Chemistry: molecular biology and microbiology – Apparatus – Including measuring or testing
Reexamination Certificate
2002-01-30
2004-02-10
Horlick, Kenneth R. (Department: 1637)
Chemistry: molecular biology and microbiology
Apparatus
Including measuring or testing
C435S287300, C435S288100, C435S288300
Reexamination Certificate
active
06689603
ABSTRACT:
This invention concerns an apparatus making it possible to carry out by remote control an investigation and/or treatment in situ in a substrate, for example, of tissues or organs, consisting of a flexible rod, to one end of which an investigation and/or treatment microsystem is attached.
Investigation microsystems employing an array of biological molecules placed in given positions on a surface are described in the prior art. Those systems, known as “biochips” or DNA chips, are useful for the investigation of polynucleotide or amino acid sequences. Examples of such systems are described, for example, in the European patent applications published under No. 619,321, No. 373,203 and No. 691,978. Other investigation microsystems are, for example, the microanalysis tests using ligand/receptor type reactions or microimmunoanalyses using antigen/antibody type reactions.
Apparatuses for in vivo investigation of organs or tissues are also known in the prior art, such as a catheter consisting of a flexible tube inserted in the vessels or through the natural routes, associated, for example, with a laser, an optical fiber, a probe or a sensor. Those apparatuses can also make possible the administration of active substances like drugs or diagnostic agents, such as, for example, the apparatus described in U.S. Pat. No. 5,938,595.
The inventors have now designed a remote-controlled apparatus for analysis and/or treatment in situ combining the two technologies mentioned above. It appears useful, in fact, to have available new means of investigation and/or treatment in situ in a substrate of an organism in vivo or in vitro the least traumatizing as possible, particularly in the case of a human patient, and which makes it possible to access (i) information useful for diagnosis as well as for screening, for example, for therapeutic indications, or (ii) new methods of administration of active pharmaceutical agents directly in a substrate consisting, for example, of target cells.
This objective is attained according to the present invention thanks to an apparatus for chemical or biological analysis or treatment in situ comprising (i) a microsystem for investigation of a substrate and/or for delivery of active agents in a substrate and (ii) a flexible rod to one end of which the microsystem is attached and the other end of which is intended for the control of said microsystem, and in that, in the case of an investigation, the microsystem is not of the type based on analysis of the emission and detection of a fluorescent signal.
Said microsystem and said flexible rod are advantageously kept together in situ. Thus, according to the invention, said microsystem and said flexible rod remain joined to one another upon use in situ and are separated only before or after the operation in situ, so that the microsystem does not constitute a system implantable or releasable in situ.
In a first embodiment, the microsystem is of the type comprising a support on the surface of which predefined regions are arrayed, each containing different chemical or biological substances for investigation or treatment of the substrate into which the microsystem is brought in contact thanks to the flexible rod. Said surface contains at least two and preferably more than 100 and especially preferably more than 1000 predefined regions on a surface in the order of several cm
2
and preferably in the order of 1 cm
2
or less. Each predefined area contains a different chemical or biological substance, but the process according to the invention also allows several or even all of said predefined regions to contain the same chemical or biological substance, for example, in case of the same analysis or of delivery of the same active substance in time.
The support can contain several faces, at least one of which consists of an active surface. The latter is the site of one or more biological bonding agents. In the midst of said active surface predefined regions are arrayed.
This surface of approximately one cm
2
can be flat and is situated in a single plane, and it can also be ribbon-shaped and spiral-wound on a rigid support which extends the flexible rod and then presents the microsystem of the same nature as the previous one, but of a more elaborate configuration.
FIG. 1
represents a working example of an apparatus according to the invention, consisting of a flexible rod (
1
) like, for example, a deformable catheter, at the end of which the microsystem (
2
) is inserted in the opening of the flexible rod, the microsystem consisting of a support (
3
) on which a ribbon (
4
) is wound or specific antibiodies of an antigen present in the substrate analyzed are fixed. The support (
3
) is rigid, while the flexible rod (
1
) is relatively deformable. The flexible rod (
1
) can be combined with an endovascular exploration system (
5
) like, for example, an endoscope.
The apparatus of the invention can be combined with an endocavitary to endovascular exploration system making it possible to bring the microsystem in contact with or in proximity to the target substrate.
In a second embodiment, the apparatus of the invention can consist of a flexible rod, possibly combined with an endocavitary or endovascular exploration system. The latter ends in a microsystem consisting of an articulated segment composed of an alternation of rigid substances (platinum ball type) and of more or less hydrophilic gel (hydrogel) on which the reactive groups, molecules or substances are fixed. The active layer surrounding the rigid support can be a flat ribbon or a round cord on which the reagents are deposited and fixed. It can involve ligands and, notably, antigens or antibodies, but also nucleotides. Thus, in this embodiment the microsystem consists of a support coming in the form of a ribbon wound around one end of the flexible rod. An example of this embodiment is represented on
FIG. 1
of the attached drawings.
As previously indicated, each predefined area can contain the same active chemical or biological substance, for example, in case of the same analysis or of delivery of the same active substance reproduced in time. Each predefined area can also contain a different chemical or biological substance, and the microsystem then supporting a plurality of different chemical or biological substances is intended to carry out a multiple analysis.
The apparatus according to the invention is useful in:
the therapeutic field for in situ delivery of agents active in a substrate, and
the field of diagnosis for in situ analysis of a substrate.
In particular, the apparatus of the invention is useful for therapeutic applications conducted within the framework of guided therapy, as proposed for intracardiac gene therapy aimed at bringing autologous myeloid cells in situ after having evaluated with the endocavitary probe the state of the cell tissue of the myocardial area to be treated. This is with the aid of different systems and, in particular, of the microsystems of diagnosis or therapeutic follow-up of the invention.
Within the scope of the therapeutic applications, the biological and/or chemical substances arrayed in each predefined region of the surface of the microsystem are active agents, notably therapeutic substances. The active agents can be any substance useful in the treatment of diseases requiring an intervention in target cells or tissues, like cancer cells, centers of infection, etc.
Within the scope of the diagnostic applications, the biological and/or chemical substances arrayed in each predefined region of the surface of the microsystem are substances making it possible to detect specific analytes of the substrate where the microsystem is taken, or even radio-labeled substances making possible the remote display of the organ targeted by any known medical imaging technique.
Said substances can be fixed in each predefined region of the support either reversibly, in order possibly to be released again by the microsystem so that they may perform their function “in vivo”, after removal of said microsystem, or irreversibly on said surface. Fixation can be
Benhamou Albert-Claude
Pompidou Alain
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