Loading device and method for loading a prosthesis
The present invention relates to a heart valve prosthesis loading device and a method for loading a heart valve prosthesis onto a delivery system.
1 . A loading device useful for loading a tricuspid stent or prosthesis onto a delivery system comprising:
a tapered part;
a loading tube;
a stent holder proximal from the tapered part;
a pulling means;
a catheter configured for advancing over the tricuspid stent or prosthesis when in a crimped state; and
a pulling means guide proximal from the stent holder and over a portion of the catheter;
wherein the pulling means is configured for pulling the tricuspid stent or prosthesis through the tapered part and into the loading tube,
wherein the pulling means has a first diameter, a second diameter and at least three releasable connecting parts for linkage with the tricuspid stent or prosthesis, wherein each of the three releasable connecting parts includes i) an eyelet or ii) a pocket or aperture, and the pulling means exhibit reduced push resistance and allow for a symmetric force application;
wherein the pulling means guide has a guidance hole for each of the pulling means and maintains the pulling means at an equal distance to one another at the second diameter.
2 . The loading device according to claim 1 , wherein the tapered part is characterized in its inner area by an angle of 10° to 30° over its length or/and wherein the tapered part over its length in the inner area is designed convex.
3 . The loading device according to claim 1 wherein an inner diameter of the loading tube is 7 to 10 mm.
4 . A system comprising:
a loading device comprising:
a tapered part;
a loading tube;
a stent holder proximal from the tapered part;
a pulling means;
a catheter configured for advancing over a stent or prosthesis when in a crimped state; and
a pulling means guide proximal from the stent holder and over a portion of the catheter;
wherein the pulling means is configured for pulling the stent or prosthesis through the tapered part and into the loading tube,
wherein the pulling means has a first diameter, a second diameter and at least three releasable connecting parts for linkage with the stent or prosthesis, wherein each of the three releasable connecting parts includes i) an eyelet or ii) a pocket or aperture, and the pulling means exhibit reduced push resistance and allow for a symmetric force application;
wherein the pulling means guide has a guidance hole for each of the pulling means and maintains the pulling means at an equal distance to one another at the second diameter;
a stent or prosthesis;
wherein the pulling means and the stent or prosthesis are mechanically connected.
5 . A system, comprising:
a stent or prosthesis;
a delivery system including:
a catheter configured for advancing over the stent or prothesis when in a crimped state; and
a loading device comprising:
a tapered part;
a loading tube;
a stent holder proximal from the tapered part;
a pulling means; and
a pulling means guide proximal from the stent holder and over a portion of the catheter;
wherein the pulling means is configured for pulling the stent or prosthesis through the tapered part and into the loading tube,
wherein the pulling means has a first diameter, a second diameter and at least three releasable connecting parts for linkage with the stent or prosthesis, wherein each of the three releasable connecting parts includes i) an eyelet or ii) a pocket or aperture, and the pulling means exhibit reduced push resistance and allow for a symmetric force application;
wherein the pulling means guide has a guidance hole for each of the pulling means and maintains the pulling means at an equal distance to one another at the second diameter.
6 . The loading device of claim 1 ,
wherein the tapered part is a funnel;
the tapered part is characterized in its inner area by an angle of 15-20° over its length or/and wherein the tapered part over its length in the inner area is convex; and
an inner diameter of the loading tube is 7 to 10 mm.
7 . The loading device according to claim 1 , wherein the pulling means comprises at least three flexible arms, wherein the flexible arms protrude from the first diameter to the second diameter, wherein the stent holder is configured to hold the tricuspid stent or prothesis in a crimped state.
8 . The loading device according to claim 7 , wherein the tricuspid stent or prosthesis has at least three pulling points, wherein each of the at least three flexible arms corresponds to one of the pulling points of the tricuspid stent or prosthesis wherein each of the flexible arms is connected with the corresponding pulling point of the tricuspid stent or prosthesis during loading of the tricuspid stent or prosthesis into the stent holder.
9 . The loading device according to claim 7 , wherein the first diameter is 7-10 mm and the second diameter is 60-80 mm.
10 . The loading device of claim 1 , wherein the at least three releasable connecting parts are mechanical connecting means for linkage with the triscupid stent or prosthesis.
11 . The loading device of claim 10 , wherein the pulling means comprises 5 to 12 flexible arms, the first diameter is 8 to 9 mm, and the second diameter is 50 to 60 mm.
12 . The loading device of claim 6 ,
wherein
the tapered part is a funnel;
the tapered part is characterized in its inner area by an angle of 10 to 30° over its length or/and wherein the tapered part over its length in the inner area is convex; and
an inner diameter of the loading tube is 7 to 10 mm.
13 . The loading device of claim 12 , wherein
the pulling means comprises 5 to 19 flexible arms that protrude from a first diameter of 7 to 10 mm to a second diameter of 60 to 80 mm, each of the flexible arms corresponds to a pulling points of the tricuspid stent or prosthesis to be connected.
14 . The loading device of claim 1 , wherein the stent holder comprises releasable connecting parts, so that the tricuspid stent or prosthesis may be disengaged from the pulling means and engaged with the stent holder.
15 . The loading device of claim 1 , wherein the pulling means is between an outer wall of an inner catheter shaft and an inner tapered wall of the tapered part.
16 . The loading device of claim 1 ,
wherein the pulling means is positioned between an inner wall of the loading tube and the stent holder, and
wherein a proximal end of the loading tube is at a proximal end of the tapered part.
17 . The loading device of claim 1 , wherein
the releasable connecting parts are eyelets on the pulling means corresponding to pockets on the stent or prosthesis, or
the releasable connecting parts are pockets on the pulling means and the stent or prosthesis includes counterpart eyelets;
wherein the eyelet in one orientation can enter into an opening of the pocket and/or the eyelet slides into the pocket.