Surgery – Body inserted urinary or colonic incontinent device or... – Stoma closures
Reexamination Certificate
2001-08-09
2003-05-27
Hindenburg, Max F. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Stoma closures
Reexamination Certificate
active
06569081
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a disposable closure for a natural or artificial intestinal or urethral opening, e.g. an artificial or an incontinent natural opening.
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 therefore of necessity be 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.
Most often, the visceral contents therefrom are collected in bags but frequently problems occur with respect to contamination of e.g. a body side member of a two-piece appliance when substituting the collecting bag with a fresh, or the peristomal skin may be contaminated with the aggressive secretions from the stoma when substituting a one-piece appliance before applying a fresh appliance which may lead to improper adhesion to the skin and leaks.
Furthermore, faeces from an incontinent natural anal opening are sometimes collected by means of diaper-like appliances and also in this connection problems are encountered when substituting a used appliance with a fresh.
2. Description of the Related Art
DE-A-2 363 563 and its addition DE-A-2 447 682 as well as corresponding other specifications, e.g. GB-A-1 471 158, propose to close artificial intestinal openings with a magnetic plug held by a ring magnet surgically implanted around the portion of the intestine adjacent the surface of the body. A seal against unintended discharge of intestinal contents is provided between a plate shaped part of the plug and the skin, which necessitates a rather strong magnetic action which in many cases is uncomfortable and in adverse cases may cause some tissue necrotization. Closures of this type are not suitable for very fat patients, for patients having varying weight and for patients in which the outer part of the intestine is oblique relative the skin surface, because in these cases there are big difficulties in rendering the closure fluid-tight. Another type of closure has therefore been developed, namely a closure plug of a suitable soft, and possibly weakly elastic, material to be inserted into the part of the intestinal duct in question adjacent to the body surface. An example of such a closure is known from DE-A-2 717 608 and consists of a magnet or magnetic core surrounded by a tampon-like material which is expandable on insertion into the intestinal duct or the anus, the closure being meant for both an incontinent natural anus and for ostomies.
As the expandable material, there are proposed materials which expand under the influence of heat or moisture, e.g. cellulosic materials of largely the same kinds as those used in catamenial tampons. The core of magnetic material or the magnet co-operates with a ring magnet implanted in the tissue surrounding the outer parts of the intestine. An analogous closure without magnetic holding means is described in U.S. Pat. No. 4,209,009 according to which a closing tampon for an incontinent natural or an artificial intestine opening consists of an elongate substantially cylindrical body of a cellular material being non homogenous in the longitudinal direction. This body is formed of longitudinally aligned parts having different radial expansion properties when wetted, first and a third sections having high expansion characteristics when wetted and being separated by a second intermediate section having lesser expansion characteristics when wetted. A holding ring of non-expanding material is surgically implanted around the intestinal opening, and in use the second section of the tampon is situated within this ring.
A further example of this type of closure is described in DE-A-2 717 607. It has similar magnetic holding means as the closure according to DE-A-2 717 608 but the magnetic core is surrounded by a soft elastic, radially compressible material such as a foam plastic and that material is the proper closure means. None of these more or less tampon-like arrangements has achieved a broad acceptance. This is presumed to be due to the fact that the proper principle of closing depends upon the absorption of liquid into cellulosic material or foam material being of fundamentally the same kind as is used in catamenial tampons, and that the absorption of liquid in these is not always sufficiently rapid as to avoid leakage in the time immediately after the insertion. The pressure against the intestinal wall is low and the sealing consequently often unsatisfactory. In cases where the tampons have so large a diameter before insertion that the seal is actually obtained because of the shape of the tampon, insertion as a rule will be difficult because compression has to take place, and this may be accompanied by discomfort or pain and risk of damaging the intestinal wall because the surface of the tampon may not be smooth.
A closure in which the sealing effect relies upon absorption of liquid into an essentially inelastic material is not very suitable for intestinal use where the pressure behind it, caused for example by intestinal gas, will tend to expel the closure or allow not only intestinal gas but also other contents of the intestine to bypass the closure between the sealing and the intestinal wall.
EP patent No. 188 376 owned by applicant discloses a disposable closure for an intestinal opening comprising an elastic body which is held in a compressed state, prior to insertion, by a material which is sensitive to heat and/or moisture such that it ceases to hold the body in the compressed state after insertion of the closure into the intestinal opening so that the body expands under the effect of its elasticity to seal the opening. The closure disclosed in EP 188 376 is insoluble and may be provided with a string for use in removal from the intestine.
The closures of the art do not offer a solution to the problems encountered when it is desired to have a temporary closure of the stoma while substituting a used appliance with a fresh as they must be pulled out of the stoma after use which will be impossible or at least rather troublesome after applying a fresh collection bag.
It is therefore desirable to provide a disposable closure for an intestinal opening that does not have the drawbacks of the known closures and which may be used for temporary closing of an intestine without the risk of mechanical damage to the intestinal wall and which rapidly thereafter assumes a state in which it seals satisfactorily and prevents intestinal contents from passing the closure and which is easy to remove after use or which does not have to be removed due to solubility.
It is an object of the invention to provide a disposable closure for a natural or artificial intestinal or urethral opening preventing contamination of the area around an ostomy when exchanging a collecting bag, as such contamination will moisten the skin and impede the adhesion of the collecting bag to the skin, such bags normally being adhered using skin-friendly adhesives only adhering and sealing reliably around the opening when adhering to dry skin. Thus, an intermediate closure of such opening will minimise the exposure of the skin to the aggressive visceral contents and furthermore improve the wearing time of the collecting appliance.
It has now been found that the above drawbacks of known ostomy plugs may be overcome accord
Nielsen Inger Mann
Sletten Carsten
Von Bulow Martin
Coloplast A/S
Foreman Jonathan
Hindenburg Max F.
Jacobson & Holman PLLC
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