WO2011070372A1 - Procédé de modification d'une partie élément d'un appareil de stomie - Google Patents

Procédé de modification d'une partie élément d'un appareil de stomie Download PDF

Info

Publication number
WO2011070372A1
WO2011070372A1 PCT/GB2010/052070 GB2010052070W WO2011070372A1 WO 2011070372 A1 WO2011070372 A1 WO 2011070372A1 GB 2010052070 W GB2010052070 W GB 2010052070W WO 2011070372 A1 WO2011070372 A1 WO 2011070372A1
Authority
WO
WIPO (PCT)
Prior art keywords
component part
incision
peripheral wall
stoma
laser
Prior art date
Application number
PCT/GB2010/052070
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
Publication of WO2011070372A1 publication Critical patent/WO2011070372A1/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
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • 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
    • A61F5/443—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type, e.g. gels, starches, karaya gums
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K26/00—Working by laser beam, e.g. welding, cutting or boring
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K26/00—Working by laser beam, e.g. welding, cutting or boring
    • B23K26/36—Removing material
    • B23K26/38—Removing material by boring or cutting
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0208—Biopsy devices with actuators, e.g. with triggered spring mechanisms
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K2101/00—Articles made by soldering, welding or cutting
    • B23K2101/04—Tubular or hollow articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K2103/00—Materials to be soldered, welded or cut
    • B23K2103/30—Organic material
    • B23K2103/42—Plastics
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K2103/00—Materials to be soldered, welded or cut
    • B23K2103/50—Inorganic material, e.g. metals, not provided for in B23K2103/02 – B23K2103/26

Definitions

  • This invention relates to a method of modifying a component part of an ostomy appliance. More particularly, but not exclusively, this invention relates to a method of modifying a device intended to surround a stoma of a user.
  • 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 body-side portion of the pouch is provided with an adhesive member for adhering the pouch to a user's skin surrounding the stoma . In use, 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 utilised .
  • 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.
  • One issue, however, with these devices is their compatibility with length of a user's stoma.
  • stomas come in a variety of lengths and it may often be the case that the length of the peripheral wall of the device is too long for a user's stoma.
  • the desired range of lengths, in combination with the variety of diameters required would have given rise to substantial manufacturing costs, because a specific mould is required for each combination of opening diameter and wall length.
  • the current situation is that the device is only manufactured in one length, but this has several disadvantages.
  • peripheral wall which needs to be removed without first placing the device over the stoma.
  • User's may attempt to cut the wall to length when the device is in situ, which is dangerous and can result in injury to the user, particularly if they have poor sight.
  • a method of modifying a component part of an ostomy appliance including the step of making an incision in the component part using a laser.
  • a laser in this way means that, for example, a device for surrounding a user's stoma can be cut to a user's desired length, before it is purchased by them.
  • the device can be manufactured (e.g. injection moulded) with only one length of peripheral wall, which can then be cut to length as desired. This reduces, considerably, manufacturing costs and renders the device more easy to use by the end user.
  • the incision may result in the removal of a portion of the component part.
  • the incision may result in the shortening of a portion of the component part.
  • the method may include the step of making a continuous, e.g. circumferential, incision in the component part.
  • the component part may be a device for surrounding a stoma, the device including an opening, to receive the stoma, surrounded by a peripheral wall, and the method including the step of making an incision in the peripheral wall of the device.
  • the method includes the step of making an incision in the peripheral wall so as to remove a portion of the wall, thus reducing its length.
  • the incision may be continuous and may extend circumferentially around the peripheral wall.
  • the laser used may be a CO2 laser, or alternatively any laser which is capable of cutting the material.
  • gas, solid state, dye, diode, green light and excimer lasers could be used.
  • Figure 1 is a side cross-sectional view of a device for use with an ostomy appliance.
  • Figure 2 is a plan view of the device of figure 1 .
  • 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 1 3. 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 opening 12 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
  • the device 10 is manufactured with a relatively long peripheral wall 13, which ends at an end face 36.
  • This length of peripheral wall 13 would be required by a user having a long stoma.
  • the peripheral wall 13 up to the end face 36 is too long for the user, its length can be reduced using the method of the present invention. This is achieved by making an incision in the peripheral wall 13 along, for example, one of the circumferentially extending lines 31 , 32, 33, 34 or 35 using a laser (or any desired axial position along the peripheral wall 13).
  • the incision is, preferably, a continuous incision and results in the removal of a length of the peripheral wall 13, thus shortening the peripheral wall 13, to the desired length.
  • the incision can be made in a number of ways - all that is required is to effect some form of relative movement between the device and the laser.
  • the device 10 may be supported on a rotatable mandrel which then effects rotation of the device 10 relative to a stationary laser angled so as to direct its beam radially onto the surface of the rotating device 10.
  • the laser makes the incision around the peripheral wall 13 as the device 10 is rotated by the mandrel.
  • the device 10 may be supported by a mandrel, but the mandrel may not rotate and instead the laser may be caused to rotate around the device 10 so as to make the incision therein, again with the laser angled so as to direct its beam radially onto the surface of the rotating device 10.
  • the device 10 may be supported and then moved unidirectionally through a stationary laser.
  • the laser may make the incision laterally through the wall 13 like a knife cutting axially through a carrot.
  • the device 10 may be supported in a fixed position, with the laser being moved unidirectionally (e.g. laterally) through the device 10, so as to make the incision. Again, the laser would make an incision through the wall 13 like a knife cutting axially through carrot.
  • the laser could make (when viewed laterally as shown in figure 1 ) V-shaped, convex or concave incisions, or indeed any shape to conform to the shape of a user's stoma. Examples of these shapes are shown in figure 1 in dotted lines 38, 39 and 40.
  • the laser used to make the incision in the device 10 is a CO2 laser, which is well known in the art of lasers.
  • any suitable laser could be utilised so long as it is capable of making an incision in the device 10, whatever material the device 10 is manufactured from.
  • the incision need not be continuous - it may have interruptions along its length (e.g. perforated).
  • multiple incisions e.g. multiple rings of perforations
  • the perforations can be made small enough such that they do not permit easily the passage of fluid.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mechanical Engineering (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Forests & Forestry (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)

Abstract

L'invention porte sur un procédé de modification d'une partie élément d'un appareil de stomie. Le procédé comprend l'étape consistant à faire une incision dans la partie élément à l'aide d'un laser.
PCT/GB2010/052070 2009-12-10 2010-12-10 Procédé de modification d'une partie élément d'un appareil de stomie WO2011070372A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0921643.3A GB2476080B (en) 2009-12-10 2009-12-10 A method of modifying a component part of an ostomy appliance
GB0921643.3 2009-12-10

Publications (1)

Publication Number Publication Date
WO2011070372A1 true WO2011070372A1 (fr) 2011-06-16

Family

ID=41666906

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2010/052070 WO2011070372A1 (fr) 2009-12-10 2010-12-10 Procédé de modification d'une partie élément d'un appareil de stomie

Country Status (2)

Country Link
GB (1) GB2476080B (fr)
WO (1) WO2011070372A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0800804A1 (fr) * 1996-04-10 1997-10-15 Bristol-Myers Company Fabrication d'appareils d'ostomie personnalisés
FR2816227A1 (fr) * 2000-11-09 2002-05-10 Air Liquide Procede de coupage laser a haute vitesse avec gaz adapte
GB2425482A (en) * 2005-04-28 2006-11-01 Maria Theresa Callus Skin barrier for stoma patients
WO2007099500A1 (fr) * 2006-02-28 2007-09-07 Ostomycure As Implant, procede d'implantation de l'implant et procede pour sa fabrication

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1146829A (fr) * 1977-10-17 1983-05-24 James L. Chen Plaque pour sac de drainage doublee d'une barriere cutanee
GB2351237B (en) * 1998-08-13 2001-06-13 Bristol Myers Squibb Co Improvements relating to ostomy pouches
ATE389497T1 (de) * 2005-06-21 2008-04-15 Fameccanica Data Spa Verfanren und vorrichtung zum laserschneiden von artikeln, insbesondere sanitärprodukten und ihren bestandteilen, mit einem laserfokuspunktdurchmesser von 0.1 bis 0.3 mm
GB2457763B (en) * 2008-02-27 2012-06-06 Welland Medical Ltd Improved filter and method

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0800804A1 (fr) * 1996-04-10 1997-10-15 Bristol-Myers Company Fabrication d'appareils d'ostomie personnalisés
FR2816227A1 (fr) * 2000-11-09 2002-05-10 Air Liquide Procede de coupage laser a haute vitesse avec gaz adapte
GB2425482A (en) * 2005-04-28 2006-11-01 Maria Theresa Callus Skin barrier for stoma patients
WO2007099500A1 (fr) * 2006-02-28 2007-09-07 Ostomycure As Implant, procede d'implantation de l'implant et procede pour sa fabrication

Also Published As

Publication number Publication date
GB2476080B (en) 2016-03-09
GB2476080A (en) 2011-06-15
GB0921643D0 (en) 2010-01-27

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