U.S. patent application number 11/814635 was filed with the patent office on 2008-08-28 for optical therapy devices, systems, kits and methods for providing therapy to a body cavity.
This patent application is currently assigned to Allux Medical, Inc.. Invention is credited to Michael Gertner, Erica Rogers.
Application Number | 20080208297 11/814635 |
Document ID | / |
Family ID | 36697938 |
Filed Date | 2008-08-28 |
United States Patent
Application |
20080208297 |
Kind Code |
A1 |
Gertner; Michael ; et
al. |
August 28, 2008 |
Optical Therapy Devices, Systems, Kits and Methods for Providing
Therapy to a body Cavity
Abstract
An optical therapy device is disclosed. The optical therapy
device provides therapeutic light therapy to a body cavity. The
device includes a housing adapted to be hand held, a UV light
source positioned in or on the housing, and an insertion member
having a distal end configured to be inserted into the body cavity
to illuminate tissue in the body cavity with light from the light
source.
Inventors: |
Gertner; Michael; (Menlo
Park, CA) ; Rogers; Erica; (Redwood City,
CA) |
Correspondence
Address: |
WILSON SONSINI GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO
CA
94304-1050
US
|
Assignee: |
Allux Medical, Inc.
|
Family ID: |
36697938 |
Appl. No.: |
11/814635 |
Filed: |
January 25, 2006 |
PCT Filed: |
January 25, 2006 |
PCT NO: |
PCT/US2006/002685 |
371 Date: |
September 11, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11152946 |
Jun 14, 2005 |
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11814635 |
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60646818 |
Jan 25, 2005 |
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60661688 |
Mar 14, 2005 |
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60646818 |
Jan 25, 2005 |
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60661688 |
Mar 14, 2005 |
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Current U.S.
Class: |
607/92 |
Current CPC
Class: |
A61N 2005/0611 20130101;
A61N 5/0616 20130101; A61N 2005/0644 20130101; A61N 5/0624
20130101; A61N 2005/0606 20130101; A61N 5/0603 20130101; A61N
2005/0645 20130101; A61N 2005/0661 20130101; A61N 2005/0608
20130101; A61N 2005/0609 20130101; A61N 2005/0607 20130101; A61N
2005/0651 20130101; A61N 2005/0605 20130101 |
Class at
Publication: |
607/92 |
International
Class: |
A61N 5/06 20060101
A61N005/06 |
Claims
1. An optical therapy device for providing therapeutic light to a
body cavity, comprising: a housing adapted to be hand-held; one or
more light sources positioned in or on said housing adapted to
deliver up to 50 mW of UV light; and an insertion member having a
distal end configured to be inserted into the body cavity to
illuminate tissue in the body cavity with light from the light
source when the distal end of the insertion member is positioned in
the body cavity.
2-44. (canceled)
Description
CROSS-REFERENCE
[0001] This application is a continuation-in-part application of
Ser. No. 11/152,946, filed Jun. 14, 2005, which is incorporated
herein by reference in its entirety and to which application
priority is claimed under 35 USC .sctn. 120.
[0002] This application claims the benefit of U.S. Provisional
Application No. 60/646,818, filed Jan. 25, 2005 and U.S.
Provisional Application 60/661,688 filed Mar. 14, 2005, which are
incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION
[0003] Infection of a patient takes many forms. Typically, acute
bacterial infections are rather easily controlled using standard
antibiotic therapies. Chronic infections, on the other hand, are
often very difficult to control for several reasons: (1) the
antimicrobial flora of chronically infected regions of the body
often develop resistance to standard antibiotics due to multiple
attempts to treat the flora with antimicrobial therapy; (2) the
microbes often form biofilms to protect themselves against the
protective mechanisms of the patient; and (3) many chronic
infections occur around man-made implants which often serve as a
nidus for microbes to proliferate as well as form biofilms.
Examples of chronic infections include: vascular access catheter
infections, chemotherapy port infections, peritoneal dialysis
access catheter infections, vaginal yeast infections,
ventriculo-peritoneal shunts, sinus tracts in patients with Crohn's
disease, chronic bronchitis and COPD, helicobacter pylori
infections of the stomach, aerobic and anaerobic infections of the
small intestine and colon, and chronic ear infections, to name a
few. There is also increasing evidence that atherosclerosis is
caused by infections by micro-organisms such as Chlamydia.
[0004] Atopy refers to an inherited propensity to respond
immunologically to many common, naturally occurring inhaled and
ingested allergens with the continual production of IgE antibodies.
Allergic rhinitis and asthma are the most common clinical
manifestations of atopic disease affecting approximately 50 million
people in the United States alone. There is a great deal of overlap
among patients with atopic disease. For example, patients with
atopic asthma have a greater likelihood of developing allergic
rhinitis and dermatitis, and vice versa. Indeed, the
pathophysiology for atopic diseases is generally the same whether
or not the affected organ is the skin, the nose, the lungs, or the
gastrointestinal tract.
[0005] Contact with an allergic particle (for example, pollen, cat
dander, or food particle) reacts with an associated antibody on the
mast cell, which leads to prompt mediator release and clinical
symptoms. The IgE antibody response is perpetuated by T cells
(antigen specific memory cells or other regulatory cells), which
also have specificity for the allergens.
[0006] Kemeny, et al., in Intranasal Irradiation with the Xenon
Chloride Ultraviolet B Laser Improves Allergic Rhinitis, 75 Journal
of Photochemistry and Photobiology B: Biology 137-144 (2004) and
Koreck, et al., in Rhinophototherapy: A New Therapeutic Tool for
the Management of Allergic Rhinitis, Journal of Allergy and
Clinical Immunology (March 2005), describe a treatment for allergic
rhinitis using the same theory espoused for the efficacy of
ultraviolet light in atopic dermatitis. Their placebo-controlled
study showed the efficacy of ultraviolet therapy to treat allergic,
or atopic, rhinitis over the course of an allergy season.
[0007] The United States Centers for Disease Control (CDC)
estimates that each year, nearly 2 million people in the United
States acquire an infection while in a hospital, resulting in
90,000 deaths. More than 70 percent of the bacteria that cause
these infections are resistant to at least one of the antibiotics
commonly used to treat them. Between 1979 and 1987, it is estimated
that only 0.02 percent of pneumococcus strains infecting a large
number of patients surveyed by the CDC were penicillin-resistant.
As of 1994 that percent was estimated to have increased to 6.6
percent, and may currently approach 25%, by some estimates. Thus,
as resistance increases, the importance of developing new treatment
modalities increases.
[0008] A variety of devices are known for delivering light therapy.
For example, U.S. Pat. No. 1,616,722 to Vernon for Kromayer Light
Attachment; U.S. Pat. No. 1,782,906 to Newman for Device for
Treating the Stomach with Ultra-Violet Rays; U.S. Pat. No.
1,800,277 to Boerstler for Method for Producing Therapeutic Rays;
U.S. Pat. No. 2,227,422 to Boerstler for Applicator for Use in
Treatment with Therapeutic Rays; U.S. Pat. No. 4,998,930 to Lundahl
for Intracavity Laser Phototherapy Method; U.S. Pat. No. 5,146,917
to Wagnieres for Fiber-Optic Apparatus for the Photodynamic
Treatment of Tumors; U.S. Pat. No. 5,292,346 to Ceravolo for
Bactericidal Therapeutic Throat Gun; U.S. Pat. No. 5,683,436 to
Mendes for Treatment of Rhinitus by Biostimulative Illumination;
U.S. Pat. No. 6,663,659 to McDaniel for Method and Apparatus for
the Photomodulation of Cells; U.S. Pat. No. 6,764,501 to Ganz for
Apparatus and Method for Treating Atherosclerotic Vascular Disease
Through Light Sterilization; and U.S. Pat. No. 6,890,346 to Ganz
for Apparatus and Method for Debilitating or Killing Microorganisms
within the Body. Additionally, U.S. Patent Publ. 2002/0029071 to
Whitehurst for Therapeutic Light Source and Method; U.S. Patent
Publ. 2004/0030368 to Kemeny for Phototherapeutical Method and
System for the Treatment of Inflammatory and Hyperproliferative
Disorders of the Nasal Mucosa; and U.S. Patent Publ. 2005/0107853
to Krespi for Control of Rhinosinusitus-Related, and Other
Microorganisms in the Sino-Nasal Tract. See, also PCT Publ. WO
03/013653 to Kemeny for Phototherapeutical Apparatus.
SUMMARY OF THE INVENTION
[0009] The invention relates to an optical therapy device for
providing therapeutic light to a body cavity. An embodiment of the
invention includes: a housing adapted to be hand-held; one or more
light sources positioned in or on said housing adapted to deliver
up to 50 mW of UV light; and an insertion member having a distal
end configured to be inserted into the body cavity to illuminate
tissue in the body cavity with light from the light source when the
distal end of the insertion member is positioned in the body
cavity.
[0010] Another embodiment of the invention includes: an insertion
member having a distal end configured to be inserted into the body
cavity; and a UV light source at the distal end of the insertion
member, wherein the insertion member is adapted to illuminate
tissue in the body cavity with UV light when the distal end of the
insertion member is positioned in the body cavity.
[0011] Still another embodiment of the invention includes a patient
interface for an optical therapy device for providing therapeutic
light to a body cavity, comprising: an insertion member having a
distal end configured to be positioned into a body cavity to
illuminate target tissue in the body cavity with UV light from a UV
light source when the distal end of the insertion member is
positioned in the body cavity. The insertion member can be further
adapted to have an alignment member adapted to align the insertion
member within the cavity and a direction element adapted to direct
light onto target tissue.
[0012] Yet another embodiment of the invention includes an optical
therapy device for providing therapeutic light to a body cavity,
comprising: an insertion member having a distal end configured to
be inserted into the body cavity; a light source at the distal end
of the insertion member and adapted to illuminate tissue in the
body cavity when the distal end of the insertion member is
positioned in the body cavity; the insertion member being further
adapted to transfer heat proximally from the light source.
[0013] The optical therapy devices of the invention may include one
or more light sources; such as light sources that are solid state
or LEDs. Alternatively, the light sources may emit non-coherent
light. In still other embodiments, the light sources may be UV
light sources that emit non-coherent light in a range from 250 nm
to 279 nm. In other embodiments, the UV light source may be limited
in wavelength to 300 nm to 320 nm. In yet other embodiments, the UV
light source in the range of 280 nm to 320 nm, while other
embodiments may use a UV light source that is restricted to a
wavelength range from 250 nm to 320 nm. In still other embodiments,
the light source may be adapted to emit substantially only UV
light.
[0014] The optical therapy devices of the embodiments of the
invention can be adapted and configured to provide any of the light
sources at the distal end of the insertion member. In some
embodiments, the light sources are provided along the length of the
insertion member or tube. In still other embodiments, the light
sources are provided in the body or hand-piece. In yet other
embodiments, light sources are provided at a plurality of locations
within or along the device.
[0015] The optical therapy devices of the embodiments of the
invention can be adapted and configured to provide a housing
supporting the insertion member and a power source disposed in or
on the housing, the power source being adapted to provide power to
the light source.
[0016] The optical therapy device of the embodiments of the
invention can be adapted and configured such that the insertion
member is further adapted to transfer heat proximally when the
light source is at the distal end of the insertion member. In other
embodiments, the insertion member can be adapted to focus eight
from the light source.
[0017] In other embodiments, the insertion member is further
adapted to comprise an expandable member adapted and configured to
expand within the body cavity. In some embodiments of the
invention, a balloon is used. The balloon may be an optical
conditioner that is at least partially transparent to UV light and
at least partially covers one or more light sources. In other
embodiments, the balloon may be configured to partially absorb
light from one or more light sources. The expandable member can be
adapted to be transparent to UV light. In other embodiments, the
expandable member can be adapted to focus light from the light
source. In some embodiments, the expandable member can be adapted
to cool the device when expanded.
[0018] The insertion member can be configured, in some embodiments,
to have a shape adapted to enter a body cavity. In some
embodiments, the insertion member can be further adapted to emit
light into more than one body cavity simultaneously. The insertion
member can be adapted to bend light at an angle defined by the
insertion member. In other embodiments, the insertion member is
adapted to be flexible and to form a variable angle. The insertion
member may be adapted to split into one or more elongate tubes. In
still other embodiments, the insertion member is adapted to be
rigid with a fixed angle. In still other embodiments, the insertion
member is adapted to be partially transparent to UV light and to at
least partially cover one or more light sources.
[0019] The optical therapy devices of the embodiments of the
invention are suitable for use in a body cavity. Body cavities
include, for example, the nasal cavity, a vestibule of the nasal
cavity, the thoracic cavity, the abdominal cavity, lumen of a
vessel, the gastrointestinal cavity, the pericardial cavity, and
the heart, to name a few.
[0020] The optical therapy devices of the embodiments of the
invention may further comprise a data collection unit connectable
to a controller. In other embodiments, the controller may be
adapted to connect a power source to the light source. The
controller may be configured to individually control one or more of
a plurality of light sources. Additionally, the controller may be
configured to store the total amount of energy emitted by one or
more of a plurality of light sources. In some embodiments, the
controller can be configured to control which of the plurality of
light sources is powered on or powered off based on the total
energy emitted by the light source. Alternatively, the controller
can be configured to control which of the light sources is powered
on or powered off based on a structure of the body cavity. In yet
another embodiment, the controller can be configured to control
which of the plurality of light sources is powered on or powered
off based on programming by an operator. A controller may be
provided that is adapted to connect a power source to the light
source. The controller can also be adapted to separately address
each of the light sources provided.
[0021] The optical therapy devices of the embodiments of the
invention may further comprise a recharger adapted to connect to a
power source. In some embodiments, the device further comprises a
power source disposed in or on the housing. The power source can be
any suitable power source, including AC, DC, rechargeable, etc.
Where a rechargeable power supply is provided, an embodiment of the
invention can include a recharger adapted to recharge the power
source.
[0022] Embodiments of the device can be configured such that the
insertion member is adapted to transfer heat away from the body
cavity. In some embodiments, the device includes a heat transfer
device. Suitable heat transfer devices may include, for example,
heat pipes, cooling modules, heat fins, heat conductors and cooling
tubes. In some embodiments, the heat transfer device can be adapted
to surround the light source. In other embodiments, the heat
transfer device can be adapted to provide a thermal interface
adapted to draw heat away from a heat sink. In still other
embodiments, the heat transfer device can be adapted, or further
adapted, to extend axially along the longitudinal axis of the hand
piece.
INCORPORATION BY REFERENCE
[0023] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0025] FIG. 1A is a cross-sectional view of an optical therapy
device in accordance with an embodiment of the present invention;
FIG. 1B is a cross-sectional view of a sheath of the optical
therapy device of FIG. 1A;
[0026] FIG. 2 illustrates an optical therapy system of the
invention utilizing the optical therapy device of FIG. 1;
[0027] FIGS. 3 and 4A are cross-sectional views of optical therapy
devices in accordance with an embodiment of the present invention;
FIG. 4B is a cross-sectional view taken along line 4B-4B of FIG.
4A;
[0028] FIGS. 5A, 5B, and 6A are cross-sectional views of optical
therapy device in accordance with additional embodiments of the
present invention; FIG. 6B is a cross-sectional view taken along
line 6B-6B of FIG. 6A;
[0029] FIG. 7A is a cross-sectional view of an optical therapy
device in accordance with other embodiments of the present
invention; FIG. 7B is a cross-sectional view taken along line 7B-7B
of FIG. 7A;
[0030] FIGS. 8A-B are cross-sectional views of an optical therapy
device according to additional embodiments of the present
invention; FIG. 8c is a cross-sectional view taken along line 8C-8C
of FIG. 8B; FIG. 8D is a cross-sectional view taken along line
8D-8D of FIG. 8c;
[0031] FIGS. 9A-C are additional embodiments of optical therapy
devices that include visualization assistance;
[0032] FIG. 10A is a cross-sectional view of an optical therapy
device in accordance with another embodiment of the present
invention; FIG. 10B is an end view of the optical therapy device of
FIG. 10A; FIG. 10C is a partial cross-sectional view of the distal
end of a medical instrument coupled to the optical therapy device
of FIGS. 10A-B;
[0033] FIGS. 11A-H illustrate optical therapy devices having
different tubes in accordance with additional embodiments of the
present invention and generally configured to treat the sinuses of
a patient;
[0034] FIGS. 12A-B illustrate another optical therapy device in
accordance with another embodiment of the present invention;
[0035] FIG. 13A illustrates another embodiment of an optical
therapy device positioned at the end of a flexible medical device;
FIG. 13B illustrates one embodiment of an indwelling catheter
according to another embodiment of the present invention; FIG. 13C
illustrates one embodiment of an optical therapy device located
inside of an at least partially optically-transparent balloon;
[0036] FIG. 14A illustrates a light emitting diode (LED) device in
accordance with one embodiment of the present invention; FIG. 14B
is an exploded view of the LED of FIG. 14A;
[0037] FIG. 14c illustrates a spectroradiometer measurement of the
optical output from an LED device, such as the LED of FIG. 14A,
having a peak at about 308 nm; FIG. 14D illustrates the output from
one embodiment of a set of three white-light emitting LEDs (wLED);
FIG. 14E illustrates a spectroradiometer measurement of the optical
output from a multi-chip LED (mLED);
[0038] FIGS. 15A-B illustrate an optical therapy device inserted
into a person's nasal cavity;
[0039] FIG. 16A is another embodiment showing the optical therapy
device of 9D and 9J inserted into the anterior portion of a
patient's nasal cavity;
[0040] FIG. 16B is another embodiment of an optical therapy device
having an annular tunnel for the optical therapy device;
[0041] FIG. 16C is a coronal view of a patient's head showing the
optical therapy device of FIG. 16A inserted into a sinus
cavity;
[0042] FIG. 17 is a sagittal view of a patient's head with a nasal
adapter inserted therein;
[0043] FIGS. 18A-18B illustrates one embodiment of an optical
therapy system to treat transplanted organs, such as transplanted
kidney; and
[0044] FIG. 19 is a flow chart illustrating a method of the
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0045] In the embodiments of the present invention, novel methods
and devices to treat diseases utilizing optical therapies are
disclosed. In addition to novel disease treatments and methods,
embodiments of the present invention can be configured to optimize
portability, and may be implemented with a variety of light
sources. Additionally, specific desired illumination pattern(s) and
spectral output control may be achieved in the various
embodiments.
[0046] The embodiments of the invention employ lighting
technologies. Suitable lighting technologies, including solid state
devices (e.g., light emitting diodes, electroluminescent inorganic
materials, organic diodes, etc.), miniature halogen lamps,
miniature mercury vapor and fluorescent lamps, offer the potential
for less expensive and more flexible phototherapeutical units. As
will be appreciated by those skilled in the art, solid state
technology has already revolutionized areas outside medicine and
holds a great deal of promise inside the biomedical sciences.
[0047] Light emitting semiconductor devices (e.g., light emitting
diodes or LEDs) offer many advantages in the biomedical sciences.
For example, LEDs are generally less expensive than traditional
light sources in terms of cost per lumen of light; are generally
smaller, even when providing a similar amount of therapeutic power;
offer well-defined and precise control over wavelength and power;
and allow for control of the pattern of illumination by allowing
the placement of discrete optical emitters over a complex surface
area and by allowing for individual control of each emitter. LEDs
also generally allow for easy integration with other
microelectronic sensors (e.g., photodiodes) to achieve low cost
integrated components; and generally permit placement of the light
source close to the treatment site rather than relying on costly,
inefficient, and unstable optical guidance systems and light
sources to do so. Solid state technology also promises portability
and patient convenience (which will likely enhance patient
compliance with treatment protocols) because the lower cost and
improved safety profile of the devices will allow for transfer of
the therapies from the physician office and hospital to the
patient's home.
[0048] Solid state lighting technology has recently advanced to the
point where it is useful in the longer wavelength ultraviolet and
even more recently in the short ultraviolet wavelengths. For
example, S-ET (Columbia, S.C.) manufactures LED dies as well as
fully packaged solid state LEDs that emit relatively non-coherent
monochromatic ultraviolet radiation from 240 nm to 365 nm.
Similarly, Nichia Corporation (Detroit, Mich.) supplies ultraviolet
light emitting diodes which emit relatively monochromatic,
non-coherent light in the range 365 nm to 400 nm. White light
emitting diodes have been available for a relatively long time and
at power densities which rival conventional lighting sources. For
example, the LED Light Corporation (Carson City, Nev.) sells high
powered white light LEDs with output from 390 nm to 600 nm. Cree
Inc. (Durham, N.C.) also produces and sells LED chips in the long
wave ultraviolet as well as the blue, amber and red portions of the
electromagnetic spectra. While LEDs with light emission >365 nm
have been optimized with respect to their output efficiency
(optical power out versus input power) which can range from 1% to
greater than 20%, LED dies with outputs from 240 nm to 365 nm have
far less efficiency, which is well below 5% at the current time. In
addition, the lifetime of LEDs in the 240-365 nm range is a lot
lower (hundreds of hours) than LEDs greater than 365 nm (typically
tens of thousands of hours). As a consequence of the decreased
efficiency, heat transfer is a critical issue with ultraviolet LEDs
in the 240-365 nm range. Similarly, the lifetime being short
requires that efficiency be optimized by placing the light sources
closer to the point of therapy which can compound the heat transfer
issues. In addition, however, there are many other reasons to have
the light source closer to the point of therapy; for example, the
resulting device can be made light weight and portable and easier
to apply to a patient. Furthermore, there are many reasons that
LEDs specifically are a preferred light source for the close
application of therapeutic light delivery to a patient; for
example, the LEDs emit light from a small volume which allows for
improved directionality of the therapeutic light and in addition,
the LEDs can be integrated well with other electronic components
such as imaging or data collection elements.
[0049] Although some embodiments of the present invention include
solid state light sources, other embodiment include non-solid state
technologies, such as low pressure lamps, with or without solid
state light sources. The Jelight Corporation (Irvine, Calif.)
provides customized low pressure mercury vapor lamps complete with
phosphors which emit a relatively narrow spectrum depending on the
phosphor used. For example, Jelight's 2021 product emits 5 mW in
the 305 nm to 310 nm portion of the electromagnetic spectrum.
[0050] Halogen lighting technology can also be used to generate
ultraviolet light, including light having wavelengths in the UVA
(e.g., 320-400 nm), UVB (e.g., 280-320 nm), and white light (e.g.,
400-700 nm) portions of the spectrum, as well as relatively
narrow-band ultraviolet light (for example, when the lamp is
provided with an appropriate filter and/or phosphors). For example,
Gilway Technical Lamp (Woburn, Mass.) supplies quartz halogen
lamps, which are enhanced for ultraviolet emission by virtue of the
quartz (rather than ultraviolet absorbing glass) bulb covering the
filament. Such lamps are generally inexpensive, small, generate
minimal heat, and may therefore be incorporated with many of the
embodiments of the present invention, as disclosed in greater
detail below.
[0051] As will be appreciated by those skilled in the art, a
variety of suitable lighting sources can be employed in the
embodiments disclosed herein, without departing from the scope of
the invention.
[0052] Turning now to the embodiments of the invention, an optical
therapy device 100 for providing therapeutic light to a body cavity
in accordance with one embodiment of the present invention is
illustrated in FIG. 1. The optical therapy device 100 generally
includes a housing or body adapted to be hand-held; and a UV light
source 126 positioned in or near the housing. An insertion member
or tube 106 is provided having a distal end configured to be
inserted into a target body cavity to illuminate tissue within the
body cavity from the light source when the distal end of the
insertion member is positioned within the body cavity.
[0053] As will be appreciated by those skilled in the art, the body
can also generally refer to the optical therapy device 100 without
the light source 126 and without the power supply 110 or power
cords 114 connected. The body of the optical therapy device in
combination with the light source 126 can be held in one's hand or
hands for an extended period of time (e.g., a therapeutic time)
without undue effort or discomfort, due to the lightweight,
portable design of the device.
[0054] In one embodiment, the insertion member or tube 106 includes
a tip 118 at the distal end 116 of the tube 106. The tip 118 of the
tube 106 is any of a variety of optically transparent or partially
transparent structures. As will be appreciated, optically
transparent components or materials can include components or
materials that are transparent to wavelengths between about 200 nm
and about 800 nm. In some cases, optically transparent can refer to
more narrow ranges of transparency. For example, optically
transparent to ultraviolet (UV) light can refer to transparency in
the range from about 200 mm to 400 nm; while optically transparent
to ultraviolet B (UVB) can refer to transparency in the range from
about 280 mm to about 320 nm.
[0055] In one embodiment, the tip 118 includes a window, a
diffusing lens, a focusing lens, an optical filter, or a
combination of one or more of such tip types or other tip types
which allow the spectral output to be conditioned. The lens can
include, for example, a device that causes radiation or light to
converge or diverge. The conditioner can be configured to modify
the spectral output or the geometric illumination pattern of the
device. In one embodiment, to provide a desired output spectrum,
three types of tips can be used in series within the tube 106. For
example, in one embodiment, a lens is used to diffuse (e.g.,
refract) certain wavelengths while filtering (e.g., transmitting
certain wavelengths and absorbing others) certain wavelengths, and
serving as a window (e.g., transmitting) certain wavelengths. In
another embodiment, the light from the tube 106 is transferred
through tip 118 through a series of internal reflections. In one
embodiment, the tip 118 is made at least in part from a different
material than that of the tube 106. The tip 118 of the tube 106 may
be shaped or designed to disperse light as it exits the reflecting
tube 106 and is transmitted to a patient.
[0056] The tube 106 can be configured as a reflecting tube and can
be manufactured from any of a variety of materials, including
plastic, stainless steel, nickel titanium, glass, quartz, aluminum,
rubber, lucite, or any other suitable material known to those of
skill in the art that may be adapted to be place inside of a
patient's body. In some embodiments, the material of the tube is
chosen to reflect certain wavelengths and/or absorb others. In some
embodiments, the tube is configured to yield near or total internal
reflection.
[0057] Additionally, the reflecting tube 106 can be configured such
that it is hollow. Where the reflecting tube 106 is hollow, the
inside wall 120 of the reflecting tube 106 can at least partially
reflects light of a selected wavelength. Thus, the inside wall 120
may include a reflecting layer 122 applied over its entire surface
although in other embodiments the inside wall 120 does not include
a reflecting layer 122. In one embodiment, the reflective layer 122
includes a coating of a reflecting material such as, for example,
aluminum, silica carbide, or other suitably reflective
material.
[0058] The proximal end 108 of the tube 106 is coupled to the
distal end 105 of the hand piece 102 by any of a variety of
couplings 124 well known to those of skill in the art. For example,
in one embodiment, the coupling 124 includes a press-fit
connection, a threaded connection, a weld, a quick-connect, a
screw, an adhesive, or any other suitable coupling as is known to
those of skill in the art. Coupling 124 includes mechanical,
optical, and electrical couplings, as well as combinations
thereof.
[0059] In one embodiment, the coupling 124 is releasable so that
the tube 106 may be decoupled or removed from the hand piece 102.
Such coupling 124 may also be made from a disposable material. In
another embodiment, the reflecting tube 106 is permanently attached
to the hand piece 102. In such case, the coupling 124 is a
permanent connection.
[0060] In one embodiment, the hand piece 102 of the body includes a
light source 126. The light source may be any of a variety of high,
low, or medium pressure light emitting devices such as for example,
a bulb, an emitter, a light emitting diode (LED), a xenon lamp, a
quartz halogen lamp, a standard halogen lamp, a tungsten filament
lamp, or a double bore capillary tube, such as a mercury vapor lamp
with or without a phosphor coating. The particular light source
selected will vary depending upon the desired optical spectrum and
the desired clinical results, as will be described in greater
detail below. Although the light source 126 of FIG. 1 is shown in
the hand piece 102, the light source 126 can be placed anywhere on,
in, or along the optical therapy device 100, including on or in the
distal end of the insertion member. In some of the embodiments
discussed below, multiple light sources are adapted for delivery by
the optical therapy device 100, some of which may reside in the
hand piece 102 and some of which may reside on or in the insertion
member or tube 106, and some of which may reside on or in the tip
118.
[0061] The light source 126 can be configured to include a
phosphor-coated, low pressure mercury vapor lamp. In a related
embodiment, the phosphor is placed distal to the mercury vapor
lamp; for example, the phosphor is coated onto the reflecting tube
106 or is incorporated into the tip 118. Optical emitter 128
illuminates the light emitting portion of the light source 126.
When light source 126 is a mercury vapor lamp, optical emitter 128
can be an inner capillary tube where the mercury plasma emits
photons. Leads 132 extending from the light source 126,
electrically couple the light source 126 with a control circuit
134. In one embodiment, the control circuit 134 is in electrical
communication with a controller 136 and with power supply 110 via
the power coupling 114.
[0062] Optical emitter 128 can also comprise a filament. Such
filaments may be used when light source 126 is an incandescent or
halogen lamp.
[0063] As will be appreciated by those skilled in the art, it may
be desirable to control variables or control parameters associated
with the output of the optical therapy device 100. Examples of such
variables include power, timing, frequency, duty cycle, spectral
output, and illumination pattern. In one embodiment, the control
circuit 134 controls the delivery of power from the power supply
110 to the light source 126 according to the activation or status
of the controller 136. For example, in one embodiment, the control
circuit 134 includes a relay, or a transistor, and the controller
136 includes a button, or a switch. When the button or switch of
the controller 136 is pressed or activated, power from the power
supply 110 is able to flow through the control circuit 134 to the
light source 126.
[0064] The variables can be controlled in response to, for example,
at least one photoreflectance parameter, which, for example, may be
measured or obtained at the distal end 116 of the therapy device
100. Other variables or control parameters include desired dosage,
or a previous dosage. In some embodiments, the patient or treating
physician can adjust the treatment time based on the prior history
with the optical therapy device 100. In some embodiments,
controller mechanisms, which can be integral to the optical therapy
device 100, allow for control over dosage and illumination. In
other embodiments, the controller tracks the total dose delivered
to a patient over a period of time (e.g., seconds, minutes, hours,
days, months, years) and can prohibit the device from delivering
additional doses after the preset dosage is achieved.
[0065] Although the control circuit 134 is illustrated within the
hand piece 102 of the optical therapy device 100, in another
embodiment, the control circuit 134 is located within the power
supply 110. Other configurations can be employed without departing
from the scope of the invention. In such embodiments, the
controller 136 communicates with the control circuit 134 through
the power coupling 114. Control data, commands, or other
information may be provided between the power supply 110 and the
hand piece 102 as desired. In one embodiment, control circuit 134
stores information and data, and can be coupled with another
computer or computing device.
[0066] In one embodiment, power from the power supply 110 flows to
the control circuit 134 of the hand piece 102 through a power
coupling 114. The power coupling 114 may be any of a variety of
devices known to those of skill in the art suitable for providing
electrical communication between two components. For example, in
one embodiment, the power coupling 114 includes a wire, a radio
frequency (RF) link, or a cable.
[0067] The light source 126 is generally adapted to emit light with
at least some wavelengths in the ultraviolet spectrum, including
the portions of the ultraviolet spectrum known to those of skill in
the art as the UVA (or UV-A), UVA.sub.1, UVA.sub.2, the UVB (or
UV-B) and the UVC (or UV-C) portions. In another embodiment of the
current invention, light source 126 emits light in the visible
spectrum in combination with ultraviolet light or by itself.
Finally, in yet another embodiment, the light source 126 emits
light within the infrared spectrum, in combination with white light
and/or ultraviolet light, or by itself. Light source 126 may be
adapted to emit light in more than one spectrum simultaneously
(with various phosphors, for example) or a multiplicity of light
sources may be provided to generate more than one spectrum
simultaneously. For example, in one embodiment, the light source
126 emits light in the UVA, UVB, and visible spectra. Light
emission at these spectra can be characterized as broad- or
narrow-band emission. In one embodiment, narrow-band is over a band
gap of about 10-20 nm and broad-band is over a band gap of about
20-50 nm.
[0068] The spectrum delivered can be continuous. Continuous (or
substantially continuous) emission is intended to have its ordinary
meaning, and also to refer to generally smooth uniform optical
output from about 320-400 nm for UVA, 280-320 nm for UVB, and below
about 280 nm for UVC. In other embodiments, the light source 126
emits light in any two of the foregoing spectra and/or spectra
portions. In addition, in some embodiments, some portions of the
spectra are smooth and others are continuous.
[0069] For example, in one embodiment, the light source 126 emits
light having a narrow-band wavelength of approximately 308 nm
within the UVB portion of the UV spectrum. In another embodiment,
the light source 126 emits light having a wavelength below
approximately 300 nm. In other embodiments, the light source 126
emits light having a wavelength between about 254 nm and about 313
nm.
[0070] The optical therapy device 100 can be configured to include
more than one light source 126, where each light source 126 has an
output centered at a different wavelength. Each light source 126
can have an output that can be characterized as broad-band,
narrow-band, or substantially single band. All light sources 126
can be the same characterization, or may have one or more different
characterizations. For example, in one embodiment, the optical
therapy device 100 includes three light sources 126: one that emits
light in the UVA region of the UV spectrum, one that emits light in
the UVB region of the UV spectrum, and one that emits light in the
visible region of the optical spectrum.
[0071] The light sources may each emit light at a different energy
or optical power level, or at the same level. The optical therapy
device 100 may be configured to provide light from three light
sources 126, each having a different relative output energy and/or
relative energy density level (e.g., fluence). For example, in one
embodiment, the optical energy emitted from the light source 126
that provides light in the UVA region of the UV spectrum is about
10%, 20%, 25%, 35%, between about 15% and about 35%, or at least
about 20% of the optical energy and/or fluence provided by the
optical therapy device 100. In one embodiment, the optical energy
emitted from the light source 126 that provides light in the UVB
region of the UV spectrum is about 1%, 3%, 5%, 8%, 10%, between
about 1% and about 11%, or at least about 2% of the optical energy
and/or fluence provided by the optical therapy device 100. In one
embodiment, the optical energy emitted from the light source 126
that provides light in the visible region of the optical spectrum
is about 50%, 60%, 75%, 85%, between about 60% and about 90%, or at
least about 65% of the optical energy and/or fluence provided by
the optical therapy device 100.
[0072] In one embodiment, the optical therapy device 100 includes a
UVA light source 126, a UVB light source 126, and a visible light
source 126, where the UVA light source 126 provides about 25%, the
UVB light source provides about 5%, and the visible light source
provides about 70% of the optical energy and/or fluence provided by
the optical therapy device 100. For example, in one embodiment, the
optical therapy device 100 provides a dose to the surface it is
illuminating (e.g., the nasal mucosa) of about 2 J/cm.sup.2, where
the UVA light source 126 provides about 0.5 J/cm.sup.2, the UVB
light source 126 provides about 0.1 J/cm.sup.2, and the visible
light source 126 provides about 1.4 J/cm.sup.2. In another
embodiment, the optical therapy device 100 provides a dose of about
4 J/cm.sup.2, where the UVA light source 126 provides about 1
J/cm.sup.2, the UVB light source 126 provides about 0.2 J/cm.sup.2,
and the visible light source 126 provides about 2.8 J/cm.sup.2. In
another embodiment, the optical therapy device 100 provides a dose
of about 6 J/cm.sup.2, where the UVA light source 126 provides
about 1.5 J/cm.sup.2, the UVB light source 126 provides about 0.3
J/cm.sup.2, and the visible light source 126 provides about 4.2
J/cm.sup.2. In yet another embodiment, the optical therapy device
100 provides a dose of about 8 J/cm.sup.2, where the UVA light
source 126 provides about 2 J/cm.sup.2, the UVB light source 126
provides about 0.4 J/cm.sup.2, and the visible light source 126
provides about 5.6 J/cm.sup.2. In some embodiments, the white light
is omitted from the therapy leaving only the doses of the
ultraviolet light. In some embodiments, the white light and the UVA
are omitted leaving only the UVB doses. In other embodiments, the
UVB and the white light are omitted leaving only the UVA dose. In
other embodiments the UVB dosage is concentrated in the range from
305 nm to 320 nm, sometimes referred to as UVB.sub.1. UVB.sub.1 can
be used in place of UVB in any of the combinations and doses above.
In other embodiments, UVA.sub.1 (e.g., 340-400 nm) is used in any
of the embodiments above in place of UVA. In yet other embodiments,
UVA.sub.2 (e.g., 320-340 nm) is used in the embodiments above in
place of UVA. In some embodiments, blue light (e.g., 400-450 nm) or
a combination of blue light and long wavelength UVA (e.g., 375-450
nm) is used to treat tissue. In some embodiments, the dose of blue
light or combination UVA-blue light is about 20-100 times greater
than UVB. In some embodiments, the fluence in the above
measurements represents energy delivered to a body cavity. For
example, when the body cavity is the nasal cavity, the area over
which the light is delivered can be approximately 5-30 cm.sup.2;
therefore the energy in each region of the optical spectrum leaving
the optical therapy device is in some embodiments 5-30 times the
energy reaching the surface of the body cavity.
[0073] In some embodiments, a ratio is defined between the
wavelengths. In one embodiment, the ratio between the total UVA
power and the total UVB power (the power ratio) is about 5:1. In
other embodiments, the ratio is between 5 and 10:1. In other
embodiments, the ratio is between 10 and 15:1. In some embodiments,
UVB.sub.1 is substituted in the defined ratios. In any of the above
ratios, visible light can be excluded or included. In some
embodiments, the power ratio is further defined between UVA.sub.1
and UVB.sub.1; for example, the power ratio can be from 40:1 to
80:1 for a ration of UVA.sub.1 to UVB.sub.1.
[0074] Optical energy densities are generally derived from a power
density applied over a period of time. Various energy densities are
desired depending on the disorder being treated and may also depend
on the light source used to achieve the optical output. For
example, in some embodiments, the energy densities are achieved
over a period of time of about 0.5 to 3 minutes, or from about 0.1
to 1 minute, or from about 2 to 5 minutes. In some embodiments, for
example, when a laser light source is used, the time for achieving
these energy density outputs may be from about 0.1 seconds to about
10 seconds. Certain components of the optical spectrum can be
applied for different times, powers, or energies. In the case where
multiple light sources are used, one or more light sources can be
powered off after its energy density is provided or achieved.
[0075] Energy density or fluence or other dosage parameter, such
as, for example, power, energy, illumination, or irradiance, may be
measured at any of a variety of positions with respect to the tip
118 of the optical therapy device 100. For example, in one
embodiment, fluence is measured substantially at the tip 118 of the
optical therapy device 100. In this case, the dosage at the
illumination surface is the fluence multiplied by the fluence area
(for total power) and then divided by the illuminated surface area
(e.g., in the nasal cavity, the surface area can range between 5
and 25 cm.sup.2). Therefore to achieve the desired dosage density,
the fluence at the tip is approximately the dosage multiplied by
illuminated surface area and then divided by the tip area. In
another embodiment, the fluence is measured at a distance of about
0.5 cm, about 1 cm, or about 2 cm from the surface of the tip 118
of the optical therapy device 100.
[0076] The particular clinical application and/or body cavity being
treated may determine the energy density or dosage requirements. If
the lining of the cavity is particularly far away from the optical
therapy device 100, a higher energy, fluence, or intensity may be
chosen. In the case where the nasal cavity is being treated and
rhinitis is the disease, the dosage from the tip 118 may be chosen
appropriately. For example, it has been shown by in-vitro work that
T-cells undergo apoptosis at energy densities of about 50-100
mJ/cm.sup.2 of combined UVA, UVB, and white light. The energy
densities exiting from the tip of the optical therapy device used
to achieve such energy densities as measured at the treatment site,
may be 5-10 times this amount because of the optical therapy
distance 100 from the treatment site during treatment.
[0077] The energy densities may be further increased from that
achieved in-vitro because of intervening biologic materials that
may absorb light. For example, the mucus, which is present on top
of the nasal mucosa in all patients, may absorb light in the
desired region of the spectrum. In this case, the fluence or output
of the optical therapy device 100 at the tip 118 can be corrected
for the extra absorption. Furthermore, the mucosa may absorb more
or less light at different time points during an allergy season
(for example) and therefore the fluence of the optical therapy
device may be controlled at these times. In many embodiments, this
control is provided by the optical therapy devices.
Photoreflectance data from the mucosa can be used by the patient,
the medical practitioner, or automatic feedback (e.g., from the tip
118) to a controller and/or data processor. Such data can be used
to estimate the thickness of the mucus layer and adjust the output
of the optical therapy device 100 accordingly. In addition, the
practitioner can evaluate the mucosa visually with a rhinoscope and
adjust the optical parameters accordingly; in another embodiment,
tube 106 delivers an image from the region surrounding the distal
tip 118.
[0078] The dosage may be measured at a planar or curved surface
with respect to the tip 118 of the optical therapy device 100. For
example, in one embodiment, the dosage is measured at a plane that
is tangential to the surface of the tip 118 of the optical therapy
device 100. In another embodiment, the dosage is measured at a
plane that is a distance of about 0.5 cm, 1 cm, 2 cm, 3 cm or 5 cm
from the surface of the tip 118 of the optical therapy device
100.
[0079] In another embodiment, the dosage is measured at a partially
spherical plane that is at least partially tangential to, or at a
distance of about 0.5 cm, 1 cm, 2 cm, 3 cm or 5 cm from the surface
of the tip 118 of the optical therapy device 100. The selection of
planar or curved surface for dosage measurement, and the distance
between the measurement plane and the optical therapy device 100
tip 118 may be selected based upon the particular geometry of tip
118 utilized.
[0080] In one embodiment, the output portion 130 of the light
source 126 is positioned so that it resides within at least a
portion of the tube 106. When the output portion 130 of the light
source 126 is so positioned, light emitted from the light source
126 is transmitted directly into the tube 106. In this embodiment,
the tube is a reflecting tube. In such a case, optical losses may
be minimized, or reduced. In addition, by positioning the output
portion 130 of the light source 126 inside of the tube 106,
additional optical focusing elements, such as lenses or mirrors,
may not be required; moreover, the geometry of the tube can be
optimized, such that light conduction is optimized by for example,
creating surfaces within the tube designed to reflect light through
and along the tube to transport the light to the distal end of the
tube. In addition, the tube can be created to optimize total
internal reflection of the light from the light source.
[0081] In some embodiments, the optical reflectance tube 120
includes one or more optical fibers that capture and guide the
light from the light source/s 126. When the light sources 126 are
small semiconductor structures, the fibers can encapsulate the
semiconductor structure and faithfully transmit substantially all
of the light from the light source 126. More than one fiber can be
used to direct the light from multiple light sources 126. For
example, each fiber can transmit light from one light source 126.
In other embodiments, the optical tube 106 is or includes a light
guide such as a liquid light guide (e.g., such as those available
from EXFO in Ontario, Calif.).
[0082] The tube 106 may taper from a large diameter at its proximal
end 108 to a smaller diameter at its distal end 116, in which case
the tube 106 has a larger diameter at its proximal end 108 than at
its distal end 116. In another embodiment, the tube 106 may taper
from a larger diameter at its distal end 116 to a smaller diameter
at its proximal end 108. In such case, the tube 106 has a larger
diameter at its distal end 116 than at its proximal end 108. In
other embodiments, the insertion member or tube 106 is
substantially cylindrical. In such case, the diameter of the tube
106 may be substantially constant along its entire length.
[0083] In one embodiment, the tube 106 is flexible so that its
shape and orientation with respect to the housing or hand piece 102
may be adjusted. A flexible material, such as rubber, plastic, or
metal may be used to construct the tube 106, and to provide
flexibility thereto. In one embodiment, a goose-neck tube, or
spiral wound coil is used to provide a flexible tube 106. In such
embodiments, an outer sheath 142 may be provided with the tube 106
to isolate the flexible portion of the tube 106 from the body
cavity, such as a patient's nasal cavity.
[0084] An outer sheath 142 can be made from any of a variety of
biocompatible materials well-known in the art such as, but not
limited to, PTFE, ePTFE, FEP, PVDF, or silicone elastomers. The
outer sheath can be disposable so that a clean, sterilized sheath
can be used for each newly treated patient. The outer sheath 142
can also have beneficial optical properties. For example, the outer
sheath can diffuse or otherwise pattern the light entering it from
the optical tube 106. The outer sheath can be made of more than one
material. For example, in some embodiments, the portion of the
sheath where the light exits (e.g., the lens) 140 can be produced
from an optically transparent material such as silicone, fused
silica, or quartz, and the biocompatible portion which surrounds
tube 106 can be produced from a material which is more flexible or
lubricious, such as PTFE, but which does not necessarily transmit
ultraviolet light.
[0085] In one embodiment, tube 106 is sized so it may be inserted
into a cavity of a patient or user. For example, when the insertion
member or tube 106 is inserted into the nasal cavity until its tip
118 reaches the turbinates, the sinuses, or the ostia to the
sinuses. The tube 106 may be made of flexible materials so that it
can bend, or be steered around corners, or conform to the shape of
the cavity, as required.
[0086] The insertion member or tube 106 may be made from any one or
a combination of materials as described above. For example, the
tube 106 may be made from polymers. In such case, since many
polymers absorb light in the ultraviolet portion of the spectrum,
the inside wall 120 of the tube 106 may be coated with a reflective
coating or layer 122, as described above. The outside of the tube
106 can also be coated with a polymer with the inner material being
one of the materials noted above.
[0087] In one embodiment, the reflective layer 122 includes an
electrolessly-deposited metal. For example, layer 122 may include
nickel, nickel-phosphorous, cobalt, cobalt-phosphorous,
nickel-cobalt-phosphorous and/or a noble metal. In other
embodiments, the layer 122 includes a reflective polymeric coating.
In other embodiments, the reflecting layer is a specialty thin
film, such as silica carbide deposited in a chemical vapor
deposition process.
[0088] In one embodiment, the tube 106 includes quartz, fused
silica, aluminum, stainless steel, or any material which reflects a
substantial amount of light in the ultraviolet region and/or
visible region of the electromagnetic spectrum.
[0089] The optical therapy device 100 generally allows for the use
of low pressure light sources 126 and can be manufactured at low
cost using safe light sources 126. By utilizing a low pressure
light source 126, the light source 126 may be manufactured at a
small size so that it can fit within a hand-held hand piece 102 of
the optical therapy device 100.
[0090] The controller 136 of the optical therapy device 100 is
adapted to control the quantity (e.g., total energy) and intensity
(e.g., power) of light emitted by the light source 126 and thereby
exiting the tip 118 of the optical therapy device 100. For example,
in one embodiment, the controller 136 determines and/or controls
the power from the power supply 110. The controller 136 may be
programmed and may include a timer so that only a pre-specified
amount of light can be provided by the optical therapy device 100
at any given time, and such that a user cannot receive more than a
predetermined dose in a specified short time period (e.g., over a
period of one day) or a number of doses in a specified time period
(e.g., over a period of months, for example). The controller 136
can also be configured to control the illumination pattern. For
example, by turning one or more light sources powered on and
powered off, the illumination pattern can be controlled. The
controller 136 can further control the illumination pattern by
moving (actively or passively) or otherwise altering the aperture
or pattern of the tip 118. The controller 136 can also apply
current to the light sources at a desired frequency or duty
cycle.
[0091] In another embodiment, the controller 136 is adapted to
deliver a large current or a current or voltage pulse to the light
source 126 to "burn out" or destroy the light source 126 after a
selected period of time. For example, after a predetermined "useful
lifetime" of the optical therapy device 100 expires, a "burn out"
current is provided and the optical therapy device 100 essentially
ceases to function. At this time, the optical therapy device 100 is
discarded. The controller 136 can also respond to or receive a
control signal from one or more photodetectors placed in or on the
tube 106 or the controller can respond to receive a control signal
from one or more photodetector devices in an external calibration
unit.
[0092] The power supply 110 of the optical therapy device 100 is
adapted to receive power from an alternating current (AC) source, a
direct current (DC) source, or both depending on the number and
types of light sources. For example, in one embodiment, power
supply 110 includes a battery, battery pack, rechargeable DC
source, capacitor, or any other energy storage or generation (for
example, a fuel cell or photovoltaic cell) device known to those of
skill in the art. In some embodiments, an LED may utilize a DC
power source whereas a mercury vapor lamp may utilize an AC power
source. Thus, where a device is configured to use more than one
light source, it may be necessary to provide more than one power
source.
[0093] In one embodiment, the light source 126 includes a low
pressure lamp with an output (measured at any of the locations
described above) between about 100 .mu.W/cm.sup.2 and about 5
mW/cm.sup.2. In one embodiment, the light source 126 generates
ultraviolet light and it includes at least a small amount of
mercury within a nitrogen atmosphere. As discussed above, the
output portion 130 of the light source 126 may be any material
translucent to ultraviolet light, such as, for example, but not
limited to, quartz, silicone or fused silica. The output portion
can direct the light in a uniform or non-uniform pattern.
[0094] When mercury vapor is used in connection with the light
source 126, the light source 126 provides ultraviolet light having
an output peak concentrated at 254 nm. The light source 126 can
include a mercury vapor lamp having a spectral output which resides
in longer wavelengths of the ultraviolet spectrum and in some
embodiments extends into the visible spectrum. Suitable mercury
vapor lamps include the type 2095 lamp manufactured by Gelight
Corporation. Additionally, a phosphor or a combination of phosphors
can be used, as is widely known to those skilled in the art. In one
embodiment, phosphors are added to the light source 126, the output
peaks from the light source 126 can be customized based upon the
desired clinical application and action spectra for the disease
process being treated.
[0095] Additionally, the light source 126 can include or be
selected from light emitting diode (LED) such as the UV LED
manufactured by S-ET Corporation (Columbia, S.C.), which can be
produced to emit narrowband light at any wavelength from about 250
nm to 365 nm. More specific wavelength, such as a wavelength of 275
nm, can be used. In such cases, the UV LED may have a sapphire
substrate with conductive layers of aluminum gallium nitrite. For
example, in one embodiment, the UV LED has about 50% aluminum. By
varying the concentration of aluminum, the wavelength peak can be
adjusted. In some embodiments, the several LEDs are packaged
together such that light output with multiple peaks in the
ultraviolet range can be achieved. In some embodiments, the
aluminum concentration is varied along a dimension of the chip such
that a more continuous spectrum is achieved when current is passed
through the chip. In addition, the UV LED packaging may include
flip-chip geometry. In such case, the LED die is flipped upside
down and bonded onto a thermally conducting sub-mount. The finished
LED is a bottom-emitting device that may use a transparent buffer
layer and substrate.
[0096] In such embodiments, the light is two-times brighter when
the LEDs are in a flip-chip geometry. This is due to the fact that
light emitted from the LED is not physically blocked by an opaque
metal contact on the top of the LED. In addition, flip-chip
sub-mount pulls heat away from the device when made from materials
having high thermal conductivity. This improves efficiency levels
with less energy being converted to heat and more energy being
converted to light. The resulting device will have a lower weight,
will be smaller, and will be resistant to vibrations and shock.
[0097] Power delivery to the LEDs can be modified to optimize the
optical power of the LEDs. In such cases, the LEDs can be
configured to switch on and off in order to prevent heat build up
which would otherwise decreases the efficiency of the LEDs. For
example, a temperature rise may decrease the potential optical
power. Such switching can increase the power output several-fold.
In other embodiments, the semiconductor structure takes the form of
a laser diode module wherein the semiconductor package contains
reflecting optics to turn the non-coherent light into coherent
light.
[0098] Although the power supply 110 of the optical therapy device
100 is illustrated in FIG. 1 as tethered to the proximal end 112 of
the hand piece 102, it should be well understood by those of skill
in the art that the power supply 110 may be incorporated into or
included on or within the body of the device, including the hand
piece 102. In such cases, the power supply 110 may include a
battery, a battery pack, a capacitor, or any other power source.
The power coupling 114 in such embodiments may include contacts or
wires providing electrical communication between the power supply
110 and the control circuit 134.
[0099] A sleeve 140 may be provided to at least partially cover the
tube 106. In one embodiment, the sleeve 140 is disposable and in
another embodiment, the sleeve is not disposable. In addition, as
will be appreciated by those skilled in the art, disposable can
also refer to the cost of production and sales price of a
component, as well as the ability to use procedures to sterilize or
otherwise clean a component between uses.
[0100] The sleeve is sterilizable and in other embodiments, the
sleeve is not sterilizable. Sterilizing methods include, without
limitation, ethylene oxide (ETO), autoclaving, soap and water,
acetone, and alcohol. The sheath or the sleeve can be molded,
thermoformed, machined or extruded. As will be appreciated, the
sleeve or sheath can be composed of multiple materials. For
example, the body of the sleeve is produced from a material such as
aluminum or a plastic coated with aluminum and the end of the
sleeve is an optically transparent material. The end of the sleeve
can also have an open configuration where the light diverges as it
leaves the sleeve. The sleeve can also be solid and produced from
the same or different materials. In this embodiment, the inner
material will transmit light without absorbing the light. These
configurations generally allow optical energy, or light, generated
by the light source 126 to travel through the tube 106 and exit
both the tip 118 of the tube 106 and the tip 140 of the sleeve. In
such embodiments, light energy is emitted from the optical therapy
device 100 and absorbed by the tissue within the body cavity (e.g.,
nasal cavity of the patient's nose).
[0101] The optical emitter 128 of the light source 126 is generally
in electrical communication with leads 132. The optical emitter 128
can be adapted to extend in a direction that transverses an axis of
the light source 126. As will be appreciated, the optical emitter
128 schematically represents only one embodiment of the light
emitting portion of the hand piece 102 and light source 126.
Optical emitter 128 (e.g., the light emitting portion of the light
source 126) can be made from any of a variety of materials known to
those of skill in the art; in cases where the optical emitter 128
represents a wire-filament type light source, the optical emitter
128 can include tungsten.
[0102] In embodiments where the light source 126 includes a
gas-filled tube, such gases may include xenon, helium, argon,
mercury, or mercury vapor, or a combination thereof, in order to
produce a desired spectral output.
[0103] Although the optical emitter 128 of the light source 126 is
shown at the distal end 124 of the hand piece 102, in other
embodiments, the optical emitter 128 is positioned closer to the
proximal end 112 of the hand piece 102. By moving the optical
emitter 128 proximal with respect to the tip 118 of the tube 106,
heat generated by the light source 126 may be at least partially
separated from the tube 106, thereby lessening thermal
communication with the patient's tissues.
[0104] Heat generated by the light source 126 may be removed from
the optical therapy device 100 by any of a variety of methods and
devices known to those of skill in the art. For example, in one
embodiment, heat is directed away from the hand piece 102 by
convection or conduction. In other embodiments, active cooling
devices, such as thermo-electric coolers or fans may be employed.
Alternatively, or in addition, passive cooling structures, such as
heat fins, heat conductors and/or cooling tubes may be used to
remove heat from the optical therapy device 100.
[0105] In one embodiment, the light source 126 includes a solid
state light emitter (e.g., an LED or laser diode module) and the
light source 126 is positioned at or near the distal end 116 of the
tube 106 instead of within the hand piece 102.
[0106] In another embodiment, the light source 126 includes a solid
state emitter and a mercury vapor lamp (or other analog-type light
source that emits ultraviolet light as described above). Such
combinations may be useful to provide light of multiple wavelengths
or intensities that correspond to select spectral peaks. Multiple
solid state emitters may be employed to achieve the same or similar
results. Additionally, a visible light solid state emitter is
combined with a mercury vapor or halogen lamp to enhance
wavelengths in the visible light region can be used. Alternatively,
an array of solid state emitters may be arranged on an integrated
circuit layout to produce spectral output that can be continuous or
semi-continuous depending upon the wavelength, number and bandwidth
of each emitter.
[0107] The tube 106 may include a soft coating on its outside
surface 138. A soft coating, such as a polymer, rubber, or
fluid-filled jacket, provides a comfortable interface between the
outside surface 138 of the reflecting tube 106 and the patient's
nose. In addition, the reflecting tube 106 may include one or more
filters along its length. A filter can be positioned within the
reflecting tube 106 near its proximal end 112 or near its distal
end 116. The filter may function as a lens if cut into an
appropriate shape and placed at the distal end 116 of the
reflecting tube 106. One such optical filter well known to those of
skill in the art is manufactured by Schott and includes glass
optimized for absorption at certain wavelengths.
[0108] The light source 126 typically is about 10% to about 15%
efficient. The light source or combinations of light sources 126
can be configured to generate about 10 mW to about 100 mW of
optical power. The light source can be configured to dissipate
between about 10 W to about 20 W of power in order to generate
about 10 mW to about 100 mW of optical power. Excess heat is
typically dissipated so that the optical therapy device 100 does
not overheat, and/or so that the patient does not experience
discomfort during its use.
[0109] Heat transfer control may become increasingly important when
the optical therapy device 100 includes a light source 126 that is
located near the distal end 116 of the tube 106 (e.g., heat may be
closer to the patient's tissue). For example, where the light
source 126 is a mercury vapor light source, heat is generated near
the output portion 130 where the mercury plasma is generated.
Since, in this embodiment, most of the light generated is
non-blackbody radiation, very little heat is generated as photons
propagate towards the distal end 116 of the tube 106 and enter the
tissue of the patient. Therefore, in such embodiments, heat
transfer mechanisms are generally confined to the output portion
130 of the light source 126, close to where the light is
generated.
[0110] In one embodiment, a fan is used to transfer heat or to
remove heat from the optical therapy device 100. The fan may be
configured to surround at least a portion of the output portion 130
of the light source 126 or the entire light source 126 itself.
Thus, the fan may surround the light source 126, or a portion
thereof, in an annular fashion, and can direct heat away from the
light source 126 and away from the patient via convection.
[0111] Alternatively, a heat tube is placed around the light source
126 and the heat tube directs heat away from the patient towards
the proximal end 112 of the hand piece 102. At the proximal end 112
of the optical therapy device 100, heat may be released into the
environment. The heat tube can be configured to terminate in a
structure optimized for heat transfer into the surrounding
environment, for example, cooling fins. Alternatively, or in
combination, in another embodiment, a fan is provided at the
proximal end 112 of the optical therapy device 100 and at the
proximal end of the heat tube. The fan provides active convection
to carry heat away from the optical therapy device 100.
[0112] A controller 136 can also be provided that is adapted to
control the power output from the power supply 110 so that the
light source 126 is activated for a predetermined time period. The
controller 136 may include a switching mechanism that is controlled
external to the device. Such external control may be implemented by
any of a variety of mechanisms, such as, for example, a radio
frequency communicator. The controller 136 helps avoid misuse or
overuse of the optical therapy device 100. The controller 136 may
also allow optimization to be carried out by the physician
prescribing the device. In another embodiment, the controller 136
provides for preset dose quantity and frequency. These parameters
can be set by the patient's physician, controller, a nurse,
caregiver, patient, or other individual, or may be set according to
prescription set forth by clinician.
[0113] The optical therapy device 100 can be adapted to include
software (not shown) to control the dosage of optical energy to a
patient. Thus, the energy, power, intensity, and/or fluence of the
optical output may be adjusted. Thereafter, adjustments and
settings may be saved within or loaded onto the optical therapy
device 100 to correspond to the requirements of a particular
patient, or clinical result.
[0114] The treatment dose can be configured to include timing
controls. Timing controls may include the amount of time the light
source 126 of the optical therapy device 100 may be activated for a
treatment. Timing controls include pulsing parameters, such as
pulse width, timing of optical pulses, or relative sequence of
pulses of light emitted from one or multiple light sources 126.
Thus, the light source 126 can be adapted to provide continuous
(non-pulsed) optical output, and the timing controls include the
duration of treatment, the time between treatments, and the number
of treatments allowed in a specified time period, for example, one
day.
[0115] As described with respect to FIG. 2 below, the controller
136 need not be included within the hand piece 102 of the optical
therapy device 100. In such embodiment, power delivery and timing
controls are provided to the hand piece 102 from a source (such as
control unit 202) outside of the hand piece 102. In such
embodiment, the hand piece 102 may be disposable, and the physician
may control the doses to the individual patient from a personal
computer 204 or directly from power supply components, such as
described below in additional detail.
[0116] The optical therapy device 100 may be used to treat or
diagnose any of a variety of diseases. In one embodiment, the
optical therapy device 100, is used to modulate immune or
inflammatory activity at an epithelial or mucosal surface.
Different immune and/or inflammatory reactions may be treated with
combinations of ultraviolet and/or white light. In one embodiment,
the optical therapy device 100 is used to treat allergic rhinitis,
chronic allergic sinusitis, hay fever, as well as other
immune-mediated mucosal diseases. In addition, the optical therapy
device 100 may be used to treat any symptom associated with such
conditions, such as sneezing, rhinorrhea, palate itching, ocular
itching, congestion, and/or nasal itching. Kemeny et. al. describe
the use of local ultraviolet light to treat allergic rhinitis in US
Patent Publication Nos. 20040030368 and 20040204747. Ultraviolet
light allows for the treatment of disorders such as allergic
rhinitis without having to resort to systemically absorbed drugs
with their related systemic side effects. Intranasal light therapy
(rhinophototherapy) is also potentially an improvement over
intranasal steroids because the light can instantly penetrate
instantly through the mucosa in the spot where the light is
directed, resulting in apoptosis of inflammatory cells. Intranasal
steroids do not penetrate immediately into the nasal mucosa and
furthermore, when they are applied to the nasal cavity, the steroid
dose is difficult to consistently apply because some of the dose is
swallowed and some is washed away in the mucus flow. Phototherapy,
and specifically ultraviolet light therapy, has the ability to
penetrate through the mucosa instantaneously and effect cellular
changes. In some embodiments, the optical therapy device also
diagnoses disease in combination with therapeutic delivery or alone
without therapy.
[0117] In other embodiments, the optical therapy device 100 is used
to directly treat microbial pathogens or non-pathogens, such as
fungi, parasites, bacteria, viruses that colonize, infect, or
otherwise inhabit epithelial and/or mucosal surfaces. For example,
patients with chronic sinusitis frequently have fungal colonization
or a frank infectious process leading to the disease process. One
clinical advantage of utilizing ultraviolet light to eradicate
infections is that it avoids problems associated with antibiotic
resistance. Antibiotic resistance is becoming an increasingly
difficult problem to contend with in the medical clinic. In
particular, patients with sinusitis generally undergo multiple
courses of antibiotic therapy, which is typically ineffective.
Antibiotic therapy is typically ineffective because the chronic
nature of the sinuses in chronic sinusitis leads to production of a
biofilm, which by its nature can prevent antibiotics from reaching
the sinuses. Adjunctive phototherapy is another weapon in the
armamentarium against microbes.
[0118] In some disease states, patients are allergic to allergens
shed by microbes, such as in allergic fungal sinusitis. Microbes,
and in particular fungi, are particularly sensitive to light with
wavelengths ranging from 250 nm to 290 nm. At these wavelengths,
the light directly affects the cellular macromolecules and can, for
example, crosslink and/or dimerize DNA. Although the 250-290 nm
wavelength light may be useful to injure or destroy pathogens,
light having higher wavelengths (e.g., 300-450 nm) can also lead to
cellular injury, albeit at higher optical powers. Ultraviolet light
in the range 150-250 nm can also be used to destroy pathogens.
[0119] When combined with other chemicals or pharmaceuticals (e.g.,
moieties), light of different wavelengths can be used to treat
pathogens. Such therapy, generally referred to as photodynamic
therapy, allows almost any wavelength of light to be used to cause
a biologic effect. This is because the light is absorbed by the
moiety, which causes a toxic effect. The moiety can be chosen based
upon its absorption characteristics, the light wavelength, or
molecular specificity.
[0120] In some cases, the moiety or chemical entity resides in or
around an epithelialized surface. For example, ultraviolet light
can induce oxygen to become ozone, which can spontaneously release
a toxic oxygen radical. The toxic oxygen radical can injure or
destroy the pathogens.
[0121] Another FDA approved and widely used photodynamic therapy is
5-aminolevulinic acid which is a photosensitizer with an absorption
maximum at 630 nm and which generates oxygen free radicals upon
light exposure. More recently, photodynamic moieties have become
increasingly complex and can include nanoparticle such as those
described by Loo, et al. in Nanoshell-Enabled Photonics-Based
Imaging and Therapy of Cancer, 3(1) Technol Cancer Res Treat 33-40
(February 2004). Nanoparticle-based therapy systems allow for
wavelength tuning so that the wavelength of maximal absorption can
be customized to the application. Nanoparticles also allow for
surface modifications so that the particle can target a specific
tissue and then when the light focuses on that particular region,
the specifically targeted nanoparticle will absorb the specific
wavelength of light; therefore, regional specificity as well as
wavelength specificity can be achieved with one particle. It is
possible that the moieties resonate in response to specific
frequencies (e.g., on-off frequency as opposed to electromagnetic
frequency) in addition to wavelengths so that certain particles are
activated when the optical therapy device deliver light of specific
wavelength and with a specific on-off frequency.
[0122] When it is desired to treat microbes at epithelial or
mucosal surfaces, such as the sinuses, an optical therapy device
100, including a mercury vapor lamp light source 126, may be
utilized. Such a light source 126 generally emits light primarily
at a 254 nm wavelength, which can destroy bacteria, fungi, viruses,
and even fungal spores (discussed above). In other embodiments, an
array (e.g., one or more) of light emitting diodes (LEDs) or laser
diode modules is used. The array emits light (typically in the
ultraviolet C and short wavelength ultraviolet B regimes) and one
or more wavelengths selected to destroy polynucleotides (e.g., DNA
and/or RNA), cell membranes, and/or proteins of the pathogens. In
other embodiments, LEDs are used in photodynamic therapy and
activate the moiety to exert its biologic effect.
[0123] An optical therapy system 200 is illustrated in FIG. 2. The
optical therapy system 200 includes an optical therapy device 100,
a control unit 202, and at least one computer 204. Control unit 202
communicates with optical therapy device 100 via power coupling
114, such as power coupling 114 described above, with respect to
FIG. 1. Power coupling 114 may provide communication of power and
electronic control signals between control unit 202 and the optical
therapy device 100. The control unit 202 is also coupled to at
least one computer 204 via computer coupling 206. Computer coupling
206 may be any of a variety of structures, devices, or methods
known to those of skill in the art that enable communication
between computers or computing devices. For example computer
coupling 206 is a cable, such as a USB or Ethernet cable. The
computer coupling 206 can also be a wireless link. Computer 204 may
include a personal computer, such as a PC, an Apple computer, or
may include any of a variety of computing devices, such as a
personal digital assistant (PDA), a cellular telephone, a
BLACKBERRY.TM., or other computing device.
[0124] Computer coupling 206 may include any wired or wireless
computing connection, including a Bluetooth.TM. infrared (e.g.,
IR), radiofrequency (e.g., RF), or IEEE 802.11(a)-, (b)-, or
(g)-standard connection. Control unit 20; and computer 204 may form
a network within which multiple computers 204 or computing devices,
or control units 202 may be included.
[0125] In one embodiment, control unit 202 is connected to a power
supply via a power cord 208. Control unit 202 also generally
includes a display 210, a keypad 212, controls 214, and a cradle
216. Display 210 may include a screen or other output device, such
as indicators, lights, LEDs, or a printer. The display 210 can be a
touch screen that includes touch controls to control the parameters
of the optical therapy device 100. Controls 214 include any of a
variety of input devices, including knobs, levers, switches, dials,
buttons, etc. Cradle 216 can be adapted to receive the hand piece
102 of the optical therapy device 100 when not in use. Such a
cradle 216 may furthermore be configured to provide electrical
power (e.g., a rechargeable battery) to the hand piece of the
optical therapy device 100 and/or control signals. Power coupling
114 may not be provided, or may be provided via the cradle 216
through electrical contacts. The cradle 216 can be adapted to
include an optical detector, such as a photodiode, which can
provide an indication of the output or strength of the optical
light source 126 and can provide for calibration of the optical
therapy device 100 over time.
[0126] An optical therapy device 100, in accordance with another
embodiment of the present invention, is illustrated in FIG. 3. The
optical therapy device 100 of FIG. 3 includes a hand piece 102 and
tube 106 similar to the optical therapy devices discussed above. In
addition, the optical therapy device 100 of FIG. 3 includes
multiple light sources 126, 126', 126''. For example, as
illustrated, optical therapy device 100 includes three light
sources 126. Any number of light sources 126 may be utilized,
including one, two, three, or more than three light sources 126.
Light source 126 may be any suitable light source or combinations
thereof, including those discussed above. Any of the control
systems and power delivery systems discussed above may be
incorporated into the optical therapy device 100 of FIG. 3.
[0127] Although the multiple light sources 126 of FIG. 3 are shown
in close proximity, individual light sources 126 can be placed
anywhere along the tube 106 or hand piece 102, and need not be
grouped together The light source(s) 126 can be located close to
the distal tip 118. For example, in one embodiment, a UVB emitting
source is placed close to the distal tip 118 and a white light
source and/or UVA light source are/is placed proximally, toward the
hand piece 102. Such a configuration can assure that UVB
wavelengths reach the nasal mucosa because in many cases UVB light
is difficult to transport faithfully. Even though the UVA and white
light sources 126 may have more losses than the UVB light source
126, this is acceptable since, in at least one embodiment, the UVA
and white light sources 126 generate a higher amount of optical
energy or power and typically undergo less loss along an optical
guidance system than UVB light.
[0128] An optical therapy device 100 in accordance with yet another
embodiment of the present invention, is illustrated in FIG. 4A.
Optical therapy device 100 includes an insertion member or tube 106
and a hand piece 102, such as those described above with reference
to FIGS. 1-3. However, in the present embodiment, optical therapy
device 100 includes a passive cooling mechanism integrated therein.
In one embodiment, the passive cooling mechanism includes a cooling
sleeve in thermal communication with a heat diffuser 502 located at
the proximal end 112 of the hand piece 102. A thermal interface 504
covers at least a portion of the proximal end 112 of the hand piece
102, and provides for dissipation of heat from the heat diffuser
502. In one embodiment, the cooling sleeve at least partially
surrounds light source 126 of the hand piece 102.
[0129] The cooling sleeve may be made from any of a variety of
thermally conductive materials, including aluminum, copper, steel,
stainless steel, etc. In addition, the cooling sleeve may be filled
with a thermally conductive material or a cooling material such as
water, alcohol, Freon.RTM., Dowtherm.TM. A (a eutectic mixture of
biphenyl ether and diphenyl oxide, used for heat transfer), etc.
For higher temperature lamps, the cooling fluid could include
sodium, silver, and others materials as are generally well-known in
the art. In one embodiment, heat diffuser 502 includes cooling for
to increase its surface area. Increased surface area of the heat
diffuser 502 provides efficient cooling for the light source 126 of
the optical therapy device 100. The thermal interface 504 and/or
heat sink 502 may be made from any of a variety of thermally
conductive materials, including metals, such as aluminum, copper,
steel, stainless steel, etc. The rounded surface of the thermal
interface 504 protects the user and his or her hand from sharp or
jagged edges of the heat sink 502. The thermal interface 504 can
further be perforated to allow for convective flow from the heat
sink 502.
[0130] Cooling sleeve can be configured from a series of cooling
pipes, or heat pipes 500, as is well-known in the art, such as
those illustrated in FIGS. 4A-4B. Heat pipes 500 extend axially
along the longitudinal axis of the hand piece 102 and generally run
parallel to the light source 126.
[0131] A cross-sectional view of optical therapy device 100, taken
along line 4B-4B, is illustrated in FIG. 4B. In the illustrated
embodiment, a circumferential arrangement of heat pipes 500 is
shown. As is well-known in the art, heat pipes 500 include a liquid
(the coolant) that generally has a boiling point in the range of
temperature of the portion to be cooled. Common fluids include
water, Freon, and Dowtherm A, which has a boiling point temperature
range of about 500-1000.degree. C. A second portion of the heat
pipe 500 is a wicking portion, which transmits the coolant in its
liquid state. The coolant picks up heat at the hot region (e.g.,
proximate to the light source 126), is vaporized and travels down
the center of the pipe, where the fluid then condenses at the
cooler portion of the heat pipe 500, and then wicks back through
the wicking portion of the heat pipe 500. The configuration of heat
pipes 500 in FIG. 4B is only one example of any numerous shapes,
sizes, and configurations of heat pipes 500, which may include
flat, horseshoe shaped, annular, as well as any other shape. The
heat pipes 500 can be placed anywhere along the insertion member or
tube 106 and even at its distal portion. The heat pipes 500 can be
used in combination with any of the configurations, devices, and
light sources above.
[0132] FIG. 5A and FIG. 5B illustrate an optical therapy device 100
in accordance with yet another embodiment of the present invention.
A fan 610 is provided near the distal end 104 of the hand piece 102
to actively transfer heat away from the optical therapy device 100.
Hand piece 102 also includes at least one light source 126 as
described in greater detail above. The fan 610 provides for active
cooling by pulling air 603 into the hand piece through distal heat
vents 600, through the hand piece 102 (e.g., in the direction of
the arrows) via channel 602, and out the proximal end 112 of the
hand piece 102 via heat vents 604 located in the thermal interface
504. In some embodiments, fan 610 is used in conjunction with fins,
heat pipes, cooling pipes, cooling sleeves, and/or cooling tubes as
described above. In another embodiment, fan 610 provides cooling by
pulling or pushing air through the hand piece 102.
[0133] In another embodiment, such as illustrated in FIG. 5B, fan
610 is located at the proximal end 112 of the hand piece 102. Air
is pulled through a channel 602 in the hand piece via distal heat
vents 600. Air flowing through the hand piece 102 via channel 602
removes heat from light source 126. In this manner, the light
source 126 can be cooled.
[0134] An optical therapy device 100 in accordance with another
embodiment of the present invention is illustrated in FIG. 6A.
Optical therapy device 100 includes housing or hand piece 102 and
insertion member or tube 106, as described above with respect to
FIGS. 1-5. However, in the present embodiment, the light source 126
of the optical therapy device 100 is located at the distal end 116
of tube 106 near its distal tip 118. In the illustrated embodiment,
tube 106 may not be configured to guide or reflect light since the
light source 126 is located at or near its distal end 116. The tube
106 may be configured to guide light in cases when light exiting
the tip of the device 118 includes light originating in the hand
piece 102 and at the distal tip 118 of the tube 106.
[0135] In addition to the light source components and
configurations discussed above, an optical guidance system may be
used to transmit or guide the light generated by the light source
126 located in the hand piece 102 to the distal tip.
[0136] Since the majority of heat generated by the light source 126
is generated at the light source's distal end, heat pipes 500 are
used to remove the heat therefrom. Thus, for example, when the
light source 126 includes a double-bore mercury vapor lamp, optical
emitter 128 is a double-bore quartz capillary tube. Mercury vapor
lamps typically generate heat at their cathode and anode, which are
generally located at the ends of the inner capillary tube.
Therefore, in some embodiments, heat is generated primarily at the
ends of the inner capillary tube. When light source 126 consists of
LEDs, optical emitter 128 is the chip array or package used to
create light, such as solid state light. Heat generated at the
circuitry may be carried away from the distal end 116 by heat pipes
500. In the case when light source 126 is an LED or a combination
of LEDs, the heat generation from the conversion from electricity
to light is minimal, or less significant; however, significant heat
can be generated in the circuitry--especially when several LEDs are
used in combination. For example, 10 mW of LED power in the UV
spectrum at less than 1% efficiency can generate several Watts of
heat. Heat pipes (e.g. Thermacore International, Lancaster, Pa.)
can transfer up to 10 Watts of heat at less than a 5 degree
temperature change between two ends (e.g. one end in a body cavity
and the other in the hand of a patient) located at 15 cm apart
where the pipe is made of copper and its diameter is between 5 and
7 mm in diameter. In such and other cases, heat pipes 500 including
heat conduction rods produced from materials that have good thermal
conductivity, such as aluminum, copper, steel, stainless steel,
etc., may be used.
[0137] Heat pipes 500 generally run parallel to the light source
126 along the axial length of the optical therapy device 100. Heat
is transmitted, or is conducted, through the heat pipes 500 to the
heat sink, as discussed in greater detail above. In other
embodiments, heat pipes 500 are circumferentially wrapped around
the light source 126 or tube 106.
[0138] Heat is carried from the light source 126 through the heat
pipes 500 to the heat sink 502 located at the proximal end 112 of
the hand piece 102. In one embodiment, heat is dissipated from the
housing or hand piece 102 through a heat sink 502 (which may
include cooling fins), after which the heat exits hand piece 102
via a thermal interface 504.
[0139] FIG. 6B shows a cross-section of the optical therapy device
100 of FIG. 6A along line 6B-6B. In this configuration, the heat
pipes 500 are configured around the light source 126 and positioned
within the insertion member or tube.
[0140] FIG. 7A illustrates an optical therapy device 100 in
accordance with yet another embodiment of the present invention.
Optical therapy device 100 includes a housing or hand piece 102 and
insertion member or tube 106 (which may or may not be a reflecting
tube depending on the combination of light sources used) as
described in greater detail above. In the present embodiment
(illustrated in FIGS. 7A and 7B), light source 126 is located near
the distal end 116 of the tube 106 similar to that described above
with respect to FIG. 6A. However, in the present embodiment, light
source 126 includes a solid state array of light sources, or a
multitude of light sources arranged in a two- or three-dimensional
array. In the case where all the desired wavelengths are emitted
from the diode array, tube 106 does not have to be a reflecting
tube. In such cases, the insertion member or tube 106 can serve as
a conducting tube for heat transfer (depending on the number and
efficiency of the light emitting diodes, specialized heat transfer
may or may not be employed). In addition, the tube 106 may be made
from a soft, flexible material comfortable to the patient. In some
embodiments, only certain wavelengths are provided by LED array and
other wavelengths are transmitted through an optical tube 106, as
described above.
[0141] A cross-sectional view of optical therapy device 100 taken
along line 7B-7B is illustrated in FIG. 7B. A diode array light
source 126 is illustrated in the cross-section view of FIG. 7B. In
one embodiment, all desired wavelengths are provided by the array
126, and a region 127 is adapted to transfer heat by any or all of
the mechanisms discussed above. The region 127 can also be used to
transmit additional optical spectra through optical fibers, tubes,
or any of the devices described above.
[0142] FIGS. 8A-c illustrate additional embodiments of an optical
therapy device 100, which may incorporate any one of or a
combination of uLeds, wLEDs, and/or mLEDs as its light source 126.
The probe can also incorporate LEDs with individual wavelengths in
the white or infrared region of the electromagnetic spectrum. The
light source 126 can be located at the distal end of a probe 106
adapted to be inserted into a patient's body. The probe 107 may be
similar to or the same as the tube 106 described with respect to
the various embodiments discussed above. The device 100 has a
simplified structure when LEDs are used as the light source 126. In
the case of rhinophototherapy, LEDs at a handheld housing or at the
distal end of a therapy device enable portability of the
rhinophototherapy device which will lead to more widespread use
because the device can be mass produced and installed in many
physician offices or patient homes affordably and with low device
maintenance. Furthermore, LEDs provide for the ability to localize
therapy to specific areas at specific times and not other areas by
individually turning one or more LEDs on or off. Such power
customization can lead to better patient outcomes through the
ability to customize the phototherapy dose.
[0143] Because LEDs are efficient light generators and because they
emit a relatively narrow band of light, they generate very little
heat and can therefore be positioned at the distal end of the probe
107 and can be placed directly into a patient's or user's body
cavity. Because of the size of the mLEDs and uLEDs and their
minimal heat creation, they can be placed directly into the body
cavity of interest without an optical guidance system and with
minimal heat transfer requirement from the device. Thus, an optical
guidance system may not be required for the ultraviolet light
portion of the action spectrum of the optical therapy device
100.
[0144] Such components and designs considerably simplify the device
100 in terms of the logistics of the therapy and ultimately the
cost of the device 100, particularly to the physician. The optical
portion (e.g., the LED chipset) can even be placed at the end of a
catheter, endoscope, or laparoscope and inserted into the body
cavity of interest. In this case, the probe portion between the
handle 102 and the light source 126 can be a long flexible
catheter, endoscope, or laparoscope, etc. The probe portion in this
embodiment is merely a structural element to allow control of the
light source 126 at the distal end of the device and deliver power
to the distal end of the device. The LED chipset at the end of the
device 100 provides the efficient light generation relative to heat
output and can minimize unwanted wavelengths in the spectrum. In
some embodiments, the LEDs chipset at the end of the catheters,
endoscopes, and laparoscopes deliver only white for the purpose of
visualization. In other embodiments, the LEDs deliver therapeutic
optical energy to a body region as discussed in many of the
embodiments above. Persons of skill in the art would be familiar
with the structure and design of catheters. See, e.g., More
detailed information on the configurations of catheters is
contained in U.S. Pat. Nos. 6,355,027 to Le et al. for Flexible
Microcatheter; 6,733,487 to Keith et al. for Balloon Catheter with
Distal Guide Wire Lumen.
[0145] The spectral output of the device 100 of FIGS. 8A-D is
derived from combinations of the LEDs and LED packages (discussed
below), which can be centered in a single narrow band (e.g., when
using an uLED), a summation of distinct bands (e.g., when using a
MLED), and/or combined with white light (e.g., either phosphor
based or through a combination of LEDs to produce to sum to white
light). Additional LED light sources 126 can also be fit into the
probe 107. Depending on the ultimate size of the probe 107 and the
body cavity to which it is desired to apply therapy, additional
LEDs (e.g., white light LEDs with the spectral output shown in FIG.
14D, below) can be added to achieve combinations of ultraviolet
light such as a combination of UVA, UVB, and white light as
described above and in U.S. Publication Nos. 2004/0204747 and
2004/0030368 both to Kemeny et al. for Phototherapeutical Apparatus
and Method for the Treatment and Prevention of Diseases of Body
Cavities and Phototherapeutical Method and System for the Treatment
of Inflammatory and Hyperproliferative Disorders of the Nasal
Mucosa, respectively.
[0146] FIG. 8B illustrates one embodiment of a device 100 that
incorporates white light generating LEDs 400 (as further
illustrated in FIG. 8c taken along line C-C of FIG. 8B) and an
ultraviolet emitting center portion 402 (as further illustrated in
FIG. 8D taken along line D-D of FIG. 8B). The illustrated
embodiment of FIG. 8B is similar to the uLED or the mLEDs depicted
in FIG. 14, below. The white light is transmitted from their
respective LEDs 400 (which may be surface mounted, chips, or
otherwise) through an optical guidance system (as illustrated in
FIG. 8D) and are directed into an annulus 404 around a uLED and/or
an MLED 402. The uLEDs and/or mLEDs may not have an optical
guidance system to transmit light, for example, if placed at or
near the distal end, including at position D-D in FIG. 8B.
[0147] It is also possible to mount the surface mounted wLEDs
directly on the same chip platform as the mLEDs (e.g., at the level
D-D in FIG. 8B). Although in many cases, phosphor based wLEDs are
preferable, in other embodiments, the chip LEDs from the white
light spectrum (e.g. blue, green, red, amber, yellow dies, etc.)
are mounted directly on the chipset with the mLEDs and/or uLEDs
(see above) rather than using a phosphor based white light surface
mount and setting the entire surface mountable wLEDs behind the
ultraviolet LEDs.
[0148] Independent of the final configuration, the arrangement of
light sources in FIGS. 8A-D generates an equivalent or greater
amount of optical power than the larger, less efficient light
sources (e.g., xenon, mercury vapor, halogen, etc.) discussed above
and at a fraction of the heat output, power, and cost. A portion of
the increase in efficiency may be due to the elimination of the
coupling steps required for more traditional light sources (e.g.,
the requirement to collect the light and direct into an optical
fiber). LEDs and other semiconductor technology allow for efficient
and precise delivery of light to body surfaces and cavities.
[0149] Such a device is also more portable and practical for a
medical practitioner or patient because the ultraviolet generating
light source is directly inside the body cavity or is positioned
directly on, in or adjacent the body surface. This arrangement of
LEDs also can obviate the need for a complex heat transfer system
within the optical therapy device or in a table top box as in U.S.
Publication Nos. 2004/0204747 and 2004/0030368 to Kemeny et al.
Although, FIG. 8B illustrates the individual sets of LED chips as
being at different positions along the axis of the device 100, the
surface mountable wLEDs 400 and/or all LED chips may be placed at
substantially the same position along the device 100 longitudinal
axis. For example, in one embodiment, the wLEDs 400 and other LED
chips are placed at the distal end of the device 100.
[0150] In some embodiments, the mLEDs and uLEDs can be placed at
the end of a flexible device (e.g., a catheter, endoscope,
ureteroscope, hysterocope, laryngoscope, bronchoscope) to enter
body cavities or body lumens and deliver ultraviolet light without
guiding the light from one place to another. For example, the mLEDs
and uLEDs can be placed at the end of a catheter or an endoscope to
treat the lumen of an internal organ. In some embodiments, the LEDs
are placed inside a balloon inside a body cavity. In these
embodiments, the mLEDs can include wavelengths in the visible to
infrared, or from the ultraviolet to visible, or combinations of
wavelengths from the ultraviolet to the infrared. Other scopes,
including, but not limited to, colonoscopes, thoracoscopes, and/or
laparoscopes, can also be used, depending upon the location of the
target site to be accessed. Additional information pertaining to
manufacture, operation and design of various types of scopes would
be known to those skilled in the art and is available in, for
example, U.S. Pat. Nos. 6,478,730 entitled Zoom Laparoscope (Bala
et al.); 6,387,044 entitled Laparascope Apparatus (Tachibana et
al.); 6,494,897 entitled Method and System for Performing
Thoracoscopic Cardiac Bypass Surgery (Sterman et al.); 6,964,662
entitled Endoscopic Forceps Instrument (Kidooka); 6,967,673
entitled Electronic Endoscope System with Color-Balance Alteration
Process (Ozawa et al.).
[0151] There are any number of disease states which can be treated
with devices where LEDs are placed at the point of therapeutic
application and on devices which can be delivered into body
cavities, surfaces, and/or lumens. One example is treatment of
infected indwelling catheters and implants. For example, indwelling
vascular catheters often become infected and have to be removed at
a very high cost to the patients and health care system. A system
of mUV LEDs or uLEDs which emit light in the wavelength range of
about 250 nm to about 400 nm at the region of infection would
eradicate infection within the catheters and obviate or delay the
need to remove the catheters and replace them.
[0152] FIG. 9A illustrates an optical therapy system 730 in
accordance with another embodiment of the present invention. The
optical therapy system 730 includes a medical instrument (e.g., an
endoscope, bronchoscope, colonoscope, etc.) 732 and an optical
therapy device 734. The optical therapy device 734 extends along
the axial length of the medical instrument 732 and terminates at a
tip 736, which is the distal end of the optical therapy device 734.
The tip 736 can be flush with the distal end 738 of the medical
instrument 732.
[0153] In the illustrated embodiment, the optical therapy device
734 is externally coupled to the medical instrument 732. Clips 740
can be used in one embodiment to attach the optical system 734 to
the medical instrument 732; however, any attachment device (for
example, a sheath which slides on the medical instrument 732) can
be used to couple the optical therapy device 734 to the medical
instrument 732. Other examples include a band, ring, annulus,
o-ring, snap, wire, cord, string, adhesive, tape, weld, lock, pin
and/or tie can be used for coupling. The clips 740 allow the
medical instrument 732 and optical system 734 of the optical
therapy device 730 to be manipulated and controlled together and/or
in tandem. When the optical therapy device is used in nasal
phototherapy, the diameter of the medical instrument 732 and the
optical therapy system 734 will typically not exceed about 1 cm,
though the diameter of the instrument and therapy device
combination in some embodiments may not exceed 8 mm and in other
embodiments, will not exceed 6 mm, and is still other embodiments,
will not exceed 3 mm. Where the device is applied to the patient's
nasal cavity, the body or insertion member can be configured such
that it is not longer than about 20 cm, 30 cm, or about 50 cm.
Thus, with this configuration, the therapy device is sized and
configured for portability such that it fits compactly within a
suitcase or bag.
[0154] The optical therapy device 734 can include a link 742 that
extends from the proximal end 744 of the optical therapy device 734
to its distal end 746 (which is also the distal end 738 of the
medical instrument 732). The link 742 can conduct electrical and/or
optical energy from a source 743 at the optical therapy device's
proximal end 744 to the tip 736 located at the optical therapy
device's distal end 746.
[0155] The source 743 can include a light source or an electrical
energy source. When the source 743 is a light source located at the
proximal end 744 of the optical therapy device 734, the link 742
conducts optical energy from the source 743 to the tip 736. The
optical energy is then emitted from the tip 736 to tissue inside of
the patient's body. When the source 743 is an electrical energy
source located at the proximal end 744 of the optical therapy
device 730, the link 742 conducts electrical energy from the source
to a light source at the tip 736. The link 742 can include an
optical guide, such as an optical guide tube, a light pipe, an
articulating arm, a fiber optic, a fiber optic bundle and/or any
other device capable of conducting optical energy. Additionally,
the link 742 can include an electrical conduit, such as a wire,
cable, or conductor, which can be shielded and/or insulated.
[0156] In some cases the source 743 is an electrical energy source
located at the proximal end 744 of the optical therapy device 734,
and a light source is located at the distal end 746, at the tip
736. In such cases, the link 742 includes at least one conductor
extending from the electrical energy source to the light source.
The light source can include ultraviolet light emitting diodes (UV
LEDs), white LEDs, infrared LEDs (IR LEDs), any other light source
known to those of skill in the art, including those described in
greater detail above, and/or a combination of any of the above.
[0157] In other cases, the source 743 is a light source at the
proximal end 744 of the optical therapy device 734 and the link 742
includes an optical cable, such as a fiber optic bundle. In such
cases, light is carried by the link 742 from the light source to
the tip 746 at the distal end 746 of the optical therapy device
734. In any case, the tip 736 can include a spectral conditioner to
modify the shape, pattern, dispersion, focus, geometry, output,
scatter, etc. of the light source output.
[0158] In yet other cases, the optical therapy device 734 includes
a light source and an electrical energy source, and both are
located at or near the distal end 746, for example, in the tip 736.
In such cases, the optical therapy device 734 might not include a
link 742 and/or clips 740 and there may only be one clip at the
distal end of the medical instrument 730. One embodiment of such an
optical therapy device 734 is described below with respect to FIGS.
10A-B.
[0159] As illustrated in FIG. 9B, the optical therapy device 734 is
adapted to fit through a multilumen medical instrument 732 (e.g.,
an endoscope) that has at least two lumens, such as an imaging
lumen 748 and an optical therapy lumen 750 adapted to carry at
least part of an optical therapy device. FIG. 9B is a
cross-sectional view of a portion of such optical therapy device
734. The optical imaging lumen 748 can provide general illumination
for the medical instrument 732. The optical therapy lumen 750 can
provide a conduit for at least part of an optical therapy device
734, such as a link 742, as described above. Alternatively, the
inside wall of the optical therapy lumen 750 can be made from
and/or coated with an optically reflective material such that the
optical therapy lumen 750 acts as the link 742, and conducts
optical energy from a proximal source (e.g., source 743) to the
distal tip (e.g., tip 746).
[0160] Although the medical instrument 732 in the embodiment of
FIG. 9B is described as having at least two lumens, it should be
clear that any medical instrument 732 can be adapted to carry or be
coupled to an optical therapy device 734. For example, a medical
instrument 732 having an elongate body with a single lumen could be
used to carry the optical therapy device 734. In addition, a
medical instrument 732 not having any lumens could also be used to
carry an optical therapy device 734, for example, in the manner
described above with respect to FIG. 9A.
[0161] The optical therapy device 734 can be adapted to couple to a
flexible medical instrument 732 (as illustrated in FIG. 9A), or a
rigid (or semi-rigid) medical instrument 732 (e.g., a rigid
endoscope), as illustrated in FIG. 9c. In either case, the
instrument 732 allows the therapeutic light from the optical
therapy device 734 source 743 to be controlled by a user and
pointed in the desired direction. When the medical instrument 732
is an endoscope, the medical instrument 732 provides direct
visualization of an area to be illuminated inside of the nasal
cavity so phototherapy from the optical therapy device 734 can be
targeted to a desired location. The clips 740 allow the optical
therapy device 734 to be retrofitted to almost any medical
instrument, providing the proper coupling devices (e.g., clips 740)
are used. For example, the medical instrument can be any shape or
size (e.g., square, round, ellipse, circular) and can be flexible
or rigid. The medical instrument can be a probe, an endoscope, a
hysteroscope, an arthroscope, a thoracoscope, a laparopscope, or
any other medical instrument which can be applied to an internal
body surface. The ability to retrofit the optical therapy device to
a medical instrument minimizes the inconvenience to the medical
practitioner. In additional embodiments, the optical therapy
devices are designed such that additional sterilization steps are
not required. For example, many endoscopes are designed and
produced such that they can be disinfected and/or cleaned
[0162] FIGS. 10A-B illustrate an optical therapy device 752, which
is adapted to be retrofit onto the distal end of a medical
instrument (e.g., an endoscope or any other medical instrument).
Alternatively, the optical therapy device 752 of FIG. 10A can be
manufactured as part of the distal end of a medical instrument. The
optical therapy device 752 includes a mount 754 on which light
elements 756 are mounted. The optical therapy device 752 also
includes a source (not shown) that can be located within the mount
754, attached to the mount 754, or electrically and/or optically
coupled to the mount 754.
[0163] The mount 754 can be made from any of a variety of
materials, including stainless steel, plastic, rubber, metal or a
combination of materials. The mount 754 has a diameter of about 10
mm, but can have a diameter of about 5 mm cm or about 1 mm
depending on the application.
[0164] The light elements 754 can be electrically powered light
emitting devices, such as lamps or LEDs, including UV LEDs, white
LEDs, and/or IR LEDs. The light elements 754 can also be the distal
ends of fiber optic cables or light guide cables coupled to a light
source at their proximal ends. Any number of light elements 754 can
be provided with the optical therapy device 752. In some cases, 6,
12, 18, 24, or 30 light elements 754 are provided.
[0165] The mount 754 can have any desired shape or configuration.
In the illustrated embodiment, the mount 754 has an annular shape,
forming a ring of light elements 754 about its distal end. However,
the mount 754 can also be elliptical, circular, square, or have an
irregular or flexible form, for example, to conform to the space
into which it is to be inserted. In some cases, the mount 754 is
merely a single light element 754 holder that attaches to the
distal end of a medical device. Any number of such mounts 754 can
be provided.
[0166] When the optical therapy device 752 is attached to the
distal end of a medical instrument 764 (as shown in the cross
sectional view of FIG. 10c), the light elements 756 are disposed at
an angle 758 with respect to the longitudinal axis 762 of the
medical instrument 764. The angle 758 is shown at approximately
45.degree.. In other cases, the angle 758 is in the range between
about 0.degree. and about 90.degree., sometimes between about
30.degree. and about 85.degree., often between about 45.degree. and
about 90.degree., and in some cases, about 60.degree.. Such angles
facilitate light delivery to regions of body cavities; furthermore,
placement of LEDs at the end of these devices facilitates
ultraviolet light delivery to specific regions within these
cavities while excluding other regions.
[0167] The angle 758 can be selected so the light beams emitted
from each of the light elements 756 of the optical therapy device
752 converge at a focal point 766 located along the longitudinal
axis 762 a predetermined distance 768 from the distal end of the
optical therapy device 752. In some cases, angles 758 of the light
elements 756 are not all the same, and the focal point 766 is not
located along the longitudinal axis 762 of the optical therapy
device 752. In some embodiments, the light emitted from the light
elements 756 do not converge and each light element 756 is directed
in a different direction. Nonetheless, the light elements 756 in
this embodiment, emit light in a direction controlled by the
underlying topography of the distal end of the optical therapy
device 752. Such light delivery is efficiently delivered to the
body cavity in this embodiment without the need for a more complex
and expensive ultraviolet light delivery and lensing system.
[0168] The optical therapy device 752 can be permanently,
semi-permanently, or removably attached to the distal end of an
elongate body 764 of a medical instrument 764. Any of a variety of
mechanisms well known to those of skill in the art can be used to
couple the optical therapy device 752 to the medical instrument
764, including threads, friction, a pin, adhesive, a weld, a
compression fit, a snap fit, or any other suitable mechanism.
[0169] The optical therapy device 752 can be mounted flush with the
distal end of the medical instrument 764, or it can extend distally
past the distal end of the medical instrument 764 (as shown in FIG.
10C). In some cases, the optical therapy device 752 forms the
distal-most surface of the medical instrument 764, and a heat
transfer structure, such as a heat pipe, extends proximally
therefrom. In one embodiment, a heat pipe is placed in the center
760 of the optical therapy device 752. In other embodiments, the
heat pipe shares the center 760 of the optical therapy device 752
with another medical instrument, such as an endoscope.
[0170] FIGS. 11A-11H represent optical therapy devices 100 having
different tubes 106 in accordance with alternative embodiments of
the present invention and generally configured to treat the sinus
cavities of a patient. The hand piece 102 is shown in a cutaway
view, as it may be substantially the same for these embodiments.
Each tube 106 is configured to optimize a particular parameter
based upon specific clinical needs and/or reach a particular body
region such as the maxillary sinus, the ethmoid sinus, the frontal
sinus, etc. As such, tubes 106 having varying lengths, shapes,
curvatures, diameters, radiuses, bends, and tapers may be utilized
or selected by a clinician as required. The insertion member or
tube 106 may also have light sources 126 placed anywhere in, on, or
along the tubes 106. In some embodiments, the tube 106 is not
optically reflecting because the light is generated at its distal
end. In such embodiment, the tube 106 may serve as a conduit for
electrical or heat transfer.
[0171] In the optical therapy device 100 illustrated in FIG. 11A,
hand piece 102 is connected to reflecting tube 106 that has a bend
at its distal end 116. The distal end 116 of the tube 106 is bent
at a bend angle 900 to create a distal segment 902. The distal
segment 902 has a distal length 904 that may be selected to
configure to the anatomy of a particular patient. In some
embodiments, optical therapy device shown in FIG. 11A is adapted to
treat the sinuses of a patient.
[0172] In some embodiments, tip 902 can be flexible and may include
a hinge (not shown) and/or a flexible material so that angle 900
can be adjusted by the practitioner. A light source 126 or
combinations of light sources 126 can be placed anywhere along tube
106 as described above. The light source 126 can also reside in
hand piece 102, as described above. Tube 106 can also contain an
optical fiber bundle or it can be hollow and configured to reflect
light, as discussed above. Furthermore, depending on the light
source 126 selected, the tube 106 can be configured to transfer
heat from the light source 126, as described above.
[0173] Similarly, as illustrated in FIG. 11B, optical therapy
system 100 includes a hand piece 102 that is connected to a
reflecting or non-reflecting tube 106 having a distal segment 902
of a different bend angle 900 at its distal end 116. The distal
length 904 of the distal segment 902 may be the same or different
than that of FIG. 11A. In addition, the bend angle 900 is shown at
a greater angle than that shown in FIG. 11B is greater than that
shown in FIG. 11A. Similarly, such designs are used to reach the
sinuses or other internal cavities or surfaces of a patient.
[0174] The distal length 904 of the distal segment 902 may be
varied as clinically required, as illustrated in FIG. 11c. The
distal length 904 may vary between 1 cm and 4 cm. Proximal length
905 varies between about 6 and 12 inches. Bend angle 900 varies
from about 45-60 degrees in some embodiments, and from about 60-80
degrees in other embodiments.
[0175] An optical therapy device 100 in accordance with yet another
embodiment of the present invention is illustrated in FIG. 11D. The
optical therapy device 100 of FIG. 11D includes a hand piece 102
coupled to a reflecting tube 106 that includes an expandable
balloon 906 at the reflecting tube's distal end 116. The reflecting
tube 106 may be inserted into a patient's nose and/or sinus and the
expandable balloon 906 may thereafter be inflated with a liquid,
gas, polymer, a hydrogel, or a combination thereof, including a
combination of fluids. By inflating the expandable balloon 906, the
tissue (e.g., mucosa) on the inside surface of the patient's nose
or sinus is flattened out to allow a more even distribution of
light energy thereto. In addition, inflating the expandable balloon
906 allows the optical therapy device 100 to be positioned within
the patient's body in such a way as to allow more exposure of
mucosal surface area. The temperature of the fluid inserted into
the balloon described above can be varied from low temperature
(e.g., lower than body temperature) to high temperature (e.g.,
above body temperature) to treat the mucosa of the sinuses and to
work independently or synergistically with the optical therapy
device 100.
[0176] The compression balloon 906 can be configured from an
optically transparent material; for example, a material which is
transparent to ultraviolet light. Examples of transparent materials
include certain formulations of PVDF as can be found in Japanese
Patent No 01241557 to Akira et al. (Bando Chem Ind Ltd) for
Pellicle Film; certain fluoropolymers such as fluorinated ethylene
propylene (FEP) produced by Zeus Inc; certain derivatives of
Teflon; (e.g., Teflon.RTM.-AF produced by DuPont); certain
formulation of silicone; and/or certain elastomeric formulations of
silicone dioxide. The balloon may be compliant or non-compliant and
may have single, double or multiple lumens.
[0177] The compression balloon 906 may be inflated by passing a
fluid, liquid, gas, or a combination through an inflation lumen 908
from the hand piece 102 to the compression balloon 906. The
compression balloon 906 may be deflated in a similar matter.
[0178] The reflecting tube 106 of the optical therapy device 100
may include more than one distal segment 902 such as is illustrated
in FIG. 11E. In the embodiment of FIG. 11E, optical therapy device
100 includes a tube 106 having two distal segments 902. In one
embodiment, the distal segments 902 have equal distal lengths 904
although in other embodiments, the distal lengths of the distal
segments 902 are different.
[0179] In another embodiment, the distal segments 902 are flexible
so that the relative spacing 903 between the distal segments 902
may be adjusted to accommodate the anatomy of particular patients.
Incorporating more than one distal segment 902 can be highly
beneficial in the clinical setting since the total amount of time
the patient spends receiving the optical therapy may be reduced.
This results in improved patient compliance because of the
decreased treatment times.
[0180] In one embodiment, the distal segments 902 are parallel to
one another although in other embodiments, they are not. In one
embodiment, each distal segment is oriented at an angle with
respect to the axis of the reflecting tube 106. For example, in one
embodiment, distal segment 902 projects at an angle between about 1
and 15 degrees with respect to the axis of the reflecting tube
106.
[0181] In the distal segments 902, flexibility may be achieved by
forming the distal segment 902 from a flexible material. For
example, the distal segment 902 may be manufactured from a polymer
coated in rubber or a thin metal sleeve coated in rubber or other
flexible coating. In other embodiments, the optical therapy device
100 (such as the optical therapy device illustrated in FIG. 11E)
includes pivots (not shown) on the end of each of the distal
segments 902, which may be parallel. Pivots will allow for the
parallel end of the optical therapy device to move or be moved
independently of the linear portions of the parallel reflecting
tubes 902.
[0182] An optical therapy device 100, in accordance with another
embodiment of the present invention, is illustrated in FIG. 11F.
The optical therapy device 100 includes a hand piece 102 and a tube
106. At the distal end 116 of the tube 106 is a rotational member
910 mounted thereto. Rotational member includes an aperture 912
through which light energy emitted from the light source 126 may be
transmitted. In one embodiment, the rotational member 910 is able
to rotate about an axis parallel to the central axis of the
reflecting tube 106.
[0183] In one embodiment, the rotational member 910 is shaped to
focus the light from the light source 126 to the aperture 912 of
the rotational member 910. The rotational member 910 is, in one
embodiment, substantially non-transmissive and substantially
reflects all of the light emitted by the light source 126 to the
aperture 912. By rotating within the nose, the rotational member
910 is able to provide the light from the light source 126 through
the aperture 912 to the soft tissue of the inside of the nose or
other body cavity in a circumferential manner.
[0184] FIG. 11G illustrates another optical therapy device in
accordance with yet another embodiment of the present invention. In
the optical therapy device 100 of FIG. 11G, tube 106 includes light
guides 114 mounted at the tube's distal end 116. Adjustable light
guides 914 may be oriented at an adjustment angle 916 with respect
to the tube 106.
[0185] In one embodiment, adjustment angle 916 may be adjusted
between an angle of about 0 and about 60 degrees with respect to
the reflecting tube 106. In another embodiment, the adjustment
angle is between about 10 and 30 degrees.
[0186] The inside surface of the light adjustable light guides 914
are generally reflective or covered with a reflective material so
that light emitted from the light source 126 reflects off the
adjustable light guides onto the tissue on the insider surface of
the nose. The outside surface of the adjustable light guide is
generally covered with a nonabrasive material or coating that is
comfortable to a user when inserted inside or his or her nose.
[0187] An optical therapy device 100, in accordance with yet
another embodiment of the present invention, is illustrated in FIG.
11H. The optical therapy device 100 of FIG. 11H includes a hand
piece 102 coupled to a tube 106. The tube 106 includes multiple
apertures 916 at its distal end 116. Apertures 116 may be provided
around the entire circumference of the reflecting tube 116 or may
be provided on only one side or along only a selected portion of
the reflecting tube 106.
[0188] The apertures 916 may be between 0.1 and 1 mm diameter, or
may be between 0.5 and 2 mm in diameter. The apertures 916 may be
spaced between 0.5 to 1.0 mm, or between 1 to 3 mm from one
another. In one embodiment, the distal end 116 of the tube 106
includes at least four apertures. In another embodiment, tube 106
includes between two and ten apertures. In another embodiment, tube
106 includes greater than ten apertures. Apertures 916 allow light
emitted from light source 126 to escape from the insider of the
tube 106 and enter the patient's nose. In this embodiment, light is
emitted through the apertures 916 of the reflecting tube 106 in a
longitudinal fashion (e.g., along the length of the tube) rather
than at a distal end alone.
[0189] FIGS. 12A-B illustrate additional embodiments of the present
invention. Hand piece 102 is connected to a flexible component 122
which has a lumen 125 within flexible component 122. As described
above and below, flexible component 122 can transmit light, can
comprise the pathway to transmit electrical power, conduct heat, or
can perform all three functions. Lumen 125 is sized to at least
allow a second flexible device such as a guidewire 120 (well-known
in the medical device arts) to pass through. The guidewire can
allow for access to small orifices such as those which lead to the
sinuses. After the guidewire 120 gains access to or purchase in the
desired small orifice, the catheter 122 is fed over the guidewire
120. The guidewire 120 can have an expandable component 124, such
as a balloon or anchor, on its end, such that the expandable
component 124 can hold the guidewire 120 in the nose. The optical
therapy can then be delivered through the guidewire with therapy
that is generated by a light source located along the body or hand
piece of the optical therapy device and delivered to the expandable
component, or light can be generated in the expandable component
124. In the embodiment illustrated in FIG. 12B, a light source 127
is located at the distal end of the guidewire 120.
[0190] FIG. 13A illustrates an optical therapy device 422 at the
end of a flexible medical device 424, such as an endoscope, a
catheter, or handheld probe. The device 422 can be flexible, as
illustrated in FIG. 13A, rigid or semi-rigid. In addition, the
device 422 or any of the devices described above and below can be
used in conjunction with one or more moieties or agents, such as
Psoralen.RTM., in a photodynamic therapy system.
[0191] Another embodiment of a method of using the devices
disclosed herein is used to treat transplanted organs. Current
treatment for organ rejection is hospitalization and administration
of pharmaceuticals directed to the destruction of T cells. OKT3 is
a monoclonal antibody directed toward CD3 positive cells, a subset
of T cells. T cells orchestrate the acute and sub-acute rejection
processes seen in organ rejection. Antibodies which destroy the T
cells can quell the rejection process. As noted above, ultraviolet
light can specifically affect T cell viability and can therefore be
used to treat organ rejection.
[0192] FIG. 13B illustrates an indwelling catheter 410 which is
used to administer parenteral nutrition (TPN) (for example) to a
patient by providing venous access in a patient. Such a catheter
can also be used for chronic or semi-chronic delivery of
chemotherapy, for dialysis access, or for a variety of additional
applications. Catheter 410 may also be used to provide chronic
implants, such as those used for chronic dialysis access or other
permanent vascular or nonvascular devices. A second catheter 412 is
shown disposed within the indwelling catheter 410. The second
catheter 412 has a series of LEDs 414 along its length with
corresponding optical windows 416 in the second catheter 412 which
allow for transmission of sterilizing wavelengths. The therapy
(e.g., sterilizing wavelengths) can be applied periodically (e.g.,
on a maintenance basis to prevent infections from occurring) or the
therapy can be applied at the time of an acute infection. Although
the LEDs are shown at the point of therapy in FIG. 13B, in some
embodiments a light guide is used to transport light some distance
to the point of therapy. The light guide can be a flexible fiber
optic light guide with total internal reflection or the light guide
can be more rigid as illustrated in several of the embodiments
above. The LEDs can deliver light to the indwelling implants from
any point along the light guide.
[0193] In another embodiment (not shown), an indwelling vascular
graft is placed in the aorta or peripheral vessels or is used in
dialysis. Similar to the case of indwelling vascular catheters,
indwelling vascular conduits often become infected and lead to
substantial morbidity and mortality in patients. A catheter based
system to deliver ultraviolet light sterilizing therapy to treat
infected indwelling grafts would be highly beneficial and may
obviate or delay the need to remove these implants. Implanted
vascular conduits such as dialysis grafts also become occluded
secondary to a process called restenosis or intimal hyperplasia.
This is a similar process to that seen in smaller vessels such as
coronary arteries when a device such as a stent is placed. Because
of the anti-proliferative properties of UV light (see Perree, et
al., UVB-Activated Psoralen Reduces Luminal Narrowing After Balloon
Dilation Because of Inhibition of Constrictive Remodeling, 75(1)
Photochem. Photobiol. 68-75), a device carrying LEDs can be used at
the region of the lesion to treat the lesion and prevent the
process of restenosis or intimal hyperplasia.
[0194] FIG. 13c depicts a device incorporated into an optically
transparent balloon 418 (e.g., a balloon that is at least partially
transparent to at least some ultraviolet light wavelengths) to
transmit the light directly to a lesion 420 within a body cavity.
The balloon 418 is expanded (e.g., with any of the fluids or
liquids known to those of skill in the art) and the light therapy
is then directly applied to the lesion 420 without interfering
blood.
[0195] FIG. 14A illustrates a light emitting diode (LED) device 500
in accordance with one embodiment of the present invention. FIG.
14C illustrates a recording by a spectroradiometer of the optical
output from an LED device 500 that emits light centered at a 308 nm
wavelength peak. In the illustrated embodiment, the total output
(e.g., optical power or area under the spectral output curve) at
the 308 nm wavelength peak is in the range of from about 0.1
.mu.W/cm.sup.2 to about 500 .mu.W/cm.sup.2, from about 500
.mu.W/cm.sup.2 to about 1 mW/cm.sup.2, or from about 1 mW/cm.sup.2
to about 5 mW/cm.sup.2.
[0196] FIG. 14A shows the size of the LED device 500 relative to an
average size finger. The temperature of the LED 500 is often
negligible, as it can be held in one's hand as shown without a
perceptible temperature change. Embodiments of an LED package 502
are provided in FIGS. 14A-B. The package 502 includes its ordinary
meaning and also generally refers to the structures supporting the
LED chip 504, including the electrical leads 510, 511, the heat
conducting element 506, and the covering optical element 508.
Covering optical element 508 can accomplish a number of functions,
including conditioning the light. Conditioning can include
diffusing the light from the LED chip, focusing the light from the
LED chip, directing the light, combining the light with a phosphor,
or mixing and combining the light from multiple chips. Although one
spectral peak is shown for the LED 500 of FIG. 14c, in another
embodiment, the LED 500 has more than one spectral peak. For
example, multiple chips (e.g., dies) may be included in the same
LED package 502. In another embodiment, the multiwiavelength
spectrum emanates from one chip. The spectrum of one embodiment of
a multi-wavelength, multi-chip LED 500 (mLED) is illustrated in
FIG. 14E. The arrows of FIG. 14E point to the mLED's spectral
peaks, which, in the illustrated embodiment, occur at 308 nm, 310
nm, 320 nm, and 330 nm.
[0197] The mLED device 500 appears (on the outside) the same as LED
device 500 of FIG. 14A; however, on the inside of the package, 502
there may be differences in that the individual diode chips (e.g.,
dies) are assembled in a cluster, or chipset. Each diode chip
(e.g., die) can further be driven at an independent current (e.g.,
20 mA) and its duty cycle (e.g., the ratio of the on time divided
by the sum of the time and the off time) can be adjusted
independently. The drive current is generally directly proportional
to the optical output power and the optical efficiency is
substantially unchanged at low temperatures. The duty cycle
variable determines the amount of optical power available from each
led die. For example, LED dies typically become less efficient at
higher temperature (for example, due to an increase in resistance)
and will generate more heat than light per electron than they would
at lower temperature. If the powered "on" time is a small fraction
of the powered "off" time, then the chip has time to cool down;
therefore the short burst of current during the "on" period can
result in a short duration of very high power. Thus, despite the
fact that the relative power at each wavelength is shown to be
similar in FIG. 14E, the relative power of each die can be varied
using a combination of current and duty cycle.
[0198] The total optical power provided by the LED devices 500 of
FIGS. 14A-E may be in the range of between approximately 100 .mu.W
and approximately 1 mW, between about 1 mW to about 5 mW, or
between about 5 mW to about 15 mW. Depending on the light
conditioning structure 508, the intensity of the output can be
concentrated greatly into a smaller spot size. Focused intensities
can range from about 1 mW/cm.sup.2 to about 1 W/cm.sup.2 depending
on how small the spot size is at the focal distance. The focal
distance can range from 0.5 mm to 10 mm depending on the focal
length of the light conditioner.
[0199] FIG. 14B illustrates a partial exploded view of the LED (or
mLED) package 502 of FIG. 14A. The light emitting portion of the
package includes LED chips (e.g., dies) 504 on a platform 506. The
platform is also referred to as the header, submount, or
combination of header and submount, and can serve as a heat
dissipating module. Typical LED chips include several semiconductor
layers having specific bandgap differences between them. When
voltage is applied across the semiconductor, light of a particular
wavelength is emitted as the current flows through the different
layers of the die.
[0200] An LED chip 504 can be a cluster of multiple chips
(otherwise referred to as a chipset) located on a platform 506, as
shown in FIG. 14B. The platform 506 can include a heat transferring
element. For example, the heat transfer element can be a ceramic
heat sink and/or diffuser. Alternatively, the heat transfer module
can be an active device, such as a thermoelectric cooling device.
Such heat transfer modules are well known to those skilled in the
art of semiconductor and LED packaging. Additional elements on the
platform 506 include reflectors, which are also well known to those
skilled in the art. A light conditioner in the form of a lens 508
can receive and direct light from the LED chip or chips 504 as
desired. In one embodiment, the lens 508 focuses the light from the
LED cluster 504. The lens 508 can be made from materials which are
generally transparent to the wavelengths of interest (e.g.,
silicone or quartz). In another embodiment, the conditioner 508
scatters or diffuses light from the LED cluster 504. In another
embodiment, the conditioner 508 contains a coating or contains
particles within the material of the conditioner 508 which act as
phosphors to alter the wavelength of output. In another embodiment,
the conditioner 508 configures the pattern of light to generate a
relatively uniform illumination pattern in an internal body cavity,
such as the nasal cavity. For example, in one embodiment, the lens
508 projects light to 70% of the exposed area of a body cavity
(e.g., the nasal cavity) such that the illumination is
substantially uniform (for example, does not vary more than 10%-20%
across the surface of the body cavity).
[0201] The LED chip or chips 504 can include about 1-5 LED chips,
about 5-10 LED chips, about 11-20 chips, or greater than about 20
chips. The electrical power to each chip can be controlled
independently by one or more of the leads 511 of FIG. 14B. The
leads 511 can be extended and/or combined into a larger connector,
leads or computer bus 510. Furthermore, in addition to power, the
duty cycle of one or more of the chips in the chipset 504 can be
controlled independently and may be turned on or off at any given
time. For example, the duty cycle of an individual or multitude of
chips 504 (e.g., dies) can be controlled at a frequency of from
about 1 Hz to about 1000 Hz, from about 1000 Hz to about 10,000 Hz,
from about 10 kHz to about 1000 kHz, from about 1 MHz to about 100
MHz, from about 100 MHz to about 1 GHz, and/or from about 1 GHz to
about 1000 GHz. It may be desired to have a very high frequency for
its own sake and not to limit the heat generation from the chip or
chips.
[0202] Thus, it is possible to integrate such packaged LED chips
(e.g., mLEDs) into a medical device to perform phototherapy to
treat diseases (as discussed above and below) with a defined or
pre-selected set of wavelengths and power outputs from an LED
package 502. The single and multi-chip packages 502 shown in FIG.
14B allows the light source of a medical device to be reduced in
size, and to be placed inside of catheters and endoscopes to
deliver phototherapy to internal organs, cavities, surfaces, and
lumens. The LEDs on such internal medical devices can be any of the
wavelengths from about 240 nm to well into the infrared portion of
the electromagnetic spectrum, such as for example, about 1.5 micron
wavelength electromagnetic energy. In addition, solid state
technology, specifically LEDs, allow for abrupt changes in spectral
output and illumination pattern. Standard light sources in use
today offer very limited control of spectral output, illumination
pattern, and on-off frequency. Furthermore, because the LED chips
can be placed anywhere on platform 506, the illumination pattern
(e.g., the optical power applied to specific tissue regions) can be
well controlled.
[0203] FIG. 14D illustrates the output from one embodiment of a set
of three white-light emitting LEDs (wLED). The relatively broadband
white light from these wLEDs is generated with a phosphor placed
between the light emitting chips and the protective casing 508
(e.g., epoxy) overlying the chips. The total output of the wLEDs in
this spectrum can be in the range of about 20 mW/cm.sup.2 to about
30 mW/cm.sup.2, about 10 mW/cm.sup.2 to about 40 mW/cm.sup.2, or
about 5 mW/cm.sup.2 to about 50 mW/cm.sup.2.
[0204] The package size of the wLEDs may be in the range of about 3
mm to about 4 mm, about 2.5 to about 5 mm, or about 2 to about 6
mm. The size of a wLED package is often smaller than that of a uLED
package. In addition, at least three fully packaged wLEDs can fit
into an area of about 1-2 cm in diameter. White light may therefore
be less expensive in terms of size and cost. In addition, white
light is often more easily transmitted through optical guidance
systems.
[0205] In other embodiments, LED chips are packaged as surface
mounts (SMTs) (such as those available from Nichia Corporation,
Southfield, Mich.), which may be produced in sizes as small as
about 1-3 mm, about 2-5 mm, about 0.5-3.5 mm, or smaller than about
3 mm in diameter and having white light power outputs from about 1
mW to about 100 mW. Surface mounts can be placed directly in the
LED package 502 (package within a larger package) shown in FIG. 14B
or the surface mounts can be placed along side of another LED
package 502.
[0206] In one embodiment, an ultraviolet LED, or uLED, is used
without an optical guidance system. The uLED may be placed at the
end of a probe that is inserted into a body cavity. An internal
body cavity includes the nasal cavity, sinuses, tracheobronchial
tree and any of the cavities mentioned above; also included, are
cavities, such as the chest, and organs, such as the heart or
lungs. The term probe is intended to have its ordinary meaning, and
in addition can mean any device, including any of the devices 100
described herein. The probe may emit one wavelength of ultraviolet
light (e.g., one narrow band, such as may be emitted by an uLED) or
it can emit several wavelengths (e.g., peaks) of ultraviolet light
(e.g., such as emitted by the MLED described above). The probe can
also combine several wavelength peaks from the white light spectrum
or it can combine a phosphor-based white light LED system as
described above to produce almost any pattern of spectrum. The
probe can also be used to cure adhesive compositions inside the
body.
[0207] In this embodiment, the probe (and light) are brought very
close to the treatment area, which has many beneficial effects in
treating disease. The probe being close to the treatment area also
creates a very beneficial economic effect in the sense that light
therapy is generated at the point of use rather than being
generated away from the point of use and then transported to the
point of use. Often times, the light-transport mechanism is highly
inefficient and costly particularly in the shorter wavelength (e.g.
ultraviolet) regimes. Light generation at the point of use also
facilitates providing a device that is disposable after one or
several uses.
[0208] FIG. 15A illustrates one embodiment of the use of the
optical therapy device 100, such as that depicted in FIG. 1. In the
illustrated embodiment, the user (e.g., medical practitioner,
nurse, doctor, or patient) holds the hand piece 102 of the optical
therapy device 100 and inserts the tube 106 into his or her nose
300 (or into the nose of the patient when the medical practitioner
is the user of the device). The light-emitting distal end 116 of
the reflecting tube 106 is inserted inside of the nasal cavity 302
of the patient. Light is emitted from the optical therapy device
100 along a light propagation access 304 where it is absorbed by
the mucosa and other soft tissues within the nasal cavity 302.
[0209] FIG. 15B illustrates one embodiment of an optical therapy
device 100 adapted to be inserted into the paranasal sinus cavities
154, to treat conditions such as sinusitis. Optical therapy device
100 can be configured with a specific shape or contour to reach the
sinus as described herein. The various wavelengths of the optical
therapy device 100 may be chosen depending upon whether fungal
sinusitis or allergic sinusitis is to be treated. When allergic
sinusitis is to be treated, wavelengths including visible light and
ultraviolet light may be utilized. In the case where it is desired
to treat fungi and/or other microbes, a lower wavelength, such as
from 250-300 nm, may be used. In some cases, it is desirable to use
all of these wavelengths separately or in combination, sequentially
or concomitantly.
[0210] Although the optical therapy device 100 is illustrated and
described herein as used for treating a patient's nose 300, the
optical therapy device 100 may be adapted to treat any of a variety
of cavities, surfaces, portions, or organs of the human or animal
body. For example, in one embodiment, the optical therapy device
100 is adapted to treat the skin, or to be inserted into and treat
tissue within the mouth, ear, vagina, stomach, esophagus, small
intestine, bladder, renal pelvis, rectum and/or colon. For example,
the optical therapy device 100 may be used to reduce inflammation
within any mucosa of the body.
[0211] Furthermore, the optical therapy device 100 may be inserted
into a body cavity to treat the walls of an organ without entering
the lumens of the organ or the organ itself. Such is the case, for
example, when the optical therapy device 100 is placed inside the
chest cavity to treat the lungs, heart, or the esophagus. Such is
also the case when the optical therapy device 100 is placed inside
of the abdominal cavity to treat the intestines, stomach, liver, or
pancreas. The optical therapy device can be adapted for insertion
through a laparoscope, hysteroscope, thoracoscope, endoscope,
otoscope, bronchoscope, cystoscope, or cardioscope.
[0212] In one such embodiment, the optical therapy device 100 is
used to treat the clinical disease state of diastolic heart
failure. In diastolic heart failure, collagen deposition in between
or in place of (as is the case of ischemic cardiomyopathy) the
myocardial fibers lead to a decreased compliance of the myocardium
and a failure of the myocardium to relax properly during diastole.
Ultraviolet light therapy, specifically ultraviolet A (UVA) light
therapy, can activate the native collagenase system in human skin
and lead to an increased compliance in diseases such as
scleroderma, as discussed in greater detail above. A similar
collagenase system is present within the myocardium and if
activated, can decrease the compliance of the myocardium with a
similar mechanism as in the skin.
[0213] In one embodiment, the optical therapy device 100 is adapted
to treat inflammation and/or infection of the gastrointestinal
tract caused by any of a variety of conditions, such as, Crohn's
disease, ulcerative colitis (inflammatory bowel diseases), C.
difficile colitis, and/or esophagitis. In some embodiments, the
optical therapy device 100 can ameliorate the internal consequences
of T-cell-mediated diseases, such as autoimmune and collagen
vascular diseases, such as rheumatoid arthritis, systernic lupus
erythematosis, etc. In yet another embodiment, the optical therapy
device 100 is adapted to be inserted into the vagina to treat any
of a variety of conditions, including yeast infection, vaginitis,
vaginosis, candidiasis, parasites, bacteria, and even an unwanted
pregnancy. The optical therapy device 100 may be inserted within
the ear, and deliver light to the external or internal auditory
canals to reduce inflammation and/or infection therein. In yet
another embodiment, the optical therapy device 100 may be provided
to the bladder, kidney, ureter, and/or urethra to treat and/or
reduce inflammation. The optical therapy device 100 may also be
used to treat rheumatoid arthritis, or to reduce or eliminate
herpetic lesions (e.g., cold sores) by decreasing viral shedding
time and/or time to healing.
[0214] In yet another embodiment, the optical therapy device 100 is
adapted for veterinary use. For example, in one embodiment, the
optical therapy device 100 is adapted to be inserted inside the
nose of an equine, such as a racehorse, to treat rhinitis, reduce
inflammation, or treat any of the diseases of conditions described
herein. Other animals may benefit from treatment with the optical
therapy device 100, including domestic animals, such as dogs, cats,
and rabbits, as well as exotic animals, such as cheetah, gorilla
and panda.
[0215] FIG. 16 illustrates another embodiment of an optical therapy
device 700. The optical therapy device 700 is shown partially
inserted into a patient's nasal cavity 702. The optical therapy
device 700 includes a handle 704 and a body 706. In the illustrated
embodiment, the insertion member or body 706 is elongated, and may
also be referred to interchangeably as a body 706 or elongate body
706; however, it should be clear to those of skill in the art that
the body 706 need not be elongated.
[0216] Light is emitted from the distal end 708 of the elongate
body 706 and a cavity expander or expander 710 is coupled to the
distal end 708 of the elongate body 706. The expander 710 can
include any suitable expanding and/or anchoring device, including a
balloon, an anchor, a solid structure, a spring, a coil, a ball, a
ring, an annulus, a ridge, or any other expanding and/or anchoring
device known to those of skill in the art. In the illustrated
embodiment, the expander 710 is an inflatable balloon. The terms
expander and balloon may be used interchangeably in the description
of the illustrated embodiment. Furthermore, although expander is
used herein and has its ordinary meaning, the function of the
expander is to position the phototherapy light in the nasal cavity
so as to prevent therapeutic light from reaching some portions of
the nasal cavity while preventing the therapeutic light from
reaching other portions of the nasal cavity. The expander is one
type of positioner; similarly, a nasal expander is a type of nasal
positioner. Other methods and devices for positioning the
phototherapeutic device in the nasal cavity exist and they may not
require actual expansion. For example, the distal end of the
phototherapeutic device can be shaped or angled for placement into
the vestibule (see below), beyond the region of the limen, to
illuminate the non-vestibular portion of the nasal cavity. The
distal end can also contain an imaging element such as a CMOS or
CCD chip or chipset which can assist in visualizing the anterior
nasal cavity, preventing therapeutic light from reaching unintended
regions. In the embodiment above where LED chips are placed at the
distal end of the optical therapy device, the imaging chip can be
included in the chipset. Alternatively, when the light sources are
placed outside the nasal cavity, the imaging chips can be included
in the optical therapy device for positioning.
[0217] The light emitted from the distal end 708 of the elongate
body 706 is generated from a light source coupled to the elongate
body. The light source can be proximal with respect to the housing
such as handle 704, it can be within the handle 704, it can be
within the elongate body 706, it can be at the distal end 708 of
the elongate body 706, or anywhere else in communication with the
elongate body 706 as described in any of the optical therapy
devices embodiments described above. The light coming from the
light source, therefore, can be generated within the nasal cavity
702 or can be generated outside of the nasal cavity 702. In the
illustrated embodiment, light is transmitted from the distal end
708 of the elongate body 706 through the expander 710 to tissue
inside the nasal cavity 702.
[0218] The expander 710 can include an inflatable, enlargeable,
expandable and/or fillable balloon. In some cases, the elongate
body 708 includes an inflation channel 712. The inflation channel
712 can be used to transfer gas or fluid into and out of the
balloon to inflate or deflate, respectively. In some cases, the
inflation channel 712 is a lumen or fluid transmission line located
within the elongate body 706. In other cases, the inflation channel
712 is a tube or fluid transmission line that is at least partially
externally located with respect to the elongate body 706.
[0219] Water, air, saline, a hydrogel, any material with sufficient
viscosity to cause the balloon to conform to the anterior portion
of the nasal cavity 702, and/or any combination of the above can be
used to inflate the expander 710. In one embodiment, the expander
710 is made from silicone and is filled with water.
[0220] In some embodiments, the expander is not fillable and
includes a compliant or semi-compliant material which can be
reduced to a non-expanded state, placed in the nasal cavity, and
then expanded to its expanded state. The expander 710 in this
embodiment can be formed from a soft semi-compliant material such
as foam, hydrogel, or any other such material known to those of
skill in the art.
[0221] The expander 710 can be positioned at the distal end 708 of
the elongate body 706 such that it extends proximally and distally
with respect to the distal end 708. In some embodiments, such as
that in FIG. 16A, the light source is emitted within the expander
710. In such embodiments, the expander 710 generally includes at
least a portion that is at least partially transparent to the
therapeutic light wavelengths of the optical therapy device 700. In
other embodiments, such as described below with respect to FIG.
16B, the expander 710 can be positioned at the distal end 708 such
that it extends only proximally with respect to the distal end 708.
In this embodiment the expander surrounds the distal end of the
optical therapy tip and can be opaque because the light radiates
from the device into the cavity and not through the expander.
Alternatively, the expander 710 can be positioned so it extends
only distally with respect to the distal end 708.
[0222] The nasal cavity 702 can be divided into a vestibular
portion 714 which is separated from the remaining nasal cavity 716
(non-vestibular portion) at the limen 718 (Lang, J., Clinical
Anatomy of the Nose, Nasal Cavity and Paranasal Sinuses, pp. 31-55,
1989). The limen 718 marks the beginning of the respiratory
epithelium, the vestibular portion being composed of squamous
epithelium similar to the skin. The limen 718 separates the
vestibular portion 714 from the non-vestibular portion of the nasal
cavity.
[0223] The optical therapy device 700 is inserted into the nasal
cavity 702 such that the expander 710 resides at least within the
vestibular portion 714. When the expander 710 is inflated, or if
not inflatable, when otherwise positioned and inserted into the
nasal cavity 702, the expander 710 can wedge open the vestibular
portion 714 of the nasal cavity 702, which does not have
respiratory mucosa. In some embodiments, the expander 710 does not
expand and is positioned within the nasal cavity 702 such that the
therapeutic light reaches one portion the nasal cavity but shields
another portion from the therapeutic light. For example, in one
embodiment, light reaches the turbinates 719 but not the vestibular
surface where there is no respiratory epithelium and which will
have a very different response to the therapeutic light. The
expander 710 can be filled or inflated prior to placement in the
nose or after insertion into the nasal cavity 702.
[0224] The expander 710 of the optical therapy device 700 can hold
the optical therapy device 700 in place while phototherapy is
delivered to the nasal cavity 702 from the optical therapy device
700. Since the expander 710 is usually produced from a flexible or
compliant material, such as a balloon, the optical therapy device
700 is able to pivot and change its orientation in the nasal cavity
702. In addition, the expander 710 allows the optical therapy
device 700 distal end 708 to be manipulated within the nasal cavity
702 without mechanically irritating the sensitive soft tissue
located at the region of the vestibule.
[0225] Further to the device depicted in FIG. 16A where the
therapeutic light travels through the expander 710, the expander
710 can include an opaque portion 720 and a transparent portion
722. The opaque portion 720 blocks light emitted from the distal
end 708 of the optical therapy device 700 and prevents light from
being absorbed by a predetermined portion of the nasal cavity 702.
For example, in the illustrated embodiment, a proximal portion of
the expander 710 is the opaque portion 720, which blocks light from
being absorbed by the vestibular portion 714 of the nasal cavity
702. A distal portion of the expander 710 is the transparent
portion 722, which allows light to be transmitted from the distal
end 708 of the optical therapy device 700, through the wall of the
expander 710, and to the tissue of the nasal cavity 702.
[0226] FIG. 16B illustrates another embodiment of a distal portion
of an optical therapy device 700. The optical therapy device 700
also includes an expander 710; however, the expander 710 of the
illustrated embodiment has an annular configuration and a lumen 724
through which the elongate body 706 of the optical therapy device
700 extends. Light is emitted from the distal end 708 of the
elongate body 706. The distal end 708 of the elongate body 706 can
also include an atraumatic tip 726.
[0227] The atraumatic tip 726 can be made from a material which is
optically transparent to the light emitted from the optical therapy
device 700. In addition, the atraumatic tip 726 can be designed to
scatter, focus, or otherwise condition the light exiting the
optical therapy device 700 distal end, as desired. The atraumatic
tip can have a smooth and/or soft surface so that it does not
irritate the inside wall of the nasal cavity 702 when inserted and
manipulated therein.
[0228] The expander 710 can be made from a completely opaque
material so that it blocks light emitted from the optical therapy
device from being absorbed by the epithelium of the nasal cavity
702 at the region where the expander 710 contacts the nasal tissue.
As in the embodiment of FIG. 16A, the expander 710 holds, or
otherwise positions, the optical therapy device 700 in place on the
region in the nasal cavity 702 while phototherapy is delivered.
This allows the optical therapy device 700 to pivot and change
direction and orientation within the nasal cavity 702 without
mechanically irritating the nasal cavity 702. Although in one
embodiment, the expander is made from an opaque material to prevent
light from reaching the area touched by the expander, the expander
can be made from an optically transparent material. In this case,
the optical therapy device, by virtue of the expander positioning
the therapeutic light such that the light is always directed
forward into the nasal cavity, illuminate only the regions intended
to receive therapeutic phototherapy.
[0229] FIG. 16c illustrates a coronal view of a human skull with an
optical therapy device 700 inserted partially within the paranasal
sinus of a nasal cavity 702. The nasal cavity 702 is in
communication with several paranasal sinuses 726. The sinuses 726
on the left side of the head are separated from those on the right
side by the nasal septum 728. The optical therapy device 700 is
inserted through the nasal cavity 702 until it reaches the
paranasal sinuses 726. In one embodiment, the device shown in FIGS.
12A-B is placed in the sinuses. Guiding wire 120 is first placed in
the sinus and then the optical therapy device 124 is placed over
the wire in the sinus.
[0230] The expander 710 of the optical therapy device 700 is
inflated so that it enters at least one of the paranasal sinuses
726 as well. In addition, the expander 710 provides a mechanical
protection or insulation layer between the distal end of the
optical therapy device 700 and the inside surface of the sinuses
726. The expander or balloon 710 is positioned to grip the sinus
726 ostium. The optical therapy device 700 can then be pivoted
and/or manipulated with respect to the balloon 710 to direct light
to different portions of the sinuses 726 while the expander wedges
the device in the sinus, holding the device in place within the
sinus. As discussed above, the expander is a positioner in some
embodiments and does not have to expand tissue. The requirements
for positioning may be different in the sinuses and therefore the
distal tip of the device may include a drill (for example), anchor,
chisel, dilator, mallet, or dilator in place of or in addition to a
balloon.
[0231] The expander 710 can have opaque and transparent portions,
as described above with respect to FIG. 16A, or it can be totally
opaque and have a configuration as shown above in FIG. 16B. The
expander 710 can cover the output of the distal end of the optical
therapy device 700 as shown in FIG. 16c, or it can wrap around the
distal end of the optical therapy device 700, as shown in FIG. 16B.
In some cases, the expander 710 is used to compress the mucosa of
the sinus 726 so the optical therapy device 700 can provide a
relatively uniform distribution of light to the sinus 726 wall. As
will be appreciated by those skilled in the art, the expander 710
can be configured for use in any of the embodiments described
herein or for any of the target tissues without departing from the
scope of the invention. The expander 710 has been described in the
context of the sinuses for purposes of illustration only.
[0232] FIG. 17 shows an expander 770 according to yet another
embodiment of the present invention. The expander 770 includes a
mating portion 772 that is adapted to be removably coupled to the
distal end of an optical therapy device 774. The mating portion 772
can be a clip, o-ring, band, snap, thread, groove, recess, or any
other suitable mating portion 772. The optical therapy device 774
has a corresponding mating portion 776 to mate with the mating
portion 772 of the expander 770. The mating portions 772, 776 allow
the expander 770 and optical therapy device 774 to be removably
coupled to each other. The mating portion can be inserted into the
nasal cavity prior to the device and then the device can be coupled
to the mating portion. In some embodiments, the mating portion 776
is a friction mate. In one embodiment, the mate is a sticky
material or has a sticky material attached to assist in the mate.
The optical therapy device 774 is placed in the expander 770 and
held in place by a frictional force between the optical therapy
device 774 and the mating portion 772.
[0233] The expander 770 is inserted into the nasal cavity 702 and
positioned so that it is comfortable for the patient and protects
the region of the nasal vestibule. As above, the expander 770 does
not have to actually expand tissue but can act to position the
device without expanding. The expander or positioner 770 is
typically made from a soft elasomeric material, such as rubber,
polymer, ePTFE, a hydrogel, or any other soft comfortable material.
The expander 770 can have elastic properties so that it can expand
to conform to the inside shape of the anterior portion of the nasal
cavity 702. The inside surface of the expander 770 conforms to the
outside surface of the optical therapy device 774. When attached
(e.g., friction coupled), the expander 770 can block or filter
light emitted from the optical therapy device 774 from being
absorbed by the tissue in the vestibular portion of the nasal
cavity 702. In addition, the expander 770 can act as a pivot about
which the distal portion of the optical therapy device 774 can be
manipulated, rotated, translated, and/or moved. As in the expanders
and positioners described above, the expander protects the tissue
of the nasal cavity 702 from the therapeutic light and mechanical
irritation from the distal end of the optical therapy device
774.
[0234] In another embodiment, the vestibular region of the nasal
cavity is protected from the therapeutic light by placing a light
absorbing substance on the surface of the vestibule of the nasal
cavity. One example is a sunscreen but any substance which is
opaque to white light and/or ultraviolet light can be used to
protect the vestibular region of the nasal cavity from the
therapeutic light. The light absorbing substance can be applied
with a medical instrument, can be applied with the optical therapy
device itself, or can be applied with a nasal spray, syringe
applicator, or a finger. In one embodiment, the light absorbing
substance is applied to the optical therapy device and therefore is
applied as the device is used.
[0235] Any of the above devices can be further applied to polymer
curing applications internally or externally to a patient. The
devices can also be used in any context with phosphors which change
the effective wavelength of light. The devices can also be used as
the light activating component of a photodynamic therapy, which
also changes the effective wavelength desired by the optical
device.
[0236] Any of the above devices can also be used in spectroscopic
applications where light (specific wavelength and/or on-off
frequency) is applied to a tissue and then an optical parameter
from the tissue is measured in response to the light application.
The sensor to detect the optical parameter can be incorporated into
the optical therapy device or can be a separate instrument.
[0237] FIGS. 18A-B illustrate an embodiment of a system to treat
transplanted organs that are being rejected. A catheter 426 with a
light source 126, such as uLEDs or mLEDS, is placed in an artery
leading to a transplanted organ 428 (in this case, a kidney). Since
white blood cells travel substantially along the outer diameter of
blood vessels and the red blood cells travel toward the center,
ultraviolet therapy can be applied more directly and specifically
to the white blood cells (T cells) by implementing the arrangement
shown in FIG. 18B.
[0238] Red blood cells and platelets generally flow in the blood
vessel's flow through lumen 430. The optical therapy device 100 is
generally configured such that it has a lumen in its center for
blood flow therethrough. The surface of the optical therapy device
100 is directed toward the outside of the vessel 432 wherein the
white blood cells and the T cells flow over the surface of the
device. With this device 100 positioned as illustrated in the
cross-sectional view of FIG. 18B, as blood flows past the catheter
100 and along its outer circumference 434, the UV light induces T
cells to undergo apoptosis. The device 100 may be placed in the
artery leading to the transplant organ, or it may systemically lead
to immunosuppression through placement in any vessel of a patient.
In at least this respect, "optical immunosuppression" therapy may
be achieved. As will be appreciated by those skilled in the art,
any of the features described above, such as the expander, lens,
etc. can be incorporated into the any of the designs or therapeutic
applications.
[0239] FIG. 19 illustrates a flow chart with the steps followed for
using the devices disclosed herein. The first step is to identify a
target tissue for therapy 1900. Target tissue includes, for
example, tissue within the nasal cavity, tissue within the thoracic
cavity, tissue within the abdominal cavity, tissue within the lumen
of a blood vessel, tissue within the gastrointestinal tract, tissue
within the pericardial cavity, tissue within the heart. Once the
target tissue has been identified, the tissue is accessed through a
body cavity 1910 using a device, such as those described above,
adapted and configured to access the body cavity. Thereafter, a
therapeutic light dose is selected 1915 for delivery to the target
tissue. The therapeutic light dosage selected can be selected for
any of a variety of parameters as discussed in more detail above. A
plurality of dosages may be appropriate in some instances, as will
be appreciated by those skilled in the art. Finally, light therapy
is delivered to target tissue 1920. As will be appreciated, the
steps need not be performed in this exact sequence, Additionally,
steps may be eliminated or replaced without departing from the
scope of the invention.
[0240] Kits can also be provided that are comprised of a
components. For example, The optical therapy device 100 disclosed
above can be provided with a plurality of sized tips, removable
sheaths, etc. Thus, allowing a practitioner to reuse the device
where clinically appropriate multiple times while adapting the
device for use with a particular patient.
[0241] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
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