Prosthetic valves and related inventions

• US 9,480,559 B2
• Filed: 08/13/2012
• Issued: 11/01/2016
• Est. Priority Date: 08/11/2011
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Inventors: Vidlund, Robert, Schankereli, Kemal, Lozonschi, Lucian, Lutter, Georg
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US14/237,023
• Publication Number:
  US 20140214159A1
• Time in Patent Office: 1,541 Days
• Field of Search: 623 211- 219
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0034 D-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 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00077 : Copper or Cu-based alloys
• CPC Class Codes: A61L 2400/16 : Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2430/20 : for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 27/3625 : Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3629 : Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 33/0011 : Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Claims

1. A prosthetic valve for implantation in a native valve annulus between an atrium and a ventricle of a heart comprising:

a self-expanding tubular stent having an atrium end and an opposite, ventricle end;

a set of valve leaflets disposed in the stent and configured to permit blood flow from the atrium end to the ventricle end of the stent and to inhibit blood flow from the ventricle end to the atrium end;

a collar disposed around the stent, having a ventricle end coupled to the ventricle end of the stent and extending axially along, and diverging radially away from, the stent towards an opposite, atrium end, the collar being formed from a web of shape-memory material covered by one of a stabilized tissue and a synthetic material,

the prosthetic valve configured to be disposed in the native valve annulus with the collar engaging the native valve annulus between the atrium end and ventricle end of the collar, with the atrium end of the collar disposed on the atrium side of the native annulus.

2. The prosthetic valve of claim 1, wherein the collar is configured to conform to the irregularities of the atrium and the shape of the native annulus and to provide a seal against the atrial tissue adjacent the native annulus when implanted therein to inhibit perivalvular leakage of blood around the prosthetic valve.

3. The prosthetic valve of claim 1, wherein the collar is formed separately from the stent and attached to the stent.

4. The prosthetic valve of claim 1, wherein the collar is formed as from loops of wire.

5. The prosthetic valve of claim 1, wherein the collar is constructed from an attached panel formed of fabric.

6. The prosthetic valve of claim 1, wherein the collar is configured to flex laterally in response to lateral pressure exerted on the collar by native annular tissue.

7. The prosthetic valve of claim 1, wherein each of the stent and the collar is formed by laser-cut stunt technology.

8. The prosthetic valve of claim 7, wherein the stent and the collar are manufactured as a unitary laser cut stent-collar construction.

9. The prosthetic valve of claim 1, further comprising a delivery catheter for delivering the prosthetic valve to the native valve annulus via an apical approach, the prosthetic valve being contained within the delivery catheter.

10. The prosthetic vale of claim 1, wherein the collar has a maximum diameter at the atrial end of the collar.

11. The prosthetic valve of claim 1, wherein the collar includes a circular support structure formed as a series of loops, and formed as an independent structure and attached to the other part of the collar at the atrial end thereof.

12. The prosthetic valve of claim 11, wherein the circular support structure is covered by tissue.

13. The prosthetic valve of claim 1, wherein the collar is configured to provide a lateral annular compressive force against the native valve annulus when implanted in the native valve annulus to immobilize the prosthetic valve and provide a seal between the atrium and the ventricle of the heart.

14. The prosthetic valve of claim 1, wherein the collar is D-shaped.

15. A prosthetic valve for implantation in a native valve annulus between an atrium and a ventricle of a heart comprising:

a self-expanding tubular stent having an atrium end and an opposite, ventricle end;

a set of valve leaflets disposed in the stent and configured to permit blood flow from the atrium end to the ventricle end of the stent and to inhibit blood flow from the ventricle end to the atrium end;

a collar disposed around the stent, having a ventricle end coupled to the ventricle end of the stent and extending axially along, and diverging radially away from, the stent towards an opposite, atrium end, the collar being formed from loops of wire,

the prosthetic valve configured to be disposed in the native valve annulus with the collar engaging the native valve annulus between the atrium end and ventricle end of the collar, with the atrium end of the collar disposed on the atrium side of the native annulus.

16. The prosthetic valve of claim 15, wherein the collar is configured to conform to the irregularities of the atrium and the shape of the native annulus and to provide a seal against the atrial tissue adjacent the native annulus when implanted therein to inhibit perivalvular leakage of blood around the prosthetic valve.

17. The prosthetic valve of claim 15, wherein the collar is formed separately from the stent and attached to the stent.

18. The prosthetic valve of claim 15, wherein the stent and the collar are manufactured as a unitary laser cut stent-collar construction.

19. The prosthetic valve of claim 15, wherein the collar has a maximum diameter at the atrial end of the collar.

20. The prosthetic valve of claim 15, wherein the collar includes a circular support structure formed from the loops of wire and formed as an independent structure and attached to the other part of the collar at the atrial end thereof.

21. The prosthetic valve of claim 20, wherein the circular support structure is covered by tissue.

22. The prosthetic valve of claim 15, wherein the collar is covered by one of a stabilized tissue and a synthetic material.

23. A prosthetic valve for implantation in a native valve annulus between an atrium and a ventricle of a heart comprising:

a self-expanding tubular stent having an atrium end and an opposite, ventricle end;

a set of valve leaflets disposed in the stent and configured to permit blood flow from the atrium end to the ventricle end of the stent and to inhibit blood flow from the ventricle end to the atrium end;

a collar disposed around the stent, having a ventricle end coupled to the ventricle end of the stent and extending axially along, and diverging radially away from, the stent towards an opposite, atrium end, the collar including a circular support structure forming as a series of loops and formed as an independent structure and attached to the other part of the collar at the atrial end thereof,

the prosthetic valve configured to be disposed in the native valve annulus with the collar engaging the native valve annulus between the atrium end and ventricle end of the collar, with the atrium end of the collar disposed on the atrium side of the native annulus.

24. The prosthetic valve of claim 23, wherein the collar is configured to conform to the irregularities of the atrium and the shape of the native annulus and to provide a seal against the atrial tissue adjacent the native annulus when implanted therein to inhibit perivalvular leakage of blood around the prosthetic valve.

25. The prosthetic valve of claim 23, wherein the collar is formed separately from the stent and attached to the stent.

26. The prosthetic valve of claim 23, wherein the stent and the collar are manufactured as a unitary laser cut stent-collar construction.

27. The prosthetic valve of claim 23, wherein the collar has a maximum diameter at the atrial end of the collar.

28. The prosthetic valve of claim 23, wherein the circular support structure is covered by tissue.

29. The prosthetic valve of claim 23, wherein the collar is covered by one of a stabilized tissue and a synthetic material.