Ultrasound guided high intensity focused ultrasound treatment of nerves

• US 7,510,536 B2
• Filed: 12/16/2004
• Issued: 03/31/2009
• Est. Priority Date: 09/17/1999
• Status: Expired due to Fees

• Current Assignee: University of Washington
• Original Assignee: University of Washington
• Inventors: Little, James W., Vaezy, Shahram, Foley, Jessica L.
• Primary Examiner(s): Winakur; Eric F
• Assistant Examiner(s): Rozanski; Michael T
• Application Number:
  US11/016,701
• Publication Number:
  US 20050240126A1
• Time in Patent Office: 1,566 Days
• Field of Search: 601/2, 600/411, 600/437
• US Class Current: 601/2
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00434 Neural system
• 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 8/0816 using echo-encephalography
• 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 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/4444 related to the probe
• 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

A method for using high intensity focused ultrasound (HIFU) to treat neurological structures to achieve a desired therapeutic affect. Depending on the dosage of HIFU applied, it can have a reversible or irreversible effect on neural structures. For example, a relatively high dose of HIFU can be used to permanently block nerve function, to provide a non-invasive alternative to severing a nerve to treat severe spasticity. Relatively lower doses of HIFU can be used to reversible a block nerve function, to alleviate pain, to achieve an anesthetic effect, or to achieve a cosmetic effect. Where sensory nerves are not necessary for voluntary function, but are involved in pain associated with tumors or bone cancer, HIFU can be used to non-invasively destroy such sensory nerves to alleviate pain without drugs. Preferably, ultrasound imaging synchronized to the HIFU therapy is used to provide real-time ultrasound image guided HIFU therapy of neural structures.

Claims

1. A method for using high intensity focused ultrasound (HIFU) to provide therapy to a treatment site corresponding to a portion of a nervous system of a patient, the treatment site being spaced apart from a HIFU therapy device, comprising the steps of:

(a) determining an appropriate treatment site to be treated to achieve a desired therapeutic effect;

(b) selecting a dose of HIFU required to achieve the desired therapeutic effect, the desired therapeutic effect comprising blocking nerve conduction for at least one of the following purposes;

(i) to alleviate pain;

(ii) to provide a palliative treatment for cancer;

(iii) to treat spasticity;

(iv) to provide an anesthetic effect; and

(v) to provide a cosmetic effect;

(c) positioning the HIFU therapy device such that a focal point of the HIFU therapy device is disposed adjacent to the treatment site;

(d) energizing the HIFU therapy device to administer HIFU at a relatively low power level, while producing an ultrasound image of the treatment site, for verifying that the focal point of the HIFU therapy device is properly positioned relative to the treatment site, and if not, repositioning the HIFU therapy device until the HIFU therapy device is properly positioned relative to the treatment site; and

(e) energizing the HIFU therapy device to provide the dose of HIFU to the treatment site that is required to achieve the desired therapeutic effect.

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

(a) using ultrasound imaging to obtain an ultrasound image of the treatment site during therapy; and

(b) synchronizing the HIFU therapy device and the ultrasound imaging such that noise in the ultrasound image arising from the HIFU therapy device does not prevent visualization of the focal point in the ultrasound image during therapy.

3. The method of claim 1, wherein the step of determining the appropriate treatment site comprises the step of selecting at least one of a nerve and a nerve ganglia as the treatment site.

4. The method of claim 1, wherein the step of selecting the dose of HIFU required to achieve the desired therapeutic effect comprises the step of selecting the dose of HIFU required to partially block nerve conduction at the treatment site.

5. The method of claim 1, wherein the step of selecting the dose of HIFU required to achieve the desired therapeutic effect comprises the step of selecting the dose of HIFU required to completely block nerve conduction at the treatment site.

6. The method of claim 1, wherein the step of selecting the dose of HIFU required to achieve the desired therapeutic effect comprises the step of selecting the dose of HIFU required to permanently block nerve conduction at the treatment site.

7. The method of claim 1, wherein the step of selecting the dose of HIFU required to achieve the desired therapeutic effect comprises the step of selecting the dose of HIFU required to temporarily block nerve conduction at the treatment site.

8. The method of claim 1, wherein the step of verifying that the focal point of the HIFU therapy device is properly positioned relative to the treatment site comprises the steps of:

(a) using ultrasound imaging to obtain an ultrasound image of the treatment site; and

(b) energizing the HIFU therapy device at a power level that is insufficient to induce damage at the treatment site, but is sufficient to enable the focal point to be visualized in the ultrasound image.

9. The method of claim 1, wherein the step of verifying that the focal point of the HIFU therapy device is properly positioned relative to the treatment site comprises the steps of:

(a) identifying a type of physiological reaction that should occur if the focal point of the HIFU therapy device is properly positioned relative to the treatment site when the HIFU therapy device is energized to stimulate the nervous system of the patient, yielding an identified physiological reaction;

(b) energizing the HIFU therapy device at a power level that is insufficient to induce damage at the treatment site, but is sufficient to stimulate the nervous system of the patient;

(c) observing any physiological reaction to achieve an observed physiological reaction; and

(d) determining if the identified physiological reaction corresponds to the observed physiological reaction, and if so, concluding that the focal point of the HIFU therapy device is properly positioned relative to the treatment site.

10. The method of claim 1, wherein the step of verifying that the focal point of the HIFU therapy device is properly positioned relative to the treatment site comprises the steps of:

(a) positioning an ultrasound imaging device and the HIFU therapy device such that the focal point lies within an image plane provided by the ultrasound imaging device;

(b) providing an indication of where the focal point lies within the image plane, such that the focal point can be visualized in the image plane even when the HIFU therapy device is not energized;

(c) fixing a position of the ultrasound imaging device relative the HIFU therapy device, such that movement of either device will not move the focal point out of the image plane;

(d) obtaining an ultrasound image of the treatment site; and

(e) manipulating at least one of the ultrasound imaging device, the HIFU therapy device, and a frame used to secure the position of the ultrasound imaging device relative to the HIFU therapy device, until the indication of the focal point is properly positioned relative to the treatment site.

11. The method of claim 1, wherein the step of verifying that the focal point of the HIFU therapy device is properly positioned relative to the treatment site comprises the steps of:

(a) using an imaging device to obtain an image of the treatment site;

(b) tracking a position of the imaging device;

(c) tracking a position of the HIFU therapy device;

(d) based on the positions of the imaging device and the HIFU therapy device, introducing an icon into the image, the icon corresponding to a predicted position of the focal point based on the positions of the imaging device and the HIFU therapy device; and

(e) manipulating the position of at least one of the imaging device and the HIFU therapy device until the icon coincides with the treatment site in the image.

12. A method for using high intensity focused ultrasound (HIFU) to treat spasticity by applying HIFU to a treatment site corresponding to a portion of a nervous system of a patient, the treatment site being spaced apart from a HIFU therapy device, comprising the steps of:

(a) determining an appropriate treatment site associated with the nervous system of the patient to treat spasticity;

(b) selecting a dose of HIFU required to achieve a desired therapeutic effect;

(c) positioning the HIFU therapy device such that a focal point of the HIFU therapy device is disposed adjacent to the treatment site;

(d) verifying that the focal point of the HIFU therapy device is properly positioned relative to the treatment site, and if not, repositioning the HIFU therapy device until the HIFU therapy device is properly positioned relative to the treatment site, wherein the step of verifying comprises the steps of;

(i) using ultrasound imaging to obtain an ultrasound image of the treatment site during administration of HIFU to treat spasticity; and

(ii) synchronizing the HIFU therapy device and the ultrasound imaging such that noise in the ultrasound image arising from use of the HIFU therapy device does not prevent visualization of the focal point in the ultrasound image; and

(e) energizing the HIFU therapy device to provide the dose of HIFU required to achieve the desired therapeutic effect.

13. A method for using high intensity focused ultrasound (HIFU) to alleviate pain by applying HIFU to a treatment site corresponding to a portion of a nervous system of a patient, the treatment site being spaced apart from a HIFU therapy device, comprising the steps of:

(a) determining an appropriate treatment site associated with the nervous system of the patient to alleviate pain;

(b) selecting a dose of HIFU required to achieve a desired therapeutic effect;

(c) positioning the HIFU therapy device such that a focal point of the HIFU therapy device is disposed adjacent to the treatment site;

(d) verifying that the focal point of the HIFU therapy device is properly positioned relative to the treatment site, and if not, repositioning the HIFU therapy device until the HIFU therapy device is properly positioned relative to the treatment site, wherein the step of verifying comprises the steps of;

(i) using ultrasound imaging to obtain an ultrasound image of the treatment site during administration of HIFU to alleviate pain; and

(ii) synchronizing the HIFU therapy device and the ultrasound imaging such that noise in the ultrasound image arising from use of the HIFU therapy device does not prevent visualization of the focal point in the ultrasound image; and

(e) energizing the HIFU therapy device to provide the dose of HIFU required to achieve the desired therapeutic effect.

14. The method of claim 13, wherein the step of selecting the dose of HIFU required to achieve the desired therapeutic effect comprises the step of selecting a dose of HIFU that will result in both thermal and mechanical interactions with the treatment site.

15. A method for using high intensity focused ultrasound (HIFU) to provide an anesthetic effect by applying HIFU to a treatment site corresponding to a portion of a nervous system of a patient, the treatment site being spaced apart from a HIFU therapy device, comprising the steps of:

(a) determining an appropriate treatment site associated with the nervous system of the patient to provide the anesthetic effect;

(b) selecting a dose of HIFU required to achieve a desired therapeutic effect;

(c) positioning the HIFU therapy device such that a focal point of the HIFU therapy device is disposed adjacent to the treatment site;

(d) verifying that the focal point of the HIFU therapy device is properly positioned relative to the treatment site, and if not, repositioning the HIFU therapy device until the HIFU therapy device is properly positioned relative to the treatment site, wherein the step of verifying comprises the steps of;

(i) using ultrasound imaging to obtain an ultrasound image of the treatment site during administration of HIFU to provide the anesthetic effect; and

(ii) synchronizing the HIFU therapy device and the ultrasound imaging such that noise in the ultrasound image arising from use of the HIFU therapy device does not prevent visualization of the focal point in the ultrasound image; and

(e) energizing the HIFU therapy device to provide the dose of HIFU required to achieve the desired therapeutic effect.

16. A method for using high intensity focused ultrasound (HIFU) to provide a cosmetic effect by applying HIFU to a treatment site corresponding to a portion of a nervous system of a patient, the treatment site being spaced apart from a HIFU therapy device, comprising the steps of:

(a) determining an appropriate treatment site associated with the nervous system of the patient to provide the cosmetic effect;

(b) selecting a dose of HIFU required to achieve the cosmetic effect;

(c) positioning the HIFU therapy device such that a focal point of the HIFU therapy device is disposed adjacent to the treatment site;

(d) verifying that the focal point of the HIFU therapy device is properly positioned relative to the treatment site, and if not, repositioning the HIFU therapy device until the HIFU therapy device is properly positioned relative to the treatment site, wherein the step of verifying comprises the steps of;

(i) using ultrasound imaging to obtain an ultrasound image of the treatment site during administration of HIFU to provide the cosmetic effect; and

(ii) synchronizing the HIFU therapy device and the ultrasound imaging such that noise in the ultrasound image arising from use of the HIFU therapy device does not prevent visualization of the focal point in the ultrasound image; and

(e) energizing the HIFU therapy device to provide the dose of HIFU required to achieve the cosmetic effect.

17. The method of claim 16, wherein the step of determining an appropriate treatment site associated with the nervous system of a patient comprises the steps of:

(a) identifying musculature associated with the cosmetic effect to be achieved; and

(b) identifying the portion of the nervous system controlling the musculature so identified, the portion so identified being determined to be the appropriate treatment site.

18. A method for using high intensity focused ultrasound (HIFU) to provide therapy to a treatment site corresponding to a portion of a nervous system of a patient, the treatment site being spaced apart from a HIFU therapy device, comprising the steps of:

(a) determining an appropriate treatment site to be treated to achieve a desired therapeutic effect, the treatment site comprising a nerve;

(b) positioning the HIFU therapy device such that a focal point of the HIFU therapy device is disposed adjacent to the treatment site, the HIFU therapy device being energized at a relatively low power level while producing an ultrasound image of the treatment site in which the focal point of the HIFU therapy device is visually evident, so as to enable the focal point of the HIFU therapy device to be properly positioned relative to the treatment site; and

(c) energizing the HIFU therapy device to administer a dose of HIFU to the treatment site sufficient to achieve the desired therapeutic effect, the desired therapeutic effect comprising at least one type of nerve blockage selected from a group consisting of;

(i) temporary and partial blockage of nerve function;

(ii) temporary and complete blockage of nerve function; and

(iii) permanent and partial blockage of nerve function.

19. The method of claim 18, wherein the dose of HIFU administered is based on:

(a) feedback from a patient during the therapy;

(b) observation of physiological responses during the therapy; and

(c) a predetermined dose.