Low profile stent graft and delivery system
A tubular prosthetic device for implantation into a body lumen includes a first part including a tubular lumen and a second part including an attachment member. The second part is secured to the first part via various configurations, where the device is capable of being reduced to a diameter less than the diameter of traditional devices, for ease of use during implantation. Methods of using the device are also provided.
1 . An endovascular device comprising:
a stent having apices at an end of the stent;
a graft having a longitudinal axis, an exterior surface, a proximal open end and a distal end; and
at least one tether connecting a corresponding one of the apices to the exterior surface the graft, the at least one tether having opposite first and second ends,
wherein in a first configuration at least one of the apices is disposed on a portion of the exterior surface distally of the proximal open end of the graft along the longitudinal axis, without contacting a portion of the graft that is folded over the at least one apices;
wherein in a second configuration a portion of the distal end of the graft is folded over the corresponding one of the apices and secured to the exterior surface of the graft,
wherein the portion of the graft covers the corresponding one of the apices and a portion of the at least one tether so that the first and second ends of the at least one tether are exposed along the same surface of the graft,
wherein the at least one tether substantially extends along the exterior surface of the graft, and
wherein a proximal edge of the folded portion of the graft is proximal of portions of the distal end of the graft that are not folded.
2 . The endovascular device of claim 1 , wherein the graft comprises a plurality of layers having one or more inner layers and one or more outer layers.
3 . The endovascular device of claim 2 , wherein the portion of the graft folded over the corresponding one of the apices comprises at least one of the one or more inner layers.
4 . The endovascular device of claim 1 , wherein the corresponding one of the apices comprises an eyelet extending from the end of the stent.
5 . The endovascular device of claim 4 , wherein the at least one tether is disposed through the eyelet.
6 . The endovascular device of claim 1 , wherein the stent is a balloon expandable stent.
7 . The endovascular device of claim 1 , wherein the stent is a self-expandable stent.
8 . The endovascular device of claim 1 , wherein at least one of the apices is disposed over a portion of the exterior surface of the graft between the proximal and distal end of the graft.
9 . An endovascular device comprising:
a stent comprising corresponding peaks and valleys, and eyelets extending from apices of the valleys;
a graft having a longitudinal axis, an exterior surface, a proximal end and a distal end, the proximal end being connected to the stent;
at least one tether disposed through a corresponding one of the eyelets,
wherein in a first configuration at least one of the apices is disposed on a portion of the exterior surface of the graft distally of the proximal end between the proximal end and the distal end of the graft along the longitudinal axis, without contacting a portion of the graft that is folded over the at least one apices;
wherein in a second configuration portions of the distal end of the graft are folded directly over corresponding valleys and the resulting plurality of folded portions secured to the exterior surface of the graft to cover the corresponding apices,
wherein proximal edges of the folded portions of the graft are proximal of the portions of the distal end of the graft that are not folded.
10 . The endovascular device of claim 9 , wherein the graft comprises a plurality of layers having one or more inner layers and one or more outer layers.
11 . The endovascular device of claim 10 , wherein the portion of the graft folded over the corresponding one of the apices comprises at least one of the one or more inner layers.
12 . The endovascular device of claim 9 , wherein a through hole of the corresponding one of the eyelets is below a concave portion of the corresponding one of the valleys.
13 . The endovascular device of claim 12 , wherein the at least one tether comprises a plurality of tethers that are looped through the through hole of the eyelet.
14 . The endovascular device of claim 13 , wherein a portion of the graft is folded over the concave portion of the corresponding one of the valleys.
15 . The endovascular device of claim 13 , wherein a portion of the graft covers a portion of each of the tethers.
16 . The endovascular device of claim 9 , wherein the stent is a balloon expandable stent.
17 . The endovascular device of claim 9 , wherein the stent is a self-expandable stent.
18 . A method of manufacturing an endovascular device comprising a stent having peaks, valleys, and eyelets extending from ends of the valleys, and a graft, having a longitudinal axis, a proximal end and a distal end, said graft being connected to the stent, the method comprising:
positioning, in a first configuration, the stent so that a corresponding one of the eyelets overlaps with a surface of the graft, said eyelet being disposed distally of the proximal end of the graft along the longitudinal axis, without contacting a portion of the graft that is to be folded over a concave portion;
looping at least one tether through a through hole of the corresponding one of the eyelets such that it extends along the graft surface; and
folding, in a second configuration, a portion of the graft over a concave portion of a corresponding one of the valleys to cover the corresponding one of the eyelets and a portion of the at least one tether; and securing the portion of the graft on the surface of the graft wherein a proximal edge of the folded portion of the graft is proximal of a portion of the graft that is not folded.
19 . An endovascular device comprising:
a stent having apices at an end of the stent;
a graft having an exterior surface, a proximal open end and a distal open end;
at least one tether connecting a corresponding one of the apices to the exterior surface of an unsupported portion of the graft, the at least one tether having opposite first and second ends,
wherein at least one of the apices is disposed on a portion of the exterior surface distally of the proximal open end of the graft; and
wherein the first and second ends of the at least one tether extend along the exterior surface of the graft, and
wherein the at least one tether is not disposed on a supported portion of the graft,
wherein length of the at least one tether extends a substantial over the exterior surface of an unsupported portion of the graft,
and wherein the distal open end comprises portions of the graft folded over at least one tether and the corresponding one of the apices and unfolded portions.