Tissue stabilization for therapeutic ultrasound

• US 9,974,983 B2
• Filed: 11/12/2015
• Issued: 05/22/2018
• Est. Priority Date: 11/12/2015
• Status: Active Grant

• Current Assignee: Sonablate Corporation
• Original Assignee: Sonacare Medical, LLC
• Inventors: Carol, Mark
• Primary Examiner(s): Smith, Ruth S
• Application Number:
  US14/938,995
• Publication Number:
  US 20170136266A1
• Time in Patent Office: 922 Days
• CPC Class Codes: A61B 2017/22015 with details of the transmission member
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/2253 using a coupling gel or liquid
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61N 2007/0043 intra-cavitary
• CPC Class Codes: A61N 2007/0052 using the same transducer for therapy and imaging
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A device including a focused ultrasound probe, a first balloon, and a second balloon. The first balloon can be located at least partially inside the second balloon. The inner balloon can be configured to act as a fluid interface, a mechanism for cooling, and a mechanism for changing tissue depth of a focal point of the probe. The second balloon can be filed with a thermosensitive hydrogel configured to turn from a fluid at room temperature to a gel at physiologic temperatures. The first and second balloons can be configured to create a fluid interface between the probe and targeted tissue of a patient.

Claims

1. A method for treating tissue with focused ultrasound, the method comprising:

inserting at least a portion of an ultrasound probe into an inner balloon of a balloon complex, the balloon complex including the inner balloon at least partially surrounded by an outer balloon;

inserting the balloon complex in an orifice of a patient;

injecting thermosensitive hydrogel into the outer balloon to cause the outer balloon to engulf or contact a region of tissue of the patient containing targeted tissue;

injecting liquid into the inner balloon;

allowing or causing the hydrogel to undergo a sol-gel transition;

delivering focused ultrasound, via the ultrasound probe, to the targeted tissue; and

removing the balloon complex from the orifice.

2. The method according to claim 1, wherein prior to removing the balloon complex the method comprises:

allowing or causing the hydrogel to undergo a gel-sol transition;

removing the hydrogel from the outer balloon;

removing the liquid from the inner balloon; and

removing the probe from the inner balloon.

3. The method according to claim 2, further comprising:

infusing water into the orifice to cause the hydrogel to undergo the gel-sol transition.

4. The method according to claim 2, further comprising:

removing the hydrogel from the outer balloon by applying suction to an egress port of the balloon complex.

5. The method according to claim 1, further comprising,

evacuating air from the inner and outer balloons prior to positioning the balloon complex in the orifice.

6. The method according to claim 1, further comprising:

closing a port of the balloon complex prior to positioning the balloon complex in the orifice.

7. The method according to claim 1, further comprising:

prior to inserting the balloon complex in the orifice, inserting a stylet into the inner balloon.

8. The method according to claim 1, further comprising:

infusing water at a temperature less than the sol-gel transition temperature into the orifice of the patient.

9. A method for treating tissue with focused ultrasound, the method comprising the steps of:

a) evacuating air from a balloon complex, the balloon complex including an inner balloon at least partially surrounded by an outer balloon;

b) inserting both a probe and a stylet into the inner balloon;

c) closing a port of the balloon complex;

d) inserting the balloon complex in an orifice of a patient;

e) injecting thermosensitive hydrogel into the outer balloon to cause the outer balloon to engulf or contact a region of tissue of the patient containing targeted tissue;

f) injecting liquid into the inner balloon;

g) allowing or causing the hydrogel to undergo a sol-gel transition which causes the shape of the outer balloon to be at least generally fixed thereby immobilizing surrounding tissue of the patient relative to the outer balloon;

h) delivering focused ultrasound, via the probe, to the targeted tissue;

i) allowing or causing the hydrogel to undergo a gel-sol transition by infusing water into the orifice;

j) removing the hydrogel from the outer balloon by applying suction to an egress port of the balloon complex;

k) removing the liquid from the inner balloon;

l) removing the probe from the inner balloon and;

m) removing the balloon complex from the orifice.

10. The method according to claim 9, wherein the step of infusing water comprises infusing water at a temperature less than the sol-gel transition temperature.