Endoluminal cardiac and venous valve prostheses and methods of manufacture and delivery thereof

• US 20040106976A1
• Filed: 11/24/2003
• Published: 06/03/2004
• Est. Priority Date: 12/31/1999
• Status: Active Grant

• Current Assignee: Advanced Bio Prosthetic Surfaces, Ltd., Vactronix Scientific, LLC
• Original Assignee: ABPS Venture One, Ltd. (Palmaz Scientific, Inc.)
• Inventors: Bailey, Steven R., Boyle, Christopher T.
• Granted Patent: US 7,018,408 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 comprised of at least two sections near the distal end of the catheter, a first section consisting of the valvular prosthesis covered by a sheath, and a second section consisting of an inflatable balloon, comprising the steps of:

passing the at least two sections of the catheter through an anatomic passageway so that the second section is passed distally through the anatomic valve such that a portion of the inflatable balloon is within the anatomic valve;

contacting the inflatable balloon to a surface of the anatomic valve by inflating the inflatable balloon to dilatate the anatomic valve;

positioning the first section within the anatomic valve for deployment of the valvular prosthesis; and

withdrawing the sheath and the catheter to release the valvular prosthesis from the sheath onto the dilatated anatomic valve to functionally replace the anatomic valve.

2. The method of endoluminally delivering a valvular prosthesis according to claim 1, wherein the first section resides near the distal end of the catheter and distal to the second section along the length of the catheter, and the passing step further comprises passing the catheter along the anatomic passageway until the first section passes distally through the anatomic valve.

3. The method of endoluminally delivering a valvular prosthesis according to claim 2, wherein the positioning step comprises withdrawing the catheter to remove the second section away from the anatomic valve and allow the first section to reside within the anatomic valve.

4. The method of endoluminally delivering a valvular prosthesis according to claim 2, 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 the sheath to deploy the anchoring flanges, and

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

5. The method of claim 2 wherein the catheter has a delivery profile of 12 French size or smaller.

6. The method of claim 2 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 the 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.

7. The method of endoluminally delivering a valvular prosthesis according to claim 1, wherein the second section resides near the distal end of the catheter and distal to the first section along the length of the catheter, and the passing step further comprises passing the catheter along the anatomic passageway until the second section resides within the anatomic valve.

8. The method of endoluminally delivering a valvular prosthesis according to claim 7, wherein the positioning step further comprises passing the second section distally through the anatomic valve and positioning the first section within the anatomic valve.

9. The method of endoluminally delivering a valvular prosthesis according to claim 7, wherein the valvular prosthesis is self-expanding and includes anchoring flanges projecting substantially radially outward from the valvular prosthesis at a distal end of the valvular prosthesis, and wherein the withdrawing step further comprises the steps of:

withdrawing the sheath to deploy the anchoring flanges, and

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

10. The method of claim 7 wherein the catheter has a delivery profile of 12 French size or smaller.

11. The method of claim 7 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 the 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.