U.S. patent application number 16/130160 was filed with the patent office on 2019-03-21 for transcutaneous stimulation method and system.
The applicant listed for this patent is GI THERAPIES PTY LTD. Invention is credited to John Medwyn Hutson, Bridget Rae Southwell, Andre Yi Feng Tan.
Application Number | 20190083783 16/130160 |
Document ID | / |
Family ID | 46757299 |
Filed Date | 2019-03-21 |
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United States Patent
Application |
20190083783 |
Kind Code |
A1 |
Southwell; Bridget Rae ; et
al. |
March 21, 2019 |
TRANSCUTANEOUS STIMULATION METHOD AND SYSTEM
Abstract
Some embodiments relate to a method of treating a waste
evacuation dysfunction, comprising administering transcutaneous
electrical stimulation (TES) to at least one lower pelvic and/or
sacral region for at least one treatment period per day over a
treatment term of at least one week.
Inventors: |
Southwell; Bridget Rae;
(Gordon, AU) ; Hutson; John Medwyn; (East Malvern,
AU) ; Tan; Andre Yi Feng; (Mulgrave, AU) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
GI THERAPIES PTY LTD |
Melbourne |
|
AU |
|
|
Family ID: |
46757299 |
Appl. No.: |
16/130160 |
Filed: |
September 13, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15634961 |
Jun 27, 2017 |
10080892 |
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16130160 |
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13824314 |
May 28, 2013 |
9789308 |
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PCT/AU2012/000212 |
Mar 2, 2012 |
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15634961 |
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61448378 |
Mar 2, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/0452 20130101;
A61N 1/0484 20130101; A61N 1/0456 20130101; A61N 1/36034 20170801;
A61N 1/36007 20130101; A61N 1/0476 20130101; A61N 1/0492
20130101 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61N 1/04 20060101 A61N001/04 |
Claims
1. (canceled)
2. A method of treating a waste evacuation dysfunction, comprising
administering transcutaneous electrical stimulation (TES) with at
least eight electrodes, wherein the at least eight electrodes
comprise a first pair of electrodes positioned in a lumbar area of
a user and a second pair of electrodes positioned in a lower front
abdominal area of the user, wherein the at least eight electrodes
provide interferential electrical stimulation.
3. The method of claim 2, wherein the TES is administered at least
once per day over a treatment term.
4. The method of claim 2, wherein the at least eight electrodes
further comprise a third pair of electrodes positioned in a sacral
region of the user and a fourth pair of electrodes positioned in a
pelvic region of the user.
5. The method of claim 2, wherein the TES is administered at least
four times per week.
6. The method of claim 2, wherein administering TES comprises
administering TES with a portable stimulation device.
7. The method of claim 6, further comprising determining, with the
portable stimulation device, an electrical stimulation energy
required for the user based on physiological parameters of the
user.
8. The method of claim 6, further comprising providing audible
signals to the user from the portable stimulation device.
9. The method of claim 6, further comprising receiving selection
from the user of a personal TES setting among multiple personalized
TES settings of the portable stimulation device associated with
different users.
10. The method of claim 6, further comprising sensing temperature
with the portable stimulation device via one or more of the at
least eight electrodes.
11. The method of claim 6, further comprising connecting the
portable stimulation device to a separate computer system, the
separate computer system facilitating firmware updates for the
portable stimulation device.
12. The method of claim 6, wherein the portable stimulation device
comprises a battery and a power supply circuitry that provides
charging circuit isolation configured to prevent electrical
stimulation during a battery charge operation.
13. The method of claim 6, wherein the portable stimulation device
comprises load-testing circuitry configured to prevent the delivery
of electrical stimulation when an improper electrical connection is
detected.
14. The method of claim 6, wherein the portable stimulation device
comprises multiple modes of access for different classes of users,
each mode of access having different authorization.
15. The method of claim 14, wherein the multiple modes of access
comprise a technician mode, the technician mode allowing an
authorized technician to fully modify a function of the portable
stimulation device.
16. The method of claim 14, wherein the multiple modes of access
comprise a clinician mode, the clinician mode allowing an
authorized clinician to alter a function of the portable
stimulation device by selecting from multiple stimulation
settings.
17. The method of claim 14, wherein the multiple modes of access
comprise a patient mode, the patient mode allowing a patient to
operate the portable stimulation device within parameters
determined by a clinician.
18. A method of treating a waste evacuation dysfunction, comprising
administering transcutaneous electrical stimulation (TES) to a user
with at least four electrodes to create interferential electrical
stimulation within the user, wherein the at least four electrodes
comprise a first electrode and a second electrode positioned in a
lower front region of the user and a third electrode and a fourth
electrode positioned in a lower back region of the user, and
wherein the TES is administered at least four times over a
treatment period of at least one week.
19. The method of claim 18, further comprising providing multiple
modes of access to the TES for different classes of users, wherein
the multiple modes of access comprise a clinician mode and a
patient mode, wherein the clinician mode allows an authorized
clinician to set stimulation settings for the TES, and the patient
mode allows a patient to administer TES within parameters
determined by the clinician.
20. A system for treating a waste evacuation dysfunction of a user,
the system comprising: a stimulation device configured to provide
electrical stimulation signals to the user at least four times per
week over a treatment period; at least eight electrodes configured
to connect with the stimulation device, the at least eight
electrodes comprising four electrodes configured to be positioned
in a lower back region of the user and four electrodes configured
to be positioned in a lower front region of the user, the at least
eight electrodes configured to provide crossing currents to produce
interferential electrical stimulation within the user.
Description
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
[0001] Any and all applications for which a foreign or domestic
priority claim is identified in the Application Data Sheet as filed
with the present application are hereby incorporated by reference
under 37 CFR 1.57. This application is a continuation of U.S.
application Ser. No. 15/634,961, filed Jun. 27, 2017, entitled
"Transcutaneous Stimulation Method and System," which is a
divisional of U.S. application Ser. No. 13/824,314, filed May 28,
2013, entitled "Transcutaneous Stimulation Method and System,"
which is a U.S. National Phase Application of PCT International
Application number PCT/AU2012/000212, filed Mar. 2, 2012, entitled
"Transcutaneous Stimulation Method and System" and designating the
United States of America and published in the English language,
which claims the benefit of priority of U.S. provisional
application No. 61/448,378, filed Mar. 2, 2011, entitled
"Transcutaneous Stimulation Method and System," the entire
disclosure of each of which is incorporated herein by reference for
all purposes.
FIELD
[0002] Described embodiments relate generally to methods and
systems for transcutaneous stimulation. More particularly, methods,
systems, devices and apparatus for transcutaneous stimulation in
one or more of the lumbar, abdominal, lower pelvic and sacral
regions are described to treat one or more dysfunctions associated
with a body's ability to evacuate waste.
BACKGROUND
[0003] Reference to any prior art in this specification is not, and
should not be taken as, an acknowledgment or any form of suggestion
that this prior art forms part of the common general knowledge in
any country.
[0004] Reference in this specification to any prior publication (or
information derived from it), or to any matter which is known, is
not, and should not be taken as, an acknowledgment or admission or
any form of suggestion that that prior publication (or information
derived from it) or known matter forms part of the common general
knowledge in the field of endeavour to which this specification
relates.
[0005] Bibliographic details of the publications referred to by
author in this specification are collected alphabetically at the
end of the description.
[0006] Waste elimination dysfunction can take many forms. For
example, urinary incontinence, intestinal incontinence or
constipation can occur.
[0007] Treatment systems exist for treating constipation by
providing electrical stimulus via subcutaneously implanted
electrodes positioned around the lower bowel. Electrical
stimulation provided using such electrodes can be used to
sequentially activate muscle fibres around the bowel to force a
peristaltic action to occur. However, such treatment systems are
undesirably invasive. Further, while such systems may have an
immediate effect in assisting to evacuate the bowel, they do not
necessarily address the cause of the constipation. Importantly,
this effect has not been described as long lasting or having an
effect beyond the immediate time of electrical stimulation.
[0008] Intractable constipation and soiling are extremely common in
the community, in both the young and old, and available treatments
are generally uncomfortable, can cause social distress for
sufferers and are a significant drain on the health care system.
Individuals that suffer from constipation and soiling who are young
or old may also have psychological issues. In addition,
constipation may be a side effect of some kinds of medication, such
as opiates. Most laxative therapies are designed to either soften
the stool or stimulate the bowel by chemicals in the lumen.
Patients with chronic constipation or intractable constipation may
have failed other treatment methods including pharmaceutical
treatment. Patients on therapies for other diseases in which
constipation is a side effect of the medication may not be able to
be co-administered pharmaceutical treatments for constipation.
Non-invasive, non-drug-based treatment methodologies may be desired
in such cases.
[0009] Sometimes constipation may be unrelated to diet or
medications, and can be due to poor motility in the whole colon
(Benninga et al, J Pediatr Gastroenterol Nutr., 23:241-51, 1996;
Hutson et al, J Pediatr Surg., 31:580-583, 1996). A newly
identified disorder, which is known as slow-transit constipation
(STC), is not uncommon amongst children who fail standard medical
therapy, and such children often have signs of colonic dysfunction
even at birth. (Shin et al, J Pediatr Surg., 37:1762-1765,
2002).
[0010] Previous electrical stimulation involved non-daily
stimulation (i.e. 12 sessions in 4 week period) of short periods
(i.e. 20 min of treatment) using transcutaneous devices that have
been developed for physiotherapy treatment of muscular injuries
(Clarke et al, J. Pediatr. Surg., 44:408-412, 2009.)
[0011] It is desired to address or ameliorate one or more
disadvantages or shortcomings associated with existing treatment
systems, methods or regimes, or to at least provide a useful
alternative thereto.
SUMMARY
[0012] Non-invasive electrical stimulation apparatus, devices,
methods and systems are described herein to be used specifically
for the treatment of constipation and improved treatment regimens.
This treatment may have long term benefits in some patients with
continued improvement after the period of treatment by the
non-invasive electrical stimulation.
[0013] Throughout this specification and the claims which follow,
unless the context requires otherwise, the word "comprise", and
variations such as "comprises" and "comprising", will be understood
to imply the inclusion of a stated integer or step or group of
integers or steps but not the exclusion of any other integer or
step or group of integers or steps.
[0014] Some embodiments relate generally to treatment regimes for
transcutaneous stimulation. More particularly, methods, devices,
apparatus and systems are provided for treating constipation or
another waste evacuation dysfunction by the administration of
transcutaneous electrical stimulation to at least one lumbar and/or
abdominal region for a period of time on a daily basis or greater
than 12 sessions in a 4 week period. The electrical stimulation may
alternatively or additionally be administered to a lower pelvic
and/or sacral region. Reference to "greater than 12 sessions"
includes from about 12 to about 100 sessions such as about 13, 14,
15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31,
32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48,
49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65,
66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82,
83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99
or 100 sessions, for example, or even more.
[0015] In some embodiments, the treatment may involve a single
treatment session each day or multiple (e.g. 2 or 3) treatment
sessions per day. The treatment sessions may be for periods of
between about 10 and about 90 minutes or from about 20 and about 60
minutes. Other time periods include about 11, 12, 13, 14, 15, 16,
17, 18, 19, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34,
35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51,
52, 53, 54, 55, 56, 57, 58, 59, 61, 62, 63, 64, 65, 66, 67, 68, 69,
70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86,
87, 88 and 89 minutes, for example.
[0016] In some embodiments, the daily (or greater than 12 sessions
in a 4 week period) electrical stimulation regime may be performed
as part of a longer-term treatment plan, in which the stimulation
is performed daily or greater than 12 sessions in a 4 week period
for between about 2 weeks and 2 to 3 months. This includes periods
of about 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 weeks, for example.
The regime may also involve repeating the longer-term treatment
within periods of about 4 months to two years. Such longer-term
periods include about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,
17, 18, 19, 20, 21, 22, 23 and 24 months, for example. The
transcutaneous electrical treatment may provide a longer term
effect of greater than 1 day, for example up to 1 month to 1 year
or more. Hence, the effect of treatment lasts beyond the immediate
time of electrical stimulation.
[0017] In some embodiments, where daily treatment (or greater than
12 treatment sessions in a 4 week period) is anticipated, for ease
of administration, the treatment device is such that it can be used
at home without the supervision of a trained professional during
the daily (or greater than 12 sessions in a 4 week period)
treatment regimen.
[0018] The stimulation may be performed using one to ten
electrodes, for example, placed on the lumbar and/or lower front
abdominal areas. Electrodes may be additionally or alternatively
placed over the lower pelvic and/or sacral regions, including the
buttocks or other tissue overlying or adjacent the ilium, to excite
or modulate the nerves and other tissues around the rectum,
including the recto-sigmoid colon.
[0019] In particular embodiments, an even number of electrodes are
employed in a spaced pair arrangement. Alternatively, one, three,
five or more electrodes may be employed. In some embodiments, the
one to ten or more electrodes may be fixed in an apparatus such as
a belt. The fixed positioning of the electrodes in a device such as
a belt may aid in the positioning of the electrodes to the lumbar
and/or lower front abdominal areas and the spacing of the
electrodes. The electrodes used to provide the electrical
stimulation may be provided on a carrier that can be removably
affixed, for example by adhesion, to a desired skin surface area to
facilitate appropriate spacing of the electrodes from each
other.
[0020] The electrodes may be coupled to and receive a stimulation
current from a stimulation device having a low voltage, low current
power source. The stimulation device may comprise a handheld
portable device, for example, that can be operated without needing
to be coupled to an external power supply. The stimulation device
may be configured to be powered by a disposable and/or rechargeable
battery or other small self-contained power source, for example.
The power source of the stimulation device may be rechargeable, for
example by coupling it via a transformer to a mains power supply.
The stimulation device may be configured to prevent or minimise the
current supply to the electrodes while the stimulation device is
having its portable power source recharged.
[0021] The stimulation device may provide or consist of a primitive
display, for example to indicate its on/off state, whether it is in
use (i.e. providing stimulation signals), a display of an accrued
time of use and/or a remaining time for use in a particular
session. The stimulation device may also be configured to prevent
electrical stimulation being provided for more than a predetermined
total amount of time for a day or 24 hour period or for more than a
predetermined amount of time (e.g. 60, 70, 80 or 90 minutes) in any
one usage session. Alternatively or in addition, the device may be
configured to restrict the total amount of electrical energy
delivered to the stimulation electrodes over a usage session or a
particular period of time.
[0022] The stimulation device may be free of external manually
operable mechanisms but for an on/off button or switch and a
stop/start button or switch. In some alternative embodiments, the
stimulation device may have external manually operable mechanisms,
for example to interface with a device display, but may be free of
any manually operable mechanisms to provide input to the
stimulation device that would alter device settings or parameters
according to which the electrical stimulation signals are
provided.
[0023] In some embodiments, the stimulation device is configured to
only operate according to a single set of operating parameters at a
given time. In some embodiments, this single set of operating
parameters may only be replaced with another single set of
operating parameters using an electronic configuration interface
separate from but communicably coupleable to the stimulation
device. For example, the stimulation device may be provided with a
default set of operating parameters by a manufacturer of the
device, and this set of parameters may be subsequently modified by
a therapist using software authorized to reconfigure the settings
of the stimulation device via a wired or wireless connection. In
other embodiments, the stimulation device may be configurable (e.g.
by a trained professional using authorised software) with multiple
stored sets of stimulation settings for separate use by multiple
users. Thus, the user interface of the stimulation device may be
configured to be quite simple and to disallow user modification of
the settings, in order to facilitate ease and appropriateness of
use of the device. However, in alternative embodiments, the
stimulation device may have greater user interface functionality
and may allow for one of two, three, four or more stimulation
settings to be selected by a user.
[0024] In some embodiments, the stimulation device may be
pre-configured or configurable to provide output signals to
stimulation electrodes having an approximately sinusoidal form,
with an approximately 4 kilohertz carrier frequency, roughly 80 to
150 hertz modulated frequency and a current intensity of around 5
to around 33 milliamps Such stimulation signals may be applied to
two or four or more electrodes, for example including two
electrodes spaced across the lower front abdominal area and two
electrodes spaced across the lumbar area, applying interferential
current stimulation from left front to right back and/or right
front to left back.
[0025] In some embodiments, the stimulation frequency may be
selected or configured to take account of the Body Mass Index (BMI)
of the patient, which can be different for a child versus an adult,
and also whether the patient is of normal weight, overweight, obese
or underweight.
[0026] Some embodiments relate to a system for configuring a
stimulation device to deliver transcutaneous electrical stimulation
(TES), the system comprising: [0027] a computing device storing or
having access to a plurality of TES settings and comprising a user
interface to enable authorised selection of one of the TES settings
for provision of TES by the stimulation device according to the one
setting; and [0028] the stimulation device communicatively coupled
to the computing device to receive and store the selected one TES
setting, the stimulation device being of a size to be readily
carried on a body and configured to selectively provide current to
external electrodes according to the one TES setting.
[0029] In some embodiments, the stimulation device may receive and
store multiple selected TES settings for delivering TES to multiple
users.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] Embodiments will now be described in further detail, by way
of example, with reference to the accompanying drawings, in
which:
[0031] FIG. 1 is a schematic diagram illustrating use of electrical
stimulation to treat intestinal dysfunction in a child;
[0032] FIG. 2 is a schematic diagram illustrating use of electrical
stimulation to treat intestinal dysfunction in an adult;
[0033] FIGS. 3A, 3B, 3C and 3D are schematic diagrams of an example
stimulation device in different views;
[0034] FIG. 4 is a block diagram of the stimulation device;
[0035] FIG. 5 is a schematic illustration of software controls
applicable to use of the stimulation device;
[0036] FIG. 6 is a block diagram of a system for configuration of
the stimulation device;
[0037] FIG. 7 is a graphical representation showing before and
after daily stimulation treatment for 1 month (Rx1) and 2 months
(Rx2) in 11 patients: [0038] A) Total number of defecations/week,
[0039] B) Number of days with soiling, and [0040] C) Number of days
with abdominal pain;
[0041] FIG. 8A is a schematic illustration showing placement of
electrodes in a lower pelvic region on a person's front side;
[0042] FIG. 8B is a schematic representation of placement of
electrodes in a sacral or lower lumbar region on a backside of the
person;
[0043] FIG. 8C is a schematic plan view illustrating crossing
interferential currents between the lower pelvic and sacral or
lower lumbar region electrodes;
[0044] FIG. 9A is a schematic illustration showing placement of
multiple frontal electrode pairs;
[0045] FIG. 9B is a schematic illustration showing placement of
multiple posterior electrode pairs; and
[0046] FIG. 10 is a schematic diagram of a belt for assisting
electrode placement of single or multiple frontal and posterior
electrode pairs.
DETAILED DESCRIPTION
[0047] Embodiments herein relate generally to methods, systems,
devices and treatment regimes for treating or enabling the
treatment of a waste elimination dysfunction, such as, for example
and without limitation, constipation, ileus, urinary incontinence
or intestinal incontinence. Such embodiments generally involve the
application of transcutaneous electrical stimulation (TES) to a
front or back (lumbar) abdominal region for at least one treatment
session per day over consecutive days of a treatment period of at
least one week. TES may alternatively or additionally be applied to
lower pelvic and/or sacral regions including the buttocks, to
excite or modulate the nerves and other tissues around the rectum,
including the recto-sigmoid colon.
[0048] The term "waste evacuation dysfunction" or "waste
elimination dysfunction" used herein is intended to include
dysfunction associated with a body's gastrointestinal and urinary
waste processing and/or elimination functions, whether or not the
processing actually immediately results in evacuation or
elimination of the waste from the body. For example, ileus or slow
transit of waste through parts of the intestinal tract to the
rectum are considered to be waste evacuation dysfunctions in this
sense because they affect the body's process of eliminating that
waste from the body, even though the ileus or slow transit may be
accurately described as a dysfunction preceding the actual
elimination of that waste.
[0049] The treatment session may be performed multiple times per
day or just once and may be performed for a time between about 10
and about 90 minutes for each session. In some embodiments, the
treatment session may be between about 20 minutes and about 60
minutes, preferably closer to 60 minutes, such as 25, 30, 35, 40,
45, 50, 55, 65 or 70 minutes or other times in between.
[0050] In some embodiments, daily treatments are anticipated of
greater than 12 sessions in a 4 week period (i.e. three sessions
per week). For ease of administration, the treatment device is such
that it can be used at home without the supervision of a trained
healthcare professional during the daily (or greater than 3
sessions a week) treatment regimen.
[0051] The treatment term of at least one week may be, for example,
between about 2 weeks and about 3 months. In some embodiments, the
treatment term may be between about 1 month and about 2 months.
[0052] The treatment term may be repeated over an extended term of
from about 4 months to about 2 years or possibly more, in order to
have the treatment suitably program, teach or train the various
muscles and/or nerves responsible for proper function of the
affected organs or tissues. Thus, the treatment period may be
repeated multiple times over the longer term, with the degree of
repetition depending on physiological response to one or more
initial treatment terms.
[0053] The treatment may have an effect beyond the immediate time
of electrical stimulation which may last 1 day, for example up to 1
week, to 1 month to one year or more beyond the last time of
electrical stimulation.
[0054] Generally, as illustrated in FIGS. 1 and 2 in relation to a
child 10 or adult 60, the electrical stimulation may be provided to
electrodes 30 positioned over a front abdomen region 12 (on either
side of the umbilicus 11) and/or on a back (lumbar) abdominal
region 14. The electrodes 30 receive electrical stimulation signals
via conductors 32 to which they are coupled and convey these to the
skin surface of the child 10 or adult 60 to which they are affixed
or otherwise conductively positioned against. A suitable conductive
gel may be used to increase conductivity of the electrical signals
from electrodes 30 into the body via the skin.
[0055] In some embodiments, four surface electrodes 30 may be used,
two electrodes 30 being positioned one to either side of the
umbilicus 11 on the anterior abdominal wall beneath the costal
margin, and two electrodes 30 being positioned on the para-spinal
area of T9-10 to L2. Positioning of the electrodes 30, whether four
or more than four electrodes 30 are used, is intended to stimulate
the proximal colon (including at least part of the ascending colon
and the transverse colon) and at least an upper part of the
descending colon, which generally correlates to the abdominal
vicinity of the umbilicus 11. Positioning of the electrodes 30 is
not made to particularly affect the sigmoid colon or distal parts
of the descending colon or rectum. Thus, although the positioning
of the electrodes 30 is applied to provide stimulation to parts of
the large bowel closer to the costal margin, not necessarily all of
the large bowel is to be stimulated in this way.
[0056] Lateral spacing of the electrode positions from the
umbilicus 11 may be in the vicinity of 1, 2, 5 or 8 to 20 cm, for
example, thereby providing a lateral separation between the
electrodes 30 of about 2, 4, 10 or 15 to 40 cm. Other lateral
spacings within such ranges may be employed, as appropriate. The
electrodes 30 may be positioned approximately level with the
umbilicus 11, although some small variation of locations, for
example slightly closer to or further from the costal margin, may
be employed. The electrodes 30 positioned in the para-spinal area
may be located substantially directly across the abdomen from the
frontal electrodes 30. In some embodiments, the electrodes 30 may
be slightly offset from each other vertically or laterally across
the pelvis and/or abdomen.
[0057] Electrodes 30 may be provided on a carrier 20 that comprises
a flexible substrate conveniently positioning the electrodes 30 a
fixed distance apart from each other to assist in proper
positioning of the electrodes in one or more regions 12, 14. The
flexible substrate 20 may comprise adhesive substances on one or
more portions thereof in order to facilitate removable application
of electrodes 30 to the skin and retention of the electrodes 30 in
a specific selected location. Each carrier 20 may comprise 1, 2, 3,
4, 5, 6, 7, 8, 9, 10 or more electrodes 30 in specific spaced
relation. Once the electrodes 30 are appropriately positioned,
either with or without the aid of a carrier 20, electrode conductor
leads 32 are used to couple the conductors 30 to respective
channels 139a, 139b (FIG. 4) of a stimulation device 100.
[0058] A stimulation device 100 and its components and features are
described in further detail below, with reference to FIGS. 3A, 3B,
3C, 3D and 4. FIG. 3A is a schematic plan view of the device 100.
FIG. 3B is one end view of the device 100. FIG. 3C is an opposed
end view of the device 100. FIG. 3D is a schematic perspective view
of the device 100. FIG. 4 is a block diagram of the device 100,
showing components and circuitry housed within a casing 105 of
device 100. Stimulation device 100 is designed to be simple,
portable and light, so that it can be worn by a user, possibly
within a carrier belt, while it provides the stimulation signals to
the electrodes 30 as the user performs normal activities.
[0059] The portable stimulator device 100 is designed to provide
therapeutic electrical stimulation for individuals suffering
dysfunction. Device 100 delivers a specified electrical signal to
the patient through a set of electrodes that are placed on the skin
surface of the abdomen, lower back, lower pelvis and/or sacral
region. The device is designed to be as simple as possible,
optionally in combination with a belt to assist electrode
positioning (FIG. 10), so that those with relatively low
technological sophistication, including some children and the
elderly, may operate the device without clinical supervision (e.g.
at home) and with minimal complication. It has been found that
devices employing too much user interface sophistication are liable
to be misused, with the result being that the patient may
experience pain from improper treatment or may not receive the
intended therapeutic benefit of the treatment. Some embodiments of
device 100 thus provide a simplified on/off type of user interface,
leaving any selection or reconfiguration of stimulation settings to
be performed by a trained clinician or therapist using external
software.
[0060] Device 100 may be provided with an accompanying software
package for use by a patient or the patient's carer on a separate
computer system 605 (FIG. 6) to facilitate user education and
instruction. Additionally, separate software may be provided for
use by a clinician to allow the clinician to set or modify settings
or functions of device 100 to further benefit patients.
[0061] The device 100 is configured to allow its internal software
(firmware) to be easily updated. Should more effective treatment
settings be determined, the device 100 can be updated through a
firmware update so that patients can have access to different
treatment regimes or settings.
[0062] The device 100 is small enough for a small child to carry,
and variations of the design may feature child-friendly shapes and
colours through changeable faceplates and covers, and also larger,
Braille-studded or other tactile buttons and/or displays for
vision-impaired or geriatric users.
[0063] Measures to provide device safety may include short-circuit
protections, isolated charging circuits to prevent mains power
being delivered to a user in the event of device malfunction and
conditional operation failsafe mechanisms (i.e. the device cannot
be operated if electrodes 30 and/or electrode leads 32 are not
connected or not correctly connected).
[0064] The device 100 may feature one or more of: [0065] 1. Two
independent electrical channels 139a, 139b, each of which is
capable of providing a specified current, voltage and waveform
characteristic via electrode leads 32 to electrodes 30. [0066] 2. A
display 120 including a liquid crystal display (LCD) and/or an
LED-based display or other form of display such as light 126,
responsive to signals received at display circuitry 138 from
microprocessor 130 to display some or all of the following
information: [0067] a. ON/OFF status of the device 100. [0068] b.
The remaining battery life of the device 100. [0069] c. START/STOP
status of the electrical stimulation. [0070] d. A timer to indicate
elapsed and/or remaining time of stimulation for a treatment
session. [0071] 3. An ON/OFF switch or button 122 to turn on or off
the device 100. [0072] 4. A START/STOP switch or button 124 to turn
on or off the electrical stimulation signals.
[0073] Device 100 may comprise various communication and power
supply inputs, including (but not limited to): [0074] a. Stimulator
electrode sockets 112--these allow the electrode leads and wires to
plug into the device. As a failsafe, the device 100 may be
configured to not be operable unless the electrode leads and
electrodes are correctly attached and connected. In some
embodiments, more than two (e.g. four) sockets 112 may be provided
and/or more than two (e.g. four) interferential current channels
may be provided in order to be able to deliver interferential TES
to multiple frontal and posterior electrode pairs. [0075] b. DC
power supply socket 114 to supply the device and internal battery
142 with power. The power may be converted from mains power
(110V/240V 60/50 Hz) to a suitable DC voltage via a switched-mode
power supply (SMPS) or other suitable electrical power converter.
[0076] c. A computer interface port 116 (Universal Serial Bus, or
other industry standard computer interface, wired or wireless) to
allow authorized users to add, modify or change the function of the
device, based on the level of authority. [0077] d. A reset button
(not shown) that cannot be easily accessed, but be accessible, for
example through battery compartment 140, should a device reset be
required. [0078] e. An in-built speaker (not shown) to provide
audible messages, beeps, alerts or other signals to vision-impaired
users and younger users.
[0079] Device 100 may comprise a rigid casing 105 to house the
electronics (e.g. on PCB 108) and may comprise environmental
sealing to industry standards (i.e. rubber gaskets on exposed
connectors, rubber sealing within the device to stop liquids and
other foreign material from breaching the device casing).
[0080] Device 100 may further comprise one or more accelerometers
to detect and record movement and/or orientation of device 100, to
thereby infer one or more states or situations of use.
Additionally, device 100 may have means for sensing and recording
temperature, for example via the electrodes 30, in order to infer
additional information concerning use of device 100. This patient
usage information can then be used to assess patient compliance
with the treatment regime.
[0081] Device 100 may, in some embodiments, comprise selection
means, such as a button or buttons, dial, touch-pad or
touch-screen, in cooperation with display 120, to vary the current
intensity of TES to be delivered via electrodes 30. This
permissible variation may be limited to within a predetermined or
pre-set range, for example. In some further embodiments, the
selection means may be employed in combination with multiple
personalised stimulation settings (for multiple different people)
stored into the device, possibly by a clinician in consultation
with the people for whom the TES is intended. This may allow a
single device 100 to be used in a setting where multiple users are
present, such as a nursing home or other shared accommodation or
treatment facility.
[0082] The physical size or external appearance of the device 100
may vary depending on the target market. It may: [0083] a. Be small
enough to fit in a small bag that a child can easily carry, may
feature various case styles and designs to give it a child-friendly
appearance, and make it more appealing to young users. [0084] b. Be
large enough to be handled by geriatric users, and feature: [0085]
i. Extra-large LCD (or other display) with larger symbols (if a
display is provided). [0086] ii. Large buttons for easy operation.
[0087] iii. Braille embedded on various parts of the device and
tactile buttons to allow users with poor vision to operate it.
[0088] c. Feature an exterior casing/faceplate that may be
changeable to modify the physical appearance of the device so that
the user may customise the "look" of the device to taste (i.e. a
case that looks like a rabbit for young children, a case that looks
like a car for a 10-yr old male user, a doll for a 6-yr old female
user). This case is completely separate from the internal case 105
that houses the device's electronics.
[0089] The device 100 may comprise a battery compartment 140
defined by casing 105 and housing a (optionally rechargeable)
battery 142 that can be coupled to an external power supply via
socket 114. Battery 142 supplies a DC voltage, such as 9V, to power
supply circuitry 134, which supplies power to the various
electrical/electronic components of device 100.
[0090] The device 100 comprises a combination of programmable and
non-programmable circuitry, digital or analog, embedded onto or
coupled to at least one printed circuit board (PCB) 108. The
circuitry includes, but is not limited to: [0091] 1. Signal
generator circuitry 136 to produce the electrical waveforms
provided to channels 139a, 139b. As a failsafe, signal generator
circuitry 136 may be current-limited to prevent oversupply of
current. [0092] 2. An on-board microprocessor system 130, which may
comprise a suitable microcontroller, an Application-Specific
Integrated Circuit (ASIC) and/or Field-Programmable Gate Array
(FPGA). The microprocessor system 130 has access to sufficient
Read-Only Memory (ROM) 131 and Random-Access Memory (RAM) 132 to
facilitate device operation, communication between external
devices, firmware update functions and service/maintenance
functions. Device 100 operates according to control software
(firmware) pre-programmed into the ROM 132 to facilitate operation
and control of the device. [0093] 3. On-board load-testing
circuitry (as part of, or controlled by and responsive to,
microprocessor 130) to check that each and all electrodes are
connected and in proper contact to an electrical load that is
representative of human tissue. [0094] 4. In-built safety features
to prevent or minimise unintended current being delivered to the
patient. This may include (but not be limited to): [0095] a.
Charging circuit isolation via power supply circuitry 134 to
prevent provision of electrical stimulation during a battery charge
operation. [0096] b. Failsafe measures provided by the load-testing
circuitry to prevent the provision of stimulation current from the
device when improper electrical connection is detected, for example
where electrodes are not connected to electrode leads, when
electrode leads are not connected to the device 100, or when
electrodes are incorrectly attached to the device 100 or when the
electrodes are not connected to a human body. [0097] c.
Short-circuit protections to prevent or mitigate delivery of
unintended current to the patient.
[0098] The device software (firmware) and separate computer
software (to be executed by computer system 605) may feature three
modes of access by which three different classes of users can
interact with it. These modes are described below and schematically
illustrated in FIG. 5.
[0099] Patient Mode: The user may operate the device for
therapeutic purposes, but may not modify, change or delete device
functions when interacting with the physical device. An exception
to this is that the user may change device function only with an
authorized software (firmware) update provided by the manufacturer.
This update should be sufficiently tamper-proof to prevent user
errors and device corruption.
[0100] The user may operate the personal computer software to
access informational or help files to learn how to operate the
device 100 or optionally to view usage statistics, for example, but
may not modify, change or delete device functions when interacting
with the device 100 through the personal computer interface 620
(FIG. 6). This user-focussed software may be provided when the
device is purchased, either as a software CD (or other
computer-readable medium) or electronic download from the
manufacturer.
[0101] Clinician Mode: The clinician user may alter the device's
function (in a restricted manner), for example to select different
stimulation settings for device 100 to improve the therapeutic
benefit of the device 100 to the patient by interacting only with
the clinician-user interface module executing on computer system
605. This may include authorized firmware updates as listed in the
section relating to Patient Mode.
[0102] Personal Computer software for use by the clinician may not
be supplied with the device, but instead may only be obtained once
a clinician has registered with the manufacturer and been certified
to make limited function modifications to the device for
therapeutic benefits only.
[0103] Technician/Service Mode: An authorized repair agent or
manufacturer technician/engineer may access the core program of the
device in order to facilitate diagnostics and repair functions.
This mode allows for full/authorized modification to device
function.
[0104] The software/firmware is split into two separate code
modules that interact with each other: [0105] 1. Software
programmed into the device 100 (firmware): [0106] a. The firmware
may be programmed into the device 100 at the time of its
manufacture. The firmware has all three levels of functionality
pre-programmed, but specific functions may only be accessed by
licence holders or authorized persons as specified above. [0107] 2.
Software programmed for use on the computer 605: [0108] a. The
software may only interact with its authorized level, and any
levels that it is authorized to interact with. For example, the
Patient Mode on the device may only interact with the Patient Mode
on the computer software, and the Technician Mode may interact with
both the Patient Mode and Clinician Mode. [0109] b. The software on
the computer 605 facilitates the firmware update in an automated
fashion to minimise complications in the upgrade process.
[0110] This will also provide security verification so that the
device cannot be tampered with through this access method.
[0111] Software and firmware updates may be provided from time to
time by the manufacturer as required.
[0112] The device is intended to be operated in the following
manner: [0113] The user attaches the electrode carrier 20 and
electrode pads 30 (or just the electrode pads 30 if they're not
provided on a carrier 20) to the lower front abdomen and lower back
as shown in FIGS. 1 (child) and 2 (adult). The electrode carrier 20
and/or electrode pads 30 may additionally or alternatively be
attached in the manner shown in FIGS. 8A to 8C, 9A, 9B and 10.
[0114] The electrode leads 32 are connected to all of the electrode
pads 30, and then to the correct sockets 112 on the device 100.
Alternatively, leads 32 may be provided to a patient pre-connected
to pads 30 and/or sockets 112.
[0115] The user then switches on the device 100 using button 122,
in response to which the device 100 performs a back-end function
check to ensure that all systems are normal and that electrodes 30
and electrode leads 32 are connected correctly. During this time,
the LCD 120 may display a short message to the user that the device
is starting up.
[0116] Once the device 100 is ready, the LCD 120 may indicate a
message or signal (e.g. green LED lights up) to inform the user
that stimulation is ready to start. A backlight of the START/STOP
button 124 may light up and flash, and the user can then press the
START/STOP button 124 to commence stimulation.
[0117] During current delivery, a counter or timer function
executed by microprocessor 130 may cause display circuitry 138
coupled to display 120 to indicate the remaining stimulation time.
Should the user wish to terminate current delivery, the user
presses the START/STOP button 124. Pressing the ON/OFF button 122
in the ON state will also terminate current delivery and switch the
device 100 off.
[0118] Once current delivery has ceased, the device 100 may
indicate on the LCD 120 that stimulation for the current treatment
session is complete. Should the user not press the ON/OFF button
122, the device 100 may be configured to automatically switch
itself off after a manufacturer-specified time to prevent
accidental operation and minimise battery consumption. The
microprocessor system 130 may control device 100 to disallow
further administration of stimulation for a period of several (e.g.
up to 24) hours, regardless of whether device 100 is turned off.
For this purpose, microprocessor 130 may comprise a suitable timer
function (with possibly a long-term back-up power supply) that
cannot be disrupted, even with the device 100 being switched off or
the battery 142 being removed or drained. This feature may be
disabled or not present in embodiments of device 100 configured for
use by multiple different users.
[0119] Device 100 may, in alternative embodiments, comprise greater
user interface functionality than is described above, for example
in order to enable a user to select from a number of stimulation
settings, including carrier frequency, modulated frequency, current
intensity, duration of the treatment session, etc. However,
regardless of the user interface functionality of device 100, it
should be operable to provide a stimulation current of magnitude
less than about 40 mA at a carrier frequency of between about 1 kHz
and about 10 kHz, with a modulated frequency of about 20 to about
300 Hz. Preferably, the device 100 is configured to provide
stimulation currents having a magnitude of 33 to 40 mA or less (but
more than zero) at a carrier frequency of about 4 kHz, with a
modulated frequency of about 80 Hz to 150 Hz. The electrical
stimulation may be provided as interferential electrical
stimulation, for example from left front to right back and/or right
front to left back.
[0120] In some embodiments, because the electric current is
delivered transcutaneously to the individual, the amount of
electrical stimulation to be delivered to an individual may vary
from individual to individual based on either Body Mass Index (BMI)
and/or circumference at waist and/or weight. For example, the
optimal energy for electrical stimulation required for a normal
weight child would be less than for an obese child. An algorithm
for determining the electrical stimulation energy required, for
example based on age, BMI, weight, or circumference around the
waist, may be included in the device firmware, together with
operating parameters to allow specific electrical stimulation
parameters to be initially set by the treating clinician or other
medically trained professional.
[0121] One specific dysfunction that some embodiments are
considered suitable for treating is slow transit constipation
(STC). However, described embodiments may be applied to treat
various other waste evacuation dysfunctions, such as other types of
constipation, incontinence, irritable bowel syndrome (IBS) and
ileus, for example. In some embodiments, stimulation device 100 may
be coupled to computer system 605, as shown in FIG. 6. In the
illustrated arrangement, computer system 605 and stimulation device
100 form part of a system 600 for facilitating configuration of
device 100 and/or facilitating communication between stimulation
device 100 and computer system 605 or a network 630 to which
computer system 605 is coupled. Computer system 605 may comprise a
desktop, laptop or handheld computing device having a processor
610, memory 615 and user interface 620. Processor 610 may comprise
more than one processing device and has access to memory 615 which
comprises volatile and non-volatile storage for executing software
functions as described herein. User interface 620 comprises normal
peripheral devices and/or user interface functionality for
facilitating user interaction with computer system 605 and may
include suitable display-related software in addition to the normal
display screen, keyboard, mouse, touch screen and/or stylus,
etc.
[0122] Computer system 605 comprises an input/output port 655 for
communicating via a wired or wireless connection 660 with port 116
of stimulation device 100, thus enabling processor 610 to
reconfigure (to the extent permitted) or otherwise interface with
stimulation device 100. Ports 116 and 655 may adopt a common
configuration, for example according to the universal serial bus
(USB) standard or may have a non-standard proprietary
port/communication configurations. Computer system 605 may be a
computer system used by a patient to interface with stimulation
device 100, for example in order to communicate with (or even power
up using USB power, for example) stimulation device 100.
[0123] Alternatively, computer system 605 may be a computing device
used by a clinician, such as a specialist therapist, to select one
or a few configuration settings stored locally on system 605 or
accessible to system 605 (for example over network 630), from among
multiple possible selections to be used to configure or reconfigure
the stimulation settings of device 100. The software operable on
system 605 in order to effect such reconfiguration of device 100
may be stored in memory 615 and executable by processor 610. Such
software may be downloaded from a remote location over network 630
in response to suitable accreditation or authentication of the
clinician for use of such reconfiguration software.
[0124] As a further alternative, computer system 605 may be a
computer used by a technician or manufacturer to interface with
device 100 as needed, for example in order to provide initial or
default stimulation settings.
[0125] In some embodiments, the electrodes 30 may be positioned in
regions closer to the anus, for example, in an anterior lower
pelvic area and in a posterior sacral or lower lumbar region, as
illustrated in FIGS. 8A and 8B. Such electrode positioning is
believed to assist with treatment of anorectal retention (AR) as
evidenced by the information described in Example 3 below. Other
than the lower positioning of the electrodes 30, such embodiments
use device 100 in combination with conductors 32 and electrodes 30
in the same way as described above.
[0126] As is illustrated in FIGS. 8A to 8C, the lower positioning
of the electrodes 30 is intended to excite or modulate nerves and
tissues around the recto-sigmoid colon to assist in evacuation of
faecal matter accumulating in the large bowel distal of the
proximal colon (i.e. through the descending colon, the sigmoid
colon and the rectum). FIG. 8C illustrates schematically how the
crossing interferential currents are arranged between front left
and back right (X to X) and between front right and back left (Y to
Y).
[0127] The anterior electrodes 30 are positioned between about 1
and about 10 cm laterally apart relative to the vertical centre
line of the umbilicus 11 in a lower pelvic area not extending down
to the genitalia and not extending to the groin. The lateral
separation of the electrodes 30 in some embodiments may be less
than the embodiments described above in relation to FIGS. 1 and 2.
On the posterior side illustrated in FIG. 8B, electrodes 30 may be
approximately placed over the dimples that are commonly visible at
the top inside part of the buttocks, generally corresponding with a
lower lumbar or sacral region overlying or adjacent parts of the
sacrum or ilium. The lateral spacing of the posterior electrodes
may thus be between about 1 cm and about 10 cm, for example.
Optionally, the posterior electrodes 30 may be positioned slightly
higher than the upper extent of the sacrum or ilium so as to reduce
the likelihood of electrical current being directed through the
bones of the sacrum and ilium as interferential current is passed
between the anterior and posterior electrodes 30.
[0128] Some embodiments may employ more than two pairs of
electrodes, such as the four pairs illustrated in FIGS. 9A and 9B.
In such embodiments, the electrode positions illustrated in FIGS.
1, 2, 8A and 8B may be combined, with two electrode pairs 810, 812
laterally and vertically spaced in anterior abdominal (810) and
lower pelvic (812) areas. Additionally, on the posterior side, two
pairs of electrodes 816, 818 are laterally and vertically spaced
relative to the spine. The lower pair of posterior electrodes (818)
may be positioned just above the buttocks on either side of the
spine or in a lower position that overlies an upper inner part of
the buttocks overlying or adjacent the sacrum or ilium. The upper
pair (816) of electrodes 30 may be positioned generally opposite
the corresponding anterior upper pair (810) of electrodes 30 so as
to be located in a para-spinal area on each lateral side of lumbar
vertebrae T9-10 to L2.
[0129] In the embodiments as illustrated in FIGS. 9A and 9B, the
electrodes 30 may be operated in two upper pairs and two lower
pairs to deliver interferential current stimulation in sequence
with one another or simultaneously. In some embodiments, the
interferential current may be applied between opposed upper and
lower electrodes. For example, stimulation current may be applied
between one lower posterior electrode 30 and one diagonally
opposite upper anterior electrode 30 and optionally also one
diagonally opposite lower anterior electrode 30.
[0130] The upper electrode pairs should be located below the costal
margin 802 and generally be positioned to excite or modulate parts
of the ascending, transverse and descending colon 804, while the
lower pairs of electrodes 30 should be generally positioned above
the anus and genitals so as to excite or modulate the rectum and
thereby assist in treatment of anorectal retention. The two upper
and two lower pairs of stimulation electrodes 30 are believed to be
likely to have a combined positive treatment effect for evacuation
dysfunction affecting parts of the large bowel, including the
proximal colon as well as parts of the large bowel distal of the
proximal colon, such as the sigmoid colon 806 and rectum.
[0131] Referring now to FIG. 10, a wearable electrode carrying
structure in the exemplary form of a belt arrangement 910 is
schematically illustrated. The belt 910 carries two pairs of
anterior electrodes 30 and a further two pairs of posterior
electrodes 30 (not shown) to provide TES using interferential
current delivered from device 100 using conductors 32. Conductors
32 are at least partially supported by the belt 910 and are
preferably threaded or passed through at least part of the belt 910
or portions thereof. Belt 910 may comprise carrying means, such as
a pocket, pouch, cradle or attachment mechanism, to support and
carry the device 100 as the patient moves around.
[0132] Although the belt 910 is illustrated as having electrodes 30
positioned to provide TES in the manner described in relation to
FIGS. 9A and 9B, belt 910 may instead carry a single anterior pair
(810/812) and a single posterior pair (816/818) of electrodes for
placement in the regions as illustrated in FIGS. 1, 2, 8A and
8B.
[0133] In further embodiments, the belt 910 may comprise a
selectable array of interior electrode connection positions by
which the electrode 30 is fixed relative to the belt and is in
electrical communication with conductors 32 in any of the array of
positions. In this way, one or more than one pair of electrodes 30
may be provided anteriorly and one or more than one pair of
electrodes 30 can be provided at a selected position or positions
posteriorly according to the desired treatment regime prescribed by
a medical professional. Once suitable positions of the electrodes
30 on the belt 910 are selected by the medical professional, the
patient 10, 60 can simply place the electrodes 30 in the correct
position on their skin for each treatment session by wearing the
belt 910 in the same position with respect to the patient's own
anatomy.
[0134] Belt 910 may be suitably flexible and may be fitted and
removed by suitable coupling means, for example such as a side flap
920 having fastening means 925 thereon, such as hook and loop
fasteners, buttons or clasps. Belt 910 may be formed of one or more
individual or composite layers of flexible (optionally at least
partially stretchable) fabric, including for example leather,
Lycra, Spandex, cotton, nylon, plastic or other suitable fabric, to
provide a wearable garment structure to support the device 100,
conductors 32 and electrodes 30. Belt 910 may be generally fluid
permeable or impermeable. Preferably, belt 910 is made of one or
more machine-washable materials. Belt 910 is preferably sized to be
worn with reasonable comfort underneath normal clothing so that a
patient wearing the belt 910 can perambulate normally while
undergoing the TES.
[0135] In self-administering the treatment prescribed by the
medical professional, each patient may be instructed to follow
particular instructions for care of the electrodes and their
placement in order to maximise effective delivery of the TES.
[0136] Modifications of the described embodiments may be apparent
to those skilled in the art, without departing from the spirit and
scope of the described embodiments. The described embodiments are
therefore intended to be exemplary and non-limiting when considered
in the context of the appended claims.
[0137] Studies involving some described embodiments are described
by the following non-limiting Examples.
Example 1
Daily Transcutaneous Electrical Stimulation Increases Defecation in
Children with Slow-Transit Constipation
Patient Groups
[0138] Halfway through a randomized control trial (Clark et al,
2009 supra) (RCT) testing transcutaneous electrical stimulation
(TES), battery-operated machines became available, thus allowing
home-based stimulation by parents. Eleven children (6M/5F, mean 14
yr, range 12-18 yrs) with slow-transit constipation who completed
the RCT study, but relapsed or without an increase in defecation,
were offered the opportunity to try the machine by a pediatrician
(11.+-.5 months after TES trial). These children all had chronic
constipation and soiling for a minimum of two years prior to the
RCT and had failed to respond significantly to the TES in the
trial, as well as medical treatments such as dietary modifications,
oral and rectal laxatives.
[0139] All eleven children had undergone a radio-nuclear transit
study to show slow-transit in the transverse colon. However, one
child was found to have normal colonic transit and because of that
he was excluded from the TES Trial. He still had the TES treatment
but did not have any improvement, so he was included in this study.
Another child had more severe symptoms requiring an appendix stoma
and his constipation and soiling was managed with antegrade
washouts every 2-3 days (King et al, J. Pediatr. Surg.,
40:1935-1940, 2005).
Stimulation Regime
[0140] Parents of the children were trained to use the
battery-operated interferential stimulating machine (EPM IF 4160,
Fuji Dynamics, Hong Kong) by the trial physiotherapist. Stimulation
was performed and monitored by the parents at home (1 hour daily
for a minimum of 2 months). Interferential treatments delivered a 4
kHz carrier frequency, a beat frequency of 80-150 Hz with an
intensity of <33 mAmp. Two adhesive 3 cm.sup.2 electrodes were
placed on the anterior abdominal wall below the costal margin of
the children and two other electrodes placed on the posterior
abdominal wall between T9 and L2 on either side. The current from
the electrodes was crossed diagonally from front to back to ensure
that the stimulation current from each electrode crossed over
within the abdomen of the child.
Outcome Measures
[0141] The number of spontaneous and "sit" defecations, number of
antegrade enema washouts or medication and number of incidents of
soiling were recorded daily in a specially designed continence
diary. The daily diary was kept one month prior and for two months
during electrical stimulation. The (a) frequency of defecation, (b)
frequency of soiling and (c) frequency of episodes of abdominal
pain per month were compared using ANOVA with post-test analysis
and paired t-tests (two tailed). P values <0.05 were considered
statistically significant.
Results
[0142] FIG. 7 is a graphical representation showing: [0143] A)
Total number of defecations/week, [0144] B) Number of days with
soiling, and [0145] C) Number of days with abdominal pain.
[0146] Daily diaries were assessed for 1 month before stimulation
(Pre Rx), and during the first month (Rx 1) and second month (Rx 2)
of stimulation performed daily at home. Statistically analysis by
paired t-test.
[0147] There were no adverse events or complaints of discomfort
reported from the children. All patients tolerated home stimulation
well.
a) Defecation
[0148] From Table 1, defecation increased in nine out of eleven
children. There was a significant increase (p=0.008) in total
defecation per week (mean.+-.SD, 2.5.+-.2.1 vs 6.7.+-.4.4) (FIG.
7A). Five of the eleven patients had less than three
defecations/week in the baseline period and all of them had normal
episodes of defecation (>3/week) during stimulation. Six
children had an increase in spontaneous defecation (Table 1) and
three experienced increase in defecation during trained sits on the
toilet. One child had no increase in total defecation but there was
a marked increase in spontaneous defecation i.e. changes from timed
sits to spontaneous defecation (urge to defecate followed by the
child performing controlled defecation in the toilet).
b) Soiling
[0149] There was a qualitative decrease in four out of eleven
children, however this was not statistically significant
(3.8.+-.1.6 vs 1.1.+-.0.5 episodes/week) (p=0.1) (FIG. 7B). In the
baseline period, soiling was frequent in 3/11 children (Table 1).
This was reduced to low episodes during stimulation in all of the
three children. The patient with an appendix stoma had his soiling
managed by antegrade enemas and therefore recorded no soiling.
c) Pain
[0150] Daily stimulation did not affect abdominal pain (0.97.+-.1.8
vs 1.03.+-.2.0 episodes/week, p=0.7) (FIG. 7C).
[0151] This study found that the use of a battery-operated,
portable machine was safe to deliver interferential TES in the home
environment. Moreover, daily stimulation of one hour per session
for .gtoreq.1 month caused a significant increase in total episodes
of defecation/week, with no adverse effects. Importantly, this
improvement in bowel function occurred in patients who had had only
marginal or temporary improvement following stimulation three times
per week in our recently conducted randomized controlled trial
(Clark et al, J. Pediatr. Surg., 43:320-324, 2008).
[0152] In the formal trial, the TES was given for 20 minutes in
each treatment session, three times per week, so that the total
duration of therapy was one hour per week. When the trial was
designed, the optimal parameters (if any) were unknown, and hence
were selected on arbitrary criteria. Having demonstrated a
statistical improvement in transit times (Clark et al, 2009 supra),
24-hour colonic manometry (King et al, Am. J. Gastroenterol.,
103:2083-2091, 2008), and quality of life (Clark et al, 2008 supra)
in the trial, the current study aimed to find out whether more
frequent TES treatment might further improve function.
[0153] Daily TES at home enabled the children in this pilot study
to receive 7 hours of treatment per week (compared to 1 hour per
week in the formal trial), which improved their overall bowel
function in frequency of defecation. Interestingly, this was one of
the few parameters which was not improved in the randomized
placebo-controlled trial, despite increased colonic transit and
peristaltic activity. The reason for this difference is unknown but
it may be that TES three times per week caused increased proximal
colonic transit, but without altering rectal evacuation. The
children then needed to learn how to defecate normally to take
advantage of this increased proximal colonic contractility. In this
pilot study, improved defecation may have occurred because more
time had passed since the trial and the patients were better able
to learn how to empty their colon under conscious control. Another
possibility is that the increased time length and frequency of
treatment from 1 hour to 7 hours per week provided a much more
substantial stimulus to colonic function, enabling not only more
rapid proximal transit but also more effective evacuation.
[0154] There was concern that the electrical stimulation might
increase soiling but this did not occur. Daily stimulation showed a
qualitative reduction in frequency of soiling but this was not
statistically significant. Although more patients need to be
tested, it is considered that this qualitative improvement is
likely to be important. The frequency of abdominal pains, assumed
to be caused by colonic peristalsis, was also measured and this is
unchanged by the daily TES.
[0155] TES has only been tested in very limited studies in
children, outside the controlled trial described herein, so its
place in the armamentarium of constipation therapies is unknown.
The initial pilot study with TES used sophisticated machines
connected to the power grid and operated by a licensed
physiotherapist (Chase et al, J. Gastroenterol. Hepatol.,
20:1054-1061, 2005). This study extends that and shows that a
simpler machine with a 9-volt rechargeable battery is adequate to
provide the requisite stimulation, and may even provide superior
effects on the bowel.
[0156] The RCT showed that TES is significantly more effective than
a placebo. Hence, an increased duration and frequency of TES
treatment times is an advantage.
[0157] In the cohort of children being treated for slow transit
constipation by transcutaneous electrical stimulation using the
battery-operated interferential stimulating device (EPM IF 4160,
Fuji Dynamics, Hong Kong), it was found during patient follow-up
that there were some treatment efficacy problems arising from
misuse or improper use of the device. The Fuji Dynamics device has
a relatively large number of buttons to push and many stimulation
settings and options to choose from.
[0158] In one case, the parent was confused by which buttons to
push to get the proper settings for the treatment (needing 6
buttons to be pushed). This parent was also illiterate and the
written instructions for use were essentially useless, leading to a
hands-on demonstration of use of the device being needed in order
to make sure the parent was getting the stimulation settings right.
It was also found that the patient or the parent would commonly
forget to set the buttons to achieve the essential settings for
treatment. In one instance, a patient had gone through the
treatment period without setting the stimulation frequency,
resulting in inadequate stimulation being applied and the patient
not experiencing any improvement in symptoms.
[0159] In younger children, it has been found that they tend to
play with the buttons of the device. The Fuji Dynamics device used
in the trial did not have any locking features to prevent
inappropriate user modification of the device settings. One child
experienced shooting pain in both legs after changing the
stimulation settings on the device.
Example 2
TES Treatment Long Term Benefits
[0160] In a follow-up study of patients that have previously been
enrolled in a TES trial it was noted that there was continued
improvement in patients after the time of usage of TES.
[0161] There are total of 105 patients which have been included
into the transcutaneous electrical stimulation (interferential)
therapy (Table 2). They comprise of 66 male patients and 39 female
patients. The age ranges of these patients are 6-18 years, with the
mean age of 11.5 years. All these patients have been selected for
the treatment after being diagnosed with slow transit constipation
using nuclear transit study. There are different phases of
development of the transcutaneous electrical stimulation, from TIC
TOC to TENS trial and the home stimulation therapy. All patients
were required to fill out the continence diaries and PedsQL
questionnaires appropriate to age upon enrolment into the trial and
as the scheme for follow-up during and after treatment.
[0162] In the TIC TOC trial, at 6 months follow-up, out of the 39
patients with data analysed at the completion of the trial, 20
patients responded to the questionnaires survey. Sixteen out of 20
patients have .gtoreq.3 episodes of defecations per week at 6
months after treatment. At 12 months follow-up, 13 responded to the
questionnaire survey. Eleven out of 13 patients have .gtoreq.3
episodes of defecations per week. As for soiling, at 6 months
follow-up, 14 out of 23 respondents have no soiling. At 12 months
follow-up, 6 out of 11 respondents have no soiling. There was
overall improvement in patients with slow-transit constipation
treated by transcutaneous interferential therapy.
[0163] In the latest home stimulation therapy, one patient has
complete resolution of abdominal pain, twofold increase in
defecation, and 3.7-fold improvement of soiling at one month
follow-up.
[0164] The described stimulation regimes in Examples 1, 2 and 3
have been used without also directly stimulating the pelvic floor
or area around the perineum or perianum.
Example 3
[0165] There are 4 children currently using the Anorectal retention
(AR) protocol to treat their chronic constipation, the results of
which are shown in Table 3. The position of the electrodes 30 is
shown and described above in relation to FIGS. 8A to 8C. The
stipulated TES treatment regime and settings were the same as the
other Examples, including the treatments being for about 60 minutes
each day over a period of several weeks or months.
TABLE-US-00001 TABLE 3 Children with chronic constipation using AR
protocol. Clinical diagnosis of Elecrode chronic positions Current
status Gender Age constipation used (25 Feb. 2011) 1 Male 9
Slow-transit STC protocol, Clinically constipation developed AR
improved after (STC) (palpable 6 months and faecaloma) 6 remained
well months later. (phone inter- AR protocol view done used. 22
Feb. 2011). No more faecaloma. 2 Male 4 STC STC protocol Feeling
for 6 months. stronger urge Repeat transit at bottom study showed
with reduced AR. Started laxative used AR protocol (phone inter-
December view done on 2010. 22 Feb. 2011) 3 Male 6 STC + Anorectal
Used STC Clinically retention (AR) protocol for 4 improved with
months before more regular switched over bowel actions. to AR
protocol. Remained same (phone inter- view done on 22 Feb. 2011). 4
Female 6 AR Palpable Still awaiting faecaloma. phone reply Started
on AR from parent. protocol on 17 Sep. 2010.
[0166] As these preliminary data in Table 3 indicate, TES treatment
using interferential current applied at lower pelvic and sacral
regions is effective to treat evacuation dysfunction in the
recto-sigmoid colon. This has been shown to be effective as a
procedure performed after treatment at higher electrode positions
for STC. The indication is that this lower electrode positioning
can be used as a supplemental or independent procedure to the
higher electrode positioning. If the treatment procedure with the
lower electrodes is supplemental to the treatment with higher
electrodes, it may be performed either simultaneously or in
sequence.
[0167] Those skilled in the art will appreciate that the invention
described herein is susceptible to variations and modifications
other than those specifically described. It is to be understood
that the invention includes all such variations and modifications.
The invention also includes all of the steps, features,
compositions and compounds referred to or indicated in this
specification, individually or collectively, and any and all
combinations of any two or more of said steps or features.
TABLE-US-00002 TABLE 1 Days with Days with Appendix Transit
Defecation/week soiling/week pain/week Sex Stoma Study Before IFT 1
IFT 2 Change Before IFT 1 IFT 2 Before IFT 1 IFT 2 With slow
transit and no appendix stoma F No Slow 0 12 14 1/2 sits &
spontaneous 0 3 0 0 1 0 F No Slow 0 4 ND .uparw. sits 0 1 ND 3 0 ND
F No Slow 1 3 ND .uparw. spontaneous 6 1 ND 5 5 ND F No Slow 3 11
11 .uparw. sits 7 3 3 0 1 1 F No Slow 7 10 12 .uparw. spontaneous 2
0 0 0 2 0 M No Slow 1 4 3 .uparw. spontaneous 0 0 0 1 3 4 M No Slow
2 6 6 .uparw. spontaneous 3 5 3 0 1 1 M No Slow 3 2 4 .uparw.
spontaneous 0 0 0 0 0 0 M No Slow 4 2 3 1/2 sits & spontaneous
4 4 3 0 2 1 With appendix stoma M Yes Slow 3 5 9 .uparw.
spontaneous 0 0 0 0 0 0 With Normal Transit M No Normal 4 12 ND
.uparw. sits 7 2 ND 2 0 ND ND: No Data
TABLE-US-00003 TABLE 2 TIC TOC Started with 60 patients; 39
patients available for analysis and on follow-up. Follow-up periods
of 1 year to 2 years. 21 patients were excluded from study. GENDER
NUMBER (N) MALE 21 FEMALE 18 AGE RANGES FROM 7-18 YEARS, MEAN AGE
OF 11.8 YEARS (OF THE 39 PATIENTS INCLUDED IN THE FINAL ANALYSIS).
GENDER NUMBER (N) MALE 39 FEMALE 21 AGE RANGES FROM 6-18 YEARS,
MEAN AGE OF 12.3 YEARS (OF THE 60 PATIENTS AT THE BEGINNING OF THE
STUDY) TENS GENDER NUMBER (N) MALE 5 FEMALE 5 AGE RANGES FROM 5-16
YEARS, MEAN AGE OF 9.3 YEARS. FOLLOW-UP OF PATIENTS FROM 6 MONTHS
TO 1 YEAR 1.sup.ST HOME STIMULATION THERAPY GENDER NUMBER (N) MALE
6 FEMALE 5 AGE RANGES FROM 9-15 YEARS, MEAN AGE OF 12 YEARS.
FOLLOW-UP OF PATIENTS FROM 6 MONTHS TO 1 YEAR. 2.sup.ND HOME
STIMULATION THERAPY GENDER NUMBER (N) MALE 16 FEMALE 8 AGE RANGES
FROM 4-16 YEARS. MEAN AGE OF 10.3 YEARS FOLLOW UP OF PATIENTS FROM
0-5 MONTHS.
BIBLIOGRAPHY
[0168] Benninga et al, J Pediatr Gastroenterol Nutr., 23:241-51,
1996 [0169] Chase et al, J. Gastroenterol. Hepatol., 20:1054-1061,
2005 [0170] Clark et al, J. Pediatr. Surg., 43:320-324, 2008 [0171]
Clark et al, J. Pediatr. Surg., 44:408-412, 2009 [0172] Hutson et
al, J Pediatr Surg., 31:580-583, 1996 [0173] King et al, J.
Pediatr. Surg., 40:1935-1940, 2005 [0174] King et al, Am. J.
Gastroenterol., 103:2083-2091, 2008 [0175] Shin et al, J Pediatr
Surg., 37:1762-1765, 2002
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