Truncated cone heart valve stent

• US 9,254,192 B2
• Filed: 06/22/2015
• Issued: 02/09/2016
• Est. Priority Date: 09/13/2007
• Status: Active Grant

• Current Assignee: Georg Lutter, Lucian Lozonschi
• Original Assignee: Georg Lutter, Lucian Lozonschi
• Inventors: Lutter, Georg, Lozonschi, Lucian
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US14/746,381
• Publication Number:
  US 20150305868A1
• Time in Patent Office: 232 Days
• US Class Current: 1/1
• 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 having a section with a heart valve implant and several proximally disposed tissue anchors, also comprising a plurality of anchoring threats, 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 method comprising:

delivering to a native annulus of an atrioventricular valve of a heart a prosthetic valve having a self-expanding body having a proximal end and a distal end, a valve disposed in the body, and

a plurality of self-expanding atrial anchoring elements distributed circumferentially about, and extending radially outwardly from, the proximal end of the body, and a plurality of anchoring sutures, each anchoring suture having a first end and a second end, the first end being attached to the distal end of the body, the delivering including disposing the atrial anchoring elements on an atrium side of the native annulus and the sutures on a ventricle side of the native annulus;

allowing the body to self-expand into engagement with the native annulus;

disposing the second end of each of the sutures outside the heart; and

with the sutures, applying tension between the wall of the ventricle and the anchoring elements to fix the prosthetic valve in the native annulus.

2. The method of claim 1, further comprising fixing the sutures to the wall of the heart with a thrust bearing.

3. The method of claim 1, wherein the body has a cross sectional shape that is an oval with a flattened side, and further comprising orienting the body within the native annulus with the flattened side in the direction of the ventricular outflow tract of the heart.

4. The method of claim 1, wherein:

the delivering the prosthetic valve includes delivering the prosthetic valve via an opening in the wall of the ventricle of the heart.

5. The method of claim 1, wherein:

the atrioventricular valve is a mitral valve.

6. The method of claim 1, wherein:

the atrioventricular valve is a tricuspid valve.

7. The method of claim 1, wherein:

the applying tension includes adjusting a length of the sutures.

8. The method of claim 7, further comprising:

confirming, during the applying tension with the sutures, an absence of paravalvular leakage associated with the atrioventricular valve.

9. A method comprising:

delivering to a native annulus of an atrioventricular valve of a heart a prosthetic valve having;

a self-expanding body having a proximal end and a distal end,

a valve disposed in the body, and

a plurality of self-expanding atrial anchoring elements distributed circumferentially about, and extending radially outwardly from, the proximal end of the body, and at least one anchoring suture, the at least one anchoring suture having a first end and a second end, the first end being attached to the body,

the delivering including disposing the atrial anchoring elements on the atrium side of the native annulus and the at least one anchoring suture on a ventricle side of the native annulus; and

with the at least one anchoring suture, applying tension between a wall of the ventricle and the anchoring elements to fix the prosthetic valve in the native annulus.

12. The method of claim 9, wherein the body has a cross sectional shape that is an oval with a flattened side, the method further comprising:

orienting the body within the native annulus with the flattened side in a direction of a ventricular outflow tract of the heart.

13. The method of claim 9, wherein:

the delivering includes delivering the prosthetic valve via an opening in the wall of the ventricle of the heart and disposing the second end of the at least one anchoring suture outside the heart.

14. The method of claim 9, wherein:

the atrioventricular valve is a mitral valve.

15. The method of claim 9, wherein:

the atrioventricular valve is a tricuspid valve.

16. The method of claim 9, wherein:

the applying tension includes adjusting a length of the at least one anchoring suture.

17. The method of claim 16, wherein:

confirming, during the applying tension with the at least one suture, an absence of paravalvular leakage associated with the atrioventricular valve.

18. The method of claim 9, further comprising:

allowing the body to self-expand into engagement with the native annulus of the atrioventricular valve.

19. The method of claim 9, wherein:

the first end of the at least one anchoring suture is attached to the distal end of the body and disposed within the ventricle side of the native annulus during the applying tension to fix the prosthetic valve in the native annulus.

10. The method of 9, further comprising:

fixing the at least one anchoring suture to the wall of the heart.

11. The method of claim 10, wherein:

the fixing includes fixing the at least one anchoring suture to the wall of the heart with a thrust bearing.

20. A method comprising:

delivering to a native annulus of an atrioventricular valve of a heart a prosthetic valve having;

a self-expanding body having a proximal end and a distal end,

a valve disposed in the body, and

a plurality of self-expanding atrial anchoring elements distributed circumferentially about, and extending radially outwardly from, the proximal end of the body, and an anchoring suture, the anchoring suture having a first end and a second end, the first end being attached to the body,

the delivering including;

inserting a catheter through an opening in the heart with the prosthetic valve disposed in the catheter,

deploying the prosthetic valve from the catheter, the deploying including disposing the atrial anchoring elements on the atrium side of the native annulus and the anchoring suture on a ventricle side of the native annulus; and

with the anchoring suture, applying tension between a wall of the ventricle and the anchoring elements to fix the prosthetic valve in the native annulus.

21. The method of claim 20, further comprising:

fixing the anchoring suture to the wall of the heart.

22. The method of claim 21, wherein:

the fixing includes fixing the anchoring suture to the wall of the heart with a thrust bearing.

23. The method of claim 20, wherein the body has a cross sectional shape that is an oval with a flattened side, the method further comprising:

orienting the body within the native annulus with the flattened side in a direction of a ventricular outflow tract of the heart.

24. The method of claim 20, wherein:

the opening is in the wall of a ventricle of the heart, the inserting including inserting the catheter via the opening in the wall of the ventricle of the heart.

25. The method of claim 24, wherein:

the delivering includes disposing the second end of the anchoring suture outside the heart.

26. The method of claim 20, wherein:

the atrioventricular valve is a mitral valve.

27. The method of claim 20, wherein:

the atrioventricular valve is a tricuspid valve.

28. The method of claim 20, wherein:

the applying tension includes adjusting a length of the anchoring suture.

29. The method of claim 28, wherein:

confirming, during the applying tension with the suture, an absence of paravalvular leakage associated with the atrioventricular valve.

30. The method of claim 20, wherein:

the deploying the prosthetic valve includes allowing the body to self-expand into engagement with the native annulus of the atrioventricular valve.