Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-05-17
2004-04-13
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S027000, C604S093010, C604S506000, C604S522000, C604S028000
Reexamination Certificate
active
06719738
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a device intended to deliver an active substance directly within all or some of a human or animal cell tissue. It also relates to the means of implanting this device within the tissue, and to the appliances intended for injecting active substance into said device.
In the remainder of the description and in the claims, the expression “active substance” will be used to denote any chemically or physically active substance and, more broadly speaking, any substance capable of being introduced into the organism whether for diagnostic, therapeutic or even cosmetic purposes.
Likewise, the expression “human or animal cell tissue” will be used to denote any organ or part of an organ.
BACKGROUND OF THE INVENTION
In the context of cancer treatments using ionizing radiation, there are a number of solutions which have been proposed with a view to concentrating the active principle in the cells of the patient that are to be treated while limiting the destruction of healthy cells.
Document WO 97/18011 has thus proposed an installation for concentrating an active principle associated with magnetic vectors in the cells of a patient that are to be treated. The installation employed is capable of creating a focused magnetic field gradient and then, by increasing the strength of the magnetic field, of causing the magnetic vectors to switch from the non-magnetized state to the magnetized state so as to cause a lasting aggregation thereof in the area of the cells that are to be treated.
However, even though this installation makes it possible to limit, or even to eliminate, the irradiation of healthy cells, it is nonetheless cumbersome to implement.
Also proposed, in document JPS Volume 71, number 4, April '82 (page 382) a method which consists in injecting, by an arterial route, an active principle associated with magnetic vectors subjected to an external magnetic field, which is then focused on the cells that are to be treated. However, it is found that a significant proportion of the magnetic vectors aggregate and remain trapped in the vessels of the circulatory system, thus irradiating a great many healthy cells.
Still in the context of cancer therapy, cancer cells are advantageously treated with heat, in addition to the conventional active principles, inasmuch as heat has an immediate cytolytic effect on said cells. In practice, the cancerous cells are heated up using a microwave treatment. This therapy thus makes it possible to raise the temperature in a localized way and thus give rise to hyperthermia.
Heat treatment is also employed for stopping hemorrhaging, particularly hemorrhaging likely to arise during surgical operations, and thus cause hemostasis. In practice, hemostasis is obtained by electro-coagulation by means of an electric lancet.
The problem of concentrating the active principle in the cells that are to be treated is not restricted to cancer treatments, but also relates to a good many other therapies whether these be chemotherapies, antibiotic therapies, etc.
Document U.S. Pat. No. 5,569,197 proposes concentrating an active principle via an endolumenal route at atheroma plaques formed on the internal walls of the arteries. The device employed corresponds to a tube made of a material said to be “superelastic” with outside diameter greater than 250 micrometers, advantageously 360 micrometers, and of which the walls at the distal end of said tube have perforations. Furthermore, the distal end of the tube is open and can be equipped with a filament which itself has an opening intended to deliver the active principle. The supple filament has the function of guiding the tube in the small vessels. The active principle, being in liquid form, is delivered exclusively to the atheroma plaques by infusion at a pressure not exceeding 4 atmospheres, that is to say slightly higher than 4 bar.
First of all, the device described in that document makes it possible to obtain a therapeutic effect only in vascularized organs, insofar as the device proposed is used exclusively by an endolumenal route. In addition, the active-principle concentration in the area to be treated is raised only temporarily, the remainder of the active principle diffusing through the organism.
In other words, the first problem that the invention sets out to solve is that of providing a device capable of delivering an active substance to any organ whatsoever.
A second problem that the invention sets out to solve, is that of providing a device capable of allowing a homogenous release of active substance in situ exclusively in all or some of the cell tissue that is to be treated, without any diffusion into the organism.
Another problem that the invention sets out to solve is that of providing a device capable of dispensing any type of active principle whether this be a chemical active principle or a physical active principle, and in any form whatsoever—liquid, solid or even vapor.
In order to do this, the present invention proposes a device capable of delivering an active substance directly within all or some of a human or animal cell tissue.
SUMMARY OF THE INVENTION
This device is characterized in that it is in the form of a hollow tube, of which the walls in contact with said tissue are equipped with at least one perforation, and of which the distal end is plugged, while the proximal end is shaped in such a way as to accommodate removable closure means, said tube being capable of withstanding a pressure of at least 50 bar.
In other words, the idea that the Applicant has had is to deliver an active principle not via an endolumenal route, but directly to the cell tissue by injecting said active principle into a target area at a high pressure of at least 50 bar, making it possible to obtain maximum effect, including into the thickness of the tissue.
Faced with this problem, the Applicant developed a device capable of withstanding a high pressure allowing the active principle to be injected directly into the tissues to a depth that varied according to the pressure used. Furthermore, and given the high pressure, the device can have active principles in liquid, solid or even vapor form passing through it.
In practice, the perforated walls of the hollow tube are positioned at the target organ to be treated, while the remainder of the tube connects to the outside of the organism, the tube thus remaining in position for the duration of the treatment. In consequence, the tube via its proximal end receives the active substance that it delivers via its perforations exclusively to the tissues that are to be treated.
As will be explained later, the active substance has to be given sufficient energy that it can be propelled through the perforations, then effectively penetrate the tissues that are to be treated.
At the same time, the tube must retain a certain suppleness to make it easier to install within the organism and, more particularly, at the tissues.
In order to satisfy these requirements, the choice of the diameter and of the thickness of the tube are the result of a compromise between said tube being supple, and its being able to withstand pressure and resist stretching.
When a chemically active substance is to be injected into the tissues, the pressure may reach 3 000 bar or even 10 000 bar if the desire is to inject a powder.
In a first embodiment, in order to withstand such a pressure while at the same time maintaining a certain suppleness, the outside diameter of the tube is between 100 and 250 micrometers, while the inside diameter of the tube is between 50 and 150 micrometers.
For an outside diameter greater than 250 micrometers, it is necessary to increase the thickness of the tube in order to withstand the pressure, which means that the flexibility disappears. By contrast, for an inside diameter smaller than 50 micrometers, the loss of energy of the active substance as it travels down the tube is too great, which means that the active substance cannot be propelled into the tissue that is to be treated.
Advantageously, the outside diameter of the tube is equal to 200 mi
Casler Brian L.
Heslin Rothenberg Farley & & Mesiti P.C.
Maynard Jennifer
Pietrangelo John
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