Device for replacing a cardiac valve by percutaneous route

• US 6,830,584 B1
• Filed: 11/26/2002
• Issued: 12/14/2004
• Est. Priority Date: 11/17/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Original Assignee: Jacques Seguin
• Inventors: Seguin, Jacques
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/130,355
• Time in Patent Office: 749 Days
• Field of Search: 623/2.11, 623/3.15, 128/898, 606/150, 606/153, 606/151
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

Abstract

A device for replacing a cardiac valve includes an elongated support element (2), two series of elongated blades (30) arranged around the circumference of the elongated elements (2), where the blades (30) have opposite cutting edges (30a, 30b) and can be extended corolla-shaped such that their cutting edges are set in the extension of one another thereby forming circular cutting edges. The blades (30) can be brought closer together so that their circular cutting edges are urged to cut the native valve (55, 56) so as to separate it from the corporeal duct (50).

Claims

1. A device (1) for replacing, via a percutaneous route, a heart valve (55, 56) located in a bodily vessel (50), characterized in that it comprises:

an elongate support element (2);

a first series (11) of elongate blades (30) arranged around the circumference of said elongate element (2);

these blades (30) are pivotably connected to said elongate element (2) at their proximal longitudinal end and each have a cutting edge (30a) at their distal longitudinal end;

said blades (30) capable of pivoting with respect to said elongate element (2) between a furled position in which they are near to the wall of the elongate element (2) so that they do not impede the introduction and sliding of the device (1) into and in the bodily vessel (50) in which a valve (55, 56) is located, particularly within the aorta, and an unfurled position in which these blades (30) are deployed into a corolla in such a way that their cutting edges (30a) are placed in the continuation of one another and thus constitute a circular cutting edge;

a second series (12) of blades (30) which is arranged after said first series (11) of blades in the distal direction;

the blades (30) of this second series (12) of blades have a structure identical to that of the blades (30) of said first series (11) of blades except that these blades (30) of this second series (12) are connected to said elongate element by their distal longitudinal end and each have a cutting edge (30b) at their proximal longitudinal end;

means (31) for bringing the blades (30) of said first and second series (11, 12) of blades from a furled position to an unfurled position;

means (6, 7) for moving said series (11, 12) of blades axially toward one another, between a position in which these series (11, 12) of blades are away from each other and in which one series (11) of blades can be placed axially on one side of the native valve (55, 56) while the other series (12) of blades is placed axially on the other side of this valve (55, 56), and a close-together position in which the circular cutting edges of these two series (11, 12) of blades are brought into mutual contact and thus cut through the native valve (55, 56) so as to detach it from said bodily vessel (50); and

means of identifying, by a percutaneous route, the axial position of the device (1) with respect to the native valve (55, 56) so as to position each of the two aforementioned series (11, 12) of blades on one side of this valve.

2. The device (1) as claimed in claim 1, characterized in that it comprises a proximal prosthetic valve (10), with a radially deployable structure, it being possible for this prosthetic valve (10) to occupy a furled position in which it is near the wall of said elongate element (2) and does not impede the introduction and sliding of the device (1) into and in said bodily vessel (50), and an unfurled position in which it bears against the wall of this vessel (50) and is able to replace the native heart valve (55, 56).

3. The device as claimed in claim 1, characterized in that said elongate support element is a tubular catheter (2).

4. The device as claimed in claim 1, characterized in that it comprises a distal inflatable balloon (13), placed at the exterior face of said elongate element (2);

this balloon (13) is shaped to be able to occupy a furled position in which it has a cross section such that it does not impede the sliding introduction of the device (1) into said bodily vessel (50), and an unfurled position in which it occupies all of the space between the exterior face of said elongate element (2) and the wall of said bodily vessel (50) and, via a peripheral edge (13a) that it comprises, bears against this wall.

5. The device as claimed in claim 1, characterized in that it comprises a distal filter (14) made of flexible material placed at the exterior face of said elongate element (2);

this filter (14) is shaped to be able to occupy a furled position in which it has a cross section such that it does not impede the introduction and sliding of the device (1) into and in said bodily vessel (50), and an unfurled position in which it occupies all of the space between the exterior face of said elongate element (2) and the wall of this vessel (50) and, via a peripheral edge (14a) that it comprises, bears against this wall.

6. The device as claimed in claim 4, characterized in that it comprises means for moving said series of blades in the axial direction independently of said balloon and/or of said filter.

7. The device as claimed in claim 4, characterized in that said balloon (13) and/or said filter (14) are mounted on an elongate support element specific to them and are separate from the device (1).

8. The device as claimed in claim 2, characterized in that the prosthetic valve (10) comprises an armature (20) made of a shape memory material, particularly a nickel-titanium alloy known by the name of “

NITINOL”

.

9. The device as claimed in claim 2, characterized in that the prosthetic valve (10) comprises valve leaflets (21) made of biological material (preserved animal or human valve leaflets) or valve leaflets made of a synthetic material such as a polymer.

10. The device as claimed in claim 1, characterized in that the blades are curved toward the axis of the device at their end that has the cutting edge.

11. The device as claimed in claim 3, characterized in that the catheter comprises a lateral distal opening to allow the blood to reach the bodily vessel, for example the ascending aorta, this opening being formed in such a way that the length of catheter through which the blood flows is as short as possible, and so as to allow the blood to flow between the heart and a peripheral vessel.