Low crossing profile delivery catheter for cardiovascular prosthetic implant

• US 9,603,708 B2
• Filed: 05/18/2011
• Issued: 03/28/2017
• Est. Priority Date: 05/19/2010
• Status: Active Grant

• Current Assignee: Speyside Medical, LLC
• Original Assignee: DFM, LLC (PDL BioPharma, Inc.)
• Inventors: Robin, Kevin, Uong, Do, Bishop, Gordon
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US13/110,780
• Publication Number:
  US 20120016468A1
• Time in Patent Office: 2,141 Days
• Field of Search: 623/2.11, 623/2.12, 623 236- 238
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: C08G 59/50 Amines
• CPC Class Codes: C08L 63/00 Compositions of epoxy resins; Compositions of derivatives of epoxy resins

Abstract

A delivery catheter and a method for deploying a cardiovascular prosthetic implant using a minimally invasive procedure are disclosed. The delivery catheter comprises an elongate, flexible catheter body having a proximal end and a distal end, wherein the distal end has an outer diameter of 18 French or less, a cardiovascular prosthetic implant at the distal end of the catheter body, wherein the cardiovascular prosthetic implant comprises an inflatable cuff and a tissue valve coupled to the inflatable cuff, and at least one link between the catheter body and the cardiovascular prosthetic implant.

Claims

1. A delivery catheter for deploying a cardiovascular prosthetic implant using a minimally invasive procedure, wherein the delivery catheter comprises:

an elongate, flexible catheter body having a proximal end and a distal end, wherein the distal end has an outer diameter of 18 French or less;

a cardiovascular prosthetic implant at the distal end of the catheter body, wherein the cardiovascular prosthetic implant comprises an inflatable cuff and a natural tissue valve comprising a leaflet having a thickness of at least about 0.011 inches coupled to the inflatable cuff; and

at least one link between the catheter body and the cardiovascular prosthetic implant, wherein the tissue valve is loaded within the distal end.

2. The delivery catheter of claim 1, further comprising an outer tubular member in which the cardiovascular prosthetic implant is stored in a collapsed state for delivery.

3. The delivery catheter of claim 1, wherein the at least one link is a position-and-fill lumen configured for positioning the implant and for filling the inflatable cuff.

4. The delivery catheter of claim 1, wherein the inflatable cuff comprises at least one inflatable channel that forms, at least in part, a distal toroid, a proximal toroid and at least two struts between the distal toroid and the proximal toroid.

5. The delivery catheter of claim 4, wherein the struts are substantially perpendicular to the distal and the proximal toroids.

6. The delivery catheter of claim 4, wherein the cardiovascular prosthetic implant further comprises at least two inflation valves disposed in two end sections of the at least one inflatable channel.

7. The delivery catheter of claim 6, wherein each of the inflation valves comprises a sealing mechanism.

8. The delivery catheter of claim 6, further comprising a directional valve between the two end sections of the at least one inflation channel.

9. The delivery catheter of claim 6, wherein the cardiovascular prosthetic implant further comprises at least two links, and the at least two links are coupled to the at least two inflation valves.

10. The delivery catheter of claim 6, wherein the cardiovascular prosthetic implant further comprises a connection port coupled to a third link between the catheter body and the cardiovascular prosthetic implant.

11. The delivery catheter of claim 10, wherein the inflation valves and the connection port are staggered when the cardiovascular prosthetic implant is in a collapsed state.

12. The delivery catheter of claim 1, wherein the cardiovascular prosthetic implant has an outside diameter of greater than about 22 millimeters when fully inflated.

13. The delivery catheter of claim 12, wherein the tissue valve is attached to the cuff.

14. The delivery catheter of claim 12, wherein the tissue valve comprises three individual leaflets that are individually attached to the cuff.

15. A method of deploying a cardiovascular prosthetic implant, the method comprising the steps of:

translumenally advancing a catheter of claim 1 to a position proximate a native valve of a patient;

inflating the inflatable cuff fully with a hardenable inflation media; and

removing the catheter from the patient, leaving the hardenable inflation media in the cardiovascular prosthetic implant within the patient.

16. The method of claim 15, further comprising inflating a distal toroid of the inflatable cuff with a first liquid and positioning the cardiovascular prosthetic implant using the at least one link before inflating the inflatable cuff fully with the hardenable media.

17. The method of claim 16, further comprising displacing the first liquid in the inflatable cuff with the hardenable inflation media.

18. The method of claim 16, wherein inflating the distal toroid and inflating the inflatable cuff are done using the at least one link.

19. The method of claim 16, further comprising allowing the inflation media to solidify within the inflatable cuff.

20. The method of claim 16, further comprising proximally retracting the cardiovascular prosthetic implant after the distal toroid is at least partially inflated.

21. A delivery catheter for deploying a cardiovascular prosthetic implant using a minimally invasive procedure, wherein the delivery catheter comprises:

an elongate, flexible catheter body having a proximal end and a distal end, wherein the distal end has an outer diameter of 18 French or less; and

a cardiovascular prosthetic implant loaded within the distal end of the catheter body, wherein the cardiovascular prosthetic implant comprises a support structure and a natural tissue valve comprising a leaflets having a thickness of at least about 0.011 inches coupled to the support structure.

22. A method of deploying a cardiovascular prosthetic implant, the method comprising the steps of:

translumenally advancing a catheter of claim 21 to a position proximate a native valve of a patient; and

deploying the cardiovascular prosthetic implant within the patient; and

removing the catheter from the patient.