Device for the implantation and fixation of prosthetic valves

• US RE45,790 E1
• Filed: 08/07/2014
• Issued: 11/03/2015
• Est. Priority Date: 10/28/2005
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology GmbH (JenaValve Technology, Inc.)
• Inventors: Figulla, Hans-Reiner, Ferrari, Markus, Damm, Christoph
• Primary Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US14/454,285
• Time in Patent Office: 453 Days
• Field of Search: 623/1.26, 623/2.38, 623/2.17, 623/2.18
• US Class Current: 1/1
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

A device for the transvascular implantation and fixation of prosthetic heart valves having a self-expanding heart valve stent (10) with a prosthetic heart valve (11) at its proximal end is introducible into a patient'"'"'s main artery. With the objective of optimizing such a device to the extent that the prosthetic heart valve (11) can be implanted into a patient in a minimally-invasive procedure, to ensure optimal positioning accuracy of the prosthesis (11) in the patient'"'"'s ventricle, the device includes a self-expanding positioning stent (20) introducible into an aortic valve positioned within a patient. The positioning stent is configured separately from the heart valve stent (10) so that the two stents respectively interact in their expanded states such that the heart valve stent (10) is held by the positioning stent (20) in a position in the patient'"'"'s aorta relative the heart valve predefinable by the positioning stent (20).

Claims

1. A method of treating a native aortic valve, comprising:

positioning an expandable first stent adjacent the native aortic valve, the first stent having a first attachment element disposed adjacent a distal end of the first stent and at least one positioning element disposed adjacent a proximal end of the first stent, wherein the proximal end of the first stent is positioned closer to a patient'"'"'s heart than the distal end of the first stent;

positioning the at least one positioning element behind a portion of a leaflet of the native valve, radially outward from the leaflet and radially inward from a portion of a vessel wall;

anchoring the first stent relative to the native aortic valve by expanding the first stent;

after expanding the first stent, positioning an expandable second stent radially within the first stent to connect the second stent to the first stent, the second stent having a second attachment element disposed adjacent a distal end of the second stent, wherein the proximal end of the second stent is positioned closer to the patient'"'"'s heart than the distal end of the second stent; and

compressing at least a portion of a leaflet of the native valve against a vessel wall such that the compressed portion of the leaflet is positioned radially inward from the at least one positioning element of the first stent and radially outward from a portion of the second stent component;

wherein the first and second attachment elements are complimentary to one another.

2. The method of claim 1, wherein the second stent includes a plurality of engagement elements configured to be selectively attached to a catheter.

3. The method of claim 1, further including:

disconnecting the second stent from the first stent; and

positioning an expandable third stent radially within the first stent to connect the third stent to the first stent, the third stent having a third attachment element adjacent a distal end of the third stent;

wherein the first and third attachment elements are complimentary to one another.

4. The method of claim 1, further including:

positioning the at least one positioning element behind the portion of the leaflet before compressing a portion of the leaflet against the vessel wall.