Method and apparatus for treatment of intracranial hemorrhages

• US 10,888,657 B2
• Filed: 08/26/2011
• Issued: 01/12/2021
• Est. Priority Date: 08/27/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: EKOS Corporation (Boston Scientific Corporation)
• Inventors: Soltani, Azita, Wolniewcz, III, Raymond M., Nistal, Brenton, Genstler, Curtis, Wilcox, Robert L., Haas, Ronald L.
• Primary Examiner(s): Nguyen, Hien N
• Application Number:
  US13/219,403
• Publication Number:
  US 20120059285A1
• Time in Patent Office: 3,427 Days
• Field of Search: 601 2
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/22021 electric leads passing through the catheter
• CPC Class Codes: A61B 2017/22028 arrays, e.g. phased arrays
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2205/058 with ultrasound therapy
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

An ultrasound catheter with a lumen for fluid delivery and fluid evacuation, and an ultrasound source is used for the treatment of intracerebral or intraventricular hemorrhages. After the catheter is inserted into a blood clot, a lytic drug can be delivered to the blood clot via the lumen while applying ultrasonic energy to the treatment site. As the blood clot is dissolved, the liquefied blood clot can be removed by evacuation through the lumen.

Claims

1. An ultrasound catheter for treatment of a blood clot resulting from an intracranial hemorrhage comprising:

an elongate tubular body having a distal portion and a proximal portion, the elongate tubular body comprising an inner surface defining a lumen and an outer surface;

a plurality of ultrasound radiating elements positioned in the distal portion of the elongate tubular body between the inner and outer surfaces of the tubular body;

a surface configured to form an electrical connection on the proximal portion of the tubular body comprising annular rings in electrical connection with the plurality of radiating elements and a proximal port located on the proximal portion of the tubular body, the proximal port adjacent and distal to the electrical connection,

wherein the lumen includes a plurality of ports on the distal portion of the elongate tubular body configured to allow fluid to flow therethrough, wherein the proximal port opens on an outer surface of the elongate tubular body and is perpendicular to a longitudinal axis of the elongate tubular body; and

a stylet configured to be received within the lumen.

2. The catheter of claim 1, wherein wires connect the electrical connection to the ultrasound radiating elements in the elongate tubular body, wherein the wires are embedded within the elongate tubular body.

3. The catheter of claim 1, further comprising a proximal port co-linear with the lumen.

4. The catheter of claim 1, wherein the ultrasound radiating elements are potted in epoxy.

5. The catheter of claim 1, wherein the ultrasound radiating elements are suspended in a fluid.

6. The catheter of claim 1, wherein the ultrasound radiating elements are positioned within a window on the outer surface of the elongate tubular body.

7. The catheter of claim 1, wherein the ultrasound radiating elements are positioned in the distal portion of the elongate tubular body.

8. The catheter of claim 1, wherein the elongate tubular body comprises a metal extrusion surrounded by a sleeve.

9. The catheter of claim 8, wherein elongate tubular body further comprises a distal extrusion configured to be affixed to the metal extrusion, wherein the distal extrusion houses the ultrasound radiating elements.

10. The catheter of claim 8, wherein, the metal extrusion includes the distal portion containing the plurality of ports.

11. The catheter of claim 8, wherein the extrusion is a spiral extrusion.

12. The catheter of claim 1, wherein the ports are circular.

13. The catheter of claim 1, wherein the ports comprise longitudinal openings in the distal portion of the elongate tubular body.

14. The catheter of claim 1, further comprising distance markers on the elongate tubular body.

18. The catheter of claim 1, wherein the elongate tubular body has material properties the same as that of standard external ventricular drainage (EVD) catheter, wherein the elongate tubular body does not have sufficient hoop strength, kink resistance, rigidity, and structural support to be pushed through an opening in a skull and into brain tissue.

19. The catheter of claim 1, wherein the electrical connection is located at an angle with respect to the elongate tubular body.

20. The catheter of claim 19, wherein the angle ranges between 10 and 60 degrees.

21. The catheter of claim 19, wherein the angle ranges between 12 and 45 degrees.

22. The catheter of claim 19, wherein the angle is 22.5 degrees.

15. An ultrasound catheter comprising:

an elongate tubular body having a distal portion and a proximal portion, the elongate tubular body comprising walls defining a first drainage lumen within the elongate tubular body and a delivery lumen within the elongate tubular body;

wherein the elongate tubular body does not have sufficient hoop strength, kink resistance, rigidity, and structural support to be pushed through an opening in a skull and into brain tissue;

wherein the drainage lumen includes a plurality of drainage ports on the distal portion of the elongate tubular body configured to allow fluid to flow therethrough;

wherein the delivery lumen includes a plurality of delivery ports on the distal portion of the elongate tubular body configured to allow fluid to flow therethrough;

a plurality of ultrasound radiating elements positioned within, the walls of the elongate tubular body, wherein the ultrasound radiating elements are piezoelectric ceramic oscillators;

a surface configured to form an electrical connection on the proximal portion of the elongate tubular body and a proximal port located adjacent and distal to the electrical connection, wherein the proximal port opens on an outer surface of the elongate tubular body in the proximal portion, wherein the proximal port is perpendicular to a longitudinal axis of the elongate tubular body; and

a stylet configured to be received within the drainage lumen.

16. The ultrasound catheter of claim 15, wherein the elongate tubular body is formed in part from silicone.

17. The ultrasound catheter of claim 15, wherein the elongate tubular body has material properties same as that of standard external ventricular drainage (EVD) catheter.