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 9,186,265 B2
• Filed: 05/12/2009
• Issued: 11/17/2015
• Est. Priority Date: 05/12/2008
• Status: Active Grant

• Current Assignee: Hexacath Co.
• Original Assignee: Hexacath Co.
• Inventors: Ascher, Gilles, Valdesuso Aguilar, Raul M.
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US12/992,244
• Publication Number:
  US 20110264189A1
• Time in Patent Office: 2,380 Days
• Field of Search: 623/1.11, 623/1.34, 623/1.35, 623/1.12, 623/1.13, 623/1.14, 623/1.15, 623/1.23, 623/1.16, 623/1.17, 623/1.18, 623/1.19, 606/194, 606/198
• US Class Current: 1/1
• 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. An implantable medical device to be implanted at an implantation site, the implantable device having a substantially, radially expandable or deployable cylindrical body with a circumferential surface and defining a longitudinal axis, and comprising a proximal end, a central portion and a distal end, said implantable device being radially expandable or deployable between an unexpanded or undeployed position and an expanded or deployed position, said implantable device having a precise positioning means at at least one of the proximal end, and the distal end, said precise positioning means for positioning the implantable device at a precise point of a branching of a blood vessel, said precise positioning means consisting of one or two closed guide wire loops of a size adapted for the precise passage of a secondary guide or guide wire to be introduced into a secondary branch of said branching of the blood vessel, a main branch of which is reached by a stenosis to be treated, and said one or two closed guide wire loops are substantially located within the circumferential surface at least in said unexpanded or undeployed position;

the one or two closed guide wire loops adapted to be located away from a main blood vessel surface in the expanded or deployed position.

2. The device as claimed in claim 1, comprising two closed guide wire loops.

3. The device as claimed in claim 2, wherein the two closed guide wire loops are located substantially diametrically opposite.

4. The device as claimed in claim 1, wherein said device further comprises at least one lateral opening in the central portion and having a precise positioning means, the precise positioning means consisting of one or two closed guide wire loops located on an edge of the lateral opening and extending within a portion of the surface of the lateral opening and further substantially located within the circumferential surface both in said unexpanded or undeployed position and in said expanded or deployed position.

5. The device as claimed in claim 1, 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, of the distal end and of the central portion.

6. The device as claimed in claim 1, 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.

7. The device as claimed in claim 6, 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.

8. The device as claimed in claim 6, 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.

9. The device as claimed in claim 1, wherein said device is produced in a medically compatible metal or alloy.

10. The device as claimed in claim 9, 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.

11. The device as claimed in claim 1, wherein the device is essentially consisting of a stent coated with at least one coating layer that improves at least one property selected from its biocompatibility, its deformability, its mechanical resistance, and reducing the risk of restenosis.

12. The device as claimed in claim 1, 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.

13. The implantable medical device of claim 1, wherein the one or two closed guide wire loops comprises a shape selected from a circular shape, a ring shape, and an oblong or elongated shape.

16. The device as claimed in claim 5, comprising two closed guide wire loops.

17. The device as claimed in claim 16, wherein the two closed guide wire loops are located substantially diametrically opposite.

20. An angioplasty method of implanting the implantable medical device of claim 1, comprising:

a) obtaining at least one said implantable medical device according to claim 1;

b) mounting said implantable medical device on a balloon of at least one dilating catheter;

c) inserting the dilating catheter in at least one delivery catheter or guide catheter;

d) implanting in the main branch of a branching of a blood vessel at least one main guide or guide wire, and implanting in the secondary branch of the branching blood vessel at least one secondary guide or guide wire, said main branch comprising at least one stenosis 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, 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 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 through the closed guide wire loop into the secondary branch of the branching of the blood vessel;

f) precisely fitting 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; and

h) first removing the dilating catheter or the fitting system;

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

14. An implantable medical device to be implanted at an implantation site, the implantable device having a substantially, aradially expandable or deployable cylindrical body having a circumferential surface and defining a longitudinal axis, comprising a proximal end, a central portion and a distal end, said implantable device being radially expandable or deployable between an unexpanded or undeployed position and an expanded or deployed position, said implantable device having a precise positioning means at the proximal end, said precise positioning means for positioning the implantable device at a precise point of a branching of a blood vessel, said precise positioning means consisting of one or two closed guide wire loops of a size adapted for the passage of a secondary guide or guide wire to be introduced into a secondary branch of said branching of the blood vessel, a main branch of which is reached by a stenosis to be treated, and

said one or two closed guide wire loops are substantially located within the circumferential surface at least in said unexpanded or undeployed position;

the one or two closed guide wire loops adapted to be located away from a main blood vessel surface in the expanded or deployed position.

15. An implantable medical device to be implanted at an implantation site, said implantable device having a substantially, radially expandable or deployable cylindrical body with a circumferential surface and defining a longitudinal axis, comprising a proximal end, a central portion and a distal end, said implantable device being radially expandable or deployable between an unexpanded or undeployed position and an expanded or deployed position, said implantable device having a precise positioning means at the distal end, said precise positioning means for positioning the implantable device at a precise point of a branching of a blood vessel, said precise positioning means consisting of one or two closed guide wire loops of a size adapted for the passage of a secondary guide or guide wire to be introduced into a secondary branch of said branching of the blood vessel, a main branch of which is reached by a stenosis to be treated,

and said one or two closed guide wire loops are substantially located within the circumferential surface at least in said unexpanded or undeployed position;

the one or two closed guide wire loops adapted to be located away from a main blood vessel surface in the expanded or deployed position.

18. An implantable medical device to be implanted at an implantation site, the implantable device having a substantially, radially expandable or deployable cylindrical body having a circumferential surface and defining a longitudinal axis and comprising a proximal end, a central portion and a distal end, said implantable device being radially expandable or deployable between an unexpanded or undeployed position and an expanded or deployed position, said implantable device having at least one lateral opening located in the central portion, said at least one lateral opening having a precise positioning means located on an edge of the lateral opening and extending within a portion of the surface of the lateral opening, said precise positioning means for positioning the implantable device at a precise point of a branching of a blood vessel, said precise positioning means consisting of one or two closed guide wire loops of a size adapted for the passage of a secondary guide or guide wire intended to be introduced into a secondary branch of said branching of the blood vessel, a main branch of which is reached by a stenosis to be treated, and said one or two closed guide wire loops are substantially located within the circumferential surface both in said unexpanded or undeployed position and in said deployed or expanded position.

19. The implantable medical device of claim 18, wherein the one or two closed guide wire loops comprises a shape selected from a circular shape, a ring shape, and an oblong or elongated shape.