Ostomy appliance

Abstract

An ostomy appliance (10) comprising a base plate (20) having a first coupling portion (40), a collecting bag (30) having a second coupling portion (50), the first coupling portion (40) and the second coupling portion (50) cooperating to provide a coupling between the collecting bag and the base plate; the first coupling portion (40) comprising a first coupling ring (41) comprising an axially extending first flange (42), the first flange (42) comprising an outer contact face (44) and a ring shaped collar (45) positioned at a distal portion of the axially extending first flange (42), a distal surface of the ring shaped collar (45) having a first diameter; the second coupling portion (50) comprising a second coupling ring (51) having an axially extending locking flange (53), the axially extending locking flange (53) of the second coupling portion (50) having an inner locking contact face (54) of a second diameter; the second coupling portion (50) comprising a radially extending second flange (52) and a sealing ring (55), the sealing ring (55) sealing between the first coupling portion (40) and the second coupling portion (50) and providing a seal at the distal surface on the ring shaped collar (45) of the axially extending first flange (42).

Description

Technical Field

[0001] This invention relates to an ostomy device. Attached Figure Description

[0002] The accompanying drawings are included to provide a further understanding of the embodiments and are incorporated in and are a part of this specification. The drawings illustrate embodiments and, together with this specification, explain the principles of the embodiments. Other embodiments and many of the anticipated advantages of the embodiments will be readily appreciated as they will become better understood by referring to the following detailed description. Elements of the drawings are not necessarily to scale. The same reference numerals indicate corresponding similar parts.

[0003] Figure 1 Two schematic side views of ostomy equipment are shown;

[0004] Figure 2 A cross-sectional side view of a two-piece connector for ostomy equipment is shown;

[0005] Figure 3 Displayed in 3D Figure 2 Part of the two-piece connector shown in the image;

[0006] Figure 4 A portion of the two-piece connector is shown in a 3D view;

[0007] Figure 5 Showing Figure 4 The side view of the two-piece connector shown in the image;

[0008] Figure 6 Showing Figure 4 and Figure 5 The image shows a three-dimensional view of the two-piece connector. Detailed Implementation

[0009] Unless otherwise specifically stated, the features of the embodiments described in this application and the various exemplary embodiments may be combined with each other (“mixed and matched”).

[0010] In the following detailed description, reference is made to the accompanying drawings, which form part of the detailed description, and which illustrate specific embodiments in which the invention may be practiced by way of illustration. Because components of the embodiments may be positioned in different orientations, directional terminology is used for illustrative purposes and not in any way limiting. It should be understood that other embodiments may be adopted, and structural or logical changes may be made without departing from the scope of the invention. Therefore, the following detailed description should not be considered limiting, and the scope of the invention is defined by the appended claims.

[0011] In the following text, whenever the proximal side of a device or part thereof is mentioned, it refers to the side facing the skin when the user wears the ostomy apparatus. Similarly, whenever the distal side of a device or part thereof is mentioned, it refers to the side facing away from the skin when the user wears the ostomy apparatus. In other words, the proximal side is the side closest to the user when the apparatus is fitted to the user, and the distal side is the opposite side, the side furthest from the user during use.

[0012] The axial direction is defined as the direction of the stoma when the user wears the device. Therefore, the axial direction is essentially perpendicular to the user's abdominal surface.

[0013] The radial direction is defined as transverse to the axial direction, that is, transverse to the direction of the stoma. Therefore, the radial direction is essentially perpendicular to the user's stoma.

[0014] The terms "internal" and "external" may be used. These qualifiers should generally be understood in relation to radial or axial directions, such that referring to an "external" element means that the element is further away from the center of the ostomy apparatus than an element referred to as "internal".

[0015] The diameter of the element disclosed in the terminology is defined as the length of a line between two points of the element in the radial direction passing through the central portion of the stoma apparatus. Therefore, when the user wears the apparatus, the diameter line is approximately parallel to the user's abdominal surface. Thus, the radius of the diameter is measured radially outward from the midpoint of the central opening of the stoma / connecting portion.

[0016] Two-piece connectors for ostomy instruments are available within a range of options corresponding to the dimensions of the base plate and collection bag assembly. This range includes connectors with a central opening having a diameter of approximately 40-70 mm, corresponding to different sizes of the ostomy instruments.

[0017] In many cases, surgery for various gastrointestinal diseases results in the creation of an abdominal stoma (such as a colostomy, ileostomy, or urethrostomy) in the patient's abdominal wall for the drainage of visceral contents. The drainage of visceral contents cannot be arbitrarily controlled. For this purpose, the user must rely on a device to collect the material emerging from this opening into a bag, which is then emptied and / or discarded at appropriate times. The solid and liquid waste flowing from the stoma can be referred to as stoma discharge.

[0018] Ostomy instruments can be two-piece devices comprising a baseplate and a collection bag, which can be attached to and detached from each other using a connecting tool. This has the advantage that the baseplate does not need to be detached from the user's skin as frequently as required for changing the collection bag. The baseplate may only need to be changed every three or four days (depending on the user), while the collection bag may need to be changed more than once a day. Typically, it is desirable to require as few baseplate changes as possible to reduce the risk of skin complications.

[0019] Two-piece connectors adapted to releasably attach collection bags to a base plate can be difficult to manipulate. Special techniques may be required to attach the collection bag to the base plate, or even significant pressure may be needed to press the connector together to attach the collection bag to the base plate.

[0020] The skin around the abdomen and stoma is typically relatively soft and flexible, and tests have shown that it may be difficult to allow the two connecting parts to engage by applying force axially toward the abdomen, as the abdomen may not comfortably provide counter-pressure to allow the connecting parts to engage properly. Additionally, because the skin around the stoma can be sensitive, especially for a period of time after the surgery to create the stoma, applying force to the skin to significantly press down on the skin and abdomen can be painful and may even damage the skin.

[0021] The amount of force required to engage and / or disengage these connecting parts can be determined by the structure of the connecting parts and varies with the amount of force required to frictionally engage the connecting parts of the collection bag and the base plate. The latter amount of force is limited, as indicated above, by the amount of force that can be acceptablely applied to the (user's) skin below the base plate.

[0022] When connecting two-piece connectors, it may be difficult to position the two connector parts relative to each other by matching the two connector parts, and preferably, the user can receive feedback, such as sensory click feedback and / or sound, to ensure that the two connector parts are properly connected together.

[0023] Therefore, there is a need for a releasable connector that is more intuitive and easy to use, requires minimal work, and remains safe in avoiding the risk of accidental release of the connector and the resulting subsequent leakage.

[0024] This is achieved through an ostomy device comprising: a base plate having a first connecting portion; a collection bag having a second connecting portion, the first and second connecting portions being configured to mate with each other to provide a connection between the collection bag and the base plate; the first connecting portion including a first connecting ring including an axially extending first flange including an outer contact surface and an annular collar positioned on a distal portion of the axially extending first flange, the distal surface of the annular collar having a first diameter; the second connecting portion including a second connecting ring including an axially extending locking flange including an inner locking contact surface having a second diameter; the second connecting portion including a radially extending second flange and a sealing ring adapted to provide a seal between the first and second connecting portions, wherein the sealing ring is adapted to be positioned on the distal surface of the annular collar of the axially extending first flange to provide a seal.

[0025] This results in an intuitive and easy-to-use connector.

[0026] Because the area used for sealing is repositioned, the sealing ring does not need to be pressed against the outer surface of the first connection portion. Furthermore, the sealing force extends primarily in the axial direction, unlike the locking force which extends radially. Therefore, the distribution of the forces related to connection, locking, and sealing is offset in different directions and at an angle.

[0027] In one embodiment, the radially extending second flange extends radially inward, and the sealing ring is positioned on the inner portion of the radially extending second flange.

[0028] In an embodiment, the second diameter is equal to or less than the first diameter.

[0029] Generally, the first and second diameters can be in the range of approximately 40-70 mm. The second diameter can be the same as or up to 10 mm smaller than the first diameter. In one embodiment, the first diameter can be 52 mm, and the second diameter can be 50 mm. In another embodiment, the first diameter can be 42 mm, and the second diameter can be 40 mm.

[0030] In an embodiment, the second diameter is 0.1-9 mm smaller than the first diameter, for example, 0.2-8 mm smaller, 0.3-7 mm smaller, 0.4-6 mm smaller, 0.5-5 mm smaller, 0.6-4 mm smaller, or 0.7-3 mm smaller.

[0031] In this embodiment, the first connecting portion is a convex connecting member, while the second connecting portion is a concave connecting member.

[0032] In an embodiment, when the first connecting portion and the second connecting portion are connected, the outer contact surface of the axially extending first flange and the inner locking contact surface of the axially extending locking flange abut against each other.

[0033] In one embodiment, the second connecting portion includes a locking ring. Thus, after the two connecting portions are connected together, the locking ring can clamp the first and second connecting portions into a locked position.

[0034] The sealing ring extends continuously around the connecting portion on the distal part of the axially extending first flange. In an embodiment, the diameter of the sealing ring is smaller than the diameter of the inner contact surface of the second connecting portion.

[0035] In the embodiments, the sealing ring is made of plastic materials, thermoplastic elastomers, polyurethanes, such as TPE or Poron. Rubber-based materials, in particular, can be extruded together to form a liquid-tight seal.

[0036] In this embodiment, the second connecting ring and the sealing ring are made of the same material.

[0037] In one embodiment, the first connecting portion includes a soft sealing portion formed by a radially extending first flange and an annular collar, and a more rigid stabilizing portion, the annular collar forming the soft sealing portion, which is radially outwardly positioned on the stabilizing portion formed by the radially extending first flange. The annular collar may be an integral part of the stabilizing portion.

[0038] In one embodiment, the annular collar extends radially outward to form a notch for providing a snap-fit ​​connection.

[0039] In one embodiment, the second connection portion includes two locking flanges, a radially extending proximal locking flange, and a radially extending distal locking flange, the two locking flanges extending radially outward from the radially extending second flange to define a locking groove.

[0040] In one embodiment, the radially extending proximal locking flange includes two or more slots in the radial direction. This results in a more flexible coupling ring, which is therefore easier to press into the locking position.

[0041] In one embodiment, two or more slits extend axially into a radially extending second flange.

[0042] In one embodiment, two or more radially extending proximal locking flanges are evenly distributed around their peripheries. This results in more flexible flanges and requires less force when connecting the two connection parts.

[0043] In one embodiment, the second connecting portion includes six slits evenly distributed along its periphery. The slits may have a width of 2-6 mm, for example 3-5 mm, or for example 4 mm, along the periphery. In another embodiment, the appliance includes four, six, or eight slits evenly distributed along its periphery.

[0044] Generally, an ostomy apparatus includes: a base plate having a first connecting portion; a collection bag having a second connecting portion, the first and second connecting portions being configured to mate with each other to provide a connection between the collection bag and the base plate; the first connecting portion includes a first connecting ring including an axially extending first flange including an outer contact surface and an annular collar positioned on a distal portion of the axially extending first flange; the second connecting portion includes a second connecting ring including an axially extending locking flange; the second connecting portion includes a radially extending second flange and a sealing ring adapted to provide a seal between the first and second connecting portions, wherein the sealing ring is adapted to be positioned on a distal surface of the annular collar of the axially extending first flange to provide a seal.

[0045] Detailed description of the attached figures

[0046] Figure 1 Two schematic side views of an ostomy apparatus 10 are shown, which includes a base plate 20 having a first connecting portion 40 and a collection bag 30 having a second connecting portion 50. The first connecting portion 40 and the second connecting portion 50 are adapted to cooperate with each other to provide a two-piece connector 25 between the collection bag and the base plate.

[0047] The base plate 20 includes a through stoma opening 15. The stoma opening is configured to receive a user's stoma, and / or the stoma opening is configured to allow discharge from the stoma to pass through the stoma opening 15 and into a collection bag 30 attached to the base plate 20. The stoma opening is configured to allow discharge to pass from the proximal side of the base plate 20 to the distal side of the base plate and into the collection bag 30.

[0048] Figure 2 A cross-sectional side view of a two-piece connector 25 for ostomy instruments is shown before it is locked in the position. The two-piece connector includes two annular connecting portions, namely a first connecting portion 40 and a second connecting portion 50.

[0049] The first connecting portion 40 includes a first connecting ring 41 having an axially extending first flange 42 forming a convex connecting member. The axially extending first flange includes an outer locking contact surface 44 and an annular collar 45. The annular collar 45 is positioned on a distal portion of the axially extending first flange 42. The annular collar 45 has an annular shape, and a sealing ring of the second connecting portion 50 is adapted to be positioned on the distal surface of the annular collar 45, wherein the sealing ring 55 is adapted to be positioned on the distal surface of the annular collar 45 of the axially extending first flange 42 to provide a seal.

[0050] The farthest portion of the curved annular collar 45 has a first diameter. The outer locking contact surface 44 has a diameter larger than the first diameter.

[0051] The second connecting portion 50 includes a second connecting ring 51 and an axially extending locking flange 53, the axially extending locking flange 53 of the second connecting portion 50 including an internal locking contact surface 54 having a second diameter. The second connecting portion 50 forms a concave connecting member that is complementary in shape to the first connecting portion 40.

[0052] The second connecting portion 50 includes a radially inwardly extending second flange 52 and a sealing ring 55 positioned on a distal portion of the second flange 52. The sealing ring 55 is adapted to be positioned on an annular collar 45 of the first flange 42 for sealing between the first connecting portion 40 and the second connecting portion 50.

[0053] The first connecting ring 41 includes a radially outwardly extending proximal flange 47. The annular collar 45 on the first connecting portion 40 includes an outwardly extending edge 46. When the convex and concave connecting members are in the locked position, the surfaces of the proximal flange 47, the locking contact surface 44, and the annular collar 45 provide contact surfaces for positioning against the second contact surface of the second connecting ring 51.

[0054] The second contact surface of the second connecting ring 51 is formed by a surface formed by an axially extending locking flange 53, a radially extending proximal locking flange 56, and a radially extending distal locking flange 57.

[0055] The first connecting portion 40 is formed as a convex connecting member, while the second connecting portion 50 is formed as a concave connecting member.

[0056] The concave connector (second connecting portion) is made of a flexible material to allow for a snap-fit ​​connection with the convex connector. The flexibility of the concave connector is enhanced by a plurality of slots 58 evenly distributed around the second connecting ring 51.

[0057] A slit 58 is formed in the axially extending locking flange 53 and the radially extending proximal locking flange 56, thereby allowing the flanges 53, 56 to flex outwards and allowing the second connecting ring 51 to pass over the outwardly extending collar edge 46 of the first connecting portion 40. As the axially extending locking flange 53 and the radially extending proximal locking flange 56 flex outwards and backwards, the concave connecting member slides over the convex connecting member, and the inner surface 54 of the second connecting portion juxtaposes with the outer locking contact surface 44 of the first connecting portion 40. Thereafter, the locking ring 60 can be tightened by reducing its diameter and by reducing the circumference of the locking ring, clamping the inner surface 54 against the outer surface 44 to lock the concave connecting member to the convex connecting member, and thus connecting the collection bag to the base plate. The locking ring 60 is shown schematically only in dashed lines.

[0058] In addition, the second connecting portion 50 includes a groove 59 for receiving the edge 46 of the annular collar 45.

[0059] The radially extending flange and the edge 46 of the annular collar 45 provide a clicking sound to the user when the concave connector is engaged, thus allowing the user to know that the correct connection has been made. In the locked position, the inner surface 54 is clamped toward the outer surface 44 by the locking ring 60, and the sealing ring 55 is positioned on the inner portion of the radially extending second flange 52, thereby forming a seal between the convex and concave connectors. The sealing ring may be formed of a flexible plastic material, such as soft TPE.

[0060] In the figure, the second connecting portion 50 is positioned juxtaposed with the first connecting portion 40 before being pressed into the locking position.

[0061] The diameter of the distal surface of the annular collar 45 is smaller than the diameters of the inner contact surface 54 and the outer surface 44. The diameter of the sealing ring 55 is smaller than the diameter of the inner contact surface 54 of the second connecting portion 50.

[0062] Figure 3 A 3D diagram shows the position before locking. Figure 2 This is part of a two-piece coupling shown in the image. From this perspective, it is clear that a gap 58 is formed in an axially extending first flange locking 53 and a radially extending proximal locking flange 56, thereby allowing both flanges 53 and 56 to flex outwards and allowing the second coupling ring 51 to pass over the convex coupling. During coupling, the axially extending locking flange 53 can act as a guide.

[0063] Figure 4 A portion of the two-piece connector is shown in a perspective view. The cross-sectional view shows that the sealing ring 55 is made of a gasket. The gasket is positioned on the inner surface of the radially extending flange 52 and seals the connection between the first connecting portion 40 and the second connecting portion 50. The gasket may be annular foam.

[0064] The convex and concave connecting portions of the two-piece connector inherently include a central opening 70 to receive the through stoma opening 15 and to allow the user's stoma and / or discharge from the stoma to pass through the stoma opening 15 and the central opening 70 formed by the annular connecting portion and enter the collection bag 30 attached to the base plate 20.

[0065] Figure 5 Showing Figure 4 The side view of the two-piece connector shown in the image. Figure 4 and Figure 5 The sealing ring and the radially extending second flange 52 shown have been modified, and the two-piece coupling includes... Figure 2 and Figure 3 Similar features are shown in the embodiments illustrated.

[0066] The second connecting portion 50 includes a second connecting ring 51 and an axially extending locking flange 53, the axially extending locking flange 53 of the second connecting portion 50 including an internal locking contact surface 54 having a second diameter. The second connecting portion 50 forms a concave connecting member that is complementary in shape to the first connecting portion 40.

[0067] The second connecting portion 50 includes a radially inwardly extending second flange 52 and a sealing ring 55 positioned on a distal portion of the second flange 52. The sealing ring 55 is adapted to be positioned on an annular collar 45 of the first flange 42 for sealing between the first connecting portion 40 and the second connecting portion 50.

[0068] The first connecting ring 41 includes a radially outwardly extending proximal flange 47. The annular collar 45 on the first connecting portion 40 includes a radially outwardly extending edge 46. When the convex and concave connecting members are in the locked position, the surfaces of the locking flange 47, the locking contact surface 44, and the annular collar 45 provide contact surfaces for positioning against the second contact surface of the second connecting ring 51.

[0069] The second contact surface of the second connecting ring 51 is formed by a surface formed by an axially extending locking flange 53, a radially extending proximal locking flange 56, and an axially extending distal locking flange 57.

[0070] The concave connector is made of a flexible material to allow for a snap-fit ​​connection with the convex connector. The flexibility of the concave connector is enhanced by a plurality of slots 58 evenly distributed around the second connecting ring 51.

[0071] A slit 58 is formed in the axially extending locking flange 53 and the radially extending proximal locking flange 56, thereby allowing flanges 53 and 56 to flex outward and allowing the second connecting ring 51 to move past the outwardly extending collar edge 46 of the first connecting portion 40. As the axially extending locking flange 53 and the radially extending proximal locking flange 56 flex outward and back, the concave connecting member slides over the convex connecting member, and the inner surface 54 of the second connecting portion juxtaposes with the outer locking contact surface 44 of the first connecting portion 40. Thereafter, the locking ring 60 can be tightened by reducing its diameter and by reducing the circumference of the locking ring, clamping the inner surface 54 against the outer surface 44 to lock the concave connecting member to the convex connecting member, and thus connecting the collection bag to the base plate. The locking ring 60 is shown schematically only in dashed lines.

[0072] In addition, the second connecting portion 50 is provided with a groove 59 for receiving the edge 46 of the annular collar 45.

[0073] Figure 6 Showing Figure 4 and Figure 5 The figure shows a perspective view of the two-piece connector. The annular connector (40, 50) includes a central opening 70.

[0074] Figure 6 The gaps 58 formed in the radially extending proximal locking flange 56 and the axially extending locking flange 53 are clearly shown, which allow the flanges to flex outward more easily when the two connecting parts are pressed together.

[0075] Unless otherwise specifically stated, the features of the embodiments described in this application and the various exemplary embodiments may be combined with each other (“mixed and matched”).

Claims

1. An ostomy apparatus, comprising: The base plate has a first connecting portion. A collection bag having a second connecting portion, wherein the first connecting portion and the second connecting portion are configured to cooperate with each other to provide a connection between the collection bag and the base plate; The first connecting portion includes a first connecting ring, the first connecting ring including an axially extending first flange, the axially extending first flange including an outer contact surface and an annular collar, the annular collar being positioned on a distal portion of the axially extending first flange, the distal surface of the annular collar having a first diameter; The second connecting portion includes a second connecting ring, the second connecting ring including an axially extending locking flange, the axially extending locking flange of the second connecting portion including an internal locking contact surface having a second diameter; The second connecting portion includes a radially extending second flange and a sealing ring adapted to seal between the first connecting portion and the second connecting portion, wherein the sealing ring is adapted to be positioned at the distal surface of the annular collar of the axially extending first flange to provide a seal.

2. The ostomy apparatus according to claim 1, wherein, The radially extending second flange extends radially inward, and the sealing ring is positioned on the inner portion of the radially extending second flange.

3. The ostomy apparatus according to claim 1 or 2, wherein, The second diameter is equal to or smaller than the first diameter.

4. The ostomy apparatus according to claim 1 or 2, wherein, The second diameter is 0.1-9 mm smaller than the first diameter.

5. The ostomy apparatus according to claim 1 or 2, wherein, The first connecting part is a convex connecting member, while the second connecting part is a concave connecting member.

6. The ostomy apparatus according to claim 1 or 2, wherein, When the first connecting portion and the second connecting portion are connected, the outer contact surface of the axially extending first flange and the inner locking contact surface of the axially extending locking flange abut against each other.

7. The ostomy apparatus according to claim 1 or 2, wherein, The second connecting part includes a locking ring.

8. The ostomy apparatus according to claim 1 or 2, wherein, The diameter of the sealing ring is smaller than the diameter of the internal locking contact surface of the second connecting part.

9. The ostomy apparatus according to claim 1 or 2, wherein, The sealing ring is made of plastic material.

10. The ostomy apparatus according to claim 1 or 2, wherein, The second connecting ring and the sealing ring are made of the same material.

11. The ostomy apparatus according to claim 1 or 2, wherein, The first connecting portion includes a soft sealing portion formed by the axially extending first flange and the annular collar, and a more rigid stabilizing portion, the annular collar forming the soft sealing portion, the soft sealing portion being radially outwardly positioned on the stabilizing portion formed by the axially extending first flange.

12. The ostomy apparatus according to claim 1 or 2, wherein, The annular collar extends radially outward to form a notch for providing a snap-fit ​​connection.

13. The ostomy apparatus according to claim 1 or 2, wherein, The second connection portion includes two locking flanges, a radially extending proximal locking flange, and a radially extending distal locking flange, the two locking flanges extending radially outward from the radially extending second flange to define a locking groove.

14. The ostomy apparatus according to claim 13, wherein, The radially extending proximal locking flange includes two or more slots in the radial direction.

15. The ostomy apparatus according to claim 14, wherein, The two or more slits extend axially into the radially extending second flange.

16. The ostomy apparatus according to claim 14, wherein, The two or more slits are evenly distributed along the periphery of the radially extending proximal locking flange.

17. The ostomy apparatus according to claim 16, wherein, The two or more slits include a width of 2-6 mm along the perimeter.

18. The ostomy apparatus according to claim 16 or 17, wherein, The ostomy apparatus includes 4, 6, or 8 slits evenly distributed along the periphery.

19. The ostomy apparatus according to claim 4, wherein, The second diameter is 0.2-8 mm smaller than the first diameter.

20. The ostomy apparatus according to claim 19, wherein, The second diameter is 0.3-7 mm smaller than the first diameter.

21. The ostomy apparatus according to claim 20, wherein, The second diameter is 0.4-6 mm smaller than the first diameter.

22. The ostomy apparatus according to claim 21, wherein, The second diameter is 0.5-5 mm smaller than the first diameter.

23. The ostomy apparatus according to claim 22, wherein, The second diameter is 0.6-4 mm smaller than the first diameter.

24. The ostomy apparatus according to claim 23, wherein, The second diameter is 0.7-3 mm smaller than the first diameter.

25. The ostomy apparatus according to claim 9, wherein, The sealing ring is made of thermoplastic elastomer.

26. The ostomy apparatus according to claim 9, wherein, The sealing ring is made of polyurethane.

27. The ostomy apparatus according to claim 9, wherein, The sealing ring is made of TPE or Poron.

28. The ostomy apparatus according to claim 17, wherein, The two or more slits include a width of 3-5 mm along the perimeter.

29. The ostomy apparatus according to claim 28, wherein, The two or more slits include a width of 4 mm along the perimeter.

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