Image guided high intensity focused ultrasound device for therapy in obstetrics and gynecology Number:7,520,856 from the United States Patent and Trademark Office (PTO) owispatent A frame ensures that the alignment between a high intensity focused ultrasound (HIFU) transducer designed for vaginal use and a commercially available ultrasound image probe is maintained, so that the HIFU focus remains in the image plane during HIFU therapy. A water-filled membrane placed between the HIFU transducer and the treatment site provides acoustic coupling. The coupling is evaluated to determine whether any air bubbles exist at the coupling interface, which might degrade the therapy provided by the HIFU transducer. HIFU lesions on tissue appear as hyperechoic spots on the ultrasound image in real time during application of HIFU therapy. Ergonomic testing in humans has demonstrated clear visualization of the HIFU transducer relative to the uterus and showed the potential for the HIFU transducer to treat fibroids from the cervix to the fundus through the width of the uterus.<H gynecology, obstetrics, Image, guided, hi, 7520856.html, Patent, pto, 7520856

Title: Image guided high intensity focused ultrasound device for therapy in obstetrics and gynecology

Abstract: A frame ensures that the alignment between a high intensity focused ultrasound (HIFU) transducer designed for vaginal use and a commercially available ultrasound image probe is maintained, so that the HIFU focus remains in the image plane during HIFU therapy. A water-filled membrane placed between the HIFU transducer and the treatment site provides acoustic coupling. The coupling is evaluated to determine whether any air bubbles exist at the coupling interface, which might degrade the therapy provided by the HIFU transducer. HIFU lesions on tissue appear as hyperechoic spots on the ultrasound image in real time during application of HIFU therapy. Ergonomic testing in humans has demonstrated clear visualization of the HIFU transducer relative to the uterus and showed the potential for the HIFU transducer to treat fibroids from the cervix to the fundus through the width of the uterus.

Patent Number: 7,520,856 Issued on 04/21/2009 to Vaezy, et al.

Inventors: Vaezy; Shahram (Seattle, WA), Chan; Arthur H. (Plano, TX), Fujimoto; Victor Y. (San Francisco, CA), Moore; Donald E. (Seattle, WA), Martin; Roy W. (Anacortes, WA)
Assignee: University of Washington (Seattle, WA)

Appl. No.: 10/977,339

Filed: October 29, 2004

Related U.S. Patent Documents


Application Number	Filing Date	Patent Number	Issue Date
10770350	Feb., 2004
10166795	Jun., 2002	6716184
09397471	Sep., 1999	6425867
60516099	Oct., 2003

Current U.S. Class: 600/439 ; 600/459; 601/3

Current International Class: A61B 8/00 (20060101); A61N 7/00 (20060101)

Field of Search: 600/437,439,459 601/2-4

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Primary Examiner: Jaworski; Francis J.
Attorney, Agent or Firm: Anderson; Ronald M.

Government Interests

GOVERNMENT RIGHTS

This invention was funded at least in part with grants (No. N00014-01-G-0460 and N00014-01-96-0630) from the Department of the Navy, and from a grant (No. 2 R42 HD38440-02) from the National Institutes of Health, and the U.S. government may have certain rights in this invention.

Parent Case Text

RELATED APPLICATIONS

This application is based on a prior provisional application Ser. No. 60/516,099, filed on Oct. 31, 2003, the benefit of the filing date of which is hereby claimed under 35 U.S.C. .sctn. 119(e). Further, this application is a continuation-in-part application of prior copending application Ser. No. 10/770,350, filed on Feb. 2, 2004, which itself is a continuation-in-part application of prior application Ser. No. 10/166,795, filed on Jun. 7, 2002 and now issued as U.S. Pat. No. 6,716,184, which itself is a divisional application of prior application Ser. No. 09/397,471, filed on Sep. 17, 1999 and now issued as U.S. Pat. No. 6,425,867, the benefit of the filing dates of which is hereby claimed under 35 U.S.C. .sctn. 120.

Claims

The invention in which an exclusive right is claimed is defined by the following:

1. A method for using ultrasound imaging to guide high intensity focused ultrasound (HIFU) to provide therapy to a treatment site associated with a patient, comprising the steps of: (a) positioning an ultrasound imaging transducer at a first location selected to enable an ultrasound image of the treatment site to be obtained; (b) positioning a HIFU transducer at a second location selected to enable a focal point of the HIFU transducer to be directed toward the treatment site; (c) generating an image of the treatment site using the ultrasound imaging transducer; (d) energizing the HIFU transducer at a power level selected such that no therapeutic effect is experienced by tissue exposed to the focal point of the HIFU transducer, while the imaging transducer generates an image of the treatment site; (e) determining if the focal point of the HIFU transducer can be visualized in the image generated by the imaging transducer, and if not, manipulating the position of at least one of the ultrasound imaging transducer and the HIFU transducer until the focal point of the HIFU transducer can be visualized in the image generated by the imaging transducer; (f) fixing a spatial relationship and orientation between the ultrasound imaging transducer and the HIFU transducer, using a frame, thereby ensuring that subsequent movement of the ultrasound imaging transducer, the HIFU transducer, or the patient will not change the spatial orientation between the ultrasound imaging transducer and the HIFU transducer, the frame comprising: (i) a first bracket configured to selectively pivotably support an imaging probe including the imaging transducer; and (ii) a second bracket configured to movably support a therapy probe including the HIFU transducer; and (g) energizing the HIFU transducer at a power level sufficient to achieve the desired therapy, such that the HIFU transducer is synchronized relative to the ultrasound imaging transducer so that any noise in the image arising from energizing the HIFU transducer is shifted away from a disposition of the treatment site in the image.

2. The method of claim 1, wherein the step of fixing a spatial relationship and orientation between the ultrasound imaging transducer and the HIFU transducer further comprises the steps of tracking and displaying the spatial relationship and orientation between the ultrasound imaging transducer and the HIFU transducer, to provide feedback that a clinician can use to keep the spatial relationship and orientation properly aligned.

3. The method of claim 1, wherein at least a portion of the HIFU transducer is encapsulated in a liquid-filled flexible membrane, and wherein the step of positioning the HIFU transducer at the second location comprises the step of positioning the HIFU transducer adjacent to a tissue mass, such that the liquid-filled flexible membrane substantially conforms to a surface of the tissue mass, thereby ultrasonically coupling the HIFU transducer with the tissue mass.

4. The method of claim 3, wherein before the step of energizing the HIFU transducer at the power level sufficient to achieve the desired therapy, further comprising the step of determining whether any air bubbles exist at the interface between the liquid-filled flexible membrane and the surface of the tissue mass, and if so, dislodging any such air bubbles.

5. The method of claim 3, wherein the step of dislodging any such air bubbles comprises the step of repositioning the HIFU transducer.

6. The method of claim 3, wherein the step of dislodging any such air bubbles comprises the step of changing a volume of liquid in the liquid-filled flexible membrane.

7. The method of claim 3, wherein the step of dislodging any such air bubbles comprises the step of flushing the interface with a liquid.

8. The method of claim 1, wherein the step of positioning the ultrasound imaging transducer at the first location comprises the step of positioning the ultrasound imaging transducer externally of the patient.

9. The method of claim 1, wherein the step of positioning the HIFU transducer at the second location comprises the step of positioning the HIFU transducer externally of the patient.

10. The method of claim 9, wherein the step of positioning the ultrasound imaging transducer at the first location comprises the step of positioning the ultrasound imaging transducer externally of the patient.

11. The method of claim 1, wherein the step of positioning the ultrasound imaging transducer at the first location comprises the step of positioning the ultrasound imaging transducer adjacent to the patient'abdomen, and the step of positioning the HIFU transducer at the second location comprises the step of positioning the HIFU transducer within the patient'vaginal canal.

12. The method of claim 1, wherein the step of manipulating the position of at least one of the ultrasound imaging transducer and the HIFU transducer until the focal point of the HIFU transducer can be visualized in the image generated by the imaging transducer comprises the step of keeping a main body of a probe to which the HIFU transducer is attached in a fixed position, while moving the HIFU transducer.

13. The method of claim 1, wherein the step of manipulating the position of at least one of the ultrasound imaging transducer and the HIFU transducer until the focal point of the HIFU transducer can be visualized in the image generated by the imaging transducer comprises the step of pivoting at least one of the ultrasound imaging transducer and the HIFU transducer relative to the frame configured to maintain a spatial relationship and orientation between the HIFU transducer and the imaging transducer.

14. The method of claim 1, further comprising the step of moving a position of the focal point of the HIFU transducer relative to the treatment site, to provide therapy to a different portion of the treatment site, by moving the HIFU transducer while keeping a main body of a probe to which the HIFU transducer is attached in a fixed position.

15. A method for using ultrasound imaging to guide high intensity focused ultrasound (HIFU) to provide therapy to a treatment site associated with a patient, comprising the steps of: (a) positioning an ultrasound imaging transducer at a first location selected to enable an ultrasound image of the treatment site to be obtained; (b) positioning a HIFU transducer at a second location selected to enable a focal point of the HIFU transducer to be aimed toward the treatment site; (c) generating an image of the treatment site using the ultrasound imaging transducer; (d) energizing the HIFU transducer at a power level selected such that no therapeutic effect is experienced by tissue exposed to the focal point of the HIFU transducer, while the imaging transducer generates an image of the treatment site; (e) determining if the focal point of the HIFU transducer can be visualized in the image generated by the imaging transducer, and if not, pivoting at least one of the ultrasound imaging transducer and the HIFU transducer relative to a frame configured to maintain a spatial relationship and orientation between the HIFU transducer and the imaging transducer, until the focal point of the HIFU transducer can be visualized in the image generated by the imaging transducer; (f) mechanically fixing a then current spatial relationship and orientation between the ultrasound imaging transducer and the HIFU transducer, using the frame, thereby ensuring that subsequent movement of the ultrasound imaging transducer, the HIFU transducer, or the patient will not change the spatial orientation between the ultrasound imaging transducer and the HIFU transducer, the frame comprising: (i) a first bracket configured to selectively pivotably support an imaging transducer; and (ii) a second bracket configured to movably support a HIFU transducer; and (g) energizing the HIFU transducer at a power level sufficient to achieve the desired therapy.

16. The method of claim 15, wherein before energizing the HIFU transducer at the power level sufficient to achieve the desired therapy, further comprising the step of determining whether any air bubbles exist in an interface provided by a liquid-filled flexible membrane coupling the HIFU transducer to a tissue mass, and if so, dislodging any such air bubbles.

17. The method of claim 16, wherein the step of dislodging any such air bubbles comprises at least one of the following steps: (a) changing a volume of liquid in the liquid-filled flexible membrane; (b) flushing the interface with a liquid; and (c) repositioning the HIFU transducer.

18. The method of claim 15, wherein at least one of the following is true: (a) the step of positioning the ultrasound imaging transducer at the first location comprises the step of positioning the ultrasound imaging transducer externally of the patient; (b) the step of positioning the HIFU transducer at the second location comprises the step of positioning the HIFU transducer externally of the patient; and (c) the step of energizing the HIFU transducer to at a power level sufficient to achieve the desired therapy comprises the step of synchronizing the HIFU transducer relative to the ultrasound imaging transducer so that any noise in the image arising from energizing the HIFU transducer is shifted away from the treatment site in the image.

19. A method for using ultrasound imaging to guide high intensity focused ultrasound (HIFU) to provide therapy to a treatment site associated with a patient, comprising the steps of: (a) positioning an ultrasound imaging transducer at a first location selected to enable an ultrasound image of the treatment site to be obtained; (b) positioning a HIFU transducer at a second location selected to enable a focal point of the HIFU transducer to be aimed toward the treatment site; (c) generating an image of the treatment site using the ultrasound imaging transducer; (d) energizing the HIFU transducer at a power level selected such that no therapeutic effect is experienced by tissue exposed to the focal point of the HIFU transducer, while the imaging transducer generates an image of the treatment site; (e) determining if the focal point of the HIFU transducer can be visualized in the image generated by the imaging transducer, and if not, manipulating the position of at least one of the ultrasound imaging transducer and the HIFU transducer until the focal point of the HIFU transducer can be visualized in the image generated by the imaging transducer; (f) mechanically fixing a then current spatial relationship and orientation between the ultrasound imaging transducer and the HIFU transducer, using a frame, thereby ensuring that subsequent movement of the ultrasound imaging transducer, the HIFU transducer, or the patient will not change the spatial orientation between the ultrasound imaging transducer and the HIFU transducer, the frame comprising: (i) a first bracket configured to selectively pivotably support an imaging probe including the imaging transducer; and (ii) a second bracket configured to movably support a therapy probe including the HIFU transducer; (g) energizing the HIFU transducer at a power level sufficient to achieve the desired therapy; and (h) wherein at least one of the following is true: (i) the step of positioning the ultrasound imaging transducer at the first location comprises the step of positioning the ultrasound imaging transducer externally of the patient; (ii)the step of positioning the HIFU transducer at the second location comprises the step of positioning the HIFU transducer externally of the patient; (iii) the step of manipulating the position of at least one of the ultrasound imaging transducer and the HIFU transducer until the focal point of the HIFU transducer can be visualized in the image generated by the imaging transducer comprises the step of pivoting at least one of the ultrasound imaging transducer and the HIFU transducer relative to the frame configured to maintain the spatial relationship and orientation between the HIFU transducer and the imaging transducer; and (iv) the step of energizing the HIFU transducer to at a power level sufficient to achieve the desired therapy comprises the step of synchronizing the HIFU transducer relative to the ultrasound imaging transducer so that any noise in the image arising from energizing the HIFU transducer is shifted away from the treatment site in the image.

20. A medical device support frame configured to fix a spatial relationship and orientation between an ultrasound imaging probe and an ultrasound therapy probe when the ultrasound imaging probe and the ultrasound therapy probe are positioned relative to a patient, thereby ensuring that once at least one of the ultrasound imaging probe and the ultrasound therapy probe has been adjusted so that a focal point of the ultrasound therapy probe is visualized in an imaging plane of the ultrasound imaging probe, subsequent movement of the ultrasound imaging probe, the ultrasound therapy probe, or the patient will not change the spatial orientation between the ultrasound imaging probe and the ultrasound therapy probe, the frame comprising: (a) a first medical device support bracket adapted to selectively pivotably support an imaging probe that is disposed external to a patient's body; (b) a second medical device support bracket adapted to movably support a therapy probe that is disposed internal to a patient's body; (c) a first generally elongate support, pivotably coupled to the first medical device support bracket; (d) a second generally elongate support, movably coupled with the second medical device support bracket; and (e) a common bracket, slidingly engaging the first and second generally elongate supports, such that the medical device support frame does not need to be coupled to a fixed object in order to fix the spatial relationship and orientation between the imaging probe and the therapy probe relative to each other, thereby enabling a self-referencing medical device support frame to be achieved.

21. The frame of claim 20, wherein the second medical device support bracket is pivotably coupled to the second generally elongate support.

22. The frame of claim 21, further comprising a common support, the first and second generally elongate supports independently slidingly engaging the common support.

23. The frame of claim 22, wherein the common support is hinged, to enable a spatial relationship between the first and second generally elongate supports to be changed.

24. The frame of claim 20, wherein the common bracket includes an orifice that is configured to slidingly engage one of the first and second generally elongate supports.

25. The frame of claim 20, wherein the common bracket comprises a channel configured to slidingly engage one of the first and second generally elongate supports.

26. The frame of claim 20, wherein the second generally elongate support includes an angled bend so that the second generally elongate support is not straight.

27. The frame of claim 20, wherein the second generally elongate support includes a channel.

28. The frame of claim 20, wherein the first generally elongate support can be translated generally normal to the second generally elongate support.

29. A medical device support frame adapted to fix a spatial relationship and orientation between an ultrasound imaging probe and an ultrasound therapy probe when the ultrasound imaging probe and the ultrasound therapy probe are positioned as desired relative to a patient, thereby ensuring that once a focal point of the ultrasound therapy probe is visualized in an imaging plane of the ultrasound imaging probe, subsequent movement of the ultrasound imaging probe, the ultrasound therapy probe, or the patient does not change the spatial relationship and orientation between the ultrasound imaging probe and the ultrasound therapy probe, the frame comprising: (a) a first medical device support bracket adapted to support an imaging probe that is disposed external to a patient's body, the first medical device support bracket being pivotably coupled to a first generally elongate support and being adapted to be coupled to the imaging probe such that the imaging probe can be pivoted about a longitude axis of the first generally elongate support; and (b) a second medical device support bracket adapted to movably support a therapy probe that is disposed internal to a patient's body, such that the first generally elongate support can be translated in a direction generally normal to a second generally elongate support.

30. The frame of claim 29, wherein the second medical device support bracket is configured to slidingly engage the therapy probe including a generally elongate main body.

31. The frame of claim 29, further comprising a third bracket, the first and second generally elongate supports slidingly engaging the third bracket.

32. The frame of claim 31, wherein the third bracket comprises an orifice that is configured to slidingly engage one of the first and second generally elongate supports.

33. The frame of claim 31, wherein the first generally elongate support comprises a pair of parallel arms, and the third bracket comprises a pair of channels configured to slidingly engage the pair of parallel arms.

34. A system configured to be used with an ultrasound imaging probe to enable ultrasound imaging to guide high intensity focused ultrasound (HIFU) to provide therapy to a treatment site, the system comprising: (a) a therapy probe comprising a HIFU transducer; and (b) a medical device support frame adapted to selectively fix a spatial orientation between an ultrasound imaging probe and the therapy probe, thereby ensuring that after the frame, the therapy probe, and an ultrasound imaging probe are properly positioned relative to a patient so that a focal point of the therapy probe is visualized in an imaging plane of an ultrasound imaging probe, subsequent movement of an ultrasound imaging probe, the therapy probe, or the patient does not change the spatial orientation between an ultrasound imaging probe and the therapy probe, the frame comprising: (i) a first medical device support bracket adapted to support the imaging probe that is disposed external to a patient's body, the first medical device support bracket being pivotably coupled to a first generally elongate support and being adapted to be coupled to the imaging probe such that the imaging probe can be pivoted about a longitudinal axis of the first generally elongate support; and (ii) a second medical device support bracket adapted to movably support the therapy probe that is disposed internal to a patient's body.

35. The system of claim 34, wherein the HIFU transducer comprises at least one of the following: (a) an air backed piezoceramic crystal coupled to an aluminum lens element; and (b) a generally spooned-shaped transducer comprising a plurality of discrete emitter elements, each emitter element having a substantially equivalent area.

36. The system of claim 34, wherein the therapy probe further comprises: (a) a generally elongate body, the HIFU transducer being disposed proximate a distal end of the generally elongate body; (b) a flexible membrane substantially encapsulating the distal end of the generally elongate body, the flexible membrane being configured to be inflated with a liquid when the distal end of the generally elongate body is disposed adjacent to a tissue mass, such that the flexible membrane will substantially conform to the tissue mass, thereby coupling the HIFU transducer to the tissue mass; and (c) an imaging element configured to enable an interface between the flexible membrane and the tissue mass to be examined, to determine whether any air bubbles are present at the interface.

37. The system of claim 36, wherein the therapy probe comprises a liquid flushing line configured to discharge a flushing liquid proximate the flexible membrane, to dislodge any air bubbles that could interfere with a HIFU beam generated by the HIFU transducer.

38. The system of claim 36, wherein the imaging element comprises an optical fiber.

39. The system of claim 36, wherein the imaging element comprises a digital imaging device.

40. The system of claim 34, wherein the frame is configured such that the first generally elongate support can be translated generally normal to the second generally elongate support.

41. A method for using ultrasound imaging to guide high intensity focused ultrasound (HIFU) to provide therapy to a treatment site associated with a patient; comprising the steps of: (a) positioning an ultrasound imaging transducer at a first location selected to enable an ultrasound image of the treatment site to be obtained; (b) positioning a HIFU transducer at a second location selected to enable a focal point of the HIFU transducer to be directed toward the treatment site; (c) generating an image of the treatment site using the ultrasound imaging transducer; (d) energizing the HIFU transducer at a power level selected such that no therapeutic effect is experienced by tissue exposed to the focal point of the HIFU transducer, while the imaging transducer generates an image of the treatment site; (e) determining if the focal point of the HIFU transducer can be visualized in the image generated by the imaging transducer, and if not, manipulating the position of at least one of the ultrasound imaging transducer and the HIFU transducer until the focal point of the HIFU transducer can be visualized in the image generated by the imaging transducer; (f) tracking and displaying the spatial relationship and orientation between the ultrasound imaging transducer and the HIFU transducer, to provide feedback that a clinician can use to keep the spatial relationship and orientation properly aligned; (g) when the spatial relationship and orientation of the ultrasound imaging transducer and the HIFU transducer are properly aligned, mechanically fixing that spatial relationship and orientation using a frame, thereby ensuring that subsequent movement of the ultrasound imaging transducer, the HIFU transducer, or the patient will not change the spatial orientation between the ultrasound imaging transducer and the HIFU transducer, the frame comprising: (i) a first bracket configured to selectively pivotably support an imaging probe including the imaging transducer; and (ii) a second bracket configured to movably support a therapy probe including the HIFU transducer; and (h) energizing the HIFU transducer at a power level sufficient to achieve the desired therapy.

42. A system for image guided high intensity focused ultrasound (HIFU) therapy comprising: (a) an ultrasound imaging probe; (b) a first display upon which a first image generated by the ultrasound imaging probe is to be displayed; (c) a therapy probe including a HIFU transducer; (d) a processor configured to: (i) track a spatial relationship and orientation between the ultrasound imaging probe and the therapy probe; and (ii) provide a signal configured to produce a second image indicating the spatial relationship and orientation between the ultrasound imaging probe and the therapy probe; (e) a second display on which the second image indicating the spatial relationship and orientation between the ultrasound imaging probe and the therapy probe is displayed, the second image providing feedback that a clinician can use to maintain a desired spatial relationship and orientation between the ultrasound imaging probe and the therapy probe; and (f) a frame configured to selectively fix a spatial orientation between the ultrasound imaging probe and the therapy probe, thereby ensuring that after the frame, the therapy probe, and the ultrasound imaging probe are properly positioned relative to a patient so that a focal point of the therapy probe is visualized in an imaging plane of the ultrasound imaging probe, subsequent movement of the ultrasound imaging probe, the therapy probe, or the patient does not change the spatial orientation between the ultrasound imaging probe and the therapy probe, the frame comprising: (i) a first bracket configured to support the imaging probe, the first bracket being coupled to a first generally elongate support; and (ii) a second bracket configured to movably support the therapy probe, such that the first generally elongate support can be translated generally normal to the second generally elongate support.

43. The system of claim 42, wherein the first display and the second display are implemented as a single display on which the first image and second image are simultaneously displayed.

44. A system configured to be used with a conventional ultrasound imaging probe to enable ultrasound imaging to guide high intensity focused ultrasound (HIFU) to provide therapy to a treatment site associated with a female anatomy, the system comprising: (a) a transvaginal therapy probe comprising a generally elongate housing and a HIFU transducer disposed at a distal end of the generally elongate housing; and (b) a medical device support frame adapted to selectively fix a spatial orientation between an ultrasound imaging probe and the transvaginal therapy probe, thereby ensuring that after the frame, the transvaginal therapy probe, and a conventional ultrasound imaging probe are properly positioned relative to a patient so that a focal point of the transvaginal therapy probe is visualized in an imaging plane of a conventional ultrasound imaging probe, subsequent movement of an ultrasound imaging probe, the transvaginal therapy probe, or the patient does not change the spatial orientation between a conventional ultrasound imaging probe and the ultrasound therapy probe, the frame comprising: (i) a first medical device support bracket adapted to support a conventional imaging probe that is disposed external to a patient's body, the first medical device support bracket being pivotably coupled to a first generally elongate support and being adapted to be coupled to the imaging probe such that the imaging probe can be pivoted about a longitudinal axis of the first generally elongate support; and (ii) a second medical device support bracket adapted to movably support the transvaginal therapy probe, such that the first generally elongate support can be translated in a direction generally normal to the second generally elongate support.

Description

FIELD OF THE INVENTION

The present invention generally relies on the use of real-time ultrasound imaging to enhance therapy utilizing high intensity focused ultrasound, and more specifically, relies on the use of a frame to maintain a spatial orientation between a therapy device and an imaging probe during a therapeutic treatment using high intensity ultrasound.

BACKGROUND OF THE INVENTION

High intensity focused ultrasound (HIFU) has emerged as a precise, non-surgical, minimally-invasive treatment for benign and malignant tumors. At focal intensities (1000-10000 W/cm.sup.2) that are 4-5 orders of magnitude greater than that of diagnostic ultrasound (approximately 0.1 W/cm.sup.2), HIFU can induce lesions (i.e., localized tissue necrosis) at a small, well defined region deep within tissue, while leaving intervening tissue between the HIFU transducer and the focal point substantially unharmed. Tissue necrosis is a result of tissue at the focal point of the HIFU beam being heated to over 70.degree. C. in a very short period of time (generally less than one second). Tissue necrosis also results from cavitation activity, which causes tissue and cellular disorganization. HIFU is currently being used clinically for the treatment of prostate cancer and benign prostatic hyperplasia, as well as the treatment of malignant bone tumors and soft tissue sarcomas. Clinical trials are currently being conducted for HIFU treatment of breast fibroadenomas, and various stage-4 primary and metastatic cancerous tumors of the kidney and liver.

Uterine fibroids are benign tumors of the uterus that cause abnormal uterine bleeding. The incidence of fibroids in women in their reproductive years has been estimated to be 20-25%, although autopsy studies show an incidence to be greater than 75%. Approximately 1/3 of women experiencing uterine fibroids will have a tumor that is symptomatic requiring treatment. Approximately 30% of all hysterectomies are related to the presence of uterine fibroids. Current treatment methods for uterine fibroids include both drug therapy and surgery. Experience with drug therapy shows almost a 100% rate of tumor reoccurrence once the drug therapy has stopped, and the drug therapy has numerous undesirable side effects. The rate of reoccurrence is significantly less for the surgical therapy (about 15%). Unfortunately, most current procedures for removing uterine fibroids are based on invasive surgical techniques, which require a significant recovery period and involve significant risks (such as blood loss, damage to related organs, and the ever present risk of infection). It is estimated that uterine fibroid procedures in the United States alone account for 1.2 to 3.6 billion dollars in annual medical costs.

It appears that HIFU, delivered using a transvaginal transducer, could provide a minimally-invasive treatment for uterine fibroids. On Oct. 22, 2004, the United States Food and Drug Administration (FDA) approved the ExAblate 2000.TM. System; a new medical device that uses magnetic resonance image (MRI) guided focused ultrasound to target and destroy uterine fibroids. While MRI guided HIFU therapy offers an alternative to more invasive surgical techniques, MRI equipment is very expensive, not nearly as available as ultrasound imaging devices, and not nearly as portable as ultrasound imaging devices. It would be desirable to provide a less costly alternative to MRI guided HIFU therapy. Such treatment is expected to compare favorably with the costs for the current drug related therapy for the treatment of uterine fibroids and its efficacy should compare favorably with the higher success rate of the current surgical procedures, but without the attendant risks.

SUMMARY OF THE INVENTION

A first aspect of the invention is directed to a support configured to spatially align a transvaginal HIFU applicator and a transabdominal ultrasound-imaging probe. The support ensures that the focal point of the HIFU beam is always visible in the image plane of the imaging transducer, regardless of the motion of the patient, the HIFU applicator, or the transabdominal ultrasound-imaging probe. In a particularly preferred embodiment, the support is configured to enable a variety of ubiquitous transabdominal ultrasound-imaging probes to be used with a newly developed transvaginal therapy probe. The support enables the transabdominal imaging probe and the transvaginal therapy probe to be moved independently of each other, when corresponding adjustment members are in an unsecured state, so that each probe can be properly positioned relative to the patient and the treatment site. The therapy probe is energized at a low power setting sufficient to enable the imaging probe to image the focal point of the therapy probe. As long as the therapy probe is energized at a low power level, no undesirable tissue necrosis will occur while the spatial orientation between the imaging probe and the therapy probe is being adjusted. The clinician can thus readily modify the spatial orientation of the imaging probe and the therapy probe, while the therapy probe is energized at the low power level, until the focal point of the therapy probe lies within the imaging plane provided by the imaging probe (i.e., until the focal point is visualized in an ultrasound image provided by the imaging probe). Once the desired focal point of the therapy probe relative to that of the imaging probe is thus achieved to deliver HIFU to the treatment site, the adjustment members are secured and the spatial orientation between the imaging probe and the therapy probe is fixed. At this point, the therapy probe can be energized at a higher power to initiate HIFU therapy. During this therapy, the therapy transducer is synchronized to the imaging transducer so as to ensure that noise generated by the HIFU beam is shifted to a portion of the ultrasound image (generated by the imaging probe) spaced apart from the portion of the ultrasound image in which the focal point of the HIFU beam is displayed.

Another aspect of this invention is directed to a transvaginal probe that includes a HIFU transducer optimized for the treatment of uterine fibroids from within the vagina. In one embodiment, the transvaginal probe includes a piezoceramic crystal bonded to an aluminum lens, to achieve a HIFU transducer having a focal length of about 4 cm. In another embodiment, the transvaginal probe includes a generally spoon-shaped transducer, which comprises a plurality of individual emitter elements.

Still another aspect of the present invention is directed to a method for evaluating a quality of a coupling between a liquid-filled volume en