Valve prosthesis for implantation in the body and a catheter for implanting such valve prosthesis

• US 20030036795A1
• Filed: 10/10/2002
• Published: 02/20/2003
• Est. Priority Date: 05/18/1990
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Hasenkam, John Michael, Knudsen, Lars Lyhne, Andersen, Henning Rud
• Granted Patent: US 7,618,446 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A valve prosthesis (9) for implantation in the body by use of catheter (11) comprises a stent made from an expandable cylinder-shaped thread structure (2,3) comprising several spaced apices (4). The elastically collapsible valve (4) is mounted on the stent as the commissural points (5) of the valve (6) is secured to the projecting apices (4).

The valve prosthesis (9) can be compressed around the balloon means (13) of the balloon catheter (11) and be inserted in a channel, for instance in the aorta (10). When the valve prosthesis is placed correctly the balloon means (13) is inflated thereby expanding the stent and wedging it against the wall of the aorta. The balloon means is provided with beads (14) to ensure a steady fastening of the valve prosthesis on the balloon means during insertion and expansion.

The valve prosthesis (9) and the balloon catheter (11) make it possible to insert a cardiac valve prosthesis without a surgical operation comprising opening the thoracic cavity.

Claims

1. A valve prosthesis (9), preferably a cardiac valve prosthesis, for implantation in the body and comprising a collapsible elastical valve (6) which is mounted on an elastical stent (1) wherein the commissural points (5) of the elastical collapsible valve (6) are mounted on the cylinder surface of the elastical stent (1) characterized in that the stent is made from a radially collapsible and re-expandable cylindrical support means (7,8,24) for folding and expanding together with collapsible valve for implantation in the body by means of a technique of catheterization.

2. A valve prosthesis according to claim 1, characterized in that the support means (7,8) is made of thread structure (2,3).

3. A valve prosthesis according to claim 2, characterized in that the thread structure (2,3) comprises several spaced apices projecting from the one side of the cylindrical structure and in direction along the longitudinal axis of the cylinder and that the commissural points (5) of the valve (6) are attached to the projecting apices.

4. A valve prosthesis according to claim 3, characterized in that the elastically collapsible valve (6) is a biological trilobate valve.

5. A valve prosthesis according to claim 4, characterized in that stent (1) is made from a stainless steel wire (2,3) folded in a number of loops (4) and bended according to a circle and welded to form a closed ring (7,8), that the stent comprises two or more such closed rings which are mutually connected end to end to form the cylindrical thread structure (2,3), that three of the loops (4) in the external ring are folded with a greater height than the remaining loops to form the apices to which the commissural points of the biological valve are attached.

6. A valve prosthesis according to claim 5, characterized in that each of the rings (7,8) of the stent (1) is made from a wire having a diameter of 0.55 mm and a loop height of approximately 8 mm and approximately 14 mm for the three greater loops, and that the cylindrical thread structure produced and the collapsible valve mounted thereon in a folded state have an outer diameter of approximately 10 mm and in expanded state an outer diameter of approximately 30 mm.

7. A valve prosthesis according to claim 5, characterized in that three or more mutually attached rings (7,8) placed on top of each other are used and that the stent (1) is made to be fixed through the expansion at one point in the channel where the valve prosthesis is inserted, which point is different from the point where the valve is mounted in the stent.

8. A valve prosthesis according to claim 1, characterized in that the cylinder surface of the support means is closed to form a tubular element (24)

9. A balloon catheter (11) for use in implantating a valve prosthesis (9) according to claim 1 and comprising a channel (15) for injection of a fluid for the inflation of the balloon means (13) of the catheter and an insertion cap (11A) wherein the balloon means (13) of the catheter and a collapsible valve prosthesis (9) mounted thereon are located during the injection, characterized in that the balloon means (13) are provided with profiled surface (14) which is made to ensure a steady fastening of the valve prosthesis (9) during the withdrawal of the balloon means (13) from the protection cap (11A) and the subsequent inflation for expanding the stent (1)

10. A balloon catheter according to claim 9, characterized in that the profiling of the surface is made by beads (14) or buds on the surface of the balloon means.

11. A balloon catheter according to claim 10, characterized in that the beads (14) are placed in pairs in a number from four to eight along lines parallel with the longitudinal axis (19) of the balloon means and with a spacing corresponding to the height of the stent (1) used.

12. A balloon catheter according to claim 9, characterized in that the profiling of the surface is made by an indentation which is formed in the surface of the balloon means (13) with an extension corresponding to the height of the stent (1) used.