Devices, systems and methods for creation of a peripherally located fistula

• US 8,641,724 B2
• Filed: 11/28/2007
• Issued: 02/04/2014
• 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): McDermott, Corrine M
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US11/946,454
• Publication Number:
  US 20080119879A1
• Time in Patent Office: 2,260 Days
• Field of Search: 606/153, 606/108, 600 16- 18, 600/464, 600/465, 600/466, 600/467, 600468-471, 604/8, 604/96.01, 623/1.11, 623/23.7, 623/1.15
• US Class Current: 606/108
• 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 device for creating a fistula in a patient comprising:

an elongate tubular structure having a proximal end and a distal end, wherein the distal end is configured to pass first through the skin of the patient, then through a first vessel, and then into a second vessel, wherein said elongate tubular structure includes an outer tube and a slidable core slidingly received by said outer tube, wherein the slidable core has a proximal end, a distal end, and a lumen therethrough;

a self-expanding fistula creation assembly disposed near the distal end of the elongate tubular structure, said self-expanding fistula creation assembly being adapted to create and maintain a fistula that provides a flow of blood between the first vessel and the second vessel; and

a needle removably received in a lumen of the slidable core, wherein the needle has a needle tip that extends beyond the distal end of the elongate tubular structure to penetrate skin and the first and second vessels as the elongate tubular structure is advanced;

wherein the self-expanding fistula creation assembly is carried on the first slidable core and constrained by the tubular structure such that the outer tube can be retracted to release the self-expanding fistula creation assembly in the penetration.

2. The device of claim 1, wherein the slidable core has a tapered or beveled distal end.

3. The device of claim 1, wherein the device is configured to be advanced and/or retracted over a guidewire contained within a lumen of the needle.

4. The device of claim 1, wherein the fistula creation assembly comprises one or more of a cone shaped dilator, an expandable assembly such as a balloon, an energy delivery element, an agent delivery element, and an anastomotic implant.

5. The device of claim 1, wherein the self-expanding fistula creation assembly comprises an anastomotic implant constructed of materials selected from the group consisting of stainless steel or Nitinol, plastically deformable materials, and combinations thereof.

6. The device of claim 5, wherein the fistula creation assembly further comprises an expandable balloon configured to apply radial force to at least a portion of the anastomotic implant, said radial force applied to said anastomotic implant during deployment of the anastomotic implant in the fistula and/or after the deployment of the anastomotic implant in the fistula.

7. The device of claim 5, wherein the anastomotic implant is configured to perform one or more of the following functions apply a radial force to the fistula, apply a compressive force to the first and second vessels, and cause the flow in the fistula to tend toward laminar flow.

8. The device of claim 1, wherein the fistula is configured to:

provide a therapy for chronic obstructive pulmonary disease, increase venous oxygen level, increase arterial oxygen level, decrease systemic vascular resistance, and combinations thereof.

9. The device of claim 1, further comprising a handle on the proximal end and at least one slidable core;

wherein the handle includes one or more controls configured to perform one or more of the following functions;

activate or otherwise control at least a portion of the fistula creation assembly such as by controlling one or more of;

expansion of a balloon deployment of an anastomotic implant;

apply force to an anastomotic implant;

delivery of energy;

delivery of an agent such as a drug; and

advance or retract the slidable core; and

combinations thereof.

10. The device of claim 1, wherein the first vessel is selected from the group consisting of axillary artery, brachial artery, ulnar artery, radial artery, profundal artery, femoral artery, iliac artery, popliteal artery, carotid artery, saphenous vein, femoral vein, iliac vein, popliteal vein, brachial vein, basilic vein, cephalic vein, medial forearm vein, medial cubital vein, axillary vein, and jugular vein.

11. The device of claim 1, wherein the second vessel wall is within 20 mm of the first vessel wall.

12. The device of claim 1, wherein the elongate tubular structure includes a lumen from its proximal end to its distal end, wherein the device is configured to reside in the patient with a guidewire in said lumen, said device further configured to be withdrawn from the patient leaving the guidewire to remain passing through the skin and into the patient, through the first vessel, through the fistula, and into the second vessel.

13. The device of claim 1, wherein the tubular structure includes a flow measurement element configured to measure flow of the patient'"'"'s blood.

14. The device of claim 1, further comprising flow adjustment means, said flow adjustment means comprising one or more of:

an inflatable balloon; and

a deployable implant such as an implant deployed within the fistula, and implant configured to be deployed within a pre-existing implant, an implant which impedes flow in the fistula, and/or an implant which enlarges the fistula.

15. A system for creating a fistula comprising the device of claim 1, and an ultrasound visualization monitor.

16. A system for creating a fistula comprising:

the device of claim 1, and an apparatus selected from the group consisting of;

a balloon catheter, an anastomotic implant deployment catheter, a flow measurement device such as a flow catheter or an external Doppler probe, an angiography catheter, a venography catheter, a guidewire, an introducer, a biopsy needle, and combinations thereof.