Surgery – Controlled release therapeutic device or system – Implanted dynamic device or system
Reexamination Certificate
1999-10-22
2001-06-12
Nguyen, Anhtuan T. (Department: 3763)
Surgery
Controlled release therapeutic device or system
Implanted dynamic device or system
C424S422000
Reexamination Certificate
active
06245057
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to a device for treating malignant, tumorous tissue areas, the device having at least one measuring sensor for determining chemical or physical signal patterns in the immediate vicinity of the tumorous tissue area, and having a control unit as well as at least one treatment assembly. The treatment assembly has at least one active agent supply container, a dosing element with dosing control, an active agent release element for chemical influencing and/or treatment electrodes for physically influencing the tumorous tissue area to be treated. The sensor(s), the active agent release element and the treatment electrodes are connected to the control unit for a physical and/or chemical treatment of the tumorous tissue area, the treatment being controlled as a function of the measured values of the tumor cells, with constant follow-up dosing of the active agent to be applied.
In cancer therapy, for example, it is already known to use chemotherapeutics, which should damage the pathogenic organ parts but, to the greatest extent possible, not the remaining organism. However, the systemic and regional dosing of chemotherapeutics is problematic since, on the one hand, a high effectiveness against a tumor, for example, is desired by using an appropriate active agent concentration, but, on the other hand, there is the danger of damage to the healthy tissue through non-specific absorption.
From the publication Brinton. J. B., “System to Detect and Treat Cancer Using Microwaves for Both Tasks,” Electronics, 26;42 (1979), a system for detecting and treating cancer is known. There, tumors are localized using microwaves and then destroyed. In particular, using a radiometer, the slightly raised temperature in the area of a tumor is used to detect the tumor. This involves a one-time, short-term overheating and destruction of the tumor. A treatment of this type can, of course, be performed for very small tumors, but for larger tumor areas this method cannot be used.
From German patent DE 196 01 487 a device is known for use in directly or operationally accessible areas. For areas which cannot be opened by operation, however, a device of this type cannot be used.
SUMMARY OF THE INVENTION
An object of the present invention is to create a device with which a target-oriented release of medication is possible, in which the burden and damage to the non-affected areas of the body are at least largely reduced.
To achieve this object, it is proposed that the device be constructed in the form of a capsule or dragee to be swallowed and that it have a sheath which at least covers the sensor(s). The sheath can be soluble (removable) at least over a certain area under the influence of bodily fluid. A sensor for detecting release parameters and the control unit are constructed with a threshold value switch for activating the active agent release element and/or the electrodes when exceeding a predetermined or predeterminable target value. For release of active agent within the active agent supply container, at least one heat resistor is provided for heating up and for release of active agent.
From PCT publication WO-A-94/01165 a capsule-shaped device is indeed known for release of medication. This device makes possible a controlled release of medication using a preprogrammed microprocessor. The beginning of the medication release is triggered by the contact of the capsule with gastric acid, for example. However, the medication release then proceeds according to a program that is prespecified prior to swallowing of the capsule. A change in the dosing in adaptation to the actual conditions is thus no longer possible.
Using the device according to the invention, in contrast, a target-oriented medication release can occur after an oral administration. Here, after the device is located in the area of a tumor or the like, which is to be treated, a medically active agent is applied to induce a chemical effect, and at the same time, in the immediate vicinity of the treatment location a constant monitoring during treatment is performed using the sensor(s). Based on the measured values, the dosing can be adapted according to the target value specifications of the control unit. Thus, an automatically operating control loop is formed, by which a constant follow-up dosing can be performed with the active agent to be applied.
In this control process, the active agent release is thus controlled during a chemical treatment and/or the intensity is controlled during the physical treatment as a function of a measured value. Thus, not only is a treatment triggered, but the treatment also proceeds by measurement of release parameters, for example the pH-value. This also means that when a threshold value is not reached, the treatment stops.
Thus, a target-oriented medication release and consequently a treatment in a selected manner is possible, since after the capsule is swallowed, the removal of the protective sheath occurs first, so that then the sensor(s) are exposed and are in a position to record specified release parameters. If the capsules in this activated condition comes into the area of malignant, tumorous tissue, then this is recognized using the pH-value, for example, and depending on the deviation of the pH-value from the standard pH-value in this surrounding area of the body, a chemical and/or physical treatment is performed in a controlled manner. When the capsule is transported further and emerges from the area of the tumorous tissue to be treated, the treatment is reduced and finally stopped.
The active agent release is accomplished by heating the active agent, wherein the active agent supply container preferably has at least one capillary tube for active agent release. This active agent release by heating the active agent can be performed in an especially simple manner, and requires almost no additional space and makes possible a quick and exact dosing. By the thermal effect of the heating resistor, the liquid expands and is released from the supply container in the direction of the support and contact area. The release of the active agent via the support and contact area can also be accomplished both iontophoretically as well as thermally via a suitable thermal micropump or a thermal valve.
Using the device according to the invention, a target-oriented medication release can also be carried out by oral ingestion for stomach and intestinal diseases, for example by a targeted alkali release or the release of another active agent.
Release parameters for the start of the treatment can be the pH-value, which is measured constantly, for example, and upon deviation from a prespecified value triggers the treatment, in particular by the release of active agent. Aside from the pH-value measurement mentioned as an example, a calcium measurement, an impedance measurement the like can be performed.
The device can be placed within the digestive tract without surgical intervention at prespecified locations, and a targeted treatment can be carried out there, or medications can be released in a targeted manner via the digestive tract.
With the sheath the capsule or the dragee is inactive prior to being swallowed, and it first becomes active when the sheath is dissolved. The sheath also practically forms a protective sheath, which is advantageous for longer storage prior to the treatment application.
For an exact positioning or activation of the device in a prespecified treatment area within the digestive tract, the sheath can be triggered especially in a time-dependent and/or substance-dependent manner by the bodily fluid. By various sheath materials and also by their wall thicknesses, the position of the device within the digestive tract can be prespecified to a sufficiently exact extent for its activation and also the point in time of activation. In the course of the digestive tract different digestive juices act on the sheath, so that by the targeted selection of the sheath substance, it can be determined under the influence of which digestive juice the activation of the device sho
Sieben Ulrich
Wolf Bernhard
Akin Gump Strauss Hauer & Feld L.L.P.
Micronas Intermetall GmbH
Nguyen Anhtuan T.
Thissell Jeremy
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