Methods and systems for delivering prostheses using rail techniques

• US 10,321,998 B2
• Filed: 05/03/2013
• Issued: 06/18/2019
• Est. Priority Date: 09/23/2010
• Status: Active Grant

• Current Assignee: Transmural Systems LLC
• Original Assignee: Transmural Systems LLC
• Inventors: Rafiee, Nasser
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): Herbermann, Erich
• Application Number:
  US13/886,983
• Publication Number:
  US 20140163668A1
• Time in Patent Office: 2,237 Days
• Field of Search: 606157, 623 211, 623 126
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/2457 Chordae tendineae prostheses
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

Exemplary embodiments provide methods and systems for delivering a prosthesis to a target location in a lumenal system of a patient. At least one tether is secured proximate the target location to serve as a rail, and a prosthesis is advanced along the rail to the target location and secured in place. Exemplary methods and systems provide for repair of the mitral and tricuspid valves, as well as abdominal aortic aneurysms, stomach valves, fallopian tubes and the pulmonary system, among others. Also disclosed are various prostheses suitable for use with the disclosed methods and systems.

Claims

1. A prosthesis, comprising:

a) a graft material sleeve; and

b) a plurality of individual, physically separated, independently articulable, independent loops of shape memory wire material coupled to the graft material sleeve at a mid portion of each separate, independent loop such that the mid portions of the loops are spaced from and not directly attached to each other to enhance compliance of the prosthesis when installed in a native valve annulus, wherein;

the mid portion of each said separate, independent loop includes two substantially straight segments of the shape memory wire material;

each said separate, independent loop further includes a proximal portion including a first curved segment of the shape memory wire material connecting proximal ends of the two substantially straight wire segments of the mid portion; and

each said separate, independent loop includes a distal portion including a second curved segment of the shape memory wire material connecting distal ends of the two substantially straight wire segments of the mid portion, wherein the plurality of individual independently articulable loops are configured and arranged to be deployed in a lumenal system of a patient.

2. The prosthesis of claim 1, further comprising:

a) a conduit defining a passage therethrough coupled to and forming a part of the prosthesis; and

b) at least one tether extending through the passage of the conduit for controlling advancement of the prosthesis over and along the at least one tether to a target location.

3. A prosthesis delivery system, comprising:

a) a longitudinal body;

b) a prosthesis according to claim 2 disposed on the longitudinal body;

c) a retractable sheath covering the prosthesis; and

d) the conduit defined through the longitudinal body for housing the least one tether, the conduit having a proximal end and a distal end, the distal end being located proximate the prosthesis.

4. The prosthesis of claim 1, wherein the prosthesis does not include a valve and is configured to receive a separate implantable device.

5. An implant including the prosthesis of claim 4 and a replacement valve installed into a lumen defined by the prosthesis.

6. A valve prosthesis, comprising:

a graft material;

a plurality of individual, separated, parallel, independently articulable, primary, loops of shape memory wire material that are spaced from and not directly attached to each other, and are coupled to the graft material at a mid portion of each separate primary loop to enhance compliance of the prosthesis when installed in a native valve annulus, each of said separate, primary loops having a curved proximal end and a curved distal end, wherein;

the proximal ends of each of the separate, primary loops are independently articulable and configured to act as a first set of fasteners that extend radially and outwardly with respect to the graft material and the mid portion and are configured to attach the valve prosthesis to cardiac tissue on an atrial side of a posterior mitral annulus.

7. The valve prosthesis of claim 6, wherein the distal ends of each of the separate, primary loops are independently articulable and configured to act as a second set of fasteners that extend radially and outwardly from the graft material and are configured to attach the valve prosthesis to cardiac tissue on a ventricular side of the mitral annulus.

8. The valve prosthesis of claim 7, further comprising:

a third set of fasteners that extend radially outwardly with respect to the graft material and said mid portion of said plurality of separate, primary loops and are configured to attach the valve prosthesis to cardiac tissue at or above the mitral annulus, the third set of fasteners being of smaller overall dimension than the plurality of primary loops.

9. The valve prosthesis of claim 7, further comprising:

a set of independently articulable, separate, parallel, secondary, independent loops of shape memory wire material nested within and disposed radially and outwardly with respect to the primary loops, each of said separate, secondary loops having a curved proximal end and a curved distal end and a length that is less than the primary loops, wherein;

the proximal ends of each of the separate, secondary loops are independently articulable and configured to act as a third set of fasteners that extend radially and outwardly with respect to the graft material; and

the distal ends of each of the separate, secondary loops are independently articulable and configured to act as a fourth set of fasteners that extend radially and outwardly with respect to the graft material and are configured to attach the valve prosthesis to cardiac tissue on the ventricular side of the mitral annulus.

10. The valve prosthesis of claim 9, wherein the graft material includes a graft material sleeve, and the separate, secondary loops are coupled to the graft material sleeve at a mid portion of each of the separate, secondary loops.