Device and method for establishing an artificial arterio-venous fistula

• US 9,468,441 B2
• Filed: 10/31/2011
• Issued: 10/18/2016
• 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): Houston, Elizabeth
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US13/285,860
• Publication Number:
  US 20120101423A1
• Time in Patent Office: 1,814 Days
• Field of Search: 606153-156, 604/8, 623/23.72, 623/1.15
• US Class Current: 1/1
• 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 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• 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 implementation in the aorta and inferior vena cava to treat chronic obstructive pulmonary disease, and a method of treating chronic obstructive pulmonary disease.

Claims

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

a proximal clinch section defined by a plurality of proximal clinch members each defined by a proximal terminus and an arcuately extending tip; and

a distal clinch section defined by a plurality of distal clinch members each defined by a proximal terminus and an arcuately extending tip, where the distal clinch members and proximal clinch members are arranged with the proximal terminus of each clinch member disposed toward a center of the device and the tips pointing generally outwardly from the device,

wherein the distal clinch members are joined at their proximal terminus to the proximal terminus of corresponding proximal clinch members and the proximal clinch members are arranged relative to each other and fixed to each other near the proximal terminus of each other, and the distal clinch members are arranged relative to each other and fixed to each other near the proximal terminus of each other,

wherein the device is characterized by a transverse centerline corresponding to the direct connection between the proximal clinch members and the distal clinch members and an axial centerline perpendicular to the transverse centerline and established by the arranged clinch members,

wherein the proximal clinch members are resiliently biased to curve radially outward and evert toward the transverse centerline of the device and a first distal clinch member of the plurality of distal clinch members is biased to curve radially outward and evert toward the transverse center of the device to a position opposite a first proximal clinch member of the plurality of proximal clinch members, wherein the arcuately extending tip of the first proximal clinch member and the arcuately extending tip of the first distal clinch member are apposed to one another along the transverse centerline,

wherein the proximal clinch members and distal clinch members are resiliently biased to curve radially outward from the center of the device;

a first pair of tension members having opposing tips which form an atraumatic bearing surface and which are biased to curve radially outward away from the axial centerline in opposing directions without everting; and

,

a second pair of tension members extending in a direction opposite to the first pair of tension members and having opposing tips which form an atraumatic bearing surface and which are biased to curve radially outward from the axial centerline in opposing directions without everting,

wherein a segment at each of the tips of the first pair of tension members and the second pair of tension members extends away from and then towards the axial centerline to form the atraumatic bearing surfaces.

2. The device of claim 1 wherein the first and second pair of tension members are biased to curve radially outwardly from the axial centerline without everting and a second distal clinch member of the plurality of distal clinch members is biased to curve radially outward.

3. The device of claim 1 wherein the proximal clinch members and distal clinch members are positioned in an alternating arrangement relative to the first pair and second pair of tension members.

4. The device of claim 1 further comprising:

a third proximal clinch member of the plurality of proximal clinch members which is biased to curve radially outward and evert toward the transverse centerline of the device and a third distal clinch member of the plurality of distal clinch members which is biased to curve radially outward and evert toward the transverse centerline of the device to a position opposite the third proximal clinch member; and

,

a third pair of tension members having opposite tips which form an atraumatic bearing surface and which are biased to curve radially outward without everting.

5. The device of claim 4 wherein the third proximal clinch member and third distal clinch member and third pair of tension members are positioned relative to the first proximal clinch member and first distal clinch member and a second proximal clinch member of the plurality of proximal clinch members and a second distal clinch member of the plurality of distal clinch members in an alternating arrangement to create a cruciform arrangement.

6. The device of claim 1 further comprising a second proximal clinch member of the plurality of proximal clinch members and a second distal clinch member of the plurality of distal clinch members, wherein the second proximal and second distal clinch members form an arcuate resilient support adapted for contacting walls of the adjacent blood vessels at points circumferentially displaced from the arterio-venous fistula.

7. The device of claim 1 wherein the first proximal and first distal clinch members form a resilient clip adapted for contacting walls of the adjacent blood vessels at points longitudinally displaced from the arterio-venous fistula.

8. The device of claim 1 where the device is elastically or pseudoelastically deformable into a tubular configuration for percutaneous delivery to the site of the arterio-venous fistula, and elastically or pseudoelastically expandable to span the arterio-venous fistula.

9. The device of claim 1 wherein at least one of the clinch members is disposed at an angle from the axial centerline of the device.