Transseptal delivery system

• US 10,631,984 B2
• Filed: 12/15/2016
• Issued: 04/28/2020
• Est. Priority Date: 12/15/2015
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Inventors: Nyuli, Colin A., Lane, Randy Matthew, Wong, Karen Tsoek-Ji
• Primary Examiner(s): Erezo, Darwin P
• Assistant Examiner(s): Schwiker, Katherine H
• Application Number:
  US15/379,748
• Publication Number:
  US 20170165064A1
• Time in Patent Office: 1,230 Days
• Field of Search: 623 211
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A delivery system includes a delivery catheter with a capsule configured to carry a prosthesis and a steering catheter for steering the delivery catheter. The delivery catheter can be advanced through a patient'"'"'s vasculature to a target treatment area. The capsule can be opened and the prosthesis can be deployed into the target treatment area. Additionally, a method for delivering a prosthesis to a target treatment area includes advancing a delivery catheter through a patient'"'"'s vasculature to the target treatment area, steering the delivery catheter toward the target treatment area, opening a capsule on the delivery catheter, and deploying the prosthesis into the target treatment area.

Claims

1. A delivery system for delivering a prosthesis to a target treatment area, the system comprising:

an inner guidewire catheter having a proximal end, a distal end, and a lumen extending therebetween, the lumen sized to slidably receive a guidewire;

a distal capsule coupled to the distal end of the inner guidewire catheter, wherein the distal capsule comprises an inner channel sized to receive the prosthesis;

a bell catheter slidably disposed over the inner guidewire catheter, the bell catheter having a bell element adjacent a distal end of the bell catheter;

an anchor catheter slidably disposed over the bell catheter, the anchor catheter having an anchor element adjacent a distal end of the anchor catheter and configured to engage the prosthesis, and wherein the bell element constrains the prosthesis into engagement with the anchor element;

a sheath catheter slidably disposed over the anchor catheter, the sheath catheter having a proximal end and a distal end;

a proximal capsule coupled to the distal end of the sheath catheter, wherein the proximal capsule comprises an inner channel sized to receive the prosthesis; and

an actuator mechanism comprising a first rotational actuator element and a second rotational actuator element, wherein the first rotational actuator element is operably coupled to both the inner guidewire catheter and the bell catheter, wherein actuation of the first rotational actuator element in a first direction moves the distal capsule toward the proximal capsule, and wherein actuation of the first rotational actuator element in a second direction opposite the first direction moves the distal capsule away from the proximal capsule and moves the bell element away from the anchor element thereby removing a constraint from the prosthesis and allowing the prosthesis to expand, and

wherein the second rotational actuator element is operably coupled to the sheath catheter, wherein actuation of the second rotational actuator element in one direction moves the proximal capsule away from the distal capsule, and wherein actuation of the second rotational actuator element in another direction opposite the one direction moves the proximal capsule into engagement with the distal capsule thereby enclosing the prosthesis therein.

2. The system of claim 1, further comprising a steerable catheter having an actuator mechanism comprising a rotatable knob, wherein the inner guidewire catheter, the bell catheter, the anchor catheter, and the sheath catheter are slidably disposed in the steerable catheter, and wherein actuation of the rotatable knob steers the steerable catheter, thereby steering the inner guidewire catheter, the bell catheter, the anchor catheter, and the sheath catheter.

3. The system of claim 2, wherein the steerable catheter comprises a plurality of pull wires coupled thereto, and wherein actuation of the rotatable knob moves the plurality of wires thereby steering the steerable catheter.

4. The system of claim 1, further comprising a handle coupled to a proximal portion of the delivery system, the actuator mechanism coupled to the handle.

5. The system of claim 4, wherein the first and the second rotational actuator elements each comprise a rotatable thumbwheel.

6. The system of claim 1, wherein the distal capsule comprises an expandable member.

7. The system of claim 6, wherein the expandable member comprises a stent or a balloon.

8. The system of claim 1, wherein the distal capsule comprises a corrugated region.

9. The system of claim 1, wherein the distal capsule comprises a plurality of hinged splines configured to radially expand at the hinge when compression is applied to the plurality of hinged splines.

10. The system of claim 1, wherein the distal capsule comprises proximal portion, a distal portion, and a plurality of filaments, and wherein movement of the plurality filaments moves the proximal portion relative to the distal portion thereby increasing or decreasing a length of the distal capsule.

11. The system of claim 1, further comprising the prosthesis, and wherein the prosthesis is a prosthetic mitral valve.

12. A method for delivering a prosthesis to a target treatment area, the method comprising:

providing a delivery system having a distal capsule coupled to an inner guidewire catheter and a proximal capsule coupled to a sheath catheter, a bell catheter having a bell element disposed adjacent a distal end of the bell catheter, an anchor catheter having an anchor element adjacent a distal end of the anchor catheter, and a sheath catheter having a proximal capsule coupled to a distal end of the sheath catheter;

actuating an actuation mechanism comprising a first rotational actuator element and a second rotational actuator element, wherein the actuating comprises actuating the first rotational actuator element in a first direction thereby moving the proximal capsule toward the distal capsule, and wherein the actuating further comprises actuating the first rotational actuator element in a second direction opposite the first direction thereby moving the proximal capsule away from the distal capsule and moving the bell element away from the anchor element, and

wherein the actuating further comprises actuating the second rotational actuator element in one direction thereby moving the proximal capsule away from the distal capsule, and wherein the actuating further comprises actuating the second rotational actuator element in another direction opposite the one direction thereby moving the proximal capsule into engagement with the distal capsule thereby enclosing the prosthesis therein;

releasing the prosthesis disposed in the proximal and distal capsules; and

deploying the prosthesis in the target treatment area.

13. The method of claim 12, wherein the inner guidewire catheter is slidably disposed in the sheath catheter, and wherein actuating the first rotational actuator element moves the inner guidewire catheter relative to the sheath catheter.

14. The method of claim 12, wherein actuating the first rotational actuator element or the second rotational actuator element comprises rotating a thumbwheel.

15. The method of claim 12, further comprising steering the delivery system with a steerable catheter disposed over the delivery system.

16. The method of claim 15, wherein the steering comprises actuating an actuator mechanism comprising a rotatable knob operably coupled to the steerable catheter.

17. The method of claim 16, wherein actuating the actuator mechanism comprises moving a plurality of pull wires coupled to the rotatable knob and the steerable catheter.

18. The method of claim 12, wherein the distal capsule comprises an expandable member, the method further comprising radially expanding or radially collapsing the expandable member.

19. The method of claim 18, wherein the expandable member comprises a stent or a balloon.

20. The method of claim 12, wherein the distal capsule comprises a corrugated region, the method further comprising axially expanding or axially collapsing the corrugated region.

21. The method of claim 12, wherein the distal capsule comprises a plurality of hinged splines, the method further comprising radially expanding the hinged splines by applying compression thereto, or radially collapsing the hinged splines by applying tension thereto.

22. The method of claim 12, wherein the distal capsule comprises a proximal portion, a distal portion, and a plurality of filaments, the method further comprising moving the plurality of filaments thereby moving the distal capsule toward or away from the proximal capsule.

23. The method of claim 12, wherein the target treatment area is a native mitral valve.

24. The method of claim 12, wherein the prosthesis is a prosthetic mitral valve.