Implantable Open Vein Valve

• US 20160256277A1
• Filed: 03/02/2016
• Published: 09/08/2016
• Est. Priority Date: 03/02/2015
• Status: Active Grant

• Current Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Original Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Inventors: Tanner, Daniel, Ku, David N.
• Granted Patent: US 10,201,425 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2240/00 Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses

Abstract

The invention provides prosthetic venous valves, and method of use thereof, for the effective treatment of individuals with venous reflux in chronic venous insufficiency (CVI). The development of such prosthetic venous valves in the areas of valve design, design specifications, verification and/or validation testing, computational analysis, valve placement and clinician guidance and procedure are provided. Manufacturing the prosthetic venous valves of the invention is also provided.

Claims

1. A prosthetic venous valve comprising:

a) a cylindrical base having a length greater than its diameter and with a thin wall of a thickness less than about 2 mm,

b) leaflets thinner than about 1 mm and longer than half the base diameter that extend downstream of the base, and

c) a transition shoulder region thinner than about 3 mm in wall thickness that joins the base and the leaflets,

wherein said prosthetic venous valve is composed of a biocompatible polymer; and

wherein said prosthetic venous valve has backflow reflux under 160 mmHg and forward flow resistance less than 20 mmHg*min/L; and

shear rates at the base wall being restricted to between 1 S<sup>−

1</sup> to 100,000 S<sup>−

1</sup>.

2. The prosthetic venous valve of claim 1, wherein said biocompatible material is hydrophilic.

3. The prosthetic venous valve of claim 1, wherein hydrophilic biocompatible material is poly(vinyl-alcohol) (PVA) cryogel or PVA hydrogel.

4. The prosthetic venous valve of claim 1, wherein said biocompatible material is polyurethane or polyester.

5. The prosthetic venous valve of claim 1, wherein said base comprises a hydrogel polymer.

6. The prosthetic venous valve of claim 5, wherein said base further comprises metal parts covered partially or all by the polymer.

7. The prosthetic venous valve of claim 1, wherein said leaflets have tips with a distance less than the base internal diameter.

8. The prosthetic venous valve of claim 7, wherein said tips of the leaflets have an oval or ellipsoidal or “

lemon shape”

with a luminal cross-sectional area less than a lumen of the base.

9. The prosthetic venous valve of claim 8, wherein said luminal cross-sectional area has a minor and major axis in luminal cross-section, with the minor axis diameter being smaller than the major axis diameter.

10. The prosthetic venous valve of claim 9, wherein said leaflets further comprise one or more slits in the major axis direction.

11. The prosthetic venous valve of claim 10, wherein said slit is about 0.1 mm wide and greater than about 1 mm long.

12. The prosthetic venous valve of claim 7, wherein a minimum distance between the tips of the leaflets in a deployed configuration is less than the internal diameter of the base.

13. The prosthetic venous valve of claim 1, wherein said prosthetic venous valve fits into a hollow catheter with inside diameter at least 1 mm smaller than the outside diameter of the base.

14. The prosthetic venous valve of claim 13, wherein said prosthetic venous valve fits into a 16 Fr. catheter for delivery.

15. The prosthetic venous valve of claim 13, wherein said prosthetic venous valve collapses into a catheter tube less than 1 mm of outside diameter of the base and is able to re-expand after deployment.

16. An invasive method of treating chronic venous insufficiency (CVI) comprising:

a) Delivering and implanting the prosthetic venous valve of claim 1 in a vein of a subject having CVI; and

b) Correcting multisystem reflux of said subject.

17. The invasive method of claim 16, wherein the vein is common femoral or popliteal vein.

18. The invasive method of claim 16, wherein the prosthetic venous valve is delivered through a catheter.

19. The invasive method of claim 18, wherein the catheter is a 16 Fr. catheter.

20. A method of manufacturing the prosthetic venous valve of claim 1, comprising the steps of mold creation, stent preparation, and subsequent valve fabrication, verification and validation.