Method and apparatus for treatment of intracranial hemorrhages

• US 9,044,568 B2
• Filed: 06/20/2008
• Issued: 06/02/2015
• Est. Priority Date: 06/22/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: EKOS Corporation (Boston Scientific Corporation)
• Inventors: Wilcox, Robert L., Haas, Ronald L.
• Primary Examiner(s): Vu, Quynh-Nhu H
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US12/143,470
• Publication Number:
  US 20080319376A1
• Time in Patent Office: 2,538 Days
• Field of Search: 604/22, 604/96.01, 604/164.01, 604/523, 604/176, 604/20, 604/503, 601/22
• US Class Current: 1/1
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2205/058 with ultrasound therapy
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Abstract

An ultrasound catheter with fluid delivery lumens, fluid evacuation lumens and a light source is used for the treatment of intracerebral hemorrhages. After the catheter is inserted into a blood clot in the brain, a lytic drug can be delivered to the blood clot via the fluid delivery lumens 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 fluid evacuation lumens.

Claims

1. A method for treating an extravascular blood clot in a patient resulting from an intracranial hemorrhage comprising:

forming a hole in the patient'"'"'s skull

extravascularly positioning at least a portion of a treatment region of an elongate tubular body of an ultrasound catheter into the extravascular blood clot by advancing the device through an opening provided in a skull of the patient;

wherein the elongate tubular body further has a distal portion and a proximal portion, and wherein the ultrasound catheter further comprises;

a plurality of ultrasound radiating members positioned within the treatment region of the elongate tubular body, the treatment region being positioned within the distal portion of the elongate tubular body;

a first fluid delivery lumen formed within the elongate tubular body, wherein the first fluid delivery lumen extends from the proximal portion of the elongate tubular body to the treatment region and includes a first fluid delivery port located on a first axial region of the treatment region of the elongate tubular body, the first fluid delivery port extending from an exterior surface of the elongate tubular body and configured to allow a fluid to flow from within the first fluid delivery lumen to a portion of the blood clot positioned outside the elongate tubular body;

a first fluid evacuation lumen formed within the elongate tubular body, wherein the first fluid evacuation lumen extends from the proximal portion of the elongate tubular body to the treatment region and includes a first fluid evacuation port located on a second axial region of the treatment region of the elongate tubular body, the first fluid evacuation lumen extending from an exterior surface of the elongate tubular body and configured to allow a fluid to flow into the first fluid evacuation lumen from a position outside the elongate tubular body, the first and second axial regions being positioned at distinct longitudinal positions on the elongate body, and;

wherein at least one of the plurality of ultrasound radiating members are located axially between the first fluid delivery port and the first fluid evacuation port;

activating the ultrasound assembly;

delivering a lytic drug to the blood clot through the first fluid delivery lumen; and

evacuating a at least a portion of the extravascular blood clot around the distal portion of the elongate tubular body into the first fluid evacuation lumen.

2. The method of claim 1, further comprising activating a light source located with the ultrasound assembly.

3. The method of claim 1, further comprising sliding a slidable sealing surface located on the proximal portion of the elongate tubular body towards the distal portion of the elongate tubular body.

4. The method of claim 1, further comprising measuring the temperature within a portion of the elongate tubular body with a temperature sensor located within the distal portion of the elongate tubular body.

5. The method of claim 1, further comprising measuring the pressure within a portion of the elongate tubular body with a pressure sensor located within the distal portion of the elongate tubular body.

6. The method of claim 5, wherein the pressure sensor is located within the first fluid delivery lumen proximate the first fluid delivery port.

7. The method of claim 5, wherein the pressure sensor is located within the first fluid evacuation lumen proximate the first fluid evacuation port.

8. A method for treating an extravascular blood clot positioned outside a blood vessel in a patient resulting from an intracranial hemorrhage in the patient, the method comprising:

forming a hole in the patient'"'"'s skull;

advancing a catheter assembly through the hole, the catheter assembly having a distal portion and a proximal portion, the catheter assembly comprising at least one ultrasound radiating member located in the distal portion, a first fluid delivery lumen extending from the proximal portion to the distal portion and a first fluid evacuation lumen extending from the proximal portion to the distal portion, wherein the first fluid delivery lumen includes a first fluid delivery port located on the distal portion of the catheter assembly and configured to allow a fluid to flow from within the first fluid delivery lumen to the extravascular blood clot positioned outside the catheter assembly, and wherein the first fluid evacuation lumen includes a first fluid evacuation port located the distal portion of the catheter assembly and configured to allow a fluid to flow into the first fluid evacuation lumen from outside the catheter assembly;

extravascularly positioning at least a portion of the distal portion of the catheter assembly comprising the at least one ultrasound radiating member, the first fluid delivery lumen and the first fluid evacuation lumen into the extravascular blood clot formed by the intracranial hemorrhage and positioned outside a blood vessel;

activating the ultrasound radiating member;

monitoring the intracranial pressure of the patient;

delivering a first fluid through the first fluid delivery lumen and the first fluid delivery port to the blood clot; and

evacuating a second fluid through the first evacuation lumen and the first evacuation port.

9. The method of claim 8, further comprising increasing the rate in which the second fluid is evacuated when the intracranial pressure exceeds a first threshold level, thereby maintaining the intracranial pressure within a desired range.

10. The method of claim 8, further comprising decreasing the rate in which the second fluid is evacuated when the intracranial pressure falls below a second threshold level, thereby maintaining the intracranial pressure within a desired range.

11. The method of claim 8, wherein first fluid comprises a thrombolytic drug and the second fluid comprises iron and thrombin.