Stentless support structure
A stentless support structure capable of being at least partly assembled in situ. The support structure comprises a braided tube that is very flexible and, when elongated, becomes very long and very small in diameter, thereby being capable of placement within a small diameter catheter. The support structure is preferably constructed of one or more thin strands of a super-elastic or shape memory material such as Nitinol. When released from the catheter, the support structure folds itself into a longitudinally compact configuration. The support structure thus gains significant strength as the number of folds increase. This radial strength obviates the need for a support stent. The support structure may include attachment points for a prosthetic valve.
1. A method of implanting a prosthetic valve comprising:
(a) percutaneously delivering a support structure, having a prosthetic valve attached to a proximal end thereof, in an elongated state inside a catheter to a target site, said support structure having at least two longitudinally spaced-apart circumferential preformed folds that have been unfolded to fit within said catheter but that are biased toward a folded configuration;
(b) retracting said catheter relative to said support structure such that a first portion of said support structure expands against native tissue of the target site;
(c) advancing a second portion of said support structure into said first portion such that a first of said preformed folds resumes said folded configuration between said first and second portions;
(d) retracting said catheter relative to said second portion until said second portion expands against an interior of said first portion, thereby creating a multi-layered support structure;
(e) repeating steps (c) and (d) if additional layers are desired;
(f) releasing the support structure and said prosthetic valve, the last of said preformed folds causing said prosthetic valve to be positioned at least partially within said support structure, and removing said catheter from the target site.
2. The method of claim 1 wherein step (b) comprises retracting said catheter relative to said support structure such that a first portion of said support structure expands against native tissue of the target site, said first portion including a distal end and a proximal end, the distal end including a cuff.
3. The method of claim 2 wherein step (b) comprises:
retracting said catheter relative to said support structure until said cuff expands and contacts the native tissue of the target site;
pulling said cuff in a proximal direction until the cuff contacts a distal side of a native valve;
retracting said catheter relative to said support structure until said proximal side of said first portion expands and contacts the native tissue of the target site.
4. A method of implanting a prosthetic valve in a target site comprising:
introducing a continuous length of material, said material having at least two longitudinally spaced-apart circumferential preformed folds that have been unfolded to fit within said catheter but that are biased toward a folded configuration into the target site;
building a supporting structure out of said material in situ by allowing said preformed folds to return to a folded configuration; and
releasing said prosthetic valve with said support structure.
5. The method of claim 4 wherein introducing a continuous length of material into the target site comprises introducing a braided, elongate mesh tube.
6. The method of claim 5 wherein introducing a braided, elongate mesh tube comprises introducing a braided, elongate mesh tube of at least one strand of a material selected from the group consisting of super-elastic and shape memory.
7. The method of claim 6 wherein introducing a braided, elongate mesh tube of at least one strand of a material selected from the group consisting of super-elastic and shape memory comprises introducing a braided, elongate mesh tube of a single Nitinol strand having been preformed to a folded configuration.
8. The method of claim 4 wherein building a supporting structure using said material in situ comprises folding said material upon itself until sufficient structural integrity to support the native tissue is attained.
9. The method of claim 8 wherein folding said material upon itself until sufficient structural integrity to support the native tissue is attained comprises:
introducing a delivery catheter to the target site containing said material in an elongated form;
exposing a first length of said material, thereby allowing said first length of material to expand;
advancing a second length of said material inside said first length;
exposing said second length of said material, thereby allowing said second length to expand against an inside surface of said first length.
10. The method of claim 9 further comprising:
advancing a third length of said material inside said second length;
exposing said third length of said material, thereby allowing said third length to expand against an inside surface of said second length.
11. A method of implanting a valvular implant comprising:
(a) percutaneously delivering a support structure having a prosthetic valve attached to a proximal end thereof in an elongated state inside a catheter to a target site;
(b) retracting said catheter relative to said support structure such that a first portion of said support structure expands outside of said catheter;
(c) advancing a second portion of said support structure into said first portion such that a first preformed fold returns to a folded configuration between said first and second portions;
(d) retracting said catheter relative to said second portion such that a second preformed fold, spaced apart from said first preformed fold, returns to a folded configuration, until said second portion expands against an interior of said first portion, thereby creating a multi-layered support structure;
(e) repeating steps (c) and (d) if additional layers are desired;
(f) releasing the support structure and the prosthetic valve and removing said catheter from the target site.
12. The method of claim 11 wherein step (b) comprises retracting said catheter relative to said support structure such that a first portion of said support structure expands against native tissue of the target site, said first portion including a distal end and a proximal end, the distal end including a cuff.
13. The method of claim 12 wherein step (b) comprises:
retracting said catheter relative to said support structure until said cuff expands and contacts the native tissue of the target site;
pulling said cuff in a proximal direction until the cuff contacts a distal side of a native orifice;
retracting said catheter relative to said support structure until said proximal side of said first portion expands and contacts the native tissue of the target site.
14. The method of claim 11 wherein retracting said catheter relative to said support structure such that a first portion of said support structure expands outside of said catheter comprises retracting said catheter relative to said support structure such that a first portion of said support structure expands outside of said catheter against native tissue of the target site.
15. The method of claim 11 wherein step (b) comprises retracting said catheter relative to said support structure such that a first portion of said support structure expands against native tissue belonging to the group consisting of valve tissue, blood vessel tissue, and heart tissue.