U.S. patent application number 11/779663 was filed with the patent office on 2008-01-17 for phototherapy device and system.
This patent application is currently assigned to LumeRx, Inc.. Invention is credited to Jon Dahm, Stephen Evans, Marc D. Friedman, Philip Levin, Paul J. Zalesky.
Application Number | 20080015661 11/779663 |
Document ID | / |
Family ID | 34623785 |
Filed Date | 2008-01-17 |
United States Patent
Application |
20080015661 |
Kind Code |
A1 |
Friedman; Marc D. ; et
al. |
January 17, 2008 |
Phototherapy Device and System
Abstract
Physically flexible radiation-emitting probes and associated
illumination methods and systems for delivering radiation or light
to the interior of a lumen or cavity. Light-emitting devices are
immersed in a flowing liquid coolant within a probe to provide high
light output power, and convoluted electrical power buss structures
provide physical flexibility of a probe about a longitudinal axis.
The probes can be configured for delivering light to the interior
of any lumen including for performing therapeutic medical
procedures at locations in body lumens including the interior of
the human gastrointestinal tract.
Inventors: |
Friedman; Marc D.; (Needham,
MA) ; Evans; Stephen; (Westford, MA) ;
Zalesky; Paul J.; (Cranston, RI) ; Dahm; Jon;
(Boulder, CO) ; Levin; Philip; (Storrs,
CT) |
Correspondence
Address: |
FOLEY HOAG, LLP;PATENT GROUP, WORLD TRADE CENTER WEST
155 SEAPORT BLVD
BOSTON
MA
02110
US
|
Assignee: |
LumeRx, Inc.
Marlborough
MA
|
Family ID: |
34623785 |
Appl. No.: |
11/779663 |
Filed: |
July 18, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10878649 |
Jun 28, 2004 |
7261730 |
|
|
11779663 |
Jul 18, 2007 |
|
|
|
60520465 |
Nov 14, 2003 |
|
|
|
Current U.S.
Class: |
607/88 ;
606/2 |
Current CPC
Class: |
H01L 2924/12044
20130101; H01L 2224/73265 20130101; A61N 2005/0661 20130101; A61N
5/0603 20130101; A61N 5/062 20130101; A61N 2005/0662 20130101; H01L
2224/48091 20130101; H01L 2924/3025 20130101; A61M 25/1011
20130101; A61N 2005/005 20130101; F21Y 2115/10 20160801; H01L 33/62
20130101; A61N 2005/0652 20130101; H01L 2924/12044 20130101; H01L
2924/00014 20130101; H01L 2924/00 20130101; H01L 2924/00 20130101;
H01L 2224/32245 20130101; H01L 2224/48247 20130101; H01L 2924/00
20130101; H01L 2924/3025 20130101; A61N 2005/0609 20130101; H01L
2224/73265 20130101; H01L 2224/32245 20130101; A61B 2090/036
20160201; A61N 5/0601 20130101; A61N 2005/0602 20130101; H01L
2224/48091 20130101; H01L 2224/48247 20130101; F21S 4/20
20160101 |
Class at
Publication: |
607/088 ;
606/002 |
International
Class: |
A61N 5/06 20060101
A61N005/06 |
Claims
1. An apparatus for delivering radiation, comprising (a) a flexible
shaft, the flexible shaft having a distal end and a proximal end,
at least two internal channels extending from the distal end to a
location closer to the proximal end and in fluid communication with
each other at a location proximate to the distal end, at least one
of the at least two channels adapted for coupling with a source of
a coolant; and (b) a plurality of radiation emitting devices
disposed within at least one of the channels, at least a portion of
the shaft proximate to the radiation emitting devices being
transmissive of at least a portion of radiation capable of being
emitted by the plurality of radiation emitting devices.
2. The apparatus of claim 1 wherein the plurality of radiation
emitting devices are at least partially in contact with the coolant
flowing from the coolant source, the coolant being substantially
electrically nonconductive and transmissive of at least a portion
of radiation capable of being emitted by the plurality of radiation
emitting devices.
3. The apparatus of claim 1, wherein the plurality of radiation
emitting devices comprises a plurality of light emitting
diodes.
4. The apparatus of claim 1, wherein at least one of the plurality
of radiation emitting device emits radiation substantially within a
band of wavelengths adapted to treat diseased tissue.
5. The apparatus of claim 4, wherein the band of wavelengths is
substantially centered between approximately 400 nanometers and 410
nanometers.
6. The apparatus of claim 1, wherein the plurality of radiation
emitting devices emits radiation substantially within a band of
wavelengths adapted to modify the rate of a chemical reaction.
7. The apparatus of claim 1 wherein the coolant has a boiling
temperature below approximately 45 degrees Celsius.
8. The apparatus of claim 1 wherein the coolant comprises a liquid
selected from the group consisting of fluorinated organic compound,
silicone oil, hydrocarbon oil and deionized water.
9. (canceled)
10. The apparatus of claim 1, wherein the shaft is made of a
substantially biocompatible polymer.
11. The apparatus of claim 1, wherein the shaft contains optically
scattering material.
12. The apparatus of claim 1, wherein the flexible shaft has a
substantially circular cross-section.
13. The apparatus of claim 1, wherein the flexible shaft is
transmissive of at least a portion of radiation capable of being
emitted by the plurality of radiation emitting devices.
14-39. (canceled)
40. An apparatus, comprising (a) at least one array comprising: (i)
a first flexible conductive buss and a second flexible conductive
buss, the first buss and the second buss being substantially
parallel and not directly in contact with each other, at least one
of the first buss and the second buss forming a plurality of
convolutions; (ii) a plurality of platforms disposed between the
first buss and the second buss, the platforms being connected to
the first buss by a first member and to the second buss by a second
member; and (iii) a plurality of electronic devices, each disposed
on one of the plurality of platforms, and electrically coupled to
the first buss and the second buss; and (b) a flexible shaft, the
flexible shaft having a distal end and a proximal end, and an outer
surface defining at least one groove extending from a location near
the distal end to the proximal end; and (c) a flexible sheath
proximate the shaft, the sheath and the at least one groove
defining at least one channel, the at least one array disposed in
the at least one channel.
41. The apparatus of claim 40, wherein the electronic devices are
light emitting devices.
42. A system for delivering light, comprising (a) a light emitting
probe, comprising: (i) a flexible shaft, the flexible shaft having
a distal end and a proximal end, at least two internal channels
extending from the distal end to a location closer to the proximal
end and in fluid communication with each other within the shaft at
a location proximate to the distal end; and (ii) a plurality of
light emitting devices disposed within at least one of the
channels; (iii) a plurality of electrical leads adapted for
electrically coupling the plurality of light emitting devices to a
source of electrical power; (b) a coolant system coupled to at
least one channel providing a coolant for flowing through the at
least two channels, the coolant and at least a portion of the shaft
proximate to the light emitting devices being transmissive of at
least a portion of light capable of being emitted by the plurality
of light emitting devices; and (c) an electrical power supply
coupled to the plurality of electrical leads providing a source of
electrical power for energizing the plurality of light emitting
devices.
Description
RELATED APPLICATIONS
[0001] This application incorporates by reference, and claims
priority to and the benefit of U.S. Provisional Patent Application
No. 60/520,465, filed on Nov. 14, 2003. The present application is
related to co-pending application Ser. No. ______ filed on the same
date as this application, entitled, "Flexible Array", by inventors
Marc D. Friedman, Stephen Evans, Paul J. Zalesky, Jon Dahm, and
Philip Levin, and such co-pending application is incorporated
herein by reference.
FIELD
[0002] This invention relates to apparatus and methods for
delivering radiation, including delivering radiation to a surface
on or within a living body and, more particularly, to apparatus and
methods for using light to debilitate or kill microorganisms on or
within a body cavity of a patient.
BACKGROUND
[0003] Infections involving the human gastrointestinal tract and
other body lumens are extremely common, involving many millions of
people on an annual basis. These infections are responsible for
significant illness, morbidity and death. One of the most common
gastrointestinal infections is a chronic infection with
Helicobacter pylori (H. pylori), a bacterial pathogen that infects
the stomach and duodenum. In industrialized nations such as the
United States, H. pylori may be found in 20% or more of the adult
population. In some South American countries, the H. pylori
infection rate approaches 90%. Although infection with H. pylori
can be asymptomatic, in a significant minority of infected people
it is associated with serious conditions including gastritis,
gastric ulcer, duodenal ulcer, gastric cancer, and gastric
lymphoma. H. pylori is believed to be responsible for approximately
90% of all reported duodenal ulcers, 50% of gastric ulcers, 85% of
gastric cancer, and virtually 100% of gastric lymphoma.
[0004] The most common treatment currently available for H. pylori
infection is a complex antibiotic regimen involving three or four
expensive drugs given over a two-week period. Even with antibiotic
treatment, 20% or more of those treated are not cured of their
infection. Further, the powerful antibiotics used are not well
tolerated by some patients, variously causing allergic reactions,
nausea, an altered sense of taste and diarrhea. In addition,
antibiotic resistance by this and many other pathogenic organisms
is growing rapidly. Up to 50% of H. pylori isolates are now
resistant to one or more of the best antibiotics known to cure the
infection. No vaccine is yet available for H. pylori, despite years
of intensive effort.
[0005] Therapeutic methods that do not rely solely on drugs to
treat disease thus have significant potential advantages over
antibiotic therapy for bacterial infections. Photodynamic therapy
(PDT) is a light therapy that includes pretreatment with a
photosensitizing drug, followed by illumination of the treatment
area to kill cells having a high concentration of the drug, which
preferentially absorbs light at specific wavelengths. A typical
application of this method is to debilitate or destroy malignant
tumor cells that have preferentially retained the photosensitizing
drug, while preserving adjacent normal tissue. Direct deactivation
or killing of H. Pylori and other microorganisms has been
demonstrated using light, without requiring pretreatment with a
photosensitizer.
[0006] Broad deployment of light therapy for H. Pylori and other
intraluminal infections will require practical and reliable light
sources with which to effect such treatment. Access can be gained
to some treatment sites within the body, including interior
surfaces of the digestive tract, using light sources configured as
elongate probes that can be guided through an external orifice into
the body and to the treatment site. One such minimally invasive
approach is to deliver light to the interior of a body lumen
through an optical fiber that is optically coupled to a remotely
located high power laser. This approach to light therapy is
expensive, generally lacks portability, and is impractical for
delivering light to large intraluminal treatment areas.
[0007] An alternative approach for developing minimally invasive
probes for intraluminal light therapy is to utilize electrically
excited light-emitting devices such as light-emitting diodes within
a probe. One problem associated with this approach is that the
light-emitting devices confined within an elongated probe produce
waste heat when electrically excited, thereby significantly
limiting the maximum average light output power achievable from the
probe without thermally damaging the light-emitting devices, and
without exceeding safe temperatures for exposure of the probe to
body tissue at the treatment site.
[0008] Additionally, it would be advantageous for a probe to be
made physically flexible to be safely guided through narrow
passages in the body and positioned at a treatment site. Attempts
to address these problems may be found in U.S. Pat. Nos. 5,800,478
and 5,576,427. However, each one of these references suffers from a
variety of disadvantages, including one or more of the following
disadvantages: the probe is lacking flexibility in the plane of a
substrate on which the array of light-emitting devices is
constructed, and thermal dissipation of the probe at high light
output power is not addressed.
[0009] Thus, a great need exists for new devices and systems to
deliver light to an interior of a lumen, for treatment of H. pylori
and other intraluminal infections. There also exists a need for
apparatus and methods to deliver light to lumens of the body in a
safe and effective manner. In addition, generally there exists a
need for the effective delivery of light to an interior space that
may benefit from treatment with radiation including light.
SUMMARY
[0010] The present invention relates to delivering radiation or
light to an interior of an object or an organism to effect or
facilitate a chemical or biological reaction, including devices and
methods for delivering light to the interior of a lumen, to effect
a treatment at a wall of the lumen. The invention is particularly
useful for performing therapeutic medical procedures on the
interior of a lumen, for example, the gastrointestinal tract of a
living human or animal. The invention can also be applied to
deliver light to the interior surface of any structure into which
the apparatus can be disposed. The invention also relates to
systems for the diagnosis and treatment of infections within a
lumen in a patient.
[0011] One aspect of the present invention is an apparatus for
delivering radiation. The apparatus includes a flexible shaft
having a distal end and a proximal end. At least two internal
channels extend along the shaft from the distal end to a location
closer to the proximal end and are in fluid communication with each
other at a location proximate to the distal end. At least one of
the channels is adapted for coupling with a source of a coolant. In
an embodiment, the shaft may be made of a substantially
biocompatible polymer. In another embodiment, the shaft has a
circular cross section.
[0012] The apparatus also includes a plurality of
radiation-emitting devices disposed within at least one of the
channels. At least a portion of the shaft proximate to the
radiation-emitting devices is transmissive of at least a portion of
radiation capable of being emitted by the plurality of
radiation-emitting devices. In an embodiment, the plurality of
radiation-emitting devices are at least partially in contact with
the coolant flowing from the coolant source, and the coolant is
substantially electrically nonconductive. The coolant also may be
transmissive of at least a portion of radiation capable of being
emitted by the plurality of radiation-emitting devices.
[0013] In an embodiment some or all of the plurality of
radiation-emitting devices are light-emitting diodes. In an
embodiment at least one of the radiation-emitting devices may emit
radiation substantially within a band of wavelengths that is
adapted to treat diseased tissue. In another embodiment the band of
wavelengths is substantially centered between approximately 400
nanometers and 410 nanometers. In yet another embodiment, the band
of wavelengths is adapted to modify the rate of a chemical
reaction.
[0014] In one embodiment, the coolant has a boiling temperature
below approximately 45 degrees Celsius. In another embodiment, the
coolant is a liquid selected from the group consisting of
fluorinated organic compound, silicone oil, hydrocarbon oil and
deionized water. In yet another embodiment, at least one of the
plurality of radiation-emitting devices includes a coating that
provides refractive index matching between the at least one of the
plurality of radiation-emitting diodes and the coolant. In still
another embodiment the flexible shaft is transmissive of at least a
portion of radiation capable of being emitted by the plurality of
radiation-emitting devices. The shaft may also include optically
scattering material.
[0015] In another aspect of the present invention, a plurality of
light-emitting diodes in the apparatus are arranged in at least one
longitudinal array. The array includes a first flexible conductive
buss and a second flexible conductive buss. The first the second
buss are substantially parallel and not directly in contact with
each other, and at least one of the first and the second buss
includes a plurality of convolutions. A plurality of platforms is
disposed substantially between the first buss and the second buss,
and connected to the first buss by a first member and to the second
buss by a second member. At least one light-emitting diode is
disposed on each platform, and each of the at least one
light-emitting diode is electrically coupled to the first buss and
the second buss. In an embodiment the electrical coupling includes
at least one electrical lead.
[0016] In another embodiment, each of the plurality of platforms
has a top surface and a bottom surface and at least one of the
plurality of light-emitting diodes is disposed on a top surface
while another of the plurality of light-emitting diodes is disposed
on a bottom surface. In yet another embodiment, the apparatus
includes at least two arrays. In still other embodiments, the at
least two arrays are substantially parallel to each other or follow
substantially parallel helical paths. At least one of the
light-emitting diodes in an array may emit light substantially
within a band of wavelengths adapted to treat diseased tissue or
substantially within a band of wavelengths adapted to modify the
rate of a chemical reaction.
[0017] Another aspect of the present invention is apparatus for
delivering radiation. The apparatus includes a flexible shaft
having a distal end and a proximal end, a bore extending from a
location near the distal end to the proximal end, and an outer
surface defining at least one groove extending from a location near
the distal end to the proximal end. A flexible sheath is proximate
to the shaft, for example, surrounding the shaft. The sheath and
the at least one groove define at least one channel. The sheath and
the distal end of the shaft define a distal volume, through which
the at least one channel and the bore are in fluid communication.
In an embodiment, the apparatus has a substantially circular cross
section.
[0018] A plurality of radiation-emitting devices is disposed within
the at least one channel. The radiation-emitting devices are
adapted to be electrically connected to a power source and the
sheath is transmissive, at a location proximate the plurality of
radiation-emitting devices, of at least a portion of radiation
capable of being emitted by the plurality of radiation-emitting
devices. A source of a coolant is connected to the at least one
channel, the coolant being at least partially transmissive of
radiation and substantially electrically nonconductive, whereby the
coolant source, the at least one channel, the distal volume and the
bore comprise a coolant loop. The light-emitting devices are cooled
through contact with the coolant.
[0019] In an embodiment, the plurality of radiation-emitting
devices are light-emitting diodes. In another embodiment, the at
least one radiation-emitting device emits radiation substantially
within a band of wavelengths adapted to treat diseased tissue. In
yet another embodiment, the at least one radiation-emitting device
emits radiation substantially within a band of wavelengths adapted
to modify the rate of a chemical reaction.
[0020] The coolant may be a liquid selected from the group
consisting of fluorinated organic compound, silicone oil,
hydrocarbon oil and deionized water, and at least one of the
plurality of radiation-emitting devices may include a coating
substantially providing refractive index matching between the at
least one of the plurality of radiation-emitting diodes and the
coolant. In an embodiment, the sheath is made of a substantially
biocompatible polymer. In other embodiments, the sheath, the shaft,
or both are transmissive of at least a portion of radiation capable
of being emitted by the plurality of radiation-emitting devices,
and may contain optically scattering material.
[0021] In an embodiment, the plurality of radiation-emitting
devices are arranged in at least one longitudinal array. The at
least one array includes a first flexible conductive buss and a
second flexible conductive buss, the busses being substantially
parallel to each other and not directly in contact with each other.
At least one of the first buss and the second buss includes a
plurality of convolutions. A plurality of platforms are disposed
between the first buss and the second buss, the platforms being
connected to the first buss by a first member and to the second
buss by a second member. A radiation-emitting device is disposed on
each platform, and each radiation-emitting device is electrically
coupled to the first buss and the second buss. The electrical
coupling may include at least one electrical lead. In another
embodiment, each platform has a top surface and a bottom surface
and a radiation-emitting device is disposed on each surface. In
still another embodiment, the plurality of radiation-emitting
devices are arranged in at least two arrays. The at least two
arrays may be parallel and may follow parallel helical paths.
[0022] Yet another aspect of the present invention is an apparatus
that includes a first flexible conductive buss and a second
flexible conductive buss, the first buss and the second buss being
substantially parallel and not directly in contact with each other,
at least one of the first buss and the second buss forming a
plurality of convolutions. A plurality of platforms is disposed
between the first buss and the second buss, the platforms being
connected to the first buss by a first member and to the second
buss by a second member. A plurality of electronic devices is
disposed on the plurality of platforms, and electrically coupled to
the first buss and the second buss. The electronic devices may be
light-emitting devices. The apparatus also includes a flexible
shaft that has a distal end and a proximal end, and an outer
surface defining at least one groove extending from a location near
the distal end to the proximal end. A flexible sheath is proximate
the shaft, the sheath and the at least one groove defining at least
one channel. The at least one array is disposed in the at least one
channel.
[0023] Still another aspect of the present invention is a system
for delivering light. The system includes a light-emitting probe.
The probe includes a flexible shaft having a distal end and a
proximal end, at least two internal channels extending from the
distal end to a location closer to the proximal end and in fluid
communication with each other within the shaft at a location
proximate to the distal end, a plurality of light-emitting devices
disposed within at least one of the channels, and a plurality of
electrical leads adapted for electrically coupling the plurality of
light-emitting devices to a source of electrical power. The system
also includes a coolant system coupled to at least one channel. The
coolant system provides a coolant for flowing through the at least
two channels, the coolant and at least a portion of the shaft
proximate to the light-emitting devices being transmissive of at
least a portion of light capable of being emitted by the plurality
of light-emitting devices. The system further includes an
electrical power supply coupled to the plurality of electrical
leads. The electrical power supply provides a source of electrical
power for energizing the plurality of light-emitting devices.
[0024] The foregoing and other features and advantages of the
present invention will become more apparent from the following
description, accompanying drawings and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Aspects and features of the present invention may be better
understood by referring to the following description in conjunction
with the accompanying drawings and claims, in which like numerals
indicate like structural elements and features in various figures.
The drawings are not necessarily to scale, emphasis instead being
placed upon illustrating embodiments and features of the
invention.
[0026] FIG. 1 is a schematic cross sectional overview of a
light-emitting probe system according to the present invention.
[0027] FIG. 2 is a distal end view cross section of light probe
shown in FIG. 1.
[0028] FIG. 3 is a perspective view of a light probe of the present
invention having four passages for light-emitting devices.
[0029] FIG. 4 is a distal end view cross section of the light probe
shown in FIG. 3.
[0030] FIG. 5 is a perspective view of a light probe of the present
invention having helical passages for light-emitting devices.
[0031] FIG. 6 is a cross sectional view of another light probe of
the present invention.
[0032] FIG. 7 is a perspective view of a flexible light-emitting
diode array of the present invention.
[0033] FIG. 8 is an electrical schematic of a series-parallel
circuit showing parallel groups of four light-emitting diodes in
series.
[0034] FIG. 9A and FIG.9B illustrate a side view of the
light-emitting diode array of FIG. 8, and an out-of-plane flexion
of the array, respectively.
[0035] FIG. 10A and FIG. 10B illustrate a plan view of the
light-emitting diode array of FIG. 8, and an in-plane flexion of
the array, respectively.
[0036] FIG. 11 is a perspective view of a light-emitting probe of
the present invention incorporating the light-emitting array of
FIG. 7
[0037] FIG. 12 is a side view of a two-sided light-emitting diode
array of the present invention.
[0038] FIG. 13 is a perspective view of another flexible
light-emitting diode array of the present invention having
transverse positioning members.
[0039] FIG. 14 shows a segmented light-emitting array of the
present invention.
[0040] FIG. 15 shows an exemplary segment of the segmented array of
FIG. 14.
[0041] FIG. 16 is an end view of the segmented array of FIG. 14,
centered in a cylindrical passage.
[0042] FIG. 17 shows an example of a three-dimensional lead
structure of a segmented array of the present invention.
[0043] FIG. 18 is an end view of the segmented array of FIG. 17,
centered in a cylindrical passage.
[0044] FIG. 19 shows a phototherapy system of the present
invention, deployed in a human gastrointestinal tract.
[0045] FIG. 20 shows a light-emitting probe 650 of the present
invention including a positioning means.
DESCRIPTION
[0046] Certain exemplary embodiments will now be described to
provide an overall understanding of the aspects and features of the
apparatus, systems and methods of use disclosed herein. Examples of
these embodiments and features are illustrated in the drawings.
Those of ordinary skill in the art will understand that the
apparatus, systems and methods of use disclosed herein can be
adapted and modified to provide apparatus, systems and methods for
other applications and that other additions and modifications can
be made without departing from the scope of the present disclosure.
For example, the features illustrated or described as part of one
embodiment or one drawing can be used on another embodiment or
another drawing to yield yet another embodiment. Such modifications
and variations are intended to be included within the scope of the
present disclosure.
[0047] The present invention relates to devices, systems and
methods for delivering radiation or light to an interior, including
to an interior of a lumen. The term lumen is used herein to mean
the interior of a hollow organ in a human or animal body, and more
generally to refer to any tubular or hollow item. Among other
things, the invention also relates to systems for the diagnosis and
treatment of infections within a lumen in a patient.
[0048] An exemplary embodiment of a radiation-generating system or
light-generating system 100 of the present invention is illustrated
in FIG. 1. The light-generating system 100 includes an elongate
light-emitting probe 102, a coolant supply 104 for cooling the
probe, and a power supply 106 for energizing the probe. The probe
102 includes a flexible shaft 108 having a distal shaft end 110, a
proximal shaft end 112 and a bore 114 extending longitudinally
through the shaft 108 between the distal shaft end 110 and the
proximal shaft end 112. The shaft 108 may comprise a flexible
material that is electrically nonconductive. The terms electrically
nonconductive and electrically insulating are used interchangeably
herein.
[0049] Examples of materials appropriate for constructing the shaft
108 include natural and synthetic polymers such as polyolefins,
fluoropolymers, polyurethanes, polyesters, and rubber products. For
some embodiments, the material of the shaft 108 is also chosen to
be optically transparent, translucent or reflective at an optical
emission wavelength of the light-emitting probe. For some
embodiments, the material of the shaft 108 is chosen to be
compatible with selected liquid coolants discussed hereinbelow. For
some embodiments, the material of the shaft 108 is chosen to be
biocompatible, that is, safe for direct contact with living tissue.
In an embodiment, the shaft 108 is made of Fluorinated Ethylene
Propylene polymer (FEP). In another embodiment, the shaft 108 is
made of polytetrafluoroethylene (Teflon). FEP and Teflon are
trademarks of DuPont.
[0050] A continuous groove 116 extends longitudinally along the
shaft 108 from the distal shaft end 110 substantially to the
proximal shaft end 112. A sheath 118 that may be flexible and
transparent closely surrounds the shaft 108, defining a continuous
longitudinal channel or passage 120 within the groove 116. The
sheath 118 has a distal sheath end 122 and a proximal sheath end
124. The distal sheath end 122 extends distally beyond the distal
shaft end 110 and is closed, defining a plenum volume 126 between
the distal sheath end 122 and the distal shaft end 110. The passage
120 is in fluid communication with the bore 114 substantially at
the distal shaft end 110. Fluid communication between the passage
120 and the bore 114 may be provided by the plenum volume 126. An
interior channel 127 may also be provided to provide fluid
communication between the passage 120 and the bore 114. The sheath
118 preferably comprises a flexible polymeric material that is
electrically nonconductive.
[0051] The sheath 118 and the shaft 108 may be fabricated or formed
as a unitary part. Alternatively, instead of using a sheath, strips
of any appropriate shape of material adapted to the shape, width
and length of the groove 116 may be secured over the groove 116 to
form a passage 120. In such case, instead of the sheath 118
defining a plenum volume, a cap or similar item may be secured at
the distal shaft end 110 to define a plenum volume.
[0052] Examples of materials appropriate for constructing the
sheath 118 include natural and synthetic polymers such as
polyolefins, fluoropolymers, polyurethanes, polyesters, and rubber
products. The material of the sheath 118, either in whole or in
part, is also chosen to be optically transparent, translucent or
reflective at an optical emission wavelength of the light-emitting
probe. The optical properties of the sheath 118 (or the strips
discussed above) may also be patterned to selectively transmit,
scatter, reflect, or absorb light at an optical emission wavelength
of the probe 102 as a function of position along the probe 102 or
circumferentially about the probe 102. For some embodiments, the
material of the shaft 108 is also chosen to be compatible with
selected liquid coolants discussed hereinbelow. For some
embodiments, the material of the sheath 118 is preferably chosen to
be biocompatible. In an embodiment, the sheath 118 is preferably
made of Fluorinated Ethylene Propylene polymer (FEP). In another
embodiment, the sheath 118 is preferably made of polyethylene.
[0053] In some embodiments, one or both of the sheath 118 and the
shaft 108 is impregnated with an optically scattering material, is
provided with a reflective coating or includes a
wavelength-converting material. The sheath may also be patterned to
provide different optical properties depending on a position along
the probe 102.
[0054] The passage 120 and the bore 114 together define a coolant
loop within the probe 102. At substantially the proximal shaft end
112 and the proximal sheath end 124, each of the bore 114 and the
passage 120 is coupled to the coolant supply 104 for flowing an
electrically nonconductive liquid coolant through the loop. The
coolant has optical properties suitable for passing light out of
the probe and, for use in medical applications, is preferably
chosen to be a room-temperature liquid that is safe for contact
with living tissue (a biosafe liquid).
[0055] Examples of coolants suitable for use in a probe of the
present invention include fluorinated organic compounds, silicone
oils, hydrocarbon oils and deionized water. A coolant may also be
selected to have a boiling temperature that is lower than a
scalding temperature of living tissue. Such a fluid vaporizes
before becoming hot enough to scald tissue. In an embodiment, the
coolant is selected to have a boiling temperature lower than about
45 degrees Celsius. Coolants having a boiling point suitable for
preventing scalding of tissue are available commercially. For
example, 3M Corporation manufactures such a coolant under the trade
name Fluorinert.
[0056] In an embodiment related to medical device applications,
coupling between the loop and the coolant supply 104 can be any
fluid coupling means appropriate for incorporation into medical
apparatus. In an embodiment, coupling between the loop and the
coolant source comprises quick-connect plumbing fittings. In an
embodiment, the coolant supply 124 is a recirculating coolant
system that maintains coolant flowing through the loop at
substantially a constant temperature. In one embodiment, coolant
flows distally through the bore 114 and proximally through the
passage 120. In another embodiment, coolant flows distally through
the passage 120 and proximally through the bore 114.
[0057] A plurality of light-emitting devices 128 is disposed within
the passage 120, spaced apart as a longitudinal array. The
plurality of light-emitting devices 128 is immersed in the coolant
within the passage 120 and oriented to direct emitted light out of
the probe 102 through the coolant and the sheath 118. The plurality
of light-emitting devices 128 may also include passive or active
electronic sensors, active devices such as acoustic or ultrasonic
transducers, radiation-emitting devices, electrically-energized
radiation sources such as x-ray sources (which are very short
wavelength light sources) or combinations thereof. The
light-emitting devices may be substituted in whole or in part by
the foregoing electronic devices in a probe of the present
invention. The sheath 118 may be opaque in particular in probes
lacking optical sensors or light-emitting devices. In an
embodiment, preferably all or substantially all of the sheath 118
near the plurality of light-emitting devices 128 is optically
transparent, translucent or reflective at an optical emission
wavelength of the light-emitting probe 102.
[0058] Each of the plurality of light-emitting devices 128 is
electrically connected in a circuit that is energized through a
plurality of electrical leads 130 routed through the passage 120 to
the proximal shaft end 112, and coupled to the power supply 106 for
energizing the plurality of light-emitting devices 128. In
connection with medical applications, coupling between the
plurality of electrical leads 130 and the power supply 106 can be
any electrical coupling means appropriate for incorporation into a
medical apparatus. In an embodiment, the electrical leads 130 are
coupled to the power supply 106 by an electrically shielded in-line
connector. In another embodiment, the proximal shaft end 112 and
the proximal sheath end 124 are connected to an integrated assembly
having both coolant and electrical connectors mounted thereon. In
an embodiment, the electrical power supply 106 is a regulated power
supply that regulates light output from the plurality of
light-emitting devices 128. In an embodiment a signal provided by a
sensor mounted within the probe 102 is used to control the power
supply 106.
[0059] The effects of light incident on a biological tissue or on a
non-living material can depend on the wavelength of the incident
light. For example, light in the wavelength range of 360 nanometers
(nm) to 650 nm, and preferably in a wavelength range of 400 nm to
410 nm, centered near 405 nm, has been demonstrated to disable or
kill H. Pylori bacteria without substantial damage to adjacent
healthy tissue. The plurality of light-emitting devices 128 can be
constructed to emit light within one or more predetermined range of
wavelengths (emission band) targeting absorption bands of a
selected photosensitizer. For example, the plurality of
light-emitting elements 128 can comprise light-emitting diodes
manufactured to have an emission band centered at a selected
infrared, visible or near-ultraviolet wavelength that induces a
photochemical reaction in a target material. In an embodiment, the
plurality of light-emitting devices 128 emits light substantially
within an emission band operative to disable or kill a bacterium
without substantially damaging adjacent healthy tissue.
[0060] The coolant and the sheath 118 transmit at least a portion
of the light emitted by the plurality of light-emitting devices
128. The coolant may be either substantially transparent to the
light or may scatter the light, in the latter case making the
coolant appear translucent. We use the term transmissive herein to
describe both transparent and translucent materials. Similarly, the
sheath 118 may be either substantially transparent or translucent
in its entirety or substantially solely in locations proximate to
the light-emitting devices 128. In an embodiment, each of the
coolant and the sheath 118 is substantially transparent to light
emitted by the plurality of light-emitting devices. Optically
transparent materials for probes of the present invention are
preferably selected so as to transmit least approximately 50% and
preferably greater than 80% of the light emitted by light-emitting
devices in the probe and directed through the transparent materials
to exit the probe.
[0061] Light-emitting surfaces of the light-emitting devices may be
coated with a transparent film that grades the refractive index at
the interface between the light-emitting device and the coolant,
thereby reducing reflective losses at that interface. The
refractive index-grading material may comprise a curable silicone
adhesive. In an embodiment, the refractive index grading material
is a silicone encapsulant having a refractive index in the range of
about 1.45 to 1.55.
[0062] FIG. 2 is a distal end view of the probe 102 of FIG. 1. In
FIG. 2, the bore 114 is shown substantially centered in the shaft
108. The plurality of light-emitting devices 128 is maintained
substantially centered in the passage 120 by retention on a
mounting member 132, thereby providing immersion of the plurality
of light-emitting devices 128 in the coolant flowing through the
passage 120. The probe 102 is shown to be substantially cylindrical
in cross section, but probes of the present invention may have any
convenient cross section. For example, a probe of the present
invention may have an oval or a polygonal cross section.
[0063] FIG. 3 shows a distal end section of another exemplary
embodiment of a probe 150 of the present invention. The probe 150
is similar in structure to the embodiment of the probe 102
illustrated in FIGS. 1 and 2, but the probe 150 includes four
passages 152 distributed circumferentially between a shaft 154 and
a sheath 156. The shaft 154 has a distal shaft end 158 and the
sheath 156 has a distal sheath end 160 that is closed.
[0064] A plurality of light-emitting devices 162 is disposed in
each of the four passages 152. The shaft 154 includes a
longitudinal bore 164 that is in fluid communication with each of
the four passages 152. The probe 150 may be configured for coolant
to flow distally through the bore 164 and proximally through each
of the four passages 152. The probe 150 may alternatively be
configured for coolant to flow distally through each of the four
passages 152 and proximally through the bore 164. The four passages
152 and the bore 164 are preferably dimensioned so as to provide a
substantially equal distribution of coolant flow among the four
passages.
[0065] FIG. 4 is a distal end view of the probe shown in FIG. 3.
The plurality of light-emitting devices 162 in each of the four
passages 152 is preferably maintained substantially centered in the
each of the four passages 152 by retention on a mounting member
166, thereby providing immersion of the plurality of light-emitting
devices 162 in the coolant. A probe of the present invention may
include any number of passages and corresponding pluralities of
light-emitting devices disposed therein. In an embodiment, a probe
of the present invention includes a plurality of light-emitting
devices disposed in each of six passages circumferentially
distributed around a shaft.
[0066] FIG. 5 illustrates an embodiment of a distal end section of
another probe 200 of the present invention. The probe 200 includes
a shaft 202 having a distal shaft end 204 and a longitudinal bore
206. The probe also includes a sheath 208 and at least one helical
passage 210 defined between the sheath 208 and the shaft 202 for
receiving a plurality of light-emitting devices 212. The probe 200
is illustrated with two helical passages, but a probe of the
present invention may include any number of helical passages, each
with a corresponding plurality of light-emitting devices. Other
than including helical rather than longitudinal passages, the probe
200 may be of similar construction to the other embodiments of
probes described previously.
[0067] FIG. 6 illustrates a distal section of another embodiment of
a light-emitting probe 250 of the present invention. The probe 250
includes a flexible tube 252 preferably polymeric having a distal
end 254 and a proximal end 256. The tube 252 has a first
longitudinal internal channel or passage 258 in fluid communication
with the proximal end 226. The tube 252 also has a second
longitudinal internal passage 260 substantially parallel to the
first passage 258. The second passage is in fluid communication
with the proximal end 256. The first passage 258 is in fluid
communication with the second passage 260 at a junction 262 within
the tube 252. The first passage 258 and the second passage 260 are
adapted at the proximal end 256 for coupling to an external coolant
source for flowing a coolant through the first 258 and second
passage 260.
[0068] One or more light-emitting device 264 is disposed in one or
both of the first internal passage 258 and the second internal
passage 260. A plurality of electrical leads 266 electrically
connects the one or more light-emitting device 264 through the
proximal end 256 to an external electric power source for
energizing the one or more light-emitting device. The one or more
light-emitting device 264 may be one or more light-emitting diode.
In an embodiment the one or more light-emitting device 264 is a
plurality of light-emitting diodes in a spaced-apart longitudinal
array along at least one of the first internal passage 258 and the
second internal passage 260. The tube is at least partially
transmissive of light emitted by the one or more light-emitting
device 264 either in whole or at locations proximate to the one or
more light-emitting device 264. In an embodiment, the tube is
biocompatible.
[0069] Liquid-cooled probes of the present invention can be
constructed to produce high light output power in small diameter
packages. For example, one light-emitting probe of the present
invention 5 mm in diameter and having four passages for arrays of
light-emitting diodes longitudinally spaced one millimeter apart
and operating in a wavelength band near 405 nm has an approximate
output power substantially equal to or greater than one watt per
centimeter of probe length. In an embodiment, a light-emitting
probe of the present invention having a radius of substantially 5
millimeters produces light having an optical power of approximately
five watts per centimeter of probe length.
[0070] A plurality of light-emitting devices for inclusion in a
flexible, light-emitting probe of the present invention can be
configured as a unitary longitudinal array of light-emitting
devices for assembly into the probe, or can be configured in
segments. FIGS. 7 through 13 and the discussions thereof illustrate
examples of unitary light-emitting arrays for use in conjunction
with the probes illustrated in FIGS. 1 through 6 and the
discussions thereof, as well as with other probes.
[0071] FIG. 7 shows an embodiment of a portion of an elongate
light-emitting diode array 300 of the present invention. The array
300 includes a first flexible, electrically conductive buss 302 and
a second flexible, electrically conductive buss 304 disposed
opposite the first buss 302. By disposed opposite we mean that the
first buss 302 and the second buss 304 are positioned substantially
parallel, but are not in electrical contact with one another. The
first buss 302 and the second buss 304 define a plane 306 and an
axis 308 in the plane. The first buss 302 has a first buss top
surface 310 defined here as being above the plane 306 and a first
buss bottom surface 312 below the plane 306. The second buss has a
second buss top surface 314 above the plane 306 and a second buss
bottom surface 316 below the plane 306. Each of the first buss 302
and the second buss 304 includes a plurality of longitudinally
spaced-apart convolutions 318. Although the first buss 302 and the
second buss 304 are described as being positioned substantially
parallel to each other, in an alternative embodiment the first buss
302 and the second buss 304 may be substantially coplanar, while
not being substantially parallel or in electrical contact to each
other. In another embodiment, first buss 302 and the second buss
304 may be in relative close proximity to each other, while not
being substantially parallel, coplanar or in electrical contact to
each other.
[0072] A plurality of electrically conductive platforms or islands
320 are spaced apart along the axis 308 between the first buss 302
and the second buss 304. Each of the plurality of islands has an
island top surface 322 above the plane 306 and an island bottom
surface 324 below the plane 306. In an embodiment, the first buss
302, the second buss 304 and the plurality of islands are
fabricated from a single planar strip of a metal. In an embodiment,
the metal is copper. Each of the plurality of islands 320 is
preferably connected to the first buss 302 and the second buss 304
through at least one flexible hinge member 326. The at least one
hinge member 326 may be discontinuous and may comprise a flexible
curable adhesive.
[0073] One of a plurality of light-emitting diodes 328 is
electrically and mechanically mounted to the island top surface of
each of the plurality of islands 320. The plurality of
light-emitting diodes 328 may be mounted using soldering, an
electrically conductive epoxy, or any mounting means compatible
with the materials and structure of the array 300. The plurality of
light-emitting diodes 328 is mounted at an orientation to direct
emitted light in a direction generally away from the plane 306. A
plurality of flexible electrical leads 330 electrically
interconnect the plurality of light-emitting diodes 328 in an
electrical circuit between the first buss 302 and the second buss
304. In an embodiment the first buss 302 is electrically connected
as a cathode and the second buss 304 is electrically connected as
an anode.
[0074] In an embodiment, the electrical circuit is a
series-parallel circuit wherein groups of electrically
series-connected light-emitting diodes of the plurality of
light-emitting diodes 328, are electrically connected in parallel
between the first buss 302 and the second buss 304. FIG. 8 shows
schematically a series-parallel electrical circuit 350 between a
cathode buss 352 and an anode buss 354. The circuit 352 includes
groups of four light-emitting diodes 356 electrically connected in
series, each of the groups 356 electrically connected in parallel
between the cathode 352 and the anode 354. The number in each group
of light-emitting diodes 356 in each group of light-emitting diodes
356 may be varied, and each group can include one or more
light-emitting diodes 356. Each of the light-emitting diodes 356 in
each group of light-emitting diodes 356 is considered to be
electrically connected to the first buss 302 or the second buss 304
either directly or indirectly.
[0075] The array 300 of FIG. 7 is flexible about the axis 308.
FIGS. 9A and 9B illustrate flexibility of the array 300 out of the
plane 306. FIG. 9A illustrates a side view of the array 300 without
flexion. For illustrative purposes, the plurality of flexible
electrical leads 330, which flex easily with flexion of the array
300, are not shown in FIGS. 9A or 9B. FIG. 9B illustrates a side
view of the array 300 in flexion out of the plane 306. Flexion of
the array 300 out of the plane 306 comprises flexion of the first
buss 302, the second buss 304, and the at least one flexible hinge
member 326 (not visible in FIGS. 9A and 9B).
[0076] FIGS. 10A and 10B illustrate flexibility of the array 300 in
the plane 306. FIG. 10A illustrates the array 300 in plan view,
without flexion. For illustrative purposes, the plurality of
flexible electrical leads 330, which flex easily with flexion of
the array 300, are not shown in FIGS. 10A or 10B. FIG. 10B
illustrates a plan view of the array 300 in flexion in the plane
306. Flexion of the array 300 in the plane 306 comprises extension
or compression of the at least one the plurality convolutions 318
along at least one of the first buss 302 and the second buss 304,
along with flexion, expansion or compression of the at least one
flexible hinge member 326.
[0077] FIG. 11 illustrates an embodiment of a flexible probe 360 of
the present invention incorporating the light-emitting array 300. A
flexible shaft 362 having a shaft axis 364 has four longitudinal
grooves 366, each configured for mounting the light-emitting array
300. A sheath 368 closely surrounds the shaft 362. The in-plane and
out-of-plane flexibility of each array 300 enables the flexible
shaft 362 to be bent in any direction about the shaft axis 364
without damaging any of the arrays 300. Flexibility is improved
through the structure of the light-emitting array 300, which can be
referred to as an "open frame" structure.
[0078] FIG. 12 shows a side view of an embodiment of a two-sided
light-emitting array 400 of the present invention. The two-sided
array 400 resembles the array 300 of FIG. 7 with the exception that
the two-sided array 400 of FIG. 11 additionally may accommodate
light-emitting diodes 402 mounted to the island bottom surface 324
of each of the plurality of islands 320. A corresponding plurality
of flexible electrical leads 404 electrically interconnect the
complementary plurality of light-emitting diodes 402 in an
electrical circuit between the first buss 302 and the second buss
304. The two-sided array 400 emits light in directions both above
and below the plane 306, and may accommodate a total of twice as
many light-emitting diodes per unit length, as does the array 300
having only the plurality of light-emitting diodes.
[0079] FIG. 13 shows an embodiment of a portion of an elongate
light-emitting diode array 450 of the present invention that has an
electrical buss structure similar to the embodiment illustrated in
FIG. 7, but wherein electrically conductive islands for mounting
light-emitting diodes are positioned out of the plane defined by
the busses, and include transverse positioning members. The array
450 includes a first flexible, electrically conductive buss 452 and
a second flexible, electrically conductive buss 454 disposed
opposite the first buss 452. The first buss 452 and the second buss
454 are substantially parallel to one another, defining a plane 456
and an axis 458 in the plane. The first buss 452 has a first buss
top surface 460 defined here as being above the plane 456 and a
first buss bottom surface 462 below the plane 456. The second buss
454 has a second buss top surface 464 above the plane 456 and a
second buss bottom surface 466 below the plane 456. Each of the
first buss 452 and the second buss 454 preferably includes a
plurality of longitudinally spaced-apart convolutions 468. The
plurality of convolutions 468 imparts flexibility of the array 450
in the plane 456. Flexibility of the first buss 452 and the second
buss 454 impart flexibility of the array 450 out of the plane
456.
[0080] A plurality of electrically conductive islands 470 are
preferably spaced apart along the axis 458 bridging the first buss
452 and the second buss 454. Each of the plurality of islands has
an island top surface 472 and a island bottom surface 474. In an
embodiment, the first buss 452, the second buss 454 and the
plurality of islands 470 are all made of copper. The island bottom
surface 474 of each of the plurality of islands 470 is connected to
the first buss top surface 460 through a first hinge member 475
which is preferably flexible. The island bottom surface 474 of each
of the plurality of islands 470 is connected to the second buss top
surface 464 through a second hinge member 476 which is preferably
flexible. Each of the first 475 and the second hinge member 476 may
comprise a flexible curable adhesive.
[0081] One of a plurality of light-emitting diodes 478 is
electrically and mechanically mounted to the island top surface of
each of the plurality of islands 470. The plurality of
light-emitting diodes 478 may be mounted using soldering, an
electrically conductive epoxy, or any mounting means compatible
with the materials and structure of the array 450. The plurality of
light-emitting diodes 478 is mounted at an orientation to direct
emitted light in a direction generally away from the plane 456. A
plurality of flexible electrical leads 480 electrically
interconnect the plurality of light-emitting diodes 478 in an
electrical circuit between the first buss 452 and the second buss
454. In an embodiment the first buss 452 is electrically connected
as a cathode and the second buss 454 is electrically connected as
an anode. The plurality of islands 470 also position the array 450
when it is disposed in a passage of a light-emitting probe.
[0082] FIG. 14 shows an embodiment of a section of a segmented
light-emitting array 500 of the present invention. The segmented
array 500 includes a plurality of light-emitting segments 502
structurally and electrically interconnected by a plurality of
flexible electrical leads 504. The plurality of flexible electrical
leads 504 interconnects the plurality of light-emitting segments
502 in electrical parallel. In an embodiment, the plurality of
flexible electrical leads 504 comprises longitudinal convolutions
along the segmented array. An exemplary segment 506 of the
plurality of light-emitting segments 502 is shown schematically in
FIG. 15. The exemplary segment 506 includes two electrical busses
508 that provide electrically parallel connections to the plurality
of electrical leads 504. Four light-emitting diodes 510 are
connected in electrical series between the busses 508 within the
exemplary segment 506. The overall electrical circuit for this
embodiment of the segmented array 500 is a series-parallel circuit
as described herein in association with FIG. 8. The segmented
light-emitting array 500 may include any number of light-emitting
diodes within each segment of a plurality of segments 502. In
another embodiment, each segment of the plurality segments 502
includes one light-emitting diode.
[0083] In another embodiment, the plurality of electrical leads 504
also serves as a plurality of positioning members to physically
center the segmented array 500 within an internal passage of a
light-emitting probe of the present invention. FIG. 16 is an end
view of the segmented array 500 of FIG. 14. Each of the plurality
of light-emitting segments 502 is substantially centered in a
passage 512 by the plurality of flexible electrical leads 504. In
an embodiment, the passage 512 has a circular cross section. In
another embodiment, the passage 512 has a polygonal cross section
having an even number of vertices for orienting the segmented array
500. In yet another embodiment, the passage 512 includes
longitudinal features for registering the plurality of electrical
leads 504, thereby orienting the segmented array 500 within the
passage 512.
[0084] FIG. 17 shows an exemplary embodiment of a segmented
light-emitting array 550 of the present invention including a
plurality of light-emitting segments 552 interconnected by a
plurality of flexible electrical leads 554 configured as a
three-dimensional structure. FIG. 18 is an end view of the
segmented array 550 of FIG. 17. Each of the plurality of
light-emitting segments 552 is substantially centered in a passage
556 by the plurality of flexible electrical leads 554. In an
embodiment, the passage 556 has a circular cross section. In
another embodiment, the passage 556 has a polygonal cross section
having an integral multiple of four vertices for orienting the
segmented array 550. In yet another embodiment, the passage 512
includes longitudinal features for registering the plurality of
electrical leads 504, thereby orienting the segmented array 500
within the passage 512.
[0085] Embodiments of segmented light-emitting arrays of the
present invention may be physically flexible through flexion of the
plurality of flexible electrical leads that interconnect
light-emitting segments. The flexible electrical leads also may
provide flexibility for a segmented light-emitting array by
compression or extension of individual leads between adjacent
light-emitting segments, in a manner similar to in-plane flexion of
the plurality of convolutions 318 of the electrical busses 302, 304
shown in FIG. 10B.
[0086] FIG. 19 shows an embodiment of a phototherapy system 600 of
the present invention. The phototherapy system 600 includes a
light-emitting probe 602 for delivering light to the interior of a
body lumen 604 (shown as a human stomach in FIG. 19). The
phototherapy system 600 also includes a control unit 606 that
provides electrical power and coolant for the probe 602. The
control unit 606 also includes a user interface 608 for controlling
the probe 602. The phototherapy system 600 may also include a
balloon catheter 610 for guiding the probe 602 into the body lumen.
The balloon catheter maintains a minimum distance between the probe
602 and a wall of the lumen 604 to limit the maximum intensity of
light from the probe 602 reaching a treatment site. The balloon
catheter 610 may be a multi-balloon catheter. Both the catheter 610
and the probe 602 may be controlled (inflated, deflated) through
the user interface 606, or the catheter 608 may be controlled
through a separate interface (not shown in FIG. 19).
[0087] An embodiment of a light-emitting probe of the present
invention may include means to maintain a minimum distance from a
wall of a lumen or for centering in a lumen. FIG. 20 illustrates an
embodiment of a light-emitting probe 650 of the present invention
including a positioning means. The probe 650 includes a probe body
652 having a distal end 654, a proximal end 656, a length
therebetween and an outer surface 658 along the length. The outer
surface 658 includes a reversibly inflatable member 660 surrounding
the probe body 652 along at least a portion of the length. The
inflatable member 660 is preferably circumferential and can be
inflated or deflated through a longitudinal tube 662 adapted for
connection at the proximal end 656 to an external inflation device
providing a gaseous or a liquid working fluid. The longitudinal
inflation tube 662 may be located external to the outer surface 658
or may be a longitudinal passage within the probe body 652. In an
embodiment, the inflatable member inflates to a substantially
predetermined working diameter. In another embodiment, the
inflatable member is an elastic balloon.
[0088] The light-emitting probes and systems disclosed herein have
many advantages, including but not limited to advantages related to
liquid cooling. Liquid cooling of light-emitting diodes may enable
these devices to output approximately four to ten times their
nominal factory-specified light power without overheating. For
example, an individual light-emitting diode having a manufacturer's
specification of a maximum light power output of 12 milliwatts in
air may be operated continuously at a light output power of
approximately 120 milliwatts using liquid cooling. This increase in
light output may enable a probe of the present invention to be used
to treat a dramatically larger surface in a lumen, or to similarly
decrease a treatment time, relative to known probes that are either
uncooled, passively cooled, or air-cooled. Liquid cooling of
light-emitting probes that incorporate these energy-consuming,
active devices also may dramatically enhance patient safety over
what can be achieved using other cooling means.
[0089] An exemplary embodiment of a medical procedure performed
according to the present invention is the treatment of H. Pylori
infection of the human stomach. Steps in an H. Pylori treatment
procedure may include setting up a light-emitting probe for use.
Setting up the probe may include attachment to a power source and a
coolant source, calibration of the probe's light emission, and
evaluation of the probe's condition and history to ensure patient
safety and efficacy of the procedure.
[0090] In an embodiment, the physician inserts an endoscope into
the patient's stomach and performs a diagnostic endoscopy. A
guidewire may be placed in a biopsy channel of the endoscope and
into the stomach, and the endoscope may be removed, leaving the
guidewire in place. The light-emitting probe, placed in a catheter
that may be a balloon catheter, is introduced into the stomach over
the guidewire, which may then be removed, leaving the probe and the
catheter in place in the stomach. One or more balloon of the
catheter may be inflated, positioning the probe in the stomach, and
the probe may be turned on to deliver a therapeutic dose of light
to the stomach wall. The dose may be a predetermined, timed dose,
or the dose may be measured and controlled during the light
exposure using feedback from one or more sensor that may be
incorporated into the probe.
[0091] Following delivery of the therapeutic light, the one or more
balloon is deflated and the probe is withdrawn from the stomach.
The probe may then cleaned and disinfected, for example, using
glutaraldehyde, in preparation for use in another procedure. In an
embodiment, the probe includes a mechanism or electronics to
determine its remaining useful functional life.
[0092] Embodiments of light emitting probes disclosed herein can be
advantageous for many applications of light-emitting probes
requiring light output, and particularly for applications requiring
light to accelerate specific chemical reactions without causing
thermal damage. Examples of non-medical applications of light
probes disclosed herein in lumens include internal disinfection of
pipes and ventilation ducts, rapid curing of internal coatings such
as epoxy repairs of pipes, chemical cross-linking of polymeric
surfaces to reduce susceptibility to chemical damage or wear, and
photochemical deposition of optical or electronic materials within
confined spaces. A probe to be used in a specific application may
be designed to include light-emitting elements that emit light in a
predetermined wavelength band for accelerating specific target
chemical reactions for the application. For example, near
ultraviolet light is used in the automotive industry and in and
other industries to cure paint rapidly without thermal damage to
the paint or an underlying part.
[0093] The enhanced physical flexibility of embodiments of
light-emitting diode arrays disclosed herein may also be
advantageous. In an embodiment, the structure of the arrays enables
the arrays to be flexed in any direction about a longitudinal array
axis. Known flexible arrays of light-emitting diodes are built on
substrates that restrict flexibility in the substrate plane.
Flexibility can be especially important, for example, in
high-output probes that include circumferentially-distributed
arrays of light-emitting diodes, where the arrays are oriented at a
range of angles about their respective axes within the probe. In an
embodiment, the structure of arrays also facilitates contact
between the light-emitting diodes and a coolant in a liquid-cooled
probe, for optimal heat transfer. Embodiments of arrays disclosed
herein can be applied advantageously not only to liquid-cooled
probes, but to any type of radiation-emitting probe, or probes
utilizing other electrical devices.
[0094] Many changes in the details, materials, and arrangement of
parts, herein described and illustrated, can be made by those
skilled in the art. Although the invention has been shown and
described with respect to detailed embodiments thereof, it will be
understood that changes may be made without departing from the
spirit and scope of the claimed invention. Accordingly, the
following claims are not to be limited to the embodiments disclosed
herein.
* * * * *