Sinus-engaging valve fixation member

• US 9,913,714 B2
• Filed: 06/10/2016
• Issued: 03/13/2018
• Est. Priority Date: 09/19/2006
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tuval, Yossi, Benary, Raphael, Kilemnik, Ido
• Primary Examiner(s): Prone, Christopher D
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US15/179,483
• Publication Number:
  US 20160354203A1
• Time in Patent Office: 641 Days
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Claims

1. A valve prosthesis comprising:

a first support structure adapted for delivery into a patient'"'"'s native heart valve complex in a collapsed condition and adapted for circumferential expansion to an expanded condition when in the native heart valve complex, the first support structure including;

a first end including a section configured to be positioned at and directly contact a valvular annulus of the patient, the first end including a plurality of circumferentially spaced commissural posts, and

a second end;

prosthetic leaflets disposed in the first support structure; and

a second support structure configured for pushing radially outwardly on the patient'"'"'s native valve leaflets when the first support structure is in the expanded condition, the second support structure having a first end connected at a junction to the first end of the first support structure prior to delivery to the patient'"'"'s native heart valve, and a free end disposed between the junction and the second end of the first support structure, the second support structure including a plurality of engagement arms that are circumferentially spaced from one another, each of the engagement arms being cantilevered from the junction,

wherein the free ends of the plurality of engagement arms are circumferentially spaced from one another between two circumferentially adjacent commissural posts of the plurality of commissural posts.

2. The valve prosthesis of claim 1 wherein the free ends of the plurality of engagement arms includes are disposed opposite the junction.

3. The valve prosthesis of claim 2, wherein all of the engagement arms extend the same distance from the junction toward the second end of the frame structure.

4. The valve prosthesis of claim 1 wherein circumferentially adjacent engagement arms of the plurality of engagement arms are coupled to each other at a location spaced from the section of the first support structure configured to be positioned at a valvular annulus of the patient.

5. The valve prosthesis of claim 1, wherein the prosthetic leaflets are attached to the commissural posts.

6. The valve prosthesis of claim 5, wherein the prosthetic leaflets consist of three leaflets and the plurality of commissural posts consist of three commissural posts, wherein each of the three commissural posts has a respective end of two of the leaflets attached thereto.

7. The valve prosthesis of claim 1, wherein the first support structure is an inner support structure and the second support structure is an outer support structure.

8. The valve prosthesis of claim 1, wherein the section configured to be positioned at a valvular annulus of the patient is a narrowed throat section.

9. The valve prosthesis of claim 1, wherein the second end bulges radially outwardly relative to the section configured to be positioned at a valvular annulus of the patient.

10. A valve prosthesis comprising:

a first support structure adapted for delivery into a patient'"'"'s native heart valve complex in a collapsed condition and adapted for circumferential expansion to an expanded condition when in the native heart valve complex, the first support structure including;

a first end including a section configured to be positioned at and directly contact a valvular annulus of the patient, and

a second end;

prosthetic leaflets disposed in the first support structure; and

a second support structure configured for pushing radially outwardly on the patient'"'"'s native valve leaflets when the first support structure is in the expanded condition, the second support structure having a first end connected at a junction to the first end of the first support structure prior to delivery to the patient'"'"'s native valve, and a free end disposed between the junction and the second end of the first support structure, the second support structure including a plurality of engagement arms that are circumferentially spaced from one another, each of the engagement arms being cantilevered from the junction,

wherein the second support structure further includes a second plurality of engagement arms disposed radially outside of the plurality of engagement arms, wherein the second plurality of engagement arms are configured for placement radially outside the patient'"'"'s native valve leaflets.