FLUID-FILLED DELIVERY SYSTEM FOR IN SITU DEPLOYMENT OF CARDIAC VALVE PROSTHESES

• US 20090069887A1
• 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 SPA
• Inventors: Righini, Giovanni, Suri, Rakesh M.
• Granted Patent: US 8,114,154 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

Abstract

An instrument for deploying a cardiac valve prosthesis, including a plurality of radially expandable portions, at an implantation site, includes a plurality of deployment elements each independently operable to obtain the radial expansion of a radially expandable portion of the valve prosthesis. Additionally, the instrument is adapted to provide a de-aired, fluid-filled, or gas filled environment in order to minimize and/or prevent air embolism during the implantation procedure. The fluid can contain a drug. A method for deploying the cardiac valve prosthesis includes advancing the instrument to an implant site and independently actuating the radially expandable portions.

Claims

1. A prosthetic valve delivery system for implanting a cardiac valve prosthesis at an implantation site associated with a cardiac valve annulus, the system comprising an expandable cardiac valve prosthesis including a plurality of radially expandable portions and a deployment instrument including a chamber for holding the valve prosthesis, wherein the chamber is filled with a fluid, gas or combination thereof.

2. The system of claim 1 wherein the cardiac valve prosthesis is an aortic valve prosthesis and further wherein the chamber includes a plurality of operable deployment elements.

3. The system of claim 2 wherein the plurality of radially expandable portions include an annular inflow portion, associated with blood inflow, and an annular outflow portion, associated with blood outflow.

4. The system of claim 1 wherein the gas is selected from a non-embolytic gas.

5. The system of claim 1 wherein the gas is selected from carbon dioxide and nitrogen.

6. The system of claim 1 wherein the fluid further comprises a drug.

7. The system of claim 6 wherein the drug is selected from the group consisting of heparin, a drug to manipulate cardiac function to assist with the delivery of the prosthesis.

8. The system of claim 1 in which the fluid comprises an electrolytic solution.

9. A minimally-invasive method of implanting an expandable cardiac valve prosthesis, the method comprising positioning the cardiac valve prosthesis in a deployment instrument including a carrier portion, substantially removing atmospheric air from the carrier portion, advancing the deployment instrument to the implantation site, and deploying the valve prosthesis at the implantation site.

10. The method of claim 9 wherein the step of removing air includes filling the carrier portion with a fluid or a non-embolytic gas.

11. The method of claim 10 wherein the fluid is saline.

12. The method of claim 10 wherein the fluid is selected from the group consisting of carbon dioxide and nitrogen.

13. The method of claim 10 further including monitoring a pressure of the fluid or gas and maintaining the pressure at a desired level.

14. The method of claim 10 wherein the step of removing air further includes sealing the delivery system to maintain the fluid or the gas in the carrier portion.

15. The method of claim 10 wherein the step of removing air further includes filling substantially an entirety of a lumen of the deployment instrument with a fluid or a non-embolytic gas.

16. The method of claim 10 wherein the step of removing air is performed under a vacuum pressure.