Method and apparatus for treatment of thrombosed hemodialysis access grafts

• US 7,182,755 B2
• Filed: 09/23/2004
• Issued: 02/27/2007
• Est. Priority Date: 09/24/2003
• Status: Active Grant

• Current Assignee: A.V. Medical Technologies, Ltd. (Medtronic Plc)
• Original Assignee: Yale University
• Inventors: Tal, Michael G.
• Primary Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/947,423
• Publication Number:
  US 20050065469A1
• Time in Patent Office: 887 Days
• Field of Search: 604/500, 604506-510, 604/93.01, 604/95.03, 604/96.01, 604/99.04, 604/101.03, 604/101.04, 604/102.01, 604/102.03, 604/912, 604/915, 606/191, 606/192, 606/194
• US Class Current: 604/507
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A method for the treatment of thrombosed hemodialysis access grafts or fistulas defining a shunt positioned between an arterial side and a venous side is achieved by inserting a balloon catheter within the shunt, wherein the balloon catheter includes a distal balloon and at least one infusion aperture located proximally of the distal balloon. Thereafter, the balloon catheter is advanced within an arterial anastomosis at an artery-shunt juncture and the distal balloon is inflated. A thrombolytic agent is then injected through the infusion apertures of the balloon catheter into the shunt to chemically destroy clot material within the shunt, wherein by applying the thrombolytic agent with the distal balloon inflated at the arterial anastomosis the possibility of the clot material moving into the artery is prevented and there is no need to worry about the migration of the clot into the arterial system and the resulting complications. Finally, the inflated distal balloon is pulled toward the venous side, eradicating the arterial plug. A balloon catheter for use in accordance with the present invention is also disclosed.

Claims

1. A method for the treatment of thrombosed hemodlialysis access grafts or fistulas defining a shunt positioned between an arterial side and a venous side, comprising the following steps:

inserting a balloon catheter within the shunt, the balloon catheter including a distal balloon and at least one infusion aperture located proximally of the distal balloon;

advancing the balloon catheter within an arterial anastomosis at an artery-shunt juncture;

inflating the distal balloon;

injecting a thrombolytic agent through the at least one infusion aperture of the balloon catheter into the shunt to chemically destroy clot material within the shunt, wherein by applying the thrombolytic agent with the distal balloon inflated at the arterial anastomosis the possibility of the clot material moving into the artery is prevented and there is no need to worry about the migration of the clot into the arterial system and the resulting complications; and

pulling the inflated distal balloon toward the venous side, eradicating the arterial plug.

2. The method according to claim 1, wherein, prior to inserting the balloon catheter, a dilatation catheter is advanced into a venous anastomosis and inflated to crush the venous anastomosis and open a shunt-vein juncture.

3. The method according to claim 2, wherein the step of advancing the dilatation catheter includes removing the dilatation catheter prior to insertion of the balloon catheter.

4. The method according to claim 2, wherein the step of injecting the thrombolytic agent includes spraying the thrombolytic agent with such force that the force of the spray created by the application of the thrombolytic agent mechanically disrupts the clot.

5. The method according to claim 4, wherein the step of injecting the thrombolytic agent is followed by the injection of saline to flush any residual clot material.

6. The method according to claim 5, wherein the step of injecting the thrombolytic agent is followed by applying a contrast material within the shunt and visualizing the shunt.

7. The method according to claim 6, wherein the step of pulling the inflated distal balloon includes removing a platelet plug and residual arterial anastomosis from the shunt-artery juncture.

8. The method according to claim 1, wherein the step of injecting the thrombolytic agent includes spraying the thrombolytic agent with such force that the force of the spray created by the application of the thrombolytic agent mechanically disrupts the clot.

9. The method according to claim 1, wherein the step of injecting the thrombolytic agent is followed by the injection of saline to flush any residual clot material.

10. The method according to claim 1, wherein the step of injecting the thrombolytic agent is followed by applying a contrast material within the shunt and visualizing the shunt.

11. The method according to claim 1, wherein the step of puffing the inflated distal balloon includes removing a platelet plug and residual arterial anastomosis from the shunt-artery juncture.

12. The method according to claim 1, wherein the step of inserting the balloon catheter includes inserting the balloon catheter into a clean shunt region.