Devices, systems and methods for repairing lumenal systems

• US 10,398,551 B2
• Filed: 01/23/2017
• Issued: 09/03/2019
• Est. Priority Date: 09/22/2011
• Status: Active Grant

• Current Assignee: Transmural Systems LLC
• Original Assignee: Transmural Systems LLC
• Inventors: Rafiee, Nasser
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US15/413,017
• Publication Number:
  US 20170128206A1
• Time in Patent Office: 953 Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• 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 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

The disclosure provides systems and related methods for delivering a prosthesis to a target location. The system includes a tether delivery catheter and a prosthesis delivery catheter, and also can include a lock delivery catheter or knot pusher, as desired. Various embodiments of useful valve prostheses are also disclosed.

Claims

1. A prosthesis delivery catheter, comprising:

a) an elongate inner body having a distal tip;

b) an elongate tubular outer body being disposed about the elongate inner body, the elongate tubular outer body being axially displaceable with respect to the elongate inner body, a distal region of the elongate tubular outer body and the elongate inner body cooperating to define a substantially annular prosthesis chamber for receiving a compressed prosthesis; and

c) a compressed prosthesis disposed about the elongate inner body in the prosthesis chamber, the compressed prosthesis having at least one tether eyelet, the at least one tether eyelet being configured for receiving an elongate tether therethrough; and

d) at least one elongate tether extending along an outside surface of the prosthesis delivery catheter, wherein the at least one tether extends along a first exterior portion of the prosthesis delivery catheter, through the at least one tether eyelet, and along a second exterior portion of the prosthesis delivery catheter, the compressed prosthesis being configured to expand radially outwardly and deployed when the elongate inner body is displaced axially with respect to the elongate tubular outer body to permit the prosthesis to be advanced along the at least one elongate tether toward an anchor that is anchored at an anatomical location where the prosthesis is to be installed.

2. The prosthesis delivery catheter of claim 1, wherein the prosthesis includes a single tether eyelet and further wherein the at least one elongate tether is radiopaque.

3. The prosthesis delivery catheter of claim 1, wherein the at least one tether eyelet includes a plurality of tether eyelets extending radially outwardly therefrom and radially outwardly past the outer surface of the elongate tubular outer body, the plurality of tether eyelets being circumferentially spaced from each other about a longitudinal axis of the prosthesis delivery catheter.

4. The prosthesis delivery catheter of claim 3, wherein the plurality of tether eyelets are spaced equally from each other about the longitudinal axis of the prosthesis delivery catheter.

5. The prosthesis delivery catheter of claim 3, wherein the at least one tether eyelet includes two tether eyelets spaced from each other about the longitudinal axis of the prosthesis delivery catheter.

6. The prosthesis delivery catheter of claim 3, wherein two tether eyelets of the plurality of tether eyelets are spaced from each other by about 180 degrees.

7. The prosthesis delivery catheter of claim 1, wherein at least one tether eyelet extends radially outwardly through a juncture defined in the tubular outer body.

8. The prosthesis delivery catheter of claim 1, wherein the tubular outer body includes a radiopaque marker.

9. The prosthesis delivery catheter of claim 1, wherein the prosthesis includes a generally tubular body configured for placement proximate a mitral annulus having a generally tubular upper portion configured to substantially reside in the left atrium above the mitral annulus, the generally tubular upper portion having a first circumferential wall that is outwardly biased to urge against cardiac tissue of the left atrium.

10. The prosthesis delivery catheter of claim 9, wherein the first circumferential wall includes a plurality of independently articulable loops that are configured to grip around the circumference of the atrial side of the mitral annulus.

11. The prosthesis delivery catheter of claim 10, wherein the prosthesis also includes a generally tubular lower portion extending downwardly from the generally tubular upper portion, the generally tubular lower portion being configured to substantially reside in the left ventricle below the mitral annulus, the tubular lower portion being defined by a generally circumferential wall that extends downwardly from the generally tubular upper portion.

12. The prosthesis delivery catheter of claim 11, wherein the generally tubular lower portion includes at least one independently articulable anchor biased to extend radially outwardly from the generally tubular lower portion to urge against the ventricular side of the mitral annulus to prevent the prosthesis from moving through the mitral opening toward the atrium.

13. The prosthesis delivery catheter of claim 12, further comprising at least one prosthetic valve leaflet disposed within the tubular body, the at least one prosthetic valve leaflet being configured to occupy at least a portion of an opening defined by the generally tubular upper portion and the lower portion.

14. The prosthesis delivery catheter of claim 11, wherein the prosthesis includes a plurality of independently articulable anchors that are biased to extend radially outwardly from the generally tubular lower portion to urge against the ventricular side of the mitral annulus to prevent the prosthesis from moving through the mitral opening toward the atrium.

15. The prosthesis delivery catheter of claim 11, wherein the generally tubular lower portion includes at least one downwardly extending pole for permitting attachment of a tissue valve thereto.

16. The prosthesis delivery catheter of claim 10, wherein the prosthesis includes a fabric spanning across a framework of the prosthesis.

17. The prosthesis delivery catheter of claim 10, wherein the plurality of independently articulable loops include a fabric material disposed on the loops.

18. The prosthesis delivery catheter of claim 1, wherein the prosthesis includes a generally tubular upper portion having a first circumferential wall that in turn has a first circumferential end and a second circumferential end, and defining a first circumferential gap therebetween.

19. The prosthesis delivery catheter of claim 18, wherein the generally tubular upper portion is biased to urge against cardiac tissue of the left atrium.

20. The prosthesis delivery catheter of claim 19, wherein the first circumferential wall includes a plurality of independently articulable frame portions configured to grip around the circumference of the atrial side of the mitral annulus.