Aortic annuloplasty ring

• US 8,034,102 B2
• Filed: 07/19/2005
• Issued: 10/11/2011
• Est. Priority Date: 07/19/2004
• Status: Active Grant

• Current Assignee: Coroneo, Inc.
• Original Assignee: Coroneo, Inc.
• Inventors: Paolitto, Anthony, Bulman-Fleming, Neil, Valentini, Valerio, Cartier, Raymond
• Primary Examiner(s): Matthews; William H.
• Application Number:
  US11/183,939
• Publication Number:
  US 20060015179A1
• Time in Patent Office: 2,275 Days
• Field of Search: 623/2.1, 623/2.36, 623/2.37, 623/2.38, 623/2.39
• 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. The attachment of the annuloplasty ring in proximity to the cardiac valve annulus allows the ring to regulate the dimensions of a dynamic aortic root during the different phases of the cardiac cycle.

Claims

1. A prosthetic ring for implantation externally around an aortic root of a patient, 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 ring comprising:

a 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 a ring 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 space frame configured and sized for placement external to said aortic root so as to;

     1) generally align said trough sections with said valve annulus at said root base portion, and

     2) generally align said crest sections with said valve annulus in proximity to said commissures;

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

whereby when said ring is in said second ring configuration said ring restrains the aortic root to a maximum dimension through action of said annulus-restraining member, and when said ring is transitioning between said second and first ring configurations the construction of said annulus-restraining member and allows substantially unhindered movement of said trough sections toward said ring 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 ring to regulate the dimension of said aortic root.

2. The prosthetic ring of claim 1, wherein said annulus-restraining member couples said at least two trough sections with a segment extending along at least a portion of the frame base portion, said segment decreasing in circumferential length when said ring is transitioning from said second ring configuration to said first ring configuration.

3. A 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 annular ring, said annular ring having a scalloped profile and being configured and sized for placement externally around said aortic root, said annular ring 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 ring 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;

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 ring 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 ring 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.

4. The device of claim 3, wherein said annulus-restraining member couples said U-shaped members with a segment coupling the base portions of said at least two U-shaped members, said segment decreasing in circumferential length when said inward displacement of said U-shaped members occurs.

5. The device of claim 4, wherein each of said U-shaped members has a generally concave trough section and two upstanding posts extending therefrom, said closed-perimeter structure resulting from a joining of each pair of adjacent U-shaped members at adjacent posts thereof, each pair of joined adjacent posts defining a corresponding crest section, said crest sections being interspaced between two adjacent trough sections and being offset in height above said trough sections along said ring axis, said annulus-restraining member connecting each of two adjacent U-shaped members in a region located below the respective crest section formed by the joining of said two adjacent U-shaped members.

6. The device of claim 5, wherein said scalloped profile of said annular ring generally conforms to the scalloped valve annulus of the aortic valve, the trough and crest sections being in proximity to the root base and sinotubular portions, respectively, when the annular ring is placed externally to the aortic root.

7. The device of claim 6, wherein the annular ring is movable as a function of the different phases of said cardiac cycle between a first ring configuration formed when the aortic root is exposed to said diastolic phase and a second ring configuration formed when said aortic root is exposed to said systolic phase, and wherein the crest sections are positioned closer to each other and to said ring axis in said first ring configuration than in said second ring configuration.

8. The device of claim 7, wherein in said second ring configuration, said trough sections are in a maximum spaced apart spatial relationship away from the ring axis when viewed in a direction along said ring axis.

9. The device of claim 8, wherein said annular ring assumes a substantially conical shape in said first ring configuration with said crest sections being closer to said ring axis than said trough sections when viewed in a direction along said ring axis, and said annular ring assumes a substantially cylindrical shape in said second ring configuration with said crest and trough sections being substantially equally spaced away from said ring axis when viewed in a direction along said ring axis.

10. The device of claim 7, wherein each pair of adjacent U-shaped members are coupled at the crest section by a connector configured and sized for coupling said adjacent upstanding posts, said connector allowing relative movement between said connector and at least one of said upstanding posts coupled thereto.

11. The device of claim 10, wherein the coupling between said connector and said upstanding posts includes a ball-and-socket arrangement, said ball-and-socket arrangement allowing articulation between said connector and said upstanding posts.

12. A device for containing an aortic root of a patient, said aortic root being exposed to alternating diastolic and systolic phases of a cardiac cycle, said aortic root being generally tubular and including therewithin an aortic valve, said device configured and sized for placement externally around said aortic root, said device comprising:

an annular base portion, said annular base portion forming a closed-perimeter structure; and

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 base portion in a direction generally along said device axis 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;

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;

whereby, in use, said annular base portion;

     1) constrains the aortic root to a maximum dimension thereby urging coaptation of the aortic valve during the diastolic phase of the cardiac cycle, and

     2) in proximity to said device annular base portion, allows substantially unhindered inward movement of the aortic root toward said device axis.

13. The device of claim 12, 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.