Endovascular system for the treatment of stenoses of the carotid and catheter for this system

• US 20040039331A1
• Filed: 06/24/2003
• Published: 02/26/2004
• Est. Priority Date: 12/03/1998
• Status: Active Grant

• Current Assignee: Gioacchino Coppi, Invatec S.P.A. (Medtronic Plc)
• Original Assignee: Invatec S.P.A. (Medtronic Plc)
• Inventors: Benedini, Roberto, Gardelli, Antonio, Coppi, Gioacchino
• Granted Patent: US 7,083,594 B2
• Time in Patent Office: Days
• US Class Current: 604/101.04
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter, in particular for endovascular applications, including a long and flexible, hollow, tubular body having an insertion end and a connection end intended to remain outside the body. The catheter includes in the insertion end at least two elements which are expandable/contractible by means of external operations. Those elements are located at a distance from each other, one upstream and the other downstream of a given section of a vessel. With the catheter it is possible to operate in the section between the two expandable elements and, if necessary, in the intermediate arterial branch which, on account of the two elements upstream and downstream, will have a zero flow.

Claims

1. Catheter in particular for endovascular applications, of the kind comprising a long and flexible, hollow, tubular body (1) having an insertion end (4) and a connection end (3) intended to remain outside the body, as well as, in the insertion end (4), at least two elements (9, 12) which are expandable/contractible by means of external operation and which are located at a distance from each other such as to be able to operate one upstream and the other downstream of a given section of a vessel, said expandable/contractible elements (9, 12) being adapted and/or being able to be adapted, with regard to their diameters in the expanded condition, to the diameters of the vessels (10, 210) inside which they are intended to be positioned, so as to block temporarily the circulation inside said vessel section,

characterised in that the two elements (9, 12) located at the insertion end (4) are inflatable/deflatable by means of supplying and discharge ducts (6,8) which are provided inside the thickness of the catheter wall.

2. Catheter according to claim 1, characterized in that it has a tubular shape (1) with a first larger diameter, provided on the outside with a first element (9) which is inflatable/deflatable by means of one (6) of the ducts provided in the thickness of the wall, whereas at least one other of the ducts (8) inside the thickness of the wall extends, after a certain length, into an extension (11) having a smaller diameter, substantially of the order of magnitude of the duct (8) and terminates in a second inflatable/deflatable element (12).

3. Catheter according to claim 1 or 2, characterised in that it comprises at least one additional duct (7) for a guide wire in the thickness of the wall, which emerges on the end side of the most distal end of the entire catheter, i.e. the distal end of the smaller-diameter extension (11).

4. Catheter according to claim 2., characterised in that said conduct (7) for the guide wire extends only in the distal portion of the catheter and has an opening (21) located between the inflatable/deflatable elements (9) and (12).

5. Catheter according to one or more of the preceding claims, characterized in that it has an additional central duct (2) for conveying treatment means (15, 16) necessary for operating in the vessel section affected by stenosis.

6. Catheter according to one or more of the preceding claims, characterized in that the length of the section comprised between the two inflatable/deflatable elements (9, 12) is generally of the order of a few centimetres to about 10 cm, substantially equivalent, for example, to the stenosis (14) of arterial vessels (10, 210) or the like or the length necessary for occluding a vascular trunk and an arterial bifurcation branch thereof, blocking the blood flow in the second branch.

7. Catheter according to one or more of the preceding claims, characterized in that the first greater external diameter is of the order of magnitude of 12-13 French (about 3.9 mm), preferably not greater than 14 French (4.2 mm) while the second smaller diameter is of the order of magnitude of 5 French (about 1.5 mm).

8. Catheter according to one or more of the preceding claims, characterized in that the connection end (3) has an end-piece (5) which is intended to remain outside the patient'"'"'s body, which end-piece (5) is provided with tubular connection elements (13) connected to the individual ducts (6, 7 and 8).

9. Catheter according to one or more of the preceding claims, characterized in that a catheter according to one or more of claims 1 to 8 is used to block the flow, towards the brain, of the internal carotid artery, inside which the stenosis (14) is present.

10. Use of a catheter according to claims 1-9, comprising the following steps:

insertion of the catheter inside the carotid artery via the femoral artery;

positioning of the catheter so that the end of the smaller-diameter extension (11) is arranged, with respect to the direction of the blood flow, in the external carotid (210) and the larger-diameter end is arranged inside the common carotid (10);

inflation of the two expandable/contractible elements (9, 12) via the two respective ducts (6, 8) provided in the thickness of the catheter wall;

operation on the stenosis of the internal carotid via insertion of the appropriate treatment instruments (15, 16) through the central duct (2);

aspiration through the central duct 2 of possible residues deriving from catheter expansion;

deflation of the two expandable/contractible elements via the two respective ducts (6, 8) provided in the thickness of the catheter wall;

final monitoring and extraction of the catheter and the guide wire.

11. Catheter according to any one of the previous claims, characterized in that said tubular body (1) and said extension (11) have a different flexibility.

12. Catheter according to claim 1, wherein the balloons 9, 10, when not inflated, are comprised within the profile of the catheter section onto which they are fitted.