U.S. patent application number 10/612216 was filed with the patent office on 2004-01-08 for method and apparatus for coagulation of superficial blood vessels in bladder and proximal urethra.
Invention is credited to Beyar, Mordechai, Klugman, Nathan.
Application Number | 20040006334 10/612216 |
Document ID | / |
Family ID | 22728209 |
Filed Date | 2004-01-08 |
United States Patent
Application |
20040006334 |
Kind Code |
A1 |
Beyar, Mordechai ; et
al. |
January 8, 2004 |
Method and apparatus for coagulation of superficial blood vessels
in bladder and proximal urethra
Abstract
An apparatus and method of use are disclosed to treat and/or
diagnose urological disorders. The non-implantable device includes
a light source housed within a light source segment. The light
source segment is of a sufficiently small size and configuration so
that it can be inserted through the urethra and positioned adjacent
the target site in the patient. Different types of light sources
can be used to achieve a variety of energy levels and distributions
useful in treating incontinence disorders. Both incoherent and
coherent light sources may be used with the present invention. In
addition, the light from the light source can be designed to be
pulsed or continuous wave and may be in any suitable spectrum,
including visible (such as white light) and infrared. The
particular characteristics of the light emitted from the light
source, such as wavelength, frequency, amplitude, etc., depend upon
the particular treatment and procedure.
Inventors: |
Beyar, Mordechai; (Caesarea,
IL) ; Klugman, Nathan; (Jerusalem, IL) |
Correspondence
Address: |
OPPENHEIMER WOLFF & DONNELLY LLP
45 SOUTH SEVENTH STREET, SUITE 3300
MINNEAPOLIS
MN
55402
US
|
Family ID: |
22728209 |
Appl. No.: |
10/612216 |
Filed: |
July 2, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10612216 |
Jul 2, 2003 |
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09834473 |
Apr 13, 2001 |
|
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6616653 |
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60197141 |
Apr 14, 2000 |
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Current U.S.
Class: |
606/15 ; 607/88;
607/89 |
Current CPC
Class: |
A61B 18/18 20130101;
A61B 1/307 20130101; A61B 2018/1807 20130101 |
Class at
Publication: |
606/15 ; 607/88;
607/89 |
International
Class: |
A61B 018/20; A61N
005/06 |
Claims
What is claimed is:
1. A non-implantable device for treating urological disorders,
comprising: a light source that provides the required therapeutic
light to treat said urological disorders; and a light source
segment that houses said light source, wherein said light source
segment is of a sufficiently small size and configuration so that
it can be inserted through the urethra of the patient.
2. The non-implantable device of claim 1 wherein said light source
is a tungsten halogen lamp.
3. The non-implantable device of claim 1 wherein said light source
is a coherent light source.
4. The non-implantable device of claim 1 wherein said light source
is pulsed at a pulse timing that varies between a range of
approximately 1.0 microsecond to 1.0 millisecond.
5. The non-implantable device of claim 1 wherein said light source
is a continuous wave light source.
6. The non-implantable device of claim 1 wherein said light is a
pulsed white light.
7. The non-implantable device of claim 1 further comprising one or
more light attenuating components to modify beam profile and
intensity of said light.
8. The non-implantable device of claim 7 wherein said light
attenuating components is selected from the group consisting of
filters, gratings, apertures, prisms, knife edges, pin holes and
lenses.
9. The non-implantable device of claim 1 wherein said light source
is any light emitting device housed within an integrating
sphere.
10. A non-implantable device for treating urological disorders,
comprising: a viewing assembly, wherein said viewing assembly
includes an eyepiece, a steering control knob and a light port, a
light source segment housing a light source that provides the
required therapeutic light to a target site to treat said
urological disorders; and an elongate portion, said elongate
portion having one or more lumen extending along the length of said
elongate portion and in communication with said viewing assembly
and said light source segment to enable direct visualization and
illumination of said target site.
11. A method of treating urological disorders, comprising:
inserting a non-implantable device through the urethra and into the
bladder of a patient; viewing a target site within said bladder
using a viewing assembly of said non-implantable device;
positioning a tip of said device adjacent said target site within
said bladder; activating said device to selectively deliver light
to said target site; said light being absorbed primarily only by
blood at said target site; coagulating superficial blood vessels
using said light; and removing said device from said bladder and
urethra of said patient.
12. The method of claim 11 further comprising using a viewing
assembly of said non-implantable device to accurately maneuver said
device and identify a location of said target site within said
bladder.
13. The method of claim 11 wherein said tip of said device through
which said light emerges is sufficiently close to said target site
so as to effect the desired treatment.
14. The method of claim 11 further comprising customizing treatment
parameters according to target site location and condition.
15. The method of claim 14 wherein said treatment parameters
include variable pulsing characteristics and wavelength spectrum of
said device.
16. The method of claim 15 wherein said wavelength spectrum and
pulsing characteristics of said light are customized so that said
light is only absorbed by blood and reacts to coagulate said
blood.
17. The method of claim 11 further comprising ablating said target
site using said light.
18. The method of claim 11 wherein said light occludes said target
site.
19. The method of claim 11 wherein said light coagulates said
target site.
20. The method of claim 11 wherein said light coagulates
superficial blood vessels.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Divisional of U.S. patent application
Ser. No. 09/834,473, filed Apr. 13, 2001, which claims priority of
U.S. Provisional Application Serial No. 60/197,141, filed Apr. 14,
2000, the entireties of which are hereby incorporated by
reference.
BACKGROUND OF THE INVENTION
[0002] Urinary incontinence, a condition involving involuntary loss
of urine, affects millions of people throughout the world.
Incontinence is often associated with medical disorders such as
decubitus ulcers, urinary tract infections, detrusor hyperactivity
and renal failure. In addition to the medical aspects of this
condition, the social implications for an incontinent patient
include loss of self-esteem, embarrassment, restriction of social
and sexual activities, isolation, depression, and, in some
instances, dependence on caregivers. As such, many affected
patients do not report the problem to their physicians even though
incontinence is highly treatable and even curable.
[0003] In general, normal continence results when the lower urinary
tract, kidneys and nervous system function properly in combination
with the patient's ability to recognize and appropriately respond
to the urge to urinate. Ordinarily, the process of urination
involves two phases. The first phase is the filling and storage
phase whereby the bladder begins to fill with urine from the
kidneys and stretches to accommodate the increased amount of urine.
The ability to fill and store urine requires proper functioning of
the sphincter muscle, to control urine output, and detrusor
(bladder wall) muscle, to control and stabilize bladder distention.
The second phase of urination is the emptying phase. The emptying
phase requires simultaneous contraction of the detrusor muscle, to
force urine out of the bladder, and relaxation of the sphincter
muscle, to allow the urine to pass out of the body.
[0004] Continence problems may occur, for example, as a result of
weakened pelvic muscles, malfunction of the urethral sphincter,
trauma to the urethral area, neurological injury, hormonal
imbalance or medication side-effects. In general, there are three
types of urinary incontinence: stress incontinence, overflow
incontinence and urge incontinence. Stress incontinence is the
involuntary loss of urine that occurs due to sudden increases in
intra-abdominal pressure resulting from activities such as
coughing, sneezing, lifting, straining, exercise and, in severe
cases, even simply changing body position. This condition usually
occurs when the sphincter or pelvic muscles are weakened, for
example by childbirth or surgery.
[0005] Overflow incontinence is a constant dripping or leakage of
urine caused by an overfilled bladder. This condition often occurs
in men due to the prevalence of obstructive prostate gland
enlargement or tumor.
[0006] Urge incontinence, also termed "hyperactive bladder,"
"frequency/urgency syndrome" or "irritable bladder," occurs when an
individual experiences the immediate need to urinate and loses
bladder control before reaching the toilet. Urge incontinence is a
common problem that increases with advancing age or results from a
kidney or bladder infection.
[0007] Detrusor hyperactivity, or urge incontinence, is the second
most common cause for urine incontinence and may be found in 10 to
15% of asymptomatic men and women between the ages of 10 to 50. The
goal in controlling or eliminating detrusor hyperactivity is to
reduce irritation of nerve endings at the bladder wall due to
inflammation and decrease detrusor (bladder wall muscle) activity.
Current treatment methods include bladder drilling, pharmacotherapy
and surgical management.
[0008] Various methods of ablating the nerves that innervate the
bladder have been used to treat incontinence. However, the most
common surgical method for treatment of urge incontinence is
bladder augmentation by enterocystoplasty. Augmentation cystoplasty
is basically a reconstructive surgery in which a segment of the
bowel is removed and used to replace a portion of the diseased
bladder. Complications associated with this procedure include the
usual complications resulting from major abdominal surgery, such as
bowel obstruction, blood clots, infection and pneumonia. Because of
the morbidity level, this procedure is generally considered a last
resort in an incontinence treatment plan.
[0009] As a result, practitioners have continually sought a less
invasive method of treating urinary incontinence. In particular,
there is a desire to obtain minimally invasive yet highly effective
device that can be used with minimal to no side effects. Such a
device must be biocompatible, non-toxic and simple to use. In
addition, the related treatment methods using the device should
reduce pain, infections and post operative hospital stays. Further,
the method of treatment should also improve the quality of life for
patients.
BRIEF SUMMARY OF THE INVENTION
[0010] In view of the foregoing, it is apparent that there is a
need for a minimally invasive device for treating urinary
incontinence, for example, by reducing detrusor hyperactivity, so
as to restore normal continence in a patient. There is also a need
to provide a method of using such a device to create the desired
continence effect.
[0011] With respect to the device of the present invention, in the
incoherent light source embodiments, the therapeutic treatment
device utilized is similar to the embodiments disclosed in U.S.
Pat. 5,405,368 to Eckhouse, issued Apr. 11, 1995, prior copending
U.S. application Ser. No. 08/508,129, filed Jul. 27, 1995, U.S.
application Ser. No.08/477,479, filed Jun. 7, 1995, U.S.
application Ser. No. 08/473,532, filed Jun. 7, 1995, and U.S.
application Ser. No. 08/383,509, filed Feb. 3, 1995 (collectively
"the Eckhouse applications"), the disclosures of which are hereby
fully incorporated herein by reference. In the laser light source
embodiment, the treatment device is similar to that of Talmore, as
described in U.S. Pat. Nos. 5,344,433 and 5,344,434, the
disclosures of which are also hereby fully incorporated herein by
reference.
[0012] The present invention differs from the Eckhouse and Talmore
devices in that the exit area, through which the light emerges from
the apparatus, is of a size and configuration such that it can be
inserted through the urethra, proximal urethra and even into the
bladder. An additional distinction is that the device of the
present invention delivers light that can be used to treat bladder
blood vessels, as opposed to external skin disorders. The present
invention may also utilize any type of selective thermolysis of the
superficial bladder vessels for the treatment of the above
mentioned pathologies.
[0013] In general, the present invention contemplates a
non-implantable device for treating urological disorders. The
device includes a light source and a light source segment, wherein
the light source provides the required therapeutic light to treat
urological disorders. In addition, the light source segment houses
the light source and is of a sufficiently small size and
configuration so that it can be inserted through the urethra of the
patient. The non-implantable device may also include a viewing
assembly, comprising an eyepiece, steering control knob and a light
port, and an elongate portion having one or more lumen extending
along the length of the elongate portion. The lumens of the
elongate portion, which are in communication with the viewing
assembly and light source segment, enable direct visualization and
illumination of the target site in the patient.
[0014] The present invention also contemplates a method of treating
urological disorders which may include the steps of inserting a
non-implantable device through the urethra and into the bladder of
a patient and positioning a tip of the device adjacent a target
site within the bladder. The next steps may include activating the
device to selectively deliver light to the target site and,
finally, removing the device from the bladder and urethra of the
patient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Other features and advantages of the present invention will
be seen as the following description of particular embodiments
progresses in conjunction with the drawings, in which:
[0016] FIG. 1 is a perspective view of an embodiment of the device
of the present invention;
[0017] FIG. 2 is a sectional view of an embodiment of the device of
the present invention;
[0018] FIG. 3 is a sectional view of another embodiment of the
device of the present invention;
[0019] FIG. 4 is a sectional view of an embodiment of the light
source segment of the coagulation device;
[0020] FIG. 5 is a sectional view of another embodiment of the
light source segment of the coagulation device;
[0021] FIG. 6A is a perspective view of another embodiment of the
device of the present invention;
[0022] FIG. 6B is a sectional view of another embodiment of the
device of the present invention; and
[0023] FIG. 7 is a view illustrating an embodiment of the device of
the present invention inserted within a patient.
DETAILED DESCRIPTION OF THE INVENTION
[0024] Referring to FIG. 1, an embodiment of the non-implantable
device 10 in accordance with the present invention includes a light
source that emits light used to treat urological disorders.
Overall, the device configuration is similar to a cystoscope.
Although the invention as disclosed herein generally refers to a
cystoscope, other similar devices, such as a urethroscope, catheter
or other similar systems, are also included within the scope of the
present invention.
[0025] In general, the non-implantable device 10 comprises a
viewing assembly 12, light source segment 14, delivery/access
section 16 and elongate portion 18. The viewing assembly 12
includes an eyepiece 20, a steering control knob or lever 22 and a
light port 24. Adjacent to the viewing assembly 12 is the light
source segment 14. The light source segment 14 and delivery/access
section 16 include a light source (not shown) and one or more ports
26, respectively. Housed within the elongate portion 18 of the
device 10 are one or more lumens that extend along the length of
the device and are in communication with the above-mentioned
components of the viewing assembly 12, light source segment 14 and
delivery/access section 16 of the invention. In the spirit of
convenience and brevity, the device 10 referenced in the text and
figures of the present disclosure is configured according to the
above-described design. However, it should be noted that other
designs of the device 10 are also within the scope of the claimed
invention.
[0026] The eyepiece 20 and light port 24 of the viewing assembly 12
may be the optical portion of, for example, a standard cystoscope.
As shown in FIGS. 1 and 2, these components, together with one or
more lumen 28 extending along the length of the device 10, enable
direct visualization and illumination of the target site by the
operator of the device 10. In an alternate embodiment (not shown),
the eyepiece 20 can be replaced with a video device for remote
viewing and recording functions.
[0027] Imaging of the target site requires locating the distal end
30 of the device at or near the desired target area. The control
knob or lever 22 of the viewing assembly 12 functions as the
steering mechanism of the device 10. In one embodiment, a
guide-wire 32, housed within a lumen 29 and extending along the
length of the device 10, is attached to the control knob 22. By
manipulating the control knob 22, an operator can steer the distal
end 30 of the device 10 through the urethra and position the tip 34
near the target site in the bladder. In an alternate embodiment, a
lever 22 and associated guide-wire 32 are used to maneuver the
device 10 through the various vessels and organs. The device
components and imaging/visualization methods of the present
invention as described above are generally known to those skilled
in the art and are similar to those used with conventional
cystoscopes.
[0028] Referring to FIG. 1, the delivery/access section 16 includes
one or more ports 26. At least one lumen 31 extends between the
ports 26 and the distal end 30 of the device 10. In general, the
ports 26 and lumen 31 provide a passageway through which surgical
instruments, saline fluid, drugs or other fluids and/or devices can
be delivered to the target site. Similarly, tissue samples, fluid
samples, implants or related devices or fluids can also be removed
from the target area through the ports 26 and associated lumen 28
of the device.
[0029] Attached to the distal end 36 of the delivery/access section
16 is the elongate portion 18. The inner diameter of the elongate
portion 18 should be large enough to adequately support the various
lumens and components housed within the elongate portion 18 of the
device 10. Furthermore, the external or outer diameter of the
elongate portion 18 should be sized and configured such that it can
be easily inserted through the urethra and into the bladder of the
patient. In one embodiment, the inner and outer diameters of the
elongate portion 18 are approximately within the range of 0.24 to
0.34 inch (0.60 to 0.87 cm) and 0.26 to 0.37 inch (0.67 to 0.93
cm), respectively. In addition, the length of the elongate portion
18 is about 3.94 to 9.84 inches (10 to 25 cm). The segment of
elongate portion 18 extending beyond the delivery/access section 16
must be of optimal length, such as that within a range of
approximately 7.08 to 7.48 inches (18 to 19 cm), to allow the
distal end 30 of the device 10 to access a target site within the
bladder of a patient during photodynamic coagulation therapy or a
similar procedure.
[0030] To minimize potential damage to surrounding tissues when the
device is inserted into the body cavity during a procedure, the
outer surface of the elongate portion 18 is relatively smooth.
Further, since the elongate portion 18 will contact the body, its
material should be biocompatible and non-toxic. In a preferred
embodiment, the material of the elongate portion 18 is stainless
steel. However, other metallic and semi-flexible polymer materials,
such as acetal or polytetrafluoroethylene, may also be used. In
general, the structure of the elongate portion 18, whether rigid,
semi-rigid or flexible, is configured to provide sufficient
rigidity to withstand the forces and pressures exerted on it during
a medical procedure.
[0031] Adjacent to the proximal end 38 of the delivery/access
section 16 is the light source segment 14. In one embodiment, the
light source segment 14 connects to a lumen 33, for example a
waveguide lumen, housed within the elongate portion 18 of the
device 10. As shown in FIG. 2, the distal end 40 of the waveguide
lumen 33 coincides with the tip 34 of the elongate portion 18. In
an alternate embodiment, shown in FIG. 3, the light source segment
14 attaches to an optical fiber 42 that is used as a conduit to
transmit light from the associated light source (not shown) to the
distal end 30 of device. The optical fiber 42 may be movable or
fixedly positioned within the elongate portion 18 of the device
10.
[0032] The light source segment 14 houses the light source that
provides the required therapeutic energy or light to treat
incontinence and other related disorders. Alternatively, the light
source segment 14 can be used as a connection mechanism that
couples the device 10 of the present invention to a separate and/or
stand-alone source of light. Different types of light sources can
be used so as to achieve a variety of energy levels and
distributions useful in treating incontinence disorders. Both
incoherent and coherent light sources, such as a flash lamps,
toroidal flashlamps, flash tubes, lasers (including holmium,
neodynium:yttrium-aluminum-garnet (i.e. Nd:YAG), CO.sub.2), arc
lamps, light emitting diodes (LED), halogen lamps (such as tungsten
halogen lamps) and other light sources may be used. In addition,
the light can be pulsed or continuous wave and may be in any
suitable spectrum, including visible (such as white light) and
infrared. In a preferred embodiment, the device 10 comprises a
tungsten halogen lamp light source with an energy dosage of
approximately 100 J/cm.sup.2. In addition, the light is pulsed at a
pulse timing that varies between the range of approximately 1.0
microsecond to 1.0 millisecond. However, the particular
characteristics of the light emitted from the light source, such as
wavelength, frequency, amplitude, etc., depend upon and can be
customized to the particular treatment and procedure.
[0033] Based upon the type of light source used and the desired
treatment or diagnostic procedure, the light source segment 14 may
also include one or more light attenuating devices/components to
modify beam profile and intensity. Examples of such components
include, but are not limited to, filters, gratings, apertures,
knife edges, filter wheels, prisms, pin holes, lenses and other
similar devices. The components may be positioned at various
locations either internal or external to the light source segment
14. For example, in one embodiment, a filter and lens are housed
within the light source segment 14 and located distal to the light
source. In an alternate embodiment, a filter and light source are
housed within the light source segment 14 and a lens is located at
the distal end of the elongate portion 18. In yet another
embodiment, the light source segment 14 includes multiple lenses
that can be either manually or automatically moved into and out of
the beam to modify the spectrum and intensity of light. Other
optical components and device configurations, though not
specifically described herein, are also included within the scope
of the claimed invention.
[0034] In another embodiment of the invention shown in FIG. 4, an
incoherent light source 44, such as a pulsed flashlamp, is housed
within the light source segment 14 of the device 10. The flashlamp
assembly comprises an arc lamp 46 and a proximally located
reflector 48 used to maximize the energy directed toward the distal
end 50 of the light source segment 14. The configuration of the
reflector 48 may be parabolic, circular or other related shapes. A
filter 52 situated between the flashlamp 46 and distal end 50 of
the light source segment 14 transmits a selected application of
desired wavelength of light to the target site within the bladder
(not shown). In addition, an iris 54 is mounted near the junction
of the light source segment 14 and the delivery/access section 16
of the device 10. The iris 54 functions to collimate the output of
the flashlamp 46 for delivery through the fiber 42 or lumen 33 of
the elongate portion 18 and onto the target site. Thus, the
non-implantable device provides controlled density, filtered pulsed
light output to the specific area for treatment.
[0035] In an alternate embodiment of the invention utilizing an
incoherent light source (not shown), a reflector 48 is disposed
around the incoherent light source and at least one optical fiber
or light guide. The fiber has a first end disposed within the
reflector 48 and a second end located at the distal end of the
elongate portion 18. The first end of the fiber collects the light
from the circular lamp. The light travels through the optical fiber
and is emitted from the second end of the fiber onto the target
site.
[0036] In another embodiment of the invention, shown in FIG. 5, the
light source 44 is any light emitting device housed within or
coupled to an integrating sphere 56. The integrating sphere 56
evenly distributes the radiant light uniformly over the entire
sphere's inner surface 58. The particular spectral distribution of
light exiting the sphere 56 is dependent upon the light source 44
and reflectance of the sphere material. The light spectrum can be
tailored to the desired shape by using filters or a variable
shutter, as is well known in the art. Further, multiple sources can
also be mixed in the sphere 56 to produce a selected uniform output
level corresponding to the desired treatment or procedure.
[0037] In an alternate embodiment, shown in FIGS. 6A and 6B, the
non-implantable device 10 comprises a viewing assembly 60 and an
elongate portion 62. The viewing assembly 60 is structurally and
functionally similar to the viewing assembly 12 detailed above. The
elongate portion 62 of the device 10 includes one or more lumen,
including a viewing lumen 64 connected to the viewing assembly 62.
A steering means, for example a guide wire 66, extends along the
length of the elongate portion 62 and is used to maneuver the
elongate portion 62 to the target site in the patient. Located at
the distal end 68 of the elongate portion 62 is the light source
segment 70. The light source segment 70 is of a sufficiently small
size and configuration so that it can be inserted through the
urethra of the patient. A light source 72 housed within the light
source segment 70 delivers light having a predefined wavelength
that effectively treats urologic disorders.
[0038] Referring to FIG. 6B, the housing 74 of the light source
segment 70 includes an opening 76 through which light can be
directly transmitted to the treatment site. In addition, a light
source 72 and, optionally, a filter 78 are also contained within
the housing 74. Depending upon the desired treatment, a variety of
light sources 72, filters 78 and other optical components, as
previously described, may be used to customize the wavelength of
the coagulation device.
[0039] Method of Use
[0040] The present invention also contemplates a method of using
the non-implantable device 10 to treat incontinence and various
urological disorders. The non-implantable device 10 can be utilized
for performing both diagnostic and therapeutic procedures. In a
preferred embodiment, the elongate portion 18 of the
non-implantable device 10 is gently inserted through the urethra 80
and into the bladder 82 of a patient. Referring to FIG. 7, the
elongate portion 18 is advanced within the bladder until the tip 84
of the device 10 is positioned near the target site.
[0041] Throughout the procedure, the operator of the device 10 uses
the viewing assembly 12 to accurately maneuver the device 10 and
identify the location of the target site within the bladder. The
non-implantable device 10 is positioned adjacent the treatment area
such that the tip 84 through which light emerges is sufficiently
close to the treatment site. Correct placement of the tip 84 allows
light to be precisely focussed onto the desired target site or
vessel.
[0042] After the tip 84 is properly positioned, the device 10 is
then activated to selectively deliver light to the target site. The
particular characteristics of the light, such as wavelength,
frequency, amplitude, etc., depend upon the desired treatment and
procedure. The variable pulsing characteristics and wavelength
spectrum of the device 10 allow an operator of the device 10 to
customize treatment parameters according to target site location,
condition and desired results. Upon completion of the photodynamic
treatment, the device 10 is removed from the bladder and urethra of
the patient.
[0043] In one embodiment, the device 10 of the present invention is
used to treat urinary frequency syndrome. Conventional cystoscopy
procedures have shown a correlation between proliferation of
superficial submucosal bladder vessels of approximately 0.1 mm in
diameter, with or without inflammation, and urinary frequency
syndrome. Reducing superficial urinary bladder vessels causes
reduced bladder hyperemia and associated symptoms, including
inflammation. As such, the device 10 of the present invention is
used to selectively ablate and, thereby, reduce these vessels.
Pulsed unit energy or laser energy in a wavelength that is absorbed
by the blood vessels is delivered to the target site according to
the above described procedure. Since the light energy is only
absorbed by the blood vessels, there is no damage to or significant
heating of the surrounding tissue.
[0044] In another embodiment, the non-implantable device 10 is used
to selectively occlude blood vessels, including bleeding blood
vessels, within the urinary tract. This procedure is generally
performed in combination with cystopic bladder tumor resection.
During cystopic bladder tumor resection, the elongate portion 18 of
the device 10 is inserted through the urethra 80 and into the
bladder 82 of a patient. The elongate portion 18 is advanced within
the bladder 82 until the tip 84 of the device 10 is positioned near
the target site/tumor. A type of snare device (not shown) is
inserted into a port 26 of the device 10, guided through the
elongate portion 18 and positioned adjacent the tumor. The snare
device is then manipulated so as to tightly lasso the tumor around
the lower stalk of the tumor near the bladder wall. With the snare
device properly positioned around the tumor, an electrosurgical
current is delivered through the snare device thereby severing the
tumor mass from the bladder wall. The snare device and tumor are
then withdrawn from the treatment site. To minimize or eliminate
post-resection bleeding, the non-implantable device 10 is activated
to selectively deliver light to the open blood vessels. As such,
light emitted from the non-implantable device 10 selectively
coagulates the target vessels, thereby eliminating the need to
electrocauterize surrounding tissue. Upon completion of the
procedure, the non-implantable device 10 is removed from the
bladder 82 and urethra 80 of the patient.
[0045] In an alternate embodiment, the non-implantable device 10
may also be used to treat hematuria, i.e. the presence of red blood
cells (RBC) in the urine. Hematuria often arises due to diffused
small blood vessels bleeding in the superficial mucosa. This
condition generally occurs after radiation or systemic chemotherapy
or in blood coagulation disorders. Similar to the above-described
procedure, the non-implantable device 10 is inserted through the
urethra 80 and into the bladder 82. The areas of the bladder wall
to be treated are identified via the optics of the device 10. After
the distal end of the elongate portion 18 of the device 18 is
properly positioned near the target site, photocoagulation of the
superficial blood vessels is performed. Upon completion of the
procedure, the non-implantable device 10 is removed from the
bladder 82 and urethra 80 of the patient.
[0046] In another embodiment, the device 10 of the present
invention is used to treat detrusor hyperactivity. A method for
reducing muscle activity and superficial neural receptors within
the bladder wall, especially on the bladder neck, involves reducing
the blood supply to these tissues. This is achievable by
coagulating the superficial blood vessels that supply blood to the
cells. For this procedure, the elongate portion 18 of the
non-implantable device 10 is positioned near the target site, i.e.
superficial blood vessel, according to the above described method.
The device 10 is activated to emit light onto the target site. The
wavelength spectrum and pulsing characteristics of the light are
customized so that the light is only absorbed by the blood in the
vessels. As a result, the hemoglobin, found in red blood cells that
flow within the superficial vessels, absorbs the light and reacts
to coagulate the blood, thereby blocking the vessels. Thus, the
superficial blood vessels are selectively and intravesically
coagulated via heat treatment, without causing damage to the
surrounding tissue yet resulting in reduced detrusor
hyperactivity.
[0047] The above described device and procedures can also be used
to ablate, occlude or photocoagulate select vessels or target sites
for treatment of urethral, prosthetic, ureteral and renal pelvis
disorders, such as tumors or transitional cell carcinoma. The
preferred method is to directly treat the vessels of interest using
light delivered by the non-implantable device 10 of the present
invention. In addition, fluids, such as saline, water, chemical
agents, etc., or gases may be used in conjunction with the device
10 to alter the treatment method. For example, in cases of active
bleeding, elevating bladder pressure by filling the bladder with
water may temporarily stop vessel bleeding, allowing easy selective
thermolysis of the vessels.
[0048] In addition to providing an effective means of treating
urological disorders, the device 10 and method of use of the
present invention effectively reduce pain, infections and post
operative hospital stays. Further, the various treatment methods
also improve the quality of life for patients.
[0049] Although the invention has been described in terms of
particular embodiments and applications, one of ordinary skill in
the art, in light of this teaching, can generate additional
embodiments and modifications without departing from the spirit of
or exceeding the scope of the claimed invention. Accordingly, it is
to be understood that the drawings and descriptions herein are
proffered by way of example to facilitate comprehension of the
invention and should not be construed to limit the scope
thereof.
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