U.S. patent application number 10/798717 was filed with the patent office on 2005-12-29 for incontinence treatment with urethral guide.
This patent application is currently assigned to Solarant Medical, Inc.. Invention is credited to Matlock, George L..
Application Number | 20050288544 10/798717 |
Document ID | / |
Family ID | 34976120 |
Filed Date | 2005-12-29 |
United States Patent
Application |
20050288544 |
Kind Code |
A9 |
Matlock, George L. |
December 29, 2005 |
Incontinence treatment with urethral guide
Abstract
Devices and methods for aligning a probe body and a treatment
surface adjacent a target tissue. A guide shaft can be positioned
in a urethra. The probe body can be positioned in a vagina and
registered relative to the guide so as to position the treatment
surface in alignment with the target tissue.
Inventors: |
Matlock, George L.;
(Pleasanton, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
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Assignee: |
Solarant Medical, Inc.
Livermore
CA
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Prior
Publication: |
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Document Identifier |
Publication Date |
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US 0236177 A1 |
November 25, 2004 |
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Family ID: |
34976120 |
Appl. No.: |
10/798717 |
Filed: |
March 10, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10798717 |
Mar 10, 2004 |
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10301561 |
Nov 20, 2002 |
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10798717 |
Mar 10, 2004 |
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09991368 |
Nov 20, 2001 |
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6685623 |
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Current U.S.
Class: |
600/29 |
Current CPC
Class: |
A61B 2090/3958 20160201;
A61B 90/11 20160201; A61B 2017/00805 20130101; A61B 2018/0016
20130101; A61B 18/1485 20130101; A61B 2018/00523 20130101 |
Class at
Publication: |
600/029 |
International
Class: |
A61F 002/00 |
Claims
What is claimed is:
1. An incontinence treatment system for directing treatment to a
target tissue of a patient, the system comprising: a urethral guide
having a proximal guide portion and a distal guide portion, the
distal guide portion configured to be inserted into a urethra of a
patient and having at least one urethral positioning surface; a
probe body having a proximal probe portion and a distal probe
portion, the distal probe portion configured to be inserted into a
vagina of the patient and having a treatment delivery surface; and
the proximal guide portion registering with the proximal probe
portion so as to register the treatment delivery surface of the
probe with the target support tissue of the patient when the at
least one urethral positioning surface engages tissue adjacent the
urethra.
2. The system of claim 1, wherein the at least one urethral
positioning surface of the urethral guide comprises a meatus
engaging surface and an expandable body, the meatus-engaging
surface disposed near the proximal guide portion and oriented
distally, the expandable body disposed near the distal guide
portion and insertable transurethrally so that the meatus and
expandable body can receive the urethra axially therebetween.
3. The system of claim 2, wherein at least one of the meatus
engaging surface and the expandable body is movable axially
relative to the other so as to accommodate variations in urethral
length, and wherein the proximal guide portion and proximal probe
portion register so as to align the treatment surface axially with
the target support tissue and away from a meatus and bladder of the
patient.
4. The system of claim 3, further comprising a threaded mechanism
registering the proximal guide portion with the proximal probe
portion, the threaded mechanism having a first thread pitch and a
second thread pitch that is less than the first thread pitch,
rotation of the threaded mechanism effecting movement of the meatus
engaging surface relative to the expandable body via the first
thread pitch and effecting registration of the treatment delivery
surface via the second thread pitch so that the treatment delivery
surface remains oriented toward the target tissue between and
safely separated from the meatus engaging surface and the
expandable body when the urethra if fittingly received
therebetween.
5. The system of claim 4, further comprising an electromagnetic
source and an electromagnetic receiver mounted to the probe body
and the urethral guide body, the receiver generating a signal
indicating axial registration when the source is registered
therewith, the source or the receiver being mounted to the threaded
mechanism.
6. The system of claim 5, wherein the treatment delivery surface
comprises a cooled electrode array, wherein the source and receiver
comprise a Hall effect system, wherein a magnet of the Hall effect
system is mounted to the threaded mechanism and at least one Hall
Effect receiver is used to generate the signal when disposed
axially along or between the at least one receiver so as to
indicate that the electrode array is aligned with a midpoint of the
urethra.
7. The system of claim 4, further comprising a first visual
alignment indicator mounted to the proximal guide portion and a
second visual alignment indicator mounted to the proximal probe
portion, the first and second visual alignment indicators providing
visual indicia of alignment when the treatment delivery surface is
oriented toward the target tissue between and safely separated from
the meatus engaging surface and the expandable body.
8. The system of claim 7 wherein the first alignment indicator or
the second alignment indicator comprises a window, the other
alignment indicator visible within the window when the probe body
is axially aligned with the urethral guide body.
9. An incontinence treatment system for directing treatment to a
target tissue of a patient, the system comprising: a urethral guide
having a proximal guide portion with a distally oriented meatus
engaging surface and a distal guide portion, the distal guide
portion configured to be inserted into a urethra of a patient and
having an expandable body insertable transurethrally so that the
meatus and expandable body can receive the urethra therebetween; a
probe body movable relative to the urethral guide and having a
proximal probe portion and a distal probe portion, the distal probe
portion configured to be inserted into a vagina of the patient and
having a treatment delivery surface; and the proximal guide portion
registering with the proximal probe portion so as to register the
treatment delivery surface of the probe with the target support
tissue of the patient when the at least one urethral positioning
surface engages tissue adjacent the urethra.
10. An incontinence treatment method comprising: introducing a
distal portion of a urethral guide into a urethra of a patient;
engaging at least one of a bladder neck of the patient and a
urethral meatus of the patient with a surface of the urethral
guide; introducing a distal portion of a probe body into a vagina
of the patient; and registering a treatment delivery surface of the
probe body by movement of the probe body relative to the urethral
guide and to a target support tissue of the patient, the target
support tissue offset laterally from the urethra and disposed
axially between and separated from the bladder neck and the
urethral meatus, registration being effected by registering a
proximal end of the probe with a proximal end of the guide; and
altering support of the urethra by the support tissue with the
treatment delivery surface of the probe.
11. The method of claim 10 wherein the registration step comprises
rotating a threaded mechanism having a first pitch so as to axially
move a meatus-engaging surface relative to an expandable body
within the bladder to fittingly receive the urethra axially
therebetween, the threaded mechanism having a second pitch less
than the first pitch so as to move a registration body a portion of
the urethral receiving movement, and at least one of:
electromagnetically axially registering the probe body with the
urethral guide with reference to the registration body; and
visually axially registering the probe body with the urethral guide
with reference to the registration body.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 09/991,368, filed Nov. 20, 2001 (now U.S. Pat.
No. 6,685,623), entitled "Incontinence Treatment with Urethral
Guide," the complete disclosure of which is incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to medical devices
methods, systems, and kits. More specifically, the present
invention provides devices and methods for positioning a treatment
surface adjacent a target tissue to selectively heat and shrink
tissues, particularly for the noninvasive treatment of urinary
incontinence, hernias, cosmetic surgery, and the like.
[0003] Urinary incontinence arises in both women and men with
varying degrees of severity, and from different causes. In men, the
condition occurs almost exclusively as a result of prostatectomies
which result in mechanical damage to the sphincter. In women, the
condition typically arises after pregnancy where musculoskeletal
damage has occurred as a result of inelastic stretching of the
structures which support the genitourinary tract. Specifically,
pregnancy can result in inelastic stretching of the pelvic floor,
the external vaginal sphincter, and most often, the tissue
structures which support the bladder and bladder neck region. In
each of these cases, urinary leakage typically occurs when a
patient's intra-abdominal pressure increases as a result of stress,
e.g. coughing, sneezing, laughing, exercise, or the like.
[0004] Treatment of urinary incontinence can take a variety of
forms. Most simply, the patient can wear absorptive devices or
clothing, which is often sufficient for minor leakage events.
Alternatively or additionally, patients may undertake exercises
intended to strengthen the muscles in the pelvic region, or may
attempt behavior modification intended to reduce the incidence of
urinary leakage.
[0005] In cases where such noninterventional approaches are
inadequate or unacceptable, the patient may undergo surgery to
correct the problem. A variety of procedures have been developed to
correct urinary incontinence in women. Several of these procedures
are specifically intended to support the bladder neck region. For
example, sutures, straps, or other artificial structures are often
looped around the bladder neck and affixed to the pelvis, the
endopelvic fascia, the ligaments which support the bladder, or the
like. Other procedures involve surgical injections of bulking
agents, inflatable balloons, or other elements to mechanically
support the bladder neck.
[0006] It has recently been proposed to selectively deliver RF
energy to gently heat fascia and other collagenated support tissues
to treat incontinence. One problem associated with delivering RF
energy to the targeted tissue is the alignment of the electrodes
with the target tissue. Direct heating of target tissue is often
complicated since the target tissue is offset laterally and
separated from the urethra by triangular shaped fascia sheets
supporting the urethra. These urethra supporting fascia sheets
often contain nerve bundles and other structure that would not
benefit from heating. In fact, injury to these nerve bundles may
even promote incontinence, instead of providing relief from
incontinence.
[0007] For these reasons, it would be desirable to provide improved
devices, methods, systems, and kits for providing improved
alignment devices and methods that would improve the positioning of
heating electrodes adjacent the target tissue and away from the
surrounding, sensitive nerve bundles.
BRIEF SUMMARY OF THE INVENTION
[0008] The present invention provides devices, methods, systems,
and kits for positioning a treatment surface adjacent a target
tissue. In one embodiment, the present invention can be used for
treating urinary incontinence. A urethral measurement assembly
facilitates registration of a treatment delivery surface with a
fractional location along the urethral axis, such as the mid-point
of the urethra. Ideally, the physician will have some freedom to
move a treatment probe manually as desired to achieve the best
thermal contact, electrical contact, ergonomic fit to the patient,
or the like, while maintaining registration with sufficient
tolerances or within an acceptable registration region. The
registration region may be established so as to avoid inadvertent
damage to nerves or other tissues which may result from treatments
outside, and particularly beyond the desired axial range of, the
registration region.
[0009] In one aspect, the invention provides an incontinence
treatment system for directing treatment to a target tissue of the
patient. The system comprises a urethral guide having a proximal
guide portion and a distal guide portion. The distal guide portion
is configured to inserted in a urethra of a patient and has at
least one urethral positioning surface. A probe body has a proximal
probe portion and a distal probe portion. The distal probe portion
is configured to be inserted into a vagina of the patient and has a
treatment delivery surface. The proximal guide registers with the
proximal probe portion so as to register the treatment delivery
surface of the probe with the target support tissue of the patient
when the at least one urethral positioning surface engages tissue
adjacent the urethra.
[0010] The urethral positioning surface of the urethral guide may
comprise a meatus engaging surface and an expandable body. The
meatus engaging surface can be disposed near the proximal guide
portion and oriented distally for engaging a urethral meatus when
the distal guide portion is inserted into the urethra. The
expandable body can be disposed near the distal guide portion and
may be insertable transurethrally. The expandable body may then be
expanded within a bladder neck or bladder of the patient so that
the meatus and expandable body receive and axially measure the
urethra therebetween.
[0011] The meatus engaging surface and/or the expandable body may
move axially relative to each other so as to accommodate variations
in urethral length. The proximal guide portion and the proximal
probe portion may register so as to align the treatment surface
axially with the target support tissue, while being safely
separated from the urethral meatus, the bladder, the bladder neck,
and incontinence-effecting nerves, and/or the like.
[0012] Optionally, a threaded mechanism may register the proximal
guide portion with the proximal probe portion. The threaded
mechanism can have a first thread pitch and a second thread pitch
that is less that the first thread pitch. Rotation of the threaded
mechanism may effect movement the meatus engaging surface relative
to the expandable body via the first thread pitch. Registration of
the treatment delivery surface may be effected via the second
thread pitch. This allows the registration to adjust some fraction
of a change in urethral length between a first patient and second
patient. For example, if it is desired to register the treatment
delivery surface with a midpoint along the patient's urethra, the
second pitch may be half of the first pitch. More broadly, a
variety of proportional adjustment means for maintaining
registration of the treatment delivery surface with a proportional
or fractional location along the patient's urethra may be
employed.
[0013] An electromagnetic source and an electromagnetic receiver
may be mounted to the probe body and the urethral guide body, with
either the source or receiver being mounted to the probe, and with
the other being mounted to the urethral guide. The receiver can
generate a signal indicating axially registration when the source
is registered therewith. The source or the receiver may be mounted,
for example, to the threaded mechanism. Alternative embodiments may
use a source and receiver without the threaded mechanism. An
exemplary treatment delivery surface may comprise a cooled
electrode array with the source and receiver comprising a Hall
effect system. The magnet may be mounted to a follower of the
threaded mechanism, and first and second sensors of the Hall effect
system may be mounted to the probe body. In the exemplary
embodiment, the sensors may be separated by about 6 mm to allow a
region of acceptable registration and/or treatment along the
proximal-distal axis. The signals from the sensors can be combined
or compared so as to indicate that the electrode array is aligned
with the midpoint of the urethra.
[0014] A first visual alignment indicator may be mounted to the
proximal guide portion and a second visual alignment indicator may
be mounted to the proximal probe portion. The first and second
visual alignment indicators can provide a visual indication of
alignment when the treatment delivery surface is oriented toward
the target tissue between (and safely separated from) the meatus
engaging surface and the expandable body. Optionally, the first
alignment indicator or second alignment indicator comprises a
window. The other alignment indicator may be visibly disposed
within the window when the probe is axially aligned with the
urethral guide body. The window may comprise a clear material, an
opening, or the like, and may define an acceptable registration or
treatment region, often having visible proximal and/or distal
limits. Such visual alignment indicators may be used with an
electromagnetic registration system such as a hall effect system,
with the electromagnetic system optionally inhibiting treatment if
the registration signal is absent, thereby facilitating manual
registration under visual guidance while inhibiting treatments that
might inflict nerve damage or the like. Such a system allows
independent manual positioning of the probe body and/or urethral
guide to effect registration.
[0015] In another aspect, the invention provides an incontinence
treatment system for directing treatment to a target tissue of the
patient. The system comprises a urethral guide having a proximal
guide portion with a distally oriented meatus-engaging surface and
a distal guide portion. The distal guide portion is configured to
be inserted into a urethra of a patient and has an expandable body
insertable transurethrally so that the meatus and expandable body
can receive the urethra therebetween. A probe body is movable
relative to the urethral guide and has a proximal probe portion and
a distal probe portion. The distal probe portion is configured to
be inserted into a vagina of a patient and has a treatment delivery
surface. The proximal guide portion is registered with the proximal
probe portion so as to register the treatment delivery surface of
the probe with the targeted support tissue of the patient when the
at least one urethral positioning surface engages tissue adjacent
the urethra.
[0016] In another aspect, the invention provides an incontinence
treatment method comprising introducing a distal portion of a
urethral guide into a urethra of a patient. A bladder neck of the
patient or a urethral meatus of the patient (or both) are engaged
with a surface of the urethral guide. A distal portion of a probe
body is inserted into a vagina of the patient and a treatment
delivery surface of the probe is registered by movement of the
probe body relative to the urethral guide, and relative to a target
support tissue of the patient. The target support tissue is offset
laterally from the urethra and disposed axially between, and
separated from, the bladder neck and the urethral meatus.
Registration is effected by registering a proximal end of the probe
with a proximal end of the guide. Support of the urethra by the
support tissue is altered with the treatment delivery surface of
the probe.
[0017] The registration step may comprise rotating a threaded
mechanism having a first pitch so as axially move a meatus-engaging
surface relative to an expandable body within the bladder. These
structures can be moved so as to fittingly receive the urethra
axially therebetween. The threaded mechanism may have a second
pitch which is less than first pitch so as to move a registration
body a portion of the urethral receiving movement. Optionally, the
registration step may also comprise electromagnetically axially
registering the probe body with the urethral guide by reference to
the registration body. Registration may also be effected by
visually axially registering the probe body with the urethral guide
with reference to the registration body.
[0018] Embodiments of the probe and guide of the present invention
can accurately position a treatment surface, such as an electrode
array, adjacent a target tissue by utilizing the human anatomy to
help guide the treatment surface into contact with the target
tissue. Generally, the guide can be inserted into a first body
orifice and the probe can be inserted into a second body orifice
and placed in a predetermined position relative to the guide so as
to position the treatment surface adjacent the target tissue in the
second body orifice.
[0019] In some embodiments, the guide can be inserted into the
urethra to help position the treatment surface adjacent the target
tissue in the vagina. In the embodiments, the probes can include a
probe body comprising a treatment surface. A probe body can be
registered with the guide that is positioned in the urethra and
positionable in the vagina to help align the treatment surface with
a target tissue in the vagina.
[0020] In one embodiment, the urethral guide can be physically
couplable to the probe body. Optionally, the urethral guide can be
removably attached to the probe body and/or rotatably attached to
the probe body. The rotatable attachment can provide flexibility in
positioning treatment surface adjacent the target tissue. The
removable attachment allows the probe body and urethral guide to be
independently inserted into the body orifices. After both have been
inserted, the two can optionally be attached to align the treatment
assembly with the target tissue. Optionally, the probes of the
present invention may have a coupling structure on each side of the
probe body to provide proper alignment of the treatment surface
with target tissue both to the left and right of the non-target
urethra tissue.
[0021] Some embodiments of the urethral guides of the present
invention can be configured to bias the electrodes into the target
tissue. Such biasing can improve the efficiency of electrical
energy delivery to the target tissue while avoiding energy delivery
to the surrounding non-target tissue if the electrodes are not in
proper contact with the target tissue.
[0022] Some embodiments of the probe body and guide means can be
rigid and rigidly connected to each other. The rigid configuration
of the probes of the present invention allows the physician to
maintain the position of the treatment surface relative to the
target tissue. Other embodiments of the probe body and guide,
however, can be partly or completely flexible.
[0023] In other embodiments, the urethral guide will not be
physically coupled to the probe body but will be registered with
the probe body through its position relative to the position of the
probe body.
[0024] In one embodiment, the urethral guide can be registered with
or in communication with the probe body based on its physical
location relative to the probe body. A palpation member (such as a
bump or indentation, landmark, a clip, a marking, or the like) on
the urethral guide and the probe body can provide landmarks for the
physician to assist the physician in positioning the treatment
surface of the probe body adjacent the target tissue.
[0025] In another embodiment, the urethral guide can be registered
with the probe body through an electromagnetic coupling such as a
Radiofrequency (RF) coupling, magnetic coupling, or light sensing
coupling (either visible or infrared). In such embodiments, the
urethral guide and probe body do not have to be physically coupled
with each other (but can be, if desired) and typically can be moved
freely, relative to each other.
[0026] In one embodiment, the urethral guide and/or the probe body
can include one or more RF transmitter(s) and RF sensor(s). The RF
coupling can provide a RF position signal to a controller that is
indicative of the spacing between the sensors and transmitters on
the urethral guide and the probe. The RF signal can be delivered to
the controller so that the controller can inform the user of the
positioning of the probe body relative to the urethral guide. Once
the urethral guide and probe have been placed in their proper
positions in the body orifices and in a proper, predetermined
position relative to each other, the RF sensor will produce a
position signal that informs the controller that the probe is
disposed in a position that places the treatment surface adjacent
the target tissue.
[0027] In another embodiment, a magnetic coupling that includes one
or more magnetic field transmitter(s) (e.g., an electromagnet)
and/or one or more magnetic field sensors (e.g., Hall Effect
sensors) to position the probe body in a proper position relative
to the urethral guide. The magnetic coupling can provide an
electromagnetic signal that is indicative of the spacing between
the urethral guide and the probe. The magnetic field signal can be
delivered to the controller through the magnetic field sensors so
that the controller can inform the user of the positioning of the
probe body. Once the urethral guide and probe have been placed in
their proper position in the body orifices and in a proper,
predetermined position relative to each other, the magnetic field
sensor will produce a signal that indicates a proper positioning of
the probe relative to the urethral guide.
[0028] In some configurations, the controller can be configured to
inform the user that there is an improper or proper spacing between
the probe body and urethral guide. In some configurations, the
controller can be configured to prevent delivery of energy to the
treatment surface until a proper spacing or proper positioning of
the treatment surface is achieved. In other configurations, the
controller can be configured to provide an indication (such as a
readout on a monitor, or an audible signal) that there is a proper
positioning of the probe body in the vagina relative to the
urethral guide.
[0029] The guides of the present invention can also optionally
include an expansible member adjacent its distal end. The urethral
guide can be moved through the urethra and into the patient's
bladder. Once in the bladder, the expansible member can be expanded
so as to prevent proximal movement of the urethral guide and probe
body.
[0030] In some embodiments, the urethral guide can include a
temperature sensor that is coupled to the controller to allow the
user to monitor the tissue temperature of the urethra.
[0031] The methods of the present invention generally comprise
positioning a guide in the patient's body and guiding a treatment
surface, such as an electrode array to a target tissue. Once the
treatment surface is positioned against the target tissue, the
target tissue can be treated. In some embodiments, treatments
comprise delivering an electrical energy to heat and shrink or
stiffen the target tissue.
[0032] One embodiment of the method of the present invention
comprises placing a guide into a first body orifice (e.g.,
urethra). A treatment probe having a treatment surface can be
inserted into a second body orifice (e.g., vagina). The probe can
be placed in a predetermined position relative to the guide (e.g.,
registered) so as to position the treatment surface in proper
alignment with a target tissue in the second body orifice.
Thereafter, the target tissue can be treated with the treatment
surface
[0033] In some embodiments, the methods of the present invention
can include the step of measuring the length of the patient's
urethra. Once the patient's urethra has been measured, the
physician can then calculate a predetermined distance of the
urethra for advancement of the urethral guide. In one embodiment,
the predetermined distance is approximately a mid-urethra point. In
other embodiments, however, the predetermined target distance can
be other target distances, that are larger or smaller than the
mid-urethra point. Locating the midpoint of the urethra can be done
automatically or the process of midpoint location can be carried
out by manually measuring the length of the patient's urethra and
inserting marked positioning devices to a position called for by
the measured urethral length.
[0034] Once the mid-urethra point is calculated (or other
predetermined distance), the urethral guide can be placed in the
urethra and advanced to the mid-urethra point to "mark" the
mid-urethra. In some embodiments, the mid-urethra point can be
marked with the urethral guide by using an RF transmitter, magnetic
field transmitter, or a mechanical palpation member that can
indicate to the physician the position of the mid-urethra. Once the
mid-urethra point is marked, a variety of methods can be used to
position the treatment surface near the marker and adjacent the
target tissue. Thereafter, the treatment surface can be used to
treat the target tissue.
[0035] The present invention further provides kits for treating
incontinence. The kits of the present invention typically include
any of the probes and guides as described herein. The kits will
generally include a package for holding the probe, guide, and
instructions for use which describe any of the exemplary methods
described herein. Optionally, the kits may include a controller,
power source, electrical connections, or the like.
[0036] A further understanding of the nature and advantages of the
invention will become apparent by reference to the remaining
portions of the specification and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037] FIG. 1A illustrates an embodiment of an electrosurgical
probe of the present invention;
[0038] FIG. 1B is a close up perspective view of an exemplary
coupling assembly;
[0039] FIG. 2 illustrates an embodiment of an urethral guide shaft
of the present invention;
[0040] FIG. 3 is a simplified end view of a distal orifice and
expansible member disposed on guide shaft;
[0041] FIG. 4 is a simplified side view of an embodiment of the
expansible member;
[0042] FIG. 5 is a simplified view of an alternative embodiment of
the noninvasive probe of the present invention;
[0043] FIG. 6 illustrates an exemplary embodiment of a coupling
structure on two sides of the probe body which allows for
positioning of the probe body against target tissue on both the
left and right side of the urethra;
[0044] FIG. 7 is a simplified cross sectional view of a radiused
electrode and a guide of the present invention illustrating a
lateral offset of the guide relative to the probe body and an
orthogonal offset relative to a plane of the electrode;
[0045] FIG. 8 is a simplified cross sectional front view of target
tissue of an exemplary method of the present invention;
[0046] FIG. 9 is a cross sectional view of the tissue that can be
targeted for non-invasive treatment using the methods of the
present invention;
[0047] FIGS. 9A-9C illustrate some embodiments that comprise a
urethral guide that is rotatably attached to the probe body about
at least one axis;
[0048] FIG. 10 illustrates placement of an embodiment of the guide
into the urethra;
[0049] FIG. 11 illustrates expanding of the expansible member in
the bladder;
[0050] FIG. 12 illustrates placement of the probe into the
vagina;
[0051] FIG. 13 illustrates coupling of the guide to the probe body
in an offset configuration and treating the target tissue;
[0052] FIG. 14 illustrates an embodiment that includes a mechanical
palpation member coupled to the urethral guide to indicate a
mid-urethra point;
[0053] FIG. 15 illustrates the urethral guide of FIG. 14 with a
probe;
[0054] FIG. 16 illustrates yet another embodiment of an urethral
guide of the present invention that includes an expansion
member;
[0055] FIG. 17 illustrates the urethral guide of FIG. 16 and a
probe of the present invention;
[0056] FIGS. 18A and 18B are cross sectional views of a simplified
urethral guide having an expandable portion;
[0057] FIGS. 19A and 19B illustrate an embodiment that includes RF
coupling;
[0058] FIGS. 20A and 20B illustrate an embodiment that include a
magnetic coupling;
[0059] FIG. 21 schematically illustrates a CPU of a controller
coupled to an output display that shows a graphic representation of
the urethral guide and probe;
[0060] FIG. 22 schematically illustrates a simplified method of the
present invention;
[0061] FIG. 23A to 23F illustrate one embodiment of a method and
device for measuring a length and a mid-urethral length;
[0062] FIG. 24A to 24C illustrates another embodiment of a method
and device for automatically locating the mid-urethral position and
placing a sensor or other position indicating device at the
mid-urethra; and
[0063] FIG. 25 illustrates an embodiment of a kit of the present
invention;
[0064] FIG. 26 is a perspective view of an incontinence treatment
system and method in which a urethral guide having a threaded
mechanism fittingly axially receives and measures the urethra
between an expandable body and a meatus engaging surface, and in
which a probe is moved independently of the urethral guide using
both electromagnetic and visual registration of the probe relative
to the urethral guide so as to align a treatment directing surface
of the probe with a target tissue;
[0065] FIG. 27 is a side-view of the system and method of FIG. 26,
showing details of the threaded urethral measurement assembly of
the urethral guide;
[0066] FIG. 28 is an axially view (relative to the urethral guide)
of the system and method of treatment of FIG. 26.
[0067] FIG. 29 is a plan view showing the treatment system and
method of FIG. 26, and showing visual registration of the treatment
probe by aligning a mark on the probe within a window of the
urethral guide, and also showing the urethral measurement assembly
and mid-point locating mechanism of the urethral guide.
[0068] FIG. 30 is a perspective view of the treatment method and
system of FIG. 26, showing the urethral measurement apparatus of
the urethral guide in more detail.
[0069] FIG. 31 is a side view of the treatment system and method of
FIG. 26, showing the Hall effect system for electromagnetic axial
registration of the treatment probe relative to the urethral
guide.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
[0070] The present invention provides methods, devices, systems,
and kits for accurately positioning a treatment surface, such as an
electrode array, adjacent fascia and other collagenated tissues to
selectively treat the target tissue. In a particular embodiment,
the present invention accurately directs an electrical current flux
through the target tissue between bipolar electrodes that are
contacting the target tissue to shrink or stiffen the collagenated
tissue.
[0071] Exemplary embodiments of the present invention heat target
tissue in the vagina for treating urinary incontinence. The urethra
is composed of muscle structures that allow it to function as a
sphincter controlling the release of urine from the bladder. These
muscles are controlled by nerve bundles that in part run in close
proximity to the urethra-bladder junction and along the axis of the
urethra. Pelvic surgery in this region has been associated with the
development of intrinsic sphincter deficiency of the urethra. It is
therefore important that any tissue treatment avoid areas
containing nerve pathways that supply the urethra. Because the
present invention provides accurate placement with the target
tissue, collateral damage to surrounding nerve bundles and other
organs can be reduced.
[0072] While the remaining discussion will be directed at treating
incontinence in a female patient, it should be appreciated that the
concepts of the present invention are further applicable to other
noninvasive and invasive surgical procedures, and are not limited
to treating urinary incontinence.
[0073] FIG. 1A illustrates an exemplary electrosurgical probe 10 of
the present invention. The electrosurgical probe includes an
applicator or probe body 12 having a proximal portion 14 and a
distal portion 16. Proximal portion 14 of the probe body 12
generally includes a handle 15 and one or more triggers or switches
17 for activating a delivery of electrical energy to the target
tissue or for deploying a temperature probe into the target tissue
to monitor the tissue temperature during treatment. Distal portion
16 can include a treatment surface 18 that has at least one
electrode or other type of treatment assembly. The treatment
assembly can include an electrode on a needle, ultrasound
transducer, microwave antenna, a needle for delivery of a
therapeutic agent, or the like. A guide body or shaft 22 can be
attachable to the probe body 12 to assist in the proper positioning
of the distal portion 16 of probe body 12 and treatment surface 18
with a target tissue. As will be described in detail below, other
embodiments include a guide 22 that is not attached to probe body
12.
[0074] Systems of the present invention can further include a power
supply 28 that is in electrical communication with the electrode
assembly 18 through electrical couplings 30. Optionally, a
controller (not shown) may be incorporated into the probe and/or
with the power supply to control the delivery of energy to the
heating electrodes and to provide visual and audio outputs to the
physician. Some exemplary controllers are described in commonly
assigned U.S. Pat. No. 6,081,749, the complete disclosure of which
is incorporated herein by reference.
[0075] Exemplary embodiments of the probes of the present invention
are for use in treating incontinence. Such probes will typically be
substantially rigid, and sized and shaped to be insertable into a
patient's vagina. In such embodiments, the distal portion will have
a length between approximately 2 cm and 8 cm, and will have a width
or diameter between approximately 1.0 cm and 3.0 cm. The probes can
be composed of a plastic (such as polyester polycarbonate, or the
like) or an inert metal (such as gold plated brass, or the like),
or other bio-compatible materials that are typical of intravaginal
devices. It should be appreciated however, that in alternative
embodiments, the probes and guides may be partially or completely
flexible. For example, in one embodiment, an electrode array may be
mounted on a balloon type surface or the electrode array can be
built in as features on a flexible printed circuit assembly (e.g.,
electrodes on flexible plastic film).
[0076] Electrodes 18 of the present invention can take a variety of
forms. As illustrated in FIG. 1A, the heating electrodes can
include a plurality of curved electrodes disposed on the distal
portion 16 of probe body 12. In the illustrated embodiment, there
are three curved electrodes 18. It should be appreciated however,
that any number of electrodes and a variety of shaped electrodes
can be used. A more complete description of various types of
electrodes that can be used with the devices and methods of the
present invention are shown and described in commonly assigned U.S.
Pat. No. 6,091,995, the complete disclosure of which is
incorporated herein by reference.
[0077] FIG. 2 illustrates an exemplary embodiment of the guide
shaft 22 of the present invention that is couplable to probe body
12. Guide shaft 22 has a proximal portion 32 and a distal portion
34. In one exemplary embodiment, guide shaft 22 of the present
invention is removably attached to the probe body 12 to allow for
independent placement of the probe 10 and guide shaft 22 in the
patient's body. A clamping structure 36, such as a series of
serrations, is disposed on the proximal portion 32 to allow the
guide 22 to be removably attached to the probe body 12.
[0078] While not illustrated, guide 22 can further include a
temperature sensor to sense the temperature of the urethra, before,
after, and during the heating treatment. Sensors may be a
thermocouple, thermistor, fiber optic light based, RTD or other
sensors known to those skilled in the art. The temperature sensor
can be coupled to the controller to allow monitoring of the
temperature of the urethral tissue. In some embodiments, if the
urethra is heated beyond a predetermined threshold temperature, the
controller can be configured to output a cue to the physician to
inform the physician of the measured temperature. Alternatively,
upon reaching a threshold temperature, the controller can be
configured to stop delivery of heating energy to the electrode
array.
[0079] As illustrated in FIGS. 2-4, guide 22 can optionally include
a tip 41 and an expansible member 42 positioned on the distal
portion 34 of guide 22. Expansible member 42 can be inflated and
deflated via an inflation lumen 44. Guide 22 can also include a
fluid lumen 46 that has a proximal orifice 47 and distal orifice
48. In the particular configuration illustrated in FIGS. 3 and 4,
the fluid lumen 46 can be coaxial with inflation lumen 44 and
disposed through expansible member 42. The fluid lumen 46 can be
used to deliver fluids to a body organ or to drain fluid from the
body organ. Proximal orifice 47 of the fluid lumen 46 can be
coupled to an aspiration or fluid source (not shown) to assist in
the transfer of fluid through the fluid lumen 46. In such
embodiments, expansible member 42 can be annular shaped and will
have a corresponding annular inflation lumen 44 and fluid lumen 46
will be concentric or lateral with each other. It should be
appreciated however, that a variety of other configurations of the
lumens 44, 46 can be used without departing from the concepts of
the present invention.
[0080] In some embodiments, urethral guide 22 can be coupled to the
probe body 12 in an angled, offset configuration (FIG. 1A).
Typically, a longitudinal axis 38 of urethral guide 22 will be
angled from a longitudinal axis 40 of the probe body 12 (FIGS. 1A
and 6). The angle .theta. will typically be between approximately 5
degrees and 30 degrees, and preferably approximately between
approximately 11 degrees and 15 degrees. It should be appreciated,
however, that in alternative embodiments, urethral guide 22 and
probe body 12 may be in a parallel configuration (FIG. 5). The
angled arrangement is more preferred than the parallel arrangement,
because in the angled offset arrangement, as the probe is moved
distally through the body orifice, the probe and guide will diverge
along the angled path so that the electrodes will be positioned
offset from the position of the guide and farther away from the
urethra-bladder junction, which extends laterally from a
longitudinal axis of the urethra.
[0081] In an embodiment most clearly illustrated in FIG. 6, a
distal end of urethral guide 22 will also be positionable distal of
the distal end 16 of the probe body. Thus, when the expansible
member 42 of the guide extends into the bladder B, the electrodes
18 on the probe body 12 will be maintained in a position proximal
of the bladder B. Such a configuration can prevent inadvertent
delivery of electrical energy to the non-target bladder tissue.
[0082] One exemplary configuration of the treatment surface 18
relative to the urethral guide 22 is illustrated schematically in
FIG. 7. In such a configuration, the treatment surface 18 includes
radiused electrodes that have an apex A. The guide 22 will be
offset laterally from an axis of the probe body 12, typically
between 5 degrees to 30 degrees, and offset below a plane P that is
orthogonal/tangent to the apex A (or parallel to an upper plane of
a planar electrode). By offsetting the distal end of the guide 22
below the top plane of the electrode, the guide 22 can tension the
vaginal surface tissue engaged by the probe body 12 and bias the
electrodes 18 into contact with the target tissue. Such a biasing
configuration can improve the delivery of the electrical energy
from the electrodes 18 into the target tissue and reduce the chance
of delivering energy to non-target tissue.
[0083] In one embodiment, guide 22 can be rigidly coupled to probe
body 12 with a coupling assembly 60 so as to maintain a rigid
assembly. By maintaining a substantially rigid connection, rigid
guide 22 can properly position electrodes 18 offset laterally from
a sensitive non-target tissue, such as the urethra, so that
delivery of electrical energy through the electrodes 18 is
sufficiently spaced from the non-target tissue.
[0084] In some configurations, the coupling assembly 60 of the
present invention can be configured to allow attachment to the
probe body along both sides of the probe body. As shown in FIG. 6,
urethral guide 22 can be positioned laterally along either the left
or right side so as to allow contact of the electrodes 18 with
tissue laterally to the left or right of the urethra.
[0085] The coupling assembly 60 of the present invention can
provide an attachment between the guide 22 and the probe body 12
that allows the user to attach and detach the guide to position the
electrodes adjacent the target tissue. One exemplary coupling
assembly is illustrated in FIG. 1B. The coupling assembly includes
a substantially symmetrical left and right pockets 62, 64 that can
receive a proximal end of the urethral guide 22. A rotatable guide
clip 66 having a left and right coupling handles 68, 70 is disposed
between left pocket 62 and right pocket 64. The left pocket 62 and
right pocket 64 can include a serrated mount 72 that can interact
with clamping structure 36 on the proximal end of the guide 22.
Additionally, the pockets 62, 64 can include a snap feature 74 that
can interact with the left and right coupling handles 68, 70 to
lock the guide 22 within the pockets.
[0086] The urethral guide can enter the pockets either by
vertically or axially sliding the proximal end of the urethral
guide 22 into a selected pocket. In exemplary embodiments, the
proximal end of the urethral guide 22 includes matching serrations
(not shown) that match the serrated mount 72 in the pocket so as to
allow for incremental axial positioning of the urethral guide with
respect to the applicator and handle. After the guide 22 is
positioned in a desired axial position, the selected handle 68, 70
can be secured by snapping it into the snap feature 74.
[0087] FIGS. 9A to 9C illustrate an embodiment of the probe and
urethral guide 22 that allows the operating physician the
flexibility of changing the position of the urethral guide 22
relative to the probe body 12. As illustrated in the top view FIG.
9A, it is preferred to position the treatment surface 18 of the
applicator in a laterally offset position relative to the urethral
tissue U. In one embodiment, the urethral guide can be coupled to
probe body 12 in a manner that allows the physician to place the
treatment surface in different orientations lateral to the urethra
tissue U. As illustrated by the arrows in FIG. 9A, in some
embodiments, the treatment surface 18 will be rotatable about one
or more axes and/or movable in at least one direction. For example,
in one embodiment, the urethral guide can be movable in at least
one of an up/down direction 80, rotation about a longitudinal axis
of the probe body 82, and rotation about an axis perpendicular to
the longitudinal axis 84 (e.g., pivot around a distal portion of
the probe body).
[0088] In the embodiment illustrated in FIG. 9B, probe body can be
coupled to the urethral guide 22 with a ball joint 86 or other
joint that allows rotation of the guide about at least some of the
degrees of freedom 80, 82, 84. In some configurations, probe body
12 can include a physical stop 88 that limits the pivoting of the
urethral guide 22 to prevent the urethral guide from being
positioned below a minimum angular offset, (e.g., 11 degrees).
Preventing the urethral guide from going below a minimum angular
offset can prevent the treatment surface from being aligned with
the urethral tissue U and fascia sheets. As illustrated further in
FIG. 9B, ball joint 86 can be disposed on the left and/or right
side of the probe body 12 so as to allow treatment on the tissue
that is laterally to the left and right of the urethral tissue.
[0089] The ball joint 86 can be implemented in a variety of ways.
For example a proximal end of urethral guide 22 can include a ball,
while probe body 12 can include a socket with a cover so as to
removably capture and rotatably hold the ball within the socket. In
another example the proximal end of urethral guide 22 can include
pins or other protrusions that can be retained in a dimple that is
in the joint of the probe body 12 so as to rotatably couple the
urethral guide to the probe body.
[0090] If it is desirable to only pivot the urethral guide 22 about
one axis, a simple joint 98 can be used to couple the urethral
guide 22 to the probe body 12 so as to allow rotation 100 about a
single axis. As can be appreciated, there are a variety of
conventional methods of rotatably attaching the urethral guide 22
to the probe body 12. In the illustrated example in FIG. 9C,
urethral guide 22 includes a hole 102 that can mate with a pin 104
on the probe body 12. In such embodiments, the urethral guide can
be removable or non-removable and the urethral guide 22 can be
attached to the left and/or right side of the probe body 12.
[0091] It should be appreciated however, that other conventional
attachment means can be used to attach the urethral guide 22 to the
probe body 12. For example, the guide 22 and probe body 12 can be
coupled with a threaded attachment, a toggle clamp mechanism for
pressing a clamping surface of the guide against the probe body, a
sliding latch mechanism clip, a 1/4 turn fastener, or the like.
[0092] In some embodiments of the methods of the present invention,
probe body 12 will be configured to be insertable in a second body
orifice, while guide shaft 22 will be configured to be inserted
into a first body orifice so as to accurately position the probe
body 12 and electrodes 18 adjacent a target tissue in the second
body orifice. Preferably, the probe body 12 will be positioned in
an offset position relative to the guide 22. In a particular
method, the guide shaft 22 is configured for insertion into a
patient's urethra U while the probe body 12 will be configured for
insertion into a patient's vagina V (FIGS. 8 and 9). In such
embodiments, urethral guide 22 will generally have a diameter and
length that allows a distal end 34 of the urethral guide 22 to
extend through the patient's urethra U and into the patient's
bladder B. As such, the urethral guide will have a length between
approximately 3 inches and 6 inches and a diameter between
approximately 0.12 inches and 0.38 inches.
[0093] As illustrated in FIGS. 8 and 9, the urethra U is supported
by triangular shaped fascia sheets FS that have nerve bundles.
Delivery of electrical energy into the fascia sheets FS is
undesirable. The electrical energy is preferably delivered to the
endopelvic fascia EF that is spaced laterally to both sides of the
urethra. To offset the probe 12 away from the fascia sheets and
urethra, a longitudinal axis of guide 22 can be aligned in an
angled arrangement with a longitudinal axis of the probe body 12.
The angled offset moves the probe body laterally (left or right)
away from the urethral tissue and fascia sheets and adjacent the
target endopelvic fascia EF for treatment. Because of the offset
configuration between guide 22 and probe 12, the electrodes 18 will
be offset from urethra U and moved against the target tissue that
is laterally spaced from the urethra (FIG. 8). In order to provide
accurate positioning, in some embodiments, urethral guide 22 is
substantially rigid so as to maintain its relative position between
the electrode 18 and guide shaft 22. As such, guide 22 is also
typically in the form of a rigid shaft. In some embodiments, rigid
guide 22 is at least partially composed of or covered with a
bio-compatible material that is typical of intraurethral catheter
devices. If the guide shaft is too flexible, then the position of
the electrodes 18 relative to the guide shaft 22 may not be
maintained in the desired position and electrical energy may be
inadvertently delivered to non-targeted tissue (e.g. urethra and
nerve bundles surrounding urethra).
[0094] An exemplary embodiment of a method of the present invention
is illustrated in FIGS. 10-13. In a noninvasive medical procedure
to treat incontinence, the urethral guide 22 can be inserted into
the urethra U (FIG. 10). During its distal movement through the
urethra U, expansible member 42 will be in its deflated
configuration. Once the expansible member enters the orifice to the
bladder B, expansible member 42 can be inflated to "lock" the
position of the urethral guide 22 to prevent proximal retraction of
the urethral guide 22 out of the bladder B (FIG. 11). In some
embodiments, the urethral guide can include markings to ensure that
the urethral guide remains in the most proximal position allowed by
the expansible member relative to the bladder neck orifice. If
desired, any liquid that is present in the bladder B can be drained
out of the bladder B through the distal orifice 48 and fluid
channel 46 within the urethral guide.
[0095] FIG. 12 illustrates that the probe body 12 can be inserted
into the patient's vagina V (for clarity guide 22 is not shown).
Once it is grossly determined that the probe has been inserted to
the proper location the urethral guide and probe body can be
attached together with the coupling structure 60 (FIG. 13). Such
coupling will ensure that the distal tip of the probe body 12 is
maintained proximal of the distal end of the guide 22 so as to
position the treatment surface adjacent the target endopelvic
fascia EF and to prevent the electrodes from delivering electrical
energy to the bladder or other non-target tissue. The coupling
structure also will maintain the offset configuration between the
axes of the guide 22 and probe body 12 so as to position the
electrodes offset laterally away from the urethra and towards the
target tissue EF. Optionally, if the guide 22 is positioned below a
top plane of the electrode, the guide may tension the tissue and
bias the electrodes 18 into the target tissue EF.
[0096] While FIGS. 10 and 12 illustrate the urethral guide 22 and
probe body 12 being separately inserted into the body orifices, it
should be appreciated that in alternative embodiments, the urethral
guide 22 and probe body 12 can be simultaneously inserted into the
urethra U and vagina V while fixedly or rotatably connected with
coupling structure 60, 86.
[0097] Some alternative methods of registering the urethral guide
and probe will now be described. FIGS. 14 to 18B illustrate other
embodiments of probe 12 and urethral guide 22 of the present
invention that incorporate a passive registration assembly to
position probe 12 in a position relative to urethral guide 22 so as
to position the treatment surface 18 adjacent the target tissue. In
the illustrated embodiments, urethral guide 22 is configured to be
maintained in a detached position relative to probe 12. Urethral
guide 22 and probe 12 can include landmarks such as an expansion
member, palpation member, or other sensors or transmitter markers
that indicate a mid urethra point. The marker(s) can be placed in
the vagina or the marker can be placed in the urethra and sensed
through the vaginal wall.
[0098] In the embodiment illustrated in FIGS. 14 and 15, a physical
marker can be used to help position probe 12 relative to urethral
guide 22. While probe 12 and urethral guide 22 are not physically
connected, the relative position and/or spacing of the probe 12 and
urethral guide 22 can be used to indicate to the physician as to
whether or not the treatment surface 18 of probe 12 is positioned
adjacent the target tissue.
[0099] After urethral guide 22 is positioned in the urethra U, a
bobby-pin type clip or a U-clip 102 can be coupled to the urethra
guide to provide a physical marker in the vagina for the physician.
In one embodiment, U-clip 102 can include a palpation member 104 at
a distal end that will be positioned in the vagina to allow the
physician to feel the mid-urethra point. In such embodiments, probe
12 can also include a corresponding palpation members 105, such
that when the probe is inserted into the vagina, the physician can
proximally/distally align and laterally offset palpation markers
104, 105 so as to position the treatment surface adjacent the
target tissue and offset from the non-target urethral tissue.
[0100] Palpation members 105 can be opposed bumps or indentations,
an enlarged portion of probe body, an embossed marking, or any
other element that allows the physician to determine by physical
contact, a position of the treatment surface 18. In one embodiment,
palpation members 105 will be on opposite sides of the probe body
and separate from the treatment surface 18. In other embodiments,
however, the palpation members 105 can be positioned on other
surfaces of the probe body, such as on the treatment surface 18 or
the like.
[0101] In the embodiments illustrated in FIGS. 16-18B, instead of
providing a marker in the vagina, the urethral guide 22 can be
configured to provide a marker of the mid-urethra point through the
vaginal wall. For example, as shown in FIG. 16, urethral guide 22
can include an expansion member 110 that creates an expanded region
112 in urethral guide 22. Expanded region 112 will be sized so as
to create a discernible bulge or bump 114 in a vaginal wall. The
physician can then manually feel along the upper vaginal wall to
find bulge 114 and use bulge 114 as a marker for the palpation
members 105 on probe 12. Similar to above, as shown in FIG. 17, the
physician can then position the treatment surface in a laterally
offset and proximally/distally aligned position relative to bulge
114 by aligning palpation members 105 with bulge 114 and
positioning the treatment surface adjacent the target tissue in the
vagina.
[0102] In one embodiment, palpation members 105 can be positioned
laterally from the bump 114 or palpation member 104 between
approximately 1 cm and 2 cm and should not be positioned proximal
or distal of the bump. As can be appreciated, however, it may not
always be possible to proximally/distally align the palpation
members 120 with bump 104, and a proximal or distal offset of
between approximately .+-.5 mm may be acceptable for delivering a
treatment to the target tissue.
[0103] FIG. 18A illustrate one embodiment of a simplified urethral
guide in a relaxed position and FIG. 18B illustrates the urethral
guide in an expanded position. Urethral guide 22 includes an
expansion member 110 and an outer tubular member 130 that defines
at least one inner lumen 132. A second tubular member 133 can be
disposed within lumen 132 such that an expandable region 112 will
be positioned near a center point of urethral guide 22. Positioning
can be achieved by first measuring the urethral length with a
marked urethral guide and pullback of the distal balloon 42 to the
bladder neck. Marks on the inner lumen of the urethral guide permit
its insertion to the correct distance based on the then known
patients urethral length. An elongate shaft 136 can include the
expansion member 110, such as a wedge, balloon, or the like, at or
near its distal end. Elongate shaft 136 can be movably disposed
within lumen 132 such that proximal actuation of elongate shaft 136
by the physician moves expansion member 110 into expandable region
112 so as to enlarge the diameter of outer tubular member 130 from
a first width 140, to a second, larger width 142 (FIG. 18B). The
expansion of the outer tubular member 130 can be used to create
bulge 114 in the vaginal wall.
[0104] FIGS. 19A to 20B illustrate other embodiments of urethral
guide 22 and probe body 12 which utilize an automatic
electromagnetic coupling to assist the physician in positioning the
probe body 12 adjacent the target tissue. In the embodiment
illustrated in FIG. 19A, an RF coupling can be used to transmit and
receive RF energy waves 151 to monitor the position of the probe
relative to the urethral guide. One or more RF transmitters 150 can
be coupled to urethral guide 22 to generate RF energy waves 151. In
the illustrated embodiment, a plurality of RF transmitters 150 are
positioned around a portion of guide 22 that will be positioned at
the mid-urethra. Probe body 12 can include one ore more RF
receivers 152. In the illustrated embodiment, probe body 12 can
include a plurality of RF receivers that are positioned around the
treatment surface. While the RF receivers 152 are illustrated on
the treatment surface, it can be appreciated that the RF receivers
152 can be positioned within probe body 12, along a bottom surface
of probe body, and/or separate from RF receivers. RF receivers 152
need only be positioned on probe body 12 to indicate the relative
position of the treatment surface.
[0105] In another embodiment, illustrated in FIG. 19B, the RF
transmitters 150 can be positioned on probe body 12 while RF
receivers 152 can be positioned on urethral guide 22.
[0106] FIGS. 20A and 20B illustrate another embodiment of probe 12
and guide 22 which use an magnetic coupling to register the probe
body 12 with guide 22. Similar to above, the embodiment illustrated
in FIG. 20A, the urethral guide 22 can include one or more magnetic
source(s) 160, such as a magnet to generate a magnetic field 161.
Probe body 12 can include one or more magnetic field sensors 162,
such as a Hall Effect Sensor to sense the strength of the magnetic
field 161 created by the magnetic sources 160. The strength of the
magnetic field generated by magnetic source 160 and sensed by the
magnetic sensors 162 will produce a signal that is proportional to
the spacing between the source 160 and sensors 162. The magnetic
field can be sensed by sensors 162 and the signal from the sensors
can be transmitted to a controller CPU (not shown) to determine the
position of the probe 12 relative to the urethral guide 22.
[0107] As illustrated in FIG. 20B, in an alternative embodiment,
the magnetic sensors 162 can be positioned on urethral guide 22 and
magnetic sources 160 can be positioned on probe body 12.
[0108] In any of the electromagnetic coupling embodiments, the
transmitters 150, 160 will emit an position signal that will be
received by sensors 152, 162 that will indicate the relative
position of the probe body 12 relative to urethral guide 22. As
illustrated in FIG. 21, in some embodiments, the data from the
sensors can be transmitted to a CPU 170 of controller so as to
generate a graphic representation of urethral guide and probe body
on an output display 172. CPU 170 can analyze the real-time data
received from the sensors to provide direct feedback to the
physician regarding the probe body 12 location within the patient's
vagina.
[0109] Some embodiments of the methods of the present invention
will now be described. As illustrated schematically in FIG. 22,
some methods of the present invention include the step of measuring
a length of the first body orifice (e.g., urethra), 200. In some
embodiments such as that shown in FIGS. 24A to 24F, it may be
possible to directly place the sensor or palpation device at the
mid-urethra position without measuring the length of the first body
orifice.
[0110] After the length of the first body orifice is determined, a
marker (e.g., transmitter, receiver, or physical marker) of the
guide can be advanced into the first body orifice and positioned at
a predetermined point (e.g., halfway into the length of the urethra
or the mid-urethra) which will allow for proper positioning of the
probe, 202. After the guide has been properly positioned, the probe
can be inserted into the second orifice and registered with the
guide, 204. After the probe has been placed in a predetermined
position relative to the guide, the target tissue can be treated
with a treatment surface of the probe, 206.
[0111] A variety of conventional and proprietary methods can be
used to measure the length of the first body orifice and to
calculate the predetermined distance. For example, in the
embodiments in which the first body orifice is the urethra, the
physician may manually measure the length of the urethra and then
calculate the mid-urethra point (approximately half the length of
the urethra).
[0112] One embodiment of a device and method for measuring the
length of the urethra and locating its midpoint is illustrated in
FIGS. 23A to 23F. The device comprises a sensor rod 210 that
includes one or more sensors 212 at or near its distal end 214.
Sensor rod 210 can fit within an inner lumen of guide shaft 22.
Sensor wires can run through a lumen of the sensor rod to
communicate with the controller. Sensor rod 210 can include
positioning graduations 216 that assist the physician in
positioning the sensor(s) at the mid-urethra.
[0113] As shown in FIG. 23B, urethral guide 22 can include a
balloon 42, a locking mechanism 218 around its proximal end 215 and
a sliding stop 220 that can fit over urethral guide 22. Sliding
stop 220 can include a marker M, such as an arrow that is
configured to align with graduations 222 on the outer surface of
the urethral guide to indicate the urethral length.
[0114] After the urethral guide is inserted into the urethra U and
locked into the bladder B with balloon 42, the urethral guide can
be pulled proximally to seat balloon 42 against the bladder neck
BN. Thereafter, the sliding stop 220 can be pushed distally until
it contacts the outer surface of the urethra tissue UT or urethra
meatus (FIG. 23C). As shown in FIG. 23D, once the sliding stop has
reached the urethral tissue, the sliding stop can be locked into
place using spring force on a squeeze clip, expansion pins or a
thumbscrew or other similar mechanisms known to those skilled in
the art. and the graduation 222 that is aligned with marker M can
be read.
[0115] As shown in FIG. 23E, the sensor rod 210 can then be
inserted into the inner lumen of the urethral shaft until the
graduation 216 that matches the graduation 222 on the guide that is
aligned with marker M is aligned with locking mechanism 218. In
such a position, sensors 212 will be positioned at approximately
the midpoint of the measured length of the urethra. The sensor 212
(or transmitter) can be used to measure or generate a position
signal to indicate the position of the mid urethra, as described
above (FIG. 23F).
[0116] In another embodiment, the methods and device illustrated in
FIGS. 24A to 24C can be used to automatically place a sensor or
palpation device at the mid urethra position once the device is
adjusted to equal the total length A of the patient's urethra. As
shown in FIG. 24A, urethral guide 22 can include a movable marker
300 such as an RF/magnetic transmitter or receiver, or an expansion
member disposed within a lumen of urethral guide 22 that is coupled
to a rotating adjustment assembly 304. A stationary proximal body
302 can be coupled to the urethral guide 22 via the rotating
adjustment assembly 304. In the illustrated embodiment, the
position of the marker 300 can move as the adjustment assembly is
rotated and moved axially and will always be positioned at a
half-way point B of the distance A.
[0117] In the illustrated embodiment, a proximal end of urethral
guide 22 can include a 2.times.-pitch screw thread 306 and a distal
end of proximal body 302 can include fine pitch screws that have an
X-fine pitch screw threads 308. Thus, in the illustrated
embodiments in FIGS. 24B and 24C, the urethral guide 22 can be
inserted into the urethra and the adjustment assembly 304 is
rotated and moved into contact against the urethra meatus, such
that the length between the balloon and the distal end of the
adjustment assembly will be equal to A which is then equal to the
patients urethral length. The marker 300 can maintain its center
position at the mid-urethra point B due to the 2:1 pitch difference
of the threads 306, 308 and the sensor or transmitter on the probe
body 12 can be positioned adjacent the mid-urethra point, as
described above. Thereafter, the probe body 12 can be inserted into
the patient's vagina and positioned adjacent the target tissue,
using any of the above recited methods.
[0118] Referring now to FIG. 25, a kit 50 includes a probe 12, a
guide 22 and instructions for use 54. Probe 12, guide 22, and
instructions 54 can be placed in packaging 56. Guide 22 can be any
of the embodiments described above, and instructions 54 can set
forth the steps of one or more of the methods described herein for
heating and shrinking or stiffening tissue for treating urinary
incontinence. Additional elements of the above described systems
may also be included in packaging 56, or may alternatively be
packaged separately.
[0119] Instructions 54 will often comprise printed material, and
may also be found in whole or in part on packaging 56.
Alternatively, instructions may be in the form of a recording disk,
CD-ROM or other computer-readable medium, video tape, sound
recording, or the like.
[0120] Referring now to FIG. 26, an exemplary embodiment of an
incontinence treatment system 400 includes a urethral guide 402 and
treatment probe 404. As generally described above, urethra guide
402 includes a distal portion 406 and proximal portion 408, with
the distal portion being insertable into a urethra 410 of a
patient. The distal portion 406 of urethral guide 402 includes an
expandable body as was also described above, with the expandable
body being insertable transurethrally to the bladder B or bladder
neck. Proximal portion 408 of urethral guide 402 includes a
distally-oriented meatus engaging surface 412 and a urethral
measurement actuating assembly 414.
[0121] Treatment probe 404 also includes a distal portion 406 and a
proximal portion 408. For the treatment probe, the distal portion
406 is insertable into a vagina of a patient (not shown). A probe
body 416 forms both the distal portion 406 and proximal portion 408
of treatment probe 404, with the proximal portion including a
handle 418. The treatment probe 404 is moveable independently of
urethral guide 402, so that the system operating registers a
treatment delivery surface 420 on the distal portion 406 of
treatment probe 404 with the target tissue by manually manipulating
handle 418 from outside the patient, with the urethral guide
providing visual and/or electromagnetic registration
information.
[0122] As illustrated in FIG. 27, the exemplary urethral
measurement assembly 414 of urethral guide 402 measures an axially
length of urethra 410 using urethral engaging surfaces. More
specifically, meatus-engaging surface 414 engages the urethral
meatus, while an expandable body 42 is inflated within the bladder
neck or bladder B. This allows the distal portion of urethral guide
402 to fittingly receive urethra 410 between the meatus-engaging
surface and the expandable body, thereby allowing the assembly to
identify the midpoint of the urethra 424.
[0123] As described above regarding FIGS. 24A-C, and as can be seen
if FIGS. 27-30, an outer urethral shaft 422 includes a lumen in
which an inner shaft 426 can move axially. Rotation of a knob 428
positions meatus-engaging surface 412 relative to expandable body
42 using a coarse-pitch thread 430. A follower 432 engages a
finer-pitch thread 434 with the finer-pitch thread ideally a pitch
1/2 of that of the coarse-pitch thread 430. This results in the
location of the follower 432 along the proximal-distal axis of
urethral guide 402 corresponding to the axial location of the
urethral midpoint 424. As the target tissue will often be disposed
at a fractional portion of the urethral length from the urethral
meatus, bladder neck, or bladder, registration of probe 404
relative to follower 432 of urethral guide 402 thereby allows the
treatment delivery surface 420 of the probe to oriented toward the
target tissue while maintaining safe distance from the nerves
adjacent the bladder neck or the like.
[0124] In the exemplary embodiment, urethral guide 402 includes two
axial registration means 436. The first registration means of
urethral guide 402 include a visual alignment indicator in the form
of a clear protrusion or wing 438, which can be seen in FIGS. 28
and 29. Wing 438 defines a clear window through which a
corresponding visual indicator 440 can be seen when probe 404 is
properly aligned with urethral guide 402, as seen most clearly in
FIG. 29. In the exemplary embodiment, the wings includes proximal
and distal limit indicia in the form of lines 442, thereby
indicating a registration tolerance or acceptable treatment region.
So long as marker 440 is seen through the window of wing 438
between the proximal and distal lines 442 when the system is viewed
from above, the treatment delivery surface 420 is sufficiently
axially registered with the target tissue treatment. Furthermore,
visibility of mark 440 through wing 438 and the visible orientation
of probe 404 relative to urethral guide 402 also provides a visual
indication of the lateral registration of treatment delivery
surface 420 relative to urethra 410, thereby inhibiting damage to
the nerves running along the urethra. A balloon-fill check valve
446 can be seen in the axially view of FIG. 28, while a drained
tube 448 providing a drain lumen for draining or filling the
balloon and/or bladder can be seen in the plane FIG. 29. As can
also be seen in FIG. 29, urethral measurement indicia 450 may be
provide on urethral guide 402 with the physician optionally turning
knob 428 to a pre-determined urethral length, or initially
measuring the urethral length with the urethral guide.
[0125] In the exemplary embodiment of the urethral guide 402,
expandable body 42 comprises an UV cured adhesive bonded
elastomeric balloon attached to a Pebax extrusion dual lumen shaft.
The attachment points of the balloon are reinforced with a heat
shrink sleeve 451 that is placed over the balloon attachment cuff
to inhibit delamination or peeling of the adhesively bonded
balloon. The exemplary heat shrink sleeve 451 may comprise at least
one of polyester, PET, applied adhesive tape, and/or similar
materials.
[0126] Referring now to FIGS. 27 and 31, an electromagnetic
registration means of system 400 comprises a magnet ring 452 which
cooperates with first and second Hall effect sensors 454, 456 to
form a Hall Effect system providing electromagnetic verification of
axial registration between treatment probe 404 and urethral guide
402. Like wing 438, magnet 452 is carried by follower 432 so as to
register the treatment probe with the urethral midpoint. Magnet 452
comprises a ring magnet having a north-south magnetic axis aligned
with the inner shaft of the urethral measurement apparatus. This
facilitates generating a signal verifying that the magnet is
disposed in the 6 mm region between the Hall Effect sensors by
comparing the signals produced from the Hall Effect sensors. A
variety of alternative mechanism may also be provided, including
mounting of one or more Hall Effect sensors on the urethral guide
and one or more magnet on the probe, the use of alternative
electromagnetic transmission/receiving structures, and the
like.
[0127] In the exemplary embodiment, a relative position of the
magnet (emitter 452) is determined by comparing signal strengths
from the Hall effect sensors 454, 456. The signal from each hall
effect sensor typically comprises a voltage, and each respective
voltage is compared to the other. For example, a voltage of 4.0
volts from the proximal sensor 456 and 4.0 volts from the distal
sensor 454 indicates a centered position. A voltage of 1.5 volts
from proximal sensor 456 and 1.5 volts from distal sensor 454 also
indicated a centered position. Signal strengths above a minimum
threshold voltage may be deemed appropriate as long as the voltages
are approximately equal (or within an acceptable range). This
comparison of signals thereby allows a positioning scheme that does
not require an absolute signal strength and does not require
calibration of each registration system and/or treatment probe
404.
[0128] Alternative and/or more accurate embodiments of
electromagnetic registration sensing may also be employed.
Optionally, a peak voltage from each Hall effect sensor 454, 456
may be determined while the user moves the applicator
proximally-distally. A processor may be programmed to retain in
memory these peak voltages, and the peak voltage may be used as a
maximum signal for each of the distal and proximal positions.
[0129] An absolute Hall effect sensor voltage output range may be,
for example 0.0 to 5.0 volts DC. A voltage of less than a
pre-determined threshold (for example, 0.3 volt or less) may
indicate the urethral guide is not sufficiently registered with the
treatment probe, so that the system may be considered out of
registration for normal use. Optionally, such a less-than-threshold
voltage or signal from at least one of sensors 454, 456 may result
in treatment being inhibited or locked out by control software
and/or hardware of treatment system 400. A max allowable threshold
voltage (for example, of 3.5 volts) on one hall effect sensor may
indicate a position at an edge of acceptable placement and will
generally be accompanied by a corresponding low voltage of 1 volt
on the opposite hall effect sensor. Hence, voltages outside an
acceptable voltage range on at least one sensor might be used to
inhibit treatment in some embodiments.
[0130] In the exemplary system, if the voltages from the sensors
are equal to or within 80% of each other, and are above the
threshold, the urethral guide 402 and probe 404 are registered with
a tolerance of +/-2 mm. If this signal threshold percentage
difference is met, the processor will allow application of R.F.
treatment. Varying thresholds may be used to produce larger or
smaller registration windows as desired for each application
[0131] In use, distal portion 406 (see FIG. 26) of urethral guide
402 is introduced into a urethra of a patient. A shaft of the
guide, the meatus-engaging surface 412, and expandable body 42
engage the urethral wall, the urethral meatus, and a bladder neck
or bladder of the patient, respectively. By adjusting the urethral
measurement apparatus 414, meatus-engaging surface 412 and
expandable body 42 can fittingly receive and measure the urethra
410 therebetween, helping to facilitate accurate axial registration
of the urethral guide with the midpoint (or other desired axial
fractional position) of the urethra.
[0132] A distal portion 406 of probe 404 is introduced into a
vagina of the patient. Treatment delivery surface 420 of probe 404
is registered with the target tissue by movement of the probe body
relative to the urethral guide 402 so as to bring the probe into
registration with the guide. This may be effected by
electromagnetically registering the probe body with the urethral
guide by reference to a registration means or body of the guide,
visually registering the probe with a registration means or
registration body of the guide, or the like. In the exemplary
embodiment, a follower of the urethral measurement assembly
includes both a visual registration indicator in the form of wing
438 and an electromagnetic registration indicator in the form of a
magnet. Hence, the system operator visually moves the probe 404
(and/or the urethral guide 402) while viewing the system from above
so as to bring mark 440 on the probe body into view through the
window of wing 438. [See FIG. 9] This indicates that the treatment
directing surface of the probe is positioned within an acceptable
treatment region.
[0133] In the exemplary embodiment, the desired registration
treatment window or tolerance between the urethral guide and the
treatment probe may be less than 10 mm, often being less than 5 mm,
and ideally being +/-2 mm proximal-distal along the urethral axis.
The treatment delivery surface will often comprise an electrode
array having an axial length greater than this registration
tolerance. The target tissue will often be offset laterally from
the urethra and separated laterally from the urethra so as to
inhibit injury to nerves running along the urethra. For example, an
edge of an electrode array (and the electrode surfaces) of the
treatment probe will often be no closer than some predetermined
lateral offset separation distance (for example, 10 mm) from a
urethral centerline. A typical medial-lateral registration
tolerance or window will may be less than 20 mm, often being less
than 10 mm, and ideally being such that a nearest surface of an
electrode of the treatment probe will be separated from the
urethral centerline by between 10 mm to 14 mm. This medial lateral
separation dimension may be revised by collecting data from
clinical trials or studies. An exemplary Hall effect registration
system may be capable registering urethral guide 402 relative to
treatment probe 404 with a tolerance of equal to or less than 1 mm
along the urethral proximal-distal axis. Tighter or looser
registration tolerances may be provided, and the electromagnetic
registration system may be used to guide registration and/or to
verify registration.
[0134] Once the probe 404 is sufficiently registered with the
target tissue and urethral guide, the Hall Effect sensor system
transmits a registration verification signal. This signal may
provide a registration verification indicator such as a light or a
tone to the system operator, or may enable the system operator to
actuate the treatment delivery probe, for example, by completing a
circuit allowing the system operator to energize electrodes.
[0135] While the above is a complete description of the preferred
embodiments of the inventions, various alternatives, modifications,
and equivalents may be used. For example, it may be possible to
make the angular offset of the urethral guide adjustable, laterally
from the probe body and/or orthogonal to a plane of the electrode.
Moreover, instead of inserting the guide and probe in different
body orifices, in alternative uses, both the guide and probe may be
inserted in the same body orifice. Although the foregoing has been
described in detail for purposes of clarity of understanding, it
will be obvious that certain modifications may be practiced within
the scope of the appended claim.
* * * * *