U.S. patent application number 12/924155 was filed with the patent office on 2011-05-12 for systems and methods for controlling use and operation of a family of different treatment devices.
This patent application is currently assigned to Mederi Therapeutics Inc.. Invention is credited to Oleg Shikhman.
Application Number | 20110112529 12/924155 |
Document ID | / |
Family ID | 43796423 |
Filed Date | 2011-05-12 |
United States Patent
Application |
20110112529 |
Kind Code |
A1 |
Shikhman; Oleg |
May 12, 2011 |
Systems and methods for controlling use and operation of a family
of different treatment devices
Abstract
A system for controlling a treatment device generates a
graphical interface that visually prompts a user in a step-wise
fashion to use the treatment device to perform a process of forming
a pattern of lesions that extends both circumferentially and
axially in different levels in a body region. The graphical
interface displays for the user a visual record of the progress of
the process from start to finish and guides the user so that so
that individual lesions desired within a given level are all
formed, and that a given level of lesions is not skipped.
Inventors: |
Shikhman; Oleg; (Trumbull,
CT) |
Assignee: |
Mederi Therapeutics Inc.
|
Family ID: |
43796423 |
Appl. No.: |
12/924155 |
Filed: |
September 22, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61277260 |
Sep 22, 2009 |
|
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Current U.S.
Class: |
606/41 ;
715/705 |
Current CPC
Class: |
A61B 18/08 20130101;
A61B 18/1485 20130101; A61B 18/02 20130101; A61B 18/1206 20130101;
A61B 2018/1425 20130101; A61B 2018/1807 20130101; G06F 3/048
20130101; A61B 34/25 20160201; G06F 3/04817 20130101; A61B 18/1815
20130101; A61B 2034/252 20160201; A61B 2018/1861 20130101; A61B
2218/007 20130101; A61B 34/20 20160201; A61B 2018/00553 20130101;
A61B 2034/2065 20160201; A61B 18/18 20130101; G06F 3/04847
20130101; A61B 18/1492 20130101; A61B 2034/254 20160201; A61B
2018/0212 20130101; A61B 2018/044 20130101; A61N 7/00 20130101;
G16H 40/63 20180101; A61B 2218/002 20130101; A61B 18/20 20130101;
A61N 2007/0043 20130101; A61B 18/1477 20130101 |
Class at
Publication: |
606/41 ;
715/705 |
International
Class: |
A61B 18/14 20060101
A61B018/14; G06F 3/00 20060101 G06F003/00 |
Claims
1. A graphical user interface comprising a controller including
means for visually prompting a user in a step-wise fashion to
perform a process of forming a pattern of lesions in a body region
comprising a plurality of axially spaced lesion levels, each lesion
level comprising a plurality of circumferential spaced lesions, and
further including means for registering the formation of lesions as
they are generated in real time, both within and between each
circumferentially spaced level, whereby the controller displays for
the user a visual record of the progress of the process from start
to finish and guides the user so that individual lesions desired
within a given level are all formed, and that a given level of
lesions is not skipped.
2. A graphical user interface comprising a controller including
means for visually prompting a user in a step-wise fashion to
perform a process of forming a pattern of lesions in a body region
comprising a plurality of axially spaced lesion levels, each lesion
level comprising a plurality of circumferential spaced lesions, and
including means for generating at each lesion level a first
stylized graphical image with a number identification of its level,
means for generating a second stylized graphical image, different
from the first stylized graphical image, generated when the
formation of lesions at a given level is indicated and further
showing the number of lesions to be formed at that level, means for
changing the second graphical image to a third graphical image,
different than the first or second images, including added indicia
to reflect the formation of lesions in real time, and means for
generating, upon forming the desired lesion pattern on the
respective lesion level, a fourth graphical image, different than
the first, second, and third graphical images, comprising an
indicator to indicate that all desired lesions have been formed at
the level, and further including means for generating a marker that
directs the user to the next lesion level to be treated and that is
updated as successive lesion levels are treated.
3. A system for controlling operation of a family of treatment
devices comprising a family of treatment devices comprising at
least first and second different treatment devices which are
intended to be individually deployed for use in different tissue
regions, a controller including a connector to which a selected one
of the first or second treatment device is coupled for use, the
controller including means for identifying which of the first and
second different treatment devices has been connected, the
controller further including an operation system to execute on a
display screen a first graphical interface guiding use of the first
treatment device only when the first treatment device is connected
and a second graphical interface different, at least in part, from
the first graphical interface and guiding use of the second
treatment device only when the second treatment device is
connected, the controller including, for at least one of the first
and second graphical interface, means for visually prompting a user
in a step-wise fashion to perform a process using the connected
treatment device of forming a pattern of lesions in a body region
comprising a plurality of axially spaced lesion levels, each lesion
level comprising a plurality of circumferential spaced lesions, and
further including means for registering the formation of lesions as
they are generated in real time, both within and between each
circumferentially spaced level, whereby the graphical user
interface displays for the user a visual record of the progress of
the process from start to finish and guides the user so that
individual lesions desired within a given level are all formed, and
that a given level of lesions is not skipped.
4. A system according to claim 3 wherein one of the treatment
devices is sized and configured to form lesions at or near a lower
esophageal sphincter.
5. A system according to claim 3 wherein one of the treatment
devices is sized and configured to form lesions at or near an anal
sphincter.
6. A method comprising generating a graphical display for visually
prompting a user in a step-wise fashion to perform a process of
forming a pattern of lesions in a body region comprising a
plurality of axially spaced lesion levels, each lesion level
comprising a plurality of circumferential spaced lesions, and
further including registering the formation of lesions as they are
generated in real time, both within and between each
circumferentially spaced level, whereby the graphical display
displays for the user a visual record of the progress of the
process from start to finish and guides the user so that individual
lesions desired within a given level are all formed, and that a
given level of lesions is not skipped.
7. A method comprising generating a graphical display for visually
prompting a user in a step-wise fashion to perform a process of
forming a pattern of lesions in a body region comprising a
plurality of axially spaced lesion levels, each lesion level
comprising a plurality of circumferential spaced lesions by
generating at each lesion level a first stylized graphical image
with a number identification of its level, generating a second
stylized graphical image, different from the first stylized
graphical image, generated when the formation of lesions at a given
level is indicated and further showing the number of lesions to be
formed at that level, changing the second graphical image to a
third graphical image, different than the first or second images,
including added indicia to reflect the formation of lesions in real
time, and generating, upon forming the desired lesion pattern on
the respective lesion level, a fourth graphical image, different
than the first, second, and third graphical images, comprising an
indicator to indicate that all desired lesions have been formed at
the level, and further generating a marker that directs the user to
the next lesion level to be treated and that is updated as
successive lesion levels are treated.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of provisional
application Ser. No. 61/277,260 filed 22 Sep. 2009.
FIELD OF THE INVENTION
[0002] In a general sense, the invention is directed to systems and
methods for treating interior tissue regions of the body. More
specifically, the invention is directed to systems and methods for
treating dysfunction in body sphincters and adjoining tissue.
BACKGROUND OF THE INVENTION
[0003] The gastrointestinal (GI) tract, also called the alimentary
canal, is a long tube through which food is taken into the body and
digested. The alimentary canal begins at the mouth, and includes
the pharynx, esophagus, stomach, small and large intestines, and
rectum. In human beings, this passage is about 30 feet (9 meters)
long.
[0004] Small, ring-like muscles, called sphincters, surround
portions of the alimentary canal. In a healthy person, these
muscles contract or tighten in a coordinated fashion during eating
and the ensuing digestive process, to temporarily close off one
region of the alimentary canal from another region of the
alimentary canal.
[0005] For example, a muscular ring called the lower esophageal
sphincter (or LES) surrounds the opening between the esophagus and
the stomach. Normally, the lower esophageal sphincter maintains a
high-pressure zone between fifteen and thirty mm Hg above
intragastric pressures inside the stomach.
[0006] In the rectum, two muscular rings, called the internal and
external sphincter muscles, normally keep fecal material from
leaving the anal canal. The external sphincter muscle is a
voluntary muscle, and the internal sphincter muscle is an
involuntary muscle. Together, by voluntary and involuntary action,
these muscles normally contract to keep fecal material in the anal
canal.
[0007] Dysfunction of a sphincter in the body can lead to internal
damage or disease, discomfort, or otherwise adversely affect the
quality of life. For example, if the lower esophageal sphincter
fails to function properly, stomach acid may rise back into the
esophagus. Heartburn or other disease symptoms, including damage to
the esophagus, can occur. Gastrointestinal reflux disease (GERD) is
a common disorder, characterized by spontaneous relaxation of the
lower esophageal sphincter.
[0008] Damage to the external or internal sphincter muscles in the
rectum can cause these sphincters to dysfunction or otherwise lose
their tone, such that they can no longer sustain the essential
fecal holding action. Fecal incontinence results, as fecal material
can descend through the anal canal without warning, stimulating the
sudden urge to defecate. The physical effects of fecal incontinence
(i.e., the loss of normal control of the bowels and gas, liquid,
and solid stool leakage from the rectum at unexpected times) can
also cause embarrassment, shame, and a loss of confidence, and can
further lead to mental depression.
SUMMARY OF THE INVENTION
[0009] One aspect of the invention provides systems and methods for
treating body tissue that comprise generating a graphical display
for visually prompting a user in a step-wise fashion to use a
treatment device to perform a process of forming a pattern of
lesions in a body region comprising a plurality of axially spaced
lesion levels, each lesion level comprising a plurality of
circumferential spaced lesions. The systems and methods include
registering the formation of lesions as they are generated in real
time, both within and between each circumferentially spaced level,
whereby the graphical display displays for the user a visual record
of the progress of the process from start to finish and guides the
user so that individual lesions desired within a given level are
all formed, and that a given level of lesions is not skipped.
[0010] In one embodiment, the systems and methods include
generating at each lesion level a first stylized graphical image
with a number identification of its level, and generating a second
stylized graphical image, different from the first stylized
graphical image, generated when the formation of lesions at a given
level is indicated and further showing the number of lesions to be
formed at that level. The systems and methods include changing the
second graphical image to a third graphical image, different than
the first or second images, including added indicia to reflect the
formation of lesions in real time. The systems and methods further
include generating, upon forming the desired lesion pattern on the
respective lesion level, a fourth graphical image, different than
the first, second, and third graphical images, comprising an
indicator to indicate that all desired lesions have been formed at
the level. The systems and methods further include generating a
marker that directs the user to the next lesion level to be treated
and that is updated as successive lesion levels are treated.
[0011] Further features and advantages of the inventions are set
forth in the following Description and Drawings, as well as in the
appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 FIG. 1 is a diagrammatic view of a unified system
usable in association with a family of different treatment devices
for treating body sphincters and adjoining tissue regions in
different regions of the body.
[0013] FIG. 2 is a perspective view, with portions broken away, of
one type of treatment device usable in association with the system
shown in Fig. I to treat tissue in the upper gastro-intestinal
tract, the treatment device having an operative element for
contacting tissue shown in a collapsed condition.
[0014] FIG. 3 is a perspective view, with portions broken away, of
the device shown in FIG. 2, with the operative element shown in an
expanded condition.
[0015] FIG. 4 is a perspective view, with portions broken away, of
the device shown in FIG. 2, with the operative element shown in an
expanded condition and the electrodes extended for use.
[0016] FIG. 5 is a lesion pattern that can be formed by
manipulating the device shown FIGS. 2 to 4 in the esophagus at or
near the lower esophageal sphincter and in the cardia of the
stomach, comprising a plurality of axially spaced lesion levels,
each lesion level comprising a plurality of circumferential spaced
lesions.
[0017] FIG. 6 is a perspective view of another type of treatment
device usable in association with the system shown in FIG. 1 to
treat tissue in the lower gastrointestinal tract, the treatment
device having an array of electrodes shown in a retracted
position.
[0018] FIG. 7 is a perspective view of the device shown in FIG. 6,
with the array of electrodes shown in their extended position.
[0019] FIG. 8 is a perspective view of the device shown in FIGS. 6
and 7, with the array of electrodes shown in their extended
position deployed in the lower gastrointestinal tract to treat
sphincter dysfunction in the anal canal.
[0020] FIG. 9 is a lesion pattern that can be formed by
manipulating the device as shown FIG. 8 in the anal canal at or
near the anal sphincter, comprising a plurality of axially spaced
lesion levels, each lesion level comprising a plurality of
circumferential spaced lesions.
[0021] FIGS. 10A and 10B are, respectively, left and right
perspective views of one embodiment of an integrated device
incorporating features of the system shown in FIG. 1 and usable
with either treatment device shown in FIG. 2 or 6 for treating body
sphincters and adjoining tissue regions, and also having controller
that a graphical user display for visually prompting a user in a
step-wise fashion to use a treatment device to perform a process of
forming a pattern of lesions in a body region like that shown in
FIG. 5 or 9, to guide the user so that individual lesions desired
within a given level are all formed, and that a given level of
lesions is not skipped.
[0022] FIG. 11 is a representative graphical user set-up display
generated by the controller prompting the user with numbers and/or
text and/or icons through the set-up and connection steps prior to
a treatment procedure.
[0023] FIG. 12 is a representative graphical user set-up display
generated by the controller upon identifying the connection of a
device like that shown in FIGS. 2 to 4 (identified by the trademark
STETTA.RTM.).
[0024] FIG. 13 is a representative graphical user set-up display
generated by the controller upon identifying the connection of a
device like that shown in FIGS. 6 to 8 (identified by the trademark
SECCA.RTM.).
[0025] FIGS. 14-A to 14-O are representative graphical user
treatment displays generated by the controller for visually
prompting a user to use a treatment device like that shown in FIGS.
2 to 4 in a step-wise fashion to perform a process of forming a
pattern of lesions in an esophagus like that shown in FIG. 5, the
graphical user display guiding the user and creating a visual
record of the progress of the process from start to finish, so that
individual lesions desired within a given level are all formed, and
that a given level of lesions is not skipped.
[0026] FIGS. 15A to 15I are representative graphical user treatment
displays generated by the controller for visually prompting a user
to use a treatment device like that shown in FIGS. 6 to 8 in a
step-wise fashion to perform a process of forming a pattern of
lesions in an anal canal like that shown in FIG. 9, the graphical
user display guiding the user and creating a visual record of the
progress of the process from start to finish, so that individual
lesions desired within a given level are all formed, and that a
given level of lesions is not skipped.
[0027] The invention may be embodied in several forms without
departing from its spirit or essential characteristics. The scope
of the invention is defined in the appended claims, rather than in
the specific description preceding them. All embodiments that fall
within the meaning and range of equivalency of the claims are
therefore intended to be embraced by the claims.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0028] This Specification discloses various systems and methods for
treating dysfunction of sphincters and adjoining tissue regions in
the body. The systems and methods are particularly well suited for
treating these dysfunctions in the upper and lower gastrointestinal
tract, e.g., gastro-esophageal reflux disease (GERD) affecting the
lower esophageal sphincter and adjacent cardia of the stomach, or
fecal incontinence affecting the internal and external sphincters
of the anal canal. For this reason, the systems and methods will be
described in this context. Still, it should be appreciated that the
disclosed systems and methods are applicable for use in treating
other dysfunctions elsewhere in the body, and dysfunctions that are
not necessarily sphincter-related. For example, the various aspects
of the invention have application in procedures requiring treatment
of hemorrhoids, or urinary incontinence, or restoring compliance to
or otherwise tightening interior tissue or muscle regions. The
systems and methods that embody features of the invention are also
adaptable for use with systems and surgical techniques that
catheter-based and not necessarily catheter-based.
I. Overview of the System
[0029] FIG. 1 shows a unified system 24 for diagnosing and/or
treating dysfunction of sphincters and adjoining tissue in
different regions of the body. In the illustrated embodiment, the
system 24 is configured to diagnose and treat dysfunction in at
least two distinct sphincter regions within the body.
[0030] The targeted sphincter regions can vary. In the illustrated
embodiment, one region comprises the upper gastro-intestinal tract,
e.g., the lower esophageal sphincter and adjacent cardia of the
stomach. The second region comprises the lower gastrointestinal
tract, e.g., in the intestines, rectum and anal canal.
[0031] The system 24 includes a family of treatment devices 26a and
26b. Each device 26a and 26b can be specifically configured
according to the physiology and anatomy of the particular sphincter
region which it is intended to treat. The details of construction
of each device 26a and 26b will be generally described later for
purposes of illustration, but are not material to the
invention.
[0032] Each device 26a/26b carries an operative element 36a and
36b. The operative element 36a and 36b can be differently
configured according to the physiology and anatomy of the
particular sphincter region which it is intended to treated. Still,
if the anatomy and physiology of the two treatment regions are the
same or similar enough, the configuration of the operative elements
36a and 36b can be same or essentially the same.
[0033] In the illustrated embodiment, the operative elements 36a
and 36b function in the system 10 to apply energy in a selective
fashion to tissue in or adjoining the targeted sphincter region.
The applied energy creates one or more lesions, or a prescribed
pattern of lesions, below the surface of the targeted region. The
subsurface lesions are desirably formed in a manner that preserves
and protects the surface against thermal damage.
[0034] Natural healing of the subsurface lesions leads to a
physical tightening of the targeted tissue. The subsurface lesions
can also result in the interruption of aberrant electrical pathways
that may cause spontaneous sphincter relaxation. In any event, the
treatment can restore normal closure function to the sphincter
region 18.
[0035] The system 24 includes a generator 38 to supply the
treatment energy to the operative element 36a/36b of the device
26a/26b selected for use. In the illustrated embodiment, the
generator 38 supplies radio frequency energy, e.g., having a
frequency in the range of about 400 kHz to about 10 mHz. Of course,
other forms of energy can be applied, e.g., coherent or incoherent
light; heated or cooled fluid; resistive heating; microwave;
ultrasound; a tissue ablation fluid; or cryogenic fluid.
[0036] A selected device 26a/26b can be individually coupled to the
generator 38 via a cable 10 to convey the generated energy to the
respective operative element 36a/36b.
[0037] The system 24 preferably also includes certain auxiliary
processing equipment. In the illustrated embodiment, the processing
equipment comprises an external fluid delivery apparatus 44 and an
external aspirating apparatus 46.
[0038] A selected device 26a/26b can be connected via tubing 12 to
the fluid delivery apparatus 44, to convey processing fluid for
discharge by or near the operative element 36a/36b. A selected
device 26a/26b can also be connected via tubing 14 to the
aspirating apparatus 46, to convey aspirated material from or near
from the operative element 36a/36b for discharge.
[0039] The system 24 also includes a controller 52. The controller
52, which preferably includes a central processing unit (CPU), is
linked to the generator 38, the fluid delivery apparatus 44, and
the aspirating apparatus 46. Alternatively, the aspirating
apparatus 46 can comprise a conventional vacuum source typically
present in a physician's suite, which operates continuously,
independent of the controller 52.
[0040] The controller 52 governs the power levels, cycles, and
duration that the radio frequency energy is distributed to the
particular operative element 36a/36b, to achieve and maintain power
levels appropriate to achieve the desired treatment objectives. In
tandem, the controller 52 also desirably governs the delivery of
processing fluid and, if desired, the removal of aspirated
material.
[0041] The controller 52 includes an input/output (I/O) device 54.
The I/O device 54 allows the physician to input control and
processing variables, to enable the controller to generate
appropriate command signals. The I/O device 54 also receives real
time processing feedback information from one or more sensors
associated with the operative element (as will be described later),
for processing by the controller 52, e.g., to govern the
application of energy and the delivery of processing fluid.
[0042] The I/O device 54 also includes a graphical user interface
(GUI), to graphically present processing information to the
physician for viewing or analysis. Further details regarding the
GUI will be provided later.
II. The Treatment Devices
[0043] The structure of the operative element 36 can vary.
[0044] Various representative embodiments will be described.
[0045] A. For Treatment of Upper Gastro-Intestinal Tract
[0046] FIGS. 2 to 4 show a catheter-based device 26a for treating
sphincter regions in the upper gastro-intestinal tract, and more
particularly, the lower esophageal sphincter and adjoining cardia
of the stomach to treat GERD. In the embodiment shown, the device
26a includes a flexible catheter tube 30 that carries a handle 28
at its proximal end. The distal end of the catheter tube 30 carries
the operative element 36a.
[0047] In the illustrated embodiment, the operative element 36a
comprises a three-dimensional basket 56. The basket 56 includes one
or more spines 58, and typically includes from four to eight spines
58, which are assembled together by a distal hub 60 and a proximal
base 62. In the illustrated embodiment, four spines 58 are shown,
spaced circumferentially at 90-degree intervals
[0048] In the illustrated embodiment, an expandable structure 72
comprising a balloon is located within the basket 56. The balloon
structure 72 can be made, e.g., from a Polyethylene Terephthalate
(PET) material, or a polyamide (non-compliant) material, or a
radiation cross-linked polyethylene (semi-compliant) material, or a
latex material, or a silicone material, or a C-Flex (highly
compliant) material.
[0049] The balloon structure 72 presents a normally, generally
collapsed condition, as FIG. 2 shows. In this condition, the basket
56 is also normally collapsed about the balloon structure 72,
presenting a low profile for deployment into the esophagus.
[0050] A catheter tube 30 includes an interior lumen, which
communicates with the interior of the balloon structure 72. A
fitting 76 (e.g., a syringe-activated check valve) is carried by
the handle 28. The fitting 76 communicates with the lumen. The
fitting 76 couples the lumen to a syringe 78 (see FIG. 3). The
syringe 78 injects fluid under pressure through the lumen into the
balloon structure 72, causing its expansion.
[0051] Expansion of the balloon structure 72 urges the basket 56 to
open and expand (see FIG. 3). The force exerted by the balloon
structure 72, when expanded, is sufficient to exert an opening or
dilating force upon the tissue surrounding the basket 56 (see FIG.
31).
[0052] Each spine 58 carries an electrode 66 (see FIG. 4).
Therefore, there are four electrodes circumferentially spaced at
90-degree intervals. In the illustrated embodiment, each electrode
66 is carried within the tubular spine 58 for sliding movement.
Each electrode 66 slides from a retracted position, withdrawn in
the spine 58 (shown in FIG. 3) and an extended position, extending
outward from the spine 58 (see FIG. 4) through a hole in the spine
58. A push-pull lever 68 on the handle 28 is coupled by one or more
interior wires to the sliding electrodes 66. The lever 68 controls
movement electrodes between the retracted position (by pulling
rearward on the lever 68) and the extended position (by pushing
forward on the lever 68).
[0053] The electrodes 66 have sufficient distal sharpness and
strength, when extended, to penetrate a desired depth into tissue
the smooth muscle of the lower esophageal sphincter 18 or the
cardia of the stomach 16 (see FIG. 32). The desired depth can range
from about 4 mm to about 5 mm.
[0054] The electrodes 66 are formed of material that conducts radio
frequency energy, e.g., nickel titanium, stainless steel, e.g., 304
stainless steel, or a combination of nickel titanium and stainless
steel.
[0055] In the illustrated embodiment (see FIG. 4), an electrical
insulating material 70 is coated about the proximal end of each
electrode 66. When the distal end of the electrode 66 penetrating
the smooth muscle of the esophageal sphincter 18 or cardia 20
transmits radio frequency energy, the material 70 insulates the
mucosal surface of the esophagus 10 or cardia 20 from direct
exposure to the radio frequency energy. Thermal damage to the
mucosal surface is thereby avoided. The mucosal surface can also be
actively cooled during application of radio frequency energy, to
further protect the mucosal surface from thermal damage.
[0056] In the illustrated embodiment (see FIG. 4), at least one
temperature sensor 80 is associated with each electrode. One
temperature sensor 80 senses temperature conditions near the
exposed distal end of the electrode 66, a second temperature sensor
80 is located on the corresponding spine 58, which rests against
the mucosal surface when the balloon structure 72 is inflated.
[0057] The external fluid delivery apparatus 44 is coupled via
tubing 12 (see FIG. 1) to connector 48 (see FIG. 4), to supply
cooling liquid to the targeted tissue, e.g., through holes in the
spines. The external aspirating apparatus 46 is coupled via tubing
14 (see FIG. 1) to connector 50 (see FIG. 4), to convey liquid from
the targeted tissue site, e.g., through other holes in the spine or
elsewhere on the basket 56. The controller 52 can govern the
delivery of processing fluid and, if desired, the removal of
aspirated material.
[0058] The controller 52 can condition the electrodes 66 to operate
in a monopolar mode. In this mode, each electrode 66 serves as a
transmitter of energy, and an indifferent patch electrode
(described later) serves as a common return for all electrodes 66.
Alternatively, the controller 52 can condition the electrodes 66 to
operate in a bipolar mode. In this mode, one of the electrodes
comprises the transmitter and another electrode comprises the
return for the transmitted energy. The bipolar electrode pairs can
electrodes 66 on adjacent spines, or electrodes 66 spaced more
widely apart on different spines.
[0059] In use, the device 26a is manipulated to create a preferred
pattern of multiple lesions comprising circumferential rings of
lesions at several axially spaced-apart levels (about 5 mm apart),
each level comprising from 8 to 12 lesions. A representative
embodiment of the lesion pattern is shown in FIG. 5. As FIG. 5
shows, the rings are preferably formed in the esophagus in regions
above the stomach, at or near the lower esophageal sphincter,
and/or in the cardia of the stomach. The rings in the cardia are
concentrically spaced about the opening funnel of the cardia. At or
near the lower esophageal sphincter, the rings are axially spaced
along the esophagus.
[0060] Multiple lesion patterns can be created by successive
extension and retraction of the electrodes 66, accompanied by
rotation and/or axial movement of the catheter tube to reposition
the basket 56. The physician can create a given ring pattern by
expanding the balloon structure 72 and extending the electrodes 66
at the targeted treatment site, to form a first set of four
lesions. The physician can then withdraw the electrodes 66,
collapse the balloon structure 72, and rotate the catheter tube 30
by a desired amount, e.g., 30-degrees or 45-degrees, depending upon
the number of total lesions desired within 360-degrees. The
physician can then again expand the structure 72 and again extend
the electrodes 66, to achieve a second set of four lesions. The
physician repeats this sequence until a desired number of lesions
within the 360-degree extent of the ring is formed. Additional
lesions can be created at different levels by advancing the
operative element axially, gauging the ring separation by external
markings on the catheter tube.
[0061] As shown in FIG. 5, a desirable pattern comprises an axially
spaced pattern of six circumferential lesions numbered Level 1 to
Level 6 in an inferior direction, with some layers in the cardia of
the stomach, and others in the esophagus above the stomach at or
near the lower esophageal sphincter. In the embodiment shown in
instant FIG. 5, in the Levels 1, 2, 3, and 4, there are eight
lesions circumferentially spaced 45-degrees apart (i.e., a first
application of energy, followed by a 45-degree rotation of the
basket 56, followed by a second application of energy). In the
Levels 5 and 6, there are twelve lesions circumferentially spaced
30-degrees apart (i.e., a first application of energy, followed by
a 30-degree rotation of the basket 56, followed by a second
application of energy, followed by a 30-degree rotation of the
basket 56, followed by a third application of energy). In Level 5,
the balloon structure 72 is only partially expanded, whereas in
Level 6, the balloon structure 72 is more fully expanded, to
provide lesion patterns that increase in circumference according to
the funnel-shaped space available in the funnel of the cardia.
[0062] B. For Treatment of Lower Gastro-Intestinal Tract
[0063] FIGS. 6 and 7 show a representative embodiment for device
26b, which takes the form of a hand manipulated device 302 for
treating sphincter regions in the lower gastro-intestinal tract,
and more particularly, the internal and/or external sphincter
muscles in the anal canal to treat fecal incontinence. The device
302 includes a hand grip 304 that carries the operative element
36b.
[0064] In the illustrated embodiment, the operative element 36b
takes the form of a hollow, tubular barrel 306 made from a
transparent, molded plastic material. The barrel 306 terminates
with a blunt, rounded distal end 308 to aid passage of the barrel
306 through the anal canal, without need for a separate introducer.
The hand grip 304 includes a viewing port 312 for looking into the
transparent, hollow interior of the barrel 306, to visualize
surrounding tissue.
[0065] An array of needle electrodes 316 are movably contained in a
side-by-side relationship along an arcuate segment of the barrel
306. In the illustrated embodiment, the needle electrodes 316
occupy an arc of about 67.5 degrees on the barrel 306. The needle
electrodes 316 are mechanically linked to a finger-operated pull
lever 318 on the hand grip 304. By operation of the pull lever 318,
the distal ends of the needle electrodes 316 are moved between a
retracted position (FIG. 5) and an extended position (FIG. 6 of the
'523 patent). An electrical insulating material 344 is coated about
the needle electrodes 316 (see FIG. 6 of the '523 patent), except
for a prescribed region of the distal ends, where radio frequency
energy is applied to tissue. The generator 38 is coupled via the
cable 10 to a connector 352, to convey radio frequency energy to
the electrodes 316.
[0066] In use (see FIG. 8), the physician grasps the hand grip 304
and guides the barrel 306 into the anal canal 320. The pull lever
318 is in the neutral position and not depressed, so the needle
electrodes 316 occupy their normal retracted position. Looking
through the viewing port 312, the physician visualizes the
pectinate (dentate) line through the barrel 306. Looking through
the barrel 306, the physician positions the distal ends of the
needle electrodes 316 at a desired location relative to the
pectinate (dentate) line. A fiberoptic can also be located in the
barrel 306 to provide local illumination. Once the distal end of
the barrel 306 is located at the targeted site, the physician
depresses the pull lever 318 (as FIG. 8 shows). The needle
electrodes 316 advance to their extended positions. The distal ends
of the electrodes 316 pierce and pass through the mucosal tissue
into the muscle tissue of the target sphincter muscle. In FIG. 8,
the distal end of the electrodes 316 are shown penetrating the
involuntary, internal sphincter muscle 322. The physician commands
the controller 52 to apply radio frequency energy through the
needle electrodes 316. The energy can be applied simultaneously by
all electrodes 316, or in any desired sequence.
[0067] The external fluid delivery apparatus 44 is coupled via
tubing 12 to a connector 348 to convey a cooling liquid, e.g.,
through holes in the barrel 306, to contact tissue at a localized
position surrounding the electrodes 316. The external aspirating
apparatus 46 is coupled via tubing 14 to a connector 350 to convey
liquid from the targeted tissue site, e.g., through an aspiration
port 358 in the distal end 308 of the barrel 306 (see FIGS. 6 and
7).
[0068] The barrel 306 (see FIG. 7) also preferably carries
temperature sensor 364, one of which is associated with each needle
electrode 316. The sensors 364 sense tissue temperature conditions
in the region adjacent to each needle electrode 316. Preferably,
the distal end of each needle electrode 316 also carries a
temperature sensor 372 (see FIG. 7).
[0069] In use (see FIG. 9), a preferred pattern of multiple lesions
is formed comprises several circumferential rings of lesions in
axially spaced-apart levels (about 5 mm apart), each ring
comprising 16 lesions in four quadrants of 4 each. The rinds are
formed axially along the anal canal, at or near the dentate
line.
[0070] The fluid delivery apparatus 68 conveys cooling fluid for
discharge at the treatment site, to cool the mucosal surface while
energy is being applied by the needle electrodes 316. The
aspirating apparatus 76 draws aspirated material and the processing
fluid through the tubing 78 for discharge.
[0071] Referring to FIG. 9, the array of needle electrodes 316 is
positioned at Level 1 to create four multiple lesions in the first
quadrant. Upon the satisfactory creation of the lesion pattern in
the first quadrant of Level 1, as just described, the physician
actuates the button 64 to release the locking pawl 58 from the
detent 62. The pull lever 52 returns to the spring-biased neutral
position, thereby moving the needle electrodes 316 back to their
retracted positions. Still grasping the hand grip 40 and
visualizing through the viewing port 46, the physician moves the
barrel 5 mm axially upward to Level 2, the first quadrant. The
physician again deploys the needle electrodes 48 and performs
another lesion generating sequence. The physician repeats this
sequence of steps until additional number of lesion patterns are
formed within the axially spaced first quadrants in Levels 1, 2, 3,
4, and 5.
[0072] Still grasping the hand grip 40 and visualizing through the
viewing port 46, the physician returns to level 1, and rotates the
barrel 42 a selected arcuate distance at the level of the first
lesion pattern 94 to the second quadrant, i.e., by rotating the
barrel 42 by ninety degrees.
[0073] The physician again deploys the needle electrodes 48 and
performs another lesion generating sequence at quadrant 2 of Level
1. The physician then moves the barrel axially upward in 5 mm
increments, at a number of axially spaced levels 2, 3, 4, and 5
generally aligned with lesion patterns 96, 98, and 100. Lesions are
formed in this way in the second quadrant of Levels 1, 2, 3, 4, and
5.
[0074] The physician repeats the above described sequence two
additional times, returning the barrel to level 1 and rotating the
barrel 42 at successive intervals and axially repositioning the
barrel 42 to form the lesion patterns quadrants 3 and 4 in the
Levels 1, 2, 3, 4, and 5. This protocol forms a composite lesion
pattern 102, which provides a density of lesions in the targeted
sphincter tissue region to provoke a desired contraction of the
sphincter tissue.
III. System Operation
[0075] In the illustrated embodiment (see FIGS. 10A and 10B), the
radio frequency generator 38, the controller 52 with I/O device 54,
and the fluid delivery apparatus 44 (e.g., for the delivery of
cooling liquid) are integrated within a single housing 400.
[0076] The I/O device 54 couples the controller 52 to a display
microprocessor 474 (see FIG. 10A). The display microprocessor 474
is coupled to a graphics display monitor 420 in the housing 400.
The controller 52 implements through the display microprocessor 474
the graphical user interface, or GUI, which is displayed on the
display monitor 420. The graphical user interface is can be
realized with conventional graphics software using the MS
WINDOWS.RTM. application. The GUI 424 is implemented by showing on
the monitor 420 basic screen displays.
[0077] A. Set-Up
[0078] Upon boot-up of the CPU (see FIG. 11), the operating system
implements the SET-UP function for the GUI 500. The GUI displays an
appropriate start-up logo and title image (not shown), while the
controller 52 performs a self-test. An array of SETUP prompts 502
leads the operator in a step-wise fashion through the tasks
required to enable use of the generator and device. The physician
can couple the source of cooling liquid to the appropriate port on
the handle of the device 26a/26b (see FIG. 10A, as previously
described) and load the tubing leading from the source of cooling
liquid (e.g., a bag containing sterile water) into the pump rotor
428 (see FIG. 10B). The physician can also couple the aspiration
source 46 to the appropriate port on the handle of the treatment
device 26a/26b (as also already described). The physician can also
couple the patch electrode 412 and foot pedal 416 (shown in FIG.
10A). In the SET-UP prompt array 502, a graphic field of the GUI
500 displays one or more icons and/or alpha-numeric indicia 502
that prompt the operator to connect the return patch electrode 412,
connect the foot pedal or switch 416, connect the selected
treatment device 26a (designed by its trademark STRETTA.RTM.) or
26b (designated by its trademark SECCA.RTM.), and to prime the
irrigation pump 44.
[0079] The controller 52 ascertains which device 26a or 26b has
been selected for use by reading a coded identification component
residing in the handle of the device 26a or 26b. Based upon this
input, the controller 52 proceeds to execute the preprogrammed
control and graphical GUI command functions for the particular
device 26a and 26b that is coupled to the generator.
[0080] If the identification code for the device 26a,
(STRETTA.RTM.) is registered, the GUI displays an appropriate
start-up logo and title image for the device 26a (see FIG. 12).
Likewise, if the identification code for the device 26b
(SECCA.RTM.) is registered, the GUI displays an appropriate
start-up logo and title image for the device 26b (FIG. 13).
[0081] B. Treatment Screens (UGUI and LGUI)
[0082] Upon completion of the SET-UP operation, the controller 52
proceeds to condition the generator and ancillary equipment to
proceed step-wise through a sequence of operational modes. The
operational modes have been preprogrammed to achieve the treatment
protocol and objective of the selected device 26a/26b. The conduct
of these operational modes and the appearance of the graphical user
interface that guides and informs the user during the course of the
selected procedure can differ between devices 26a and 26b.
[0083] For ease of description, the GUI 500 displays for the upper
gastro-intestinal procedure (i.e., for the device 26a) a treatment
screen that will in shorthand be generally called UGUI 504 (FIG.
14A). Likewise, the GUI displays for the lower gastro-intestinal
procedure (i.e., for the device 26b) a treatment screen that will
in shorthand be generally called LGUI 506 (FIG. 15A).
[0084] In both the UGUI 504 (FIG. 14A) and LGUI 506 (FIG. 15A),
there is a parameter icon 462 designating cooling fluid flow
rate/priming. In both the UGUI 504 and the LGUI 506, the Flow
Rate/Priming Icon 462 shows the selected pump speed by the number
of bars, one bar highlighting a low speed, two bars highlighting a
medium speed, and three bars highlighting a high speed.
[0085] Each UGUI 504 (FIG. 14A) and LGUI 506 (15A) includes an
Electrode Icon 466. In general, each Electrode Icon 466 comprises
an idealized graphical image, which spatially models the particular
multiple electrode geometry of the treatment device 26a/26b that
has been coupled to the controller 42. Just as the multiple
electrode geometries of the devices 26a and 26b differ, so, too,
does the Electrode Icon 466 of the UGUI 504 differ from the
Electrode Icon 466 of the LGUI 506.
[0086] As FIG. 14A shows, in the UGUI 504, four electrodes are
shown in the graphic image of the Icon 466, which are spaced apart
by 90 degrees. This graphic image reflects the geometry of the
four-electrode configuration of the device 26a, as shown in FIG.
4.
[0087] As FIG. 15A shows, in the LGUI 506, four electrodes are
shown in the graphic image of Icon 466 in a circumferentially
spaced relationship along a partial arcuate sector. This graphic
image reflects the arrangement of electrodes on the treatment
device 26b, as shown in FIG. 7.
[0088] For each electrode, the respective Icon 466 incorporates
graphic regions O1, O2, and O3 in the spatial display. Regions O1
and O2 display temperature conditions encountered for that
electrode. Region O1 numerically displays the magnitude of sensed
electrode tip temperature in UGUI 504 (FIG. 14A) and LGUI 506 (FIG.
15A). Region O2 numerically displays sensed tissue temperatures for
that electrode in UGUI 504 (FIG. 14A) and LGUI 506 (FIG. 15A).
Region O3 displays the derived impedance value for each electrode.
Both UGUI 504 and LGUI 506 display instantaneous, sensed
temperature readings from the tip electrode and tissue surface, as
well as impedance values, which are continuously displayed in
spatial relation to the electrodes in the regions O1, O2, and
O3.
[0089] The numeric displays of the regions O1/O2/O3 can be blanked
out for a given electrode if the corresponding electrode/channel
has been disabled, either by the physician or by a sensed
out-of-bounds condition. An "acceptable" color indicator (e.g.,
green) can also displayed in the background of the regions O1/O2/O3
as long as the sensed condition is within the desired
pre-established ranges. However, if the sensed conditions fall
outside the desired range, the color indicator changes to an
"undesirable" color indicator (e.g., to grey), and numeric display
is blanked out.
[0090] There is also a Lesion Level Icon 510 in each display UGUI
504 and LGUI 506, adjacent to the respective Electrode Icon 466.
The Lesion Level Icon 510 comprises an idealized graphical image,
which spatially models the desired lesion levels and the number of
lesions in each level. Just as the lesion patterns created by the
devices 26a and 26b differ, so, too, does the Lesion Level Icon 510
of the UGUI 504 differ from the Electrode Icon 466 of the LGUI
506.
[0091] As will be described in greater detail later, the Lesion
Level Icons 510 change in real time, to step-wise guide the
physician through the procedure and to record the progress of the
procedure from start to finish. In many fundamental respects, the
look and feel of the Lesion Level Icons 510 for the LGUI 504 and
the LGUI 506 are similar, but they do differ in implantation
details, due to the difference of the protocols of lesion
formation.
[0092] Exemplary changes in the Lesion Level Icons 510 for the UGUI
504 and the LGUI 506 will now be described.
[0093] 1. The UGUI
[0094] In the UGUI 504 (se FIG. 14A), six numbered Lesion Levels 1,
2, 3, 4, 5, and 6 are displayed, to correspond with the lesion
levels already described and shown in FIG. 5. The UGUI 504 also
displays a squiggle line 514, which marks where the physician has
visualized a selected anatomic home base reference for the
formation of lesions within the esophagus for treatment. Guided by
the UGUI 504, lesions are placed relative to this anatomic home
base.
[0095] In preparation for the treatment, the physician visualizes
in the esophagus the Z-line or other desired anatomic landmark.
Markers are arranged at 5 mm intervals along the catheter tube.
Upon visualizing the Z-line, the physician notes the external
marker on the catheter tube that corresponds to this position. With
reference to the markers, the physician can then axially advance or
retract the catheter tube in 5mm increments, which correspond to
the desired spacing between the lesion levels. This orientation of
lesion levels is also shown in FIG. 5.
[0096] The UGUI 504 graphically orients the location of Lesion
Levels 4, 5, and 6 relative to this anatomical base, displaying
Lesion Levels either below (inferior to) the squiggle line 514
(Lesion Levels 4, 5, and 6) or at or above the squiggle line 514
(Lesion Levels 1, 2, and 3).
[0097] As will be described, the UGUI 504 graphically changes the
display of the the Lesion Levels, depending upon the status of
lesion formation within the respective levels.
[0098] FIG. 14A shows a representative first graphical form of a
given lesion level. The graphical form comprises, e.g., a cylinder
that faces edgewise on the UGUI 504, as is shown for Lesion Levels
1 to 6 in FIG. 14A. This graphical form indicates at a glance that
no lesions are present in the respective lesion levels.
[0099] As is shown in FIG. 14A, next to the graphical form of the
edgewise cylinder of Lesion Level 1 is a Guide Marker 512. The
Guide Marker 514 indicates that formation of lesions in Lesion
Level 1 is the first to be indicated. A numeric value (15 mm) is
displayed in association with the edgewise cylinder of Lesion Level
1, which indicates that Lesion Level 1 is 15 mm from the anatomic
landmark. The orientation of Lesion Level 1 above (superior to) the
squiggle line 514 guides the physical to advance the catheter tube
upward from the anatomic marker by 15 mm, to place it at Lesion
Level 1. A Balloon Icon 516 prompts the physician to expand the
basket of the device 26a at Lesion Level 1.
[0100] Upon sensing electrode impedance, indicating contact with
tissue at Lesion Level 1 (or in response to another input
indicating deployment of the device 26a at the desired lesion
level), the controller commands the UGUI 504 to change the
graphical form of Lesion Level 1 to a second graphical form, which
is shown in FIG. 14B. The second graphical form (shown in FIG. 14B)
is different than the first graphical form (shown in FIG. 14A). The
graphical form comprises, e.g., a segmented circle, with a numeric
indicator next to it. This is shown for Lesion Level 1 in FIG. 14B.
In visual effect, the second graphical form shows the previously
cylinder form rotated for viewing along its axis. The number of
segments shown (in FIG. 14B, there are eight segments) corresponds
with the number of lesions that are to be formed at Lesion Level
1.
[0101] In FIG. 14B, all segments of the circle are unmarked. This
graphical form indicates at a glance that (i) formation of lesions
at this lesion level is now indicated (due to the axial circle view
of the lesion level icon), (ii) eight circumferentially spaced
lesions are to be formed (due to the number of segments); (iii) no
lesions have as yet been formed (by the lack of other markings in
the segments).
[0102] The location of the Marker 512 also changes to align with
Lesion Level 2, with a numeric indicator of 5 mm. This informs the
physician that, after Lesion Level 1, the next lesion level to be
treated is Lesion Level 2, which is 5 mm below (inferior to) Lesion
Level 1.
[0103] With the device 26a positioned at Lesion Level 1, the
physician actuates the electrodes for a first pre-set period. The
balloon icon 516 disappears as treatment progresses on a given
level. A Timer Icon 518 shows the application of radio frequency
energy for the pre-set period. At the end of this pre-set period
(see FIG. 14C), treatment indicia (e.g., dots) appear in four
segments of the graphical segmented circle, indicating the
formation of the first four lesions, as well as their spatial
orientation.
[0104] The open segments remaining in the segmented circle prompt
the physician to rotate the basket by 45-degrees, and actuate the
electrodes for second time. After the pre-set period (tracked by
the Timer Icon 518) (see FIG. 14D), more treatment indicia (the
dots) appear in the remaining segments of the circle. This
indicates that all the lesions prescribed for Lesion Level 1 have
been formed, and to deflate the basket and move to the next
treatment level. The Marker 512 that is displayed directs the
physician to Lesion Level 2, which is 5 mm below Lesion Level 1.
The Balloon Icon 516 can reappear to prompt the physician to
deflate the balloon.
[0105] The physician is thereby prompted to deflate the basket,
move to Lesion Level 2, and expand the basket. As FIG. 14E shows,
upon sensing electrode impedance, indicating contact with tissue at
Lesion Level 2, the UGUI 504 changes the graphical form of Lesion
Level 1 back to an edgewise cylinder. The edgewise cylinder for
Lesion Level 1 includes an indicator, e.g., checkmark, to indicate
that Lesion Level 1 has been treated (as shown in FIG. 14E). The
insertion of the treatment completed indicator is yet another
graphical form the UGUI 504 displays to communicate status
information to the physician.
[0106] Also referring to FIG. 14E, upon sensing electrode
impedance, indicating contact with tissue at Lesion Level 2, the
UGUI 504 changes the graphical form of Lesion Level 2 to the second
graphical form, comprising, e.g., the segmented circle, as already
described. This is shown for Lesion Level 2 in FIG. 14E. The
location of the Marker 512 also changes to align with Lesion Level
3, with a numeric indicator of 5 mm. This informs the physician
that after Lesion 2, the next lesion level will be Lesion Level 3,
which is 5 mm below (inferior to) Lesion Level 2.
[0107] As shown in FIGS. 14F and 14G, with the device 26a
positioned at Lesion Level 2, the physician actuates the electrodes
for a first pre-set period, then rotate the device 26a 45-degrees,
and actuate the electrodes for the second pre-set period. The Timer
Icon 518 reflects the application of radio frequency energy for the
pre-set periods, and the treatment indicia (e.g., dots) are added
to the segments of the graphical segmented circle, indicating the
formation of the first four lesions (FIG. 14F) and the next four
lesions (FIG. 14G), as well as their spatial orientation.
[0108] Upon formation of the eight lesions in Lesion Level 2, the
balloon icon 518 again appears. This indicates that all the lesions
prescribed for Lesion Level 2 have been formed, and to deflate the
basket and move to the next treatment level. The Marker 512 that is
displayed directs the physician to Lesion Level 3, which is 5 mm
below Lesion Level 2.
[0109] The physician is thereby prompted to deflate the basket,
move to Lesion Level 3, and expand the basket. Upon sensing
electrode impedance, indicating contact with tissue at Lesion Level
3 (see FIG. 14H), the UGUI 504 changes the graphical form of Lesion
Level 2 back to an edgewise cylinder (as FIG. 14H shows). The
edgewise cylinder for Lesion Level 2 now includes an indicator,
e.g., the checkmark, to indicate that Lesion Level 2 has been
treated (as FIG. 14H also shows).
[0110] As FIG. 14I also shows, upon sensing electrode impedance,
indicating contact with tissue at Lesion Level 3, the UGUI 504
changes the graphical form of Lesion Level 3 to the second
graphical form, comprising, e.g., the segmented circle, as already
described. This is shown for Lesion Level 3 in FIG. 14H. The
location of the Marker 512 also changes to align with Lesion Level
4, with a numeric indicator of 5 mm. This informs the physician
that after Lesion 3, the next lesion level will be Lesion Level 3,
which is 5 mm below (inferior to) Lesion Level 3.
[0111] The physician proceeds to form eight lesions in Lesion Level
3 (FIGS. 14I and 14J), then moving on to Lesion Level 4 (not shown,
but following the same progression as already described). All the
while, the UGUI 504 visually records and confirms progress. As
shown in FIG. 14K, the graphical Lesion Level cylinders for Lesion
Levels 3 and 4 return edgewise when the desired number of lesions
has been formed on the respective level and treatment at the level
has been completed. At that time, a check mark appears on the
edgewise cylinder, indicating that treatment at that level has been
completed for Lesion Levels 1, 2, 3, and 4 (as shown in FIG.
14K).
[0112] As FIGS. 14K to 14N, on Lesion Levels 5 and 6, the segments
in the segmented circle number twelve, indicating that twelve
lesions are to be formed on these levels. In the Levels 5 and 6,
there are twelve lesions circumferentially spaced 30-degrees apart
(i.e., a first application of energy, followed by a 30-degree
rotation of the basket 56, followed by a second application of
energy, followed by a 30-degree rotation of the basket 56, followed
by a third application of energy). In Level 5, the balloon
structure is only partially expanded, whereas in Level 6, the
balloon structure 72 is more fully expanded, to provide lesion
patterns that increase in circumference according to the
funnel-shaped space available in the funnel of the cardia.
[0113] The UGUI 504 reflects completion of the treatment (see FIG.
14O).
[0114] Thus, the UGUI 504, by purposeful manipulation of different
stylized graphical images, visually prompts the physician step wise
to perform a process of forming a pattern of lesions comprising a
plurality of axially spaced lesion levels, each lesion level
comprising a plurality of circumferential spaced lesions. The UGUI
504 registers the formation of lesions as they are generated in
real time, both within and between each circumferentially spaced
level. The UGUI 504 therefore displays for the physician a visual
record of the progress of the process from start to finish. The
UGUI 504 assures that individual lesions desired within a given
level are not skipped, or that a given level of lesions is not
skipped.
[0115] In the UGUI 508, each Lesion Level 1 to 6 is initially
depicted by a first stylized graphical image comprising an edgewise
cylinder with a number identification of its level. When the
formation of lesions at a given level is indicated, the UGUI 504
changes the first stylized graphical image into a second stylized
graphical image, different than the first image, comprising an
axial view of the cylinder, presented a segmented circle, with the
numbers of segments corresponding to the number of lesions to be
formed. There also appears juxtaposed with the next lesion level to
be treated (still displayed as an edgewise cylinder), a marker
along with a number indicating its distance from the present legion
level. As the physician manipulates the device 26a to form lesions
on the indicated levels, the second graphical image further changes
to a third graphical image, different than the first or second
images, by adding indicia within the segmented circle to reflect
the formation of lesions, to guide the physician successively
rotate and operate the device 26a at the lesion level. Upon forming
the desired lesion pattern on a given level, the UGUI 504 again
changes the third graphical image to a fourth graphical image,
different than the first, second, and third graphical images,
comprising an edgewise cylinder with a number identification of its
level, and further an indicator (e.g. a check mark) that indicates
all desired lesions have been formed at the respective level. A
Marker 512 is successively updated to direct the physician to the
next Lesion Level. In this way, the UGUI 504 prompts the formation
of eight lesions circumferentially spaced 45-degrees apart in the
Levels 1, 2, 3, and 4, and the formation of twelve lesions
circumferentially spaced 30-degrees apart at Lesion Levels 5 and
6.
[0116] 2. The LGUI
[0117] The LGUI 506 (FIG. 15A) generates a graphical user display
that guides the physician in manipulating the device 26b to form a
prescribed lesion pattern in the anal canal, as shown in FIG. 9.
The lesion pattern comprises a plurality of axially spaced lesion
levels (in the illustrated embodiment, numbered 1 to 5), each
lesion level comprising a plurality of circumferential spaced
lesions (in the illustrated embodiment, there are sixteen lesions,
arranged in sets of four).
[0118] The display of the LGUI 506 (see FIG. 15A) shows Lesion
Levels 1, 2, 3, 4, and 5, corresponding with the multiple lesion
levels to be formed in the anal canal. Lesion Levels 1 to 5 are
displayed as segmented discs, numbered 1 to 5, which are tilted
slightly on their axes, and arranged one above the other. Each disc
is divided into four quadrants.
[0119] The LGUI 506 also shows (see FIG. 15A) a dentate squiggle
line 514. In preparation for the treatment, the physician
visualizes in the anal canal dentate line or other desired anatomic
landmark. Markers are arranged at 5 mm intervals along the barrel
of the device 26b. Upon visualizing the dentate line, the physician
notes the external marker on the barrel that corresponds to this
position. With reference to the markers, the physician can then
axially advance or retract the barrel in 5mm increments, which
correspond to the spacing between the lesion levels.
[0120] Next to the graphical form of the disc of Lesion Level 1 is
a Guide Marker 512 (see FIG. 15A). The Guide Marker 514 indicates
that formation of lesions in Lesion Level 1 is indicated. A numeric
value (5 mm) is displayed in association with the edgewise cylinder
of Lesion Level 1, which indicates that Lesion Level 1 is 5 mm from
the anatomic landmark.
[0121] In FIG. 15A, all quadrants of the lesion level discs are
unmarked. This graphical form indicates at a glance that (i)
formation of lesions at Lesion Level 1 is now indicated (due to the
position of the Marker 512) and (ii) no lesions have as yet been
formed (by the lack of markings in the quadrants).
[0122] The device 26b includes an array of four needle electrodes
arrange in an arc, which can be advanced and retracted (see FIG.
6). The array of needle electrodes is positioned at Level 1, in
alignment with quadrant 1, and advanced. The physician actuates the
electrodes for a first pre-set period. A Timer Icon 518 shows the
application of radio frequency energy for the pre-set period. At
the end of this pre-set period, treatment indicia (e.g., four dots)
appear in the first quadrant of the graphical segmented discs (see
FIG. 15B), indicating the formation of the first four lesions, as
well as their spatial orientation in the first quadrant.
[0123] The location of the Marker 512 also changes to align with
Lesion Level 2, with a numeric indicator of 5 mm. This informs the
physician that after Lesion Level 1, the next lesion level will be
Lesion Level 2, which is 5 mm above (superior to) Lesion Level
1.
[0124] Upon the satisfactory creation of the lesion pattern in the
first quadrant of Level 1, as just described, and as prompted by
the Marker 512 (now aligned with Lesion Level 2), the physician
actuates the button to move the needle electrodes back to their
retracted positions. Still grasping the hand grip and visualizing
through the viewing port, the physician moves the barrel 5mm
axially upward to Level 2, remaining rotationally aligned in the
first quadrant. The physician again deploys the needle electrodes
and performs another lesion generating sequence. The location of
the Marker 512 also changes to align with Lesion Level 3, with a
numeric indicator of 5 mm. This informs the physician that after
Lesion Level 2, the next lesion level will be Lesion Level 3, which
is 5 mm above (superior to) Lesion Level 2. Treatment indicia
(e.g., four dots) appear in the first quadrant of the graphical
segmented disc of Lesion Level 2 (see FIG. 15C), indicating the
formation of the four lesions, as well as their spatial orientation
in the first quadrant.
[0125] The physician repeats this sequence of steps until
additional number of lesion patterns are formed within the axially
spaced first quadrants in Levels 2, 3, 4, and (see FIGS. 15D, 15E,
and 15F). The location of the Marker 512 also changes to align with
successive Lesion Levels, to guide the physician through the lesion
levels. Treatment indicia (e.g., four dots) appear in the first
quadrant of the graphical segmented discs of Lesion Levels 2, 3, 4,
and 5 (see FIG. 15F), indicating the formation of the four lesions,
as well as their spatial orientation in the first quadrant.
[0126] Upon formation of the four lesions in quadrant 1 of Lesion
Level 5, the Marker 512 returns to Lesion Level 1 (see FIG. 15F),
prompting the physician to return to Lesion Level 1, and again
rotate the barrel a selected arcuate distance at Lesion Level 1
into alignment with the second quadrant, i.e., by rotating the
barrel by ninety degrees.
[0127] Guided by the LGUI 506, the physician again deploys the
needle electrodes and performs another lesion generating sequence
at quadrant 2 of Level 1. Guided by the LGUI 506 (as shown in FIG.
15G), and following the Marker 512, the physician then moves the
barrel axially upward in 5 mm increments, sequentially to quadrant
2 of Lesion Level 2, then quadrant 2 of Lesion Level 3, the
quadrant 2 of Lesion Level 4, and quadrant 2 of Lesion Level 5. At
each Lesion Level, the physician deploys the needle electrodes and
performs another lesion generating sequence at quadrant 2 of the
respective level. After lesion formation at each Lesion Level,
treatment indicia (e.g., four dots) appear in the second quadrant
of the graphical segmented discs of Lesion Levels 2, 3, 4, and 5
(see FIG. 15G), indicating the formation of the four lesions, as
well as their spatial orientation in the second quadrant.
[0128] Upon formation of the four lesions in quadrant 2 of Lesion
Level 5, the Marker 512 returns to Lesion Level 1. The physician
returns to Lesion Level 1, and again rotates the barrel a selected
arcuate distance at Lesion Level 1 into alignment with the third
quadrant, i.e., by rotating the barrel by ninety degrees.
[0129] Guided by the LGUI 506 (see FIG. 15H), the physician again
deploys the needle electrodes 48 and performs another lesion
generating sequence at quadrant 3 of Level 1. Treatment indicia
(e.g., four dots) appear in the quadrant 3 of the graphical
segmented disc of Lesion Levels 1, indicating the formation of the
four lesions, as well as their spatial orientation in the third
quadrant.
[0130] As shown in FIG. 15H, guided by the LGUI 506, and following
the Marker 512 as it advances with lesion formation at each level,
the physician then moves the barrel axially upward in 5 mm
increments, sequentially to quadrant 3 of Lesion Level 2, then
quadrant 3 of Lesion Level 3, then quadrant 3 of Lesion Level 4,
and quadrant 3 of Lesion Level 5. At each Lesion Level, the
physician deploys the needle electrodes and performs another lesion
generating sequence at quadrant 3 of the respective level.
Treatment indicia (e.g., four dots) appear in the third quadrant of
the graphical segmented discs of Lesion Levels 2, 3, 4, and 5 (see
FIG. 15H), indicating the formation of the four lesions, as well as
their spatial orientation in the third quadrant.
[0131] The physician repeats the above described sequence one
additional time, returning the barrel to Lesion Level 1 and
rotating the barrel ninety degrees into alignment with quadrant 4
of Lesion Level 1 (see FIG. 15I). The physician forms the lesion
patterns quadrant 4 in the Levels 1, 2, 3, 4, and 5. Treatment
indicia (e.g., four dots) appear in the fourth quadrant of the
graphical segmented discs of Lesion Levels 1, 2, 3, 4, and 5 (see
FIG. 15B), indicating the formation of the four lesions, as well as
their spatial orientation in the second quadrant. In addition, with
the formation of lesions in the fourth quadrant at each Lesion
Level, the graphical disc representing the Lesion Level, each
quadrant marked by four dots (indicating completion of lesion
creation) is changed to additionally include an indicator, e.g.,
checkmark, to indicate that the respective Lesion Level has been
treated (see FIG. 15I).
[0132] As described, the LGUI 506 visually prompts a user in a
step-wise fashion to perform a process of forming a pattern of
lesions in the anal canal comprising a plurality of axially spaced
lesion levels, each lesion level comprising a plurality of
circumferential spaced lesions. The LGUI 506 registers the
formation of lesions as they are generated in real time, both
within and between each circumferentially spaced level. The LGUI
506 displays for the user a visual record of the progress of the
process from start to finish and guides the user so that individual
lesions desired within a given level are all formed, and that a
given level of lesions is not skipped.
[0133] Each Lesion Level 1 to 5 of the LGUI 506 is depicted by a
first stylized graphical image comprising a edge-tilted disc with a
number identification of its level. The discs are segmented
corresponding to the regions in which lesions to be formed. There
also appears juxtaposed with the next lesion level to be treated, a
marker along with a number indicating its distance from the present
legion level. As the physician manipulates the device 26b to form
lesions on the indicated levels, the second graphical image further
changes to a second graphical image, different than the first
image, by adding indicia within the segmented circle to reflect the
formation of lesions, to guide the physician as the device is
successively operated at the lesion level. Upon forming the desired
lesion pattern, the UGUI 506 again changes the second graphical
image to a third graphical image, different than the first, second,
and third graphical images, comprising an indicator (e.g. a check
mark) indicating that all desired lesions have been format at the
level. The Marker 512 is updated to direct the physician to the
next Lesion Level. In this way, the UGUI 506 prompts the formation
of four lesions sets of four lesions each (totaling twelve lesions)
circumferentially spaced apart in the Levels 1, 2, 3, 4, and 5.
* * * * *