Method and apparatus for monitoring and controlling thermally induced tissue treatment

• US 7,824,395 B2
• Filed: 08/29/2006
• Issued: 11/02/2010
• Est. Priority Date: 08/29/2005
• Status: Expired due to Fees

• Current Assignee: Reliant Technologies, Inc. (Bausch Health Cos., Inc.)
• Original Assignee: Reliant Technologies, Inc. (Bausch Health Cos., Inc.)
• Inventors: Sink, Robert Kehl, Chan, Kin F., Frangineas, George, DeBenedictis, Leonard C.
• Primary Examiner(s): Farah; Ahmed M
• Application Number:
  US11/468,275
• Publication Number:
  US 20070093797A1
• Time in Patent Office: 1,526 Days
• Field of Search: 606 2- 19, 607 88- 94, 128/898
• US Class Current: 606/10
• 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, the apparatus comprising:

an electromagnetic source that generates electromagnetic energy for creating a fractional treatment;

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

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; and

a controller operably connected to the dosage evaluation sensor, the controller configured to automatically adjust in real-time at least one operational parameter of the apparatus in response to the measurements of the dosage evaluation sensor and while delivering the electromagnetic energy to the target region of human skin, and said automatic adjustment controlling the fractional treatment created by the electromagnetic energy.

2. The apparatus of claim 1, wherein the dosage evaluation sensor measures changes in skin birefringence due to the fractional treatment.

3. The apparatus of claim 1, wherein the controller adjusts a spacing of treatment zones or a density of the treatment zones in the fractional treatment if overtreatment or undertreatment is detected by the dosage evaluation sensor.

4. The apparatus of claim 1, wherein the dosage evaluation sensor comprises:

an ultrasonic transmitter that generates an ultrasonic beam; and

an ultrasonic receiver that measures characteristic parameters of the ultrasonic beam to quantify changes in the skin response.

5. The apparatus of claim 1, wherein the dosage evaluation sensor measures changes in skin tension or changes in distance between two features located in or on the skin.

6. The apparatus of claim 1, wherein the dosage evaluation sensor uses coherent detection methods.

7. The apparatus of claim 1, wherein the dosage evaluation sensor captures images of the treatment region when illuminated with different wavelength ranges and the images are compared by the dosage evaluation sensor or by the controller.

8. The apparatus of claim 1, wherein the dosage evaluation sensor comprises two sensors that generate data corresponding to the skin condition prior to the fractional treatment or portion thereof and to the skin condition following said fractional treatment or portion thereof.

9. The apparatus of claim 1, wherein the fractional treatment forms a plurality of treatment zones, and a density of the treatment zones is adjusted in response to measurements of the dosage evaluation sensor.

10. The apparatus of claim 1, wherein the dosage evaluation sensor is configured to measure the response to at least one prior treatment pulse to evaluate the appropriate treatment level for at least one subsequent pulse.

11. The apparatus of claim 1, wherein the dosage evaluation sensor captures two or more images formed by different illumination wavelengths.

12. The apparatus of claim 1, wherein the dosage evaluation sensor captures two or more images formed by different polarizations.

13. The apparatus of claim 12, wherein the dosage evaluation sensor detects skin birefringence.

14. The apparatus of claim 1, wherein the dosage evaluation sensor comprises:

a radiation source configured to generate a stress wave; and

a detector configured to measure characteristic parameters of the stress wave to quantify changes in the skin response.

15. The apparatus of claim 1, further comprising:

a positional sensor operably connected to the controller, the positional sensor configured to measure a positional parameter of the handpiece and communicate the at least one positional parameter to the controller.

16. The apparatus of claim 15, wherein the positional parameter is velocity, distance, or position, and the controller is configured to adjust in real-time the at least one operational parameter of the apparatus in response to the measurements of the velocity, the distance, or the position by the positional sensor.

17. The apparatus of claim 15, wherein the controller is configured to adjust in real-time the at least one operational parameter of the apparatus while manually moving the handpiece across the target region of skin.

18. The apparatus of claim 1, wherein the electromagnetic source is a laser configured to generate the electromagnetic energy with a beam size of less than 1 mm for use in creating the fractional treatment.

19. A method for controlled fractional tissue treatment, the method comprising:

directing electromagnetic energy via a handpiece toward a target region of human skin for creating a fractional treatment;

manually moving the handpiece across the target region;

while directing electromagnetic energy toward the target region of human skin, sensing a skin response to the fractional treatment created by the electromagnetic energy at the target region of human skin; and

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

20. An apparatus for controlled fractional tissue treatment, the apparatus comprising:

source means for generating electromagnetic energy skin so as to create a fractional treatment;

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

sensor means for measuring a skin response to the fractional treatment created by the electromagnetic energy at the target region of human skin while the handpiece is manually moved relative to the target region and the electromagnetic energy is delivered to the target region of human skin; and

control means operably connected to the sensor means, said control means for automatically adjusting in real-time at least one operational parameter of the apparatus in response to the measurements of the sensor means and while delivering the electromagnetic energy to the target region of human skin, said automatic adjustment controlling the fractional treatment created by the electromagnetic energy.