METHODS AND SYSTEMS FOR DELIVERING PROSTHESES USING RAIL TECHNIQUES

• US 20140018906A1
• Filed: 05/03/2013
• Published: 01/16/2014
• Est. Priority Date: 09/23/2010
• Status: Active Grant

• Current Assignee: Transmural Systems LLC
• Original Assignee: Transmural Systems LLC
• Inventors: Rafiee, Nasser
• Granted Patent: US 9,579,193 B2
• Time in Patent Office: Days
• US Class Current: 623/1.26
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22047 Means for immobilising the guide wire in the patient
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

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 tubular member configured for deployment in a lumenal system of a patient;

b) at least one tether extending from the prosthesis for controlling placement of the prosthesis.

2. The prosthesis of claim 1, further comprising at least one conduit connected to the tubular member, the conduit being adapted and configured to guide placement of the prosthesis.

3. A prosthesis delivery system, comprising:

a) a central shaft;

b) a prosthesis according to claim 1 disposed on the central shaft;

c) a retractable sheath covering the prosthesis; and

d) a passage in the catheter 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. A prosthesis, comprising:

a) a tubular member configured for deployment in a lumenal system of a patient;

b) at least one conduit connected to the tubular member, the conduit being adapted and configured to guide placement of the prosthesis.

5. The prosthesis of claim 4, further comprising at least one tether extending from the prosthesis for controlling placement of the prosthesis.

6. A prosthesis delivery system, comprising:

a) a central shaft;

b) a prosthesis according to claim 4 disposed on the central shaft;

c) at least one tether passing through the conduit.

7. A valve prosthesis, comprising:

a tubular member configured for deployment in a heart valve annulus;

a first set of fastening mechanisms radially and outwardly disposed from the tubular member and configured to attach the valve prosthesis to cardiac tissue above the heart valve annulus; and

a second set of fastening mechanisms radially and outwardly disposed from the tubular member and configured to attach the valve prosthesis to cardiac tissue below the heart valve annulus.

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

a third set of fastening mechanisms radially and outwardly disposed from the tubular member and configured to attach the valve prosthesis to cardiac tissue at or above the heart valve annulus.

9. The valve prosthesis of claim 7, wherein the first set of fastening mechanisms is formed by proximal portions of a series of loop elements that are connected to form a looped structure.

10. The valve prosthesis of claim 7, wherein the second set of fastening mechanisms is formed by distal portions of a series of loop elements that are connected to form a looped structure.

11. The valve prosthesis of claim 7, comprising:

a plurality of first loop elements connected to form a ring shape, each first loop element comprising;

a mid portion;

a proximal portion that extends radially and outwardly away from the mid portion at a first terminal end of the mid portion; and

a distal portion that extends radially and outwardly away from the mid portion at a second terminal end of the mid portion.

12. The valve prosthesis of claim 11, wherein the mid portions of the plurality of first loop elements configured in the ring shape form the tubular member.

13. The valve prosthesis of claim 11, wherein the proximal portions of the plurality of first loop elements configured in the ring shape form the first set of fastening mechanisms.

14. The valve prosthesis of claim 11, wherein the distal portions of the plurality of first loop elements configured in the ring shape form the second set of fastening mechanisms.

15. The valve prosthesis of claim 11, further comprising:

a plurality of second loop elements connected to form a ring shape, each second loop element comprising;

a mid portion; and

a proximal portion that extends radially and outwardly away from the mid portion at a first terminal end of the mid portion.

16. The valve prosthesis of claim 13, wherein the mid portions of the plurality of first loop elements and the mid portions of the plurality of second loop elements form the tubular member.

17. The valve prosthesis of claim 15, wherein:

the proximal portions of the plurality of first loop elements configured in the ring shape form the first set of fastening mechanisms;

the distal portions of the plurality of first loop elements configured in the ring shape form the second set of fastening mechanisms; and

the proximal portions of the plurality of second loop elements configured in the ring shape form a third set of fastening mechanisms radially and outwardly disposed from the tubular member and configured to attach the valve prosthesis to cardiac tissue at or above the heart valve annulus.

18. The valve prosthesis of claim 15, wherein the plurality of first loop elements and the plurality of second loop elements are connected side-by-side in an alternating manner to form the ring shape.

19. The valve prosthesis of claim 11, wherein each of the plurality of second loop elements is provided within one of the plurality of first loop elements, and wherein pairs of first and second loop elements are connected side-by-side to form the ring shape.

20. The valve prosthesis of claim 11, wherein one or more spacings between the first loop elements and a spacing within each of the first loop elements is configured such that the valve prosthesis is compliant and conforms to the shape and anatomy of the heart valve annulus in a natural manner.