Articulatable prosthetic valve

• US 10,524,910 B2
• Filed: 07/30/2015
• Issued: 01/07/2020
• Est. Priority Date: 07/30/2014
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Limited 3 Ariel Sharon Avenue
• Inventors: Hammer, Tal, Iamberger, Meni, Herman, Yaron, Zipory, Yuval, Hoffer, Eran, Albitov, Michael, Kruglova, Natalia, Reich, Tal, Hariton, Ilia, Baum, Aviram
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): Mendoza, Michael G
• Application Number:
  US15/329,920
• Publication Number:
  US 20170266003A1
• Time in Patent Office: 1,622 Days
• 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 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A rod (508) is transfemorally advanceable to the heart. An implant (460) comprises (i) a first frame (462), compressed around a first longitudinal site of a distal portion of the rod, (ii) a second frame (464), compressed around a third longitudinal site of the distal portion, (iii) a valve member (50), disposed within the second frame, and (iv) a flexible sheet (466), coupling the first frame to the second frame, and disposed around a second longitudinal site of the distal portion, the second longitudinal site being between the first longitudinal site and the third longitudinal site. An extracorporeal controller (569) is coupled to a proximal portion of the rod, and is operably coupled to the distal portion of the rod. Operating the controller bends the distal portion of the rod causing articulation between the frames. Other embodiments are also described.

Claims

1. Apparatus, for use with a native atrioventricular valve between an atrium and a ventricle of a heart of a subject, the apparatus comprising:

a delivery tool, comprising;

a rod, transfemorally advanceable to the heart, and having a proximal portion, a steerable distal portion, and an intermediate portion therebetween; and

an extracorporeal rod-controller; and

an implant implantable at the native atrioventricular valve, the implant, comprising;

a first frame, compressed onto the distal portion,

a second frame, compressed around the distal portion in tandem with the first frame, and articulatably coupled to the first frame, and

a valve member, disposed within the second frame,

wherein;

the implant is configured to serve as a prosthetic atrioventricular valve between the atrium and the ventricle, such that the valve member facilitates one-way blood flow from the atrium, via the first and second frames, to the ventricle,

the extracorporeal rod-controller is;

coupled to the proximal portion of the rod, and

operably coupled, via the intermediate portion of the rod, to the distal portion of the rod such that operating the extracorporeal rod-controller steers the steerable distal portion of the rod at at least a longitudinal site of the distal portion, causing articulation between the first frame and the second frame, and

the delivery tool is configured to implant the first frame and the second frame at the native atrioventricular valve.

2. The apparatus according to claim 1, further comprising a sheath, disposed over the implant, and being sufficiently flexible to passively bend in response to the bending of the rod and the articulation between the first frame and the second frame.

3. The apparatus according to claim 1, further comprising a first catheter and a second catheter, wherein:

the first catheter is dimensioned for transfemoral and transseptal advancement into a left atrium of a heart of a subject, and has a lumen that has an internal diameter;

the second catheter has an external diameter that is smaller than the internal diameter, and is sufficiently long to extend through the first catheter such that a steerable distal portion of the second catheter extends out of a distal end of the first catheter; and

the prosthetic valve has a compressed state in which the implant is transfemorally and transseptally advanceable into the left atrium by the first catheter and the second catheter, and in which a width of the prosthetic valve is greater than the internal diameter.

4. The apparatus according to claim 1, further comprising:

a first restraint, coupled to the rod, restraining the first frame in a compressed state thereof; and

a second restraint, coupled to the rod, restraining the second frame in a compressed state thereof,

wherein the extracorporeal rod-controller is configured to disengage the first restraint from the first frame, and to disengage the second restraint from the second frame.

5. The apparatus according to claim 1, wherein the longitudinal site of the distal portion is a second longitudinal site of the distal portion, the first frame is compressed around a first longitudinal site of the distal portion, and the second frame is compressed around a third longitudinal site of the distal portion, the second longitudinal site being between the first longitudinal site and the third longitudinal site.

6. The apparatus according to claim 5, wherein the prosthetic valve further comprises a flexible sheet, coupling the first frame to the second frame, and disposed around the second longitudinal site of the distal portion.

7. The apparatus according to claim 1, wherein the second frame is compressed around the distal portion at a longitudinal location distally from the first frame.