Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Patent
1991-11-07
1995-06-06
Green, Randall L.
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
383 67, 383 68, A61F 544
Patent
active
054218276
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
The field of the invention pertains to medical appliances and, in particular, to devices that can be attached to the exterior skin of a person about or in an opening with the purpose of accepting and containing any solid or liquid material flowing from the opening. Such devices require a means of attachment that does not damage the skin but is reasonably secure.
Lognion, U.S. Pat. No. 4,496,356, discloses an anal excretion collecting rectal catheter that is Insertable beneath the sphincter muscles about the opening. The Lognlon device comprises a collecting tube open at one end with a resilient ring that fits within the rectal opening.
Wade, U.S. Pat. No. 2,564,773, discloses a therapeutic agent comprising a thimble and latex bag insertable into a bodily opening for the collection of fluids. The bag folds within the thimble before use and may be attached to the thimble with an adhesive. The thimble includes an opening for the admission of fluids and Is directly insertable into the bodily opening.
Wayne, U.S. Pat. No. 2,448,938 and Swiss Pat. No. 113 453 each disclose a sanitary protective appliance of similar structure to receive bodily fluids and semi-solids from infections and incisions. The appliances comprise soft thin rubber tubes of accordion like shape with an opening of relatively large diameter. On the inside surface adjacent the opening is an adhesive ring to enable the device to be adhesively attached to the skin about the body opening from which there is a discharge.
Chen et al., U.S. Pat. No. 4,253,460 and Allen, Jr. et al., U.S. Pat. No. 4,650,817 both disclose adhesives suitable for attaching applicances such as ostomy devices to the skin about a body opening. Such adhesives must be secure, reasonably fluid tight but nevertheless easy to remove without damage to the skin.
U.S. Pat. No. 3,522,807 discloses an incontinence bag that has a pleated arrangement about the anus to expand and contract with the opening and closing of the anus. The overlapping leaves of the pleats do not provide for complete adhesive attachment to the skin thus permitting leakage and providing a difficult attachment.
U.S. Pat. No. 4,445,898 discloses a foam backed skin barrier attachment and incontinence bag. The skin barrier is disclosed as soft, pliable, stretchable and contractable foam backed plastic 0.080 to 0.400 inches thick. Plastic backed by foam has limited stretchability of less than 25% which limits the expandability of the anal hole in the skin barrier to an amount less than needed for most patients, in such cases, the anus can not open sufficiently thereby causing severe pain or the adhesive fails and the bag detaches and leaks.
Devices insertable within body openings have been found to cause permanent damage to the sphincter muscles after prolonged use. With a view toward overcoming and avoiding damage to the sphincter muscles of the anal opening but nevertheless providing a secure receptacle for bodily waste that does not damage the skin surrounding the anus, is sufficiently elastic (an elastic limit of about 200% or more) to accomodate the full opening of the anus and is easy to install the following described incontinence device has been developed.
SUMMARY OF THE INVENTION
The incontinence device comprises a generally tubular soft latex shape, tube or bag open at both ends but having a clip to retain the lower end partially folded up and closed. The upper end of the device is curved and tapered inward to the opening with the latex of minimal thickness, preferably 0.003 to 0.006 inches (0.076 to 0.152 millimeters), and coated on the outside with a suitable adhesive for contact with the skin about the anal opening. The latex is purposefully made as thin as possible to enable the latex to offer little or no resistance to stretching with the skin as the anus is fully opened and closed by the sphincter muscles. Soft latex of the above thickness has a better than 400% elastic limit.
A specifically shaped applicator is provided to enable a nurse or physician to easily apply th
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Green Randall L.
Jones Mary Beth
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