DEVICE AND METHOD FOR ESTABLISHING AN ARTIFICIAL ARTERIO-VENOUS FISTULA

• US 20070249985A1
• Filed: 04/04/2007
• Published: 10/25/2007
• Est. Priority Date: 08/27/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: ROX Medical, Inc.
• Inventors: Kellerman, Brad, Davis, Peter, Brenneman, Rodney, Schaefer, Dean, Flaherty, J.
• Granted Patent: US 7,828,814 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: C09K 8/5083 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: C09K 8/518 Foams
• CPC Class Codes: C09K 8/5753 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: C09K 8/62 Compositions for forming crevices or fractures
• CPC Class Codes: C09K 8/68 containing organic compounds

Abstract

A shunt rivet for implantation in the aorta and inferior vena cava to treat chronic obstructive pulmonary disease, and a method of treating chronic obstructive pulmonary disease.

Claims

1. An intravascular connector, comprising:

a first pair of clinch members comprising a first member and an apposed second member;

a second pair of clinch members opposite from the first pair of clinch members and comprising a first member and an apposed second member;

wherein the first and second pairs of clinch members has a deployed configuration longitudinally disposed relative to contiguous portions of a first vessel and a second vessel such that the first and second pairs of clinch members are biased to close upon contiguous parallel portions of the first and second vessels, and

wherein the first and second members of the first pair of clinch members comprise non-uniform lengths relative to one another and the first and second members of the second pair of clinch members comprise non-uniform lengths relative to one another.

2. The connector of claim 1 further comprising at least a third pair of clinch members having a deployed configuration transverse to the first and second pairs such that the third pair of clinch members are biased to exert a nominal pressure on circumferentially spaced points on side walls of the first and second vessels.

3. The connector of claim 1 wherein each first member of the first and second pair of clinch members each have a length less than each second member of the first and second pair of clinch members.

4. The connector of claim 3 wherein each first member of the first and second pair of clinch members are deployed on opposite ends of the connector within first and second vessels, respectively.

5. The connector of claim 4 wherein each second member of the first and second pair of clinch members are deployed on opposite ends of the connector within first and second vessels, respectively.

6. The connector of claim 1 further comprising a clip connector extending between the first and second pair of clinch members and defining a lumen therethrough fluidly coupling the first and second vessels.

7. The connector of claim 6 wherein the clip connector is angled relative to a centerline of the connector.

8. The connector of claim 6 wherein the clip connector defines a tapered cross-sectional area along its length.

9. The connector of claim 6 wherein the clip connector is angled relative to a centerline of the connector and defines a tapered cross-sectional area along its length.

10. The connector of claim 6 further comprising at least one deformable segment along a length of the clip connector.

11. The connector of claim 1 further comprising a hinge or flange between clinch members.

12. The connector of claim 1 further comprising at least one break-away or frangible segment along a periphery of the connector.

13. The connector of claim 1 further comprising at least one deformable segment along a periphery of the connector.

14. The connector of claim 1 further comprising a delivery instrument having an outer sheath and an inner shaft slidable within the outer sheath such that the connector is deployable from within the outer sheath.

15. The connector of claim 14 further comprising an inflatable member near or at a distal end of the outer sheath and/or inner shaft.

16. The connector of claim 14 wherein the outer sheath and/or inner shaft are articulatable.

17. The connector of claim 14 wherein the delivery instrument further comprises an inflatable balloon thereupon.

18. The connector of claim 17 wherein the balloon defines a circular cross-sectional area when inflated.

19. The connector of claim 17 wherein the balloon defines a non-circular cross-sectional area when inflated.

20. The connector of claim 1 wherein the first and second pairs of clinch members are biased to evert such that a distal portion of each apposed member is proximate to one another when released in its deployed configuration.

21. The connector of claim 1 wherein a distal portion of each apposed clinch member is configured to form an atraumatic bearing surface therebetween for impingement on the first and second vessels.

22. The connector of claim 1 wherein the first and second pairs of clinch members comprise a continuously formed clip absent an intervening waist segment.

23. The connector of claim 1 wherein the first vessel comprises an artery.

24. The connector of claim 1 wherein the second vessel comprises a vein.

25. The connector of claim 2 wherein the third pair of clinch members are biased to establish a slight compliance mismatch between the first and second vessels.

26. The connector of claim 2 wherein the third pair of clinch members each define a distal portion which is spaced apart from one another in the deployed configuration.

27. The connector of claim 1 wherein the third pair of clinch members comprise a continuously formed clip absent an intervening waist segment.

28. The connector of claim 1 further comprising a therapeutic drug coating or membrane at least partially covering the connector.

29. A method for creating an intravascular connection, comprising:

advancing an intravascular connector through a first vessel, the intravascular connector having a first pair of clinch members comprising a first member and an apposed second member and a second pair of clinch members opposite from the first pair of clinch members and also comprising a first member and an apposed second member;

introducing the second member of the first pair and the first member of the second pair into a second vessel from the first vessel such that the respective members deploy into contact against an inner wall of the second vessel; and

deploying the first member of the first pair and the second member of the second pair into contact against an inner wall of the first vessel,

wherein the first and second members of the first pair of clinch members comprise non-uniform lengths relative to one another and the first and second members of the second pair of clinch members comprise non-uniform lengths relative to one another.

30. The method of claim 29 wherein advancing an intravascular connector comprises advancing the connector within an outer sheath.

31. The method of claim 29 wherein prior to introducing, intravascularly crossing a guidewire from the first vessel into the second vessel such that the guidewire is disposed within the first and second vessels.

32. The method of claim 31 wherein introducing comprises advancing the intravascular connector at least partially from the first vessel and into the second vessel over or along the guidewire.

33. The method of claim 29 wherein introducing comprises releasing the first member of the second pair in an arc contained within the second vessel into contact against the inner wall of the second vessel.

34. The method of claim 29 wherein deploying comprises releasing the first member of the first pair in an arc contained within the first vessel into contact against the inner wall of the first vessel.

35. The method of claim 29 further comprising adjusting a physical parameter of the intravascular connector to modify a flow rate between the first and second vessels through the connector.

36. The method of claim 35 wherein adjusting a physical parameter comprises modifying a configuration of the intravascular connector via break-away, frangible, or deformable segments comprising at least a portion of the connector.

37. The method of claim 35 wherein adjusting a physical parameter comprises adjusting a cross-sectional area of the intravascular connector to adjust the flow rate therethrough.

38. The method of claim 35 wherein adjusting a physical parameter comprises adjusting a lumen length of the intravascular connector between the first and second vessels.

39. The method of claim 35 wherein adjusting a physical parameter comprises adjusting an angle of the intravascular connector extending between the first and second vessels.

40. The method of claim 29 further comprising deploying at least a third pair of clinch members having a deployed configuration transverse to the first and second pairs such that the third pair of clinch members are biased to exert a nominal pressure on circumferentially spaced points on side walls of the first and second vessels.

41. A method for implanting an intravascular connector, comprising:

advancing an intravascular connector through a first vessel, the intravascular connector having a first pair of clinch members comprising a first member and an apposed second member and a second pair of clinch members opposite from the first pair of clinch members and also comprising a first member and an apposed second member;

introducing the second member of the first pair and the first member of the second pair into a second vessel from the first vessel;

visualizing a deflection of the second member of the first pair against a tissue wall of the second vessel to determine suitable positioning of the connector relative to the second vessel;

deploying the first member of the second pair such that the first member of the second pair swings from a distal position to a proximal position against the tissue wall of the second vessel; and

deploying the first member of the first pair and the second member of the second pair into contact against an inner wall of the first vessel such that the first vessel and second vessel are in fluid communication with one another.

42. The method of claim 41 wherein the first and second members of the first pair of clinch members comprise non-uniform lengths relative to one another and the first and second members of the second pair of clinch members comprise non-uniform lengths relative to one another.

43. The method of claim 41 wherein advancing an intravascular connector comprises advancing the connector within an outer sheath.

44. The method of claim 41 wherein prior to introducing, intravascularly crossing a guidewire from the first vessel into the second vessel such that the guidewire is disposed within the first and second vessels.

45. The method of claim 41 further comprising adjusting a physical parameter of the intravascular connector to modify a flow rate between the first and second vessels through the connector.

46. The method of claim 45 wherein adjusting a physical parameter comprises modifing a configuration of the intravascular connector via break-away, frangible, or deformable segments comprising at least a portion of the connector.

47. The method of claim 41 wherein visualizing a deflection comprises determining when deflection of the second member of the first pair is minimized relative to the tissue wall of the second vessel as indicative of suitable connector positioning.

48. The method of claim 47 further comprising perceiving force feedback of the connector against the tissue wall of the second vessel.

49. The method of claim 41 further comprising deploying at least a third pair of clinch members having a deployed configuration transverse to the first and second pairs such that the third pair of clinch members are biased to exert a nominal pressure on circumferentially spaced points on side walls of the first and second vessels.