Ultrasound catheter and methods for making and using same

• US 8,152,753 B2
• Filed: 08/07/2009
• Issued: 04/10/2012
• Est. Priority Date: 01/14/2003
• Status: Active Grant

• Current Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Original Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Inventors: Nita, Henry, Sarge, Jeff, Nguyen, Simon
• Primary Examiner(s): Koharski, Christopher D
• Application Number:
  US12/537,959
• Publication Number:
  US 20100023036A1
• Time in Patent Office: 977 Days
• Field of Search: 604/22, 604/523, 600/145, 600/146, 600/149
• 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 2017/00141 continuous, e.g. wave
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/22011 Combined types of vibration, e.g. ultrasonic and electrohydraulic
• 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 2017/22015 with details of the transmission member
• CPC Class Codes: A61B 2017/320072 Working tips with special features, e.g. extending parts
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/001 Forming the tip of a catheter, e.g. bevelling process, join or taper
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04

Abstract

Ultrasound catheter devices and methods provide enhanced disruption of blood vessel obstructions. Generally, ultrasound catheters include an elongate flexible catheter body with one or more lumens, an ultrasound transmission member extending longitudinally through the catheter body lumen and, in some embodiments, a guidewire tube extending through the lumen. A distal head for disrupting occlusions is coupled with the distal end of the ultrasound transmission member and is positioned adjacent the distal end of the catheter body. Some embodiments include improved features such as a bend in the catheter body for enhancing positioning and/or advancement of the catheter.

Claims

1. A method for disrupting an occlusion in a blood vessel, the method comprising:

positioning an ultrasound catheter in the blood vessel such that a distal end of the catheter is in contact with the occlusion;

transmitting a first type of ultrasound energy to an ultrasound transmission member of the ultrasound catheter to disrupt the occlusion; and

transmitting a second type of ultrasound energy to the ultrasound transmission member to further disrupt the occlusion.

2. A method as in claim 1, wherein the first type of ultrasound energy comprises pulsed energy and the second type of energy comprises continuous energy.

3. A method as in claim 1, wherein the first type of ultrasound energy comprises continuous energy and the second type of energy comprises pulsed energy.

4. A method as in claim 1, further comprising switching from transmitting the second type of ultrasound energy to transmitting the first type of ultrasound energy.

5. A method as in claim 4, further comprising repeating at least one of the transmitting and switching steps at least once.

6. A method as in claim 1, further comprising activating an actuator on a separate ultrasound generating device coupled with the ultrasound catheter.

7. A method as in claim 1, wherein positioning the ultrasound catheter comprises using a pre-formed bend in the catheter to advance the distal end of the catheter to the location.

8. A method as in claim 1, further comprising:

using a pre-formed bend in the catheter to reposition the catheter in an additional blood vessel adjacent to an additional occlusion;

and transmitting a form of ultrasound energy to the ultrasound transmission member to disrupt the additional occlusion.

9. A method as in claim 1, wherein positioning the ultrasound catheter comprises advancing the catheter over a guidewire.

10. A method as in claim 9, wherein the guidewire is disposed in a guidewire lumen of the catheter.

11. A method as in claim 10, wherein the guidewire lumen extends the full length of the catheter and is coupled with a connector device coupled with a proximal end of the ultrasound catheter.

12. A method as in claim 10, wherein the guidewire lumen is coupled with a flexible, proximal port near the proximal end of the catheter.

13. A method as in claim 10, further comprising injecting a dye into the blood vessel through the guidewire lumen.

14. A method as in claim 1, further comprising injecting a dye through the ultrasound catheter.

15. A method for disrupting an occlusion in a blood vessel, the method comprising:

positioning an ultrasound catheter in the blood vessel, wherein the ultrasound catheter comprises a catheter body, an ultrasound transmission member, a distal end, and a pre-formed bend in the catheter body, the ultrasound transmission member having a degree of curvature along its length that is less than a degree of curvature of the pre-formed bend in the catheter body;

using the pre-formed bend to advance the distal end of the ultrasound catheter into a location that is adjacent to the occlusion; and

transmitting ultrasound energy through the ultrasound transmission member to disrupt the occlusion.

16. The method of claim 15, further comprising:

using the pre-formed bend to reposition the catheter in an additional blood vessel adjacent to an additional occlusion; and

transmitting ultrasound energy to the ultrasound transmission member to disrupt the additional occlusion.

17. The method of claim 15, wherein positioning the ultrasound catheter comprises advancing the ultrasound catheter over a guidewire.

21. The method of claim 15, wherein the degree of curvature of the ultrasound transmission member is zero.

18. A method for disrupting an occlusion in a blood vessel, the method comprising:

positioning an ultrasound catheter in the blood vessel, wherein the ultrasound catheter comprises a catheter body, a distal end, a pre-formed bend in the catheter body, and an ultrasound transmission member having a degree of curvature along its length that is less than a degree of curvature of the pre-formed bend in the catheter body;

using the pre-formed bend of the ultrasound catheter to advance the distal end of the ultrasound catheter into a location that is adjacent to the occlusion;

transmitting ultrasound energy through the ultrasound transmission member to disrupt the occlusion; and

maintaining the ultrasound transmission member at a desired temperature with an infused fluid.

19. The method of claim 18, further comprising:

using the preformed bend in the ultrasound catheter to reposition the ultrasound catheter in an additional blood vessel adjacent to an occlusion; and

transmitting ultrasound energy to the ultrasound transmission member to disrupt the additional occlusion.

20. The method of claim 18, wherein positioning the ultrasound catheter comprises advancing the ultrasound catheter over a guidewire.

22. The method of claim 18, wherein the degree of curvature of the ultrasound transmission member is zero.