Note: Descriptions are shown in the official language in which they were submitted.
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EIECIP~ICAL TREATM~T APPARATUS
THIS INVENTION relates to electrical treatment
apparatus.
WO-92/14ilO discloses an electrode assembly for use in
muscular Stim~ tinn shaped for insertion in a body orifice and having
an axis and ~U~ illg two spaced electrodes on an external surface,
each electrode extending both axially and circumferentially.
According to this invention, an electrode assembly for
use in muscular stim~ tinn shaped for insertion in a body orifice and
having an axis comprises two spaced electrodes in an external surface,
each electrode extending both axially and circumferentially
~ IIGIC~ l ised in that the electrodes are formed on a flexible sheet
mounted on a support for the flexible sheet.
The flexible sheet may carry electrical contacts outwards of
the support for location exterior to the body orifice for l~nnn~rtinn to
supply leads.
The sheet may be separate from the support and be
closed at an inner end.
An outer portion of the flexible sheet may be disposed to
limit insertion into the body orifice.
The invention includes an electrode device for use in an
assembly as above and comprising a flexible sheet carrying two spaced
external electrodes, each electrode extending both axially and
circumferentially.
The flexible sheet may be closed at an inner end and
carries electrical contacts for location exterior to the body orifice for
rnnn~ctinn to supply leads.
An outer portion of the flexible sheet may be shaped to
limit insertion into the body orifice.
~IIC.
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The invention may be performed in various ways and
some specific embodiments with possible modifications will now be
described by way of example only with reference to the ac.,u..lp~l..,i..g
drawings, in which:
Fig. I is a perspective view of a vaginal electrode
assembly;
Fig. 2 is a view of Fig. 1 with part folded open;
Fig. 3 is a p~-:,ye~ive view of a modification;
Fig. 4 is a pe~ye~Liv~ view of another elecuode;
Fig. S is an end view of Fig. 4;
Fig. 6 is a view of dissembled parts of a further
elecuode of Fig. 6;
Fig. 7 is a view of the assembled electrode of Fig. 6;
Figs. 8, 9, 10 show use of the electrode;
Fig. I l shows a conuol unit;
and Figs 12-~4 show another ~ .lL.
It is kno~vn to treat conditions of stress inrnntin,~nee,
detrussor instability and anorectal problems such as anorectal
i""~ n. ~ by ~ u-llu,~,~lar qtTmll17tTon
A clearer understanding of the normal mP~ h7nisnn of
conuol which exisu between nerves and muscle makes it possible to
take over control of muscle mPt~hnlicm by the ~Iyy.~ylia~c: 7rplTr7t~nn
of precise electronic signals. It has been shown that nerves control
muscle by transmitting a neuroiogical code. This code occurs in two
frequency bands according to the type of muscle fibre required.
Postural fibres require a tonic feeding at the rate of 10 pulses per
second. If given for periods of one hour or more per day, it is
possible to maintain all their essential ~ ,L~i~Lics. This treatment
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far muscles can act as a life support system until normal function
can be resumed. Muscles treated in this way are able to preserve
bulk, capillary bed density, and their essential ability to utilise
oxygen.
The second frequency band occurs at 30pps, and feeds
information to the fast contracting muscle fibres which giYe power to
8 movement. This feeding occurs naturally in a phasic way, and
therefore treatment protocols to promote these fibres are given for
shorter periods of time.
This physiological approach to l~u-u~-u,. ular Stim~ tion
also requires pulses, which are shaped like the naturally occurring
nerve signals and have very brief pulse widths. By mimi~kin~ nature
as accurately as possible, electricai Stiml~i~tinn has been used for
prolonged periods, when required, without causing any side effects.
N~u. u...ua~ular stim~ tifln may be used in patients with
anûrectal incontinence to increase the postural tone of the pelvic
floor ml~Cc--1~1t~1re and to strengthen the internal and external anal
sphincter. The use of an internal electrode also increases sensory
awareness of rectal distension, thus helping the patient to
differentiate between flatus, liquid and solid stool. Reflex activity
increases the colonic shuttle reflex and leads to the formation of
601id stool form; most oi these patients are only i"~ of liquid
or soft form stool.
In genuine stress incontinence slight leakage of urine
occurs on coughing, laughing, sneezing etc. The volume of urine
leaked is less than a t~a,uoul,iul and is not associated with detrussor
instability. The pelvic floor muscles have lost postural tone and the
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fast twitch fibres, although present, are not In a suitable position
effectively to reinforce the sphincter Cu.lLI.lCLiull during sudden rises
in intra-abdominal pressure.
The electrodes are placed in the vagina or rectum and
eiectrical pulses are supplied from a control unit in accu~ with a
treatment ,u. u~- Gl.l--.e.
For example treatment programme I may be of I hour
per day for 12 weeics, the u~u~;l~llllle I being puises of 2ûO~lS width, 2
seconds on 2 seconds ûff at a frequency of 10 pulses per second.
This can be succeeded by treatment programme 11 in
which the muscles are voluntarily contracted by the patient during
stim~ tinn from the electrodes. For example treatment programme 11
may be for I minute per day rising to 10 minutes per day with a
pulse width of 2ûOIlS, for 4 seconds on 4 seconds off at a frequency
of 35 pulses per second.
Other treatment l~u~ es are Fossible as advised.
The present invention provides an electrode device for
use in n~ul u",u:,~ular Stim~ tinn
Referring to Figs. 1, 2, an electrode assembly 10
comprises an electrically insulating and medically inert substrate or
support 11 which carries an electrode portion 12 in the form of a
heiix.
_, _
The substrate 11 may for example be of foamed
polystyrene, so-called pod grade, and is thus light in weight.
Although not rigid, the substrate or support 11 is effectively of fixed
shape with no tendency to expand.
The substrate 11 has a domed inner end 13, a tapered
body 14, and a locating enlarged outer end 15, the portions 13, 15
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providing opposed shoulders 13a, 15a.
An axial recess 16 in the substrste receives electric
cul~duuLulo 17, 18 respectively connected to flat con(~lr~ine elements
17a, 18a.
An electrically insuiating Oheet 19, for exampie of thin
flexible piastics-coated cardboard, is cut to~size and In its outer
surface 20 has secured by adhesive two strip ci~ LIudes 21, 22 which
are generally helically wound and include inner parts 21a, which, when
the sheet 19 is wrapped round the body 14, leOpecLively contact
elements 17a, 18a so that electrodes 21, 22 can receive electrical
pulses from a controi device 23 Fig. 9 which can be operated by a
user. The radially inner surface of the sheet 19 can be adhered to
the body 14. The shoulders 13a, 15a help to locate the sheet lg.
The ele~ LIudci 21, 22 may for example be of Plllmini~rn It wi~l be
understood that a user may in some cases carry the control unit 23
about with them. Programme I may be used to treat detrussor
instability.
The assembly 10 in use is inserted intû the vagina 30
Figs. 8, 10. Indicated are bladder 31, urethra 32, coccyx 33, uterus
34, pelvic floor or levator ani muscies 35, rectum 36.
The enlarged outer end 15 enables shoulder 15a to locate
the assembly 10 by ~ ( with the body ad)acent the entrance
to the vagina 30. The-electrodes 21, 22 cbntact the vaginal wall
surface.
The (liqroqitlon of electrodes 21, 22 on body 14 is such
that each electrode 21, 22 is present at each axial position of the
body 14 i--~"e Li~ of the axial or rotational position of the body 14
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Into the vagina.
The end portions ~3, IS can take different shapes (Flgs.
3, 4, 5) and body 14 can be of uniform cross-section (Fig. 4).
In Figs. 6, 7 the assembly 10 is formed e.g. by casting
two parts 40, 41 with grooves 42, for receipt of ~ u..lu. Lul~ 17, 18,
and projections 43 and recesses 44 which can co-operate with a snap
action when the parts are brought together Fig. 7.
The assembly 10 can be used for muscle 51;,...1 11.~ ~ also
in the rectum, see Fig. 9.
The piug or assembly 10 is fitted with a small flange 15
which ensures that the treatment areas of the cle~ ~-u~ sre placed
- on the relevant levator ani muscles.
The helical winding of electrodes 21, 22 gives even
charge density in any position. However, the flange also ensures
u~ L~Iu~.
The light bright nature of the plug in addition to the
above design features enables the woman to walk around and generally
take part in most day to day activities whilst receiving treatment.
Pulsed electric supply to the electrodes 21, 22 can be
from control unit 23 Fig. Il which may be battery driven, with on/off
switch 50, LED 51 to indicate "on", a switch 52 to seiect ,U~U~
I or 11; manually operable buttons 53, 54 to increase or decrease the
~mrijt~lril~ or intensity of the pulses, and output leads 55, 56 for
removable att~ hment respectively to ends of fly leads 17, 18
themselves l~~ LIV~ly secured at their other ends to the clc. L-uiics
17a, 18a. The fly leads 17, 18 can be secured to the electrodes
during or after S~-,UI~ of the electrodes to the blank 19.
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After a single use, the device 10 can be disposed of, or
it can be re-used. The substrate is electrically non-cu,~du- ~iv~:.
Figs. 12, 13, 14 illustrate another ~ lIL in which
the substrate lla is a plastics support e.g. blow moulded, generally
cylindrical with a rounded end llb. The cle~ ~-udes are formed on a
separate flexible sheath 60 of electrically insulating material e.g.
cellulose or polypropylene. The sheath 60 is in the form of a
cûntainer having a~ generally projecting tubular portion 61 and a flared
pûrtlon 62. In use Fig. 14, the support lla fills and thus stiffens the
portion 61 into s~hst~n~ ly a cylinder and the flared portion 62
sssists (Fig. 14~ in locating the device 10 axially. As can be seen in
Flg. 14, the end of support lla can be f~ared to assist in correct
axial pncitinnin~
The electrodes 63, 64 are formed as coatings on the
sheath 60 e.g. by sputterlng and in part receive an outer electrlcally
insulating coating 65 leaving a contact area 66 which can be engaged
by clips 67 at the ends of leads 55, 56. The electrodes are generally
helical in use in portion 61.
The support can be used with a s ~ -~in~ of sheaths 60
which are disposed of after use.
It will be observed that each of the electrodes (one
anode, one cathode) is present Ll--uu~lluuL the length of the body 14,
61 and effective muscle stimulation is thus obtained sllh5t~nti:l11y
ill~ue~ LIv~ of variation in axial pûsition of the muscle 35 in relation
to the body 14, 61 which results from vaginas of different size, and
any need for rotational ~jllctmPnt is partly or wholly removed having
regard to the fact that muscle damage may be at any place around
the vagina or rectum wall.
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Preferably each electrode 21, 22; 63, 64 extends
circumferentially sI-hct~nti~lly 180 to give a total of ~ ly 360
as vlewed axially, but effective a~ can have a greater or
lesser circumferential extent.
Preferably the electrodes are uniform helices of equal
width and of equal width to the angular helical gaps between the
electrodes, as shown in Figs. I, 7 so that a maximum area of muscle
is 5tim~ t~ preferably all the 51,11~UUl~dill~ wall.
The vaginal and rectum wall . ..`.'.~ has angularly
spaced pudendal nerve networks whose positions can vary, possibly
positioned on the left and right side of the orifice. The nerve
networks are both motor and sensory. The circumferentially extend~ng
e~ectrodes make it more likely that one or both nerve networks are
5tim~lRtPi wlthout rotary .~ g of the device.
It will be understood that an electrode extending
circumferentially contacts, and thus stim~IRtPs a greater area of
muscle than an axial electrode of equal width for a given axial
dlstance, and th,e greater area permits a lesser, and therefore more
confortable, charge density for a given power input; and the helical
configuration enables stim~ t~on of a greater amount of axially
extending muscles and circumferentially extending muscles because the
~IcL.L..,des and the gaps between have both axial and circumferential
, at each axial position.
This is in contrast to an arrangement having a non-
ccnductive support carrying two axially spsced annular cor.du~ L
rings or an a11a11".~ L having a non-cu..du..~l~. support carrying two
axially extending parallel ~ ùl~du~,Lu~ which sre sngularly spaced.
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The vaginal or rectal orifice can change in cross-section
wlth the posture of the individual and the circumferential
conflguration of electrodes and gaps reduces the possibility of a
change in cross-section reducing the amount of muscle stim~ tinn
whlch would occur if the electrodes lost contact with the orifice
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