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Title:
AN OSTOMY DRAINAGE SYSTEM
Document Type and Number:
WIPO Patent Application WO/2024/033637
Kind Code:
A1
Abstract:
An ostomy drainage system 1 including an ostomy appliance 10 and a drainage connector 20, the ostomy appliance 10 include: an internal collecting volume 8 defined by a first and a second wall 4, 6 connected about a periphery; a stoma receiving opening 10 defined in the first wall 4, and a valve 14 including: a valve body 16 connected to one or both of the first and second walls 4, 6, a valve inlet 16a and a valve outlet 16b, connected by a flow path and fluidly connected to the internal collecting volume 8; and the drainage connector 20, which is connectable to the valve 14, including: a body 22; an inlet 24 and an outlet 26 connected by a passage extending through the body 22; a contact formation 50 including: a first angled surface 52 which extends at least partially around the body 22, and a second angled surface 54 which extends at least partially around the body 22, and a sealing member which also extends at least partially around the body, wherein the first and second angled surfaces 52, 54 are arranged to provide a channel and the sealing member 60 is positioned in the channel.

Inventors:
SMITH LEE (GB)
HOWARD LEE (GB)
Application Number:
PCT/GB2023/052099
Publication Date:
February 15, 2024
Filing Date:
August 09, 2023
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
SALTS HEALTHCARE LTD (GB)
International Classes:
A61F5/44; A61F5/445
Foreign References:
GB2125130A1984-02-29
US20220125618A12022-04-28
US20150025483A12015-01-22
Attorney, Agent or Firm:
FORRESTERS IP LLP (GB)
Download PDF:
Claims:
CLAIMS

1. An ostomy drainage system including an ostomy appliance and a drainage connector, the ostomy appliance include: an internal collecting volume defined by a first and a second wall connected about a periphery; a stoma receiving opening defined in the first wall, and a valve including: a valve body connected to one or both of the first and second walls, a valve inlet and a valve outlet, connected by a flow path and fluidly connected to the internal collecting volume; and the drainage connector, which is connectable to the valve, including: a body; an inlet and an outlet connected by a passage extending through the body; a contact formation including: a first angled surface which extends at least partially around the body, a second angled surface which extends at least partially around the body, and a sealing member which also extends at least partially around the body, wherein the first and second angled surfaces are arranged to provide a channel and the sealing member is positioned in the channel.

2. An ostomy drainage system according to claim 1 wherein the first and / or the second angled surface extend completely around the body.

3. An ostomy drainage system according to any one of the preceding claims wherein the first angled surface includes a first frustoconical section.

4. An ostomy drainage system according to claim 3 wherein the first frustoconical section narrows towards the inlet.

5. An ostomy drainage system according to any one of the preceding claims wherein the second angled surface includes a second frustoconical section.

6. An ostomy drainage system according to claim 5 wherein the second frustoconical section narrows towards the outlet.

7. An ostomy drainage system according to claim 5 or 6 where further dependent on claim 4 or 5 wherein a widest portion of the first and second frustoconical sections are spaced apart by the channel.

8. An ostomy drainage system according to any one of the preceding claims wherein a third angled surface is provided.

9. An ostomy drainage system according to claim 8 wherein the third angled surface is a third frustoconical section that narrows towards the inlet and / or in substantially the same direction as the first angled surface.

10. An ostomy drainage system according to any one of the preceding claims wherein the drainage connector includes a user graspable formation.

1 1. An ostomy drainage system according to claim 10 wherein the user graspable formation is a radially extending flange.

12. An ostomy drainage system according to claim 11 including a fourth angled surface which widens towards the radially extending flange.

13. An ostomy drainage system according to any one of the preceding claims wherein the drainage connector further includes a conduit connecting formation for connecting to a conduit.

14. An ostomy drainage system according to claim 13 wherein the conduit connecting formation includes a one or more frustoconical surfaces.

15. An ostomy drainage system according to any one of the preceding claims wherein the passage extending through the body is substantially cylindrical, and optionally the passage widens at a generally central location.

16. An ostomy drainage system according to any one of the preceding claims wherein the drainage connector further include a mucus guard member which surrounds the inlet.

17. An ostomy drainage system according to claim 16 wherein the mucus guard member includes a plurality of openings / slots which are radially offset from the inlet.

18. An ostomy drainage system according to any one of the preceding claims wherein the sealing member is an O-ring that extends around the body between the first and second angled surfaces.

19. An ostomy drainage system according to any of claims 1 to 17 wherein the sealing member is integrally formed with the first and second angled surfaces.

20. A drainage connector for use in an ostomy drainage system of claim 1 , including: a body; an inlet and an outlet connected by a passage extending through the body; a contact formation including: a first angled surface which extends at least partially around the body, and a second angled surface which extends at least partially around the body, and a sealing member which extends at least partially around the body, wherein the first and second angled surfaces are arranged to provide a channel and the sealing member is positioned in the channel. ge connector according to claim 19 including any of the features according to claims

Description:
An ostomy drainage system

FIELD

Embodiments of the present invention relate to an ostomy drainage system.

BACKGROUND

Ostomy appliances are well known in the field. They are typically attached to a user via an adhesive member that extends around the user’s stoma with adhesive and provide a collecting volume to collect waste (mostly liquid waste) exiting the stoma. A mechanism for draining the collecting volume is often provided - typically, these are in the form of a tap, so that a user can empty waste that is collected in the collecting volume without having to remove and dispose of the entire appliance.

At times, a user may want to extend the time between emptying their appliance, for example, when they are sleeping. Typically, a larger capacity bag is used to contain waste while the user is sleeping. In this scenario, the outlet valve is connected to the larger capacity bag by a tube, so that the bag fills with waste.

Embodiments of the present invention seek to alleviate one or more problems associated with the prior art.

BRIEF DESCRIPTION OF THE INVENTION

According to a first aspect of the invention we provide an ostomy drainage system including an ostomy appliance and a drainage connector, the ostomy appliance include: an internal collecting volume defined by a first and a second wall connected about a periphery; a stoma receiving opening defined in the first wall, and a valve including: a valve body connected to one or both of the first and second walls, a valve inlet and a valve outlet, connected by a flow path and fluidly connected to the internal collecting volume; and the drainage connector, which is connectable to the valve, including: a body; an inlet and an outlet connected by a passage extending through the body; a contact formation including: a first angled surface which extends at least partially around the body, and a second angled surface which extends at least partially around the body, and a sealing member which also extends at least partially around the body, and wherein the first and second angled surfaces are arranged to provide a channel and the sealing member is positioned in the channel.

The first and / or the second angled surface may extend completely around the body. The first angled surface may include a first frustoconical section. The first frustoconical section may narrow towards the inlet.

The second angled surface may include a second frustoconical section. The second frustoconical section may narrow towards the outlet.

The widest portion of the first and second frustoconical sections may be spaced apart by the channel.

A third angled surface may be provided. The third angled surface may include a third frustoconical section. The third frustoconical section may narrow towards the inlet. The third frustoconical section may narrow in substantially the same direction as the first angled surface.

The drainage connector may include a user graspable formation. The user graspable formation may be radially extending flange. The drainage connector may include a fourth angled surface. The fourth angled surface may widen towards the radially extending flange.

The drainage connector may further include a conduit connecting formation for connecting to a conduit. The conduit connecting formation may include a one or more frustoconical surfaces. The passage extending through the body may be substantially cylindrical, and optionally the passage may widen at a generally central location.

The drainage connector may further include a mucus guard member which surrounds the inlet.

The mucus guard member may include a plurality of openings / slots which are radially offset from the inlet.

The sealing member may be an O-ring that extends (at least partially or completely) around the body between the first and second angled surfaces. Alternatively, the sealing member may be integrally formed with the first and second angled surfaces.

According to a second aspect of the invention we provide a drainage connector for use in an ostomy drainage system of the first aspect, including: a body; an inlet and an outlet connected by a passage extending through the body; a contact formation including: a first angled surface which extends at least partially around the body, and a second angled surface which extends at least partially around the body, and a sealing member which extends at least partially around the body, wherein the first and second angled surfaces are arranged to provide a channel and thea sealing member is positioned in the channel.

The drainage connector may include one or more of the optional features recited in relation to the first aspect.

BRIEF DESCRIPTION OF THE FIGURES

In order that the present disclosure may be more readily understood, preferable embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, in which:

FIGURE 1 is a schematic view of an ostomy drainage system;

FIGURE 2 is a schematic side cross-sectional view of an ostomy appliance;

FIGURE 3 is a side view of a urostomy valve connector;

FIGURE 4 is a side view of the urostomy valve connector connected to a valve of a urostomy appliance; and

FIGURE 5 is a cross-sectional view of the urostomy valve connector connected to the valve of the urostomy appliance.

DETAILED DESCRIPTION OF THE DISCLOSURE

Referring to figure 1 , an ostomy drainage system 1 is illustrated. The ostomy drainage system 1 includes an ostomy appliance 2 and a drainage connector 20.

The ostomy appliance 2 (or appliance 2) includes a first wall 4 and a second wall 6. The first and second wall 4, 6 are connected about a periphery to define an internal collecting volume 8. In the illustrated example, the first wall 4 is on a “body” side of the appliance 2 (i.e. it is closer to the body than the internal collecting volume 8 when the appliance 2 is in use) and the second wall 6 is on a “non-body” side of the appliance 2 (i.e. it is further / furthest from the body than the internal collecting volume 8 when the appliance 2 is in use).

A stoma receiving opening 10 is defined in the first wall 4. The stoma receiving opening 10 is in fluid communication with the internal collecting volume 8 such that in use, waste entering the appliance via the stoma receiving opening 10 flows into the collecting volume 6.

In some embodiments, an adhesive member 12 is attached to the first wall 4 and extends around the stoma receiving opening 10. The adhesive member 12 permits a user of the appliance 2 to attach the appliance 2 to their abdomen around their stoma. A valve 14 is provided to allow waste to be emptied from the internal collecting volume 8. The valve includes a valve body 16, a valve inlet 16a and a valve outlet 16b. The valve body 16 is connected to the first and second walls 4, 6. The valve inlet 16a and the valve outlet 16b are connected by a flow path and are fluidly connected to the internal collecting volume 8.

The valve 14 includes a closure member (not shown) which is used to close the valve 14. The closure member is inserted into the valve outlet 16b and blocks the flow path out of the appliance 2. When a user wishes to open the valve 14 (i.e. to empty their appliance 2 or to connect a drainage connector 20 as discussed below), the closure member is removed from the valve outlet 16b so that the flow path is open and waste can flow from the internal collecting volume 8 through the valve and out of the appliance 2.

In some embodiments, the ostomy drainage system 1 further includes a second collecting container 100 into which waste can flow from the ostomy appliance 2, through the drainage connector 20.

The drainage connector 20 is connectable to the valve 14 of the ostomy appliance 2. The drainage connector 20 includes a body 22, an inlet 24 and an outlet 26 and a contact formation 50. The inlet 24 is connected to the outlet 26 by a passage that extends through the body 22.

The body 22 is generally elongate and extends along a central axis. The passage extends generally centrally through the body and, thus, along the central axis of the drainage connector 20. A first end 22a of the body 22 is configured to be inserted into the valve 14 of the ostomy appliance 10. A second end 22b of the body 22 connects to a conduit 92 (leading to the second collecting volume 100) and presents the portion of the body 22 that is configured to be handled by a user in use (discussed in more detail below).

In the present example, the contact formation 50 extends on / around an outside surface of the body 22, which in use contacts an inside surface of the valve 14. In other words, the contact formation 50 is present on the first end 22a of the body 22.

The contact formation 50 includes a first angled surface 52 and a second angled surface 54. The first angled surface 52 extends at least partially around the body 22 (in the illustrated example, the first angled surface 52 extends around the body completely - i.e. it forms an annular surface about an outer circumference of the body 22). Likewise, the second angled surface 54 extends at least partially around the body 22 (and in the illustrated example, the second angled surface extends around the entire body 22 - and, thus, forms a second annular surface about the circumference of the body 22). In the present example, the first angled surface 52 includes a first frustoconical section. In other words, the annular surface forms a ramp from the outer surface of the body 22 that extends radially outwards. The first frustoconical section is oriented so that it narrows towards the inlet 24 / widens towards the outlet 26. In other words, the ramp forming the section is closest to the outer surface of the body 22 at the “inlet end” of the section (i.e. has the smallest radius from the central axis closest to the inlet 24) and the ramp extends gradually radially outwardly axially towards the outlet 26.

The second angled surface 54 includes a second frustoconical section. Likewise to the first frustoconical section, the annular surface of the second frustoconical section forms a second ramp from the outer surface of the body 22 and extends radially outwards. Opposite to the first angled surface 52, the second frustoconical section is oriented so that it narrows towards the outlet 26 / widens towards the inlet 24. In other words, the ramp forming the section is closest to the outer surface of the body 22 at the “outlet end” of the section (i.e. has the smallest radius from the central axis closest to the outlet 26) and the ramp extends gradually radially outwardly axially towards the inlet 24.

This configuration means that the widest sections of the first and second frustoconical sections are adjacent each other while the narrow sections are furthest apart. A channel is formed between the widest sections for a sealing member 60. In other words, a generally transverse surface extends towards the central axis from the widest part of the frustoconical section and forms a side wall of the channel. Each of the frustoconical sections includes such a radially extending wall, so each provides one side wall of the channel. The side walls are spaced to provide space for the sealing member 60 to be located within the channel formed by those side walls. Therefore, the first and second angled surfaces 52, 54 are arranged to provide a channel for receiving a sealing member 60 between them. The sealing member 60 is received in the channel and in this example, the sealing member 60 is an O-ring. The O-ring extends around the body 22 between the first and second angled surfaces 52, 54. It should be appreciated that the sealing member 60 could be integrally formed with the first and second angled surfaces 52, 54. In other words, the sealing member 60 is permanently located in the channel to form a single piece construction (i.e. a construction that cannot easily be disassembled). This could be achieved through a moulding process (i.e. an over moulding process or twin-shot / two-shot moulding process may be appropriate to provide the desired structure).

The sealing member 60 is formed of a softer / less rigid material than the remainder of the connector 20 (i.e. the body 22 and angled surfaces 52, 54, 56 are formed of a more rigid material than the seal). The sealing member 60 may be made of a silicon, rubber-like or appropriate plastics material (i.e. a material that naturally provides good sealing when engaged / contacting a surface).

In some embodiments, a third angled surface 56 is provided. In the illustrated example, the third angled surface 56 is a third frustoconical section that forms the outer surface of the body 22. In this example, third frustoconical section is oriented so that it narrows towards the inlet 24 / widens towards the outlet 26 (i.e. has the same orientation as the first angled surface 52).

In some embodiments, the third angled surface 56 is closer to the inlet 24 than the first and second angled surface 52, 54. In the present example, the widest portion of the third angled surface 56 is closest to the narrowest portion of the first angled surface 52 (as can be seen in figure 3), the first and third angled surfaces 52, 56 are spaced apart.

In some embodiments, there is a single angled surface (which could be the first or second angled surface 52, 54 already described) which is located adjacent the sealing member. Thus, the channel may be formed between that angled surface and a second non-angled surface (i.e. the second surface is formed from an annular flange / projection that extends around the body). The O-ring extends around the body and is received in the channel. The remainder of the body may include the same or similar features as already described (e.g. the third surface discussed above may be present).

In some embodiments, a mucus guard member 70 is provided which surrounds the inlet 24. The mucus guard 70 includes a plurality of openings / slots 70a which are radially offset from the inlet 24. The mucus guard member 70 reduces the amount of mucus that is permitted to flow through the passage of the drainage connector 20 (and, thus, into a conduit 92). The openings 70a collect mucus as it has a higher viscosity than most of the waste collected and as such it gets caught on the formations / wall sections provided between the openings 70a.

It should be appreciated that, in use, the entirety of the first end 22a of the body 22 will be positioned inside the ostomy appliance 10. The contact formation 50 is configured to contact and seal against the internal surface of the valve 14. Additionally, the mucus guard member 70 is configured to be positioned directly inside the valve inlet 16a of the valve 14. Thus, the mucus guard member 70 forms a cage-like formation around the valve inlet 16a to the valve 14 (and around the inlet 24 to the drainage connector 20 itself).

The first and second angled surfaces 52, 54 are configured to engage / provide firm contact against the valve 14 to ensure a good sealing action (i.e. to prevent waste egress between the drainage connector 20 and the valve 14). The sealing member 60 works in combination with the angled surfaces 52, 54 to improve the sealing action. Thus, the frustoconical sections and the sealing member 60 all contact the internal surface of the valve 14. It should be appreciated that the valve may be deformable or made of a material that provides some degree of resilience. Thus, the surfaces 52, 54, the sealing member 60 and the outer surface of the body 22 between the angled surfaces 52, 54 may all provide some degree of contact and sealing against a deformable internal wall of the valve 14. Thus, it is important that there are no additional formations on the outer surface of the first end 22a, so that this engagement is as complete as possible. It should be appreciated that if there is one angled surface and one non-angled surface either side of the sealing member, the sealing against the valve will be different - the non-angled surface may not achieve the same contact as the construction illustrated.

More details of the use of the drainage connector 20 are outlined below.

The second end 22b of the drainage connector 20 is not inside the ostomy appliance 2 in use.

In some embodiments, the drainage connector 20 includes a user graspable formation. In the illustrated example, the user graspable formation is a radially extending flange 80. In other words, a section projects outwards from the outer surface of the body 22 to form a rim. The rim projects outwardly enough so that it extends further than the valve 14 (when the connector 20 is connected). Thus, the radially extending flange 80 is easily grasped by a user when the connector 20 is in use.

In some embodiments, the drainage connector includes a fourth angled surface 82 which widens towards the radially extending flange 80. This may help to ensure the drainage connector 20 is centrally seated within the valve 14 when in use.

In some embodiments, the drainage connector 20 further includes a conduit connecting formation 90 for connecting to a conduit 92 (see figures 3 and 4 particularly). The conduit connecting formation 90 includes a one or more frustoconical surfaces. These frustoconical surfaces assist with contact against the conduit 92 and ensure the conduit 92 is held on the drainage connector 20 securely.

Figure 5 illustrates a cross-sectional view of the drainage connector 20 in positioned / connected to the valve 14. As can be seen, the internal surface of the valve 14 (i.e. the passage between the valve inlet 16a and the valve outlet 16b) contacts the outer surface of the body 22 of the drainage connector 20. The valve 14 / passage is formed from a relatively soft / deformable material that temporarily moulds around the drainage connector 20 when connected. The first, second and third angled surfaces 52, 54, 56 all contact the internal surface of the valve 14 and provide sealing surfaces when the connector 20 is connected. Further, the sealing member 60 also contacts the internal surface and provides sealing.

In some embodiments, the passage extending through the body 22 is substantially cylindrical. In the illustrated example (see figure 5), the passage widens at a generally central location to allow an increased cross-sectional area for waste to flow.

The use of the drainage connector 20 will now be described. The drainage connector 20 is connected at the second end 22b to the conduit 92. When the user wants to connect the drainage connector 20 to their ostomy appliance 10 the following steps are taken. The valve 14 of the ostomy appliance 10 is opened so that the valve outlet 16b is open and provides a passage through to the valve inlet 16a.

The drainage connector 20 is pushed into the valve outlet 16b - the mucus guard 70 deforms the valve outlet 16b, the passage and the valve inlet 16a as it is moved into position as it is wider than the valve passage and the widest part of the first end 22a of the connector 20. The mucus guard 70 is pushed out of the valve inlet 16a so that it is located to provide the cage like structure immediately outside the valve inlet 16a.

The contact formation 50 is in contact with the internal surface of the valve 14. Thus, the first and second angled surfaces 52, 54 and the sealing member 60 all form the seal with the valve 14. Due to the directions of the surfaces, even if the connector 20 is pulled around and out of alignment with the valve 14 the surfaces 52, 54 and sealing member 60 ensure that fluid (waste) is not permitted between the valve 14 and the drainage connector 20 (and, thus, leakages are reduced). Further, the surfaces on the connector 20 (the outer surface of the body 22, the first and second angled surface 52, 54, the sealing member 60, etc) are all arranged to extend generally smoothly about the body 22 (with no ribs or projections that extend longitudinally along the axis) which improves the contact / sealing against the valve 14. Minimising leaks is especially important as the drainage connector 20 will often be used at night while the user is sleeping, so they are not able to monitor the connection formed with the valve 14 at all times. Further, they may roll on the connection and deform parts or all of the valve 14, so a consistent and reliable seal must be provided.

When the user wishes to disconnect the drainage connector 20 from the valve 14, they can grasp the user graspable formation (the radially extending flange 80). This is easily done as it extends outwards of the valve body 16 to provide a rim or step to grip. The user then pulls the drainage connector 20 through the valve passage and out of the valve outlet 16b.

The valve 14 returns to its normal shape after the drainage connector 20 is removed and the closure I stopper is returned to the valve outlet 16b.

When used in this specification and claims, the terms "comprises" and "comprising" and variations thereof mean that the specified features, steps or integers are included. The terms are not to be interpreted to exclude the presence of other features, steps or components.

The invention may also broadly consist in the parts, elements, steps, examples and/or features referred to or indicated in the specification individually or collectively in any and all combinations of two or more said parts, elements, steps, examples and/or features. In particular, one or more features in any of the embodiments described herein may be combined with one or more features from any other embodiment(s) described herein.

Protection may be sought for any features disclosed in any one or more published documents referenced herein in combination with the present disclosure.

Although certain example embodiments of the invention have been described, the scope of the appended claims is not intended to be limited solely to these embodiments. The claims are to be construed literally, purposively, and/or to encompass equivalents.




 
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