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 System and method for implanting cardiac valves

Details
Inventors: Andersen, Henning Rud; Hasenkam, John Michael; Knudsen, Lars Lyhne;
Assignee:
Primary Examiner: Willse; David H.
Assistant Examiner:
Attorney, Agent or Firm: Grainger; Jeffry J., Hoekendijk; Jens E., Lynch; Michael J.

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) are 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 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.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG.
1 shows a stent 1 made by support means in the form of two 0.
55 mm surgical stainless steel wires 2,3.
The wires are folded in 15 loops.
Three loops 4 are 14 mm in height and are intended to secure the commissural points 5 (see FIG.
2) from a biological cardiac valve 6 which is mounted in the stent 1.
The remaining loops have a height of 8 mm.
These loops form circumferentially expandable sections 25 between the commissural points 5 forming commissural supports.
Each of the two folded wires 2,3 is bent to form rings 7,8 which are closed by welding the ends.
The two rings are placed on top of each other as will appear from FIG.
1 and they are mutually secured by means of a number of sutures (not shown).
The lower ring is circumferentially expandable at least along sections thereof which correspond to the circumferentially expandable sections 25.
By using a substantially cylindrical thread structure projecting apices, a reduction in weight is obtained as compared to a stent which is exclusively cylindrical with the same loop heights for all the loops.
The biological valve 6 was removed from a slaughtered pig of 100 kg.
The valve was cleaned before mounting in the stent 1.
The cleaned valve has an outer diameter of 25-27 mm and the height of the three commissural points 5 is 8 mm.
The valve 6 is mounted in the stent by means of a suitable number of sutures to form the cardiac valve prosthesis 9 shown in FIG.
2.
The valve prosthesis produced is used for performing tests in pigs by implantation of cardiac valve prosthesis.
However, the cardiac valve prosthesis for use in human beings has a corresponding form.
FIG.
3 shows a partial view through the aorta 10.
A balloon catheter 11 is introduced in the aorta according to the direction of an arrow 12.
In the Figure shown the balloon means 13 of the balloon catheter is led out of the protection cap 11A and is partly inflated through a fluid channel 15, which is led to the surface of the patient



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