Device and method for establishing an artificial arterio-venous fistula

• US 9,510,832 B2
• Filed: 01/09/2015
• Issued: 12/06/2016
• Est. Priority Date: 08/27/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: ROX Medical, Inc.
• Inventors: Brenneman, Rodney A.
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US14/593,624
• Publication Number:
  US 20150127030A1
• Time in Patent Office: 697 Days
• Field of Search: 606/151, 606/153, 604/8, 604/9, 623/1.13
• US Class Current: 1/1
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• 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

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. The shunt rivet may be formed to have a central section, a proximal clinch section, and a distal clinch section each having one or more clinch members. These one or more clinch members may be trained to be resiliently biased to bend radially outwardly from the central section.

Claims

1. A device for establishing and maintaining a fistula between a pair of adjacent blood vessels, comprising:

a central section with a first diameter;

a proximal first member and an apposed proximal second member;

a distal first member and an apposed distal second member, wherein the distal first member and the distal second member are opposite the proximal first member and the proximal second member;

wherein the proximal first member and the distal first member are configured to be deployed on opposite ends of the central section within a first vessel and a second vessel,

wherein the proximal first member and the proximal second member are configured to be resiliently biased to bend radially outwardly from the central sections,

wherein the distal first member and the distal second member are configured to be resiliently biased to bend radially outwardly from the central section, and

wherein the proximal first and second members and the distal first and second members are configured to produce a grip strength from 3-45 gram-force upon an intervening blood vessel.

2. The device of claim 1, wherein the proximal first member and the distal first member are sized to arc entirely within each respective vessel into a deployed position when the proximal second member and the distal second member contact each respective vessel wall.

3. The device of claim 1, wherein the proximal first member and the proximal second member are configured to arc greater than 270 degrees.

4. The device of claim 1, wherein the distal first member and the distal second member are configured to form a blind head allowance of 10-16 mm.

5. The device of claim 1, wherein the proximal first member and the proximal second member are configured to form a head diameter of 5-16 mm.

6. The device of claim 1, wherein the central structure is a pseudoelastic material, wherein the pseudoelastic material is configured to be pseudoelastic at body temperature.

7. The device of claim 1, wherein the distal first and second members and the proximal first and second members have a deployed configuration longitudinally disposed relative to contiguous portions of the first and second vessels such that the distal first and second members and the proximal first and second members are biased to close upon the contiguous portions.

8. The device of claim 1, wherein the central structure is a resilient material.

9. A device for establishing and maintaining a fistula between a pair of adjacent blood vessels, comprising:

a central section with a first diameter;

a proximal first member and an apposed proximal second member, wherein the proximal first member and the proximal second member are configured to be resiliently biased to bend radially outwardly from the central section; and

a distal first member and an apposed distal second member, wherein the distal first member and the distal second member are configured to be resiliently biased to bend radially outwardly from the central section, wherein the distal first member and the distal second member are configured to form a blind head allowance of 10-16 mm, and wherein the proximal first and second members and the distal first and second members are configured to produce a grip strength from 3-45 gram-force upon an intervening blood vessel.

10. The device of claim 9, wherein the proximal first member and the proximal second member are configured to form a head diameter of 5-16 mm.

11. The device of claim 9, wherein the central structure is a pseudoelastic material, wherein the pseudoelastic material is configured to be pseudoelastic at body temperature.

12. The device of claim 9, wherein the central structure is a resilient material.

13. The device of claim 9, wherein the proximal first member or the proximal second member comprise a radiopaque portion.

14. The device of claim 13, wherein the radiopaque portion is platinum or iridium.

15. The device of claim 9, wherein the proximal first member and the proximal second member are configured to arc greater than 180 degrees.

16. The device of claim 9, wherein the proximal first member or the proximal second member are configured to form a pigtail structure.

17. The device of claim 9, wherein the device has an overall initial length of between 8 mm-10 mm.

18. A method of treating a patient comprising:

providing a device having a central tubular section with a first diameter, a proximal clinch section defined by one or more clinch members, and a distal clinch section defined by one or more clinch members;

said distal clinch members being resiliently or pseudoelastically biased to bend radially outwardly from the central section;

said proximal clinch members being resiliently or pseudoelastically biased to bend radially outwardly from the central section;

making a first perforation or aperture or hole or incision through the aorta of the patient and a second incision in the vena cava of the patient, said first and second incisions being in apposition so as to permit insertion of the device through both incisions;

compressing the device into a generally tubular configuration and inserting the device into the distal end of a catheter;

percutaneously inserting the device into the perforation or aperture or hole or incision so that the distal clinch members extend into the vena cava and the proximal clinch members extend into the aorta;

releasing the distal clinch, members from the catheter to allow the distal clinch members to resiliently or pseudoelastically bend outwardly to form a distal clinch operable to impinge on the vena cava wall proximate the incision;

releasing the proximal clinch members from the catheter to allow the proximal clinch members to resiliently or pseudoelastically bend outwardly to form a proximal clinch operable to impinge on the aorta wall proximate the incision; and

expanding the central section through plastic deformation to a second diameter such that the distal clinch members and the proximal clinch member each produce a grip strength from 3-45 gram-force upon the vena cava wall and the aorta wall, respectively.