Device and method for vascular re-entry

• US 8,679,049 B2
• Filed: 07/17/2012
• Issued: 03/25/2014
• Est. Priority Date: 06/12/2009
• Status: Active Grant

• Current Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Original Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Inventors: Nita, Henry
• Primary Examiner(s): ROZANSKI, MICHAEL T
• Application Number:
  US13/551,424
• Publication Number:
  US 20120283571A1
• Time in Patent Office: 616 Days
• Field of Search: 600/433, 600/437, 600/462, 600/466, 604/22, 604/164.01, 604/509, 601/2
• US Class Current: 604/22
• 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 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 8/13 Tomography A61B8/10, A61B8/12 take precedence; tomography for radiation diagnosis A61B6/02
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

In a method for re-entry from extraluminal space into the central lumen of a vessel, a guidewire is advanced into the extraluminal space of the vessel, and then a directional catheter is advanced over the guidewire through the extraluminal space. Thereafter, the guidewire is removed from the directional catheter, an ultrasound device is placed through the directional catheter, and the ultrasound device is advanced through the extraluminal space into the central lumen and then activated.

Claims

1. A method for re-entry from an extraluminal space into a central lumen of a vessel, comprising:

advancing a directional catheter over a guidewire through the extraluminal space;

removing the guidewire from the directional catheter;

advancing an ultrasound device through the directional catheter;

activating the ultrasound device to penetrate the vessel and re-enter the central lumen; and

advancing the directional catheter into the central lumen so that a distal end of the directional catheter is distal to an occlusion.

2. The method of claim 1 further comprising contacting the ultrasound device with a pre-shaped distal end of the directional catheter to deflect the ultrasound device towards the vessel.

3. The method of claim 1 further comprising advancing the guidewire into the extraluminal space of the vessel.

4. The method of claim 1, wherein the ultrasound device is an ultrasound catheter.

5. The method of claim 4, wherein the ultrasound catheter comprises:

a catheter body having at least one lumen therethrough;

an ultrasound transmission member extending through the lumen of the catheter body; and

a distal tip attached to a distal end of the ultrasound transmission member.

6. The method of claim 1 further comprising operating the ultrasound device in one of the following modes of operation:

continuous, pulse or combination of both.

7. The method of claim 1 further comprising operating the ultrasound device at frequencies between 17 KHz-20 MHz.

8. The method of claim 1, wherein the ultrasound device operates over a guidewire.

9. The method of claim 1 further comprising providing a radiopaque feature on the distal end of the directional catheter.

10. The method of claim 1 further comprising:

removing the ultrasound device; and

advancing the guidewire through the directional catheter into the central lumen.

11. The method of claim 1 further comprising:

removing the directional catheter;

advancing a catheter over the guidewire; and

performing a therapeutic procedure using the catheter.

12. The method of claim 1 further comprising:

removing the directional catheter;

advancing a catheter over the guidewire; and

performing a diagnostic procedure using the catheter.

13. A method for re-entry from an extraluminal space into a central lumen of a vessel, comprising:

advancing a catheter over a guidewire through the extraluminal space, the catheter having a pre-shaped distal end;

advancing an ultrasound device through the catheter and the extraluminal space;

deflecting at least a distal portion of the ultrasound device towards the vessel through the pre-shaped distal end;

activating the ultrasound device to penetrate the vessel and re-enter the central lumen; and

advancing the catheter into the central lumen so that a distal end of the catheter is distal to an occlusion.

14. The method of claim 13 further comprising removing the guidewire from the catheter.

15. The method of claim 13 further comprising removing the ultrasound device.

16. The method of claim 13 further comprising advancing the guidewire through the catheter into the central lumen.

17. A method for re-entry from an extraluminal space into a central lumen of a vessel, comprising:

advancing a catheter over a guidewire through the extraluminal space;

advancing an ultrasound device through the catheter and through the extraluminal space;

activating the ultrasound device to penetrate the vessel and re-enter the central lumen; and

advancing the catheter into the central lumen so that a distal end of the catheter is distal to an occlusion.

18. The method of claim 17 further comprising deflecting the ultrasound device towards the vessel through a pre-shaped distal end of the catheter.

19. The method of claim 17, further comprising:

advancing a guidewire into the extraluminal space of the vessel; and

removing the guidewire from the catheter.

20. The method of claim 17, wherein the ultrasound device is an ultrasound catheter.