Systems and methods for providing an ostomy plate in proximity to a negative pressure wound device - Patents.com

Abstract

In general, the present invention is directed to systems and methods for providing an ostomy faceplate in proximity to a negative pressure wound dressing. This may be accomplished, for example, through the use of an ostomy appliance or faceplate having a non-circular flange for attaching a bag or pouch. According to some embodiments, the non-circular flange may be substantially "D" shaped and / or have at least one substantially straight edge. In some embodiments, the ostomy faceplate may itself be non-circular and / or "D" shaped, may include cutting guides for cutting materials used with NPWD, may include asymmetrically positioned openings, and / or may have one or more tapered edges.

Description

Related Applications

[0001]

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 871,670, entitled "Ostomy Appliance," filed July 8, 2019, the entire contents of which are incorporated by reference herein. [Background technology]

[0002]

[0002] Emergency surgery can result in both an ostomy (such as an ileostomy or colostomy) and a surgical wound. Ileostomies (stomas made from the last part of the small intestine) are generally placed in the right lower quadrant of the patient's abdominal wall, below the level of the navel but above the level of the pubic hair. Colostomies (stomas made from a portion of the large intestine) are generally placed in the left lower quadrant, although they can be placed in other locations as well. However, location options for ostomies are often limited, since the stoma must be located within the rectus abdominis muscle, which runs vertically down the front of the abdomen. Placing the stoma within this muscle can help prevent later complications such as parastomal hernias.

[0003]

[0003] To ensure proper adhesion of the ostomy baseplate to the patient's skin, a flat surface is recommended 2 to 3 inches circumferentially from the base of the stoma.

[0004]

[0004] Emergency abdominal surgery generally requires and results in a surgical wound. To reduce the risk of developing a wound infection after skin closure - and in situations where bacteria or fecal matter may cause intraperitoneal contamination - many surgeons utilize a negative pressure wound device (NPWD) to promote healing by secondary intention. The use of NPWD in the treatment of open wounds is known in the art. For example, Kinetic Concepts, Inc. of San Antonio, Texas, markets and sells the Vacuum Assisted Closure®, or VAC®, product line, which typically involves mechanical contraction of the wound with simultaneous removal of excess fluid, often accomplished by using polymer foam and occlusive drape dressings in communication with a negative pressure source. Similarly, Smith & Nephew PLC, London, UK, offers NPWD such as the PICO® and RENASYS® devices, which utilize silicone adhesive dressings that purportedly can promote healing and reduce dressing changes.

[0005]

[0005] For any NPWD to function properly, an adequate seal must be created on the patient's wound. Failure to provide an adequate seal may result in a failure to promote proper healing or in the NPWD drawing undesirable fluids and materials into the open and / or healing wound.

[0006]

[0006] Unfortunately, patients undergoing emergency abdominal surgery often undergo a fecal diversion strategy as part of their care. Typically, this involves moving a segment of intestine through a separate incision in the abdominal wall to create a fecal or urinary stoma, through which the patient may discharge into a container attached to the abdomen. The container is typically a bag or pouch that may be attached to the body around the stoma by a faceplate or wafer of bioadhesive material. The faceplate or wafer may protect the peristomal skin from stomal effluent, preventing infection, pain, and / or other complications.

[0007]

[0007] However, such stomas are often located in close proximity to the surgical wound. The short distance between the surgical wound and the ostomy opening, which may be only a few centimeters, can impede successful placement of the NPWD. This can often result in additional or excessive resource utilization, including suboptimal function of the NPWD, unscheduled dressing changes, multiple provider visits (often overnight), abandonment of NPWD treatment, and increased discomfort or distress for the patient.

[0008]

[0008] Thus, proper sealing of the NPWD is highly desirable to prevent any discharge from the ostomy from being drawn into the wound. However, the shapes and sizes of existing ostomy appliances or faceplates are not suitable for use in the presence of an abdominal wound and often preclude the placement or use of the NPWD.

[0009]

[0009] It would therefore be desirable to provide an ostomy appliance that can be used in synergy with NPWD, which would allow patients to fully benefit from NPWD treatment while minimizing additional resource utilization to achieve this goal.

[0010] For example, it is often difficult to position an ostomy appliance or faceplate in close proximity to a drape used in NPWD. Therefore, it is desirable to provide an ostomy appliance that can be used to position NPWD as close as possible to the ostomy appliance. Similarly, it is desirable to have an ostomy appliance that is configured to accept the overlapping drape of a NPWD in a manner that maintains the effectiveness of both mechanisms.

[0011]

[0011] In addition to the above-mentioned difficulties, when the ostomy and the surgical wound are in close proximity, the ostomy bag or pouch often sags over the surgical wound. This can cause discomfort and can make it more difficult for a healthcare provider to properly check and examine the surgical wound. Therefore, it is desirable to have an ostomy pouch or bag that is configured to sag - either through the bag or through the ostomy faceplate - on the opposite side of the surgical wound. Summary of the Invention

[0012] According to some embodiments, some aspects of the present invention may include an ostomy appliance or faceplate having a non-circular flange for attaching a bag or pouch.

[0013] According to some embodiments, some aspects of the invention may include additional features, such as a substantially "D" shaped flange; a non-circular flange having at least one substantially straight edge; an ostomy appliance or faceplate that is non-circular and / or substantially "D" shaped; a cutting guide disposed on the ostomy appliance or faceplate; a cutting guide that may be used to guide a cutting device when cutting a drape or bandage material, such as a drape or bandage material used with the NPWD; a cutting guide that may include a channel or groove; a cutting guide that may include one or more protrusions; an ostomy appliance or faceplate that is non-circular and / or substantially "D" shaped; may include a tapered edge on the faceplate; the tapered edge being disposed on the substantially straight portion of the "D" shape; an ostomy appliance or faceplate constructed from an impermeable (or substantially impermeable, vapor permeable, etc.) material; a flange for attaching a bag or pouch on the ostomy appliance or faceplate disposed at an angle relative to the bottom surface of the ostomy appliance or faceplate; an attachment device for attaching a bag or pouch to the ostomy appliance or faceplate; and / or an opening that is asymmetrically positioned in the faceplate / flange to minimize the space between the edge of the faceplate / flange and the ostomy itself.

[0014]

[0014] According to some embodiments, some aspects of the present invention may include a non-circular ostomy device including a non-circular face plate, a non-circular flange for attaching a bag or pouch, the non-circular flange having at least one substantially straight edge, and a cutting guide for guiding a cutting device when cutting materials used with the NPWD, the cutting guide being disposed co-linearly with the substantially straight edge.

[0015]

[0015] According to some embodiments, some aspects of the present invention may include additional features such as: a non-circular ostomy appliance having at least one substantially straight and tapered edge; an opening configured to receive a stoma; an asymmetrically located opening, the opening being located within the flange; one or more lines of weakness disposed within the flange, such lines of weakness being used to remove a portion of the non-circular ostomy appliance or faceplate to form the opening; a cutting guide for guiding a cutting device; a cutting guide for guiding a cutting device while cutting materials used with the NPWD; and / or a cutting guide which may comprise a channel or groove in the ostomy appliance or faceplate, or one or more protrusions.

[0016]

[0016] According to some embodiments, some aspects of the present invention may include an ostomy device or faceplate having a substantially planar surface and a flange, where at least a portion of the outer planar surface of the flange is removable.

[0017]

[0017] According to some embodiments, some aspects of the present invention may include an ostomy device or faceplate having a substantially planar surface of thickness with substantially straight edges, where the substantially planar edges have tapered edges reducing the thickness of the substantially planar surface.

[0018]

[0018] According to some embodiments, some aspects of the present invention may include an ostomy appliance or base plate configured to guide an ostomy bag or pouch attached to the ostomy appliance or base plate to a particular side of the ostomy appliance or base plate.

[0019] These and other aspects will become apparent from the following description of the invention taken together with the following drawings, in which variations and modifications can be effected without departing from the scope of the novel concepts of the invention.

[0020]

[0020] The present invention may be more fully understood by reading the following detailed description in conjunction with the accompanying drawings, in which like reference indicators are used to denote like elements. The accompanying drawings illustrate certain exemplary embodiments and may aid in the understanding of the following detailed description. Before any embodiment of the present invention is described in detail, it should be understood that the invention is not limited in its application to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The illustrated embodiments should be understood as illustrative and in no way limit the overall scope of the invention. It should also be understood that the phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting. The detailed description refers to the following drawings. [Brief description of the drawings]

[0021] [Figure 1] FIG. 1 illustrates a typical interaction between an ostomy appliance and a NPWD that is often found in the prior art. [Diagram 2]

[0022] FIG. 2 illustrates an exemplary "D" shaped ostomy appliance having a "D" shaped flange, according to some embodiments of the present invention. [Diagram 3]

[0023] FIG. 3 illustrates an exemplary "D" shaped ostomy appliance with a typical circular flange, according to some embodiments of the present invention. [Figure 4]

[0024] FIG. 4 illustrates an exemplary "D" shaped ostomy appliance with a circular flange and an asymmetrically positioned stoma, according to some embodiments of the present invention. [Diagram 5]

[0025] FIG. 5 illustrates an exemplary "D" shaped ostomy appliance having a "D" shaped flange and an asymmetrically positioned stoma, according to some embodiments of the present invention. [Figure 6]

[0026] FIG. 6 illustrates an exemplary ostomy appliance having a channel, according to some embodiments of the present invention. [Figure 7]

[0027] FIG. 7 illustrates an exemplary ostomy appliance and NPWD drape, according to some embodiments of the present invention. [Figure 8]

[0028] FIG. 8 illustrates a cross section of an exemplary ostomy appliance, according to some embodiments of the present invention. [Figure 9]

[0029] FIG. 9 illustrates a cross section of an exemplary ostomy appliance and NPWD, according to some embodiments of the present invention. [Figure 10]

[0030] FIG. 10 illustrates a cross section of an exemplary ostomy appliance and NPWD, according to some embodiments of the present invention. [Figure 11]

[0031] FIG. 11 illustrates a cross section of an exemplary ostomy appliance, according to some embodiments of the present invention. [Figure 12]

[0032] FIG. 12 illustrates a cross section of an exemplary ostomy appliance and NPWD with an attached bag or pouch, according to some embodiments of the present invention. [Figure 13]

[0033] FIG. 13 illustrates a cross section of an exemplary ostomy appliance and NPWD, according to some embodiments of the present invention. [Figure 14]

[0034] FIG. 14 illustrates an exemplary ostomy appliance, according to some embodiments of the present invention. [Figure 15]

[0035] FIG. 15 illustrates an exemplary ostomy appliance, according to some embodiments of the present invention. [Figure 16]

[0036] FIG. 16 illustrates an exemplary ostomy appliance having an attachment device, according to some embodiments of the present invention. [Figure 17]

[0037] FIG. 17 illustrates a cross section of an exemplary ostomy appliance, according to some embodiments of the present invention. [Figure 18]

[0038] FIG. 18 illustrates a cross section of an exemplary ostomy appliance, according to some embodiments of the present invention. [Figure 19]

[0039] FIG. 19 illustrates a cross section of an exemplary ostomy appliance, according to some embodiments of the present invention. [Figure 20]

[0040] FIG. 20 illustrates a cross section of an exemplary ostomy appliance, according to some embodiments of the present invention. [Figure 21]

[0041] FIG. 21 illustrates a cross section of an exemplary ostomy appliance, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022]

[0042] Before any embodiments of the invention are described in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0023]

[0043] The matters exemplified in this specification are provided to aid in a comprehensive understanding of various exemplary embodiments disclosed with reference to the accompanying drawings. Accordingly, those skilled in the art will recognize that various changes and modifications of the exemplary embodiments described herein can be made without departing from the spirit and scope of the claimed invention. Descriptions of well-known functions and structures are omitted for clarity and conciseness. Furthermore, as used herein, the singular form may be interpreted as the plural form, and alternatively, any term in the plural form may be interpreted as the singular form.

[0024]

[0044] In general, the present invention is directed to improved ostomy appliance systems and methods. In particular, the present invention is directed to an ostomy faceplate specially configured for interference with NPWD.

[0025]

[0045] The present invention describes ostomy appliances and / or systems that may include one or more of several features, including, but not limited to, having straight edges that may be aligned with a drape or other component of the NPWD; one or more channels for cutting the drape material; one or more protrusions or rails for cutting the drape material; a "D" shaped ostomy appliance; a "D" shaped flange for attaching an ostomy bag or pouch; a tapered edge to facilitate overlap with the drape material or other component of the NPWD; an ostomy appliance with an asymmetric and / or non-centered opening for the stoma; an asymmetric ostomy bag or pouch configured to hang down on the non-wound side; an attachment device for the ostomy bag or pouch; and / or a breakaway or sump to reduce or prevent any stoma output from being drawn into the wound by the NPWD.

[0026]

[0046] According to some embodiments (and as described in more detail below), the design may include a straight edge as part of the ostomy faceplate, a "D" shaped flange, and an asymmetric drainage bag that may not intrude toward the midline. There may be channels in the faceplate so that an organized linear cut of the impermeable (or substantially impermeable, vapor permeable, etc.) negative pressure dressing may occur just before it becomes enmeshed with the drainage bag. The straighter end of the faceplate (closest to the wound) may include a tapered end to facilitate a proper seal with the negative pressure dressing. The ostomy appliance may also have an impermeable (or substantially impermeable, vapor permeable, etc.) dressing surrounding the faceplate that may be compatible with one or more types of NPWD.

[0027]

[0047] The ostomy appliance bag itself may also include a vent / sump system and / or snaps. More specifically, according to some embodiments of the present invention, there may be a vent / sump system that may prevent waste from being drawn into the wound by negative pressure, such as a break-away flap to prevent backflow. Additionally, according to some embodiments, snaps may be included. For example, snaps (or other attachment devices, including but not limited to mechanical attachments (hook and loop fasteners, zippers, latches, screw connections, etc.), magnetic attachments, or any other type of suitable attachment) may be positioned to help secure an asymmetric bag to the faceplate. The location of the snaps may vary. The male portion of the snap may be embedded in the faceplate and the female portion may be embedded in the bag, or vice versa. According to some embodiments, other attachment devices may be embedded or attached to the faceplate and / or bag, or may be attachable to the faceplate and / or bag, such that other bags may be utilized.

[0028]

[0048] With reference to FIG. 1, a prior art overlapping system 100 is described. System 100 illustrates the use of an ostomy appliance 110 and a NPWD 120. Note that the NPWD 120 overlaps a portion of the ostomy appliance 110 due to the proximity between the stoma 130 and the wound 131. The ostomy appliance 110 may be substantially circular and centered over and substantially concentric with the stoma 130. The ostomy appliance may further include a circular flange 111 for attaching a bag or pouch (not shown). The NPWD 120 may include a drape or dressing 121 that may be placed over the wound 120 and may include a conduit or tube 122 to a negative pressure device, such as a vacuum system.

[0029]

[0049] From the prior art shown in FIG. 1, it can be seen that if a wound is near or adjacent to an ostomy, there may be unintentional interference between the ostomy appliance and the NPWD.

[0030]

[0050] Referring now to FIG. 2, an exemplary "D" shaped ostomy appliance having a "D" shaped flange will be described according to some embodiments of the present invention. FIG. 2 illustrates a "D" shaped ostomy appliance 210, which may include a flange 211 for attaching a bag or pouch and may be positioned over a stoma 231. The "D" shaped ostomy appliance 210 may include a straight edge 212, which may be positioned to have little or no interference with the NPWD 220. The NPWD 220 may include a drape material 221 having a conduit or tube 222 that may be positioned over a wound 232 and connected to a negative pressure device (not shown). It will be appreciated that the straight edge of the ostomy appliance allows both the NPWD and ostomy appliance features to function independently without interfering with each other.

[0031]

[0051] It is also contemplated that the ostomy appliance may be "D" shaped but maintain a circular or substantially circular flange. With reference to Figure 3, the ostomy appliance 310 may include a straight edge 312 but may include a conventional and / or standard circular flange 311, which may be substantially centered over the stoma 331. In this manner, a standard ostomy bag or pouch may be used to attach to the flange 311.

[0032]

[0052] It should be noted that although the present invention uses terminology such as "D" shaped, this particular shape is not required. Rather, it is the straight edge of the ostomy appliance that may be positioned adjacent or even abutting the NPWD that provides for simultaneous use without unwanted or undesirable interference. Thus, the present invention should not be limited to this exact configuration.

[0033]

[0053] It is further contemplated that the location of the ostomy appliance may not be centered on the stoma. With reference to FIG. 4, the ostomy appliance 410 may include a flange 411 and a straight edge 412. The straight edge 412 may be positioned in close proximity to the NPWD 420, which in turn may comprise a drape 421 positioned over the wound 432 with a conduit or tube 422 connected to a negative pressure device (not shown). Due to the close proximity of the stoma 431 and the wound 432, the ostomy appliance 410 may be positioned as close to the stoma as possible - and as far away from the wound as possible. This may result in the stoma being positioned in a non-concentric position. Note that although this may not be ideal from a drainage perspective, once the wound has healed properly and the NPWD is no longer necessary, the ostomy faceplate may be positioned more centrally on the stoma.

[0034]

[0054] 5, an exemplary ostomy face plate 510 having a cutout is shown. Again, the ostomy face plate 510 may include a flange 511 for attachment to a bag or pouch. The ostomy face plate 510 may further include two straight edges 512A, 512B, which may be used to position the face plate 510 as close as possible to the drape material 521 for the NPWD 520. Again, the NPWD 520 may cover the wound 532 and may be attached to a negative pressure device (not shown) for generating negative pressure. It is noted that while the ostomy face plate 510 is shown with a quarter removed, it is anticipated that a variety of designs, configurations, or configurations may be utilized to achieve close placement of the ostomy appliance to the NPWD or its associated drape or dressing.

[0035]

[0055] It should also be noted that while the ostomy appliance 510 is shown with approximately one-quarter removed, it is also contemplated that the appliance 510 may include one or more lines of weakness 513 that may be used to remove a portion of the face plate. For example, the ostomy appliance 510 may be sold in a substantially circular or rectangular shape but may include one or more lines of weakness 513. The lines of weakness 513 may be used to remove a portion of the ostomy appliance or face plate. For example, a substantially circular ostomy face plate may include at least two lines of weakness. These lines of weakness may be substantially perpendicular to each other such that a portion of the face plate may be removed. To maintain a consistent flange for attachment of the bag or pouch, the flange may be asymmetric (such as the illustrated "D" shape) or offset to one or more sides of the face plate. In this manner, a portion of the face plate may be removed to allow for installation closer to NPWD.

[0036]

[0056] According to some embodiments of the present invention, the ostomy appliance or faceplate may include features to aid in the cutting of the NPWD drape or dressing - or indeed any adjacent dressing. As described in more detail below, such features may comprise a channel, one or more ridges or protrusions, a joint or junction for guiding a cutting device, or other such alignment or guidance features.

[0037]

[0057] Referring to FIG. 6, an ostomy appliance 610 is illustrated. The ostomy appliance 610 is illustrated as being "D" shaped, but it should be noted that it may take on a variety of shapes, as described above. The ostomy appliance 610 may include a flange 611, which is also illustrated as being "D" shaped, but may be any other shape or configuration, as described above. Adjacent or near the ostomy appliance 610 may be a NPWD 621. The negative pressure wound device 620 may include a drape or dressing 621, which may be attached to a device (not shown) that generates negative pressure, such as a vacuum. The ostomy appliance 621 may be placed on or around a stoma 631, while the NPWD 620 may be placed on or around a wound 632. The ostomy appliance 610 may further include a channel or groove 613. The channel or groove 613 may be created in any number of ways, such as by a depression in the surface of the ostomy appliance 610 or by one or more ridges or protrusions. In this manner, a drape or dressing to be used with the NPWD may be cut as close as possible to the ostomy appliance.

[0038]

[0058] 6, there may be some overlap, where the drape or dressing 621 overlaps a portion of the ostomy appliance or faceplate 610. According to some embodiments of the invention, the ostomy appliance or faceplate may include features to aid in the seal of a drape or dressing used with NPWD. For example--and as described in more detail below--one or more sides of the ostomy appliance or faceplate may taper from its normal thickness to a thinner thickness, providing a more gradual transition between the drape or dressing and the ostomy appliance, thereby assisting in obtaining and maintaining a proper seal of the drape or dressing.

[0039]

[0059] Figure 7 illustrates a similar arrangement to that shown in Figure 6 above, but illustrates the orientation of the channels in an ostomy appliance or faceplate 710 that is substantially square or rectangular. The ostomy appliance or faceplate 710 may include a flange 711 that may be circular, "D" shaped, square, or any other variation, and may further include a channel or guide 713 that may extend substantially parallel or collinear with an edge 712. A drape or dressing 721 may be configured over and / or around the wound 732 and may overlap or abut a portion of the appliance or faceplate 710 (as described above).

[0040]

[0060] 8, a cross section of an ostomy appliance 800 according to some embodiments of the present invention will be described. Ostomy appliance 800 may include a face plate 810, a hole or opening 820 through which a stoma may protrude, a flange 830 (which may be of any size or shape sufficient to attach to an ostomy bag or pouch), a channel or groove 840, and a tapered portion 850 proximate to channel or groove 840.

[0041]

[0061] 9, the interference between an ostomy appliance 910 and a drape or dressing 960 for NPWD will be described. As illustrated above, the ostomy appliance 910 may include a hole or opening 920 through which the stoma may protrude, a flange 930 (which may be of any size or shape sufficient to attach to an ostomy bag or pouch), a channel or groove 940, and a tapered portion 950 proximate to the channel or groove 940. A drape or dressing 960 for use in conjunction with NPWD may be placed over the wound 970 and may have a portion that extends over the tapered portion 950 of the ostomy appliance 910. It can be seen that the drape or dressing 960 may extend up to the channel or groove 940. During installation, the channels or grooves 940 can provide guidance for organized, linear cutting of an impermeable (or substantially impermeable, vapor permeable, etc.) negative pressure bandage or drape.

[0042]

[0062] It is contemplated that there may be various other arrangements or interferences between the ostomy appliance and the dressing or bandage for NPWD. For example, as illustrated in FIG. 10, it is contemplated that the ostomy appliance faceplate 1010 may comprise an impermeable material (or substantially impermeable, vapor permeable, etc.) and may be integrally connected to or part of a drape or bandage for NPWD 1040. The faceplate portion 1010 of the integrated device 1000 may include an opening or aperture 1020 for the stoma and a flange 1030 for connecting a bag or pouch. According to some embodiments, the faceplate portion 1010 may be constructed of one material while the drape portion 1040 may be constructed of a second material. For example, the faceplate portion 1010 may be made of a rigid material while the drape portion 1040 may be made of a flexible material typically used for bandages or drapes.

[0043]

[0063] According to some embodiments of the invention, certain mechanisms, devices, or arrangements may be used to guide the ostomy bag or pouch to dangle on the side of the patient away from the surgical (or other) wound. For example, as illustrated in Fig. 11, an ostomy faceplate or appliance 1110 may be configured to provide a typical opening for a stoma 1120, but may be configured to cause a flange for attaching the ostomy bag or pouch to be positioned at an angle such that, while the flanges lie in a single plane, a portion 1160 of the flange support is positioned further from the patient's skin (i.e., further in the Y axis), while another portion 1170 of the flange support is positioned closer to the patient's skin.

[0044]

[0064] 11, a channel or groove 1140 may be disposed in the ostomy appliance 1110 to aid in cutting a drape or other material associated with or used with the NPWD. Similarly, as described in more detail above, the ostomy appliance 1110 may also include a tapered portion 1150 that may aid in creating a seal between the drape material and the ostomy appliance 1110.

[0045]

[0065] It should be noted that in some alternatives, the channel or groove 1140 may be omitted as the surgeon may utilize the seam 1180 between the raised portion 1160 of the flange support and other portions of the faceplate.

[0046]

[0066] 12, the use of an angled ostomy appliance 1210 in conjunction with an ostomy bag or pouch 1280 is illustrated. Again, the ostomy appliance 1210 may include an opening or aperture 1220 for a stoma and a flange 1230 that may be positioned on an angle by resting on a first flange support portion 1260 that may be positioned further from the patient's skin than a second flange support 1270. The ostomy appliance 1210 may further include a channel or groove 1240 and a tapered portion 1250. In use, a NPWD drape or dressing 1290 may cover the wound 1295 and extend over the tapered portion 1250 of the ostomy appliance.

[0047]

[0067] It should be noted that while the above description with reference to Figures 11 and 12 describes a first and second flange support, such supports are not necessarily separate from one another. In other words, the flange itself may lie in a single plane, said plane being configured at an angle relative to the patient's skin surface. In a cross-sectional view, this may result in the appearance of a first flange support portion and a second flange support portion. However, this may present a single surface that is at an angle, with a smooth transition from one portion to the next. The above language is included not to limit the device to two such portions or their arrangement, but to illustrate that the ostomy bag or pouch may be forced to lie in a certain orientation by angling the flange and bag support.

[0048]

[0068] 13, the interference between an ostomy faceplate or appliance 1310 and a drape material 1340 for NPWD will be described. As before, the ostomy faceplate 1310 may include an opening or aperture 1320 for the stoma and a flange 1330 for attaching a bag or pouch. The flange may be of any shape, e.g., circular, square, "D" shaped, etc. The drape material 1340 may be placed over a wound 1350. To prevent pressure communication between the drape material 1340 and the ostomy appliance 1310, a coaptation barrier 1360 may be utilized. The adhesive barrier 1360 may be constructed from an impermeable (or substantially impermeable, vapor permeable, etc.) material to prevent the negative pressure drawn by a negative pressure device (not shown) and applied beneath the drape material 1340 from drawing any exudates from the stoma, for example, from around the flange 1330 (potentially due to a bag or pouch not being fully engaged or a leaky seal therebetween), or from drawing exudates from beneath the ostomy faceplate 1310. This adhesive barrier 1360 may be, for example, "T" shaped and may include adhesive under the arms of the "T" such that the adhesive barrier may be attached to one or both of the ostomy faceplate 1310 and the drape material 1340.

[0049]

[0069] Referring now to FIG. 14, a top view of a quadrilateral shaped ostomy appliance 1400 will be described. The ostomy appliance 1400 may include a face plate 1410 that may include a flange 1420 and one or more tapered portions 1430. Within the flange 1420 (which may be of any shape, such as circular or "D" shaped) there may be various lines of weakness 1440 so that the opening for the stoma may be located in the most desired location within the flange 1430 (based on the desired location of the stoma and the surgeon's preference). Similar to FIG. 14, FIG. 15 illustrates an ostomy appliance 1500 that includes a flange 1520 and both tapered portions 1530 and channels or grooves 1540 that may be present on all edges of the face plate 1510. Again, within the flange 1520 there may be various lines of weakness 1550 so that the opening for the stoma may be located in any number of locations within the flange 1530.

[0050]

[0070] 16, a "D" shaped ostomy appliance 1600 will be described. The ostomy appliance 1600 may include a face plate 1610, a flange 1620, an opening 1630 for the stoma, and a channel or groove 1640 and / or a tapered portion 1650 disposed along the straight edge of the "D". The ostomy appliance 1600 may further include a snap, hook, or other attachment device 1660 for connecting a bag or pouch to the ostomy appliance 1600. Such attachment devices 1660 are illustrated at the 7, 9, and 11 o'clock positions, but may be present at any position on the face plate 1610.

[0051]

[0071] 17, an ostomy appliance 1700 can include a face plate 1710, a flange 1720, an opening 1730 for the stoma, a tapered portion 1740, and a cutting guide 1750. In this embodiment, rather than a complete channel or groove, a raised rail 1750 can be used to guide a surgeon's cutting device (e.g., a knife, scalpel, scissors or scissor blade, etc.) to make a linear cut along the edge of the ostomy appliance 1700. For example, the surgeon can place the edge of the cutting device at the junction 1760 of the raised rail and the tapered portion to guide the cutting device.

[0052]

[0072] Similar to FIG. 17, FIG. 18 illustrates an ostomy appliance 1800 that may include a face plate 1810, a flange 1820, an opening 1830 for the stoma, and a tapered portion 1840. However, in this embodiment, the tapered portion steps up to the body of the ostomy face plate 1810 at a step 1850. The junction 1860 between the tapered portion 1840 and the step 1850 may be used to guide the surgeon's cutting device. Note that in some embodiments, the thickness of the step 1850 may be comparable to the thickness of the drape used in NPWD, such that when worn, there is a relatively smooth surface between the ostomy appliance and the drape.

[0053]

[0073] 19, a different approach to positioning the NPWD as close to the ostomy as possible is shown. Here, an ostomy appliance 1900 may include a face plate 1910, a flange 1920, and an opening 1930 for the stoma. The ostomy face plate 1910 may include one or more removable portions 1940 joined by lines of weakness. In this manner, portions 1940A, 1940B, 1940C, etc. may be removed as needed so that the ostomy appliance 1910 may be placed as close as possible to the NPWD and / or its associated drape or dressing.

[0054]

[0074] Figures 20 and 21 show alternative embodiments of the cutting guide. Figure 20 illustrates a face plate 2010 having a combination of a protrusion 2020 and a channel, slot, or groove 2030. In this way, the depth of the channel 2030 can be maintained deep enough to guide the cutting device without jeopardizing the rigidity of the face plate 2010. Figure 21 illustrates an ostomy face plate 2110 having a channel, slot, or groove 2120 formed between two protrusions 2130. This again can allow for the presence of a channel or groove on the face plate 2110 without jeopardizing the structure or structural rigidity of the face plate 2110.

[0055]

[0075] It is noted that, according to some embodiments of the present invention, an ostomy bag or pouch that mates or connects with the flange of the present invention may have a corresponding shape or attachment mechanism. In other words, it is anticipated that a "D" shaped flange on an ostomy appliance or faceplate may require an ostomy bag or pouch having a corresponding mating "D" shaped attachment device.

[0056]

[0076] The following description is exemplary, but is intended to provide background information to the fitting and use of improved ostomy appliances in conjunction with NPWD. If a patient presents with both a wound and an ostomy, the ostomy appliance may first be fitted over or around the stoma. In doing so, the ostomy appliance may have a pre-existing opening or an opening may be cut into the appliance. The ostomy appliance may be attached to the patient, typically using an adhesive attached to the bottom surface of the ostomy appliance.

[0057]

[0077] During application of the NPWD, a drape or bandage may be placed over the wound and cut as close to the ostomy device as possible, for example, by using a cutting guide disposed on the edge of the ostomy appliance. According to some embodiments, the edges of the ostomy appliance may be tapered so that the drape or bandage may overlap a small portion of the ostomy appliance but may be configured to maintain a proper or adequate seal. It is contemplated that the ostomy appliance - or the portion of the ostomy appliance that the drape or bandage is expected to overlap - may be made from a non-permeable material, a hydrocolloid film, a drape with a silicone layer and an acrylic adhesive coating, etc.

[0058]

[0078] It will be understood that the specific embodiments of the invention shown and described herein are illustrative only. Numerous variations, changes, substitutions and equivalents will now occur to those skilled in the art without departing from the scope of the invention. Accordingly, all subject matter described herein and shown in the accompanying drawings is intended to be regarded as illustrative only and not in a limiting sense. The invention as originally claimed in the present application is set forth below. [1] An ostomy appliance or faceplate having a non-circular flange for attaching a bag or pouch. [2] The ostomy device or base plate of [1], wherein the non-circular flange is substantially "D" shaped. [3] The ostomy device or base plate described in [1], wherein the non-circular flange has at least one substantially straight edge. [4] The ostomy device or base plate according to [1], wherein the ostomy device or base plate is non-circular. [5] The ostomy device or base plate of [4], wherein the ostomy device or base plate is substantially "D" shaped. [6] An ostomy device or base plate as described in [1], which is provided with a cutting guide portion. [7] The ostomy device or base plate of [6], wherein the cutting guide is used to guide a cutting device when cutting a drape or bandage material. [8] The ostomy device or base plate according to [7], wherein the drape or bandage material is used in conjunction with NPWD. [9] The ostomy device or face plate of [6], wherein the cutting guide portion has a channel or groove.

[10] The ostomy device or base plate described in [6], wherein the cutting guide portion has one or more protrusions.

[11] The ostomy device or base plate described in [1], further comprising a tapered edge.

[12] The ostomy device or face plate of [5], further comprising a tapered edge, wherein the tapered edge extends along the substantially straight portion of the "D" shape.

[13] The ostomy device or base plate of [1], wherein the ostomy device or base plate is constructed from an impermeable, substantially impermeable, or vapor-permeable material.

[14] The ostomy device or base plate described in [1], wherein the non-circular flange for attaching a bag or pouch is disposed at an angular position relative to the bottom surface of the ostomy device or base plate.

[15] The ostomy appliance or base plate of [1], further comprising an attachment device for attaching a bag or pouch to the ostomy appliance or base plate.

[16] A non-circular ostomy device or base plate, a non-circular flange for attaching a bag or pouch, said non-circular flange having at least one substantially straight edge; a cutting guide for guiding a cutting device when cutting a material used with a NPWD, said cutting guide being aligned in line with said substantially straight edge.

[17] The non-circular ostomy device or face plate of

[16] , wherein the non-circular ostomy device has at least one substantially straight, tapered edge.

[18] The non-circular ostomy device or face plate of

[16] , further comprising an opening configured to receive a stoma.

[19] The non-circular ostomy device or face plate of

[18] , wherein the opening is asymmetrically located, the opening being located within the flange.

[20] The non-circular ostomy device or base plate of

[16] , further comprising one or more lines of weakness disposed within the flange, such lines of weakness being used to remove a portion of the non-circular ostomy device or base plate to form an opening.

[21] An ostomy appliance or faceplate having a cutting guide for guiding a cutting device.

[22] The ostomy device or face plate of

[21] , wherein the cutting guide guides a cutting device used in conjunction with the NPWD.

[23] The ostomy device or base plate of

[21] , wherein the cutting guide comprises a channel or groove in a surface of the ostomy device or base plate.

[24] The ostomy device or base plate of

[21] , wherein the cutting guide portion comprises one or more protrusions.

[25] An ostomy appliance or faceplate comprising a substantially planar surface and a flange, wherein at least a portion of the planar surface exterior to the flange is removable.

[26] An ostomy device or faceplate comprising a substantially planar surface of thickness having a substantially straight edge, wherein the substantially planar edge has a tapered edge, reducing the thickness of the substantially planar surface.

[27] An ostomy appliance or base plate configured to direct an ostomy bag or pouch attached to the ostomy appliance or base plate to a particular side of the ostomy appliance or base plate.

Claims

1. An ostomy appliance or faceplate having a non-circular flange for attaching a bag or pouch, the flange connects the bag or pouch to the device or faceplate; The ostomy appliance or faceplate is aligned with or abutted against a negative pressure wound device (NPWD).

2. The ostomy appliance or faceplate of claim 1 , wherein the non-circular flange has at least one substantially straight edge.

3. The ostomy appliance or faceplate of claim 1 , wherein the ostomy appliance or faceplate is non-circular.

4. 10. The ostomy appliance or faceplate of claim 1, wherein the ostomy appliance or faceplate is substantially "D" shaped.

5. 10. The ostomy appliance or faceplate of claim 1, wherein the ostomy appliance or faceplate is constructed from a liquid impermeable, substantially liquid impermeable, or vapor permeable material.

6. 10. The ostomy appliance or base plate of claim 1, further comprising an attachment device for attaching a bag or pouch to the ostomy appliance or base plate.

7. 10. The ostomy appliance or faceplate of claim 1, further comprising an opening configured to receive a stoma.

8. The ostomy appliance or faceplate of claim 7, wherein the opening is asymmetrically positioned relative to the flange.

9. 1. An ostomy appliance or faceplate having a non-circular, substantially "D" shaped flange for attachment of a bag or pouch, the flange connects the bag or pouch to the device or faceplate; said ostomy appliance or faceplate being substantially "D" shaped; The ostomy appliance or faceplate is aligned with or abutted against a negative pressure wound device (NPWD).

10. An ostomy appliance or faceplate having a non-circular flange having at least one substantially straight edge, said non-circular flange for attaching a bag or pouch; The ostomy appliance or faceplate is aligned with or abutted against a negative pressure wound device (NPWD).

11. The ostomy appliance or faceplate of claim 10, wherein the ostomy appliance or faceplate is non-circular.

12. 11. The ostomy appliance or faceplate of claim 10, wherein the ostomy appliance or faceplate is constructed from a liquid impermeable, substantially liquid impermeable, or vapor permeable material.

13. 11. The ostomy appliance or faceplate of claim 10, further comprising an opening configured to receive a stoma.

14. 14. The ostomy appliance or face plate of claim 13, wherein the aperture is asymmetrically located relative to the flange, the aperture being located within the flange.

Images