An ostomy coupling device

Abstract

A coupling device for securing an ostomy bag to an ostomate comprises: (i) a first annular member having an inner edge, an outer edge, a first side and a second side, and on the first side an adhesive for temporarily adhering the first annular member to the ostomate's skin about a stomal opening, and on the second side a first annular bonding region, and an upstanding projection, which is arcuate and projects from part of the outer edge; and (ii) a second annular member for securing to an ostomy bag, the second annular member having an inner edge and an outer edge, and a second annular bonding region for bonding to the first annular bonding region; the outer edge of the second annular member having a diameter corresponding to an inner diameter of the upstanding projection, and the first and second annular bonding regions thereof being provided with means for forming a releasable adhesive bond therebetween.

Description

[0001] An Ostomy Coupling Device

[0002] The present invention relates to an ostomy bag and more specifically to coupling devices for fastening ostomy bags to an ostomate's body.

[0003] Background of the Invention

[0004] The use of ostomy bags, such as ileostomy and colostomy bags, to collect bodily waste draining from a stomal opening in the patient's body wall, is well known. Ostomy bags can be secured to the patient by means of a belt or strap, but more usually they are affixed to the patient by means of an adhesive flange which surrounds the stomal orifice. Typically, the adhesive flange has a layer of a dermatologically compatible hydrocolloid adhesive. Although the hydrocolloid adhesives are relatively benign, repeated application and removal of fresh adhesive flanges can cause irritation and discomfort to the patient and, for this reason, in situations where an ostomy bag needs to be changed frequently, a two-piece bag is used. Such two-piece bags typically consist of a two-part connector, one part of which has the adhesive flange attached thereto, and the other part of which is attached to the ostomy bag. With such an arrangement, the adhesive flange may be left in position on the patient's skin whilst the ostomy bag can be replaced as required.

[0005] The benefit of a two-piece system is that it enables the application of multiple bags to a single hydrocolloid wafer allowing the hydrocolloid wafer to remain in place for an extended period thereby minimising the stress on the peristomal skin caused when removing multiple hydrocolloid wafers.

[0006] However, a disadvantage with existing two-part connectors is that it can be difficult for an ostomate to align an adhesive coupling system flange on the ostomate's body with a flange on an ostomy bag properly.

[0007] Some devices use a locking ring arrangement which requires accurate positioning and good manual dexterity. This can pose problems for people who have impaired manual dexterity. In light of the problems discussed above, various proposals have been made, but there remains a need for an improved device which addresses one or more of the problems presented by prior art arrangements. In this regard, the present invention seeks to provide an alternative which preferably addresses one or more of the problems presented by prior art arrangements.

[0008] Summary of the In vention

[0009] Accordingly, in a first aspect, the present invention provides a coupling device for securing an ostomy bag to an ostomate; the device comprising:

[0010] (i) a first annular member having an inner edge, an outer edge, a first side and a second side, the first side facing the ostomate's skin about a stomal opening in use, and on the second side a first annular bonding region and an upstanding projection, which is arcuate and projects from the second side adjacent part of the outer edge; and

[0011] (ii) a second annular member for securing to an ostomy bag, the second annular member having an inner edge and an outer edge, and on one side a second annular bonding region for bonding to the first annular bonding region; the outer edge of the second annular member having a diameter corresponding to an inner diameter of the upstanding projection, and the first and second annular bonding regions thereof being provided with means for forming a releasable adhesive bond therebetween.

[0012] In a second aspect, the invention provides an ostomy bag comprising a coupling device as herein before described.

[0013] The combination of a projection which projects from part of the outer edge of the first annular member, and the matching inner diameter of this projection with the outer diameter of the second annular member facilitates correct positioning of the two annular members before the adhesive contact between the two bonding regions takes place. This is particularly important in cases where the ostomates using the ostomy bag have impaired or reduced manual dexterity or where, for example because of obesity or poor sight, it is difficult for the patient to see the ostomy coupling clearly. Preferably, at least one of the annular bonding regions has a layer of a releasable adhesive thereon, the releasable adhesive preferably being in the form of an adhesive tape which is protected by a release tape prior to use. More preferably, the second annular bonding region has a layer of a releasable adhesive thereon.

[0014] The annular bonding regions are preferably defined by substantially planar annular surfaces.

[0015] Preferably, the projection can take the form of an arcuate guide wall which extends between two spaced apart points on the periphery of the first annular member adjacent the outer edge of the first annular member.

[0016] Preferably, the spaced apart points on the periphery of the first annular member are located on a minor segment of the first annular member. In other words, the angle at which two lines from the points meet at the centre of the first annular member is 180° degrees or less. In one embodiment, the angle at which two lines from the points meet at the centre of the first annular member is 76°.

[0017] Preferably, the arcuate guide wall projects about 1mm to about 5mm from the second side of the first annular member. More preferably, the arcuate guide wall projects about 3mm from the second side of the first annular member. Advantageously, this provides sufficient alignment surface for alignment of the second annular member with the arcuate guide wall.

[0018] Preferably, the arcuate guide wall projects substantially perpendicular to the second side of the first annular member.

[0019] Preferably, the arcuate guide wall has a thickness of about 1mm to about 3mm. Advantageously, this thickness provides sufficient structural integrity to enable alignment to the second annular member with the arcuate guide wall. Advantageously, by including an outwardly projecting arcuate guide wall for receiving the outer edge of the adhesive flange located on the bag, alignment of the inner edge of the adhesive flange on the pouch relative to the inner edge of the first annular member is facilitated.

[0020] Preferably, the outwardly projecting arcuate guide wall is positioned on the outer periphery of the first annular member and has an inner diameter which communicates with the outer diameter of the second annular member, thereby allowing independent rotation of the second annular member relative to the first annular member about an axis which extends perpendicularly through the plane of the first and second annular members.

[0021] Preferably, the first annular member comprises two flanges sealed to each other, each flange having an inner edge, an outer edge, a first side and a second side, a first flange having on one side thereof an adhesive for temporarily adhering the first annular member to the ostomate's skin about a stomal opening and a second side facing a second flange, the second flange having a first side facing the first flange, and a second side having the first annular bonding region thereon, the upstanding projection projecting from part of the outer edge of the second flange.

[0022] Preferably, the first flange and the second flange are sealed to each other by a seal adjacent their inner edges and the outer edges of each flange are not sealed to each other. Preferably, the seal is provided by a film.

[0023] Advantageously, this allows the radially outer parts of the first flange and the second flange to move relative to each other and, in use, it minimises the thickness of material in contact with the body of an ostomate, thereby improving comfort. It additionally minimises stresses placed on the second flange and the upstanding projection caused by bending of the torso of the ostomate, thereby minimising the risk of leaks. Preferably, the first flange has an outer edge which has a plurality of indents. In one embodiment, the outer edge of the first flange has four indents and the outer edge defines a cross shape, wherein edges of the cross are rounded.

[0024] Advantageously, this enables the flange to hug the contours of a body of an ostomate, thereby helping to achieve a better fit around a stoma.

[0025] The first annular member has on one side thereof an adhesive for temporarily adhering the first annular member to the patient's skin. The adhesive is typically in the form of an adhesive flange or disc and may be formed from, for example, a hydrocolloid adhesive.

[0026] Brief Description of the Drawings

[0027] The invention will now be further described with reference to the accompanying drawings in which:

[0028] Figure 1 shows a device according to the invention;

[0029] Figures 2 and 3 show how participants were asked to apply the bag to the baseplate, firstly with the bag pointing straight down (figure 2) and then with the bag at angle (figure 3);

[0030] Figure 4 shows measurements recorded in mm of the displacement found in the spacing between the inner diameters of the bag flange and wafer flange after the application process;

[0031] Figure 5 shows a graph to show the direction and average distance of misalignment of the bag onto the wafer when aligned vertically;

[0032] Figure 6 shows a graph to show how confident participants felt that they had aligned the bag flange to the wafer flange when aligning the bag in a vertical position; Figure 7 shows graph to show how difficult participants found aligning the bag to the wafer flange when the bag is positioned vertically;

[0033] Figure 8 shows graph to show the direction and average distance of misalignment of the bag onto the wafer when aligned at an angle;

[0034] Figure 9 shows graph to show how difficult participants found aligning the bag to the wafer flange when the bag is positioned at an angle; and

[0035] Figure 10 shows graph to show how confident participants felt that they had aligned the bag flange to the wafer flange when aligning the bag in a vertical position.

[0036] Detailed Description of the Invention

[0037] It will be appreciated that aspects, embodiments and preferred features of the invention have been described herein in a way that allows the specification to be written in a clear and concise way. However, unless circumstances clearly dictate otherwise, aspects, embodiments and preferred features can be variously combined or separated in accordance with the invention. Thus, preferably, the invention provides a device having features of a combination of two or more, three or more, or four or more of the aspects described herein. In a preferred embodiment, a device in accordance with the invention comprises all aspects of the invention.

[0038] Within the context of this specification, the word "about" means plus or minus 20%, more preferably plus or minus 10%, even more preferably plus or minus 5%, most preferably plus or minus 2%.

[0039] Within the context of this specification, the word "substantially" means preferably at least 90%, more preferably 95%, even more preferably 98%, most preferably 99%.

[0040] Within the context of this specification, the word "comprises" means "includes, among other things" and should not be construed to mean "consists of only". With reference to Figures 1 to 3, an embodiment of the invention provides a solution for enabling users to manually align and adhere an opening in a flange (3) of an ostomy bag (1) to an opening in a wafer (4) to permit the receipt of waste from a stoma into the bag (1).

[0041] Features located on the wafer (4) and bag flange (3) come together to support the user in achieving accurate alignment of the bag flange (3) onto the wafer (4).

[0042] In this regard, an embodiment of the invention provides a coupling device for securing an ostomy bag (1) to an ostomate; the device comprising:

[0043] (i) a first annular member (4) which comprises two flanges (2) (7) sealed to each other, each flange (2) (7) having an inner edge (8)(9), an outer edge (10)(l 1), a first side (12)(13) and a second side (14) (15), the first flange (2) having on one side (12) thereof an adhesive for temporarily adhering the first annular member (4) to the ostomate's skin about a stomal opening and a second side (14) facing a second flange (7), the second flange (7) having a first side (13) facing the first flange (2), and a second side (15) having a first annular bonding region (16) thereon, and an upstanding projection (5), which is arcuate and projects from the second side (15) adjacent part of the outer edge (11); and

[0044] (ii) a second annular member (3) for securing to an ostomy bag (1), the second annular member (3) having an inner edge (17) and an outer edge (18), and on one side (19) a second annular bonding region (20) for bonding to the first annular bonding region (16); the outer edge (18) of the second annular member (3) having a diameter corresponding to an inner diameter of the surface (6) of the upstanding projection (5), and the first and second annular bonding regions (16)(20) thereof being provided with means for forming a releasable adhesive bond therebetween.

[0045] The invention also provides an ostomy bag (1) comprising a coupling device as described herein. The second annular bonding region (20) has a layer of a releasable adhesive thereon. The releasable adhesive is in the form of an adhesive tape which is protected by a release tape (21) prior to use.

[0046] The annular bonding regions (16)(20) are preferably defined by substantially planar annular surfaces.

[0047] The projection (5) takes the form of an arcuate guide wall which extends between two spaced apart points on the periphery of the second side (15) of the second flange (7) of the first annular member (4) adjacent the outer edge (11) of the first annular member (4).

[0048] The spaced apart points on the periphery of the first annular member (4) are located on a minor segment of the first annular member (4). The angle at which two lines from the points meet at the centre of the first annular member is 76°.

[0049] The projection (5) projects substantially perpendicularly about 3mm from the second side (15) of the second flange (7) of the first annular member (4).

[0050] The projection (5) has a thickness of about 1mm to about 3mm.

[0051] The projection (5) is positioned on the outer periphery of the second flange (7) of the first annular member (4) and has an inner diameter which communicates with the outer edge (18) of the second annular member (3), thereby allowing independent rotation of the second annular member (3) relative to the first annular member (4) about an axis which extends perpendicularly through planes of both the first and second annular members (3)(4).

[0052] The first flange (2) and the second flange (7) of the first annular member (4) are sealed to each other by a film seal adjacent their inner edges (8)(9). The outer edges (10)(l 1) of each flange (2)(7) are not sealed to each other. The outer edge (10) of the first flange (2) has four indents (22) so that the outer edge (10) defines a cross shape, wherein edges of the cross are rounded.

[0053] Thus, the ostomy bag (1) of the invention has an annular foam flange (3) having adhesive thereon protected by a release liner (21). In use, the release liner (21) is removed immediately prior to use to expose the adhesive.

[0054] The bag flange (3) defines an opening for receiving the stoma. The bag flange (3) has an outer diameter which is equal to the inner diameter of an arcuate guide wall (5) which projects outwardly from the wafer flange (4). In use, the arcuate guide wall (5) is positioned on the lower portion of the wafer flange (4). The arcuate guide wall (5) is between about 1.2mm and about 3 mm in thickness to provide sufficient surface around the circumference of the hydrocolloid wafer flange (4) and sufficient structural integrity to enable alignment of the bag flange (3) to the hydrocolloid wafer flange (4).

[0055] The hydrocolloid wafer flange (4) is adhered to the body of a user and thereafter it receives the adhesive foam flange (3) of the bag. The hydrocolloid wafer flange (4) has a bonding region which bonds with the foam flange (3) of the bag and has a diameter which is larger than the diameter of the adhesive bag flange (3) by about 5mm around the circumference. Offsetting the edge of bonding region of the wafer flange (4) from the bag flange (3) provides additional surface area for the bag flange (3) to adhere if the user is not accurate in applying the adhesive bag flange (3) to the hydrocolloid wafer flange (4), minimising the risk of leakage.

[0056] The lower portion of the hydrocolloid wafer flange (4) has an arcuate guide wall (5) formed by a projection which extends between two spaced apart points on the periphery of the hydrocolloid wafer flange (4). The angle at which two lines from the points meet at the centre of the first annular member is 76°.

[0057] The arcuate guide wall (5) projects outwardly from the outer planar face of the wafer flange (4) for receiving the outer edge of the adhesive bag flange (3). The alignment guide wall (5) projects outwardly 3mm from the planar surface of the hydrocolloid wafer flange providing sufficient alignment surface (6) for alignment.

[0058] The purpose of the invention is to enable the user to accurately bring together the bag flange and hydrocolloid wafer flange which make up a 2-piece system to minimise the risk of leakage. In addition the invention also allows the user to achieve accurate alignment of the bag flange onto the wafer flange at an angle of their choosing to promote comfort and usability across a variety of use cases e.g. during exercise or sleeping. It may also be beneficial to position the bag at an angle during hospital use to make the draining and changing of bags more accessible to nurses when a patient is laying down.

[0059] Examples

[0060] Comparative Testing Comparative Test Data

[0061] The below test results reference R&D test number (21088) and demonstrate novelty in relation to the user's ability to achieve more accurate and consistent alignment of the hydrocolloid wafer opening and the bag flange opening when the hydrocolloid wafer and bag flange are positioned at independent angles about an axis which extends perpendicular through the landing ring and bag flange.

[0062] Samples tested

[0063] 30 participants were asked to apply a wafer flange containing a simulated stoma to their stomach using a belt with the wafer flange of a comparative example already applied. Participants were then asked to apply the accompanying bag having a flange to the wafer flange, first with the bag pointing straight down (figure 2) and then with the bag at angle (figure 3). Participants were then asked to remove the assembled two-piece system intact. Measurements of any off set between the opening in the wafer flange and the bag flange were then recorded to determine the accuracy of the application. In addition to these measurements, users were also asked how easy they felt it was to align the bag flange to the wafer flange vertically and at an angle. Participants were also asked how confident they felt that they had aligned the bag flange to the wafer flange accurately vertically and at an angle.

[0064] Measurements recorded in mm of the displacement found in the spacing between the inner diameters of the bag flange and wafer flange after the application process. The measurements taken are shown in Figure 4.

[0065] A graph was plotted to show the direction and average distance of misalignment of the bag onto the wafer when aligned vertically. The results are shown in Figure 5 and Table 1 below. Table 1

[0066] A table to show the combined average directional misalignment of the bag onto the wafer.

[0067] Figure 5 and table 1 show that on average participants displayed the most accurate levels of alignment when using the device of the invention, offsetting the centre of the bag flange from the wafer flange by 1.46mm on average across 30 participants.

[0068] A graph was plotted to show the direction and average distance of misalignment of the bag onto the wafer when aligned vertically. The results are shown in Figure 5.

[0069] A graph was plotted to show how confident participants felt that they had aligned the bag flange to the wafer flange when aligning the bag in a vertical position. The results are shown in Figure 6.

[0070] Figure 6 is a bar graph showing the percentage of participants indicating how confident they felt that their ostomy bag had been applied accurately. There is a bar indicating no confidence for comparative example 1; there are bars indicating little confidence in the invention, comparative example 1 and comparative example 2 from left to right respectively; there are bars indicating okay, confident and very confident in the invention, comparative example 1, comparative example 2 and comparative example 3 from left to right respectively in each case. A graph was plotted to show how difficult participants found aligning the bag to the wafer flange when the bag is positioned vertically. The results are shown in Figure 7.

[0071] Figure 7 is a bar graph showing the percentage of participants indicating how they found the process of aligning the wafer to the landing ring. There are bars indicating very difficult for the invention and comparative example 1 from left to right respectively; there are bars indicating difficult for comparative example 1 and comparative example 2 from left to right respectively; there are bars indicating okay for comparative example 1, comparative example 2 and comparative example 3 from left to right respectively; and there are bars indicating easy and very easy for the invention, comparative example 1, comparative example 2 and comparative example 3 from left to right respectively in each case.

[0072] Figure 7 show that 97% of the 30 participants found the alignment of the Welland bag flange onto the wafer flange to be either easy or very easy. Figure 6 shows that 90% of the 30 participants felt either confident or very confident that they had aligned the bag flange to the wafer flange vertically accurately.

[0073] Table 2

[0074] A table to show the combined average directional misalignment of the bag onto the wafer when aligned at an angle

[0075] A graph was plotted to show the direction and average distance of misalignment of the bag onto the wafer when aligned at an angle. The results are shown in Figure 8. Figure 8 and Table 2 show that when the participants aligned the bag to the wafer at an angle the greatest accuracy was achieved using the device of the invention, where on average participants only demonstrated a misalignment of 2.5mm.

[0076] A graph was plotted to show how difficult participants found aligning the bag to the wafer flange when the bag is positioned at an angle. The results are shown in Figure 9.

[0077] Figure 9 is a bar graph showing the number of participants indicating how they found the process of aligning the wafer to the landing ring, with the bag positioned at an angle. There is a bar indicating very difficult for comparative example 2; there are bars indicating difficult for comparative example 1, comparative example 2 and comparative example 3 from left to right respectively; there are bars indicating okay, easy and very easy for the invention, comparative example 1, comparative example 2 and comparative example 3 from left to right respectively in each case.

[0078] A graph was plotted to show how confident participants felt that they had aligned the bag flange to the wafer flange when aligning the bag at an angle. The results are shown in Figure 10.

[0079] Figure 10 is a bar graph showing the number of participants indicating how confident they felt that their ostomy bag had been applied accurately. There are bars indicating no confidence for comparative example 2 and comparative example 3 from left to right respectively; there are bars indicating little confidence in comparative example 1, comparative example 2 and comparative example 3 from left to right respectively; there are bars indicating okay, confident and very confident in the invention, comparative example 1, comparative example 2 and comparative example 3 from left to right respectively in each case.

[0080] Figure 9 shows that 86.6% of participants found aligning the bag flange to the wafer flange easy or very easy when using the Welland product. Figure 10 shows that 93% of participants felt either confident or very confident that they had aligned the bag flange to the wafer flange at an angle accurately.

[0081] The above described embodiments have been given by way of example only, and the skilled reader will naturally appreciate that many variations could be made thereto without departing from the scope of the invention.

Claims

CLAIMS1. A coupling device for securing an ostomy bag to an ostomate; the device comprising:(i) a first annular member having an inner edge, an outer edge, a first side and a second side, the first side facing the ostomate's skin about a stomal opening in use, and on the second side a first annular bonding region and an upstanding projection, which is arcuate and projects from the second side adjacent part of the outer edge; and(ii) a second annular member for securing to an ostomy bag, the second annular member having an inner edge and an outer edge, and on one side a second annular bonding region for bonding to the first annular bonding region; the outer edge of the second annular member having a diameter corresponding to an inner diameter of the upstanding projection, and the first and second annular bonding regions thereof being provided with means for forming a releasable adhesive bond therebetween.

2. The coupling device according to claim 1, wherein at least one of the annular bonding regions has a layer of a releasable adhesive thereon.

3. The coupling device according to claim 2, wherein the releasable adhesive is in the form of an adhesive tape which is protected by a release tape prior to use.

4. The coupling device according to claim 2 or claim 3, wherein the second annular bonding region has a layer of a releasable adhesive thereon.

5. The coupling device according to any one of the preceding claims, wherein the annular bonding regions are defined by substantially planar annular surfaces.

6. The coupling device according to any one of the preceding claims, wherein the projection takes the form of an arcuate guide wall which extends between two spaced apart points on the periphery of the first annular member adjacent the outer edge of the first annular member.The coupling device according to claim 6, wherein the spaced apart points on the periphery of the first annular member are located on a minor segment of the first annular member. The coupling device according to claim 6 or claim 7, wherein the angle at which two lines from the points meet at the centre of the first annular member is about 76°. The coupling device according to any one of the preceding claims, wherein the projection projects about 1mm to about 5mm from the second side of the first annular member. The coupling device according to any one of the preceding claims, wherein the projection projects substantially perpendicular to the second side of the first annular member. The coupling device according to any one of the preceding claims, wherein the projection has a thickness of about 1mm to about 3mm. The coupling device according to any one of the preceding claims, wherein the projection is positioned on the outer periphery of the first annular member and has an inner diameter which communicates with the outer diameter of the second annular member, thereby allowing independent rotation of the second annular member relative to the first annular member about an axis which extends perpendicularly through the plane of the first and second annular members. The coupling device according to any one of the preceding claims, wherein the first annular member comprises two flanges sealed to each other, each flange having an inner edge, an outer edge, a first side and a second side, a first flange having on one side thereof an adhesive for temporarily adhering the first annular member to the ostomate's skin about a stomal opening and a second side facing a second flange, the second flange having a first side facing the first flange, and a second side having the first annular bonding region thereon,the upstanding projection projecting from part of the outer edge of the second flange. The coupling device according to claim 13, wherein the first flange and the second flange are sealed to each other by a seal adjacent their inner edges and the outer edges of each flange are not sealed to each other. The coupling device according to claim 14, wherein the seal is provided by a film. The coupling device according to any one of claims 13 to 15, wherein the first flange has an outer edge which has a plurality of indents. The coupling device according to claim 16, wherein the outer edge of the first flange has four indents and the outer edge defines a cross shape, wherein edges of the cross are rounded. The coupling device according to any one of the preceding claims, wherein the first annular member has on one side thereof an adhesive for temporarily adhering the first annular member to an ostomate's skin. The coupling device according to claim 18, wherein the adhesive is in the form of an adhesive flange or disc and may be formed from a hydrocolloid adhesive. An ostomy bag comprising the coupling device according to any one of the preceding claims.

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