Implantable scaffolding containing an orifice for use with a prosthetic or bio-prosthetic valve

• US 9,622,864 B2
• Filed: 02/17/2015
• Issued: 04/18/2017
• Est. Priority Date: 04/10/2009
• Status: Active Grant

• Current Assignee: Lon Sutherland Annest
• Original Assignee: Lon Sutherland Annest
• Inventors: Annest, Lon Sutherland
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US14/624,053
• Publication Number:
  US 20150164641A1
• Time in Patent Office: 791 Days
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• 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 2/2439 Expansion controlled by filaments
• 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 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/006 : modular

Abstract

In a surgical method for improving cardiac function, an implantable scaffold or valve support device is inserted inside a patient'"'"'s heart and attached to the heart in a region about a natural mitral valve. The scaffold or valve support device defines an orifice and, after the attaching of the scaffold or valve support device to the heart, a prosthetic or bio-prosthetic valve is seated in the orifice. The scaffold or valve support device is at least indirectly secured to cordae tendenae of the heart.

Claims

1. A device or assembly for use in heart valve placement in a subject, the device or assembly comprising an implantable scaffold including:

an inner margin element defining an orifice for receiving or seating a prosthetic or bio-prosthetic valve; and

a flexible outer margin element conformable to an irregular internal wall surface of a heart chamber, said outer margin element surrounding said inner margin element, said outer margin element and said inner margin element being different from one another and spaced in their entireties from one another, said outer margin element and said inner margin element being coplanar substantially in their entireties with one another, the device or assembly further comprising a placement and positioning mechanism engageable with said scaffold and particularly said outer margin element for conforming said outer margin element to an irregularly shaped tissue surface, said placement and positioning mechanism including a plurality of manipulator tethers or wires extending to said outer margin element, said manipulator tethers or wires being detachably connected at their distal ends directly to said outer margin element, said manipulator tethers or wires being individually or independently manipulable for locating said scaffold in a desired position and conforming said outer margin element to an internal tissue surface.

2. The device or assembly of claim 1, further comprising a delivery catheter for positioning said scaffold into the heart chamber, said scaffold being disposed in a collapsed delivery configuration inside said catheter.

3. The device or assembly of claim 2 wherein said manipulator tethers or wires extend within said delivery catheter, said tethers or wires being attached at distal ends to said outer margin element at spaced locations thereon for maneuvering said scaffold into position by moving said wires or cords independently of one another, said wires or cords being detachable post fixation of said outer margin element of said scaffold to the internal tissue surface.

4. The device or assembly of claim 1, further comprising at least one fastener or fixation mechanism connected to said outer margin element for attaching said outer margin element to an internal tissue surface of a heart chamber.

5. The device or assembly of claim 4 wherein said fastener or fixation mechanism attaches said outer margin element circumferentially all around a perimeter of said outer margin element to the internal tissue surface, creating a continuous or near continuous contact between the internal tissue surface and said scaffold.

6. The device or assembly of claim 1, further comprising a membrane extending between said outer margin element and said inner margin element.

7. The device or assembly of claim 6 wherein said membrane tents away from one side of said scaffold, to provide a space between said scaffold and a native valve.

8. The device or assembly of claim 1, further comprising elements for attachment of a valve or valve prosthesis to the implantable scaffold.

9. The device or assembly of claim 1 wherein a valve or valve leaflets are pre-attached to a circumference of said orifice prior to placement in the desired position.

10. The device or assembly of claim 1, further comprising means for attaching a sub-valvular apparatus of a heart valve to said scaffold.