ANASTOMOTIC CONNECTOR AND SYSTEM FOR DELIVERY

• US 20140088685A1
• Filed: 06/15/2012
• Published: 03/27/2014
• Est. Priority Date: 06/15/2011
• Status: Active Grant

• Current Assignee: Phraxis, Inc.
• Original Assignee: Phraxis, Inc.
• Inventors: Yevzlin, Alexander S., Houge, Reed A., Welch, Jeff M.
• Granted Patent: US 10,456,239 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure

Abstract

An anastomotic connector comprises a vessel anchor, a midgraft connector and graft material. The vessel anchor has a generally tubular main body including a distal end and a proximal end, the distal end defining a plurality of flanges integrally formed with the tubular main body and being movable from a first loaded position to a second expanded position. The midgraft connector operably couples the graft to the vessel anchor to form an anastomotic connector between an artery and a vein.

Claims

1. An anastomotic connector system comprising:

a vessel anchor including a generally tubular main body having a distal end and a proximal end; and

a plurality of flanges integrally formed with the main body at a distal end thereof, said flanges movable between a loaded position and an expanded position and forming an flange aperture at the distal end;

a midgraft connector including a main body defining a lumen and including a distal end defining an aperture and a proximal open end; and

a graft defining a lumen therewithin operably coupled to said midgraft connector, wherein the distal end of said midgraft connector is positioned operably adjacent the flange aperture to create a fluid pathway through the flange aperture, the midgraft connector aperture, the midgraft lumen and the graft lumen.

2. The system of claim 1 wherein the graft material includes a reinforced wall.

3. The system of claim 1 wherein the distal end of midgraft connector is conical-shaped.

4. The system of claim 1 wherein the midgraft connector further comprises a stepped portion at the proximal end thereof, said stepped portion forming a 90 degree angle with the main body.

5. The system of claim 1 wherein said vessel anchor has an inner diameter at said proximal end that is larger than an inner diameter at said distal end.

6. The system of claim 1 wherein said vessel anchor further comprises a plurality of flanges circumferentially disposed about the distal end.

7. The system of claim 6 wherein said tubular main body comprises a plurality of struts and connectors forming a stent.

8. The system of claim 1 wherein said flanges are configured to expand upon deployment to an angle equal to or less than 90 degrees offset from a longitudinal axis of the tubular main body.

9. The system of claim 1 wherein said flanges are configured to expand upon deployment at an angle equal to or greater than 90 degrees offset from a longitudinal axis of the tubular main body.

10. The system of claim 1 wherein said vessel anchor include a plurality of tines at the proximal end thereof.

11. The system of claim 10 wherein said tines extend inwardly toward the main body lumen at an acute angle from the tubular main body.

12. The system of claim 11 wherein said tines exert a compressive force on said graft.

13. The system of claim 1 wherein said vessel anchor is formed from a shape memory material.

14. The system of claim 1 wherein said vessel anchor is coated with a fluid impermeable material.

15. The system of claim 14 wherein said fluid impermeable material is woven.

16. The system of claim 14 wherein said fluid impermeable material is a polymeric material.

17. The system of claim 4 wherein the stepped portion has an outer diameter that is smaller than an outer diameter of the main body.

18. The system of claim 17 wherein an internal diameter of the graft is equal to or smaller than the outer diameter of the stepped portion.

19. The system of claim 1 wherein the midgraft connector is fabricated from a material selected from stainless steel, plastic and polymers.

20. The system of claim 4 wherein a surface of the stepped portion is contoured.

21. The system of claim 1 wherein a surface of the midgraft connector is non-thrombogenic.

22. A vessel anchor for use in an anastomotic connector device comprising:

a tubular main body defining a lumen therewithin and formed from a plurality of struts and connectors, said tubular main body including a distal end and a proximal end;

a plurality of flanges integrally formed with said tubular main body, said plurality of flanges movable between a loaded position and an expanded position; and

a plurality of tines integrally formed with said tubular main body adjacent said proximal end and extending into the lumen of said main body.

23. The vessel anchor of claim 22 wherein said tines extend inwardly at an acute angle from the tubular main body.

24. The vessel anchor of claim 22 wherein said plurality of flanges are offset from a longitudinal axis of said tubular main body by an acute angle.

25. The vessel anchor of claim 22 wherein said plurality of flanges are offset from a longitudinal axis of said tubular main body by an angle equal to or greater than 90 degrees.

26. The vessel anchor of claim 22 wherein an inner diameter at said proximal end of the main tubular body is larger than an inner diameter at said distal end.

27. The vessel anchor of claim 22 wherein said plurality of flanges are circumferentially disposed about the distal end.

28. The vessel anchor of claim 27 wherein said tubular main body comprises a plurality of struts and connectors forming a stent.

29. The vessel anchor of claim 22 wherein said tines exert a compressive force on a graft.

30. The vessel anchor of claim 22 wherein said vessel anchor is formed from a shape memory material.

31. The vessel anchor of claim 22 wherein said vessel anchor is coated with a fluid impermeable material.

32. The vessel anchor of claim 31 wherein said fluid impermeable material is woven.

33. The vessel anchor of claim 31 wherein said fluid impermeable material is a polymeric material.

34. A method of positioning a vessel anchor within fluid passageway comprising:

providing a vessel anchor, said vessel anchor including a generally tubular main body having a distal end and a proximal end, said distal end integrally defining a plurality of flanges circumferentially disposed about the distal end of said tubular main body, said tubular main body and said flanges movable between a loaded configuration and preset expanded configuration;

providing a seating device comprising a wire shaft and a balloon member adapted to be inflated and deflated, said wire shaft positioned within a lumen of said tubular main body and said balloon member extending past said flanges;

providing a delivery device, said delivery device including an outer sheath and an inner sheath having a lumen;

compressibly loading said seating device and said vessel anchor within the lumen of said inner sheath;

deploying the delivery device through an access site into a fluid passageway of a vessel;

retracting the inner sheath to expose said flanges and said balloon member, wherein upon retracting the inner sheath said flanges revert to the preset expanded configuration;

inflating said balloon member and causing said flanges to engage an inner surface of the fluid passageway by proximally moving said wire shaft proximally to cause said balloon member to adjacently abut said flanges thereby seating the vessel anchor in the fluid passageway;

removing said delivery device and seating device from said vessel.

35. A method of forming an anastomotic connector between two vessels in a body of a patient comprising:

(i) providing a vessel anchor, said vessel anchor including a generally tubular main body having a distal end and a proximal end, said distal end integrally defining a plurality of flanges circumferentially disposed about the distal end of said tubular main body, said tabular main body and said plurality of flanges movable between a loaded configuration and preset expanded configuration;

(ii) providing a seating device comprising a wire shaft and a balloon member adapted to be inflated and deflated, said wire shaft positioned within a lumen of said tubular main body and said deflated balloon member extending past said flanges;

(iii) providing a delivery device, said delivery device including an outer sheath and an inner sheath defining a lumen therewithin;

(iv) compressibly loading said seating device and said vessel anchor within the lumen of said inner sheath;

(v) deploying the delivery device through an access site into a fluid passageway of a vessel to a predetermined position;

(vi) retracting the inner sheath to expose said flanges and said balloon member, wherein upon retracting the inner sheath said flanges revert to the preset expanded configuration;

(vii) inflating said balloon member and causing said flanges to engage an inner surface of the fluid passageway by proximally retracting said wire shaft to cause said balloon member to adjacently abut said flanges thereby seating the vessel anchor in the fluid passageway;

(viii) retracting said outer sheath to cause said tubular main body to revert to the preset expanded configuration outside the vessel wall;

(ix) operably connecting a midgraft connector to a length of graft material;

(x) inserting said midgraft connector into said expanded tubular main body;

(xi) withdrawing said delivery device and said seating device from said vessel; and

(xii) repeating (i) through (xi) in a second vessel of a patient.