Ostomy Pouch

Abstract

An ostomy pouch, comprises: inner and outer walls of flexible sheet material defining a cavity for containing stomal output; a deployable drain for draining stomal output from the cavity; and at least one sheet of comfort material comprising a hot-melt adhesive coating. The first sheet of comfort material is attached to the outer wall and at least a portion of the first sheet of comfort material forms a flap. The flap is configured to cover the deployable drain when the drain is in a retracted position.

Claims

1. An ostomy pouch, comprising: inner and outer walls of flexible sheet material defining a cavity for containing stomal output; a deployable drain for draining stomal output from the cavity; and at least one sheet of comfort material comprising a hot-melt adhesive coating; wherein a first sheet of comfort material is attached to the outer wall, at least a portion of the first sheet of comfort material forming a flap; wherein the flap is configured to cover the deployable drain when the drain is in a retracted position.

2. An ostomy pouch according to claim 1 wherein the pouch comprises a second sheet of comfort material attached to the outer wall at least about at least part of the periphery thereof, wherein the first sheet of comfort material is attached to the outer wall via the second sheet of comfort material.

3. An ostomy pouch according to claim 1 wherein the first sheet of comfort material is attached directly to the outer wall at the periphery thereof

4. An ostomy pouch according to claim 1 or 3 wherein the first sheet of comfort material is attached to the outer wall about at least part of the periphery thereof

5. An ostomy pouch according to claim 3 wherein a fold line about which the flap is configured to fold is defined by a line extending between two points about the periphery of the pouch where the attachment between the first sheet of comfort material and the outer wall terminates; wherein the fold line is located between the deployable drain in the retracted position and an uppermost edge of the ostomy pouch.

6. (canceled)

7. An ostomy pouch according to claim 1 wherein the deployable drain is configured to move between an extended configuration for draining the stomal output from the cavity and a retracted configuration for storage of the deployable drain, the flap configured to fold along a fold line, between a covering position in which the flap covers the deployable drain when the deployable drain is in the retracted configuration, and an access position, in which the deployable drain, in the retracted configuration is uncovered by the flap and is able to be accessed for deployment.

8. An ostomy pouch according to claim 1 wherein the hot-melt adhesive coats at least an inner surface of the flap, the inner surface facing the deployable drain when the flap covers the deployable drain.

9. An ostomy pouch according to claim 1 wherein the hot-melt adhesive is applied as a web.

10. An ostomy pouch according to claim 9 wherein the web comprises a mass and a plurality of voids.

11. An ostomy pouch according to claim 10 wherein the voids make up at least 50% of the web.

12. An ostomy pouch according to claim 1 wherein the hot-melt adhesive is EVA.

13. An ostomy pouch according to claim 1 wherein the comfort material is a woven comfort material.

14. An ostomy pouch according to claim 5 wherein the flap is shaped such that an edge distal from the fold line conforms to the shape of the periphery of the ostomy pouch.

15. An ostomy pouch according to claim 1 further comprising a fastener arrangement configured to retain the deployable drain in the retracted position, the fastener arrangement comprising a first fastener located on an exterior surface of the deployable drain and a second fastener located on an exterior surface of the cavity wherein the second fastener comprises a tab, which is secured to the outer wall of the cavity.

16. (canceled)

17. An ostomy pouch according to claim 15 wherein the tab comprises a tab fold line about which the tab is configured to fold between a fastened configuration and an unfastened configuration wherein a foldable portion of the tab is exposed when the flap is in the access position.

18. (canceled)

19. An ostomy pouch according to claim 1 further comprising a further sheet of comfort material, attached to the inner wall to form an inner comfort layer; wherein an opening is provided proximate to the deployable drain between the inner comfort layer and the inner wall; wherein the inner comfort layer is attached to the inner wall about a periphery thereof and the opening is provided by a gap in a region of the periphery.

20. (canceled)

21. (canceled)

22. An ostomy pouch according to claim 5 wherein the flap is configured to fold around the fold line such that to move to the access position the end of the flap distal from the fold line is lifted away from the pouch and towards the uppermost edge of the pouch.

23. An ostomy pouch according to claim 1 wherein the pouch further comprises a window opening for viewing the cavity wherein the window opening is arranged on the outer wall, the first sheet of comfort material comprising a first and second part, wherein the first part partially overlaps the second part, or the second part overlaps the first part in an overlap region to form the window.

24. A method of forming an ostomy pouch, the method comprising: providing an inner wall and an outer wall which define a cavity for containing stomal output, and a deployable drain for draining stomal output from the cavity; attaching a portion of a first sheet of comfort material to the outer wall, leaving a flap arranged to cover the deployable drain when in the retracted position; wherein the first sheet of comfort material is at least partially coated in hot-melt adhesive.

25. A method of forming an ostomy pouch according to claim 24 wherein at least the flap is coated in hot-melt adhesive.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0057] In order that the invention may be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which:

[0058] FIG. 1 is a perspective view of the body-side of an embodiment of an ostomy pouch in accordance with the invention;

[0059] FIG. 2 is a perspective view of the clothing-side of the ostomy pouch of FIG. 1;

[0060] FIG. 3a is a cross-sectional schematic view of the drain of the ostomy pouch of FIG. 1 in a deployed position;

[0061] FIG. 3b is a cross-sectional schematic view of the drain of the ostomy pouch of FIG. 1 in a retracted position;

[0062] FIG. 4 is a perspective view of the clothing side of an alternative embodiment of an ostomy pouch in accordance with the invention;

[0063] FIG. 5 is a cross-sectional schematic view of the drain of the ostomy pouch of FIG. 4 in a deployed position; and

[0064] FIG. 6 is a partial view of the inside surface of the material which forms the comfort layer of the pouches of FIGS. 1 to 5 showing the hot-melt adhesive applied thereto.

[0065] When used herein and throughout the specification, the term “stomal output” refers to any gases, liquids or solids produced by an ostomate that may be secreted from a stoma or that exit a stoma of the ostomate. The stomal output may comprise gaseous, fluid, liquid and/or solid stomal output.

[0066] The term “stoma” refers to an opening in the body. Generally, the stoma is a surgical opening in the torso of the body. In some instances, the term “stoma” also refers to internal tissue, organs or portions thereof that are exposed by the opening. By way of non-limiting example, internal tissue may be selected from colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue may be an end or a loop of a small or large intestine.

[0067] The term “ostomate” refers to a subject that may have use of the ostomy pouch described herein. While ostomate usually refers to a subject with a surgical opening, as used herein, “ostomate” may refer to a subject who has a stoma, regardless of whether the stoma was created by surgery or other means.

[0068] The term “user” may refer to an ostomate, or to another person assisting the ostomate, for example, with emptying of the stomal output from the cavity.

[0069] Ostomy pouches disclosed herein may, for example, be used for managing a stoma created by an esophagostomy, a gastrostomy, a cholecystostomy, a choledochostomy, a cecostomy, a colostomy, a duodenostomy, an ileostomy, a jejunostomy, an appendicostomy, a tracheostomy, a urostomy, a nephrostomy, a ureterostomy, or a vesicostomy. The ostomy pouches disclosed herein may be used with additional devices including, but not limited to, a shunt, a catheter, a plug or a faecal management system.

[0070] In this specification locations and orientations of features may be described with reference to the ostomy pouch being “in use”, “orientated as it would be in use” or similar. Such terms refer to the intended orientation of the ostomy pouch when it is adhered or otherwise secured to a body of an ostomate, e.g. with the ostomate in a standing position, irrespective of whether the ostomy pouch is currently performing such a use or the actual position of the ostomate. The terms “upper” and “lower” and related terms refer to the relative position of a part or portion of the ostomy pouch when orientated as it may be in use. For example, a section of the ostomy pouch may be referred to as an “upper” section of the ostomy pouch, and reference may be made to the uppermost edge of the pouch. In such an example, said section/edge will be intended to be the uppermost section (in the vertical direction) of the ostomy pouch when attached to the body of a standing ostomate. However, the reader skilled in the art will appreciate that before attachment to the ostomate said section may not always be the uppermost section and in addition when attached the section may not always be the uppermost section if the ostomate adopts a non-standing position, for example lying down.

[0071] The terms “left-hand” and “right-hand” and related terms may refer to the ostomy pouch when viewed from the rear (for example, as shown in FIG. 1). Thus, as an illustrative example, a “left-hand” edge of the ostomy appliance will be towards a left-hand side of the ostomate in the situation where the ostomy pouch is attached to the front torso of the ostomate.

[0072] The terms “concave” and “convex” and related terms refer to shaping of features of the ostomy pouch when viewed from an exterior of the ostomy pouch. Thus, as an illustrative example, an ostomy wafer of circular shape would be considered to have a convexly shaped peripheral edge.

[0073] The terms “inner” and “outer” refer to the relative position of a part or portion of the ostomy pouch with reference to the body of an ostomate when the ostomy pouch is attached (e.g. adhesively or otherwise) to the body of the ostomate. “Inner” refers to a position relatively closer to the body of the ostomate than a comparative position that is “outer”. “Outer” refers to a position relatively further away from the body of the ostomate than a comparative position that is “inner”. Inner is synonymous with “body-side” in the art, whilst outer is synonymous with “clothing-side”.

[0074] Ostomy pouches are commonly attached to the body of an ostomate by means of an ostomy wafer which includes an adhesive layer or layers. The ostomy wafer typically has an opening for the stoma sometimes referred to as a starter hole which may be cut to a required size by a user before attachment. The ostomy wafer typically comprises an adhesive layer on a body-facing side for adhering the ostomy wafer to the body of the ostomate. Typically, a release liner covers a body-facing side of the ostomy wafer that is removed by the user prior to fitting to the skin. In this specification, the term “ostomy wafer” may be used interchangeably with the terms “adapter,” “wafer,” “baseplate”, or “layered adhesive wafer.” The “ostomy wafer”, “adapter,” “wafer,” “baseplate”, or “layered adhesive wafer” may form a skin barrier between the ostomate and the pouch. In this specification, the term “ostomy wafer” includes ostomy wafers for a “two-piece appliance” and for a “one-piece appliance”.

[0075] A “two-piece pouch” refers to an ostomy pouch where the ostomy wafer forms part of a separate body fitment component that is attached by a releasable coupling to a pouch. A two-piece pouch permits the body fitment component to be separated from the pouch without damage, so that at least one of the parts continues to be functionally usable. For example, the body fitment component may remain in place on the body of the ostomate. In contrast, a “one-piece pouch” refers to an ostomy pouch where the ostomy wafer is permanently attached to the appliance, to the extent that the ostomy wafer cannot easily be separated without risk of damaging the appliance. A one-piece pouch is intended to be used as an integral unit.

[0076] Ostomy pouches may commonly be configured as “closed” pouches or “open” pouches. In this specification a “closed pouch” refers to an ostomy pouch where it is not intended that stomal output is drained from the cavity. Thus, a closed pouch may typically be configured as a one-use, disposable and non-reusable pouch. In this specification an “open pouch” refers to an ostomy pouch where it is possible for the stomal output to be drained from the cavity and the pouch reused. Thus, an open pouch may be configured as a reusable pouch, such that it can be reused and emptied multiple times whilst attached to the body, although this is not essential. In an open pouch the stomal output may be drained intermittently as instigated by an action of the ostomate or may be drained intermittently or continuously due to the cavity being fluidly connected to a drain, for example a night drain line.

[0077] The use of a closed pouch or an open pouch may be, in part, due to user preference, but equally either a closed or open pouch may be more suited depending on the particular ostomate's needs, and depending on the position of the stoma for the ostomate. For example, for stomas formed via ileostomy the stomal output may tend to be looser and be easily drainable which may lead to an open pouch being suitable. For stomas formed by colostomy, the stomal output may tend to be more solid and may not be readily drained by a user. In such instances, a closed pouch may be more suited.

[0078] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.

[0079] FIGS. 1 to 3 illustrate an exemplary ostomy pouch 10, having an inner wall 19 and an outer wall 21 sealed about at least part of the periphery 11 thereof to define a cavity 12 for containing a stomal output and a deployable drain 13. The pouch 10 is therefore “open”, with the seal 14 being provided as a single, continuous seal about the perimeter 11 of the pouch 10, except at a drain aperture 15, described in detail hereinbelow. In this embodiment the cavity includes a first, upper section 16 and a second lower section 17, which are generally rounded in shape with convex curved edges. The upper section 16 and lower section 17 are separated by a waist section 18 which is narrower in width than the upper section 16 and lower section 17. The waist section 18 has concave curved edges. The deployable drain 13 is provided extending from the lower section 17 of the pouch.

[0080] Those skilled in the art will readily appreciate that the shape of the ostomy pouch is not restricted to that described above, indeed the teachings disclosed here within could equally apply other pouch shapes, such as pouches with no waist section, or a plurality of waist sections.

[0081] The inner wall 19 and outer wall 21 of this embodiment are formed of a flexible plastic sheet material. The pouch 10 also includes a first sheet of comfort material forming an outer comfort layer 31 and in this embodiment also includes a second sheet of comfort material forming an inner comfort layer 32. The inner comfort layer 32 overlaying the inner wall 19 and the outer comfort layer 31 overlaying the outer wall 21. In this embodiment the comfort layers 31, 32 are formed of a woven fabric material and define the outer surfaces of the pouch 10. The surfaces of the inner and outer comfort layers 31, 32 facing the inner and outer walls 19, 21 respectively, are coated in a web of hot-melt adhesive (in this instance, EVA, further elaborated on hereinbelow). However, it will be appreciated that the comfort layer could be formed of various other materials, could be provided as a plurality of layers and so forth.

[0082] In this embodiment the outer comfort layer is provided in two parts, a first part 31a covering the lower section 17, the waist section 18 and partially covering the upper section 16; and a second part 31b partially covering the upper section 16. The first and second parts partially overlap in an overlap region. The second part 31b is joined to the outer wall 21 about the periphery 11 thereof. The first part 31a is joined to the outer wall 21 along a part of the periphery thereof, the first part 31a is joined along a right periphery 35a and a left periphery 35b the joins terminating at lower weld ends 35a′ and 35b′. The lower edge of the first part 31a is not joined to the outer wall and instead forms a flap 33. The flap 33 folds along a flap fold line 34, the fold line extends between the lower weld ends 35a′, 35b′ of the right and left peripheral joins of the first part 31a.

[0083] The flap 33 is shaped such that when in a covering position, wherein it covers the deployable drain (further elaborated on hereinbelow) in a retracted position, the edge 36 distal from the flap fold line 34 conforms with the shape of the pouch when the drain is in the retracted position.

[0084] In this embodiment the flap 33, as with the rest of the outer comfort layer 31 and inner comfort layer 32, is coated on its inner surface 80 with a hot-melt adhesive 81. FIG. 6 shows an exemplary hot-melt adhesive coating, in this embodiment, where the hot-melt adhesive forms a web, the web comprising a mass M of hot-melt adhesive with numerous voids V therein, where there is an absence (or substantial absence, possibly including a trace) of hot-melt adhesive, this it takes the general form of a lattice, mesh or grid. As can be seen in this embodiment the voids are irregularly shaped and spaced and a relatively smaller area is covered by the mass than that which is free of adhesive in the voids.

[0085] Whilst providing hot-melt adhesive on the inner surface of all comfort layers simplifies manufacture, and allows the hot-melt adhesive to serve other purposes (most notably adhering the comfort layers 31, 32 to the walls 19, 21), those skilled in the art will appreciate that hot-melt adhesive may be applied selectively to only the flap 33 and optionally to one or more sections of the remainder of the comfort material. Further it will be appreciated that by varying the application method, the voids could be regularly shaped and/or spaced.

[0086] In this embodiment, the hot-melt adhesive comprises ethylene-vinyl acetate (EVA).

[0087] In another embodiment the hot-melt adhesive is a polyolefin.

[0088] In another embodiment the hot-melt adhesive is polyurethane.

[0089] In another embodiment the hot-melt adhesive is polyvinylidene chloride (PVDC).

[0090] In another embodiment the hot-melt adhesive is silicon rubber.

[0091] In another embodiment the hot-melt adhesive is a fluoropolymer.

[0092] In another embodiment the hot-melt adhesive is polycarbonate.

[0093] In another embodiment the hot-melt adhesive is styrene block co-polymer.

[0094] In another embodiment the hot-melt adhesive is polyester.

[0095] In another embodiment the hot-melt adhesive is polyamide.

[0096] In another embodiment the hot-melt adhesive is polycaprolactone.

[0097] In this embodiment, the web of hot-melt adhesive has an area density of 25 g/m.sup.2.

[0098] A suitable EVA hot-melt adhesive is available from Protechnic SA of Cernay, France under the designation 3Z8.

[0099] The first and second parts 31a, 31b of the outer comfort layer are, in use, separable from each other in the overlap region 22 to form a window opening for viewing the cavity. Whilst in this illustrated embodiment, the second part 31b overlays the first part 31a in the overlap region, one skilled in the art will recognise that such an overlap could be formed in the opposite manner, that is the first part 31a overlapping the second part 31b in the overlap region 22, and of course in other embodiments, the outer comfort layer may be formed in one-part without an overlap.

[0100] The inner wall 19 comprises an opening 50 therein defining a stomal inlet 51 in the pouch 10 for receiving stomal output into the cavity. The stomal inlet 51 is arranged in the upper section 16 of the pouch. In this embodiment the inner comfort layer 32 is provided with an opening 35 arranged concentrically with the stomal inlet, thereby allowing an ostomy wafer 52 to be applied to the stoma in use. In this embodiment, the ostomy wafer 53 is permanently attached to the pouch, i.e. it is a one-piece pouch, but of course it could be separable (i.e. a two-piece pouch).

[0101] In this embodiment the weld between the inner wall and the inner comfort layer does not extend around the entire periphery thereof, a section 76 is proximate to the drain 13 remains unwelded such that a gap is formed between the inner wall and inner comfort layer.

[0102] As stated above, the inner and outer walls 19, 21 further define a deployable drain 13. The drain 13 is integral with the inner and outer walls and in this embodiment is elongate, extending from the lower edge of the lower section 17, with the weld about the periphery 11 extending along each edge of the drain to a drain aperture 15 where the pouch remains unsealed, i.e. a region of the periphery 11 where the inner and outer walls are not joined together. In use the drain aperture 15 may be used to remove stomal output from the cavity.

[0103] In this embodiment the drain 13 is separated into three equal sections 66, 67, 68 along its length by first and second fold lines 63, 64 extending laterally across the drain 13, a third fold line 65 extends laterally across the drain 13 at the interface of the drain and the cavity defining the lowermost edge of the pouch (when the drain is retracted). Arranged on a portion of the inner wall 19 defining the section 66 proximate to the drain aperture 15, this embodiment includes a first pursing strip 61. A second pursing strip 62 is arranged on a portion of the outer wall 21 defining the middle section 67 of the drain 13 of this embodiment. Arranged on a portion of the inner wall 19 defining the section 68 proximate to the cavity is a first fastening means 69, in this illustrative embodiment the fastening means is a strip of self-gripping fastener hook tape. Those skilled in the art will appreciate that other means of fastening are also suitable, that pursing strips are a desirable, but optional feature, and that other arrangements are within the ambit of the invention.

[0104] Arranged on the lower portion 17 of the outer wall 21 of this exemplary pouch is the second fastener 70. The second fastener 70 is arranged at the middle of and below the fold line extending between lower weld ends 35a′ and 35b′. The second fastener 70 of this particular embodiment is formed of a foldable foam tab, the tab folding around a tab fold line 75, the tab fold line defining two sections of the second fastener 70, an adhesive section 71 and a fastening section 73. One side of the adhesive section 71 is coated in an adhesive 72 which adheres the foam tab to the exterior surface of the outer wall 21. The fastening section 73 is provided with a second fastening means 74 (in this illustrative embodiment a strip of self-gripping fastener hook tape), arranged on the opposite surface of the tab to the adhesive 72 on the adhesive section. In this embodiment the foldable foam tab is arranged such that the fold line 75 thereof, is arranged parallel to, but below the fold line 34 of the flap 33 (that is the fold line of the foldable foam tab is arranged closer to the lower edge of the pouch). In use the drain 13 is moveable between an extended configuration (as shown in FIG. 3a) and a retracted configuration (as shown in FIG. 3b). In this embodiment the drain 13 is moved from the extended configuration, to the retracted configuration in the following manner: First the section 66 of the drain proximate to the drain aperture 15 away from the body if folded about the first fold line 63 such that the sections of the outer wall 21 forming the middle section 67 of the drain and the section 66 proximate to the drain aperture 15 are in contact. Next the drain is folded away from the body about the second fold line 64 such that the section of the inner wall 19 forming the section 66 proximate to the drain aperture 15 and the section of the outer wall 21 forming the section 68 proximate to the cavity are in contact. A third fold is performed about the third fold line 65, again folding the drain 13 away from the body, such that section 62 of the inner wall 19 forming the middle section 67 is in contact with the outer wall 21 of the cavity. In the retracted configuration the top of the retracted drain, as formed by the second fold line 64 is arranged below the line extending between lower weld ends 35a′ and 35b′. One skilled in the art will appreciate that the drain could be provided with a greater number of, or fewer, sections to which a corresponding increase or decrease in the number of folds could be applied. Further it will be appreciated that as an alternative to folding the drain may instead be retracted in an alternative way, such as rolling.

[0105] When the drain 13 is in the retracted configuration, the repeated folds about the three fold lines 63, 64, 65 effectively seal the drain 13, such that no stomal output can escape the cavity. The drain can be held in the retracted configuration by folding the second fastener 70 about the fold line 72 such that the first and second fastening means 69, 74 come into contact. Thereafter the flap 33 can be folded down about the flap fold line 34 to cover the drain 13 in the retracted configuration.

[0106] Conversely, to allow draining of the pouch 10, the drain 13 can be moved from the retracted configuration to the deployed configuration. First the flap is folded back about the flap fold line 34 to fully expose the retracted drain 13 and fastener tab 70 (i.e.

[0107] the flap fold line does not overlie the retracted drain or fastener tab). The fastener tab 70 can then be detached from the drain, and the folding action is undertaken in the reverse order, moving the drain from the retracted configuration to the extended configuration (i.e. unfolding about the third fold line 65, then the second fold line 64 and finally the first fold line 63) the drain 12 is no longer sealed and the stomal output can be drained from the cavity via the drain aperture 15.

[0108] FIGS. 4 and 5 illustrate a further exemplary ostomy pouch according to the present disclosure. Like reference numerals, incremented by 100, have been used for like features. Only those features that differ in this embodiment compared to the previous embodiment will be described in detail in the following description. For features that are common to one or more embodiments, reference should be made to the description as a whole.

[0109] In this embodiment the outer comfort layer 131 is provided in three sections: a first part 131a, covering the waist section 118 and partially covering the upper and lower sections 116, 117; a second part 131b partially covering the upper section 16; and a third part 131c forming the flap 133.

[0110] Similarly, to the previous example, the first and second parts partially overlap in an overlap region 122. The second part 131b is joined to the outer wall of the pouch about the periphery 111 thereof. The first part 131a is joined to the outer wall along a part of the periphery thereof, the first part 131a is joined along a right periphery 135a and a left periphery 135b. The third part 131c is attached to the first part 131a along a lower edge thereof. In this embodiment the first and third parts 131a, 132c are joined by a weld along a weld line 134 which in this particular embodiment extends in a straight line across the width of the pouch. The welding is facilitated by the hot-melt adhesive coating 80 on the inner surface of the third part 131c which faces the outer surface of the first part in the region of the weld 134. A fold line 137 (about which the flap is configured to fold between an access position and a covering position) is formed by the interface between the section of the third part 131c which is joined to the first part 131a and the section of the third part 131c which forms the flap 133. The flap 133 is shaped such that when in the covering position, where it covers the deployable drain in a retracted position, the edge 136 distal from the flap fold line 137 conforms with the shape of the pouch when the drain is in the retracted position.

[0111] In other respects this exemplary embodiment is the same as the previous exemplary embodiment as described above.

[0112] Except in Examples, or where otherwise explicitly indicated, all numerical quantities in this description specifying amounts of materials, device dimension, and the like, are to be understood as modified by the word “about.”

[0113] The one or more embodiments are described above by way of example only. Many variations are possible without departing from the scope of protection afforded by the appended claims.