Vascular re-entry device

• US 10,357,263 B2
• Filed: 01/23/2017
• Issued: 07/23/2019
• Est. Priority Date: 01/18/2012
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Sarge, Jeff
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/413,259
• Publication Number:
  US 20170128090A1
• Time in Patent Office: 911 Days
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22014 the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire not applied in A61B17/22012
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/32007 with suction or vacuum means
• CPC Class Codes: A61B 2017/320071 with articulating means for working tip
• CPC Class Codes: A61B 50/13 Trolleys, e.g. carts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0093 Ultrasound system, e.g. for inducing coagulation during eye surgery
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

An ultrasonic device having a tri-axial configuration including an ultrasound transmission member, a dilator, and a sheath is disclosed. The ultrasound device may be used in a procedure to treat an occluded blood vessel. The ultrasound transmission member can transmit ultrasonic energy from an ultrasonic transmission member into the subintimal space of a blood vessel. The sheath may articulate to aid in the process of re-entering the central lumen of the blood vessel.

Claims

1. An ultrasonic reentry device comprising:

an ultrasound transmission member having a proximal end disposed proximally of a distal end of a device handle and a distal end configured to penetrate a vessel wall;

a catheter body having a distal end and at least one lumen, the lumen surrounding the ultrasound transmission member;

a dilator slidably disposed within the lumen and surrounding the ultrasound transmission member, the dilator adapted to expose the distal end of the ultrasound transmission member;

and a sheath disposed over the dilator, the catheter body, and the ultrasound transmission member.

2. The device of claim 1 wherein the sheath includes an articulating distal end.

3. The device of claim 2 wherein the articulating distal end articulates up to 90 degrees away from a longitudinal axis.

4. The device of claim 3 wherein the sheath comprises a proximal handle.

5. The device of claim 4 wherein the proximal handle comprises an actuating member.

6. The device of claim 5 wherein the sheath is adapted to expose a distal end of the dilator.

7. The device of claim 6 wherein the ultrasound transmission member protrudes 1-5 mm past the distal end of the dilator.

8. The device of claim 2 wherein the sheath comprises a proximal handle and the proximal handle comprises an actuating member.

9. The device of claim 8 wherein the sheath is adapted to expose a distal end of the dilator.

10. The device of claim 9 wherein the ultrasound transmission member protrudes 1-5 mm past the distal end of the dilator.

11. The device of claim 2 wherein the sheath is adapted to expose a distal end of the dilator.

12. The device of claim 11 wherein the ultrasound transmission member protrudes 1-5 mm past the distal end of the dilator.

13. The device of claim 2 wherein the ultrasound transmission member protrudes 1-5 mm past the distal end of the dilator.

14. An ultrasonic device for entering and exiting an extraluminal space of a vessel comprising:

a catheter body having at least one lumen;

an ultrasound transmission member disposed in the lumen having a taper to a needle-like distal end;

a dilator disposed over the ultrasound transmission member and configured to follow the ultrasound transmission member into the extraluminal space, the dilator being slidably disposed within the catheter body; and

a sheath disposed over the catheter body and the dilator wherein the sheath includes an articulating distal end.

15. The device of claim 14 wherein the articulating distal end articulates up to 90 degrees away from a longitudinal axis.

16. The device of claim 15 wherein the sheath comprises a proximal handle.

17. A method comprising:

providing an ultrasonic device for entering and exiting an extraluminal space of a vessel comprising;

a catheter body having at least one lumen;

an ultrasound transmission member disposed in the lumen having a taper to a needle-like distal end;

a dilator disposed over the ultrasound transmission member and configured to follow the ultrasound transmission member into the extraluminal space, the dilator being slidably disposed within the catheter body;

and

a sheath disposed over the catheter body and the dilator wherein the sheath includes an articulating distal end.

18. The method of claim 17 wherein the articulating distal end articulates up to 90 degrees away from a longitudinal axis.

19. The method of claim 18 wherein the sheath is adapted to expose a distal end of the dilator.

20. The method of claim 19 wherein the ultrasound transmission member protrudes 1-5 mm past the distal end of the dilator.