Aortic annuloplasty ring

• US 8,734,506 B2
• Filed: 09/08/2011
• Issued: 05/27/2014
• Est. Priority Date: 07/19/2004
• Status: Active Grant

• Current Assignee: Coroneo, Inc.
• Original Assignee: Coroneo, Inc.
• Inventors: Bulman-Fleming, Neil, Cartier, Raymond, Valentini, Valerio, Paolitto, Anthony
• Primary Examiner(s): Matthews, William H
• Application Number:
  US13/227,999
• Publication Number:
  US 20120010701A1
• Time in Patent Office: 992 Days
• Field of Search: 623/2.1, 623 236- 239
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus

Abstract

An annuloplasty ring to resize a dilated aortic root during valve sparing surgery includes a scalloped space frame having three trough sections connected to define three crest sections. The annuloplasty ring is mounted outside the aortic root, and extends in height between a base plane and a spaced apart commissure plane of the aortic root. At least two adjacent trough sections are coupled by an annulus-restraining member or tether that limits the maximum deflection of the base of the annuloplasty ring. In use, the tether is preferably located in proximity to the base plane of the aortic root. The annuloplasty ring is movable between a first, substantially conical configuration occurring during a diastolic phase of the cardiac cycle, and a second, substantially cylindrical configuration occurring during a systolic phase of the cardiac cycle.

Claims

1. An prosthetic device for replacing a portion of a patient'"'"'s ascending aorta located adjacent to an aortic root, said aortic root including an aortic valve therewithin, said aortic root and aortic valve being exposed to alternating diastolic and systolic phases of a cardiac cycle, said prosthetic device comprising:

an aortic conduit, said conduit being substantially tubular and extending in length along a longitudinal device axis between a first conduit end and a second conduit end, said first conduit end configured and sized for implantation adjacent to said aortic root; and

an annuloplasty ring, said annuloplasty ring coupled to said aortic conduit, said annuloplasty ring having an annular base portion forming a closed perimeter structure adjacent said conduit first end, said annular base portion including an annulus-restraining member, said annular base portion defining a first diameter and constructed to allow radially inward movement toward said device axis to define a second diameter smaller than said first diameter, said annulus restraining member decreasing in circumferential length during said radially inward movement;

whereby, in use, said radially inward movement occurs during a transition from the systolic phase to the diastolic phase of the cardiac cycle, said prosthetic device constraining the aortic root to a maximum dimension during the systolic phase of the cardiac cycle, and said prosthetic device urging coaptation of the aortic valve during the diastolic phase of the cardiac cycle by allowing substantially unhindered inward movement of the aortic root toward said device axis.

2. The prosthetic device of claim 1 wherein said annuloplasty ring further includes a plurality of upstanding post sections, said upstanding post sections each having a first and second post end, said post sections extending away from said annular base portion in a direction generally along said device axis and toward said second conduit end to terminate at said second post end, said second post ends adapted to move outwardly away from said device axis during a transition from the diastolic phase to the systolic phase of the cardiac cycle, and adapted to retract inwardly toward said device axis during a transition from the systolic phase to the diastolic phase of the cardiac cycle during use of the device.

3. The prosthetic device of claim 2 wherein said conduit is attached to said annuloplasty ring at said second post ends, said conduit attached portions being held by said second post ends closer to said device axis than unattached conduit portions located circumferentially between said upstanding post sections, said unattached conduit portions free to bulge outwardly away from said device axis to form a plurality of conduit bulging sections in said conduit during the diastolic phase of the cardiac cycle, said conduit attached portions moving away from said device axis together with said second post ends during a transition from the diastolic phase to the systolic phase of the cardiac cycle.

4. The prosthetic device of claim 3 wherein when said aortic root is exposed to the diastolic phase of the cardiac cycle, said post sections and said annular base portion assume a substantially conical shape in which said second post ends are in an approximated spatial relationship relative to each other and to said device axis when viewed in a direction along the device axis, said conical shape transitioning to a substantially cylindrical shape when said aortic root is exposed to the systolic phase of the cardiac cycle in which said second post ends are spaced farther apart from each other and from said device axis relative to said approximated spatial relationship.

5. The prosthetic device of claim 2 wherein said aortic conduit is constructed with axially stacked pleats over a first conduit portion spanning between said second conduit end and proximate to said ring second post ends.

6. The prosthetic device of claim 5 wherein said aortic conduit is constructed with circumferentially stacked pleats over a second conduit portion spanning between said conduit first end and said ring second post ends.

7. The prosthetic device of claim 1 wherein said aortic conduit is constructed from an elastic material suitable for implant use, and said annuloplasty ring is embedded within said aortic conduit during the fabrication thereof to form an integral assembly therewith.

8. The prosthetic device of claim 1, wherein said aortic conduit further comprises a conduit portion between the first and second conduit ends and, during the diastolic phase of the cardiac cycle, said conduit portion is configured to bulge radially outward relative to said device axis.

9. A prosthetic device for replacing a portion of a patient'"'"'s ascending aorta located adjacent to an aortic root, said aortic root defining a scalloped valve annulus, said valve annulus serving as attachment for three semilunar valve cusps within said aortic root, said aortic root spanning in height between a root base portion located in general proximity to a left ventricular outflow tract and a root sinotubular portion located in general proximity to a sinotubular junction, said valve cusps collectively defining three commissures at the junction of each of two adjacent cusps in proximity to said valve annulus, said prosthetic device comprising:

an aortic conduit, said conduit being substantially tubular and extending in length along a longitudinal device axis between a first conduit end and a second conduit end;

a space frame, said space frame connected to said aortic conduit adjacent said conduit first end, said space frame including a frame base portion and a frame upper portion spaced from the frame base portion, said space frame having a scalloped profile defining three trough sections at said frame base portion and three crest sections extending to said frame upper portion arranged circumferentially around said device axis, said space frame defining a first diameter proximate said frame base portion, said space frame constructed to allow circumferential movement of said trough sections closer to one another such that said space frame defines a second diameter proximate said base portion, said second diameter being smaller than said first diameter;

said prosthetic device configured and sized for placement external to said aortic root so as to;

     1) generally align said trough sections of said space frame with said valve annulus at said root base portion,

     2) generally align said crest sections of said space frame with said valve annulus in proximity to said commissures, and

     3) provide a conduit replacing said portion of the patient'"'"'s ascending aorta downstream of said aortic root; and

an annulus-restraining member, said annulus-restraining member extending across at least one of said crest portions and generally proximate said frame base portion, and coupling at least two of said trough sections that are adjacent to each other;

said space frame movable between a first device configuration and a second device configuration, in said first device configuration said space frame assumes a substantially conical shape in which said crest sections are spaced closer to said device axis than said trough sections, and in said second device configuration said space frame assumes a substantially cylindrical shape in which said crest and trough sections are spaced generally equally away from said device axis;

whereby when said space frame is in said second device configuration said annulus-restraining member restrains the aortic root to a maximum dimension, and when said device is transitioning between said second and first device configurations the construction of said annulus-restraining member allows substantially unhindered movement of said trough sections toward said device axis in proximity to the root base portion, the substantially unhindered movement also resulting in the circumferential movement of said trough sections closer to one another thereby allowing said device to regulate the dimension of said aortic root.

10. The prosthetic device of claim 9, wherein said aortic conduit further comprises respective conduit portions between adjacent crest sections and, during the diastolic phase of the cardiac cycle, said conduit portions are configured to bulge radially outward relative to said device axis.

11. A prosthetic device for the surgical repair of an aortic valve of a patient, the aortic valve defining a valve axis and contained within a generally tubular aortic root, the aortic root extending in height along the valve axis between a root base portion located in proximity to a left ventricular outflow tract and a spaced away root sinotubular portion located in proximity to a sinotubular junction, the aortic valve attached to the aortic root through a scalloped valve annulus extending circumferentially around the valve axis, the aortic valve including a plurality of valve leaflets connected to the valve annulus, the leaflets each having a free margin portion spaced from the valve annulus, the aortic root movable as a function of the different phases of a cardiac cycle between a first root configuration in which the aortic root is exposed to a diastolic phase of the cardiac cycle and in which the leaflet free margins are in an approximated spatial relationship to restrict blood flow therethrough and a second root configuration in which the aortic root is exposed to a systolic phase of the cardiac cycle and in which the leaflet free margins are in a spaced apart relationship to allow blood flow therethrough, said device comprising:

an aortic conduit, said conduit being substantially tubular and extending in length along a longitudinal device axis between a first conduit end and a second conduit end;

an annular ring, said annular ring coupled to said aortic conduit generally adjacent to said conduit first end, said annular ring having a scalloped profile including three generally U-shaped members connected to each other and arranged around a ring axis to form a closed-perimeter structure, said U-shaped members each having a base portion and an upper portion, said annular ring defining a first diameter proximate said base portion and constructed to allow circumferential movement of said base portions of said U-shaped members closer to one another such that said annular ring defines a second diameter proximate said base portion and being smaller than said first diameter, said closed-perimeter structure extending in height along said device axis from said base portions to said upper portions of said U-shaped members; and

an annulus-restraining member, said annulus-restraining member extending between and coupling at least two adjacent U-shaped members proximate said base portions of said at least two adjacent U-shaped members;

said prosthetic device being configured and sized for placement externally around said aortic root adjacent said first conduit end, and configured and sized for implantation to the patient'"'"'s ascending aorta adjacent said second conduit end;

whereby, in use, under influence of the different phases of the cardiac cycle, said annulus-restraining member is constructed to;

     1) allow inward displacement of said U-shaped members toward said device axis, the inward displacement occurring substantially without restraint from said annulus-restraining member and resulting in the circumferential movement of said base portions of said U-shaped members closer to one another, and

     2) limits maximum displacement of said base portions of said U-shaped members away from said device axis in order to constrain the maximum size of the aortic root so as to promote coaptation of the leaflet free margins during the diastolic phase of the cardiac cycle.

12. The prosthetic device of claim 11, wherein said aortic conduit further comprises respective conduit portions between adjacent crest sections and, at the maximum displacement of the base portions during the diastolic phase of the cardiac cycle, said conduit portions are configured to bulge radially outward relative to said device axis.