Methods and systems for delivering prostheses using rail techniques

• US 9,579,193 B2
• Filed: 05/03/2013
• Issued: 02/28/2017
• 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): Sevilla, Christian
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US13/887,043
• Publication Number:
  US 20140018906A1
• Time in Patent Office: 1,397 Days
• US Class Current: 1/1
• 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 method for treating a lumenal anatomical location, comprising:

a) advancing a distal region of a delivery catheter proximate a target location in a patient'"'"'s lumenal system;

b) dispensing a penetrating member from the delivery catheter proximate the target location;

c) advancing the penetrating member through a first portion of lumenal tissue proximate the target location to define a first passage;

d) advancing an end of a first tether through the first passage, the first tether having a first anchor disposed at the end thereof;

e) advancing the first tether through the first passage until the first anchor bears against tissue proximate the first passage;

f) disposing a prosthesis over the first tether; and

g) advancing the prosthesis over the first tether to a position proximate the target location; and

h) installing the prosthesis at the target location, wherein the prosthesis is compliant and conforms to the shape and the anatomy of the target location.

2. The method of claim 1, wherein the method further comprises:

a) advancing the penetrating member through a second portion of lumenal tissue proximate the target location to define a second passage;

b) advancing an end of a second tether through the second passage, the second tether having a second anchor disposed at the end thereof;

c) advancing the second tether through the second passage until the second anchor bears against tissue proximate the second passage;

d) disposing the prosthesis over the first and second tethers; and

e) advancing the prosthesis over the first and second tethers to a position proximate the target location.

3. The method of claim 2, wherein the target location is proximate a patient'"'"'s mitral annulus.

4. The method of claim 3, wherein the first and second passages pass through the commissures of the mitral valve.

5. The method of claim 1, further comprising anchoring the prosthesis in place in the target location using at least one lock.

6. The method of claim 5, wherein the lock is attached to the first tether and urges the prosthesis and anchor toward one another along the first tether.

7. The method of claim 1, wherein the prosthesis defines an open lumen therethrough upon installation.

8. The method of claim 7, further comprising disposing a second prosthesis within the open lumen, the second prosthesis defining an open lumen therethrough upon installation, the second prosthesis also being compliant and conforming to the shape and the anatomy of the target location.

9. The method of claim 8, wherein the second prosthesis includes a lumenal valve.

10. The method of claim 9, wherein the lumenal valve includes synthetic material.

11. The method of claim 9, wherein the lumenal valve includes living tissue.

12. The method of claim 1, wherein the prosthesis includes a stent graft.

13. The method of claim 1, wherein the prosthesis includes at least one prosthesis tether attached thereto, and the method further includes attaching the prosthesis tether to the first tether to secure the prosthesis in place.

14. The method of claim 1, wherein the delivery catheter enters the heart through an incision proximate the bottom of the left ventricle.

15. The method of claim 1, wherein the delivery catheter enters the heart through an incision proximate the top of the left atrium.

16. The method of claim 1, wherein the delivery catheter enters the heart percutaneously via an artery.

17. A method for treating a lumenal anatomical location, comprising:

a) advancing a distal region of a delivery catheter proximate a target location in a patient'"'"'s lumenal system;

b) deploying a prosthesis from a distal region of the catheter, the prosthesis having at least one tether connected thereto for controlling placement of the prosthesis;

c) directing a fixation catheter over the tether to the prosthesis; and

d) applying at least one lock to secure the prosthesis.

18. The method of claim 17, further comprising inflating an inflatable member inside the prosthesis to prevent leakage around a periphery of the prosthesis after at least partial deployment of the prosthesis.