Prosthetic valves and related inventions

• US 10,639,145 B2
• Filed: 12/01/2017
• Issued: 05/05/2020
• 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:
  US15/829,091
• Publication Number:
  US 20180147055A1
• Time in Patent Office: 886 Days
• Field of Search: 623 21- 219
• 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. An apparatus, comprising:

a prosthetic valve configured to be implanted within a native valve annulus of a heart between an atrium and a ventricle of the heart, the prosthetic valve including a tubular stent body having an atrial end and an opposite, ventricle end, an anterior side and an opposite, posterior side, and a collar support portion extending from the atrial end of the body, and

a set of valve leaflets disposed in a lumen defined by the body and configured to permit blood flow through the body from the atrial end to the ventricle end of the body and to inhibit blood flow from the ventricle end to the atrial end of the body when the valve is disposed within a native valve annulus,

the body being self-expandable from a compacted configuration to an expanded configuration in which the collar support portion extends radially outwardly from the atrial end of the body,

the body having a first height on the posterior side and a second height on the anterior side greater than the first height when viewed in a side view and in the expanded configuration such that the collar support portion slopes downward from the anterior side of the body to the posterior side of the body when the body is in the expanded configuration.

2. The apparatus of claim 1, wherein the valve is configured to be implanted within the native annulus of a mitral valve of a heart with the body in the expanded configuration and the collar support portion disposed within the native annulus such that the body is disposed at an angle directed away from an aortic valve of the heart.

3. The apparatus of claim 1, wherein a longitudinal axis of the collar support portion is angularly offset from a longitudinal axis of the body.

4. The apparatus of claim 3, wherein an angle defined between the longitudinal axis of the collar support portion and the longitudinal axis of the body is between about 5 and about 45 degrees.

5. The apparatus of claim 1, wherein the collar support portion has an atrium side and an opposite, ventricle side, an angle defined between the ventricle side of the collar support portion and the anterior side of the body is greater than an angle defined between the ventricle side of the collar support portion and the posterior side of the body, when the valve is viewed from a side view.

6. The apparatus of claim 5, wherein the angle defined between the ventricle side of the collar support portion and the anterior side of the body is an obtuse angle and the angle defined between the ventricle side of the collar support portion and the posterior side of the body is an acute angle.

7. The apparatus of claim 1, wherein an angle of the collar support portion to an exterior wall of the body is between about 5 and about 45 degrees.

8. The apparatus of claim 1, wherein the collar support portion includes a plurality of posts.

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

10. The apparatus of claim 1, wherein the collar support portion is integrally formed with the body.

11. The apparatus of claim 1, wherein the collar support portion is formed separately from and coupled to the body.

12. An apparatus, comprising:

a prosthetic valve for implantation in a native valve annulus of a heart between an atrium and a ventricle of the heart, the prosthetic valve including a tubular stent body having an atrial end and an opposite, ventricle end, an anterior side and an opposite, posterior side, and a collar support portion extending from the atrial end of the body, the atrial end defining an atrial orifice, the ventricle end defining a ventricle orifice; and

a set of valve leaflets disposed in a lumen defined by the body and configured to permit blood flow from the atrial end to the ventricle end of the body and to inhibit blood flow from the ventricle end to the atrial end of the body when the valve is disposed within a native valve annulus of a heart,

the body being self-expandable from a compacted configuration to an expanded configuration in which the collar support portion extends radially outwardly from the atrial end of the body,

when the body is in the expanded configuration, the atrial orifice is laterally offset from the ventricle orifice of the body.

13. The apparatus of claim 12, wherein when the valve is implanted within the native annulus of a mitral valve with the body in the expanded configuration, based on the atrial orifice being laterally offset from the ventricle orifice of the body, blood flow in a direction from the atrial orifice to the ventricle orifice of the body is directed away from an aortic valve of the heart.

14. The apparatus of claim 12, wherein an interior portion of the body defines a non-linear flow path for the blood flow from the atrial end to the ventricle end of the body.

15. The apparatus of claim 12, wherein the atrial end at the anterior side of the body is laterally offset from the ventricle end at the anterior side of the body.

16. The apparatus of claim 12, wherein an exterior side of the body is non-linear.

17. The apparatus of claim 12, wherein a portion of the posterior side of the body is concave, and a portion of the anterior side of the body is convex.

18. The apparatus of claim 12, wherein a portion of tubular stent body defines a bend, the bend configured to direct blood flow from the atrial end to the ventricle end of the body in a lateral direction offset from a longitudinal axis of the collar support portion when the valve is implanted within a native valve annulus of a heart.

19. The apparatus of claim 12, wherein the collar support portion includes a plurality of posts.

20. The apparatus of claim 12, wherein the body in the expanded configuration has a curved shape.

21. The apparatus of claim 12, wherein the body in the expanded configuration has a bend along a length of the body between the ventricle end and the atrial end.

22. The apparatus of claim 12, wherein an axis defined at a centerline of the body is non-linear.