Method and apparatus for delivery of genes, enzymes and...

Surgery – Specula – Retractor

Reexamination Certificate

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Details

C604S105000

Reexamination Certificate

active

06461296

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to methods and apparatus for injecting treatment fluid into a body, and more particularly to a method for interstitially injecting treatment fluid including genes, enzymes, biological agents, etc., using a needle, guided to a target tissue of any body organ through use of minimally invasive endoscopic instruments or non-invasive imaging techniques.
2. Brief Description of the Prior Art
A variety of treatment fluids are currently known to be of benefit in treating illness in particular body parts. For example, there are a number of tumor suppressor genes, viral vectors, markers, vaccines, enzymes, proteins and biological agents that can be used for gene therapy and cancer treatment. The current method of delivery of these substances is to inject them into the blood stream through use of a conventional needle and syringe. The result is that the substance is carried by the blood to every part of the body. In many cases, it would be advantageous to be able to treat only a particular organ, or part of an organ.
Laparoscopic/endoscopic surgical instruments exist that allow a surgeon to see inside the body cavity of a patient without the necessity of large incisions. This reduces the chances of infection and other complications related to large incisions. The endoscope further allows the surgeon to manipulate microsurgical instruments without impeding the surgeon's view of the area under consideration. Although endoscopic surgical instruments are well developed and in use for surgical operations, an apparatus and method is not described or used in the prior art for delivering a treatment fluid interstitially to a precise target area within a body.
It is therefore apparent that there is a need for a method and apparatus that can deliver a treatment fluid to an interior localized body area.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide a method of injecting a specific treatment fluid to a localized interior body part.
It is another object of the present invention to provide a method of injecting treatment fluid to a localized body portion through use of an endoscopic surgical instrument.
It is a further object of the present invention to provide a method of injecting treatment fluid to a localized body portion by guiding a needle through the body to the localized portion by use of a non-invasive imaging device.
It is a still further object of the present invention to provide an apparatus for injecting treatment fluid to a target area in a body.
It is another object of the present invention to provide an apparatus for directing a needle tip to a target area in a body.
It is a further object of the present invention to provide an apparatus for non-invasive observation of needle position for guiding the needle to a target area, and for monitoring injection of treatment fluid.
Briefly, a preferred embodiment of the present invention includes a method and apparatus wherein treatment fluids, including genes, enzymes and biological agents, are injected into a target area of a body providing selective attachment to the specific target cells without affecting normal tissue cells. The method is used to treat prostate cancer, breast cancer, uterine cancer, bladder cancer, stomach, lung, colon, and brain cancer, etc. A hollow core needle is inserted into a body, the needle being visually guided by a selected imaging technique. A first embodiment utilizes an endoscopic instrument, wherein a probe is inserted into the body, guided by the endoscope to the vicinity of the target area. The hollow core needle is guided to the vicinity by a channel through the probe. A needle adjustment apparatus is used to extend or retract the needle and adjust needle tip orientation toward a target area. The endoscope provides a view to an operator for adjustment of the apparatus to extend the tip of the needle into and through tissue, interstitially, to a target area for deposit of the specific treatment fluid. A non-invasive imaging technique is used either alone, or in addition to the endoscope, to give an operator a view of the needle for guiding the needle tip to the precise target. area. Typical non-invasive techniques include CT scan, MRI, ultrasound, etc.
An advantage of the present invention is that it allows a lethal fluid to be injected into a tumor without seriously affecting the surrounding healthy tissue.
A further advantage of the present invention is that it provides a selective treatment of cancer cells, avoiding the need to inject toxic substances throughout a patient's body.


REFERENCES:
patent: 4854302 (1989-08-01), Allred
patent: 5073166 (1991-12-01), Parks
patent: 5122122 (1992-06-01), Allgood
patent: 5613950 (1997-03-01), Yoon

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