Surgery – Means for introducing or removing material from body for... – Treating material applied to or removed from external...
Reexamination Certificate
2002-04-23
2004-07-27
Calvert, John J. (Department: 3761)
Surgery
Means for introducing or removing material from body for...
Treating material applied to or removed from external...
C424S447000, C602S048000
Reexamination Certificate
active
06767342
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is directed toward a bandage system and more particularly, toward a bandage which protects a wound yet also supplies oxygen to the wound.
Hyperbaric apparatus for the treatment of open wounds and lesions by applying a therapeutic gas such as oxygen thereto is generally known. See, for example, U.S. Pat. Nos. 5,154,697 and 4,801,291 to Loori. These patents describe various arrangements for the treatment of open lesions in wounds in a hyperbaric chamber with oxygen. This treatment promotes granulation, raises capillary blood oxygen levels, and elevates redox potential thereby suppressing bacterial growth and encouraging revascularization.
In Applicant's prior Patent Application WO94/21323, a topical hyperbaric bandage comprising a gas diffusion resistant flexible and/or resilient sheet material which includes an adhesive layer to be fixed to the skin is disclosed. The adhesive layer surrounds the treatment area. A release layer is disposed over the adhesive layer and means for supplying a therapeutic gas to the treatment area. The device is adapted to retain a single charge of a therapeutic gas over a treatment period.
Heretofore, the containment of oxygen with the exclusion of air has been difficult and has only been practicable in hospitals. However, the advantage of the arrangements discussed above is that they all allow for hyperbaric treatment at home. Yet, these devices are not all self-contained systems.
Hyperbaric oxygen treatment has been somewhat controversial in the past because of the problems with oxygen toxaemia. It has been found that relatively small superatmospheric pressures are effective to assist in revascularization as long as the treatment does not go on for too long. For example, treatments of many conditions for longer than four hours at one time may induce oxygen toxaemia and hence be counterproductive. The practice of flowing oxygen over a lesion for an indeterminate period was not only unnecessary, but clinically counterproductive.
Patent Application No. GB-A-2024012 discloses a two-part storable topical hyperbaric wound dressing which comprises a peroxy compound such as hydrogen peroxide and an agent for activating the hydrogen peroxide in order to produce oxygen. Both components are absorbed or disposed on juxtaposed sheets and rely on either moisture from the wound to achieve activation or from the crushing of microspheres of the initiator prior to assembly about the wound. The problem with this device is that the peroxy compounds are labile when not liquid. Although they may be absorbed on a particular material experimentally, storage in commercial conditions results in the peroxy compound deteriorating rapidly. This is particularly so at higher temperatures.
In Applicant's prior U.S. Pat. No. 6,000,403, a topical hyperbaric bandage comprising a reservoir for a source of therapeutic gas in liquid form is disclosed. Release of the gas from the reservoir is initiated after the bandage has been secured to the skin. This device is a further improvement over the prior art in that it is ready to use, easy to store, and is reliable.
A need still exists, however, for a device which is self-contained, comfortable, sterile, easy to use, and may be self-administered.
SUMMARY OF THE INVENTION
The present invention is designed to overcome the deficiencies of the prior art discussed above. It is an object of the present invention to provide a bandage which protects a wound yet allows oxygen to be introduced to the wound in order to treat it.
It is another object of the present invention to provide a self generating oxygen and containment system which can be used to bathe wounds with oxygen in most parts of the body.
It is yet another object of the present invention to provide a bandage which provides oxygen to a wound and can be self-administered.
It is a further object of the present invention to provide a bandage which is sterile and disposable.
In accordance with the illustrative embodiments demonstrating features and advantages of the present invention, there is provided a bandage with first and second sterile pads attached to a covering with an adhesive backing secured thereto. Pressure sensitive capsules containing hydrogen peroxide are embedded within the first pad. Covering the first pad and secured thereto is the second pad which has a bottom, wound contacting side and a top side which contacts the first pad. Secured to the top side of the second pad is a film containing potassium manganate. A release liner covers the pads and adhesive backing. In order to use the bandage, the release liner is removed. The bottom side of the second pad is placed over the wound and the adhesive backing is secured to the person's skin surrounding the wound. The hydrogen peroxide is released from the capsule by applying pressure thereto so that the hydrogen peroxide saturates the first pad. The first pad which is now wet is in contact with the second pad and film. The potassium permanganate is a catalyst which causes the release of oxygen from the hydrogen peroxide. Oxygen is now released to the wound.
Other objects, features, and advantages of the invention will be readily apparent from the following detailed description of a preferred embodiment thereof taken in conjunction with the drawings.
REFERENCES:
patent: 4801291 (1989-01-01), Loori
patent: 4909244 (1990-03-01), Quarfoot et al.
patent: 5106629 (1992-04-01), Cartmell et al.
patent: 5128137 (1992-07-01), Muller et al.
patent: 5154697 (1992-10-01), Loori
patent: 5792090 (1998-08-01), Ladin
patent: 5855570 (1999-01-01), Scherson et al.
patent: 6000403 (1999-12-01), Cantwell
patent: 6485736 (2002-11-01), Shirley et al.
patent: 2 024 012 (1980-01-01), None
patent: WO 94/21232 (1994-09-01), None
Calvert John J.
Lehrer Norman E.
Truong Linh
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