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EP-4611698-B1 - A BASEPLATE FOR AN OSTOMY APPLIANCE

EP4611698B1EP 4611698 B1EP4611698 B1EP 4611698B1EP-4611698-B1

Inventors

  • SAVITSKI, ALEXANDER
  • EVANS, JENNIFER
  • ELLIS, Matt

Dates

Publication Date
20260513
Application Date
20231101

Claims (15)

  1. A method of manufacturing a baseplate (100, 500, 600) configured to secure an ostomy appliance (300) to the body of a user, the method comprising providing a convex disc (110, 510, 610) and a collar (120, 520, 620), characterised in that the convex disc (110, 510, 610) is formed from a material that is more rigid than the collar (120, 520, 620) and the method comprises directing a laser beam onto the convex disc and collar to form a laser weld (130, 530a, 530b, 630) therebetween.
  2. A method according to claim 1 wherein the method includes absorbing part of the laser beam into the convex disc (110, 510, 610) to cause melting of the convex disc (110, 510, 610) during formation of the laser weld (130, 530a, 530b, 630).
  3. A method according to claim 2 wherein the method includes absorbing part of the laser beam into the collar (120, 520, 620) to cause melting of the collar (120, 520, 620) during formation of the laser weld (130, 530a, 530b, 630).
  4. A method according to claim 2 or 3 wherein the convex disc (110, 510, 610) comprises a thermoplastics material which volumetrically absorbs the laser beam to cause melting of the convex disc (110, 510, 610).
  5. A method according to any preceding claim wherein the laser beam has a wavelength of 1.2 to 2.2 µm.
  6. A method according to claim 5 wherein the laser beam has a wavelength of 1.6 to 2.2 µm.
  7. A method according to any preceding claim wherein the collar (120, 520, 620) is configured to secure the baseplate to the body of a user and comprises a stomal aperture (121, 521, 621).
  8. A method according to claim 7 wherein the collar (120, 520, 620) comprises a proximal surface (112) configured to contact the body of a user in use and the proximal surface (112) comprises an adhesive (124, 624).
  9. A method according to any preceding claim wherein the method comprises melting the convex disc (110, 510, 610) and/or collar (120, 520, 620) during formation of the laser weld (130, 530a, 530b, 630) wherein the part of the convex disc (110, 510, 610) and/or collar (120, 520, 620) that melts during formation of the laser weld (130, 530a, 530b, 630) is free from additives configured to absorb visible light.
  10. A method according to any preceding claim wherein the method comprises clamping the convex disc (110, 510, 610) and collar (120, 520, 620) together during formation of the laser weld (130, 530a, 530b, 630).
  11. A method according to claim 10 further comprising clamping the convex disc (110, 510, 610) and collar (120, 520, 620) between a support plate (410, 710) and a transfer plate (420, 720), wherein the transfer plate (420, 720) comprises a marking (721a) provided in relief on a clamping surface of the transfer plate (420, 720), and the method comprises clamping the transfer plate (420, 720) against the convex disc (110, 510, 610), and melting the convex disc (110, 510, 610) during formation of the laser weld (130, 530a, 530b, 630) such that a corresponding marking (613a) is formed in relief on a surface of the convex disc (110, 510, 610).
  12. A method according to any preceding claim wherein the method comprises directing the laser beam onto the collar (120, 520, 620) via the convex disc (110, 510, 610) and melting substantially the entire thickness of the convex disc (110, 510, 610) during formation of the laser weld (130, 530a, 530b, 630).
  13. A method of manufacturing an ostomy appliance comprising manufacturing a baseplate according to any of claims 1 to 12, providing a pouch configured to receive stomal output from the baseplate, and heat sealing the baseplate to the pouch.
  14. A method of forming a body fitment component for a two-piece ostomy pouch, the method comprising manufacturing a baseplate (100, 500, 600) according to any of claims 1 to 12 and providing the baseplate (100, 500, 600) with a coupling element for coupling to a corresponding coupling element on a pouch.
  15. A baseplate (100, 500, 600) for securing an ostomy appliance (300) to the body of a user comprising a convex disc (110, 510, 610), a collar (120, 520, 620), characterised in that the convex disc (110, 510, 610) is formed from a material that is more rigid than the collar (120, 520, 620), and the baseplate comprises a laser weld (130, 530a, 530b, 630) between the convex disc and collar (120, 520, 620).

Description

Technical Field of the Invention The present invention relates to ostomy appliances and methods of manufacturing an ostomy appliance. In particular, the present invention relates to a baseplate configured to secure an ostomy appliance to the body of a user and most particularly to baseplates adapted for use with a recessed stoma, overweight user and/or stomas with complications such as scar tissue, as well as methods of manufacturing said baseplates. Background to the Invention When using an ostomy appliance, it is paramount that the ostomy appliance is securely attached to the user's body around the stoma in a manner that it can efficiently receive and collect stomal output. It is particularly important that leaks of liquid and/or gas are prevented/minimised as any leaking can cause discomfort or injury, such as skin damage around the stoma, and presents a hygienic risk to the user as well as potential embarrassment and inconvenience. Typically, an ostomy appliance comprises a pouch in fluid communication with the stoma via an adhesive collar that attaches the ostomy appliance to the skin of the user around the stoma. Conventionally, the collar is attached to the pouch directly via an adhesive or weld, such as a heat weld or ultra-sonic weld. However, in certain circumstances, it is beneficial to control the shape of the collar to enhance transport of stomal output into the pouch and provide a better seal between the user and the ostomy appliance. To achieve this, a shaped-disc that is more rigid than the collar or pouch is attached to the collar to form a baseplate which can then be attached to the pouch - for example a convex disc may be provided for users with a recessed stoma. An exemplary baseplate/wafer incorporating a convex layer is disclosed in WO2020/220026. In that disclosure, the convex layer is an internal layer i.e. arranged such that one side abuts the skin of the patient in use, and is attached on its opposite side to an external layer, which in turn is coupled to the ostomy pouch. The convex layer of WO2020/220026 is fairly complex, with perforations though which liquid adhesive seeps to attach the wafer to the user. It would be more straightforward for the internal layer (i.e. that which abuts the patient in use) to be a conventional adhesive collar, with the convex disc provided externally of the adhesive collar and between the adhesive collar and the pouch. The convex disc could then provide a shape that the adhesive collar conforms to. Unfortunately, use of a shaped-disc (such as the convex layer in WO2020/220026) between the adhesive collar and the pouch could lead to poor performance of the ostomy appliance due the shape of the disc increasing the likelihood of leaks between the different components of the ostomy appliance. For example, if ultrasonic or heat welding were used to attach the shaped-disc to the collar, this could lead to an undulating surface on the disc which compromises a subsequent weld between the disc and pouch of the ostomy appliance. If an adhesive is used to attach the disc to the pouch, the cost of the ostomy appliance is increased due to the extra raw materials required and through the additional complexity of delivering the correct amount of liquid adhesive to the right place on the shaped-disc and pouch. US2009/0216208A1 discloses an ostomy carrier device comprising a base plate for securing the carrier device to a user's skin around a stoma; a circumferential flange adapted for connection with and removal of an ostomy collecting bag, the circumferential flange having an opening for receiving a stoma; and at least one connecting ring between the flange and base plate. The connecting ring may be laser welded to the flange and/or base plate. It is an object of embodiments of the present invention to at least partially overcome or alleviate the above problems. Summary of the Invention In broad terms, the invention concerns a method of manufacturing an ostomy appliance comprising providing at least two layers of material and directing a laser beam onto two of the at least two layers to form a weld between the two layers. The method may be a method of manufacturing a baseplate of an ostomy appliance. One of the at least two layers of material may comprise a collar. One of the at least two layers of material may comprise a shaped-disc. The method may comprise directing the laser onto the shaped disc and collar to form a weld therebetween. The shaped disc may not be substantially flat. The shaped disc may be convex in shape. The shaped disc may be a convex disc. According to a first aspect of the present invention, there is provided a method of manufacturing a baseplate configured to secure an ostomy appliance to the body of a user, the method comprising providing a convex disc and a collar and directing a laser beam onto the convex disc and collar to form a weld therebetween. Advantageously, the use of a laser to form a weld between the convex disc and collar allo