Systems and Methods for Ultrasound Treatment of Thyroid and Parathyroid

• US 20100094178A1
• Filed: 02/03/2009
• Published: 04/15/2010
• Est. Priority Date: 10/14/2008
• Status: Active Grant

• Current Assignee: The Theraclion
• Original Assignee: The Theraclion
• Inventors: Lacoste, Francois
• Granted Patent: US 8,353,832 B2
• Time in Patent Office: Days
• US Class Current: 601/2
• 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 comprises identifying a treatment zone and directing high intensity focused ultrasound energy towards the treatment zone. The treatment device comprises the first sensor for detecting swallowing motion and the second sensor for tracking the motion of the thyroid and parathyroid tissue with ultrasound imaging. Thus, the treatment device allows for safe and non-invasive use of HIFU on thyroid and parathyroid tissue of patients by synchronizing HIFU pulse delivery with patient swallowing and/or directing the applicator of HIFU energy to follow the appropriate tissue when the patient moves.

Claims

1-17. -17. (canceled)

18. 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 towards said treatment zone

the method comprising the further step of monitoring the 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.

19. 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 and

(ii) directing high intensity focused ultrasound energy towards said treatment zone.

20. A method according to claim 19 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 poise to the subject.

21. A method according to claim 19 comprising

positioning, for said step of identifying said ultrasound sensor to detect a position of a parathyroid to be treated in the subject.

22. A method according to claim 20 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.

23. A method according to claim 20 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.

24. A method according to claim 20 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.

25. A method, according to claim 20 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.

26. A method according to claim 19 wherein

only one of the four parathyroid glands is treated.

27. A method according to claim 19 wherein

more than one of the four parathyroid glands are treated sequentially.

28. A method according to claim 19 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.

29. A method according to claim 28 wherein

said treatment steps are repeated at least one week after the previous treatment.

30. A method according to claim 19 comprising the further step of

monitoring the values of at least one blood level from the group of parathyroid hormone blood level calcium blood level, blood phosphorus level.

31. A method according to claim 30 comprising the 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 the value of the said blood level.

32. A method according to claim 31 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.

39. A method according to claim 28 wherein

said treatment steps are repeated at the same treatment zone or at a treatment zone separated by 1 mm to 1 cm from the previously treated treatment zone.

33. 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 and

(ii) directing high intensity focused ultrasound energy towards the treatment zone.

34. An ultrasound therapeutic device comprising:

a sensor for detecting a parathyroid in the subject;

a high intensity focused ultrasound (HIFU) pulse generator;

wherein said high intensity focused ultrasound (HIFU) pulse generator is operable such that it provides a focal zone being located in a treatment zone including at least a part of the parathyroid.

35. The ultrasound therapeutic treatment device according to claim 34, wherein said focal zone is located in a distance from the treatment unit able to reach, target depths up to 35 mm.

36. The ultrasound therapeutic treatment device according to claim 35, wherein

said focal zone is located in a distance from the treatment unit able to reach target depths up to 24.5 mm.

37. 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 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 toff

and wherein said paused are selected in such a way as to allow for prefocal tissue to return to normal temperature thereby avoiding or skin burn.

38. The method according to claim 37, wherein the pauses are determined according to the following formula:

$\mathrm{toff}=\frac{F·<br><br>\mathrm{AcousticPower}·<br><br>\mathrm{ton}}{\mathrm{SkinTol}·<br><br>\left[\mathrm{TxdArea}·<br><br>{\left(\frac{\mathrm{TissueDepth}}{\mathrm{FocusToRim}}\right)}^2\right]}-\mathrm{ton}$

where;

ton=pulse duration in seconds

F=acoustic frequency in MHz

Acoustic power=3 MHz acoustic power delivered by the transducer during the HIFU pulse in Watts

TissueDepth=Thickness of tissues to go through, from the skin to the focal point over the lesion to be treated in mm

FocustoRim=distance from the fecal point to the border of the active surface of the transducer projected over the ultrasound axis in mm.

TxdArea=cross section area of the transducer projection on the skin in cm².

SkinTol=allowable average acoustic intensity through the skin in WxMHz/cm².