Devices, systems and methods for creation of peripherally located fistula

• US 9,955,970 B2
• Filed: 09/29/2015
• Issued: 05/01/2018
• Est. Priority Date: 06/30/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: ROX Medical, Inc.
• Inventors: Brenneman, Rodney, Schaefer, Dean A., Flaherty, J. Christopher
• Primary Examiner(s): Dang, Son
• Application Number:
  US14/868,652
• Publication Number:
  US 20160228122A1
• Time in Patent Office: 945 Days
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

Devices, systems and methods are disclosed for the formation of an arteriovenous fistula in the limb of the patient. Embodiments include a device for the creation, modification and maintenance of a fistula that includes an integral fistula creation assembly near its distal end that passes through the skin of the patient, through a first vessel such as an artery, and into a second vessel such as a vein. The fistula creation assembly preferably includes an anastomotic implant that is placed within the fistula to maintain long-term blood flow therethrough. The devices, systems and methods can be used to treat patients with one or more numerous ailments including chronic obstructive pulmonary disease, congestive heart failure, hypertension, hypotension, respiratory failure, pulmonary arterial hypertension, lung fibrosis and adult respiratory distress syndrome.

Claims

1. A method for percutaneously creating a fistula in a patient between a first blood vessel and a second blood vessel, said method comprising:

providing an assembly comprising a sheath having a lumen therethrough, a needle slidingly received in the sheath, and a clip disposed within the sheath, wherein the needle has a needle tip configured to be advanced through tissue;

percutaneously advancing the assembly through a skin layer of the patient and into a lumen of the first blood vessel;

advancing the needle from the lumen of the first blood vessel and into a lumen of the second blood vessel;

advancing a guidewire through a lumen of the needle and into the lumen of the second blood vessel;

retracting the needle proximally over the guidewire while the sheath and the clip of the assembly remain in place; and

deploying the clip over the guidewire to scaffold the fistula between the first and second blood vessels.

2. A method as in claim 1, wherein the first blood vessel is located above the second blood vessel in relation to the skin surface.

3. A method as in claim 1, further comprising determining the fistula location at least one of prior to or concurrently with advancing the assembly through the skin layer.

4. A method as in claim 3, wherein determining the fistula location comprises assessing data generated while using one or more visualization techniques selected from angiography, venography, extra-vascular ultrasound, intravascular ultrasound, and MRI.

5. A method as in claim 3, wherein determining the fistula location comprises assessing data generated while using Doppler ultrasound.

6. A method as in claim 1, wherein the assembly is inserted at an angle in the range from 20°

to 80°

relative to an external surface of the skin layer.

7. A method as in claim 1, wherein the assembly is inserted at an angle approximately 90°

relative to an external surface of the skin layer.

8. A method as in claim 1, wherein the first blood vessel and the second blood vessel are peripheral blood vessels.

9. A method as in claim 1, further comprising advancing the sheath from the first blood vessel into the second blood vessel over the guidewire.

10. A method as in claim 1, further comprising positioning at least a portion of the clip between the lumens of the first and second blood vessels prior to deploying the clip over the guidewire.

11. A method as in claim 1, wherein deploying the clip comprises partially advancing the clip from a distal end of the sheath to release one or more tensioning arms on the clip.

12. A method as in claim 11, further comprising retracting the sheath to contact the tensioning arm(s) against a wall of the second blood vessel prior to fully deploying the clip.

13. A method as in claim 12 wherein fully deploying the clip engages two tensioning arms against the wall of the second blood vessel and two tensioning arms against a wall of the first blood vessel.

14. A method as in claim 1, wherein the fistula has an oval cross-section.

15. A method as in claim 14, wherein the oval has a major axis which is at least 20% greater than a minor axis.

16. A method as in claim 15, wherein a length of the major axis is larger than a diameter of the first blood vessel or second blood vessel.

17. A method as in claim 1, further comprising introducing a catheter over the guidewire after the clip has been deployed.

18. A method as in claim 17, wherein the catheter is introduced to perform at least one of visualize the fistula, measure fistula flow, or modify the fistula.

19. A method as in claim 1, further comprising selecting a patient suffering from at least one of chronic obstructive pulmonary disease, congestive heart failure, hypertension, hypotension, respiratory failure, pulmonary arterial hypertension, lung fibrosis and adult respiratory distress syndrome.

20. A method as in claim 1, wherein deploying the clip comprises retracting the sheath of the assembly to free the clip from constraint such that the clip self-expands.

21. A method as in claim 1, wherein deploying the clip comprises expanding an expandable element within the sheath of the assembly to deploy the clip.

22. A method as in claim 1, wherein the first blood vessel is an artery and the second blood vessel is a vein.

23. A method as in claim 1, wherein the first blood vessel is a vein and the second blood vessel is an artery.