ANCHOR FOR PROSTHETIC CARDIAC VALVE DELIVERY DEVICES AND SYSTEMS
A device for treating a diseased native valve in a patient is provided, the device including a frame structure and a plurality of leaflets. The device can further include a spiral anchor configured to extend around an outer circumference of the frame structure, the spiral anchor comprising a spiral portion and a proximal portion that extends radially outwards relative to a circumference of the spiral portion. Other embodiments and methods of use are also provided.
1 . A prosthesis for treating a diseased native valve, the prosthesis comprising:
a frame structure having a plurality of leaflets therein; and
a spiral anchor configured to extend around an outer circumference of the frame structure, the spiral anchor comprising a spiral portion and a proximal portion that extends radially outwards relative to a circumference of the spiral portion.
2 . The prosthesis of claim 1 , wherein the proximal portion crosses the spiral portion to extend beyond the circumference of the spiral portion.
3 . The prosthesis of claim 1 , wherein the proximal portion further extends at a 60°-90° angle relative to a plane of the spiral portion.
4 . The prosthesis of claim 1 , wherein the proximal portion has a length of up to 5 mm.
5 . The prosthesis of claim 1 , wherein the proximal portion has a length of up to 10 mm.
6 . The prosthesis of claim 1 , wherein the proximal portion has a smaller cross-sectional area than that of the spiral portion.
7 . The prosthesis of claim 6 , wherein the proximal portion comprises an abutment at the transition between the proximal portion and the spiral portion.
8 . The prosthesis of claim 1 , further comprising a delivery tether configured to releasably engage with the proximal portion of the spiral anchor.
9 . The prosthesis of claim 1 , wherein the spiral portion is substantially contained within the plane.
10 . A prosthesis for treating a diseased native valve, the prosthesis comprising:
a frame structure having a plurality of leaflets therein; and
a spiral anchor configured to extend around an outer circumference of the frame structure, the spiral anchor comprising a spiral portion and a proximal extension at a proximal end of the spiral portion, the proximal extension extending at a 60°-90° angle relative to a plane of the spiral portion.
11 . The prosthesis of claim 10 , wherein the proximal extension is configured to extend along an outer surface of the frame structure.
12 . The prosthesis of claim 10 , wherein the frame structure comprises a flared proximal portion, the proximal extension terminating distal to the flared proximal portion.
13 . The prosthesis of claim 10 , wherein the proximal extension is configured to position the proximal end to extend at a 60°-90° angle relative to the plane of the spiral portion.
14 . The prosthesis of claim 10 , wherein the proximal extension is less than 10 mm long.
15 . A prosthesis for treating a diseased native valve, the prosthesis comprising:
a frame structure having a plurality of leaflets therein; and
a spiral anchor configured to extend around an outer circumference of the frame structure, the spiral anchor having a proximal portion that is more flexible than a distal portion.
16 . The prosthesis of claim 15 , wherein the proximal portion is thinner or has a smaller cross-sectional area than that of the distal portion.
17 . The prosthesis of claim 15 , wherein a cross-sectional area of the spiral anchor increases along its length from the proximal portion to the distal portion.
18 . The prosthesis of claim 17 , wherein the increasing cross-sectional area of the spiral portion is gradual along an angular extent of the spiral portion.
19 . The prosthesis of claim 17 , wherein the increasing cross-sectional area of the spiral portion is gradual along a linear extent of the spiral portion.
20 . The prosthesis of claim 17 , wherein the increasing cross-sectional area of the spiral portion is abrupt along an angular extent of the spiral portion.
21 . The prosthesis of claim 17 , wherein the increasing cross-sectional area of the spiral portion is abrupt along a linear extent of the spiral portion.
22 . A method of delivering a valve prosthesis, comprising the steps of:
coupling a delivery tether to a proximal portion of a spiral anchor;
providing the spiral anchor into a delivery sheath;
advancing the delivery sheath to a target tissue location;
deploying the spiral anchor from the delivery sheath into a plane to encircle one or more mitral leaflets and chordae at the target location;
delivering a frame structure over the delivery tether into place within the spiral anchor; and
adjusting an axial position of the spiral anchor relative to the frame structure by the delivery tether while maintaining the planarity of the spiral anchor.
23 . The method of claim 22 , wherein the axial position of the spiral anchor is adjusted without rotating the spiral anchor relative to the frame structure.
24 . The method of claim 22 , wherein the axial position of the spiral anchor is adjusted without increasing a radius of curvature of the spiral anchor.
25 . The method of claim 22 , wherein the axial position of the spiral anchor is adjusted without increasing a radius of curvature of a proximal end portion of the spiral anchor.