VASCULAR ANASTOMOSIS STENT

• US 20150094744A1
• Filed: 05/28/2013
• Published: 04/02/2015
• Est. Priority Date: 05/25/2012
• Status: Abandoned Application

• Current Assignee: H Lee Moffitt Cancer Center & Research Institute (State University System of Florida), University of South Florida (State University System of Florida)
• Original Assignee: H Lee Moffitt Cancer Center & Research Institute (State University System of Florida), University of South Florida (State University System of Florida)
• Inventors: Aghayev, Kamran, Vrionis, Frank
• Application Number:
  US14/402,351
• Publication Number:
  US 20150094744A1
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/128 for applying or removing clamps or clips
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1132 End-to-end connections
• 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

Abstract

Provided herein are devices, methods, and kits for a stent based anastomosis.

Claims

1. A vascular anastomosis stent device comprising:

a) A biocompatible elongated tube structure comprising a first and second open end, the tube structure having an inside surface facing a central axis of the tube structure and an outside surface facing away from the central axis, wherein the inside surface of the elongated tube is continuous between the first and second open end;

b) a first radially expandable metallic ring encircling the tube structure at or near the first open end; and

c) a second radially expandable metallic ring encircling the tube structure at or near the second open end.

2. The stent device of claim 1, further comprising

a) a third open end, wherein the inside surface of the elongated tube structure is continuous between the first, second, and third open end;

and

b) a third radially expandable metallic ring encircling the elongated tube at or near the third open end.

3. The stent device of claim 1, wherein the radially expandable metallic rings are partially embedded in the outside surface of the elongated tube structure and do not extend to the inside surface.

4. The stent device of claim 1, wherein the radially expandable metallic rings comprise a circumferential groove.

5. The stent device of claim 1, wherein the radially expandable metallic rings comprise a ratcheting mechanism that permits expansion but not collapse of the rings.

6. The stent device of claim 1, wherein the radially expandable metallic rings comprise a plastically deformable metal.

7. The stent device of claim 1, wherein the radially expandable metallic rings are expandable by a balloon catheter.

8. The stent device of claim 1, wherein the radially expandable metallic rings have a radial stiffness when expanded sufficient to resist deformation when circumferential force sufficient to provide a hermetical seal between the radially expandable metallic rings and a vascular wall is applied.

9. The stent device of claim 1, further comprises a ring clip comprising first jaw and second jaw that actuate at a pivot point to define an open and closed conformation, wherein the ring clip is sized so that the jaws reside substantially within the circumferential groove when the clip is released from the open conformation.

10. The stent device of claim 9, wherein the ring clip is positionable over the circumferential groove and the wall of the vascular lumen in the open conformation, wherein the ring clip compresses the vascular wall against the radially expandable metallic ring when released from the open conformation with sufficient force to create a hermetical seal but not to deform the radially expandable metallic ring.

11. The stent device of claim 9, wherein the ring clip comprises a continuous length of wire having a coil formed at its proximal end so as to create a spring force that biases the jaws into the closed conformation.

12. The stent device of claim 1, wherein the biocompatible elongated tube structure comprises a vascular graft material.

13. The stent device of claim 12, wherein the vascular graft material water comprises a water impermeable, non-thrombogenic, and elastic material.

14. The stent device of claim 1, wherein the vascular graft material comprises polytetrafluoroethylene or a combination thereof.

15. The stent device of claim 1, wherein the first open end has a diameter of about 3 mm to about 100 mm.

16. The stent device of claim 1, wherein elongated tube structure has a length of about 1 cm to about 30 cm.

17. The stent device of claim 1, further comprising a port having an open end and an inside and outside surface, wherein the inside surface of the port is continuous between the first and second open end.

18. A method of performing a vascular anastomosis comprising:

a) inserting the vascular anastomosis stent device of claim 1 into a bisected vessel such that the first and second radially expandable metallic rings reside within the vessel lumen on opposing sides relative the bisection;

b) expanding the first and second metallic rings to match the diameter of the lumen of the bisected vessel;

c) applying a first ring clip or ligature around the outside of the vessel at a location over the first expanded metallic ring; and

d) applying a second ring clip or ligature around the outside of the vessel at a location over the second expanded metallic ring.

19. The method of claim 18, wherein the first and second metallic rings are expanded until the lumen of the bisected vessel is fully dialated.

20. The method of claim 18, wherein the first and second metallic rings are expanded with a first balloon catheter.

21. The method of claim 18, wherein prior to step a) the vessel is bisected by occluding blood flow proximally and distally to the site of bisection.

22. The method of claim 21, wherein blood flow is occluded with one or more aneurism clips.

23. The method of claim 21, wherein blood flow is occluded with one or more of a second balloon catheter.

24. The method of claim 23, wherein the second balloon catheter functions as a guide wire for the first balloon catheter.

25. The method of claim 21, further comprising

e) removing the blood flow occlusion;

f) flushing blood and air out of the port; and

g) sealing the port.

26. The method of claim 25, wherein the port is sealed with an aneurism clip.

35. A kit comprising the vascular anastomosis stent device of claim 1 and one or more balloon catheters for expanding the radially expandable rings.

36. The kit of claim 35, further comprising one or more guide wires.

37. The kit of claim 35, further comprising one or more aneurism clips.

27. A method of performing a vascular anastomosis comprising:

a) providing a vascular anastomosis stent device comprising

i) a biocompatible elongated tube structure comprising a first and second open end, the tube structure having an inside surface facing a central axis of the tube structure and an outside surface facing away from the central axis, wherein the inside surface of the elongated tube is continuous between the first and second open end;

ii) a first metallic ring encircling the tube structure at or near the first open end; and

iii) a second metallic ring encircling the tube structure at or near the second open end;

b) serially dilating the lumen of the bisected vessel;

c) inserting the vascular anastomosis stent device into the dilated lumen of the bisected vessel such that the first and second metallic rings reside within the dilated vessel lumen on opposing sides relative the bisection;

d) applying a first ring clip or ligature around the outside of the vessel at a location over the first metallic ring; and

e) applying a second ring clip or ligature around the outside of the vessel at a location over the second metallic ring.

28. The method of claim 27, wherein step b) comprises serially dilating the lumen of the bisected vessel to its maximally dilated diameter

29. The method of claim 27, wherein prior to step a) the vessel is bisected by occluding blood flow proximally and distally to the site of bisection.

30. The method of claim 29, wherein blood flow is occluded with aneurism clips.

31. The method of claim 29, wherein blood flow is occluded with a balloon catheter.

32. The method of claim 28, wherein the vascular anastomosis stent device further comprises a port having an open end and an inside and outside surface, wherein the inside surface of the port is continuous between the first and second open ends of the stent device.

33. The method of claim 32, further comprising

e) removing the blood flow occlusion;

f) flushing blood and air out of the stent device through the open end of the port; and

g) sealing the open end of the port.

34. The method of claim 33, wherein the port is sealed with an aneurism clip.

38. A kit comprising

a) a vascular anastomosis stent device comprising

i) a biocompatible elongated tube structure comprising a first and second open end, the tube structure having an inside surface facing a central axis of the tube structure and an outside surface facing away from the central axis, wherein the inside surface of the elongated tube is continuous between the first and second open end;

ii) a first metallic ring encircling the tube structure at or near the first open end; and

iii) a second metallic ring encircling the tube structure at or near the second open end; and

b) a serial dilator.

39. The kit of claim 38, further comprising one or more guide wires.

40. The kit of claim 38, further comprising one or more aneurism clips.