Ostomy devices and their method of use

• US 4,723,952 A
• Filed: 02/13/1986
• Issued: 02/09/1988
• Est. Priority Date: 02/25/1985
• Status: Expired due to Term

• Current Assignee: Archie Campbell, Rose M. Campbell
• Original Assignee: Thomas Esposito
• Inventors: Esposito, Thomas
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): KRUTER, JEROME
• Application Number:
  US06/829,479
• Time in Patent Office: 726 Days
• Field of Search: 604/277, 604/332-345
• US Class Current: 604/338
• CPC Class Codes: A61F 2005/4483 Convex pressure ring
• CPC Class Codes: A61F 5/448 Means for attaching bag to seal ring
• CPC Class Codes: A61F 5/449 Body securing means, e.g. belts, garments

Abstract

An ostomy device is disclosed which comprises a simple, rigid frame having an opening which is registered with the stoma of an ostomate and secured on his torso by an elastic belt. The tension of the belt cause the frame to press into the user'"'"'s flesh and thus stabilize the peristomal region within the confines of the frame opening. The peristomal region is given sufficient firmness to insure secure attachment of an adhesive sheet of a waste management adjunct. This frame is also employed in a method which obviates the need for a collection container for body wastes. In this method, a protective sheet may be adhered to the peristomal skin, with an opening registered with the stoma. A absorbent pad is held against the stoma by the frame as it stabilizes the peristomal region. The solid matter is then periodically removed by replacement of the pad. For use with a sanitary wafer which is adhered to the torso and has a flange on which a collection container is detachably mounted, a broader based stabilization is provided through the provision of a relatively rigid planar portion, spanning the inner end of the frame opening. This planar portion may be provided by a separate insert or formed integrally with the frame. The planar portion concentrates stabilization to the periphery of the stoma where the adhesive sheet portion extends to an opening which is registered with the stoma. The wafer flange projects through a central opening in the planar portion to permit mounting of the collection bag.

Claims

1. A method of body waste management, for ostomates, through the use of a device comprising a relatively rigid frame having a central opening therein, which opening has a span substantially greater than the nominal diameter of the ostomate'"'"'s stoma, and belt means attached to opposite sides of the frame, at points spaced from the inner surface thereof, said method comprising the steps of

positioning said frame on the torso of the ostomate, with the opening thereof registered with the ostomate'"'"'s stoma,

securing the belt means about the ostomate'"'"'s torso with sufficient tension to draw the frame inwardly and stabilize the ostomate'"'"'s peristomal region disposed generally within the outline of said opening, and

adhering a waster management adjunct to the skin surface of the ostomate, peripherally of the stoma and within the outline of the frame opening, said adjunct is in the form of a sanitary wafer comprising a flexible, impervious sheet having a layer of adhesive on its inner surface, said sheet also having a flange, projecting from its outer surface, and on which a waste container may be mounted, said sheet further having an opening whose outline approximates the nominal diameter of the ostomate'"'"'s stoma and disposed within and adjacent to the inner bounds of said flange, and

waste management is attained through the additional use of an insert which includes a relatively rigid, central planar portion with a central opening having an outline approximating, but larger than the outline of the wafer flange, said planar portion, peripherally of said central opening, having a thickness less than the height of said flange, said planar portion having a lateral extend approximating that of the inner surface of said frame, and

said frame and said insert having means for preventing relative lateral movement therebetween when the frame is in engagement with the outer surface of the insert,

and including the further step of

interposing said insert between the frame and the ostomate'"'"'s torso, with the insert opening telescoped over the wafer flange.

whereby when the belt means are tensioned, the peristomal region of the ostomate is stabilized, with the stabilization pressure spread over the substantial area of the planar portion of the insert lying within the outline of the frame opening, with a concentration of pressure on the adhesive layer of the wafer, peripherally of the ostomate'"'"'s stoma, and further with the immediate peripheral region of the stoma being stabilized so that there is a minimum of relative movement which would deteriorate the effectiveness of the seal when the flange is subjected to inward and outward pressures incident to attachment and removal of the waste container.

2. A method as in claim 1 wherein

the steps of positioning the frame, tensioning the belt means and adhering the sanitary wafer are performed in that order and then the belt means are loosened and the insert is so interposed, and the belt means are retensioned with the frame opening again registered with the ostomate'"'"'s stoma.

3. A method of body waste management, for ostomates, through the use of a device comprising a relatively rigid frame having a central opening therein, which opening has a span substantially greater than the nominal diameter of the ostomate'"'"'s stoma, and belt means attached to opposite sides of the frame, at points spaced from the inner surface thereof, said method being particularly adapted to ostomates who, through dietary control, have a minimal liquid content in their faces, and comprising the steps of

positioning a pad of absorbent material against the ostomate'"'"'s stoma and peristomal skin surface, said absorbent pad having portions with a span greater than the frame opening, positioning said frame on the torso of the ostomate, with the opening thereof registered with the ostomate'"'"'s stoma, and in engagement with said portions of the absorbent pad,

securing the belt means about the ostomate'"'"'s torso with sufficient tension to draw the frame inwardly and stabilize the ostomate'"'"'s peristomal region disposed generally within the outline of said opening and maintaining the absorbent pad in engagement therewith, and

manually removing accumulated, solid feces through use of said adsorbent pad, and

placing a barrier sheet of greater outline than the frame against the absorbent prior to stabilization of the peristomal region by the frame.

4. A method of body waste management, for ostomates, through the use of a device comprising a relatively rigid frame having a central opening therein, which opening has a span substantially greater than the nominal diameter of the ostomate'"'"'s stoma, and belt means attached to opposite sides of the frame, at points spaced from the inner surface thereof, said method being particularly adapted to ostomates who, through dietary control, have a minimal liquid content in their feces, and comprising the steps of

positioning a pad of absorbent material against the ostomate'"'"'s stoma and peristomal skin surface, said absorbent pad having portions with a span greater than the frame opening, positioning said frame on the torso of the ostomate, with the opening thereof registered with the ostomate'"'"'s stoma, and in engagement with said portions of the absorbent pad,

securing the belt means about the ostomate'"'"'s torso with sufficient tension to draw the frame inwardly and stabilize the ostomate'"'"'s peristomal region disposed generally within the outline of said opening and maintaining the absorbent pad in engagement therewith, and

manually removing accumulated, solid feces through use of said absorbent pad, and

placing a perforated barrier sheet of greater outline than the frame against the absorbent pad, prior to stabilization of the peristomal region by the frame.

5. A combination for use in enhancing the effectiveness of a sanitary wafer which comprises a flexible, impervious sheet having a layer of adhesive on its lower, or inner surface, for its attachment to the peristomal skin surface of an ostomate, said sheet having an opening which closely approximates the outline of the ostomate'"'"'s stoma, said wafer further comprising a relatively rigid, circular flange, projecting from the upper, or outer, surface of said sheet, the inner diameter of which approximates the outline of said opening, said flange providing means for attachment of a waste disposal container to said sanitary wafer, said combination comprising

an insert which includes a relatively rigid, central planar portion with a central opening having a diameter approximating, but larger than the outer diameter of the wafer flange, said planar portion, peripherally of said central opening, having a thickness less than the height of said flange, said planar portion having a lateral extent approximating that of the inner surface of sad frame, and

a rigid frame having an opening for registration with the planar portion of said insert, said opening being clear of obstruction, the outline of said frame opening being substantially greater than the outline of said central opening of the insert,

belt means attached to opposite sides of the frame, at points spaced outwardly from the inner surface thereof, for securing said frame to the ostomate'"'"'s torso with said opening registered with the ostomate'"'"'s stoma,

whereby when the belt means are tensioned, the peristomal region of the ostomate is stabilized, with the stabilization pressure spread over the substantial area of the planar portion of the insert lying within the outline of the frame opening, with a concentration of pressure on the adhesive layer of the wafer, peripherally of the ostomate'"'"'s stoma, and further with the immediate peripheral region of the of the stoma being stabilized so that there is a minimum of relative movement which would deteriorate the effectiveness of the adhesive seal when the flange is subjected to inward and outward pressures incident to attachment and removal of a disposal container.

6. A combination as in claim 5 wherein

the insert and frame have means for preventing relative lateral movement therebetween when the frame is held against the insert by the belt means.

7. A combination as in claim 6 wherein

the frame has a circular outline and the lower inner surface thereof is convexly curved, and

the insert includes an outwardly curved flange, into which the lower inner surface of the frame nests, to provide the means for preventing lateral movement.

8. A combination as in claim 5 wherein

the insert has a plurality of openings through through said planar portion, within the outline of said frame opening.

whereby, upon tensioning of the belt means, portions of the ostomate'"'"'s flesh will protrude through these openings, such protruding portions providing means preventing the insert and frame from shifting laterally relative to the ostomate'"'"'s torso, as well as providing lines of pressure concentration on the adhesive which deter shifting of the sanitary wafer relative to the ostomate'"'"'s skin surface.

9. A combination as in claim 8 wherein

the frame opening has a "rounded square" outline at its inner end, and

the openings in the planar portion of the insert take the form of angularly spaced, arcuate slots, concentric of the central opening through which the wafer flange extends.

10. For use in combination with a santiary wafer comprising a flexible, impervious sheet having a layer of adhesive on its lower, or inner surface, for its attachment to the peristomal skin surface of an ostomate, said sheet having an opening which closely approximates the outline of the ostomate'"'"'s stoma, said wafer further comprising a relatively rigid, circular flange, projecting from the upper, or outer, surface of said sheet, the inner diameter of which approximates the outline of said opening, said flange providing means for attachment of a waste disposal container to said sanitary wafer,

a rigid frame having an opening, said opening being clear of obstruction outwardly of the frame, the outline of said frame opening being substantially greater than said wafer flange,

said frame further having an integral planar portion extending across the bottom or inner end of said frame opening, and having a central opening, having a diameter approximating but slightly larger than the outer diameter of said flange, the thickness of said planar portion, peripherally of said central opening, being less than the height of the wafer flange, and

belt means attached to opposite sides of the frame, at points spaced outwardly from the inner surface thereof, for securing said frame to the ostomate'"'"'s torso with said opening registered with the ostomate'"'"'s stoma.

whereby, when the belt means are tensioned, the peristomal region of the ostomate is stabilized, with the stabilization pressure spread over the substantial area of said planar portion, with a concentration of pressure on the adhesive layer of the wafer, peripherally of the ostomate'"'"'s stoma, and further with the immediate peripheral region of the of the stoma being stabilized so that there is a minimum of relative movement which would deteriorate the effectiveness of the seal when the flange is subjected to inward and outward pressures incident to attachment and removal of a disposal container.

11. A device as in claim 10 wherein

said planar portion has openings therethrough, said openings being disposed within the outline of the inner end of said frame opening,

whereby, upon tensioning of the belt means, portions of the ostomate'"'"'s flesh will protrude through these openings, such protruding portions providing means preventing the insert and frame from shifting laterally relative to the ostomate'"'"'s torso, as well as providing lines of pressure concentration on the adhesive which deter shifting of the sanitary wafer relative to the ostomate'"'"'s skin surface.

12. A device as in claim 11 wherein

the frame has a circular outline and the frame opening has a "rounded square" outline at its inner end, and

the outer bounds of the openings through the planar portion are defined by the corners of the inner end of the frame opening and the inner bounds of these openings are spaced from and concentric with the central opening through which the wafer flange extends.

13. A device as in claim 12 wherein

bridges and connecting posts are formed integrally with the frame, said bridge being spaced outwardly from the outer end of the frame opening and generally outwardly of the outer surface of the frame, and

said belt means include belt portions provided with loops by which they are respectively secured to the bridges.

14. An ostomy device for stablizing the flesh of an ostomate, peristomally of the ostomate'"'"'s stome,

said device comprising a relatively rigid frame having a central opening terminating in a lip at the inner surface of the frame, the wall of said opening being angled outwardly from said lip to the outer surface of said frame,

said device being unobstructed from the inner end of said opening to the outer surface of the frame,

belt means attached to opposite sides of the frame, at points spaced outwardly from the inner surface thereof, for securing said frame to the ostomate'"'"'s torso with said opening registered with the ostomate'"'"'s stoma,

characterized in that

the inner, flesh engaging surface of the frame extends generally normal to said opening, peripherally of said lip and then curves outwardly towards the outer surface of the frame, whereby the belt means may be tensioned to draw the frame into the flesh of the ostomate to stabilize the peristomal region of flesh within the outline of said opening, without discomfort to the ostomate, and

the minimum span across the inner end of said opening is between about 2 and 4 times the nominal diameter of the ostomate'"'"'s stoma, whereby the stabilized region will be sufficiently large for body waste management and yet sufficiently firm for such purpose, and

the thickness of said frame, from its inner surface to its outer surface, is between about 15% and 25% of the minimum span of said opening at its inner end,

further characterized in that

the frame has bridges at its opposite sides which are supprted by posts in spaced relation from the outer surface of the frame, and

the belt means include belt portions provided with loops by which they are respectively secured to the bridges.