Method and Apparatus for Monitoring and Controlling Thermally Induced Tissue Treatment

• US 20070093798A1
• Filed: 08/29/2006
• Published: 04/26/2007
• Est. Priority Date: 08/29/2005
• Status: Abandoned Application

• Current Assignee: Reliant Technologies, Inc. (Bausch Health Cos., Inc.)
• Original Assignee: Reliant Technologies, Inc. (Bausch Health Cos., Inc.)
• Inventors: Stumpp, Oliver, DeBenedictis, Leonard, Chan, Kin, Myers, Thomas, Hantash, Basil, Stuart, B., Sink, Robert
• Application Number:
  US11/468,279
• Publication Number:
  US 20070093798A1
• Time in Patent Office: Days
• US Class Current: 606/12
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/203 applying laser energy to the outside of the body
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00476 Hair follicles
• CPC Class Codes: A61B 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2059 Mechanical position encoders
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2034/2065 Tracking using image or pattern recognition
• CPC Class Codes: A61B 2090/373 using light, e.g. by using optical scanners
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3958 emitting a signal
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

A method and apparatus for thermal treatment of tissue by irradiating the skin with electromagnetic energy is disclosed. Sources of electromagnetic energy include radio frequency (RF) generators, lasers, and flashlamps. The apparatus includes either a positional sensor or a dosage evaluation sensor, or both types of sensors. These sensors provide feedback to a controller. The controller may control the electromagnetic source parameters, the electromagnetic source activation, and/or the sensor measurement parameters. An additional scanning delivery unit may be operably coupled to the controller or to the sensors to provide a controlled distribution of electromagnetic energy to the target region of the skin. The use of positional measurement sensors and dosage evaluation sensors permits the controller to automatically determine the proper electromagnetic source parameters including, for example, pulse timing and pulse frequency.

Claims

1. An apparatus for controlled fractional tissue treatment comprising:

an electromagnetic source that generates electromagnetic energy;

a manually movable handpiece that delivers the electromagnetic energy to a target region of human skin;

a positional sensor that measures at least one positional parameter of the handpiece; and

a controller operably connected to the positional sensor, the controller adjusting in real-time at least one operational parameter of the apparatus in response to the at least one positional parameter measured by the positional sensor, said adjustment causing the electromagnetic energy to create a fractional treatment for the target region of human skin.

2. The apparatus of claim 1, further comprising:

a dosage evaluation sensor that measures a skin response to the fractional treatment created by the electromagnetic energy at the target region of human skin, wherein the controller further adjusts in real-time at least one operational parameter of the apparatus in response to the measurements of the dosage evaluation sensor, said adjustment controlling the fractional treatment created by the electromagnetic energy.

3. The apparatus of claim 2, wherein the positional sensor is a non-mechanical positional sensor.

4. The apparatus of claim 3, wherein the controller is not configured to maintain a scanner rate substantially proportional to a handpiece velocity and/or speed over a preselected range of velocities and wherein a laser pulse rate of the electromagnetic source is adjusted in proportion to a handpiece velocity and/or speed.

5. The apparatus of claim 2, wherein the positional sensor comprises a magnetic positional sensor.

6. The apparatus of claim 2, wherein the dosage evaluation sensor comprises two sensors that generate data corresponding to a skin condition prior to the fractional treatment or portion thereof and to a skin condition following said fractional treatment or portion thereof.

7. The apparatus of claim 2, wherein a treatment zone density is adjusted in response to the measurements of the dosage evaluation sensor.

8. The apparatus of claim 2, wherein the dosage evaluation sensor is configured to measure a response to at least one prior treatment pulse to evaluate the appropriate treatment level for at least one subsequent pulse.

9. The apparatus of claim 1, wherein the positional sensor is a non-mechanical positional sensor.

10. The apparatus of claim 9, wherein the controller adjusts in real-time at least one operational parameter of the electromagnetic source to affect the fractional treatment by causing at least one of a new treatment rate, a new treatment density, and a new treatment pattern in response to measurements by the nonmechanical positional sensor.

11. The apparatus of claim 1, wherein the electromagnetic source is an optical source that generates an optical beam and the apparatus further comprises an optical scanner that directs the optical beam to multiple locations at the target region.

12. The apparatus of claim 11, wherein the controller maintains a scanner rate substantially proportional to a handpiece velocity and/or speed over a preselected range of velocities.

13. The apparatus of claim 11, wherein the controller adjusts a laser pulse rate in proportion to a variable handpiece velocity and/or speed.

14. The apparatus of claim 11, wherein the scanner blurs the optical beam along the treatment zone by a predefined amount by adjusting a scanning rate of the optical scanner or pulse duration of the optical source.

15. The apparatus of claim 1, wherein the positional sensor comprises a plurality of positional sensors that are configured to measure positional parameters that span two-dimensional space and/or three-dimensional space.

16. The apparatus of claim 1, wherein the positional sensor comprises at least one of an accelerometer and a gyroscope.

17. The apparatus of claim 1, wherein the positional sensor comprises a magnetic positional sensor.

18. The apparatus of claim 17, wherein the magnetic positional sensor comprises at least two loop antennas.

19. The apparatus of claim 1, wherein the positional sensor comprises at least two transmitter-receiver pairs whereby a wireless communication occurs between the transmitter and the receiver and positional parameters are calculated from at least one of time-of-flight measurements and phase measurements of the wireless communication signals.

20. The apparatus of claim 1, wherein the positional sensor comprises an ultrasonic transmitter and an ultrasonic receiver.

21. The apparatus of claim 1, further comprising multiple light sources to illuminate the skin and wherein the controller discrimates between two images illuminated with separate illumination sources.

22. A method for controlled fractional tissue treatment comprising:

directing electromagnetic energy via a handpiece toward a target region of human skin;

manually moving the handpiece across the target region;

sensing at least one positional parameter of the handpiece; and

automatically adjusting in real-time at least one operational parameter of the electromagnetic energy in response to the at least one positional parameter, said adjustment controlling the fractional treatment created by the electromagnetic energy.

23. The method of claim 22 wherein the step of sensing a positional parameter comprises the step of optically sensing a positional parameter using an optical positional sensor that is mechanically coupled to the handpiece.

24. The method of claim 23, wherein the step of optically sensing a positional parameter further comprises applying a contrast enhancing agent into or onto the skin, and the contrast enhancing agent enhances the signal to noise ratio of the optical positional sensor.

25. The method of claim 23, wherein optical contrast for the optical positional sensor is enhanced by the step of creating treatment zones.

26. The method of claim 25 wherein the step of creating treatment zones comprises ablating tissue.

27. The method of claim 23, wherein optical contrast for the optical positional sensor is enhanced by applying an optical contrast enhancing agent to the human skin.

28. The method of claim 27, wherein the total optical absorption of the optical contrast enhancing agent in the wavelength range of 300-400 nm is higher than the total optical absorption in the wavelength range of 400-700 nm.

29. The method of claim 27, wherein the total optical absorption of the optical contrast enhancing agent in the wavelength range of 750-1000 nm is higher than the total optical absorption in the wavelength range of 400-700 nm.

30. The method of claim 27, further comprising the steps of illuminating the contrast enhancing agent with a wavelength in the range of 300-1000 nm and detecting a fluorescent signal from the contrast enhancing agent substantially in the wavelength range of 350-1050 nm.

31. The method of claim 27, wherein the step of applying an optical contrast agent comprises spraying and/or applying the optical contrast agent using one or more of rollers, stamps, and stencils.

32. The method of claim 27, wherein the optical contrast enhancing agent is applied with a pattern with nonuniform spacing between adjacent figures.

33. The method of claim 27, wherein the step of applying the optical contrast agent comprises the step of attaching an adhesive to the skin in which the optical contrast enhancing agent is embedded.

34. An apparatus for controlled fractional tissue treatment comprising:

source means for generating electromagnetic energy;

manually movable handpiece means for delivering the electromagnetic energy to a target region of human skin;

first sensor means for measuring at least one positional parameter of the handpiece means;

second sensor means for measuring a skin response to the fractional treatment created by the electromagnetic energy at the target region of human skin; and

control means operably connected to the first and second sensor means, for adjusting in real-time at least one operational parameter of the apparatus in response to the measurements from the first and second sensor means, said adjustment causing the electromagnetic energy to create a fractional treatment for the target region of human skin.