IMPLANTABLE MEDICAL DEVICE HAVING A MEANS FOR POSITIONING IT AT THE PRECISE SITE OF A BRANCHING OF A BLOOD VESSEL SUCH AS A CORONARY ARTERY

• US 20110264189A1
• Filed: 05/12/2009
• Published: 10/27/2011
• Est. Priority Date: 05/12/2008
• Status: Active Grant

• Current Assignee: Hexacath Co.
• Original Assignee: Hexacath Co.
• Inventors: Valdesuso Aguilar, Raul M., Ascher, Gilles
• Granted Patent: US 9,186,265 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

The invention relates to an implantable medical device.

This implantable medical device (10) to be implanted at an implantation site comprises a proximal end (P), a central portion (C) and a distal end (D), characterized in that it comprises, at its proximal end (P), at least one means (20) for positioning the implantable device (10) at a precise point of a branching (E) of a blood vessel (V), such as a coronary artery.

The invention provides precise, exact and almost perfect positioning of the implantable medical device 10 such as a stent 11 at the branching E of the blood vessel V to be treated, in order to treat the ostial lesions or stenoses that have been very difficult to treat until now.

Claims

1-11. -11. (canceled)

12. An implantable medical device to be implanted at an implantation site comprising a proximal end (P), a central portion (C) and a distal end (D), comprising at at least one of the proximal end (P), the distal end (D) and the central portion (C), at least one positioning means for positioning the implantable device at a precise point of a branching (E) of a blood vessel (V) comprising a closed mesh defining an orifice for the passage of a guide or guide wire intended to be introduced into a secondary branch of said branching (E) of the blood vessel, a main branch (V1) of which is reached by a stenosis to be treated.

13. The device as claimed in claim 12, wherein the at least one closed mesh of the positioning means comprises a circular or ring shape, at said proximal end P.

14. The device as claimed in claim 12, comprising two closed meshes.

15. The device as claimed in claim 14, wherein the two closed meshes are located substantially diametrically opposite.

16. The device as claimed in claim 12, wherein the positioning means comprises at least one closed mesh defining an orifice, produced at the distal end (D).

17. The device as claimed in claim 16, comprising two closed meshes.

18. The device as claimed in claim 17, wherein the two closed meshes are located substantially diametrically opposite.

19. The device as claimed in claim 12, wherein the positioning means is located in the central portion (C) and comprises at least one closed mesh defining an orifice for the passage of a guide or guide wire.

20. The device as claimed in claim 12, further comprising reinforcing means for reinforcing the device structure, thereby resulting in no substantial deformation of the implantable medical device when using a guide or guide wire exerting an action on at least one of the proximal end (P), of the distal end (D) and of the central portion (C).

21. The device as claimed in claim 12, which consists essentially of a stent or endoprosthesis comprising one or more filament elements configured with bends or zigzags, resulting in a form selected from an annular turn form, an helical turn form, and a combination of both.

22. The device as claimed in claim 21, further comprising structure reinforcing means comprising one link or several links between successive zigzags or bends of the proximal end (P) of the stent or endoprosthesis.

23. The device as claimed in claim 21, wherein at least some of the adjacent bends or zigzags of successive turns are provided with one or several link arms ensuring continuity of the device from the proximal end to the distal end.

24. The device as claimed in claim 12, wherein said device is produced in a medically compatible metal or alloy.

25. The device as claimed in claim 23, wherein said medically compatible metal or alloy is selected from the group consisting of nitinol, a cobalt-based metal or a cobalt-based alloy, a medically compatible steel, and a 316L steel.

26. The device as claimed in claim 12, wherein the device is essentially consisting of a stent coated with at least one coating layer that improves at least one property selected from biocompatibility, deformability, mechanical resistance, and reducing the risk of restenosis.

27. The device as claimed in claim 12, wherein the device is essentially consisting of a stent comprising several filament elements with bends or zigzags in the form of successive annular turns, at least some of which adjacent bends or zigzags are provided with one or several link arm(s) ensuring continuity of the device from the proximal end to the distal end.

28. An angioplasty method of implanting the implantable medical device of claim 12, comprising:

a) the provision of at least one said implantable medical device or endoprosthesis as described in claim 12;

b) the provision of at least one dilating catheter on the balloon of which is mounted said implantable medical device;

c) the provision of at least one delivery catheter or guide catheter in which the dilating catheter is inserted;

d) the provision of at least one main guide or guide wire, and at least one secondary guide or guide wire, said main guide wire being provided for implantation in the main branch of a branching of a blood vessel, which comprises at least one stenosis to be treated, the secondary guide or guide wire being intended to be implanted in the secondary branch of said blood vessel, in which there is no restenosis to be treated, said stenosis to be treated being situated in immediate proximity to the branching of said blood vessel, called an ostial lesion;

e) using said guide catheter and the dilating catheter, on the one hand, the fitting of the implantable medical device in the vicinity of the branching of the blood vessel whose main branch includes the stenosis to be treated, and on the other hand the fitting of each of the two respectively main and secondary guides being careful to ensure that the main guide guiding the implantable medical device penetrates into the main branch and that the secondary guide penetrates into the secondary branch of the branching of the blood vessel;

f) the precise fitting of the implantable medical device at the branching itself, by exerting a push on the main guide or guide wire toward the distal end, the secondary guide or guide wire forming a stop abutment against the edge of the branching of the blood vessel;

g) the deployment of the implantable medical device to apply it firmly against the wall of the blood vessel including the ostial stenosis;

f) after deployment of the implantable medical device, the dilating catheter or the fitting system is first removed;

then, the respectively secondary and main guides or guide wires and finally the guide catheter are removed.