Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-08-21
2001-03-20
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S246000
Reexamination Certificate
active
06203526
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention pertains to instruments and methods for use in delivery of compositions, such as therapeutic fluids, through a tissue while minimizing exposure of the tissue to the compositions. More particularly, the invention pertains to treatment of a targeted tissue within an area of healthy tissue, and more particularly, to a multi-body apparatus and method capable of delivering compositions to a target tissue mass, such as, for example, a tumor, in the otherwise healthy tissue of a body organ, with minimum loss or exposure of the composition to the healthy tissue. The invention is particularly directed to multi-body apparatus capable of delivering compositions to a target tissue, such as brain tumor, while minimizing or preventing the exposure of healthy brain tissue to compositions that could potentially harm the healthy tissue.
DESCRIPTION OF THE PRIOR ART
In a method of treating a target tissue, such as, for example, a tumor, located within an otherwise healthy body organ, a composition in the form of a chemical, a therapeutic fluid, a dye, a contrast agent, a drug or a “cocktail” of chemicals, compositions and/or drugs, is delivered directly to the target tissue by injection.
Although this method is well suited for injection of fluid compositions, it will be understood by those skilled in the art that other compositions, such as, for example, viscous compounds, semi-fluids, or solids in granular or powdered form may also be injectable. Furthermore, the compositions may be injected in a liquid state and, after injection, solidify under the influence of body heat or by the application of an external energy source, such as, for example, microwave, radio frequency or electromagnetic energy. Alternatively, a solid or semisolid composition may be injected, and, after injection, liquify under the influence of body heat or an external energy source.
In this treatment method, after the location of the target tissue in an organ has been determined by MRI or other mapping or imaging method, a treatment apparatus having, for example, a needle or cannula capable of transporting a composition preferably in a fluid or semi-fluid state and having an opening at or near the tip for delivering fluid, is passed through healthy organ tissue until the tip opening is located within the tissue targeted for treatment, e.g. a tumor. A composition for treating the target tissue is transported from a reservoir at a proximal end of the treatment apparatus, through a needle shaft, and out through an opening at the distal tip of the needle. The fluid is delivered directly into the target tissue. This method has the advantage of localizing the treatment by specifically targeting tissue mass to be treated and is extremely successful in delivering the majority of the transported composition to the targeted tissue. The injection method is far less invasive than more radical treatments, such as, for example, surgery to remove tumor tissue, which can damage large amounts of healthy tissue. It also has advantages over traditional chemotherapy and radiology, which expose significant amounts of healthy tissue to side effects and possible damage.
This method of delivering a composition to a targeted tissue mass is particularly effective in treating brain tumors, since brain tissue is especially sensitive and susceptible to damage. For this reason, in the case of brain tissue treatment, needles are used which have a closed, rounded tip to minimize damage to healthy tissue and to prevent tissue from “packing” in the needle end. It will be understood by those skilled in the art that a variety of tips are also suitable, such as, for example, open tips, or pointed needle tips which are not “cutting” tips, etc. In addition to the particularly sensitive nature of brain tissue, certain types of brain tumors are known to have a high incidence of regrowth or recurrence. Patients with regrowing or recurring brain tumors may require multiple therapeutic treatments in the same location in the brain and, it is therefore desirable to keep to a minimum cumulative damage by multiple treatments. Thus, therapies for brain treatments in general need to be minimally damaging to healthy brain tissue.
Although the method of directly injecting fluids has been shown to be effective in specifically targeting and treating tissues, particularly in the brain, certain drawbacks are known. Compositions that are best suited to destroy tumor tissue are also known to negatively effect and possibly damage healthy tissue. And, although the method delivers the majority of the composition to the targeted tissue, some fluid may escape the shaft opening near the tip prematurely as it is being transported through healthy tissue to be located in the targeted tissue mass. Also, if the composition is injected under pressure into the target tissue, the fluid may not be absorbed quickly enough by the target tissue. If the fluid is not absorbed in the target tissue as quickly as it is injected, the fluid will seek a path of least resistance to escape the area of injection. The fluid may flow back along a track in the tissue. The track may be a pre-existing track in the tissue made by, for example, a diagnostic or other surgical instrument, or the track may be made by the treatment apparatus passing through the tissue. Alternatively, the track may be a naturally occurring lumen in the tissue, such as, for example, a vascular lumen, or may comprise an element of a guiding or positioning apparatus or device through which the treatment apparatus passes to reach the target tissue. The tendency for compositions to flow back along a track in the tissue, either while the treatment apparatus is in place or after the apparatus is withdrawn, will hereinafter be designated as “flow-back” or, alternatively, “retro-grade flow”. In the case of either premature escape of fluid or flow-back of fluid, the effects are the same: healthy tissue is exposed to composition and may be damaged, and doses of composition intended for treating the target tissue may fail to be absorbed by or delivered to the target tissue. The problems of premature escape and flow-back are amplified by the fact that some of the most desirable compositions are low viscosity liquids with low surface tension characteristics. Due to their low viscosity, these fluids are highly likely to leak from the apparatus prematurely and/or flow back along the track to effect healthy tissue.
In view of the above-identified advantages and disadvantages, the present invention is directed to an apparatus and injection method for minimizing the adverse effects of compositions on healthy tissue in the tracks of surgical devices by minimizing or preventing premature escape and migration or flow-back of compositions during treatment
OBJECTS OF THE INVENTION
It is an object of the invention to provide a device and a method for treating target tissues, particularly brain tumors, by injecting a composition into the target tissue.
It is another object of the invention to provide a device and method for treating target tissues by injecting a composition while minimizing damage to healthy tissue caused by exposure to the composition.
It is another object of the invention to provide a multiple shaft apparatus capable of delivering composition to a target tissue without prematurely leaking the fluid onto the tissue of a patient or other person.
It is another object of the invention to provide a multiple shaft device with means capable of preventing premature escape of a composition.
It is another object of the invention to provide an injection device with a means to prevent flow-back of composition along an apparatus track.
It is another object of the invention to prevent flow-back of a composition so that the composition is more effectively delivered to the targeted tissue.
It is another object of the invention to prevent composition delivered to a target tissue from flowing back into the apparatus by providing a means of sealing the composition out of the apparatus to ensure full delivery to t
DeCrescito Vincent
Kronenthal Richard
McBeth Dean M.
Darby & Darby
Direct Therapeutics, Inc.
Kennedy Sharon
LandOfFree
Apparatus for preventing loss of a composition during a... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Apparatus for preventing loss of a composition during a..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Apparatus for preventing loss of a composition during a... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2520297