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EP-4498996-B1 - EMPTYING DEVICE FOR A STOMA

EP4498996B1EP 4498996 B1EP4498996 B1EP 4498996B1EP-4498996-B1

Inventors

  • APELSTEDT, Kristoffer Jens Olle
  • HVIRF, David Karl Theodor
  • KINDAHL CARDELL, Mats Erik

Dates

Publication Date
20260506
Application Date
20230424

Claims (14)

  1. A connector ring (150) for attachment of a further device to an ostomy implant (300) or a lid (200) of an ostomy implant (300), the connector ring (150) comprising an annular base (152) defining a connector hole (151); characterised in that the connector ring further comprises a plurality of radially inwardly protruding flanges (153), wherein at least a subset of the protruding flanges (153) are adapted to engage with an outer circumferential groove (301) of a cylindrical ostomy implant (300) or a lid (200) of an ostomy implant (300);
  2. The connector ring (150) according to claim 1, wherein the plurality of radially inwardly protruding flanges (153) are separated by gaps (154).
  3. The connector ring (150) according to any one of the preceding claims, wherein the plurality of radially inwardly protruding flanges (153) comprise engagement flanges (155) adapted to engage with an outer circumferential groove (301) of a cylindrical ostomy implant (300) or a lid (200) of an ostomy implant (300); such as: - wherein the connector ring (150) comprises restriction means, for restricting bending of one or more engagement flanges (155) in a first direction but allowing bending of the engagement flanges (155) in a direction opposite to the first direction; and - wherein the engagement flanges (155) are made of a resilient material.
  4. The connector ring (150) according to claim 3, wherein the restriction means comprises two adjacent protrusions (161, 162) arranged to restrict bending of at least one engagement flange (155), in the direction of the protrusions (161, 162); and/or wherein each engagement flange (155) comprises a hook element or a guide element (156) at an inner engagement flange edge (157) towards a centre of the connector hole (151).
  5. The connector ring (150) according to any one of the preceding claims, wherein the plurality of radially inwardly protruding flanges (153) comprise support flanges (158) adapted to stabilize the connector ring (150) during use.
  6. The connector ring (150) according to claim 5, wherein each support flange (158) has an inner support flange edge (160) towards a centre of the connector hole (151), wherein the support flange (158) is dimensioned such that the inner support flange edge (160) is arranged to abut an outer circumferential ring (232) of the cylindrical ostomy implant (300) or the lid (200) of the ostomy implant (300); such as wherein each support flange (158) has a support structure (159) adapted to increase the structural rigidity of the connector ring (150).
  7. The connector ring (150) according to any one of claims 5-6, wherein the plurality of radially inwardly protruding flanges (153) comprise engagement flanges (155) adapted to engage with an outer circumferential groove (301) of a cylindrical ostomy implant (300) or a lid (200) of an ostomy implant (300); and wherein every second radially inwardly protruding flange (153) is an engagement flange (155) and every second radially inwardly protruding flange (153) is a support flange (158).
  8. The connector ring (150) according to claim 7, wherein the engagement flanges (155) protrude more than the support flanges (158).
  9. The connector ring (150) according to any one of claims 7-8, wherein the support flanges (158) are stiffer than the engagement flanges (155).
  10. An emptying device assembly (100) for evacuation of a stoma, comprising: a first film layer (111) and a second film layer (112), said first film layer (111) and second film layer (112) being attached along a peripheral part (113) to form an emptying device (110), wherein the first film layer (111) comprises a first hole (114); and an integrated connector ring (150) according to any one of claims 1-9, wherein the connector hole (151) is concentric with the first hole (114), and wherein the annular base (152) is attached to an annular attachment area (119) of the first film layer (111) around the first hole (114).
  11. The emptying device assembly (100) according to claim 10, wherein the first film layer (111) is elastic and wherein the first hole (114) is smaller than the connector hole (151).
  12. The emptying device assembly (100) according to any one of claims 10-11, wherein the emptying device assembly (100) comprises an annular protection area (120) arranged to, during use, decrease leakages and/or form a seal to the ostomy implant (300) or the lid (200) of an ostomy implant (300).
  13. The emptying device assembly (100) according to claim 12, wherein the annular protection area (120) is formed by having the first film layer (111) extending radially inwards from the annular attachment area (119) and wherein the annular protection area (120) extends radially inwards and extends beyond the radially inner edges of the flanges (153).
  14. A method of manufacturing an emptying device assembly (100) according to any one of the claims 10-13, the method comprising the steps of: • forming a first circular hole (114) in the first film layer (111); • attaching the first film layer (111) and the second film layer (112) along peripheral parts (113) of the layers to form a sleeve or pouch; and • attaching a connector ring (150) according to any one of claims 1-9 to the first film layer (111) around the first hole (114), wherein the connector hole (151) is concentric with the first hole (114).

Description

The present disclosure relates to medical devices for ostomy management, in particular to a connector ring for attachment to an ostomy implant or a lid, to an emptying device assembly comprising the connector ring, and to a method of manufacturing the emptying device assembly. Background Ileostomy and colostomy are common operations which may be necessitated, for example, by malignancy or chronic bowel inflammation. The surgery is called an ileostomy if the colon and rectum are removed and a colostomy if the rectum alone is removed. Similarly, an abdominal urostomy is created when the urinary bladder has to be removed due to, for example, bladder cancer. In these operations, a stoma is formed in the abdominal wall to which a bowel segment is connected. Ileostomy is a stoma constructed by bringing the end or loop of small intestine (the ileum) out onto the surface of the skin, or the surgical procedure which creates this opening. Intestinal waste passes out of the ileostomy and is collected in an external ostomy system which is placed over the opening. A colostomy is a stoma in the large intestine (colon), or the surgical procedure that creates one. The opening is formed by drawing the healthy end of the colon through an incision in the anterior abdominal wall and suturing it into place. This opening, often in conjunction with an attached ostomy system, provides an alternative channel for feces to leave the body. An ostomy pouching system is a medical device that provides a means for the collection of waste from a stoma. Traditional pouching systems usually consist of a collection pouch, a barrier on the skin, and connect with the stoma itself, which is the part of the body that has been diverted to the skin. In the traditional ostomy pouching systems, the ostomy bags are typically attached directly to the skin. As an alternative to traditional ostomy pouching systems, an implant-based system has been developed. This system is based on a percutaneous ostomy implant, which is anchored in the body of the user and allows serosal tissue of a bowel segment to attach to the implant. The ostomy implant comprises a usually cylindrical body with an open end, to which a lid may be attached. When the lid is removed, the open end can be connected to an emptying device, such as an ostomy pouch. The solution allows the users to exercise their needs when it suits them and minimizes skin complications as well as discomfort, noise and smell. Attaching an ostomy pouch to an ostomy implant is, however, associated with several technical challenges related to, for example, ease of use, potential leakages, and the ability to withstand forces caused by waste in the ostomy pouch. A number of prior devices have attempted to address these limitations. US 5,269,774 discloses a combination ring and collection pouch for an ostomy, said combination comprising a ring portion having a first side, a second side and an aperture substantially centered through said first side and said second side. US 5,139,492 discloses a two-piece ostomy appliance comprising a pouch and a faceplate having matching coupling rings. US 2012/0123361 discloses a percutaneous ostomy implant for implantation into the abdominal wall of a patient. US 4,183,357 discloses a chronic transcutaneous implant device for enterostomies comprised of a barrel portion and flange portion. While these documents address some limitations of traditional pouch systems, there are still significant drawbacks that need to be addressed in terms of for example leakage prevention, ease of use and the prevention of accidental disconnection between the pouch system and the stoma. Summary The invention is defined by the claims. Any subject matter falling outside the scope of the claims is provided for information purposes only. The present disclosure relates to an emptying device assembly for evacuation of a stoma, comprising: a first film layer and a second film layer, said first film layer and second film layer being attached along a peripheral part to form an emptying device, wherein the first film layer comprises a first hole; andan integrated connector ring comprising: ∘ an annular base defining a second hole that is concentric with the first hole, wherein the annular base is attached, such as welded, to the emptying device around the first hole;∘ a plurality of radially inwardly protruding flanges, wherein at least a subset of the protruding flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a lid of an ostomy implant. The connector ring can be attached to a lid of an ostomy implant. Preferably the connector ring is attached to the lid by positioning the subset of the protruding flanges to fit into the circumferential groove of the lid. From this position the emptying device, in case it is a closed pouch can be opened in one end. The lid can then be opened from the outside of the emptying device to avoid soiling the hands of the user. Pre