U.S. patent application number 10/196504 was filed with the patent office on 2002-12-05 for ablation of rectal and other internal body structures.
Invention is credited to Edwards, Stuart D., Marcus, Steven V..
Application Number | 20020183735 10/196504 |
Document ID | / |
Family ID | 24227709 |
Filed Date | 2002-12-05 |
United States Patent
Application |
20020183735 |
Kind Code |
A1 |
Edwards, Stuart D. ; et
al. |
December 5, 2002 |
Ablation of rectal and other internal body structures
Abstract
The invention provides an apparatus and system for ablation of
body structures or tissue in the region of the rectum. A catheter
is inserted into the rectum, and an electrode is disposed thereon
for emitting energy. The environment for an ablation region is
isolated or otherwise controlled by blocking gas or fluid using a
pair of inflatable balloons at upstream and downstream locations.
Inflatable balloons also serve to anchor the catheter in place. A
plurality of electrodes are disposed on the catheter and at least
one such electrode is selected and advanced out of the catheter to
penetrate and ablate selected tissue inside the body in the region
of the rectum. The electrodes are coupled to sensors to determine
control parameters of the body structure or tissue, and which are
used by feedback technique to control delivery of energy for
ablation or fluids for cooling or hydration. The catheter includes
an optical path disposed for coupling to an external view piece, so
as to allow medical personnel to view or control positioning of the
catheter and operation of the electrodes. The catheter is disposed
to deliver flowable substances for aiding in ablation, or for
aiding in repair of tissue, such as collagen or another substance
for covering lesions or for filling fissures. The flowable
substances are delivered using at least one lumen in the catheter,
either from at least one hole in the catheter, from an area of the
catheter covered by a microporous membrane, or from microporous
balloons.
Inventors: |
Edwards, Stuart D.; (Portola
Valley, CA) ; Marcus, Steven V.; (Los Altos,
CA) |
Correspondence
Address: |
GLENN PATENT GROUP
3475 EDISON WAY
SUITE L
MENLO PARK
CA
94025
US
|
Family ID: |
24227709 |
Appl. No.: |
10/196504 |
Filed: |
July 15, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10196504 |
Jul 15, 2002 |
|
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|
09557993 |
Apr 25, 2000 |
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6419673 |
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Current U.S.
Class: |
606/32 ;
606/41 |
Current CPC
Class: |
A61B 18/18 20130101;
A61B 2018/00636 20130101; A61B 2018/00744 20130101; A61B 2018/00702
20130101; A61B 17/24 20130101; A61B 18/1477 20130101; A61B 2017/306
20130101; A61B 2018/00666 20130101; A61B 2018/00708 20130101; A61B
2017/00084 20130101; A61B 18/20 20130101; A61B 2018/00761 20130101;
A61B 2018/00261 20130101; A61B 18/1402 20130101; A61B 2018/00577
20130101; A61B 18/1815 20130101; A61B 2018/00065 20130101; A61B
2018/1425 20130101; A61N 1/06 20130101; A61B 2017/22077 20130101;
A61B 18/1492 20130101; A61B 2018/00023 20130101; A61B 2018/00553
20130101; A61B 2218/003 20130101; A61B 2017/00296 20130101; A61B
2018/00898 20130101; A61B 2018/00773 20130101; A61B 2018/00886
20130101; A61B 2017/00026 20130101; A61B 90/361 20160201; A61B
2090/3782 20160201; A61B 2018/00982 20130101; A61B 2018/00547
20130101; A61M 2025/0096 20130101; A61B 2018/00678 20130101; A61B
18/04 20130101; A61N 1/403 20130101; A61B 2018/00791 20130101; A61B
2018/00101 20130101; A61B 2017/22067 20130101; A61B 18/1485
20130101; A61B 2018/00285 20130101; A61B 2018/00196 20130101; A61B
2018/00214 20130101; A61B 2018/00011 20130101; A61B 2018/00327
20130101; A61B 2018/00875 20130101 |
Class at
Publication: |
606/32 ;
606/41 |
International
Class: |
A61B 018/14 |
Claims
We claim:
1. A method for ablating a structure within a body, said method
including the steps of: inserting a catheter into a region of said
body; isolating said region from gas or fluid from outside said
region; emitting, from an electrode coupled to said catheter into
said region, an effective amount of energy to ablate said
structure.
2. A method as in claim 1, wherein said region is in or near the
sphincter, rectum, colon, or prostate.
3. A method as in claim 1, wherein said structure includes a cyst,
hemorrhoid, polyp, tumor, or lesion.
4. A method as in claim 1, wherein said energy includes RF energy
having a frequency between about 435 megahertz and about 485
megahertz.
5. A method as in claim 1, wherein said step of emitting is
conducted for less than about 10 minutes.
6. A method as in claim 1, including the step of advancing said
electrode from within said catheter to a point inside a selected
mass of tissue within said region.
7. A method as in claim 1, wherein said step of isolating includes
the step of blocking gas or fluid from entering said region using
at least one balloon.
8. A method as in claim 7, wherein said at least one balloon
includes a balloon disposed at an upstream location or disposed at
a downstream locations from said region.
9. A method as in claim 7, wherein said step of isolating includes
the step of inflating said at least one balloon.
10. A method as in claim 7, including the step of anchoring said
catheter in a selected location using said at least one
balloon.
11. A method as in claim 1, including the step of anchoring said
catheter in a selected location.
12. A method as in claim 11, wherein said step of anchoring
includes the step of disposing at least one balloon against a wall
of said region.
13. A method as in claim 1, including the steps of: sensing at
least one control parameter of said region; and controlling said
step of emitting using a feedback technique including said control
parameter.
14. A method as in claim 1, including the step of delivering a
flowable substance to said region.
15. A method as in claim 14, including the steps of: sensing at
least one control parameter of said region; and controlling said
step of delivering using a feedback technique including said
control parameter.
16. A method as in claim 14, wherein said flowable substance
includes an effective amount of fluid to cool said region to a
selected temperature.
17. A method as in claim 14, wherein said flowable substance
includes an effective amount of fluid to rehydrate a selected mass
of tissue in said region.
18. A method as in claim 14, wherein said flowable substance
includes saline.
19. A method as in claim 14, wherein said flowable substance
includes an antibiotic.
20. A method as in claim 14, wherein said flowable substance
includes collagen.
21. A method as in claim 14, wherein said flowable substance
includes a substance for covering or filling a selected structure
within said region.
22. A method as in claim 14, wherein said step of delivering
includes exuding said flowable substance from at least one hole in
said catheter.
23. A method as in claim 14, wherein said step of delivering
includes exuding said flowable substance from a microporous
membrane.
24. A method as in claim 14, wherein said step of delivering
includes exuding said flowable substance from a balloon having a
microporous membrane.
25. A method as in claim 1, including the step of coupling light
from said region to a point outside the body, whereby an operator
is able to view said region.
26. A method as in claim 1, including the steps of: receiving light
from said region representative of a view of said region; and
controlling an orientation or position of said catheter responsive
to said view.
27. A method for treatment of a sphincter in a body, comprising the
following steps: providing RF energy from a source coupled to a
catheter; disposing said catheter in a region of said body near
said sphincter; delivering said RF energy from said catheter to a
tissue of said sphincter in an amount effective for treatment of
said tissue.
28. A method as in claim 27, wherein said sphincter is a lower
esophogeal sphincter, a GI sphincter, a rectum, a colon, a blood
vessel, an organ, a urethra, a vagina, a prostate.
29. A method as in claim 27, wherein at least a portion of said
region is a cavity in said body.
30. A method as in claim 29, wherein said cavity is an element of a
gastrointestinal tract, a vascular system, a circulatory tract, a
uro-genital tract, a pulmonary system, a lymphatic tract, or an
organ.
31. A method as in claim 27, wherein at least a portion of said
tissue is an esophogeal varice, a hemorrhoid, a cyst, a polyp, a
tumor, or a lesion.
32. A method as in claim 27, wherein said effective amount of RF is
effective to heat at least a portion of said tissue, to ablate at
least a portion of said tissue, to destroy at least a portion of
said tissue, or to contract at least a portion of said tissue.
33. A method as in claim 27, including: providing a substance
effective to treat said tissue; providing said substance from a
source coupled to said catheter; and delivering said substance from
said catheter to said tissue in an amount effective to treat said
tissue.
34. A method as in claim 33, wherein said substance comprises a
flowable substance, a medicament, a saline solution, an astringent,
a collagenous fluid or other bulking agent, a bio-active substance,
a chemo-active substance, a radioactive substance, or a sclerosing
agent.
35. A method as in claim 1, wherein said region is in or near a
ligament, bone or cartilage.
36. A method as in claim 1, wherein said energy includes microwave,
infrared, ultraviolet, visible and invisible laser, visible and
invisible light.
37. A method as in claim 27, wherein said sphincter is in or near
ligament, bone or cartilage.
38. A method as in claim 27, wherein at least a portion of said
tissue is a ligament, bone or cartilage.
39. A method as in claim 29, wherein said cavity is an element of a
ligament, bone or cartilage.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 09/557,993, filed Apr. 25, 2000 (Attorney Docket No.
STUA0012C).
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to ablation of rectal and other
internal body structures.
[0004] 2. Description of Related Art
[0005] Human beings are subject to a number of disorders in the
area of the rectum and colon, including hemorrhoids (external and
internal), prolapse of the rectal muscles, rectal muscle spasms,
anal fissures, polyps, diverticulosus and diverticulitus, and
pilonital cysts. Other internal disorders in nearby regions of the
body include (in men) prostate cancer, (in women) incontinence,
vaginal bleeding, vaginal cysts, vaginal fibroids, prolapse of the
uterus, and related tumors or cancerous tissue.
[0006] Although there are treatments available for these disorders,
such as surgery, systemic or topical medication, these treatments
suffer from various drawbacks, including (for surgery) their
relative invasiveness and expense, and (for medicinal approaches)
their relative ineffectiveness and the causation of serious
side-effects. Accordingly, it would be advantageous to provide
methods and apparatus for treatment which are not subject to the
drawbacks of surgery and medicinal approaches.
[0007] Although it is known to use RF energy to ablate tissue in
the body (such as heart muscle tissue) to treat disorders, one
problem which has arisen in the art is accounting for the flow of
bodily fluids and gases while ablating tissue. Bodily fluids can
dissipate, and can detrimentally absorb, energy to be applied to
tissue.
[0008] Accordingly, it would be advantageous to provide improved
techniques for treatment of disorders in the area of the rectum and
colon. This advantage is achieved by a method and system according
to the present invention in which a catheter is inserted into the
rectum, and at least one electrode is disposed thereon for emitting
energy to ablate body structures or other tissue in an ablation
region in or near the rectum, such as the sphincter, rectum, colon,
or prostate.
SUMMARY OF THE INVENTION
[0009] The invention provides a method and system for ablation of
body structures or tissue in an ablation region in or near the
rectum (such as the sphincter, rectum, colon, or prostate). A
catheter is inserted into the rectum, and at least one electrode is
disposed thereon for emitting energy to ablate body structures or
other tissue, such as by cell death, dehydration, or denaturation.
The environment for the ablation region is isolated or otherwise
controlled, such as by blocking gas or fluid using a pair of
inflatable balloons at upstream and downstream locations from the
ablation region. In a preferred embodiment, inflatable balloons
also serve to anchor the catheter in place and prevent the catheter
from being expelled from the body.
[0010] In preferred embodiments, the catheter is flexible for
reaching a selected internal organ or region, a plurality of
electrodes are disposed on the catheter and at least one such
electrode is selected and advanced out of the catheter to penetrate
and ablate selected tissue inside the body in ablation region in or
near the rectum, such as an individual cyst, hemorrhoid, polyp,
tumor, or other selected lesion or tissue. The electrodes are
coupled to sensors to determine control parameters of the body
structure or tissue, such as impedance or temperature, and which
are used by feedback technique to control delivery of energy for
ablation or fluids for cooling or hydration. In a preferred
embodiment, the catheter includes an optical path disposed for
coupling to an external view piece, so as to allow medical
personnel to view or control positioning of the catheter and
operation of the electrodes.
[0011] In further preferred embodiments, the catheter is disposed
to deliver flowable substances for aiding in ablation, such as
saline or antibiotics, or for aiding in repair of tissue (either
before or after ablation), such as collagen or another substance
for covering lesions or for filling fissures in or near the
ablation region, or for other medicinal effects, such as
anesthetic, anti-inflammatory, or antispasmodic substances. The
flowable substances are delivered using at least one lumen in the
catheter, either from at least one hole in the catheter, from an
area of the catheter covered by a microporous membrane, or from
microporous balloons (either the same as or in addition to balloons
used to anchor the catheter in place or to block gas or fluid).
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIGS. 1 and 1a show a side view of a catheter and electrode
assembly.
[0013] FIGS. 2 and 2a show a cut-away view of a catheter and
electrode, taken along a line 2--2 in FIG. 1.
[0014] FIG. 3 shows a method of treatment of a hemorrhoid.
[0015] FIG. 4 shows a method of treatment of a prolapsed or
spasmodic muscle.
[0016] FIG. 5 shows a method of treatment of an anal fissure.
[0017] FIG. 6 shows a method of treatment of a tumor in the
prostate.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0018] Catheter and Electrode Assembly
[0019] FIG. 1 shows a side view of a catheter and electrode
assembly.
[0020] An assembly 100 for ablating rectal and other internal body
structures includes a catheter 110, a control and delivery linkage
120, and a control element 130.
[0021] The catheter 110 is coupled to the control and delivery
linkage 120 using a gearing element 121, which allows the catheter
110 to be rotated with respect to the control and delivery linkage
120 by an operator using the control element 130.
[0022] The catheter 110 includes a base 111, having a substantially
cylindrical shape, coupled at a proximal end to the gearing element
121, and having a distal end. The catheter 110 is preferably
disposed for insertion into the rectum at an angle to the control
and delivery linkage 120, preferably an angle between about
30.degree. and about 45.degree. less than a right angle. The
catheter 110 is between about 1 inch (2.54 cm) and about 2 inches
(5.08 cm) in diameter, and between about 6 inches (15.24 cm) and
about 8 inches (20.32 cm) in length.
[0023] The catheter 110 includes a plurality of holes 112, and a
plurality of electrodes 113 which may be extended from at least
some of the holes 112. The holes 112 are spaced regularly around
the circumference and along the length of the catheter 110, having
a spacing of about 0.25 inches (0.64 cm) between adjacent holes
112. The electrodes 113 are spaced regularly to occupy about
one-half of the holes 112, and are between about 0.5 cm and about
1.0 cm in length.
[0024] The electrodes 113 each include a metallic tube 114 defining
a hollow lumen 115, shaped similarly to an injection needle, so as
to be disposed to deliver at least one flowable substance to a
region 140 near the catheter 110. In a preferred embodiment, the
deliverable flowable substance includes saline with a concentration
of less than about 10% NaCl, which aids in both hydration of body
structures and other tissue, and in delivery of RF energy to the
region 140. However, in alternative embodiments, the deliverable
flowable substance includes other substances, including saline with
other concentrations, systemic or topical antibiotics, collagen or
another hardenable substance, or other bioactive, chemoactive, or
radioactive substances (including anesthetic, anti-inflammatory, or
antispasmodic substances, or tracer materials).
[0025] The catheter 110 includes at least one balloon 116, disposed
for inflation so as to block gas or fluid from the body from
entering the region 140. In a preferred embodiment, there is a
distal balloon 116 disposed at the distal end of the catheter 110
and there is a proximal balloon 116 disposed at the proximal end of
the catheter 110. The distal balloon 116 and the proximal balloon
116 preferably each comprise ring-shaped balloons, disposed so that
when inflated each surrounds the catheter 110 and makes a gas-tight
or fluid-tight seal, both with the catheter 110 and with a wall 141
of the rectum or other body structure into which the catheter 110
is inserted. However, in alternative embodiments, the distal
balloon 116 may comprise a spherical or ellipsoidal balloon
disposed at the distal end of the catheter 110 in such manner that
when inflated it surrounds the catheter 110 and makes a gas-tight
or fluid-tight seal with the wall 141.
[0026] The catheter 110 also includes at least one balloon 116
disposed to anchor the catheter 110 at a selected location within
the rectum or other body structure into which the catheter 110 is
inserted. In a preferred embodiment, the balloon 116 used to anchor
the catheter 110 is the proximal balloon 116, which when inflated
prevents the catheter 110 from being expelled from the body in like
manner as the operation of a Foley catheter. However, in
alternative embodiments, the balloon 116 used to anchor the
catheter 110 may comprise an additional or alternative balloon
which is disposed solely or primarily for the purpose of anchoring
the catheter 110 into its selected place, again in like manner as
the operation of a Foley catheter.
[0027] The catheter 110 includes a fluid circulation system 117,
including at least one fluid outlet port and at least one fluid
inlet port. The fluid circulation system 117 is disposed for
providing fluid in the region near the catheter 110, such as for
delivering fluid for cooling the region 140 and for removing other
fluid for aspirating the region 140.
[0028] The catheter 110 includes an optical view port 118, possibly
including a lens or other transparent or translucent covering,
disposed to allow inflow of light (visible or infrared) for
transmission to an operator for viewing and control of the
operation of the catheter 110.
[0029] The catheter 110 includes at least one sensor 119, such as a
sensor 119 for impedance or temperature. In a preferred embodiment,
the temperature sensor 119 includes a thermocouple, but in
alternative embodiments, the temperature sensor 119 may include a
thermistor or other device for sensing temperature and providing
signals responsive to temperature near the catheter 110.
[0030] The control and delivery linkage 120 includes a metallic
tube 223 defining a hollow lumen 224, and is further described with
reference to FIG. 2.
[0031] In a preferred embodiment, the control and delivery linkage
120 is between about 1/2 inch (1.27 cm) and about 5/8 inches (1.59
cm) in diameter, and between about 6 inches (15.24 cm) and about 8
inches (20.32 cm) in length.
[0032] The control element 130 includes an electrode actuation
element 131 for advancing the electrodes 113 out from the catheter
110, a electrode retraction element 132 for retracting the
electrodes 113 into from the catheter 110, and an operation element
133 for controlling operation of the catheter 110, including
delivery of flowable substances using the holes 112 and delivery of
energy using the electrodes 113.
[0033] Advancing and Retracting Electrodes
[0034] FIG. 2 shows a cut-away view of a catheter, taken along a
line 2--2 in FIG. 1.
[0035] The catheter 110 comprises a rotatable element 210 which is
disposed for rotation in a first direction 211 to advance the
electrodes 113 out of the catheter 110 and in a second direction
212 opposite the first direction 211 to retract the electrodes 113
back into the catheter 110.
[0036] In a preferred embodiment, the rotatable element 210 is
coupled to a spring (not shown) or other device which holds the
rotatable element 210 in a steady state with the electrodes 113
retracted into the catheter 110.
[0037] The rotatable element 210 is coupled to the electrode
actuation element 131, which forces the rotatable element 210 to
rotate in the first direction 211 so as to advance the electrodes
113 out of the catheter 110. When the actuator element is not
actuated, the spring causes the rotatable element 210 to rotate in
the second direction 212 so as to retract the electrodes 113 back
into the catheter 110.
[0038] Each electrode 113 is coupled to an electrode carrier 220.
In a preferred embodiment, each electrode carrier 220 is
substantially bar-shaped (but is shown end-on in the figure) and is
coupled to a plurality of electrodes 113, such as about between
about three and about six electrodes 113, so as to substantially
simultaneously advance that plurality of electrodes 113 out of the
catheter 110 and retract that plurality of electrodes 113 back into
the catheter. A plurality of electrode carriers 220 are each
disposed in a set of lines corresponding to lines of electrodes 113
disposed for advancement out of the catheter 110 and retraction
back into the catheter 110.
[0039] In a preferred embodiment, the electrodes 113 may be
disposed so that when advanced, the electrodes 113 extend to
selected depths within the body structure to be ablated. These
selected depths may be the same depth for all electrodes 113 which
are advanced, or may include a first depth for a first set of
electrodes 113 and a second depth for a second set of electrodes
113.
[0040] In a preferred embodiment, the electrode carriers 220 are
coupled to a set of controls (not shown) in the control element 130
for selecting one or more electrode carriers 220 independently
using one or more actuation levers 221, so as to be able to
independently advance one or more sets of electrodes 113 coupled
thereto out of the catheter 110 and to independently retract one or
more sets of electrodes 113 back into the catheter 110.
[0041] Each electrode carrier 220 is coupled to the rotatable
element 210 using a bearing 222, in such manner so as to translate
rotation of the rotatable element 210 into linear radial movement
of the electrodes 113. When the rotatable element 210 is rotated in
the first direction 211, the electrodes are advanced in a first
linear movement 223, while when the rotatable element 210 is
rotated in the second direction 212, the electrodes are retracted
in a second linear movement 224.
[0042] An interior 230 of the rotatable element 210 includes a
lumen 225 through which fluids and other flowable substances are
provided, and in which conductors providing control signals and
sensor signals are disposed.
[0043] Operation of the Catheter and Electrode Assembly
[0044] Operation of the catheter and electrode assembly 100
includes at least the following steps:
[0045] The catheter 110 is inserted into the body at an opening,
such as the rectum.
[0046] In a preferred embodiment, the opening is the rectum. A
region of the rectum is first infused with a lubricant, such as K-Y
jelly, and with an anesthetic, such as lidocaine. An
anti-inflammatory, antispasmodic, or other condign medication would
also be applied as appropriate. Thereafter, the catheter 110 is
inserted into the lubricated region of the rectum. Due to the
potential pain induced by the presence of the catheter 110 or
electrodes 113, during operation the catheter 110 infuses a mixture
of saline and lidocaine into the region 140 to be ablated.
[0047] In alternative embodiments, the opening may be another
opening into the body, such as a natural orifice such as the vagina
or the urethra, or an opening which has been made surgically, such
as an incision which allows the catheter 110 to be inserted into a
blood vessel.
[0048] The preferred size of the catheter 110 will of course be
responsive to the size of the opening if other than the rectum. The
choice of medicinal elements to be infused prior to or coeval with
the catheter 110 will of course be responsive to judgments by
medical personnel, and may include lubricants, anesthetics,
antispasmodics, antiinflammatories, antibiotics, or other materials
with bioactive, chemoactive, or radio-active effect.
[0049] The catheter 110 is positioned within the body at a selected
orientation and location, such as a position near a hemorrhoid.
[0050] In one preferred embodiment, the catheter 110 is positioned
in the rectum near an eternal or internal hemorrhoid, in a manner
as shown in FIG. 3. In this preferred embodiment, the electrodes
113 are ultimately advanced into the hemorrhoid to ablate the
hemorrhoid.
[0051] In another preferred embodiment, the catheter 110 is
positioned in the rectum near a prolapsed or spasmodic muscle, in a
manner as shown in FIG. 4. In this preferred embodiment, the
electrodes 113 are ultimately advanced into the prolapsed or
spasmodic muscle to ablate selected portions of the prolapsed or
spasmodic muscle.
[0052] In another preferred embodiment, the catheter 110 is
positioned in the rectum near an anal fissure, in a manner as shown
in FIG. 5. In this preferred embodiment, collagen is deposited into
the fissure and the electrodes 113 are ultimately advanced into a
region near the collagen to harden the collagen for filling the
fissure.
[0053] In another preferred embodiment, the catheter 110 is
positioned in the colon near a polyp, in a manner similar to that
shown in FIG. 3. In this preferred embodiment, the electrodes 113
are ultimately advanced into the polyp to ablate the polyp.
[0054] In another preferred embodiment, the catheter 110 is
positioned in the rectum near a pilonital cyst, in a manner similar
to that shown in FIG. 3. In this preferred embodiment, the
electrodes 113 are ultimately advanced into the cyst to ablate the
cyst.
[0055] In another preferred embodiment, the catheter 110 is
positioned in the rectum, colon, large intestine, or small
intestine, near a cyst or tumor, in a manner similar to that shown
in FIG. 3. In this preferred embodiment, the electrodes 113 are
ultimately advanced into the cyst or tumor to ablate the cyst or
tumor.
[0056] In another preferred embodiment, the catheter 110 is
positioned in a male patient, in the rectum near the prostate, in a
manner as shown in FIG. 6. In this preferred embodiment, the
electrodes 113 are ultimately advanced into a tumor in the prostate
to ablate the tumor.
[0057] In another preferred embodiment, the catheter 110 is
positioned in a female patient, in the vagina, near a cyst or
fibroid, in a manner similar to that shown in FIG. 3. In this
preferred embodiment, the electrodes 113 are ultimately advanced
into the cyst or fibroid to ablate the cyst or fibroid.
[0058] In another preferred embodiment, the catheter 110 is
positioned in a female patient, in the vagina, near a prolapsed
uterus, in a manner similar to that shown in FIG. 4.
[0059] In this preferred embodiment, the electrodes 113 are
ultimately advanced into the prolapsed uterus selected portions of
the prolapsed uterus.
[0060] The catheter 110 is anchored into place at the selected
orientation and location by inflating a balloon 116, such as the
distal balloon 116 and the proximal balloon 116.
[0061] In embodiments where the catheter 110 is positioned in the
rectum, the catheter 110 is anchored into place using the proximal
balloon 116 and the proximal balloon 116 operates in similar manner
as a Foley catheter.
[0062] In alternative embodiments, the catheter 110 includes a stop
balloon 116, such as a ring balloon (as shown in FIG. 3), disposed
outside the body so as to prevent the catheter 110 from being
inserted "too far", i.e., beyond its selected location.
[0063] The region 140 near the catheter 110 is isolated from the
rest of the body by inflating the distal balloon 116 and the
proximal balloon 116. In a preferred embodiment, this step uses the
same distal balloon 116 and the proximal balloon 116 as the step of
anchoring the catheter 110 into place.
[0064] Isolation of the region 140 near the catheter 110 from the
rest of the body need not be absolute. In a preferred embodiment,
the distal balloon 116 and the proximal balloon 116 are
microporous, are inflated using saline or water, and thus are
disposed to provide saline or water into the region 140 near the
catheter 110. However, in such an embodiment, gas and fluids from
the rest of the body are allowed to leak into one or more of the
balloons 116 and from there are allowed to leak into the region 140
near the catheter 110.
[0065] Moreover, while in a preferred embodiment the seal made with
the wall 141 of the region 140 by the balloon 116 is gas-tight, in
alternative embodiments, that seal is allowed to be simply
fluid-tight, and might allow gas to leak from the rest of the body
into the region 140 near the catheter 110.
[0066] One or more sets of electrodes 113 are selected for
advancement into a selected mass of tissue in the region 140. The
rotatable element 210 is rotated in the first direction 211,
causing the selected sets of electrodes 113 to advance out of the
catheter 110 and into the selected mass of tissue.
[0067] The selected set of electrodes 113 are just those electrodes
113 which are needed to penetrate the selected mass of tissue for
ablation.
[0068] In a preferred embodiment where the selected mass of tissue
for ablation is a hemorrhoid, the selected set of electrodes 113
are just those electrodes 113 which are needed to penetrate the
hemorrhoid. If a plurality of hemorrhoids are selected for
ablation, either (1) electrodes 113 needed to penetrate the
plurality of hemorrhoids are selected, or (2) electrodes 113 needed
to penetrate one of the hemorrhoids are selected, and the operation
is repeated for each individual one of the hemorrhoids.
[0069] Similarly, in preferred embodiments where the selected body
structure for ablation is an individual cyst, fibroid, polyp, or
tumor, the selected set of electrodes 113 are just those electrodes
113 which are needed to penetrate the selected body structure. If
there is more than one such selected body structure, either (1)
more than one set of electrodes 113 may be selected, or (2) just
one set of electrodes 113 may be selected and the operation is
repeated for each individual such body structure.
[0070] Similarly, in preferred embodiments where the selected body
structure for ablation is muscle tissue or other tissue which is
part of a larger body structure, such as a prolapsed or spasmodic
muscle, the selected set of electrodes 113 are just those one or
more sets of electrodes 113 which are needed to penetrate the
portion of the body structure which has been selected for
ablation.
[0071] Flowable substances are provided using the holes 112, and
energy is provided to the electrodes 113, so as to ablate the mass
of tissue in the region 140.
[0072] In a preferred embodiment, the flowable substances are
provided using the holes 112 to the region 140 near the catheter
110.
[0073] In alternative embodiments, the flowable substances may be
provided, in addition or instead, (1) from an area of the catheter
covered by a microporous membrane, or (2) from one or more
microporous balloons. The microporous balloons may either be the
same as or in addition to the balloons 116 used to anchor the
catheter in place or to block gas or fluid.
[0074] In preferred embodiments, the flowable substances have one
of the following functions: (1) to aid in ablation, such as by
transmitting RF energy from the electrodes 113 to the body
structure to be ablated, as is done by saline or other electrolytic
solutions, (2) to rehydrate tissue, as in done by saline or water,
or (3) to repair tissue, such as by flowing into cysts or fissures
or voids, or by covering lesions, as is done by collagen in a soft
form which can be hardened by RF energy.
[0075] In a preferred embodiment, the electrodes 113 deliver RF
energy having a frequency between about 435 megahertz and about 485
megahertz, for a period between about 5 minutes and about 10
minutes. The RF energy is received by and heats tissue and other
body structures near the electrodes 113, causing ablation by means
of cell death, dehydration, or denaturation.
[0076] In alternative embodiments, the electrodes 113 may deliver
other forms of energy, such as heat, microwaves, or infrared or
visible laser energy.
[0077] The electrodes 113 are controlled by a feedback technique,
using the at least one sensor 119. In embodiments where there is
more than one sensor 119, the feedback technique may be responsive
to each sensor 119.
[0078] In one preferred embodiment, the at least one sensor 119
includes a temperature sensor 119 and the feedback technique
includes a microprocessor (not shown) disposed in or coupled to the
control element 130 and operating under control of application
software for maintaining the temperature of the body structure to
be ablated at a selected temperature, such as a temperature
exceeding between about 90.degree. Celsius and about 120.degree.
Celsius. In this preferred embodiment, the microprocessor also
controls delivery of fluids for cooling or hydration, so as to
maintain the temperature of surrounding tissue (i.e., other than
the tissue selected for ablation) at temperatures less than between
about 90.degree. Celsius and about 120.degree. Celsius.
[0079] In another preferred embodiment, the at least one sensor 119
also includes an impedance sensor 119 and the feedback technique
includes a microprocessor operating to terminate delivery of RF
energy when a measured impedance of the body structure to be
ablated undergoes a substantial change indicative of dehydration or
denaturation.
[0080] One or more sets of electrodes 113 are selected for
retraction back from the selected mass of tissue in the region 140.
The rotatable element 210 is rotated in the second direction 211,
causing the selected sets of electrodes 113 to retract out of the
selected mass of tissue and back into the catheter 110.
[0081] The same electrodes 113 which were advanced out of the
catheter 110 are retracted back into the catheter 110.
[0082] The catheter 110 is withdrawn from the body at the opening
through which it was inserted.
[0083] Before removal, the balloons 116 are deflated so the
catheter 110 is no longer anchored in place, all electrodes 113 are
retracted back into the catheter 110, and the catheter 113 is
configured to no longer provide flowable substances or energy for
ablation.
[0084] Particular Methods and Apparatus for Treatments
[0085] In preferred embodiments, the catheter and electrode
assembly 100 may also be used for treatments in addition to, or
instead of, ablation of body structures or tissue.
[0086] In one preferred embodiment, operation of the catheter and
electrode assembly 100 includes at least the following steps:
[0087] The catheter 110 is inserted into a natural body lumen, such
as the urethra.
[0088] In a preferred embodiment, the natural body lumen comprises
a normally tubular body structure which has prolapsed, is
spasmodic, or is otherwise subject to blockage (partial or
complete) or damage (such as to a wall of the natural body
lumen).
[0089] The catheter 110 infuses a hardenable substance into the
natural body lumen, so as to coat at least one selected section of
the wall of the natural body lumen.
[0090] In a preferred embodiment, the hardenable substance includes
a collagen which is capable of being flowed onto the wall of the
natural body lumen and which is capable of being hardened by
application of RF energy, heat, or another agent to be provided by
the catheter and electrode assembly 100.
[0091] The electrodes 113 are advanced and deliver energy to the
hardenable substance to harden it.
[0092] In a preferred embodiment, the holes 112 provide saline and
the electrodes 113 deliver RF energy to the collagen to harden it,
so as to form a hard covering to the wall of the natural body
lumen. If appropriate, more than one layer of collagen is applied,
so as to provide a hard covering having a thickness exceeding a
selected threshold, such as 0.1 inch (0.25 cm). The particular
selected threshold will of course depend on the preferred diameter
of the natural body lumen.
[0093] In a preferred embodiment for treatment of a prolapsed or
spasmodic muscle, (1) the catheter 110 is inserted and pushed
through a region where the muscle has prolapsed or blocked the
rectum, colon, large intestine, or small intestine, (2) the
prolapsed or spasmodic muscle is partially ablated, and (3)
collagen is infused and hardened to strengthen the muscle wall. In
alternative embodiments, the collagen may be infused before
ablation in one or more boluses deposited within the muscle (or on
the muscle or near the muscle), so that the steps of muscle
ablation and collagen hardening will occur substantially
simultaneously.
[0094] In a preferred embodiment for treatment of an anal fissure,
(1) the catheter 110 is inserted into a region where the fissure
has occurred, (2) a suspension of collagen and saline is infused
and fills the fissure, and (3) the collagen is hardened while the
saline is removed from the suspension. In this preferred
embodiment, the isolated region between the distal balloon 116 and
the proximal balloon 116 is maintained at a positive differential
pressure with respect to the rest of the rectum, so that the
collagen infuses into the fissure; this procedure or a similar
procedure is also followed for treatment of diverticulosus and
diverticulitus.
[0095] In a preferred embodiment for treatment, in a female
patient, of a prolapsed uterus, (1) the catheter 110 is inserted
into a region where the uterus has prolapsed, (2) the prolapsed
uterus is partially ablated, and (3) collagen is infused and
hardened to strengthen, the muscle wall. Similarly to treatment of
a prolapsed muscle, in alternative embodiments, the collagen may be
infused before ablation, so that the steps of muscle ablation and
collagen hardening will occur substantially simultaneously.
[0096] Although preferred embodiments are disclosed herein, many
variations are possible which remain within the concept, scope, and
spirit of the invention, and these variations would become clear to
those skilled in the art after perusal of this application.
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