U.S. patent application number 12/161323 was filed with the patent office on 2009-08-27 for method and apparatus for light-activated drug therapy.
This patent application is currently assigned to Light Sciences Oncology, Inc.. Invention is credited to James C. Chen, Erik Hagstrom, Joseph M. Hobbs, Llew Keltner, Jay Winship, Frank Zheng.
Application Number | 20090216300 12/161323 |
Document ID | / |
Family ID | 37960404 |
Filed Date | 2009-08-27 |
United States Patent
Application |
20090216300 |
Kind Code |
A1 |
Keltner; Llew ; et
al. |
August 27, 2009 |
METHOD AND APPARATUS FOR LIGHT-ACTIVATED DRUG THERAPY
Abstract
A prostate treatment system having a light delivery device
positionable in a transurethral device for treatment of benign
prostatic hyperplasia (BPH). The light delivery device includes
light generator, such as light emitting diodes (LED), laser diodes
(LDs) or a diffusion quartz fiber tip connected to a light
generator or a light emitting polymer which produces light at a
selected wavelength or waveband or alternative sources of suitable
light energy. The treatment device may further include a
temperature monitoring system for monitoring the temperature at the
treatment site. A light-activated drug is administered to the
treatment site prior to light activation. The light-activated drug
therapy induces cell death of the target tissue. The device
provides a minimally invasive transurethral method for treatment of
BPH or prostate cancer.
Inventors: |
Keltner; Llew; (Portland,
OR) ; Winship; Jay; (Bellevue, WA) ; Hagstrom;
Erik; (Woodinville, WA) ; Zheng; Frank;
(Kirkland, WA) ; Chen; James C.; (Clyde Hill,
WA) ; Hobbs; Joseph M.; (Issaquah, WA) |
Correspondence
Address: |
SEED INTELLECTUAL PROPERTY LAW GROUP PLLC
701 FIFTH AVE, SUITE 5400
SEATTLE
WA
98104
US
|
Assignee: |
Light Sciences Oncology,
Inc.
Bellevue
WA
|
Family ID: |
37960404 |
Appl. No.: |
12/161323 |
Filed: |
January 18, 2007 |
PCT Filed: |
January 18, 2007 |
PCT NO: |
PCT/US07/01324 |
371 Date: |
November 19, 2008 |
Current U.S.
Class: |
607/89 ;
607/88 |
Current CPC
Class: |
A61B 2018/00285
20130101; A61B 2018/2261 20130101; A61B 2017/00084 20130101; A61N
5/062 20130101; A61B 2018/00547 20130101; A61N 2005/067 20130101;
A61N 2005/063 20130101; A61B 2017/00274 20130101; A61N 2005/0652
20130101; A61B 2017/22068 20130101; A61N 5/0603 20130101; A61N
2005/0602 20130101; A61N 5/0601 20130101; A61B 2018/00821 20130101;
A61K 41/0071 20130101; A61N 2005/061 20130101 |
Class at
Publication: |
607/89 ;
607/88 |
International
Class: |
A61N 5/06 20060101
A61N005/06 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 18, 2006 |
CN |
200620088987.8 |
Claims
1. A transurethral light activate drug therapy device for the
treatment of prostate conditions comprising: an elongated support
member configured to pass through the urethra, the elongated
support member having a proximal end and a distal end; a light
delivery device having a light generator along the support member
and a light emitting region configured to be positioned within the
urethra at least proximate to a treatment site, wherein the light
generator is configured to generate light at a preselected
wavelength or waveband in the range of an activation waveband of a
photoactive composition; and a positioning element carried by the
support member, wherein the positioning element is configured to
locate the support member within the urethra.
2. The transurethral light-activated drug therapy device of claim
1, wherein the light generator comprises at least one or more of a
light emitting diode (LED), solid-state laser diode (LD),a light
emitting polymer, a laser, a light-emitting transistor, or another
light source transmitting fiber through which light can be
conducted.
3. The transurethral light-activated drug therapy device of claim 1
wherein the light generator comprises an array of LEDs having a
size from about 0.25 mm to about 1 mm.
4. The transurethral light-activated drug therapy device of claim 1
wherein the light generator comprises an array of LEDs having a
size from about 1 mm to about 5 mm.
5. The transurethral light-activated drug therapy device of claim 3
or 4 wherein the array of LEDs is configured to provide from about
5 mW to about 50 mW per centimeter of array length.
6. The transurethral light-activated drug therapy device of claim 3
or 4, further comprising a power controller configured to pulse the
array according to a frequency or according to a timed pattern.
7. The transurethral light-activated drug therapy device of claim 3
or 4 wherein the array of LEDs has an operational frequency in the
range from about 50 Hz to about 5 kHz.
8. The transurethral light-activated drug therapy device of claim 1
wherein the light generator comprises a laser configured to
generate light from along the support member and a light channel
configured to transmit the light to the light emitting region.
9. The transurethral light-activated drug therapy device of claim 7
wherein the light delivery device further includes a diffusion
quartz fiber tip.
10. The transurethral light-activated drug therapy device of claim
1, further comprising a temperature monitor electrically coupled to
the temperature sensor.
11. The transurethral light-activated drug therapy device of claim
9 wherein the temperature monitor includes a visual indicator,
audible indicator and/or an automatic shut-off when the temperature
rises above a preselected value.
12. The transurethral light-activated drug therapy device of claim
1 wherein the support member comprises a catheter having a first
lumen in which the light delivery system is positionable and a
second lumen adapted for transmitting a fluid between a location
inside a body of a patient to a location outside the body of the
patient.
13. The transurethral light-activated drug therapy device of claim
1, further comprising echogenic material on or in a fixed relation
to the light delivery device in predetermined locations to provide
positional information about the light delivery device.
14. The transurethral light-activated drug therapy device of claim
1 wherein the temperature sensor is a thermocouple electrically
connected to a control loop, wherein the temperature sensor
measures temperature at the treatment site during treatment.
15. The transurethral light-activated drug therapy device of claim
1 wherein the light deliver device is fixed to the support
member.
16. A transurethral light-activated drug therapy device for the
treatment of prostate diseases comprising: a transurethral catheter
having a proximal end, a distal end, and a first lumen, wherein the
distal end is sized to be inserted in the urethra of a patient; a
balloon at the distal end of the catheter, wherein the balloon is
sized to insert in the bladder of a patient in a deflated
configuration; a drain aperture at a distal end of the catheter and
open to the first lumen; and an array of light emitting diodes
(LEDs) or solid-state laser diodes (LDs) carried by the catheter,
wherein the array of LEDs or LDs light source produces light at a
preselected wavelength or waveband in the range of an activation
waveband of a photoactive composition.
17. The transurethral light-activated drug therapy device of claim
16, further comprising a monitoring device electrically coupled to
the temperature sensor.
18. The transurethral light-activated drug therapy device of claim
16 wherein the monitoring device further includes an output device,
wherein the output device provides a visual indicator, audible
indicator or other temperature indicator for the temperature at the
treatment site.
19. The transurethral light-activated drug therapy device of claim
16 wherein the catheter has a selective coating to control where
light emits from the distal end.
20. The transurethral light-activated drug therapy device of claim
16, further comprising a second lumen in which the array of LEDs or
LDs is contained and can move axially within the catheter.
21. The transurethral light-activated drug therapy device of claim
16 wherein the array of LEDs or LDs is fixed at a selected location
within the catheter during treatment.
22. The transurethral light-activated drug therapy device of claim
16, further comprising a fixation device for releasably retaining
the catheter in the urethra tract during treatment.
23. The transurethral light-activated drug therapy device of claim
22 wherein the fixation device is a balloon, umbrella, tines,
and/or disk.
24. The transurethral light-activated drug therapy device of claim
22 wherein the fixation device is retractable.
25. The transurethral light-activated drug therapy device of claim
16, further comprising echogenic markings on the distal end of the
catheter or on the light source or both.
26. The transurethral light-activated drug therapy device of claim
16, further comprising positioning indicia on the proximal end of
the catheter.
27. A method for light-activated drug therapy of benign prostate
hyperplasia, comprising: positioning a support member of a
transurethral treatment device in the urethra such that a light
emitting region of the transurethral treatment device is at least
proximate to a treatment site; providing a photoreactive agent to
the treatment site; and generating light from a light generator
along the support member of the transurethral treatment device and
passing the light through the light emitting region, wherein the
light has one or more wavelengths or wavebands substantially equal
to a waveband of absorption of the photoreactive agent.
28. The method of claim 27 further comprising monitoring the
temperature of the treatment site with a temperature sensor.
29. The method of claim 27 further comprising modifying the
administration of light therapy based on the temperature at the
treatment site.
30. The method of claim 27 further comprising releasably fixing the
support member prior to administering the light therapy.
31. The method of claim 27 further comprising monitoring echogenic
marking on a distal end of the support member to position the
support member in the urethra tract.
32. The method of claim 27 further comprising moving the light
emitting region during administration of the light therapy.
33. The method of claim 27 further comprising controlling the
emission of light from the light generator according to a
predetermined pattern.
34. The method of claim 27 wherein the support member comprises a
catheter, and the method further comprises moving the light
generator and the light emitting region along the catheter to
position the light emitting region at least proximate to the
treatment site.
35. The method of claim 27 wherein the light generator and the
light emitting region are fixed to the support member, and the
method further comprises moving the support member within the
urethra to position the light emitting region at least proximate to
the treatment site.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates generally to a prostate
treatment system for treating prostatic tissue in combination with
a photoactive agent, and more specifically a transurethral device
in combination with a light-activated drug for use in treating
benign prostatic hyperplasia (BPH).
[0003] 2. Description of the Related Art
[0004] Benign prostatic hyperplasia (BPH) and prostate cancer are
common conditions in the older male population. For people with
BPH, the enlarged prostate can compress the urethra causing
obstruction of the urine pathway, which results in difficulty
urinating. The enlarged prostate can also cause urethral stones,
inflammation, infection and in some instances, kidney failure.
[0005] Major treatment methods for BPH include surgical treatment
such as a prostatectomy or transurethral resection of the prostate.
These treatments require the patient to be hospitalized, which can
be a financial burden to the patient. Additionally, surgical
procedures can result in significant side effects such as bleeding,
infection, residual urethral obstruction or stricture, retrograde
ejaculation, and/or incontinence or impotence. Patients who are too
old or who have weak cardiovascular functions are not good
candidates for receiving these treatment methods.
[0006] Photodynamic treatment (PDT) methods are new methods for
treating cancers. In light-activated drug therapy, also known as
PDT, light of a specific wavelength or waveband is directed toward
a target cell or cells that have been rendered photosensitive
through the administration of a photoreactive, photoinitiating, or
photosensitizing agent. The drug is commonly administered to the
patient via intravenous injection, oral administration, or by local
delivery to the treatment site. A light source emitting certain
wavelength or waveband can be used to irradiate the cancerous tumor
or the enlarged tissue by activating the photosensitizer to produce
a strong oxidizing agent that can kill the cancerous tumor or
enlarged tissues. As compared to surgical alternatives, the
light-activated drug therapy is minimally invasive, less costly,
and has a lower risk of complications.
[0007] One type of light delivery system used for light-activated
drug therapy comprises the delivery of light from a light source,
such as a laser, to the targeted cells using an optical fiber
delivery system with special light-diffusing tips on the fibers.
This type of light delivery system may further include optical
fiber cylindrical diffusers, spherical diffusers, micro-lensing
systems, an over-the-wire cylindrical diffusing multi-optical fiber
catheter, and a light-diffusing optical fiber guide wire. This
light delivery system generally employs a remotely located
high-powered laser, or solid-state laser diode array, coupled to
optical fibers for delivery of the light to the targeted cells.
[0008] The light source for the light delivery system used for
light-activated drug therapy may also be light emitting diodes
(LEDs) or solid-state laser diodes (LDs). LEDs or LDs may be
arrayed in an elongated device to form a "light bar" for the light
delivery system. The LEDs or LDs may be either wire bonded or
electrically coupled utilizing a "flip chip" technique that is used
in arranging other types of semiconductor chips on a conductive
substrate. Various arrangements and configurations of LEDs or LDs
are described in U.S. Pat. Nos. 5,445,608; 6,958,498; 6,784,460;
and 6,445,011, which are incorporated herein by reference.
[0009] One of the challenges in design and production of light bars
relates to size. The largest diameter of the light bar is defined
by human anatomy and the smallest diameter is defined by the size
of the light emitters that emit light of a desired wavelength or
waveband at a sufficient energy level, and the fragility of the bar
as its thickness is reduced, which increases the risk of breaking
in the patient.
[0010] Presently, there exists a need for an apparatus for
light-activated drug therapy for effectively treating prostate via
the urethra that is cost effective, less invasive than other
treatments, and has less risk of complications. Accordingly, there
is a need for smaller LEDs or LDs and other light sources that are
safe for use in a urethra tract introduced via a catheter-like
device.
SUMMARY
[0011] The invention describes devices, methods and systems for
light-activated drug therapy for treating the prostate
transurethrally. One embodiment of a transurethral treatment device
can include an elongated support member configured to pass through
the urethra, a light delivery device, and a positioning element
carried by the support member. The support member can be a catheter
having at least one lumen, or in other embodiments the support
member can be a generally closed body without a lumen. The light
delivery device can have a light generator along the support member
and a light emitting region configured to be positioned within the
urethra at least proximate to a treatment site. The light generator
is configured to generate light at a preselected wavelength or
waveband in the range of an activation waveband of a photoactive
composition. The positioning element is configured to locate the
light emitting region within the urethra at least proximate to the
treatment site. The positioning element, for example, can be a
balloon or indicators on the support member.
[0012] In other embodiments a transurethral treatment device
comprises a light delivery device positionable within or along an
elongated support member for treatment of benign prostatic
hyperplasia (BPH). The light delivery system may include light
emitting diodes (LEDs), laser diodes (LDs), or may include a
diffusion quartz fiber tip connected to an internal source of light
energy. The treatment device may further include a temperature
monitoring system for monitoring the temperature at the treatment
site and a urine drainage system.
[0013] According to another embodiment of the invention, the
treatment device has a light delivery device positioned within a
catheter-like device, such as a Foley catheter or a conventional
balloon catheter. In one embodiment, a light bar, sized to fit into
a standard or custom optically clear Foley catheter, is inserted
into the catheter which has been placed via the urethra at the
prostate. The device can be used in a sterile Foley catheter or can
be delivered in a sterile pack kit prepackaged with the catheter
and/or an appropriate photoactive agent dose so that it is
convenient for prostatic procedures, and thus facilitates treatment
in a non-surgical environment leading to potential reduction in
costs and medical complications.
[0014] In additional embodiments, the transurethral treatment
device can have an outer diameter of about 0.8 mm to about 10 mm
(e.g., 2.5 mm). The light source may have a cross-sectional
dimension of about 0.5 mm to about 1.5 mm, but in other embodiments
it can be larger. The size of an LED, for example, can be
approximately 0.25 mm to 1 mm. In other embodiment, the
transurethral treatment device, light source and LEDs can have
other cross-sectional dimensions. The light bar may further include
an encapsulant made from a flexible polymeric material with an
appropriate refractive index to ensure efficient light coupling
into the body. The encapsulant can also be made from opaque or
reflective material to direct the light to the targeted tissues and
to protect other tissues.
[0015] In additional embodiments, non-LED light sources such as
laser diodes (LDs) can be used. Generated light can be transmitted
to the treatment site via optical fibers. The light delivery system
may further include a diffusion quartz fiber tip connected to a
source of light.
[0016] In additional embodiments, the light emitting region of the
treatment device is fixed in place in the elongated support member.
In yet another embodiment, the light emitting region of the light
delivery device is movable within or along the elongated support
member. For example, at the end of the treatment the light delivery
device may be removed and the elongated support member left in
place to act as a urine drain. The treatment device may further
include printed markings or indicia on the catheter to aid in
placement of the light bar within the catheter.
[0017] In additional embodiments, the catheter has a selective
coating to control where light transmits to the prostatic tissue
thus directing the light activate drug therapy and reducing the
potential to treat adjacent tissue.
[0018] According to still further embodiments, a Y-connection with
a leakage control valve is included to allow the light delivery
device to be inserted into the elongated support member through a
separate lumen from a urine collection lumen. The elongated support
member may include one or more lumens as needed to provide light
transmission source manipulation and placement. In additional
embodiments, the elongated support member may include a balloon to
further aid in positioning the light delivery device proximate to
the prostate using non-incision type methods. In additional
embodiments, the catheter may include a retractable fixation device
such as balloon, umbrella, tines, disk or other means for fixation
and placement within the bladder.
[0019] In additional embodiments, to make the light bar visible to
ultrasound, the elongated support member and light bar may include
echogenic material to reflect high-frequency sound waves and thus
be imageable by ultrasound techniques. Echogenic material will aid
in proper placement of the elongated support member and the light
bar in operation. In additional embodiments, the light delivery
system also includes temperature sensors which are electrically
connected to temperature monitors for monitoring temperature at the
treatment site.
[0020] Several embodiments of the present invention are expected to
provide efficient, low cost, and minimally-invasive treatments of
prostate conditions. The treatment device may be used to treat
prostate cancer, prostatits, cystitis, bladder cancer, hypertrophic
trigone, and hypertrophic urethral sphincter. The present invention
utilizes light-activated drug therapy to minimally-invasively treat
BPH or prostate cancer via the urethra. As a result, patients with
BPH or prostate cancer can be treated using the present invention
without being admitted to a hospital, undergo general anesthesia
and blood transfusion, and thus have lower risk of
complications.
[0021] For many of the described embodiments, a photosensitizer is
administered intravenously before activating the light delivery
device. The light activates the photosensitizer to promote cell
death in the prostatic tissue. The device provides a minimally
invasive transurethral method for treating BPH, prostate cancer or
other prostatic conditions. This type of light-activated drug
therapy would treat prostatic tissue, for example, by causing cell
death in the prostatic tissue. Such cell death and the absorption
of the tissue by the patient's body would create an opening for
urine to flow from the bladder out the urethra.
[0022] The invention also provides methods of administering
light-activated drug therapy to treat targeted tissue of a human or
non-human patient. In one embodiment, the method includes
identifying a location of tissue to be treated in the prostate;
inserting an elongated support member into the urethral tract to
position a light emitting region at least proximate to the location
of the targeted tissue; and administering an effective dose of a
photoactive composition to the targeted tissue. The method may
include confirming placement of the light source prior to
treatment. The method further includes treating the targeted tissue
with light-activated drug therapy for a predetermined period of
treatment.
[0023] In some embodiments, the light-activated drug is
mono-L-aspartyl chlorine e.sub.6, also referred to herein as
Talaporfin Sodium. This compound's absorption spectrum has several
absorption bands: 400-420 nm (e.g., peak of about 411 nm), 500-520
nm (e.g., peak of about 507 nm), and 655-670 nm (e.g., peak of
about 664 nm). The drug could be excited at any of these bands.
Alternative light-activated drugs of suitable excitation
wavelengths may also be used as is known in the art.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The following drawings are intended as an aid to an
understanding of the invention to present examples of the
invention, but do not limit the scope of the invention as described
and claimed herein. In the drawings, identical reference numbers
identify similar elements or acts. The sizes and relative positions
of elements in the drawings are not necessarily drawn to scale. For
example, the shapes of various elements and angles are not drawn to
scale, and some of these elements are arbitrarily enlarged and
positioned to improve drawing legibility. Further, the particular
shapes of the elements as drawn, are not intended to convey any
information regarding the actual shape of the particular elements,
and have been solely selected for ease of recognition in the
drawings.
[0025] FIG. 1 is an elevational side view of a prostate treatment
system having a transurethral treatment device according to one
embodiment of the invention.
[0026] FIG. 2 is a cross-sectional view taken along line 2-2 of
FIG. 1 illustrating one embodiment of lumens in the transurethral
treatment device.
[0027] FIG. 3 is side view of a transurethral treatment device
positioned in the urethra tract of a patient according to an
embodiment of the invention.
[0028] FIG. 4 is a cross-sectional view of a transurethral
treatment device in accordance with another embodiment of the
invention.
[0029] FIG. 5 is a cross-sectional view of a transurethral
treatment device in accordance with yet another embodiment of the
invention.
[0030] FIG. 6 is a cross-sectional view of a transurethral
treatment device in accordance with still another embodiment of the
invention.
[0031] FIG. 7 is a cross-sectional view of a transurethral
treatment device in accordance with another embodiment of the
invention.
DETAILED DESCRIPTION
[0032] In the following description, certain specific details are
set forth in order to provide a thorough understanding of various
embodiments of the invention. However, one skilled in the relevant
art will recognize that the invention may be practiced without one
or more of these specific details, or with other methods,
components, materials, etc. In other instances, well-known
structures associated with light sources, catheters and/or
treatment devices have not been shown or described in detail to
avoid unnecessarily obscuring descriptions of the embodiments of
the invention.
[0033] Generally, a prostate treatment system can include a
transurethral treatment device having a light delivery device
positioned within or along an elongated support member for
treatment of benign prostate hyperplasia (BPH) and other prostate
conditions. In one embodiment, the treatment device includes a
light delivery device disposed on the surface of the elongated
support member, or in other embodiments, the light delivery device
is within a lumen of the elongated support member. The light
generator can be optically connected to a light emitting region via
optical fibers or light guides. Alternatively, the light generator
and the light emitting region may be positioned together at the
distal end of the elongated member at least proximate to a
treatment site. Thus, the light generator may include a laser, an
LED, a thin plastic sheet material which produces light at a
selected wavelength or waveband, or other suitable light sources
that can be transmitted to or placed at the treatment site.
According to a further embodiment of the invention, the
transurethral treatment device also includes temperature sensors
which are electrically connected to temperature monitors.
A. Treatment Device for Treating Benign Prostate Hyperplasia
(BPH)
[0034] FIG. 1 illustrates a prostate treatment system 20 including
a power supply 1 and a transurethral treatment device 21 having an
elongated support member 2 and a light delivery device 6 positioned
along or within the support member 2. The transurethral treatment
device 20 may further includes a balloon 3 or other type of
positioning element carried by the elongated support member 2. The
support member 2 can be a catheter having a lumen 4, or the support
member 2 can be a closed body without a lumen. According to an
embodiment, the support member 2 has a total length of 400 to 450
mm and has an outer diameter of 3.327 mm, and the balloon 3 at the
distal end of the support member 2 has a volume of 10 to 30 ml and
is used to position and fix the light delivery device 6 proximate
to the treatment site such as the prostate.
[0035] The light delivery device 6 can have a light generator 6a
and a light emitting region 6b. In the embodiment shown in FIG. 1,
the light generator 6a and the light emitting region 6b are at
approximately the same location of the elongated member, but in
other embodiments shown below, the light generator 6a may not be
coincident with the light emitting region 6b. As shown below, the
light generator 6a may be located towards the proximal end of the
support member 2. When the support member 2 is a catheter with a
lumen 4, the light delivery device 6 can move within the lumen to
be positioned relative to the treatment site. In other embodiments,
the light delivery device 6 can be disposed on the surface of the
catheter 2 below the balloon 3 or other type of positioning
element. The power for the light generator can be transmitted to
the light delivery device 6 via a lead wire 7 coupled to the power
source 1. According to an embodiment of the invention, light could
be emitted by a light emitting diode (LED), a laser diode,
light-emitting polymer, or a quartz fiber tip optically coupled to
another internal source of light energy.
[0036] As illustrated in FIG. 2, the support member 2 can include a
plurality of lumens therein. For example, the balloon 3 is
connected to a fluid inlet 5 via lumen 4. Gas or liquid can be
pumped into inlet 5 and through lumen 4 to inflate balloon 3.
Referring to FIGS. 1 and 2 together, the transurethral treatment
device 21 can optionally have a urine aperture 11 positioned at the
distal end of the support member 2 that is connected to a urine
collection bag 13 via a urine lumen 12. The urine aperture 11 can
be used to collect the patient's urine during treatment.
[0037] The transurethral treatment device 21 can also optionally
include a temperature measuring system having at least one of a
temperature sensor 8 and a temperature monitor 10. The temperature
sensor 8 can be a thermocouple or other sensor as is known in the
art. The temperature sensor 8 is disposed on or thermally coupled
to a surface of the support member 2 and is electrically connected
to the temperature monitor 10 via wires 9 disposed within the
support member 2. The temperature sensor 8 measures a temperature
at the treatment site, for example, proximate to the prostate
during treatment. A control loop (not shown) may further be
connected to the temperature monitor 10 to automatically shut the
treatment device off in the event that the temperature at the
treatment site exceeds a predetermined value. Alternatively, the
temperature monitor 10 may further include a warning device (not
shown), such as a visual indicator or audible indicator, to provide
an operator with a warning that a predetermined temperature has
been reached or is being exceeded during treatment.
[0038] As illustrated in FIG. 3, the treatment device is positioned
transurethrally to allow access to the prostate, followed by
administration of a photoactive drug, by injection, intravenously,
or orally. The transurethral treatment device 21, and more
specifically a portion of the support member 2, can be directed
into the urethra under topical anesthesia. Once the support member
is positioned, 4 to 10 ml of saline or air can be pumped into the
balloon 3 via the air pumping channel 4 to inflate the balloon 3.
After inflation of the balloon 3, the support member 2 can be
pulled slightly proximally such that the balloon 3 can be fixed at
the inner opening of the urethra. Accordingly, the light delivery
device 6 can be positioned at least proximate to or within the
prostate. The photoactive drug can then be administered to the
patient, and the light generator 6b can be activated.
[0039] The support member 2 has a proximal portion and a distal
portion relative to a power controller. The distal portion of
support member 2 includes the light delivery device 6. In one
embodiment, the light delivery device comprises a plurality of LEDs
in electrical communication with the power supply via lead wires 7
as shown in FIG. 1. The lead wires may be selected from any
suitable conductor that can be accommodated within the dimensions
of the support member, for example: a bus bar that electronically
couples the LEDs to the controller; flexible wires; a conductive
film or ink applied to a substrate, and the like. Additionally or
alternatively, the light delivery device may include Bragg
reflectors to better control the wavelength of the light that is to
be transmitted to the target cells.
[0040] A power controller 1 may be programmed to activate and
deactivate LEDs of a light delivery device in a pulsed sequence or
a continuous sequence. For example, the LEDs may form two halves of
the light array that may be turned on and off independently from
each other. Alternatively, the system may be programmed to
selectively activate and deactivate (e.g., address) different
selected individual or groups of LEDs along the length of the bar.
In this manner, a treatment protocol, for example causing the LEDs
to be lit in a certain sequence or at a particular power level for
a selected period of time, may be programmed into the controller.
Therefore, by selectively timing the pulses and/or location of the
light, the system delivers light in accordance with a selected
program. Alternatively, LEDs can be powered by DC continuously.
Examples of addressable light transmission arrays are disclosed in
U.S. Pat. No. 6,096,066, herein incorporated in its entirety by
reference. Exemplary light transmission arrays which include
shielding or distal protection are disclosed in U.S. patent
application Ser. Nos. 10/799,357 and 10/888,572, herein
incorporated in their entirety by reference.
[0041] Without being bound by any theory, applicants believe that
by delivering light in pulses, the efficacy of the light-activated
drug therapy is improved, given that the treated tissue is allowed
to reoxygenate during the cycles when the light is off. Applicants
further believe that tissue oxygenation during therapy is improved
by using a lower frequency. In one embodiment the operational
frequency is 50 Hz-5 kHz, and in one embodiment, is 50-70 Hz.
[0042] According to a further embodiment of the invention, the
treatment device may further include a temperature monitoring
system for monitoring the temperature at the treatment site.
[0043] In one embodiment, the support member 2 is a Foley catheter
and the light delivery device 6 is disposed in the Foley catheter.
Alternatively, the treatment device has a light delivery device
disposed in a conventional balloon catheter. Foley catheters are
available in several sub-types, for example, a Coude catheter has a
45.degree. bend at the tip to allow easier passage through an
enlarged prostate. Council tip catheters have a small hole at the
tip which allows them to be passed over a wire. Three-way catheters
are used primarily after bladder, prostate cancer or prostate
surgery to allow an irrigant to pass to the tip of the catheter
through a small separate channel into the bladder. This serves to
wash away blood and small clots through the primary arm that drains
into a collection device.
[0044] FIG. 4 is a cross-sectional view of still another embodiment
of a transurethral treatment device 21. In this embodiment, the
light delivery device includes a light generator 6a along the
support member 2 at a location that is either within or external
(shown) to the patient. The light delivery device can further
include a light emitting region 6b positioned at least proximate to
the treatment site and a light transmitting region 6c (e.g., fiber
optic) between the light generator 6a and the light emitting region
6b. In FIG. 4, the support member 2 can be a catheter through which
the light delivery device 6 can be moved for positioning, or the
support member can be a closed body to which the light delivery
device 6 is attached (e.g., fixed at a set position).
[0045] FIGS. 5-7 are cross-sectional views showing additional
embodiments of portions of transurethral treatment devices. FIG. 5,
more specifically, shows a device having a closed body support
member 2 and a light delivery device fixed to the support member 2.
The light delivery device has a light generator 6a, a light
emitting region spaced apart from the light generator 6a distally
along the support member 2, and a light transmitting region 6c
between the light generator 6a and the light emitting region 6b.
The light transmitting region 6c conducts light from the light
generator 6a to the light emitting region 6b. FIG. 6 illustrates a
device having a solid or otherwise lumen-less support member 2 and
a light delivery device 6 with a light generator 6a and a light
emitting region 6b at the same location longitudinally along the
support member 2. In FIGS. 5 and 6, the light generator is within
the support member 2. FIG. 7 shows still another embodiment in
which the light delivery device is on a surface of the support
member. More specifically, the light delivery device 6 has the
light generator 6a and the light emitting region 6b disposed on an
external surface of the support member.
[0046] In one embodiment, a light delivery system that is sized to
fit into a standard or custom optically clear Foley catheter is
inserted into that catheter which has been placed via the urethra
at the prostate. The light delivery device can be used with a
sterile Foley catheter or can be delivered in a sterile pack kit
prepackaged with the catheter and/or an appropriate photoactive
agent dose so that it is convenient for prostatic procedures.
[0047] The light bar or light array may include a plurality of LEDs
contained in a catheter assembly or otherwise attached to a closed
elongated support member. The support member 2 may have an outer
diameter of about 0.8 to about 10 mm. Example of LED arrays are
disclosed in U.S. application Ser. No. 11/416,783 entitled "Light
Transmission system for Photo-reactive Therapy," and U.S.
application Ser. No. 11/323,319 entitled "Medical Apparatus
Employing Flexible Light Structures and Methods for Manufacturing
Same," herein incorporated in their entirety by reference.
[0048] Additional embodiments have a power controller drive circuit
capable of producing constant current D.C., A.C., square wave and
pulsed wave drive signals. This is accomplished by combining a
constant source with a programmable current steering network
allowing the controller to selectively change the drive wave form.
For example, the steering network may be modulated to achieve the
various functions described above, for example, producing the
desired impedance to fully discharge the battery. Furthermore, use
of an A.C. drive allows for a two-wire connection to the LEDs,
thereby reducing the cross-sectional diameter of the catheter,
while still permitting use of two back-to-back emission sources,
that when combined, produce a cylindrical light source emission
pattern.
[0049] Therefore, as discussed above, the transurethral treatment
device 21 can comprise a unitary, single use disposable system for
light-activated drug therapy. It should be noted that in certain
embodiments the catheter is fused to the power controller to form
an integrated single unit. Any attempt to disconnect the support
member in this embodiment results in damage to either the catheter,
or module, or both.
[0050] The prostate treatment system can be used in connection with
any light-activated drug of which there are many known in the art
and some of which are listed in U.S. Pat. No. 7,015,240 which is
fully incorporated by reference with regard to disclosed
photoactive compositions. In one particular embodiment, the
light-activated drug is Talaporfin Sodium. Talaporfin Sodium is a
chemically synthesized photosensitizer, having an absorption
spectrum that exhibits a maximum peak at 664 nm. In one embodiment,
the Talaporfin Sodium is presented as a lyophilized powder for
reconstitution. One hundred milligrams of Talaporfin Sodium is
reconstituted with 4 milliliters of 0.9% isotonic sterile sodium
chloride solution, to give a solution at a concentration of 25
mg/ml.
[0051] The drug must be activated with light, and light energy is
measured here in Joules (J) per centimeter of length of the light
transmitting array. Likewise the fluence of light is measured in
milli-watts (mW) per centimeter of length of the light emitting
array. Clearly, the amount of energy delivered will depend on
several factors, among them: the photoactive agent used, the dose
administered, the type of tissue being treated, the proximity of
the light array to the tissue being treated, among others. The
energy (E) delivered is the product of the fluence (F) and the time
period (T) over which the fluence is delivered: E=F.times.T. The
fluence may be delivered for only a fraction of the treatment time,
because the light array may be pulsed, for example in a frequency
such as 60 kHz, or may be controlled by a timing pattern. An
example of a timing pattern is that the array is at full fluence
for 20 seconds, then off for 10 seconds in a repetitive cycle. Of
course, any pattern and cycle that is expected to be useful in a
particular procedure may be used. The control module may further be
programmable in embodiments for such fractionated light
delivery.
[0052] In accordance with an embodiment, fifteen minutes to one
hour following Talaporfin Sodium administration, light energy in
the range from about 50 to about 1000 J/cm of light array fluence
in the range from about 5 to about 50 mW/cm of light array is
delivered to the treatment site. As may be expected, the equation
discussed above relating energy time and fluence plays a role in
selection of the fluence and energy delivered. For example,
depending upon the patient, a certain time period may be selected
as suitable. In addition, the nature of treatment might dictate the
energy required. Thus, fluence F is then determined by F=E/T. The
light array should be capable of providing that fluence in the
allotted time period. For example, if a total of 200 J/cm of light
array must be delivered to the treatment site at 20 mW/cm of light
array, then the treatment period is approximately 2.8 hours.
[0053] In additional embodiments, the support member further has a
selective coating to control where light transmits to the prostatic
tissue thus directing the light activate drug therapy and reducing
the potential to treat adjacent tissue.
[0054] In another embodiment, the light delivery device is fixed in
place in the catheter. In yet another embodiment, the light
delivery device is movable within the catheter. According to this
embodiment, the treatment device may further include printed
markings or indicia on the catheter to aid in placement of the
light bar within the catheter. The light delivery device can also
have asymmetric light delivery to protect the colon or rectum. For
example, the light deliver device can be double sided and/or
shielded so that one side of the light bar emits light at a higher
intensity than another side. Exemplary light delivery devices are
disclosed in U.S. Pat. No. 5,876,427, herein incorporated in its
entirety by reference.
[0055] In additional embodiments, a Y-connection with a leakage
control valve is included to allow the light transmission source to
be inserted into the catheter through a separate lumen from a urine
collection lumen. The catheter may include two or more lumens as
needed to provide light transmission source manipulation and
placement.
[0056] In additional embodiments, the catheter includes a balloon
or other positional element to further aid in positioning the light
source transmission end proximate to the prostate using
non-incision type methods. In additional embodiments, the catheter
may include a retractable fixation device such as balloon,
umbrella, tines, disk or other means for fixation and placement
within the bladder.
[0057] In additional embodiments, to make the light bar visible to
ultrasound, the light source catheter and/or the light bar may
include echogenic material to reflect high-frequency sound waves
and thus be imageable by ultrasound techniques. In operation,
echogenic material will aid in proper placement of the catheter and
the light source.
[0058] In additional embodiments, the light transmission source
also includes temperature sensors which are electrically connected
to temperature monitors.
[0059] Several embodiments of the prostate treatment systems are
expected to provide highly efficient, low cost, and
minimally-invasive treatment of prostate conditions. The treatment
device may be used to treat prostate cancer, prostatis, cystitis,
bladder cancer, hypertrophic trigone, and hypertrophic urethral
sphincter. The present invention utilizes light-activated drug
therapy methods to minimally-invasively treat BPH or prostate
cancer via the urethra. As a result patients with BPH or prostate
cancer can be treated using the present invention without being
hospitalized, undergo general anesthesia and blood transfusion, and
thus have lower risk of complications.
B. Methods of Treating BPH Using the Treatment Device
[0060] The invention also provides methods of administering
photoactive therapy to treat targeted tissue of a human or
non-human patient. In one embodiment, the method includes
identifying a location of tissue to be treated in the prostate;
inserting a catheter into the urethra tract; inserting a light
delivery device at least proximate to the location of the targeted
tissue; and administering an effective dose of a photoactive drug.
The method may include confirming placement of the light source
prior to treatment. The method further includes treating the
targeted tissue by activating the light delivery device for a
predetermined period of treatment. In some embodiments, the
light-activated drug is mono-L-aspartyl chlorine e.sub.6, also
referred to herein as Talaporfin Sodium. Compositions and methods
of making Talaporfin Sodium are disclosed and taught in co-pending
U.S. patent application Ser. No. ______ entitled "Compositions and
Methods of Making a Photoactive Agent" filed Jun. 30, 2006, herein
incorporated in its entirety. This compound has an absorption
spectrum that exhibits several peaks, including one with the
excitation wavelength of 664 nm, which is the wavelength favored
when it is used in photoreactive therapy. Alternative
light-activated drugs of suitable excitation wavelengths may also
be used as is known in the art.
[0061] The method further includes monitoring a temperature at
treatment site. The temperature measuring system includes a
temperature sensor for monitoring the temperature at the treatment
site. The temperature sensor may be a thermal couple or any
suitable device for providing temperature information at the
treatment site. The temperature sensor may be disposed at the
surface of the support member and is further electrically connected
to the temperature monitor via wires. Alternatively, the
temperature sensor may be wirelessly connected to the temperature
monitor. The temperature sensor provides the temperature proximate
to the treatment site during treatment to ensure safe operating
temperatures during the treatment at the treatment site.
[0062] The above description of illustrated embodiments, including
what is described in the Abstract, is not intended to be exhaustive
or to limit the invention to the precise forms disclosed. Although
specific embodiments of and examples are described herein for
illustrative purposes, various equivalent modifications can be made
without departing from the spirit and scope of the invention, as
will be recognized by those skilled in the relevant art. The
teachings provided herein of the invention can be applied to light
sources, catheters and/or treatment devices, not necessarily the
exemplary light sources, catheters and/or treatment devices
generally described above.
[0063] Unless the context requires otherwise, throughout the
specification and claims which follow, the word "comprise" and
variations thereof, such as, "comprises" and "comprising" are to be
construed in an open, inclusive sense that is as "including, but
not limited to."
[0064] Reference throughout this specification to "one embodiment"
or "an embodiment" means that a particular feature, structure or
characteristic described in connection with the embodiment is
included in at least one embodiment of the present invention. Thus,
the appearances of the phrases "in one embodiment" or "in an
embodiment" in various places throughout this specification are not
necessarily all referring to the same embodiment. Further more, the
particular features, structures, or characteristics may be combined
in any suitable manner in one or more embodiments. The headings
provided herein are for convenience only and do not interpret the
scope or meaning of the claimed invention.
[0065] The various embodiments described above can be combined to
provide further embodiments. All of the U.S. patents, U.S. patent
application publications, U.S. patent applications, foreign
patents, foreign patent applications and non-patent publications
referred to in this specification and/or listed in the Application
Data Sheet, are incorporated herein by reference, in their
entirety. Embodiments of the invention can be modified, if
necessary, to employ systems, circuits and concepts of the various
patents, applications and publications to provide yet further
embodiments of the invention.
[0066] These and other changes can be made to the invention in
light of the above-detailed description. In general, in the
following claims, the terms used should not be construed to limit
the invention to the specific embodiments disclosed in the
specification and the claims, but should be construed to include
all catheters, light transmission sources and treatment devices
that operate in accordance with the claims. Accordingly, the
invention is not limited by the disclosure, but instead its scope
is to be determined entirely by the following claims.
[0067] From the foregoing, it will be appreciated that specific
embodiments of the invention have been described herein for
purposes of illustration, but that various modifications may be
made without deviating from the spirit and scope of the invention.
Accordingly, the invention is not limited except as by the appended
claims.
* * * * *