Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
2000-02-25
2001-12-25
Lewis, Kim M. (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C604S332000, C604S336000, C604S342000
Reexamination Certificate
active
06332879
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an ostomy appliance, an ostomy appliance body side member, an ostomy sealing member and to a method of applying an ostomy appliance body side member around a stoma.
DESCRIPTION OF THE RELATED ART
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 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. Also in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening.
Ostomy appliances are well known. 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.
When using one-piece appliances, the whole appliance, including the adhesive wafer or pad securing the appliance to the skin, is removed and replaced by a fresh appliance. When using two-piece appliances, the body side ostomy member is let in place for several days, and only the receiving member or bag is replaced.
The service time of the body side ostomy member depends on the amount and aggressiveness of the exudates and of the tightness between the ostomy and the body side ostomy member.
In the known appliances it is necessary to change the body side member of a two-piece appliance when the center part of the adhesive wafer or pad had been sufficiently deteriorated to allow access of the aggressive exudates to the skin surrounding the stoma, irrespective of the fact that the wafer as such has a much longer wearing time. The access of aggressive exudates to the skin will cause skin problems.
Skin problems are common for persons having a stoma. Generally, about 40% have skin problems (Pearl et al. 1985 “Early local complications from intestinal stomas”, Arch. Surg. 120; 1145-1147) and the frequency is especially high for persons having a urostomy or ileostomy. About 80% of the persons having an ileostomy have skin problems (Hellman, J. D., Lago, C. P. 1990 “Dermatologic complications in colostomy and ileostomy patients”, International Journal of Dermatology, 29 (2); 129-133). The skin problems are more pronounced in a circular area about the stoma (½ inch from the stoma) (Hellman and Lago 1990).
Frequent changing of the body side member of a two-piece appliance or the frequent exchange of a one-piece appliance is undesirable due to the irritation of the skin and the quality of life may be improved and the nuisance of the wearing of an ostomy appliance reduced if the intervals between exchanging of the body side member can be increased.
It is known to place a ring on the skin before applying the body side member or to make a filling between the edge of the stoma and the shaped whole of the ostomy appliance in order to form a seal between the stoma and the ostomy appliance in order to alleviate the problems of using a commercially available medical grade adhesive paste. Such pastes are, e.g., sold by Bristol-Myers Squibb under the trademark Stomahesive® or by Coloplast under the trademark Coloplast® Paste.
These pastes, however, do not have a composition which has a sufficient cohesion to ensure safe removal thereof without leaving residues on the skin and, on the other hand, the pastes often are so sticky that they cannot easily be shaped using the finger without sticking to the finger. If using a paste, it should have a composition which is sufficiently tacky to secure the appliance or skin barrier to the abdomen and a cohesion ensuring safe removal thereof without leaving residues on the skin. On the other hand, the paste must not be so sticky that it cannot easily be shaped by a finger or hand without sticking to the hand. Furthermore, the paste must have a sufficient elasticity in order to be able to follow the movements of the patient without slipping on the skin and should also have a great resistance to erosion caused by aggressive exudates from an ostomy.
In GB Patent Application No. GB 2 290 974 is disclosed an ostomy appliance wherein a body-side member is combined with a moldable mass of non-hypoallergenic, non-memory putty-like adhesive, particularly based on a hydrocolloid or hydrogel. Thus, GB Patent Application No. GB 2 290 974 discloses a body-side ostomy member comprising a ring to which a bag-side coupling ring or a bag can be attached, the ring comprising a rib and a flange, the flange being mounted on a wafer of medical grade adhesive having a central whole of diameter of at least 65% of the internal diameter of the ring. A moldable mass of non-hypoallergenic, non-memory putty-like adhesive, particularly based on a hydrocolloid or hydrogel, is disposed radially inward of the wafer so that it forms a protective mass surrounding the stoma. The moldable mass has a thickness of 1.25-3 times that of the wafer and a central hole therein of a diameter no more than {fraction (1/10)} of the internal diameter of the ring. Both the medical grade adhesive and the moldable adhesive are adhered to the skin.
The moldable mass of non-hypoallergenic, non-memory putty-like adhesive or flexible patch disclosed in GB Patent Application No. GB 2 290 974 is secured to the rim of the hole for receiving the stoma and may be displaced to engage with the stoma. The ostomy appliance disclosed in GB Patent Application No. GB 2 290 974 suffers from the drawback that the moldable sealing material is only foreseen to be changed together with the body side member of the appliance.
Furthermore, there is only disclosed that moldable sealing material is to be disposed or extruded towards the stoma which still leaves a considerable risk of an insufficient sealing as a sufficient amount of sealing material must be disposed to form a cohesive layer of adhesive sealing against the stoma. Thus, there is still a need for a sealing against a stoma which ensures that no leaks occur at the rim of the stoma and at the same time avoids the risk of thin spots or holes in the adhesive layer next to the stoma which may give rise to lack of protection of the skin next to the stoma and lead to a shorter service time between exchange of the body side member.
U.S. Pat. No. 4,095,599 discloses an ostomy appliance comprising a body side member comprising an adhesive wafer or pad for securing the appliance to the user's skin, said wafer or pad having a hole for receiving a stoma, and an optionally separately exchangeable receiving member or bag secured to the body side ostomy member for receiving secretions from the ostomy.
It has surprisingly been found that it is possible to provide an ostomy appliance having a separate or integrated sealing member disposed in the hole of the wafer or pad surrounding the stoma offering a convenient and comfortable solution to the above problems and which at the same time enables a separation of the two functions, the sealing around an ostomy and the securing of a separately exchangeable receiving member or bag for receiving secretions from an ostomy to a body side ostomy member.
None of the above mentioned patents describe the use of a separate sealing member which may be exchanged or substituted separately.
This idea according to the invention differs from the above mentioned patents since the central ring (sealing member) in this case in some embodiments can be substituted without substituting the adhesive of a body side member which carries the bag and further more in that the adaptation of the ostomy appliance to the specific ostomy is rendered very simple and independent of the use of tools and in that
Ciok Danuta
Gothjaelpsen Laila Busk
Nielsen Inger Mann
Olsen Eskil Hoejland
Sletten Carsten
Coloplast A/S
Jacobson & Holman PLLC
Lewis Kim M.
LandOfFree
Ostomy appliance does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Ostomy appliance, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Ostomy appliance will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2561369