Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
2002-07-01
2004-03-23
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
06709422
ABSTRACT:
BACKGROUND ART
The invention relates to an ostomy bag of the kind that comprises a flexible wall having an opening for receiving a stoma, and a coupling for coupling the ostomy bag with a mainly annular implant fitted around the stoma. The implant has a circumferential groove along its outer part, and the coupling has the form of a spring ring with overlapping end parts shaped as handles arranged to open the spring ring when they are pressed together manually.
It is generally known to adhere ostomy bags to the skin around a stoma, e.g., a colostomy. Known ostomy bags can either adhere directly to the skin or, if desired, can be adhered to an adhesive disc provided with attachment means for the ostomy bag. The attachment means can have different designs.
U.S. Pat. No. 4,917,691 discloses ostomy equipment comprising an ostomy bag having a first coupling member and a second coupling member that is part of a device for being adhered around the stoma. The first coupling member has a collar with a lip for snap engagement with a deformable collar in the second coupling member. The coupling members are squeezed together and a ring with a ratchet lock serves for drawing the coupling members tightly together.
Ostomy bags with coupling devices based on similar principles are known from U.S. Pat. Nos. 5,269,773 and 4,685,990.
European patent application 853933 discloses another type of coupling that also comprises, respectively, a first coupling member on an ostomy bag and a second coupling member that is part of a device that is adhered around the stoma. These coupling members engage with each other through the action of an inserted locking ring. The locking ring has two handles that initially are pressing in a direction away from each other in order to reduce the diameter of the ring so that it can be put under catches on the adhesive coupling member. During mounting of the coupling member of the ostomy bag on the adhered coupling member, the diameter of the ring is forced to increase in order to, after mounting, spring back to form sealing between the surfaces of the coupling members. Such a locking ring cannot be used for mounting of its associated ostomy bag on an annular implant that completely lacks a correspondingly arranged second coupling member.
What these known ring coupling systems have in common is that they are composed of a coupling member adhered to the skin around the stoma, and a coupling member extending from the opening in the ostomy bag which is to receive the stoma. These coupling systems are therefore bulky and awkward for a patient to use, and a reliable fastening of a coupling member depends on prior careful cleaning of the skin to reduce the risk of leakage.
A considerable part of these disadvantages is remedied by the inventions according to the inventor's prior U.S. patent applications, including Ser. No. 09/103,919 and DK/PA 1999 01026, each of which is expressly incorporated herein by reference thereto. From these, implants are known for implantation in an animal or human body and comprising an inner part for fastening in the body, and an outer part extending outward from the body and serving for mounting of e.g., an ostomy bag, which can be detachably connected with the body via the implant.
The coupling means of ostomy bags mentioned above and applied so far can in a few cases be applied to couple the ostomy bag onto the implant but these coupling means are not directly designed for this purpose. The ostomy bag can therefore not always be coupled optimally onto the implant and can therefore not form a completely tight connection with it. For example, small differences in diameters of the coupling means cause a very loose coupling that cannot effectively ensure against leakage.
To couple the ostomy bag with the implant or to decouple the ostomy bag, it can furthermore be necessary to either twist and press the ostomy bag toward the implant or to pull at the ostomy bag, but these motions can cause malaise and inconveniences in form of pains or bleedings in the places where the implant is in contact with tissue.
Locking rings designed to ensure that the coupling means are pressed tightly together are often difficult to manipulate, and a locking ring can, in the cases where the locking mechanism of the lock ring cannot be released, have the very unfortunate consequence that the ostomy bag to be changed has to clipped or cut off the implant.
The present invention now overcomes the shortcomings of the prior art.
SUMMARY OF THE INVENTION
The present invention provides an ostomy bag of the kind mentioned in the opening paragraph. In a simple manner and without causing inconvenience to the patient who has had an implant implanted around a stoma, this ostomy bag can both be coupled onto an implant of the above kind to form a tight-fitting connection between the implant and the ostomy bag, and can be quickly and easily decoupled the implant in a similarly simple manner when the ostomy bag is to be changed.
The novel and unique features according to the invention, whereby this is achieved, is the fact that the spring ring is composed of a spring wire having, in a position of rest, a diameter that is smaller than the smallest diameter of the circumferential groove of the implant. It also has an edge reinforcement made along the opening of the ostomy bag which is formed by joining at least a part of the spring ring and an area of the wall of the ostomy bag, such that the edge reinforcement, upon coupling of the ostomy bag and the implant o a mounted position, serves for being received in the circumferential groove of the implant. Also, when manually pressed towards each other, the handles are provided and arranged to be able to open the spring ring at least so much that the diameter of the spring ring and edge reinforcement are each made larger than the largest diameter of the circumferential groove of the implant.
When the end parts of the spring ring overlap each other, these end parts can pass over each other slidably so that the size of the opening of the coupling easily can be changed, and easily can be taken in over a second coupling member, such as an implant.
A part of the spring ring and an area of the wall of the ostomy bag can be joined to form an edge reinforcement along the opening of the ostomy bag. This edge reinforcement can completely or partly surround the spring wire of the spring ring so that at least part of the spring ring is integrated inside in the ostomy bag.
The edge reinforcement can advantageously be formed from at least a part of the spring ring and an area of the wall around the opening of the ostomy bag so that this wall area is wrapped at least partly around the spring wire of the spring ring. Thus, upon joining of the ostomy bag and the implant, the edge reinforcement will be received in the circumferential groove of the implant.
By allowing the area of the ostomy bag wall, which together with the spring ring form the edge reinforcement around the opening of the ostomy bag, to extend over the entire periphery of this opening, the edge reinforcement can be pressed together so that the ostomy bag expediently can be guided down over the implant without the wall of the ostomy bag being damaged.
The spring ring has two handles made on the overlapping end parts of the spring ring and arranged to, when they are pressed together manually, open the spring ring at least so much that the diameter of the spring ring and edge reinforcement are each made larger than the largest diameter of the circumferential groove of the implant. This facilitates connection of the ostomy bag to the stoma or removal of the ostomy bag from the stoma.
When each of the end parts of the spring wire has a handle, the spring power in the spring ring can easily be overcome by pressing the handles towards each other with e.g., two fingers, in order to open the spring ring so that the opening of the edge reinforcement is made sufficiently large to be able to pass over the circumferential groove of the implant at mounting and decoupling of the ostomy bag.
The spring ring
Hessel Lasse L
Malling Jesper
Biotap A/S
Bogart Michael G.
Lo Weilun
Winston & Strawn LLP
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