Ultrasound catheter and methods for making and using same

• US 8,043,251 B2
• Filed: 08/07/2009
• Issued: 10/25/2011
• 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, Nguyen, Simon, Sarge, Jeff
• Primary Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US12/537,988
• Publication Number:
  US 20100022920A1
• Time in Patent Office: 809 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. An ultrasound catheter for disrupting occlusions in blood vessels, the ultrasound catheter comprising:

an elongate flexible catheter body comprising a proximal end, a distal end, and a lumen, at least a portion of the catheter body having a preset bend at an angle, the bend being formed prior to insertion of the catheter body into the patient;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member comprising a proximal end connectable to a separate ultrasound generating device, and a distal end disposed adjacent the distal end of the catheter body, at least a portion of the ultrasound transmission member being bent at an angle when the portion is disposed within the preset bend portion of the catheter body; and

a distal head coupled with the distal end of the ultrasound transmission member;

wherein the angle of the bend of the catheter body is greater than the angle of the bend of the ultrasound transmission member.

2. An ultrasound catheter as in claim 1, further comprising a sheath disposed over at least a portion of the distal end of the catheter body for maintaining the bend in the catheter body.

3. An ultrasound catheter as in claim 1, wherein the distal head comprises a side opening.

4. An ultrasound catheter as in claim 3, further comprising a guidewire tube, wherein the guidewire tube extends at least partially through the distal head, and the elongate flexible catheter body is attached with the guidewire tube via an adhesive disposed within the side opening of the distal head.

5. An ultrasound catheter as in claim 1, wherein the preset bend comprises a heat-formed bend.

6. An ultrasound catheter comprising:

an elongate body having a proximal end, a distal end, and a lumen, at least a portion of the body having a preset bend at an angle, the bend being formed prior to insertion of the catheter into the patient; and

an ultrasound transmission member extending longitudinally through the lumen of the body and having a proximal end connectable to an ultrasound generating device, at least a portion of the ultrasound transmission member being bent at an angle at least when the portion is disposed within the preset bend portion of the body,

wherein the angle of the bend of the body is greater than the angle of the bend of the ultrasound transmission member.

7. The ultrasound catheter of claim 6 further comprising a distal head coupled with the ultrasound transmission member.

8. The ultrasound catheter of claim 6, further comprising an actuator for switching between transmitting a first type of ultrasound energy to the ultrasound transmission member and transmitting a second type of ultrasound energy to the ultrasound transmission member.

9. An ultrasound catheter of claim 6 further comprising a sheath disposed over at least a portion of the distal end of the body for maintaining the bend in the body.

10. The ultrasound catheter of claim 6, wherein the preset bend comprises a heat-formed bend.

11. The ultrasound catheter of claim 6, wherein the angle of the preset bend is between 20 degrees and 50 degrees.

12. An ultrasound system for disrupting occlusions in blood vessels, the system comprising:

an ultrasound catheter comprising;

an elongate flexible catheter body having a proximal end, a distal end, and a lumen, at least a portion of the catheter body having a preset bend at a first angle, the bend being formed prior to insertion of the catheter body into the patient;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a proximal end and a distal end, at least a portion of the ultrasound transmission member being bent at a second angle when the portion is disposed within the preset bend portion of the catheter body, the second angle being different than the first angle; and

a distal head coupled with the distal end of the ultrasound transmission member; and

an ultrasound generating device coupled with the proximal end of the ultrasound transmission member via an ultrasound transducer and a sonic connector.

13. An ultrasound system as in claim 12, wherein the preset bend comprises a heat-formed bend.

14. An ultrasound system as in claim 12, further comprising an actuator for switching between transmitting a first type of ultrasound energy to the ultrasound transmission member and transmitting a second type of ultrasound energy to the ultrasound transmission member.

15. An ultrasound system as in claim 14, wherein the first type of ultrasound energy comprises pulsed ultrasound energy and the second type of ultrasound energy comprises continuous ultrasound energy.

16. An ultrasound system as in claim 12, wherein the angle of the preset bend of the catheter body is greater than the angle of the bend of the ultrasound transmission member.

17. An ultrasound system as in claim 12, further comprising a guidewire tube, wherein the guidewire tube extends at least partially through the distal head, and the elongate flexible catheter body is attached with the guidewire tube via an adhesive disposed within a side opening of the distal head.

18. An ultrasound system as in claim 12, further comprising a sheath disposed over at least a portion of the distal end of the catheter body for maintaining the bend in the catheter body.

19. An ultrasound system as in claim 12, further comprising a guidewire tube, wherein the guidewire tube includes micro-perforations disposed along a surface of the guidewire tube for allowing passage of fluid.

20. An ultrasound system as in claim 12, further comprising a guidewire tube, wherein the guidewire tube comprises a polyimide material.