Therapeutic ultrasound system

• US 9,282,984 B2
• Filed: 04/05/2006
• Issued: 03/15/2016
• Est. Priority Date: 04/05/2006
• Status: Active Grant

• Current Assignee: Flowerdia, Inc.
• Original Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Inventors: Nita, Henry
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US11/398,385
• Publication Number:
  US 20070239027A1
• Time in Patent Office: 3,632 Days
• Field of Search: 600/466, 604/22, 604/21, 606/41, 606/169, 606/127, 606/128, 601/4
• US Class Current: 1/1
• 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 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2217/007 with irrigation system

Abstract

An ultrasound system has a catheter including an elongate flexible catheter body having at least one lumen extending longitudinally therethrough. An ultrasound transmission wire extends longitudinally through the lumen of the catheter body, and has a proximal region, a distal region, and an intermediate region between the proximal region and the distal region. A sonic connector is connected to the proximal region of the ultrasound transmission wire, and a distal head is positioned at the distal end of the catheter body and coupled to the distal region of the ultrasound transmission wire. The proximal region of the ultrasound transmission wire has a larger diameter than the intermediate region, the intermediate region is continuously tapered with a progressively decreasing diameter from its proximal end to its distal end, and the distal region has a greater diameter than the distal end of the intermediate region.

Claims

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

providing a catheter having;

a catheter body having a wall, a proximal end, a distal end, and irrigation outlets through the wall near the distal end of the body;

a lumen extending through the catheter body;

a distal head disposed within and extending out from the distal end of the body, wherein the head has an irrogation outlet aperture that extends through the head; and

an ultrasound transmission member comprising;

a proximal-most first region with a first-region diameter;

a second region that extends distally from the first region wherein the second region narrows from a second-region proximal end to a second-region distal end;

a third region that extends distally from the second region wherein the third region has a constant third-region diameter less than the first-region diameter;

an intermediate region comprising;

a fourth region that extends distally from the third region; and

a fifth region that extends distally from the fourth region;

wherein the intermediate region progressively narrows from a fourth-region proximal end to a fifth-region distal end and wherein the narrow-most diameter of the ultrasound transmission member occurs at the fifth-region distal end,

a sixth region that extends distally from the fifth region wherein the sixth region progressively widens from a sixth-region proximal end to a sixth-region distal end;

a distal-most seventh region that extends distally from the sixth region at a constant seventh region diameter;

positioning the catheter in a blood vessel such that the distal head is adjacent the occlusion;

providing microbubbles in irrigation fluid;

transmitting ultrasound energy through the ultrasound transmission member to the distal head, the energy being of sufficient power to create fluid cavitation near the distal head within the blood vessel, the cavitation disrupting the occlusion into multiple occlusion fragments; and

during the transmission of ultrasound energy, flowing the irrigation fluid and microbubbles through at least the lumen and the irrigation outlet aperture and into the blood vessel near the occlusion, whereby the presence of microbubbles in the irrigation fluid enhances said cavitation.

2. The method of claim 1, further including removing the occlusion fragments that are outside the ultrasound catheter in the blood vessel through the ultrasound catheter.

3. The method of claim 1, further including:

providing an irrigation inlet aperture at a proximal end of the catheter; and

introducing the irrigation fluid through the aperture.

4. The method of claim 1, further including:

providing a side aperture piercing the wall proximal to the distal end of the catheter.

5. The method of claim 4, further comprising flowing the irrigation fluid and microbubbles through the side aperture.

6. The method of claim 1, wherein the irrigation fluid is refrigerated.

7. The method of claim 1, wherein the microbubbles are made from agitated saline solution.

8. The method of claim 1, wherein the microbubbles are made of gas encapsulated in shells.

9. The method of claim 1, further including causing the microbubbles to contact the occlusion.

10. The method of claim 1 further including providing a pharmacological agent in the irrigation fluid.

11. The method of claim 1 wherein the ultrasound member has distal end disposed near the distal end of the catheter and a proximal end disposed near the proximal end of the catheter.

12. The method of claim 1 wherein the catheter further comprises a guidewire lumen and the distal head further comprises a guidewire aperture substantially aligned with the guidewire lumen.

13. The method of claim 1 wherein the distal head has at least two different diameters and the distal diameter is greater than the proximal diameter.

14. A method for disrupting an occlusion in a blood vessel comprising:

providing a catheter comprising a catheter body having a wall, a proximal end, a distal end, and irrigation outlets through the wall near the distal end of the body;

an ultrasound transmission member extending through the lumen and comprising;

a proximal-most first region with a first-region diameter;

a second region that extends distally from the first region wherein the second region narrows from a second-region proximal end to a second-region distal end;

a third region that extends distally from the second region wherein the third region has a consistent third-region diameter less than the first-region diameter;

an intermediate region comprising;

a fourth region that extends distally from the third region; and

a fifth region that extends distally from the fourth region;

wherein the intermediate region progressively narrows from a fourth-region proximal end to a fifth-region distal end and wherein the narrow-most diameter of the ultrasound transmission member occurs at the fifth-region distal end,

a sixth region that extends distally from the fifth region wherein the sixth region progressively widens from a sixth-region proximal end to a sixth-region distal end;

a distal-most seventh region that extends distally from the sixth region at a consistent seventh region diameter;

a distal end;

a distal head disposed within and extending out from the distal end of the catheter body and having an irrigation outlet aperture, wherein the distal end of the transmission member couples to the distal head;

positioning the catheter in a blood vessel such that the distal head is adjacent the occlusion;

introducing an irrigation fluid that contains microbubbles, through the lumen, the irrigation outlet aperture and into the vessel at or near the distal head; and

transmitting ultrasound energy through the ultrasound transmission member to create cavitation in a liquid containing the microbubbles, the microbubbles enhancing the cavitation.

15. The method of claim 14 wherein the ultrasound member has distal end disposed near the distal end of the catheter and a proximal end disposed near the proximal end of the catheter.

16. The method of claim 14 wherein the catheter further comprises a guidewire lumen and the distal head further comprises a guidewire aperture substantially aligned with the guidewire lumen.

17. The method of claim 14 wherein the distal head has at least two different diameters and the distal diameter is greater than the proximal diameter.

18. The method of claim 14, wherein positioning the ultrasound catheter comprises using a guiding catheter.

19. The method of claim 14, wherein positioning the ultrasound catheter comprises using a guidewire.

20. The method of claim 14, wherein positioning the ultrasound catheter comprises using both a guiding catheter and a guidewire.

21. The method of claim 14, wherein the irrigation fluid is refrigerated.

22. The method of claim 21, wherein the refrigerated irrigation fluid is delivered during an interventional procedure.

23. The method of claim 21, further including providing a pharmacological agent in the refrigerated irrigation fluid.

24. The method of claim 21, further comprising refrigerating the irrigation fluid to a temperature between 40 and 60 degrees Fahrenheit.

25. A method for disrupting an occlusion in a blood vessel comprising:

providing an ultrasound catheter wherein providing an ultrasound catheter comprises

providing

a catheter part having a catheter body, a lumen extending through the catheter body, an ultrasound transmission member with a distal end extending through the lumen, distally located side irrigation outlets, and a distal head having an irrigation outlet aperture, the ultrasound transmission member comprising;

a proximal-most first region with a first-region diameter;

a second region that extends distally from the first region wherein the second region narrows from a second-region proximal end to a second-region distal end;

a third region that extends distally from the second region wherein the third region has a consistent third-region diameter throughout its length less than the first-region diameter;

an intermediate region comprising;

a fourth region that extends distally from the third region; and

a fifth region that extends distally from the fourth region;

wherein the intermediate region progressively narrows from a fourth-region proximal end to a fifth-region distal end and wherein the narrow-most diameter of the ultrasound transmission member occurs at the fifth-region distal end,

a sixth region that extends distally from the fifth region wherein the sixth region progressively widens from a sixth-region proximal end to a sixth-region distal end;

a distal-most seventh region that extends distally from the sixth region with a consistent seventh region diameter through its length;

coupling the ultrasound transmission member to the distal head; and

coupling the catheter part to the distal head,

positioning the ultrasound catheter in a blood vessel such that the distal head is adjacent the occlusion;

transmitting ultrasound energy through the ultrasound transmission member to form bubbles in a liquid at the distal head; and

introducing an irrigation fluid that contains microbubbles from a location outside the blood vessel through the lumen and exiting at least the irrigation outlet aperture in the distal head, the microbubbles enhancing cavitation, wherein the irrigation fluid is different than the liquid.

26. The method of claim 25, wherein the liquid comprises blood.

27. The method of claim 25, wherein the irrigation fluid is saline solution.