Valve Prosthetic Fixation Techniques Using Sandwiching

• US 20110288634A1
• Filed: 07/25/2011
• Published: 11/24/2011
• Est. Priority Date: 09/19/2006
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Kilemnik, Ido, TUVAL, Yosi, Benary, Raphael
• Granted Patent: US 8,771,346 B2
• Time in Patent Office: Days
• US Class Current: 623/1.26
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 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 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A prosthesis is provided for implantation at a native semilunar valve of a native valve complex. The prosthesis includes a distal fixation member, configured to be positioned in a downstream artery, and shaped so as to define exactly three proximal engagement arms that are configured to be positioned at least partially within respective ones of semilunar sinuses, and, in combination, to apply, to tissue that defines the semilunar sinuses, a first axial force directed toward a ventricle. The prosthesis further includes a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native semilunar valve, and to apply, to the ventricular side of the native valve complex, a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex.

Claims

1-188. -188. (canceled)

189. An expandable stent for implantation in a patient comprising a plurality of positioning arches configured to be positioned within a plurality of pockets of the patient'"'"'s native heart valve and positioned on a first side of a plurality of native heart valve leaflets, and a plurality of retaining arches configured to be positioned on a second side of the plurality of native heart valve leaflets opposite the first side.

190. The expandable stent according to claim 189, further including at least one auxiliary arch interspaced between two adjacent retaining arches, wherein:

the at least one auxiliary arch includes a first arm connected at a first end thereof to a first retaining arch and a second arm connected at a first end thereof to a second retaining arch; and

the first and second arms each including respective second ends connected to one another at a joint that includes at least one fastening hole configured to receive a suture.

191. The expandable stent according to claim 190, further comprising at least one additional fastening portion substantially circumferentially aligned with one of the plurality of auxiliary arches, the at least one additional fastening portion including a plurality of fastening holes configured to receive a suture.

192. The expandable stent according to claim 189, further comprising at least one radial arch substantially circumferentially aligned with at least one of the plurality of positioning arches.

193. The expandable stent according to claim 192, wherein the at least one radial arch includes a substantially U-shaped structure.

194. The expandable stent according to claim 189, further comprising a plurality of auxiliary arches, each interspaced between two adjacent retaining arches and including a first arm connected at a first end thereof to a first retaining arch and a second arm connected at a first end thereof to a second retaining arch.

195. The expandable stent according to claim 194, further comprising a plurality of extra arches, each interspaced between a retaining arch and an adjacent auxiliary arch and including a first arm connected at a first end thereof to one arm of a retaining arch and a second arm connected at a first end thereof to one arm of an auxiliary arch, wherein the first and second arms of each of the plurality of extra arches include respective second ends connected to one another at a connection defining a head.

196. The expandable stent according to claim 189, further comprising a plurality of extra arches, each interspaced between a first retaining arch and an adjacent second retaining arch and including a first arm connected at a first end thereof to one arm of the first retaining arch and a second arm connected at a first end thereof to one arm of the second retaining arch, wherein the first and second arms of each of the plurality of extra arches include respective second ends connected to one another at a connection defining a head.

197. The expandable stent according to claim 189, wherein each of the plurality of positioning arches includes first and second arms joined to one another at a head portion, and wherein the expandable stent further comprises a plurality of leaflet guard arches, each interspaced between the two arms of one of the plurality of positioning arches and including a first arm and a second arm, wherein the first and second arms of each of the plurality of leaflet guard arches are connected to one another at a connection defining a head, and wherein each of the plurality of leaflet guard arches extends in the same direction as the positioning arch in between the corresponding leaflet guard arch is provided.

198. The expandable stent according to claim 197, wherein each of the plurality of leaflet guard arches includes a first arm connected at a first end thereof to the first arm of one positioning arch and a second arm connected at a first end thereof to the second arm of the positioning arch, wherein the first and second arms of each of the plurality of leaflet guard arches include respective second ends connected to one another at a connection defining a head.

199. The expandable stent according to claim 189, wherein, in the expanded state of the stent, the respective arms of the retaining arches have a shape that matches the leaflets of a valvular prosthesis attached to the stent.

200. A method of treating a native valve with a valve prosthesis supported on a stent including a plurality of first arches each having an open end joined to an open end of an adjacent first arch, a plurality of second arches each having an open end joined to an open end of an adjacent second arch, and at least one third arch having an open end and being interspaced between and joined to two adjacent first arches, the method comprising the steps of:

positioning the plurality of first arches within pockets of the native heart valve;

positioning at least a portion of the native heart valve between the plurality of first arches and the plurality of second arches; and

applying a radial force against a portion of a vascular wall with the at least one third arch.