Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1999-10-29
2001-01-09
Weiss, John G. (Department: 3763)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
34
Reexamination Certificate
active
06171289
ABSTRACT:
The present invention concerns a novel device intended to prevent the risk of inadvertent detachment of an adhesive seal providing for the leaktightness of a colostomy.
PRIOR ART
In certain diseases such as cancer of the colon, it may be necessary to modify the natural course of the intestine and to perform a colostomy, that is to say establish an artificial outlet from the intestine through the abdomen wall, the orifice created being called a stoma and having to be connected to an exchangeable plastic ostomy bag. In practice, the plastic bag must be connected in a leaktight manner to the stoma and, in order to do this, use is made of an adhesive seal which is fixed directly on the patient's skin. This adhesive seal can be directly integral with the bag, which means that the whole assembly must be detached from the skin each time the bag is changed. A system made up of two parts is now more often preferred: a first part comprises the adhesive part to be fixed on the skin, integral with a joining device on which the exchangeable ostomy bag is fixed; this assembly allows the adhesive part to be left in place for several days, which limits the risks of skin irritation caused by repeated removal and fitting of an adhesive. However, there is the problem of knowing at what time it becomes necessary to change the adhesive seal; indeed the adhesive layer of the seal gradually loses its effectiveness until such time as the possible appearance of leaks with unpleasant consequences; it therefore seemed desirable to have a system capable of signalling the need to change the adhesive seal.
It is also known that the adhesive part of the device in direct contact with the skin is preferably an adhesive composition charged with hydrocolloid, the said adhesive composition charged with hydrocolloid being generally well tolerated by the skin in the case of long-term applications. Moreover, as the hydrocolloid is hydrophilic, it gradually absorbs the biological fluids present in the environment, which eliminates one of the causes of the deterioration in the adhesive power of the device as a whole.
Electrical or electronic devices are also known which are capable of detecting wetness in diapers and of signalling the need to change the diaper. For example, EP 810 847 describes an assembly comprising quite a large adjustable electrical circuit and a sensitive strip supporting two electrodes. The sensitive strip is arranged inside the diaper, while the means for processing the signals delivered by the electrodes are arranged in an articulated casing accessible from outside the diaper. After use, the wetness detection strip is removed from the casing and renewed. In order to avoid direct contact between the electrodes and the babies'skin, a permeable layer is applied on the electrodes. However, such a wetness detection device cannot be adapted to a device for securing an ostomy bag, if only because of the difficulty in positioning the detection support strip. Moreover, it is necessary to isolate the electrodes by specific means in order to prevent contact between the electrodes and the babies'skin.
OBJECT OF THE INVENTION
The object of the invention is to propose a technical solution for detecting a risk of leaks from the adhesive of an ostomy bag, the said leak resulting from an appreciable reduction in the adhesive power of the layer of adhesive composition.
SUBJECT OF THE INVENTION
According to the invention, a novel disposable device is proposed for securing an ostomy bag to a stoma created in a patient, of the type comprising means for joining the ostomy bag to an adhesive seal which is applied on the patient via a contact face, a through-passage communicating with the stoma being formed in the said adhesive seal, of which the contact face on the patient is at least partially covered by an adhesive composition containing a hydrocolloid dispersion, and wetness detection means, characterized in that the wetness detection means comprise at least two series of electrodes for measuring conductivity of the adhesive composition, the electrodes being lodged at least in part in the adhesive composition and not being in contact with the patient, and means for triggering an alarm when a predetermined level of wetness is reached in the adhesive composition.
DESCRIPTION OF THE INVENTION
The securing and sealing device according to the invention comprises an adhesive inner face intended to be fixed directly to the patient's skin, around the stoma, and another face provided with a mechanical joining means, able to receive an exchangeable bag.
The adhesive face is in the form of a disc provided, at the centre, with a through-passage, and it can be made up of a single type of adhesive composition containing a hydrocolloid dispersion. It can also be made up of a central disc whose inner face is covered by an adhesive composition of the type described above, surrounded by a peripheral ring whose inner face is covered by an adhesive composition not containing hydrocolloids and having a greater adhesive power than that of the central disc. The adhesive layer (simple or complex) is integral with a flexible support which ensures the connection with the joining means provided for securing the ostomy bag. According to the invention, this flexible support is provided with an electronic circuit capable of measuring the degree of hydration of the adhesive composition charged with hydrocolloids and of activating an alarm means when the degree of hydration of the said adhesive composition becomes greater than a predetermined threshold value, the said threshold value being calculated for a degree of hydration beyond which the adhesive power becomes insufficient to ensure satisfactory securing and sealing of the device.
In practice, a flexible support is used which is non-stretchable and does not conduct electricity, for example a nonwoven of synthetic material. The means for measuring the degree of hydration of the adhesive composition charged with hydrocolloids is composed essentially of two electrodes or electrode lines arranged separately within the thickness of the adhesive composition. These two electrodes are connected to a miniaturized electronic circuit powered by a battery or a cell and capable of measuring the conductivity between the two electrodes. The conductivity of the adhesive composition charged with hydrocolloids increases substantially in proportion to the degree of hydration of these hydrocolloids and, for a given formulation of the adhesive composition and a defined arrangement of the electrodes, it is possible to provide a conductivity value beyond which there is a risk of the adhesive composition no longer ensuring sufficient sealing and adhesion functions because it will have reached an unacceptable degree of wetness.
When this conductivity threshold is reached, the electronic device triggers an alarm means which warns the patient of the need to take action. This alarm means can be connected directly to the device and cause a periodic vibration which the wearer will be able to feel, or activation of a light emitting diode (LED) which the patient will be able to see when checking the device. The alarm means can also be in the form of a radio frequency transmission capable of activating a remote receiver, which can, for example, be combined with a watch which emits a light or acoustic signal.
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Millot Philippe
Tavernier Laurent
Evenson, McKeown, Edwards & Lenahan P.L.L.C.
Plasto SA
Thanh Loan H.
Weiss John G.
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