Stoma Cleaning Apparatus and Method

Abstract

An apparatus for restraining and/or containing a stoma during cleaning and disinfection of an area, and in particular the skin area, around a stoma in preparation for attaching an ostomy bag or appliance.

Claims

1. An apparatus for restraining and/or containing a stoma, said apparatus adapted to aid cleaning and disinfecting an area around the stoma, the apparatus comprising: a silo, said silo including a hole, and said silo having an open end and a closed end, and a seal ring or a cap, said seal ring or cap having a predetermined shape adapted to couple with the open end of the silo and encase the stoma.

2. The apparatus of claim 1, further comprising: the seal ring or cap having an adjustable and/or moldable inner diameter adapted for releasably attaching the seal ring or cap to the stoma, and wherein the silo is comprised of an absorbent transparent or semi-transparent material configured to capture waste exiting the stoma.

3. The transparent or semi-transparent material of claim 2 comprising a gauze inner layer and a leak-proof transparent outer layer.

4. The apparatus of claim 1, further comprising: the cap comprised of a cylindrical shaped semi-rigid material with a hole for allowing waste to pass therethrough the hole to the silo, and wherein the inner diameter of the cap is comprised of a moldable and/or adjustable inner diameter adapted for releasably attaching the inner diameter of the cap to the stoma, and wherein the silo is comprised of an absorbent transparent or semi-transparent material configured to capture waste exiting the stoma.

5. The silo of claim 2 wherein the absorbent transparent or semi-transparent material is of a semi-rigid or rigid construction.

6. The cap of claim 1, further comprising a flanged end adapted for contacting the skin area of a user, and wherein the flanged end is straight, concave, or convex in shape.

7. An apparatus for restraining and/or containing a stoma, said apparatus adapted to aid cleaning and disinfecting an area around a stoma, the apparatus comprising: a transparent or semi-transparent silo or silo portion, said silo or silo portion including a hole, and said silo or silo portion having an open end and a closed end, wherein said open end is elastic.

8. The transparent or semi-transparent material of claim 7 comprising a gauze inner layer and a leak-proof transparent outer layer.

9. The silo of claim 7 wherein the absorbent transparent or semi-transparent material is of semi-rigid or rigid construction.

10. The apparatus of claim 7, being of one-piece construction, said apparatus further comprising an absorbent transparent or semi-transparent material.

11. A method, including an apparatus for restraining and/or containing a stoma adapted for cleaning and disinfecting an area around the stoma, the apparatus comprising a transparent or semi-transparent silo or silo portion, said silo or silo portion including a hole, and said silo or silo portion having an open end and a closed end, wherein said open end is elastic, the method comprising: removing an ostomy bag or appliance, thereby exposing the area around the stoma; covering and encasing the stoma by attaching the open end of the apparatus to the stoma; cleaning and/or disinfecting the area around the stoma; attaching an ostomy appliance wafer, baseplate, or flange assembly by threading said ostomy appliance wafer, baseplate, or flange over the attached apparatus; viewing through the transparent or semi-transparent silo or silo portion, thereby assuring the stoma is inactive; removing the apparatus from the area, wherein the stoma is determined to be inactive; and attaching an ostomy bag to the area around the stoma.

12. A method, including an apparatus for restraining and/or containing a stoma, said apparatus adapted to aid cleaning and disinfecting an area around the stoma, the apparatus comprising: a silo, said silo including a hole, and said silo having an open end and a closed end, and a seal ring or a cap, said seal ring or cap having a predetermined shape adapted to couple with the open end of the silo and encase the stoma, the method comprising: removing an ostomy bag or appliance, thereby exposing the area around the stoma; covering and encasing the stoma by attaching the open end of the apparatus to the stoma, or encasing a stoma within the cap portion or annular ring of the apparatus and applying pressure to the area around the stoma via the cap and/or silo; cleaning and/or disinfecting the area around the stoma; viewing through the transparent or semi-transparent silo or silo portion, thereby assuring the stoma is inactive; removing the apparatus from the area, wherein the stoma is determined to be inactive; and attaching an ostomy bag or appliance to the area around the stoma.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0044] While the specification concludes with claims particularly pointing out and distinctly claiming particular embodiments of the instant invention, various embodiments of the invention can be more readily understood and appreciated from the following descriptions of various embodiments of the invention when read in conjunction with the accompanying drawings in which:

[0045] FIG. 1A shows a perspective view of a user having a one-piece stoma-clean apparatus located on a stoma, according to an embodiment of the present disclosure;

[0046] FIG. 1B shows a perspective view of a stoma exited through an opening of an ostomy appliance baseplate/flange feature; and

[0047] FIG. 2 shows an enlarged perspective view of the stoma-clean apparatus of FIG. 1, according to an embodiment of the present disclosure;

[0048] FIG. 3A shows a perspective view of a stoma-clean apparatus showing an exemplary cap, according to another embodiment of the present disclosure;

[0049] FIGS. 3B-3D show perspective views of exemplary caps of a stoma-clean apparatus, according to various embodiments of the present disclosure;

[0050] FIG. 4A is a front view of a stoma-clean apparatus showing an exemplary conical/spherical cap, according to another embodiment of the present disclosure;

[0051] FIG. 4B is a front view of a stoma-clean apparatus showing an exemplary conical/spherical cap with a lip, according to another embodiment of the present disclosure;

[0052] FIGS. 5 and 6 details exemplary processes for using a stoma-clean apparatus, according to various embodiments of the present disclosure; and

[0053] FIGS. 7A and 7B show a side elevational view and a sectional view, respectively of an exemplary stoma-clean apparatus, according to another embodiment of the present disclosure.

DETAILED DESCRIPTION

[0054] Reference will now be made in detail to specific embodiments or features, examples of which are illustrated in the accompanying drawings. Wherever possible, corresponding or similar reference numbers will be used throughout the drawings to refer to the same or corresponding parts. Moreover, references to various elements described herein, are made collectively or individually when there may be more than one element of the same type. However, such references are merely exemplary in nature. It may be noted that any reference to elements in the singular may also be construed to relate to the plural and vice-versa without limiting the scope of the disclosure to the exact number or type of such elements unless set forth explicitly in the appended claims.

[0055] The detailed description describes non-limiting exemplary embodiments. Any individual features may be combined with other features as required by different applications for at least the benefits described herein. As used herein, for example, the terms “proximal” refers to parts closer to a relevant feature, while “distal” refers to parts away from a relevant feature unless specifically indicated otherwise.

[0056] FIGS. 1A and 1B illustrate perspective views of a user 10 with a stoma-clean apparatus 100 releasably held onto an exposed stoma 101 in proximity to the user's skin area 102, according to an embodiment of the present disclosure. By reference to FIG. 2, the exemplary one-piece stoma-clean apparatus 110 includes an absorbent, semi-transparent, flexible, lightweight waste collection tube (i.e., silo) 112. The silo 112 includes an open end 117, a closed end 118, wherein the open end 117 is elasticized to allow hands-free attachment of the stoma-clean apparatus 110 to the stoma. The one-piece stoma-clean apparatus 110 may be constructed from moldable, absorbent, and transparent medical grade materials such as those engineered by 3M, Adhesives Research, and Parafix Engineered Adhesives Solutions.

[0057] In an alternative embodiment, the open end 117 of the stoma-clean apparatus 100 may be substantially configured with an elastic annular seal ring 115 (not shown). The seal ring 115 is disposed on, or integrated with, the open end 117 of the silo 112. The annular seal ring 115 may be elasticized or constructed of a moldable wafer to assist the user 10 in holding the stoma-clean apparatus 100 onto the stoma 101. In an exemplary aspect, the annular seal ring 115 may be configured as an adjustable diameter clasp or other mechanism allowing adjustability of the inside diameter of the annular seal ring 115 to allow a user to attach the stoma-clean apparatus 100 to the stoma 101 in a hands-free manner.

[0058] To contain any waste exiting the stoma 101, a user 10 attaches the stoma-clean apparatus 110 substantially over the stoma 101 so as to cover and encase the active portion of the stoma 101 as shown in FIG. 1A. The stoma-clean apparatus 110 is held in-place on the stoma 101 by the elasticized open end 117 whereby the open end 117 is held proximal to the skin area 102. With the stoma-clean apparatus 110 situated hands-free on the stoma 101, a user 10 is able to clean the skin area 102 around the periphery of the open end 117 of the stoma-clean apparatus 110.

[0059] In an alternative embodiment, to contain waste exiting the stoma 101, a user 10 places the seal ring 115 over the stoma 101 and seats the ring 115 onto the skin area 102 around the stoma 101 thereby containing the stoma 101 in the stoma-clean apparatus 110. The stoma-clean apparatus is held in-place on the skin area 102 with one hand while the user 10 cleans the skin area 102 around the periphery of the seal ring 115 with the other hand. In another aspect, the annular seal ring 115 may be elasticized or constructed of a moldable wafer to assist the user 10 in holding the stoma-clean apparatus 100 onto the stoma 101. In an exemplary embodiment, the annular seal ring 115 may be configured as an adjustable diameter clasp or other mechanism allowing adjustability of the inside diameter of the annular seal ring 115.

[0060] By reference to FIG. 3A, according to an exemplary embodiment of the present disclosure, a stoma-clean apparatus 200 includes an absorbent, semi-transparent, rigid/semi-rigid silo 112 with a closed end 118, an open end 117, and a cap 205. The cap 205 is shaped as a cylindrical rigid body with a thru-hole configured to enclose a stoma 101. In an aspect, the cap 205 may be of another shape such as an elbow while still enabling enclosure of the stoma 101. The stoma-clean apparatus 200 also includes a coupling ring 201 for attaching the silo 112 to the cap 205. In an aspect, a stoma-clean apparatus may be constructed without utilizing a coupling ring 201 such as by directly fusing/molding the silo 112 to the cap 205.

[0061] FIGS. 3B-3D illustrate other caps 206, 207, and 208 according to various exemplary embodiments of the present disclosure. In an aspect, cap 206 is configured with a convex flange at its distal end which is useful for contacting a user's surrounding skin area which is inward in shape. Likewise, cap 207 is configured with a straight flange at its distal end which is useful for contacting a user's surrounding skin area which is regular (i.e., flat) in shape. Similarly, cap 208 is configured with a concave flange at its distal end which is useful for contacting a user's surrounding skin area which is outward in shape. However, it is to be understood that the shape of the caps in the stoma-clean apparatus 200 is not limiting the scope of the present disclosure.

[0062] In yet another embodiment of the present disclosure, a stoma-clean apparatus 300 includes an absorbent, semi-transparent, rigid/semi-rigid silo 112 with a closed end 118 and an open end 117, a conical/spherical cap 310, and a coupling ring 201 for attaching the silo 112 to the conical/spherical cap 310 as shown in FIG. 4A. The cap 310 is configured with a rigid/semi-rigid conical/spherical end for contacting a portion of the skin area 102 around a stoma 101 and provides a smaller diameter “D.sub.C” around the stoma peripheral diameter “D.sub.S” proximal to the user's skin area 102. The conical/spherical configuration of exemplary cap 310 enables a user 10 to clean the skin area 102 closer to the stoma peripheral diameter “D.sub.S” and thereby affords a user the ability to clean a larger surface skin area 102 surrounding the stoma 101. In an exemplary aspect, conical/spherical cap 312 (as shown in FIG. 4B) includes a lip 314 configured thereon to allow a user to seat the stoma-clean apparatus on the user's skin area 102 with greater stability while also utilizing cap 312 configured with the lip 314 to apply pressure to a portion of the skin area 102 around a stoma.

[0063] By reference to FIG. 4B, the exemplary cap 312 includes a lip 314 configured on its surface generally perpendicular to the longitudinal axis “A-A” of cap 312. Cap 312 may have lip 314 installed anywhere on its surface and in any angular orientation “∅0” with respect to longitudinal axis “A-A”. Lip 314 may be integrally constructed on cap 312, such as by molding, or separately affixed to cap 312 using known construction methods (e.g., adhesively bonded).

[0064] In the case of a two/multi-piece ostomy appliance, FIG. 5 illustrates a flow chart of a method 600 using a stoma-clean apparatus 110, 200, 300, 400 for cleaning and disinfecting an area around a stoma. The sequence in which the method 600 is described is not intended as a limitation, and any number of the described method steps may be combined in any order to implement the method, or an alternative method. Additionally, individual blocks may be deleted from the method without departing from the spirit and scope of the present disclosure.

[0065] At step 602, the method 600 includes removing an entire ostomy bag appliance from the body of a user 10 thereby exposing the user's skin area 102 around a stoma 101.

[0066] At step 604, the method 600 includes covering/encasing a stoma 101 by attaching a stoma-clean apparatus 110, 200, 300, 400 to the stoma 101. Alternatively, in accordance with other embodiments of the present disclosure, the method 600 includes a user 10 encasing a stoma 101 within the stoma-clean apparatus 110, 200, 300, 400 (for example, within annular seal ring 115, cap 205 and/or silo 112, etc.) and applying pressure via the ring, cap, and/or silo (for example, via the annular seal ring 115, cap 205 and/or silo 112, etc.) to the skin area 102 around the stoma 101.

[0067] At step 606, the method 600 includes a user 10 cleaning and/or disinfecting the skin area 102 around the stoma 101.

[0068] At step 608, the method 600 includes a user 10 attaching an ostomy bag appliance assembly (e.g., baseplate/flange) to the skin area 102 by threading the appliance assembly over the attached stoma-clean apparatus 110.

[0069] At step 610, the method 600 includes a user 10 assessing whether a stoma 101 is active via viewing said activity through the transparent/semi-transparent silo 112.

[0070] At step 612, the method 600 includes removing the stoma-clean apparatus 110, 200, 300, 400 from a non-active stoma.

[0071] At step 614, the method 600 includes, attaching an ostomy bag onto the user's skin area 102 or ostomy bag appliance attachment feature 102A, around the stoma 101.

[0072] In an exemplary aspect, an ostomy bag may be of a two-piece configuration such as those known in the art and discussed above. Where a baseplate, or the like, remains attached to a user's skin area 102 after removal of an ostomy bag, a stoma-clean apparatus 110, 200, 300, 400 would be used to cooperate with the surface of the device baseplate/flange versus directly onto a user's skin area 102 without departing from or limiting the essential scope or teachings of the present disclosure.

[0073] For a one-piece or two/multi-piece ostomy appliance, where in the case of a two/multi-piece ostomy appliance a wafer or baseplate/flange portion remains attached to the user's skin area, FIG. 6 illustrates a flow chart of a method 700 for using a stoma-clean apparatus 110, 200, 300, 400 for cleaning and disinfecting an area 102/102A around a stoma 101. The sequence in which the method 700 is described is not intended as a limitation, and any number of the described method steps may be combined in any order to implement the method, or an alternative method. Additionally, individual blocks may be deleted from the method without departing from the spirit and scope of the present disclosure.

[0074] At step 702, the method 700 includes removing an ostomy bag, such as a one-piece bag, or an ostomy appliance, such as a two-piece bag with a wafer and/or flanged assembly (See FIG. 1B) thereby exposing an area around a stoma 101 for cleaning.

[0075] At step 704, the method 700 includes covering and encasing a stoma 101 by attaching a stoma-clean apparatus 110, 200, 300, 400 to the stoma 101. locating a stoma-clean apparatus 110, 200, 300, 400 by encasing a stoma 101. Alternatively, in accordance with other embodiments of the present disclosure, the method 700 includes a user 10 encasing a stoma 101 within the stoma-clean apparatus 110, 200, 300, 400 (for example, within annular seal ring 115, cap 205 and/or silo 112, etc.) and applying pressure via the ring, cap, and/or silo (for example, via the annular seal ring 115, cap 205 and/or silo 112, etc.) to the area 102/102A around the stoma 101.

[0076] At step 706, the method 700 includes a user 10 cleaning/disinfecting the area 102/102A around the stoma 101.

[0077] At step 708, the method 700 includes a user 10 assessing whether a stoma 101 is active via viewing said activity through the transparent/semi-transparent silo 112.

[0078] At step 710, the method 700 includes removing the stoma-clean apparatus 110, 200, 300, 400 from a non-active stoma and attaching an ostomy appliance assembly or one-piece bag to the area 102/102A.

[0079] In an exemplary aspect, an ostomy device may be a two-piece configuration such as those known in the art and discussed above. Where a baseplate, or the like, remains attached to a user's skin area 102 after removal of an ostomy bag, a stoma-clean apparatus 110, 200, 300, 400 would be used to cooperate with the surface of the device baseplate/flange area 102A versus directly onto a user's skin area 102 without departing from or limiting the essential scope or teachings of the present disclosure.

[0080] FIGS. 7A and 7B illustrate views of an exemplary stoma-clean apparatus 800 according to yet a further embodiment of the present disclosure. A stoma-clean apparatus 800, including an open end 117, a closed end 118, and a silo 112, may be constructed by layering and/or adhering a moisture resistant transparent/semi-transparent sheath 801 onto an absorbent, semi-transparent layer 802 comprised of an absorbent material such as gauze. The stoma-clean apparatus 800 and, independently, layers 801 and 802 may be flexible, semi-rigid, or rigid. Those of skill in the art will recognize that the stoma-clean apparatus 800 may be constructed using engineered materials (e.g., Vancive™ MED 5580H) such as those engineered and manufactured by Adhesives Research or Parafix Engineered Adhesive Solutions, for example.

[0081] The exemplary stoma-clean apparatus 800 includes features and performance aspects similar to that of stoma-clean apparatus 110, without limitation, such as an elasticized open end 117.

[0082] While the disclosure has been described with reference to one or more different exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the disclosure. For example, in some cases reference to application of a stoma-clean apparatus to a user's skin area may similarly include application of the stoma-clean apparatus to the exposed area of an ostomy device (e.g., wafer, flange, etc.). In addition, many modifications may be made to adapt to a particular situation without departing from the essential scope or teachings thereof. Therefore, it is intended that the disclosure not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention.

LIST OF ELEMENTS

[0083] 10 User

[0084] 100 Stoma-clean apparatus

[0085] 101 Stoma

[0086] 102 Skin area

[0087] 110 Stoma-clean apparatus

[0088] 112 Waste collection tube, Silo

[0089] 115 Seal ring

[0090] 117 Open end

[0091] 117A Open end, seal ring

[0092] 118 Closed end

[0093] 200 Stoma-clean apparatus

[0094] 201 Coupling ring

[0095] 205 Cylindrical cap

[0096] 206 Convex-flanged cap

[0097] 207 Straight-flanged cap

[0098] 208 Concave-flanged cap

[0099] 300 Stoma-clean apparatus

[0100] 310 Conical/Spherical cap

[0101] 312 Conical/Spherical cap with lip

[0102] 314 Lip

[0103] 600 Method

[0104] 602 Step

[0105] 604 Step

[0106] 606 Step

[0107] 608 Step

[0108] 610 Step

[0109] 700 Method

[0110] 702 Step

[0111] 704 Step

[0112] 706 Step

[0113] 708 Step

[0114] 710 Step

[0115] 800 Stoma-clean apparatus

[0116] 801 Sheath

[0117] 802 Absorbent layer

[0118] A-A Longitudinal axis of cap

[0119] D.sub.C Diameter at contact area

[0120] D.sub.S Stoma periphery diameter

[0121] ∅ Angle