IMPLANTABLE VALVE AND METHOD

• US 20170196692A1
• Filed: 06/30/2016
• Published: 07/13/2017
• Est. Priority Date: 10/13/2015
• Status: Active Grant

• Current Assignee: Venarum Medical LLC
• Original Assignee: Venarum Medical LLC
• Inventors: KIRK, Taylor, FILACHEK, Andrew, BURPEE, Janet
• Granted Patent: US 10,492,910 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0028 Shapes in the form of latin or greek characters
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Implantable valve for treating venous insufficiency having a self-expanding frame encased in polymer having a distal section for blood in-flow, a bulbous center section and a proximal section for blood out-flow. Polymeric leaflets have proximal ends forming a valve outlet which opens and closes in response to venous blood flow and distal portions integral with the inner polymer surface of the distal end of said bulbous section. The leaflets define a predominantly biomimetic sinus region with the bulbous section. Opening of the valve induces flushing of blood from the sinus region for smooth non-traumatic blood flow through said valve.

Claims

1. Implantable valve for treating venous insufficiency, comprising:

a. an expandable scaffold having a distal section for blood in-flow, a center section and a proximal section for blood out-flow;

b. said center section comprising an enlarged bulbous section adjacent said distal section which is wider than a vein in a front view and about the width of a vein in a side view, said bulbous section tapering towards said proximal section;

c. said scaffold being embedded in a biocompatible, thrombus-resistant polymer forming a frame with a smooth inner surface throughout the distal, center and proximal sections which is substantially even with the scaffold interior without exposing same;

d. at least two polymeric leaflets having proximal ends transverse to the wider width of the bulbous section, said leaflets forming a valve outlet which opens and closes in response to venous blood flow, said leaflets having distal portions integral with the inner polymer surface at the distal end of said bulbous section;

e. said leaflets being formed from a biocompatible, thrombus-resistant polymer and defining a biomimetic sinus region with said bulbous section;

h. wherein opening of the valve induces predominantly biomimetic flushing of blood from the sinus region for smooth non-traumatic blood flow through said valve.

2. Implantable valve of claim 1 wherein said frame is embedded in a biocompatible, thrombus-resistant polymer forming smooth inner and outer surfaces throughout the distal, center and proximal sections which are substantially even with the frame interior and exterior without exposing same.

3. Implantable valve of claim 1 wherein said polymeric leaflets and said inner polymer surface are the same polymer.

4. Implantable valve of claim 2 wherein said distal leaflet portions are integral with the inner polymer surface of the adjacent end of the distal section and wherein said polymeric leaflets and said inner polymer surface are the same polymer.

5. Implantable valve of claim 1 wherein said valve outlet is linear.

6. Implantable valve of claim 1 wherein said valve outlet is S-shaped.

7. Implantable valve of claim 1 wherein said valve outlet spirals toward the proximal section.

8. Implantable valve of claim 1 wherein said valve outlet includes reflux apertures.

9. Implantable valve of claim 1 wherein said leaflets include one or more reflux apertures.

10. Implantable valve of claim 1 wherein said bulbous section is narrower than a vein in a side view.

11. Implantable valve of claim 1 wherein said valve outlet and said sinus region is in about the lower quarter of said bulbous section.

12. Implantable valve of claim 1 herein the polymer embedding said frame is a urethane polymer.

13. Implantable valve of claim 1 herein said leaflets are a urethane polymer.

14. Implantable valve claim 1 wherein the frame is self-expanding nitinol, stainless steel or cobalt chromium.

15. Implantable valve of claim 1 wherein said bulbous section is non-circular and transversely symmetrical.

16. Implantable valve of claim 15 wherein said non-circular bulbous section is oval shaped, racetrack shaped or formed from overlapping non-circular shapes.

17. Implantable valve of claim 15 wherein the shortest dimension of the non-circular shape is smaller than the width of a vein.

18. Process for treating venous insufficiency, which comprises:

a. providing an implantable valve of claim 1;

b. compressing said implantable valve and inserting same into an intravenous delivery catheter;

c. positioning the catheter in a vein and delivering said implantable valve to a desired site in the vein; and

d. allowing implantable valve to self-expand such that said valve is oversized relative to a vein for retention of the implantable valve in a desired site or position;

19. Implantable valve for treating venous insufficiency, comprising:

a. a self-expanding scaffold having a distal section for blood in-flow, a center section and a proximal section for blood out-flow;

b. said center section comprising an enlarged bulbous section adjacent said distal section which is wider than a vein in a front view and about the same width or narrower in a vein in a side view, said bulbous section being non-circular and transversely symmetrical and tapering towards said proximal section;

c. said scaffold being embedded in a biocompatible, thrombus-resistant polymer forming a frame with a smooth inner surface throughout the distal, center and proximal sections which is substantially even with the scaffold interior without exposing same;

d. at least two polymeric leaflets having proximal ends transverse to the wider width of the bulbous section, said leaflets forming an S-shaped valve outlet which opens and closes in response to venous blood flow, said leaflets having distal portions integral with the inner polymer surface at the distal end of said bulbous section;

e. said leaflets being formed from a biocompatible, thrombus-resistant polymer and defining a biomimetic sinus region with said bulbous section, said valve outlet and said sinus region being in about the lower quarter of said bulbous section;

h. wherein opening of the valve induces predominantly biomimetic flushing of blood from the sinus region for smooth non-traumatic blood flow through said valve.