IP Library Granted Patent US 9,962,527
Granted Patent B2
US 9,962,527 · App. 14/515,435 · Granted May 8, 2018

Methods and devices for treatment of stenosis of arteriovenous fistula shunts

Inventors: James B. Laudenslager (Carlsbad, CA); Dean S. Irwin (Carlsbad, CA)
Assignee: RA MEDICAL SYSTEMS, INC.
A61M25/09A61B18/245A61B50/30A61B2018/0041A61B2018/00285A61B2018/00577A61B2018/2222A61B2018/2238A61B2050/314A61B2090/3966A61M25/002A61M2025/0177A61M2025/105
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Quick Facts
Patent No.
US 9,962,527
App. No.
14/515,435
Granted
May 8, 2018
Kind
B2
Abstract

Devices and methods are discussed directed to the use of a low profile laser ablation catheter for use in laser ablation removal of arterial plaque blockages to restore blood flow in the treatment of arteriovenous fistulas. Also discussed are devices and methods directed to packaging, long term storage and sterilization of liquid core ablation catheters.

Claims (22)

1. A method of treating an arteriovenous fistula of a patient, comprising:

advancing a guiding device to the arteriovenous fistula;

advancing a liquid core ablation catheter adjacent a blockage that is disposed within or adjacent the arteriovenous fistula;

guiding the distal end of the liquid core ablation catheter with the guiding device; and

axially advancing the liquid core ablation catheter through the blockage while emitting pulsed ultraviolet laser ablation energy from a distal end of the liquid core ablation catheter, ablating the blockage and debulking the blockage until the blockage is axially traversed by the distal end of the liquid core ablation catheter.

2. The method of claim 1 further comprising removing the liquid core ablation catheter from the arteriovenous fistula after the blockage has been traversed.

3. The method of claim 1 further comprising treating the blockage with a drug eluting balloon catheter after the liquid core ablation catheter has traversed the blockage to improve long term patency of a lumen through the blockage.

4. The method of claim 3 wherein treating the blockage with a drug eluting balloon catheter comprises treating the blockage with a suitable drug configured to control restenosis following an angioplasty procedure.

5. The method of claim 4 wherein treating the blockage with a drug configured to control restenosis following an angioplasty procedure comprises treating the blockage with a compound comprising paclitaxel.

6. The method of claim 5 wherein treating the blockage with a compound comprising paclitaxel comprises treating the blockage with a paclitaxel-iopromide mixture.

7. The method of claim 1 wherein the guiding device comprises a guidewire and guiding the distal end of the liquid core ablation catheter comprises advancing the liquid core ablation catheter over the guidewire.

8. The method of claim 1 wherein the guiding device comprises a support catheter and guiding the distal end of the liquid core ablation catheter comprises advancing a distal end of the liquid core ablation catheter from a distal end of the support catheter up to about 5 mm from the distal end of the support catheter.

9. The method of claim 8 wherein guiding the distal end of the liquid core ablation catheter comprises advancing a distal end of the liquid core ablation catheter from a distal end of the support catheter up to about 5 mm from the distal end of the support catheter then axially advancing the support catheter relative to the liquid core ablation catheter while holding the liquid core ablation catheter stationary, and then repeating this process at least one additional time.

10. The method of claim 8 further comprising injecting a saline solution through a lumen disposed between an outside surface of the liquid core ablation catheter and an inside surface of the support catheter and from the distal end of the support catheter.

11. The method of claim 8 further comprising advancing the support catheter through an inner lumen of an introducer sheath and injecting a saline solution through a lumen disposed between an outside surface of the support catheter and an inside surface of the introducer sheath and from the distal end of the introducer sheath.

12. The method of claim 8 wherein a distal portion of the liquid core ablation catheter further comprises a radiopaque marker and a distal portion of the support catheter further comprises a radiopaque marker and wherein guiding the distal end of the liquid core ablation catheter comprises using the radiopaque markers to identify an axial position of each of the support catheter and liquid core ablation catheter relative to each other while emitting pulsed ultraviolet laser ablation energy from the distal end of the liquid core ablation catheter.

13. The method of claim 8 further comprising ablating a lumen through the blockage that is greater in transverse dimension than a transverse dimension of the liquid core ablation catheter by transversely re-positioning the distal end of the liquid core ablation and then axially advancing the liquid core ablation catheter through the blockage again with distal end of the liquid core ablation catheter transversely re-positioned while emitting pulsed ultraviolet laser ablation energy from the distal end of the liquid core ablation catheter and further ablating additional material of the blockage.

14. The method of claim 13 wherein the distal end of the support catheter comprises an angled distal section and transversely re-positioning the distal end of the support catheter comprises nutating the angled distal section of the support catheter.

15. The method of claim 13 wherein the distal end of the support catheter comprises a deflectable distal section and transversely re-positioning the distal end of the support catheter comprises deflecting the deflectable distal section of the support catheter.

16. The method of claim 1 further comprising emitting red light from a red diode laser and from the distal end of the liquid core ablation catheter and visualizing a position of the distal end of the liquid core ablation catheter through skin of the patient by visualizing the red light through the skin of the patient.

17. The method of claim 1 wherein emitting pulsed ultraviolet laser ablation energy comprises emitting pulsed ultraviolet laser ablation energy at a pulsed energy fluence greater than a threshold of ablation of a type of blockage material being ablated from a laser source of the laser ablation energy comprising a XeCl pulsed 308 nm excimer laser with a pulse duration of less than about 100 nsec, and a repetition rate of less than about 100 Hz.

18. The method of claim 1 wherein emitting pulsed ultraviolet laser ablation energy from the distal end of the liquid core ablation catheter comprises emitting pulsed ultraviolet laser ablation energy from an active emitting surface of the distal end of the liquid core ablation catheter which comprises at least about 50 percent of an area of the distal end of the liquid core ablation catheter.

Assignments (2)
MERGER Recorded Jul 26, 2018
From: RA MEDICAL SYSTEMS, INC. (A CALIFORNIA CORPORATION)
To: RA MEDICAL SYSTEMS, INC. (A DELAWARE CORPORATION)
Reel/Frame 046475/0442 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 26, 2015
From: LAUDENSLAGER, JAMES B.; IRWIN, DEAN S.
To: RA MEDICAL SYSTEMS
Reel/Frame 035269/0304 →
Continuity (2)
Provisional Application 61891830 · Oct 16, 2013
Related Publication 20150105714A1 · Apr 16, 2015