Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Light application
Reexamination Certificate
2000-07-21
2002-09-24
Dvorak, Linda C. M. (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Light application
C604S101040, C604S101050
Reexamination Certificate
active
06454790
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the invention
The present invention relates to the apparatus and method for necrotizing of the interior lining of an organ and more particularly for Barrett's tissue and other lesions of the gastrointestinal tract by PhotoDynamic Therapy (PDT) of the gastrointestinal mucosa (gastrointestinal tract lining).
2. Invention Disclosure Statement
The current state of the art for the treatment of Barrett's syndrome uses a Nd:YAG laser to treat the afflicted areas. (Ertan et al, Am. J. Gastro. 90:2201-2203[1995]). This method uses a 2.2-mm diameter beam ablate the afflicted tissue. With such a narrow beam as compared to the size of the area being treated, the treatment procedure becomes time consuming and laborious. Often the patient will have to undergo multiple procedures for a complete treatment. Also to achieve ablation of tissue, a laser with significant power must be used. This increased power creates a larger potential for damage to the healthy tissue underneath. This method does not reveal how to treat a larger area more quickly, efficiently and more safely.
One method of treating a larger area is demonstrated in U.S. Pat. No. 6,027,499. This method uses nitrogen gas to quickly freeze the afflicted areas. Gas by its nature expands to fill the volume exposed. This expansion increases the area exposed to treatment. The freezing then kills the cells contacted. However, this method is limited by the lack of depth control in the treating of the tissue. Freezing depth is difficult to control. It would be useful to have fine control on the layer of treatment, so as not to damage the unaffected non-cancerous cells in the intima of the esophagus.
Gels have been used to transfer medicines at a controlled rate or to insure transfer through a tissue of the medicine. (e.g. U.S. Pat. Nos. 4,474,752; 4,474,753; 4,478,822).
U.S. Pat. No. 4,474,752 utilizes a thermosetting gel, which gels at body temperature after injection into soft tissue. This liquid is injected into soft tissue where it gels. The gel state releases medication at a measured pace and remains in the injected area until dissolved by the body. The purpose of this invention was to create a slow release subcutaneous mechanism for medication without the discomfort of hard capsules. This invention does not reveal how to deliver medication internally to a site for sole treatment of that site.
U.S. Pat. No. 4,474,753, also utilizes a gel which solidifies on contact with the skin. This gel delivers medicine transdermally while it is attached to the skin. This is also a delivery system for medication for general release, not a site specific medication. It would be useful for a gel to release medication for a specific site.
U.S. Pat. No. 4,478,822 utilizes another gel system to be injected into body cavities for dose sparing purposes. This again is a general release mechanism designed for a prolonged period of controlled drug release. The medicines released are not meant just for the area where the gel has been injected.
It would be useful to have the capability to affect a broad area of treatment during the application of PDT, which will quickly necrotize only the afflicted area and efficiently use the photosensitizer. It would be further useful to have a delivery system for medication to affect one area or system of a body. The present invention addresses these problems.
BRIEF SUMMARY OF THE INVENTION
It is an object of the present invention to provide a treatment for Barrett's Syndrome using the application of photosynthesizer in a gel form, increasing the area which can be treated at one time and minimizing the use of photosensitizers, although reaching a higher concentration locally than it would have been achieved following a systemic administration.
It is another object of the present invention to provide a device to deliver the gel photosensitizer, activate the gel and localize the treatment to just the esophagus.
Briefly stated the present invention provides an apparatus and method for treating Barrett's tissue by removal of the mucosa through PhotoDynamic Therapy(PDT). A viscous gel is the medium used to carry the photosensitizer to the treatment site and allow sufficient time to transfer to the tissue. The gel's viscosity allows it to adhere to the tissue for a sufficient amount of time to transfer the photosensitizer or sufficient time for a mechanical device such as an expanding balloon to press the gel into the tissue. The photosensitizer within the gel is activated by the corresponding wavelength of radiation. An extended multi-balloon system limits the area of treatment and localizes the spread of the gel. An endoscope with fiber optics may be used to view the operation. A preferred embodiment of the apparatus contains a catheter with at least two balloons, one to block drainage of the photosensitizer into the stomach and one to limit the height of the treatment area and to press the gel into the tissue. Included in this embodiment is a tube for the delivery of the gel, a tube for cooling purposes or aspiration, an image bundle and a diffuse light source. The apparatus and method may be used to treat various other diseases involving the gastrointestinal diseases of the mucosa. The most salient feature of this invention is the multi-balloon system used to limit the area of treatment, but effect the entire desired area at one time.
The above, and other objects, features and advantages of the present invention will become apparent from the following description read in conjunction with the accompanying drawing, (in which like reference numbers in different drawings designate the same elements.)
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Neuberger Wolfgang
Thierry Patrice
BJ Associates
CeramOptec Industries Inc.
Dvorak Linda C. M.
Johnson, III H M.
Skutnik Bolesh J.
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