Prosthetic implant delivery device with introducer catheter

• US 9,445,897 B2
• Filed: 02/26/2013
• Issued: 09/20/2016
• 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.
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): GABR, MOHAMED GAMIL
• Application Number:
  US13/777,745
• Publication Number:
  US 20130297010A1
• Time in Patent Office: 1,302 Days
• Field of Search: 623/2.11
• US Class Current: 1/1
• 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 method of positioning a prosthetic implant within a heart, the method comprising:

advancing together a delivery catheter and an introducer catheter that is preassembled over the delivery catheter into a patient'"'"'s vascular system, the delivery catheter comprising a prosthetic valve and a distal tip that can be inserted directly into the access vessel such that the distal tip dilates the access vessel for the introducer catheter,

wherein during advancement, an outer diameter of a distal end of the delivery catheter being greater than an inner diameter of a distal end of the introducer catheter, the introducer catheter comprising a hemostasis valve assembly at a proximal end of the introducer catheter;

translumenally advancing the prosthetic valve to a position proximate a native valve of the heart, the prosthetic valve being at least partially disposed within the distal end of the delivery catheter during advancement of the introducer catheter; and

deploying the prosthetic valve.

2. The method of claim 1, wherein the step of advancing the introducer catheter preassembled over the delivery catheter comprising the prosthetic valve into the patients vascular system comprises advancing the introducer catheter and delivery catheter over a guidewire.

3. The method of claim 1, wherein the step of advancing the introducer catheter preassembled over the delivery catheter comprising the prosthetic valve into the patient'"'"'s vascular system comprises inserting the introducer catheter into a femoral artery.

4. The method of claim 1, wherein the step of translumenally advancing the prosthetic valve to a position proximate the native valve of the heart comprises advancing the prosthetic valve through an aorta.

5. The method of claim 1, wherein deploying the prosthetic valve comprises inflating a portion of the prosthetic valve.

6. The method of claim 1, wherein the distal end of the delivery catheter is inserted directly into an access vessel.

7. The method of claim 1, further comprising removing the delivery catheter and introducer catheter together from the patient.

8. The method of claim 1, wherein deploying the prosthetic valve comprises retracting the delivery catheter to expose the prosthetic valve.

9. The method of claim 8, wherein deploying the prosthetic valve comprises holding the prosthetic valve stationary as the delivery catheter is retracted.

10. The method of claim 1, wherein the delivery catheter comprises an outer tubular member and an inner tubular member extending through the outer tubular member.

11. The method of claim 10, wherein deploying the prosthetic valve comprises advancing the inner tubular member to push the prosthetic valve out of the outer tubular member.

12. The method of claim 11, wherein deploying the prosthetic valve comprises holding the outer tubular member stationary as the inner tubular member is advanced.

13. The method of claim 1 further comprising adjusting an angular position of the prosthetic valve using control wires.

14. The method of claim 13, further comprising releasing the prosthetic valve from the control wires.

15. The method of claim 13, further comprising delivering fluid through the control wires to inflate the prosthetic valve.

16. The method of claim 1, wherein deploying the prosthetic valve comprises:

partially deploying the prosthetic valve;

adjusting an angular position of the prosthetic valve; and

fully deploying the prosthetic valve.

17. The method of claim 1, further comprising simultaneously removing the introducer catheter and the delivery catheter.

18. The method of claim 1, wherein the distal end of the delivery catheter comprises a 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 introducer catheter at the distal end of the introducer catheter.

19. The method of claim 18, further comprising, after deploying the prosthetic valve, retracting the delivery catheter until a proximal end of the sheath jacket abuts the distal end of the introducer catheter.

20. The method of claim 1, wherein the delivery catheter comprises an outer tubular member and a guidewire tubing extending through the outer tubular member, the guidewire tubing being coupled to the distal tip of the delivery catheter, wherein during advancement, the distal tip closes a distal end of the outer tubular member.

21. The method of claim 20, further comprising distancing the distal tip from the outer tubular member.

22. The method of claim 21, wherein distancing the distal tip comprising retracting the outer tubular member while holding the guidewire tubing stationary.

23. The method of claim 21, wherein distancing the distal tip comprising advancing the guidewire tubing while holding the outer tubular member stationary.

24. The method of claim 20, further comprising, after deploying the prosthetic valve, retracting the guidewire tubing until the distal tip closes the distal end of the outer tubular member.