Truncated Conical Heart Valve Stent with Anchoring Threads and Methods of Use

• US 20120035703A1
• Filed: 10/18/2011
• Published: 02/09/2012
• Est. Priority Date: 09/13/2007
• Status: Abandoned Application

• Current Assignee: Tendyne Medical, Inc. (Abbott Laboratories)
• Original Assignee: Tendyne Medical, Inc. (Abbott Laboratories)
• Inventors: Lutter, Georg, Lozonschi, Lucian
• Application Number:
  US13/275,751
• Publication Number:
  US 20120035703A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

A heart valve stent and methods of use thereof, such stent having a heart valve implant and several proximally disposed tissue anchors, also comprising a plurality of anchoring threads, each with a proximate end fastened to the stent or valve and a distal end attached to tissue within a heart chamber to provide tension between the heart chamber tissue and the stent.

Claims

1. A heart valve stent, shaped as a truncated cone, comprising:

a foldable, self-expanding stent body section equipped with a heart valve implant;

a plurality of tissue anchors attached to a proximal end of the stent body section in a radial pattern; and

a plurality of anchoring threads, each such thread having a proximal end attached to the stent and a distal end anchored to the tissue of the heart chamber via a tissue anchor.

2. The heart valve stent of claim 1, further comprising at least one suture-length regulatory element for adjusting the length of at least one of the plurality of anchoring threads.

3. The heart valve stent of claim 1, further comprising a plurality of serrated, arched or triangular atrial anchoring elements radiating outward from the upper rim of the stent body section.

4. The heart valve stent of claim 1, further comprising wherein the heart valve implant is integrated within in the lumen of the stent body section near or at the proximal end of the stent body section.

5. The heart valve stent of claim 1, further comprising wherein at least one of the plurality of anchoring elements is made from a shape memory alloy.

6. The heart valve stent of claim 4, wherein the plurality of anchoring threads are attached around the annulus of integrated valve implant directly.

7. The heart valve stent of claim 1, wherein the plurality of anchoring threads are of varying lengths for multiple positions of tissue affixation within the ventricle.

8. The heart valve stent of claim 1, wherein distal ends of the plurality of anchoring threads are attached to, without limitation, tissue from one or more of the following areas:

the chamber wall, the papillary muscles, the chordae tendineae, or the ventricular apex.

9. The heart valve stent of claim 8, wherein the distal ends of all anchoring threads perforate the heart apex and attach to a pledget or button resting on the outside of the apex pericardium.

11. A method of delivering the heart valve stent of claim 1 via catheter insertion into one of the heart chambers, either by percutaneous or intravenous delivery, wherein the stent is folded within the catheter for delivery and then unfolded in a heart chamber, whereupon the tissue anchors radiating from the proximate end of the stent body section are fixed into supravalvular tissue.

12. The method claim 11, further comprising affixing the proximal ends of the plurality of anchoring threads either at intervals around the distal rim of the valve stent or at similar intervals around the annulus of the inserted valve, while anchoring the distal end of each thread to tissue inside the heart chamber via a tissue anchoring element.

13. The method of claim 12, further comprising wherein the distal ends of the threads are anchored to the tissue of one or more of the areas within the group comprising the ventricular apex, the chordae tendineae, the papillary muscles, and the chamber wall.

14. The method of claim 13, further comprising wherein the distal ends of all anchoring threads perforate the heart apex and attach to a pledget or button resting on the outside of the apex pericardium

15. The method of claim 13, further comprising wherein the lengths of the anchoring threads are adjusted by one or more adjusting elements after implantation to provide a degree of tension between the threads and the tissue anchors radiating from the proximal end of the stent body section that is similar to the tension provided a natural valve by the chordae tendineae.

16. The method of claim 14, further comprising wherein the adjusting element(s) remain in place after delivery of the stent, allowing for future re-adjustment of the tension of one or more anchoring threads without opening the heart.

10. A heart valve stent, shaped as a truncated cone, comprising:

a foldable, self-expanding stent body section with a heart valve implant;

a plurality of serrated, arched or triangular atrial anchoring elements attached to a proximal end of the stent body section in a radial pattern;

said heart valve implant integrated within the lumen of the stent body section, at or near the proximal end of the stent body section;

a plurality of anchoring threads made of material with elastic properties, each such thread having a proximal end attached to the stent and a distal end anchored to the tissue the heart chamber via a tissue anchor made of a shape memory alloy;

at least one suture-length regulatory element for adjusting the length of at least one of the plurality of anchoring threads; and

wherein the distal ends of the plurality of anchoring threads are attached to, without limitation, tissue from one or more of the following areas;

the chamber wall, the papillary muscles, the chordae tendineae, and the apex.