Noise-free real time ultrasonic imaging of a treatment site undergoing high intensity focused ultrasound therapy

• US 6,425,867 B1
• Filed: 09/17/1999
• Issued: 07/30/2002
• Est. Priority Date: 09/18/1998
• Status: Expired due to Term

• Current Assignee: Mirabilis Medica, Inc., University of Washington, Washington University In St Louis
• Original Assignee: University of Washington
• Inventors: Vaezy, Shahram, Martin, Roy W., Keilman, George W., Crum, Lawrence A., Fujimoto, Victor Y., Carter, Stephen J.
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US09/397,471
• Time in Patent Office: 1,047 Days
• Field of Search: 601/2-4, 600/439
• US Class Current: 600/439
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2090/378 using ultrasound
• 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 8/0833 involving detecting or locating foreign bodies or organic structures
• 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 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/4254 using sensors mounted on the probe
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4483 characterised by features of the ultrasound transducer
• CPC Class Codes: A61B 8/4488 the transducer being a phased array
• CPC Class Codes: A61B 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• 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

Abstract

Method and apparatus for the simultaneous use of ultrasound on a probe for imaging and therapeutic purposes. The probe limits the effects of undesirable interference noise in a display by synchronizing high intensity focused ultrasound (HIFU) waves with an imaging transducer to cause the noise to be displayed in an area of the image that does not overlap the treatment site. In one embodiment, the HIFU is first energized at a low power level that does not cause tissue damage, so that the focal point of the HIFU can be identified by a change in the echogenicity of the tissue caused by the HIFU. Once the focal point is properly targeted on a desired treatment site, the power level is increased to a therapeutic level. The location of each treatment site is stored and displayed to the user to enable a plurality of spaced-apart treatment sites to be achieved. As the treatment progresses, any changes in the treatment site can be seen in the real time, noise-free image. A preferred application of the HIFU waves is to cause lesions in blood vessels, so that the supply of nutrients and oxygen to a region, such as a tumor, is interrupted. The tumor will thus eventually be destroyed. In a preferred embodiment, the HIFU is used to treat disorders of the female reproductive system, such as uterine fibroids. The HIFU treatment can be repeated at spaced-apart intervals, until any remaining fibroid tissue is destroyed.

Claims

1. A method for using ultrasound to simultaneously image a target area and to provide therapy to a treatment site disposed within said target area, producing a lesion in a blood vessel that occludes a blood supply relative to a region, comprising the steps of:

(a) providing;

(i) a scanning ultrasonic transducer system adapted to scan a target area and to provide imaging data for said target area;

(ii) a processor adapted to process said imaging data;

(iii) a display capable of providing a visual representation of said imaging data to a user; and

(iv) a therapeutic ultrasonic transducer system adapted to provide waves of high intensity focused ultrasound (HIFU) to said treatment site;

(b) energizing said scanning ultrasonic transducer system to continually scan said target area to produce said imaging data;

(c) displaying a visual representation of said imaging data to the user on the display to produce a displayed target area;

(d) selecting the treatment site from within the displayed target area proximate a blood vessel supplying blood to the region; and

(e) directing the therapeutic waves of the HIFU at the treatment site with the therapeutic ultrasonic transducer system, said therapeutic ultrasonic transducer system being synchronized relative to the scanning ultrasonic transducer system such that any noise in said imaging data arising from said therapeutic waves is shifted away from the treatment site in the displayed target area, enabling the treatment site to be observed in real time as the therapeutic waves of the HIFU are administered to the treatment site, said therapeutic waves being of sufficient intensity to form a lesion in the blood vessel that occludes the blood vessel, preventing blood from continuing to flow into the region, so that oxygen and nutrients conveyed by blood flowing through the blood vessel do not reach the region.

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

(a) initially energizing the therapeutic ultrasonic transducer system at a reduced energy level so as to produce a pulsed wave that is not energetic enough to produce a therapeutic effect at the treatment site, but is sufficiently energetic to produce a change in an echogenicity of tissue at the treatment site, a focal point of the therapeutic ultrasonic transducer system being visually apparent in the displayed target area visually represented on the display where the echogenicity of the tissue has thus been changed;

(b) moving the focal point of the therapeutic ultrasonic transducer system to a desired position; and

(c) increasing the energy level of the therapeutic ultrasonic transducer system to a therapeutic level to generate the therapeutic waves with sufficient energy to produce a desired therapeutic effect at the focal point.

3. The method of claim 2, further providing a blood soluble material that has a high vapor pressure, and further comprising the step of administering the blood soluble material to the selected blood vessel before initially energizing the therapeutic ultrasonic transducer system at a reduced energy level, such that bubbles produced by the interaction of the blood soluble material and the therapeutic wave at a focal point of the therapeutic wave are detected by the scanning ultrasonic transducer system.

4. The method of claim 2, further comprising the step of:

(a) storing the visual representation of the focal point in the displayed target area for the position at which the therapeutic waves of the HIFU are being administered;

(b) reducing the energy level of the therapeutic ultrasonic transducer system to the reduced level of the pulsed wave after the desired therapeutic effect has been achieved at the focal point;

(c) moving the focal point of the therapeutic ultrasonic transducer system to a different desired position to define a new treatment site, said focal point be visually apparent in the displayed target area due the change in the echogenicity caused by the reduced level of the pulsed wave at the new treatment site in relationship to the visual representation of the focal point stored in step (a) of this claim;

(d) energizing said therapeutic ultrasonic transducer system;

thereby producing the therapeutic waves of HIFU directed at the new treatment site; and

(e) repeating steps (a)-(d) of this claim until the therapeutic waves of HIFU have been administered to all desired treatment sites, the visual representation of all focal points on the display at which the therapeutic waves of the HIFU were previously administered enabling positions of each new treatment sites to be readily selected in relationship to previous treatment sites.

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

(a) monitoring the displayed target area on the display for any changes in an area outside the treatment site caused by the therapeutic waves of HIFU delivered to the treatment site; and

(b) de-energizing the therapeutic ultrasonic transducer system to prevent further changes to the area outside the treatment site, even if the desired therapeutic effect has not yet been achieved at the treatment site.

6. The method of claim 1, further comprising the step of processing the imaging data to effect at least one of:

a scan conversion processing, a color flow processing, a Doppler processing, a B-mode processing, and an M-mode processing.

7. The method of claim 1, wherein the target area is associated with a reproductive system of a mammalian female.

8. The method of claim 7, wherein the therapeutic waves of the HIFU are administered to produce a lesion in the blood vessel to therapeutically affect a region that includes one of:

a uterine fibroid, an endometrial polyp, a follicular cyst, a polycystic ovary, a dermoid cyst, a corpus luteum cyst, an ectopic pregnancy, a cornual pregnancy, a multifetal pregnancy, a uterine malformation, an endometrial hyperplasia, an adenomyosis condition, an endometriosis condition, an excessive bleeding condition, a placental abruption, a fetal anomaly, and a twin-twin infusion.

9. The method of claim 1, further comprising the step of:

(a) providing a probe incorporating both the scanning ultrasonic transducer system and the therapeutic ultrasonic transducer system and having a size and shape adapted to be inserted through one of;

(i) a human vaginal canal;

(ii) a human rectum;

(iii) a human abdominal cavity; and

(iv) a laparoscopic dermal incision;

(b) inserting the probe through a part of the human body through which it is adapted to be inserted; and

(c) advancing the probe until it is adjacent to the target area before energizing the therapeutic ultrasonic transducer system.

10. The method of claim 1, wherein said therapeutic ultrasonic transducer system generates the therapeutic waves of the HIFU at frequencies within the range of 0.5 MHz to 10 MHz.

11. The method of claim 1, wherein the therapeutic ultrasonic transducer system comprises a phased array of ultrasonic transducers, said step of directing the therapeutic waves comprising the step of varying a position of a focal point of the phased array.

12. The method of claim 11, wherein the phased array of ultrasonic transducers comprises a plurality of concentric transducer elements.

13. The method of claim 1, wherein the therapeutic ultrasonic transducer system includes a vibrating element, further comprising the step of energizing the vibrating element to vary a focal point of the therapeutic ultrasonic transducer system.

14. The method of claim 13, wherein the step of energizing the vibrating element comprises the step of causing the therapeutic ultrasonic transducer system to vibrate with a frequency in the range of 1 to 5 Hz so that the position of the focal point within the target area is varied.

15. The method of claim 13, wherein the step of energizing the vibrating element comprises causing the therapeutic ultrasonic transducer system to vibrate with a frequency in the range of 10 to 50 Hz, thereby increasing an amount of energy applied to the treatment site while avoiding undesired cavitational effects.

16. The method of claim 1, further comprising the step of causing a focal point of the therapeutic ultrasonic transducer system to be varied within the target area in a random manner.

17. The method of claim 1, wherein administering the therapeutic waves to produce the lesion cause at least one of:

arresting a bleeding at the treatment site, preventing bleeding at the treatment site, and causing tissue necrosis at the treatment site.

18. The method of claim 17, wherein the necrosis of tissue at the treatment site is caused by cavitation effects.

19. The method of claim 1, wherein a desired therapeutic effect of administering the therapeutic waves is one of an ablation of tissue at the treatment site and a hemostasis at the treatment site.

20. A method for using ultrasound to visualize and to provide therapy to a treatment site within a target area, such that an image is displayed to a clinician in real time, to continually provide feedback to the clinician relating to a focal point of therapeutic waves of high intensity focused ultrasound (HIFU) and a change in the treatment site, said method enabling a plurality of lesions to be produced in blood vessels supplying a region to occlude blood flow through the blood vessels into the region, comprising the steps of:

(a) providing;

(i) a scanning ultrasonic transducer system adapted to scan the target area with a probe and to provide imaging data for said target area;

(ii) a processor adapted to process said imaging data;

(iii) a display that provides a visual representation of said imaging data to a clinician; and

(iv) a therapeutic ultrasonic transducer system adapted to provide the pulsed waves of the HIFU from the probe;

(b) positioning the probe of the scanning ultrasonic transducer system and energizing the scanning ultrasonic transducer system so that an image comprising a visual representation of the target area is continually generated on the display as a displayed target area;

(c) directing the therapeutic ultrasonic transducer system at a prospective treatment site that is within the displayed target area;

(d) initially energizing the therapeutic ultrasonic transducer system at a reduced energy level that is so as to produce a pulsed wave that is not energetic enough to produce a therapeutic effect at the treatment site, but is sufficiently energetic to produce a change in an echogenicity of tissue at the treatment site, a focal point of the therapeutic ultrasonic transducer system being visually apparent in the displayed target area visually represented on the display where the echogenicity of the tissue has thus been changed;

(e) moving the focal point of the therapeutic ultrasonic transducer system to a desired position on a blood vessel;

(f) increasing the energy level of the therapeutic ultrasonic transducer system to a therapeutic level to produce the therapeutic waves with sufficient energy to produce a lesion in the blood vessel at the focal point; and

(g) repeating steps (c) through (f) for treatment sites comprising each additional blood vessel from the plurality of blood vessels, until blood flow into the region is substantially terminated.

21. The method of claim 20, further comprising the step of:

(a) storing the visual representation of the focal point in the displayed target area for the position at which the therapeutic waves of the HIFU are being administered;

(b) reducing the energy level of the therapeutic ultrasonic transducer system to the reduced level of the pulsed wave after the desired therapeutic effect has been achieved at the focal point;

(c) moving the focal point of the therapeutic ultrasonic transducer system to a different desired position within the displayed target area to define a new treatment site, said focal point be visually apparent in the displayed target area due the change in the echogenicity caused by the reduced level of the pulsed wave at the new treatment site in relationship to the visual representation of the focal point stored in step (a) of this claim;

(d) energizing said therapeutic ultrasonic transducer system;

thereby producing the therapeutic waves of HIFU directed at the new treatment site; and

(e) repeating steps (a)-(d) of this claim until the therapeutic waves of HIFU have been administered to all desired treatment sites, the visual representation of all focal points on the display at which the therapeutic waves of the HIFU were previously administered enabling positions of each new treatment sites to be readily selected in relationship to previous treatment sites.

22. The method of claim 20, further comprising the step of monitoring the displayed target area to determine with the desired effect has been obtained at a current treatment site before administering the therapeutic waves of the HIFU to a new treatment site.

23. The method of claim 20, further comprising the step of processing the imaging data to effect at least one of:

a scan conversion processing, a color flow processing, a Doppler processing, a B-mode processing, and an M-mode processing.

24. The method of claim 20, wherein the target area is the reproductive system of a mamalian female, and the therapeutic waves of the HIFU are administered to the region to treat at least one of:

a uterine fibroid, an endometrial polyp, a follicular cyst, a polycystic ovary, a dermoid cyst, a corpus luteum cyst, an ectopic pregnancy, a cornual pregnancy, a multifetal pregnancy, a uterine AV malformation, an endometrial hyperplasia, an adenomyosis condition, an endometriosis condition, and an excessive bleeding condition.

25. The method of claim 20, wherein the probe has a size and shape adapted to be inserted through one of:

a vaginal canal, a rectum, an abdominal cavity, and a laparoscopic incision, further comprising the steps of;

(a) inserting the probe into an area of the body through which the probe is adapted to be inserted; and

(b) advancing the probe until the probe is adjacent to the target area.

26. The method of claim 20, wherein said therapeutic ultrasonic transducer system generates the therapeutic waves of the HIFU at frequencies within the range of 0.5 MHz to 10 MHz.

27. The method of claim 26, wherein said therapeutic ultrasonic transducer system generates the therapeutic waves of the HIFU at frequencies within the range of 3.4 MHz to 3.6 MHz.

28. The method of claim 20, wherein the therapeutic ultrasonic transducer system comprises a phased array of transducer elements that enable focusing of the therapeutic waves of the HIFU.

29. The method of claim 28, wherein the phased array of transducer elements are arranged in a concentric pattern.

30. The method of claim 20, wherein the therapeutic ultrasonic transducer system includes a vibrating element, further comprising the step of energizing the vibrating element to vibrate the therapeutic ultrasonic transducer system, so that a focal point of the therapeutic ultrasonic transducer system is varied.

31. The method of claim 30, wherein the step of energizing the vibrating element comprises causing the therapeutic ultrasonic transducer system to vibrate at a frequency in the range of from 1 to 50 Hz.

32. The method of claim 20, wherein the desired effect produced by causing lesions that occlude the plurality of blood vessels comprises one of a cauterization of tissue, a necrosis of tissue, and an ablation of tissue at the treatment site.

33. A method for treating a tumorous growth by damaging selected regions affecting a viability of the tumorous growth, comprising the steps of:

(a) providing;

(i) a scanning ultrasonic transducer system adapted to scan a target area and to produce imaging data for said target area;

(ii) a processor adapted to process said imaging data;

(iii) a display that is adapted to present a visual representation of said imaging data; and

(iv) a high intensity ultrasonic transducer system that is adapted to produce high intensity focused ultrasound (HIFU) capable of damaging tissue affecting the viability of the tumorous growth;

(b) positioning and energizing the scanning ultrasonic transducer system to continually produce an image of the target area on the display comprising a displayed target area;

(c) selecting a treatment site affecting the viability of the tumorous growth that is visually represented in the displayed target area;

(d) focusing pulsed HIFU produced by the high intensity ultrasonic transducer system on the treatment site that was selected to damage tissue affecting the viability of the tumorous growth;

(e) focusing the high intensity ultrasonic transducer system onto a different selected region affecting the viability of the tumorous growth; and

(f) repeating steps (d) through (e) until a desired pattern of damaged areas affecting the viability of the tumorous growth has been achieved, said desired pattern comprising less than all of the tumorous growth.

34. The method of claim 33, further comprising the step of monitoring a condition of each treatment site in the tumorous growth to determine when sufficient tissue has been damaged before moving to a new treatment site.

35. The method of claim 33, further comprising the step of repeating steps (a) to (f) at spaced-apart intervals of time, to enable any tissue in the tumorous growth that was destroyed by the HIFU to be removed by natural bodily processes, until the tumorous growth has been substantially eliminated.

36. The method of claim 33, further comprising the steps of:

(a) initially energizing the high intensity ultrasonic transducer system at a reduced energy level so as to produce a pulsed wave that is not energetic enough to damage the tissue at the treatment site, but is sufficiently energetic to produce a change in an echogenicity of the tissue at the treatment site, a focal point of the high intensity ultrasonic transducer system being visually apparent in the displayed target area visually represented on the display where the echogenicity of the tissue has thus been changed;

(b) moving the focal point of the high intensity ultrasonic transducer system within the displayed target area to a desired position; and

(c) increasing the energy level of the high intensity ultrasonic transducer system to a therapeutic level to produce therapeutic waves with sufficient energy to damage the tissue of the tumorous growth at the focal point.

37. The method of claim 33, further comprising the step of de-energizing the high intensity ultrasonic transducer if the displayed target area shows that an undesired change has taken place to tissue in the target area, even if a desired level of damage to tissue within the tumorous growth has not yet been achieved.

38. The method of claim 33, further comprising the step of processing the imaging data comprises to effect at least one of:

a color flow processing, a Doppler processing, a B-mode processing, and an M-mode processing.

39. The method of claim 33, wherein the target area includes the reproductive system of a ma alian female, and wherein the tumorous growth is one of a uterine fibroid, an endometrial polyp, a follicular cyst, a polycystic ovary, a dermoid cyst, and a corpus luteum cyst.

40. The method of claim 33, further comprising the step of providing a probe incorporating both the scanning ultrasonic transducer system and the high intensity ultrasonic transducer system having a size and shape adapted to be inserted through one of a vaginal canal, a rectum, an abdominal cavity, and a laparoscopic incision.

41. The method of claim 33, wherein said high intensity ultrasonic transducer system generates the therapeutic waves of the HIFU at frequencies within the range of 0.5 MHz to 10 MHz.

42. The method of claim 36, further providing a blood soluble material that has a high vapor pressure, and further comprising the step of administering the blood soluble material to the treatment site before initially energizing the therapeutic ultrasonic transducer system at a reduced energy level, such that bubbles produced by the interaction of the blood soluble material and the therapeutic wave at a focal point of the therapeutic wave are detected by the scanning ultrasonic transducer system.

43. The method of claim 33, wherein the damage to tissue within the tumorous growth is achieved by causing one of:

cauterization of the tissue, necrosis of the tissue, and ablation of the tissue.

44. The method of claim 35, wherein macrophages remove the tissue that was destroyed from the tumorous growth.

45. A system for simultaneously using ultrasound for both imaging and therapeutic purposes, enabling a lesion to be produced in a blood vessel to occlude blood flow, comprising:

(a) an ultrasonic scanning transducer disposed on a probe, said ultrasonic scanning transducer being adapted to generate an ultrasonic scanning wave and to receive the ultrasonic scanning wave after it is reflected from a target area in a patient'"'"'s body, producing a signal that is useful for deriving imaging data for the target area;

(b) a processor electrically coupled to the scanning ultrasonic transducer system capable to receive the signal, said processor processing the signal to produce the imaging data;

(c) a display electrically coupled to the processor, said display presenting a visual representation of the imaging data;

(d) a therapeutic ultrasonic transducer disposed on the probe and adapted to generate a pulsed high intensity focused ultrasonic (HIFU) therapeutic wave directed at a treatment site within the target area;

(e) a control circuit electrically coupled to the therapeutic ultrasonic transducer system that synchronizes generation of the pulsed HIFU therapeutic wave relative to the ultrasonic scanning wave produced by the scanning ultrasonic transducer system, such that any noise within the imaging data arising from the pulsed HIFU therapeutic wave is shifted within the visual representation of the imaging data appear outside the treatment site, said control circuit providing sufficient energy to the therapeutic ultrasound transducer to cause a lesion in a blood vessel that is included in the visual representation of the target area, so that blood flow through the blood vessel to a region is occluded by the lesion; and

(f) a power supply electrically coupled to supply an electrical current to energize the scanning ultrasonic transducer system, the therapeutic ultrasonic transducer system and the control circuit.

46. The system of claim 45, wherein the processor processes the signal to effect at least one of:

a color flow processing, a Doppler processing, a B-mode processing, and an M-mode processing, said processor storing a portion of the imaging data that defines each position at which the pulsed HIFU therapeutic wave was focused on the treatment site.

47. The system of claim 45, wherein the target area is the reproductive system of a mamalian female.

48. The system of claim 47, wherein the pulsed HIFU therapeutic wave therapeutic wave is employed to treat one of:

a uterine fibroid, an endometrial polyp, a follicular cyst, a polycystic ovary, a dermoid cyst, a corpus luteum cyst, an ectopic pregnancy, a cornual pregnancy, a multifetal pregnancy, a uterine malformation, an endometrial hyperplasia, an adenomyosis condition, an endometriosis condition, and an excessive bleeding condition.

49. The system of claim 45, wherein the probe has a size and shape adapting it to being inserted into and manipulated within in a human vaginal canal.

50. The system of claim 49, wherein the probe comprises a handle having the ultrasonic scanning transducer and the therapeutic ultrasonic transducer mounted on a distal end of the handle.

51. The system of claim 50, wherein the therapeutic transducer is mounted to the handle with a pivot joint, enabling a disposition of the transducer relative to the handle to be adjusted by manipulating the therapeutic transducer about the pivot joint.

52. The system of claim 50, wherein the therapeutic transducer includes a fluid filled cavity that couples ultrasonic wave emitted by the therapeutic transducer to the treatment site.

53. The system of claim 45, wherein probe has a size and shape adapting it to being inserted into and manipulated within a human rectum.

54. The system of claim 45, wherein the therapeutic ultrasonic transducer generates frequencies within the range of 0.5 MHz to 10 MHz.

55. The system of claim 45, wherein the therapeutic ultrasonic transducer generates frequencies within the range of 3.4 MHz to 3.6 MHz.

56. The system of claim 45, wherein the therapeutic ultrasonic transducer comprises a phased array of transducer elements that enables a focal point of the therapeutic ultrasonic transducer to be selectively varied.

57. The system of claim 56, wherein the phased array of transducer elements is configured in a concentric pattern.

58. The system of claim 45, wherein the therapeutic ultrasonic transducer system comprises a vibrating element that when energized causes a focal point of the therapeutic ultrasonic transducer system to be randomly varied within the target area.

59. The system of claim 58, wherein the vibrating element vibrates with a frequency in the range of 1 to 5 Hz, variation of the focal point preventing undesired heating of tissue not associated with the treatment site.

60. The system of claim 58, wherein the vibrating element vibrates with a frequency in the range of 10 to 50 Hz and increases an amount of energy applied to the treatment site while avoiding undesired cavitational effects.

61. A probe for administering ultrasound therapy from within a vaginal canal of a patient, said therapy being administered to a treatment site within the patient'"'"'s body and outside the vaginal canal, comprising:

(a) an elongate supporting structure having a distal end and a proximal end, said elongate supporting structure including a section at its proximal end that is adapted to be grasped and manipulated by a clinician to at least initially position the elongate supporting structure at a desired location within the vaginal canal of the patient;

(b) an imaging transducer disposed at the distal end of the elongate supporting structure, said imaging transducer being adapted to emit ultrasound imaging pulses when excited by an imaging signal for use in producing an image of a target area in the patient'"'"'s body;

(c) a high intensity focused ultrasound (HIFU) transducer disposed at the distal end of the elongate supporting structure, proximate to the imaging transducer and sized and shaped to fit within the vaginal canal, said HIFU transducer having an aperture through which HIFU waves are transmitted, said aperture being of a sufficient size to produce therapeutic HIFU waves, so that the therapeutic HIFU waves have sufficient intensity remaining upon reaching the treatment site after being attenuated by their passage through up to 6 cm of intervening tissue, to achieve a desired therapeutic effect, while said therapeutic HIFU waves do not have so much intensity when emitted by the HIFU transducer as to damage adjacent tissue through which the therapeutic HIFU waves initially propagate toward the treatment site; and

(d) means for directing the therapeutic HIFU waves at the treatment site within the target area, said HIFU transducer being energized to render the HIFU therapy while the imaging transducer is energized to provide a signal for imaging the target area.

62. The probe of claim 61, wherein a maximum circumference of the aperture of the HIFU transducer, measured in a plane that is generally transverse to a longitudinal axis of the elongate supporting structure, is about 10.6 cm.

63. The probe of claim 61, wherein the desired therapeutic effect produced at the treatment site by the therapeutic HIFU waves comprises at least one of the following:

(a) damage to undesired tissue;

(b) hemostasis of a blood vessel;

(c) necrosis of undesired tissue;

(d) ablation of undesired tissue; and

(e) obstruction of a blood vessel.

64. A method for using ultrasound to simultaneously image a target area and to provide therapy to a treatment site disposed within said target area, thereby inducing a therapeutic effect at the target area, comprising the steps of:

(a) disposing a device incorporating both a scanning ultrasonic transducer and a therapeutic ultrasonic transducer generally adjacent to the treatment site;

(b) energizing the scanning ultrasonic transducer to continually scan the target area to produce imaging data;

(c) displaying a visual representation of the imaging data to the user on a display to produce a displayed target area;

(d) selecting the treatment site from within the displayed target;

(e) energizing the therapeutic ultrasonic transducer to produce pulses of high intensity focused ultrasound (HIFU) therapeutic waves, generally directed toward the treatment site;

(f) synchronizing the HIFUF therapeutic waves relative to the imaging waves produced by the scanning ultrasonic transducer, such that noise in the imaging data arising from the therapeutic waves is displayed in a specific portion of the displayed target area; and

(g) enabling a user to shift the noise arising from the HIFU therapeutic waves that is displayed in the specific portion of the displayed target area to a different portion of the displayed target area, so that the noise arising from the HIFU therapeutic waves can be moved to a portion of the displayed target area that does not correspond to the treatment site, thereby enabling the treatment site to be observed in real time as the HIFU therapeutic waves are administered to the treatment site.

65. The method of claim 64, further comprising the step of enabling a user to adjust a duration of each pulse of HIFU therapeutic waves, to ensure that the duration of each pulse of HIFU therapeutic waves is not so great as to overwhelm the imaging data used to generate the visual representation.

66. A system for simultaneously using ultrasound for both imaging and therapeutic purposes, in which noise arising from ultrasonic therapeutic waves that is included in an image generated by ultrasonic scanning waves can be selectively positioned within the image, thereby allowing the noise to be moved to a portion of the image not corresponding to a treatment site in the image, comprising:

(a) an ultrasonic scanning transducer disposed on a probe, said ultrasonic scanning transducer being adapted to generate the ultrasonic scanning waves, and to receive the ultrasonic scanning waves after they are reflected from a target area in a patient'"'"'s body, producing a signal that is useful for deriving imaging data for the target area;

(b) an ultrasound imaging machine electrically coupled to the scanning ultrasonic transducer system, said ultrasound imaging machine comprising;

(i) a processor that receives and processes the signal to produce the imaging data; and

(ii) a display electrically coupled to the processor, the display using the imaging data to generate the image;

(c) a therapeutic ultrasonic transducer disposed on the probe and adapted to generate pulses of high intensity focused ultrasound (HIFU) therapeutic waves directed at the treatment site, wherein the treatment site is significantly smaller than a scanned area displayed in the image, said treatment site also being displayed in the image;

(d) means for synchronizing a generation of the pulses of HIFU relative to the ultrasonic scanning waves produced by the scanning ultrasonic transducer, said means being electrically coupled to the therapeutic ultrasonic transducer and causing the noise arising from the pulses of HIFU to be displayed in a first portion of the image;

(e) a synchronization delay control electrically coupled to the means for synchronizing, said synchronization delay control enabling a user to cause the noise in the image to be displayed in a second portion of the image; and

(f) a power supply electrically coupled to supply an electrical current to energize the scanning ultrasonic transducer, the therapeutic ultrasonic transducer, the ultrasound imaging machine, the means for synchronizing, and the synchronization delay control.

67. The system of claim 66, further comprising a HIFU duration control electrically coupled to the therapeutic ultrasonic transducer, said HIFU duration control enabling a user to manipulate a duration of each pulse of HIFU, thereby enabling the noise in the image from the pulses of HIFU be displayed in a portion of the image that is variable in size.

68. The system of claim 66, wherein said means for synchronizing comprises a stable synchronization generator electrically coupled to the therapeutic ultrasonic transducer.

69. The system of claim 66, wherein said means for synchronizing comprises the processor, the processor being adapted to generate a synchronization output signal and being electrically coupled to the therapeutic ultrasonic transducer to provide the synchronization output signal to the therapeutic ultrasonic transducer.

70. A system for simultaneously using ultrasound for both imaging and therapeutic purposes, in which noise arising from ultrasonic therapeutic waves that is included in an image generated in response to ultrasonic scanning waves can be selectively positioned within the image, thereby enabling the noise to be moved to a portion of the image not corresponding to a treatment site, comprising:

(a) an scanning ultrasonic transducer disposed on a probe, said scanning ultrasonic transducer being adapted to generate the ultrasonic scanning waves, and to receive the ultrasonic scanning waves after they are reflected from a target area in a patient'"'"'s body, producing a signal that is useful for deriving imaging data for the target area;

(b) a processor electrically coupled to the scanning ultrasonic transducer, said processor receiving and processing the signal to produce the imaging data;

(c) a display electrically coupled to the processor, the processor using the imaging data to generate the image on the display;

(d) a therapeutic ultrasonic transducer disposed on the probe and adapted to generate pulses of high intensity focused ultrasound (HIFU) therapeutic waves directed at the treatment site, wherein the treatment site is significantly smaller than a scanned area displayed in the image, and wherein the treatment site is also displayed in the image;

(e) a synchronizer capable of synchronizing a generation of the pulses of HIFU therapeutic waves relative to the ultrasonic scanning waves produced by the scanning ultrasonic transducer, said synchronizer electrically coupled to the therapeutic ultrasonic transducer, said synchronizer causing the noise arising from the pulses of HIFU therapeutic waves to be displayed in a first portion of the image;

(f) a synchronization delay control electrically coupled to the synchronizer, said synchronization delay control enabling a user to adjust said synchronizer, thereby causing the noise in the image to be displayed in a second portion of the image; and

(g) a power supply electrically coupled to supply an electrical current to energize the scanning ultrasonic transducer, the therapeutic ultrasonic transducer, the ultrasound imaging machine, the synchronizer, and the synchronization delay control.

71. The system of claim 70, further comprising a HIFU duration control electrically coupled to the therapeutic ultrasonic transducer, said HIFU duration control enabling a user to vary a duration of the pulses of HIFU therapeutic waves, thereby enabling the noise in the image from the pulse of HIFU therapeutic waves be displayed in a portion of the image having a variable size.

72. The system of claim 70, wherein said synchronizer comprises a stable synchronization generator electrically coupled to the therapeutic ultrasonic transducer.

73. The system of claim 70, wherein said synchronizer comprises the processor, the processor being adapted to generate a synchronization output signal and being electrically coupled to the therapeutic ultrasonic transducer to provide the synchronization output signal to the therapeutic ultrasonic transducer.

74. A probe for administering ultrasound therapy from within a vaginal canal of a patient, said therapy being administered to a treatment site within the patient'"'"'s body and outside the vaginal canal, comprising:

(a) an elongate supporting structure having a distal end and a proximal end, said elongate supporting structure including a section at its proximal end that is adapted to be grasped and manipulated to at least initially position the elongate supporting structure at a desired location within a vaginal canal of a patient, said distal end comprising a minimum transverse dimension of about 4.5 cm, and a maximum transverse dimension of about 6 cm;

(b) an imaging transducer disposed at the distal end of the elongate supporting structure, said imaging transducer being adapted to emit ultrasound imaging pulses when excited by an imaging signal for use in producing an image of a target area in a patient'"'"'s body;

(c) a high intensity focused ultrasound (HIFU) transducer disposed at the distal end of the elongate supporting structure, proximate to the imaging transducer and sized and shaped to fit within a vaginal canal, said HIFU transducer having an aperture through which HIFU waves are transmitted, said aperture comprising;

(i) a relative aperture between about 1.25 and about 1.75; and

(ii) at least one axis comprising a minimum transverse dimension of about 4.5 cm; and

(d) means for directing the therapeutic HIFU waves at the treatment site within the target area, said HIFU transducer being energized to render the HIFU therapy while the imaging transducer is energized to provide a signal for imaging the target area.

75. A probe for administering ultrasound therapy from within a vaginal canal of a patient, said therapy being administered to a treatment site within a patient'"'"'s body and outside the vaginal canal, comprising:

(a) an elongate supporting structure having a distal end and a proximal end, said elongate supporting structure including a section at its proximal end that is adapted to be grasped and manipulated to at least initially position the elongate supporting structure at a desired location within a vaginal canal of a patient;

(b) a generally paddle shaped head disposed at said distal end of the elongate supporting structure, said generally paddle shaped head being sized and shaped to fit within a vaginal canal, said generally paddle shaped head having a minimum transverse dimension of about 4.5 cm, and a maximum transverse dimension of about 6 cm, said generally paddle shaped head being independently positionable relative to said elongate supporting structure;

(c) an imaging transducer disposed on said generally paddle shaped head, said imaging transducer being adapted to emit ultrasound imaging pulses when excited by an imaging signal for use in producing an image of a target area in a patient'"'"'s body;

(d) a high intensity focused ultrasound (HIFU) transducer disposed on said generally paddle shaped head, proximate to the imaging transducer, said HIFU transducer having an aperture through which HIFU waves are transmitted, said aperture comprising a relative aperture of between about 1.0 and about 1.75, and

(e) means for directing the therapeutic HIFU waves at the treatment site within the target area, said HIFU transducer being energized to render the HIFU therapy while the imaging transducer is energized to provide a signal for imaging the target area.