METHOD AND SYSTEM FOR CONTROLLED THERMAL INJURY OF HUMAN SUPERFICIAL TISSUE

• US 20060116671A1
• Filed: 10/06/2005
• Published: 06/01/2006
• Est. Priority Date: 10/06/2004
• Status: Abandoned Application

• Current Assignee: Guided Therapy Systems Llc
• Original Assignee: Guided Therapy Systems Llc
• Inventors: Makin, Inder Raj S., Slayton, Michael H., Barthe, Peter G.
• Application Number:
  US11/163,148
• Publication Number:
  US 20060116671A1
• Time in Patent Office: Days
• US Class Current: 606/27
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 8/08 Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61B 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/4483 characterised by features of the ultrasound transducer
• CPC Class Codes: A61B 8/546 involving monitoring or regulation of device temperature
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A method and system for controlled thermal injury of human superficial tissue based on the ability to controllably create thermal lesions of variable shape, size, and depth via precise spatial and temporal control of acoustic energy deposition. The apparatus includes a control system and probes that facilitate treatment planning, control and delivery of energy, and monitoring of treatment conditions.

Claims

1. A therapeutic treatment system for controlled thermal injury in human superficial tissue within a region-of-interest, said treatment system comprising:

a control system configured for control of said treatment system;

a probe configured for generating a conformal lesion within the region-of-interest, said control system and said probe being configured for spatial and temporal control to generate the conformal lesion.

2. The therapeutic treatment system according to claim 1, wherein said spatial control comprises operational control of one or more spatial parameters comprising transducer configuration, distance, placement, orientation, and movement.

3. The therapeutic treatment system according to claim 1, wherein said temporal control comprises operational control of one or more temporal parameters comprising drive amplitude levels, frequency/waveforms, and timing sequences.

4. The therapeutic treatment system according to claim 1, wherein said spatial and temporal control is facilitated through an open-loop feedback control loop.

5. The therapeutic treatment system according to claim 1, wherein said spatial and temporal control is facilitated through a closed-loop feedback control loop.

6. The therapeutic treatment system according to claim 1, wherein said control system comprises:

power source components configured to provide energy to said control system and said probe;

sensing and monitoring components configured for monitoring said spatial and temporal parameters;

cooling and coupling controls configured to facilitate temperature control at superficial human tissue interface and deeper into tissue; and

processing and control logic components for overall control of said therapeutic treatment system.

7. The therapeutic treatment system according to claim 1, wherein said probe comprises:

a control interface for interfacing with said control system;

a transducer configured for providing ablative ultrasound energy to the region-of-interest;

coupling components for acoustically coupling said transducer to the region of interest;

monitoring and sensing components for facilitating control by said control system; and

motion mechanism comprising one of manual and automated movement of said probe.

8. The therapeutic treatment system according to claim 2, wherein said transducer configuration comprises one or more structures of focused, planar, unfocused elements, one or more single-element, multi-element, and array transducers, one or more 1-D, 2-D, annular arrays, linear, curvilinear, sector, and spherical arrays.

9. The therapeutic treatment system according to claim 8, wherein said transducer configuration comprises one or more spherically, cylindrically, electronically focused, concave-shaped and low-profile lens, composed of at least one of plastics, polyurethanes, ceramics, metals, liquids, and composite materials.

10. The therapeutic treatment system according to claim 2, wherein said transducer configuration comprises a broadband transducer excited at one or more frequencies.

11. The therapeutic treatment system of claim 7, wherein said probe comprises at least one of sensors, motion sensors, switches, actuators, indicators, encoders, probe identification, memory devices, aperture selection and multiplexers, electric matching networks, and switching, interconnect, connectors, handle, and disposable members.

12. The therapeutic treatment system according to claim 6, wherein said control system comprises at least one of treatment planning, display, switches, microcontroller, microprocessor, computer, control firmware, user and control software.

13. The therapeutic treatment system of claim 6, whereby said control system comprises one or more of DC power supplies, current sensors, power detection and measurement, waveform synthesizer, oscillator, digital programmable logic, amplifier/driver, beamformer, harmonic filter, matching networks, cooling/acoustic coupling/thermal control/acoustic focusing control hardware, motion mechanism drivers and control, motion sensors, monitoring and closed loop control, interfacing and control, external input/output hardware and external interfaces.

14. The therapeutic treatment system according to claim 6, wherein said probe comprises transducer acoustic coupling, cooling, and/or liquid-filled acoustic lensing mechanisms configured to regulate temperature at an interface between said transducer and the region-of-interest, and into region-of-interest.

15. The therapeutic treatment system according to claim 1, wherein said probe can be depressed against a tissue interface whereby blood perfusion is at least partially cut-off, and tissue flattened in the superficial treatment region-of-interest.

16. The therapeutic treatment system according to claim 1, wherein said controlled thermal injury is deposited in a continuous or discrete manner to trigger biological repair mechanisms.

17. The therapeutic treatment system according to claim 1, wherein said controlled thermal injury is deposited to facilitate an optimized cycle of recovery by way of varying of shapes and depths of thermal injuries in at least one location of said superficial human tissue.

18. The therapeutic treatment system according to claim 2, wherein said transducer configuration comprises a convex-shaped lens, in the form of at least one of a liquid-filled, gel-filled, solid gel lens, rubber or composite lens or any material with velocity less than that of superficial tissue and/or acoustic coupling medium and with adequate power handling capacity.

19. The therapeutic treatment system according to claim 2, wherein said transducer configuration comprises a combined imaging/therapy transducer within a single transduction element, wherein said imaging transducer is electrically isolated from said therapy transducer.

20. The therapeutic treatment system according to claim 1, wherein said control system comprises an imaging system configured for facilitating at least one of one-dimensional, two-dimensional and three-dimensional imaging or treatment.

22. The method according to claim 20, wherein said controlling operation comprises utilizing an open-loop feedback loop to determine when said thermal lesion has achieved said selected shape, size and orientation.

23. The method according to claim 20, wherein said controlling operation comprises utilizing an closed-loop feedback loop to determine when said thermal lesion has achieved said selected shape, size and orientation.

24. The method according to claim 20, wherein said spatial parameters comprise transducer configuration, distance, placement, orientation, and movement.

25. The method according to claim 20, wherein said temporal parameters comprise drive amplitude levels, frequency/waveforms, and timing sequences.

26. The method according to claim 20, wherein said control system and probe are controlled to generate the thermal lesion within a variable depth of 0-30 mm and a frequency range of 1 to 40 MHz, with a time duration and energy level sufficient to overcome tissue thermal capacity.

28. The treatment system according to claim 26, wherein said control system is configured to control operation of more than one spatial parameters comprising transducer configuration, distance, placement, orientation, and movement and control operation of more than one temporal parameters comprising drive amplitude levels, frequency/waveforms, and timing sequences.

30. The treatment system according to claim 26, wherein said transducer comprises an combined imaging/therapy transducer.

21. A method for controlled thermal injury in human superficial tissue within a region-of-interest, said method comprising:

selecting at least one shape, size and orientation of a thermal lesion from a variety of selection choices;

providing a control system and a probe with one or more spatial parameters;

providing said control system and said probe with one or more temporal parameters;

controlling operation of said control system and said probe based on said spatial parameters and said temporal parameters to produce said selected shape, size and orientation of the thermal lesion within the region-of-interest.

27. A treatment system configured for controlled thermal injury within a region-of-interest, said treatment system comprising:

a control system configured for facilitating spatial and temporal control of said treatment system;

a probe comprising a transducer configured for spatial and temporal control, said probe being configured for generating conformal lesions of variable shape, size and orientation, said lesions being configured within a depth of superficial human tissue between zero and 30 mm and through operation of said transducer at a frequency of between 1 MHz and 40 MHz and for a time duration and energy level sufficient to overcome tissue thermal capacity for the region-of-interest.

29. The treatment system according to claim 27, wherein said treatment system is configured within at least one of an open-loop and a closed-loop feedback system.