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

• US 20130018449A1
• Filed: 07/11/2012
• Published: 01/17/2013
• Est. Priority Date: 12/31/1999
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: ABPS Venture One, Ltd. (Palmaz Scientific, Inc.)
• Inventors: Bailey, Steven R., Boyle, Christopher T.
• Granted Patent: US 8,992,597 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. An implantable valvular prosthesis, comprising:

a. a stent body member having luminal and abluminal surfaces thereof and a central opening along a central longitudinal axis of the stent body member;

b. a graft member comprising an outer graft member coupled to the abluminal surface of the stent body member and an inner graft member coupled to the luminal surface of the stent body member, wherein a terminal portion of the inner graft member is everted inwardly toward the central longitudinal axis of the stent body member;

c. at least one biasing arm projecting from the stent body member and into the central opening of the stent body member;

d. at least one valve flap member formed by the terminal portion of the inner graft member coupled to the at least one biasing arm, the at least one valve flap member assuming a position, under zero pressure differential across the prosthesis, which occludes the central opening of the stent body member.

2. The implantable valvular prosthesis according to claim 1, wherein the stent body member further comprises a proximal anchoring section.

3. The implantable valvular prosthesis according to claim 2, wherein the stent body further comprises a distal anchoring section.

4. The implantable valvular prosthesis according to claim 2, wherein the proximal anchoring section further comprises a plurality of stent struts which project radially outward away from the central longitudinal axis of the stent body member.

5. The implantable valvular prosthesis according to claim 1, wherein the stent body member further comprises a distal anchoring section.

6. The implantable valvular prosthesis according to claim 5, wherein the distal anchoring section further comprises a radially enlarged section of the stent body member which communicates with the central opening of the stent body member.

7. The implantable valvular prosthesis according to claim 1, wherein the at least one valve flap member comprise a plurality of valve flap members coupled at portions thereof to the luminal surface of the inner graft member.

8. The implantable valvular prosthesis according to claim 7, wherein the plurality of valve flap members are coupled at equidistantly spaced intervals about the luminal surface of the inner graft member.

9. The implantable valvular prosthesis according to claim 1, further comprising:

a. a catheter body defining a central longitudinal lumen, the catheter body comprises a distal stent capturing section capturing the stent body member;

b. a guidewire shaft positioned co-axially within the central longitudinal lumen of the catheter body and passing through an entire longitudinal length of the catheter body; and

c. an annular plug member concentrically coupled to the guidewire shaft and positioned proximal the distal stent capturing section, the annular plug member terminating the central longitudinal lumen of the catheter body in a fluid tight manner and being moveable within the distal stent capturing section.

10. A method of endoluminally delivering a valvular prosthesis within an anatomic passageway to replace an anatomic valve using a catheter comprised of at least one section near a distal end of the catheter, a first section consisting of the valvular prosthesis covered by a sheath, comprising the steps of:

passing the at least one section of the catheter through an anatomic passageway so that the first section is positioned distal 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 dilitated anatomic valve to functionally replace the anatomic valve.

11. The method of endoluminally delivering a valvular prosthesis according to claim 10, wherein the first section resides near the distal end of the catheter 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.

12. The method of endoluminally delivering a valvular prosthesis according to claim 11, wherein the positioning step comprises withdrawing the catheter to allow the first section to reside within the anatomic valve.

13. The method of endoluminally delivering a valvular prosthesis according to claim 11, 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.

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

15. The method of claim 12, 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.

16. A method of manufacturing an implantable valvular prosthesis, comprising the steps of:

Fashioning a generally tubular stent body member, having a luminal and an abluminal surface and a central opening along a central longitudinal axis;

Fashioning a graft; and

Attaching the graft to at least portions of either or both the luminal and abluminal surfaces of the stent body member, wherein the attachment of the graft to the stent body member forms at least one valve flap.

17. The method of claim 16, wherein the step of fashioning the generally tubular stent body member further comprises shaping the stent body member to include proximal and distal anchors.

18. The method of claim 17, wherein the proximal and distal anchors are present at opposing ends of the prosthesis

19. The method of claim 16, wherein the step of fashioning the generally tubular stent body member further comprises shaping the stent body member to include an intermediate stent section.

20. The method of claim 16, wherein the step of fashioning the generally tubular stent body member further comprises shaping the stent body member to include at least one valve arm or blood flow regulator strut.