WO2001078830A2 - Photostimulaton treatment apparatus and methods for use - Google Patents

Photostimulaton treatment apparatus and methods for use Download PDF

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Publication number
WO2001078830A2
WO2001078830A2 PCT/US2001/012422 US0112422W WO0178830A2 WO 2001078830 A2 WO2001078830 A2 WO 2001078830A2 US 0112422 W US0112422 W US 0112422W WO 0178830 A2 WO0178830 A2 WO 0178830A2
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WO
WIPO (PCT)
Prior art keywords
energy
biological tissue
radiation
temperature
change
Prior art date
Application number
PCT/US2001/012422
Other languages
French (fr)
Other versions
WO2001078830A3 (en
Inventor
Sean M. Casey
Harold M. Gerdes
Original Assignee
Medelaser, Llc
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Filing date
Publication date
Priority to US55077800A priority Critical
Priority to US09/550,778 priority
Application filed by Medelaser, Llc filed Critical Medelaser, Llc
Publication of WO2001078830A2 publication Critical patent/WO2001078830A2/en
Publication of WO2001078830A3 publication Critical patent/WO2001078830A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/0616Skin treatment other than tanning
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00057Light
    • A61B2017/00066Light intensity
    • A61B2017/0007Pyrometers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B2018/2015Miscellaneous features
    • A61B2018/2025Miscellaneous features with a pilot laser

Abstract

A therapeutic treatment apparatus (10) for photostimulation of biological tissue (20, 30, 40) that includes at least one treatment radiation source (50) configured to radiate energy at a predetermined wavelength selected from the range approximately between 400 and 11,500 nanometers and adapted to illuminate the biological tissue (20, 30, 40).

Description

PHOTOSTIMULATION TREATMENT APPARATUS AND METHODS FOR USE

Technical Field

This invention relates to an apparatus for treating various biological tissues and bio-

medical conditions in mammals with a photostimulation device that is precisely controlled

using, in part, a high-precision temperature monitoring device such as a thermographic

diagnostic device.

Background of the Invention

The treatment of various biomedical conditions in mammals have been treated by

physicians and therapists using a wide variety of photostimulation devices. Many such devices

are configured to emit radiation having visible and infrared wavelengths (approximately

between 400 to 11,500 nanometers) as it has been shown that therapeutic benefits may result

from irradiating biological tissue with certain wavelengths of radiation for various periods of

time. In various surgical applications, photostimulation devices are configured to emit radiation

outside the visible and near-infrared ranges described above to induce photoablation of various

tissues, which, depending upon the type of resulting effect, is also referred to by those with skill

in the art as ablation, vaporization, ionization, and destruction. In both surgical and therapeutic

applications, various attempts have been made to monitor the temperature of the biological

tissues subject to the incident radiation so that minimum and maximum energy input to the biological tissues can be induced and/or maintained. Li any application of photostimulation techniques to biological tissue, various incident

radiation parameters are to be selected, adjusted, and monitored including the wave length,

energy, pulse duration (including a continuous pulse), divergence of the incident radiation beam,

and luminosity. In the past, a wide variety of focusing and defocusing optics have been used to

establish a quantified cross-sectional area of the incident radiation beam at the point along a

beam axis that intersects the upper surface of the biological tissue. By selecting, monitoring,

and controlling at least these parameters, then the user can control the effects on the target

biological tissue from the incident radiation, which effects include thermal effects such as

vaporization, ionization, heating by phonon absorption, and atomic and molecular electronic,

rotational, and vibrational excitation.

fn therapeutic applications, it is desirable to induce only so much energy of a selected

wavelength on the biological tissue whereby certain desirable effects can be induced. These

effects typically do not irradiate the target with enough energy to cause vaporization and/or

ionization. However, in most therapeutic applications, the biological tissue is irradiated with

enough energy to induce he desired therapeutic effect, which can include photocoagulation as

well as less damaging thermal effects such as denaturing of the tissue proteins. Even less

damaging effects can also be initiated that include photostimulated biochemical changes

induced by electronic, rotational, and vibrational excitation of the various constituents of the

target biological tissue. At least one study has attempted to classify the various optical

properties of human tissue. See, e.g., p. 1386, Parrish. J.A., Deutsch, T. F., Laser

Photomedicim, I.E.E.E. J. of Quantum Electronics, Vol. QE-20, No. 12, 12/1984; Meyer, R.

A., et al., A Laser Stimulator for the Study of Cutaneous Hiermal and Pain Sensation, I.E.E.E.

Transactions on Biomedical Engineering, Vol. BME-23, No. 1 , pp. 54-60, 1/1976; A Brief Report, and Some Abstracts from the International Discussions of Laser Applications in Medicine, Paris, 7-8 July 1969, Medical and Biological Engineering, Vol. 8, pp. 427-430,

Pergamon Press, 1970, Great Britain.

Various photostimulation devices have been taught in the prior art that are configured

for irradiating and/or ablating target biological tissue. U.S. Pat. No. 5,346,488 to Prince et al. is

limited to ablation of atherosclerotic plaque using short-duration laser pulses. U.S. Pat. Nos.

5,112,328; 5,196,004; 5,520,697; and 5,540,676 are directed to laser-based surgical devices that

incorporate one or more laser radiation sources emitting electromagnetic radiation having one or

more wavelengths and which are adapted to be used in various photomedicinal applications.

U.S. Pat. No. 5,150,704 is directed to a device that incorporates multiple radiation sources for

irradiating selected body parts with a plurality of laser probes. U.S. Pat. Nos. 4,854,320 and

5,002,051 are both limited to irradiation of laser energy to cause the denaturing of collagenous

proteins of biological tissue to produce a biological glue to purportedly improves healing of

wounds. Other examples of laser-based photostimulation devices configured for use in a variety

of surgical and therapeutic applications include U.S. Pat. Nos. 4,573,465; 4,966,144; 5,161,526;

5,409,482; 5,445,146; 5,527,350; and 5,951,596; French Pat. Nos. 2,458,272; 2,561,515;

2,577,425; German Pat. Nos. 2,820,908; 3,401,492; andU.S.S.R. Pat Nos. 871,802; 1,242,187;

1,771,762; and 1,782,617.

None of these references disclose, teach, suggest, or provide any motivation for

incorporating energy management devices that can precisely measure the actual amount of

energy absorbed by the target biological tissue. In the applications described in the prior art

where certain predetermined dosages of energy were to be applied to the target biological tissue,

the radiation source and the method of its use to irradiate the target biological tissue was

preconfigured to operate at a preselected wavelength, energy output, pulse rate, frequency, and/or exposure time. Various types of temperature measuring devices exist. However, very few of the temperature measurement devices available in the prior art are suitable for use for purposes of the present invention. The prior art describes various types of temperature measurement devices. In most applications, surface contact thermistors and/or thermometers are used to measure the surface temperature of the target biological tissue. However, these types of devices are unsuitable for purposes of the present invention because they cannot be moved in real-time in applications where the target biological tissue includes a wide area that is irradiated in sections that are changed or rotated over some time interval. Additionally, the presence of a contact temperature measurement can interfere with the desired irradiation treatment modality. U.S. Pat. Nos. 5,115,815; 5,386,117; 5,458,418; 5,467,126; 5,595,444; and 5,637,871 disclose various non-contact devices that are configured to measure the temperature of a target surface using various types of infrared radiation detection devices that operate using well-known thermography principles. Despite the capabilities of the various systems disclosed in the prior

art, none the references discloses, suggests, or describes any motivation to use the thermography devices in accordance with the aspects of the present invention.

What has been needed but unavailable in the prior art is the accurate, real-time detection of temperature during treatment of a target biological tissue using surgical and therapeutic photostimulation devices. In particular, what has been needed is a photostimulation device and method for use that can impart a precisely controlled amount of energy to a target biological tissue and that can simultaneously, continuously, and precisely monitor the energy imparted to the target tissue. Accordingly, the present invention discloses an apparatus and a method for use that incorporates these and other capabilities. SUMMARY OF THE INVENTION

h general, the present invention relates to an apparatus, and a method for using it, that

is directed to the photostimulation of biological tissue such as, for example without

limitation, cutaneous and subcutaneous biological tissues. Many types of electromagnetic

radiation sources, guides, projectors, detectors, and controllers are available that are suitable

for purposes of the present invention. The apparatus includes a therapeutic treatment

apparatus for photostimulation of biological tissue that includes at least one treatment

radiation source that is configured to emit radiation at a predetermined wavelength selected

from the range of approximately between 400 and 11 ,500 nanometers.

The treatment radiation source may be one of a plurality of sources each configured to

emit radiation at one or more wavelengths including, for purposes of illustration but not

limitation, the above described range, hi configurations where more than one treatment

radiation source is used, then the sources are preferably coupled to an optical coupler. The

coupler is further coupled to a radiation guide such as a fiber optic guide adapted to

communicate the radiation of the treatment source or sources.

Preferably, the at least one treatment radiation source is selected from the group

including semiconductor laser diodes, super-luminous diodes, light emitting devices, and

solid-state laser diodes ("SSD"). More preferably, the at least one treatment radiation source

is configured to emit radiation having a wavelength of approximately between 800 and 1,100

nanometers. Even more preferably, the at least one treatment radiation source is a

neodymium-yttrium-aluminum-garnet ("Nd: YAG") laser tuned to emit radiation having a

wavelength of approximately 1,064 nanometers.

The fiber optic guide may be further connected to a radiation focusing device such as

a radiation emitting probe or wand that can be manipulated by a user for purposes of

irradiating the target biological tissue. Each of the treatment radiation sources may alternatively be coupled to additional, independent wands or probes via' additional, separate

fiber optic cables.

For configurations of the present that employ treatment radiation that is invisible to

the unaided human eye, an additional radiation source configured to emit radiation in the

visible spectrum may be coupled to the previous treatment radiation sources to operate as an

aiming radiation source. Alternatively, the aiming radiation source may be coupled to each of

the radiation sources that are independently coupled to separate wands or probes, hi other

variations, additional aiming radiation sources may be used to emit radiation at various

visible wavelengths of light so that multiple aiming radiation wavelengths maybe employed

and coupled to selected treatment radiation sources. For example, visible blue light may

indicate treatment radiation of a first wavelength, while visible red light may be used to

indicate a different treatment radiation wavelength, and other colors may be used to indicate

other types of treatment radiation. Alternatively, multiple different wavelengths of aiming

radiation may be used to indicate modes of operation. For example, power settings below a

certain predetermined threshold may be identified by visible red light, while higher power

settings may be indicated using visible blue light.

The present invention also incorporates a video-type camera that is preferably

configured to detect infrared radiation having a wavelength approximately between 700 and 20,000 nanometers. The camera is further preferably adapted to produce image signals

corresponding to the detected radiation. A data processing and recording device is also

included in the present invention, which is capable of receiving and processing the image

signals and adapted to generate an electronic signal in the form of a plurality of digitally

encoded frames corresponding to the image signals. The data processing and recording

device preferably captures and analyzes the frames. In analyzing the frames, the data

processing and recording device is configured to quantify the radiation emitted by the biological tissue in units of measurement selected from the group including wavelength,

radiance, luminosity, temperature, area, volume, change in temperature, rate of change of temperature, relative temperature, energy, change in energy, rate of change of energy, and

relative energy.

The data processing and recording device may also include a memory or storage

component capable of temporarily and/or permanently storing the image signals, electronic

signals, and/or frames to any of a number of such components including, for example but not

for limitation, random access memory, floppy disks, CD-ROMs, conventional hard disks,

analog or digital video tape, and any other type of readily available storage media that is

presently available for such purposes.

In a variation of the preceding embodiment, the therapeutic treatment apparatus for

photostimulation of biological tissue incorporates at least one treatment radiation source

providing radiation at a predetermined wavelength selected from the range approximately

between 800 and 1,100 nanometers and adapted to illuminate the biological tissue, h a

further variation, the data processing and recording device is capable of receiving and

processing the image signal and adapted to generate an electronic signal in the form of a

plurality of frames corresponding to the image signal at various time intervals. Preferably,

the data processing and recording device captures and analyzes the frames to quantify the

radiation emitted by the biological tissue in units of measurement selected from the group

described above. More preferably, the data processing and recording device is further

configured to control the energy output of the at least one treatment radiation source to induce

and maintain a preselected energy input to and output from the biological tissue.

The present invention also contemplates a variation wherein the data processing and

recording device is configured to measure the temperature of the biological tissue and to control the output of the at least one treatment radiation source whereby the biological tissue

is heated to and maintained at a predetermined temperature for a selected period of time.

In another variation of the instant invention, the therapeutic treatment apparatus for

photostimulation of biological tissue is modified wherein the data processing and recording

device is further configured to block the energy emitted by the at least one treatment radiation

source that is reflected by the biological tissue and subtract the reflected energy from

quantified unit of measure.

The present invention is also directed to a variation wherein the data processing and

recording device is further configured to control the energy output of the at least one

treatment radiation source to induce and maintain a preselected energy input to and output

from the biological tissue sans the reflected energy.

In yet another variation of the present invention, a therapeutic treatment apparatus for

photostimulation of biological tissue includes at least one treatment radiation source

providing radiation at a predetermined wavelength selected from the range approximately

between 400 and 11,500 nanometers and adapted to illuminate the biological tissue. Also

included is an infrared camera configured to detect infrared radiation emitted by the target

biological tissue and adapted to produce an image signal corresponding to the detected

radiation and further including a filter component adapted to block radiation having the

predetermined wavelength, the filter selected from the group including optical and electronic

filters. This variation further incorporates a data processing and recording device that is

capable of receiving and processing the image signal and adapted to generate an electronic

signal in the form of a plurality of frames corresponding to the image signal. The data

processing and recording device is adapted to capture and analyze the frames to quantify the

radiation emitted by the biological tissue in at least one unit of measurement selected from the

group including wavelength, radiance, luminosity, area, volume, temperature, change in temperature, rate of change of temperature, relative temperature, energy, change in energy,

rate of change of energy, and relative energy.

hi an alternative configuration, the instant invention contemplates a therapeutic

treatment apparatus for photostimulation of biological tissue that incorporates at least one

treatment radiation source providing radiation at a predetermined wavelength selected from

the range approximately between 400 and 11,500 nanometers and adapted to illuminate the

biological tissue. This configuration includes an infrared camera configured to detect infrared

radiation emitted by the target biological tissue and adapted to produce an image signal

corresponding to the detected radiation at windows corresponding to precise moments in

time. A data processing and recording device is also incorporated that is capable of receiving

and processing the image signal, and which is adapted to generate an electronic signal in the

form of a plurality of frames corresponding to the image signal. The data processing and i recording device in this alternative configuration is adapted to capture and analyze the frames

to quantify the radiation emitted by the biological tissue in at least one unit of measurement

selected from the group including wavelength, radiance, luminosity, area, volume,

temperature, change in temperature, rate of change of temperature, relative temperature,

energy, change in energy, rate of change of energy, and relative energy. This configuration of

the data processing and recording device is further modified to control the infrared camera

and the energy output of the at least one treatment radiation source to emit pulses of radiation to induce and maintain a preselected energy input to and output from the biological tissue

sans the reflected energy. Lastly, the data processing and recording device is further

configured to block the detection of treatment radiation reflected by the biological tissue by

synchronizing the timing the emitted treatment radiation pulses with the infrared camera

detection windows so that the camera captures an image of the radiation emitted by the target

biological tissue at a moment between radiation pulses. The present invention also contemplates a method for use of a therapeutic treatment

apparatus for photostimulation of biological tissue that includes the steps of selecting at least

one treatment radiation source that provides radiation at a predetermined wavelength selected

from the range approximately between 400 and 11,500 nanometers and adapted to illuminate

the biological tissue. Also included is the step of selecting an infrared camera that is

configured to detect infrared radiation emitted by the target biological tissue, the camera

being adapted to produce image signals corresponding to the detected radiation. A data

processing and recording device is selected that is capable of receiving and processing the

image signals and adapted to generate an electronic signal in the form of a plurality of frames

corresponding to the image signals. The data processing and recording device captures and

analyzes the frames and also quantifies the radiation emitted by the biological tissue. The

radiation is quantified in at least one unit of measurement selected from the group including

wavelength, radiance, luminosity, area, volume, temperature, change in temperature, rate of

change of temperature, relative temperature, energy, change in energy, rate of change of

energy, and relative energy.

In a variation of the preceding method, the method further includes the steps of

controlling the energy output of the at least one treatment radiation source to induce and

maintain a preselected energy input to and output from the biological tissue; blocking the

energy emitted by the at least one treatment radiation source that is reflected by the biological

tissue and subtracting the reflected energy from quantified unit of measure; and controlling

the energy output of the at least one treatment radiation source to induce and maintain a

preselected energy input to and output from the biological tissue sans the reflected energy. Brief Description of the Drawing

Without limiting the scope of the present invention as claimed below and referring

now to the drawings, wherein like reference numerals and numerals with primes across the

several views refer to identical, corresponding, or equivalent features and parts:

Figure 1 is a schematic representation of the various elements of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The therapeutic treatment apparatus of the present invention is generally configured

for photostimulation of biological tissue. The apparatus includes at least one treatment

radiation source adapted to radiate electromagnetic energy at a predetermined wavelength

selected from the range approximately between 400 and 11,500 nanometers. The apparatus

further incorporates an infrared camera configured to precisely and continuously detect

infrared radiation. The camera is adapted to produce image signals corresponding to the

detected radiation. A data processing and recording device is also included that is capable of

receiving and processing the image signals. The data processing and recording device is

further adapted to generate an electronic signal in the form of a plurality of digital frames that

correspond to the image signals. The data processing and recording device is also configured

to capture and analyze the frames and to quantify the radiation emitted by the biological

tissue. The radiation is quantified in units of measurement selected from the group including

wavelength, radiance, luminosity, temperature, area, volume, change in temperature, rate of

change of temperature, relative temperature, energy, change in energy, rate of change of

energy, and relative energy. The data processing and recording device is also configured to

detect and/or block the energy emitted from the at least one treatment radiation source that is reflected by the target biological tissue. The therapeutic treatment apparatus is also

configured to quantify the energy emitted by the biological tissue by blocking or subtracting the reflected energy from the quantified result. A method for using the device in its multiple

configurations, variations, modifications, and alternatives is also disclosed.

Referring now to FIG. 1, the present invention relates to an apparatus 10, and a

method for using it, that is directed to the photostimulation of biological tissue 20 such as, for

example without limitation, cutaneous and subcutaneous biological tissues 30, 40. Many

types of electromagnetic radiation sources, guides, projectors, detectors, and controllers are

available that are suitable for purposes of the present invention. Many such devices that

include such components are disclosed in co-owned U.S. patent application serial no.

09/281,443, filed on March 29, 1999, now U.S. Pat. No. , and in U.S. Pat.

Nos. 4,573,465; 4,966,144; 5,002,051; 5,049,147; 5,112,328; 5,139,494; 5,150,704;

5,445,146; 5,527,350; 5,540,676; 5,755,752; and 5,951,596, each of which are hereby

incorporated by reference in their entirety.

The apparatus of the instant includes a therapeutic treatment apparatus for

photostimulation of biological tissue that includes at least one treatment radiation source 50

that is configured to emit radiation at a predetermined wavelength selected from the range of

approximately between 400 and 11,500 nanometers.

The treatment radiation source 50 may be one of a plurality of sources 50, 60, 70 each

configured to emit radiation at one or more wavelengths including, for purposes of illustration

but not limitation, the above described range. In configurations where more than one

treatment radiation source is used, then the sources 50, 60, 70 are preferably coupled to an

optical coupler 80. The coupler 80 is further coupled to a radiation guide 90 such as a fiber

optic guide adapted to communicate the radiation of the treatment source or sources.

Preferably, the at least one treatment radiation source 50 is selected from the group

including semiconductor laser diodes, super-luminous diodes, light emitting devices, and

solid-state laser diodes ("SSD"). More preferably, the at least one treatment radiation source 50 is configured to emit radiation having a wavelength of approximately between 800 and

1,100 nanometers. Even more preferably, the at least one treatment radiation source 50 is a neodymium-yttrium-aluminum-garnet ("Nd: YAG") laser tuned to emit radiation having a

wavelength of approximately 1,064 nanometers.

The fiber optic guide 90 may be further connected to a radiation focusing device such

as a radiation emitting probe or wand 100 that can be manipulated by a user for purposes of

irradiating the target biological tissue 20. Each of the treatment radiation sources 50, 60, 70

may alternatively be coupled to additional, independent wands or probes via additional,

separate fiber optic cables (not shown).

For configurations of the present that employ treatment radiation that is invisible to

the unaided human eye, an additional radiation source configured to emit radiation in the

visible spectrum, such as for example, source 70, may be coupled to the previous treatment

radiation sources 50, 60 to operate as an aiming radiation source. Alternatively, the aiming

radiation source 70 maybe coupled to each of the radiation sources 50, 60 that are

independently coupled to separate wands or probes similar to probe 100. hi other variations,

additional aiming radiation sources (not shown) may be used to emit radiation at various

visible wavelengths of light so that multiple aiming radiation wavelengths may be employed

and coupled to selected treatment radiation sources. Alternatively, the radiation emitted by

aiming source 70 may be split and coupled to various probes. For example, visible blue light

may indicate treatment radiation of a first wavelength, while visible red light emitted by a

separate source may be used to indicate a different treatment radiation wavelength, and other

colors may be used to indicate other types of treatment radiation. Alternatively, multiple

different wavelengths of aiming radiation may be used to indicate modes of operation. For

example, power settings below a certain predetermined threshold may be identified by visible

red light, while higher power settings may be indicated using visible blue light. The present invention also incorporates a video-type infrared camera 110 that is

preferably configured to detect infrared radiation having a wavelength approximately between

700 and 20,000 nanometers. The camera 110 is further preferably adapted to produce image

signals corresponding to the detected radiation. A data processing and recording device 115

is also included in the present invention, which is coupled by signal line 120 to the camera

110 and which is capable of receiving and processing the image signals and adapted to

generate an electronic signal in the form of a plurality of digitally encoded frames

corresponding to the image signals. The data processing and recording device 115 preferably

captures and analyzes the frames. In analyzing the frames, the data processing and recording

device 115 is configured to quantify the radiation emitted by the biological tissue 20 in units

of measurement selected from the group including wavelength, radiance, luminosity,

temperature, area, volume, change in temperature, rate of change of temperature, relative

temperature, energy, change in energy, rate of change of energy, and relative energy.

The data processing and recording device 115 may also include a memory or storage

component (not shown but known to those with skill in the art) capable of temporarily and/or

permanently storing the image signals, electronic signals, and/or frames to any of a number of

such components including, for example but not for limitation, random access memory,

floppy disks, CD-ROMs, conventional hard disks, analog or digital video tape, and any other

type of readily available storage media 130 that is presently available for such purposes.

In a variation of the preceding embodiment, the therapeutic treatment apparatus 10 for

photostimulation of biological tissue incorporates at least one treatment radiation source 50

providing radiation at a predetermined wavelength selected from the range approximately

between 800 and 1,100 nanometers and adapted to illuminate the biological tissue 20. In a

further variation, the data processing and recording device 115 is configured for receiving and

processing the image signal and adapted to generate an electronic signal in the form of a plurality of frames corresponding to the image signal at various time intervals. Preferably,

the data processing and recording device 115 captures and analyzes the frames to quantify the

radiation emitted by the biological tissue 20 in units of measurement selected from the group

described above. More preferably, the data processing and recording device 115 is further

configured to control the energy output 140 of the at least one treatment radiation source 50 to

induce and maintain a preselected energy input to and output from the biological tissue 20.

The present invention also contemplates a variation wherein the data processing and

recording device 115 is configured to measure the temperature of the biological tissue 20 and

to control the output of the at least one treatment radiation source 50 whereby the biological

tissue 20 is heated to and maintained at a predetermined temperature for a selected period of

time.

In another variation of the instant invention, the therapeutic treatment apparatus 10 for

photostimulation of biological tissue 20 is modified wherein the data processing and

recording device 115 is further configured to block the energy 140 emitted by the at least one

treatment radiation source 50 that is reflected by the biological tissue 20 and subtract the

reflected energy 150 from quantified unit of measure.

The present invention is also directed to a variation wherein the data processing and

recording device 115 is further configured to control the energy output of the at least one

treatment radiation source 50 to induce and maintain a preselected energy input to and output

from the biological tissue 20 sans the reflected energy 150. This is accomplished either by

configuring the device 115 or by coupling the device 115 with an independent controller 160

configured to communicate with and control the at least one treatment radiation source 50 as

well as any additional sources 60, 70. If desired, a visible light video camera 170 may also be incorporated into the apparatus of the present invention for purposes of monitoring and / or

recording operation of the instant invention.

In yet another variation of the present invention, a therapeutic treatment apparatus 10

for photostimulation of biological tissue 20 includes at least one treatment radiation source 50

providing radiation at a predetermined wavelength selected from the range approximately

between 400 and 11,500 nanometers and adapted to illuminate the biological tissue 20. Also

included is an infrared camera 110 configured to detect infrared radiation emitted by the

target biological tissue 20 and adapted to produce an image signal corresponding to the

detected radiation and further including a filter component (not shown) adapted to block

radiation having the predetermined wavelength, the filter selected from the group including

optical and electronic filters. This variation further incorporates a data processing and

recording device that is capable of receiving and processing the image signal and adapted to

generate an electronic signal in the form of a plurality of frames corresponding to the image

signal. The data processing and recording device 115 is adapted to capture and analyze the

frames to quantify the radiation emitted by the biological tissue 20 in at least one unit of

measurement selected from the group including wavelength, radiance, luminosity, area,

volume, temperature, change in temperature, rate of change of temperature, relative

temperature, energy, change in energy, rate of change of energy, and relative energy.

In an alternative configuration, the instant invention contemplates a therapeutic

treatment apparatus 10 for photostimulation of biological tissue that incorporates at least one

treatment radiation source 50 providing radiation at a predetermined wavelength selected

from the range approximately between 400 and 11,500 nanometers and adapted to illuminate

the biological tissue 20. This configuration includes an infrared camera 110 configured to

detect infrared radiation 150 emitted by the target biological tissue 20 and adapted to produce

an image signal corresponding to the detected radiation 150 at windows corresponding to precise moments in time. A data processing and recording device 115 is also incorporated

that is capable of receiving and processing the image signal, and which is adapted to generate

an electronic signal in the form of a plurality of frames corresponding to the image signal.

The data processing and recording device 115 in this alternative configuration is adapted to

capture and analyze the frames to quantify the radiation emitted by the biological tissue 20 in

at least one unit of measurement selected from the group including wavelength, radiance,

luminosity, area, volume, temperature, change in temperature, rate of change of temperature,

relative temperature, energy, change in energy, rate of change of energy, and relative energy.

This configuration of the data processing and recording device 115 is further modified to

control the infrared camera 110 and the energy output of the at least one treatment radiation

source 50 to emit pulses of radiation 140 to induce and maintain a preselected energy input to

and output from the biological tissue 20 sans the reflected energy 150. Lastly, the data

processing and recording device 115 is further configured to block the detection of treatment

radiation 150 reflected by the biological tissue 20 by synchronizing the timing the emitted

treatment radiation pulses with the infrared camera detection windows so that the camera 110

captures an image of the radiation being emitted by target biological tissue 20 at a moment

between radiation pulses.

The present invention also contemplates a method for use of a therapeutic treatment

apparatus for photostimulation of biological tissue 20 that includes the steps of selecting at

least one treatment radiation source 50 that provides radiation at a predetermined wavelength

selected from the range approximately between 400 and 11,500 nanometers and adapted to

illuminate the biological tissue. Also included is the step of selecting an infrared camera 110

that is configured to detect infrared radiation emitted by the target biological tissue 20, the

camera 110 being adapted to produce image signals corresponding to the detected radiation. A data processing and recording device 115 is selected that is capable of receiving and

processing the image signals and adapted to generate an electronic signal in the form of a

plurality of frames corresponding to the image signals. The data processing and recording

device 115 captures and analyzes the frames and also quantifies the radiation 150 emitted by

the biological tissue 20. The radiation is quantified in at least one unit of measurement

selected from the group including wavelength, radiance, luminosity, area, volume,

temperature, change in temperature, rate of change of temperature, relative temperature,

energy, change in energy, rate of change of energy, and relative energy.

In a variation of the preceding method, the method further includes the steps of

controlling the energy output of the at least one treatment radiation source 50 to induce and

maintain a preselected energy input to and output from the biological tissue 20; blocking the

energy emitted by the at least one treatment radiation source 50 that is reflected by the

biological tissue 20 and subtracting the reflected energy from quantified unit of measure; and

controlling the energy output of the at least one treatment radiation source 50 to induce and

maintain a preselected energy input to and output from the biological tissue 50 sans the

reflected energy 150.

The present invention establishes a significant advance over the previously known

devices and methods and the advance is achieved with improved accuracy, simplicity, and

without any significant increase complexity of technology.

Thermography is a preferred technique for detecting soft tissue anomalies occurring in

various types of biological tissues. Anomalous tissues often experience an altered blood flow

circulation. One of the most prominent indicators of anomalies such as inflammation and

other injuries is heat, which is due to increased blood circulation. A medical thermogram is a

methodology, which allows the detection of such biological soft tissue anomalies by measuring the surface temperature of the target biological tissue. Thermography is a noninvasive diagnostic application that uses infrared radiation

detection technology to quantify the surface temperatures of the target biological tissue and

subjacent structures. By converting thermal emissions into a multi-colored "map" wherein

various colors correspond to certain wavelengths of emitted radiation, temperature differences

as small as approximately between 0.05 and 0.08 degrees Celsius can be detected. In addition

to detecting increased heat radiation of target biological tissues, the thermographic techniques

of the present invention also contemplate detection of areas where blood circulation is

decreased. This can occur where anomalies exist such as nerve damage, a blood clot, and

development of subjacent scar tissue. In these anomalous biological tissues regions, the

thermographic image may depict cooler than expected temperatures, such as may be expected

in tissues that suffer from the initial stages of atrophy or other form of deterioration. It will

understood by those with skill in the art that pathologies of the cutaneous and subcutaneous

structures including, for example, tendons, ligaments may be identifiable through

identification of the "hot spots" and "cool spots" that while invisible to the unaided human

eye, are prominently revealed by thermography. Such anomalous biological tissues can thus

be detected as far in advance as two weeks before the onset of clinically detectable signs of

injury and/or anomaly.

Various types of thermographic cameras, signal processing, and analysis equipment

are known in the prior art that includes U.S. Pat. Nos. 5,959,444; 5,467,126; 5,637,871; and

5,386,117. Vendors known to have cameras and related equipment that are suitable for

purposes of use with the present invention include Sierra Pacific Innovations #2,

www.x20.org, 1034 Emerald Bay Rd., Dept. 437, South Lake Tahoe, California; Rod Hall

International, Inc., www.rodhall.com, 1360 Kleppe Lane, Sparks, Nevada; Microlytics, Inc.,

www.endeavorship.com, P.O. Box 2022, Stillwater, Oklahoma; Raytheon Systems Company,

www.raytheoninfrared.com, 6380 Hollister Avenue, Goleta, California; Infrared Components Corporation, www.infraredcomponents.com, 2306 Bleecker Street, Utica, New York; and

Indigo Systems Corporation, www.indigosystems.com/ cameras.html, 5385 Hollister Ave

#103, Santa Barbara, California.

Numerous modifications and variations of the preferred embodiments disclosed herein

will be apparent to those skilled in the art. For example, although specific embodiments have

been described in detail, those with skill in the art can understand that the preceding

embodiments and variations can be modified with various types of treatment radiation

sources and thermographic camera and data processing devices for desired compatibility with

the wide variety of modalities presently in use for photostimulation of biological tissues.

Accordingly, even though only few variations of the present invention are described herein, it

is to be understood that the practice of these additional modifications and variations and the

equivalents thereof, are within the spirit and scope of the invention as defined in the following claims.

Claims

WE CLAIM:
1. A therapeutic treatment apparatus for photostimulation of biological tissue,
comprising:
at least one treatment radiation source emitting a predetermined wavelength selected
from the range approximately between 400 and 11,500 nanometers and adapted to irradiate
the biological tissue;
an infrared camera configured to detect infrared radiation emitted by the target
biological tissue and adapted to produce image signals corresponding to the detected
radiation;
a data processing and recording device configured for receiving and processing the
image signals and adapted to generate an electronic signal in the form of a plurality of frames
corresponding to the image signals; and
wherein the data processing and recording device captures and analyzes the frames to
quantify the radiation emitted by the biological tissue in at least one unit of measurement
selected from the group including wavelength, radiance, luminosity, temperature, change in
temperature, rate of change of temperature, relative temperature, energy, change in energy,
rate of change of energy, and relative energy.
2. The therapeutic treatment apparatus of Claim 1, wherein the data processing
and recording device records only temporarily.
3. The therapeutic treatment apparatus of Claim 1, wherein the data processing
and recording device is further configured to quantify the radiation emitted by the biological
tissue in units of measurement selected from the group including area and volume.
4. The therapeutic treatment apparatus of Claim 1 , wherein the at least one
treatment radiation source is selected from the group including semiconductor laser diodes,
super-luminous diodes, light emitting devices, and solid-state laser diodes.
5. The therapeutic treatment apparatus of Claim 1 , wherein the at least one
treatment radiation source is a NdNAG SSD laser tuned to emit radiation having a
wavelength of approximately 1,064 nanometers.
6. The therapeutic treatment apparatus of Claim 1, wherein the at least one
treatment radiation source is configured to emit radiation having a wavelength of
approximately between 800 and 1,100 nanometers.
7. A therapeutic treatment apparatus for photostimulation of biological tissue,
comprising:
at least one treatment radiation source providing radiation at a predetermined
wavelength selected from the range approximately between 800 and 1,100 nanometers and
adapted to illuminate the biological tissue;
an infrared camera configured to detect infrared radiation emitted by the target
biological tissue and adapted to produce an image signal corresponding to the detected
radiation;
a data processing and recording device configured for receiving and processing the
image signal and adapted to generate an electronic signal in the form of a plurality of frames
corresponding to the image signal at various time intervals;
wherein the data processing and recording device captures and analyzes the frames to
quantify the radiation emitted by the biological tissue in at least one unit of measurement selected from the group including wavelength, radiance, luminosity, temperature, area,
volume, change in temperature, rate of change of temperature, relative temperature, energy,
change in energy, rate of change of energy, and relative energy; and
wherein the data processing and recording device is further configured to control the
energy output of the at least one treatment radiation source to induce and maintain a
preselected energy input to and output from the biological tissue.
8. The therapeutic treatment apparatus of Claim 7, wherein the data processing
and recording device is configured to measure the temperature of the biological tissue and to
control the output of the at least one treatment radiation source whereby the biological tissue
is heated to and maintained at a predetermined temperature for a selected period of time.
9. The therapeutic treatment apparatus of Claim 7, wherein the at least one
treatment radiation source is selected from the group including semiconductor laser diodes,
super-luminous diodes, light emitting devices, and solid-state laser diodes.
10. The therapeutic treatment apparatus of Claim 7, wherein the at least one
treatment radiation source is a NdNAG SSD laser tuned to emit radiation having a
wavelength of approximately 1,064 nanometers.
11. The therapeutic treatment apparatus of Claim 7, further comprising:
at least one additional treatment radiation source configured to emit radiation having a
wavelength of approximately between 800 and 1,100 nanometers.
12. A therapeutic treatment apparatus for photostimulation of biological tissue,
comprising:
at least one treatment radiation source providing radiation at a predetermined
wavelength selected from the range approximately between 800 and 1,100 nanometers and
adapted to illuminate the biological tissue; an infrared camera configured to detect infrared radiation emitted by the target
biological tissue and adapted to produce an image signal corresponding to the detected
radiation;
a data processing and recording device configured for receiving and processing the
image signal and adapted to generate an electronic signal in the form of a plurality of frames
corresponding to the image signal at various time intervals;
wherein the data processing and recording device captures and analyzes the frames to
quantify the radiation emitted by the biological tissue in at least one unit of measurement
selected from the group including wavelength, radiance, luminosity, area, volume,
temperature, change in temperature, rate of change of temperature, relative temperature,
energy, change in- energy, rate of change of energy, and relative energy; and
wherein the data processing and recording device is further configured to block the
energy emitted by the at least one treatment radiation source that is reflected by the biological
tissue and subtract the reflected energy from quantified unit of measure.
13. The therapeutic treatment apparatus of Claim 12, wherein the at least one
treatment radiation source is selected from the group including semiconductor laser diodes,
super-luminous diodes, light emitting devices, and solid-state laser diodes.
14. The therapeutic treatment apparatus of Claim 12, wherein the at least one
treatment radiation source is a NdNAG SSD laser tuned to emit radiation having a
wavelength of approximately 1,064 nanometers.
15. The therapeutic treatment apparatus of Claim 12, further comprising:
at least one additional treatment radiation source configured to emit radiation having a
wavelength of approximately between 800 and 1,100 nanometers.
16. A therapeutic treatment apparatus for photostimulation of biological tissue,
comprising:
at least one treatment radiation source providing radiation at a predetermined
wavelength selected from the range approximately between 800 and 1,100 nanometers and
adapted to illuminate the biological tissue;
an infrared camera configured to detect infrared radiation emitted by the target
biological tissue and adapted to produce an image signal corresponding to the detected
radiation;
a data processing and recording device configured for receiving and processing the
image signal and adapted to generate an electronic signal in the form of a plurality of frames
corresponding to the image signal at various time intervals;
wherein the data processing and recording device captures and analyzes the frames to
quantify the radiation emitted by the biological tissue in at least one unit of measurement
selected from the group including wavelength, radiance, luminosity, area, volume,
temperature, change in temperature, rate of change of temperature, relative temperature,
energy, change in energy, rate of change of energy, and relative energy; wherein the data processing and recording device is further configured to block the
energy emitted by the at least one treatment radiation source that is reflected by the biological
tissue and subtract the reflected energy from quantified unit of measure; and
wherein the data processing and recording device is further configured to control the
energy output of the at least one treatment radiation source to induce and maintain a
preselected energy input to and output from the biological tissue sans the reflected energy.
17. The therapeutic treatment apparatus of Claim 16, wherein the at least one
treatment radiation source is selected from the group including semiconductor laser diodes,
super- luminous diodes, light emitting devices, and solid-state laser diodes.
18. The therapeutic treatment apparatus of Claim 6, wherein the at least one
treatment radiation source is a NdNAG laser tuned to emit radiation having a wavelength of
approximately 1,064 nanometers.
19. The therapeutic treatment apparatus of Claim 16, further comprising:
at least one additional treatment radiation source configured to emit radiation having a
wavelength of approximately between 800 and 1,100 nanometers.
20. A therapeutic treatment apparatus for photostimulation of biological tissue,
comprising:
at least one treatment radiation source providing radiation at a predetermined wavelength selected from the range approximately between 400 and 11,500 nanometers and
adapted to illuminate the biological tissue; an infrared camera configured to detect infrared radiation emitted by the target
biological tissue and adapted to produce an image signal corresponding to the detected
radiation and further including a filter component adapted to block radiation having the
predetermined wavelength, the filter selected from the group including optical and electronic
filters; a data processing and recording device configured for receiving and processing the
image signal and adapted to generate an electronic signal in the form of a plurality of frames
corresponding to the image signal; and
wherein the data processing and recording device captures and analyzes the frames to
quantify the radiation emitted by the biological tissue in at least one unit of measurement
selected from the group including wavelength, radiance, luminosity, area, volume,
temperature, change in temperature, rate of change of temperature, relative temperature,
energy, change in energy, rate of change of energy, and relative energy.
21. A therapeutic treatment apparatus for photostimulation of biological tissue,
comprising:
at least one treatment radiation source providing radiation at a predetermined
wavelength selected from the range approximately between 400 and 11,500 nanometers and
adapted to illuminate the biological tissue;
an infrared camera configured to detect infrared radiation emitted by the target
biological tissue and adapted to produce an image signal corresponding to the detected
radiation at windows corresponding to precise moments in time;
a data processing and recording device configured for receiving and processing the
image signal and adapted to generate an electronic signal in the form of a plurality of frames corresponding to the image signal; wherein the data processing and recording device captures and analyzes the frames to
quantify the radiation emitted by the biological tissue in at least one unit of measurement
selected from the group including wavelength, radiance, luminosity, area, volume,
temperature, change in temperature, rate of change of temperature, relative temperature,
energy, change in energy, rate of change of energy, and relative energy;
wherein the data processing and recording device is further configured to control the
infrared camera and the energy output of the at least one treatment radiation source to emit
pulses of radiation to induce and maintain a preselected energy input to and output from the
biological tissue sans the reflected energy; and
wherein the data processing and recording device is further configured to block the
detection of treatment radiation reflected by the biological tissue by synchronizing the timing
the emitted treatment radiation pulses with the infrared camera detection windows so that the
camera captures an image of the target biological tissue at a moment between radiation
pulses.
22. A method for using a therapeutic treatment apparatus for photostimulation of
biological tissue, that includes the steps of:
selecting at least one treatment radiation source that provides radiation at a
predetermined wavelength selected from the range approximately between 400 and 11,500
nanometers and adapted to illuminate the biological tissue;
selecting an infrared camera configured to detect infrared radiation emitted by the
target biological tissue and adapted to produce image signals corresponding to the detected radiation; selecting a data processing and recording device configured for receiving and
processing the image signals and adapted to generate an electronic signal in the form of a
plurality of frames corresponding to the image signals; and
capturing and analyzing the frames with the data processing and recording device;
and
quantifying the radiation emitted by the biological tissue in at least one unit of
measurement selected from the group including wavelength, radiance, luminosity, area,
volume, temperature, change in temperature, rate of change of temperature, relative
temperature, energy, change in energy, rate of change of energy, and relative energy.
23. The method according to Claim 22, further comprising the step of controlling
the energy output of the at least one treatment radiation source to induce and maintain a
preselected energy input to and output from the biological tissue.
24. The method according to Claim 22, further comprising the step of blocking the
energy emitted by the at least one treatment radiation source that is reflected by the biological
tissue and subtracting the reflected energy from quantified unit of measure.
25. The method according to Claim 22, further comprising the step of controlling
the energy output of the at least one treatment radiation source to induce and maintain a
preselected energy input to and output from the biological tissue sans the reflected energy.
PCT/US2001/012422 2000-04-17 2001-04-17 Photostimulaton treatment apparatus and methods for use WO2001078830A2 (en)

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US9780518B2 (en) 2012-04-18 2017-10-03 Cynosure, Inc. Picosecond laser apparatus and methods for treating target tissues with same
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