METHOD AND APPARATUS FOR THE TREATMENT OF TISSUE

• US 20150321027A1
• Filed: 07/20/2015
• Published: 11/12/2015
• Est. Priority Date: 07/08/2005
• Status: Active Grant

• Current Assignee: Sonablate Corporation
• Original Assignee: Focus Surgery, Inc. (Sonacare Medical, LLC)
• Inventors: Fedewa, Russell J., Uchida, Toyoaki, Sanghvi, Narendra T., Carlson, Roy F.
• Granted Patent: US 10,293,188 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61N 2007/0052 using the same transducer for therapy and imaging
• CPC Class Codes: A61N 2007/0082 Scanning transducers
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A method and apparatus is disclosed for determining the success of a proposed HIFU Treatment, of an ongoing HIFU Treatment, and/or of a completed HIFU Treatment. An energy density of a given HIFU Treatment may be used as a comparison factor between the given HIFU Treatment and other HIFU Treatments and as a predictor of the success of the given HIFU Treatment. One exemplary energy density is the amount of energy deposited in the treatment region divided by the volume of the treatment region. Another exemplary energy density is the amount of energy deposited in the treatment region divided by the pre-treatment mass of the treatment region. A method and apparatus is disclosed to detect the presence of focal hyperechoic features and non-focal hyperechoic features. A method and apparatus is disclosed to detect the presence of an acoustic obstruction.

Claims

1-21. -21. (canceled)

22. An apparatus for treating tissue, the apparatus comprising:

a transducer configured to be positioned proximate to the tissue, the transducer being configured to emit ultrasound energy and to sense ultrasound energy;

a positioning member coupled to the transducer and configured to position the transducer; and

a controller operably coupled to the transducer and to the positioning member, the controller being configured to position the transducer with the positioning member and to operate the transducer in an imaging mode wherein images of the tissue are obtained from ultrasound energy sensed by the transducer and in a therapy mode wherein a plurality of treatment sites are treated with a HIFU Therapy with the transducer;

the controller being further configured to plan a HIFU Treatment of a treatment region of the tissue to determine prior to commencement of the HIFU Treatment whether the HIFU Treatment should be successful in treating the tissue of the treatment region based on an energy density of the energy planned to be deposited into the treatment region.

23. The apparatus of claim 22, wherein the controller is further configured to monitor the HIFU Treatment as the HIFU Treatment progresses to determine whether the HIFU Treatment should be successful in treating the tissue of the treatment region based on an amount of energy deposited into the treatment region and an amount of energy planned to be deposited in the treatment region.

24. The apparatus of claim 22, further comprising;

a display operably coupled to the controller, the controller being configured to present the images of the tissue on the display and to provide a visual cue on the display of whether the planned HIFU Treatment should be successful in treating the tissue based on the amount of energy planned to be deposited into the treatment region and the amount of energy deposited in the treatment region.

25. The apparatus of claim 22, wherein the HIFU Treatment should be successful if the energy density is at least equal to a reference energy density.

26. A non-transitory computer-readable medium having computer-readable code stored thereon that, when executed by one or computing devices, causes the one or more computing devices to:

receive, by at least one of the one or more computing devices, image information from a transducer;

generate, by at least one of the one or more computing devices, at least one image from the received image information;

determine, by at least one of the one or more computing devices, a treatment region based on the received image information;

plan, by at least one of the one or more computing devices, a HIFU Treatment of at least a portion of the treatment region, the HIFU Treatment including a plurality of treatment sites;

calculate, by at least one of the one or more computing devices, an energy density corresponding to the planned HIFU Treatment;

provide, by at least one of the one or more computing devices, an indication of whether the planned HIFU Treatment is likely to be successful based on the energy density; and

control, by at least one of the one or more computing devices, the transducer to conduct the planned HIFU Treatment.

27. The computer readable medium of claim 26, the computer-readable code further causing the one or more computing devices to:

prevent the planned HIFU Treatment from commencing if the planned HIFU Treatment is not likely to be successful based on the energy density.

28. The computer readable medium of claim 26, the computer-readable code further causing the one or more computing devices to:

monitor the planned HIFU Treatment as the planned HIFU Treatment progresses and to permit a modification to the planned HIFU Treatment.

29. The computer readable medium of claim 28, the computer-readable code further causing the one or more computing devices to:

calculate an updated energy density corresponding to the planned HIFU Treatment with the modification and to provide an updated indication of whether the planned HIFU Treatment with the modification is likely to be successful based on the updated energy density.

30. The computer readable medium of claim 29, the computer-readable code further causing the one or more computing devices to:

prevent a further progression of the planned HIFU Treatment with the modification if the updated energy density does not indicate that the planned HIFU Treatment with the modifications is likely to be successful.

31. The computer readable medium of claim 26, wherein the planned HIFU Treatment is likely to be successful if the energy density is at least equal to a reference energy density.

32. The computer readable medium of claim 26, wherein the energy density is calculated by the steps of:

estimating an amount of energy to be deposited at each of the plurality of treatment sites;

summing the amount of energy to be deposited at each of the plurality of treatment sites; and

dividing the summed amount of energy to be deposited by one of a volume of the treatment region and a mass of the treatment region.

33. A method of providing treatment to a treatment region of tissue with a HIFU Treatment, the HIFU Treatment including the provision of HIFU Therapy at spaced apart intervals to a plurality of treatment sites within the treatment region, the method comprising:

driving the HIFU Treatment to generate a focal hyperechoic feature for a given treatment site; and

maintaining the HIFU Treatment at a level to maintain the generation of subsequent focal hyperechoic features at subsequent treatment sites.

34. The method of claim 33, further comprising:

pausing the HIFU Treatment if a non-focal hyperechoic feature is generated.

35. The method of claim 34, further comprising:

reducing the total acoustic power for subsequent treatment sites of the HIFU Treatment if a non-focal hyperechoic feature is generated which migrates from the respective focal zone.

36. A method of providing treatment to a treatment region of tissue with a HIFU Treatment, the HIFU Treatment including the provision of HIFU Therapy at spaced apart intervals to a plurality of treatment sites within the treatment region, the method comprising:

distinguishing between a focal hyperechoic feature and a non-focal hyperechoic feature;

continuing the HIFU Treatment upon the observance of the focal hyperechoic feature; and

pausing the HIFU Treatment upon the observance of the non-focal hyperechoic feature.

37. The method of claim 36, wherein distinguishing between a focal hyperechoic feature and a non-focal hyperechoic feature includes:

generating a post-treatment image of a first treatment site;

comparing a region of interest of the treatment region in the post-treatment image to the region of interest of the treatment region in a pre-treatment image;

classifying the region of interest as containing a hyperechoic feature based on the comparison of the region of interest of the treatment region in the post-treatment image and the pre-treatment image; and

comparing a location of the region of interest to a location of the treatment site, wherein the hyperechoic feature is classified as a focal hyperechoic feature if the location of the region of interest generally coincides with the location of the treatment site.

38-47. -47. (canceled)