In vivo micro-invasive investigation device including a metal guide

• US 8,969,010 B2
• Filed: 02/24/2009
• Issued: 03/03/2015
• Est. Priority Date: 02/26/2008
• Status: Active Grant

• Current Assignee: Biostems, Ltd.
• Original Assignee: Biostems, Ltd.
• Inventors: Benhamou, Albert-Claude, Pompidou, Alain
• Primary Examiner(s): LAM, ANN Y
• Application Number:
  US12/919,655
• Publication Number:
  US 20110092783A1
• Time in Patent Office: 2,198 Days
• Field of Search: None
• US Class Current: 435/7.1
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/6851 Guide wires

Abstract

The invention relates to an analysis device, wherein said system includes at least one metal guide at one end of which is provided at least one series of pits to which are directly coupled reagents specific to a substrate, said end being a perforating one, while the other end is intended for controlling said guide and is optionally associated with a suction system. The guide may be inserted into a protection system that is removable at the level of the functionalized end, up to the micro-analysis and/or micro-sampling site, and/or into a medical instrument having an inner channel in which said guide may slide. The present invention also relates to the use of such a device for making a tool for diagnosing cancer, an inflammation, an infection, a neurodegenerative disease or a graft rejection in a patient, preferably by transparietal delivery. The invention further relates to a method for the ex vivo analysis of a substrate using such a device.

Claims

1. An analysis device comprising:

a system for at least one of a micro-invasive and a micro-sampling investigation of a substrate, said system comprising at least one metal guide including;

a first extremity having a surface structured to define at least a series of wells to which are directly coupled at least one reactive group specific to said substrate, said first extremity being perforating, and

a second extremity intended for handling said metal guide.

2. A device according to claim 1, further comprising a removable protection system at the level of the first extremity.

3. A device according to claim 2, wherein said removable protection system is a flexible catheter.

4. A device according to claim 1, further comprising a medical instrument having an internal opening wherein said at least one metal guide can slide.

5. A device according to claim 4, wherein said medical instrument is selected from the group comprising a transparietal aspiration needle and/or an endoscope, inclusive of an endovascular navigation system.

6. A device according to claim 5, wherein said transparietal aspiration needle is a transcutaneous or transmucosal aspiration needle.

7. A device according to claim 1, wherein said at least one metal guide is selected from the group comprising one or several flexible solid metal butts and/or one or several hollow rigid metal butts having a diameter from 0.3 to 3.5 mm and a length from 5×

10<sup>−

2</sup> to 2 m.

8. A device according to claim 1, wherein said at least one metal guide is associated with a visual display system on at least one part of the length thereof.

9. A device according to claim 8, wherein said visual display system is an optical fibre.

10. A device according to claim 7, wherein said at least one flexible solid metal butt is an optical fibre at a first extremity of which a metal ring provided with at least a series of wells is associated, to which at least one reactive group specific to said substrate is directly coupled, with said first extremity of said optical fibre being perforating.

11. A device according to claim 1, wherein said at least one metal guide is constituted, as a whole or in part, of a metal alloy selected from the group comprising stainless steel, titanium-, nickel-, cobalt-based alloys or a mixture thereof.

12. A device according to claim 11, wherein said metal guide is constituted, as a whole or in part, of a titanium and nickel alloy.

13. A device according to claim 1, wherein said at least one metal guide is coated, except for the first extremity, with a protective polymer layer having a thickness of 2×

10<sup>−

3</sup> to 1 μ

m.

14. A device according to claim 1, wherein said at least one reactive group is specific to a substrate or an antigen specific of cancer, an inflammation, an infection, a graft rejection or a neurodegenerative pathology.

15. A device according to claim 1, wherein said at least one reactive group specific to a substrate is an antibody or a fragment of antibody selected from the group constituted of fragments Fab, Fab′

, F(ab′

)₂ and Fv.

16. A tool intended for diagnosing a cancer, an inflammation, an infection, a graft rejection or a neurodegenerative pathology such as Alzheimer'"'"'s disease, Parkinson'"'"'s disease or an amyotrophic lateral sclerosis, the tool comprising:

an endoscope,

a flexible catheter configured for insertion into the endoscope, and

at least one metal guide configured for insertion into the flexible catheter, each metal slide comprising;

a first extremity having a surface structured to define at least a series of wells to which are directly coupled at least one reactive group specific to said substrate, said first extremity being perforating, and

a second extremity intended for handling said metal guide.

17. The tool according to claim 16, wherein said at least one metal guide comprises a transparietal aspiration needle configured for diagnosing cancer, an inflammation, an infection, a graft rejection or a neurodegenerative pathology.

18. The tool according to claim 16, wherein said at least one metal guide and the flexible catheter cooperate so as to place the functionalized first extremity in contact with a micro-analysis and/or micro-sampling site.

19. The tool according to claim 17, wherein the transparietal aspiration needle is selected from the group consisting of a transmucosal aspiration needle and a transcutaneous aspiration needle.

20. The tool according to claim 16, wherein said at least one metal guide is associated with an optical fibre on at least a part of the length thereof.

21. A method for detecting ex-vivo a substrate existing in a tissue or an organ, comprising:

a) providing a device comprising a system for a micro-invasive and/or micro-sampling investigation of a substrate, said system comprising at least one metal guide including;

a first extremity having a surface defining at least a series of wells to which are directly coupled at least one reactive group specific to said substrate, said extremity being perforating, and

a second extremity intended for handling said metal guide;

b) incubating the functionalised first extremity of the device with a solution comprising at least one detection agent specific to said substrate when said first extremity is in contact with said tissue or organ to be examined; and

c) detecting said substrate.

22. A method according to claim 21, wherein said at least one detection agent of step b) is a possibly marked antibody specific to said substrate.

23. A method according to claim 21, wherein a step b′

) of incubation of said first extremity in a solution including at least one detection agent specific of the detection agent of step b) is interposed between steps b) and c).

24. A method according to claim 23, wherein said at least one detection agent of step b′

) is a marked antibody specific to the detection agent of step b).

25. A method according to claim 21, wherein a step of washing follows step b).

26. A method according to claim 23 wherein a step of washing follows at least one of step b) and step b′

).