Device for the implantation and fixation of prosthetic valves

• US 9,044,320 B2
• Filed: 09/06/2013
• Issued: 06/02/2015
• 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): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US14/020,497
• Publication Number:
  US 20140074229A1
• Time in Patent Office: 634 Days
• Field of Search: 623/1.24, 623/1.26, 623 21- 219
• US Class Current: 1/1
• 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 valve prosthesis, comprising:

a self-expandable outer stent component including exactly three struts configured for placement between each of three respective portions of a native aortic valve and an aorta wall upon implantation of the valve prosthesis relative to the native aortic valve;

a self-expandable inner stent component coupled to the self-expandable outer stent component at a distal end of the outer stent component configured to be positioned farther from a native heart than a proximal end of the outer stent component, at least a portion of the inner stent component being radially inward of the struts, the valve prosthesis configured to receive the three portions of the native aortic valve between the respective three struts and the inner stent component upon implantation of the valve prosthesis relative to the native aortic valve; and

a prosthetic valve component coupled to the self-expandable inner stent component.

2. The valve prosthesis of claim 1, wherein the prosthetic valve component is configured to function as the native aortic valve upon implantation of the valve prosthesis relative to the native aortic valve.

3. The valve prosthesis of claim 1, wherein the valve prosthesis has a collapsed configuration and includes a plurality of attachment elements for attachment to a catheter in the collapsed configuration.

4. The valve prosthesis of claim 3, wherein the attachment elements include eyelets.

5. A valve prosthesis, comprising:

an outer stent component including exactly three struts equidistant to one another, the exactly three struts configured for placement between three respective portions of a native aortic valve and an aorta wall upon implantation of the valve prosthesis relative to the native aortic valve, each strut having an apex pointing in the proximal direction towards a native heart;

an inner stent component coupled to the outer stent component, at least a portion of the inner stent component being radially inward of the struts to receive the respective three portions of the native aortic valve between the three struts and the inner stent component upon implantation of the valve prosthesis relative to the native aortic valve; and

a prosthetic valve component coupled to the inner stent component;

wherein the valve prosthesis is configured to maintain a position relative to the native aortic valve by holding the portions of the native heart valve between the inner stent component and the outer stent component.

6. The valve prosthesis of claim 5, wherein both of the outer stent component and the inner stent component are self-expandable.

7. The valve prosthesis of claim 5, wherein the inner stent component is coupled to the outer stent component at a distal end of the outer stent component configured to be positioned farther from a native heart than a proximal end of the outer stent component.

8. The valve prosthesis of claim 7, wherein the inner stent component is coupled to the outer stent component at distal ends of the struts.

9. The valve prosthesis of claim 5, wherein the inner stent component includes a plurality of first elements and the outer stent component includes a plurality of second elements, the first elements being complementary to the second elements to couple the inner stent component to the outer stent component.