Method and Apparatus for Selective Treatment of Tissue

• US 20070219448A1
• Filed: 05/05/2005
• Published: 09/20/2007
• Est. Priority Date: 05/06/2004
• Status: Abandoned Application

• Current Assignee: Focus Surgery, Inc. (Sonacare Medical, LLC)
• Original Assignee: Focus Surgery, Inc. (Sonacare Medical, LLC)
• Inventors: Seip, Ralf, Carlson, Roy, Chen, Wo-Hsing, Sanghv, Narendra, Dines, Kris, Penna, Michael, Pfile, Richard
• Application Number:
  US11/568,599
• Publication Number:
  US 20070219448A1
• Time in Patent Office: Days
• US Class Current: 600/454
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00547 Prostate
• 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: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/483 involving the acquisition of a 3D volume of data
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A IIIFU System (100) is disclosed which may automatically generate a proposed treatment plan for treating a tissue treatment area (10) with HIFU Therapy. In one example, the proposed treatment plan includes a plurality of treatment sites selected based on a three-dimensional model generated from ultrasound data. In another example, the proposed treatment plan excludes portions of the tissue treatment area (10) corresponding to blood flow, such as the neuro-vascular bundles (20) when treating the prostate (11).

Claims

1. A method of providing treatment to a tissue treatment area including a plurality of tissue components, the method comprising the steps of:

generating ultrasound data related to the tissue treatment area; and

automatically generating a proposed treatment plan of the tissue treatment area, the proposed treatment plan including a plurality of treatment sites selected to receive HIFU Therapy, the plurality of treatment sites being selected based on a three-dimensional model of a first tissue component located in the tissue treatment area, the three-dimensional model of the first tissue component being based on the generated ultrasound data.

2. The method of claim 1, further comprising the steps of:

detecting blood flow in the tissue treatment area; and

excluding a first portion of tissue from the proposed treatment plan, the exclusion of the first portion of tissue being based on the detection of blood flow at a location generally corresponding to the first portion of tissue.

3. The method of claim 2, wherein the exclusion of the first portion of tissue is further based on the location of the first portion relative to the three-dimensional model of the first tissue component.

4. The method of claim 2, wherein the tissue treatment area generally corresponds to a prostate of a patient, the first tissue component corresponds to a prostatic capsule, and the first portion generally corresponds to a neuro-vascular bundles and wherein the step of generating the ultrasound data includes the steps of positioning an ultrasound transducer proximate to the tissue treatment area by the transrectal insertion of the ultrasound transducer and obtaining multiple two-dimensional images of the tissue treatment area including a plurality of sector images and a plurality of linear images.

5. The method of claim 1, wherein substantially all of an interior of the first tissue component is treated with HIFU Therapy in the proposed treatment plan.

6. The method of claim 1, wherein a first portion of tissue in the tissue treatment area is excluded from the proposed treatment plan, the first portion of tissue generally corresponding to the location of a second tissue component.

7. The method of claim 6, wherein the location of the second tissue component is based on a three-dimensional model of the second tissue component, the three-dimensional model of the second tissue component being based on the generated ultrasound data.

8. The method of claim 7, wherein the first tissue component is a prostatic capsule and the second tissue component is selected from one of a rectal wall, a seminal vesicle, and an urethra.

9. The method of claim 1, wherein the three-dimensional model is generated by the steps of:

locating a first boundary trace of the first tissue component in a first set of ultrasound data generally corresponding to a first plane;

locating a second boundary trace of the first tissue component in a second set of ultrasound data generally corresponding to a second plane, the second plane being generally orthogonal to the first plane; and

computing a boundary surface of the first tissue component based on the first boundary trace and the second boundary trace.

10. The method of claim 1, further comprising the steps of:

presenting the proposed treatment plan on a display device along with a three dimensional representation of the tissue treatment area for review by a user;

determining a first location within the tissue treatment area having blood flow associated therewith;

further presenting on the display for review by a user an indicia to indicate the presence of blood flow at the first location, the indicia being positioned to correspond to the first location;

receiving a modification to the proposed treatment plan from the user thereby generating a modified proposed treatment plan; and

commencing the modified proposed treatment.

11. The method of claim 10, wherein the indicia provides an indication of the level of blood flow at the first location.

12. A method of providing treatment to a tissue treatment area including a plurality of tissue components, the method comprising the steps of:

generating ultrasound data related to the tissue treatment area;

generating blood flow data related to the tissue treatment area;

determining the location of a first tissue component based on the ultrasound data;

determining the location of a second tissue component based on the blood flow data; and

automatically generating a proposed treatment plan of the tissue treatment area, the proposed treatment plan including a plurality of treatment sites, the plurality of treatment sites being selected such that HIFU Therapy is provided to the first tissue component and such that the second tissue component is excluded from HIFU Therapy.

13. The method of claim 12, wherein the blood flow data is generated by Doppler ultrasound imaging and wherein the location of the first tissue component is determined based on a three-dimensional model of the first tissue component, the three-dimensional model of the first tissue component being based on the ultrasound data.

14. The method of claim 13, wherein the location of the second tissue component is determined based on an indication of the presence of blood flow at the location of the second tissue component and the relative position of the of the location of the second tissue component and the three-dimensional model of the first tissue component.

15. The method of claim 14, further comprising the steps of:

presenting on a display device for review by a user

a three dimensional representation of the tissue treatment area;

a plurality of treatment indicia, each of the treatment indicia corresponding to a respective treatment site,

a representation of a boundary of the first tissue component, the boundary being determined from the three-dimensional model of the first tissue component; and

a blood flow indicia indicating the location of the second tissue component, the blood flow indicia providing an indication of the amount of blood flow;

receiving a modification to the proposed treatment plan from the user thereby generating a modified proposed treatment plan; and

commencing the modified proposed treatment plan.

16. The method of claim 12, wherein the tissue treatment area generally corresponds to a prostate of a patient, the first tissue component generally corresponds to a prostatic capsule, and the second tissue component generally corresponds to a neuro-vascular bundles and wherein the step of generating the ultrasound data includes the steps of positioning an ultrasound transducer proximate to the tissue treatment area by the transrectal insertion of the transducer and obtaining multiple two-dimensional images of the tissue treatment area including a plurality of sector images and a plurality of linear images.

17. An apparatus for treating a tissue treatment area including a plurality of tissue components, the apparatus comprising:

a transducer which is positionable proximate to the tissue treatment area of tissue, the transducer being configured to emit ultrasound energy and to sense ultrasound energy; and

a controller operably coupled to the transducer, the controller being configured to operate the transducer in an imaging mode wherein images of the tissue are obtained by ultrasound energy sensed by the transducer and blood flow information and in a therapy mode wherein portions of the tissue in the tissue treatment area are treated with a HIFU Therapy with the transducer;

the controller being further configured to automatically generate a proposed treatment plan having a plurality of treatment sites, the plurality of treatment sites of the proposed treatment plan being selected to provide HIFU Therapy to a first tissue component, while excluding a second tissue component from HIFU Therapy, the location of the second tissue component being determined based on blood flow information obtained during the imaging mode of operation.

18. The apparatus of claim 17, wherein the tissue treatment area generally corresponds to a prostate of a patient and wherein the transducer is contained within a probe, the probe being configured for transrectal insertion to position the transducer proximate to the tissue treatment area.

19. The apparatus of claim 18, wherein the first tissue component generally corresponds to a prostatic capsule, and the second tissue component generally corresponds to a neuro-vascular bundles.

20. The apparatus of claim 18, wherein the location of the first tissue component is determined based on a three-dimensional model of the first tissue component, the three-dimensional model being generated by the steps of:

locating a first boundary trace of the first tissue component in a first image obtained during the imaging mode of operation, the first image generally corresponding to a first plane;

locating a second boundary trace of the first tissue component in a second image obtained during the imaging mode of operation, the second image generally corresponding to a second plane, the second plane being generally orthogonal to the first plane; and

computing a boundary surface of the first tissue component based on the first boundary trace and the second boundary trace.

21. The apparatus of claim 20, wherein the boundary surface is based on Fourier ellipsoids.

22. The apparatus of claim 17, further comprising a display device, the controller being configured to present with the display device for review by a user a three dimensional representation of the tissue treatment area, a plurality of treatment indicia, each of the treatment indicia corresponding to a respective treatment site in the proposed treatment plan, a representation of a boundary of the first tissue component, the boundary being determined from a three-dimensional model of the first tissue component;

and a blood flow indicia indicating the location of the second tissue component.

23. The apparatus of claim 22, wherein the blood flow indicia provides an indication of the amount of blood flow.

24. The apparatus of claim 22, further comprising an user input device, the controller being configured to generate a modified proposed treatment plan based on a requested modification received with the user input device.

25. The apparatus of claim 17, wherein the controller includes a multiple gate system for sampling Doppler information which provides the blood flow information, each gate of the multiple gate system being configured to sample a given time period of Doppler information.

26. An apparatus for treating a tissue treatment area including a plurality of tissue components, the apparatus comprising:

a transducer which is positionable proximate to the tissue treatment area, the transducer being configured to emit ultrasound energy and to sense ultrasound energy; and

a controller operably coupled to the transducer, the controller being configured to operate the transducer in an imaging mode wherein images of the tissue are obtained by ultrasound energy sensed by the transducer and in a therapy mode wherein portions of the tissue in the tissue treatment area of tissue are treated with a HIFU therapy with the transducer;

the controller being further configured to automatically generate a proposed treatment plan of the tissue treatment area, the proposed treatment plan including a plurality of treatment sites selected based on a three-dimensional model of a first tissue component located in the tissue treatment area of tissue, the three-dimensional model of the first tissue component being based on the images obtained in the imaging mode of operation.

27. The apparatus of claim 26, wherein the tissue treatment area generally corresponds to a prostate of a patient and wherein the transducer is contained within a probe, the probe being configured for transrectal insertion to position the transducer proximate to the tissue treatment area.

28. The apparatus of claim 27, wherein the first tissue component is a prostatic capsule.

29. The apparatus of claim 26, wherein the three-dimensional model of the first tissue component is generated by the steps of:

locating a first boundary trace of the first tissue component in a first image obtained during the imaging mode of operation, the first image generally corresponding to a first plane;

locating a second boundary trace of the first tissue component in a second image obtained during the imaging mode of operation, the second image generally corresponding to a second plane, the second plane being generally orthogonal to the first plane; and

computing a boundary surface of the first tissue component based on the first boundary trace and the second boundary trace.

30. The apparatus of claim 26, further comprising a display device, the controller being configured to detect the presence of blood flow in the tissue treatment area of tissue and present with the display device for review by a user a three dimensional representation of the tissue treatment area including the three-dimensional model of the first tissue component, a plurality of treatment indicia, each of the treatment indicia corresponding to a respective treatment site in the proposed treatment plan, and a blood flow indicia indicating the location of blood flow in the tissue treatment area.

31. The apparatus of claim 30, wherein the blood flow indicia provides an indication of an amount of blood flow.

32. The apparatus of claim 26, further comprising an user input device, the controller being configured generate a modified proposed treatment plan based on a requested modification received with the user input device.

33. A method for treating tissue in a tissue treatment area including tissue components, comprising the steps of:

providing a HIFU system having software configured to provide therapy to diseased tissue by focusing ultrasound proximate to the diseased tissue and further configured to provide location information of blood flow in the tissue and location information on at least one of the tissue components;

identifying potential treatment areas based on the location information of the tissue components;

excluding potential treatment areas based on the location information of blood flow in the tissue treatment area; and

providing therapy to all of the identified non-excluded treatment areas with the HIFU system.

34. The method of claim 33, wherein the location information of the tissue components is presented to the a user by the following steps:

identifying the location of blood flow with Doppler imaging;

identifying the location of at least some of the tissue components with at least one of ultrasound 2-D imaging and ultrasound 3-D imaging;

generating a three-dimensional model representation of the location of tissue components based on the location of blood flow and the ultrasound imaging information; and

displaying the three-dimensional model on a display.

35. The method of claim 34, further comprising the step of overlaying representations of the treatment zones on the three-dimensional model.

36. The method of claim 35, further comprising the step providing a user input device associated with the HIFU system to permit the selection and deletion of the representations of the treatment zones.

37. The method of claim 36, wherein the deletion of the representation of the treatment site indicates to the HIFU system to exclude the area of tissue corresponding to the treatment site from therapy.

38. A method of providing treatment to a tissue treatment area including a prostatic capsule and a neuro-vascular bundles, the method comprising the steps of:

imaging the tissue treatment area; and

automatically generating a proposed treatment plan of the tissue treatment area, the proposed treatment plan including a plurality of treatment sites selected to receive HIFU Therapy, the plurality of treatment sites being selected to provide HIFU Therapy to the prostatic capsule and to exclude the neuro-vascular bundles from the provision of HIFU Therapy.

39. The method of claim 38, wherein the location of the neuro-vascular bundles is determined based on blood flow information obtained during the imaging of the tissue treatment area.

40. The method of claim 38, further comprising the steps of:

presenting the proposed treatment plan to a user for review;

receiving a modification to the proposed treatment plan from the user; and

generating a modified proposed treatment plan based on the received modification.