Ultrasound catheter devices and methods

• US 8,956,375 B2
• Filed: 09/23/2011
• Issued: 02/17/2015
• Est. Priority Date: 08/26/2002
• Status: Active Grant

• Current Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Original Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Inventors: Nita, Henry, Sarge, Jeff, Nguyen, Simon, Spano, Richard
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US13/243,648
• Publication Number:
  US 20120016272A1
• Time in Patent Office: 1,243 Days
• Field of Search: 606/49, 606/159, 606169-172, 604/22, 601/2
• US Class Current: 606/169
• 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 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes 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 2017/22015 with details of the transmission member
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22065 Functions of balloons dilating A61M29/02
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2017/320088 with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath
• CPC Class Codes: Y10S 29/019 Method or apparatus with grinding

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 a distal head coupled with the transmission member and positioned adjacent the distal end of the catheter body for disrupting occlusions. Improved features of ultrasound catheters include prevention of independent rotation of the ultrasound transmission member, a safety anchor for the distal head, a one-piece transmission member/distal head and the like.

Claims

1. A method comprising:

providing a catheter with

a body comprising one or more distal apertures, an outer diameter, and a distal portion;

one or more lumens situated substantially longitudinally through the body;

a member partially disposed within one of the lumens that continuously tapers through a region from a wider end to a distal head at a narrower end, wherein the distal head has a proximal end disposed within the distal portion, wherein the proximal end has a diameter smaller than the diameter of the distal portion, wherein the distal head has a distal end disposed distally to the distal portion, and wherein the distal end has a diameter approximately equal to the outer diameter of the body; and

a guide catheter disposed over the body, the guide catheter having a lumen;

a sheath disposed over the body and within the guide catheter lumen, the sheath having a lumen;

a balloon disposed on the guide catheter;

positioning the distal head adjacent a blood vessel occlusion;

transmitting ultrasound energy through the member to fragment the occlusion;

introducing fluid into the blood vessel through the one or more distal apertures and the guide catheter lumen;

expanding the balloon;

and

removing fragments through the sheath lumen.

2. The method of claim 1 in which

the catheter further comprises a guidewire extending through one of the lumens

and

positioning the distal head comprises guiding the catheter using the guidewire.

3. The method of claim 1 in which removing fragments uses at least one distal aperture.

4. The method of claim 3 in which at least one distal aperture forms a conduit with the guidewire lumen and removing fragments uses the conduit.

5. The method of claim 1 in which at least one distal aperture forms a conduit with an irrigation lumen located in the body and removing fragments uses the conduit.

6. The method of claim 1 in which removing fragments comprises evacuating a fragment through an aperture.

7. The method of claim 6 in which evacuating uses a syringe, a pump, or both.

8. The method of claim 1 further comprising introducing a fluid through the catheter.

9. The method of claim 8 wherein fluid comprises a radiopaque material to improve visualization of the distal end.

10. A method comprising:

providing a catheter with

a body comprising one or more distal apertures, and a distal portion;

one or more lumens situated substantially longitudinally through the body;

a member partially disposed within one of the lumens that continuously tapers through a region from a wider end to a distal head at a narrower end, wherein the distal head has a proximal end disposed within the distal portion, wherein the proximal end has a diameter smaller than the diameter of the distal portion, wherein the distal head has a distal end disposed distally to the distal portion, and wherein the distal end has a diameter approximately equal to the outer diameter of the body; and

a guide catheter disposed over the body, the guide catheter having a lumen;

a sheath disposed over the body and within the guide catheter lumen, the sheath having a lumen;

a balloon disposed on the guide catheter;

positioning the distal head adjacent a blood vessel occlusion;

transmitting ultrasound energy through the member to fragment the occlusion;

expanding the balloon;

introducing a fluid into a region distal to the balloon;

introducing a second fluid into the blood vessel through the one or more distal apertures and the guide catheter lumen;

and

removing fragments through the sheath lumen.

11. The method of claim 10 in which

the catheter further comprises a guidewire extending through one of the lumens

and

positioning the distal head comprises guiding the catheter using the guidewire.

12. The method of claim 11 in which removing fragments uses at least one distal aperture.

13. The method of claim 12 in which at least one distal aperture forms a conduit with the guidewire lumen and removing fragments uses the conduit.

14. The method of claim 13 in which at least one distal aperture forms a conduit with an irrigation lumen located in the body and removing fragments uses the conduit.

15. The method of claim 14 wherein the fluid comprises a radiopaque material to improve visualization of the distal end.

16. A method comprising:

providing a catheter with

a body comprising one or more distal apertures, and a distal portion;

one or more lumens situated substantially longitudinally through the body;

a member partially disposed within one of the lumens that continuously tapers through a region from a wider end to a distal head at a narrower end, wherein the distal head has a proximal end disposed within the distal portion, wherein the proximal end has a diameter smaller than the diameter of the distal portion, wherein the distal head has a distal end disposed distally to the distal portion, and wherein the distal end has a diameter approximately equal to the outer diameter of the body; and

a guide catheter disposed over the body, the guide catheter having a lumen;

a sheath disposed over the body and within the guide catheter lumen, the sheath having a lumen;

a balloon disposed on the guide catheter;

positioning the distal head adjacent a blood vessel occlusion;

transmitting ultrasound energy through the member to fragment the occlusion;

introducing at least one radiopaque fluid into the blood vessel through at least one distal aperture to improve visualization of the distal end;

introducing a second fluid into the blood vessel through the one or more distal apertures and the guide catheter lumen;

and

removing fragments through the sheath lumen.

17. The method of claim 16 in which at least one distal aperture forms a conduit with an irrigation lumen located in the body and removing fragments uses the conduit.

18. The method of claim 16 further comprising expanding the balloon, wherein introducing occurs at a region distal to the balloon.

19. The method of claim 16 in which positioning the catheter comprises introducing the catheter through the guide catheter.

20. The method of claim 19 in which at least one distal aperture forms a conduit with an irrigation lumen located in the body and removing fragments uses the conduit.