Systems and methods for ultrasound treatment of thyroid and parathyroid

• US 8,353,832 B2
• Filed: 02/03/2009
• Issued: 01/15/2013
• Est. Priority Date: 10/14/2008
• Status: Active Grant

• Current Assignee: The Theraclion
• Original Assignee: The Theraclion
• Inventors: Lacoste, Francois
• Primary Examiner(s): Casler, Brian
• Assistant Examiner(s): Selkin, Saurel J
• Application Number:
  US12/364,916
• Publication Number:
  US 20100094178A1
• Time in Patent Office: 1,442 Days
• Field of Search: 601/2, 600/437
• US Class Current: 600/437
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 5/4205 Evaluating swallowing
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A treatment device and methods for HIFU treatment of thyroid and parathyroid disorders are provided. The treatment method includes steps of identifying a treatment zone and directing high intensity focused ultrasound energy towards the treatment zone. The treatment device has a first sensor for detecting swallowing motion and a second sensor for tracking the motion of the thyroid and parathyroid tissue with ultrasound imaging.

Claims

1. A method for treating disorders of thyroid and/or parathyroid with HIFU in a subject in need thereof comprising

(i) identifying a treatment zone to which ultrasonic energy should be applied to, said treatment zone including at least a part of the parathyroid and

(ii) directing high intensity focused ultrasound energy, with an energy level sufficient to cause tissue necrosis, towards said treatment zone

the method comprising the further step of monitoring values of at least one blood level selected from the group of parathyroid hormone blood level, calcium blood level, blood phosphorous level, TSH hormone blood level, T3 hormone blood level and T4 hormone blood level of a patient.

2. A method for treating primary or secondary hyperparathyroidism comprising the steps of

(i) identifying a treatment zone to which ultrasonic energy should be applied to, said treatment zone including at least a part of the parathyroid,

(ii) directing high intensity focused ultrasound energy, with an energy level sufficient to cause tissue necrosis, toward said treatment zone, and

(iii) monitoring a value of at least one blood level from the group of parathyroid hormone blood level, calcium blood level and blood phosphorus level.

3. A method according to claim 2 comprising positioning, for said step of directing high intensity focused ultrasound energy towards the treatment zone, a HIFU pulse generator to provide at least one HIFU pulse to a subject.

4. A method according to claim 3 wherein said step of directing high intensity focused ultrasound energy towards the treatment zone comprises providing of 10 to 100 pulses when treating secondary hyperparathyroidism.

5. A method according to claim 3 wherein said step of directing high intensity focused ultrasound energy towards the treatment zone comprises providing of 35 to 70 pulses when treating secondary hyperparathyroidism.

6. A method according to claim 3 wherein said step of directing high intensity focused ultrasound energy towards the treatment zone comprises delivering a total of between 4 kJ and 42 kJ of acoustic energy.

7. A method according to claim 3 wherein said step of directing high intensity focused ultrasound energy towards said treatment zone comprises delivering a total of between 7 kJ and 27 kJ, of acoustic energy.

8. A method according to claim 2 comprising positioning, for said step of identifying an ultrasound sensor to detect a position of a parathyroid to be treated in a subject.

9. A method according to claim 2 wherein only one of the four parathyroid glands is treated.

10. A method according to claim 2 wherein more than one of the four parathyroid glands are treated sequentially.

11. A method according to claim 2 comprising the further step of repeating the treatment steps of said identifying a treatment zone and of said directing high intensity focused ultrasound energy towards said treatment zone at least once.

12. A method according to claim 11 wherein said treatment steps are repeated at least one week after a previous treatment of primary or secondary hyper parathyroidism by directing high intensity focused ultrasound energy towards the treatment zone.

13. A method according to claim 11 wherein said treatment steps are repeated at the same treatment zone or at a treatment zone separated by 1 mm to 1 cm from said treatment zone.

14. A method according to claim 2 comprising further steps of repeating the treatment steps of said identifying a treatment zone and of said directing high intensity focused ultrasound energy towards said treatment zone at least once in dependence of a monitored value of said at least one blood level.

15. A method according to claim 14 comprising the further steps of repeating said treatment steps if value of the blood level of parathyroid hormones does not decrease by more than 30% after a previous treatment.

16. A method for modifying a parathyroid tissue comprising the steps of

(i) identifying a treatment zone to which ultrasonic energy should be applied to, said treatment zone including at least a part of the parathyroid,

(ii) directing high intensity focused ultrasound energy, with an energy level sufficient to cause tissue necrosis, towards the treatment zone, and

(iii) monitoring a value of at least one blood level selected from the group of parathyroid hormone blood level, calcium blood level and blood phosphorus level.

17. A method for treating disorders of thyroid and/or parathyroid with HIFU in a subject in need thereof comprising the steps of:

(i) identifying a treatment zone to which ultrasonic energy should be applied to, said treatment zone including at least a part of the parathyroid and

(ii) directing high intensity focused ultrasound energy, with an energy level sufficient to cause tissue necrosis, towards said treatment zone,

wherein said ultrasound energy is directed towards said treatment zone as a series of a least two pluses separated by pauses wherein said pauses are selected in such a way as to allow for prefocal tissue to return to normal temperature thereby avoiding or skin burn.

18. A method for treating a subject with HIFU, said method comprising steps of:

(i) identifying a treatment zone to which ultrasonic energy should be applied and

(ii) directing high intensity focused ultrasound energy toward said treatment zone,

wherein said ultrasound energy is directed towards said treatment zone as a series of at least two pulses separated by pauses, and

wherein the pauses are determined according to the following formula;

19. A method according to claim 18, wherein the method is for treating disorders of thryoid and/or parathyroid and wherein the treatment zone includes at least a part of the parathyroid.