PROSTHETIC IMPLANT DELIVERY DEVICE WITH INTRODUCER CATHETER

• US 20130297010A1
• Filed: 02/26/2013
• Published: 11/07/2013
• Est. Priority Date: 05/01/2012
• Status: Active Grant

• Current Assignee: Speyside Medical, LLC
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Bishop, Gordon B., Robin, Kevin C.
• Granted Patent: US 9,445,897 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A delivery system and a method for deploying a cardiovascular prosthetic implant using a minimally invasive procedure are disclosed. The delivery system comprises an introducer catheter, a delivery catheter having a proximal end and a distal end, and a seal assembly, wherein an outer diameter of the distal end of the delivery catheter is greater than an inner diameter of the distal end of the introducer catheter.

Claims

1. A delivery system for delivering a cardiovascular prosthetic implant using a minimally invasive procedure, wherein the deployment system comprises:

an introducer catheter having a proximal end and a distal end;

a delivery catheter extending through the introducer catheter, the delivery catheter having a proximal end and a distal end extending beyond the distal end of the introducer catheter; and

a hemostasis seal assembly at a proximal end of the introducer catheter;

wherein an outer diameter of the distal end of the delivery catheter is greater than an inner diameter of the distal end of the introducer catheter.

2. The delivery system of claim 1 further comprising a cardiovascular prosthetic implant at the distal end of the delivery catheter.

3. The delivery system of claim 2, wherein the cardiovascular prosthetic implant comprises an inflatable cuff and a tissue valve.

4. The delivery system of claim 1, further comprising at least one link between the catheter body and the cardiovascular prosthetic implant.

5. The delivery system of claim 1, wherein the inner diameter of the distal end of the introducer is 16 F or less.

6. The delivery system of claim 1, wherein the introducer catheter includes an elongated tapered tip.

7. The delivery system of claim 1, wherein the introducer catheter includes a tapered tip configured to transition between a first enlarged length configuration and a second shorter configuration.

8. The delivery system of claim 1, wherein the system further comprises a long tip in a first configuration and a short tip in a second configuration.

9. The delivery system of claim 1, wherein the system further comprises a tip that has a straight configuration and a bent configuration.

10. A delivery system for delivering a cardiovascular prosthetic implant using a minimally invasive procedure, wherein the deployment system comprises:

a introducer catheter having a proximal end and a distal end and a lumen extending from the proximal end to the distal end of the introducer catheter, the introducer catheter having an outer diameter defined by an outer surface of the introducer catheter and an inner diameter defining the through lumen;

a delivery catheter extending through the introducer catheter, the delivery catheter comprising a tubular body having a proximal end and a distal end, the distal end including a sheath jacket and stem portion extending proximally from the sheath jacket, the sheath jacket having an outer surface that defines an outer diameter of the sheath jacket, the outer diameter of the sheath jacket being greater than the inner diameter of the introduced catheter at the distal end of the introducer catheter, the stem portion having an outer surface that defines an outer diameter of the stem portion, the outer diameter of the stem portion being smaller than the inner diameter of the introducer catheter; and

a cardiovascular prosthetic implant positioned at least partially within the sheath jacket.

11. The delivery system of claim 10, comprising a seal assembly at a proximal end of the introducer catheter.

12. The delivery system of claim 10, wherein the cardiovascular prosthetic implant comprises an inflatable cuff and a tissue valve.

13. The delivery system of claim 10, including at least one inflation lumen extending between the inflatable cuff and the proximal end of the introducer catheter, the inflation lumen extending through the delivery catheter.

14. The delivery system of claim 10, further comprising at least one link between the catheter body and the cardiovascular prosthetic implant.

15. The delivery system of claim 10, wherein the inner diameter of the distal end of the introducer catheter is about 16 F.

16. The delivery system of claim 10, comprising a tubing extending through the delivery catheter and the cardiovascular prosthetic implant.

17. The delivery system of claim 10, comprising a distal tip coupled to a distal end of the tubing, the distal tip having a maximum outside diameter that is approximately the same as the outside diameter of the jacket sheath.

18. The delivery system of claim 10, wherein the sheath jacket is coupled to a distal end of the stem portion.

22. The method of claim 15, wherein the step of translumenally advancing the prosthetic valve to a position proximate a native valve of the heart comprises advancing the prosthetic valve through the aorta.

19. A method of positioning a prosthetic implant within a heart, the method comprising:

advancing an introducer catheter positioned over a delivery catheter comprising a prosthetic valve into a patient'"'"'s vascular system;

translumenally advancing the prosthetic valve to a position proximate a native valve of the heart; and

deploying the prosthetic valve.

20. The method of claim 19, wherein the step of advancing an introducer catheter positioned over a delivery catheter comprising a prosthetic valve into a patient'"'"'s vascular system comprises advancing the introducer catheter and delivery catheter over a guidewire.

21. The method of claim 19, wherein the step of advancing an introducer catheter positioned over a delivery catheter comprising a prosthetic valve into a patient'"'"'s vascular system comprises inserting the introducer catheter into the femoral artery.

23. The method of claim 19, wherein deploying the prosthetic valve comprises inflating a portion of the prosthetic valve.

24. The method of claim 19, wherein a distal end of the delivery catheter is inserted directly into an access vessel.

25. The method of claim 19, further comprising removing the delivery catheter and introducer catheter together from the patient.