Sinus-Engaging Valve Fixation Member

• US 20140379077A1
• Filed: 09/12/2014
• Published: 12/25/2014
• 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
• Granted Patent: US 9,387,071 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• 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 support structure, comprising:

a collapsible outer support structure having exactly three distal outer strut supports and exactly three proximal engagement arms, each engagement arm linking two distal outer strut supports, and each engagement arm having an upwardly concave shape so as to define respective peaks at junctures with the distal outer strut supports and respective troughs between each of respective peaks; and

a collapsible inner support structure having exactly three distal inner strut supports extending from a proximal skirt, wherein the proximal skirt includes a flared distal portion, a narrowed throat portion, and a bulging proximal portion;

wherein the outer support structure is sutured to the inner support structure at respective outer and inner strut supports.

2. The valve prosthesis support structure of claim 1, wherein each engagement arm is at a distance of about 0.5 mm to about 8 mm from the other respective engagement arms.

3. The valve prosthesis support structure of claim 1, wherein the trough of each engagement arm is at a distance of about 1 mm to about 14 mm from the proximal skirt of the inner support structure.

4. The valve prosthesis support structure of claim 1, wherein the inner diameter at the level of the inner support struts of the inner support structure has a diameter of about 23 mm, and the trough of each engagement arm is at a distance of about 1 mm to about 10 mm from the proximal skirt of the inner support structure.

5. The valve prosthesis support structure of claim 1, wherein the inner diameter at the level of the inner support struts of the inner support structure has a diameter of about 26 mm, and the trough of each engagement arm is at a distance of about 1 mm to about 12 mm from the proximal skirt of the inner support structure.

6. The valve prosthesis support structure of claim 1, wherein the throat portion of the proximal skirt of the inner support structure has a diameter of about 29 mm, and the trough of The valve prosthesis support structure of claim 1, wherein the inner diameter at the level of the inner support struts of the inner support structure has a diameter of about 29 mm, and the trough of each engagement arm is at a distance of about 1 mm to about 14 mm from the proximal skirt of the inner support structure.

7. A valve prosthesis, comprising:

a distal fixation member having exactly three distal outer strut supports and exactly three proximal engagement arms, each engagement atm linking two distal outer strut supports, and each engagement arm having an upwardly concave shape so as to define respective peaks at junctures with the distal outer strut supports and respective troughs between each of respective peaks;

a proximal fixation member having exactly three distal inner strut supports extending from a proximal skirt, wherein the proximal skirt includes a flared distal portion, a narrowed throat portion, and a bulging proximal portion, wherein the distal fixation member is sutured to the proximal fixation member at respective outer and inner strut supports; and

a valve sutured to the proximal fixation member.

8. The valve prosthesis of claim 7, wherein each engagement arm is at a distance of about 0.5 mm to about 8 mm from the other respective engagement arms.

9. The valve prosthesis support structure of claim 7, wherein the trough of each engagement arm is at a distance of about 1 mm to about 14 mm from the proximal skirt of the proximal fixation member.

10. The valve prosthesis support structure of claim 7, wherein the inner diameter at the level of the inner support struts of the proximal fixation member has a diameter of about 23 mm, and the trough of each engagement arm is at a distance of about 1 mm to about 10 mm from the proximal skirt of the proximal fixation member at a distance of about 1 mm to about 10 mm from the proximal skirt of the proximal fixation member.

11. The valve prosthesis support structure of claim 7, wherein the inner diameter at the level of the inner support struts of the proximal fixation member has a diameter of about 26 mm, and the trough of each engagement arm is at a distance of about 1 mm to about 12 mm from the proximal skirt of the proximal fixation member.

12. The valve prosthesis support structure of claim 7, wherein the inner diameter at the level of the inner support struts of the proximal fixation member has a diameter of about 29 mm, and the trough of each engagement arm is at a distance of about 1 mm to about 14 mm from the proximal skirt of the proximal fixation member.