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
2003-12-02
Lo, Weilun (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
Reexamination Certificate
active
06656169
ABSTRACT:
This invention relates to an ostomy or incontinence pouch containing a pocket or capsule for release of an agent for affecting the contents of the pouch. For example, the agent may be a malodour counteractant for countering unpleasant odours (by chemical reaction, absorption or masking), or a disinfectant for reducing the harmfulness of the contents, or a preservative for slowing decomposition of the contents.
An ostomy pouch using rupturable container bubbles is known, for example, from U.S. Pat. No. 5,411,496. The bubbles contain a deodorising agent which is released by application of external pressure to rupture a bubble. The bubbles are attached to a carrier which is secured to the interior face of the front or rear wall of the pouch at the bottom of the pouch. However, the specification does not explain how the bubbles are attached, in practice, to the pouch walls.
A urine pouch using rupturable containers is known, for example, from U.S. Pat. No. 4,461,100. The containers contain disinfectant, and rupture in response to the application of external pressure. In one form, the containers are included within a seam of the pouch. Such a construction requires careful handling during manufacture, to ensure that a good seal is obtained in the seam around the containers, but without risking accidental pressure rupture of any containers. Such rupture would prevent the seam from being welded properly, and could also interfere with the welding machinery which would then have to be stopped and cleaned. In other forms, the containers are placed loose, or in a loose strip, within the pouch. However, such loose squeezable containers are not preferred by customers, since it can be difficult to find a mobile unruptured container simply by feel, and it may be difficult to hold a container stationary while applying sufficient pressure to rupture the container.
The present invention has been devised bearing the above problems in mind.
BRIEF SUMMARY OF THE INVENTION
In contrast to the prior art, one aspect of the present invention is to provide at least one capsule containing an agent for affecting the pouch contents, the capsule releasing the agent when the capsule is affected by environmental conditions within the pouch. For example, the capsule may be responsive to temperature and/or humidity conditions.
With the above technique, the capsule does not have to be ruptured by application of external pressure. Instead, the capsule can release the agent automatically in response to conditions within the pouch when the pouch is used. Such a capsule can provide a method of automatically releasing the agent into the pouch with very little manual intervention.
When the pouch is worn on the body, the temperature and humidity within the pouch typically increase, providing a warm, humid environment which can be used to trigger release of the agent.
The material may be of a type which dissolves, or thins, or becomes permeable to some extent, in the presence of elevated temperature and/or humidity conditions. Additionally, the capsule may have a construction which is responsive to the humidity and/or temperature conditions. For example, the capsule may consist of a plurality of shell parts which separate or become leaky at the joint between the shell parts.
The material may, for example, comprise gelatine. Additionally, or alternatively, the material may comprise a synthetic material. A capsule can be provided which is stable in relatively dry conditions at room temperature, but which releases the agent when subjected to the temperature and humidity conditions normally found in an ostomy or incontinence pouch when in use.
Preferably, the agent is in liquid form. This can provide good dispersion of the agent within the pouch when the agent is released from the capsule.
Preferably, the agent is water based. For example, the agent may consist of an aqueous solution of a malodour counteractant. For example, the malodour counteractant may be an oxidising agent, such as hydrogen peroxide.
The capsule may be loose in the pouch, or it may be secured or captively mounted within the pouch. If a loose capsule is used, then this might be introduced into the pouch by the user prior to fitting the pouch. Such a technique can avoid the potential manufacturing problems associated with producing pouches with one or more capsules installed within the pouch.
It will be appreciated that a loose capsule in accordance with the above aspect of the invention does not suffer from the drawbacks associated with the squeezable capsules of the prior art because the user does not have to locate, and squeeze, the capsule through the pouch wall.
In a closely related aspect, the invention provides a capsule introducable into an ostomy or incontinence pouch, the capsule containing an agent for affecting the contents of the pouch, the capsule comprising a material able to release the agent in response to temperature and/or humidity conditions.
A further aspect of the present invention is to mount one or more pockets (also referred to herein as “bubbles” or “capsules”) on or in a wall or wall segment positioned between the front and rear walls of the pouch, and attached to both the front and rear walls at a common weld seam between the front and rear walls, the pockets being clear of the weld seam.
This aspect can be used with the self-activating capsules of the first aspect, or with rupturable pockets which, in use, are squeezed by the user to cause the pocket to rupture and to release the agent into the pouch.
Such a construction can permit the pockets or capsules to be fixed in position relative to the front and rear walls, without risking accidental rupture of the pockets during welding, and without compromising the seal strength of the seam. Furthermore, the wall carrying the pockets or capsules can be welded during the same welding operation for securing the front and rear walls together. Therefore, no additional welding steps are required.
Another closely related aspect is to provide, in an ostomy or incontinence pouch, an internal wall to shield, at least to some extent, the stoma or entrance aperture from direct contact with the agent released from a pocket or capsule during release.
For example, the wall may be a curtain which extends over the aperture. Additionally, or alternatively, the wall may be a curtain which extends over the pocket or capsule.
The agent contained in the pocket or capsule will normally be in concentrate form, and it can be highly undesirable for the concentrate to directly contact the ostomate's sensitive stoma. For example, the concentrate may cause very unpleasant irritation of the stoma.
With a shielding wall as defined above, the sensitive stoma can be protected. This can allow even stronger concentrates of agents to be used. It will be appreciated that, once the agent has dispersed into the pouch, there is less risk of stoma irritation. Nevertheless, the shielding wall can provide excellent protection during initial release of the agent when the concentration is at its strongest.
It will be appreciated that the ostomate may rupture a rupturable pocket either before fitting the pouch, or after fitting the pouch. In the former case, the shielding wall provides a further advantage in preventing the agent from accidentally spurting out through the stoma aperture as the pocket is “popped” open. Such spurting is highly undesirable, as it may result in the agent landing on the ostomate's skin, or clothes. For example, if the agent is a concentrated deodorising agent, it may have a very pungent odour which would be difficult to wash away from clothes or from the skin, and would be very embarrassing.
The use of a shielding wall can also allow the safe use of a pocket or capsule on or in a wall of an ostomy pouch and clear of a peripheral seam of the pouch, the pocket or capsule being positioned closer to the pouch stoma aperture than to the lowermost point of the pouch when in its normal orientation.
Such an arrangement can provide two advantages. Firstly, the elevation of the pocket(s) or capsules
Bogart Michael G.
Bristol--Myers Squibb Company
Krieger Stuart E.
Lo Weilun
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