Prosthetic valves and related inventions
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.
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.