PROSTHETIC VALVES AND RELATED INVENTIONS

• US 20160331527A1
• Filed: 06/16/2016
• Published: 11/17/2016
• Est. Priority Date: 08/11/2011
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: VIDLUND, Robert, SCHANKERELI, Kemal, LOZONSCHI, Lucian, LUTTER, Georg
• Granted Patent: US 9,833,315 B2
• Time in Patent Office: 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 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 method of deploying a prosthetic valve in the annulus of a native valve, comprising:

disposing the prosthetic valve to the annulus of the native valve,

the prosthetic valve including 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, and 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; and

allowing the valve to expand in the native valve annulus with the collar engaging the native valve annulus between the atrium end and ventricle end of the collar and with the atrium end of the collar disposed on the atrium side of the native annulus.

2. The method 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 to inhibit perivalvular leakage of blood around the prosthetic valve.

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

4. The method of claim 1, wherein the collar has a maximum diameter at the atrial end of the collar.

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

6. The method of claim 1, wherein the collar provides a lateral annular compressive force against the native valve annulus to immobilize the prosthetic valve and provide a seal between the atrium and the ventricle of the heart.

7. The method of claim 1, further comprising expelling the prosthetic valve from a delivery catheter.

8. The method of claim 7, further comprising introducing the delivery catheter through the apex of the ventricle.

9. The method of claim 1, wherein the prosthetic valve further includes one or more tethers attached to one of the stent or the collar, and further comprising attaching the one or more tethers to one or more anchoring locations in the heart.

10. The method of claim 9, further comprising pulling the one or more tethers to tighten the collar onto the tissue around the native annulus.