ENDOLUMINAL CARDIAC AND VENOUS VALVE PROSTHESES AND METHODS OF MANUFACTURE AND DELIVERY THEREOF

• US 20170049565A1
• Filed: 08/23/2016
• Published: 02/23/2017
• Est. Priority Date: 12/31/1999
• Status: Abandoned Application

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: ABPS Venture One, Ltd. (Palmaz Scientific, Inc.)
• Inventors: Bailey, Steven R., Boyle, Christopher T.
• Application Number:
  US15/245,068
• Publication Number:
  US 20170049565A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

This invention relates to prosthetic cardiac and venous valves and a single catheter device and minimally invasive techniques for percutaneous and transluminal valvuloplasty and prosthetic valve implantation.

Claims

1. A method of endoluminally delivering a valvular prosthesis within an anatomic passageway to replace an anatomic valve using a catheter, the valvular prosthesis carried on a distal end of the catheter, the valvular prosthesis comprising an distal anchor section, a proximal anchor section and an intermediate section, the method comprising the step of:

passing the catheter through an anatomic passageway so that the distal anchor section of the valvular prosthesis is positioned distal the anatomic valve;

positioning the intermediate section within the anatomic valve; and

releasing the valvular prosthesis from the catheter into a space occupied by the anatomic valve such that the distal anchor section is distal the anatomic valve, the proximal anchor section is proximal the anatomic valve and the intermediate section operates to exclude and replace the anatomic valve.

2. The method of endoluminally delivering a valvular prosthesis according to claim 1, wherein the positioning step comprises withdrawing the catheter to allow the intermediate section to exclude the anatomic valve.

3. The method of endoluminally delivering a valvular prosthesis according to claim 1, wherein the valvular prosthesis is self-expanding and has anchoring flanges projecting substantially radially outwardly from the valvular prosthesis and positioned at a distal end of the valvular prosthesis, and wherein the withdrawing step further comprises the steps of:

withdrawing a sheath to deploy the anchoring flanges, and

engaging the anchoring flanges to a distal end of the anatomic valve, thereby positioning the valvular prosthesis within the anatomic valve.

4. The method of claim 1, wherein the catheter has a delivery profile of 12 French size or smaller.

5. The method of claim 1, wherein the catheter is further comprised of a guidewire shaft positioned co-axially within the central longitudinal lumen and an annular plug member concentrically coupled to the guidewire shaft, and wherein the withdrawing step further includes the step of maintaining a position of the guidewire shaft as the catheter is withdrawn in retrograde fashion so that the annular plug member maintains the position of the valvular prosthesis while deploying the valvular prosthesis within the anatomic valve.

6. The method of claim 1, wherein the valvular prosthesis further comprises at least one valve flap member positions within a lumen defined within the intermediate section, wherein the at least one valve flap member is biased toward a position that occludes the lumen within the intermediate section.

7. The method of claim 6, wherein further comprising at least one biasing member positioned at the intermediate section that acts on and biases the at least one valve flap member.

8. The method of claim 6, wherein the valvular prosthesis further comprises a shape memory alloy.

9. The method of claim 6, wherein the valvular prosthesis further comprises a balloon-expandable material.

10. The method of claim 6, wherein the valvular prosthesis further comprises a generally tubular configuration and the proximal end and distal ends have a larger diameter than the intermediate section when in the valvular prosthesis is in a deployed deployed state.

11. The method of claim 10, wherein the valvular prosthesis further comprises a plurality of struts forming walls of the generally tubular valvular prosthesis.

12. The method of claim 11, wherein the valvular prosthesis further comprises a plurality of struts forming walls of the generally tubular valvular prosthesis and a biasing member positioned at the intermediate section that acts on and a biases the at least one valve flap member.

13. The method of claim 11, further comprising a covering on at least one of a luminal or abluminal surfaces of the generally tubular valvular prosthesis, wherein the covering forms the at least one valve flap member.

14. The method of claims 13, further comprising the step of balloon expanding the anatomic valve prior to positioning the intermediate section within the anatomic valve.