Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1999-12-20
2002-02-26
Weiss, John G. (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C604S327000, C604S331000, C604S337000, C604S338000, C604S355000
Reexamination Certificate
active
06350256
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a body fitting faecal management device. In particular, the present invention is directed towards faecal management devices with improved skin attachment means such that improved body fit and a tight seal is provided between the body of the wearer and the skin, thereby preventing contact between the faecal material and the urinary tract. The devices find particular utility for female wearers of such devices.
BACKGROUND OF THE INVENTION
Faecal management devices are known articles of manufacture that are designed to be worn principally by incontinence sufferers and infants. Such faecal management devices are attached to the anal region of the wearer and are intended to entrap and immediately contain faecal material and other bodily discharges. As a consequence, these devices are functionally effective in eliminating the problem of smearing on the skin of the wearer; in lessening epidermal irritation; in preventing contamination of articles such as clothing and bedding; and even in preventing the soiling of the carers themselves. Nevertheless, a problem often encountered during the use of such faecal management devices is that some of the faecal material can flow towards the urinary tract of the wearer in particular for female wearers into the sensitive urethra of the wearer. Typically, the presence of such faecal material can lead to a nasty infections in this area. Such a condition is most undesirable, painful and distressing to the bedridden wearer or to the infant.
Many articles exist on the market that allege the entrapment and immediate containment of faecal material in an effective manner. The prior art is rich with such examples. For instance, WO 96/19167 describes an absorbent article adapted to contain faecal material and highly fluidic material that is expelled at high velocity. The absorbent article comprises faecal containment members positioned transversely outward of the absorbent assembly, which function by interrupting the lateral movement of the faecal material. The faecal containment members are formed of resilient and porous materials to maintain and provide sufficient void volume to collect the faecal material, respectively. WO 94/14395 discloses a disposable absorbent article comprising a transverse partition disposed on the body facing surface of the topsheet and extending outwardly therefrom, to be upstanding and extend away from the plane of the disposable absorbent article. The transverse partition divides the absorbent article into a front portion and a rear portion, and presents an abrupt discontinuity between the two portions. Faecal material deposited in the rear portion is obstructed from longitudinally migrating to the front portion by the transverse partition. WO 97/01316 details a diaper with a bag for collecting faecal material and a urine collector for storing urine. The bag is formed by doubling over the diaper along a central imaginary line (perpendicular to the longitudinal sides of the diaper) and by drawing the edges (spaced apart from the central imaginary line) parallel to the imaginary line together. In such a manner, the faecal material is isolated from the skin of the wearer.
Japanese application JP 08-117 261 A discloses a diaper having a bag like structure, which is designed for incontinence sufferers. The bag comprises a slit or a hole in a position facing the anus with the slit or hole being surrounded by a surface coated with adhesive. The bag is formed of a water-repellent material. U.S. Pat. No. 3 577 989 details a disposable plastic elimination-rapping bag for incontinence sufferers. The flange is specifically designed and shaped such that it is generally convex at its curved rearward end while being generally concave at its forward end. In particular, for a female patient, the convex portion of the flange is adapted to closely follow the curved body contour and to fit between the cheeks of the buttocks and below and around the anus while the concave forward end portion of the flange is designed to closely follow the curved contour of the body of the patient above the vulva. Between the end portions of the flange are elongated side portions dimensioned to closely follow the curved body contour between the anus, cheeks and upper legs of the sufferer. EP 0 245 064 describes a faecal incontinence bag having flexible front and rear walls secured together around their periphery. The front wall has a hole for entry of the matter discharged by the wearer. The hole is surrounded by an adhesive pad of skincompatible water-resistant material secured to the external surface of the front wall. The pad is generally heart-shaped so that when in position the concave portion of the heart-shaped pad is towards the front of the wearer. For all the prior art cases, the faecal matter is not entirely contained in the bag of the faecal management device. It is known that some of the faecal material seeps forward from the anal region and creeps into the urethra.
Nonetheless, the need exists for a faecal management device that is extremely effective in completely isolating the faecal material from the sensitive urinary tract of the wearer. The present invention addresses this need by providing a projection at the front portion of the flange. It has been found that the presence of such a projection is uniquely advantageous and prevents the flow of faecal material out of the front portion of the flange towards the urinary tract. Furthermore, the presence of such a projection on the faecal management device causes no discomfort to the wearer, leads to a great reduction in infections and epidermal irritations derived from faecal material and results in a high level of wearer and carer satisfaction in relation to skin healthiness.
In another aspect of the present invention, the faecal management device with this projection can be advantageously used with a disposable diaper. The prior art is silent on such a combination. As described above, none of the prior art documents discloses two separate entities that work synergetically to isolate the faecal material from the sensitive organs of the wearer and which furthermore isolate the skin of the wearer from the absorbent material of the diaper.
SUMMARY OF THE INVENTION
A faecal management device constructed in accordance with the present invention comprises a bag having an aperture and an anatomically-shaped flange surrounding the aperture for adhesive attachment to the perianal area of the wearer. The anatomically-shaped flange is attached to the bag and comprises an outer periphery, an inner periphery adjacent to the aperture, a longitudinal centerline and a transverse centerline wherein the transverse centerline segments the flange into a front portion and a rear portion.
In particular, the flange comprises a projection in the front portion. The projection is disposed between the outer periphery and the inner periphery of the flange in a direction parallel to the longitudinal direction. Preferably, the projection extends from the outer periphery to the inner periphery and is disposed in a symmetrical manner. The projection has an effective height ranging from 0.5 millimeters to 15 millimeters, preferably from 2 millimeters to 10 millimeters, more preferably an effective height of about 3 to 7 millimeters. The projection is particularly beneficial for female wearers where the projection is are adapted to fit snugly between the vulva and the anus, i.e., the perineum of the female wearer.
In another aspect of the present invention, the present faecal management device is used in combination with a disposable diaper.
REFERENCES:
patent: 3577989 (1971-05-01), Anderson
patent: 3804093 (1974-04-01), Fell
patent: 4968312 (1990-11-01), Kahn
patent: 6168583 (2001-01-01), Tanji et al.
patent: 6168584 (2001-01-01), Allen et al.
patent: A 0 245 064 (1987-11-01), None
patent: 0 753 290 (1997-01-01), None
patent: 1 092 274 (1967-11-01), None
patent: 2 116 849 (1983-10-01), None
patent: 08 117261 (1996-05-01), None
D'Acchioli Vincenzo
Palumbo Gianfranco
Bogart Michael
Huston Larry L.
Lewis Leonard W.
Moore Jeffrey R.
The Procter & Gamble Co.
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