CA2187282A1

CA2187282A1 - Electrical treatment apparatus

Info

Publication number: CA2187282A1
Application number: CA 2187282
Authority: CA
Inventors: Malcolm Stanley Marks; Ian Gregson
Original assignee: Individual
Current assignee: Dmi Medical Ltd
Priority date: 1994-04-05
Filing date: 1995-04-04
Publication date: 1995-10-12
Also published as: WO1995026780A1; GB9406700D0; AU2111995A; EP0754076A1; JPH09510902A

Abstract

An electrode assembly for use in muscle stimulation eg. by insertion into a vagina or rectum comprises an electrically non-co support (11a) which can be inserted into portion (61) of flexible bag (60) having helical electric contacts (63,64), a non-conducting sheet (62) and connectable by leads (55,56) to a control unit for supplying electric pulses in accordance with a treatment programme. The helical disposition of electrodes generally avoids ineffective positioning of the device.

Description

2~ ~72~2 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.

W0 95/26~80 ~ r~ 768 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 wo 9512678~) ~ P~~
~ 3 ~ 2187282 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 W0 95/26780 . ~ ~ o8 _ 4 _ 2~87282 -,. .
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 .

w0 ss/267so P~ l ~ ~,~ /o8 ~ - 5 ~ 2 1 ~7282 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 Wo 95/26780 ~ ~ . Q ~ 768 .

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.

-WO 9S/26780 - , 2 ~ ~ 7 2 8 2 , ~1 ~ s ~Oli 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.

W0 95/26780 ` ` ~ 2 f ~ /68 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.

.... _ . , .. . , . , , _, ..

WO9S126780 21 ~12~2 r~ ,x g 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 _ . , .
-.

Claims

- 10 -

1. An electrode assembly for use in muscular stimulation shaped for insertion in a body orifice and having an axis and comprising two spaced electrodes (21, 22; 63, 64), in an external surface, each electrode (21, 22; 63, 64) extending both axially and circumferentially characterised in that the electrodes (21, 22; 63, 64) are formed on a flexible sheet (19; 60) mounted on a support (14;
11a) for the flexible sheet (19, 60).

2. An electrode assembly as claimed in Claim 1, characterised in that the flexible sheet (60) carries electrical contacts (66) outwards of the support (11a) for location exterior to the body orifice for connection to supply leads.

3. An electrode assembly as claimed in Claim 1 or Claim 2, characterised in that the sheet (60) is separate from the support (11a) and is closed at an inner end.

4. An electrode assembly as claimed in any preceding claim, characterised in that an outer portion (62) of the flexible sheet (60) is disposed to limit insertion into the body orifice.

5. An electrode device for use in an assembly as claimed in any preceding claim comprising a flexible sheet (19, 60) carrying two spaced external electrodes (21, 22, 63, 64), each electrode (21, 22; 63, 64) extending both axially and circumferentially.

6. An electrode device as claimed in Claim 5, in which the flexible sheet (60) is closed at an inner end and carries electrical contacts (66) for location exterior to the body orifice for connection to supply leads.

7. An electrode device as claimed in Claim 5 or Claim 6, characterised in that an outer portion (62) of the flexible sheet (60) is shaped to limit insertion into the body orifice.