PROSTHETIC VALVE DELIVERY SYSTEM INCLUDING RETROGRADE/ANTEGRADE APPROACH

• US 20090069886A1
• Filed: 09/07/2007
• Published: 03/12/2009
• 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 Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Phillips, Brent R., Vallana, Franco, Righini, Giovanni, Suri, Rakesh M., Roloando, Giovanni
• Granted Patent: US 8,808,367 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

Abstract

A device for implanting an expandable heart valve prosthesis at a valve annulus in a patient'"'"'s heart includes an implantation device configured to extend from a first opening in the patient'"'"'s body, through the patient'"'"'s aorta, through a valve annulus, through an opening in a ventricle, and to exit through the patient'"'"'s thoracic region. The device further includes a port having a hemostasis valve for providing access through the patient'"'"'s thoracic region and into the ventricle and at least two interchangeable modules configured for delivery using the implantation device.

Claims

1. A device for implanting an expandable heart valve prosthesis at a valve annulus in a patient'"'"'s heart, the device comprising:

an implantation device configured to extend from a first opening in the patient'"'"'s body, through the patient'"'"'s aorta, through a valve annulus, through an opening in a ventricle, and to exit through the patient'"'"'s thoracic region; and

at least one module configured for delivery using the implantation device, and an optional second module.

2. The access system of claim 1, wherein at least one of the modules is selected from the group consisting of:

an expandable heart valve prosthesis delivery module, a leaflet removal module, and a blood pumping module.

3. The access system of claim 2, wherein the leaflet excision module comprises a rigid portion having an actuator exerting sufficient force to cut through a calcified leaflet.

4. The access system of claim 1, wherein the implantation device is a guidewire.

5. The access system of claim 1, wherein the implantation device is a guide catheter.

6. The access system of claim 1, wherein the implantation device is structurally-continuous between the first opening and the second opening.

7. The access system of claim 1, wherein the modules can be delivered to the target location within the heart using either of an antegrade approach or a retrograde approach.

8. The access system of claim 1, wherein the implantation device is bendable and steerable.

9. The device of claim 8 in which the implantation device is reversibly lockable.

10. An access system for delivery of an expandable heart valve prosthesis to a patient'"'"'s heart, the system comprising an implantation device configured to extend from a first opening in the patient'"'"'s body, through the patient'"'"'s aortal tree, through a valve annulus, through an opening in a ventricle, and to exit through the patient'"'"'s thoracoabdominal region.

11. The system of claim 10 further comprising a port having a hemostasis valve for providing access into the ventricle.

12. The access system of claim 10 further comprising at least one interchangeable module capable of traveling along the implantation device to the valve annulus.

13. A method of implanting an expandable heart valve prosthesis comprising:

establishing a pathway extending from a first access port in a patient'"'"'s body, through a valve annulus, and through a second access port in the patient'"'"'s body;

delivering a first module from a first direction along the pathway, the first module configured to perform a first function; and

delivering a second module from a second direction along the pathway, the second module configured to perform a second function.

14. The method of claim 13 in which one of the first function and the second function is selected from the group consisting of:

excising a portion of or all of a native leaflet, deploying an expandable heart valve prosthesis, and pumping blood.

15. The method of claim 13 further comprising providing a guidewire that extends to the outside of the patient through the first access port, the guidewire passing through an aorta and a ventricle of the patient, and the guidewire exiting the patient at the second access port.

16. A kit for implanting an expandable heart valve prosthesis, the kit comprising:

a guidewire sized and dimensioned to enter a patient through a first opening or portal, extend through some or all of the patient'"'"'s aorta and ventricle, and to exit the patient through a second opening or portal; and

an expandable heart valve prosthesis delivery module.

17. The kit of claim 16 further comprising a leaflet removal module.

18. The kit of claim 17, wherein the leaflet removal module includes a leaflet capture device, the leaflet capture device adapted to capture and remove debris.

19. The kit of claim 18 further comprising a blood pumping module.

20. The kit of claim 16 further comprising a port for establishing access through an apex of the heart.

21. A device for implanting an expandable heart valve prosthesis in a patient'"'"'s heart, the device comprising:

a first module configured to be delivered from a first opening in a patient'"'"'s aortic tree and through the patient'"'"'s aorta, and

a second module configured to be delivered through an opening in a ventricle, said first module free of mechanical connection to said second module.

22. The device of claim 21 in which said first or second module is selected from the group consisting of:

a ballooning module, a cutting module, an expandable valve prosthesis module, and a debris catching module.