Device for the in situ delivery of heart valves

• US 8,403,982 B2
• Filed: 05/13/2009
• Issued: 03/26/2013
• Est. Priority Date: 05/13/2009
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Giannetti, Arnaldo, Ghione, Laura, Gaschino, Paolo
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): TANNER, JOCELIN C
• Application Number:
  US12/465,262
• Publication Number:
  US 20100292782A1
• Time in Patent Office: 1,413 Days
• Field of Search: 623/1.11, 623/2.11, 623/1.24, 623/1.26, 623/1.12, 623/2.17, 623/1.23, 623/902, 623/23.68, 623/2.38, 623/904, 623/6.12, 606/194, 606/108, 606/192, 606/200, 606/107, 600/144, 600/146, 600/147, 600/433, 600/434, 600/149, 600/150, 600/139, 604/164.09, 604/164.11, 604/164.12, 604/165.04, 604/171, 604/165.01, 604/165.02
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor

Abstract

A device for deploying a cardiac valve prosthesis includes at least one constraint member for radially constraining radially expandable annular portions of the valve. The constraint member is actuatable to release the annular formations constrained thereby and permit radial expansion of these annular formations. The constraint member has associated a first, slow-acting actuating mechanism and a second, fast-acting mechanism, adapted to produce relatively slow and fast release of the annular formations constrained thereby. The device may include a first constraint member and second constraint member in the form of telescoping sleeves. The slow-acting actuating mechanism will thus act on the outer sleeve, while the fast-acting mechanism will act on the inner sleeve to produce, respectively, slow and fast release of the annular formations.

Claims

1. A device for deploying a cardiac valve prosthesis, including a first expandable portion and a second expandable portion, at an implantation site, the device comprising:

a first constraint member for radially constraining the first expandable portion, the first constraint member comprising an outer telescoping sleeve including a proximal portion having an outer threaded surface;

a second constraint member for radially constraining the second expandable portion, the second constraint member comprising an inner telescoping sleeve having a distal end disposed within the first constraint member and a proximal end terminating in an annular member;

a rotary actuation member coupled to the first constraint and having a thread formation for cooperating with the outer threaded surface of the first constraint member adapted for retracting the first constraint member, such that the first expandable portion is deployed;

a slidable actuation member coupled to the second constraint member and coupled to the first constraint member for retracting both the first and second constraint members, such that the second expandable portion is deployed; and

a stop member that is removable or disengageable, wherein the annular member of the inner telescoping sleeve is adapted to abut against the stop member when the stop member is in place and to prevent the inner telescoping sleeve from being retracted;

wherein the rotary and the slidable actuation members are independently adjustable, such that the first and second expandable portions may be independently deployed,.

and wherein the first and second constraint members having associated a first slow-acting actuating mechanism and a second, fast-acting actuating mechanism, respectively, to produce relatively slow and fast release of the first and second expandable portions of the prosthesis constrained thereby.

2. The device of claim 1, wherein the second constraint member includes at least one sleeve slidably actuatable along an axis whereby the second constraint member releases the second expandable portion.

3. The device of claim 2, wherein the inner and outer telescoping sleeves are slidably actuatable along a common axis whereby the constraint members release the expandable portions constrained thereby.

4. The device of claim 1, wherein the inner and outer telescoping sleeves are configured to slide along a common axis in correspondence with one another.

5. The device of claim 1, wherein the rotary actuation member is a screw-actuated mechanism.

6. The device of claim 5, wherein the screw-actuated mechanism includes a rotary member rotatable around the outer threaded surface of the outer telescoping sleeve.

7. The device of claim 1, wherein the slidable actuation member includes a lock member which, once defeated, renders the second constraint member freely movable to release the expandable portion constrained thereby.

8. The device of claim 1, wherein the outer telescoping sleeve has a diameter of between about 10 and about 27 mm.

9. The device of claim 1, wherein the second constraint member has a marginal outer edge with at least one notch to provide a reference in the angular positioning of the cardiac valve prosthesis.

10. The device of claim 1, wherein the outer telescoping sleeve having associated the first, slow-acting actuating mechanism and the inner telescoping sleeve having associated the second, fast-acting actuating mechanism.

11. The device of claim 1, wherein when the stop member is removed or disengaged, both the inner telescoping sleeve and the outer telescoping sleeve can be retracted.