System and method for control and monitoring of conformal thermal therapy

• US 8,998,889 B2
• Filed: 09/26/2012
• Issued: 04/07/2015
• Est. Priority Date: 09/26/2011
• Status: Active Grant

• Current Assignee: Profound Medical Inc. (Profound Medical Corp.)
• Original Assignee: Profound Medical Inc. (Profound Medical Corp.)
• Inventors: Mahon, Cameron, Burtnyk, Mathieu
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/627,029
• Publication Number:
  US 20130158577A1
• Time in Patent Office: 923 Days
• Field of Search: 606/27
• US Class Current: 606/27
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/015 By temperature mapping of body part
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/4381 Prostate evaluation or disorder diagnosis
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 2007/0095 by modifying an excitation signal
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A system and method are disclosed for thermal therapy that takes into account predictive calculations of tissue temperature, and can be used to control the operation of a conformal thermal therapy procedure and device. In some embodiments, the tissue ablation area is part or all of a prostate gland. The method includes, in preferred embodiments, simulations and or calculations of future temperatures based on some or all of the following information: current temperatures, heat diffusion in the tissue, blood perfusion in the tissue, and planned ultrasound energy depositions. The calculated temperature maps can be used to design, control, or terminate the therapy.

Claims

1. A method for treating a prostate, comprising:

determining a target boundary defining a target treatment volume within the prostate;

inserting a multi-element ultrasonic thermal therapy applicator at least partially within said target treatment volume;

applying controlled driving signals to a plurality of elements of said applicator so as to controllably raise a temperature of a portion of said target treatment volume including in a region proximal to an active face of said applicator and along a direction radially emanating therefrom;

imaging said target treatment volume using an imaging modality to determine a current temperature distribution within said target treatment volume;

determining a future temperature distribution in a portion of said target treatment volume based at least on the current temperature distribution in and proximal to that portion using a thermal response model;

controlling said driving signals to the plurality of elements of the applicator based at least on the determined future temperature distribution; and

generating an alarm condition in the event that a temperature excursion is predicted to occur in said future temperature distribution according to a pre-programmed threshold for said alarm condition.

2. A system for treating a prostate, comprising:

an ultrasonic thermal therapy applicator in the form of an elongated cylindrical applicator sized and shaped for insertion into a male patient'"'"'s urethra so as to be able to reach at least partially into a prostate of said patient;

a controllable motor and mechanical driver assembly coupled to said applicator so as to cause the elongated cylindrical applicator to rotate about an axis thereof within the patient'"'"'s urethra;

a plurality of transducer elements in said applicator, each being controllably driven by an electrical driving signal and having an active surface and capable of generating an acoustic radiation field emanating radially outwardly from its active surface into said prostate;

a thermometry module receiving data from an imaging system and executing instructions in a processor to determine a current temperature distribution map within said prostate;

a temperature prediction module receiving said current temperature distribution map as data, and using programmed thermal response model instructions, generating data representative of a future temperature distribution within said prostate;

a controller receiving at least said future temperature distribution, comparing said future temperature distribution to an indicated reference temperature at least in some region within said prostate, and modifying the controllable electrical driving signals to said plurality of transducer elements in said applicator; and

a special event module that generates an alarm condition in the event that a temperature excursion is predicted to occur in said future temperature distribution according to a pre-programmed threshold for said alarm condition.

3. The system of claim 2, said controller further controlling an electrical driving signal that controls a movement of said controllable motor so as to cause a corresponding controlling of an angular motion of said applicator within the urethra of the patient.

4. The system of claim 2, further comprising a user interface module allowing an operator to enter inputs into said system and to receive outputs from said system.

5. The system of claim 4, said user interface comprising a graphical representation of a temperature distribution within said prostate and further comprising a graphical indication of at least a portion of said target treatment volume delineated by a target boundary surrounding said portion of the target treatment volume.

6. The system of claim 2, said alarm condition being associated with an audible or visible alarm signal to an operator of the system.

7. The system of claim 2, said alarm condition causing a reduction or interruption of at least some electrical driving signals to at least some elements of said applicator.

8. The system of claim 2, said alarm condition causing a reduction or interruption of a rotation of said motor and mechanical driver assembly so as to slow down or halt a rotation of said applicator within the urethra.

9. A method for conformal thermal therapy of a diseased organ using a thermal therapy device, comprising:

calculating a plurality of parameters in a treatment plan, including a target boundary, corresponding to conditions of a diseased organ and corresponding to therapeutic operating conditions of the therapy device;

delivering thermal therapy to a diseased region of said diseased organ by application of a prescribed power to at least one of a plurality of ultrasound transducer elements of said therapy device;

monitoring a temperature of said diseased organ using an imaging modality capable of mapping acquired images to corresponding present temperature maps within said diseased organ;

executing, in a processor, programmed steps representing a thermal model, taking as input at least said present temperature maps and outputting at least a future temperature distribution predicted by said thermal model;

generating control signals, at least in part based on said future temperature distribution predicted by said thermal model; and

controlling operation of said therapy device at least in part based on said generated control signals; and

generating an alarm condition in the event that a temperature excursion is predicted to occur in said future temperature distribution according to a pre-programmed threshold for said alarm condition.

10. The method of claim 9, monitoring said temperature in said diseased organ comprises monitoring a temperature at a control point defined by intersection of a direction of a beam of ultrasound emitted from said therapy device and said target boundary.

11. The method of claim 9, monitoring said temperature in said diseased organ comprises monitoring temperatures at a plurality of control points spatially defined along a radial direction of a beam of ultrasound energy emitted from said therapy device.

12. The method of claim 9, monitoring said temperature in said diseased organ comprises monitoring temperatures at a plurality of control points spatially defined along at least a portion of said target boundary.

13. The method of claim 9, controlling said operation of the therapy device comprising controlling a movement of said therapy device so as to cause a corresponding translation of a heating zone of said thermal therapy.

14. The method of claim 9, controlling said operation of the therapy device comprising controlling phasing of a multi-element phased array in said therapy device so as to cause a corresponding shift in a location of a focal spot of said therapy device.

15. The method of claim 9, further comprising placing at least a portion of an unfocused ultrasound therapy device into an interior volume of said target boundary and emitting an unfocused acoustic field from an active surface of said therapy device.

16. The method of claim 15, further comprising rotating said unfocused ultrasound therapy device about an axis thereof to conformally treat an extended volume of tissue within said target volume.

17. The method of claim 9, further comprising placing a focused ultrasound therapy device outside said target boundary and directing a focus of said focused ultrasound therapy device into an interior volume of said target boundary and delivering a focused acoustic field from an active surface of said focused therapy device.

18. The method of claim 17, further comprising controlling respective phases of a plurality of elements of a focused multi-element phased array to conformally treat an extended volume of tissue within said target volume.