Streamlined, apical delivery system for in situ deployment of cardiac valve prostheses

• US 8,486,137 B2
• Filed: 06/27/2008
• Issued: 07/16/2013
• Est. Priority Date: 09/07/2007
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc), Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc), Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Inventors: Suri, Rakesh M., Vallana, Franco, Rolando, Giovanni, Righini, Giovanni, Phillips, Brent R., Manasse, Eric
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US12/147,558
• Publication Number:
  US 20090069889A1
• Time in Patent Office: 1,845 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.13, 623/2.11, 623/2.14, 623/2.17, 623/2.18
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

Abstract

A system for implanting a heart valve prosthesis in a patient'"'"'s heart includes a balloon expandable, tissue, stented heart valve, and an apical valve delivery device for delivering the stented heart valve to a target site in the patient'"'"'s heart. The delivery device includes an inflation balloon module for expanding the stented heart valve prosthesis, markers on the delivery device to assist in location of the delivery device at an appropriate location, and a streamlined cap.

Claims

1. A system for implanting a heart valve prosthesis in a patient'"'"'s heart, comprising, in combination,

a heart valve prosthesis having a principal axis extending longitudinally therethrough, the heart valve prosthesis including an armature and prosthetic valve, leaflets, the heart valve prosthesis armature including an annular inflow portion and an annular outflow portion connected by a plurality of axially extending anchoring formations spaced about the principal axis of the heart valve prosthesis and configured to radially protrude beyond the annular inflow portion and annular outflow portion, and

an apical valve delivery device for delivering the heart valve prosthesis to a target site in the patient'"'"'s heart, the delivery device comprising:

a deployment module for expanding the heart valve prosthesis, the deployment module comprising a first deployment element configured to enclose the annular outflow portion and a second deployment element configured to enclose the annular inflow portion, wherein each of the first and second deployment elements are independently operable, and

markers on the delivery device to assist in location of the delivery device at an appropriate location,

wherein the first deployment element includes a streamlined cap.

2. The system of claim 1 in which the streamlined cap further comprises a delivery sheath.

3. The system of claim 1 in which the delivery device further comprises a non-embolic gas and or a non-embolic fluid.

4. The system of claim 1 in which the device is bendable.

5. The system of claim 1 further comprising a port for establishing access to an apex of the patient'"'"'s heart.

6. The system of claim 5 in which the port comprises a valve and or seal configured to provide a blood tight seal during a procedure.

7. The system of claim 1 further comprising an imaging module.

8. A system for implanting a heart valve prosthesis in a patient'"'"'s heart, comprising, in combination,

a port for establishing access to an apex of the patient'"'"'s heart,

heart valve prosthesis having a principal axis extending longitudinally therethrough, the heart valve prosthesis including an armature and prosthetic valve, leaflets, the heart valve prosthesis armature including an annular inflow portion and an annular outflow portion connected by a plurality of axially extending anchoring formations spaced about the principal axis of the heart valve prosthesis and configured to radially protrude beyond the annular inflow portion and annular outflow portion, and

an apical valve delivery device for delivering the heart valve prosthesis to a target site in the patient'"'"'s heart, the delivery device comprising:

a deployment module for expanding the heart valve prosthesis, the deployment module comprising a first deployment element configured to enclose the annular outflow portion and a second deployment element configured to enclose the annular inflow portion, wherein each of the first and second deployment elements are independently operable, and

markers on the delivery device to assist in location of the delivery device at an appropriate location,

wherein the first deployment element includes a streamlined cap.

9. The system of claim 8 in which the streamlined cap further comprises a delivery sheath.

10. The system of claim 8 in which the delivery device further comprises a non-embolic gas and or a non-embolic fluid.

11. The system of claim 8 in which the device is bendable.

12. The system of claim 8 in which the port comprises a valve and or seal configured to provide a blood tight seal during a procedure.

13. The system of claim 8 further comprising an imaging module.