Ostomy device

Abstract

The present invention relates to an ostomy device for contacting a stoma. The present invention also relates to the use of an ostomy device for contacting a stoma and a kit of parts for preparing an ostomy assembly or system.

Claims

1. An ostomy device for contacting a stoma comprising: a laminate structure comprising a substrate layer and an adhesive layer; and an aperture formed through the laminate structure and defined by a peripheral wall; wherein the laminate structure has (i) an extensibility in a range of about 1 newton per centimeter (N/cm) to about 10 N/cm and (ii) a permanent set value of less than or equal to about 5%; wherein the peripheral wall is configured to: expand in a plane of the laminate structure from a pre-expanded state to an expanded state to radially enlarge the aperture to allow insertion of the stoma through the aperture and, once in its expanded state, the peripheral wall is further operable to contract from the expanded state towards its pre-expanded state to radially reduce the aperture and contact the stoma with the peripheral wall, wherein the contact between the peripheral wall and the stoma forms a seal between the peripheral wall and the stoma.

2. The ostomy device according to claim 1, wherein the substrate layer comprises a foam and/or film.

3. The ostomy device according to claim 1, wherein the substrate layer comprises a polymer.

4. The ostomy device according to claim 3, wherein the polymer comprises a polyurethane or polyethylene.

5. The ostomy device according to claim 1, wherein the adhesive layer comprises a hydrocolloid, a silicone adhesive, an acrylic adhesive, a polyurethane adhesive, or any combination of two or more thereof.

6. The ostomy device according to claim 5, wherein the hydrocolloid comprises sodium carboxymethylcellulose, polysaccharides and pectin.

7. The ostomy device according to claim 1, wherein a thickness of the substrate layer is from about 0.005 mm to about 0.1 mm.

8. The ostomy device according to claim 7, wherein the thickness of the substrate layer is from about 0.005 mm to about 0.05 mm.

9. The ostomy device according to claim 1, wherein a thickness of the adhesive layer is from about 0.1 mm to about 10 mm.

10. The ostomy device according to claim 9, wherein a thickness of the adhesive layer is from about 0.1 mm to about 5 mm, 0.2 mm to about 4.0 mm or from about 0.5 mm to about 3.0 mm.

11. The ostomy device according to claim 1, wherein: (a) an overall thickness of the laminate structure is from about 0.1 mm to about 10 mm, 0.2 mm to about 5.0 mm or about 0.5 mm to about 1.0 mm; or (b) the laminate structure has an extensibility of from about 3 N/cm to about 8 N/cm or from about 5 N/cm to about 6 N/cm; or (c) the laminate structure has a permanent set (%) of less than or equal to about 2%; or (d) the substrate layer has a moisture vapour transmission rate of at least about 500 g/m.sup.2/24 hr, or at least about 2000 g/m.sup.2/24 hr, or at least about 4000 g/m.sup.2/24 hr, or from about 4000 g/m.sup.2/24 hr to about 5000 g/m.sup.2/24 hr; or (e) a peel adhesive force of the laminate structure is from about 10N/2.5 cm to about 20N/2.5 cm or from about 12N/2.5 cm to about 18N/2.5 cm; or (f) a fluid absorbance of the laminate structure is from about 3 grams/10 cm.sup.2/24 hours to about 6 grams/10 cm.sup.2/24 hours, or from about 4 grams/10 cm.sup.2/24 hours to about 5 grams/10 cm.sup.2/24 hours.

12. The ostomy device according to claim 1, wherein a total fluid handling of the laminate structure is from about 8 grams/10 cm2/24 hours to about 12 grams/10 cm.sup.2/24 hours, or from about 9 grams/10 cm.sup.2/24 hours to about 10 grams/10 cm.sup.2/24 hours.

13. The ostomy device according to claim 1, wherein when the peripheral wall is in its pre-expanded state, the aperture is substantially circular.

14. The ostomy device according to claim 1, further comprising a release liner to protect the adhesive layer prior to use.

15. A method for contacting a stoma with the ostomy device of claim 1, the method comprising: expanding the peripheral wall in the plane of the laminate structure of the ostomy device from the pre-expanded state to the expanded state to radially enlarge the aperture; inserting the stoma through the enlarged aperture; and contacting the stoma with the peripheral wall.

16. The method according to claim 15 wherein, following insertion of the stoma into the enlarged aperture, the peripheral wall is contracted from the expanded state towards the pre-expanded state to cause the peripheral wall to contact the stoma.

17. The method according to claim 15 wherein the contact between the peripheral wall and the stoma forms a seal between the peripheral wall and the stoma.

18. A kit of parts for preparing an ostomy assembly, the kit comprising: an ostomy device for contacting a stoma as defined in claim 1; and an ostomy pouch capable of engaging the ostomy device.

19. An ostomy device for contacting a stoma comprising: a laminate structure including a substrate layer and an adhesive layer; and an aperture formed through the laminate structure and defined by a peripheral wall; wherein the laminate structure has (i) an extensibility in a range of about 1 newton per centimeter to about 10 newtons per centimeter and (ii) a permanent set value of less than or equal to about 5%; and wherein the aperture is configured to allow insertion of the stoma through the aperture.

20. The ostomy device of claim 19, wherein the laminate structure has a fluid absorbance in a range of about 5 grams per 10 centimeters squared per 24 hours (g/10 cm.sup.2/24 h).

Description

DESCRIPTION OF THE FIGURES

(1) The present invention will now be described with reference to the following non-limiting examples and figures, which show:

(2) FIG. 1: A plan view of an ostomy device according to an embodiment of the invention shown in its pre-expanded state and in various expanded states (i.e. when a stretching force is applied by a user during application to a stoma to enlarge the aperture before insertion of a stoma has occurred).

(3) FIG. 2: A plan view of an ostomy device according to an embodiment of the invention shown in its expanded state (i.e. when a stretching force is applied by a user during application) with insertion of a stoma.

(4) FIG. 3: A plan view of an ostomy device according to an embodiment of the invention shown in its sealed state (i.e. applied to a stoma to form a seal).

(5) FIG. 4: A side or cross-sectional view of an ostomy device according to an embodiment of the invention shown in its sealed state.

DETAILED DESCRIPTION OF THE INVENTION

(6) Referring to FIG. 1, there is depicted an ostomy device 1, for application to a stoma (not shown) according to a preferred embodiment of the present invention. As described herein, the ostomy device 1 can vary in size or shape depending on the nature and dimensions of the stoma to which the device 1 is to be applied. In a preferred embodiment, the ostomy device 1 has a laminate structure, as described herein, including a substrate layer and adhesive layer. It can be seen in FIG. 1 that ostomy device 1 has an aperture 2 which is suitable for receiving a stoma, during use. The aperture 2 is defined by a peripheral wall 3 of the ostomy device 1. During application, the user increases the size of the aperture 2 by applying a stretching force (depicted by the arrows in FIG. 1) in the plane of the device 1. This stretching force causes the peripheral wall 3 to expand in a radial direction to cause radial enlargement of the aperture 2. The extent of the expansion of the peripheral wall 3 and enlargement of the aperture 2 can be varied by the user via control of the stretching force applied to the device 1. FIG. 1 shows the device 1 in its pre-expanded state (A) before the user has applied a stretching force to the device. Also shown is the device in expanded states (B) and (C) wherein a stretching force is applied to the device 1 causing expansion of the peripheral wall 3 in the radial direction and thus causing radial enlarging of the aperture 2.

(7) Referring now to FIG. 2, during application, the user may apply and maintain a stretching force to device 1 which allows an expanded state to be adopted. The user can ensure that the expanded state is suitable for insertion of a given stoma 4 by creating an aperture which has an enlarged diameter that is greater than the diameter of the stoma 4. When stoma 4 is inserted into aperture 2, it is preferred that no contact is made between the outer surface/wall 5 of the stoma 4 and the peripheral wall 3. This will prevent irritation and/or discomfort to the user whilst applying the device 1 to the stoma 4.

(8) With reference to FIG. 3, once the user has inserted stoma 4 into the expanded aperture 2, the user may then release the stretching force applied to the device 1. In this example, the material of the device is able to retract under its own force once the user has released the tension. This causes the peripheral wall 3 to radially contract (as indicated by the arrows in FIG. 3) and contact the outer wall 5 of the stoma 4, preferably forming a seal with the outer wall 5 of the stoma 4. However, in alternative embodiments, the material may not retract under its own force. As shown in FIG. 3, when the seal is preferably formed, the peripheral wall 3 contracts and conforms to the anatomy or profile of the stoma outer wall 5. In order to ensure that a secure seal is formed between the peripheral wall 3 of the device and the stoma 4 (i.e. no gaps exist between the peripheral wall 3 and the outer wall 5 of the stoma 4 through which bodily fluid may pass), it is preferred that the user ensure that the diameter of the aperture 2 in its pre-expanded state is smaller than the diameter of the stoma to which the device is applied. This will enable the device to better form a seal as the device material retracts back towards its pre-expended state but is impeded by the stoma, and thus exerts a force on the stoma. By virtue of this retractiretracts back towards its pre-expended state but is impeded by the stoma, and thus exerts a force on the stoma. By virtue of this reretracts back towards its pre-expended state but is impeded by the stoma, and thus exerts a force on the stoma. By virtue of this retraction mechanism, this force is typically much less than the force exerted by certain prior art devices which do not operate in the same way.

(9) FIG. 4 provides a cross-sectional view of an ostomy device 1 shown in its sealed state. The laminate structure of the device 1 is shown in FIG. 4 wherein the adhesive layer 7 is adhered to the peristomal skin and supports a substrate layer 6. The peripheral wall 3 of the device and the outer wall 5 of the stoma are also shown.

(10) As illustrated in FIGS. 1-4, the device of the present invention may operate using a “stretch-fit” mechanism which allows the user to easily apply the ostomy device of the present invention to a stoma. Unlike known conventional skin barrier devices, the “stretch-fit” mechanism achieved by the device of the present invention is easy to apply. This fit mechanism also allows for a less forceful contact with the stoma, which may prevent leakages whilst avoiding discomfort for the user, thus protecting the peristomal skin.

(11) Preparation of the Ostomy Device

(12) The ostomy device of the present invention may be suitably manufactured according to conventional manufacturing methods. An exemplary method of manufacturing an ostomy device of the present invention is provided below: 1. A suitable hydrocolloid roll stock (e.g. sodium carboxymethylcellulose, polysaccharides and pectin containing hydrocolloid roll stocks) is mixed at a temperature of 80° C.-120° C. to form a hydrocolloid dope. 2. The hydrocolloid dope is then shaped into hydrocolloid logs for downstream processing. 3. The hydrocolloid logs are then extruded through a heated die with a set aperture at 90° C.-120° C. onto a suitable carrier liner (e.g. paper or film) to form an hydrocolloid sheet. 4. A suitable substrate layer (e.g. a polyurethane backing film) is then laid on top of the extruded hydrocolloid sheet. 5. The hydrocolloid sheet and the substrate layer are then laminated using nip rollers to provide a laminate material. 6. The laminate material can then be wound into a roll stock before then being cut to the required size and dimensions to form an ostomy device of the present invention.

(13) Suitable hydrocolloid roll stock materials and or substrate layers are readily available and may be purchased or prepared using conventional methods.

(14) Experimental Tests

(15) A series of tests were performed to measure the performance of an exemplary ostomy device of the present invention and a number of commercially available mouldable ostomy devices, the details of which are set out below. All test methods and procedures used to obtain the test data are provided herein and, unless specified otherwise, are known to the person skilled in the art.

(16) Product details of the commercially available mouldable ostomy devices which were tested are provided in Table 1a below.

(17) TABLE-US-00001 TABLE 1a Product Name Product Reference Number ConvaTec ™ Esteem (stoma range 413516 30-40 mm) Coloplast ™ Brava Ring Mouldable 12030 Hollister ™ Adapt (largest diameter 8815 48 mm) Eakin ™ Cohesive Seals (largest 839001 diameter 98 mm)

(18) The exemplary ostomy device of the present invention used for the purposes of the following tests is referred to herein as the “AMS Ostomy Device (OD)”. AMS OD may be manufactured using the exemplary manufacturing method as described above using the hydrocolloid specified in Table 1 b below and substrate film, MEDIFOL™ 3D. Physical characteristics and performance characteristics of the resulting AMS OD device according to the invention are described below in comparison to prior art devices. The hydrocolloid may be manufactured and formulated using techniques and procedures known to the person skilled in the art. One example technique for manufacturing hydrocolloids involves mixing the hydrocolloid ingredients using a Z-blade mixer at a suitable temperature, such as 80° C.-120° C., preferably 90° C.

(19) An exemplary hydrocolloid for use in embodiments of the invention is described in Table 1 b below. This hydrocolloid composition was the composition used in the tested “AMS Ostomy Device (OD)” described herein.

(20) TABLE-US-00002 TABLE 1b Hydrocolloid Component Amount (wt %) Polyisobutylene 28.36 Carboxymethylcellulose 29.63 Poly(styrene-butadiene-styrene) Block 16.29 Copolymer Hydrocarbon Resin 10.40 Purified Powdered Cellulose, Flock 8.44 Pectin 6.35 Other ingredients (including preservative and 0.53 liquid phase oil)

(21) A series of tests were performed on AMS OD and the resulting pH, Total Fluid Handling (TFH), Moisture Vapour Transmission Rate (MTVR), Fluid Absorbance and Peel/Adhesion Force data can be found presented in Table 2 below.

(22) TABLE-US-00003 TABLE 2 Batch 1 Batch 2 Batch 3 Batch 4 Average pH 6.67 6.71 6.60 6.68 6.66 Total Fluid Handling 9.224 9.022 8.723 9.976 9.24 (g/10 cm.sup.2/24 hr) Moisture Vapour Transmission 4079 4399 3424 6717 4655 Rate (g/m.sup.2/24 hr) Fluid absorbance 5.144 4.623 5.299 3.259 4.581 (g/10 cm.sup.2/24 hr) Peel/Adhesion Force (N/2.5 cm) 16.916 17.824 14.817 — 16.519

(23) For each of the test performed on batch samples 1 to 4 as shown in Table 2, 10 data points were taken before being averaged to provide the batch data presented in batch 1-4 columns. The average column (shown at the far right of the Table 2) is an average value of the data provided in the batch 1-4 columns provided.

(24) pH Measurements of AMS OD

(25) The method used to assess the pH of the AMS OD is aligned with British Pharmacopoeia Appendix V A120 L.

(26) A sample of the AMS OD device (0.3 g) is measured using a calibrated analytical balance and transferred into a suitable container. This is followed by the addition of purified water (30 ml) before the mixture is shaken from 30 seconds using a vortex. The solution is decanted into clean containers and the pH is measured using a calibrated pH meter and probe.

(27) A neutral pH was observed for the AMS OD which is ideal for devices applied onto the surface of the skin.

(28) Total Fluid Handling of AMS OD

(29) The Total Fluid Handling (TFH), Moisture Vapour Transmission Rate (MTVR) and Fluid Absorbance data presented in Table 2 was obtained using a method which is aligned with ISO 13726-1:2002 Test Methods for Primary Wound Dressings—Part 1: Aspects of Absorbent section 3.3 Fluid Handling Capacity. The procedure requires a circle of the AMS OD to be cut to have a 55 cm diameter. The circle of AMS OD was then attached to the flange of a Paddington Cup (a hollow cup with a 10 cm.sup.2 cross section) and secured in place with a retaining ring (e.g. screw top). The weight of the AMS OD and the Paddington Cup is measured (W1) and recorded using a calibrated balance. Then 20 ml of Solution A is added to the Paddington Cup and the screw top applied. Solution A is a standard test solution used in wound care contains 142 milimoles of sodium ions and 2.5 milimoles of calcium ions dissolved in distilled water (made as per ISO 13726-1:2002). The Paddington Cup is positioned such that the adhesive side of the AMS OD sample is in contact with Solution A. The Paddington Cup is then weighed again (W2) and the weight is recorded. The Paddington Cup is placed into a 37° C. environmental chamber for 24 hours. Upon removal, the Paddington Cup is left to stand for 30 minutes and the weight recorded (W3). The solution is drained and the Paddington Cup is inverted for 15 minutes before having the weight of the cup measured and recorded for the final time (W4).

(30) The Moisture Vapour Transmission Rate (MVTR) and Fluid Absorbance for the AMS OD sample was calculated according to the following.
MVTR=W2−W3×1000 (Units: g/m.sup.2/24 hrs)
Fluid Absorbance=W4−W1 (Units: g/10 cm.sup.2/24 hrs)

(31) The total fluid handling is the sum of MVTR and Fluid absorbance values. The MVTR indicates the breathability of the device, which is an important factor for the AMS OD as it will usually be secured to and contact with the peristomal skin of a user when in operation. The MTVR of the AMS OD was found to be surprisingly high. This shows that the AMS OD possesses excellent breathability properties which would allow for the safe and comfortable application of the device to a stoma. Lower MVTR values would indicate poorer breathability, rendering the device more prone to impair the intact skin.

(32) It has also been observed that upon hydration/full saturation, the exemplary AMS OD swelled to form a soft seal and remained integral under compression. This effect is advantageous when compared to other devices (e.g. Coloplast Brava Ring Mouldable) since the other devices tend to swell upon hydration but disintegrate upon compression. This would make it more difficult and messier for the user to change the prior art devices (e.g. adhesive wipes are required) and may allow stomal output to come into contact with the peristomal skin which can cause redness, soreness and irritation to the user. The AMS OD thus avoids these negative effects.

(33) Peel Adhesion of AMS OD

(34) The peel adhesion data was obtained using a method which is aligned with ASTM D6282-11.

(35) A sample of the AMS OD was cut to 25 mm×100 mm using a cutting press and die. The sample was tape wrapped around one end to form a tab for use with the tensometer. A stainless steel plate was then cleaned with isopropyl alcohol wipes or acetone. The release liner of the cut sample is removed and the sample is applied to the stainless steel plate. The sample and plate were placed on a calibrated ‘roll down’ machine at a speed of 12 inch/min. The stainless steel plate was mounted onto the test rig of a tensometer (Zwick model) so that the tab created is secured in the upper jaw at a 90 degree angle. The upper jaw was moved up, peeling the adhesive from the stainless steel plate at a rate of 254 mm/min. The maximum force and the average force are measured by the tensometer in Newtons.

(36) Thickness Tests

(37) TABLE-US-00004 TABLE 3 Thickness of device Thickness of Thickness of with auxiliary layers auxiliary layers device Product Name (mm) (mm) (mm) ConvaTec Esteem+ 18.12 0.11 18.01 mouldable Coloplast Brava 20.47 0.047 20.42 Ring Moudable Hollister Adapt 22.96 0.050 22.91 Eakin Cohesive 25.91 0.161 25.75 Seals AMS OD — — 0.70

(38) The thickness data presented in Table 3 for the commercially available mouldable ostomy devices and the AMS OD was obtained using the following method. The device is first removed from its primary packaging. The total thickness of the device including any auxiliary layers (e.g. release liners) is then measured using a calibrated digital calliper and the measurement is recorded at three points on the device. The measurement is taken with release liners on in order to avoid the equipment becoming tacky. This also reduces the risk of the calliper compressing the adhesive and thus giving a false lower reading. The release liners are then removed and measured using the same calliper at three points on the release liner. The final thickness of the device is calculated as the average thickness of the device (as measured with the release liners) minus the average thickness of the release liners.

(39) It can be seen that the average thickness of the exemplified AMS OD is significantly less than that of the commercially available mouldable ostomy devices. The thickness of the AMS OD is important in providing the device of the present invention with its desirable flexibility and strength. Moreover, the thickness of the device plays a major role in the device achieving excellent conformability properties and allows for the device to adapt to the contours of a user's body when in use. Conformability data for the AMS OD and commercially available ostomy devices is provided and discussed in more detail below. In addition, the thickness of the device of the present invention is crucial in achieving the gentle fit against a stoma wall in use.

(40) Conformability Tests

(41) Conformability tests were performed on the ConvaTec Esteem+ mouldable device, Eakin Cohesive Seals and the AMS OD. The conformability data presented in Tables 4-6 below was obtained using the following method. The resulting data is shown in Table 4 for the ConvaTec Esteem+ mouldable device, in Table 5 for the Eakin Cohesive Seals and in Table 6 for the AMS OD.

(42) The method used to obtain the conformability presented herein is aligned with ISO EN 13426-4:2003 Test methods for primary wound dressings—Part 4: Conformability. This method sees a sample of the device cut in to a rectangular strip having a width of 2.5 cm. The strip then has two pieces of tape wrapped around either of its ends, which are approximately 100 mm apart. The release liners of the device are then removed, if necessary, and the product is left to relax for a minimum of 300 seconds. The distance between the two pieces of tape is measured using a digital calliper and recorded as L1. The sample is then mounted into a tensometer (AMS use Zwick Roell machine) and clamped into the jaws of the machine via the taped ends. The sample is extended by 20% at a rate of 300 mm/min and is held at the maximum extension for 60 seconds. The force to extend by 20% is recorded by the tensometer as the Fmax/Maximum force (Newtons). After 60 seconds the sample is released from the jaws of the tensometer and left to relax for a further 300 seconds. The distance between the taped ends is measured again using the digital callipers and recorded as L2. Each experiment was repeated five times to provide samples number 1-5 in the tables below.

(43) Extensibility is defined as the force required to stretch a wound dressing sample to a known extension. To calculate the extensibility the Fmax is divided by 2.5 cm.

(44) Permanent set is defined as the increase in length of a sample after the stretching and relaxing expressed as a percentage of the original length. The permanent set is calculated as follows:
Permanent Set (%)=((L2−L1)/L1)×100

(45) Conformability is an important factor for medical devices that are in contact with the skin as the higher the conformability the better the ability of the device to adapt to the shape and movement of the body. The measurement of the permanent set provides an assessment of the memory of a device and ability of a device to contract. The force required to stretch or mould the device is also represented by the Fmax.

(46) TABLE-US-00005 TABLE 4 ConvaTec Esteem + mouldable device Initial length Final length Max force Extensibility Permanent (L1) mm (L2) mm (Fmax) N N/cm Set % Nr A B C D E F G 1 40.75 41.0 41.98 42 9.9 3.96 2.44 2 44.26 44.5 44.80 45 9.4 3.76 1.12 3 43.94 44.0 44.05 44 8.4 3.36 0.00 4 44.05 44.0 46.54 46.5 8.3 3.32 5.68 5 45.65 45.5 47.93 48 8.1 3.24 5.49 Mean 3.53 2.95 StDev 0.31 2.56

(47) TABLE-US-00006 TABLE 5 Table 5 for the Eakin Cohesive Seals Initial length Final length Max force Extensibility Permanent (L1) mm (L2) mm (Fmax) N N/cm Set % Nr A B C D E F G 1 55.86 56 71.29 71.5 2.8 1.12 27.68 2 65.29 65.5 79.85 80 2.9 1.16 22.14 3 58.93 59 73.68 73.5 2.5 1.00 24.58 4 59.12 59 77.07 77 2.7 1.08 30.51 5 64.64 64.5 77.46 77.5 2.6 1.04 20.16 Mean 1.08 25.01 StDev 0.06 4.16

(48) TABLE-US-00007 TABLE 6 AMS OD according to the invention Initial length Final length Max force Extensibility Permanent (L1) mm (L2) mm (Fmax) N N/cm Set % Nr A B C D E F G 1 84.83 85 85.83 86 13.6 5.44 1.18 2 93.23 93 94.37 94.5 13.1 5.24 1.61 3 92.55 92.5 93.82 94 13 5.2 1.62 4 92.64 92.5 93.9 94 13 5.2 1.62 5 92.6 92.5 94.24 94 12.7 5.08 1.62 Mean 5.23 1.53 StDev 0.13 0.20

(49) As can be seen from the data in Table 6 above, an AMS OD of the present invention demonstrated higher Fmax and extensibility values as compared to the comparative ConvaTec Esteem+ moudlable and Eakin Cohesive Seals devices. Moreover, the permanent set value obtained for the AMS OD of the present invention, is significantly lower than the comparator devices. This illustrates that the exemplified device of present invention showed a greater tendency to return to its original shape after a stretching force was applied. This indicates that if the user were to apply the device of the present invention to a stoma (as described herein with reference to FIGS. 1-4), the relative ease of stretching and increased tendency to return to its original state (i.e. pre-expanded or resting state) would make the device of the invention more able to form a secure seal between the peripheral wall defining the aperture of the device and the wall of the stoma once the device has contracted.

(50) As mentioned above, the “stretch-fit” mechanism achieved by the device of the present invention is generally easy to apply and is able to form a seal with the wall of the stoma (e.g. to prevent fluid leakage from the stoma contacting the skin) without imparting excessive compression forces on the stoma. The exemplary device of the invention described above possesses exceptional mechanical strength and stretching characteristics (demonstrated by the Fmax and extensibility values described above) as well as excellent contraction and sealing properties (demonstrated by the permanent set values described above). In addition to these characteristics, the present inventors have also been able to advantageously achieve a desirable rebounding effect on the stoma by the device. This can be attributed to the novel mechanism of action of the device (typically delivered by virtue of a relatively thin laminate structure), and may be accentuated by the choice of laminate material.

(51) It will be appreciated that numerous modifications to the above described ostomy device and use may be made without departing from the spirit and scope of the invention, for instance, the scope of the invention as defined in the appended claims. Moreover, any one or more of the above described embodiments could be combined with one or more features of the other embodiments and all such combinations are intended within the present disclosure.

(52) Optional and/or preferred features may be used in other combinations beyond those explicitly described herein and optional and/or preferred features described in relation to one aspect of the invention may also be present in another aspect of the invention, where appropriate.

(53) The described and illustrated embodiments are to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the scope of the inventions as defined in the claims are desired to be protected. It should be understood that while the use of words such as “preferable”, “preferably”, “preferred” or “more preferred” in the description suggest that a feature so described may be desirable, it may nevertheless not be necessary and embodiments lacking such a feature may be contemplated as within the scope of the invention as defined in the appended claims. In relation to the claims, it is intended that when words such as “a,” “an,” or “at least one,” are used to preface a feature there is no intention to limit the claim to only one such feature unless specifically stated to the contrary in the claim.