device 10 connected thereto. In the latter case, the user can connect the device to the flange 31 in the way described above.
  • the laser may be used to make an incision of any desired shape, and in any desired direction.
  • the incision may originate in a central region of the removable cover member or elsewhere on the removable cover member.
  • incisions could be made in the removable cover member 32, e.g. concentric circular incisions, with it being left to the user to decide which annular ring(s) of removable cover member need to be removed for their size of device 10 (as defined by the diameter of their stoma).
  • the incision need not be continuous - it may have interruptions along its length (e.g. perforated).
  • the method in accordance with the present invention could be utilised in connection with any adhesive member which is covered by a removable cover member.
  • the method could be used on the removable cover member of an adhesive wound dressing, an adhesive wound management device, an adhesive plaster or the like.
  • the method can be used on any adhesive member which is covered by a removable cover member.

Landscapes

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

Abstract

L'invention porte sur un procédé de modification d'un élément adhésif, ledit élément adhésif possédant une surface adhésive recouverte par un élément de fermeture amovible, caractérisé en ce que le procédé comprend l'étape consistant à faire une incision dans l'élément de fermeture amovible à l'aide d'un laser, ladite incision définissant une partie de l'élément de fermeture amovible pouvant être retirée séparément du reste de l'élément de fermeture amovible. L'invention porte également sur un procédé de fabrication d'un appareil de stomie, l'appareil comportant une poche destinée à recevoir des déchets, une bride (30) de poche reliée à la poche. La bride de poche comporte une ouverture (38) communiquant avec l'intérieur de la poche, une surface de la bride du sac faisant face, en utilisation, à un utilisateur et comprenant un adhésif (31) destiné à coller la bride de la poche soit à la peau d'un utilisateur soit à une bride latérale du corps, la surface adhésive étant recouverte par un élément de fermeture amovible (32), et un dispositif (10) destiné à entourer une stomie d'un utilisateur, le dispositif comportant une ouverture (12) entourée par une paroi périphérique (13) et une partie de bride (14) reliée à la paroi périphérique.
PCT/GB2010/052071 2009-12-10 2010-12-10 Procédé de modification d'un élément adhésif et procédé de fabrication d'un appareil de stomie WO2011070373A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP10793289A EP2509545A1 (fr) 2009-12-10 2010-12-10 Procédé de modification d'un élément adhésif et procédé de fabrication d'un appareil de stomie

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0921645.8A GB2476081B (en) 2009-12-10 2009-12-10 A method of manufacturing an ostomy appliance
GB0921645.8 2009-12-10

Publications (1)

Publication Number Publication Date
WO2011070373A1 true WO2011070373A1 (fr) 2011-06-16

Family

ID=41666908

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2010/052071 WO2011070373A1 (fr) 2009-12-10 2010-12-10 Procédé de modification d'un élément adhésif et procédé de fabrication d'un appareil de stomie

Country Status (3)

Country Link
EP (1) EP2509545A1 (fr)
GB (1) GB2476081B (fr)
WO (1) WO2011070373A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1987000121A1 (fr) * 1979-04-09 1987-01-15 Avery International Corporation Etiquette dont le support presente des lignes d'entailles discontinues et procede de production
EP0800804A1 (fr) * 1996-04-10 1997-10-15 Bristol-Myers Company Fabrication d'appareils d'ostomie personnalisés
WO2004062536A1 (fr) * 2003-01-10 2004-07-29 Coloplast A/S Appareillage stomique
US20050033249A1 (en) 2003-08-08 2005-02-10 Whiteford Bruce W. Adapter arrangement, ostomy appliance, and methods
GB2458662A (en) * 2008-03-26 2009-09-30 Salts Healthcare Ltd Ostomy appliance with alignment positioning means

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3081771A (en) * 1961-04-19 1963-03-19 Clarence I Lee Ileostomy device
CA1146829A (fr) * 1977-10-17 1983-05-24 James L. Chen Plaque pour sac de drainage doublee d'une barriere cutanee
US5000748A (en) * 1986-01-02 1991-03-19 Marlen Manufacturing & Development Company Ostomy drainage receptacle
GB8812096D0 (en) * 1988-05-21 1988-06-22 Smith & Nephew Ass Adhesive sheet
GB2340398C (en) * 1998-08-13 2007-03-16 Bristol Myers Squibb Co Improvements relating to ostomy pouches
CA2398376C (fr) * 2000-01-28 2009-03-10 Coloplast A/S Sac collecteur
ES2303215T3 (es) * 2005-06-21 2008-08-01 Fameccanica.Data S.P.A. Procedimiento y dispositivo para cortar articulos por laser, en particular unos productos sanitarios y sus componentes, con un punto de laser de diametro comprendido entre 0,1 y 0,3 mm.
GB2457763B (en) * 2008-02-27 2012-06-06 Welland Medical Ltd Improved filter and method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1987000121A1 (fr) * 1979-04-09 1987-01-15 Avery International Corporation Etiquette dont le support presente des lignes d'entailles discontinues et procede de production
EP0800804A1 (fr) * 1996-04-10 1997-10-15 Bristol-Myers Company Fabrication d'appareils d'ostomie personnalisés
WO2004062536A1 (fr) * 2003-01-10 2004-07-29 Coloplast A/S Appareillage stomique
US20050033249A1 (en) 2003-08-08 2005-02-10 Whiteford Bruce W. Adapter arrangement, ostomy appliance, and methods
GB2458662A (en) * 2008-03-26 2009-09-30 Salts Healthcare Ltd Ostomy appliance with alignment positioning means

Also Published As

Publication number Publication date
GB0921645D0 (en) 2010-01-27
GB2476081A (en) 2011-06-15
GB2476081B (en) 2015-11-18
EP2509545A1 (fr) 2012-10-17

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