Surgery – Instruments
Reexamination Certificate
2001-11-06
2003-10-21
Dvorak, Linda C. M. (Department: 3739)
Surgery
Instruments
C604S332000, C604S344000, C606S116000
Reexamination Certificate
active
06635050
ABSTRACT:
This is a nationalization of PCT/DK00/00223, filed May 3, 2000 and published in English.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a device for locating and marking the optimal position of an artificial intestinal or urethral opening, e.g. a stoma before the operation is carried out.
In connection with surgery for a number of diseases in the gastrointestinal tract a consequence is, in many cases, that the colon, the ileum or the urethra has been exposed surgically and the patient is left with an abdominal stoma. Such artificial intestinal openings or fistulae cannot be controlled at will and are therefore of necessity incontinent and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma. Such appliances may be two-piece or one-piece appliances. In both types of appliances, a body side member is attached to the wearer's abdomen, and optionally a receiving member or bag is attached to the body side ostomy member for receiving exudates from the ostomy in case of a two-piece appliance.
The quality of life for the patient after this kind of surgery is very much dependent on the placing of the stoma, which can be varied within limits determined by physiological criteria to take into account the patient's natural folds in the abdominal skin, etc.
2. Description of the Related Art
Determination of the site for placing the stoma is normally carried out prior to the operation by a nurse having experience in this field by observing the patient in different postures, e.g. sitting, standing and bending over, finding the less critical area and marking the position for placing the stoma on the patient's skin e.g. with a permanent marking ink.
This method, however, does only to a limited degree take into account the patient's preferred clothing style, position of optional belts, etc. Furthermore, the patient has very little chance of evaluating the consequence of the placing of the stoma, the more so, as the patient is only attentive to this situation on a theoretical level at this stage.
It is therefore desirable to provide a device which more clearly can illustrate to the nurse and the patient the consequences of different sitings of an ostomy and to enable the choice of siting which will give the least possible degree of discomfort.
It is an object of the invention to provide a device which can simulate the stoma in a chosen position, also representing the adhesive wafer and the collecting device, in a way that allows the normally dressed patient and the nurse to thoroughly test different positions of the stoma and evaluate the pros and cons of each position, thereby ensuring the optimal siting and hence, quality of life for the patient after surgery.
It would seem obvious to carry out this simulation with the adhesive wafers and collecting units intended for use by ostomates.
These products, however, are not suitable for repositioning, as the adhesives normally used for this purpose are designed to adhere strongly to the patient's skin over an extended period of time, thereby giving an undesirable pain when removed to be repositioned, which will inherently be a limiting factor to the number of trials accepted by the patient. Also, the adhesive forces of such products will deteriorate rapidly after the first removal for repositioning, thereby increasing the number of wafers necessary and hence, the cost of a thorough investigation.
It has now been found that the above drawbacks of known principles of preparation for operation may be overcome by providing a readily repositionable and reusable system for simulating the placement and physical configuration of the stoma and the collection system and for marking the optimum position of the stoma to be.
SUMMARY OF THE INVENTION
The present invention relates to an ostomy siting device for determining and marking the position of a possible stoma.
The ostomy siting device comprises a stoma simulating first element and a second element simulating an adhesive wafer of an ostomy appliance and an optional separately detachable collecting bag, having on the proximal surface an adhesive suitable for repeated adhering to and removal from the abdominal skin of an ostomate to be.
The invention furthermore relates to an ostomy siting device having a centrally placed hole or cavity, which may be communicating only with the proximal side of the adhesive disc. The cavity may contain a marking ink and may be provided with a valve to prevent unintentional marking of the skin, the ink may be confined in a separately mountable container, the proximal side of the cavity may be provided with a felt-like printing pad or the cavity may contain a transferable marking label.
Still further, the invention relates to an ostomy pi siting device having a centrally placed through-bore having a diameter suitable for centering and guiding a marking pen.
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Jensen Henrik Jessen
Olsen Eskil Hoejland
Olsen Hans
Coloplast A/S
Dvorak Linda C. M.
Jacobson & Holman PLLC
Ram Jocelyn
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