Systems and methods for ultrasound assisted lipolysis

• US 6,626,854 B2
• Filed: 12/27/2000
• Issued: 09/30/2003
• Est. Priority Date: 12/27/2000
• Status: Expired due to Term

• Current Assignee: InSightec Ltd.
• Original Assignee: Insightec-Txsonics Limited
• Inventors: Friedman, Zvi, Vitek, Shuki, Maor, Dov
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US09/753,273
• Publication Number:
  US 20020082528A1
• Time in Patent Office: 1,007 Days
• Field of Search: 601/2, 601/4, 601/3
• US Class Current: 601/2
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 2017/22007 Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Cells are destroyed within a subcutaneous tissue region using a transducer disposed externally adjacent to a patient'"'"'s skin. The transducer emits acoustic energy that is focused at a linear focal zone within the tissue region, the acoustic energy having sufficient intensity to rupture cells within the focal zone while minimizing heating. The transducer may include one or more transducer elements having a partial cylindrical shape, a single planar transducer element coupled to an acoustic lens, or a plurality of linear transducer elements disposed adjacent one another in an arcuate or planar configuration. The transducer may include detectors for sensing cavitation occurring with the focal zone, which is correlated to the extent of cell destruction. A frame may be provided for controlling movement of the transducer along the patient'"'"'s skin, e.g., in response to the extent of cell destruction caused by the transducer.

Claims

1. A system for destroying tissue within a subcutaneous tissue region, comprising:

a transducer device comprising an emission surface for emitting acoustic energy and defining a longitudinal axis, the transducer device configured for focusing the acoustic energy at a substantially linear focal zone that extends substantially parallel to the longitudinal axis in the subcutaneous tissue region;

drive circuitry coupled to the transducer device for providing drive signals to the transducer device whereby the transducer device may emit acoustic energy from the emission surface; and

a controller coupled to the drive circuitry, the controller configured for controlling the drive signals delivered by the drive circuitry such that the acoustic energy emitted by the transducer device has sufficient intensity to cause cavitation and destroy cells within the focal zone, the controller configured for controlling the drive circuitry such that the transducer has a duty cycle of about twenty percent (20%) or less to minimize heating within the focal zone.

2. The system of claim 1, wherein the drive circuitry is configured for providing drive signals having a frequency ranging from approximately 0.25 MHz to 30 MHz.

3. The system of claim 1, wherein the transducer device has a partial cylindrical emission surface extending substantially parallel to a longitudinal axis of the transducer.

4. The system of claim 3, wherein the transducer device comprises a substantially planar transducer element and a partial cylindrical lens defining the emission surface, the lens acoustically coupled to the planar transducer element for focusing the acoustic energy at the substantially linear focal zone.

5. The system of claim 3, wherein the emission surface is concave and has a predetermined radius of curvature for focusing the acoustic energy at a predetermined focal distance from the emission surface to the focal zone.

6. The system of claim 3, wherein the transducer device comprises one or more transducer elements disposed in an elongate arcuate configuration, the emission surface comprising an elongate concave inner surface of the one or more transducer elements.

7. The system of claim 6, wherein:

the transducer comprises a plurality of linear transducer elements disposed adjacent one another and extending substantially parallel to the longitudinal axis of the transducer;

the drive circuitry is configured for providing respective drive signals to each of the linear transducer elements; and

the controller is configured for controlling a phase of the respective drive signals to adjust a focal distance from the emission surface to the focal zone.

8. The system of claim 1, wherein the transducer comprises a plurality of elongate linear transducer elements disposed adjacent one another in a substantially planar configuration.

9. The system of claim 8, wherein the drive circuitry is configured for providing respective drive signals to each of the linear transducer elements, and wherein the controller is configured for controlling a phase of the respective drive signals to adjust a focal distance from the emission surface to the focal zone.

10. The system of claim 1, wherein the transducer device comprises a plurality of transducers disposed adjacent to one another, the transducers configured for generating respective substantially linear focal zones that extend generally parallel to one another.

11. The system of claim 10, wherein a first of the plurality of transducers has a first focal distance and wherein a second of the plurality of transducers has a second focal distance that is different than the first focal distance.

12. The system of claim 1, further comprising a frame to which the transducer device is mounted, the transducer device being movable along the frame for moving the focal zone to successive tissue regions.

13. The system of claim 1, wherein the controller is configured for controlling the drive circuitry such that the transducer has a duty cycle of about ten percent (10%) or less.

14. The system of claim 1, wherein the controller is configured for controlling the drive circuitry such that the transducer has a duty cycle of about one percent (1%) or less.

15. The system of claim 1, wherein the transducer device comprises a plurality of transducer elements defining respective portions of an arc projected generally onto a plane.

16. A method for destroying cells within a subcutaneous tissue region located beneath a patient'"'"'s skin, comprising:

disposing a transducer defining a longitudinal axis externally adjacent to the patient'"'"'s skin; and

driving the transducer with drive signals using a relatively low duty cycle such that the transducer emits acoustic energy, while focusing the acoustic energy from the transducer at a substantially linear focal zone extending substantially parallel to the longitudinal axis within the tissue region, the acoustic energy having sufficient intensity to cavitate cells within the focal zone while substantially minimizing heating of tissue within the focal zone.

17. The method of claim 16, wherein the acoustic energy has a frequency ranging from approximately 0.25 MHz to 30 MHz.

18. The method of claim 16, wherein the transducer comprises an acoustic emission surface defining a portion of a cylinder for focusing the acoustic energy at the substantially linear focal zone.

19. The method of claim 18, wherein the transducer comprises a plurality of transducer elements disposed substantially parallel to the longitudinal axis, and wherein the step of driving the transducer comprises controlling a phase of the drive signals to adjust a focal distance to the focal zone.

20. The method of claim 18, wherein the transducer comprises a generally planar transducer and an acoustic lens defining the emission surface, and wherein the acoustic energy is focused at the focal zone by directing the acoustic energy through the acoustic lens.

21. The method of claim 18, wherein the transducer comprises an arcuate transducer extending substantially parallel to the longitudinal axis.

22. The method of claim 16, further comprising moving the transducer in a direction substantially perpendicular to the longitudinal axis of the transducer, thereby moving the focal zone to a position substantially parallel to a previous position within the tissue region.

23. The method of claim 22, wherein the transducer is mounted to a frame, the transducer being movable along the frame in a direction substantially perpendicular to the longitudinal axis of the transducer.

24. The method of claim 16, further comprising introducing a fluid into the tissue region, the fluid comprising gas bubbles for enhancing cavitation within the tissue region.

25. The method of claim 16, wherein the subcutaneous tissue region comprises adipose tissue, and wherein the ruptured cells comprise adipose cells.

26. A system for treating tissue within a subcutaneous tissue region, comprising:

a transducer device comprising a plurality of transducer elements defining respective portions of an arc projected generally onto a plane, thereby providing an emission surface extending substantially parallel to a longitudinal axis of the transducer device, the emission surface configured for emitting acoustic energy at a substantially linear focal zone extending substantially parallel to the longitudinal axis;

drive circuitry coupled to the transducer device for providing drive signals to the transducer device whereby the transducer device may emit acoustic energy from the emission surface; and

a controller coupled to the drive circuitry, the controller configured for controlling the drive signals delivered by the drive circuitry to focus the acoustic energy at the substantially linear focal zone.

27. The system of claim 26, wherein the drive circuitry is configured for providing respective drive signals to each of the linear transducer elements, and wherein the controller is configured for controlling a phase of the respective drive signals to adjust a focal distance to the focal zone.

28. The system of claim 26, wherein the controller is configured for activating the drive circuitry in relatively short-burst pulses to provide a relatively low duty cycle of the transducer.

29. The system of claim 28, wherein the duty cycle is about twenty percent or less.

30. The system of claim 26, further comprising a frame to which the transducer device is mounted, the transducer device being movable along the frame for moving the focal zone to successive tissue regions.

31. A system for destroying cells within a subcutaneous tissue region, comprising:

a transducer device comprising an emission surface for emitting acoustic energy, the transducer device configured for focusing the acoustic energy at a substantially linear focal zone within the subcutaneous tissue region;

drive circuitry coupled to the transducer device for providing drive signals to the transducer device whereby the transducer device emits acoustic energy from the emission surface;

a controller coupled to the drive circuitry, the controller configured for controlling the drive signals delivered by the drive circuitry such that the acoustic energy emitted by the transducer device has sufficient intensity to cause cavitation and destroy cells within the focal zone;

a cavitation detector mounted in a predetermined arrangement with the transducer device such that the cavitation detector is oriented towards the focal zone, the detector configured for sensing cavitation within the focal zone; and

a monitoring system coupled to the cavitation detector, the monitoring system configured for correlating cavitation signals generated by the cavitation detector to determine an extent of cell destruction occurring within the focal zone.

32. The system of claim 31, wherein the monitoring system is configured for correlating a rate of change in intensity of the cavitation signals with the extent of cell destruction occurring within the focal zone.

33. The system of claim 31, wherein the monitoring system is configured for integrating the cavitation signals over time until a predetermined value is reached.

34. The system of claim 31, further comprising a frame to which the transducer is mounted, the transducer being movable along the frame for moving the focal zone to successive tissue regions.

35. The system of claim 34, further comprising a mechanical controller for moving the transducer along the frame.

36. The system of claim 35, wherein the mechanical controller is coupled to the monitoring system and configured for automatically moving the transducer to a new location along the frame when a predetermined extent of cell destruction is determined by the monitoring system.

37. The system of claim 31, wherein the transducer device comprises a plurality of transducers disposed in a substantially planar arrangement, the transducers being configured for generating substantially linear focal zones that extend substantially parallel to one another.

38. The system of claim 37, wherein the transducer device comprises a first transducer configured for focusing acoustic energy at a first focal distance a second transducer configured for focusing acoustic energy at a second focal distance different from the first focal distance.

39. A method for destroying cells within a subcutaneous tissue region using a transducer mounted to a frame, the method comprising:

disposing the frame in close proximity to an external surface of a patient with the transducer oriented towards the subcutaneous tissue region;

driving the transducer with drive signals such that the transducer emits acoustic energy while focusing the acoustic energy from the transducer at a substantially linear focal zone within the tissue region, thereby causing cavitation and destroying cells within the focal zone;

monitoring cavitation within the focal zone;

correlating the cavitation within the focal zone with an extent of cell destruction within the focal zone; and

automatically moving the transducer along the frame to a new location along the external surface of the patient when a predetermined level of cell destruction within the focal zone is obtained.

40. The method of claim 39, wherein the cavitation is monitored by one or more cavitation detectors.

41. The method of claim 40, wherein the cavitation detectors comprise acoustic sensors that produce signals in response to cavitation within the focal zone, and wherein the signals are compared to a database to correlate the cavitation occurring within the focal zone to the extent of cell destruction.

42. The method of claim 41, wherein a rate of change in amplitude of the signals is correlated with an empirical database to determine when the predetermined level of cell destruction is obtained.

43. The method of claim 42, wherein the cavitation detectors comprise acoustic sensors that produce signals in response to cavitation within the focal zone, and wherein the signals are integrated over time until a predetermined value is reached, the predetermined value corresponding to the predetermined level of cell destruction.

44. The method of claim 39, wherein the transducer simultaneously generates multiple substantially linear focal zones when driven by the drive signals.

45. The method of claim 44, wherein the multiple substantially linear focal zones are focused at different focal distances, such that multiple layers of tissue are substantially simultaneously destroyed by the transducer.

46. The method of claim 39, wherein the transducer is moved incrementally along the frame when a predetermined level of cell destruction is obtained within successive focal zones.

47. The method of claim 39, further comprising introducing a fluid into the tissue region, the fluid comprising gas bubbles for enhancing cavitation within the tissue region.

48. The method of claim 39, wherein the subcutaneous tissue region comprises adipose tissue, and wherein the ruptured cells comprise adipose cells.